Aalberg, K., et al. (2021). "Effect of oral and transdermal oestrogen therapy on bone mineral density in functional hypothalamic amenorrhoea: A systematic review and meta-analysis." BMJ Open Sport and Exercise Medicine 7(3): e001112.
	Background Female athletes might develop reduced bone mineral density (BMD) and amenorrhoea due to low energy intake. Objective To systematically review the literature of randomised controlled trials (RCTs) assessing the effect of oestrogen oral contraceptives (OCP), conjugated oestrogens (CE) and transdermal estradiol (TE) on BMD in premenopausal women with functional hypothalamic amenorrhoea (FHA) due to weight loss, vigorous exercise and/or stress. Methods A comprehensive literature search in PubMed, MEDLINE, Cochrane Library, Ovid and CINAHL from inception to 1 October 2020. Data extraction and synthesis Two authors independently extracted data. When possible, the data were pooled in a random-effects meta-analysis. Main outcomes Difference in BMD (g/cm 2) at the lumbar spine. Results Nine RCTs comprising 770 participants met the inclusion criteria; five studies applied OCP, two CE and two TE. Four RCTs (two OCP, two TE) found an increased BMD in premenopausal women with FHA, and five (three OCP, two CE) found a decreased BMD compared with controls. A meta-analysis showed no difference in BMD between the treatment and control groups, (standardised mean difference (SMD) 0.30, 95% CI -0.12 to 0.73). A secondary analysis for change scores from baseline to first assessment point, showed a similar overall result (SMD 0.17, 95% CI -0.16 to 0.51). No serious adverse events were reported. Conclusion The literature suggests that TE might increase lumbar BMD in premenopausal women with FHA, but pooled results revealed no effect of the intervention. The findings do not support oestrogen therapy to improve BMD in these patient groups.Copyright © 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.

Aarti, L., et al. (2022). "Psychological interventions for depression/anxiety/fear of recurrence in women with ovarian cancer: A Systematic Review." PROSPERO International prospective register of systematic reviews.
	
Abbas Ahmed, M., et al. (2020). "The role of levonorgestrel intra-uterine system in the management of adenomyosis: A systematic review and meta-analysis of prospective studies." Acta Obstetricia et Gynecologica Scandinavica 99(5): 571-581.
	Introduction: The levonorgestrel intrauterine system (LNG-IUS) is a long-acting hormone-releasing uterine device that has many non-contraceptive benefits. The study aims to assess the safety and efficacy of LNG-IUS in the management of adenomyosis.; Material and Methods: We searched the following bibliographic databases: MEDLINE via PubMed, SCOPUS, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE and Google Scholar for the relevant studies which used LNG-IUS in management of patients with clinically or ultrasonographic diagnosed adenomyosis.The main outcome measures are pain score at the end of follow-up, bleeding, symptomatic relief, uterine volume (mL), endometrial thickness (mm) and/or hemoglobin level.; Results: Ten prospective studies (patients n = 551) were included. The overall effect estimates showed that the LNG-IUS led to significant reductions in pain score after 12 months (standardized mean difference [SMD[ -3.87, 95% confidence interval [CI] -5.51 to -2.23, P < .001), 24 months (SMD -5.56, 95% CI -9.80 to -1.32, P = .01) and 36 months of insertion (SMD -3.81, 95% CI -4.27 to -3.36, P < .001). Similarly, the Pictorial Blood Assessment Chart (PBAC) showed significant reduction up to 36 months after LNG-IUS insertion (SMD -2.32, 95% CI -2.91 to -1.73, P < .001). The LNG-IUS led to significant reductions in the uterine volume 12 months (SMD -.60, 95% CI -0.88 to -.31, P < .001) and 36 months after insertion (SMD -0.42, 95% CI -0.69 to -0.14, P = .003).; Conclusions: LNG-IUS is a promising and effective option for the management of adenomyosis. Its use effectively reduced the severity of symptoms, uterine volume and endometrial thickness, and improved laboratory outcomes. (© 2019 Nordic Federation of Societies of Obstetrics and Gynecology.)

AbbVie (2022). "Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer (GLORIOSA)." ClinicalTrials.gov.
	Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell‐killing drug to the tumor cells carrying a tumor‐associated protein called folate receptor alpha (FRα). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum‐sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor‐alpha expression. Patients must have confirmation of FRα positivity by the Ventana FOLR1 Assay. .

AbbVie (2022). "Study of BOTOX Injections to Assess Change in Disease Activity and Adverse Events in Adult Female Participants With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)." ClinicalTrials.gov.
	No Results Available Drug: BOTOX|Drug: Placebo for BOTOX Change in Average Daily Worst Bladder Pain|Change in the Average Number of Micturition Episodes per 24-hour Period|Change in the Average Number of Urgency Episodes per 24-hour Period|Change in the Average Number of Nocturia Episodes per 24-hour Period Female Phase 2 80 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment M21-459 February 4, 2025

Abd El Aziz, M. A., et al. (2019). "Secnidazole for treatment of bacterial vaginosis: a systematic review." BMC Women's Health 19(1): 121.
	Background: Bacterial vaginosis (BV) is one of the common vaginal infections among childbearing women. The usual treatment for BV is metronidazole; hence 30% of women have recurrence within 60 to 90 days after treatment. There are some studies which assessed the effect of secnidazole on BV. The aim of this systematic review was to investigate the effectiveness of secnidazole for treatment of BV.; Methods: The Cochrane Library, MEDLINE (PubMed), Scopus, and Web of Science (all databases from inception till October 28, 2018) were searched. Primary outcomes were clinical cure rate and microbiologic cure rate and the secondary outcomes were adverse events. Data was extracted from eligible studies by two review authors individually and analyzed by RevMan 5.3.; Results: Our search found six trials involving 1528 participants. Treatment with 2 g secnidazole could significantly reduce the risk of BV in patients with three or less episodes of BV in the last year by OR: 7.54 (95% CI, 3.89-14.60, p < 0.00001) and in patients with four or more episodes of BV in the last year (OR: 4.74, 95% CI: 1.51-14.84, p = 0.0.008). Secnidazole (2 g) could significantly increase the microbiologic cure rate in women with 3 or less episodes of BV in the last year (OR: 7.63, 95% CI: 2.30-25.33, p = 0.0009) but not in the women with 4 or more episodes of BV in the last year (OR: 20.17, 95% CI: 1.06-382.45, p = 0.05). The clinical cure rate, microbiological effect and the therapeutic cure rate of 2 g secnidazole was significantly more than that of 1 g secnidazole. The results showed that the clinical cure rate of 2 g secnidazole was not different from the following medications: metronidazole (500 mg bid for 5 days), secnidazole plus vaginal metronidazole, 2 g single dose of oral metronidazole and 2 g secnidazole plus vaginal ornidazole.; Conclusion: This review showed that 2 g and 1 g secnidazole were better than placebo, however, 2 g secnidazole was more effective than 1 g. Secnidazole 2 g was not different from metronidazole (500 mg bid for 5 days), or from secnidazole plus vaginal metronidazole, or 2 g single dose of oral metronidazole or from 2 g secnidazole plus vaginal ornidazole.

Abdalla Mohammed, A., et al. (2022). "Effect of pharmacological interventions on lipid profiles and C-reactive protein in polycystic ovary syndrome: A systematic review and meta-analysis." Clinical Endocrinology 96(4): 443-459.
	Context: Polycystic ovary syndrome (PCOS) is a heterogeneous condition affecting women of reproductive age. It is associated with dyslipidaemia and elevated plasma C-reactive protein (CRP), which increase the risks of cardiovascular disease (CVD).; Objective: To review the existing evidence on the effects of different pharmacological interventions on lipid profiles and CRP of women with PCOS.; Data Sources: We searched PubMed, MEDLINE, Scopus, Embase, Cochrane Library, and Web of Science in April 2020 and updated the results in March 2021.; Study Selection: The study included randomized controlled trials (RCTs) and follows the 2020 Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA).; Data Extraction: Two independent researchers extracted data and assessed for risk of bias using the Cochrane risk of bias tool. Covidence systematic review software were used for blinded screening and study selection.; Data Synthesis: In 29 RCTs, there were significant reductions in triglycerides with atorvastatin versus placebo [mean difference (MD): -0.21 mmol/L; 95% confidence interval (CI): -0.39, -0.03, I 2 = 0%, moderate grade evidence]. Significant reductions were seen for low-density lipoprotein cholesterol (LDL-C) with metformin versus placebo [standardized mean difference (SMD): -0.41; 95% CI: -0.85, 0.02, I 2 = 59%, low grade evidence]. Significant reductions were also seen for total cholesterol with saxagliptin versus metformin (MD: -0.15 mmol/L; 95% CI: -0.23, -0.08, I 2 = 0%, very low grade evidence). Significant reductions in C-reactive protein (CRP) were seen for atorvastatin versus placebo (MD: -1.51 mmol/L; 95% CI: -3.26 to 0.24, I 2 = 75%, very low-grade evidence).; Conclusion: There were significant reductions in the lipid parameters when metformin, atorvastatin, saxagliptin, rosiglitazone and pioglitazone were compared with placebo or other agents. There was also a significant reduction of CRP with atorvastatin. (© 2021 John Wiley & Sons Ltd.)

Abdalla Mohammed, A., et al. (2022). "Impact of metformin on the clinical and metabolic parameters of women with polycystic ovary syndrome: a systematic review and meta-analysis of randomised controlled trials." Therapeutic Advances in Endocrinology and Metabolism 13: 20420188221127142.
	Context: Polycystic ovary syndrome (PCOS) is one of the commonest endocrine disorders affecting women of reproductive age, and metformin is a widely used medication in managing this condition.; Aim: To review the available literature comprehensively on the therapeutic impact of metformin on the clinical and metabolic parameters of women with PCOS.; Data Source: We searched PubMed, MEDLINE, Scopus, Embase, Cochrane Library and the Web of Science and selected sources for grey literature from their inception to April 2020. An updated search in PubMed was performed in June 2022.; Data Synthesis: Two reviewers selected eligible studies and extracted data, and the review is reported following the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).; Results: In 24 eligible randomised controlled trials (RCTs) involving 564 participants who received metformin therapy, metformin was associated with significant reduction in body weight by 3.13 kg (95% CI: -5.33, -0.93), body mass index (BMI) by 0.82 kg/m² (95% CI: -1.22, -0.41), fasting blood glucose [standardised mean difference (SMD): -0.23; 95% CI: -0.40, -0.06], low-density lipoprotein cholesterol (LDL-C) (SMD: -0.41; 95% CI: -0.85, 0.03), total testosterone (SMD: -0.33; 95% CI: -0.49, -0.17), androstenedione (SMD: -0.45; 95% CI: -0.70, -0.20), 17-hydroxyprogesterone (17-OHP) (SMD: -0.58; 95% CI: -1.16, 0.00) and increase the likelihood of clinical pregnancy rate [odds ratio (OR): 3.00; 95% CI: 1.95, 4.59] compared with placebo.; Conclusion: In women with PCOS, metformin use has shown a positive impact in reducing body weight, BMI, total testosterone, androstenedione, 17-OHP, LDL-C, fasting blood glucose and increasing the likelihood of pregnancy in women with PCOS.; Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article. (© The Author(s), 2022.)

Abdalla Mohammed, A., et al. (2022). "Impact of pharmacological interventions on anthropometric indices in women with polycystic ovary syndrome: A systematic review and meta-analysis of randomized controlled trials." Clinical Endocrinology 96(6): 758-780.
	Context: Polycystic ovary syndrome (PCOS) is a heterogeneous condition affecting women of reproductive age and is associated with increased body weight.; Objective: To review the literature on the effect of different pharmacological interventions on the anthropometric indices in women with PCOS.; Data Sources: We searched PubMed, MEDLINE, Scopus, Embase, Cochrane library, and the Web of Science in April 2020 with an update in PubMed in March 2021.; Study Selection: The study followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA)2020.; Data Extraction: Reviewers extracted data and assessed the risk of bias using the Cochrane risk of bias tool.; Results: 80 RCTs were included in the meta-analysis. Metformin vs placebo showed significant reduction in the mean body weight (MD: -3.13 kg; 95% confidence interval [CI]: -5.33 to -0.93, I² = 5%) and the mean body mass index (BMI) (MD: -0.75 kg/m 2 ; 95% CI: -1.15 to -0.36, I² = 0%). There was a significant reduction in the mean BMI with orlistat versus placebo (MD: -1.33 kg/m²; 95% CI: -2.16 to -0.66, I² = 0.0%), acarbose versus metformin (MD: -1.26 kg/m²; 95% CI: -2.13 to -0.38, I² = 0%), and metformin versus pioglitazone (MD: -0.91 kg/m²; 95% CI: -1.62 to -0.19, I² = 0%). A significant increase in the mean BMI was also observed in pioglitazone versus placebo (MD: + 2.59 kg/m²; 95% CI: 1.78-3.38, I² = 0%) and in rosiglitazone versus metformin (MD: + 0.80 kg/m²; 95% CI: 0.32-1.27, I² = 3%). There was a significant reduction in the mean waist circumference (WC) with metformin versus placebo (MD: -1.21 cm; 95% CI: -3.71 to 1.29, I² = 0%) while a significant increase in the mean WC with pioglitazone versus placebo (MD: + 5.45 cm; 95% CI: 2.18-8.71, I² = 0%).; Conclusion: Pharmacological interventions including metformin, sitagliptin, pioglitazone, rosiglitazone orlistat, and acarbose have significant effects on the anthropometric indices in women with PCOS. (© 2021 John Wiley & Sons Ltd.)

Abdalla Mohammed, A., et al. (2022). "Impact of pharmacological interventions on insulin resistance in women with polycystic ovary syndrome: A systematic review and meta-analysis of randomized controlled trials." Clinical Endocrinology 96(3): 371-394.
	Objective: Polycystic ovary syndrome (PCOS) is a complex endocrine condition affecting women of reproductive age. It is characterized by insulin resistance and is a major risk factor for type 2 diabetes mellitus (T2DM). The objective was to review the literature on the effect of different pharmacological interventions on insulin resistance in women with PCOS.; Design: We searched PubMed, MEDLINE, Scopus, Embase, Cochrane library and the Web of Science in April 2020 and updated in March 2021. The study follows the 2020 Preferred Reporting Items for Systematic reviews and Meta-ana. Reviwers extracted data and assessed the risk of bias using the Cochrane risk of bias tool.; Results: In 58 randomized controlled trials there were significant reductions in the fasting blood glucose (FBG) with metformin versus placebo (standardized mean difference [SMD]: -0.23; 95% confidence interval [CI]: -0.40, -0.06; I² = 0%, low-grade evidence), and acarbose versus metformin (mean difference [MD]: -10.50 mg/dl; 95% CI: -15.76, -5.24; I² = 0%, low-grade evidence). Significant reductions in fasting insulin (FI) with pioglitazone versus placebo (SMD: -0.55; 95% CI: -1.03, -0.07; I² = 37%; p = .02, very-low-grade evidence). A significant reduction in homoeostatic model assessment of insulin resistance (HOMA-IR) was seen with exenatide versus metformin (MD: -0.34; 95% CI: -0.65, -0.03; I² = 0%, low-grade evidence). No effect on homoeostatic model assessment of beta cells (HOMA-B) was observed.; Conclusions: Pharmacological interventions, including metformin, acarbose, pioglitazone and exenatide have significant effects on FBG, FI, HOMA-IR but not on HOMA-B. (© 2021 John Wiley & Sons Ltd.)

Abdalla Mohammed, A., et al. (2023). "Impact of pharmacological interventions on biochemical hyperandrogenemia in women with polycystic ovary syndrome: a systematic review and meta-analysis of randomised controlled trials." Archives of Gynecology and Obstetrics 307(5): 1347-1376.
	Context: Polycystic ovary syndrome (PCOS) is a complex endocrine disease that affects women of reproductive age and is characterised by biochemical and clinical androgen excess.; Aim: To evaluate the efficacy of pharmacological interventions used to decrease androgen hormones in women with PCOS.; Data Source: We searched PubMed, MEDLINE, Scopus, Embase, Cochrane library and the Web of Science from inception up to March 2021.; Data Synthesis: Two reviewers selected eligible studies and extracted data, and the review is reported according to the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).; Results: Of the 814 randomised clinical trials (RCTs) located in the search, 92 met the eligibility criteria. There were significant reductions in total testosterone level with metformin versus (vs) placebo (SMD: - 0.33; 95% CI - 0.49 to - 0.17, p < 0.0001, moderate grade evidence) and dexamethasone vs placebo (MD:-0.86 nmol/L; 95% CI - 1.34 to - 0.39, p = 0.0004, very low-grade evidence). Significant reductions in the free testosterone with sitagliptin vs placebo (SMD: - 0.47; 95% CI - 0.97 to 0.04, p = 0.07, very low-grade evidence), in dehydroepiandrosterone sulphate (DHEAS) with flutamide vs finasteride (MD: - 0.37 µg/dL; 95% CI - 0.05 to - 0.58, p = 0.02, very low-grade evidence), a significant reduction in androstenedione (A4) with rosiglitazone vs placebo (SMD: - 1.67; 95% CI - 2.27 to - 1.06; 59 participants, p < 0.00001, very low-grade evidence), and a significant increase in sex hormone-binding globulin (SHBG) with oral contraceptive pill (OCP) (35 µg Ethinyl Estradiol (EE)/2 mg cyproterone acetate (CPA)) vs placebo (MD: 103.30 nmol/L; 95% CI 55.54-151.05, p < 0.0001, very low-grade evidence) were observed.; Conclusion: Metformin, OCP, dexamethasone, flutamide, and rosiglitazone use were associated with a significant reduction in biochemical hyperandrogenemia in women with PCOS, though their individual use may be limited due to their side effects.; Prospero Registration No: CRD42020178783. (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Abdelazeem, B., et al. (2022). "The effects of curcumin as dietary supplement for patients with polycystic ovary syndrome: An updated systematic review and meta-analysis of randomized clinical trials." Phytotherapy Research 36(1): 22-32.
	This review aims to evaluate if there are clinical benefits of curcumin (CUR) in patients with polycystic ovary syndrome (PCOS). Electronic databases (PubMed, EMBASE, Scopus, Web of Science, Cochrane Central, and Google Scholar) were systematically searched to identify only randomized clinical trials (RCTs) that assessed CUR in patients with PCOS from inception to May 5, 2021. Five RCTs were included with a total of 296 patients, with 148 among the CUR groups and 148 patients among the control group. Revised Cochrane risk-of-bias tool for randomized trials was used to assess the risk of bias, three RCTs provided a low risk of bias and two provided a high risk of bias. Compared with the control group, CUR was associated with a statistically significant improvement in the glycemic control including fasting blood glucose (MD = -3.67; 95% CI = [-5.25, -2.08], p < .00001), insulin level (MD = -1.91; 95% CI = [-2.97, -0.84], p = .0005), homeostasis model assessment of insulin resistance (MD = -0.55; 95% CI = [-0.83, -0.27], p = .0001), and quantitative insulin sensitivity check index (MD = 0.01; 95% CI = [0.00, 0.02], p = .0005). The mean difference in total cholesterol was also statistically significant (MD = -15.55; 95% CI = [-30.33, -0.76], p < .04). The rest of the secondary outcomes, including LDL, HDL, sex hormone, body weight, and CRP, were not statistically significant. This review concluded that among patients with PCOS, the use of CUR demonstrated a significant difference from the control group for glycemic control. Those findings suggest that CUR confers clinical benefits in patients with PCOS. However, due to the limited number of the included studies, further high-quality studies are needed to establish the clinical efficacy of the CUR. (© 2021 John Wiley & Sons Ltd.)

Abdel-fattah, M., et al. (2021). "Female Urgency, Trial of Urodynamics as Routine Evaluation (FUTURE study): a superiority randomised clinical trial to evaluate the effectiveness and cost-effectiveness of invasive urodynamic investigations in management of women with refractory overactive bladder symptoms." Trials 22(1): 745.
	Background: Overactive bladder (OAB) syndrome is a symptom complex affecting 12-14% of the UK adult female population. Symptoms include urinary urgency, with or without urgency incontinence, increased daytime urinary frequency and nocturia. OAB has a negative impact on women's social, physical, and psychological wellbeing. Initial treatment includes lifestyle modifications, bladder retraining, pelvic floor exercises and pharmacological therapy. However, these measures are unsuccessful in 25-40% of women (refractory OAB). Before considering invasive treatments, such as Botulinum toxin injection or sacral neuromodulation, most guidelines recommend urodynamics to confirm diagnosis of detrusor overactivity (DO). However, urodynamics may fail to show evidence of DO in up to 45% of cases, hence the need to evaluate its effectiveness and cost-effectiveness. FUTURE (Female Urgency, Trial of Urodynamics as Routine Evaluation) aims to test the hypothesis that, in women with refractory OAB, urodynamics and comprehensive clinical assessment is associated with superior patient-reported outcomes following treatment and is more cost-effective, compared to comprehensive clinical assessment only. Method(s): FUTURE is a pragmatic, multi-centre, superiority randomised controlled trial. Women aged >= 18 years with refractory OAB or urgency predominant mixed urinary incontinence, and who have failed/not tolerated conservative and medical treatment, are considered for trial entry. We aim to recruit 1096 women from approximately 60 secondary/tertiary care hospitals across the UK. All consenting women will complete questionnaires at baseline, 3 months, 6 months and 15 months post-randomisation. The primary outcome is participant-reported success at 15 months post-randomisation measured using the Patient Global Impression of Improvement. The primary economic outcome is incremental cost per quality-adjusted life year gained at 15 months. The secondary outcomes include adverse events, impact on other urinary symptoms and health-related quality of life. Qualitative interviews with participants and clinicians and a health economic evaluation will also be conducted. The statistical analysis of the primary outcome will be by intention-to-treat. Results will be presented as estimates and 95% CIs. Discussion(s): The FUTURE study will inform patients, clinicians and policy makers whether routine urodynamics improves treatment outcomes in women with refractory OAB and whether it is cost-effective. Trial registration: ISRCTN63268739. Registered on 14 September 2017.Copyright © 2021, The Author(s).

Abdel-Fattah, M., et al. (2022). "Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT." Health Technology Assessment 26(47): 1-220.
	Background: Stress urinary incontinence is the most common type of urinary incontinence in premenopausal women. Until recently, synthetic mid-urethral slings (mesh/tape) were the standard surgical treatment, if conservative management failed. Adjustable anchored single-incision mini-slings are newer, use less mesh and may reduce perioperative morbidity, but it is unclear how their success rates and safety compare with those of standard tension-free mid-urethral slings. Objective(s): The objective was to compare tension-free standard mid-urethral slings with adjustable anchored single-incision mini-slings among women with stress urinary incontinence requiring surgical intervention, in terms of patient-reported effectiveness, health-related quality of life, safety and cost-effectiveness. Design(s): This was a pragmatic non-inferiority randomised controlled trial. Allocation was by remote web-based randomisation (1: 1 ratio). Setting(s): The trial was set in 21 UK hospitals. Participant(s): Participants were women aged >= 18 years with predominant stress urinary incontinence, undergoing a mid-urethral sling procedure. Intervention(s): Single-incision mini-slings, compared with standard mid-urethral slings. Main Outcome Measure(s): The primary outcome was patient-reported success rates on the Patient Global Impression of Improvement scale at 15 months post randomisation (= 1 year post surgery), with success defined as outcomes of 'very much improved' or 'much improved'. The primary economic outcome was incremental cost per quality-adjusted life-year gained. Secondary outcomes were adverse events, impact on other urinary symptoms, quality of life and sexual function. Result(s): A total of 600 participants were randomised. At 15 months post randomisation, adjustable anchored single-incision mini-slings were non-inferior to tension-free standard mid-urethral slings at the 10% margin for the primary outcome [single-incision mini-sling 79% (212/268) vs. standard mid-urethral sling 76% (189/250), risk difference 4.6, 95% confidence interval -2.7 to 11.8; pnon-inferiority < 0.001]. Similarly, at 3 years' follow-up, patient-reported success rates in the single-incision mini-sling group were non-inferior to those of the standard mid-urethral sling group at the 10% margin [single-incision minisling 72% (177/246) vs. standard mid-urethral sling 67% (157/235), risk difference 5.7, 95% confidence interval -1.3 to 12.8; pnon-inferiority < 0.001]. Tape/mesh exposure rates were higher for single-incision mini-sling participants, with 3.3% (9/276) [compared with 1.9% (5/261) in the standard mid-urethral sling group] reporting tape exposure over the 3 years of follow-up. The rate of groin/thigh pain was slightly higher in the single-incision mini-sling group at 15 months [single-incision mini-sling 15% (41/276) vs. standard mid-urethral sling 12% (31/261), risk difference 3.0%, 95% confidence interval -1.1% to 7.1%]; however, by 3 years, the rate of pain was slightly higher among the standard mid-urethral sling participants [single-incision mini-sling 14% (39/276) vs. standard mid-urethral sling 15% (39/261), risk difference -0.8, 95% confidence interval -4.1 to 2.5]. At the 3-year follow-up, quality of life and sexual function outcomes were similar in both groups: For the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life, the mean difference in scores was -1.1 (95% confidence interval -3.1 to 0.8; p = 0.24), and for the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Urogynecological Association-Revised, it was 0 (95% confidence interval -0.1, 0.1; p = 0.92). However, more women in the single-incision mini-sling group reported dyspareunia [12% (17/145), compared with 4.8% (7/145) in the standard mid-urethral sling group, risk difference 7.0%, 95% confidence interval 1.9% to 12.1%]. The base-case economics results showed no difference in costs (-6, 95% confidence interval -228 to 208) or quality-adjusted life-years (0.005, 95% confidence interval -0.068 t 0.073) between the groups. There is a 56% probability that singleincision mini-slings will be considered cost-effective at the 20,000 willingness-to-pay threshold value for a quality-adjusted life-year. Limitation(s): Follow-up data beyond 3 years post randomisation are not available to inform longer-term safety and cost-effectiveness. Conclusion(s): Single-incision mini-slings were non-inferior to standard mid-urethral slings in patientreported success rates at up to 3 years' follow-up. Future work: Success rates, adverse events, retreatment rates, symptoms, and quality-of-life scores at 10 years' follow-up will help inform long-term effectiveness.Copyright © 2022 Abdel-Fattah et al.

Abdelhakim Ahmed, M., et al. (2020). "Vaginal versus intramuscular progesterone for luteal phase support in assisted reproductive techniques: a systematic review and meta-analysis of randomized controlled trials." Gynecological Endocrinology 36(5): 389-397.
	We aimed to compare the efficacy of vaginal progesterone versus intramuscular progesterone (IMP) for luteal phase support in assisted reproductive techniques (ART). A comprehensive electronic search of four electronic databases (PubMed, Cochrane Library, Scopus, and ISI Web of Science) was performed from inception till August 2019 for randomized controlled trials (RCTs). We included studies performed different ART with the use of vaginal progesterone versus IMP for luteal phase support. Our primary outcome was clinical pregnancy rate. Our secondary outcomes were ongoing pregnancy, miscarriage, live birth rates, and satisfaction in both groups. 15 RCTs met our inclusion criteria with a total of 5656 patients. Our analysis indicated no significant differences between vaginal progesterone and IMP regarding clinical and ongoing pregnancies (RR = 0.90, 95% CI [0.80, 1.00], p = .06), (RR = 0.90, 95% CI [0.76, 1.06], p = .21), respectively. No significant differences were found between both routes of progesterone in miscarriage ( p = .98) and live birth ( p = .99). Subgroup analysis between fresh and frozen embryo transfer cycles in above outcomes showed no difference between progesterone routes. Vaginal progesterone was significantly associated with more satisfaction compared to IMP ( p < .00001). In conclusion, vaginal progesterone can be used an alternative method for luteal phase support instead of IMP in ART.

Abdel-Maboud, M., et al. (2021). "The comparative effectiveness of 55 interventions in obese patients with polycystic ovary syndrome: A network meta-analysis of 101 randomized trials." PloS One 16(7): e0254412.
	Background: Polycystic ovary syndrome (PCOS) affects up to 18% of reproductive-age females. The prevalence of obesity in PCOS patients reaches up to 80%, which is 2-fold higher than the general population.; Objective: The present study aimed to compare the effectiveness of 55 pharmacological interventions across 17 different outcomes in overweight/obese PCOS patients with hyperandrogenism manifestations for both short- and long-term follow-ups. A comprehensive literature search was performed on PubMed, Scopus, Embase, Science Direct, Web of Science, and Cochrane CENTRAL for randomized controlled trials comparing any conventional pharmacological intervention as a monotherapy or a combination in overweight/obese patients with polycystic ovary syndrome and hyperandrogenism manifestations. Extracted data included three main parameters; I. Anthropometric parameters (BMI, Waist and Hip circumferences, and Waist/HIP ratio), II. Hormonal parameters (FSH, LH, FSG, SHBG, Estradiol, Total Testosterone, Free testosterone, DHEAS, Androstenedione), and III. Metabolic parameters (Total Cholesterol, LDL-C, HDL-C, Triglycerides, Fasting glucose, Fasting glucose, HOMA-IR). Critical appraisal and risk of bias assessments were performed using the modified Jadad scale, and the overall quality of this network meta-analysis was evaluated according to the CINeMA framework. We performed both a pairwise meta-analysis and a network meta-analysis to evaluate the effect sizes with 95% CI, and we calculated the surface under the cumulative ranking curve (SUCRA) for each intervention.; Results: Our final search on May 15th 2021 retrieved 23,305 unique citations from searching six electronic databases. Eventually, 101 RCTs of 108 reports with a total of 8,765 patients were included in our systematic review and multi-treatments meta-analysis. 55 different interventions were included: 22 monotherapies, and 33 combinations. The two-dimensional cluster ranking of the average SUCRA values for metabolic and hormonal parameters with significant estimates revealed flutamide (77.5%, 70%; respectively) as the highest and rosiglitazone (38.2%, 26.3%; respectively) as the lowest, in terms of the overall efficacy in reducing weight and hyperandrogenism. However, cyproterone-acetate+ethinylestradiol exhibited a higher ranking in improving hormonal parameters (71.1%), but even a lower-ranking regarding metabolic parameters (34.5%).; Conclusions and Relevance: Current evidence demonstrated the superiority of flutamide in improving both metabolic and hormonal parameters, and the higher efficacy of cyproterone-acetate+ethinylestradiol only in improving hormonal parameters. Nearly all interventions were comparable in female hormones, FGS, HDL, glucose, and insulin levels improvements.; Competing Interests: The authors have declared that no competing interests exist.

Abdi, F., et al. (2021). "Role of vitamin D and calcium in the relief of primary dysmenorrhea: a systematic review." Obstetrics & Gynecology Science 64(1): 13-26.
	Dysmenorrhea is one of the well-established problems among women of reproductive age and can have adverse effects on the quality of life of the individual. Some studies suggest a relationship between vitamin D (Vit D) and calcium deficiency and the emergence of early dysmenorrhea. Accordingly, a systematic study was performed to investigate the role of calcium and Vit D in the relief of primary dysmenorrhea. A systematic literature search was performed in PubMed, Web of Science, Scopus, Science Direct, and Google Scholar for papers published between 2010 and 2020. The Consolidated Standards of Reporting Trials and Strengthening the Reporting of Observational Studies in Epidemiology checklists were used to assess the quality of the studies. The risk of bias was assessed using the Cochrane risk-of-bias assessment tool. Low calcium levels lead to an increase in uterine muscle contraction and can cause pain after decreased uterine blood flow. Furthermore, low levels of Vit D can increase primary dysmenorrhea by increasing prostaglandin production or reducing intestinal calcium absorption. That being the case, Vit D and calcium intake can be effective in reducing the severity of primary dysmenorrhea and in reducing the rate of analgesic use. Low levels of Vit D and calcium are inversely related to the severity of primary dysmenorrhea, and Vit D and calcium intake can reduce the severity of primary dysmenorrhea and its associated systemic symptoms. Therefore, the use of calcium and Vit D supplements can be recommended to relieve dysmenorrhea.

Abdulla, A., et al. (2022). "Magnitude of the placebo effect across adjuvant treatment modalities used in recurrent implantation failure: A network meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Abhijit, D., et al. (2023). "Efficacy of Homeopathic Interventions in Primary Dysmenorrhea: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Abolhassani, N., et al. (2023). "Major malformations risk following early pregnancy exposure to metformin: a systematic review and meta-analysis." BMJ Open Diabetes Research & Care 11(1).
	Metformin is considered as first-line treatment for type 2 diabetes and an effective treatment for polycystic ovary syndrome (PCOS). However, evidence regarding its safety in pregnancy is limited. We conducted a systematic review and meta-analysis of major congenital malformations (MCMs) risk after first-trimester exposure to metformin in women with PCOS and pregestational diabetes mellitus (PGDM). Randomized controlled trials (RCTs) and observational cohort studies with a control group investigating risk of MCM after first-trimester pregnancy exposure to metformin were searched until December 2021. ORs and 95% CIs were calculated separately according to indications and study type using Mantel-Haenszel method; outcome data were combined using random-effects model. Eleven studies (two RCTs; nine observational cohorts) met the inclusion criteria: four included pregnant women with PCOS, four included those with PGDM and three evaluated both indications separately and were considered in both indication groups. In PCOS group, there were two RCTs (57 exposed, 52 control infants) and five observational studies (472 exposed, 1892 control infants); point estimates for MCM rates in RCTs and observational studies were OR 0.93 (95% CI 0.09 to 9.21) (I 2 =0%; Q test=0.31; p value=0.58) and OR 1.35 (95% CI 0.37 to 4.90) (I 2 =65%; Q test=9.43; p value=0.05), respectively. In PGDM group, all seven studies were observational (1122 exposed, 1851 control infants); the point estimate for MCM rates was OR 1.05 (95% CI 0.50 to 2.18) (I 2 =59%; Q test=16.34; p value=0.01). Metformin use in first-trimester pregnancy in women with PCOS or PGDM do not meaningfully increase the MCM risk overall. However, further studies are needed to characterize residual safety concerns.; 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.)

Aboshama Rehab, A., et al. (2021). "Effect of piroxicam administration in infertile women undergoing assisted reproductive technologies: A systematic review and meta-analysis." Gynecological Endocrinology 37(9): 785-791.
	Objective: To evaluate piroxicam effect on different pregnancy outcomes among infertile women undergoing assisted reproductive technologies (ART).; Methods: We searched for the available randomized clinical trials (RCTs) in four different databases during January 2021 that compared piroxicam (intervention group) to placebo/no treatment (control group) in infertile women performing ART. We extracted the available data from included studies and pooled them in a meta-analysis model using RevMan software. We pooled the dichotomous data as risk ratios (RR) with the corresponding 95% confidence intervals (CI) using RevMan software. Our outcomes were rates of clinical pregnancy, ongoing pregnancy, miscarriage, and any adverse events.; Results: Seven RCTs met our inclusion criteria with a total number of 1226 patients. Piroxicam was linked to a significant increase in clinical pregnancy rate compared to control group (RR = 1.30, 95% CI [1.09, 1.55], p = .003). However, we did not report any significant difference between both groups in ongoing pregnancy rate (RR = 1.27, 95% CI [0.72, 2.24], p = .41). In addition, the rates of miscarriage and adverse events were not different among both groups.; Conclusions: Piroxicam administration increases the clinical pregnancy rate among infertile women. However, piroxicam does not affect miscarriage and ongoing pregnancy rates.

Abril-Coello, R., et al. (2023). "Benefits of physical therapy in improving quality of life and pain associated with endometriosis: A systematic review and meta-analysis." International Journal of Gynaecology and Obstetrics 162(1): 233-243.
	Objective: To assess whether non-pharmacologic conservative therapeutic interventions are beneficial in improving pain intensity and quality of life in women with endometriosis compared with placebo.; Methods: A systematic review with meta-analysis was designed. A literature search was performed in the following databases: PubMed, PEDro, Embase, CINAHL, Isi Web of Science, Enfispo, and Cochrane. Randomized controlled trials included women with endometriosis treated with conservative treatment versus placebo. The quality of the studies was assessed using the PEDro scale, and the risk of bias of the individual studies was assessed using the Cochrane Risk of Bias tool. For the overall quality of the studies, the GRADE guidelines were used.; Results: Meta-analysis included six studies. Significant results were obtained for pain intensity (standardized mean difference [SMD] -0.89; 95% confidence interval [CI] -1.21 to -0.57; I 2 69%) and concerning quality of life, significant results were only obtained for the sub-variable physical function (SMD -1.49; 95% CI -2.88 to -0.10; I 2 95%). No statistically significant differences were found for the rest of the variables analyzed.; Conclusion: Non-pharmacologic conservative therapies are a therapeutic option for women with endometriosis for improving pain intensity and physical function. (© 2022 International Federation of Gynecology and Obstetrics.)

Abu-Zaid, A., et al. (2021). "Astodrimer gel for treatment of bacterial vaginosis: A systematic review and meta-analysis of randomized controlled trials." International Journal of Clinical Practice 75(7): e14165.
	Background: Bacterial vaginosis is a frequent source of vaginal infection among reproductive-aged women. Astodrimer gel is a novel drug which demonstrated favourable outcomes for treatment of patients with bacterial vaginosis.; Aim: We attempted to conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) which examined the efficacy and safety of astodrimer gel in patients with bacterial vaginosis.; Methods: We searched four databases from inception to August 15, 2020, using relevant keywords. We identified all RCTs which surveyed the efficacy and safety of astodrimer gel in treating patients with bacterial vaginosis. We appraised the quality of the included RCTs using the Cochrane risk of bias assessment tool. We pooled dichotomous outcomes as numbers and totals and reported them as risk ratios (RR) with 95% confidence intervals (95% CI) under random- or fixed-effects meta-analysis models depending on heterogeneity.; Results: Three eligible studies comprising four independent RCTs and 1165 patients were identified (614 and 551 patients received astodrimer gel and placebo, respectively). For efficacy outcomes (n = 320 astodrimer gel versus n = 260 placebo), astodrimer gel was significantly superior to placebo for all pooled efficacy outcomes, including clinical cure rate (at 9-12 and 21-30 days), microbiological Nugent cure rate (at 9-12 and 21-30 days), patient self-reported absence of vaginal odor/discharge (at 9-12 and 21-30 days), resolution of Amsel criteria (at 9-12 days) and percentage of patients who did not receive rescue therapy during study. With respect to safety outcomes (n = 614 astodrimer gel versus n = 551 placebo), astodrimer gel demonstrated equal tolerability to placebo for all pooled safety endpoints, expect unfavourably for vulvovaginal candidiasis and treatment-related vulvovaginal candidiasis.; Conclusions: Astodrimer gel is effective in treating bacterial vaginosis and corroborated by clinical (Amsel criteria) and microbiological (Nugent score) measurements as well as patient-reported symptoms. Moreover, astodrimer gel is largely safe and associated with marginal rate of vulvovaginal candidiasis. (© 2021 John Wiley & Sons Ltd.)

Abu-Zaid, A., et al. (2023). "The effect of alpha-lipoic acid supplementation on anthropometric, glycemic, lipid, oxidative stress, and hormonal parameters in individuals with polycystic ovary syndrome: a systematic review and meta-analysis of randomized clinical trials." Obstetrics & Gynecology Science.
	This systematic review and meta-analysis aimed to examine the effect of the antioxidant alpha-lipoic acid (ALA) on various cardiometabolic risk factors and hormonal parameters in patients with polycystic ovary syndrome (PCOS). We searched PubMed, EMBASE, SCOPUS, Cochrane Library, and Web of Science databases without language restrictions until May 2023 to find randomized controlled trials (RCTs) that assessed the impact of ALA supplementation on anthropometric, glycemic, lipid, oxidative stress, and hormonal parameters in women with PCOS. Outcomes were summarized using the standardized mean difference (SMD) and 95% confidence interval (CI) in a random-effects model. An I2 statistic of >60% established significant between-study heterogeneity. The overall certainty of the evidence for each outcome was determined using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) System. Seven RCTs met the inclusion criteria. The ALA group had significant reductions in fasting blood sugar (FBS; n=7 RCTs; SMD, -0.60; 95% CI, -1.10 to -0.10; I2=63.54%, moderate certainty of evidence) and homeostatic model assessment for insulin resistance (HOMA-IR; n=4 RCTs; SMD, -2.03; 95% CI, -3.85 to -0.20; I2=96.32%, low certainty of evidence) compared with the control group. However, significant differences were observed between the groups in body mass index, insulin, estrogen, follicle-stimulating hormone, luteinizing hormone, testosterone, low-density lipoprotein, high-density lipoprotein, triglyceride, total cholesterol, malondialdehyde, or total antioxidant capacity profiles. ALA supplementation improves FBS and HOMA-IR levels in women with PCOS. ALA consumption is an effective complementary therapy for the management of women with PCOS.

Abu-Zaid, A., et al. (2023). "Comparison of Letrozole and Clomiphene Citrate in Pregnancy Outcomes in Patients with Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis." Reproductive Sciences.
	Clomiphene citrate (CC) and letrozole are the predominant medical interventions for the management of infertility in patients with polycystic ovary syndrome (PCOS). To comprehensively summarize the evidence, a systematic review and meta-analysis of randomized clinical trials (RCTs) was carried out to assess the effect of letrozole and CC on pregnancy outcomes in PCOS patients. We searched PubMed/MEDLINE, Scopus, and Cochrane Central Register of Controlled Trials from inception to January 2023. We included RCTs conducted on PCOS women comparing letrozole to CC and assessing endometrial thickness, the number and size of follicles, and ovulation and pregnancy rates. The endpoints were summarized as risk ratio (RR) or standardized mean difference (SMD) with 95% confidence interval (CI) using the random-effects model. Heterogeneity was examined using the I 2 statistic. Fifty trials met our inclusion criteria. The mean endometrial thickness was significantly higher in the letrozole group compared to CC group (SMD: 0.89; 95% CI: 0.49, 1.28; I 2 =97.72%); however, the number of follicles was higher in the CC group (SMD: -0.56; 95% CI: -0.96, -0.17; I 2 =96.34%). Furthermore, letrozole intake induced higher ovulation rate (RR: 1.20; 95% CI: 1.13, 1.26; I 2 =54.49%) and pregnancy rate (RR: 1.44; 95% CI: 1.28, 1.62; I 2 =65.58%) compared to CC. Compared to CC, letrozole has a positive effect on endometrial thickness, monofollicular development, and ovulation and pregnancy rates suggesting that letrozole may be a strong alternative to CC as a first-line medical intervention for chronic anovulation in PCOS women. Larger studies are warranted to further clarify these findings. (© 2023. The Author(s), under exclusive licence to Society for Reproductive Investigation.)

Acharya, A., et al. (2023). "Spontaneous miscarriage/abortion in the first trimester and expectant management - a meta-analysis approach." Menopause Review 22(3): 135-141.
	Introduction: To determine effectiveness and side effects of expectant care in first-trimester miscarriage. An increase in the spontaneous miscarriage rate and its associated complications exerts a burden on the overall health and quality of life of women. Expectant care in a first-trimester miscarriage has shown success ranging 75-80%. This study was designed to search the literature for information on the clinical safety and effectiveness of expectant management on spontaneous miscarriage during the first trimester.; Material and Methods: The review included studies that included women in expectant care for spontaneous miscarriage in the first trimester. Trial studies were recognized through a methodical and organized database search from PubMed, COCHRANE, MEDLINE, Embase, and bibliography from January 2000 until December 2022. The methodological assessment and risk of bias was assessed using the Joanna Briggs Institute criteria.; Results: Eleven studies in systematic review and 7 studies in the meta-analysis were included. The included studies showed a low to moderate risk of bias. The odds of success in expectant intervention were low when compared with surgical intervention (odds ratio - OR: OR: 0.37 [0.28, 0.48]) and medical management (OR: 0.47 [0.36, 0.61]), and the need for surgical evacuation was high (OR: 2.59 [1.88, 3.59]).; Conclusions: Future trials should consider women's opinions and the effect on quality of life along with clinical consequences, to provide improved suggestions on the efficiency and adverse effects.; Competing Interests: The authors report no conflict of interest. (Copyright © 2023 Termedia.)

Achimaș-Cadariu Patriciu, A., et al. (2023). "Impact of Hormone Replacement Therapy on the Overall Survival and Progression Free Survival of Ovarian Cancer Patients: A Systematic Review and Meta-Analysis." Cancers 15(2).
	Background: Frequently, patients treated for Ovarian Cancer (OC) undergo menopause with subsequent symptoms. This review scrutinised the impact of Hormone Replacement Therapy (HRT) on the Overall Survival (OS) and Progression-Free Survival (PFS) of patients diagnosed with OC. Methods: A systematic literature search was conducted in the most popular English databases. Inclusion and exclusion criteria were applied to select publications that evaluate OS and PFS in these patients. End-point analysis targeted values of log(HR) and its Standard Error (SE). Results: Up to 1 September 2022, 11 studies were included in the qualitative synthesis. Eight publications, totalling 4191 patients, were included in the meta-analyses. Eight studies were considered for the OS analysis and pooled an HR of 0.66 with respective 95% CI between 0.57 and 0.76, with a p-value < 0.00001 at a Z value of 5.7, in favour of the HRT group. Results for PFS showed an overall HR of 0.73 in favour of the HRT group; CI between 0.57 and 0.95, p = 0.02 at a Z value of 2.36. Further subgroup analyses highlighted the non-inferiority of this treatment. Conclusions: Patients treated for OC that receive HRT for menopausal symptoms after various treatments appeared to have better OS than never-users.

Achtari, C. (2021). "Sacrocolpopexy Versus Sacro-spinous Fixation for Prolapse Treatment." ClinicalTrials.gov.
	Genital prolapse is caused by the collapse of the supporting structures of the pelvic organs. This results in the organs sliding down through the pelvic hiatus. The pelvic organs involved are the bladder, which rests on the anterior vaginal wall like a hammock made of supportive connective tissue called the anterior endopelvic fascia. When too much stress is placed on this support tissue, microtrauma or tears gradually weaken this tissue, which relaxes and causes the bladder to gradually lower. In the same way, the rectum is separated from the posterior vaginal wall by this same endopelvic fascia which can suffer the same kind of lesion with the same consequences. The middle compartment, i.e. the top of the vagina is made up of the cervix which is supported by a condensation of this endopelvic tissue in the form of ligaments that suspend this cervix in the center of the pelvic cavity. If these ligaments weaken, the uterus, or the "vaginal cuff" in the event of a previous hysterectomy, will also gradually lower, or even externalize. The middle compartment is considered the keystone of pelvic organ support. All interventions to correct severe prolapse should include suspension of the middle compartment. Traditionally, the sacro‐spinal ligament is used during the intervention via the low approach and the sacral promontory via the high approach. There is a classification (Pelvic Organ Prolapse Quantification or POP‐Q) in stages of descent of the pelvic organs. At the first stage, the organs are not exteriorized and in most cases asymptomatic. In the second stage, the vaginal walls reach the vaginal introitus and begin to cause symptoms such as pelvic discomfort or heaviness, whether or not associated with functional disorders of the organs involved. In the following stages, the patients are generally symptomatic. Prolapse is a condition that causes up to 13% of women to have to have surgery in their lifetime. It causes both an impairment of the quality of life by the discomfort caused by the externalization of the organs and by the functional disorders that it causes, such as urinary or fecal incontinence, bladder emptying disorder, sexual disorders, etc. all of these disorders can be measured by dedicated questionnaires and validated in this population. There are many surgical techniques for the treatment of prolapse, each with its advantages and disadvantages. The techniques by vaginal approach aim to put back in tension of the native supporting tissue damaged and released. This technique has the advantage of not causing an abdominal scar, a quick recovery and often little pain. On the other hand, the use of already damaged tissue results in a recurrence rate of up to 15‐30%. In an attempt to reduce this rate of recurrence, by taking the example of abdominal hernia surgery, prosthetic reinforcements have started to be used in order to make the repair more solid and durable. The prostheses were introduced through a vaginal incision (naturally contaminated medium) and directly under the mucosa. It turned out that a reduction in recurrence was achieved, especially in the anterior compartment, but at the cost of complications directly linked to the use of prostheses such as erosions of the vaginal mucosa, infections and, when using implantation kits supplied by industry, pain that is often difficult to treat. The other technique is the abdominal route either by laparotomy or by a minimally invasive approach such as laparoscopy, assisted or not by robotics. With this technique, prosthetic material is also used but it is introduced around the vaginal wall without opening it, therefore without contamination and without dissection of the vaginal wall, with a much lower rate of erosion or other complication. Many studies have compared these different techniques without reaching a definitive conclusion on the best approach. The use of synthetic material introduced vaginally using kits has recently been the subject of warnings from the FDA due to the sometimes severe complications followed by a gradual withdrawal of thes roducts or even a ban in most Anglo‐Saxon countries. On the other hand, the use by the abdominal route not causing the same complications has not been questioned by the FDA . In our department, the management of symptomatic prolapse involves two techniques, vaginal without prosthesis or minimally invasive abdominal with prosthesis, according to various criteria such as age, surgical history or severity of the prolapse. During upper surgery, a subtotal hysterectomy is performed, i.e. the uterine cervix is preserved and serves as an anchoring point for the synthetic nets which are attached to the cervix and then sutured to the promontory of the sacrum. (sacro‐cervicopexy). In the vaginal route, a total hysterectomy is traditionally performed and the vaginal dome is sutured to the sacro‐spinal ligament (Richter's operation). The stitches are then passed through the thickness of the often thin vaginal wall constituting a possible release point of the assembly. There are currently no studies that compare prosthetic sacro‐cervicopexy with fixation of the remaining cervix to the sacro‐spinal ligament without prosthesis and repair of the endopelvic fascia with native tissue. The study consists of performing a subtotal hysterectomy by minimally invasive first in both cases and then randomise for the mode of suspension of the uterine cervix, either a prosthetic sacro‐cervicopexy or to fix the remaining cervix to the sacro‐sinous ligament by abdominal or vaginal route. We would thus obtain more solid anchoring points at the level of the middle compartment with less risk of dropping and a more lasting result. The main objective is to demonstrate that this new intervention gives similar results to the reference intervention by the upper route. For this we use a composite definition of the success of the intervention which takes into account the anamnestic aspect, the absence of a sensation of prolapse, the clinical examination, the absence of measurable prolapse, and the absence of secondary surgery. The secondary objectives are to ensure a similar improvement in the quality of life in the two groups by relying on specific questionnaires validated for this indication.

Acién, P., et al. (2021). "Anastrozole and levonorgrestrel-releasing intrauterine device in the treatment of endometriosis: a randomized clinical trial." BMC Women's Health 21(1): 211.
	BACKGROUND: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated with levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis. METHODS: Prospective, randomized clinical trial. SETTING: University Hospital (single center). Elegibility criteria: Endometriomas > 3 × 4 cm, CA-125 > 35 U/mL and endometriosis symptoms. PATIENTS: Thirty-one women randomized to anastrozole + Mirena® + Conservative Surgery(CS) (n = 8), anastrozole + Mirena® + transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n = 7), Mirena® + CS (n = 9), or Mirena® + TUGPA (n = 7). INTERVENTIONS: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. MAIN OUTCOME MEASURES: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences. RESULTS: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients including anastrozole in their treatment (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed in patients not taking anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena® + anastrozole). After CS for endometriosis, a reduction of ultrasound findings of endometriomas and long-term recurrence occurred, with or without anastrozole. At 4.2 ± 1.7 years (95% CI 3.57-4.85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p = 0.019). CONCLUSIONS: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces significantly the painful symptoms and delays recurrence, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective. TRIAL REGISTRATION: Eudra CT System of the European Medicines Agency (London, 29-Sept-2008) Nº EudraCT: 2008-005744-17 (07/11/2008). Date of enrolment of first patient: 15/01/2009.

Ackerman, A. L. (2022). "Transvaginal Electrical Stimulation for Myofascial Pelvic Pain." ClinicalTrials.gov.
	This will be a prospective randomized trial. Sixty subjects with suspected myofascial pelvic pain will be recruited from the University of California, Los Angeles (UCLA) Center for Women's Pelvic Health. Patients will be informed of the opportunity to participate in this study by their clinician during routine office visits after a diagnosis of interstitial cystitis or bladder pain syndrome (IC/BPS) is assigned. Interested subjects will be screened for eligibility and allowed as much time as they wish to complete informed consent. MPP subjects who meet inclusion/exclusion criteria will be approached for study inclusion and randomized 2:1 to high frequency transvaginal electrical stimulation (HF‐TES) vs. usual care. Baseline demographics and clinical data, including age, body mass index (BMI), comorbidities, past surgeries, and medications, including hormones, will be captured at enrollment. History will include comprehensive characterization of the pain. Standard examination will include vaginal speculum and bimanual pelvic exam, assessment of pelvic floor myofascial pain and trigger points, pelvic organ prolapse quantification (POP‐Q) and vulvovaginal Q‐tip testing. Urine culture and post‐void residual will rule out infection and urinary retention. After providing informed consent, subjects will complete the female Genitourinary Pain Index (fGUPI), Colorectal Functional Outcome questionnaire (COREFO), International Consultation on Incontinence Questionnaire‐female Lower Urinary Tract Symptoms (ICIQ‐fLUTS), and Pelvic Floor Distress Index (PFDI‐20), the Vulvar and Vaginal Assessment Scales (VuAS and VAS) and Female Sexual Functional Index (FSFI) to measure visceral pelvic symptoms. The Hospital Anxiety and Depression Scale (HADS) and Short Form 12 (SF‐12) will assess symptom impact on physical and mental quality of life. As no validated measures assess myofascial pelvic pain specifically, the McGill Pain Questionnaire will provide additional pain characterization. Two 24‐hour voiding and bowel diaries will be completed at baseline, capturing frequency of voids and defecation, episodes of urinary or bowel urgency or incontinence, stool type, and fluid intake levels. At 1‐2 weeks and 3 months (±10 days) after completing treatment, the investigators will reacquire baseline measures (including voiding and bowel diaries) as well as the Patient Global Impression of Improvement (PGI‐I), satisfaction with treatment (Likert scale: 0 = not satisfied to 10 = completely satisfied) and a binary assessment of meaningful benefit from treatment (yes/no). Participants will be randomized to receive usual care or usual care and HF‐TES administered by either a specialized urogynecology provider or licensed vocational nurse (LVN) using a secure online randomization system. Minimization will balance trial group assignments according to the presence or absence of sexual dysfunction (FSFI total score <26), psychological distress (HADS total score > 10) and current hormonal medication use (yes/no). Trial group assignments will be made after initial counseling orienting the patient to usual care to avoid undue bias during the education session and training in usual care. Treatment will be 8 weeks in duration. Therapy will be performed by a trained, registered LVN or physician, and any adverse evens, patient complains or study attrition due to perceived side effects reported immediately. There will be a post‐treatment assessment, repeating pelvic floor exam, symptomatic and patient global impression of improvement surveys. A 3 month post‐treatment symptomatic assessment will take place to complete determination of treatment outcomes.

Ackroyd, S. A., et al. (2021). "Pembrolizumab and lenvatinib versus carboplatin and paclitaxel as first-line therapy for advanced or recurrent endometrial cancer: A Markov analysis." Gynecologic Oncology 162(2): 249-255.
	Objective: To determine the cost effectiveness of pembrolizumab/lenvatinib (P/L) versus standard-of-care carboplatin/paclitaxel (C/T) as first-line systemic therapy for patients with advanced/recurrent endometrial cancer. Method(s): We designed a Markov model to simulate treatment outcomes for advanced/recurrent endometrial cancer patients whose tumors are either microsatellite stable (MSS) or have high microsatellite instability (MSI-high). We adopted a healthcare sector perspective for the analysis. Model inputs for costs, health utility, and clinical estimates were obtained from the literature including data from GOG0209 and KEYNOTE-146. Primary outcomes included costs of care, quality-adjusted life years (QALYs), and the incremental cost-effectiveness ratio (ICER). The time-horizon was three years and the discount rate was 3% annually. Result(s): In a MSS cohort, compared to C/T, first-line treatment with P/L increased treatment costs by $212,670 and decreased QALYs by 0.28 per patient. In a MSI-high cohort, compared to C/T, P/L increased costs by $313,487 and increased QALYs by 0.11 per patient, representing an ICER of $2,849,882 per QALY. Sensitivity analyses found that the price of the new drugs was the most important determinant of the ICER and that the price of the new drugs would need to decrease by 85% to $2817 per cycle to reach a $150,000/QALY threshold. Conclusion(s): In the MSS model, we found that first-line therapy for advanced or recurrent endometrial cancer with P/L increased costs and worsened outcomes compared to C/T. In the MSI-high model, P/L improved survival and QALYs compared to C/T but was not cost-effective at the current cost of the drugs.Copyright © 2021 Elsevier Inc.

Acquarulo, E. L., et al. (2024). "The efficacy of purified pollen extract for reducing vasomotor symptoms in women: a systematic review and meta-analysis." Menopause 31(2): 154-159.
	Importance: Menopause impacts the quality of life for women, with symptoms varying from hot flashes to night disturbances. When menopausal hormonal therapy is contraindicated or women refuse menopausal hormonal therapy, many consider alternatives such as pollen extract for treating vasomotor symptoms. Objective(s): This meta-analysis focuses on the impact of using purified pollen extract as a treatment option to reduce vasomotor symptoms in women, specifically focusing on symptoms such as hot flashes, night disturbances, myalgias, and depression. Evidence Review: A comprehensive literature search was conducted using the following Boolean search string "women OR females" AND "purified pollen OR pollen extract OR cytoplasmic pollen OR Bonafide OR Femal OR Estroven OR Serelys" AND "menopausal symptoms OR vasomotor symptoms OR hot flashes OR night sweats OR sleep disturbance." Publications in English from 2003 to the present were included. To assess the risk of bias, authors used the Cochrane Risk-of-Bias 2 for a randomized controlled trial and Risk-of-Bias in Non-Randomized Studies of Interventions (ROBINS-I) for observational studies. Using ReviewManager, a Der Simonian-Laird random-effects model meta-analysis was conducted to determine the standardized mean differences (SMDs) in the outcomes for each study. Finding(s): Five articles were retained: one randomized controlled trial and four observational studies (N = 420). An overall decrease in scores from the baseline of studies compared with a 3-month follow-up after purified cytoplasm of pollen (PCP) treatment was recognized when compiling the data. Overall, there was significant improvement across all outcomes at 3 months: hot flashes demonstrated an overall improvement in SMD of -1.66 (P < 0.00001), night disturbance scores were improved with an SMD of -1.10 (P < 0.0001), depression scores were improved with an SMD of -1.31 (P < 0.0001), and myalgia had an improvement in SMD of -0.40 (P < 0.00001). When controlled studies were pooled for meta-analysis, outcomes, however, were no longer statistically significant. Conclusions and Relevance: Evaluating the risk-to-benefit ratio of alternative therapies, such as PCP extract, is important to care for women who cannot take traditional vasomotor symptom therapies. Pooled data from controlled studies evaluating PCP extract suggest that vasomotor symptom improvements seen in noncontrolled studies may have been due to the placebo effect; however, its use was not associated with significant adverse effects.Copyright © 2024 by The Menopause Society.

Acs, J., et al. (2023). "Safety and Efficacy of Vaginal Implants in Pelvic Organ Prolapse Surgery: A Meta-analysis of 161 536 Patients." European Urology Focus.
	Context: Among the many surgical treatments for pelvic organ prolapse (POP), better results can be achieved with the use of vaginal implants. However, owing to perceived complications, vaginal implant surgeries have been restricted or banned in many countries. Objective(s): To assess the real value of vaginal implants in POP surgery and compare the safety and efficacy of operations with and without implants. Evidence Acquisition: A systematic search was performed in three medical databases. Randomised controlled trials and observational studies comparing the safety and efficacy of vaginal POP surgery with implants versus native tissue were included. Safety outcomes were defined as different types of complications (functional and non-functional) and reoperations for complications. Efficacy outcomes were parameters of anatomical success and the rate of reoperations due to recurrence. A multivariate meta-analysis framework was used to estimate pooled odds ratios (ORs) with confidence intervals (CIs) with simultaneous control for study correlations and estimation of multiple correlated outcomes. Evidence Synthesis: We included 50 comparative studies in the analysis. Rates of reoperation for complications (OR 2.15, 95% CI 1.20-3.87), vaginal erosion (OR 14.05, 95% CI 9.07-21.77), vaginal bleeding (OR 1.67, 95% CI 1.25-2.23), and de novo stress urinary incontinence (OR 1.44, 95% CI 1.18-1.75) were significantly higher in the implant group. Rates of anatomical success (OR 3.22, 95% CI 2.06-5.0) and reoperation for recurrence (OR 0.55, 95% CI 0.36-0.85) were superior in the implant group. Conclusion(s): POP surgeries with vaginal implants are more effective than surgeries without implants, with acceptable complication rates. Therefore, the complete prohibition of implants for POP surgeries should be reconsidered. Patient Summary: We compared vaginal surgery with and without implants for repair of pelvic organ prolapse. Despite higher complication rates, vaginal implants provide better long-term results overall than surgery without implants.Copyright © 2023 The Author(s)

Adeeba, S., et al. (2022). "Role of different physical therapy interventions in treatment of primary Dysmenorrhgea: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Adi, G., et al. (2021). "Effectiveness of Surgery for Infertile Women with Moderate-Severe Endometriosis - a Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Adina, J., et al. (2022). "Effect of Parenting Interventions on Perinatal Depression and Implications for Infant Developmental Outcomes: A Systematic Review and Meta-Analysis." Clinical Child and Family Psychology Review 25(2): 316-338.
	Considering the significant impact of perinatal depression on both maternal wellbeing and infant development, it is important to examine the effectiveness of interventions designed to prevent or reduce these risks. This systematic review and meta-analysis synthesised evidence on parenting intervention in relation to how such programs affect symptoms of perinatal depression and infant outcomes within 12 months of postpartum. We followed the Cochrane Collaboration guidelines on conducting systematic reviews and meta-analyses. A total of five electronic databases were searched for controlled trials that met pre-determined eligibility criteria. Outcomes of interest were maternal depressive symptoms and infants' language, motor and socioemotional development. Seventeen studies involving 1665 participants were included in the systematic review. Estimates from a random effects model of 15 studies in the final meta-analysis revealed statistically significant reductions in maternal depressive symptoms at post-intervention for mothers allocated to receive parenting interventions (SMD=- 0.34, 95%CI- 0.44, - 0.24; z=5.97, p<0.001; I2=0%). Data on infant development outcomes from the included studies were scarce, and therefore, infant outcomes were not analysed in this review. For individual study outcomes, the majority of studies reported a general trend for reductions in maternal depressive symptoms from pre- to post-intervention. Although parenting interventions are frequently considered preventive strategies that are designed to offer support to parents and impart skills that promote their physical and psychological wellbeing, our findings suggest that these interventions have a positive effect on perinatal depressive symptoms. Implications and recommendations for future research are addressed. The systematic review protocol was registered with PROSPERO 2020 CRD42020184491.Copyright © 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Aditi, M. and S. Sunita (2021). "Physiotherapy and Rehabilitation impact on Quality of life of patients suffering from Endometriosis: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Adriele Souza de, S., et al. (2021). "Pilates Method in primary dysmenorrhea." PROSPERO International prospective register of systematic reviews.
	
Afifirad, R., et al. (2022). "Effects of Pro/Prebiotics Alone over Pro/Prebiotics Combined with Conventional Antibiotic Therapy to Treat Bacterial Vaginosis: A Systematic Review." International Journal of Clinical Practice 2022: 4774783.
	Background: Bacterial vaginosis (BV), caused by an imbalance in the vaginal microbiota, can be treated and prevented by probiotics. Pregnant women with BV can experience premature labor and spontaneous abortions. Probiotics and prebiotics promote the proliferation of beneficial microorganisms, alter the composition of the vaginal microbiota, and prevent intravaginal infections in postmenopausal women. In addition to reducing infection symptoms, pre/probiotics can also help prevent vaginal infections.; Materials and Methods: A systematic review was conducted on studies from 2010 to 2020 to determine the efficacy of pre/probiotics on the treatment of BV in pregnant and nonpregnant women. The databases Medline, Scopus, Embase, and Google Scholar were systematically searched using the following keywords: "bacterial vaginosis," "probiotics," "prebiotics," and "synbiotics."; Results: A total of 1,871 articles were found in the initial search, and 24 clinical trials were considered eligible. In studies comparing the effects of pre/probiotics and placebos with or without antibiotic therapy in patients with BV, significant differences in clinical outcomes were observed. Probiotics reduced the levels of IL-1 β and IL-6, as well as the overall Nugent score and Amsel's criteria for restitution of a balanced vaginal microbiota. In addition, probiotics can reduce the vaginal colonization of Group B streptococci among pregnant women. In subjects treated with probiotics, BV cure rates were higher than those in subjects treated with antibiotics. There were no additional adverse events.; Conclusion: Pre/probiotic regimens, when used for BV treatment, are usually safe and can exhibit long-term and short-term benefits. In order to prove the benefits of pre/probiotics in BV treatment, additional high-quality research is required.; Competing Interests: The authors declare that there are no conflicts of interest. (Copyright © 2022 Roghayeh Afifirad et al.)

Agarwal, S. K., et al. (2021). "Endometriosis-related pain reduction during bleeding and nonbleeding days in women treated with elagolix." Journal of Pain Research 14: 263‐271.
	Objective: In this post hoc analysis, we evaluated the impact of elagolix on dysmenorrhea and nonmenstrual pelvic pain across menstrual period (bleeding days) and nonmenstrual (nonbleeding) days. Methods: Data from two randomized, 6‐month, placebo‐controlled trials (Elaris Endometriosis (EM)‐I and EM‐II) of elagolix (150 mg once daily (QD) and 200 mg twice daily (BID)) in premenopausal women with moderate to severe endometriosis‐associated pain (N = 1686) were pooled. Women recorded the presence of menstrual period and severity of dysmenorrhea or nonmenstrual pelvic pain in a daily electronic diary. Results: At baseline, women in the placebo group and both elagolix treatment groups reported moderate or severe dysmenorrhea, on average, 81% of their menstrual period days and moderate/severe nonmenstrual pelvic pain, on average, 56% of their nonmenstrual (nonbleeding) days. Compared with placebo at month 6, elagolix‐treated women had a significantly lower mean (standard deviation (SD)) percentage of menstrual period days with moderate or severe dysmenorrhea (elagolix 150 mg QD = 52.4 (38.9), p = 0.002; elagolix 200 mg BID = 38.5 (43.6), p <0.001, placebo = 61.3 (33.7)) and a significantly lower mean (SD) percentage of nonmenstrual (nonbleeding) days with moderate or severe nonmenstrual pelvic pain (elagolix 150 mg QD = 31.1 (35.8), p < 0.001; elagolix 200 mg BID = 19.7 (29.9), p < 0.001; placebo = 35.6 (33.9)). Conclusion: Following 6 months of elagolix treatment, women who still menstruated had a lower proportion of menstrual period days with moderate or severe dysmenorrhea compared with placebo, demonstrating pain reduction despite continued menses. Additionally, pain did not shift from dysmenorrhea to nonmenstrual pelvic pain, as the percentage of days with moderate or severe nonmenstrual pelvic pain was also reduced for elagolix‐treated women compared with placebo. Trial Registration: The Elaris EM‐I study is registered with the US National Library of Medicine, www.ClinicalTrials.gov, NCT01620528. The Elaris EM‐II study is registered with the US National Library of Medicine, www.ClinicalTrials.gov, NCT01931670. Both studies are registered with the EU Clinical Trial Register, www.clinicaltrialsregister.ed, 2011‐004295‐11.

Agnew, H., et al. (2023). "Interventions for weight reduction in obesity to improve survival in women with endometrial cancer." The Cochrane Database of Systematic Reviews 3: CD012513.
	Background: This is an updated version of the original Cochrane Review published in Issue 2, 2018. Diagnoses of endometrial cancer are increasing secondary to the rising prevalence of obesity. Obesity plays an important role in promoting the development of endometrial cancer, by inducing a state of unopposed oestrogen excess, insulin resistance and inflammation. It also affects treatment, increasing the risk of surgical complications and the complexity of radiotherapy planning, and may additionally impact on subsequent survival. Weight-loss interventions have been associated with improvements in breast and colorectal cancer-specific survival, as well as a reduction in the risk of cardiovascular disease, which is a frequent cause of death in endometrial cancer survivors.; Objectives: To evaluate the benefits and harm of weight-loss interventions, in addition to standard management, on overall survival and the frequency of adverse events in women with endometrial cancer who are overweight or obese compared with any other intervention, usual care, or placebo.; Search Methods: We used standard, extensive Cochrane search methods. The latest search date was from January 2018 to June 2022 (original review searched from inception to January 2018).; Selection Criteria: We included randomised controlled trials (RCTs) of interventions to facilitate weight loss in women with endometrial cancer who are overweight or obese undergoing treatment for, or previously treated for, endometrial cancer compared with any other intervention, usual care, or placebo. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. overall survival and 2. frequency of adverse events. Our secondary outcomes were 3. recurrence-free survival, 4. cancer-specific survival, 5. weight loss, 6. cardiovascular and metabolic event frequency and 7. quality of Life. We used GRADE to assess certainty of evidence. We contacted study authors to obtain missing data, including details of any adverse events.; Main Results: We identified nine new RCTs and combined these with the three RCTs identified in the original review. Seven studies are ongoing. The 12 RCTs randomised 610 women with endometrial cancer who were overweight or obese. All studies compared combined behavioural and lifestyle interventions designed to facilitate weight loss through dietary modification and increased physical activity with usual care. Included RCTs were of low or very low quality, due to high risk of bias by failing to blind participants, personnel and outcome assessors, and significant loss to follow-up (withdrawal rate up to 28% and missing data up to 65%, largely due to the effects of the COVID-19 pandemic). Importantly, the short duration of follow-up limits the directness of the evidence in evaluating the impact of these interventions on any of the survival and other longer-term outcomes. Combined behaviour and lifestyle interventions were not associated with improved overall survival compared with usual care at 24 months (risk ratio (RR) mortality, 0.23, 95% confidence interval (CI) 0.01 to 4.55, P = 0.34; 1 RCT, 37 participants; very low-certainty evidence). There was no evidence that such interventions were associated with improvements in cancer-specific survival or cardiovascular event frequency as the studies reported no cancer-related deaths, myocardial infarctions or strokes, and there was only one episode of congestive heart failure at six months (RR 3.47, 95% CI 0.15 to 82.21; P = 0.44, 5 RCTs, 211 participants; low-certainty evidence). Only one RCT reported recurrence-free survival; however, there were no events. Combined behaviour and lifestyle interventions were not associated with significant weight loss at either six or 12 months compared with usual care (at six months: mean difference (MD) -1.39 kg, 95% CI -4.04 to 1.26; P = 0.30, I 2 = 32%; 5 RCTs, 209 participants; low-certainty evidence). Combined behaviour and lifestyle interventions were not associated with increased quality of life, when measured using 12-item Short Form (SF-1 ) Physical Health questionnaire, SF-12 Mental Health questionnaire, Cancer-Related Body Image Scale, Patient Health Questionnaire 9-Item Version or Functional Assessment of Cancer Therapy - General (FACT-G) at 12 months when compared with usual care (FACT-G: MD 2.77, 95% CI -0.65 to 6.20; P = 0.11, I 2 = 0%; 2 RCTs, 89 participants; very low-certainty evidence). The trials reported no serious adverse events related to weight loss interventions, for example hospitalisation or deaths. It is uncertain whether lifestyle and behavioural interventions were associated with a higher or lower risk of musculoskeletal symptoms (RR 19.03, 95% CI 1.17 to 310.52; P = 0.04; 8 RCTs, 315 participants; very low-certainty evidence; note: 7 studies reported musculoskeletal symptoms but recorded 0 events in both groups. Thus, the RR and CIs were calculated from 1 study rather than 8). AUTHORS' CONCLUSIONS: The inclusion of new relevant studies has not changed the conclusions of this review. There is currently insufficient high-quality evidence to determine the effect of combined lifestyle and behavioural interventions on survival, quality of life or significant weight loss in women with a history of endometrial cancer who are overweight or obese compared to those receiving usual care. The limited evidence suggests that there is little or no serious or life-threatening adverse effects due to these interventions, and it is uncertain if musculoskeletal problems were increased, as only one out of eight studies reporting this outcome had any events. Our conclusion is based on low- and very low-certainty evidence from a small number of trials and few women. Therefore, we have very little confidence in the evidence: the true effect of weight-loss interventions in women with endometrial cancer and obesity is currently unknown. Further methodologically rigorous, adequately powered RCTs are required with follow-up of five to 10 years of duration. These should focus on the effects of varying dietary modification regimens, and pharmacological treatments associated with weight loss and bariatric surgery on survival, quality of life, weight loss and adverse events. (Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Agnieszka, M.-B. and T. Sabina (2023). "Physiotherapy in endometriosis - as an effective method of supporting traditional treatment: a systematic review." PROSPERO International prospective register of systematic reviews.
	
aharon, d., et al. (2021). "Comparison of Oral GnRH Antagonist, Injectable GnRH Agonists and Dienogest for Endometriosis Associated Pain: A Meta-Analysis and Network Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Ahlström, A., et al. (2022). "A double-blind randomized controlled trial investigating a time-lapse algorithm for selecting Day 5 blastocysts for transfer." Human Reproduction 37(4): 708-717.
	Study Question: Can use of a commercially available time-lapse algorithm for Day 5 blastocyst selection improve pregnancy rates compared with morphology alone?; Summary Answer: The use of a time-lapse selection model to choose blastocysts for fresh single embryo transfer on Day 5 did not improve ongoing pregnancy rate compared to morphology alone.; What Is Known Already: Evidence from time-lapse monitoring suggests correlations between timing of key developmental events and embryo viability. No good quality evidence exists to support improved pregnancy rates following time-lapse selection.; Study Design, Size, Duration: A prospective multicenter randomized controlled trial including 776 randomized patients was performed between 2018 and 2021. Patients with at least two good quality blastocysts on Day 5 were allocated by a computer randomization program in a proportion of 1:1 into either the control group, whereby single blastocysts were selected for transfer by morphology alone, or the intervention group whereby final selection was decided by a commercially available time-lapse model. The embryologists at the time of blastocyst morphological scoring were blinded to which study group the patients would be randomized, and the physician and patients were blind to which group they were allocated until after the primary outcome was known. The primary outcome was number of ongoing pregnancies in the two groups.; Participants/materials, Setting, Methods: From 10 Nordic IVF clinics, 776 patients with a minimum of two good quality blastocysts on Day 5 (D5) were randomized into one of the two study groups. A commercial time-lapse model decided the final selection of blastocysts for 387 patients in the intervention (time-lapse) group, and blastocysts with the highest morphological score were transferred for 389 patients in the control group. Only single embryo transfers in fresh cycles were performed.; Main Results and the Role of Chance: In the full analysis set, the ongoing pregnancy rate for the time-lapse group was 47.4% (175/369) and 48.1% (181/376) in the control group. No statistically significant difference was found between the two groups: mean difference -0.7% (95% CI -8.2, 6.7, P = 0.90). Pregnancy rate (60.2% versus 59.0%, mean difference 1.1%, 95% CI -6.2, 8.4, P = 0.81) and early pregnancy loss (21.2% versus 18.5%, mean difference 2.7%, 95% CI -5.2, 10.6, P = 0.55) were the same for the time-lapse and the control group. Subgroup analyses showed that patient and treatment characteristics did not significantly affect the commercial time-lapse model D5 performance. In the time-lapse group, the choice of best blastocyst changed on 42% of occasions (154/369, 95% CI 36.9, 47.2) after the algorithm was applied, and this rate was similar for most treatment clinics.; Limitations, Reasons for Caution: During 2020, the patient recruitment rate slowed down at participating clinics owing to coronavirus disease-19 restrictions, so the target sample size was not achieved as planned and it was decided to stop the trial prematurely. The study only investigated embryo selection at the blastocyst stage on D5 in fresh IVF transfer cycles. In addition, only blastocysts of good morphological quality were considered for transfer, limiting the number of embryos for selection in both groups: also, it could be argued that this manual preselection of blastocysts limits the theoretical selection power of time-lapse, as well as restricting the results mainly to a good prognosis patient group. Most patients were aimed for blastocyst stage transfer when a minimum of five zygotes were available for extended culture. Finally, the primary clinical outcome evaluated was pregnancy to only 6-8 weeks.; Wider Implications of the Findings: The study suggests that time-lapse selection with a commercially available time-lapse model does not increase chance of ongoing pregnancy after single blastocyst transfer on Day 5 compared to morphology alone.; Study Funding/competing Interest(s): The study was financed by a grant from the Swedish state under the AL -agreement between the Swedish government and the county councils (ALFGBG-723141). Vitrolife supported the study with embryo culture dishes and culture media. During the study period, T.H. changed his employment from Livio AB to Vitrolife AB. All other authors have no conflicts of interests to disclose.; Trial Registration Number: ClinicalTrials.gov registration number NCT03445923.; Trial Registration Date: 26 February 2018.; Date of First Patient’s Enrolment: 11 June 2018. (© 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.)

Ahmed, A., et al. (2021). "The use of dienogest in treatment of symptomatic adenomyosis." PROSPERO International prospective register of systematic reviews.
	
Ahmed, E., et al. (2023). "Effectiveness of Extracorporeal shock wave on primary dysmenorrhea: Systematic Review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Ahmed, I., et al. (2022). "The efficacy of Coenzyme Q10 in improving hormonal and metabolic profile in patients with Polycystic Ovary Syndrome, a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Ahmed, M. and M. Safaa (2023). "Endometrial injury in infertile women trying to conceive through intrauterine insemination." PROSPERO International prospective register of systematic reviews.
	
Ahmed, M. and L. Yossra (2023). "Endometrial injury in infertile women trying to conceive through natural or ovulation induction cycles." PROSPERO International prospective register of systematic reviews.
	
Ahmed, S., et al. (2022). "Effectiveness of Aerobic exercises on primary dysmenorrhea." PROSPERO International prospective register of systematic reviews.
	
Áine, A. and H. Suzanne (2023). "Behavioural and psychological interventions for parental trauma following perinatal loss: A systematic review and narrative synthesis." PROSPERO International prospective register of systematic reviews.
	
Ainehchi, N., et al. (2019). "The effect of herbal medicine supplementation on clinical and para-clinical outcomes in women with PCOS: A systematic review and meta-analysis." International Journal of Women's Health and Reproduction Sciences 7(4): 423-433.
	Objectives: The aim of this study is to assess the impact of Cinnamomum verum, Mentha spicata, Zingiberene officinal on polycystic ovary syndrome (PCOS) treatment. Material(s) and Method(s): MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, Scopus, Web of Science, Google Scholar, ProQuest, Clinicaltrial.gov, and for Persian articles SID, Magiran, Irandoc, and Iranmedex were searched without any time limitation. Result(s): Thirteen randomized controlled trials (RCTs) consisting 668 women were entered in the meta-analysis. Significant differences in fasting blood sugar (FBS; weighted mean difference (WMD)=-3.69 mg/dL, 95% CI:-6.67 to-0.7, P = 0.02; 241 participants), fasting insulin (WMD =-4.53 microIU/mL, 95% CI:-6.45 to-2.61, P < 0.001;183 participants), triglyceride (TG; WMD =-17.97 mg/ dL, 95% CI:-30.51 to-5.43, P = 0.005;183 participants), total cholesterol (TC; WMD=-14.60 mg/dL, 95% CI:-22.93 to-6.26, P = 0.0006; 183 participants), low-density lipoprotein cholesterol (LDL; WMD =-16.58 mg/dL, 95% CI-23.91 to-9.24, P < 0.001; 183 participants), malondialdehyde (MDA; WMD =-0.25 nmol/ml, 95% CI-0.41 to-0.09, P < 0.002;124 participants), total testosterone (TT; WMD =-0.18 ng/mL, 95% CI-0.27 to-0.09, P < 0.001; 116 participants), free testosterone (FT; WMD =-5.47 pg/mL, 95% CI-8.34 to-2.61, P = 0.0002;78 participants) were obtained by using cinnamon alone and herbal mixture containing cinnamon in comparison to control. Conclusion(s): This meta-analysis showed that cinnamon alone and herbal mixture containing cinnamon improve level of FBS, fasting insulin, TG, TC, LDL, MDA, TT, and FT serum level.Copyright © 2019 The Author (s).

Akar, E. (2023). "360 Degree Expanded Diaphragm Breathing Pattern Training in Individuals With Urinary Incontinence." ClinicalTrials.gov.
	66 people with a score of 3 or higher on the Incontinence Severity Index will be included in the study. All participants will complete the King Health Questionnaire and Incontinence Quality of Life Questionnaires. The control group will consist of 33 people and will apply only Kegel exercises 2 sets a day, 3 days a week for 8 weeks. The experimental group will consist of 33 people and the participants will apply Kegel exercises for 8 weeks, 3 days a week, 2 sets a day. In addition to this, 360 degree expanded diaphragm breathing training will be given to the experimental group. Practices for using this breathing pattern will be done 2 sets per day, each set for 10 minutes. At the end of 8 weeks, all 3 questionnaires will be asked to be filled again. The variation between the initial results and the final results, as well as the differences between the final changes, will also be compared.

Aksu, A. and Y. Vefikulucay (2024). "The effect of yoga practice on pain intensity, menstruation symptoms and quality of life of nursing students with primary dysmenorrhea." Health Care for Women International: 1-15.
	The researchers aimed to determine the effects of yoga on pain severity, menstrual symptoms and quality of life of undergraduate nursing students with primary dysmenorrhea. The 60 female students were divided into intervention (n=30) and control groups (n=30) by block randomization. In the study, data were evaluated with the Visual Analog Scale for Pain, the Menstruation Symptom Scale and the Short Form-36 Health Survey Scale. The 12-week intervention program, which included all components of Hatha yoga, was carried out twice a week for a total of 24 sessions of 60min. The control group did not receive any intervention. The severity of menstrual pain and symptoms decreased in yoga group compared to control group, and there were significant improvements in quality of life (p<0.001). The researchers shows that regular Hatha yoga may be a possible nonpharmacological treatment for primary dysmenorrhea in young women in this study.

Al Khalifah Reem, A., et al. (2020). "Efficacy of Treatments for Polycystic Ovarian Syndrome Management in Adolescents." Journal of the Endocrine Society 5(1): bvaa155.
	Limited evidence on treatment options for polycystic ovarian syndrome (PCOS) has led to considerable variation in health care practices. We aimed to compare the effects of metformin and/or oral contraceptive pills (OCP) in combination with pioglitazone, spironolactone, flutamide, and lifestyle interventions among adolescents aged 11 to 19 years with PCOS. Literature searches were performed in Medline, Embase, and the Cochrane Central Register of Controlled Trials from database inception through December 2018, with no language restriction. Two reviewers screened titles and abstracts, assessed full text eligibility, and extracted information from eligible trials. Evidence was synthesized through network meta-analyses (NMA) using a Bayesian random-effects approach. We identified 37 randomized controlled trials, in which 2400 patients were randomized. NMA showed no statistically important difference among all interventions to improve menstrual regulation or body mass index. Moderate-quality evidence showed hirsutism scores were reduced by multiple interventions that included single and combination medications namely; lifestyle intervention, metformin, OCP, spironolactone, pioglitazone, metformin-OCP, metformin-spironolactone, and metformin-flutamide against placebo. Moderate-quality evidence showed OCP results in more dysglycemia compared to metformin (odds ratio, 2.98; 95% credible interval, 1.02-8.96), no intervention resulted in dysglycemia reduction. In conclusion, metformin and OCP as monotherapy or in combination with other interventions compared with placebo can reduce hirsutism scores, but none of these medications lead to effective menstrual cycle regulation or weight reduction. However, the use of OCP leads to worse cardiometabolic risk factors. Further research into new treatment options is urgently needed.; Prospero Registration Number: CRD42015016148. (© The Author(s) 2020. Published by Oxford University Press on behalf of the Endocrine Society.)

Al Wattar Bassel, H., et al. (2019). "Management of first-trimester miscarriage: a systematic review and network meta-analysis." Human Reproduction Update 25(3): 362-374.
	Background: First-trimester miscarriage affects up to a quarter of women worldwide. With many competing treatment options available, there is a need for a comprehensive evidence synthesis.; Objectives and Rationale: We conducted a systematic review and network meta-analysis to assess the effectiveness and safety of treatment options for first-trimester miscarriage: expectant management (EXP), sharp dilation and curettage (D+C), electric vacuum aspiration (EVAC), manual vacuum aspiration (MVA), misoprostol alone (MISO), mifepristone+misoprostol (MIFE+MISO) and misoprostol plus electric vacuum aspiration (MISO+EVAC).; Search Methods: We searched MEDLINE, Embase, CINAHL, AMED and Cochrane Library from inception till June 2018. We included randomized trials of women with first-trimester miscarriage (<14 weeks gestation) and conducted a network meta-analysis generating both direct and mixed evidence on the effectiveness and side effects of available treatment options. The primary outcome was complete evacuation of products of conception. We assessed the risk of bias and the global network inconsistency. We compared the surface under the cumulative ranking curve (SUCRA) for each treatment.; Outcomes: A total of 46 trials (9250 women) were included. The quality of included studies was overall moderate with some studies demonstrating a high risk of bias. We detected unexplained inconsistency in evidence loops involving MIFE+MISO and adjusted for it. EXP had lower effectiveness compared to other treatment options. The effectiveness of medical treatments was similar compared to surgery. Mixed evidence of low confidence suggests increased effectiveness for MIFE+MISO compared to MISO alone (RR 1.49, 95% CI: 1.09-2.03). Side effects were similar among all options. Fewer women needed analgesia following EVAC compared to MISO (RR for MISO 0.43, 95% CI: 0.27-0.68) and in the EXP group compared to EVAC (RR 2.07, 95% CI: 1.25-3.41). MVA had higher ranking (low likelihood) for post-treatment infection and serious complications (SUCRA 87.6 and 79.2%, respectively) with the highest likelihood for post-treatment satisfaction (SUCRA 98%).; Wider Implications: Medical treatments for first-trimester miscarriage have similar effectiveness and side effects compared to surgery. The addition of MIFE could increase the effectiveness of MISO and reduce side effects, although evidence is limited due to inconsistency. EXP has lower effectiveness compared to other treatment options.Systematic review registration: Prospero CRD42016048920. (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Al Wattar, B. H., et al. (2024). "Effectiveness of treatment options for tubal ectopic pregnancy: A systematic review and network meta-analysis." BJOG: An International Journal of Obstetrics and Gynaecology 131(1): 5-14.
	Background: Tubal ectopic pregnancy (TEP) is a common gynaecological emergency. Several medical and surgical treatment options exist, but it is not clear which is the safest and most effective treatment. Objective(s): To compare the effectiveness of expectant, medical and surgical treatment options for TEP using a systematic review and network meta-analysis. Search Strategy: MEDLINE, EMBASE, and CENTRAL from inception till September 2022. Selection Criteria: Randomised trials that evaluated any treatment option for woman with a TEP. Data Collection and Analysis: We performed pairwise and network meta-analyses using a random effect model. We assessed the studies' risk of bias, heterogeneity and network inconsistency. We reported primarily on TEP resolution and treatment failure using relative risk (RR) and 95% confidence-intervals (CI). Main Result(s): We included 31 randomised trials evaluating ten treatments (n = 2938 women). Direct meta-analysis showed no significant benefit for using methotrexate compared to expectant management for TEP resolution. Network meta-analysis showed similar effect-size for most conservative treatment options compared to expectant management for TEP resolution (glucose intra-sac instillation vs. expectant RR 0.84, 95% CI 0.63-1.12; methotrexate intra-sac instillation vs. expectant RR 0.91, 95% CI 0.75-1.10; multi-dose methotrexate vs. expectant RR 1.00, 95% CI 0.88-1.15; prostaglandin intra-sac instillation vs. expectant RR 0.75, 95% CI 0.53-1.07; salpingotomy vs. expectant RR 0.99, 95% CI 0.84-1.16; single dose methotrexate vs. expectant RR 0.97, 95% CI 0.85-1.10; single dose methotrexate + mifepristone vs. expectant RR 1.09, 95% CI 0.89-1.33). All treatment options showed a higher risk of failure compared to salpingectomy. Conclusion(s): There is insufficient evidence to support the use of any medical treatment option for TEP over expectant management.Copyright © 2023 John Wiley & Sons Ltd.

Albalawi Nada, S., et al. (2023). "Comparison of the Efficacy of Vaginal Hyaluronic Acid to Estrogen for the Treatment of Vaginal Atrophy in Postmenopausal Women: A Systematic Review." Cureus 15(8): e44191.
	Topical estrogen is effective for treating postmenopausal vaginal atrophy. However, there is a potential risk of estrogen-related adverse effects. There is a need for finding effective non-hormonal treatment for vaginal atrophy. The topical application of moisturising agents, such as hyaluronic acid (HA), represents a promising non-hormonal treatment for the relief of vaginal atrophy. This study aimed to summarize the evidence regarding the efficacy of topical HA compared to topical estrogen in postmenopausal women with vaginal atrophy. The literature search covered English-published studies from database inception till February 2023. The search included the electronic databases of MEDLINE/PubMed, Cochrane Library, Web of Science, ProQuest, and Scopus, using the terms "Hyaluronic Acid" AND "Postmenopause" AND "Vagina" AND "Atrophy". Due to the diversity in reporting outcomes, meta-analysis was not feasible. A narrative synthesis with a systematic approach was conducted by vote counting of studies that included a direct comparison between topical HA and topical estrogen. Six studies were included. Intra-group comparisons showed that both interventions were significantly effective in alleviating the symptoms of vaginal atrophy and dyspareunia as well as improving vaginal pH and cell maturation index. However, inter-group comparisons in most studies showed that estrogen was superior to HA in relieving vaginal symptoms and improving vaginal pH, dyspareunia, and the cell maturation index. There is no evidence to show the superiority of HA to estrogen in the treatment of postmenopausal vaginal atrophy. However, the therapeutic efficacy of HA seems to be comparable to estrogen and considering its safety, HA can be used as an alternative to estrogen in patients who do not want to use estrogen. The available studies have several limitations, and the reporting of outcomes was considerably heterogeneous.; Competing Interests: The authors have declared that no competing interests exist. (Copyright © 2023, Albalawi et al.)

Albayati, S., et al. (2019). "Robotic vs. laparoscopic ventral mesh rectopexy for external rectal prolapse and rectal intussusception: a systematic review." Techniques in Coloproctology 23(6): 529-535.
	Background: Laparoscopic ventral mesh rectopexy (LVR) is a treatment with promising results in external rectal prolapse, rectal intussusception, and rectocele. Because of the emergence of robotic-assisted surgery and the technical advantage it provides, we examined the potential role and place of robotic surgery in ventral rectopexy.; Methods: MEDLINE, PubMed, and other databases were searched, by two independent reviewers, to identify studies comparing robotic to laparoscopic ventral mesh rectopexy. The primary outcome was the rate of unplanned conversion to open. The secondary outcomes were morbidity, length of hospital stay and recurrence rate.; Results: Five studies (4% male, n = 259) met the inclusion criteria. All 5 studies reported on conversion rate and showed no significant difference between the conversion rate of robotic and laparoscopic groups [OR 0.58 (95% CI 0.09-3.77)]. Robotic surgery was also similar to laparoscopic surgery for both morbidity [OR 0.71 (95% CI 0.34-1.48)] and recurrence rate [OR 0.56 (95% CI 0.18-1.75)]. Operative time was longer in the robotic group with a MWD of 22.88 minutes (CI 5.73-40.04, p < 0.0007). There was a statistically significant reduction in length of stay with robotic surgery [mean difference - 0.36 days (95% CI - 0.66 to - 0.07)].; Conclusions: This systematic review shows that robotic-assisted ventral rectopexy requires longer operative time with no significant added benefit over laparoscopic ventral rectopexy. The conversion rate was low in both groups and the trends to benefit did not reach statistical significance. More studies are required to clarify whether the potential technical advantage of robotic surgery in ventral rectopexy translates to an improvement in clinical outcome.

Albrecht Helmut, H. (2022). "FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms." ClinicalTrials.gov.
	This randomized, double‐blind, parallel‐group, placebo‐controlled, clinical trial is designed to compare patient‐reported changes in Vasomotor Symptoms (VMS) for FP‐101 vs. placebo in peri‐ and post‐menopausal women. The study will be run as a fully decentralized clinical trial (DCT), by use of components such as electronic Consent (eConsent), mobile/tele health visits, electronic Patient Reported Outcomes (ePROs), and direct‐to‐participant shipping of the (investigational medicinal product (IMP). The DCT approach to this study will rely on a digital platform through which subjects can consent, enroll, and interact with the PI and study staff. Proper regulatory framework and technology use will ensure compliance with Good Clinical Practice (GCP), ethics & legal/regulatory requirements. Healthy peri‐ and post‐menopausal women (>45 years of age) suffering from VMS will be recruited if they have >=7‐ 8 moderate to severe hot flushes per day at baseline. After meeting all eligibility criteria subjects will be enrolled and start a 1‐week run‐in period to identify/eliminate placebo responders, as well as to exclude subjects who have difficulty completing the eDiary. Any Adverse Events (AEs) during the run‐in period will serve as baseline for the safety assessments at the end of the treatment period. Eligible subjects will undergo a tele health baseline visit during which the criteria for inclusion in the treatment period will be confirmed. Over a 1‐week treatment period, subjects will complete a daily electronic Diary (eDiary) to record any AEs and the frequency and severity of hot flashes during the past 12hr interval. In the morning, subjects will record the number of awakenings during the past night and the number of night sweats. The PI will conduct an end‐of‐study visit with each of the subjects randomized to the study medications to review safety and efficacy data, complete a Patient Global Improvement Scale, and clarify any open issues with the subjects. ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐

Albrechtsen Pernille, H. (2021). "Immunotherapy and radiation therapy in combination with chemotherapy in relapsed ovarian cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Code: APX005M Pharmaceutical Form: Solution for injection INN or Proposed INN: Not yet established CAS Number: 2305607‐45‐6 Current Sponsor code: APX005M Other descriptive name: APX005‐01 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ CONDITION: Patients with histologically diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer with radiologically or histologically confirmation of relapsed disease, and with known BRCA wildtype. Platinum combination therapy must be an option. ; 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) ; MedDRA version: 20.0 Level: PT Classification code 10016180 Term: Fallopian tube cancer System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 20.1 Level: PT Classification code 10080244 Term: Peritoneal cancer index System Organ Class: 10022891 ‐ Investigations Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: To evaluate the preliminary efficacy of APX005M‐carboplatin‐PLD and APX005M‐radiotherapy‐carboplatin‐PLD combinations by overall response rate (ORR) at 12 weeks Primary end point(s): Overall Response Rate (ORR) at 12 weeks Secondary Objective: ‐ To evaluate the preliminary efficacy of APX005M‐carboplatin‐PLD and APX005M‐radiotherapy‐carboplatin‐PLD combinations by overall response rate (ORR) at 24 weeks, progression‐free survival (PFS), and disease control rate (DCR); ‐ To evaluate safety; ‐ To evaluate Patient Reported Outcomes (PROs) in treatment arms; Exploratory/Translational research:; ‐ To describe genetic, molecular and immunological mechanisms in blood and tumor; ‐ To explore the efficacy of APX005M in combination in the molecular and immunological subgroups; Timepoint(s) of evaluation of this end point: 12 weeks SECONDARY OUTCOME: Secondary end point(s): 1. ORR at 24 weeks; 2. Progression‐free survival (PFS); 3. Disease control rate (DCR); 4. Adverse Events until 30 days after last dose of study drug(s); 5. Patient Reported Outcomes (PROs) by EORTC QLQ C30 and OV28 overall measures and single items at baseline and every 12 weeks; 6. Changes in molecular and immunological markers of response and/or resistance over time; 7. Changes in molecular and immunological markers and efficacy and/or resistance to treatment in defined subgroups Timepoint(s) of evaluation of this end point: 1. 24 weeks; 2. 24 months; 3. 12 weeks and 24 weeks; 4. 30 days after last dose; 5. 24 months; 6. 24 weeks; 7. 24 weeks INCLUSION CRITERIA: 1. Have signed an Institutional Review Board/Independent Ethics Committee‐approved informed consent form prior to any study‐specific evaluation. 2. Histologically diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer. 3. Radiological or histological confirmation of relapse disease = 6 month after last chemotherapy. 4. Known BRCAwt. 5. Have completed at least one line of platinum‐containing chemotherapy (maximum 3 previous lines of therapy are permitted). Earlier PARPi and earlier bevacizumab therapies are permitted. 6. Must have measurable or evaluable disease according to RECIST 1.1. 7. Baseline biopsy: Tissue biopsy for submission to central laboratory prior to study treatment should be from a newly obtained metastatic biopsy, if there is a lesion suitable for biopsy and the subject consents to this procedure. If a metastatic biopsy is not feasible, or patient is unwilling to provide new biopsy, archival tissue samples sh

Alessandro, C., et al. (2022). "Therapeutic options for women with a diminished ovarian reserve: a systematic review and meta-analysis of randomized control trials." PROSPERO International prospective register of systematic reviews.
	
Alessandro, T., et al. (2022). "Laser therapies and genitourinary syndromes: systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Al-Hendy, A., et al. (2021). "Treatment of Uterine Fibroid Symptoms with Relugolix Combination Therapy." New England Journal of Medicine 384(7): 630‐642.
	BACKGROUND: Uterine fibroids are a common cause of heavy menstrual bleeding and pain. Treatment with the combination of relugolix (an oral gonadotropin‐releasing hormone‐receptor antagonist), estradiol, and norethindrone acetate, administered once daily, may have efficacy in women with uterine fibroids and heavy bleeding while avoiding hypoestrogenic effects. METHODS: We conducted two replicate international, double‐blind, 24‐week, phase 3 trials involving women with fibroid‐associated heavy menstrual bleeding. Participants were randomly assigned in a 1:1:1 ratio to receive once‐daily placebo, relugolix combination therapy (40 mg of relugolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate), or delayed relugolix combination therapy (40 mg of relugolix monotherapy, followed by relugolix combination therapy, each for 12 weeks). The primary efficacy end point in each trial was the percentage of participants with a response (volume of menstrual blood loss <80 ml and a ≥50% reduction in volume from baseline) in the relugolix combination therapy group, as compared with the placebo group. Key secondary end points were amenorrhea, volume of menstrual blood loss, distress from bleeding and pelvic discomfort, anemia, pain, fibroid volume, and uterine volume. Safety and bone mineral density were assessed. RESULTS: A total of 388 women in trial L1 and 382 in trial L2 underwent randomization. A total of 73% of the participants in the relugolix combination therapy group in trial L1 and 71% of those in trial L2 had a response (primary end point), as compared with 19% and 15%, respectively, of those in the placebo groups (P<0.001 for both comparisons). Both relugolix combination therapy groups had significant improvements, as compared with the placebo groups, in six of seven key secondary end points, including measures of menstrual blood loss (including amenorrhea), pain, distress from bleeding and pelvic discomfort, anemia, and uterine volume, but not fibroid volume. The incidence of adverse events was similar with relugolix combination therapy and placebo. Bone mineral density was similar with relugolix combination therapy and placebo but decreased with relugolix monotherapy. CONCLUSIONS: Once‐daily relugolix combination therapy resulted in a significant reduction in menstrual bleeding, as compared with placebo, and preserved bone mineral density in women with uterine fibroids. (Funded by Myovant Sciences; LIBERTY 1 [L1] and LIBERTY 2 [L2] ClinicalTrials.gov numbers, NCT03049735 and NCT03103087, respectively.).

Al-Hendy, A., et al. (2023). "LIBERTY randomized withdrawal study: relugolix combination therapy for heavy menstrual bleeding associated with uterine fibroids." American Journal of Obstetrics and Gynecology 229(6): 662.e661-662.e625.
	Background: In the pivotal LIBERTY 1 and 2 trials and long-term extension study, once-daily relugolix combination therapy (40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate) reduced menstrual blood loss volume and pain among women with uterine fibroids. Relugolix combination therapy was well tolerated with preservation of bone mineral density through 52 weeks.; Objective: This study aimed to report the 2-year relugolix combination therapy efficacy and safety results of the phase 3 LIBERTY randomized withdrawal study.; Study Design: Women with uterine fibroid-associated heavy menstrual bleeding who completed the 24-week LIBERTY 1 or 2 trials, followed by the 28-week long-term extension study (up to 52 weeks total treatment), and who met the responder criteria (menstrual blood loss volume <80 mL and ≥50% reduction from pivotal study baseline at week 48 [week 24 of long-term extension]) were randomized in a 1:1 ratio to either blinded treatment with relugolix combination therapy or placebo for 52 weeks (total treatment period, 104 weeks). For women who had a relapse of heavy menstrual bleeding during the study (menstrual blood loss volume ≥80 mL), open-label relugolix combination therapy was offered. The primary endpoint was the proportion of women who maintained menstrual blood loss volume <80 mL through week 76 (week 24 of randomized withdrawal study). Secondary endpoints included time to menstrual blood loss volume ≥80 mL, proportion of women who maintained a menstrual blood loss volume of <80 mL through week 104 (over the 52-week randomized treatment period), the proportion of women who achieved or maintained amenorrhea at week 76 at the end of treatment, and the change in Uterine Fibroid Symptom-Quality of Life Bleeding and Pelvic Discomfort Scale and symptom severity scores. Analyses were performed for the modified intent-to-treat population, including all randomized women who received ≥1 dose of the study drug.; Results: Of the 229 randomized women (relugolix combination therapy, n=115; placebo, n=114), 228 received the study drug and 175 (76.7%) completed the randomized withdrawal study. Through week 76, 78.4% of women on relugolix combination therapy maintained menstrual blood loss volume <80 mL vs 15.1% in the placebo group (difference, 63.4%; 95% confidence interval, 52.9%-73.9%; P<.0001). At week 104, 69.8% of women on relugolix combination therapy maintained menstrual blood loss volume <80 mL vs 11.8% in the placebo group (difference, 58.0%; 95% confidence interval, 47.0%-69.1%; P<.0001). Through week 104, 88.3% of women on placebo relapsed with heavy menstrual bleeding (median time to relapse, 5.9 weeks). Among the 89 women in the placebo group who relapsed and received open-label rescue treatment, 87 women responded to relugolix combination therapy with a menstrual blood loss volume <80 mL. The proportion of women who achieved or maintained amenorrhea were 57.4% vs 13.3% at week 76 (difference, 44.1%; 95% confidence interval, 33.10%-55.1%; P<.0001) and 58.3% vs 10.6% at week 104 (difference, 47.6%; 95% confidence interval, 37.0%-58.3%; nominal P<.0001) for relugolix combination therapy and the placebo group, respectively. Relugolix combination therapy was generally well tolerated; no new safety signals were identified, and the adverse event profile over the second year was consistent with that reported through the first year of treatment. Bone mineral density remained stable in women who received relugolix combination therapy from week 52 to week 104. In women continuously treated with relugolix combination therapy up to 2 years, bone mineral density was generally preserved.; Conclusion: After 2 years of treatment with relugolix combination therapy, there was evidence of durability of the effect in maintaining low menstrual blood loss volume in women with symptomatic uterine fibroids. Most women had return of heavy menstrual bleeding and associated symptoms after treatment cessation, which improved upon retreatment with relugolix combination therapy. Relugolix combination therapy was well tolerated, the adverse event profile remained consistent, and the mean bone mineral density was generally preserved through 2 years of treatment. (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Ali, F., et al. (2023). "Efficacy of resveratrol in women with polycystic ovary syndrome: a systematic review and meta-analysis of randomized clinical trials." The Pan African Medical Journal 44: 134.
	Polycystic ovarian syndrome (PCOS) is a metabolic and hormonal condition affecting women of a reproductive age. It causes an abnormal menstrual cycle, anovulation, infertility, acne, hirsutism, obesity, hyperlipidemia, and cardiovascular disorders. Because resveratrol decreases testosterone levels, it may be of value in treating PCOS. We aimed to evaluate the efficacy of resveratrol in treating women with PCOS. We searched for randomized clinical trials (RCTs) in PubMed, Cochrane CENTRAL, Scopus and Web of Science. With 95% confidence intervals, the data was retrieved and analyzed as a mean difference (MD) or a standardized mean difference (SMD). Four RCTs with 218 women were included in the analysis. Resveratrol significantly reduced testosterone (SMD = -0.40; 95% CI [-0.71, -0.10], P = 0.009), luteinizing hormone (LH) (SMD = -0.32; 95% CI [-0.62, 0.01], P = 0.04), and dehydroepiandrosterone sulfate (DHEAS) (MD = -0.85; 95% CI [-1.25, -0.45], P < 0.0001) compared with the placebo. Resveratrol is effective in treating women with PCOS due to reducing the levels of testosterone, LH, and DHEAS. In combination with other treatments, especially for hyperlipidemia, resveratrol is beneficial for women diagnosed with PCOS.; Competing Interests: The authors declare no competing interests. (Copyright: Hammad Ali Fadlalmola et al.)

Alife, H. (2022). "Evaluation of the Alife Hera System as an Adjunctive Tool for the Prioritization of Embryos Deemed Suitable for Transfer." ClinicalTrials.gov.
	No Results Available Device: Hera Score Primary Endpoint|Incidence of disagreement|User Experience Female Not Applicable 230 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CIP-01 April 2023

Allen, L. M., et al. (2023). "Efficacy of Behavioral Interventions for Urinary Incontinence Among Women Residing in Nursing Homes: A Systematic Review." Journal of Wound, Ostomy, and Continence Nursing 50(1): 57-65.
	PURPOSE: The purpose of this systematic review was to summarize recent evidence on the efficacy of behavioral interventions for the management of urinary incontinence (UI) among women in nursing homes. METHOD(S): Systematic review of the literature. For this review, behavioral interventions were defined as those that included some form of physical exercise or behavior modification such as scheduled toileting. SEARCH STRATEGY: A search of MEDLINE/PubMed, CINAHL, Scopus, and Cochrane Library electronic databases was conducted seeking randomized controlled trials published since 2010 in female participants residing in long-term care facilities (nursing homes, skilled nursing facilities) and diagnosed with UI. Inclusion criteria were studies that addressed the effects of voiding regimens, lower extremity strengthening, functional training, food and fluid management, and pelvic floor muscle training. Independent reviewers extracted relevant data and assessed methodological quality using the PEDro scale. FINDINGS: Five studies (pooled sample, N = 399) met inclusion criteria; mean age of participants was 81.1 +/- 6.8 years; 85% were female. The PEDro scores ranged from 6 to 9; only 2 studies included residents with cognitive impairment. Interventions included voiding strategies, increasing physical activity, functional mobility training, pelvic floor muscle training, fluid management, and multicomponent combinations of approaches. Three of the 5 studies were multicomponent interventions and 2 focused on a single intervention. Outcomes included objective measures of incontinent episodes and subjective assessments of UI severity. CONCLUSION(S): Behaviorally based interventions can be successful in improving UI among nursing residents with and with no cognitive impairment. IMPLICATIONS: Future studies should examine logistic and labor costs associated with sustaining behavioral interventions using nursing home staff and investigate the effects of these therapies using appropriate quality-of-life metrics for this population.Copyright © 2023 by the Wound, Ostomy and Continence Nurses Society.

AlMahdy AlBatool, M., et al. (2021). "Prognostic value of systematic lymphadenectomy in patients with ovarian cancer: A systematic review and meta-analysis." European Journal of Obstetrics, Gynecology, and Reproductive Biology 267: 179-185.
	Objective: To appraise clinical outcomes of systematic lymphadenectomy in women with ovarian cancer based on stage, control group and type of chemotherapy.; Study Design: A literature search was conducted on SCOPUS, PUBMED, COCHRANE, MEDLINE, and WEB OF SCIENCE databases. All comparative studies that assess outcomes of systematic lymphadenectomy in patients with ovarian cancer were eligible. Overall survival was analyzed by pooling log hazard ratio (HR) and standard error of multivariable Cox regression models. MOGGE Meta-analysis Matrix is a novel illustration tool that was used to demonstrate multiple subgroup analyses of included studies.; Results: Twenty-two studies were eligible. Systematic lymphadenectomy was associated with better overall survival, that was close to significance, compared to control group (HR 0.93, 95 %CI 0.86-1.00). Among women treated with adjuvant chemotherapy, overall survival improved in women with stage IIB-IV who underwent systematic lymphadenectomy (HR 0.91, 95 %CI 0.84-0.99) and was most significant among patients with stage III to IV (HR 0.85, 95 %CI 0.73-0.99). Systematic lymphadenectomy did not improve survival in women who received neoadjuvant chemotherapy (HR 0.97, 95 %CI 0.73-1.29). Systematic lymphadenectomy was associated with improved progress-free survival compared to control group (HR 0.88, 95 %CI 0.79-0.99).; Conclusion: Although data from clinical trials do not support role of systematic lymphadenectomy in advanced ovarian cancer, overall data conveys stage-specific survival benefit. Further clinical trials may be warranted to assess substage survival outcomes in women with advanced stages.; Competing Interests: Declaration of Competing Interest The authors report no declarations of interest. (Copyright © 2021. Published by Elsevier B.V.)

Almalki Hussain, H., et al. (2020). "Comparative efficacy of statins, metformin, spironolactone and combined oral contraceptives in reducing testosterone levels in women with polycystic ovary syndrome: a network meta-analysis of randomized clinical trials." BMC Women's Health 20(1): 68.
	Background: Polycystic ovary syndrome (PCOS) is an endocrine disorder affecting about 10% of women in reproductive age and associated with a variety of hormonal abnormalities, including hyperandrogenemia and infertility, all of which could lead to PCOS. Statins were previously introduced as a therapeutic option for reducing testosterone levels in women with PCOS, either alone or in combination. The aim of this study is to evaluate the effectiveness of different statins alone or in combination with metformin in reducing testosterone levels in women with PCOS.; Methods: Medline, Embase, and clinicaltrials.gov were searched for studies that investigated the efficacy of statins, metformin, spironolactone, or combined oral contraceptives (COCs), individually or in combination, in reducing the testosterone level in patients with PCOS. The search was limited to randomized clinical trials and conducted according to the preferred reporting items for systematic reviews and meta-analyses - extension statement for network meta-analyses (PRISMA-NMA). The quality of included studies was assessed using the Cochrane Collaboration risk of bias (RoB) assessment tool. A frequentist network meta-analysis using random-effects models was used to assess the efficacy in reducing testosterone level and were expressed as odds ratios (OR) and 95% credible interval (95%Crl). All statistical analyses were performed using netmeta Version 1.0 on R statistical package.; Result: Nine RCTs involving 613 patients were included. Atorvastatin showed greater reduction in testosterone level compared to COC (MD -2.78, 95%CrI -3.60, -1.97), spironolactone plus metformin (MD -2.83, 95%CrI -3.80, -1.87), simvastatin (MD -2.88, 95%CrI -3.85, -1.92), spironolactone (MD -2.90, 95%CI -3.77, -2.02), simvastatin plus metformin (MD -2.93, 95%CrI -3.79, -2.06), metformin (MD -2.97, 95%CrI -3.69, -2.25), lifestyle modification (MD -3.02, 95%CrI -3.87, -2.18), and placebo (MD -3.04, 95%CrI -3.56, -2.53).; Conclusion: Atorvastatin was found to be more effective than the other management strategies in reducing the total testosterone level for patients with PCOS. Future studies should focus on the optimal dose.

Almeida Balieiro, C. C., et al. (2024). "Effects of polyphenol in women with polycystic ovary syndrome: A systematic review and meta-analysis of randomized controlled trials." European Journal of Obstetrics and Gynecology and Reproductive Biology 294: 84-91.
	Objective: Polycystic ovary syndrome (PCOS) is an endocrinopathy with a high prevalence in women of reproductive age. Different treatments were tested to increase insulin sensitivity and hormone regulation, and recently polyphenols have emerged as a promising option for these women. We aimed to perform a systematic review and meta-analysis of randomized clinical trials (RCTs) comparing polyphenols to placebo in PCOS. Design(s): A systematic review and meta-analysis. Method(s): PubMed, Cochrane Library, and Embase databases were searched for RCTs comparing polyphenols to placebo. Random-effects model was used to calculate the Mean Difference (MD) and Standardized Mean Difference (SMD), with 95% confidence interval (CIs). Result(s): A total of fifteen RCTs comprising 916 patients were included, of whom 445 (49 %) received polyphenols. Compared to placebo, polyphenols significantly reduced serum insulin level (MD -2.49; 95 % CI [-3.72, -1.25]; p < 0.01), BMI levels (MD -0.12; 95 % CI [-0.18, -0.06]; p < 0.01), and LH levels (MD -0.87; 95 % CI [-1.54, -0.20]; p = 0.01). There was no significant difference between groups in testosterone levels (SMD -0.14; 95 % CI [-0.53, 0.25]; p = 0.48). Conclusion(s): In this meta-analysis polyphenols were associated with a reduction in serum insulin, LH levels, and BMI in women with PCOS, compared to placebo. These findings support the effectiveness of polyphenols in women with PCOS. Significant statement: There are no comprehensive systematic recommendations for polyphenols in PCOS treatment. However, increasing evidence has highlighted its substantial impact on women's health. This systematic review and meta-analysis provide evidence for the efficacy of polyphenols in reducing serum insulin, LH, and BMI in women with PCOS compared with placebo.Copyright © 2023 Elsevier B.V.

Alomari, M. S., et al. (2022). "Non-inferior and more feasible transcutaneous tibial nerve stimulation in treating overactive bladder: A systematic review and meta-analysis." International Journal of Urology 29(10): 1170-1180.
	Objectives: Overactive bladder (OAB) is identified as a urinary urgency accompanied by frequency and nocturia with or without urgency urinary incontinence in the nonexistence of a urinary tract infection or other evident pathologies. This systematic review and meta-analysis aimed to evaluate the efficacy of the transcutaneous tibial nerve stimulation (TTNS) versus percutaneous tibial nerve stimulation (PTNS) or anticholinergic drugs in reducing symptoms and improving the quality of life for OAB patients. Method(s): We performed a systematic search in Medline, Embase, and CENTRAL, in which we included randomized controlled trials that compared TTNS with anticholinergic drugs or PTNS in treating idiopathic OAB. We evaluated the following outcomes: 3-day voiding diary (voiding frequency/day, daytime micturition frequency/day, nighttime micturition frequency/day, number of urgency episodes/day, number of incontinence episodes/day, and mean voiding volume), symptom bother, health related quality of life (HRQoL), and adverse events. We used 95% as a confidence interval (CI) and p < 0.05. Standardized mean difference (SMD) was used for continuous outcomes, and the risk ratio (RR) was used for dichotomous outcomes. Result(s): There was no significant difference comparing TTNS with anticholinergic drugs or PTNS regarding voiding frequency/day (SMD = -0.01, 95% CI -0.33 to 0.32), nighttime micturition frequency/day (SMD = -0.28, 95% CI -0.94 to 0.37), number of urgency episodes/day (SMD = -0.05, 95% CI -0.36 to 0.26), number of incontinence episodes/day (SMD = -0.04, 95% CI -0.32 to 0.25), symptom bother (SMD = -0.19, 95% CI -0.55 to 0.16), HRQoL (SMD = 0.27, 95% CI -0.32 to 0.85), and adverse events (RR = 0.07, 95% CI 0.01 to 0.54). Conclusion(s): The current meta-analysis reveals that there is no statistically significant difference between TTNS versus PTNS or anticholinergic drugs for the nonsurgical management of OAB patients.Copyright © 2022 The Japanese Urological Association.

AlSwayied, G., et al. (2022). "Assessing the Acceptability and Effectiveness of Mobile-Based Physical Activity Interventions for Midlife Women During Menopause: Systematic Review of the Literature." JMIR mHealth and uHealth 10(12): e40271.
	Background: Midlife women with menopausal symptoms are less likely to meet the recommended level of physical activity (PA). Promoting PA among women in midlife could reduce their risk of cardiovascular diseases and perhaps improve menopausal symptoms. Mobile PA interventions in the form of smartphone apps and wearable activity trackers can potentially encourage users to increase PA levels and address time and resource barriers to PA. However, evidence on the acceptability and effectiveness of these interventions among midlife women is unclear.; Objective: This systematic review evaluated the effectiveness, acceptability, and active behavior change techniques (BCTs) of mobile PA technologies among midlife menopausal women.; Methods: A mixed methods systematic review of qualitative and quantitative studies was conducted. MEDLINE (Ovid), Embase, Scopus, CINAHL, Web of Science, SPORTDiscus, CENTRAL, PsycINFO, and the ProQuest Sports Medicine and Education Index were systematically searched. Studies were selected and screened according to predetermined eligibility criteria. In total, 2 reviewers independently assessed the risk of bias using the Mixed Methods Appraisal Tool and completed BCT mapping of the included interventions using the BCT Taxonomy v1.; Results: A total of 12 studies were included in this review. Overall risk of bias was "Moderate to high" in 58% (7/12) of the included studies and "low" in 42% (5/12) of the studies. Of the 12 studies, 7 (58%) assessed changes in PA levels. The pooled effect size of 2 randomized controlled trials resulted in a small to moderate increase in moderate to vigorous PA of approximately 61.36 weekly minutes among midlife women, at least in the short term (95% CI 17.70-105.01; P=.006). Although a meta-analysis was not feasible because of heterogeneity, positive improvements were also found in a range of menopause-related outcomes such as weight reduction, anxiety management, sleep quality, and menopause-related quality of life. Midlife women perceived mobile PA interventions to be acceptable and potentially helpful in increasing PA and daily steps. The average number of BCTs per mobile PA intervention was 8.8 (range 4-13) according to the BCT Taxonomy v1. "Self-monitoring of behaviour," "Biofeedback," and "Goal setting (behaviour)" were the most frequently described BCTs across the included interventions.; Conclusions: This review demonstrated that mobile PA interventions in the form of smartphone apps and wearable trackers are potentially effective for small to moderate increases in moderate to vigorous PA among midlife women with menopausal symptoms. Although menopause is a natural condition affecting half the population worldwide, there is a substantial lack of evidence to support the acceptability and effectiveness of mobile PA interventions on menopause-related outcomes, which needs further investigation.; Trial Registration: PROSPERO CRD42021273062; https://www.crd.york.ac.uk/prospero/display&#95;record.php?RecordID=273062. (©Ghada AlSwayied, Haoyue Guo, Tasmin Rookes, Rachael Frost, Fiona L Hamilton. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 09.12.2022.)

Alvendal, C. (2021). "A Clinical Trial for Chlorhexidine as Treatment for Vulvovaginal Candidiasis." ClinicalTrials.gov.
	The study is a 6 months clinical Phase II trial to compare if 1% chlorhexidine gluconate vaginal cream (Hibitane®) is at least as effective and safe as fluconazole (reference treatment) for culture‐verified recurrent vulvovaginal candidiasis. The study is a randomized open non‐inferiority trial with parallel treatment groups. The trial is not possible to blind for neither participants nor investigators due to the differences between study treatments. There is low risk of bias since the primary outcome variable is objective (negative vaginal culture for Candida albicans). The participants will be randomization to; ‐ Investigational medication with Hibitane® vaginal cream 8 ml every night for a week and then prophylactic treatment with 8 ml/week for another 11 weeks or ‐ Reference treatment with Fluconazole® 150 mg (oral capsule) every 3 days for the first 3 doses, then prophylactic treatment with 150 mg/week for another 11 weeks. The randomization ratio between the treatment groups will be 1:1. A computer generated block randomization of 15 participants will be performed by the research midwife. Allocation to the study medications will be carried out via opening of opaque sealed envelopes in consecutive order. All women will be identified through a patient log with name and Swedish personal identification number and the randomization number. The randomization number will be used on all paper and CRFs. Five research visits are planned: Visit 1 Screening ‐ oral and written study information, signing of informed consent, vaginal culture for Candida albicans and chlamydia/gonorrhea (PCR test). Visit 2 Inclusion (baseline), within 1 week after Visit 1. Control for inclusion/exclusion criteria, randomization to study medication after positive culture for Candida albicans and negative chlamydia/gonorrhea (PCR test) ‐ health survey, control of concomitant medications, examination, pregnancy test and control of adequate contraceptive methods to avoid pregnancy throughout the study. Visit 3 1 week (+2 days) after completed treatment. Control of AE, culture for Candida albicans and examination. Visit 4 After 12 weeks (+ 1 week) from inclusion when prophylactic treatment is completed. Control of AE and relapses, culture for Candida albicans and examination. Visit 5 Follow‐up 6 months (+ 1‐2 weeks) from baseline/inclusion. Control of AE and relapses, culture for Candida albicans and examination. End of study. A weekly web‐based dairy (eCRF (Entermedic)) will be used for follow‐up of treatment compliance, efficacy and adverse events. During the prophylactic treatment (Visits 2‐3) and during the observational phase of the study (Visit 4‐5), the participants are asked to report any suspicious relapses in the dairy and contact the research midwife if needed. They will also receive equipment for vaginal cultures that can be used for self‐sampling at home to detect true relapses. In case of positive cultures for Candida albicans, they will be offered the same medication as previously used in the study if the treatment was effective and no adverse events occurred. Otherwise, an individual treatment option will be used. The end of study is defined as completion of the last visit of the last subject. The sponsor and the investigators reserve the rights to discontinue the study at any time for safety reasons or other reasons jeopardizing the justifications of the study. Supply, labelling, handling and storage: Chlorhexidine gluconate (Hibitane®) vaginal cream is commercially available in Sweden and will be prescribed from the hospital pharmacy for each participant. It will be stored and kept according to the instructions of the manufacturer. ‐ Participants randomized to Hibitane® will receive a bottle (250ml) with the vaginal cream together with 10 ml syringes for vaginal administration. The Hibitane® bottle can be stored in the fridge at home between use. Women will receive specific written information as well as oral information on how to self‐administer drug vaginally with the syringe. ‐ Participa s randomized to Fluconazole® will receive 14 oral capsules of 150 mg according to the dosage describe above. Compliance: Compliance will be evaluated at the follow up visits and the participants will fill out a dairy how the study medications have been taken. Data collection and data handling: Every participant will be given an individual, study specific number (i.e. study identifying code) at the time of inclusion. A code key with each individual personal data connected to the identifying code will be created (i.e. patient identification log) and stored separately at the research department at the department of Obstetrics and Gynecology, Danderyd Hosptial, Stockholm, Sweden. Data will be recorded on individual printed case report forms (CRFs) after which they will be entered into a computerized database before statistical analyses. The database will contain information on demographic variables, type of treatment and measurements in addition to the variables above.

Amant, F. (2022). "Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC." ClinicalTrials.gov.
	A phase 2 randomised controlled trial will be performed in which the efficacy and safety of standard treatment (primary chemoradiation; consisting of 64.5 Gy in 30 fractions of external beam radiotherapy with weekly cisplatin for six weeks) and experimental treatment (NACT; consisting of carboplatin and paclitaxel in a 3‐weekly scheme) will be compared in 98 patients with LAVC, registered from eight national medical centres.

Amelia, F., et al. (2022). "Pre-conception weight loss interventions in women with polycystic ovary syndrome and the effect on perinatal outcomes: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Amelia, M. and F. Grace (2023). "The potential of the Mediterranean diet to effectively reduce and manage PCOS: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Ameratunga, D., et al. (2023). "Antibiotics prior to or at the time of embryo transfer in ART." The Cochrane Database of Systematic Reviews 11: CD008995.
	Background: After an assisted reproductive technology (ART) cycle, embryo transfer (ET) involves the placement of one or more embryos into the uterine cavity, usually by passing a catheter through the cervical os. Despite the transfer of high-quality embryos, many ETs do not result in a pregnancy. There are many factors that may affect the success of ET. There is some evidence to suggest that increased endocervical microbial colonization at the time of ET results in lower pregnancy rates. The association between the cervico-vaginal microbiome and reduced pregnancy rates after ET may indicate either pre-existing dysbiosis in this patient population, or that the passage of the ET catheter itself may be introducing microbes that alter the microbiome of the endometrial cavity or lead to infection. Such an upper genital tract infection, contamination or alteration may have a negative impact on implantation and in vitro fertilization (IVF) success rates by both endometrial and embryonic mechanisms. The administration of antibiotics at the time of ET has been suggested as an intervention to reduce levels of microbial colonization and hence improve pregnancy rates.; Objectives: To evaluate the benefits and harms of antibiotic administration prior to or at the time of embryo transfer (ET) during assisted reproductive technology (ART) cycles.; Search Methods: We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL (now containing output from two trial registers and CINAHL), MEDLINE, Embase and PsycINFO, together with reference checking and contact with study authors and experts in the field to identify additional studies. The search date was November 2022.; Selection Criteria: We included two randomized controlled trials (RCT) that compared antibiotics administered by any route versus no antibiotics prior to ET.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane, including assessing risk of bias of the included studies using the RoB 2 tool. The primary review outcome was live birth rate (LBR) or ongoing pregnancy, and secondary outcomes were clinical pregnancy rate (CPR), genital tract colonization rate, miscarriage rate, ectopic pregnancy rate, multiple pregnancy rate, fetal abnormalities, adverse events and pelvic infection.; Main Results: We included two RCTs with 377 women in the review. Using the GRADE method, we assessed the certainty of the evidence as very low to low across measured outcomes. We are uncertain whether antibiotics given prior to or at the time of ET improved LBR (odds ratio (OR) 0.48, 95% confidence interval (CI) 0.10 to 2.23; 1 study, 27 women; low-certainty evidence). The evidence suggests that if LBR without antibiotics was 60%, the rate with antibiotics would be between 13% and 77%. We are uncertain whether antibiotics given prior to or at the time of ET improve CPR (OR 1.01, 95% CI 0.67 to 1.55; I² = 0%; 2 studies, 377 women; low-certainty evidence). If the CPR without antibiotics was 37%, the rate with antibiotics would be between 29% and 48%. The administration of antibiotics prior to or at the time of ET may reduce genital tract colonization slightly (OR 0.59, 95% CI 0.37 to 0.95; 1 study, 130 women; very low-certainty evidence). If the genital tract colonization rate without antibiotics was 29%, the rate with antibiotics would be between 13% and 28%. However, this did not correspond to an effect on the pregnancy outcome. Only one study with low numbers of women reported on miscarriage rate, with one miscarriage reported in the group not receiving antibiotics (OR 4.04, 0.15 to 108.57; 1 study, 27 women; low-certainty evidence). There was insufficient evidence to reach a conclusion regarding adverse effects and other outcomes as no studies reported data suitable for analysis.; Authors' Conclusions: We are uncertain if administration of antibiotics prior to or at the time of ET improves LBR in women undergoing ART based on a single study of 27 women with low-certainty evidence. We are uncertain whether there was a dif erence in CPR. There was evidence for a reduction in genital tract colonization rates, but the evidence was very low certainty. Data were lacking on other secondary outcomes. The pooled results should be interpreted with caution, due to the small number of women included in the analysis. (Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Amin-Florin, E.-K. and S. Florin (2021). "Fertility outcomes following different approach of ectopic pregnancy." PROSPERO International prospective register of systematic reviews.
	
Ana, K., et al. (2022). "Efficacy of non-pharmacological treatment for vulvodynia: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Ana, K., et al. (2023). "Psychotherapy and psychotherapeutic techniques for vulvodynia: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Ana, S., et al. (2023). "Impact of Immunusuppressants in Improving Live Birth Outcomes for Women with Recurrent Pregnancy Loss." PROSPERO International prospective register of systematic reviews.
	
Ana, S., et al. (2023). "Role of immunusuppressants in women with repeated implantation failure in ivf/icsi." PROSPERO International prospective register of systematic reviews.
	
Andéll, P. (2021). "Transcutaneous Electrical Nerve Stimulation for Endometriosis-related Chronic Pain." ClinicalTrials.gov.
	Endometriosis affects approximately one in ten women of childbearing age and may involve both acute pain related to the menstrual cycle and chronic pain. Usual analgesic therapy is often inadequate and/or involves unacceptable side effects and risks with long‐term use. Transcutaneous electrical nerve stimulation (TENS) is a patient controlled treatment for pain relief with few side‐effects. To date there is limited knowledge of how TENS treatment should be carried out for optimal pain relief in this patient group. The aim of the study is asses the effect of TENS as add‐on treatment compared with conventional analgesic treatment in patients with endometriosis‐related chronic pain. Patients with frequent pain and high pain intensity (≥ 4 according to Numeric Rating Scale, NRS) will be randomized to additional treatment with TENS or conventional treatment for 8 weeks in order to evaluate the acute effects of TENS treatment (n=40). Patients with endometriosis‐related pain that is not frequent or without high pain intensity constitute an external control group. All patients in the study will receive TENS treatment for a total of 16 weeks, for evaluation of long‐term effects of TENS treatment in chronic endometriosis‐related pain. Prior to start of TENS treatment, all patients receive education on chronic endometriosis‐related pain and TENS treatment. Study participants will be asked to participate in a qualitative follow‐up within the study including a semi‐structured individual interview (n=10‐15) before intervention and a semi‐structured focus group (n=9‐15) interview after completion of TENS treatment.

Andrade Marcela, A., et al. (2022). "The Effect of Neuromodulatory Drugs on the Intensity of Chronic Pelvic Pain in Women: A Systematic Review." Revista Brasileira de Ginecologia e Obstetricia 44(9): 891-898.
	Objective: To evaluate the effect of neuromodulatory drugs on the intensity of chronic pelvic pain (CPP) in women.; Data Sources: Searches were carried out in the PubMed, Cochrane Central, Embase, Lilacs, OpenGrey, and Clinical Trials databases.; Selection of Studies: The searches were carried out by two of the authors, not delimiting publication date or original language. The following descriptors were used: chronic pelvic pain in women OR endometriosis , associated with MESH/ENTREE/DeCS: gabapentinoids , gabapentin , amitriptyline , antidepressant , pregabalin , anticonvulsant , sertraline , duloxetine , nortriptyline , citalopram , imipramine , venlafaxine , neuromodulation drugs , acyclic pelvic pain , serotonin , noradrenaline reuptake inhibitors , and tricyclic antidepressants , with the Boolean operator OR . Case reports and systematic reviews were excluded.; Data Collection: The following data were extracted: author, year of publication, setting, type of study, sample size, intervention details, follow-up time, and results.; Data Synthesis: A total of 218 articles were found, with 79 being excluded because they were repeated, leaving 139 articles for analysis: 90 were excluded in the analysis of the titles, 37 after reading the abstract, and 4 after reading the articles in full, and 1 could not be found, therefore, leaving 7 articles that were included in the review.; Conclusion: Most of the studies analyzed have shown pain improvement with the help of neuromodulators for chronic pain. However, no improvement was found in the study with the highest statistical power. There is still not enough evidence that neuromodulatory drugs reduce the intensity of pain in women with CPP.; Competing Interests: None 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/).)

Andrea, W., et al. (2022). "Investigating the role of mifepristone in the management of ectopic pregnancy: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Andrews, R., et al. (2021). "Evaluating the Effects of Symptom Monitoring on Menopausal Health Outcomes: A Systematic Review and Meta-Analysis." Frontiers in Global Women's Health 2: 757706.
	Evidence suggests that monitoring and appraising symptoms can result in increased engagement in medical help-seeking, improved patient-doctor communication, and reductions in symptom prevalence and severity. To date, no systematic reviews have investigated whether symptom monitoring could be a useful intervention for menopausal women. This review explored whether symptom monitoring could improve menopausal symptoms and facilitate health-related behaviours. Results suggested that symptom monitoring was related to improvements in menopausal symptoms, patient-doctor communication and medical decision-making, heightened health awareness, and stronger engagement in setting treatment goals. Meta-analyses indicated large effects for the prolonged use of symptom diaries on hot flush frequencies. Between April 2019 and April 2021, PsychInfo, EMBASE, MEDLINE, CINAHL, Cochrane, ProQuest, PsychArticles, Scopus, and Web of Science were searched. Eighteen studies met the eligibility criteria and contributed data from 1,718 participants. Included studies quantitatively or qualitatively measured the impact of symptom monitoring on menopausal populations and symptoms. Research was narratively synthesised using thematic methods, 3 studies were examined via meta-analysis. Key themes suggest that symptom monitoring is related to improvements in menopausal symptoms, improved patient-doctor communication and medical decision-making, increased health awareness, and stronger engagement in goal-setting behaviours. Meta-analysis results indicated large effects for the prolonged use of symptom diaries on hot flush frequency: 0.73 [0.57, 0.90]. This review is limited due to the low number of studies eligible for inclusion, many of which lacked methodological quality. These results indicate that symptom monitoring has potential as an effective health intervention for women with menopausal symptoms. This intervention may be beneficial within healthcare settings, in order to improve patient-doctor relations and adherence to treatment regimes. However, findings are preliminary and quality assessments suggest high risk of bias. Thus, further research is needed to support these promising outcomes. Systematic Review Registration Number: https://www.crd.york.ac.uk/prospero/display&#95;record.php?, PROSPERO, identifier: CRD42019146270.; 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 Andrews, Hale, John and Lancastle.)

Angelo Alessandro, M., et al. (2023). "The clinical effects of Preimplantation Genetic Testing for Aneuploidy (PGT-A) with Comprehensive Chromosome Screening in IVF/ICSI: a systematic review and meta-analysis of Randomized Controlled Trials." PROSPERO International prospective register of systematic reviews.
	
Angioni, S. (2021). "Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS)." ClinicalTrials.gov.
	No Results Available Drug: LNG-IUS 13,5 mg Levonorgestrel|Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg Change of Pelvic pain as measured by visual analogue scale|Quality of sexual life Female Not Applicable 50 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment ADENOMYOSIS June 1, 2022

Angioni, S. (2021). "Psychological Impact of Amenorrhea in Women With Endometriosis." ClinicalTrials.gov.
	No Results Available Drug: Estroprogestinic therapy (Etinil-estradiol/levonorgestre)|Drug: Gonadotropin-releasing hormone agonist (Leuprorelin acetate)|Drug: Add back therapy 1 (tibolone)|Drug: Add back therapy 2 (calcium carbonate/colecalciferol) Quality of life (self reported questionnaires)|Sexual health (self reported questionnaires)|Psychological impact (self reported questionnaires) Female Phase 4 50 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment AMENORREA June 2022

Ankara Yildirim Beyazıt, U. (2023). "Education and Counseling Program Based on the Health Promotion Model." ClinicalTrials.gov.
	The research was carried out in two stages. In the first phase of the study, in a cross‐sectional research design, in order to determine the prevalence and risk factors of urinary incontinence in women who are over 18 years old and who are not menopausal, registered in a Family Health Center; In this study, a pretest‐posttest randomized controlled experimental research design was conducted to evaluate the effect of education and counseling program based on Pender's Health Promotion Model on self‐esteem, sexual satisfaction and quality of life in women with second‐stage urinary incontinence. In the first phase of the study, 1042 women over the age of 18 who were registered at the Family Health Center and who did not go through menopause were included. In the first stage, the data; It was collected between 18 January 2021 and 31 May 2021, using the 'Questionnaire on Descriptive Characteristics', 'International Incontinence Inquiry Form' and 'Incontinence Severity Index'. The second stage of the study continued with 46 women who met the sample selection criteria for the second stage. After the pre‐test was completed, 46 women were assigned to the intervention and control groups (M:23, F:23) by stratified block randomization and stratified according to urinary incontinence severity (mild, moderate). In the second stage of the research, the data; Between September 24, 2021 and January 13, 2022, 'International Incontinence Inquiry Form', 'Incontinence Severity Index', 'Information Form Based on Pender's Health Promotion Model', 'Self‐Esteem Sub‐Scale', 'Golombok‐Rust Sexual Satisfaction Scale‐ It was collected using the 'Female Form', 'Incontinence Quality of Life Scale', 'Self‐Efficacy/Efficacy Scale'. In the second stage of the study, the 'Training and Counseling Program Based on Pender's Health Promotion Model' and 'Home Monitoring and Counseling Program' were applied to the intervention group, which was prepared according to Pender's Health Promotion Model. During the three‐month period, the intervention group received 3 home visits one, two and three months after the training program, and 3 phone calls 15 days after the training program and each home visit. No intervention was made in the control group; Data collection forms were applied simultaneously with the intervention group and they were reminded that they were in the research by making a phone call. In both stages of the study, the forms and scales were filled by the women themselves, and the women were guided during this period. Frequency, percentage and descriptive statistics for data evaluation, Shapiro‐Wilk Test, Independent Samples T‐Test, Repeated Measurements Anova Test, Chi‐square Test of Independence, Fisher Test, Cochran‐Q Test, Mann‐Whitney U Test, McNemar Test, Friedman Test and Marginal Homogeneity Test were used.

Ann Jin, S. (2022). "Evaluation of electronic PRO application system." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Others(electronic PRO application system) : The intervention group is applied to use the ePRO‐CTCAE mobile application at least once weekly with routine care until they visit the outpatient clinic after completing the last cycle of chemotherapy (or within a month after completing its last cycle). The control group receives routine care only. Clinical outcomes are assessed at starting the first cycle of the treatment (visit 1), visiting the outpatient clinic after completing the third cycle (visit 2), visiting the clinic after completing the last cycle (visit 3), and at 6‐month (visit 4, ± 1 month) and 12‐month (visit 5, ± 2 months) after the completion. CONDITION: Neoplasms PRIMARY OUTCOME: Changes in physical function between those who receive the symptom management during chemotherapy through the ePRO‐CTCAE mobile application and those who does not. SECONDARY OUTCOME: Additional medical expenditure for symptom management between those who receive the symptom management during chemotherapy through the ePRO‐CTCAE mobile application and those who does not. Changes in depressive symptom score between those who receive the symptom management during chemotherapy through the ePRO‐CTCAE mobile application and those who does not. Changes in health‐related quality of life between those who receive the symptom management during chemotherapy through the ePRO‐CTCAE mobile application and those who does not. Changes in pain interference score between those who receive the symptom management during chemotherapy through the ePRO‐CTCAE mobile application and those who does not. Changes in physical activity between those who receive the symptom management during chemotherapy through the ePRO‐CTCAE mobile application and those who does not. Survival rate at 12 months after the end of chemotherapy between those who receive the symptom management during chemotherapy through the ePRO‐CTCAE mobile application and those who does not. The completion rate of planned chemotherapy between those who receive the symptom management during chemotherapy through the ePRO‐CTCAE mobile application and those who does not. The rate of unplanned clinical visits between those who receive the symptom management during chemotherapy through the ePRO‐CTCAE mobile application and those who does not. INCLUSION CRITERIA: 1) 20 years of age or older (if necessary due to the nature of the disease, people aged 70 or older may be included in this study with the consent of their caregivers according to the decision of the healthcare professionals) 2) diagnosed with breast, endometrial, colon, or lung cancer; planning to receive the first cycle of therapy (for both curative and palliative intent) or one year has been passed after the end of therapy (for curative intent only) 3) 0 or 1 in ECOG (Eastern Cooperative Oncology) performance status 4) capable to use a smartphone (Android OS only) and mobile applications 5) understanding the purpose of this study and expressing willingness to participate in this study

Annah, J. V. (2022). "Platelet-Rich Plasma for Stress Urinary Incontinence." ClinicalTrials.gov.
	Platelet‐rich plasma (PRP) is an autologous solution of human plasma with a high concentration of platelets. While the preparation and injection of PRP is not a new technology, it has not been well‐studied in the field of urogynecology. Small case series have suggested PRP may be used in the treatment of stress urinary incontinence (SUI). The aim of this randomized controlled trial study is to evaluate the efficacy and safety of PRP in the treatment of female SUI, compared to placebo. Adult females with SUI or with stress‐predominant mixed urinary incontinence will be eligible. Subjects will undergo an injection of PRP (or injectable saline) into the anterior vaginal wall in the office. At baseline and at time points of 1, 3, and 6 months, subjects will complete the validated questionnaires. A pelvic exam with a stress test will be performed by a blinded provider at the 3 and 6‐month visits. Primary outcomes will include a negative urinary stress test plus improvement with the Patient Global Impression of Improvement (PGI‐I) at 6‐months. Secondary outcomes will include the Female Sexual Function Index (FSFI), the Incontinence Quality of life (I‐QOL), Questionnaire for Urinary Incontinence Diagnosis (QUID), and the visual analog scale for pain.

Anneveldt, K. J., et al. (2021). "Comparison of (Cost-)Effectiveness of Magnetic Resonance Image-Guided High-Intensity-Focused Ultrasound With Standard (Minimally) Invasive Fibroid Treatments: protocol for a Multicenter Randomized Controlled Trial (MYCHOICE)." JMIR Research Protocols 10(11): e29467.
	BACKGROUND: Magnetic resonance image‐guided high‐intensity‐focused ultrasound (MR‐HIFU) is a rather new, noninvasive option for the treatment of uterine fibroids. It is safe, effective, and has a very short recovery time. However, a lack of prospectively collected data on long‐term (cost‐)effectiveness of the MR‐HIFU treatment compared with standard uterine fibroid care prevents the MR‐HIFU treatment from being reimbursed for this indication. Therefore, at this point, when conservative treatment for uterine fibroid symptoms has failed or is not accepted by patients, standard care includes the more invasive treatments hysterectomy, myomectomy, and uterine artery embolization (UAE). Primary outcomes of currently available data on MR‐HIFU treatment often consist of technical outcomes, instead of patient‐centered outcomes such as quality of life (QoL), and do not include the use of the latest equipment or most up‐to‐date treatment strategies. Moreover, data on cost‐effectiveness are rare and seldom include data on a societal level such as productivity loss or use of painkillers. Because of the lack of reimbursement, broad clinical implementation has not taken place, nor is the proper role of MR‐HIFU in uterine fibroid care sufficiently clear. OBJECTIVE: The objective of our study is to determine the long‐term (cost‐)effectiveness of MR‐HIFU compared with standard (minimally) invasive fibroid treatments. METHODS: The MYCHOICE study is a national, multicenter, open randomized controlled trial with randomization in a 2:1 ratio to MR‐HIFU or standard care including hysterectomy, myomectomy, and UAE. The sample size is 240 patients in total. Women are included when they are 18 years or older, in premenopausal stage, diagnosed with symptomatic uterine fibroids, conservative treatment has failed or is not accepted, and eligible for MR‐HIFU. Primary outcomes of the study are QoL 24 months after treatment and costs of treatment including direct health care costs, loss of productivity, and patient costs. RESULTS: Inclusion for the MYCHOICE study started in November 2020 and enrollment will continue until 2024. Data collection is expected to be completed in 2026. CONCLUSIONS: By collecting data on the long‐term (cost‐)effectiveness of the MR‐HIFU treatment in comparison to current standard fibroid care, we provide currently unavailable evidence about the proper place of MR‐HIFU in the fibroid treatment spectrum. This will also facilitate reimbursement and inclusion of MR‐HIFU in (inter)national uterine fibroid care guidelines. TRIAL REGISTRATION: Netherlands Trial Register NL8863; https://www.trialregister.nl/trial/8863. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1‐10.2196/29467.

Anselem, O., et al. (2022). "Cervical Dilators Used Concurrently With Misoprostol to Shorten Labor in Second-Trimester Termination of Pregnancy: A Randomized Controlled Trial." Obstetrics and Gynecology 140(3): 453-460.
	Objective: To evaluate the use of cervical dilators concurrently with misoprostol to shorten labor in second-trimester medical termination of pregnancy.; Methods: This multicenter randomized controlled trial compared the efficacy of cervical dilators inserted concurrently with misoprostol with that of misoprostol, alone, to shorten labor for women undergoing termination of pregnancy between 15 0/7 and 27 6/7 weeks of gestation. The primary outcome was the proportion of women with a duration of labor exceeding 12 hours. Secondary outcomes included median duration of labor, time to amniotomy, side effects, complications, NPRS (Numeric Pain Rating Scale) score, and women's distress as measured by the IES-R (Impact of Event Scale-Revised). These outcomes also were studied separately in the nulliparous subgroup. To demonstrate a reduction of 50% of the proportion of women with a duration of labor exceeding 12 hours in the dilator group, with a power of 80% and a 2-sided 0.05 significance level, a sample of 268 women (134 in each group) was required.; Results: Between December 2017 and September 2019, this study enrolled and analyzed 347 women: 174 in the dilator group and 173 in the control group, including 87 and 93 nulliparous patients, respectively. Sociodemographic and obstetric characteristics were similar between groups. The proportion of women with labor exceeding 12 hours was not different between groups (49/174 [28.2%] in the dilator group vs 53/173 [30.6%] in the control group [ P =.61] for the whole population, and 37/87 [42.5%] vs 42/93 [45.2%] [ P =.72], respectively, among nulliparous patients). Median duration of labor was 8.5 hours in the dilator group compared with 9.2 hours in the control group ( P =.65) for the whole population, and 10.5 hours compared with 11.8 hours, respectively, among nulliparous patients ( P =.33). Median time to amniotomy was 3.6 hours in the dilator group compared with 5.0 hours in the control group ( P =.08) for the whole population, and 3.5 hours compared with 6.7 hours, respectively, among nulliparous patients ( P =.003). Side effects, complications, NPRS score, and IES-R score were similar between groups.; Conclusion: Cervical dilators inserted concurrently with misoprostol did not reduce the proportion of women whose labor exceeded 12 hours compared with misoprostol alone.; Clinical Trial Registration: ClinicalTrials.gov , NCT03194230.; 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.)

Antic, A., et al. (2023). "Magnetic stimulation in the treatment of female urgency urinary incontinence: a systematic review." International Urogynecology Journal 34(8): 1669-1676.
	Introduction and hypothesis: This systematic review analyzes published studies about magnetic stimulation (MS) treatment for UUI and determines whether this treatment is effective and non-invasive. Method(s): A systematic literature search was conducted using PubMed, the Cochrane Library, and Embase. The international standard for reporting results of systematic reviews and meta-analyses (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) was used to guide the methodology of this systematic review. The key search terms were as follows: "magnetic stimulation" and "urinary incontinence." We limited the time frame to articles published from 1998, when the FDA approved MS as a conservative treatment option for UI. The last search was performed on 5 August 2022. Result(s): Two authors independently reviewed 234 article titles and abstracts, of which only 5 fitted the inclusion criteria. All 5 studies included women with UUI, but every study had different diagnostic and entry criteria for patients. They also differed in their treatment regimens and methodological approaches to assessing the efficacy of treating UUI with MS, which made it impossible to compare the results. Nonetheless, all five studies established that MS is an effective and non-invasive way of treating UUI. Conclusion(s): The systematic literature review led to the conclusion that MS is an effective and conservative way of treating UUI. Despite this, literature in this area is lacking. Further randomized controlled trials are needed, with standardized entry criteria, UUI diagnostics, MS programs, and standardized protocols to measure the efficacy of MS in UUI treatment, with a longer follow-up period for post-treatment patients.Copyright © 2023, The Author(s).

Antonio Cascales Campos, P., et al. (2022). "Cytoreductive Surgery With or Without HIPEC After Neoadjuvant Chemotherapy in Ovarian Cancer: A Phase 3 Clinical Trial." Annals of Surgical Oncology 29(4): 2617-2625.
	Background: Cytoreductive surgery (CRS) and administration of hyperthermic intraperitoneal chemotherapy (HIPEC) have shown their efficacy in multiple malignancies and also could offer a prognostic benefit for patients with advanced ovarian cancer.; Methods: A prospective, single-center, parallel-group, randomized phase 3 clinical trial analyzed patients with a diagnosis of carcinomatosis from ovarian cancer treated with neoadjuvant systemic chemotherapy (NACT). In this trial, 71 patients were randomized to receive CRS alone (36 patients) or CRS with HIPEC (35 patients) using cisplatin (75 mg/m 2 for 60 min at 42 °C). The primary end point was disease-free survival (DFS). Overall survival (OS), morbidity, and quality of life (QoL) were the secondary end points.; Results: During a median follow-up period of 32 months, the median DFS was 12 months in the control group (CRS) and 18 months in the experimental group (CRS and HIPEC). The findings showed HIPEC to be an independent protective factor against the development of recurrence (hazard ratio [HR], 0.12, 95 % confidence interval [CI], 0.02-0.89; p = 0.038). The median OS was 45 months in the control group and 52 months in the experimental group. The respective morbidity rates for any grade (1 to 5) were respectively 58.3 % and 45.7 % (p > 0.05), with a mortality rates of 2.8 % and 2.9 % (p > 0.05). In the dimensions evaluated, CRS with or without HIPEC had no impact on QoL.; Conclusions: For patients who had advanced ovarian cancer treated with NACT, CRS and HIPEC was associated with better DFS and OS, but without a difference in postoperative morbidity, mortality, or in the QoL evaluation. (© 2021. Society of Surgical Oncology.)

Antonio, D. A., et al. (2024). "Ovarian activation techniques for women with premature ovarian insufficiency or poor ovarian reserve: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Anuj Kumar, P., et al. (2022). "Safety of medicinal preparations to induce abortion during pregnancy: a systematic review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Anupama, B., et al. (2021). "Effectiveness and Safety of Robotic-assisted hysterectomy in benign gynecology: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Anwar, F., et al. (2023). "The effectiveness of kangaroo mother care in lowering postpartum depression in mothers of preterm and low birth weight babies: a systematic review and meta-analysis." Annals of Medicine and Surgery 85(6): 2841-2848.
	Background: Kangaroo mother care (KMC) intervention involves skin-to-skin contact between mother and infant. Some studies have shown a decrease in postpartum depression (PPD) in mothers of preterm and low birth weight (LBW) infants. However, the literature is scattered and of variable quality.; Aims: To conduct a systematic review of available literature and provide a comprehensive picture of the effect of KMC on PPD among mothers of preterm and LBW infants.; Methods: The study was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Guidelines. After PROSPERO registration, a systematic search was conducted using PubMed, Cochrane Central Library, and Google Scholar from the inception of the databases till 14 June 2021. Of the 2944 studies assessed for titles and abstracts, nine studies with 2042 participants were included in the review. Included articles targeted mothers with LBW (<2500 g) or preterm infants (<37 weeks), used an authentic PPD tool, and had standard care or an incubator as the control group. Studies not published in English and in which mothers had a previous psychiatric illness were excluded. The risk of bias was assessed using the Cochrane Risk of Bias Tool for randomized control trials and the Newcastle-Ottawa Scale for observational studies. All the results were converted to standard mean deviation and pooled together using a random-effects model with a 95% CI. A P -value of less than 0.05 is considered significant.; Results: KMC Intervention was significantly associated with a lower depression score than control groups. The reduction in depression in the intervention (KMC) group was moderate: SMD=-0.38 (-0.68 to -0.08; 95% CI; I 2 =86%; P =0.013). No significant difference was found between the PPD scores of both groups using the Edinburgh Postpartum Depression Scale score.; Conclusions: The authors conclude that the negative effects of LBW and preterm birth experience on maternal mental health can be avoided to a moderate degree by KMC. Due to a lack of methodological uniformity, different scales for outcome measurement, and discrepancies in intervention features, significantly high heterogeneity was detected. The authors need further larger-scale studies with a uniform study design to better predict the efficacy of KMC better.; Competing Interests: Authors have no conflict of interest to declare. (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Anya, S. and J. Kanna (2023). "Effectiveness and safety of uterine septum division." PROSPERO International prospective register of systematic reviews.
	
Ao, M., et al. (2020). "Efficacy and Toxicity of Adjuvant Therapies for High-Risk Endometrial Cancer in Stage I-III: A Systematic Review and Network Meta-Analysis." Medical Science Monitor 26: e925595.
	BACKGROUND The use of adjuvant therapy for high-risk endometrial cancer patients (HREC) in International Federation of Gynecology and Obstetrics (FIGO) stage I-III remains debatable. This network meta-analysis was conducted to compare and rank adjuvant therapies based on efficacies and toxicities to facilitate clinical decision-making and further research. MATERIAL AND METHODS We searched 3 databases - PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials - from inception to December 9, 2019. Only randomized controlled trials that compared any of these adjuvant therapies (pelvic radiotherapy, vaginal brachytherapy, chemotherapy, and chemoradiotherapy) with each other or surgery alone were included. The network meta-analysis was performed in a frequentist framework using Stata software 15.0. RESULTS Fourteen RCTs with 5872 participants were eligible. No significant difference between treatments was observed in 5-year overall survival (OS) or distant metastasis. Compared with surgery alone, adjuvant pelvic radiotherapy plus chemotherapy (pelvic RT-CT) prolonged 5-year progression-free survival (PFS) and pelvic radiotherapy (pelvic RT) (RR=0.61, 95% CI 0.39-0.96; RR=0.779, 95% CI 0.63-0.95). Compared with surgery alone, pelvic RT, the combination of pelvic RT and vaginal brachytherapy (pelvic RT-VBT), chemotherapy (CT), and pelvic RT-CT led to fewer local recurrences (RR=0.33, 95% CI 0.21-0.50; RR=0.15, 95% CI 0.03-0.74; RR=0.39, 95% CI 0.21-0.73; RR=0.17, 95% CI 0.06-0.46). Adjuvant CT was found to result in more grade III/IV late toxicities than surgery alone (RR=11.8, 95% CI 1.02-137.14). Pelvic RT-CT ranked first for OS, PFS, distant metastasis, and local recurrence. CONCLUSIONS Pelvic RT-CT is superior to other treatments for PFS and local recurrence rate, and associated related toxicities are tolerable, suggesting it may be an ideal adjuvant therapy for HREC patients.

Aparicio Laura, F. (2024). "Therapeutic-educational Physiotherapy on Pain, Physical-functionality and Quality of Life in Women With Endometriosis." ClinicalTrials.gov.
	No Results Available Other: therapeutic-educational physiotherapy and pain education program|Other: pain education program Musculoskeletal pain - Pressure pain threshold|Musculoskeletal pain - quantitative Sensory Testing|Musculoskeletal pain - pain drawing|Musculoskeletal pain - Central Sensitisation Inventory|Physical-Funcionality - Hand grip Strength|Physical-Funcionality - functional performance|Physical-Funcionality- Pelvic floor Dynamometry|Physical-Funcionality - Body composition|Physical-Funcionality - Motor control|Physical-Funcionality - Lumbar spine flexibility|Physical-Funcionality - Catastrophyzing|Physical-Funcionality - Kinesophobia|Quality of Life - Endometriosis|Quality of Life - Gastrointestinal|Quality of Life - Sexual Function|Quality of Life - Stress|Biomarkers - Inflamation|Patient's satisfaction|Patient's perception of change|APP usability|Adherence to treatment Female Not Applicable 62 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Care Provider, Outcomes Assessor)|Primary Purpose: Treatment UV_Dep_FISIO December 22, 2026

Aramburu Naiara, B. (2024). "The Effectivenes of Non-invasive Neuromodulation in Adult Women With Primary Dysmenorrhea, Through the TENS Stimulation at Different Times of Mentrual Cycle in Each Group." ClinicalTrials.gov.
	No Results Available Device: Transcutaneous Electrical Nerve Stimulation (TENS) Pain: Numerical Pain Scale (NPRS)|Pressure pain threshold (PDU): Analog pressure algometer (Wagner FPX, United States)|Pain: McGill Pain Index (MPQ)|Quality of life related to menstruation: Specific quality of life questionnaire related to menstruation (CVM-22)|Quality of life: SF12 Health Questionnaire|Anxiety and Depresion: Hospital Anxiety and Depression Scale (HADS)|Catastrophic thinking: Pain Catastrophizing Scale (PCS):|Sleep quality: Pittsburgh Sleep Quality Index (PSQI): Female Phase 3 30 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment 2023.211 June 2024

Aravive, I. (2021). "Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer." ClinicalTrials.gov.
	This is a randomized, double‐blind Phase 3 study to compare the efficacy and safety of batiraxcept (AVB‐S6‐500) in combination with paclitaxel (PAC) versus placebo in combination with PAC in patients with platinum resistant recurrent ovarian cancer.

Arbat, A. (2021). "Phase II Clinical Trial to Evaluate the Ongoing Pregnancy Rate With OXO-001 in IVF/ICSI With Donor Oocytes." ClinicalTrials.gov.
	Assisted reproductive techniques are the most common procedures to fulfill the desire for pregnancy in infertile women. Unfortunately, more than half of the assisted reproduction cycles result in implantation failure or early pregnancy loss, the two main causes of infertility and the most important unmet medical need in the field of infertility with current treatments. This clinical trial aims to test the capacity of OXO‐001 to enhance embryo implantation. It is a phase II, randomised, double‐blind, parallel‐group, placebo‐controlled trial that will assess the ongoing pregnancy rate with OXO‐001 (200 mg, 300 mg) or placebo at 10 weeks following fresh single blastocyst transfer resulting from donor oocyte IVF/ICSI.

Arcagy, G. (2022). "Randomized phase III trial in MMR deficient endometrial cancer patients comparing chemotherapy alone versus Dostarlimab in first line advanced/metastatic setting: DOMENICA STUDY (GINECO-EN105b/ENGOT-en13 study)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: dostarlimab Product Code: TSR‐042 Pharmaceutical Form: Solution for solution for infusion INN or Proposed INN: Dostarlimab Other descriptive name: TSR‐042 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ Trade Name: CARBOPLATIN Product Name: Carboplatin Pharmaceutical Form: Solution for infusion INN or Proposed INN: CARBOPLATIN CAS Number: 41575‐94‐4 Other descriptive name: CARBOPLATIN Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 5 AUC mg/mL/min‐6 AUC mg/mL/min Trade Name: PACLITAXEL Product Name: PACLITAXEL Pharmaceutical Form: Solution for infusion INN or Proposed INN: Paclitaxel CAS Number: 33069‐62‐4 Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 175‐ CONDITION: Endometrial cancer ; 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) Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: Progression Free Survival (PFS) defined as the time from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first Primary end point(s): Progression Free Survival (PFS) Secondary Objective: • Quality of Life (QoL) ; • Objective Response Rate (ORR); • Overall survival (OS) ; • Duration of Response Rate (DoR); • Safety and tolerability Assessed by CTCAE v5.0 (by investigators) and assessed by NCI PRO‐CTCAE (by patients); • Time to first and second Subsequent Treatment (TFST and TSST) Timepoint(s) of evaluation of this end point: from the date of randomization until objective tumor progression based on RECIST 1.1, or death due to any cause, whichever occurs first. SECONDARY OUTCOME: Secondary end point(s): • Quality of Life (QoL); • Objective Response Rate (ORR); • Overall survival (OS); • Duration of Response Rate (DoR); • Safety and tolerability; • Time to first and second Subsequent Treatment Timepoint(s) of evaluation of this end point: A COMPLETER INCLUSION CRITERIA: 1. Female patient is at least 18 years of age, 2. Patient has signed the Informed Consent (ICF) and is able to comply with protocol requirements. 3. Patient with histologically proven endometrial adenocarcinoma with recurrent or advanced disease. 4. Patient with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 5. Patient must have primary Stage IIIC2 or Stage IV disease or first recurrent endometrial cancer (see International Federation of Gynecology and Obstetrics staging FIGO Staging – Appendi X18.1) without curative treatment by radiation therapy or surgery alone or in combination, and meet at least one of the following situations: a) Patient has primary Stage IIIC2 (with nodes involvement from the outset, not allowing a curative radiotherapy, or with remaining measurable lumbo‐aortic nodes after lumbo‐aortic dissection, which cannot be treated by curative radiotherapy) or Stage IV disease. b) Patient has firs

Arend, R. C., et al. (2024). "Ofranergene Obadenovec (Ofra-Vec, VB-111) With Weekly Paclitaxel for Platinum-Resistant Ovarian Cancer: Randomized Controlled Phase III Trial (OVAL Study/GOG 3018)." Journal of Clinical Oncology 42(2): 170-179.
	PURPOSE To evaluate the addition of ofranergene obadenovec (ofra-vec, VB-111), a novel gene-based anticancer targeted therapy, to once a week paclitaxel in patients with recurrent platinum-resistant ovarian cancer (PROC). METHODS This placebo-controlled, double-blind, phase III trial (ClinicalTrials.gov identifier: NCT03398655) randomly assigned patients with PROC 1:1 to receive intravenous ofra-vec every 8 weeks with once a week IV paclitaxel or placebo with paclitaxel until disease progression. The dual primary end points were overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review. RESULTS Between December 2017 and March 2022, 409 patients were randomly assigned. The median PFS was 5.29 months in the ofra-vec arm and 5.36 months in the control arm, hazard ratio (HR) 1.03 (CI, 0.83 to 1.29; P =. 7823). The median OS with ofra-vec was 13.37 months versus 13.14 months, HR 0.97 (CI, 0.75 to 1.27; P =. 8440). Objective response rates (ORRs) per RECIST 1.1 were similar in both arms: 28.9% with ofra-vec versus 29.6% with control. In both treatment arms, response to CA-125 was a substantial prognostic factor for both PFS and OS. In the ofra-vec arm, the HR in CA-125 responders compared with that in nonresponders for PFS was 0.2428 (CI, 0.1642 to 0.3588), and for OS, the HR was 0.3343 (CI, 0.2134 to 0.5238). Safety profile was characterized by common transient flu-like symptoms such as fever and chills. CONCLUSION The addition of ofra-vec to paclitaxel did not improve PFS or OS. The PFS and ORR in the control arm exceeded the results that were anticipated on the basis of the AURELIA chemotherapy control arm. CA-125 response was a substantial prognostic biomarker for PFS and OS in patients with PROC treated with paclitaxel.Copyright © 2023 by American Society of Clinical Oncology.

Armour, M., et al. (2019). "Exercise for dysmenorrhoea." The Cochrane Database of Systematic Reviews 9: CD004142.
	Background: Exercise has a number of health benefits and has been recommended as a treatment for primary dysmenorrhoea (period pain), but the evidence for its effectiveness on primary dysmenorrhoea is unclear. This review examined the available evidence supporting the use of exercise to treat primary dysmenorrhoea.; Objectives: To evaluate the effectiveness and safety of exercise for women with primary dysmenorrhoea.; Search Methods: We searched the Cochrane Gynaecology and Fertility specialised register, CENTRAL, MEDLINE, Embase, PsycINFO, AMED and CINAHL (from inception to July 2019). We searched two clinical trial databases (inception to March 2019) and handsearched reference lists and previous systematic reviews.; Selection Criteria: We included studies if they randomised women with moderate-to-severe primary dysmenorrhoea to receive exercise versus no treatment, attention control, non-steroidal anti-inflammatory drugs (NSAIDs) or the oral contraceptive pill. Cross-over studies and cluster-randomised trials were not eligible for inclusion.; Data Collection and Analysis: Two review authors independently selected the studies, assessed eligible studies for risk of bias, and extracted data from each study. We contacted study authors for missing information. We assessed the quality of the evidence using GRADE. Our primary outcomes were menstrual pain intensity and adverse events. Secondary outcomes included overall menstrual symptoms, usage of rescue analgesic medication, restriction of daily life activities, absence from work or school and quality of life.; Main Results: We included a total of 12 trials with 854 women in the review, with 10 trials and 754 women in the meta-analysis. Nine of the 10 studies compared exercise with no treatment, and one study compared exercise with NSAIDs. No studies compared exercise with attention control or with the oral contraceptive pill. Studies used low-intensity exercise (stretching, core strengthening or yoga) or high-intensity exercise (Zumba or aerobic training); none of the included studies used resistance training.Exercise versus no treatmentExercise may have a large effect on reducing menstrual pain intensity compared to no exercise (standard mean difference (SMD) -1.86, 95% confidence interval (CI) -2.06 to -1.66; 9 randomised controlled trials (RCTs), n = 632; I 2 = 91%; low-quality evidence). This SMD corresponds to a 25 mm reduction on a 100 mm visual analogue scale (VAS) and is likely to be clinically significant. We are uncertain if there is any difference in adverse event rates between exercise and no treatment.We are uncertain if exercise reduces overall menstrual symptoms (as measured by the Moos Menstrual Distress Questionnaire (MMDQ)), such as back pain or fatigue compared to no treatment (mean difference (MD) -33.16, 95% CI -40.45 to -25.87; 1 RCT, n = 120; very low-quality evidence), or improves mental quality of life (MD 4.40, 95% CI 1.59 to 7.21; 1 RCT, n = 55; very low-quality evidence) or physical quality of life (as measured by the 12-Item Short Form Health Survey (SF-12)) compared to no exercise (MD 3.40, 95% CI -1.68 to 8.48; 1 RCT, n = 55; very low-quality evidence) when compared to no treatment. No studies reported on any changes in restriction of daily life activities or on absence from work or school.Exercise versus NSAIDsWe are uncertain if exercise, when compared with mefenamic acid, reduced menstrual pain intensity (MD -7.40, 95% CI -8.36 to -6.44; 1 RCT, n = 122; very low-quality evidence), use of rescue analgesic medication (risk ratio (RR) 1.77, 95% CI 1.21 to 2.60; 1 RCT, n = 122; very low-quality evidence) or absence from work or school (RR 1.00, 95% CI 0.49 to 2.03; 1 RCT, n = 122; very low-quality evidence). None of the included studies reported on adverse events, overall menstrual symptoms, restriction of daily life activities or quality of life.; Authors' Conclusions: The current low-quality evidence suggests that exercise, performed for about 45 to 60 minutes each time, three times per week or more, regardless of intensity, may provide a clinically significant reduction in menstrual pain intensity of around 25 mm on a 100 mm VAS. All studies used exercise regularly throughout the month, with some studies asking women not to exercise during menstruation. Given the overall health benefits of exercise, and the relatively low risk of side effects reported in the general population, women may consider using exercise, either alone or in conjunction with other modalities, such as NSAIDs, to manage menstrual pain. It is unclear if the benefits of exercise persist after regular exercise has stopped or if they are similar in women over the age of 25. Further research is required, using validated outcome measures, adequate blinding and suitable comparator groups reflecting current best practice or accounting for the extra attention given during exercise.

Armour, M., et al. (2019). "The effectiveness of self-care and lifestyle interventions in primary dysmenorrhea: a systematic review and meta-analysis." BMC Complementary and Alternative Medicine 19(1): 22.
	Background: Menstrual pain is very common amongst young women. Despite the significant impact that menstrual pain has on academic attendance and performance, social activities and quality of life, most young women do not seek medical treatment but prefer to use self-care; commonly OTC analgesic medications and rest. Many women do not get significant pain relief from these methods, therefore other low cost, easy to learn self-care methods may be a valuable approach to management. This review and meta-analysis examines the evidence for participant lead self-care techniques.; Methods: A search of Medline, PsychINFO, Google Scholar and CINAHL was carried out in September 2017.; Results: Twenty-three trials including 2302 women were eligible and included in the meta-analysis. Studies examined self-delivered acupressure, exercise and heat as interventions. Risk of bias was unclear for many domains. All interventions showed a reduction in menstrual pain symptoms; exercise (g = 2.16, 95% CI 0.97 to 3.35) showed the largest effect size, with heat (g = 0.73, 95% CI 0.06 to 1.40) and acupressure (g = 0.56, 95% CI 0.10 to 1.03) showing more moderate effect sizes. Exercise (g = 0.48, 95% CI 0.12 to 0.83) and heat (g = 0.48, 95% CI 0.10 to 0.87), were more effective than analgesics in reducing pain intensity, whereas acupressure was significantly less effective (g = - 0.76, 95% CI -1.37 to - 0.15).; Conclusion: Exercise showed large effects, while acupressure and heat showed moderate effects in reducing menstrual pain compared to no treatment. Both exercise and heat are potential alternatives to analgesic medication. However, difficulties in controlling for non-specific effects, along with potential for bias, may influence study findings.

Armstrong, S., et al. (2019). "Time-lapse systems for embryo incubation and assessment in assisted reproduction." The Cochrane Database of Systematic Reviews 5: CD011320.
	Background: Embryo incubation and assessment is a vital step in assisted reproductive technology (ART). Traditionally, embryo assessment has been achieved by removing embryos from a conventional incubator daily for quality assessment by an embryologist, under a microscope. In recent years time-lapse systems (TLS) have been developed which can take digital images of embryos at frequent time intervals. This allows embryologists, with or without the assistance of embryo selection software, to assess the quality of the embryos without physically removing them from the incubator.The potential advantages of a TLS include the ability to maintain a stable culture environment, therefore limiting the exposure of embryos to changes in gas composition, temperature, and movement. A TLS has the potential advantage of improving embryo selection for ART treatment by utilising additional information gained through continuously monitoring embryo development. Use of a TLS often adds significant extra cost to ART treatment.; Objectives: To determine the effect of a TLS compared to conventional embryo incubation and assessment on clinical outcomes in couples undergoing ART.; Search Methods: We used standard methodology recommended by Cochrane. We searched the Cochrane Gynaecology and Fertility (CGF) Group Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, and two trials registers on 7 January 2019 and checked references of appropriate papers.; Selection Criteria: We included randomised controlled trials (RCTs) comparing TLS, with or without embryo selection software, versus conventional incubation with morphological assessment; and TLS with embryo selection software versus TLS without embryo selection software among couples undergoing ART.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. The primary review outcomes were live birth or ongoing pregnancy, miscarriage and stillbirth, and cumulative live birth or ongoing pregnancy rate. The secondary outcomes were clinical pregnancy and cumulative clinical pregnancy. We assessed the quality of the evidence using GRADE methodology. We made the following comparisons.TLS with conventional morphological assessment of still TLS images versus conventional incubation and assessmentTLS utilising embryo selection software versus TLS with conventional morphological assessment of still TLS images TLS utilising embryo selection software versus conventional incubation and assessment MAIN RESULTS: We included nine RCTs (N = 2955 infertile couples). The quality of the evidence ranged from very low to low. The main limitations were high risk of bias in the included studies, imprecision, indirectness, and inconsistency. There were no data on cumulative live birth or ongoing pregnancy rate or cumulative clinical pregnancy rate.TLS with conventional morphological assessment of still TLS images versus conventional incubation and assessmentIt is unclear whether there is any difference between interventions in rates of live birth or ongoing pregnancy (odds ratio (OR) 0.91, 95% confidence interval (CI) 0.67 to 1.23, 3 RCTs, N = 826, I 2 = 33%, low-quality evidence) or in miscarriage rates (OR 1.90, 95% CI 0.99 to 3.61, 3 RCTs, N = 826, I 2 = 0%, low-quality evidence). The evidence suggests that if the rate of live birth or ongoing pregnancy associated with conventional incubation and assessment is 35%, the rate with the use of TLS with conventional morphological assessment of still TLS images would be between 27% and 40%, and if the miscarriage rate with conventional incubation is 4%, the rate associated with conventional morphological assessment of still TLS images would be between 4% and 14%. It is unclear whether there is a difference between the interventions in rates of stillbirth (OR 1.00, 95% CI 0.13 to 7.49, 1 RCT, N = 76, low-quality evidence) or clinical pregnancy (OR 1.06, 95% CI 0.79 to 1.41, 4 RCTs, N = 875, I 2 = 0%, low-quality evidence).TLS utilising embryo selection software versus TLS with conventional morphological assessment of still TLS images ll findings for this comparison were very uncertain due to the very low-quality of the evidence. No data were available on live birth, but one RCT reported ongoing pregnancy. It is unclear whether there is any difference between the interventions in rates of ongoing pregnancy (OR 0.61, 95% CI 0.32 to 1.20, 1 RCT, N = 163); miscarriage (OR 1.39, 95% CI 0.64 to 3.01, 2 RCTs, N = 463, I 2 = 0%); or clinical pregnancy (OR 0.97, 95% CI 0.67 to 1.42, 2 RCTs, N = 463, I 2 = 0%). The evidence suggests that if the rate of ongoing pregnancy associated with TLS with conventional morphological assessment of still TLS images is 47%, the rate associated with TLS utilising embryo selection software would be between 22% and 52%, and if the miscarriage rate associated with conventional morphological assessment of still TLS images is 5%, the rate associated with TLS utilising embryo selection software would be between 4% and 15%. No studies reported stillbirth.TLS utilising embryo selection software versus conventional incubation and assessmentThe findings for this comparison were also very uncertain due to the very low quality of the evidence. It is unclear whether there is any difference between the interventions in rates of live birth (OR 1.12, 95% CI 0.92 to 1.36, 3 RCTs, N = 1617, I 2 = 84%). There was very low-quality evidence that TLS might reduce miscarriage rates (OR 0.63, 95% CI 0.45 to 0.89, 3 RCTs, N = 1617, I 2 = 0%). It is unclear whether there is any difference between the interventions in rates of clinical pregnancy (OR 0.95, 95% CI 0.78 to 1.16, 3 RCTs, N = 1617, I 2 = 89%). The evidence suggests that if the rate of live birth associated with conventional incubation and assessment is 48%, the rate with TLS utilising embryo selection software would be between 46% and 55%, and if the miscarriage rate with conventional incubation and assessment is 11%, the rate associated with TLS would be between 5% and 10%. No stillbirths occurred in the only study reporting this outcome.; Authors' Conclusions: There is insufficient good-quality evidence of differences in live birth or ongoing pregnancy, miscarriage and stillbirth, or clinical pregnancy to choose between TLS, with or without embryo selection software, and conventional incubation. As the evidence is of low or very low-quality, our findings should be interpreted with caution.

Armstrong, S., et al. (2020). "GM-CSF (granulocyte macrophage colony-stimulating factor) supplementation in culture media for women undergoing assisted reproduction." The Cochrane Database of Systematic Reviews 7: CD013497.
	Background: GM-CSF (granulocyte macrophage colony-stimulating factor) is a growth factor that is used to supplement culture media in an effort to improve clinical outcomes for those undergoing assisted reproduction. It is worth noting that the use of GM-CSF-supplemented culture media often adds a further cost to the price of an in vitro fertilisation (IVF) cycle. The purpose of this review was to assess the available evidence from randomised controlled trials (RCTs) on the effectiveness and safety of GM-CSF-supplemented culture media.; Objectives: To assess the effectiveness and safety of GM-CSF-supplemented human embryo culture media versus culture media not supplemented with GM-CSF, in women or couples undergoing assisted reproduction.; Search Methods: We used standard methodology recommended by Cochrane. We searched the Cochrane Gynaecology and Fertility Group Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, LILACS, DARE, OpenGrey, PubMed, Google Scholar, and two trials registers on 15 October 2019, checked references of relevant papers and communicated with experts in the field.; Selection Criteria: We included RCTs comparing GM-CSF (including G-CSF (granulocyte colony-stimulating factor))-supplemented embryo culture media versus any other non-GM-CSF-supplemented embryo culture media (control) in women undergoing assisted reproduction.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. The primary review outcomes were live birth and miscarriage rate. The secondary outcomes were clinical pregnancy, multiple gestation, preterm birth, birth defects, aneuploidy, and stillbirth rates. We assessed the quality of the evidence using GRADE methodology. We undertook one comparison, GM-CSF-supplemented culture media versus culture media not supplemented with GM-CSF, for those undergoing assisted reproduction.; Main Results: We included five studies, the data for three of which (1532 participants) were meta-analysed. We are uncertain whether GM-CSF-supplemented culture media makes any difference to the live-birth rate when compared to using conventional culture media not supplemented with GM-CSF (odds ratio (OR) 1.19, 95% confidence interval (CI) 0.93 to 1.52, 2 RCTs, N = 1432, I 2 = 69%, low-quality evidence). The evidence suggests that if the rate of live birth associated with conventional culture media not supplemented with GM-CSF was 22%, the rate with the use of GM-CSF-supplemented culture media would be between 21% and 30%. We are uncertain whether GM-CSF-supplemented culture media makes any difference to the miscarriage rate when compared to using conventional culture media not supplemented with GM-CSF (OR 0.75, 95% CI 0.41 to 1.36, 2 RCTs, N = 1432, I 2 = 0%, low-quality evidence). This evidence suggests that if the miscarriage rate associated with conventional culture media not supplemented with GM-CSF was 4%, the rate with the use of GM-CSF-supplemented culture media would be between 2% and 5%. Furthermore, we are uncertain whether GM-CSF-supplemented culture media makes any difference to the following outcomes: clinical pregnancy (OR 1.16, 95% CI 0.93 to 1.45, 3 RCTs, N = 1532 women, I 2 = 67%, low-quality evidence); multiple gestation (OR 1.24, 95% CI 0.73 to 2.10, 2 RCTs, N = 1432, I 2 = 35%, very low-quality evidence); preterm birth (OR 1.20, 95% CI 0.70 to 2.04, 2 RCTs, N = 1432, I 2 = 76%, very low-quality evidence); birth defects (OR 1.33, 95% CI 0.59 to 3.01, I 2 = 0%, 2 RCTs, N = 1432, low-quality evidence); and aneuploidy (OR 0.34, 95% CI 0.03 to 3.26, I 2 = 0%, 2 RCTs, N = 1432, low-quality evidence). We were unable to undertake analysis of stillbirth, as there were no events in either arm of the two studies that assessed this outcome.; Authors' Conclusions: Due to the very low to low quality of the evidence, we cannot be certain whether GM-CSF is any more or less effective than culture media not supplemented with GM-CSF for clinical outcomes that reflect effectiveness and safety. It is important that independent information on the available evidence is made accessible to those considering using GM-CSF-supplemented culture media. The claims from marketing information that GM-CSF has a positive effect on pregnancy rates are not supported by the available evidence presented here; further well-designed, properly powered RCTs are needed to lend certainty to the evidence. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Armstrong-Buisseret, L., et al. (2022). "Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT." Health Technology Assessment 26(2): 1-170.
	Background: Bacterial vaginosis is a common and distressing condition associated with serious comorbidities. Antibiotic treatment is usually clinically effective in the short term, but recurrence is common and side effects can occur.; Objectives: The objective is to assess whether or not intravaginal lactic acid gel is clinically effective and cost-effective for treating recurrent bacterial vaginosis compared with oral metronidazole (Flagyl, Sanofi).; Design: This was an open-label, multicentre, parallel-arm, randomised (1 : 1) controlled trial.; Setting: This took place in one general practice and 19 sexual health centres in the UK.; Participants: Women aged ≥ 16 years with bacterial vaginosis symptoms and one or more episode(s) within the past 2 years took part.; Interventions: The interventions were 5 ml of intravaginal lactic acid gel taken once daily for 7 days (intervention) or 400-mg oral metronidazole tablets taken twice daily for 7 days (control).; Main Outcome Measures: The primary outcome was the resolution of bacterial vaginosis symptoms 14 days after randomisation. The secondary outcomes were time to first recurrence of symptoms; number of recurrences and treatment courses over 6 months; microbiological resolution on microscopy of vaginal smears at week 2; time to resolution of symptoms; tolerability, adherence and acceptability of the treatment; prevalence of concurrent sexually transmitted infections; quality of life; and cost-effectiveness.; Results: Recruitment stopped prior to reaching the target of 1900 participants on recommendation from the Data Monitoring Committee and Trial Steering Committee after a planned review of the results indicated that the research question had been answered. Overall, 518 participants were randomised and primary outcome data were available for 409 participants (79%; 204 in the metronidazole arm, 205 in the lactic acid gel arm). Participant-reported symptom resolution at week 2 was higher with metronidazole (143/204; 70%) than with lactic acid gel (97/205; 47%) (adjusted risk difference -23.2%, 95% confidence interval -32.3% to -14.0%). Recurrence in 6 months in a subset of participants who had initial resolution and were available for follow-up was similar across arms (metronidazole arm: 51/72, 71%; lactic acid gel arm: 32/46, 70%). A higher incidence of some side effects was reported with metronidazole than with lactic acid gel (nausea 32% vs. 8%; taste changes 18% vs. 1%; diarrhoea 20% vs. 6%, respectively). At week 2, the average cost per participant with resolved symptoms was £86.94 (metronidazole), compared with £147.00 (lactic acid gel). Some participants preferred using lactic acid gel even if they perceived it to be less effective than metronidazole.; Limitations: Loss to follow-up for collection of the primary outcome data was 21% and was similar in both arms. There is a risk of bias owing to missing outcome data at 3 and 6 months post treatment.; Conclusions: A higher initial response was seen with metronidazole than with lactic acid gel, but subsequent treatment failure was common with both. Lactic acid gel was less cost-effective than metronidazole. In general, women disliked taking repeated courses of metronidazole and preferred lactic acid gel, even when they were aware that it was less likely to provide symptom resolution. In the absence of effective curative therapy, further evaluation of non-antibiotic treatments to control the symptoms of recurrent bacterial vaginosis is required to improve quality of life for these patients. Further microbiological analysis of vaginal samples would be useful to identify additional factors affecting response to treatment.; Trial Registration: Current Controlled Trials ISRCTN14161293.; 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. 26, No. 2. See the NIHR Journals Library website for further project information.

Artur Menegaz, d., et al. (2023). "Fezolinetant Therapy in Menopausal Women Experiencing Vasomotor Symptoms: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." PROSPERO International prospective register of systematic reviews.
	
Aslan, B. (2023). "Ethanol Sclerotherapy Prior to ART." ClinicalTrials.gov.
	The effect of ethanol sclerotherapy before assisted reproductive technology (ART) cycle in patients with endometrioma on reproductive outcomes will be investigated. While endometrioma may result in technical difficulties in the ART process, the superiority of ethanol sclerotherapy has yet to be examined before the ART procedure in randomized controlled studies and meta‐analyses. The negative effect of ethanol sclerotherapy on ovarian reserve was found to be less than other existing interventions such as cyst stripping. However, randomized controlled studies did not determine its direct effect on ART outcome. Our current study aimed to assess the effect of ethanol sclerotherapy on ART outcomes. Infertile patients aged 18‐40 years with at least one endometrioma 4‐10 cm and scheduled for ART will be included in the study. Patients with any untreated thyroid dysfunction or additional disease, such as hyperprolactinemia, those who did not accept the study information and consent, and patients younger than 18 or older than 40 will not be included. Those who underwent surgery for endometrioma within 3 months before ART will be excluded. In addition, patients with an anti‐mullerian hormone value below 0.3 ng/ml will not be included in the study.

Aslan, K. (2021). "The Effect of Dienogest vs. Norethindrone Acetate Treatment in Endometriosis." ClinicalTrials.gov.
	No Results Available Drug: Dienogest Pill|Drug: Norethindrone Acetate Chronic Pelvic Pain|Side Effect Rate Female Not Applicable 70 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2022-8/23 June 30, 2023

Asmaa, R., et al. (2022). "Immunotherapy for Unexplained Recurrent Pregnancy Loss:A systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Astellas Pharma Global Development, I. (2021). "A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause." ClinicalTrials.gov.
	This study is for women in menopause who have moderate to severe hot flashes. It is for women who are unable to use hormone replacement therapy (HRT). Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life. The study medicines (also called investigational products, or IP) are tablets of fezolinetant or placebo. An investigational product means that the product is not yet licensed. In this study, a placebo is a dummy treatment that looks like fezolinetant but does not have any medicine in it. The study will compare fezolinetant with the placebo to learn if fezolinetant reduces the number and severity of hot flashes. Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes. Some women may be able to use the app on their own smartphone. In the last 10 days before their next clinic visit, the women will record information about their hot flashes. They can take part in the study if they have an average of 7 or more moderate to severe hot flashes each day. Women will be picked for 1 of 2 treatments (fezolinetant or placebo) by chance alone. Women who take part in the study will take 2 tablets every day for 24 weeks. Treatment will be double‐blinded. That means that the women in the study and the study doctors will not know who takes which of the study medicines (fezolinetant or placebo). The women will continue recording information about their hot flashes on the electronic device or their phone. They will also use another device to answer questions about how hot flashes affect their daily life. During the study, the women will visit their study clinic several times for a check‐up. This will happen during Weeks 2, 4, 8, 12, 16, 20, 24, and 27. Some women may be able to have home visits instead, from Week 2 to Week 20. At the check‐up, they will be asked if they have any medical problems. Other checks will include vital signs (heart rate, temperature and blood pressure) and some blood samples taken for laboratory tests. At some check‐ups, the women will have a physical exam. In Week 2 and Week 24, the women will have an ECG to check their heart rhythm. Women who have a uterus will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs. The last check‐up (at Week 27) will be 3 weeks after they take their last tablets of study medicine (fezolinetant or placebo).

Astellas Pharma Global Development, I. (2021). "A study to test how effective and safe fezolinetant is in women who have moderate to severe hot flashes due to menopause and who cannot take hormone therapy." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Fezolinetant Product Code: ESN364 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: FEZOLINETANT CAS Number: 1629229‐37‐3 Current Sponsor code: ESN364 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Fezolinetant Product Code: ESN364 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: FEZOLINETANT CAS Number: 1629229‐37‐3 Current Sponsor code: ESN364 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated with Menopause ; MedDRA version: 21.0 Level: LLT Classification code 10020407 Term: Hot flashes System Organ Class: 100000004866 Therapeutic area: Diseases [C] ‐ Hormonal diseases [C19] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of fezolinetant 45 mg versus placebo on the frequency of moderate to severe VMS Primary end point(s): ‐ Mean change in the frequency of moderate to severe Vasomotor Symptoms (VMS) from baseline to week 24 Secondary Objective: Key secondary: ‐ To evaluate the efficacy of fezolinetant 45 mg versus placebo on the severity of moderate to severe VMS;; Secondary: ‐ To evaluate the effect of fezolinetant 45 mg versus placebo on patient‐reported sleep disturbance; ‐ To evaluate the efficacy of fezolinetant 45 mg versus placebo on the frequency and severity of moderate to severe VMS; ‐ To evaluate the safety and tolerability of fezolinetant 45 mg Timepoint(s) of evaluation of this end point: ?Baseline to week 24. SECONDARY OUTCOME: Secondary end point(s): ‐ 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 Patient‐Reported Outcomes Measurement Information System Sleep Disturbance – Short Form 8b (PROMIS SD SF 8b) total score from baseline to week 24;; ‐ Mean change in the frequency of moderate to severe VMS from baseline to weeks 1, 4, 8, 12, 16 and 20;; ‐ Mean change in the severity of moderate to severe VMS from baseline to weeks 1, 4, 8, 12, 16 and 20;; ‐ Mean percent change in the frequency of moderate and severe VMS from baseline to weeks 1, 4, 8, 12, 16, 20 and 24;; ‐ Responder of percent reduction = 50%, = 75% and at 100% in the frequency of moderate and severe VMS from baseline to weeks 1, 4, 8, 12, 16, 20 and 24;; ‐ Frequency and severity of treatment‐emergent adverse events (TEAEs), clinical laboratory assessments, vital signs and electrocardiogram (ECG);; Timepoint(s) of evaluation of this end point: ?Up to week 27; INCLUSION CRITERIA: 1. IRB/IEC approved written informed consent and privacy language as per national regulations must be obtained from the participant prior to any study‐related procedures. 2. Participant is born female, aged = 40 years and = 65 years of age at the screening visit 3. Participant must be seeking treatment or relief for VMS associated with menopause and confirmed as menopausal per one of the following criteria at the screening visit: • Spontaneous amenorrhea for = 12 consecutive months • Spontaneous amenorrhea for = 6 months with biochemical criteria of menopause (follicle‐stimulating hormone [FSH] > 40 IU/L) • Had bilateral oophorectomy = 6 weeks prior to the screening visit (with or without hysterectomy) 4. Participant has VMS and is unsuitable to receive HRT (HRT contraindicated, HRT caution, HRT stoppers and HRT averse participants). The definitions for HRT unsuitable categories are provided below: • HRT Contraindicated: participants with

Astellas Pharma, I. (2021). "A Study to Find the Best Dose of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause." ClinicalTrials.gov.
	This study is for menopausal women who have hot flashes. Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life. This study will take place in Japan. This study will provide more information on a potential new treatment, called fezolinetant. The treatments in this study are fezolinetant or a placebo. In this study, a placebo is a dummy treatment that looks like fezolinetant but does not have any medicine in it. The study will compare fezolinetant with the placebo to find the best dose of fezolinetant to reduce the number and severity of hot flashes. Women that want to take part in the study will be given an electronic handheld device to track their hot flashes. In the last 10 days before their next clinic visit, the women will record information about their hot flashes. Women will be picked for 1 of 3 treatments (lower or higher dose of fezolinetant, or placebo) by chance alone. Women who take part in the study will take 2 tablets every day for 12 weeks. Treatment will be double‐blinded. That means that the women in the study and the study doctors will not know who takes which of the study medicines (lower or higher dose of fezolinetant, or placebo). The women will continue recording information about their hot flashes on the electronic device. They will also use another device to answer questions about how hot flashes affect their daily life. During the study, the women will visit their study clinic several times for a check‐up. This will happen during weeks 2, 4, 8, 12 and 15. At the check‐up, they will be asked if they have any medical problems. Other checks will include some blood samples taken for laboratory tests. At some check‐ups, the women will have a physical exam, an ECG to check their heart rhythm, and their vital signs checked (pulse rate, temperature and blood pressure). At the first visit and in week 15, women who have a uterus will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs. The last check‐up (at week 15) will be 3 weeks after they take their last tablets of study medicine (lower or higher dose of fezolinetant or placebo).

Astellas Pharma, I. (2024). "A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause." ClinicalTrials.gov.
	No Results Available Drug: Fezolinetant|Drug: Placebo Number of participants with Adverse Events (AEs)|Change from baseline in endometrial thickness in post-menopausal participants|Number of participants with laboratory value abnormalities and/or AEs|Number of participants with vital sign abnormalities and/or AEs|Number of participants with electrocardiogram (ECG) abnormalities and/or AEs|Pharmacokinetics (PK) of fezolinetant in plasma: Concentration|Pharmacokinetics (PK) of metabolite ES259564 in plasma: Concentration Female Phase 3 260 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 2693-CL-0311 April 30, 2026

Astellas Pharma, I. (2024). "A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Japanese Women Going Through Menopause." ClinicalTrials.gov.
	No Results Available Drug: Fezolinetant|Drug: Placebo Mean change from baseline in the frequency of mild to severe vasomotor symptoms (VMS)|Mean change from baseline in the frequency of mild to severe VMS|Mean change from baseline in the frequency of moderate to severe VMS|Mean percent reduction in the frequency of mild to severe VMS from baseline|Mean percent reduction in the frequency of moderate to severe VMS from baseline|Percent reduction of >/= 50% in the frequency of mild to severe VMS from baseline|Percent reduction of >/= 75% in the frequency of mild to severe VMS from baseline|Percent reduction of 100% in the frequency of mild to severe VMS from baseline|Percent reduction of >/= 50% in the frequency of moderate to severe VMS from baseline|Percent reduction of >/= 75% in the frequency of moderate to severe VMS from baseline|Percent reduction of 100% in the frequency of moderate to severe VMS from baseline|Number of participants with Adverse Events (AEs)|Change from baseline in endometrial thickness|Number of participants with laboratory value abnormalities and/or AEs|Number of participants with vital sign abnormalities and/or AEs|Number of participants with electrocardiogram (ECG) abnormalities and/or AEs|Pharmacokinetics (PK) of fezolinetant in plasma: Concentration|Pharmacokinetics (PK) of metabolite ES259564 in plasma: Concentration Female Phase 3 390 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 2693-CL-0310 March 31, 2026

Athanasiou, A., et al. (2021). "Neoadjuvant chemotherapy and surgery versus chemoradiotherapy for locally advanced cervical cancer." The Cochrane Database of Systematic Reviews 2021(7): CD014684.
	Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. The aim of this review is to compare neoadjuvant chemotherapy (NACT) followed by radical surgery (RS) versus chemoradiotherapy (CRT) for locally advanced cervical cancer.Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Athanasiou, S., et al. (2021). "Can pelvic organ prolapse in postmenopausal women be treated with laser therapy?" Climacteric 24(1): 101-106.
	PURPOSE: This study aims to assess the effectiveness of the non-ablative photothermal erbium laser (Er:YAG laser) for managing anterior and/or posterior vaginal compartment prolapse. METHODS: A randomized, single-blind, 1:1 trial was performed comparing Er:YAG laser treatment to watchful waiting in postmenopausal women with symptomatic cystocele and/or rectocele stage 2 or 3 who opted to undergo surgery due to bothersome prolapse symptoms. Three Er:YAG laser treatments at monthly intervals were applied for the Er:YAG laser group, while there was no treatment for the watchful-waiting group. The primary outcome was the proportion of patients with stage 0 or 1 following laser treatment, while secondary outcomes included the Pelvic Organ Prolapse Quantification System (POP-Q points), Pelvic Floor Distress Inventory Questionnaire short-form, Pelvic Floor Impact Questionnaire short-form, and Patients Global Impression of Improvement (PGI-I). All outcomes were evaluated at baseline and 4 months post baseline. RESULTS: Thirty women (15 vs. 15) were eligible to be included. No participants (0%) in either group had POP-Q stage 0 or 1 at 4 months. Moreover, no change was present in the secondary outcomes. In the PGI-I, 2/15 (14%) and 0/15 (0%) participants declared much better/very much better in the laser and watchful-waiting group, respectively. CONCLUSIONS: The findings of this study do not support use of the intravaginal Er:YAG laser for treatment of the anterior/posterior vaginal wall. Clinical trial identification number: NCT03714607.

Augustinus, S., et al. (2023). "Delayed Versus Immediate Start of Chemotherapy in Asymptomatic Patients With Advanced Cancer: A Meta-Analysis." The Oncologist 28(11): 961-968.
	Background: Due to increased use of imaging, advanced stages of cancer are increasingly being diagnosed in an early, asymptomatic phase. Traditionally, chemotherapy is started immediately in these patients. However, a strategy wherein chemotherapy is withheld until symptoms occur may be beneficial for patients in terms of quality of life (QOL). A systematic review regarding optimal timing of chemotherapy including survival and QOL is lacking.; Methods: We systematically searched PubMed, EMBASE, and Cochrane for studies investigating the timing of start of chemotherapy in asymptomatic patients with advanced cancer. Overall survival (OS) was abstracted as primary, QOL, and toxicity as secondary outcomes. A meta-analysis was performed on OS. QOL was described using the global health status derived from the EORTC-QLQ-C30 questionnaire and toxicity as grade 3-4 adverse events.; Results: Overall, 919 patients from 4 randomized controlled trials and 1 retrospective study were included. The included studies investigated colorectal cancer (n = 3), ovarian cancer (n = 1), and gastric cancer (n = 1). Pooled analysis demonstrated no significant differences in OS between delayed and immediate start of chemotherapy (pooled HR: 1.05, 95% CI, 0.90-1.22, P = .52). QOL, evaluated in 3 studies, suggested a better QOL in the delayed treatment group. Toxicity, evaluated in 2 studies, did not differ significantly between groups.; Conclusion: This meta-analysis confirms the need for prospective studies on timing of start of chemotherapy in asymptomatic patients with advanced cancer. The limited evidence available suggests that delayed start of chemotherapy, once symptoms occur, as compared to immediate start in asymptomatic patients does not worsen OS while it may preserve QOL.

Auxiliadora Renê de Melo, A., et al. (2023). "Is Transcutaneous Electrical Nerve Stimulation effective in primary dysmenorrhea? A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Avani, J., et al. (2022). "The Effectiveness of Educational Interventions on Quality of Life and Body Image of Gynaecological Cancer patients compared to the usual care or other non-educational interventions." PROSPERO International prospective register of systematic reviews.
	
Avation Medical, I. (2022). "A Sham-Controlled Study to Evaluate the Safety and Efficacy of a Smart, Self-Adjusting, Surgery-Free, Wearable Bladder Neuromodulation System for Overactive Bladder." ClinicalTrials.gov.
	This is a prospective, multi‐center, sham‐controlled study comparing the safety and effectiveness of the self‐adjusting, surgery‐free, wearable Active System to a Sham System on adult Subjects diagnosed with OAB.

Axelle, R., et al. (2023). "Clinical efficacy of Exacyl/ Tranexamic Acid in menorrhagia : a systematic review and meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Aydin, R. (2021). "The Effect of Kegel Exercise in Nursing Students With Primary Dysmenorrhoea." ClinicalTrials.gov.
	No Results Available Behavioral: Kegel Exercise Personal Information Form|Visual Analogue Scale|The Menstrual Symptom Scale|The Severity of Dysmenorrheic Symptoms|The Quality of Life Scale Female Not Applicable 89 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Supportive Care GU-SBF-OPA-01 July 31, 2021

Ayeleke Reuben, O., et al. (2020). "Intra-uterine insemination for unexplained subfertility." The Cochrane Database of Systematic Reviews 3: CD001838.
	Background: Intra-uterine insemination (IUI) is a widely-used fertility treatment for couples with unexplained subfertility. Although IUI is less invasive and less expensive than in vitro fertilisation (IVF), the safety of IUI in combination with ovarian hyperstimulation (OH) is debated. The main concern about IUI treatment with OH is the increase in multiple pregnancy rates.; Objectives: To determine whether, for couples with unexplained subfertility, the live birth rate is improved following IUI treatment with or without OH compared to timed intercourse (TI) or expectant management with or without OH, or following IUI treatment with OH compared to IUI in a natural cycle.; Search Methods: We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and two trials registers up to 17 October 2019, together with reference checking and contact with study authors for missing or unpublished data.; Selection Criteria: Randomised controlled trials (RCTs) comparing IUI with TI or expectant management, both in stimulated or natural cycles, or IUI in stimulated cycles with IUI in natural cycles in couples with unexplained subfertility.; Data Collection and Analysis: Two review authors independently performed study selection, quality assessment and data extraction. Primary review outcomes were live birth rate and multiple pregnancy rate.; Main Results: We include 15 trials with 2068 women. The evidence was of very low to moderate quality. The main limitation was very serious imprecision. IUI in a natural cycle versus timed intercourse or expectant management in a natural cycle It is uncertain whether treatment with IUI in a natural cycle improves live birth rate compared to treatment with expectant management in a natural cycle (odds ratio (OR) 1.60, 95% confidence interval (CI) 0.92 to 2.78; 1 RCT, 334 women; low-quality evidence). If we assume the chance of a live birth with expectant management in a natural cycle to be 16%, that of IUI in a natural cycle would be between 15% and 34%. It is uncertain whether treatment with IUI in a natural cycle reduces multiple pregnancy rates compared to control (OR 0.50, 95% CI 0.04 to 5.53; 1 RCT, 334 women; low-quality evidence). IUI in a stimulated cycle versus timed intercourse or expectant management in a stimulated cycle It is uncertain whether treatment with IUI in a stimulated cycle improves live birth rates compared to treatment with TI in a stimulated cycle (OR 1.59, 95% CI 0.88 to 2.88; 2 RCTs, 208 women; I 2 = 72%; low-quality evidence). If we assume the chance of achieving a live birth with TI in a stimulated cycle was 26%, the chance with IUI in a stimulated cycle would be between 23% and 50%. It is uncertain whether treatment with IUI in a stimulated cycle reduces multiple pregnancy rates compared to control (OR 1.46, 95% CI 0.55 to 3.87; 4 RCTs, 316 women; I 2 = 0%; low-quality evidence). IUI in a stimulated cycle versus timed intercourse or expectant management in a natural cycle In couples with a low prediction score of natural conception, treatment with IUI combined with clomiphene citrate or letrozole probably results in a higher live birth rate compared to treatment with expectant management in a natural cycle (OR 4.48, 95% CI 2.00 to 10.01; 1 RCT; 201 women; moderate-quality evidence). If we assume the chance of a live birth with expectant management in a natural cycle was 9%, the chance of a live birth with IUI in a stimulated cycle would be between 17% and 50%. It is uncertain whether treatment with IUI in a stimulated cycle results in a lower multiple pregnancy rate compared to control (OR 3.01, 95% CI 0.47 to 19.28; 2 RCTs, 454 women; I 2 = 0%; low-quality evidence). IUI in a natural cycle versus timed intercourse or expectant management in a stimulated cycle Treatment with IUI in a natural cycle probably results in a higher cumulative live birth rate compared to treatment with expectant management in a stimulated cycle (OR 1.95, 95% CI 1.10 to 3.44; 1 RCT, 342 women: moderate-quality evidence). If we assume the chance of a live birth with expectant management in a stimulated cycle was 13%, the chance of a live birth with IUI in a natural cycle would be between 14% and 34%. It is uncertain whether treatment with IUI in a natural cycle results in a lower multiple pregnancy rate compared to control (OR 1.05, 95% CI 0.07 to 16.90; 1 RCT, 342 women; low-quality evidence). IUI in a stimulated cycle versus IUI in a natural cycle Treatment with IUI in a stimulated cycle may result in a higher cumulative live birth rate compared to treatment with IUI in a natural cycle (OR 2.07, 95% CI 1.22 to 3.50; 4 RCTs, 396 women; I 2 = 0%; low-quality evidence). If we assume the chance of a live birth with IUI in a natural cycle was 14%, the chance of a live birth with IUI in a stimulated cycle would be between 17% and 36%. It is uncertain whether treatment with IUI in a stimulated cycle results in a higher multiple pregnancy rate compared to control (OR 3.00, 95% CI 0.11 to 78.27; 2 RCTs, 65 women; low-quality evidence).; Authors' Conclusions: Due to insufficient data, it is uncertain whether treatment with IUI with or without OH compared to timed intercourse or expectant management with or without OH improves cumulative live birth rates with acceptable multiple pregnancy rates in couples with unexplained subfertility. However, treatment with IUI with OH probably results in a higher cumulative live birth rate compared to expectant management without OH in couples with a low prediction score of natural conception. Similarly, treatment with IUI in a natural cycle probably results in a higher cumulative live birth rate compared to treatment with timed intercourse with OH. Treatment with IUI in a stimulated cycle may result in a higher cumulative live birth rate compared to treatment with IUI in a natural cycle. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Ayesha, A., et al. (2023). "Systematic review of patient-initiated follow-up (PIFU) in low-risk endometrial cancer after surgery." PROSPERO International prospective register of systematic reviews.
	
Ayoubi, J.-M. (2021). "Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis." ClinicalTrials.gov.
	No Results Available Drug: GnRH agonist Clinical pregnancy rate in both groups at last visit ultrasound|Successful implantation rate on the number of patients included|Rates of miscarriages on the number of patients included|Side effects related to treatment with Decapeptyl 3 mg Female Phase 2|Phase 3 180 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2019_0012 June 18, 2025

Ayse Filiz, G., et al. (2023). "Does Lenvatinib Plus Pembrolizumab for the Treatment of Recurrent Endometrial Cancer increase Progression Free survival, Disease Free Survival?" PROSPERO International prospective register of systematic reviews.
	
Azienda Ospedaliera Per L'Emergenza, C. (2021). "Maintenance therapy with Trabectedin after combination therapy Liposomal Doxorubicin plus Trabectedin vs Liposomal Doxorubicin plus Trabectedin in patients affected by relapsed ovarian cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: YONDELIS ‐ 1 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE ‐ USO ENDOVENOSO ‐ FLACONCINO (VETRO) 1 FLACONCINO Product Name: Trabectedina Product Code: [Trabectedina] Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: TRABECTEDINA CAS Number: 114899‐77‐3 Current Sponsor code: Trabectedina Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 1‐ CONDITION: Ovarian cancer ; MedDRA version: 21.0 Level: PT Classification code 10033160 Term: Ovarian epithelial 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: Progression free survival. ; To demonstrate non inferiority (PFS) of Trabectedin maintenance therapy vs combination arm with liposomal doxorubicin (PLD) and Trabectedin after a common treatment with 6 cycles of (PLD) and Trabectedin. Primary end point(s): To demonstrate non inferiority of Trabectedin maintenance therapy vs combination arm with liposomal doxorubicin (PDL) and Trabectedin after a common treatment with 6 or 8 cycles of PDL and Trabectedin . Secondary Objective: OS; ; Safety;; Role of CA 125 as a predictor of response;; Role of PET/CT as a detector of early response; ; To compare Quality of life (QoL) in each arm using the European Organization for Reserch and Treatment of Cancer (EORTC) Quality of Life Questionaire C30 and Quality of life.; Timepoint(s) of evaluation of this end point: Progression Free Survival (PFS) will be measured from the date of 1th cycle to the date of documented PD or death (regardless of cause of death). SECONDARY OUTCOME: Secondary end point(s): Objective RR will be the best response obtained in any evaluation according to RECIST 1.1; CA‐125 serological response will be the best response obtained in each arm according to Rustin criteria.; Investigate the role of PET/CT as a detector of early response.; Overall survival will be evaluated in both arms.; Timepoint(s) of evaluation of this end point: From the date of 1th cycle to the date of documented PD or death (regardless of cause of death). INCLUSION CRITERIA: ‐ Histologically and/or cytologically proven epithelial ovarian, epithelial fallopian tube cancer or primary peritoneal cancer ‐ Female, Age = 18 years ‐ Indication for chemotherapy ‐ No more of 3 previous lines of chemotherapy ‐ Life expectancy of more of 3 months ‐ Presense of CVC ‐ Completion of n 6 cycles of combined therapy of Liposomal Doxorubincin plus Trabectidine ‐ Stable disease, partial response, complete response confirmed by radiological imaging, such as magnetic resonance imaging (MR1), computed tomography (CT) scan, or PET/CT scan, after n. 6 cycles of combined therapy of Liposomal Doxorubincin plus Trabectidine ‐ Relapsed ovarian cancer with a progression free interval of six and twelve (6‐12) months (calculated from the first day of the last cycle of the last platinum‐based chemotherapy until the date of progression confirmation through radiologic imaging). Patients may have received up to three platinum‐based chemother

Azizi, K., et al. (2021). "The effects of myo-inositol vs. metformin on the ovarian function in the polycystic ovary syndrome: a systematic review and meta-analysis." European Review for Medical and Pharmacological Sciences 25(7): 3105-3115.
	Objective: Recent studies have revealed that myo-inositol could be more influential in patients with polycystic ovary syndrome (PCOS). This study was aimed to determine and compare the effects of myo-inositol and metformin on hormonal and metabolic profiles and fertility outcomes.; Materials and Methods: A comprehensive search was carried out among the English-language databases, including PubMed, Scopus, Cochrane Library, Google Scholar, and Web of Science, and the articles published from April 2010 to February 2019 were tracked down. The fixed and random-effects meta-analysis was used to estimate the pooled effect size. The meta-analysis was performed in Stata Version 14.0.; Results: Nine studies with 331 patients treated with metformin and 307 patients treated with myo-inositol groups were included in the analysis. The research groups did not diverge significantly in terms of the basic characteristics, such as age and Body Mass Index (BMI). In the myo-inositol group, the levels of Luteinizing Hormone (LH) [12.55% (95% I: 11.41-13.68%)], S. testosterone [44.38% (95% CI: 38.09-50.67%)] and prolactin [7.97% (95% CI: 6.58- 9.37%)] were significantly higher than those recorded, i.e., LH [7.97% (95% CI: 6.58- 9.37%)], S. testosterone [8.48% (95% CI: 3.14-13.83%)] and prolactin [7.14% (95% CI: 1.50-14.79%)] for the metformin group (p<0.001).; Conclusions: Due to the dearth of related research and the high heterogeneity of the Randomized Clinical Trials (RCTs) included in other studies, the present systematic review could not establish any differences between metformin and myo-inositol concerning the hormonal profile and the ovarian function. However, the findings indicated that myo-inositol could improve fertility outcomes by modulating hyperandrogenism. Randomized trials are required to understand the mechanistic actions of myo-inositol in comparison with those of metformin regarding oocyte and embryo quality, fertilization, pregnancy, and live birth rates.

Azizi, M., et al. (2022). "The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors and Serotonin-Norepinephrine Reuptake Inhibitors in the Treatment of Menopausal Hot Flashes: A Systematic Review of Clinical Trials." Iranian Journal of Medical Sciences 47(3): 173-193.
	Background: Hot flashes (HF) are a common symptom during the menopausal transition. It is therefore important to identify effective drugs that can alleviate HF. This study aimed to systematically review published clinical trials on the efficacy and safety of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) in the treatment of HF in healthy menopausal women. Method(s): In this systematic review, articles published during 2003-2019 in PubMed, MEDLINE, Web of Science, Scopus, Science Direct, PsycINFO, CINAHL, the Cochrane Central Register of Controlled Trials, and Google Scholar as well as Iranian databases such as SID, and Magiran were searched. The quality of the selected articles was assessed using the Jadad score calculation. Result(s): Thirty-six articles on randomized controlled trials were included in this study, out of which 27 articles had acceptable, and nine had weak methodological quality. Findings on SSRIs class of drugs indicated that escitalopram, paroxetine, and fluoxetine have higher efficacy and safety in the treatment of menopausal HF than other drugs. Studies on the effectiveness of sertraline, citalopram, and fluvoxamine are limited in number or show inconsistent results. Therefore, further high-quality studies are required to confirm their effectiveness in alleviating HF. Within the SNRIs class, venlafaxine and desvenlafaxine showed significant efficacy in the treatment of menopausal HF. However, studies on the effectiveness of duloxetine are also limited, which requires further research. Conclusion(s): Most studies have indicated the efficacy and safety of some antidepressants, such as SSRIs and SNRIs, in decreasing the frequency and severity of HF. These drugs are therefore recommended for the treatment of menopausal HF.Copyright © 2022, Shriaz University of Medical Sciences. All rights reserved.

Baak Nora, A., et al. (2019). "Temperature of embryo culture for assisted reproduction." The Cochrane Database of Systematic Reviews 9: CD012192.
	Background: 'Infertility' is defined as the failure to achieve pregnancy after 12 months or more of regular unprotected sexual intercourse. One in six couples experience a delay in becoming pregnant. In vitro fertilisation (IVF) is one of the assisted reproductive techniques used to enable couples to achieve a live birth. One of the processes involved in IVF is embryo culture in an incubator, where a stable environment is created and maintained. The incubators are set at approximately 37°C, which is based on the human core body temperature, although several studies have shown that this temperature may in fact be lower in the female reproductive tract and that this could be beneficial. In this review we have included randomised controlled trials which compared different temperatures of embryo culture.; Objectives: To assess different temperatures of embryo culture for human assisted reproduction, which may lead to higher live birth rates.; Search Methods: We searched the following databases and trial registers: the Cochrane Gynaecology and Fertility (CGF) Group Specialised Register of Controlled Trials, the Cochrane Central Register of Studies Online, MEDLINE, Embase, PsycINFO, CINAHL, clinicaltrials.gov, The World Health Organization International Trials Registry Platform search portal, DARE, Web of Knowledge, OpenGrey, LILACS database, PubMed and Google Scholar. Furthermore, we manually searched the references of relevant articles and contacted experts in the field to obtain additional data. We did not restrict the search by language or publication status. We performed the last search on 6 March 2019.; Selection Criteria: Two review authors independently screened the titles and abstracts of articles retrieved by the search. Full texts of potentially eligible randomised controlled trials (RCTs) were obtained and screened. We included all RCTs which compared different temperatures of embryo culture in IVF or intracytoplasmic sperm injection (ICSI), with a minimum difference in temperature between the two incubators of ≥ 0.5°C. The search process is shown in the PRISMA flow chart.; Data Collection and Analysis: Two review authors independently assessed trial eligibility and risk of bias and extracted data from the included studies; the third review author resolved any disagreements. We contacted trial authors to provide additional data. The primary review outcomes were live birth and miscarriage. Clinical pregnancy, ongoing pregnancy, multiple pregnancy and adverse events were secondary outcomes. All extracted data were dichotomous outcomes, and odds ratios (OR) were calculated with 95% confidence intervals (CIs) on an intention-to-treat basis. We assessed the overall quality of the evidence for the main comparisons using GRADE methods.; Main Results: We included three RCTs, with a total of 563 women, that compared incubation of embryos at 37.0°C or 37.1°C with a lower incubator temperature (37.0°C versus 36.6°C, 37.1°C versus 36.0°C, 37.0° versus 36.5°C). Live birth, miscarriage, clinical pregnancy, ongoing pregnancy and multiple pregnancy were reported. After additional information from the authors, we confirmed one study as having no adverse events; the other two studies did not report adverse events. We did not perform a meta-analysis as there were not enough studies included per outcome. Live birth was not graded since there were no data of interest available. The evidence for the primary outcome, miscarriage, was of very low quality. The evidence for the secondary outcomes, clinical pregnancy, ongoing pregnancy and multiple pregnancy was also of very low quality. We downgraded the evidence because of high risk of bias (for performance bias) and imprecision due to limited included studies and wide CIs.Only one study reported the primary outcome, live birth (n = 52). They performed randomisation at the level of oocytes and not per woman, and used a paired design whereby two embryos, one from 36.0°C and one from 37.0°C, were transferred. The data from this study were not interpretable in a meaningful way and therefore not presented. Only one study reported miscarriage. We are uncertain whether incubation at a lower temperature decreases the miscarriage (odds ratio (OR) 0.90, 95% CI 0.52 to 1.55; 1 study, N = 412; very low-quality evidence).Of the two studies that reported clinical pregnancy, only one of them performed randomisation per woman. We are uncertain whether a lower temperature improves clinical pregnancy compared to 37°C for embryo incubation (OR 1.08, 95% CI 0.73 to 1.60; 1 study, N = 412; very low-quality evidence). For the outcome, ongoing pregnancy, we are uncertain if a lower temperature is better than 37°C (OR 1.10, 95% CI 0.75 to 1.62; 1 study, N = 412; very low quality-evidence). Multiple pregnancy was reported by two studies, one of which used a paired design, which made it impossible to report the data per temperature. We are uncertain if a temperature lower than 37°C reduces multiple pregnancy (OR 0.80, 95% CI 0.31 to 2.07; 1 study, N = 412; very low-quality evidence). There was insufficient evidence to make a conclusion regarding adverse events, as no studies reported data suitable for analysis.; Authors' Conclusions: This review evaluated different temperatures for embryo culture during IVF. There is a lack of evidence for the majority of outcomes in this review. Based on very low-quality evidence, we are uncertain if incubating at a lower temperature than 37°C improves pregnancy outcomes. More RCTs are needed for comparing different temperatures of embryo culture which require reporting of clinical outcomes as live birth, miscarriage, clinical pregnancy and adverse events.

Babazadeh-Zavieh Seyedeh, S., et al. (2023). "Effects of Transcutaneous Electrical Nerve Stimulation on Chronic Pelvic Pain in Women: A Systematic Review and Meta-Analysis." Complementary Medicine Research 30(2): 161-173.
	Introduction: The study aimed to identify the effects of transcutaneous electrical nerve stimulation (TENS) in women with chronic pelvic pain (CPP) by conducting a systematic review and meta-analysis of randomized controlled trials.; Methods: We used five international databases from 2000 to 2020 and selected the clinical trials that reported the effects of TENS on CPP. We excluded the case reports, acute pelvic pain reports, men-related, animal-related, and intravaginal and intrarectal electrical stimulation articles. The level of pain (based on the visual analog scale) was considered for pooling data through the meta-analysis.; Results: Ten studies met the inclusion criteria, and three articles were included in the meta-analysis. The results showed that TENS application mildly reduced pain in women with primary dysmenorrhea (mean difference = -1.29; 95% CI: -2.57 to -0.01; Z = 1.98, p = 0.05). Also, to reduce pain in patients with CPP, the TENS must be applied at least for 20 min, with a pulse duration of 50-400 μs, at a frequency of 2-120 Hz. The meta-analysis was followed by assessing the risk of bias, including publication bias. Based on the Cochrane risk of bias evaluation, the majority of the included trials were assessed with moderate methodological quality.; Conclusion: TENS application can mildly improve the level of pain in patients with CPP caused by primary dysmenorrhea. Although no distinct agreement was observed among the effective parameters, the high-frequency mode with maximum tolerated intensity was more effective compared to the low-frequency mode. (© 2022 S. Karger AG, Basel.)

Babb, C. (2023). "Effect of Flourish HEC Vaginal Care System on BV Recurrence and the Vaginal Microbiome." ClinicalTrials.gov.
	No Results Available Device: Flourish HEC Vaginal Care System Recurrence of bacterial vaginosis (BV)|Vaginal pH changes|Vaginal microbiome whole-genome sequencing changes|Vulvovaginal symptoms by questionnaires Female Not Applicable 400 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention BV30123 December 2026

Babiy, Z., et al. (2024). "One-Day Peer-Delivered Cognitive Behavioral Therapy-Based Workshops for Postpartum Depression: A Randomized Controlled Trial." Psychotherapy and Psychosomatics: 1-12.
	INTRODUCTION: Myriad treatment barriers prevent birthing parents with postpartum depression (PPD) from receiving timely treatment. We aimed to determine whether a peer-delivered online 1-day cognitive behavioral therapy (CBT)-based workshop added to treatment as usual (TAU) improves PPD and its comorbidities and is more cost-effective than TAU alone. METHODS: This parallel-group, randomized controlled trial took place in Ontario, Canada (June 7, 2021, to February 18, 2022). Participants were ≥18 years old, had an infant ≤12 months old, and an Edinburgh Postnatal Depression Scale (EPDS) score ≥10. Participants were allocated to receive the workshop plus TAU (n = 202) or TAU and waitlisted to complete the workshop 12 weeks later (n = 203). The primary outcome was change in PPD (EPDS score) from enrollment to 12 weeks later. The secondary outcome was cost-effectiveness and tertiary outcomes included anxiety, social support, partner relationship quality, the mother-infant relationship, parenting stress, and infant temperament. RESULTS: Participants had a mean age of 32.3 years (SD = 4.30) and 65% were White. The workshop led to a significant reduction in EPDS scores (15.95-11.37; d = 0.92, p < 0. 01) and was associated with higher odds of exhibiting a clinically significant decrease in EPDS scores (OR = 2.03; 95% CI: 1.26-3.29). The workshop plus TAU was more cost-effective than TAU alone. It also led to improvements in postpartum anxiety, infant-focused anxiety, parenting stress, and infant temperament. CONCLUSIONS: Peer-delivered 1-day CBT-based workshops can improve PPD and are a potentially scalable low-intensity treatment that could help increase treatment access.

Backstrom, T., et al. (2021). "A randomized, double-blind study on efficacy and safety of sepranolone in premenstrual dysphoric disorder." Psychoneuroendocrinology 133.
	Women with premenstrual dysphoric disorder (PMDD) experience mood symptoms related to the increase in progesterone and the neuroactive steroid allopregnanolone. Our hypothesis is that allopregnanolone is the symptom provoking factor. The rationale for the present study was to treat PMDD patients with the GABAA receptor modulating steroid antagonist, sepranolone (isoallopregnanolone). Patients (n = 206) with PMDD from 12 European centers were randomized in a parallel double-blind study and treated with placebo, sepranolone 10 mg and 16 mg. Patients administered sepranolone subcutaneously every 48 h during the 14 premenstrual days of three consecutive menstrual cycles. After obtaining informed consent, the PMDD diagnosis was confirmed according to DSM-5 and verified with two menstrual cycles of daily symptom ratings using the Daily Record of Severity of Problems (DRSP) scale in an eDiary. Inclusion and exclusion criteria stipulated that the women should be essentially healthy, not pregnant, have no ongoing psychiatric disorder or take interfering medications, and have regular menstrual cycles. The study's primary endpoint was the Total symptom score (Sum21, the score for all 21 symptom questions in the DRSP). In the prespecified statistical analysis the average score of the 5 worst premenstrual days in treatment cycles 2 and 3 were subtracted from the corresponding average score in the two diagnostic cycles. The treatment effects were tested using analysis of variance in a hierarchal order starting with the combined active sepranolone treatments vs. placebo. The prespecified analysis of Sum21 showed a large treatment effect of all three treatments but no statistically significant difference to placebo. However, the ratings of distress showed a significant treatment effect of sepranolone compared to placebo (p = 0.037) and the ratings of impairment showed a trend to greater treatment effect of sepranolone compared to placebo. Many women with PMDD had symptoms during a longer period than the late luteal phase. It has previously been shown that 9 premenstrual days may be more representative for comparison of PMDD symptom periods than the 5 worst premenstrual days. A post hoc analysis was undertaken in the per protocol population investigating the treatment effect during 9 premenstrual days in the third treatment cycle. The Sum21 results of this analysis showed that the sepranolone 10 mg was significantly better than placebo (p = 0.008). Similar significant treatment effects were found for the impairment and distress scores. A significantly larger number of individuals experienced no or minimal symptoms (Sum21 < 42 points) with the 10 mg sepranolone treatment compared to placebo (p = 0.020). The results indicate that there is an attenuating effect by sepranolone on symptoms, impairment, and distress in women with PMDD especially by the 10 mg dosage. Sepranolone was well tolerated, and no safety concerns were identified. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

Bader, S., et al. (2024). "A systematic review of GLP-1 on anthropometrics, metabolic and endocrine parameters in patients with PCOS." Women's Health 20: 17455057241234530.
	Polycystic ovary syndrome is a common reproductive endocrine condition that affects women of fertile age and is characterized by three main features, including hyperandrogenism, chronic anovulation, and polycystic ovaries. In addition, half of women with polycystic ovary syndrome have insulin resistance, and obesity or overweight, type 2 diabetes, hypertension, and hyperlipidemia are the most common metabolic abnormalities affecting (30%) women with polycystic ovary syndrome. Weight loss is regarded as the first-line treatment as it can potentially improve polycystic ovary syndrome parameters (androgen levels, menstrual cyclicity, lipid and glucose metabolism). However, achieving and maintaining weight loss can be challenging, and pharmacological agents could be essential to achieve optimal glycemic control and improve the endocrine disturbance associated with polycystic ovary syndrome. Glucagon-like peptide-1 receptor agonist has been demonstrated as monotherapy or in combination with metformin for managing obesity and insulin resistance associated with polycystic ovary syndrome. Yet, its effect on endocrine and metabolic parameters remains elusive, and further research is needed to close the gap. The aim is to evaluate the efficacy of glucagon-like peptide-1 receptor agonist monotherapy and/or a combined treatment between glucagon-like peptide-1 receptor agonist and metformin for improving anthropometric measurements, endocrine and metabolic parameters in lean and obese women with polycystic ovary syndrome. A systematic review of longitudinal cohort studies was conducted across databases including Ovid Medline, PubMed Central, and Cochrane Library between 2015 and 2022. Eligible studies included participants with polycystic ovary syndrome diagnosed according to the 2003 Rotterdam or the 1990 National Institutes of Health criteria. A total of eight studies including 486 patients with polycystic ovary syndrome were analyzed. The mean age was between 18 and 45 years with mean follow-up period between 12 and 32 weeks. In all these studies, results were comparable for the reduction in body mass index, waist circumference, fat mass, and visceral fat mass; however, it was more in combination therapy versus comparator. In conclusion, glucagon-like peptide-1 receptor agonists effectively reduce body weight and improve some of the endocrine and metabolic parameters of polycystic ovary syndrome. A combined treatment with glucagon-like peptide-1 receptor agonist and metformin had significant effects on weight loss and favorable results on endocrine and metabolic parameters, yet further research is needed to discover the long-term safety of combined therapy in women diagnosed with polycystic ovary syndrome and obesity or overweight.

Bafort, C., et al. (2020). "Laparoscopic surgery for endometriosis." The Cochrane Database of Systematic Reviews 10: CD011031.
	Background: Endometriosis is associated with pain and infertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy.; Objectives: To assess the effectiveness and safety of laparoscopic surgery in the treatment of pain and infertility associated with endometriosis.; Search Methods: This review has drawn on the search strategy developed by the Cochrane Gynaecology and Fertility Group including searching the Cochrane Gynaecology and Fertility Group's specialised register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, reference lists for relevant trials, and trial registries from inception to April 2020.; Selection Criteria: We selected randomised controlled trials (RCTs) that compared the effectiveness and safety of laparoscopic surgery with any other laparoscopic or robotic intervention, holistic or medical treatment, or diagnostic laparoscopy only.; Data Collection and Analysis: Two review authors independently performed selection of studies, assessment of trial quality and extraction of relevant data with disagreements resolved by a third review author. We collected data for the core outcome set for endometriosis. Primary outcomes included overall pain and live birth. We evaluated the quality of evidence using GRADE methods.; Main Results: We included 14 RCTs. The studies randomised 1563 women with endometriosis. Four RCTs compared laparoscopic ablation or excision with diagnostic laparoscopy only. Two RCTs compared laparoscopic excision with diagnostic laparoscopy only. One RCT compared laparoscopic ablation or excision with laparoscopic ablation or excision and uterine suspension. Two RCTs compared laparoscopic ablation and uterine nerve transection with diagnostic laparoscopy only. One RCT compared laparoscopic ablation with diagnostic laparoscopy and gonadotropin-releasing hormone (GnRH) analogues. Two RCTs compared laparoscopic ablation with laparoscopic excision. One RCT compared laparoscopic ablation or excision with helium thermal coagulator with laparoscopic ablation or excision with electrodiathermy. One RCT compared conservative laparoscopic surgery with laparoscopic colorectal resection of deep endometriosis infiltrating the rectum. Common limitations in the primary studies included lack of clearly described blinding, failure to fully describe methods of randomisation and allocation concealment, and poor reporting of outcome data. Laparoscopic treatment versus diagnostic laparoscopy We are uncertain of the effect of laparoscopic treatment on overall pain scores compared to diagnostic laparoscopy only at six months (mean difference (MD) 0.90, 95% confidence interval (CI) 0.31 to 1.49; 1 RCT, 16 participants; very low quality evidence) and at 12 months (MD 1.65, 95% CI 1.11 to 2.19; 1 RCT, 16 participants; very low quality evidence), where a positive value means pain relief (the higher the score, the more pain relief) and a negative value reflects pain increase (the lower the score, the worse the increase in pain). No studies looked at live birth. We are uncertain of the effect of laparoscopic treatment on quality of life compared to diagnostic laparoscopy only: EuroQol-5D index summary at six months (MD 0.03, 95% CI -0.12 to 0.18; 1 RCT, 39 participants; low quality evidence), 12-item Short Form (SF-12) mental health component (MD 2.30, 95% CI -4.50 to 9.10; 1 RCT, 39 participants; low quality evidence) and SF-12 physical health component (MD 2.70, 95% CI -2.90 to 8.30; 1 RCT, 39 participants; low quality evidence). Laparoscopic treatment probably improves viable intrauterine pregnancy rate compared to diagnostic laparoscopy only (odds ratio (OR) 1.89, 95% CI 1.25 to 2.86; 3 RCTs, 528 participants; I 2 = 0%; moderate quality evidence). We are uncertain of the effect of laparoscopic treatment compared to diagnostic laparoscopy only on ectopic pregnancy (MD 1.18, 95% CI 0.10 to 13.48; 1 RCT, 100 participants; low quality evidence) and miscarriage (MD 0.94, 95% CI 0.35 to 2.54; 2 RCTs, 112 participants; low quality evidence). There was limited reporting of adverse ev nts. No conversions to laparotomy were reported in both groups (1 RCT, 341 participants). Laparoscopic ablation and uterine nerve transection versus diagnostic laparoscopy We are uncertain of the effect of laparoscopic ablation and uterine nerve transection on adverse events (more specifically vascular injury) compared to diagnostic laparoscopy only (OR 0.33, 95% CI 0.01 to 8.32; 1 RCT, 141 participants; low quality evidence). No studies looked at overall pain scores (at six and 12 months), live birth, quality of life, viable intrauterine pregnancy confirmed by ultrasound, ectopic pregnancy and miscarriage. Laparoscopic ablation versus laparoscopic excision There was insufficient evidence to determine whether there was a difference in overall pain, measured at 12 months, for laparoscopic ablation compared with laparoscopic excision (MD 0.00, 95% CI -1.22 to 1.22; 1 RCT, 103 participants; very low quality evidence). No studies looked at overall pain scores at six months, live birth, quality of life, viable intrauterine pregnancy confirmed by ultrasound, ectopic pregnancy, miscarriage and adverse events. Helium thermal coagulator versus electrodiathermy We are uncertain whether helium thermal coagulator compared to electrodiathermy improves quality of life using the 30-item Endometriosis Health Profile (EHP-30) at nine months, when considering the components: pain (MD 6.68, 95% CI -3.07 to 16.43; 1 RCT, 119 participants; very low quality evidence), control and powerlessness (MD 4.79, 95% CI -6.92 to 16.50; 1 RCT, 119 participants; very low quality evidence), emotional well-being (MD 6.17, 95% CI -3.95 to 16.29; 1 RCT, 119 participants; very low quality evidence) and social support (MD 5.62, 95% CI -6.21 to 17.45; 1 RCT, 119 participants; very low quality evidence). Adverse events were not estimable. No studies looked at overall pain scores (at six and 12 months), live birth, viable intrauterine pregnancy confirmed by ultrasound, ectopic pregnancy and miscarriage.; Authors' Conclusions: Compared to diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis. No data were reported on live birth. There is moderate quality evidence that laparoscopic surgery increases viable intrauterine pregnancy rates confirmed by ultrasound compared to diagnostic laparoscopy only. No studies were found that looked at live birth for any of the comparisons. Further research is needed considering the management of different subtypes of endometriosis and comparing laparoscopic interventions with lifestyle and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Bajerska, J. (2023). "The Impact of Time-restricted Eating on the Outcomes Associated With Polycystic Ovary Syndrome." ClinicalTrials.gov.
	No Results Available Behavioral: Time-restricted eating Change in body weight|Change in circumferences|Change in body composition|Change in composition of the intestinal microbiota|Change in selected hormonal parameters|Change in lipid profile|Change in glucose metabolism|Assessment of changes in eating behavior pre- and post-intervention|Change in bone density|Change in the concentration of short-chain fatty acids in feces|Change in the expression of genes encoding kisspeptin and gamma-aminobutyric acid|Change in intestinal barrier integrity|Change in neurohormonal status Female Not Applicable 52 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment 646/23 December 31, 2025

Bakali, E., et al. (2019). "Interventions for treating recurrent stress urinary incontinence after failed minimally invasive synthetic midurethral tape surgery in women." The Cochrane Database of Systematic Reviews 2019(9): CD009407.
	Background Surgery is a common treatment modality for stress urinary incontinence (SUI), usually offered to women for whom conservative treatments have failed. Midurethral tapes have superseded colposuspension because cure rates are comparable and recovery time is reduced. However, some women will not be cured after midurethral tape surgery. Currently, there is no consensus on how to manage the condition in these women. This is an update of a Cochrane Review first published in 2013. Objectives To assess the effects of interventions for treating recurrent stress urinary incontinence after failed minimally invasive synthetic midurethral tape surgery in women; and to summarise the principal findings of economic evaluations of these interventions. Search methods We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 9 November 2018). We also searched the reference lists of relevant articles. Selection criteria We included randomised and quasi-randomised controlled trials in women who had recurrent stress urinary incontinence after previous minimally invasive midurethral tape surgery. We included conservative, pharmacological and surgical treatments. Data collection and analysis Two review authors checked the abstracts of identified studies to confirm their eligibility. We obtained full-text reports of relevant studies and contacted study authors directly for additional information where necessary. We extracted outcome data onto a standard proforma and processed them according to the guidance in the Cochrane Handbook for Systematic Reviews of Interventions. Main results We included one study in this review. This study was later reported in an originally unplanned secondary analysis of 46 women who underwent transobturator tape for recurrent SUI after one or more previous failed operations. We were unable to use the data, as they were not presented according to the nature of the first operation. We excluded 12 studies, five because they were not randomised controlled trials (RCTs) and four because previous incontinence surgery was not performed using midurethral tape. We considered a further three to be ineligible because neither the trial report nor personal communication with the trialists could confirm whether any of the participants had previously undergone surgery with tape. We had also planned to develop a brief economic commentary summarising the principal findings of relevant economic evaluations but supplementary systematic searches did not identify any such studies. Authors' conclusions There were insufficient data to assess the effects of any of the different management strategies for recurrent or persistent stress incontinence after failed midurethral tape surgery. No published papers have reported exclusively on women whose first operation was a midurethral tape. Evidence from further RCTs and economic evaluations is required to address uncertainties about the effects and costs of these treatments.Copyright © 2019 The Cochrane Collaboration.

Balk, E. M., et al. (2019). "Pharmacologic and nonpharmacologic treatments for urinary incontinence in women a systematic review and network meta-analysis of clinical outcomes." Annals of Internal Medicine 170(7): 488-496.
	Background: Urinary incontinence (UI), a common malady in women, most often is classified as stress, urgency, or mixed. Purpose(s): To compare the effectiveness of pharmacologic and nonpharmacologic interventions to improve or cure stress, urgency, or mixed UI in nonpregnant women. Data Sources: MEDLINE, Cochrane Central Register of Controlled Trials (Wiley), Cochrane Database of Systematic Reviews (Wiley), EMBASE (Elsevier), CINAHL (EBSCO), and PsycINFO (American Psychological Association) from inception through 10 August 2018. Study Selection: 84 randomized trials that evaluated 14 categories of interventions and reported categorical cure or improvement outcomes. Data Extraction: 1 researcher extracted study characteristics, results, and study-level risk of bias, with verification by another independent researcher. The research team collaborated to assess strength of evidence (SoE) across studies. Data Synthesis: 84 studies reported cure or improvement outcomes (32 in stress UI, 16 in urgency UI, 4 in mixed UI, and 32 in any or unspecified UI type). The most commonly evaluated active intervention types included behavioral therapies, anticholinergics, and neuromodulation. Network meta-analysis showed that all interventions, except hormones and periurethral bulking agents (variable SoE), were more effective than no treatment in achieving at least 1 favorable UI outcome. Among treatments used specifically for stress UI, behavioral therapy was more effective than either -agonists or hormones in achieving cure or improvement (moderate SoE); -agonists were more effective than hormones in achieving improvement (moderate SoE); and neuromodulation was more effective than no treatment for cure, improvement, and satisfaction (high SoE). Among treatments used specifically for urgency UI, behavioral therapy was statistically significantly more effective than anticholinergics in achieving cure or improvement (high SoE), both neuromodulation and onabotulinum toxin A (BTX) were more effective than no treatment (high SoE), and BTX may have been more effective than neuromodulation in achieving cure (low SoE). Limitation(s): Scarce direct (head-to-head trial) evidence and population heterogeneity based on UI type, UI severity, and history of prior treatment. Conclusion(s): Most nonpharmacologic and pharmacologic interventions are more likely than no treatment to improve UI outcomes. Behavioral therapy, alone or in combination with other interventions, is generally more effective than pharmacologic therapies alone in treating both stress and urgency UI.Copyright © 2019 American College of Physicians.

Bandara, E. M. I. A., et al. (2022). "Safety and efficacy of therapeutic taping in primary dysmenorrhea: a systematic review and meta-analysis." Scientific Reports 12(1): 7146.
	Primary dysmenorrhea (PD) is a common gynecological condition among adolescent and adult women. Several pharmacological and alternative therapies (e.g. therapeutic taping) have been used to treat PD, with varying effect. This systematic review and meta-analysis was performed to evaluate the safety and efficacy of therapeutic taping on clinical symptoms of PD, considering pain as the primary outcome. MEDLINE, Cochrane Library, Embase, PEDro, CINAHL and gray literature sources were searched from inception to February 2022 for randomized controlled trials (RCTs) that assessed the effect of therapeutic taping for PD. The language was restricted to English. A total of ten studies were included in the systematic review, involving 685 participants. Eight studies were included in quantitative analysis. The quality of the studies ranged from 4 to 7 with a median of 5 as assessed by PEDro scale. Meta-analyses indicated short-term improvements of pain compared to sham and no interventions. Elastic therapeutic taping (ETT) indicated short term improvements in anxiety associated with PD. Moderate to high quality of evidence suggested that ETT is an effective intervention in improving pain, anxiety, and quality of life of women with PD. A scarcity of evidence on the long-term effects of therapeutic taping in PD is observed. (© 2022. The Author(s).)

Banerjee, S., et al. (2023). "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 Oncology 9(5): 675-682.
	Importance: Patients with platinum-resistant or refractory ovarian high-grade serous carcinoma (PR-HGSC) have a poor prognosis and few therapeutic options. Preclinical studies support targeting PI3K/AKT/mTOR signaling in this setting, and a phase 1 study of the dual mTORC1/mTORC2 inhibitor vistusertib with weekly paclitaxel showed activity.; Objective: To evaluate whether the addition of vistusertib to weekly paclitaxel improves clinical outcomes in patients with PR-HGSC.; Design, Setting, and Participants: This phase 2, double-blind, placebo-controlled multicenter randomized clinical trial recruited patients from UK cancer centers between January 2016 and March 2018. Patients with PR-HGSC of ovarian, fallopian tube, or primary peritoneal origin and with measurable or evaluable disease (Response Evaluation Criteria in Solid Tumors version 1.1 and/or Gynecological Cancer Intergroup cancer antigen 125 criteria) were eligible. There were no restrictions on number of lines of prior therapy. Data analysis was performed from May 2019 to January 2022.; Interventions: Patients were randomized (1:1) to weekly paclitaxel (80 mg/m2 days 1, 8, and 15 of a 28-day cycle) plus oral vistusertib (50 mg twice daily) or placebo.; Main Outcomes and Measures: The primary end point was progression-free survival in the intention-to-treat population. Secondary end points included response rate, overall survival, and quality of life.; Results: A total of 140 patients (median [range] age, 63 [36-86] years; 17.9% with platinum-refractory disease; 53.6% with ≥3 prior therapies) were randomized. In the paclitaxel plus vistusertib vs paclitaxel plus placebo groups, there was no difference in progression-free survival (median, 4.5 vs 4.1 months; hazard ratio [HR], 0.84; 80% CI, 0.67-1.07; 1-sided P = .18), overall survival (median, 9.7 vs 11.1 months; HR, 1.21; 80% CI, 0.91-1.60) or response rate (odds ratio, 0.86; 80% CI, 0.55-1.36). Grade 3 to 4 adverse events were 41.2% (weekly paclitaxel plus vistusertib) vs 36.7% (weekly paclitaxel plus placebo), and there was no difference in quality of life.; Conclusions and Relevance: In this randomized clinical trial of weekly paclitaxel and dual mTORC1/2 inhibition in patients with PR-HGSC, vistusertib did not improve clinical activity of weekly paclitaxel.; Trial Registration: isrctn.org Identifier: ISRCTN16426935.

Bapir, R., et al. (2023). "Treatment of urge incontinence in postmenopausal women: A systematic review." Archivio Italiano di Urologia e Andrologia 95(3): 11718.
	Background: Urinary incontinence and other urinary symptoms tend to be frequent at menopause because of hormonal modifications and aging. Urinary symptoms are associated with the genitourinary syndrome of menopause which is characterized by physical changes of the vulva, vagina and lower urinary tract. The treatment strategies for postmenopausal urinary incontinence are various and may include estrogens, anticholinergics, and pelvic floor muscle training. A comparison of these treatments is difficult due to the heterogeneity of adopted protocols. We systematically reviewed the evidence from randomized controlled trials (RCTs) focusing on treatment of postmenopausal women with urge incontinence.; Methods: We conducted a systematic review and meta-analysis by searching PubMed and EMBASE databases for randomized controlled trials (RCTs) reporting results of treatments for postmenopausal urinary urge incontinence. Odds ratios for improvement of urinary incontinence were calculated using random effect Mantel-Haenszel statistics.; Results: Out of 248 records retrieved, 35 eligible RCTs were assessed for risk of bias and included in the meta-analysis. Compared with placebo, systemic estrogens were associated with decreased odds of improving urinary incontinence in postmenopausal women (OR = 0.74, 95% CI: 0.61-0.91, 7 series, 17132 participants, Z = 2.89, P = 0.004, I2 = 72%). In most studies, no significant improvement in urinary symptoms was observed in patients treated with local estrogens, although they showed to be helpful in improving vaginal symptoms. Vitamin D, phytoestrogens and estrogen modulators were not effective in improving symptoms of incontinence and other symptoms of genitourinary menopause syndrome or yielded contradictory results. A randomized controlled trial demonstrated that oxybutynin was significantly better than placebo at improving postmenopausal urgency and urge incontinence. The combination of anticholinergics with local estrogens has not been shown to be more effective than anticholinergics alone in improving urinary incontinence symptoms in postmenopausal women. Physical therapy showed an overall positive outcome on postmenopausal urinary incontinence symptoms, although such evidence should be further validated in the frame of quality RCTs.; Conclusions: The evidence for effective treatment of postmenopausal urinary incontinence is still lacking. Welldesigned large studies having subjective and objective improvement primary endpoints in postmenopausal urinary incontinence are needed. At present, a combination of different treatments tailored to the characteristics of the individual patient can be suggested.

Baradacs, I., et al. (2024). "PARP inhibitor era in ovarian cancer treatment: a systematic review and meta-analysis of randomized controlled trials." Journal of Ovarian Research 17(1): 53.
	Background: Ovarian cancer is the eighth leading cause of cancer-related death among women, characterized by late diagnosis and a high relapse rate. In randomized controlled trials, we aimed to evaluate the efficacy and safety of PARP inhibitors (PARPi) in treating advanced ovarian cancer. Method(s): This review was registered on PROSPERO (CRD42021283150), included all phase II and phase III randomized controlled trials (RCTs) assessing the effect of PARPi on ovarian cancer until the 13th of April, 2022. The main outcomes were progression- free survival (PFS), overall survival (OS), and adverse events (AEs). Pooled hazard ratios (HRs), and risk ratios (RRs) were calculated with 95% confidence intervals (95% CI). The random-effects model was applied in all analyses. Result(s): In the meta-analysis, 16 eligible RCTs were included, with a total of 5,815 patients. In recurrent ovarian cancer, PARPi maintenance therapy showed a significant PFS benefit over placebo in the total population (HR 0.34, CI 0.29-0.40), BRCA mutant (HR 0.24, CI 0.18-0.31), germline BRCA mutant (HR 0.23, CI 0.18-0.30), and BRCA wild-type cases (HR 0.50, CI 0.39-0.65). PARPi monotherapy also improved PFS (HR 0.62, CI 0.51-0.76) compared with chemotherapy in BRCAm patients with recurrent ovarian cancer. The use of PARPi maintenance therapy resulted in an improvement in PFS over placebo in newly-diagnosed cancers in the overall population (HR 0.46, CI 0.30-0.71) and the BRCAm population (HR 0.36, CI 0.29-0.44). Although the risk of severe AEs was increased by PARPi therapy compared to placebo in most settings investigated, these side effects were controllable with dose modification, and treatment discontinuation was required in the minority of cases. Conclusion(s): PARPis are an effective therapeutic option for newly-diagnosed and recurrent ovarian cancer. Despite a minor increase in the frequency of serious adverse effects, they are generally well tolerated.Copyright © The Author(s) 2024.

Baradwan, S., et al. (2023). "Transvaginal needle versus laparoscopic ovarian drilling in hormonal profile and pregnancy outcomes of polycystic ovary syndrome: A systematic review and meta-analysis." Journal of Gynecology Obstetrics and Human Reproduction 52(6): 102606.
	Background: Polycystic ovary syndrome (PCOS) is a prevalent hormonal disorder distinguished by a persistent absence of ovulation. Ovarian drilling is a recognized therapeutic approach for PCOS patients who are unresponsive to medication and can be performed through invasive laparoscopic access or less-invasive transvaginal access. The aim of this systematic review and meta-analysis was to assess the efficacy of transvaginal ultrasound -guided ovarian needle drilling with conventional laparoscopic ovarian drilling (LOD) in patients with PCOS.; Methods: PUBMED, Scopus, and Cochrane databases were systematically searched for eligible randomized controlled trials (RCTs) from articles published from inception to January 2023. We include RCTs of PCOS that compared transvaginal ovarian drilling and LOD and reported on ovulation and pregnancy rates as the main outcome variable. We evaluated study quality using the Cochrane Risk of bias 2 tool. A random-effects meta-analysis was performed and the certainty of the evidence was assessed according to the GRADE approach. We registered the protocol prospectively in PROSPERO (CRD42023397481).; Results: Six RCTs including 899 women with PCOS met the inclusion criteria. LOD was found to significantly reduce anti-Mullerian hormone (AMH) (SMD: -0.22; 95% CI: -0.38, -0.05; I 2 = 39.85%) and antral follicle count (AFC) (SMD: -1.22; 95% CI: -2.26, -0.19; I 2 = 97.55%) compared to transvaginal ovarian drilling. Our findings also indicated that LOD significantly increased the ovulation rate by 25% compared to transvaginal ovarian drilling (RR: 1.25; 95% CI: 1.02, 1.54; I2 = 64.58%). However, we found no significant difference between the two groups in terms of follicle stimulating hormone (SMD: 0.04; 95% CI: -0.26, 0.33; I2 = 61.53%), luteinizing hormone (SMD: -0.07; 95% CI: -0.90, 0.77; I2 = 94.92%), and pregnancy rate (RR: 1.37; 95% CI: 0.94, 1.98; I2 = 50.49%).; Conclusion: LOD significantly lowers circulating AMH and AFC and significantly increases ovulation rate in PCOS patients compared to transvaginal ovarian drilling. As transvaginal ovarian drillingremains a less-invasive, more cost-effective, and simpler alternative, further studies are warranted to compare these two techniques in large cohorts, with a particular focus on ovarian reserve and pregnancy outcomes.; Competing Interests: Declaration of Competing Interest All authors declare that they have no competing interests. (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)

Baradwan, S., et al. (2024). "The effect of antioxidant supplementation on dysmenorrhea and endometriosis-associated painful symptoms: a systematic review and meta-analysis of randomized clinical trials." Obstetrics & Gynecology Science.
	This study aimed to review randomized controlled trials (RCTs) investigating the effects of dietary antioxidant supplements on the severity of endometriosis-related pain symptoms. The PubMed/Medline, Scopus, and Web of Science databases were searched until April 2022. Additionally, we manually searched the reference lists. Endpoints were summarized as standardized mean difference (SMD) with 95% confidence intervals (CIs) in a random-effects model. The I2 statistic was used to assess heterogeneity. Ten RCTs were included in this meta-analysis. Overall, 10 studies were related to dysmenorrhea, four to dyspareunia, and four to pelvic pain. Antioxidants significantly reduced dysmenorrhea (SMD, -0.48; 95% CI, -0.82 to -0.13; I2=75.14%). In a subgroup analysis, a significant reduction of dysmenorrhea was observed only in a subset of trials that administered vitamin D (SMD, -0.59; 95% CI, -1.13 to -0.06; I2=69.59%) and melatonin (SMD, -1.40; 95% CI, -2.47 to -0.32; I2=79.15%). Meta-analysis results also suggested that antioxidant supplementation significantly improved pelvic pain (SMD, -1.51; 95% CI, -2.74 to -0.29; I2=93.96%), although they seem not to have a significant beneficial impact on the severity of dyspareunia. Dietary antioxidant supplementation seems to beneficially impact the severity of endometriosis-related dysmenorrhea (with an emphasis on vitamin D and melatonin) and pelvic pain. However, due to the relatively small sample size and high heterogeneity, the findings should be interpreted cautiously, and the importance of further well-designed clinical studies cannot be overstated.

Barbe, C., et al. (2023). "Utility of early, short psychological care for women who experience early miscarriage: protocol for the randomized, controlled MisTher trial." BMC Psychology 11(1): 368.
	Background: Around one in ten women will have a miscarriage in their lifetime. Miscarriage is often considered a trivial event by caregivers, but it is associated with a high burden of psychological morbidity, especially during the first 6 months. There is no validated psychological management strategy for women who have had a miscarriage. The MisTher study aims to evaluate the utility of early, short psychological care for women who have had early miscarriage, in terms of anxiety, depression and post-traumatic stress disorder.; Methods: This is a prospective, multicenter, randomized, controlled, superiority study. In total, 932 women who have experienced early miscarriage (spontaneous interruption of pregnancy prior to 14 weeks of gestation) will be randomly assigned to either the intervention or the control group. The intervention consists of 4 teleconsultations of 45 min with a psychologist. All women, regardless of their allocated group, will be encouraged to seek an early consultation with a general practitioner or midwife. The primary endpoint will be anxiety at 3 months after randomization evaluated using State Trait Anxiety Inventory. The secondary endpoints will be anxiety at 6 months evaluated using State Trait Anxiety Inventory, depression at 3 and 6 months evaluated with the Beck Depression Inventory, and post-traumatic stress disorder at 3 and 6 months, evaluated using the Posttraumatic stress disorder Checklist Scale.; Discussion: This project will validate the importance of early psychological management, based on primary care and accessible to most women, via teleconsultation, in reducing the frequency of psychological disorders after early miscarriage. Our results should provide a basis for new recommendations for the management of women who have experienced miscarriage, notably by recommending the involvement of trained psychologists in the management pathway for these women.; Trial Registration: The trial is registered with ClinicalTrials.gov: NCT05653414. December 15th, 2022. (© 2023. The Author(s).)

Barnard Neal, D., et al. (2023). "A dietary intervention for vasomotor symptoms of menopause: a randomized, controlled trial." Menopause 30(1): 80-87.
	Objective: Postmenopausal vasomotor symptoms disrupt quality of life. This study tested the effects of a dietary intervention on vasomotor symptoms and menopause-related quality of life.; Methods: Postmenopausal women (n = 84) reporting at least two moderate-to-severe hot flashes daily were randomly assigned, in two successive cohorts, to an intervention including a low-fat, vegan diet and cooked soybeans (½ cup [86 g] daily) or to a control group making no dietary changes. During a 12-week period, a mobile application was used to record hot flashes (frequency and severity), and vasomotor, psychosocial, physical, and sexual symptoms were assessed with the Menopause-Specific Quality of Life questionnaire. Between-group differences were assessed for continuous ( t tests) and binary ( χ2 /McNemar tests) outcomes. In a study subsample, urinary equol was measured after the consumption of ½ cup (86 g) of cooked whole soybeans twice daily for 3 days.; Results: In the intervention group, moderate-to-severe hot flashes decreased by 88% ( P < 0.001) compared with 34% for the control group ( P < 0.001; between-group P < 0.001). At 12 weeks, 50% of completers in the intervention group reported no moderate-to-severe hot flashes at all. Among controls, there was no change in this variable from baseline ( χ2 test, P < 0.001). Neither seasonality nor equol production status was associated with the degree of improvement. The intervention group reported greater reductions in the Menopause-Specific Quality of Life questionnaire vasomotor ( P = 0.004), physical ( P = 0.01), and sexual ( P = 0.03) domains.; Conclusions: A dietary intervention consisting of a plant-based diet, minimizing oils, and daily soybeans significantly reduced the frequency and severity of postmenopausal hot flashes and associated symptoms.; Competing Interests: Financial disclosure/conflicts of interest: N.D.B. is an adjunct professor of medicine at the George Washington University School of Medicine. He serves without compensation as president of the Physicians Committee for Responsible Medicine and Barnard Medical Center in Washington, DC, nonprofit organizations providing educational, research, and medical services related to nutrition. He writes books and articles and gives lectures related to nutrition and health and has received royalties and honoraria from these sources. H.K., D.N.H., T.Z.-M., M.S., and R.H. received compensation from the Physicians Committee for Responsible Medicine for their work on this study. R.H. currently receives funding from Pfizer for Data Safety and Monitoring Board service and DURECT Corporation for biostatistical consulting. He has received funding from Revance for Data Safety and Monitoring Board consulting in the past. K.D.R.S. holds equity in Aliveris s.r.l., Asklepion Pharmaceuticals, and Ausio Pharmaceuticals, and is a consultant to Travere and Mirum Pharmaceuticals. (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The North American Menopause Society.)

Barnes, K. L., et al. (2021). "Home Biofeedback Versus Physical Therapy for Stress Urinary Incontinence: A Randomized Trial." Female Pelvic Medicine & Reconstructive Surgery 27(10): 587-594.
	OBJECTIVE: The aim of the study was to assess whether home biofeedback is noninferior to supervised pelvic floor physical therapy (PFPT) for the treatment of stress urinary incontinence (SUI) in women. METHODS: The study used a randomized controlled noninferiority trial to compare a home biofeedback device with PFPT. Women older than 18 years with SUI and no history of a prior incontinence surgery or PFPT were eligible. Forty-two participants were required to determine noninferiority for the primary outcome, improvement in quality of life as measured by the International Consultation on Incontinence Questionnaire Short Form. The noninferiority margin was 4 points. Secondary outcomes included sexual function, overactive bladder symptoms, and patient impression of improvement. RESULTS: From June 2018 to October 2019, 54 women with SUI were recruited (27 biofeedback, 27 PFPT) and 43 (21 biofeedback, 22 PFPT) completed follow-up. The groups had comparable baseline characteristics. For the primary outcome of change in mean International Consultation on Incontinence Questionnaire-Short Form scores (where lower scores indicate less incontinence), home biofeedback was found to be noninferior to PFPT with a mean decrease from baseline of -3.95 (95% confidence interval [CI] = -2.21 to -5.70) in the home biofeedback group versus -4.73 (95% CI = -3.21 to -6.25) and -3.95 (95% CI = -2.21 to -5.70) in the PFPT group (P = 0.009). The PFPT group showed more improvement in overactive bladder symptoms, but not in incontinence severity without difference in sexual function. CONCLUSIONS: Home biofeedback was noninferior to PFPT for the primary treatment of SUI in women at 3 months. These results support the use of personal biofeedback devices for the treatment of SUI.Clinical Trial Registration: ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT03443687.

Barrington, D. A., et al. (2021). "Lenvatinib plus pembrolizumab in advanced recurrent endometrial cancer: A cost-effectiveness analysis." Gynecologic Oncology 162(3): 626-630.
	Objective: To determine the cost-effectiveness of lenvatinib plus pembrolizumab (LP) in patients with microsatellite stable (MSS), recurrent, pretreated endometrial cancer (EC). Method(s): A decision analysis model was created to evaluate the cost-effectiveness of LP relative to doxorubicin, pegylated liposomal doxorubicin (PLD), and bevacizumab in patients with recurrent pretreated MSS EC. Published data was used to estimate quality adjusted life years (QALYs) and drug cost estimates were obtained using average wholesale prices. A health state utility (HSU) penalty of -0.10 was applied to the LP group to account for treatment toxicity. Incremental cost-effectiveness ratios (ICERs) were calculated to determine cost/QALY. The willingness to pay threshold (WTP) was set at $100,000 per QALY saved. Sensitivity analyses were performed on cost, effectiveness, and HSU penalty for LP. Result(s): Costs of treatment with doxorubicin, PLD, and bevacizumab are $23.7 million (M), $56.9 M, and $250.8 M respectively. Cost of treatment with LP is $1.8 billion. Relative to doxorubicin, the ICERs for PLD, bevacizumab, and LP are $56,808, $345,824, and $1.6 M respectively. A sensitivity analysis varying the cost of LP shows that if the combined drug cost decreases from over $58,000 to less than $11,000 per cycle, this strategy would be cost-effective. Eliminating the HSU penalty for LP decreased the ICER $1.0 M while increasing the penalty to -0.20 increased the ICER to $3.7 M. Conclusion(s): LP is not cost-effective in patients with recurrent pretreated, MSS EC. A dramatic reduction in cost of LP is required for this novel strategy to be cost-effective.Copyright © 2021 Elsevier Inc.

Barrington David, A., et al. (2022). "Pembrolizumab with or without bevacizumab for recurrent or metastatic cervical cancer: A cost-effectiveness analysis." Gynecologic Oncology 165(3): 500-505.
	Objective: To determine the cost-effectiveness of the addition of pembrolizumab in various combinations in patients with recurrent/metastatic cervical cancer.; Methods: A decision-analysis model evaluated the cost-effectiveness of chemotherapy plus pembrolizumab and bevacizumab (CPB) relative to chemotherapy plus pembrolizumab (CP) and chemotherapy plus bevacizumab (CB) in cervical cancer patients. Data from KEYNOTE-826 was used to estimate quality-adjusted life-years (QALYs). Drug cost estimates were obtained using average wholesale prices. Incremental cost-effectiveness ratios (ICERs) were calculated to determine cost/QALY. The willingness-to-pay threshold (WTP) was set a $100,000/QALY. Sensitivity analyses were performed on cost and effectiveness for pembrolizumab-containing regimens.; Results: Cost of treatment with CB, CP, and CPB were $416 million (M), $713 M, and $1.51 billion, respectively. Relative to CB, the ICER for CP was $92,678. CPB was dominated. Sensitivity analyses were performed varying the cost and efficacy of CP and CPB. If overall survival (OS) with CP decreased from 24.4 months to 23.4 months, the ICER would exceed the WTP. If the OS from CP is assumed to be 20.4 months, the ICER increases to $187,746. The ICER for CP improves to $63,670 when the model is restricted to PD-L1 positive cancers. With CP eliminated, CPB becomes cost-effective relative to CB if the cost of pembrolizumab per cycle decreases from $12,080 to $2913 for the baseline model and to $4644 for the PD-L1 model.; Conclusions: CP is cost-effective relative to CB for recurrent or metastatic cervical cancer. The efficacy of CPB would need to far exceed both CB and CP to be cost-effective. Restricting the model to patients with PD-L1 positive tumors dramatically improves the ICER for CP relative to CB by $30,000/QALY.; Competing Interests: Declaration of Competing Interest The authors have no relevant conflicts of interest. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Bartoletti, M., et al. (2024). "Incorporation of anti-PD1 or anti PD-L1 agents to platinum-based chemotherapy for the primary treatment of advanced or recurrent endometrial cancer. A meta-analysis." Cancer Treatment Reviews 125: 102701.
	Importance: Various randomized trials have explored the efficacy of combining immune checkpoint inhibitors (ICIs) with first-line chemotherapy in advanced endometrial cancer. We aimed to summarize available data and clarify the benefit of adding immunotherapy according to the DNA mismatch repair status (deficient, dMMR or proficient, pMMR) and the specific type of agent used (anti-PD1 or anti-PD-L1). Objective(s): To assess whether the addition of ICIs to standard platinum-based chemotherapy enhances progression-free survival (PFS) for patients with advanced endometrial cancer both overall and based on DNA mismatch repair status. Data sources: Electronic databases (PubMed, Embase and Cochrane Library) and conference proceedings were searched for first line, randomized and controlled trials integrating ICIs with chemotherapy for the treatment of advanced endometrial cancer published or presented by November 1, 2023. Study selection: Five studies, comprising 2456 patients (1308 received ICIs with chemotherapy and 1148 treated with chemotherapy alone) met the selection criteria and were included in the analysis. Experimental arms included pembrolizumab, dostarlimab (anti-PD1) and durvalumab, atezolizumab and avelumab (anti-PD-L1) combined with standard three-weekly carboplatin-paclitaxel chemotherapy backbone. Endometrial carcinosarcoma were included in 3 out of 5 trials. Data extraction and synthesis: For comparison of PFS outcomes, extrapolation of hazard ratios (HRs), 95% confidence intervals (CI) and PFS events was performed for each included study in the overall population and according to subgroups. Data analysis was conducted using a random-effects model. Result(s): The addition of ICIs to chemotherapy improved PFS compared to chemotherapy alone in the overall population (pooled HR, 0.63; 95 % CI, 0.52--0.76; P <.001). In the dMMR subgroup the benefit was more pronounced (pooled HR, 0.34; 95 % CI, 0.27--0.44; P <.001) and not affected by drugs used with pooled HRs of 0.39 (95 % CI, 0.28--0.55; P <.001) and 0.34 (95 % CI, 0.27--0.44; P <.001) for PD-L1 and PD1 inhibitors, respectively. For pMMR patients, a statistically significant benefit in terms of PFS was confirmed only when anti-PD1 were used (anti-PD-1: HR 0.64, 95 % CI: 0.46-0.90, P =.010 vs anti-PD-L1: HR 0.87, 95 % CI: 0.73-1.03, P =.104) Conclusions and relevance: This meta-analysis confirmed the advantage in terms of PFS of adding ICIs to standard platinum-based chemotherapy. While dMMR patients benefit from the incorporation of both anti PD-1 or anti PD-L1, this benefit is confined to the association of anti-PD1 agents in pMMR patients. Updated analysis of trials is awaited to clarify the impact of immunotherapy on overall survival.Copyright © 2024 The Authors

Bashir, R., et al. (2023). "Do Pleiotropic Effects of Spironolactone in Women with PCOS Make it More than an Anti-androgen? Evidence from a Systematic Review and Meta-analysis." Current Pharmaceutical Design 29(19): 1486-1496.
	Background: Spironolactone use as a treatment for hirsutism and other dermatological conditions among polycystic ovary syndrome (PCOS) and idiopathic hirsutism shows varied results.; Objective: This study thus summarizes the entire evidence to better define its impact on Ferriman-Gallwey (FG) score in addition to other derangements associated with PCOS.; Methods: PubMed, Embase, Scopus and bibliographies of relevant articles were searched. Randomized controlled trails (RCTs) investigating the efficacy of spironolactone in PCOS and idiopathic hirsutism were included. Pooled mean difference (MD) was calculated using random effects model and relevant subgroup analysis was done. Potential heterogeneity and publication bias was assessed.; Results: Of 1041 retrieved studies, 24 RCTs were included. Spironolactone (100 mg/daily) exhibited a significant reduction in FG score in idiopathic hirsutism compared to finasteride (MD: -2.43; 95% C.I: -3.29, -1.57) and cyproterone acetate (MD: -1.18; 95% C.I: -2.10, -0.26), however, no significant difference was found among PCOS subjects in comparison to flutamide and finasteride. A lower dose of spironolactone (50 mg/day) exhibited no significant difference relative to metformin on FG Score (MD: -0.61; 95% C.I: -1.76, 0.54, I 2 = 57%), serum total testosterone (MD: -0.61; 95% C.I: -1.76, 0.54), I 2 = 57% and HOMA-IR (MD: 1.03; 95% C.I: -1.22, 3.29), I 2 = 60% among PCOS women. The main side effects reported by the studies were menstrual irregularity, mild nausea, vomiting and diarrhea.; Conclusion: Spironolactone is well tolerated among idiopathic hirsute and PCOS women. The drug significantly improved hirsutism in the former group and shows a positive trend in the latter women, however, displays no effect on FSH, LH, menstrual cyclicity, BMI, and HOMA-IR in PCOS women. (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Baszak-Radomańska, E. (2023). "Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia." ClinicalTrials.gov.
	No Results Available Drug: Naltrexone Hydrochloride Treatment effectiveness - change in pain intensity|Treatment effectiveness - change in type and severity of pain|Treatment effectiveness - change in emotional functioning|Patient's satisfaction|Treatment tolerability Female Phase 2 300 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment VN21 December 31, 2026

Batalini, F., et al. (2023). "Comparison of PARPi efficacy according to homologous recombination deficiency biomarkers in patients with ovarian cancer: a systematic review and meta-analysis." Chinese Clinical Oncology 12(3): 21.
	Background: Mutations in the BRCA1/2 (BRCA) genes are associated with response to poly(ADP-ribose) polymerase (PARP) inhibitors (PARPi). In addition, there are different homologous recombination deficiency (HRD) biomarkers available in clinical practice [e.g., genome-wide loss-of-heterozygosity (gLOH) and myChoice® score] that identify patients who can benefit from PARPi. Inconsistencies in biomarkers used in PARPi clinical trials make it challenging to identify clinically relevant predictive biomarkers. This study aims to compare clinically available HRD biomarkers in terms of benefits from PARPi.; Methods: We performed database search for phase II or III randomized clinical trials comparing PARPi versus chemotherapy, and meta-analysis using generic inverse variance and a Random Effects model. Patients were classified according to their HRD status: (I) BRCAm (patients with BRCA mutation of germline or somatic origin); (II) non-BRCA HRD [patients BRCA wild-type (wt) with another HRD biomarker-gLOH or myChoice®]; and (III) homologous recombination proficiency (HRP) (BRCAwt and without HRD biomarkers). From those that were BRCAwt, we compared myChoice®+ with gLOH-high.; Results: Five studies (3,225 patients) analyzing PARPi in first line setting were included. Patients with BRCAmut had progression-free survival (PFS) with hazard ratio (HR) 0.33 [95% confidence interval (CI): 0.30-0.43]; patients with non-BRCA HRD had a PFS HR 0.49 (95% CI: 0.37-0.65), and patients with HRP had a PFS HR 0.78 (95% CI: 0.58-1.03). Eight studies (5,529 patients) with PARPi including first line and recurrence settings were included. BRCAmut had PFS HR 0.37 (95% CI: 0.30-0.48), BRCAwt & HRD 0.45 (95% CI: 0.37-0.55) and HRP 0.70 (95% CI: 0.57-0.85). Patients with BRCAwt & myChoice® ≥42 had PFS HR 0.43 (95% CI: 0.34-0.56), similar to patients with BRCAwt & gLOH-high with PFS HR 0.42 (95% CI: 0.28-0.62).; Conclusions: Patients with HRD derived significantly more benefit from PARPi when compared to patients with HRP. The benefit of PARPi in patients with HRP tumors was limited. Careful cost-effectiveness analysis, and alternative therapies or clinical trial enrollment should strongly be considered for patients with HRP tumors. Among patients with BRCAwt, a similar benefit was found in patients with gLOH-high and those myChoice®+. The clinical development of further HRD biomarkers (e.g., Sig3) may help identify more patients who benefit from PARPi.

Bayer (2021). "Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb." ClinicalTrials.gov.
	Has Results Drug: BAY1817080|Drug: Elagolix|Drug: Placebo Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS)|Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set|Number of Participants With Treatment-emergent Adverse Events (TEAE) Female Phase 2 215 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 20584|2020-003131-16 May 3, 2022

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)." ClinicalTrials.gov.
	Researchers are looking for a better way to treat women who have hot flashes after women have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman's body has been through the menopause. Menopause is when women stop having a menstrual cycle, also called a period. During the menopause, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life. The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. It works by blocking a protein called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. There are treatments for hot flashes in women who have been through the menopause, but may cause medical problems for some people. In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes. A placebo looks like a treatment but does not have any medicine in it. To compare these study treatments, the doctors will ask the participants to record information about the participants' hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe the hot flashes are. The researchers will look at the results from before treatment, after 4 weeks, and after 12 weeks of treatment. The participants in this study will take two capsules of either elinzanetant or the placebo once a day. The participants who take elinzanetant will take it for 26 weeks. The participants who take the placebo will take it for 12 weeks and then take elinzanetant for the next 14 weeks. During the study, the participants will visit the site approximately 9 times and perform 1 visit by phone. Each participant will be in the study for approximately 36 weeks. The treatment duration will be 26 weeks. During the study, the participants will: ‐ record information about the participants' hot flashes in an electronic diary ‐ answer questions about the participants' symptoms The doctors will: ‐ check the participants' health ‐ take blood samples ‐ ask the participants questions about what medicines the participants are taking and if the participants are having adverse events An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if doctors do not think the adverse events might be related to the study treatments.

Bayer Consumer Care, A. G. (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 52 weeks in women who have been through the menopause." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: BAY 3427080 SOFT CAPS 60 MG 001 Product Code: BAY 3427080 (formerly NT‐814) Pharmaceutical Form: Capsule, soft INN or Proposed INN: Elinzanetant CAS Number: 929046‐33‐3 Current Sponsor code: BAY 3427080 Other descriptive name: formerly used NT‐814 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 60‐ Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use CONDITION: Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] Vasomotor symptoms associated with menopause ; MedDRA version: 21.1 Level: LLT Classification code 10050903 Term: Postmenopausal symptoms System Organ Class: 100000004872 PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of elinzanetant for the treatment of vasomotor symptoms (VMS) associated with the menopause. Primary end point(s): Mean change in frequency of moderate to severe hot flashes (HFs) from baseline to Week 12 (assessed by hot flash daily diary [HFDD]). Secondary Objective: 1. To evaluate the efficacy of elinzanetant on: sleep quality; menopause related quality of life; weight and body composition in women being treated for relief of VMS associated with the menopause.; 2. To evaluate the safety of elinzanetant for the treatment of VMS associated with the menopause. Timepoint(s) of evaluation of this end point: Baseline to Week 12. SECONDARY OUTCOME: Secondary end point(s): 1. Mean change in patient‐reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline over time.; 2. Mean change in menopause specific quality of life scale (MENQOL) total score from baseline over time. Timepoint(s) of evaluation of this end point: 1. Baseline to Week 56.; 2. Baseline to Week 56. INCLUSION CRITERIA: 1. Females aged 40 to 65 years, inclusive, at signing of informed consent. 2. Postmenopausal, defined as: a. at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or b. at least 6 months of spontaneous amenorrhea prior to signing of informed consent with serum follicle‐stimulating hormone (FSH) levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or c. at least 6 months after hysterectomy at signing of informed consent with serum FSH levels > 40 mIU/mL^2 and a serum estradiol concentration of < 30 pg/mL, or d. surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks prior to signing of informed consent. 3. Moderate to severe hot flash (HF) associated with the menopause and seeking treatment for this condition. 4. Negative urine pregnancy test at Screening. 5. In good general health, in the opinion of the investigator, based on the medical history, physical examination, 12‐

Beatriz Austregesilo de Athayde de Hollanda, M., et al. (2024). "The Efficacy Of Glp1 Receptor Agonists In Obese Women With PCOS In Promoting Weight Loss And Hormonal Regulation: A Systematic Review And Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Beaumont, T., et al. (2022). "Does group physiotherapy improve pain scores and reduce the impact of pelvic pain for women referred with persistent pelvic pain? A clinical trial." Journal of Endometriosis and Pelvic Pain Disorders 14(4): 169-177.
	Introduction: This study aimed to test group Physiotherapy sessions - pain education and supervised exercise - in addition to individual consultations, for women referred with persistent pelvic pain (with/without endometriosis), with the primary outcomes being pain scores and pain impact. Method(s): Parallel study design with three treatment arms: (1) usual care: a suite of individual Physiotherapy consultations; (2) introductory group pain education session followed by usual care and (3) introductory group pain education session followed by usual care and an 8-week supervised group exercise programme. Result(s): Ninety women were recruited (30/treatment arm), with 66 women (73%) completing their allocated treatment. Participants were aged between 16 and 51 years; endometriosis was confirmed in 41% (n = 27/66) of the study population. Data was analysed using descriptive and inferential statistics. Statistically significant gains (p < 0.05) in pain scores and pelvic pain impact scores were observed in all arms. Between groups, there was statistically significant improvement (p < 0.05) in pelvic pain impact score for those who attended the group pain education session followed by usual care (arm 2), compared to usual care (arm 1) alone. There was no significant added improvement with the weekly supervised group exercise programme (arm 3), when compared to those who received the group pain education programme and usual care (arm 2). Conclusion(s): This study has demonstrated positive benefits of a group pain education session on pain scores and pelvic pain impact for women referred with persistent pelvic pain, when added as a precursor to individual Physiotherapy consultations.Copyright © The Author(s) 2022.

Beauquier-Macotta, 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.
	The investigators will compare the efficacy of Interactive Guidance Therapy, a parent‐infant psychotherapy using video feed back versus a dyadic treatment conduct as usual (TAU) in women who present a post traumatic stress disorder related to childbirth or pregnancy. The main assessment is the maternal sensitivity, assessed during a video recorded free play interaction between the mother and the baby and rate with the Coding of interactive Behaviour (CIB). This is a Single Blind Randomized clinical trial. Only the rating of the (CIB), which is the primary end point, will be done blind for the treatment the dyad received. The randomization will proceed after the inclusion visit and the first assessment that take place at 6 weeks of post partum. The following assessments will take place at 4 months and 12 months. The investigators will conduct a national multicentre study with 5 inclusions centres, which are all child psychiatry unit specialized in perinatal period and already train or in training for the IGT method. ‐ Pre‐screening in post partum ward or during post partum consultation. ‐ Pre Inclusion at 5 (+‐1) weeks to assess PTSD with Post traumatic checklist (PCL ‐5) ‐ Inclusion and First assessment at 6 weeks post partum ‐ Randomization: 3 session of IGT or TAU at 8 weeks, 10 weeks and 12 weeks Assessment at 4 months (+/‐2W) and 12 months (+/‐ 1M)

Beelen, P., et al. (2021). "Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding." American Journal of Obstetrics and Gynecology 224(2): 187.e181-187.e110.
	BACKGROUND: Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel-releasing intrauterine system and endometrial ablation are 2 frequently applied treatments in women with heavy menstrual bleeding. OBJECTIVE: This study aimed to compare the effectiveness of the levonorgestrel-releasing intrauterine system with endometrial ablation in women with heavy menstrual bleeding. STUDY DESIGN: This multicenter, randomized controlled, noninferiority trial was performed in 26 hospitals and in a network of general practices in the Netherlands. Women with heavy menstrual bleeding, aged 34 years and older, without a pregnancy wish or intracavitary pathology were randomly allocated to treatment with either the levonorgestrel-releasing intrauterine system (Mirena) or endometrial ablation, performed with a bipolar radiofrequency device (NovaSure). The primary outcome was blood loss at 24 months, measured with a Pictorial Blood Loss Assessment Chart score. Secondary outcomes included reintervention rates, patient satisfaction, quality of life, and sexual function. RESULTS: We registered 645 women as eligible, of whom 270 women provided informed consent. Of these, 132 women were allocated to the levonorgestrel-releasing intrauterine system (baseline Pictorial Blood Loss Assessment Chart score, 616) and 138 women to endometrial ablation (baseline Pictorial Blood Loss Assessment Chart score, 630). At 24 months, mean Pictorial Blood Loss Assessment Chart scores were 64.8 in the levonorgestrel-releasing intrauterine system group and 14.2 in the endometrial ablation group (difference, 50.5 points; 95% confidence interval, 4.3-96.7; noninferiority, P=.87 [25 Pictorial Blood Loss Assessment Chart point margin]). Compared with 14 women (10%) in the endometrial ablation group, 34 women (27%) underwent a surgical reintervention in the levonorgestrel-releasing intrauterine system group (relative risk, 2.64; 95% confidence interval, 1.49-4.68). There was no significant difference in patient satisfaction and quality of life between the groups. CONCLUSION: Both the levonorgestrel-releasing intrauterine system and endometrial ablation strategies lead to a large decrease in menstrual blood loss in women with heavy menstrual bleeding, with comparable quality of life scores after treatment. Nevertheless, there was a significant difference in menstrual blood loss in favor of endometrial ablation, and we could not demonstrate noninferiority of starting with the levonorgestrel-releasing intrauterine system. Women who start with the levonorgestrel-releasing intrauterine system, a reversible and less invasive treatment, are at an increased risk of needing additional treatment compared with women who start with endometrial ablation. The results of this study will enable physicians to provide women with heavy menstrual bleeding with the evidence to make a well-informed decision between the 2 treatments.

BeiGene, L. (2021). "Study of Tislelizumab (BGB-A317) Combined With or Without BGB-A1217 in Patients With Previously Treated Recurrent or Metastatic Cervical Cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Tislelizumab Product Code: BGB‐A317 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: TISLELIZUMAB CAS Number: 1858168‐59‐8 Current Sponsor code: BGB‐A317 Other descriptive name: BGB‐A317, BGN1, JHL2108 Concentration unit: mmol/l millimole(s)/litre Concentration type: equal Concentration number: 0.068‐ Product Name: BGB‐A1217 Product Code: BGB‐A1217 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Ociperlimab Current Sponsor code: BGB‐A1217 Other descriptive name: Humanized IgG1 monoclonal antibody against TIGIT Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ CONDITION: Previously Treated Recurrent or Metastatic Cervical Cancer ; MedDRA version: 21.1 Level: LLT Classification code 10008229 Term: Cervical cancer System Organ Class: 100000004864 ; MedDRA version: 21.1 Level: LLT Classification code 10008231 Term: Cervical cancer recurrent System Organ Class: 100000004864 Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of BGB‐A1217 combined with tislelizumab as measured by ORR according to RECIST v1.1, by Independent Review Committee (IRC) in patients who had previously treated recurrent or metastatic cervical cancer. Primary end point(s): ORR, defined as the proportion of patients who had complete response (CR) or partial response (PR) assessed by IRC per RECIST v1.1 for Cohort 1 Secondary Objective: •To evaluate the efficacy of BGB‐A1217 combined with tislelizumab as assessed by ORR by investigator review; •To evaluate the efficacy of tislelizumab monotherapy as assessed by ORR by both IRC and investigator review; •To evaluate the efficacy of BGB‐A1217 combined with tislelizumab and tislelizumab monotherapy as measured by DOR, PFS, time to response (TTR), disease control rate (DCR), and clinical benefit rate (CBR) by both IRC and investigator review ; •To evaluate the efficacy of BGB‐A1217 combined with tislelizumab and tislelizumab monotherapy as measured by OS; •To evaluate Health Related Quality of Life (HRQoL) via cancer‐specific patient‐reported outcomes (PROs) in patients treated with BGB‐A1217 combined with tislelizumab and tislelizumab monotherapy; •To evaluate the safety and tolerability of BGB‐A1217 combined with tislelizumab and tislelizumab monotherapy; •To characterize the PK of BGB‐A1217 and tislelizumab; •To assess host immunogenicity to BGB‐A1217 and tislelizumab Timepoint(s) of evaluation of this end point: Approximately 3 years SECONDARY OUTCOME: Secondary end point(s): • ORR, defined as above assessed by investigator’s review per RECIST v1.1 for Cohort 1 ; • ORR, defined as above assessed by both IRC and investigator’s review per RECIST v1.1 for Cohort 2 ; • DOR, defined as the time from the first confirmed objective response until the first documentation of progression or death, whichever comes first, assessed by both IRC and investigator’s review according to RECIST v1.1 for Cohorts 1 and 2 ; • Other efficacy endpoints (PFS, TTR, DCR, and CBR) that need tumor assessments by both IRC and investigator’s review per RECIST v1.1 for Cohorts 1 and 2 ; ‐ PFS, defined as the time from the date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first ; ‐ TTR, defined as the time from the date of first dose of study drug to first documentation of response ; ‐ DCR, defined as the proportion of patients who achieve CR, PR, or stable disease (SD) ; ‐ CBR, defined as the proportion of patients who achieve CR, PR, or durable SD (SD = 24 weeks) ; • OS, defined as the time from the date of first dose of study drug until the date of death from any cause for Cohorts 1 and 2 ; • HRQoL, defined as assessment of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire‐Core 30 (EORTC QLQ‐C30), European Organisation for Research and Treat nt of Cancer Quality of Life Questionnaire‐Cervical Cancer Module (EORTC QLQ‐CX24) for Cohorts 1 and 2 ; • Adverse events (AEs) and serious adverse events (SAEs) as characterized by type, frequency, severity (as graded by National Cancer Institute – Common Terminology Criteria for Adverse Events [NCI‐CTCAE] v5.0), timing, seriousness, and relationship to study drugs, physical examinations, electrocardiograms (ECGs), and laboratory assessments for Cohorts 1 and 2 ; • Serum BGB‐A1217 and tislelizumab concentrations at specified timepoints ; • Immunogenic responses to BGB‐A1217 and tislelizumab, evaluated through the detection of antidrug antibodies (ADAs) Timepoint(s) of evaluation of this end point: Approximately 3 years INCLUSION CRITERIA: Adult patients (= 18 years of age or the legal age of consent, at the time of voluntarily signing of informed consent) with histologically or cytologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix and who had progression on or after one or more lines of chemotherapy for management of recurrent or metastatic disease and are not amenable to curative treatment are eligible. Patients must submit qualified archival tumor tissue with an associated pathology report or agree to a tumor biopsy for determination of PD‐L1 expression and other biomarker analyses. Patients must have an ECOG PS of = 1 and life expectancy = 12 weeks with adequate organ functions. Patients must have = 1 measurable lesion as defined per RECIST v1.1. 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 134 F.1.3 Elderly (>=65 years)

Belan, M., et al. (2022). "Protocol of the Fit-For-Fertility study: a multicentre randomised controlled trial assessing a lifestyle programme targeting women with obesity and infertility." BMJ Open 12(4): e061554.
	Introduction: Women with obesity are at a higher risk of infertility as well as gestational and neonatal complications. Lifestyle changes are universally recommended for women with obesity seeking fertility treatments, but such intervention has only been assessed in very few robust studies. This study's objectives are therefore to assess the clinical outcomes and cost-effectiveness of an interdisciplinary lifestyle intervention (the Fit-For-Fertility Programme; FFFP) targeting women with obesity and subfertility in a diverse population.; Methods and Analysis: This pragmatic multicentre randomised controlled trial (RCT) will include 616 women with obesity (body mass index ≥30 kg/m 2 or ≥27 kg/m 2 with polycystic ovary syndrome or at-risk ethnicities) who are evaluated at a Canadian fertility clinic for subfertility. Women will be randomised either to (1) the FFFP (experimental arm) alone for 6 months, and then in combination with usual care for infertility if not pregnant; or (2) directly to usual fertility care (control arm). Women in the intervention group benefit from the programme up to 18 months or, if pregnant, up to 24 months or the end of the pregnancy (whichever comes first). Women from both groups are evaluated every 6 months for a maximum of 18 months. The primary outcome is live birth rate at 24 months. Secondary outcomes include fertility, pregnancy and neonatal outcomes; lifestyle and anthropometric measures; and cost-effectiveness. Qualitative data collected from focus groups of participants and professionals will also be analysed.; Ethics and Dissemination: This research study has been approved by the Research Ethics Board (REB) of Centre intégré universtaire de santé et des services sociaux de l'Estrie-CHUS (research coordinating centre) on 10 December 2018 and has been or will be approved successively by each participating centres' REB. This pragmatic RCT will inform decision-makers on improving care trajectories and policies regarding fertility treatments for women with obesity and subfertility.; Trial Registration Number: NCT03908099.; Protocol Version: 1.1, 13 April 2019.; Competing Interests: Competing interests: Ferring has provided an unrestricted grant for the trial, without influencing the design or conduct of the trial, or the analysis or dissemination of the study’s results. (© 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.)

Beltrán Cynthia del Rocío, M. (2024). "The Effectiveness of an Intervention of Fresh Strawberries on Menstrual Pain and Menstrual Distress." ClinicalTrials.gov.
	No Results Available Dietary Supplement: Fortuna Intervention|Dietary Supplement: Marisma or Rociera Intervention Pain intensity|Distress menstrual|Changes in Quality of life|Anxiety State and Anxiety Trait|Perceived well-being|Sleep quality|Changes amount of bleeding|Changes menstrual issues|Changes in menstrual pain management|Changes in absenteeism and presenteeism days|The impact on daily and academic activities Female Not Applicable 150 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment PFH-1123 June 2024

Benaglia, L. (2021). "IVF Versus Surgery for Endometriosis Related Infertility." ClinicalTrials.gov.
	Women accepting to enter the study will be randomized to either surgery and then natural pregnancy seeking or a program of three complete IVF cycles (i.e. three oocytes retrievals regardless of the number of embryo transfers performed). The initial time point will be the time of randomization. Women of both study groups will initiate treatment (surgery or IVF) in a shortest delay, maximum 3 months. Only live birth pregnancies and initiating within a 12‐months period starting from this time point will be included in the primary outcome.

Ben-Arye, E., et al. (2023). "Acupuncture during gynecological oncology surgery: A randomized controlled trial assessing the impact of integrative therapies on perioperative pain and anxiety." Cancer 129(6): 908-919.
	Background: In this study, the impact of a multimodal integrative oncology pre- and intraoperative intervention on pain and anxiety among patients undergoing gynecological oncology surgery was explored.; Methods: Study participants were randomized to three groups: Group A received preoperative touch/relaxation techniques, followed by intraoperative acupuncture; Group B received preoperative touch/relaxation only; and a control group (Group C) received standard care. Pain and anxiety were scored before and after surgery using the Measure Yourself Concerns and Wellbeing (MYCAW) and Quality of Recovery (QOR-15) questionnaires, using Part B of the QOR to assess pain, anxiety, and other quality-of-life parameters.; Results: A total of 99 patients participated in the study: 45 in Group A, 25 in Group B, and 29 in Group C. The three groups had similar baseline demographic and surgery-related characteristics. Postoperative QOR-Part B scores were significantly higher in the treatment groups (A and B) when compared with controls (p = .005), including for severe pain (p = .011) and anxiety (p = .007). Between-group improvement for severe pain was observed in Group A compared with controls (p = .011). Within-group improvement for QOR depression subscales was observed in only the intervention groups (p <0.0001). Compared with Group B, Group A had better improvement of MYCAW-reported concerns (p = .025).; Conclusions: A preoperative touch/relaxation intervention may significantly reduce postoperative anxiety, possibly depression, in patients undergoing gynecological oncology surgery. The addition of intraoperative acupuncture significantly reduced severe pain when compared with controls. Further research is needed to confirm these findings and better understand the impact of intraoperative acupuncture on postoperative pain.; Plain Language Summary: Integrative oncology programs are increasingly becoming part of supportive/palliative care, with many working within the Society for Integrative Oncology. This study examined the impact of a multimodal integrative oncology program on pain and anxiety among 99 patients undergoing gynecological oncology surgery. Participants were randomized to three groups: preoperative touch/relaxation treatments, followed by intraoperative acupuncture; preoperative touch/relaxation without acupuncture; and a control group receiving standard care only. The preoperative touch/relaxation intervention significantly reduced perioperative anxiety, with the addition of intraoperative acupuncture significantly reducing severe pain as well, when compared with controls. Further research is needed to confirm these findings. (© 2023 American Cancer Society.)

Benetti-Pinto Cristina, L., et al. (2019). "Pharmacological Treatment for Symptomatic Adenomyosis: A Systematic Review." Revista Brasileira de Ginecologia e Obstetricia 41(9): 564-574.
	Objective: To assess the efficacy of non-surgical treatment for adenomyosis.; Data Sources: A search was performed by two authors in the Pubmed, Scopus, and Scielo databases and in the grey literature from inception to March 2018, with no language restriction.; Selection of Studies: We have included prospective randomized studies for treating symptomatic women with adenomyosis (abnormal uterine bleeding and/or pelvic pain) diagnosed by ultrasound or magnetic resonance imaging.; Data Collection: Studies were primarily selected by title and abstract. The articles that were eligible for inclusion were evaluated in their entirety, and their data was extracted for further processing and analysis.; Data Synthesis: From 567 retrieved records only 5 remained for analysis. The intervention groups were: levonorgestrel intrauterine system (LNG-IUS)(n = 2), dienogest (n = 2), and letrozole (n = 1). Levonorgestrel intrauterine system was effective to control bleeding when compared to hysterectomy or combined oral contraceptives (COCs). One study assessed chronic pelvic pain and reported that LNG-IUS was superior to COC to reduce symptoms. Regarding dienogest, it was efficient to reduce pelvic pain when compared to placebo or goserelin, but less effective to control bleeding than gonadotropin-releasing hormone (GnRH) analog. Letrozole was as efficient as GnRH analog to relieve dysmenorrhea and dyspareunia, but not for chronic pelvic pain. Reduction of uterine volume was seen with aromatase inhibitors, GnRH analog, and LGN-IUD.; Conclusion: Levonorgestrel intrauterine system and dienogest have significantly improved the control of bleeding and pelvic pain, respectively, in women with adenomyosis. However, there is insufficient data from the retrieved studies to endorse each medication for this disease. Further randomized control tests (RCTs) are needed to address pharmacological treatment of adenomyosis.; Competing Interests: The authors have no conflicts of interest to declare. (Thieme Revinter Publicações Ltda Rio de Janeiro, Brazil.)

Berg, T., et al. (2019). "Gemcitabine for recurrent ovarian cancer - a systematic review and meta-analysis." Gynecologic Oncology 155(3): 530-537.
	Introduction: More than 80 % of women with advanced ovarian cancer relapse either during or after adjuvant therapy. Platinum-sensitive women are rechallenged with a platinum-combination therapy and platinum-resistant women are challenged with non-platinum drugs. Gemcitabine is one of many treatments that can be used both as single-agent or as combination therapy for the treatment of recurrent ovarian cancer.; Methods: We included all randomised controlled trials investigating patients treated with gemcitabine for recurrent ovarian cancer and reporting data on overall survival, progression-free survival and toxicity. CENTRAL, EMBASE and MEDLINE were searched on the 31 st of May 2019.; Results: We included six randomised controlled trials that evaluated gemcitabine either alone or as combination therapy. Two studies compared gemcitabine to pegylated liposomal doxorubicin in women with platinum-resistant recurrent ovarian cancer. Difference in overall and progression-free survival was non-significant. Gemcitabine treatment was associated with significantly more neutropenia, whereas pegylated liposomal doxorubicin was associated with significantly more hand-foot syndrome. One study evaluated carboplatin and gemcitabine to carboplatin. Difference in overall survival was non-significant, but progression-free survival was longer with gemcitabine and carboplatin (HR: 0.72, 95% CI 0.58-0.9). One study evaluated gemcitabine with gemcitabine and pertuzumab. Overall survival and progression-free survival was similar between the two arms. One study compared gemcitabine and carboplatin to gemcitabine, carboplatin and bevacizumab. Overall survival was similar in the two arms. Progression-free survival was significantly better in the bevacizumab arm (HR 0.48 95% CI 0.39-0.61). One study compared etoposide and gemcitabine to etoposide. The study showed similar overall survival and progression-free survival.; Discussion: The results show that gemcitabine is an active and safe agent in the treatment of both platinum-sensitive and resistant recurrent ovarian cancer but might highlight the need of new randomised studies in heavily pre-treated patients. (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." Obstetrical and Gynecological Survey 75(8): 473-474.
	One of the most common gynecological conditions, abnormal uterine bleeding (AUB), affects approximately 30% of women throughout their reproductive lifetime. Abnormal uterine bleeding has a significant impact on quality of life and sexual function. Two well-established treatment options, endometrial ablation/resection (EA/R) and the levonorgestrel intrauterine system (LNG-IUS), avoid the more invasive alternative, hysterectomy, which is the most definitive treatment option. Recommended as first-line therapy, these 2 treatment options allow shorter recovery and lower risk of complications and costs. Choice of treatment depends on the underlying causes of AUB, the woman's medical conditions, desire for contraception, and preservation of fertility, as well as the patient's expectations and tolerance to adverse effects and risks. Over the last few decades, both EA/R and the LNG-IUS have significantly contributed to the decrease in hysterectomies. Several randomized controlled trials have compared the relative risks and benefits of EA/R and LNG-IUS. Previous systematic reviews have demonstrated similar therapeutic effects for these 2 treatments, but have failed to explain heterogeneity between studies. The aim of this systematic review with meta-analysis was to compare the efficacy and safety of EA/R and LNG-IUS for treatment of premenopausal women with AUB and identify clinical situations modifying the relative performance of the 2 modalities. A search was conducted of the following databases to identify relevant articles published up to August 2019: MEDLINE, EMBASE, CENTRAL, Web of Science, Biosis, and Google Scholar. Additional eligible reports were identified from reference lists and citations of included studies and previous reviews. Study selection and data abstraction were performed independently by 2 of the authors who screened 3701 citations for eligibility. Included randomized controlled trials published in any language compared treatment outcomes for EA/R (first and second generation) with those of the LNG-IUS in premenopausal women with heavy menstrual bleeding (HMB) and a normal uterine cavity. The primary study outcome was the proportion of hysterectomies subsequently required following each treatment modality. A total of 13 eligible studies, representing 884 women, were identified. The quality of included studies was assessed independently by the same authors who had extracted data. The modalities were compared, and sources of heterogeneity were evaluated using random-effects models. In the pooled data, there were no significant differences between EA/R and the LNG-IUS in the need for subsequent hysterectomy; the risk ratio (RR) was 1.13, with a 95% confidence interval (CI) of 0.60 to 2.11 (P = 0.71, I2 = 14%, 12 studies, 726 women). Similarly, no significant differences between groups were found for satisfaction, quality of life, amenorrhea, and treatment failure. However, fewer adverse effects were observed in women treated with EA/R than with the LNG-IUS, which was associated with more adverse effects, most notably unscheduled bleeding, pelvic pain, breast tenderness, mood changes, weight gain, and acne (RR, 0.52; 95% CI, 0.37 0.71; P < 0.001; I2 = 0%; 10 studies, 580 women). Only a few complications were reported: 3 in the EA/R and none in the LNG-IUS group (P = 0.25). In subgroup analysis, a significant source of heterogeneity between studies was mean age of the studied populations (P = 0.01). Compared with the LNG-IUS, EA/R was associated with a higher risk of subsequent hysterectomy in younger populations (mean age, =42 years); RR, 5.26; 95% CI, 1.21 22.91; P = 0.03; I2= 0%; 3 studies, 189 women). Conversely, risk of subsequent hysterectomy was lower with EA/R than for the LNG-IUS in older populations (mean age, >42 years); however, the reduction was not statistically significant (RR, 0.51; 95% CI, 0.21 1.24; P = 0.14; I2 = 0%; 5 studies, 297 women). With sensitivity analysis, risk of bias in the included studies and type of surgical devices (first and second generation) did not modify the results. tcomes of up to 3 years were reported in most of the included studies. The relative performance of EA/R and LNG-IUS in the longer term remains unknown. This systematic review shows no significant differences in the therapeutic effects of EA/R and LNG-IUS among women with HMB and comparable probability of requiring a subsequent hysterectomy. Both these methods are excellent treatment options, but the risk of adverse effects is higher in women treated with the LNG-IUS. Younger women treated with the LNG-IUS are at lower risk of subsequent hysterectomy than EA/R, suggesting that age represents a primary factor to consider in decision-making.Copyright © 2020 Lippincott Williams and Wilkins. All rights reserved.

Berin, E., et al. (2022). "Effects of resistance training on quality of life in postmenopausal women with vasomotor symptoms." Climacteric 25(3): 264-270.
	Objective: Most women experience vasomotor symptoms (VMS) around menopause that may affect quality of life negatively. Effective pharmacological treatment exists but is not recommended for all women, and there is a demand for alternatives to reduce symptoms and improve quality of life. The objective of this study was to investigate the effect of a resistance training intervention on health-related quality of life (HRQoL) in postmenopausal women with VMS.; Methods: This open randomized controlled trial included 65 postmenopausal women >45 years old with daily VMS. The participants were randomized to 15 weeks of resistance training three times per week or an untreated control group. The Women's Health Questionnaire (WHQ) and Short Form Health Survey (SF-36) were used to assess HRQoL at baseline and after 15 weeks.; Results: The resistance training group improved compared to the control group in the WHQ domains of VMS ( p = 0.002), sleep problems ( p = 0.003) and menstrual symptoms ( p = 0.01) from baseline to post intervention. No significant between-group differences were found in SF-36 summary scores, or in any of the domains.; Conclusion: In postmenopausal women with moderate to severe VMS, resistance training three times per week for 15 weeks improved menopause-specific HRQoL.

Berman, C. (2023). "REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1." ClinicalTrials.gov.
	No Results Available Drug: Luveltamab tazevibulin|Drug: Pegfilgrastim Objective Response Rate (ORR)|Duration of Response (DOR)|Progression Free Survival (PFS)|Overall Survival (OS)|Safety and tolerabilty Female Phase 2 140 Industry|Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment STRO-002-GM3 February 2026

Bettencourt-Silva, B., et al. (2023). "The role of mifepristone on first trimester miscarriage treatment - A double-blind randomized controlled trial - MiFirsT." European Journal of Obstetrics, Gynecology, and Reproductive Biology 289: 145-151.
	Objectives: To evaluate the efficacy of combined mifepristone and misoprostol compared to misoprostol alone in outpatient medical treatment of first trimester miscarriage. Additionally, the study intends to compare the rate of complications, adverse effects, and treatment acceptability between groups.; Study Design: Single-center double-blind randomized placebo-controlled trial including women with diagnosis of missed first trimester miscarriage up to 9 weeks of gestation.; Results: Between April 2019 and November 2021, 216 women diagnosed with first trimester miscarriage up to 9 weeks of gestation were randomly assigned to mifepristone group or to misoprostol-alone group. Data from 105 women in mifepristone group and 103 women in misoprostol-alone group were analyzed, with no differences in baseline characteristics. The median time between medications (oral mifepristone/placebo and vaginal misoprostol) was nearly 43 h in both groups (p = 0.906). The median time to first follow-up was 2.6 weeks (IQR 1.0) in mifepristone group and 2.4 weeks (IQR 1.0) in misoprostol-alone group (p = 0.855). The overall success rate of medical treatment was significantly higher in the mifepristone-group comparing to misoprostol-alone group (94.3% vs. 82.5%, RR 1.14, 95% CI, 1.03-1.26; p = 0.008). Accordingly, the rate of surgical treatment was significantly lower in the mifepristone-group (5.7% vs.14.6%, RR 0.39, 95% CI, 0.16-0.97; p = 0.034). The composite complication rate was similar and lower than 4% in both groups. No case of complicated pelvic infection, hemodynamic instability or inpatient supportive treatment was reported. There were no significant differences in the rates of adverse events, median score for vaginal bleeding intensity or analgesics use. Despite the same median value, the score of abdominal pain intensity was significantly higher in the mifepristone-group (p = 0.011). In both groups, more than 65% of the women classified the treatment as "good" and 92% would recommend it to a friend on the same clinical situation.; Conclusion: The mifepristone plus vaginal misoprostol combined treatment for medical resolution of first trimester miscarriage resulted in significant higher success rate and lower rate of surgical uterine evacuation comparing to misoprostol-alone treatment, with no relevant differences in adverse events or treatment acceptability.; Competing Interests: Declaration of Competing Interest The authors declare no conflict of interest. The treatment was supplied by the Hospital Senhora da Oliveira (Guimarães, Portugal). There were no external funding or fees for the professionals or participants involved. (Copyright © 2023 Elsevier B.V. All rights reserved.)

Bezmialem Vakif, U. (2023). "Comparison of 3 Different Protocols for Preventing Premature Ovulation in Ovarian Stimulation Cycles." ClinicalTrials.gov.
	Approximately %10‐15 of couples of reproductive age have infertility issues. Ovulation induction and in vitro fertilization (IVF) are the main treatments for infertility. With ovarian stimulation (OS), the efficiency of IVF has been increased by collecting more than one oocytes and thus providing more embryos. Multifollicular growth in OS may cause an increase in sex steroids and an early LH peak, thus premature ovulation. Pituitary suppression with certain drugs has been used to prevent premature ovulation.. Among these drugs, it has been observed that GnRH agonists can cause down‐regulation, hypo‐estrogenic symptoms, ovarian cyst formation and Ovarian Hyperstimulation Syndrome (OHSS), while antagonists may have side effects such as low oocyte count and high cycle cancellation. The use of progesterone preparations as an alternative to these drugs recently gained ground. Data including age, BMI, the duration of infertility, the type of infertility, antral follicle count, serum day 3 FSH level, Serum anti‐Müllerian hormone level, total gonadotropin dose, stimulation time, pituitary suppression starting day, duration of pituitary suppression, premature ovulation, number of total oocyte count, the number of total M2, the number of PN , the number of Day 5 blast, number of transferred embryos, endometrial thickness on the day of transfer will be recorded. When the follicle size reaches 13‐14 mm, patients will be randomized into 3 groups. Group 1 (Cetrorelix: n=99, 0.25 mg/day subcutaneously), Group 2 (Medroxyprogesterone Acetate: n=99, 2x5mg/day orally) and Group 3 (Dydrogesterone: n=99, 3x10 mg/day orally). Human chorionic gonadotropin (hCG) will be used for trigger when at least 2 follicles' diameter reaches 17‐18mm for ovulation. Thirty‐six hours after the hCG injection, the patient's oocytes will be collected. During 2‐5 days of embryo culture, embryo quality will be determined according to D.Gardner criteria (1999). Embryos will be frozen as blast on the 5th day and transferred to the frozen cycle to be planned within the next month. Clinical pregnancy rates will be recorded by performing a blood test for on the 12th day after the procedure. The aim of this study is to evaluate the results of three different protocols for prevention of premature ovulation in ovarian stimulation cycles. All patients undergo IVF cycles are randomly divided in to three groups. The first group is cetrorelix, the second group is medroxyprogesterone acetate and the third group is dydrogesterone.

Bhide, P., et al. (2019). "The effect of myo-inositol/di-chiro-inositol on markers of ovarian reserve in women with PCOS undergoing IVF/ICSI: A systematic review and meta-analysis." Acta Obstetricia et Gynecologica Scandinavica 98(10): 1235-1244.
	Introduction: High levels of anti-Mullerian hormone and a high antral follicle count in women with polycystic ovary syndrome, reflecting increased ovarian antral follicles, predisposes them to have a high number of retrieved oocytes with in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) and an increased risk of ovarian hyperstimulation syndrome. Inositols, which act as insulin sensitizers, have the potential to alter folliculogenesis and the functional ovarian reserve, with subsequent benefits to reproductive outcomes following IVF/ICSI treatment. Published literature is, however, unable to provide definitive evidence of its efficacy. The objective of our review was to evaluate the effect of inositols on anti-Mullerian hormone, antral follicle count and reproductive outcomes in women with polycystic ovary syndrome undergoing IVF/ICSI.; Material and Methods: We performed a literature search using standard methodology recommended by Cochrane. Randomized controlled trials and non-randomized studies comparing inositols with no treatment, placebo or other treatment were included in the review. Using standard methodology recommended by Cochrane we pooled results using the random effects model; our findings were reported as relative risk or mean differences. PROSPERO registration: CRD42017082275.; Results: We included 18 trials. The primary outcome was a change in anti-Mullerian hormone and antral follicle count before and after treatment, for which data were unsuitable for meta-analysis. A narrative review showed no consistent direction or size of effect. A meta-analysis for the secondary outcomes showed no evidence of a significant difference between inositol and control groups for any outcome: number of oocytes (mean difference -0.39, 95% confidence interval [CI] -1.11 to 0.33), number of metaphase II oocytes (mean difference 0.29, 95% CI -0.83 to 1.40), number of top grade embryos (risk ratio [RR] 1.02, 95% CI 0.93-1.12), clinical pregnancy rate (RR 1.16, 95% CI 0.87-1.53), and risk of ovarian hyperstimulation syndrome (RR 0.73, 95% CI 0.39-1.37). The quality of evidence was assessed as very low.; Conclusions: There is insufficient evidence for an effect of inositols on ovarian reserve markers and to support their use as pretreatment before IVF/ICSI in women with polycystic ovary syndrome. (© 2019 Nordic Federation of Societies of Obstetrics and Gynecology.)

Bi, C., et al. (2021). "Network meta-analysis of 6 kinds of Chinese patent medicines combined with mifepristone in the treatment of uterine fibroids: A protocol for systematic review and network meta-analysis." Medicine 100(42): e27523.
	Background: Uterine fibroids are benign. They belong to the category of "abdominal mass" in traditional Chinese medicine, and pathogenesis is mainly caused by weakness of the body, qi stagnation, and blood stasis. Drug therapy is the preferred treatment of uterine fibroids in clinical practice, and mifepristone is the most commonly used drug. In the past decade, a large number of clinical randomized controlled trials have proven that Chinese patent medicine combined with mifepristone in the treatment of uterine fibroids has a better curative effect, fewer adverse reactions, and higher safety than mifepristone alone. However, there is a lack of evidence-based research. This study aims to integrate clinical data through network meta-analysis to provide more evidence-based medical evidence for clinical medication.; Methods: The comprehensive search included Chinese and other-language databases, such as MEDLINE (PubMed), Web of Science, The Cochrane Library, China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform, China Scientific Journal Database, and China Biomedical Literature Database. Clinical randomized controlled trials of 6 Chinese patent medicines combined with mifepristone for the treatment of uterine fibroids, including Guizhi Fuling Capsule, Gongliuxiao Capsule, Gongliuqing Capsule, Danbie Capsule, Gongliuning Capsule, and Xiaojiean Capsule were retrieved. The search period was from January 2010 to April 2021. Two researchers screened the literature through EndNote and used Excel to extract data. RevMan 5.3 was used to evaluate the quality of the literature. Treatment measures were analyzed in R language, and a forest map and probability ranking map of various interventions were drawn. The network evidence map and correction comparison funnel map of various interventions were drawn by STATA 14.0 software.; Results: This study provides the clinical efficacy and safety of network meta-analysis of 6 kinds of Chinese patent medicines combined with mifepristone in the treatment of uterine fibroids will be systematically evaluated or descriptively analyzed.; Conclusion: This study's purpose is to provide a reference for the clinical treatment of uterine fibroids to choose more effective intervention therapies.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Bian, C., et al. (2023). "Effectiveness of psychological interventions on pregnancy rates in infertile women undergoing assisted reproductive technologies: a meta-analysis of randomised controlled trials." Biotechnology & Genetic Engineering Reviews: 1-20.
	The purpose of this study was to assess the effects of psychological interventions on the pregnancy rates of infertile women undergoing assisted reproductive technology (ART). Using the electronic databases PubMed, EM Base, Cochrane Library, WOS, CNKI, WanFang Data, CSTJ, and CBM, a systematic literature search was conducted in the second week of August 2019. Randomized controlled trials (RCTs) on the effect of psychological interventions on the pregnancy rate of infertile women undergoing assisted reproductive technology were collected. There is no time limit for this search setting. The language is limited to Chinese or English. Two investigators independently screened the literature, extracted data, and assessed the risk of bias of the included studies, and then used Revman5.3 and STATA16.0 software for meta-analysis. A total of 25 randomized controlled trials were included in this meta-analysis, including 2098 patients in the experimental group and 2075 patients in the control group. There was a significant difference in the pregnancy rate between the two groups [RR=1.31, 95%CI(1.22,1.40)]. Subgroup analysis showed that this is also true of infertile women of different nationalities, different intervention timing and format. However, different psychological interventions may indeed have different effects. Current evidence suggests that psychological interventions may improve pregnancy rates in infertile women undergoing assisted reproductive technology. Limited by the quantity and quality of included studies, the above conclusions need to be verified by more high-quality studies. Our PROSPERO registration number is: CRD42019140666.

Bian, C., et al. (2023). "Effect of interpersonal psychotherapy on social functioning, overall functioning and negative emotions for depression: A meta-analysis." Journal of Affective Disorders 320: 230-240.
	Background: Interpersonal psychotherapy (IPT) has been widely used for depression. However, current studies of IPT have been restricted to depressive symptoms, and the results for improving social functioning were controversial. Method(s): A comprehensive literature search of randomized controlled trials (RCTs) was conducted through eleven databases. Data analysis was performed by RevMan5.3, and effects were summarized by using a random effects model of mean differences with 95 % confidence intervals. Result(s): From 2443 records, eleven studies met inclusion and exclusion criteria were used for meta-analysis. The results showed that IPT had significant effects on improving social functioning (SMD: -0.53, 95 % CI: -0.80 to -0.26), reducing depression (SMD: -0.49, 95 % CI: -0.80 to -0.19) and anxiety (SMD: -0.90, 95 % CI: -1.28 to -0.52), but the effect on the overall functioning (SMD: -0.37, 95 % CI: -0.73 to -0.01) is not obvious. Moreover, subgroup analysis showed that IPT was effective in improving social functioning in adolescent depression (SMD: -0.35, 95 % CI: -0.58 to -0.13) and perinatal depression (SMD: -1.01, 95 % CI: -1.35 to -0.67), while there was no significant difference in the adult depression group (SMD: -0.39, 95 % CI: -1.05 to 0.27). Limitation(s): The blind method cannot be carried out in most studies due to the particularity of psychotherapy, heterogeneity in some results. Conclusion(s): IPT has a significant effect on improving social functioning and reducing depression and anxiety, while the effect on overall functioning requires further research. Overall, IPT is one of the effective nonpharmacological treatments for depression.Copyright © 2022 Elsevier B.V.

Bick, L., et al. (2021). "Embryo Culture Media Influence on Live Birth Rate and Birthweight after IVF/ICSI: A Systematic Review Comparing Vitrolife G5 Media to Other Common Culture Media." JBRA Assisted Reproduction 25(3): 480-492.
	Previous studies have indicated that culture media vary in efficiency and outcomes, such as live birth rate, birthweight and embryo quality. Does Vitrolife G5 series culture media result in higher live birth rates and birthweight compared to other common culture media? This study is a systematic review based on the PRISMA criteria. Relevant search terms, mesh terms (PubMed and Cochrane) and Emtree terms (Embase) were identified. We searched the literature using PubMed, Embase and Cochrane, on November 10, 2019. The inclusion criteria involved published articles in English comparing Vitrolife G5 to other common culture media. We included randomized controlled trials (RCTs) and cohort studies. The quality of the studies was assessed using the Cochrane Risk of Bias tool 2.0 and the Newcastle-Ottawa Scale. Primary outcomes were live birth rate and birthweight. Secondary outcomes were fertilization rate, implantation rate, biochemical pregnancy rate, clinical pregnancy rate, miscarriage rate, multiple pregnancies and congenital malformations. Of 187 articles screened, 11 studies fulfilled the inclusion criteria: Five RCTs and six retrospective cohort studies. Only one study reported live birth rate, showing a non-significantly higher live birth rate for Vitrolife G5 media. Birthweight had equivocal results with three of six studies, showing significantly lower (2)/higher (1) birthweights, whereas the others were non-significant. Overall, there were no significant differences concerning secondary outcomes. The results are equivocal, and we need more studies to evaluate culture media and their effect on short- and long-term health.

Bin, S., et al. (2021). "Electronic acupuncture for the treatment of menopausal syndrome: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Bin-fei, N., et al. (2022). "Manual-related therapies for ovarian function of women with diminished ovarian reserve: A protocol for systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Bin-fei, N., et al. (2022). "Study on moxibustion in the treatment of ovarian function of women with diminished ovarian reserve and its related brain changes based on rs-fMRI: a protocol for a systematic reviews and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Bing, C., et al. (2023). "Efficacy of Acupuncture-Related Therapy in the Treatment of Primary Dysmenorrhea: A Network Meta-Analysis of Randomized Controlled Trials." PROSPERO International prospective register of systematic reviews.
	
Bixel, K. (2021). "A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer." ClinicalTrials.gov.
	This is a multi‐center, open‐label, randomized, non‐inferiority clinical trial with the hypothesis that robotically assisted radical hysterectomy with tumor containment prior to colpotomy is non‐inferior to abdominal radical hysterectomy with respect to disease free survival. A t the commencement of surgery, a thorough inspection of all peritoneal surfaces should be performed. The location of any suspected metastatic disease should be documented in the operative report and a biopsy should be performed to confirm the diagnosis. If intraperitoneal disease is detected, the radical hysterectomy should be abandoned. In patients with macroscopic evidence of metastatic disease to the lymph nodes, intraoperative frozen section should be performed to confirm the presence of metastatic disease. Intraoperative management will be left to the discretion of the surgeon. Patients who have confirmed macroscopic lymph node metastases intraoperatively will be excluded from final analysis and replaced due to the controversy surrounding the decision to perform a radical hysterectomy in this setting. Patients in whom the radical hysterectomy is abandoned will be deemed non‐evaluable and excluded from final analysis and will be replaced. For all patients, the surgeon should document operative time from incision to close, detailed description of operative findings, intraoperative complications, and blood loss. For patients randomized to the robotic arm, the surgeon should document the use of and specify the type of vaginal manipulator and the reason for conversion to laparotomy (if applicable). Transcervical manipulators are not permitted. Standard arm: Radical hysterectomy is performed as per standard technique (peon radical hysterectomy (Piver type 2 or 3 or Querleu & Morrow Type B or C) with salpingectomy +/‐ oophorectomy. Ovaries may be removed or preserved +/‐ transposition. Prior to colpotomy, the vagina must be closed over the tumor (ie, Wertheim clamps, contour stapling device). Study arm: Radical hysterectomy is performed as per standard robotic technique (Querleu & Morrow Type B or C) with salpingectomy +/‐ oophorectomy. Ovaries may be removed or preserved +/‐ transposition. Colpotomy may be made intracorporally or vaginally. Vagina must be closed prior to intracorporeal colpotomy (see below, #10)

Blikkendaal, M. (2023). "Esketamine as Treatment for Chronic Pain Due to Endometriosis: a RCT Study." ClinicalTrials.gov.
	Endometriosis is a chronic inflammatory disease affecting approximately 10% of reproductive‐aged women. Severe pain symptoms and subfertility result in a lower quality of life, higher prevalence of depression and loss of productivity. Consequently, the economic impact of endometriosis is high. Treatment options to suppress chronic pain symptoms in patients with (deep) endometriosis are inadequate, resulting in increased opioid consumption. Ketamine (in our study we will use the S‐enantiomer, esketamine), is a versatile drug with analgesic, anti‐inflammatory and antidepressant effects and is commonly used in the treatment of chronic pain patients and has shown promising outcomes. However, whilst esketamine targets multiple aspects of endometriosis simultaneously (pain, inflammation, depression), studies on esketamine as treatment for chronic pain due to endometriosis have never been reported. Therefore we aim to conduct a randomized controlled trial to assess the efficacy of esketamine infusion versus placebo in the treatment of chronic endometriosis‐induced pain.

Blockeel, C. (2021). "Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles." ClinicalTrials.gov.
	A randomized controlled trial comparing dydrogesterone 30 mg versus micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles. Patients will undergo an embryo transfer in a hormone replacement therapy cycle using Progynova 2 mg three times daily until an endometrium thickness of at least 7 mm is reached. Afterwards two different luteal phase supplementation methods will be compared. The primary outcome of the study is ongoing pregnancy at 12 weeks of gestation. We will also investigate other prenatal and neonatal outcome factors as well as patients satisfaction and safety of dydrogesterone.

Bø, K., et al. (2023). "Are hypopressive and other exercise programs effective for the treatment of pelvic organ prolapse?" International Urogynecology Journal 34(1): 43-52.
	Introduction and Hypothesis: Pelvic floor muscle training (PFMT) is effective for the treatment of pelvic organ prolapse (POP), but other exercise programs have also been promoted and used. The aim of this review was to evaluate the effect of hypopressive and other exercise programs besides PFMT for POP.; Methods: A literature search was conducted on Ovid Medline, EMBASE, CINAHL, Cochrane, PEDro, and Scopus databases from January 1996 to 30 December 2021. Only randomized controlled trials (RCTs) were included. The keywords were combinations of "pelvic organ prolapse" or "urogenital prolapse," and "exercise therapy," "hypopressive exercise," "Kegel," "pelvic floor muscle training," "pelvic floor muscle exercises," "Pilates," "treatment," "yoga," "Tai Chi." Methodological quality was assessed using the PEDro rating scale (0-10).; Results: Seven RCTs containing hypopressive exercise, yoga or breathing and hip muscle exercises in an inverted position were retrieved and analyzed. PEDro score ranged from 4 to 7. There was no additional effect of adding hypopressive exercise to PFMT, and PFMT was more effective than hypopressive exercise alone. The studies that included the term "yoga" included regular PFMT and thus can be classified as PFMT. Hip exercises in an inverted position added to PFMT vs PFMT alone showed better improvement in some secondary outcomes but not in the primary outcome, POP stage.; Conclusions: There are few RCTs assessing the effects of other exercise programs besides PFMT in the treatment of POP. To date, there is no evidence that other exercise programs are more effective than PFMT for POP. (© 2022. The Author(s).)

Bo, K., et al. (2020). "Is pelvic floor muscle training effective for symptoms of overactive bladder in women? A systematic review." Physiotherapy 106: 65-76.
	Background: Overactive bladder (OAB) syndrome can be very bothersome and is associated with impaired quality of life and work productivity. Objective(s): To evaluate the effect of pelvic floor muscle training (PFMT) on OAB symptoms in women. Furthermore, to assess the influence of PFMT on pelvic floor muscle (PFM) function, satisfaction with treatment, side effects, adherence and the quality of exercise reporting. Data sources: Systematic review of randomized controlled trials (RCTs). Electronic search was conducted on MEDLINE/PubMed, Embase, CINAHL, SciELO, SCOPUS, Web of Science and Physiotherapy Evidence Database (PEDro). The risk of bias was assessed using the PEDro scale. The Consensus on Exercise Reporting Template (CERT) was used to assess the quality of exercise reporting. Study selection: Full text RCTs including non-pregnant female participants, investigating PFMT vs inactive control or usual care, other life style modifications or other interventions. Synthesis methods: Descriptive analysis. Result(s): Eleven RCTs were included. There was considerable heterogeneity of PFMT protocols, outcome measures and follow-up periods. Hence, a qualitative analysis was undertaken. PFMT provided a significant reduction of OAB symptoms in five studies with a reduction in urinary frequency (n = 1), and urgency urinary incontinence (n = 4). PFM function was assessed in three studies, and two studies found improvement in favor of PFMT. Limitation(s): A meta-analysis was not possible due to huge heterogeneity of included studies. Conclusion(s): PFMT might reduce OAB symptoms, however, due to many limitations of the published studies it is not possible to clearly determine the effect of PFMT on OAB symptoms and PFM function. Systematic Review Registration Number PROSPERO CRD42018085640.Copyright © 2019 Chartered Society of Physiotherapy

Bodner-Adler, B. (2022). "Continuous Stitches Versus Simple Interrupted Stitches for Anterior Colporrhaphy." ClinicalTrials.gov.
	This trial is a single‐center, prospective, randomized trial conducted with the aim of determining the superiority of continuous sutures over simple interrupted stitches with regard to the primary outcome in POP patients undergoing anterior colporrhaphy. The study will be a single‐blind study, as it is impossible to blind the study surgeon for the surgical procedure to which the subject is assigned. However, all outcome assessors and the subjects will be blinded to the treatment assignment. Postoperative follow‐up will take place after 4‐6 weeks, 6 months and 12 months. Patients will undergo a standardized urogynecological examination that includes assessment of prolapse with POP‐Q measurement. Furthermore subjective outcome will be assessed with standardized questionnaires ‐ our study participants will receive the German version of the pelvic floor questionnaire. Study setting This study will be conducted at the urogynecologic outpatient clinic (Division of General Gynecology and Gynecologic Oncology, Department of Obstetrics and Gynecology, Medical University of Vienna). Enrolment, treatment and data collection will be standardized by all sites according to the approved study protocol. Participants and recruitment The study population will consist of women aged 18 years or older who are referred to our urogynecologic outpatient clinic due to symptomatic POP. Women with anterior vaginal wall prolapse and an indication for reconstructive pelvic floor surgery ‐ including anterior colporrhaphy with native tissue repair ‐ can be included in this trial. Intervention Anterior colporrhaphy will be performed in a traditional and standardized manner in accordance to our surgical policy. Any other concomitant procedures (e.g. vaginal hysterectomy, sacrospinous suspension, superficial perineorrhaphy, posterior recto‐vaginal fascia plication, McCall's culdoplasty) will be performed in accordance with each surgeon's preferred technique. All patients will be operated by the vaginal route. They are prepared under strict aseptic conditions in the dorsal lithotomy position. The bladder is emptied preoperatively with a thin disposable catheter and antibiotic prophylaxis (cefazolin) is administered before incision. A vasoconstricting solution (combination of vasopression and NaCl) is administered and a vertical anterior vaginal incision is made from the apex to two centimeters short of the external urethral meatus using an electric cautery or a scalpel. The vaginal epithelium is grasped on both sides and the fibromuscular layer of the anterior vaginal wall is sharply dissected laterally to the inferior pubic ramus. The bladder is completely dissected from the apex and up to 4 to 6 cm from the pubic ramus. The anterior colporrhaphy is defined as a native tissue repair and rows of absorbable sutures (2/0 vicryl) are used. Depending on preoperative randomization, patients will receive either continuous stitches versus simple interrupted stitches for plication during anterior colporrhaphy. Sutures will be in a distance of no more than 0.5 cm. Trimming of the vagina will be performed if necessary. Anterior vaginal skin is closed with continuous 2/0 vicryl sutures. Participating surgeons will be defined as high volume surgeons in prolapse surgery and will also be part of the urogynecologic core team. Perioperative management is also standardized and includes preoperative single‐shot antibiotics as well as vaginal pack and an indwelling urinary catheter for 24 hours after the surgical procedure. Patients undergoing anterior with or without apical prolapse correction will have postvoid residual volume measurement at the first postoperative day (when urinary catheter is removed). A postvoid residual volume of 2 x < 100 ml is defined as normal and no further follow‐ ups are necessary. Postvoid residual volumes of > 150 mL or greater will be considered as abnormal. These patients' volumes will continue mechanical bladder drainage via clean intermittent (self)‐catheterisation until the postvoid residual volumes are cons tently less than 150 ml. Patients will receive standard analgesic therapy in accordance with the local hospital protocol (Metamizol 1g intravenously, 3 times a day). Postoperative Management: The patients are instructed to rest for 2 weeks after the operation (not to work, to do sport, to do the cleaning and to carry more than five kilos). They are allowed to return to work after 4 weeks and to take part in sport or have intercourse after 6 weeks. Follow‐up visits are scheduled after 4‐6 weeks, 6 months and 1 year in our outpatient clinic due to our study protocol. Urogynecological examination is performed at each visit and evaluations are made using the POP‐Q measurement system on maximum Valsalva effort in the seated semi‐lithotomy position. Objective anatomical cure was defined as a Ba point < ‐1. Postoperative functional results for symptoms, quality of life and sexuality are evaluated with the Deutsche Beckenboden‐Fragebogen. This Pelvic Floor Questionnaire consists of four domains: bladder, bowel, pelvic organ prolapse and sexual function. In every domain various questions assess severity and condition‐specific quality of life. Every question is scored on a scale from zero to four. The sum of each individual domain is divided by the maximum reachable score and multiplied by ten, giving a value between zero (0= no symptoms) and ten (10=maximum of symptoms) for each of the domains. Data collection At baseline, the following data will be collected: demographics and medical history data (age, body mass index, parity, menopausal and hormone therapy status, current smoking, previous hysterectomy and previous anti‐incontinence surgery, and medical comorbidities (diabetes mellitus, connective tissue disorders)), and data from the standardized POPQ examination in a 45° upright sitting position during maximal Valsalva. Patients will be asked to complete the validated questionnaire (Deutscher Beckenboden‐Fragebogen). Scheduled in‐person follow‐ups will occur at 4 to 6 weeks, 6 and 12 months after the operation. Each check‐up will include a clinical examination including POPQ and written questionnaire identical to this at baseline. In addition, an update of current medications, an assessment of new or continuing pelvic floor disorders and adverse events that occurred since the previous evaluation will be obtained by the study coordinator at each visit. All data will be anonymized and collected using case report forms by examiners or trained research coordinators who are blinded to the treatment assignment.

Boedt, T., et al. (2021). "Preconception lifestyle advice for people with infertility." The Cochrane Database of Systematic Reviews 4: CD008189.
	Background: Infertility is a prevalent problem that has significant consequences for individuals, families, and the community. Modifiable lifestyle factors may affect the chance of people with infertility having a baby. However, no guideline is available about what preconception advice should be offered. It is important to determine what preconception advice should be given to people with infertility and to evaluate whether this advice helps them make positive behavioural changes to improve their lifestyle and their chances of conceiving.; Objectives: To assess the safety and effectiveness of preconception lifestyle advice on fertility outcomes and lifestyle behavioural changes for people with infertility.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL, MEDLINE, Embase, PsycINFO, AMED, CINAHL, trial registers, Google Scholar, and Epistemonikos in January 2021; we checked references and contacted field experts to identify additional studies.; Selection Criteria: We included randomised controlled trials (RCTs), randomised cross-over studies, and cluster-randomised studies that compared at least one form of preconception lifestyle advice with routine care or attention control for people with infertility.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. Primary effectiveness outcomes were live birth and ongoing pregnancy. Primary safety outcomes were adverse events and miscarriage. Secondary outcomes included reported behavioural changes in lifestyle, birth weight, gestational age, clinical pregnancy, time to pregnancy, quality of life, and male factor infertility outcomes. We assessed the overall quality of evidence using GRADE criteria.; Main Results: We included in the review seven RCTs involving 2130 participants. Only one RCT included male partners. Three studies compared preconception lifestyle advice on a combination of topics with routine care or attention control. Four studies compared preconception lifestyle advice on one topic (weight, alcohol intake, or smoking) with routine care for women with infertility and specific lifestyle characteristics. The evidence was of low to very low-quality. The main limitations of the included studies were serious risk of bias due to lack of blinding, serious imprecision, and poor reporting of outcome measures. Preconception lifestyle advice on a combination of topics versus routine care or attention control Preconception lifestyle advice on a combination of topics may result in little to no difference in the number of live births (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.79 to 1.10; 1 RCT, 626 participants), but the quality of evidence was low. No studies reported on adverse events or miscarriage. Due to very low-quality evidence, we are uncertain whether preconception lifestyle advice on a combination of topics affects lifestyle behavioural changes: body mass index (BMI) (mean difference (MD) -1.06 kg/m², 95% CI -2.33 to 0.21; 1 RCT, 180 participants), vegetable intake (MD 12.50 grams/d, 95% CI -8.43 to 33.43; 1 RCT, 264 participants), alcohol abstinence in men (RR 1.08, 95% CI 0.74 to 1.58; 1 RCT, 210 participants), or smoking cessation in men (RR 1.01, 95% CI 0.91 to 1.12; 1 RCT, 212 participants). Preconception lifestyle advice on a combination of topics may result in little to no difference in the number of women with adequate folic acid supplement use (RR 0.98, 95% CI 0.95 to 1.01; 2 RCTs, 850 participants; I² = 4%), alcohol abstinence (RR 1.07, 95% CI 0.99 to 1.17; 1 RCT, 607 participants), and smoking cessation (RR 1.01, 95% CI 0.98 to 1.04; 1 RCT, 606 participants), on low quality evidence. No studies reported on other behavioural changes. Preconception lifestyle advice on weight versus routine care Studies on preconception lifestyle advice on weight were identified only in women with infertility and obesity. Compared to routine care, we are uncertain whether preconception lifestyle advice on weight affects the number of live births (RR 0.94, 95% CI 0.62 to 1.43; 2 RCTs, 707 participants; I² = 68%; very low-quality evidence), adverse events including gestational diabetes (RR 0.78, 95% CI 0.48 to 1.26; 1 RCT, 317 participants; very low-quality evidence), hypertension (RR 1.07, 95% CI 0.66 to 1.75; 1 RCT, 317 participants; very low-quality evidence), or miscarriage (RR 1.50, 95% CI 0.95 to 2.37; 1 RCT, 577 participants; very low-quality evidence). Regarding lifestyle behavioural changes for women with infertility and obesity, preconception lifestyle advice on weight may slightly reduce BMI (MD -1.30 kg/m², 95% CI -1.58 to -1.02; 1 RCT, 574 participants; low-quality evidence). Due to very low-quality evidence, we are uncertain whether preconception lifestyle advice affects the percentage of weight loss, vegetable and fruit intake, alcohol abstinence, or physical activity. No studies reported on other behavioural changes. Preconception lifestyle advice on alcohol intake versus routine care Studies on preconception lifestyle advice on alcohol intake were identified only in at-risk drinking women with infertility. We are uncertain whether preconception lifestyle advice on alcohol intake affects the number of live births (RR 1.15, 95% CI 0.53 to 2.50; 1 RCT, 37 participants; very low-quality evidence) or miscarriages (RR 1.31, 95% CI 0.21 to 8.34; 1 RCT, 37 participants; very low-quality evidence). One study reported on behavioural changes for alcohol consumption but not as defined in the review methods. No studies reported on adverse events or other behavioural changes. Preconception lifestyle advice on smoking versus routine care Studies on preconception lifestyle advice on smoking were identified only in smoking women with infertility. No studies reported on live birth, ongoing pregnancy, adverse events, or miscarriage. One study reported on behavioural changes for smoking but not as defined in the review methods.; Authors' Conclusions: Low-quality evidence suggests that preconception lifestyle advice on a combination of topics may result in little to no difference in the number of live births. Evidence was insufficient to allow conclusions on the effects of preconception lifestyle advice on adverse events and miscarriage and on safety, as no studies were found that looked at these outcomes, or the studies were of very low quality. This review does not provide clear guidance for clinical practice in this area. However, it does highlight the need for high-quality RCTs to investigate preconception lifestyle advice on a combination of topics and to assess relevant effectiveness and safety outcomes in men and women with infertility. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Bofill, R., et al. (2019). "Non-steroidal anti-inflammatory drugs for heavy menstrual bleeding." The Cochrane Database of Systematic Reviews 9: CD000400.
	Background: Heavy menstrual bleeding (HMB) is an important cause of ill health in premenopausal women. Although surgery is often used as a treatment, a range of medical therapies are also available. Non-steroidal anti-inflammatory drugs (NSAIDs) reduce prostaglandin levels, which are elevated in women with excessive menstrual bleeding and also may have a beneficial effect on dysmenorrhoea.; Objectives: To determine the effectiveness, safety and tolerability of NSAIDs in achieving a reduction in menstrual blood loss (MBL) in women of reproductive years with HMB.; Search Methods: We searched, in April 2019, the Cochrane Gynaecology and Fertility specialised register, Cochrane Central Register of Studies Online (CENTRAL CRSO), MEDLINE, Embase, PsycINFO, the clinical trial registries and reference lists of articles.; Selection Criteria: The inclusion criteria were randomised comparisons of individual NSAIDs or combined with other medical therapy with each other, placebo or other medical treatments in women with regular heavy periods measured either objectively or subjectively and with no pathological or iatrogenic (treatment-induced) causes for their HMB.; Data Collection and Analysis: We identified 19 randomised controlled trials (RCTs) (759 women) that fulfilled the inclusion criteria for this review and two review authors independently extracted data. We estimated odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes from the data of nine trials. We described in data tables the results of the remaining seven cross-over trials with data unsuitable for pooling, one trial with skewed data, and one trial with missing variances. One trial had no data available for analysis.; Main Results: As a group, NSAIDs were more effective than placebo at reducing HMB but less effective than tranexamic acid, danazol or the levonorgestrel-releasing intrauterine system (LNG IUS). Treatment with danazol caused a shorter duration of menstruation and more adverse events than NSAIDs, but this did not appear to affect the acceptability of treatment, based on trials from 1980 to 1990. However, currently danazol is not a usual or recommended treatment for HMB. There was no clear evidence of difference between NSAIDs and the other treatments (oral luteal progestogen, ethamsylate, an older progesterone-releasing intrauterine system and the oral contraceptive pill (OCP), but most studies were underpowered. There was no evidence of a difference between the individual NSAIDs (naproxen and mefenamic acid) in reducing HMB. The evidence quality ranged from low to moderate, the main limitations being risk of bias and imprecision.; Authors' Conclusions: NSAIDs reduce HMB when compared with placebo, but are less effective than tranexamic acid, danazol or LNG IUS. However, adverse events are more severe with danazol therapy. In the limited number of small studies suitable for evaluation, there was no clear evidence of a difference in efficacy between NSAIDs and other medical treatments such as oral luteal progestogen, ethamsylate, OCP or the older progesterone-releasing intrauterine system.

Bofill, R., et al. (2020). "Progestogen-releasing intrauterine systems for heavy menstrual bleeding." The Cochrane Database of Systematic Reviews 6: CD002126.
	Background: Heavy menstrual bleeding (HMB) impacts the quality of life of otherwise healthy women. The perception of HMB is subjective and management depends upon, among other factors, the severity of the symptoms, a woman's age, her wish to get pregnant, and the presence of other pathologies. Heavy menstrual bleeding was classically defined as greater than or equal to 80 mL of blood loss per menstrual cycle. Currently the definition is based on the woman's perception of excessive bleeding which is affecting her quality of life. The intrauterine device was originally developed as a contraceptive but the addition of progestogens to these devices resulted in a large reduction in menstrual blood loss: users of the levonorgestrel-releasing intrauterine system (LNG-IUS) reported reductions of up to 90%. Insertion may, however, be regarded as invasive by some women, which affects its acceptability.; Objectives: To determine the effectiveness, acceptability and safety of progestogen-releasing intrauterine devices in reducing heavy menstrual bleeding.; Search Methods: We searched the Cochrane Gynaecology and Fertility Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL (from inception to June 2019); and we searched grey literature and for unpublished trials in trial registers.; Selection Criteria: We included randomised controlled trials (RCTs) in women of reproductive age treated with LNG-IUS devices versus no treatment, placebo, or other medical or surgical therapy for heavy menstrual bleeding.; Data Collection and Analysis: Two authors independently extracted data, assessed risk of bias and conducted GRADE assessments of the certainty of evidence.; Main Results: We included 25 RCTs (2511 women). Limitations in the evidence included risk of attrition bias and low numbers of participants. The studies compared the following interventions. LNG-IUS versus other medical therapy The other medical therapies were norethisterone acetate, medroxyprogesterone acetate, oral contraceptive pill, mefenamic acid, tranexamic acid or usual medical treatment (where participants could choose the oral treatment that was most suitable). The LNG-IUS may improve HMB, lowering menstrual blood loss according to the alkaline haematin method (mean difference (MD) 66.91 mL, 95% confidence interval (CI) 42.61 to 91.20; 2 studies, 170 women; low-certainty evidence); and the Pictorial Bleeding Assessment Chart (MD 55.05, 95% CI 27.83 to 82.28; 3 studies, 335 women; low-certainty evidence). We are uncertain whether the LNG-IUS may have any effect on women's satisfaction up to one year (RR 1.28, 95% CI 1.01 to 1.63; 3 studies, 141 women; I² = 0%, very low-certainty evidence). The LNG-IUS probably leads to slightly higher quality of life measured with the SF-36 compared with other medical therapy if (MD 2.90, 95% CI 0.06 to 5.74; 1 study: 571 women; moderate-certainty evidence) or with the Menorrhagia Multi-Attribute Scale (MD 13.40, 95% CI 9.89 to 16.91; 1 trial, 571 women; moderate-certainty evidence). The LNG-IUS and other medical therapies probably give rise to similar numbers of women with serious adverse events (RR 0.91, 95% CI 0.63 to 1.30; 1 study, 571 women; moderate-certainty evidence). Women using other medical therapy are probably more likely to withdraw from treatment for any reason (RR 0.49, 95% CI 0.39 to 0.60; 1 study, 571 women, moderate-certainty evidence) and to experience treatment failure than women with LNG-IUS (RR 0.34, 95% CI 0.26 to 0.44; 6 studies, 535 women; moderate-certainty evidence). LNG-IUS versus endometrial resection or ablation (EA) Bleeding outcome results are inconsistent. We are uncertain of the effect of the LNG-IUS compared to EA on rates of amenorrhoea (RR 1.21, 95% CI 0.85 to 1.72; 8 studies, 431 women; I² = 21%; low-certainty evidence) and hypomenorrhoea (RR 0.98, 95% CI 0.73 to 1.33; 4 studies, 200 women; low-certainty evidence) and eumenorrhoea (RR 0.55, 95% CI 0.30 to 1.00; 3 studies, 160 women; very low-certainty evidence). We are uncertain whether both treatments may have similar rates of s tisfaction with treatment at 12 months (RR 0.95, 95% CI 0.85 to 1.07; 5 studies, 317 women; low-certainty evidence). We are uncertain if the LNG-IUS compared to EA has any effect on quality of life, measured with SF-36 (MD -14.40, 95% CI -22.63 to -6.17; 1 study, 33 women; very low-certainty evidence). Women with the LNG-IUS compared with EA are probably more likely to have any adverse event (RR 2.06, 95% CI 1.44 to 2.94; 3 studies, 201 women; moderate-certainty evidence). Women with the LNG-IUS may experience more treatment failure compared to EA at one year follow up (persistent HMB or requirement of additional treatment) (RR 1.78, 95% CI 1.09 to 2.90; 5 studies, 320 women; low-certainty evidence); or requirement of hysterectomy may be higher at one year follow up (RR 2.56, 95% CI 1.48 to 4.42; 3 studies, 400 women; low-certainty evidence). LNG-IUS versus hysterectomy We are uncertain whether the LNG-IUS has any effect on HMB compared with hysterectomy (RR for amenorrhoea 0.52, 95% CI 0.39 to 0.70; 1 study, 75 women; very low-certainty evidence). We are uncertain whether there is difference between LNG-IUS and hysterectomy in satisfaction at five years (RR 1.01, 95% CI 0.94 to 1.08; 1 study, 232 women; low-certainty evidence) and quality of life (SF-36 MD 2.20, 95% CI -2.93 to 7.33; 1 study, 221 women; low-certainty evidence). Women in the LNG-IUS group may be more likely to have treatment failure requiring hysterectomy for HMB at 1-year follow-up compared to the hysterectomy group (RR 48.18, 95% CI 2.96 to 783.22; 1 study, 236 women; low-certainty evidence). None of the studies reported cost data suitable for meta-analysis.; Authors' Conclusions: The LNG-IUS may improve HMB and quality of life compared to other medical therapy; the LNG-IUS is probably similar for HMB compared to endometrial destruction techniques; and we are uncertain if it is better or worse than hysterectomy. The LNG-IUS probably has similar serious adverse events to other medical therapy and it is more likely to have any adverse events than EA. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Bofill, R., et al. (2019). "Cyclical progestogens for heavy menstrual bleeding." The Cochrane Database of Systematic Reviews 8: CD001016.
	Background: Heavy menstrual bleeding (HMB) is a menstrual blood loss perceived by women as excessive that affects the health of women of reproductive age, interfering with their physical, emotional, social and material quality of life. Whilst abnormal menstrual bleeding may be associated with underlying pathology, in the present context, HMB is defined as excessive menstrual bleeding in the absence of other systemic or gynaecological disease. The first-line therapy is usually medical, avoiding possibly unnecessary surgery. Of the wide variety of medications used to reduce HMB, oral progestogens were originally the most commonly prescribed agents. This review assesses the effectiveness of two different types and regimens of oral progestogens in reducing ovulatory HMB.This is the update of a Cochrane review last updated in 2007, and originally named "Effectiveness of cyclical progestagen therapy in reducing heavy menstrual bleeding" (1998).; Objectives: To determine the effectiveness, safety and tolerability of oral progestogen therapy taken either during the luteal phase (short cycle) or for a longer course of 21 days per cycle (long cycle), in achieving a reduction in menstrual blood loss in women of reproductive age with HMB.; Search Methods: In January 2019 we searched Cochrane Gynaecology and Fertility's specialized register, CENTRAL, MEDLINE, Embase, CINAHL and PsycInfo. We also searched trials registers, other sources of unpublished or grey literature and reference lists of retrieved trials. We also checked citation lists of review articles to identify trials.; Selection Criteria: Randomized controlled trials (RCTs) comparing different treatments for HMB that included cyclical oral progestogens were eligible.; Data Collection and Analysis: Two review authors independently selected trials for inclusion, assessed trials for risk of bias and extracted data. We contacted trial authors for clarification of methods or additional data when necessary. We only assessed adverse events if they were separately measured in the included trials. We compared cyclical oral progestogen in different regimens and placebo or other treatments. Our primary outcomes were menstrual blood loss and satisfaction with treatment; the secondary outcomes were number of days of bleeding, quality of life, compliance and acceptability of treatment, adverse events and costs.; Main Results: This review identified 15 randomized controlled trials (RCTs) with 1071 women in total. Most of the women knew which treatment they were receiving, which may have influenced their judgements about menstrual blood loss and satisfaction. Other aspects of trial quality varied among trials.We did not identify any RCTs comparing progestogen treatment with placebo. We assessed comparisons between oral progestogens and other medical therapies separately according to different regimens.Short-cycle progestogen therapy during the luteal phase (medroxyprogesterone acetate or norethisterone for 7 to 10 days, from day 15 to 19) was inferior to other medical therapy, including tranexamic acid, danazol and the progestogen-releasing intrauterine system (Pg-IUS (off of the market since 2001)), releasing 60 mcg of progesterone daily, with respect to reduction of menstrual blood loss (mean difference (MD) 37.29, 95% confidence interval (CI) 17.67 to 56.91; I 2 = 50%; 6 trials, 145 women). The rate of satisfaction and the quality of life with treatment was similar in both groups. The number of bleeding days was greater on the short cycle progestogen group compared to other medical treatments. Adverse events (such as gastrointestinal symptoms and weight gain) were more likely with danazol when compared with progestogen treatment. We note that danazol is no longer in general use for treating HMB.Long-cycle progestogen therapy (medroxyprogesterone acetate or norethisterone), from day 5 to day 26 of the menstrual cycle, is also inferior to the levonorgestrel-releasing intrauterine system (LNG-IUS), releasing tranexamic acid and ormeloxifene, but may be similar to the combined vaginal ring with respect to reduction of menstrual blood loss (MD 16.88, 95% CI 10.93 to 22.84; I 2 = 87%; 4 trials, 355 women). A higher proportion of women taking norethisterone found their treatment unacceptable compared to women having Pg-IUS (Peto odds ratio (OR) 0.12, 95% CI 0.03 to 0.40; 1 trial, 40 women). However, the adverse effects of breast tenderness and intermenstrual bleeding were more likely in women with the LNG-IUS. No trials reported on days of bleeding or quality of life for this comparison.The evidence supporting these findings was limited by low or very low gradings of quality; thus, we are uncertain about the findings and there is a potential that they may change if we identify other trials.; Authors' Conclusions: Low- or very low-quality evidence suggests that short-course progestogen was inferior to other medical therapy, including tranexamic acid, danazol and the Pg-IUS with respect to reduction of menstrual blood loss. Long cycle progestogen therapy (medroxyprogesterone acetate or norethisterone) was also inferior to the LNG-IUS, tranexamic acid and ormeloxifene, but may be similar to the combined vaginal ring with respect to reduction of menstrual blood loss.

Bohan, L., et al. (2023). "Assessing the Efficacy of Contemporary Protocols in Fertility-Sparing Treatment for Endometrial Cancer: A Systematic Review and Bayesian Network Meta-Analysis Based on Prospective Studies." PROSPERO International prospective register of systematic reviews.
	
Bohm-Starke, N., et al. (2022). "Treatment of Provoked Vulvodynia: A Systematic Review." The Journal of Sexual Medicine 19(5): 789-808.
	Background: Treatment recommendations for provoked vulvodynia (PVD) are based on clinical experiences and there is a need for systematically summarizing the controlled trials in this field.; Aim: To provide an overview of randomized controlled trials and non-randomized studies of intervention for PVD, and to assess the certainty of the scientific evidence, in order to advance treatment guidelines.; Data Sources: The search was conducted in CINAHL (EBSCO), Cochrane Library, Embase (Embase.com), Ovid MEDLINE, PsycINFO (EBSCO) and Scopus. Databases were searched from January 1, 1990 to January 29, 2021.; Study Eligibility Criteria: Population: Premenopausal women with PVD.; Interventions: Pharmacological, surgical, psychosocial and physiotherapy, either alone or as combined/team-based interventions.; Control: No treatment, waiting-list, placebo or other defined treatment.; Outcomes: Pain during intercourse, pain upon pressure or touch of the vaginal opening, sexual function/satisfaction, quality of life, psychological distress, adverse events and complications.; Study Design: Randomized controlled trials and non-randomized studies of interventions with a control group.; Study Appraisal and Synthesis Methods: 2 reviewers independently screened citations for eligibility and assessed relevant studies for risk of bias using established tools. The results from each intervention were summarized. Studies were synthesized using a narrative approach, as meta-analyses were not considered appropriate. For each outcome, we assessed the certainty of evidence using grading of recommendations assessment, development, and evaluation (GRADE).; Results: Most results of the evaluated studies in this systematic review were found to have very low certainty of evidence, which means that we are unable to draw any conclusions about effects of the interventions. Multimodal physiotherapy compared with lidocaine treatment was the only intervention with some evidential support (low certainty of evidence for significant treatment effects favoring physiotherapy). It was not possible to perform meta-analyses due to a heterogeneity in interventions and comparisons. In addition, there was a heterogeneity in outcome measures, which underlines the need to establish joint core outcome sets.; Clinical Implications: Our result underscores the need of stringent trials and defined core outcome sets for PVD.; Strength and Limitations: Standard procedures for systematic reviews and the Population Intervention Comparison Outcome model for clinical questions were used. The strict eligibility criteria resulted in limited number of studies which might have resulted in a loss of important information.; Conclusion: This systematic review underlines the need for more methodologically stringent trials on interventions for PVD, particularly for multimodal treatments approaches. For future research, there is a demand for joint core outcome sets. Bohm-Starke N, Ramsay KW, Lytsy P, et al. Treatment of Provoked Vulvodynia: A Systematic Review. J Sex Med 2022;19:789-808. (Copyright © 2022 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Bohn Jacqueline, A., et al. (2022). "Does obesity influence the preferred treatment approach for early-stage cervical cancer? A cost-effectiveness analysis." International Journal of Gynecological Cancer 32(2): 133-140.
	Objective: Abdominal radical hysterectomy in early-stage cervical cancer has higher rates of disease-free and overall survival compared with minimally invasive radical hysterectomy. Abdominal radical hysterectomy may be technically challenging at higher body mass index levels resulting in poorer surgical outcomes. This study sought to examine the influence of body mass index on outcomes and cost effectiveness between different treatments for early-stage cervical cancer.; Methods: A Markov decision-analytic model was designed using TreeAge Pro software to compare the outcomes and costs of primary chemoradiation versus surgery in women with early-stage cervical cancer. The study used a theoretical cohort of 6000 women who were treated with abdominal radical hysterectomy, minimally invasive radical hysterectomy, or primary chemoradiation therapy. We compared the results for three body mass index groups: less than 30 kg/m 2 , 30-39.9 kg/m 2 , and 40 kg/m 2 or higher. Model inputs were derived from the literature. Outcomes included complications, recurrence, death, costs, and quality-adjusted life years. An incremental cost-effectiveness ratio of less than $100 000 per quality-adjusted life year was used as our willingness-to-pay threshold. Sensitivity analyses were performed broadly to determine the robustness of the results.; Results: Comparing abdominal radical hysterectomy with minimally invasive radical hysterectomy, abdominal radical hysterectomy was associated with 526 fewer recurrences and 382 fewer deaths compared with minimally invasive radical hysterectomy; however, abdominal radical hysterectomy resulted in more complications for each body mass index category. When the body mass index was 40 kg/m 2 or higher, abdominal radical hysterectomy became the dominant strategy because it led to better outcomes with lower costs than minimally invasive radical hysterectomy. Comparing abdominal radical hysterectomy with primary chemoradiation therapy, recurrence rates were similar, with more deaths associated with surgery across each body mass index category. Chemoradiation therapy became cost effective when the body mass index was 40 kg/m 2 or higher.; Conclusion: When the body mass index is 40 kg/m 2 or higher, abdominal radical hysterectomy is cost saving compared with minimally invasive radical hysterectomy and primary chemoradiation is cost effective compared with abdominal radical hysterectomy. Primary chemoradiation may be the optimal management strategy at higher body mass indexes.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Bolukbas Nalan, C. (2023). "Sacral Transcutaneous Electrical Stimulation Efficacy in Chronic Pelvic Pain: a Randomized Clinical Trial." ClinicalTrials.gov.
	Our study aiming to test the efficacy of sacral transcutaneous electrical stimulation (TENS) intervention in patients with chronic pelvic pain. We aim to test the efficacy and compare it with sham stimulation therapy in chronic pelvic pain.

Bonga, K. N., et al. (2024). "Efficacy and Safety of Fezolinetant for the Treatment of Menopause-Associated Vasomotor Symptoms A Meta-analysis." Obstetrics and Gynecology 143(3): 393-402.
	OBJECTIVE: To evaluate the efficacy and adverse events of fezolinetant for treating vasomotor symptoms (VMS) of menopause. DATA SOURCES: PubMed/MEDLINE, ClinicalTrials.gov, EMBASE, Cochrane Database, Scopus, and WHO International Clinical Trials Registry Platform were searched through June 2023 for publications and randomized controlled trials on fezolinetant compared with placebo in menopausal women who experienced moderate-to-severe VMS. METHODS OF STUDY SELECTION: Our literature search identified 330 articles, of which five studies with six reports were included in our meta-analysis per our eligibility criteria. TABULATION, INTEGRATION, AND RESULTS: The risk of bias was evaluated using Cochrane's RoB 2 (Risk of Bias version 2) tool, quality of evidence was graded using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach, and outcome measures data for effect size were pooled in random-effects model and rated. A total of 2,168 participants from five randomized clinical trials (six reports) were included. Fezolinetant significantly lowered VMS frequency, with pooled mean difference of 2.62 (95% CI, 1.84-3.41). The pooled mean difference for fezolinetant compared with placebo for the MENQOL (Menopause-Specific Quality of Life) measure was 20.60 (95% CI, 20.92 to 20.28), and the mean percentage improvement in VMS frequency was 22.51% (95% CI, 15.35-29.67). Fezolinetant was associated with improvement in sleep quality when compared with placebo. CONCLUSION(S): Fezolinetant is effective in lowering moderate-to-severe VMS frequency and sleep disturbances in postmenopausal women.Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.

Boomsma Carolien, M., et al. (2022). "Peri-implantation glucocorticoid administration for assisted reproductive technology cycles." The Cochrane Database of Systematic Reviews 6: CD005996.
	Background: The use of peri-implantation glucocorticoids has been advocated to improve embryo implantation during assistive reproductive technology (ART) cycles such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). It has been proposed that glucocorticoids may improve the intrauterine environment by acting as immunomodulators to reduce the uterine natural killer (NK) cell count and activity, normalising the cytokine expression profile in the endometrium and by suppression of endometrial inflammation.; Objectives: To evaluate the effectiveness and safety of glucocorticoids versus no glucocorticoids administered around the time of anticipated implantation in women undergoing IVF or ICSI.; Search Methods: We searched the Cochrane Gynaecology and Fertility (CGF) Group specialised register, CENTRAL (now also containing output from two trial registers and CINAHL), MEDLINE and Embase, on 20 December 2021, together with reference checking, contact with experts in the field and relevant conference proceedings to identify additional studies. This review is an update of the review first published in 2007 and last updated in 2012.; Selection Criteria: Randomised controlled trials (RCTs) comparing the efficacy of supplementary systemic administration of glucocorticoids in the peri-implantation period with a placebo or no glucocorticoids in subfertile women undergoing IVF or ICSI were included.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. The primary review outcomes were live birth rate and multiple pregnancy.; Main Results: We included 16 RCTs (2232 couples analysed). We are uncertain whether glucocorticoids improved live birth rates (odds ratio (OR) 1.37, 95% confidence interval (CI) 0.69 to 2.71; 2 RCTs, n = 366; I 2 = 7%; very low-certainty evidence). This suggests that if the chance of live birth following no glucocorticoids/placebo is assumed to be 9%, the chance following glucocorticoids would be between 6% and 21%. We are also uncertain whether there was a difference between peri-implantation glucocorticoids on multiple pregnancy rates per couple (OR 0.86, 95% CI 0.33 to 2.20; 4 RCTs, n = 504; I 2 = 53%; very low-certainty evidence). The I 2 of 53% may represent moderate statistical heterogeneity and results have to be interpreted with caution. With regard to pregnancy rates, we are uncertain whether there was a difference between ongoing pregnancy rates after glucocorticoids versus no glucocorticoids/placebo (OR 1.19, 95% CI 0.80 to 1.76; 3 RCTs, n = 476; I 2 = 0%; very low-certainty evidence) and clinical pregnancy rates after glucocorticoids versus no glucocorticoids/placebo (OR 1.17, 95% CI 0.95 to 1.44; 13 RCTs, n = 1967; I 2 = 0%; low-certainty evidence). This suggests that if the chance of clinical pregnancy following no glucocorticoids/placebo is assumed to be 25%, the chance following glucocorticoids would be between 24% and 32%. Furthermore, we are also uncertain whether peri-implantation glucocorticoids influenced miscarriage rates per couple (OR 1.09, 95% CI 0.63 to 1.87; 6 RCTs, n = 821; I 2 = 0%; very low-certainty evidence), the incidence of ectopic pregnancies per couple (OR 2.28, 95% CI 0.33 to 15.62; 3 RCTs, n = 320; I 2 = 0%; very low-certainty evidence) and ovarian hyperstimulation syndrome (OHSS) per couple (OR 1.07, 95% CI 0.60 to 1.90; 3 RCTs, n = 370; I 2 = 0%; very low-certainty evidence) compared to no glucocorticoids/placebo. The evidence was very low to low certainty: the main limitations were serious risk of bias due to poor reporting of study methods, and serious imprecision.; Authors' Conclusions: Overall, there was insufficient evidence that administration of peri-implantation glucocorticoids in IVF/ICSI cycles influenced clinical outcomes. These findings were limited to the routine use of glucocorticoids in subfertile women undergoing IVF or ICSI. (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Borcoman, E., et al. (2023). "Phase Ib/II trial of tipapkinogene sovacivec, a therapeutic human papillomavirus16-vaccine, in combination with avelumab in patients with advanced human papillomavirus16-positive cancers." European Journal of Cancer 191: 112981.
	Purpose: To evaluate tipapkinogene sovacivec (TG4001), a viral immunotherapeutic vaccine expressing human papillomavirus (HPV)16 E6/E7 non-oncogenic proteins and IL-2, in combination with avelumab in HPV16+ cancer patients. Patients and Methods: In this open-label, phase Ib/II, multicenter study, HPV16+ advanced cancer patients received subcutaneous TG4001 at two dose levels (DL) in phase Ib and at the recommended phase II dose (RP2D) in phase II weekly for 6 weeks, then every 2 weeks (q2Wk) until 6 months, thereafter every 12 weeks, in combination with avelumab q2Wk starting from day 8. Exploratory end-points included immunomonitoring from sequential tumour and blood samples. Result(s): Forty-three patients, mainly heavily pretreated (88% >= 1 previous line), were included in the safety analysis, with a majority of anal cancer (44%). No dose-limiting toxicities were reported, and DL2 (5 x 107 Plaque forming units (PFU)) was selected as the RP2D. Treatment-related adverse events to TG4001 occurred in 93% of patients, mostly grade 1/2, with grade 3 anaemia in one patient and no grade 4/5. Overall response rate (ORR) was 22% (8/36) and 32% (8/25) in all and patients without liver metastases, respectively. Median progression-free survival (PFS) and Overall Survival (OS) were 2.8 months (95% CI: 1.4-5.6) and 11.0 months (95% CI:7.5-16.7) in the total population and 5.6 months (95% CI:1.6-9.6) and 13.3 months (95% CI:8.7-32.7) in patients without liver metastases. Antigen-specific T-cell response was identified in 7/11 patients by IFNgamma ELISpot. Conclusion(s): TG4001 in combination with avelumab is safe, demonstrated antitumour activity in heavily pre-treated HPV16+ cancer patients, and is currently being evaluated in a randomised phase II trial in patients with incurable anogenital cancer and limited hepatic involvement. ClinicalTrials.gov Identifier: NCT03260023.Copyright © 2023 Elsevier Ltd

Bordewijk Esmée, M., et al. (2020). "Laparoscopic ovarian drilling for ovulation induction in women with anovulatory polycystic ovary syndrome." The Cochrane Database of Systematic Reviews 2: CD001122.
	Background: Polycystic ovary syndrome (PCOS) is a common condition affecting 8% to 13% of reproductive-aged women. In the past clomiphene citrate (CC) used to be the first-line treatment in women with PCOS. Ovulation induction with letrozole should be the first-line treatment according to new guidelines, but the use of letrozole is off-label. Consequently, CC is still commonly used. Approximately 20% of women on CC do not ovulate. Women who are CC-resistant can be treated with gonadotrophins or other medical ovulation-induction agents. These medications are not always successful, can be time-consuming and can cause adverse events like multiple pregnancies and cycle cancellation due to an excessive response. Laparoscopic ovarian drilling (LOD) is a surgical alternative to medical treatment. There are risks associated with surgery, such as complications from anaesthesia, infection, and adhesions.; Objectives: To evaluate the effectiveness and safety of LOD with or without medical ovulation induction compared with medical ovulation induction alone for women with anovulatory polycystic PCOS and CC-resistance.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group (CGFG) trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and two trials registers up to 8 October 2019, 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) of women with anovulatory PCOS and CC resistance who underwent LOD with or without medical ovulation induction versus medical ovulation induction alone, LOD with assisted reproductive technologies (ART) versus ART, LOD with second-look laparoscopy versus expectant management, or different techniques of LOD.; Data Collection and Analysis: Two review authors independently selected studies, assessed risks of bias, extracted data and evaluated the quality of the evidence using the GRADE method. The primary effectiveness outcome was live birth and the primary safety outcome was multiple pregnancy. Pregnancy, miscarriage, ovarian hyperstimulation syndrome (OHSS), ovulation, costs, and quality of life were secondary outcomes.; Main Results: This updated review includes 38 trials (3326 women). The evidence was very low- to moderate-quality; the main limitations were due to poor reporting of study methods, with downgrading for risks of bias (randomisation and allocation concealment) and lack of blinding. Laparoscopic ovarian drilling with or without medical ovulation induction versus medical ovulation induction alone Pooled results suggest LOD may decrease live birth slightly when compared with medical ovulation induction alone (odds ratio (OR) 0.71, 95% confidence interval (CI) 0.54 to 0.92; 9 studies, 1015 women; I 2 = 0%; low-quality evidence). The evidence suggest that if the chance of live birth following medical ovulation induction alone is 42%, the chance following LOD would be between 28% and 40%. The sensitivity analysis restricted to only RCTs with low risk of selection bias suggested there is uncertainty whether there is a difference between the treatments (OR 0.90, 95% CI 0.59 to 1.36; 4 studies, 415 women; I 2 = 0%, low-quality evidence). LOD probably reduces multiple pregnancy rates (Peto OR 0.34, 95% CI 0.18 to 0.66; 14 studies, 1161 women; I 2 = 2%; moderate-quality evidence). This suggests that if we assume the risk of multiple pregnancy following medical ovulation induction is 5.0%, the risk following LOD would be between 0.9% and 3.4%. Restricting to RCTs that followed women for six months after LOD and six cycles of ovulation induction only, the results for live birth were consistent with the main analysis. There may be little or no difference between the treatments for the likelihood of a clinical pregnancy (OR 0.86, 95% CI 0.72 to 1.03; 21 studies, 2016 women; I 2 = 19%; low-quality evidence). There is uncertainty about the effect of LOD compared with ovulation induction alone on miscarriage (OR 1.11, 95% CI 0.78 to 1.59; 19 studi s, 1909 women; I 2 = 0%; low-quality evidence). OHSS was a very rare event. LOD may reduce OHSS (Peto OR 0.25, 95% CI 0.07 to 0.91; 8 studies, 722 women; I 2 = 0%; low-quality evidence). Unilateral LOD versus bilateral LOD Due to the small sample size, the quality of evidence is insufficient to justify a conclusion on live birth (OR 0.83, 95% CI 0.24 to 2.78; 1 study, 44 women; very low-quality evidence). There were no data available on multiple pregnancy. The likelihood of a clinical pregnancy is uncertain between the treatments, due to the quality of the evidence and the large heterogeneity between the studies (OR 0.57, 95% CI 0.39 to 0.84; 7 studies, 470 women; I 2 = 60%, very low-quality evidence). Due to the small sample size, the quality of evidence is not sufficient to justify a conclusion on miscarriage (OR 1.02, 95% CI 0.31 to 3.33; 2 studies, 131 women; I 2 = 0%; very low-quality evidence). Other comparisons Due to lack of evidence and very low-quality data there is uncertainty whether there is a difference for any of the following comparisons: LOD with IVF versus IVF, LOD with second-look laparoscopy versus expectant management, monopolar versus bipolar LOD, and adjusted thermal dose versus fixed thermal dose.; Authors' Conclusions: Laparoscopic ovarian drilling with and without medical ovulation induction may decrease the live birth rate in women with anovulatory PCOS and CC resistance compared with medical ovulation induction alone. But the sensitivity analysis restricted to only RCTs at low risk of selection bias suggests there is uncertainty whether there is a difference between the treatments, due to uncertainty around the estimate. Moderate-quality evidence shows that LOD probably reduces the number of multiple pregnancy. Low-quality evidence suggests that there may be little or no difference between the treatments for the likelihood of a clinical pregnancy, and there is uncertainty about the effect of LOD compared with ovulation induction alone on miscarriage. LOD may result in less OHSS. The quality of evidence is insufficient to justify a conclusion on live birth, clinical pregnancy or miscarriage rate for the analysis of unilateral LOD versus bilateral LOD. There were no data available on multiple pregnancy. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Borghi, C., et al. (2023). "Neoadjuvant chemotherapy prior to radical hysterectomy in locally advanced cervical cancer: a systematic review and meta-analysis." International Journal of Gynecological Cancer.
	Objective: The objective of this systematic review was to evaluate the effect of different types of neoadjuvant chemotherapy regimens, in terms of optimal pathological response and oncological outcomes, in patients with locally advanced cervical cancer.; Methods: A systematic search of the literature was performed. MEDLINE through PubMed and Embase databases were searched from inception to June 2023. The study was registered in PROSPERO (ID number CRD42023389806). All women with a pathological diagnosis of locally advanced cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2009 classification stages IB2-IVA), any age or histology, who underwent intravenous neoadjuvant chemotherapy before radical surgery, and articles only in English language, were included. We conducted a meta-analysis for optimal pathological response after surgery and survival outcomes. The risk of bias was assessed using the Newcastle-Ottawa scale and the Risk of Bias 2 (RoB) tools. The review methods and results were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.; Results: 25 studies with a total number of 1984 patients fulfilled the eligibility criteria of our review and were included for data extraction and efficacy analysis. When compared with a two-drug regimen, the three-drug combination including cisplatin, paclitaxel, and ifosfamide or anthracyclines showed superior efficacy in terms of optimal pathological response with an odds ratio of 0.38 (95% CI 0.24 to 0.61, p<0.0001), with no difference in disease-free survival (hazard ratio (HR) 0.72, 95% CI 0.50 to 1.03, I 2 =0%, p=0.07) and higher overall survival (HR 0.63, 95% CI 0.41 to 0.97, I 2 =0%, p=0.03).; Conclusions: The three-drug combination of cisplatin, paclitaxel, and ifosfamide or anthracyclines showed a higher rate of complete or optimal partial response, with the triple regimens having an advantage over the platinum-based schedules in terms of overall survival. Neoadjuvant chemotherapy followed by radical surgery should not be considered a standard of care in locally advanced cervical cancer.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Borzan, V., et al. (2023). "Probiotic vs. placebo and metformin: probiotic dietary intervention in polycystic ovary syndrome - A randomized controlled trial." BMC Endocrine Disorders 23(1): 82.
	Background: Polycystic Ovary Syndrome (PCOS) is a very common endocrine disorder with a variety of symptoms. Current treatment options include the contraceptive pill as well as metformin, however both treatments are limited to specific symptoms and have common side effects.; Methods: This phase IV study is a monocentric, double blinded randomized clinical trial comparing the effects of six months of probiotic intervention to a placebo, with an additional open-label metformin arm as a positive control in a total of 180 participants with PCOS. The first of three visits is the screening visit, where inclusion/exclusion criteria are assessed. At the first visit, they are randomised into one of the three treatment arms equally and receive their study medication. After six months, all assessments from the first two visits are repeated. The primary endpoint is the change in free testosterone levels after the intervention, while secondary endpoints include changes in hormonal and metabolic parameters associated with PCOS as well as the gut microbial composition and diversity after intervention.; Discussion: Based on new insights into the role of the gut microbiome in PCOS development, this study is exploring the potential of using probiotics to treat women with PCOS symptoms. If successful, this new therapy approach could open a new realm of possibilities for treating PCOS. To our knowledge, this is the first study comparing probiotic intervention with not only placebo treatment, but also metformin. This study has been approved by the ethics committee of the Medical University of Graz (EC number 32-230 ex 19/20).; Registration: EudraCT number: 2020-000228-20.; Clinicaltrials: gov identifier: NCT04593459.; Protocol Version: Version 1.5 dated 29th November 2021. (© 2023. The Author(s).)

Bosdou, J. K., et al. (2019). "Higher probability of live-birth in high, but not normal, responders after first frozen-embryo transfer in a freeze-only cycle strategy compared to fresh-embryo transfer: a meta-analysis." Human Reproduction 34(3): 491-505.
	Study Question: Does the outcome of the comparison of live birth rates between the first frozen embryo transfer (ET) (in a freeze-only cycles strategy, i.e. frozen ET group) and a fresh embryo transfer (fresh ET group) differ considering the type of ovarian response?; Summary Answer: Α significantly higher probability of live birth is present in high, but not normal, responders, after the first frozen ET in a freeze-only cycle strategy as compared to a fresh ET.; What Is Known Already: It has been hypothesised that freezing all good embryos in a fresh in-vitro fertilisation (IVF) cycle and deferring embryo transfer in subsequent cycles may provide a more physiological endometrial environment for embryo implantation when compared to a fresh ET. However, currently, three relevant meta-analyses have been published with conflicting results, while none of them has taken into consideration the type of ovarian response. Recently, the publication of additional, large relevant randomised controlled trials (RCTs) in patients with different types of ovarian response makes possible the comparative evaluation of the first frozen ET (in a freeze-only cycle strategy) versus fresh ET, considering the type of ovarian response.; Study Design, Size, Duration: A systematic review and meta-analysis was performed aiming to identify RCTs comparing the first frozen ET (in a freeze-only cycle strategy) to a fresh ET. The main outcome was live birth, while secondary outcomes included ongoing pregnancy, clinical pregnancy, moderate/severe ovarian hyperstimulation syndrome (OHSS) and miscarriage.; Participants/materials, Setting, Methods: We identified eight eligible RCTs, including 5265 patients, which evaluated the first frozen ET in a freeze-only cycle strategy versus a fresh ET either in high responders (n = 4) or in normal responders (n = 4). No relevant RCTs were present in poor responders. Meta-analysis of weighted data using fixed and random effects model was performed. Results are reported as relative risk (RR) with 95% confidence interval (CI).; Main Results and the Role of Chance: Eligible RCTs were published between 2011 and 2018. Four RCTs (n = 3255 patients) compared the first frozen ET (in a freeze-only cycle strategy) to a fresh ET in normal responders and four RCTs (n = 2010 patients) did the comparison in high responders. In high responders, a significantly higher probability of live birth was observed in the frozen ET group when compared with the fresh ET group (RR: 1.18, 95% CI: 1.06-1.31; fixed effects model; heterogeneity: I2 = 0%; three studies; n = 3398 patients). However the probability of live birth was not significantly different between the frozen ET group and the fresh ET group in normal responders (RR: 1.13, 95% CI: 0.90-1.41; random effects model; heterogeneity: I2 = 77%; three studies; n = 1608 patients). The risk of moderate/severe OHSS was significantly lower in the frozen ET group when compared with the fresh ET group both in high (RR: 0.19, 95% CI: 0.10-0.37; fixed effects model; heterogeneity: not applicable; a single study; n = 1508 patients) and normal responders (RR: 0.39, 95% CI: 0.19-0.80; fixed effects model; heterogeneity: I2 = 0%; two studies; n = 2939 patients).; Limitations, Reasons for Caution: Considerable heterogeneity was present among the studies, regarding ovarian stimulation protocols and the triggering signal used for inducing final oocyte maturation as well as the cryopreservation methods, while the quality of evidence was poor for the live birth rate in high responders. Moreover, the analysis did not apply a standard for determining 'high' or 'normal' responders since the type of ovarian response followed the characterisation of populations as reported by the authors of the eligible studies.; Wider Implications of the Findings: A freeze-only cycle strategy should be the preferred option in high responders since it enhances the probability of live birth, while reducing the chance of moderate/severe OHSS. In normal responders, the same strategy could be applied, in the interest of patien safety or clinic convenience, without compromising the chances of live birth.; Study Funding/competing Interest(s): No external funding was used and there were no competing interests.; Prospero Registration Number: PROSPERO registration number: CRD42018099389. (© The Author(s) 2019. 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.)

Bouallalene-Jaramillo, K. and J. Calvo-Sanz (2023). "Parameterization of electrotherapy interventions in physiotherapy for pelvic floor dysfunctions: a systematic review." Actas Urologicas Espanolas.
	OBJECTIVE: To determine which parameters of the currents used with electrotherapy in pelvic floor dysfunctions are more appropriate for the proposed objectives regarding the relief of the symptomatology of certain clinical conditions. MATERIAL AND METHODS: A systematic review was performed in CENTRAL, PubMed/MEDLINE and PEDro databases. The risk of bias and methodological quality in the included studies was assessed using the ROBINS-I, JADAD and PEDro scales, respectively. STUDY SELECTION: The review included randomized controlled trials, with adult patients aged 18 years or older, that incorporated the use of electrical currents in the conservative treatment of pelvic floor dysfunctions. RESULTS: After meeting the evaluation and inclusion-exclusion criteria, 14 articles were selected following the PRISMA guidelines. CONCLUSIONS: There is a certain lack of homogeneity in the choice of the parameters of the electrotherapy currents used in pelvic floor dysfunctions. There is evidence supporting the effectiveness of neuromuscular electrostimulation in pelvic floor muscle re-education due to its functional improvements, as well as the application of analgesic electrical current therapy such as TENS for the modulation of clinical conditions involving pain.

Bouchard-Fortier, G., et al. (2020). "Oncologic outcomes and morbidity following heated intraperitoneal chemotherapy at cytoreductive surgery for primary epithelial ovarian cancer: A systematic review and meta-analysis." Gynecologic Oncology 158(1): 218-228.
	Objectives: Heated intraperitoneal chemotherapy (HIPEC) has not been universally adopted at the time of interval cytoreductive surgery for primary epithelial ovarian cancer (EOC) despite evidence of a 12-month overall survival (OS) benefit in a recent landmark randomized trial. We performed a systematic review and meta-analysis to assess oncologic outcomes and perioperative morbidity following HIPEC among primary EOC patients.; Methods: We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews, from inception to August 2019, for observational and randomized studies of primary EOC patients undergoing HIPEC. We assessed risk of bias using the Institute of Health Economics Quality Appraisal Checklist for single-arm cohort studies, Newcastle-Ottawa Scale for comparative cohort studies, and Cochrane Collaboration's Tool for randomized trials. We qualitatively summarized survival outcomes and calculated the pooled proportion of 30-day grade III-IV morbidity and postoperative death.; Results: We identified 35 articles including 2252 primary EOC patients; one study was a randomized trial, and only six studies included a comparator group of surgery alone. The timing, temperature, and chemotherapeutic agents used for HIPEC differed across studies. Reported OS was highly variable (3-year OS range: 46-77%); three comparative cohort studies and the sole randomized trial reported statistically significant survival benefits for HIPEC over surgery alone, while two comparative cohort studies did not. The pooled proportions for grade III-IV morbidity and postoperative death at 30 days were 34% (95% CI 20-52) and 0% (95% CI 0-5) respectively.; Conclusion: One randomized trial suggests that HIPEC at time of interval cytoreductive surgery should be considered in patients with primary EOC. However, there is significant heterogeneity in literature with respect to an appropriate HIPEC regimen, short- and long-term outcomes. High-quality prospective randomized trials are urgently needed to clarify the role of HIPEC in the first-line treatment of primary EOC.; Competing Interests: Declaration of competing interest The authors report no conflicts of interest. (Copyright © 2020 Elsevier Inc. All rights reserved.)

Boudallaa Yasmin Er, R. (2022). "The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary Incontinence." ClinicalTrials.gov.
	Urinary incontinence (UI) is a health burden for more than 200 million people in the world. 34% of women over the age of 40 experience or have already experienced some significant experience with UI, thus affecting their health‐related quality of life (QoHR). SUI is endowed with a complex and multifactorial pathophysiology, generally involving the pelvic floor musculature and adjacent collagen‐dependent tissues that help in support. According to the literature, there are two clearly described mechanisms: ‐ The loss of urethral support, of the anterior vaginal wall, transforming into urethral hypermobility. ‐ Deficiency of urethral closure, such as rotational descent of the proximal part of the urethra, of the pubourethral ligament, with loss of internal urethral integrity. The pelvic floor musculature plays an important role in helping the urethral support, during voluntary contraction. If the muscles are weak, urine loss is greater. RF is an electrophysical and medical technique that generates tissue heating for therapeutic purposes. This technology uses electromagnetic RF fields with frequencies between 434 and 925 MHz, these forming part of the techniques classified as high frequency. The increases in temperature can reach 41.5ºC to 45ºC, according to some studies, and in another reaching 50ºC, acting at 6 and 8 cm3 depth, and generating biological effects on the skin and in the deeper layers. It is known that RF promotes angiogenesis and increases local vascularization, stimulating collagen and elastin, resulting in changes in the helical structure of collagen, due to the denaturation and restructuring of its fibers. Changing the nature of connective tissues. Investigators will make use of the non‐ablative resistive RF mode, which does not have the capacity to section, but does have cell stimulation through superficial application on the skin, generating anti‐inflammatory effects at the physiological level and collagen contraction, as an effect of short duration, and the stimulation of collagen synthesis or neocollagenesis thanks to the inflammation of the fibroblasts, to repair the damage present, as a long‐lasting effect. Which would be interesting, because the pelvic floor is formed in its great majority by connective tissue and this would help to regenerate the tissue. Treatment with this technology has not been sufficiently investigated in the intravaginal treatment of the pelvic floor. Previous studies lead to transurethral medical treatments that require local anesthesia, and the pathologies treated are the different types of urinary incontinence (stress, urgency, and mixed) and vaginal laxity. However, from the transvaginal approach the investigators found few studies.

Bozbulut, R. (2021). "Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome." ClinicalTrials.gov.
	No Results Available Behavioral: intervention diet|Behavioral: control diet Luteinizing hormone (LH) (IU/L)|Follicle-stimulating hormone (FSH) (IU/L)|Total and free (ng/mL)|Prolactin (ng/mL)|Dehydroepiandrosterone sulfate (DHEA-S) (µg/dL)|Androstenedione (ng/mL)|17-hydroxyprogesterone (17-OH progesterone) (ng/mL)|Sex hormone binding globulin (SHGB) (nmol/L)|Free Androgen Index (FAI)|The Ferriman-Gallwey score (FGS)|fasting blood glucose (mg/dl)|fasting insulin (IU/ml)|HOMA-IR index|QUICKI index|Total cholesterol (mg/dl) composition|high-density lipoprotein (HDL-C) (mg/dl)|low-density lipoprotein (LDL) (mg/dl)|triglyceride (mg/dl)|high-sensitivity CRP (HsCRP)(mg/l)|tumor necrosis factor-alpha (TNF-α) (pg/ml)|interleukin-6 (IL-6) (pg/ml)|Weight in kilograms|Height in meters|BMI = body mass index (kg/m2)|Neck circumference in cm|. Waist circumference in cm|body composition analysis Female Not Applicable 40 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment Gazi University Medicine February 1, 2022

Bozbulut, R., et al. (2023). "Beneficial effects of RESMENA diet on anthropometric, metabolic and reproductive profile in adolescents with obesity and polycystic ovary syndrome: a randomized controlled intervention study." Hormone Research in Paediatrics.
	Introduction: The optimal dietary strategy to improve the metabolic and reproductive endocrine profile in adolescents with obesity and polycystic ovary syndrome is undefined. This study was conducted to evaluate the efficacy of the MEtabolic Syndrome REduction in NAvarra (RESMENA) diet versus a control diet based on American Heart Association (AHA) recommendations for the treatment of PCOS in adolescents with PCOS.; Methods: A total of 40 adolescents diagnosed with PCOS between the ages of 13-18 years were randomized to either a RESMENA or control diet for 6 months. Dietary status, anthropometry, body composition, biochemical parameters, and reproductive endocrine hormones were compared between the 2 groups before and after the intervention.; Results: Both diet groups showed significant decreases in anthropometric parameters whereas the RESMENA diet provided a greater decrease in all these parameters except neck circumference and fat percentage (p<0.05). At the end of the study fasting insulin, ALT, and total cholesterol levels decreased in both control and RESMENA group, HbA1c, HOMA-IR, and hsCRP levels decreased and QUICKI score increased in the RESMENA group (p<0.05). There was no statistical difference in the androgen levels of the control group compared to the baseline. In the RESMENA group, there was a significant decrease in total testosterone, free testosterone, 17-OH progesterone, androstenedione, LH levels and LH/FSH ratio and free androgen index and a significant increase in SHGB levels (p<0.05).; Conclusions: Both dietary patterns resulted in significant improvement in anthropometric measurements and body composition, but the RESMENA diet showed beneficial effects on insulin resistance parameters and androgen levels. (The Author(s). Published by S. Karger AG, Basel.)

Bozdemir, T. (2023). "Responsive Web-based Roadmap (InT-mAp) in Infertility Treatment." ClinicalTrials.gov.
	No Results Available Other: On going treatment|Other: InT-mAp Change from Anxiety Level at 12 weeks|Pregnancy rate|Treatment success|Cycle success|Nursing Needs of Infertile Women Female Not Applicable 74 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Outcomes Assessor)|Primary Purpose: Supportive Care 2022/20-02 February 2024

Bristol-Myers, S. (2022). "A Study of MORAb-202 Versus Investigator's Choice Chemotherapy in Female Participants With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer." ClinicalTrials.gov.
	The purpose of the study is to assess the safety, tolerability, and efficacy of farletuzumab ecteribulin (MORAb‐202) and compare it to Investigator's choice (IC) chemotherapy in female participants with platinum‐resistant HGS ovarian, primary peritoneal, or fallopian tube cancer.

Bristol-Myers Squibb International, C. (2022). "A Phase 2 Study of MORAb-202 in Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: MORAb‐202 Product Code: BMS‐986445 Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: Farletuzumab ecteribulin Current Sponsor code: BMS‐986445 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ Product Name: MORAb‐202 Product Code: BMS‐986445 Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: Farletuzumab ecteribulin Current Sponsor code: BMS‐986445 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ Trade Name: Paclitaxel Product Name: Paclitaxel Product Code: L01C D01 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Paclitaxel CAS Number: 33069‐62‐4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6‐ Trade Name: Pegylated Liposomal Doxorubicin Product Name: Pegylated Liposomal Doxorubicin Product Code: L01DB01 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: doxorubicin CAS Number: C50664300 Other descriptive name: DOXORUBICIN, LIPOSOMAL, PEGYLATED Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2‐ Trade Name: topotecan Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Topotecan CAS Number: 123948‐87‐8 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ Trade Name: topotecan Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Topotecan CAS Number: 123948‐87‐8 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ CONDITION: Platinum‐resistant High‐grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube 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) ; MedDRA version: 20.0 Level: PT Classification code 10016180 Term: Fallopian tube cancer System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 20.0 Level: LLT Classification code 10052171 Term: Peritoneal carcinoma 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): 1. Occurrence of the AEs/SAEs, treatment‐related AEs/SAEs, AEs leading to discontinuation, AESIs, deaths and laboratory abnormalities; 2. DoR by RECIST v1.1 per investigator Assessment among responders; 3. PFS by RECIST v1.1 per Investigator Assessment; 4. DCR by RECIST v1.1 per Investigator Assessment Timepoint(s) of evaluation of this end point: 1. Up to 2 years; 2. Up to 2 years; 3. Up to 2 years; 4. Up to 2 years PRIMARY OUTCOME: Main Objective: 1. To compare objective response rate of MORAb‐202 vs Investigator’s Choice (IC) chemotherapy (in all randomized participants); 2. To evaluate the proportion of participants with treatment‐related adverse events (TRAEs) leading to discontinuation in each arm within 6 months from first dose of study drug administration in all treated participants Primary end point(s): 1. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per Investigator assessment; 2. Occurence of TRAEs leading to discontinuation. Secondary Objective: 1. To evaluate Disease Control Rate (DCR) of MORAb‐202 and IC chemotherapy in all randomized participants; 2. To evaluate Duration of Response (DoR) of MORAb‐202 and IC chemotherapy in all randomized participants; 3. To evaluate Progression‐Free Survival (PFS) of MORAb‐202 and IC chemotherapy in all randomized participants Timepoint(s) of evaluation of this end point: 1. Up to 2 years; 2. Up to 2 years INCLUSION CRITERIA: 1) Participants must be 18 years old or local age of majority at the time of signing the i ormed consent 2) Female participants with histologically confirmed diagnosis of HGS ovarian, primary peritoneal, or fallopian tube cancer. 3) Platinum‐resistant disease, defined as: ‐ For participants who had only 1 line of platinum‐based therapy: progression between > 1 month and = 6 months after the last dose of platinum‐based therapy of at least 4 cycles. ‐ For participants who had 2 or 3 lines of platinum‐based therapy: progression = 6 months after the last dose of platinum‐based therapy. 4) Participants have received at least 1 but no more than 3 prior lines of systemic therapy and for whom single‐agent therapy is appropriate as the next line of therapy. Participants may have been treated with up to 1 line of therapy subsequent to determination of platinum‐resistance. ‐ Participants must have received prior treatment with bevacizumab or mu

Broekmans, F. (2021). "Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment." ClinicalTrials.gov.
	Participating sites consist of academic and non‐academic hospitals and fertility clinics in The Netherlands. There are two treatment arms (MOH/IUI treatment with LPS vs MOH/IUI treatment with placebo) with a non‐blinded superiority design. Participants are randomly distributed across both treatment arms for the entire study‐period (six months, non‐crossover). Eligibility criteria are: 1) couples starting IUI with Mild Ovarian HyperStimulation (MOH), with the intend to receive this treatment for at least six months. 2) Indication for MOH/IUI treatment is in accordance with current (dutch) NVOG guidelines; Diagnosis of unexplained (primary or secondary) infertility with Hunault <30% (or >30%, after an expectant management period of at least 6 additional months). Total mobile sperm count (VCM) >10 million. 3) Females aged >18 years with regular menstrual cycle. (Mild) Ovarian stimulating treatment and insemination are according to regular treatment protocol. Females assigned to the treatment group start LPS, applying 3dd200mg Utrogestan in vaginal capsules, on the day of IUI. Treatment is continued until the onset of menstruation, a negative pregnancy test, miscarriage or confirmed vital intra‐uterine pregnancy at 7 weeks gestation. Main outcome is pregnancy within 6 months of treatment, leading to Live birth. Secondary outcomes are; Clinical pregnancy rate. Miscarriage rate. Multiple pregnancy rate. Pregnancy complications. Perinatal outcomes. Side effects and compliance to therapy. Added Medication Costs. Budget impact. The analyses will include a cost‐effectiveness analysis.

Brown, E., et al. (2023). "Low-Dose Elagolix for the Treatment of Heavy Menstrual Bleeding in Patients With Uterine Leiomyomas: A Randomized Controlled Trial." Obstetrics and Gynecology 142(5): 1068-1076.
	Objective: To evaluate the safety and efficacy of elagolix 150 mg once-daily monotherapy in patients with heavy menstrual bleeding associated with uterine leiomyomas.; Methods: A phase 4, randomized, double-blind, placebo-controlled, 6-month treatment study was conducted in premenopausal patients aged 18-51 years with heavy menstrual bleeding (defined as menstrual blood loss greater than 80 mL during one menstrual cycle) associated with uterine leiomyomas. Patients were randomized 2:1 to receive elagolix 150 mg once daily or placebo. The primary endpoint was reduction in menstrual blood loss volume to less than 80 mL at the final month and at least a 50% reduction in menstrual blood loss volume from baseline to the final month.; Results: Of 82 randomized patients, 54 received elagolix 150 mg and 28 received placebo. With elagolix, 49.4% (95% CI 35.1-63.8%) of patients met the primary endpoint, compared with 23.3% (95% CI 7.2-39.5%) of patients who received placebo ( P =.035). Statistically significant differences between elagolix and placebo in mean reduction of menstrual blood loss from baseline were seen as early as month 1 ( P <.05 for months 1-3 and 5). Significantly more patients receiving elagolix experienced suppression of bleeding compared with placebo ( P =.036). Greater improvements were observed in the elagolix group (vs placebo) in the proportion of patients with amenorrhea, in hemoglobin concentrations, and in health-related quality of life. No serious or severe adverse events were reported for elagolix, compared with 7.1% of participants in the placebo group having serious adverse events (coronavirus disease 2019 [COVID-19] n=1, enlarged uvula n=1). Three patients (5.6%) discontinued elagolix due to adverse events.; Conclusion: Elagolix 150 mg once-daily monotherapy significantly improved heavy menstrual bleeding associated with uterine leiomyomas compared with placebo in premenopausal patients. Treatment with elagolix 150 mg once daily was generally well-tolerated in this study, with no new safety signals.; Funding Source: AbbVie Inc.; Clinical Trial Registration: ClinicalTrials.gov , NCT03886220.; Competing Interests: Financial Disclosure Robin Kroll has received research support from AbbVie, Agile, Bayer, Merck, Myovant, ObsEva, and Sebela. Hong Li is a former employee of AbbVie Inc., and is currently employed by Takeda. Juki Ng, Brett Pinsky, James Thomas, and Michael C. Snabes are full-time employees of AbbVie Inc., and may hold AbbVie stock and/or stock options. Michael Snabes disclosed that this article discusses elagolix 150 mg once daily, which is U.S. Food and Drug Administration–approved for use in endometriosis pain. However, elagolix 150 mg QD is not FDA approved for use in heavy menstrual bleeding associated with uterine leiomyomas. The other authors did not report any potential conflicts of interest. (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Brown Jennifer Valeska, E., et al. (2021). "Antidepressant treatment for postnatal depression." The Cochrane Database of Systematic Reviews 2: CD013560.
	Background: Depression is one of the most common morbidities of the postnatal period. It has been associated with adverse outcomes for women, children, the wider family and society as a whole. Treatment is with psychosocial interventions or antidepressant medication, or both. The aim of this review is to evaluate the effectiveness of different antidepressants and to compare their effectiveness with placebo, treatment as usual or other forms of treatment. This is an update of a review last published in 2014.; Objectives: To assess the effectiveness and safety of antidepressant drugs in comparison with any other treatment (psychological, psychosocial, or pharmacological), placebo, or treatment as usual for postnatal depression.; Search Methods: We searched Cochrane Common Mental Disorders's Specialized Register, CENTRAL, MEDLINE, Embase and PsycINFO in May 2020. We also searched international trials registries and contacted experts in the field.; Selection Criteria: We included randomised controlled trials (RCTs) of women with depression during the first 12 months postpartum that compared antidepressant treatment (alone or in combination with another treatment) with any other treatment, placebo or treatment as usual.; Data Collection and Analysis: Two review authors independently extracted data from the study reports. We requested missing information from study authors wherever possible. We sought data to allow an intention-to-treat analysis. Where we identified sufficient comparable studies we pooled data and conducted random-effects meta-analyses.; Main Results: We identified 11 RCTs (1016 women), the majority of which were from English-speaking, high-income countries; two were from middle-income countries. Women were recruited from a mix of community-based, primary care, maternity and outpatient settings. Most studies used selective serotonin reuptake inhibitors (SSRIs), with treatment duration ranging from 4 to 12 weeks. Meta-analysis showed that there may be a benefit of SSRIs over placebo in response (55% versus 43%; pooled risk ratio (RR) 1.27, 95% confidence interval (CI) 0.97 to 1.66); remission (42% versus 27%; RR 1.54, 95% CI 0.99 to 2.41); and reduced depressive symptoms (standardised mean difference (SMD) -0.30, 95% CI -0.55 to -0.05; 4 studies, 251 women), at 5 to 12 weeks' follow-up. We were unable to conduct meta-analysis for adverse events due to variation in the reporting of this between studies. There was no evidence of a difference between acceptability of SSRI and placebo (27% versus 27%; RR 1.10, 95% CI 0.74 to 1.64; 4 studies; 233 women). The certainty of all the evidence for SSRIs was low or very low due to the small number of included studies and a number of potential sources of bias, including high rates of attrition. There was insufficient evidence to assess the efficacy of SSRIs compared with other classes of antidepressants and of antidepressants compared with other pharmacological interventions, complementary medicines, psychological and psychosocial interventions or treatment as usual. A substantial proportion of women experienced adverse effects but there was no evidence of differences in the number of adverse effects between treatment groups in any of the studies. Data on effects on children, including breastfed infants, parenting, and the wider family were limited, although no adverse effects were noted.; Authors' Conclusions: There remains limited evidence regarding the effectiveness and safety of antidepressants in the management of postnatal depression, particularly for those with more severe depression. We found low-certainty evidence that SSRI antidepressants may be more effective in treating postnatal depression than placebo as measured by response and remission rates. However, the low certainty of the evidence suggests that further research is very likely to have an important impact on our effect estimate. There is a continued imperative to better understand whether, and for whom, antidepressants or other treatments are more effective for postnatal depression, and whether me antidepressants are more effective or better tolerated than others. In clinical practice, the findings of this review need to be contextualised by the extensive broader literature on antidepressants in the general population and perinatal clinical guidance, to inform an individualised risk-benefit clinical decision. Future RCTs should focus on larger samples, longer follow-up, comparisons with alternative treatment modalities and inclusion of child and parenting outcomes. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Brucker, S. (2022). "Sonata Uterine Preserving TrEatment CompaRed to Myomectomy for TIme tO Recovery Randomized Controlled Trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention 1: transcervical fibroid ablation using the Sonata‐System Intervention 2: standard laparoscopic myomectomy CONDITION: D25 ‐ Leiomyoma of uterus PRIMARY OUTCOME: The primary objective of the trial is to determine if Return to Normal Activity (RTNA) following TFA is shorter than that following a myomectomy procedure. SECONDARY OUTCOME: procedure duration and details; length of stay; vitals and procedure recovery pain score during hospitalization and at discharge; pain medications through 30 days as an indicator for procedure recovery; number, maximal diameter, location, and type of fibroids treated; time (days) to return to work, resume normal bowel movements, resumption of normal urinary function, resumption of a normal diet; intraoperative, 30‐day and 1‐year serious device/procedure related adverse events (AEs); 6‐ and 12‐month symptom severity score (SSS) and health‐related quality of life outcomes (HRQL) using the Uterine Fibroid System and Quality of Life (UFS‐QoL) questionnaire; 6‐ and 12‐month overall treatment effect (OTE) and subject satisfaction (OTE Subject Satisfaction Questionnaires); pregnancy occurrence and outcome; relevant surgical reinterventions INCLUSION CRITERIA: Subjects who meet all of the following conditions may be included: ‐ Written informed consent ‐ Women who are = 18 and = 50 years old ‐ Have symptomatic uterine fibroids including heavy menstrual bleeding ‐ Are seeking a uterus‐preserving fibroid treatment ‐ For whom TFA treatment with Sonata is deemed appropriate by their treating physicians ‐ For whom fibroid treatment with laparoscopic myomectomy with OR without adjunct hysteroscopic myomectomy is appropriate ‐ Have up to 10 non‐pedunculated fibroids that are <8cm

Bruheim, K. (2022). "Plan of the Day Radiotherapy." ClinicalTrials.gov.
	No Results Available Radiation: Plan of the day|Radiation: Standard plan To investigate whether implementation of the plan of the day concept results in less gastro-intestinal toxicity. Female Not Applicable 190 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 236807 December 31, 2032

Budden, A., et al. (2020). "Identifying the Problems of Randomized Controlled Trials for the Surgical Management of Endometriosis-associated Pelvic Pain." Journal of Minimally Invasive Gynecology 27(2): 419-432.
	Objective: To report on randomized controlled trials (RCTs) that examine the surgical treatment of endometriosis-associated pelvic pain and to highlight their strengths and weaknesses.; Data Sources: We performed a systematic review of English-language, full-text articles addressing the surgical management of pain symptoms associated with endometriosis. The terms endometriosis, pain, surgery, laparoscopy, plasma, and laser were used for searches in Cochrane, MEDLINE, EMBASE, and clinical trial databases. Additional studies were identified from references in electronically located articles.; Methods of Study Selection: A literature search was conducted by 2 authors, and abstracts were independently screened for inclusion, with the resolution of any discrepancy by a third author. Randomized studies that reported pain before and after surgery were eligible for inclusion. Supporting data from nonrandomized trials were used for discussion. The Cochrane risk-of-bias assessment was performed on included studies.; Tabulation, Integration, and Results: Search results for available articles from 1996 to October 2019 revealed 594 potential studies, with 20 studies meeting the final inclusion criteria. Comparative studies of surgery vs no surgery for an effect on pain, surgical approach, the effect of different locations of disease on pain, nerve-dividing techniques for pain, and nerve-sparing effects for pain were studied. RCTs reported a substantial reduction in pain compared with no surgery in up to 80% of women; however, up to a third of women in these studies reported a placebo response. There was no evidence of a difference in pain reduction with the mode of surgery (laparoscopy, laparotomy, or robot-assisted laparoscopy). There is limited evidence stating that excision is superior to ablative surgery; however, there are confounders in the reporting of disease location and depth and the pain symptoms most affected. We need to reconsider the hypothesis that disc excision results in fewer complications and has superior outcomes to those of segmental resection in light of the first RCT on this subject. Nerve-dividing surgery for pain has been demonstrated to be of no value for uterosacral nerve ablation and/or division and of limited (if any) value for presacral neurectomy.; Conclusion: Although surgical RCTs have always been difficult to undertake, there are 16 RCTs on endometriosis-associated pain. Ethical considerations, the equipoise of surgeons and participants, and follow-up duration are important parameters in establishing RCTs. In addition, we must be willing to accept and adopt the evidence when it does demonstrate a particular outcome, such as the fact that surgical uterosacral nerve disruption does not improve pain or that disc excision does not substantially reduce complications compared with segmental resection for bowel disease, as suggested by previous nonrandomized studies. If we accept that a well-conducted RCT provides best-quality evidence, then we should at least be open to the possibility that our long-held views may be challenged and changed with new science in our practice. (Copyright © 2019 AAGL. All rights reserved.)

Bugge, C., et al. (2020). "Pessaries (mechanical devices) for managing pelvic organ prolapse in women." The Cochrane Database of Systematic Reviews 11: CD004010.
	Background: Pelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an ageing population. Women experience a variety of troublesome symptoms as a consequence of prolapse, including a feeling of 'something coming down' into the vagina, pain, urinary symptoms, bowel symptoms and sexual difficulties. Treatment for prolapse includes surgery, pelvic floor muscle training (PFMT) and vaginal pessaries. Vaginal pessaries are passive mechanical devices designed to support the vagina and hold the prolapsed organs back in the anatomically correct position. The most commonly used pessaries are made from polyvinyl-chloride, polythene, silicone or latex. Pessaries are frequently used by clinicians with high numbers of clinicians offering a pessary as first-line treatment for prolapse. This is an update of a Cochrane Review first published in 2003 and last published in 2013.; Objectives: To assess the effects of pessaries (mechanical devices) for managing pelvic organ prolapse in women; and summarise the principal findings of relevant economic evaluations of this intervention.; Search Methods: We searched the Cochrane Incontinence Specialised Register which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 January 2020). We searched the reference lists of relevant articles and contacted the authors of included studies.; Selection Criteria: We included randomised and quasi-randomised controlled trials which included a pessary for pelvic organ prolapse in at least one arm of the study.; Data Collection and Analysis: Two review authors independently assessed abstracts, extracted data, assessed risk of bias and carried out GRADE assessments with arbitration from a third review author if necessary.; Main Results: We included four studies involving a total of 478 women with various stages of prolapse, all of which took place in high-income countries. In one trial, only six of the 113 recruited women consented to random assignment to an intervention and no data are available for those six women. We could not perform any meta-analysis because each of the trials addressed a different comparison. None of the trials reported data about perceived resolution of prolapse symptoms or about psychological outcome measures. All studies reported data about perceived improvement of prolapse symptoms. Generally, the trials were at high risk of performance bias, due to lack of blinding, and low risk of selection bias. We downgraded the certainty of evidence for imprecision resulting from the low numbers of women participating in the trials. Pessary versus no treatment: at 12 months' follow-up, we are uncertain about the effect of pessaries compared with no treatment on perceived improvement of prolapse symptoms (mean difference (MD) in questionnaire scores -0.03, 95% confidence interval (CI) -0.61 to 0.55; 27 women; 1 study; very low-certainty evidence), and cure or improvement of sexual problems (MD -0.29, 95% CI -1.67 to 1.09; 27 women; 1 study; very low-certainty evidence). In this comparison we did not find any evidence relating to prolapse-specific quality of life or to the number of women experiencing adverse events (abnormal vaginal bleeding or de novo voiding difficulty). Pessary versus pelvic floor muscle training (PFMT): at 12 months' follow-up, we are uncertain if there is a difference between pessaries and PFMT in terms of women's perceived improvement in prolapse symptoms (MD -9.60, 95% CI -22.53 to 3.33; 137 women; low-certainty evidence), prolapse-specific quality of life (MD -3.30, 95% CI -8.70 to 15.30; 1 study; 116 women; low-certainty evidence), or cure or improvement of sexual problems (MD -2.30, 95% -5.20 to 0.60; 1 study; 48 women; low-certainty evidence). Pessaries may result in a large increase in risk of adverse events om ared with PFMT (RR 75.25, 95% CI 4.70 to 1205.45; 1 study; 97 women; low-certainty evidence). Adverse events included increased vaginal discharge, and/or increased urinary incontinence and/or erosion or irritation of the vaginal walls. Pessary plus PFMT versus PFMT alone: at 12 months' follow-up, pessary plus PFMT probably leads to more women perceiving improvement in their prolapse symptoms compared with PFMT alone (RR 2.15, 95% CI 1.58 to 2.94; 1 study; 260 women; moderate-certainty evidence). At 12 months' follow-up, pessary plus PFMT probably improves women's prolapse-specific quality of life compared with PFMT alone (median (interquartile range (IQR)) POPIQ score: pessary plus PFMT 0.3 (0 to 22.2); 132 women; PFMT only 8.9 (0 to 64.9); 128 women; P = 0.02; moderate-certainty evidence). Pessary plus PFMT may slightly increase the risk of abnormal vaginal bleeding compared with PFMT alone (RR 2.18, 95% CI 0.69 to 6.91; 1 study; 260 women; low-certainty evidence). The evidence is uncertain if pessary plus PFMT has any effect on the risk of de novo voiding difficulty compared with PFMT alone (RR 1.32, 95% CI 0.54 to 3.19; 1 study; 189 women; low-certainty evidence).; Authors' Conclusions: We are uncertain if pessaries improve pelvic organ prolapse symptoms for women compared with no treatment or PFMT but pessaries in addition to PFMT probably improve women's pelvic organ prolapse symptoms and prolapse-specific quality of life. However, there may be an increased risk of adverse events with pessaries compared to PFMT. Future trials should recruit adequate numbers of women and measure clinically important outcomes such as prolapse specific quality of life and resolution of prolapse symptoms. The review found two relevant economic evaluations. Of these, one assessed the cost-effectiveness of pessary treatment, expectant management and surgical procedures, and the other compared pessary treatment to PFMT. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Buhrman, M., et al. (2024). "Guided internet-based acceptance and commitment therapy for provoked vestibulodynia: A randomized controlled trial." European Journal of Pain.
	BACKGROUND: Provoked vestibulodynia (PVD) causes suffering in many women's lives due to its impact on relationships, sexual functioning and functioning in other key domains. OBJECTIVE(S): Here, we report a randomized controlled trial conducted to examine whether Acceptance and Commitment Therapy (ACT) with a focus on values-based exposure, delivered online, benefits women with PVD. METHOD(S): Participants (n=88) were randomized to either guided online ACT for 10weeks or a wait-list control group. Outcomes were assessed at baseline, post treatment and 1year later. Analyses were based on intention to treat using linear mixed models. RESULT(S): There were significant group differences on the primary outcomes, Female Sexual Index and Female Sexual Distress Scale, in favour of online ACT with moderate effect sizes. Differences were also found on several secondary outcomes and therapeutic process measures, all in favour of ACT. No differences were found at post-treatment for depression or anxiety. At the 1-year follow-up, results were maintained and a difference between baseline and follow-up was also found for depression. CONCLUSION/SIGNIFICANCE: In summary, a relatively brief, guided, online version of ACT appears to produce benefits for women with PVD and related impacts on daily functioning. 50% to 60% of the women who participated in the treatment reliably improved in sexual functioning and distress.Copyright © 2024 The Authors. European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation - EFIC .

Bui Bich, N., et al. (2022). "Endometrial injury for pregnancy following sexual intercourse or intrauterine insemination." The Cochrane Database of Systematic Reviews 10: CD011424.
	Background: Intentional endometrial injury is being proposed as a technique to improve the probability of pregnancy in women undergoing assisted reproductive technologies (ART) such as in vitro fertilisation (IVF). Endometrial injury is often performed by pipelle biopsy and is a common gynaecological procedure with established safety. However, it causes a moderate degree of discomfort/pain and requires an additional pelvic examination. The effectiveness of this procedure outside of ART, in women or couples attempting to conceive via sexual intercourse or with intrauterine insemination (IUI), remains unclear.; Objectives: To assess the effectiveness and safety of intentional endometrial injury performed in infertile women or couples attempting to conceive through sexual intercourse or intrauterine insemination (IUI).; Search Methods: The Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS, ISI Web of Knowledge, and clinical trial registries were searched from inception to 21 May 2020, as were conference abstracts and reference lists of relevant reviews and included studies.; Selection Criteria: We included randomised controlled trials (RCTs) that evaluated any kind of intentional endometrial injury in women planning to undergo IUI or attempting to conceive spontaneously (with or without ovarian stimulation (OS)) compared to no intervention, a mock intervention, or intentional endometrial injury performed at a different time.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. Primary outcomes were live birth/ongoing pregnancy and pain experienced during the procedure. Due to high risk of bias associated with many of the studies, primary analyses of all review outcomes were restricted to studies at low risk of bias. Sensitivity analysis including all studies was then performed.; Main Results: We included 22 RCTs (3703 women). Most of these studies included women with unexplained infertility. Intentional endometrial injury versus either no intervention or a sham procedure The primary analysis was restricted to studies at low risk of bias, which left only one study included. We are uncertain whether endometrial injury has an effect on the probability of live birth, as only one study is included in the analysis and the confidence interval is wide (risk ratio (RR) 1.11, 95% confidence interval (CI) 0.78 to 1.59; 1 RCT, 210 participants). Evidence suggests that if the chance of live birth with no intervention/a sham procedure is assumed to be 34%, then the chance with endometrial injury would be 27% to 55%. When all studies were included in the sensitivity analysis, we were uncertain whether endometrial injury improves live birth/ongoing pregnancy, as the evidence was of very low quality (RR 1.71, 95% CI 1.32 to 2.21; 8 RCTs, 1522 participants; I² = 16%). Evidence suggests that if the chance of live birth/ongoing pregnancy with no intervention/a sham procedure is assumed to be 13%, then the chance with endometrial injury would be 17% to 28%. A narrative synthesis conducted for the other primary outcome of pain during the procedure included studies measuring pain on a zero-to-ten visual analogue scale (VAS) or grading pain as mild/moderate/severe, and showed that most often mild to moderate pain was reported (6 RCTs, 911 participants; very low-quality evidence). Timing of intentional endometrial injury Four trials compared endometrial injury performed in the cycle before IUI to that performed in the same cycle as IUI. None of these studies reported the primary outcomes of live birth/ongoing pregnancy and pain during the procedure. One study compared endometrial injury in the early follicular phase (EFP; Day 2 to 4) to endometrial injury in the late follicular phase (LFP; Day 7 to 9), both in the same cycle as IUI. The primary outcome live birth/ongoing pregnancy was not reported, but the study did report the other primary outcome of pain during the procedure assessed by a zero-to-ten VAS. The average pain score w s 3.67 (standard deviation (SD) 0.7) when endometrial injury was performed in the EFP and 3.84 (SD 0.96) when endometrial injury was performed in the LFP. The mean difference was -0.17, suggesting that on average, women undergoing endometrial injury in the EFP scored 0.17 points lower on the VAS as compared to women undergoing endometrial injury in the LFP (95% CI -0.48 to 0.14; 1 RCT, 110 participants; very low-quality evidence).; Authors' Conclusions: Evidence is insufficient to show whether there is a difference in live birth/ongoing pregnancy between endometrial injury and no intervention/a sham procedure in women undergoing IUI or attempting to conceive via sexual intercourse. The pooled results should be interpreted with caution, as the evidence was of low to very low quality due to high risk of bias present in most included studies and an overall low level of precision. Furthermore, studies investigating the effect of timing of endometrial injury did not report the outcome live birth/ongoing pregnancy; therefore no conclusions could be drawn for this outcome. Further well-conducted RCTs that recruit large numbers of participants and minimise bias are required to confirm or refute these findings. Current evidence is insufficient to support routine use of endometrial injury in women undergoing IUI or attempting to conceive via sexual intercourse. (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Burgell, R. (2021). "Evaluating the effect of dietary strategies on gastrointestinal symptoms associated with endometriosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Participants will be provided with a low Fermentable Oligosaccharide Disaccharide, Monosaccharide and Polyols (FODMAP) diet for a month, and a high FODMAP, or typical Australian diet for a month. They will be randomized to receive which diet first. Participants won't be told that it involves FODMAPs as many will not be naive. By naïve we mean those not familiar with this diet as it is very popular in people with gut symptoms. Both diets are very similar in composition. The control diet is a typical Australian diet. The intervention is the low FODMAP diet. The low FODMAP diet will be similar in design to the typical Australian diet, both being cooked by professional chefs experienced in this area. Examples of meals provided to look like a typical Australian diet in both diets are lasgna, spaghetti Bolognese, where the pasta is either gluten free making it low FODMAP, or normal, which is high FODMAP. there will be no onion or garlic in the low FODMAP diet. Another is a chicken cacciatore, where in one diet there will be no onion, and in the other, onion. Weetbix and bread will be supplied, which is again attainable as being either low or high FODMAP. Drink examples are apple juice,(high FODMAP) vs black currant (low FODMAP). recommended fruit snacks will be either apple, pear, stone fruit (high FODMAP) or berries, bananas, oranges (low) The low FODMAP diet avoids the use of certain fermentable fibres such as onion, garlic, high fructose containing fruits such as apples, pears, and other high fructans containing food. Lactose free milk will be provided, but participants will not know which is which. Their involvement is for 3 months with a 1 week baseline food diary and symptom collection before commencing the first diet. Then follows a month off where CONDITION: endometriosis with gut symptoms; ; endometriosis with gut symptoms Reproductive Health and Childbirth ‐ Menstruation and menopause PRIMARY OUTCOME: Composite measure: a decrease of >20 mm of VAS score compared to baseline score, and/or VAS of <30mm at conclusion of interventions as compared to baseline VAS score pre commencing diet.; ; [conclusion of both diets] SECONDARY OUTCOME: We are looking to see if there is a change in microbiota from stool and vaginal swab collected at the end of both dietary periods as compared with the run in period pre study. ; This is an exploratory outcome.[at the end the one week run in and at the end of each diet] A change in gastrointestinal symptoms which include abdominal bloating, abdominal pain, wind, satisfaction with stool consistency, tiredness and lethargy, nausea, and stool type as per the Bristol stool scale. ; ; This will be via a composite group of validated questionnaires, such as the gastrointestinal quality of life (GIQLI), endometriosis health profile questionnaire (EHP), and the NIH, PROMIS GI symptoms scale[At the end of both diets] A change in Quality of life and psychological status. This is part of a composite questionnaire as described above ; The GIQLI questionnaire is used to capture this[At the end of the 2 diets] INCLUSION CRITERIA: Women with diagnosed endometriosis experiencing gastrointestinal symptoms with a mean VAS symptom score >30mm at baseline

Burger, R. (2022). "Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)." ClinicalTrials.gov.
	This is a multi‐center randomized study of XMT‐1536 (upifitamab rilsodotin) in patients with tumors expressing high levels of NaPi2b, focusing on patients with recurrent, platinum‐sensitive high‐grade serous ovarian cancer (HGSOC) including fallopian tube and primary peritoneal cancer. The randomized study design is a double‐blind, placebo‐controlled study, with a randomization ratio of 2:1. All adverse events will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria version (CTCAE v5.0). Participants must have had 4 to 8 cycles of platinum‐based chemotherapy in their most recent treatment regimen, including carboplatin or cisplatin ± paclitaxel, docetaxel, pegylated liposomal doxorubicin or gemcitabine in the 2nd‐4th line setting for the treatment of platinum‐sensitive recurrent disease, with no evidence of disease (NED)/complete response (CR)/partial response (PR)/ or stable disease (SD) as best response.

Burt, L. (2023). "Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies." ClinicalTrials.gov.
	The goal of this open label, randomized, controlled clinical trial is to assess the benefits of providing Reiki therapy to subjects receiving their first brachytherapy treatment for gynecological malignancies. Participants will either receive a session of Reiki therapy or usual care during the standard wait time between the placement of the brachytherapy device and brachytherapy treatment. Questionnaires will be administered at various time points on the day of the participant's first brachytherapy treatment as well as at the three month follow‐up time point. Researchers will compare the intervention (Reiki therapy) and control (usual care) groups to assess the impact of the Reiki therapy on anxiety, pain, state anxiety, depression, and physiological measurements.

Burton, J. (2022). "Effect of PreforPro® on Urinary and Vaginal Health." ClinicalTrials.gov.
	This is a double‐blinded, placebo controlled study. Each study participant will be in the study for 90 days. During the first 28 days the participants will not take study product, and will collect samples for the study in order to act as their own controls. On day 29, participants will be randomized to intervention with either PreforPro® or placebo, which they will take once daily for the remaining 62 days. There will be a total of 5 study visits during which samples will be collected, a Quality of Life questionnaire will be completed at baseline and end of study visit. Samples for the study are: vaginal swab, faecal sample, urine sample.

Busnelli, A., et al. (2021). "Efficacy of therapies and interventions for repeated embryo implantation failure: a systematic review and meta-analysis." Scientific Reports 11(1): 1747.
	The aim of the present systematic review and meta-analysis was to assess the effect of the different therapeutic options for repeated embryo implantation failure (RIF) on a subsequent IVF cycle outcome. Twenty-two RCTs and nineteen observational studies were included. Pooling of results showed a beneficial effect of intrauterine PBMC infusion on both CPR (RR 2.18; 95% CI 1.58-3.00; p < 0.00001; OR 2.03; 95% CI 1.22-3.36; p = 0.006) and LBR (RR 2.41; 95% CI 1.40-4.16; p = 0.002; OR 3.73; 95% CI 1.13-12.29; p = 0.03), of subcutaneous G-CSF administration on CPR (RR 2.29; 95% CI 1.58-3.31; p < 0.0001) and of intrauterine PRP infusion on CPR (RR 2.45; 95% CI 1.55-3.86; p = 0.0001). Observational studies also demonstrated a positive effect of IVIG and intrauterine hCG infusion on both CPR and LBR and of atosiban on CPR. Studies investigating intrauterine G-CSF infusion, LMWH, intravenous intralipid, hysteroscopy, blastocyst-stage ET, ZIFT, PGT-A and AH failed to observe an impact on IVF outcome. The quality of the evidence that emerged from RCTs focused on intrauterine PBMC infusion and subcutaneous G-CSF administration was moderate. For all other therapies/interventions it varied from low to very low. In conclusion, intrauterine PBMC infusion and subcutaneous G-CSF administration are the most promising therapeutic options for RIF. However, further well conducted RCTs are necessary before their introduction into clinical practice.

Buyuk, A. (2023). "Telerehabilitation in Chronic Pelvic Pain." ClinicalTrials.gov.
	No Results Available Other: Telerehabilitation Treatment Pelvic Pain Impact Questionnaire|VAS|The Female Sexual Function Index|The Female Sexual Distress Scale-Revised|Vaginal Penetration Cognition Questionnaire|The Patient Global Impression of Change Female Not Applicable 43 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment Akdeniz May 10, 2023

Cacciari, L. P., et al. (2022). "Group-based pelvic floor muscle training is a more cost-effective approach to treat urinary incontinence in older women: economic analysis of a randomised trial." Journal of Physiotherapy 68(3): 191-196.
	QUESTION(S): How cost-effective is group-based pelvic floor muscle training (PFMT) for treating urinary incontinence in older women? DESIGN: Economic evaluation conducted alongside an assessor-blinded, multicentre randomised non-inferiority trial with 1-year follow-up. PARTICIPANTS: A total of 362 women aged >= 60 years with stress or mixed urinary incontinence. INTERVENTION: Twelve weekly 1-hour PFMT sessions delivered individually (one physiotherapist per woman) or in groups (one physiotherapist per eight women). OUTCOME MEASURES: Urinary incontinence-related costs per woman were estimated from a participant and provider perspective over 1 year in Canadian dollars, 2019. Effectiveness was based on reduction in leakage episodes and quality-adjusted life years. Incremental cost-effectiveness ratios and net monetary benefit were calculated for each of the effectiveness outcomes and perspectives. RESULT(S): Both group-based and individual PFMT were effective in reducing leakage and promoting gains in quality-adjusted life years. Furthermore, group-based PFMT was >= 60% less costly than individual treatment, regardless of the perspective studied: -$914 (95% CI -970 to -863) from the participant's perspective and -$509 (95% CI -523 to -496) from the provider's perspective. Differences in effects between study arms were minor and negligible. Adherence to treatment was high, with low loss to follow-up and no between-group differences. CONCLUSION(S): Compared with standard individual PFMT, group-based PFMT was less costly and as clinically effective and widely accepted. These results indicate that patients and healthcare decision-makers should consider group-based PFMT to be a cost-effective first-line treatment option for urinary incontinence. TRIAL REGISTRATION: ClinicalTrials.govNCT02039830.Copyright © 2022 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Cadena, M. (2024). "Vaginal Orthosis Use After Vaginal Reconstructive Surgery." ClinicalTrials.gov.
	No Results Available Device: Vaginal Orthosis (COSM Medical) Objective recurrent anterior prolapse|Subjective recurrent prolapse|Objective recurrent prolapse|Device use complications Female Not Applicable 30 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment IRB-300010943 September 2025

Caio Dabbous, d., et al. (2023). "PD-1/PD-L1 inhibitors plus chemotherapy improves outcomes as first-line treatment for patients with advanced or recurrent endometrial cancer: a systematic review and meta-analysis of randomized clinical trials." PROSPERO International prospective register of systematic reviews.
	
Çakmak, Y. (2021). "Investigation of the Effect of Online Yoga Based Exercise Program on Women With Primary Dysmenorrhea." ClinicalTrials.gov.
	This study will be conducted online between March 2021 and May 2021 in their own settings for women with regular menstrual cycles to investigate the impact of online yoga‐based exercise programs on women with primary dysmenorrhea. All participants will be given detailed information about the study and a written informed consent form will be signed that they agree to work voluntarily. The GPower program was used to determine the number of people to be included in the study and control groups. When the results of two studies similar to our study were evaluated in the literature review, it was seen that the Effect size d value for the VAS score was distributed between 0.17 and 2.06 and clustered around 1. When the effect size was d = 1, α = 0.05, Power (1‐β) = 0.90 (90%) was taken in the GPower package program, and the minimum sample size was determined to be 50, 25 in the study and control groups. They will be randomly divided into two groups of 25 people each, according to the order of application. While an online yoga‐based exercise program and an informative training program was applied to the experimental group from two randomly separated groups, only an informative training program will be given to the control group.

Can Ahu, A. (2023). "The Effect of Laughter Yoga on Vasomotor Symptoms and Sleep Quality." ClinicalTrials.gov.
	No Results Available Other: Laughter yoga Visual Analog Scala (VAS)|Sleep quality Female Not Applicable 36 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Supportive Care 246 August 31, 2023

Can, L., et al. (2022). "Efficacy and Safety of CO2-laser Treatments of Genitourinary Syndrome of Menopause(GSM): A Systematic Review and Meta-analysis of Randomized Clinical Trials." PROSPERO International prospective register of systematic reviews.
	
Can, L., et al. (2022). "Is EMG Biofeedback Effective for the Treatment of Vulvar Vestibulitis sydrome? A Systematic Review." PROSPERO International prospective register of systematic reviews.
	
Can, L., et al. (2021). "Effectiveness and Safety of Carbon Dioxide Laser Treatment for Urinary Incontinence in Women：A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Cancer Trials, I. (2023). "A clinical trial testing the hormonal drug letrozole alone or in addition to the usual chemotherapy treatment (paclitaxel and carboplatin) in low-grade serous ovarian or peritoneal cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: Femara® Product Name: Letrozole Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Letrozole CAS Number: 112809‐51‐5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5‐ Product Name: Paclitaxel Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Paclitaxel CAS Number: 33069‐62‐4 Other descriptive name: Paclitaxel Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: Per site policy. ‐ Product Name: Carboplatin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Carboplatin Other descriptive name: Carboplatin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: Per site policy. ‐ Product Name: Anastrozole Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Anastrozole Other descriptive name: Anastrozole Concentration unit: mg milligram(s) Concentration type: range Concentration number: Per site policy. ‐ Product Name: Exemestane Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Exemestane Other descriptive name: Exemestane Concentration unit: mg milligram(s) Concentration type: range Concentration number: Per site policy. ‐ Product Name: Cisplatin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Cisplatin Other descriptive name: Cisplatin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: Per site policy. ‐ Product Name: Docetaxel Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Docetaxel Other descriptive name: Docetaxel Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: Per site policy. ‐ CONDITION: Primary low‐grade serous carcinoma of the ovary or peritoneum. ; MedDRA version: 20.0 Level: LLT Classification code 10007107 Term: Cancer of ovary System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 21.0 Level: LLT Classification code 10026340 Term: Malignant neoplasm of peritoneum, unspecified 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): • Toxicity ; ; • Objective Tumour Response ; ; • Overall Survival ; ; • Adherence to Letrozole Maintenance Therapy ; Timepoint(s) of evaluation of this end point: The study includes two interim analyses. At 20% information time, a futility analysis will be conducted. At 40% information time, both efficacy and futility will be assessed.; ; Full analysis will be performed after the date on which the last participant was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events. PRIMARY OUTCOME: Main Objective: 1. To examine if letrozole monotherapy/maintenance (L/L) is non‐inferior to IV paclitaxel/carboplatin and maintenance letrozole (CT/L) with respect to PFS in women with stage II‐IV primary low‐grade serous carcinoma of the ovary or peritoneum after primary surgical cytoreduction. Primary end point(s): The primary efficacy endpoint is Progression Free Survival (PFS). PFS is defined as the time (in months) from the randomized treatment assignment to documentation of disease progression (RECIST 1.1) or death from any cause, whichever comes first. Secondary Objective: 1. To compare the nature, frequency and maximum degree of toxicity as assessed by CTCAE v5.0 for each treatment arm.; ; 2. To compare the relative frequency of objective tumour response in those with measurable disease after cytoreductive surgery for each treatment arm.; ; 3. To compare overall survival for each treatment arm.; ; 4. To compare the CT\L and L\L arms with respect to patients adherence to letrozole therapy as measured by pill counts. Timepoint(s) of evaluation of this end po t: The study includes two interim analyses. At 20% information time, a futility analysis will be conducted. At 40% information time, both efficacy and futility will be assessed. The PFS comparison will be assessed at the second interim and final analyses using a logrank test stratified by country and residual disease status.; ; Full analysis will be performed after the date on which the last participant was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events. INCLUSION CRITERIA: A patient cannot be considered eligible for this study unless ALL of the following conditions are met. 1. Patients must have newly diagnosed, Stage II‐IV low‐grade serous ovarian cancer (submission of pathology report(s) required). Ovarian cancer = ovarian, fallopian tube and primary peritoneal cancers. NOTE: Patients with a prior history of serous borderline tumors but a new diagnosis of Stage II‐IV low‐grade serous ovarian cancer are eligible. • p53 immunohistochemistry (IHC) is required and must show nonaberrant pattern (nonaberrant p53 expression is consistent with normal/wildtype TP53). If aberrant p53 expression is found on p53 IHC, the patient is NOT eligible (e.g., aberrant p53 expression is consistent with mutant TP53 and supports a diagnosis of high grade serous ovarian cancer). 2. Appropriate stage for study entry based on the following diagnostic workup: o History/physical examination within 14 days prior to registration; <

Cantineau Astrid, E., et al. (2021). "Agents for ovarian stimulation for intrauterine insemination (IUI) in ovulatory women with infertility." The Cochrane Database of Systematic Reviews 11: CD005356.
	Background: Intrauterine insemination (IUI), combined with ovarian stimulation (OS), has been demonstrated to be an effective treatment for infertile couples. Several agents for ovarian stimulation, combined with IUI, have been proposed, but it is still not clear which agents for stimulation are the most effective. This is an update of the review, first published in 2007.; Objectives: To assess the effects of agents for ovarian stimulation for intrauterine insemination in infertile ovulatory women.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and two trial registers from their inception to November 2020. We performed reference checking and contacted study authors and experts in the field to identify additional studies.; Selection Criteria: We included truly randomised controlled trials (RCTs) that compared different agents for ovarian stimulation combined with IUI for infertile ovulatory women concerning couples with unexplained infertility. mild male factor infertility and minimal to mild endometriosis.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane.; Main Results: In this updated review, we have included a total of 82 studies, involving 12,614 women. Due to the multitude of comparisons between different agents for ovarian stimulation, we highlight the seven most often reported here. Gonadotropins versus anti-oestrogens (13 studies) For live birth, the results of five studies were pooled and showed a probable improvement in the cumulative live birth rate for gonadotropins compared to anti-oestrogens (odds ratio (OR) 1.37, 95% confidence interval (CI) 1.05 to 1.79; I 2 = 30%; 5 studies, 1924 participants; moderate-certainty evidence). This suggests that if the chance of live birth following anti-oestrogens is assumed to be 22.8%, the chance following gonadotropins would be between 23.7% and 34.6%. The pooled effect of seven studies revealed that we are uncertain whether gonadotropins lead to a higher multiple pregnancy rate compared with anti-oestrogens (OR 1.58, 95% CI 0.60 to 4.17; I 2 = 58%; 7 studies, 2139 participants; low-certainty evidence). Aromatase inhibitors versus anti-oestrogens (8 studies) One study reported live birth rates for this comparison. We are uncertain whether aromatase inhibitors improve live birth rate compared with anti-oestrogens (OR 0.75, CI 95% 0.51 to 1.11; 1 study, 599 participants; low-certainty evidence). This suggests that if the chance of live birth following anti-oestrogens is 23.4%, the chance following aromatase inhibitors would be between 13.5% and 25.3%. The results of pooling four studies revealed that we are uncertain whether aromatase inhibitors compared with anti-oestrogens lead to a higher multiple pregnancy rate (OR 1.28, CI 95% 0.61 to 2.68; I 2 = 0%; 4 studies, 1000 participants; low-certainty evidence). Gonadotropins with GnRH (gonadotropin-releasing hormone) agonist versus gonadotropins alone (4 studies) No data were available for live birth. The pooled effect of two studies revealed that we are uncertain whether gonadotropins with GnRH agonist lead to a higher multiple pregnancy rate compared to gonadotropins alone (OR 2.53, 95% CI 0.82 to 7.86; I 2 = 0; 2 studies, 264 participants; very low-certainty evidence). Gonadotropins with GnRH antagonist versus gonadotropins alone (14 studies) Three studies reported live birth rate per couple, and we are uncertain whether gonadotropins with GnRH antagonist improve live birth rate compared to gonadotropins (OR 1.5, 95% CI 0.52 to 4.39; I 2 = 81%; 3 studies, 419 participants; very low-certainty evidence). This suggests that if the chance of a live birth following gonadotropins alone is 25.7%, the chance following gonadotropins combined with GnRH antagonist would be between 15.2% and 60.3%. We are also uncertain whether gonadotropins combined with GnRH antagonist lead to a higher multiple pregnancy rate compared with gonadotropins alone (OR 1.30, 95% CI 0.74 to 2.28; I 2 = 0%; 10 studi s, 2095 participants; moderate-certainty evidence). Gonadotropins with anti-oestrogens versus gonadotropins alone (2 studies) Neither of the studies reported data for live birth rate. We are uncertain whether gonadotropins combined with anti-oestrogens lead to a higher multiple pregnancy rate compared with gonadotropins alone, based on one study (OR 3.03, 95% CI 0.12 to 75.1; 1 study, 230 participants; low-certainty evidence). Aromatase inhibitors versus gonadotropins (6 studies) Two studies revealed that aromatase inhibitors may decrease live birth rate compared with gonadotropins (OR 0.49, 95% CI 0.34 to 0.71; I 2 =0%; 2 studies, 651 participants; low-certainty evidence). This suggests that if the chance of a live birth following gonadotropins alone is 31.9%, the chance of live birth following aromatase inhibitors would be between 13.7% and 25%. We are uncertain whether aromatase inhibitors compared with gonadotropins lead to a higher multiple pregnancy rate (OR 0.69, 95% CI 0.06 to 8.17; I 2 =77%; 3 studies, 731 participants; very low-certainty evidence). Aromatase inhibitors with gonadotropins versus anti-oestrogens with gonadotropins (8 studies) We are uncertain whether aromatase inhibitors combined with gonadotropins improve live birth rate compared with anti-oestrogens plus gonadotropins (OR 0.99, 95% CI 0.3 8 to 2.54; I 2 = 69%; 3 studies, 708 participants; very low-certainty evidence). This suggests that if the chance of a live birth following anti-oestrogens plus gonadotropins is 13.8%, the chance following aromatase inhibitors plus gonadotropins would be between 5.7% and 28.9%. We are uncertain of the effect of aromatase inhibitors combined with gonadotropins compared to anti-oestrogens combined with gonadotropins on multiple pregnancy rate (OR 1.31, 95% CI 0.39 to 4.37; I 2 = 0%; 5 studies, 901 participants; low-certainty evidence).; Authors' Conclusions: Based on the available results, gonadotropins probably improve cumulative live birth rate compared with anti-oestrogens (moderate-certainty evidence). Gonadotropins may also improve cumulative live birth rate when compared with aromatase inhibitors (low-certainty evidence). From the available data, there is no convincing evidence that aromatase inhibitors lead to higher live birth rates compared to anti-oestrogens. None of the agents compared lead to significantly higher multiple pregnancy rates. Based on low-certainty evidence, there does not seem to be a role for different combined therapies, nor for adding GnRH agonists or GnRH antagonists in IUI programs. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Cao, C. and H. Li (2022). "Meta-analysis of therapeutic effect of ear point pressing beans on primary dysmenorrhea." PROSPERO International prospective register of systematic reviews.
	
Cao, F., et al. (2022). "The effect of acupuncture on postpartum stress urinary incontinence: A protocol for systemic review and meta-analysis." Medicine 101(29): E29177.
	Background: Postpartum stress urinary incontinence (PSUI) is a widespread complaint in postpartum women, which significantly affects their quality of life. Acupuncture has been widely used as an alternative complementary therapy for the treatment of PSUI. This protocol is carried out to comprehensively explore the effectiveness and safety of acupuncture for treating PSUI. Method(s): Randomized clinical trials related to acupuncture treatment of PSUI will be searched in Chinese and English literature databases: PubMed, Web of Science, EMBASE, Cochrane Central Register of Controlled Trials, Chinese National Knowledge Infrastructure, Chinese Biomedical Literature Database, Wanfang Database, and the Technology Periodical Database. Changes in pelvic floor muscle strength compared with baseline will be accepted as the primary outcomes, and secondary outcomes will be the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score, the urodynamic indexes, the incontinence quality of life questionnaire, and adverse effects of acupuncture. All publications will be screened and extracted by 2 reviewers independently. Quality of the eligible publications will be assessed according to the Cochrane Risk of Bias tool and statistical analyses will be conducted by using the Review Manager V.5.3. Result(s): This study will provide a high-quality comprehensive evaluation for the clinical efficacy and safety of acupuncture for PSUI. Conclusion(s): This systematic review will provide comprehensive evidence of acupuncture treatment on specific outcomes for PSUI. Ethics and Dissemination: Because of the study will not collect personal information, ethical approval will not be required. The results will be published in a peer-reviewed journal. Trial registration: INPLASY 202220045.Copyright © 2022 Lippincott Williams and Wilkins. All rights reserved.

Cao, M., et al. (2023). "Effectiveness of auricular acupoint therapy targeting menstrual pain for primary dysmenorrhea: A systematic review and meta-analysis of randomized controlled trials." Worldviews on Evidence-based Nursing 20(6): 621-633.
	Background: Primary dysmenorrhea (PD) is a global public health concern affecting women's health and quality of life, leading to productivity loss and increased medical expenses. As a non-pharmacological intervention, auricular acupoint therapy (AAT) has been increasingly applied to treat PD, but the overall effectiveness remains unclear.; Aims: The aim of this review was to synthesize the effects of AAT targeting menstrual pain among females with PD.; Methods: Eight databases (PubMed, EMBASE, AMED, CINAHL Plus, Cochrane Library, Web of Science, China National Knowledge Infrastructure and Wanfang Data) and three registries (ClinicalTrials.gov, ISRCTN Registry and the Chinese Clinical Trial Registry) were searched to identify existing randomized controlled trials (RCTs) from inception to 21 August 2022. Two reviewers independently screened, extracted the data, and appraised the methodological quality and the evidence strength using the Cochrane risk-of-bias tool for randomized trials (RoB 2) and the GRADE approach.; Results: A total of 793 participants from 11 RCTs were included. Despite substantial heterogeneity, AAT was more effective in reducing menstrual pain and related symptoms than placebo and nonsteroidal anti-inflammatory medications (NSAIDs). No significant subgroup differences were found between study locations as well as invasiveness, duration, type, acupoints number, ear selection and provider of AAT. Only minor adverse effects of AAT were reported.; Linking Evidence to Action: AAT can help women with PD, particularly those who are refrained from pharmaceuticals. Primary healthcare professionals, including nurses, can be well-equipped to provide evidence-based and effective AAT for people with PD. AAT can be used in a broader global clinical community. To provide an optimal effect and have wider usability, a unified practice standard is required, which would necessitate further adaptation of clinical care of people with PD. AAT effectively decreased menstrual pain and other accompanying symptoms of PD. More research is needed to identify effective AAT features and explore optimal therapy regimes for PD. (© 2023 Sigma Theta Tau International.)

Cao, Q., et al. (2021). "Gestational metformin administration in women with polycystic ovary syndrome: A systematic review and meta-analysis of randomized control studies." The Journal of Obstetrics and Gynaecology Research 47(12): 4148-4157.
	Aims: To evaluate metformin's effects on pregnancy outcomes in women with polycystic ovary syndrome.; Methods: A literature search was conducted using PubMed, EMBASE, Web of Science, MEDLINE, and the Cochrane Library. All randomized controlled trials comparing metformin administration during pregnancy versus placebo or blank in PCOS women were selected. The primary outcomes were the incidence of gestational diabetes mellitus (GDM), preterm delivery, and miscarriage. We combined data with the Review Manager. Bayesian meta-analysis was employed for further verification with the R software.; Results: Six randomized control trial studies involving 1229 participants were included. Metformin use was associated with reduced risk of preterm delivery (Risk ratios [RR], 0.45; 95% CI, 0.25-0.80; p, 0.007) and higher larger neonatal head circumference (Mean difference (MD), 0.47; 95% CI, 0.20-0.74; p, 0.0006] but had no effect on the incidence of GDM (RR 1.87; 95% CI, 0.58-1.87; p, 0.89), miscarriage (RR, 0.85; 95% CI, 0.45-1.60; p, 0.62), pre-eclampsia (RR, 1.18; 95% CI, 0.43-3.21; p, 0.75), neonatal length (MD, 0.33; 95% CI, -0.12-0.78; p, 0.15) and birthweight (MD, 73.78; 95% CI, -52.98-200.53; p, 0.17).; Conclusions: Metformin administration in PCOS pregnancies was associated with reduced preterm delivery risk and larger neonatal head circumference. (© 2021 Japan Society of Obstetrics and Gynecology.)

Cao, X., et al. (2020). "The effectiveness of different down-regulating protocols on in vitro fertilization-embryo transfer in endometriosis: a meta-analysis." Reproductive Biology and Endocrinology 18(1): 16.
	Background: To investigate the effectiveness of the GnRH-a ultra-long protocol, GnRH-a long protocol, and GnRH-a short protocol used in in vitro fertilization-embryo transfer (IVF-ET) in infertile women with endometriosis.; Methods: We searched PubMed, Embase, Web of Science, Cochrane Library, Elsevier Science Direct, OA Library, Google Scholar, China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform, China Science and Technology Journal database, and the China Biology Medicine disc for randomized controlled trials (RCTs) and observational studies (non-RCTs) to evaluate the efficacy of the GnRH-a ultra-long protocol, GnRH-a long protocol, and GnRH-a short protocol in IVF-ET in infertile patients with endometriosis.; Results: A total of 21 studies in compliance with the standard literature were included, and RCT and non-RCT studies were analyzed separately. This meta-analysis showed that the GnRH-a ultra-long protocol could improve the clinical pregnancy rate of infertile patients in RCT studies, especially in patients with stages III-IV endometriosis (RR = 2.04, 95% CI: 1.37~3.04, P < 0.05). However, subgroup analysis found the different down-regulation protocols provided no significant difference in improving clinical outcomes in patients with endometriosis in the non-RCT studies.; Conclusion: This study suggests that the GnRH-a ultra-long protocol can improve the clinical pregnancy rate of the patients with stages III-IV endometriosis in RCT studies. Although it is generally believed that the results of RCT are more reliable, the conclusions of the non-RCT studies cannot be easily neglect, which let us draw conclusions more cautious.

Capel-Alcaraz Ana, M., et al. (2023). "The Efficacy of Strength Exercises for Reducing the Symptoms of Menopause: A Systematic Review." Journal of Clinical Medicine 12(2).
	Background: The aim of this systematic review was to determine whether strength exercises improve the symptoms of menopause and to provide an update on the most recent scientific evidence on the type and regimen of exercise that help reduce the symptoms.; Methods: An electronic search of scientific databases was performed from 2015 to 2022. Randomized clinical trials that analyzed the effects of strength exercises versus other types of interventions, considering all the outcome measures of interest, were included in this review.; Results: We found 5964 potential articles. After applying the selection criteria, we selected 12 of the articles. The studies compared strength exercises versus other therapies or compared strength exercises versus no intervention in one of the groups. The results showed improvements in the strength of the legs and pelvic floor, physical activity, bone density, metabolic and hormonal changes, heart rate and blood pressure and a change in hot flashes.; Conclusions: There is evidence that strength exercises can be beneficial for improving strength, physical activity, bone density and hormonal and metabolic levels. In terms of the appropriate type of strength training, the evidence is still unclear given that the same benefits are achieved by various types of exercises.

Capobianco, G., et al. (2022). "Native tissue repair (NTR) versus transvaginal mesh interventions for the treatment of anterior vaginal prolapse: Systematic review and meta-analysis." Maturitas 165: 104-112.
	The aim of the present systematic review and meta-analysis was to compare native tissue repair (NTR) against transvaginal mesh augmentation for the repair of anterior vaginal prolapse. A total of 2289 articles were found but only 27 (24.8 %) were included in the review. Guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) were followed to guide the process of the systematic review and meta-analysis. The quality of the observational studies was evaluated according to the Scottish Intercollegiate Guidelines Network, whereas the quality of randomized control trials (RCT) was assessed by the Cochrane risk-of-bias scale. The mesh repair intervention was associated with a higher anatomical cure rate in comparison with NTR repair when the follow-up was ≤24 months [pooled risk difference (95 % CI): -0.18 % (-0.22 %; 0.13 %); p-value: <0.0001; I 2 : 36.0 %]. Studies reporting anatomical failure had similar findings [pooled risk difference (95 % CI): 0.17 % (0.01 %; 0.33 %); p-value: 0.03; I 2 : 88.6 %]. No differences in the risk of re-operation were observed between NTR repair and mesh augmentation. Pooled risk differences in the incidence of post-surgical and late complications were higher for the mesh repair intervention [-0.05 % (95 % CI: -0.10 %; 0.00 %) p-value: 0.05; I 2 : 68.3 %] [-0.05 % (95 % CI: -0.14 %; 0.03 %) p-value: 0.25; I 2 : 82.0 %]. Women who underwent mesh repair reported greater satisfaction than women who underwent NTR [pooled risk difference (95 % CI): -0.07 % (-0.16 %; 0.02 %); p-value: 0.15; I 2 : 65.3 %]. In conclusion, mesh repair surgery had higher anatomical cure and satisfaction rates, with no differences in re-operation rate, but had higher post-surgical and late complications in comparison with NTR.; Competing Interests: Declaration of competing interest The authors declare that they have no competing interest. (Copyright © 2022 Elsevier B.V. All rights reserved.)

Caracena, L. (2024). "Efficacy of Oocyte Activation With Two Types of Ca2+ Ionophore." ClinicalTrials.gov.
	No Results Available Drug: Ionomycin SIGMA|Drug: A23187 Improvement in the percetage of usable blastocyst per injeected oocyte|Sequencing unfertilized oocytes and arrested embryos using RNAseq|Quantification of PLCZ in sperm cells by flow Female Not Applicable 44 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2303-VLC-043-MD December 2024

Carcelén-Fraile María Del, C., et al. (2020). "Effects of Physical Exercise on Sexual Function and Quality of Sexual Life Related to Menopausal Symptoms in Peri- and Postmenopausal Women: A Systematic Review." International Journal of Environmental Research and Public Health 17(8).
	During the menopausal period, sexual dysfunction is associated with the development or worsening of psychological conditions, causing deterioration in women's mental health and quality of life. This systematic review aims to investigate the effects of different exercise programs on sexual function and quality of sexual life related to menopausal symptoms. With this purpose, a systematic literature search was conducted in PubMed, CINAHL, Scopus, Web of Science, and Cochrane Plus. A total of 1787 articles were identified in the initial search and 11 prospective studies (including 8 randomized controlled trials) were finally included. The most commonly recommended training programs are based on exercising pelvic floor muscles, as they seem to have the largest impact on sexual function. Mind-body disciplines also helped in managing menopausal symptoms. However, as far as the most traditional programs were concerned, aerobic exercises showed inconsistent results and resistance training did not seem to convey any benefits. Although positive effects have been found, evidence supporting physical exercise as a strategy to improve sexual function and quality of sexual life related to menopausal symptoms is limited, and further studies on this topic are needed.

Carcelén-Fraile María Del, C., et al. (2023). "Impact of Qigong exercises on the severity of the menopausal symptoms and health-related quality of life: A randomised controlled trial." European Journal of Sport Science 23(4): 656-664.
	The aim of the present study was to analyze the effects of a Qigong exercise programme on the severity of the menopausal symptoms and health-related quality of life (HRQoL) of community-dwelling postmenopausal women. This was done by means of a randomised clinical trial with a sample of 125 women who were assigned to either a control ( n = 62) or an experimental group ( n = 63). The severity of their menopause-related symptoms and HRQoL were assessed through the Menopause Rating Scale (MRS) and the 36-item Short-Form Health Survey (SF-36) respectively, before and after the intervention period. The main findings of our study reveal significant improvement in the severity of menopausal symptoms at the somatic, psychological, and urogenital levels, as well as in the total score of the MRS. Additionally, participants assigned to the Qigong group experienced improvement in the general health, physical functioning, role-physical, bodily pain, vitality, and mental health domains of the 36-item Short-Form Health Survey, as well as in its physical component and mental component summaries. We can therefore conclude that, among Spanish postmenopausal women, a twelve-week Qigong exercise programme has beneficial effects on the severity of menopausal symptoms and HRQoL. Highlights We have studied the effects of Qigong on menopause-related quality of life.Qigong is a useful tool in the management of the severity of menopausal symptoms.A 12-week Qigong programme showed benefits on health-related quality of life. Trial registration: ClinicalTrials.gov identifier: NCT03989453.

Carlin Greta, L. (2023). "PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy." ClinicalTrials.gov.
	Introduction: Pelvic organ prolapse is a common gynecological disease, which about 50% of women develop in the course of their lives. There are many different options for surgical care, e.g. the uterus‐preserving sacrospinal fixation (= sacrospinal hysteropexy = SSHP). This technique has been increasingly used in recent years. However, there is still no data on whether the fixation sutures should be performed with absorbable or non‐absorbable threads. Internationally, both types of threads are routinely used and both types of threads are described in publications. So far, there is no comparative data on the effectiveness and subjective results. The aim of this study is to compare subjective symptom improvement Materials & Methods: This is a randomized, single‐center superiority study. The sacrospinal fixation is performed according to a standardized method and two different types of threads (absorbable PDS sutures vs. non‐absorbable Prolene sutures) are used for the fixation suture. Patients are randomized to either the absorbable PDS sutures group or the non‐absorbable Prolene sutures group. The primary outcome of interest is the subjective symptom improvement 12 months after surgery (evaluated using the German version of the pelvic floor questionnaire). Secondary outcome variables are anatomical outcomes, condition‐specific quality of life, and adverse events. 52 patients will be included in the study. The results of the study will be published in peer‐reviewed journals and the results will be presented at scientific meetings.

Carolina, L., et al. (2022). "Interventions for dysmenorrhoea: a network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Caroline Wanderley, S., et al. (2023). "Comparative effectiveness of conservative care for pelvic pain due to endometriosis: protocol of a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Caroliny, S., et al. (2023). "Effect of GLP1 receptor agonist treatment versus metformin on insulin resistance and body weight in PCOS overweight/ obese patients: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Carreño Jose, A. (2021). "Curcumin in Advanced Cervical Cancer." ClinicalTrials.gov.
	No Results Available Drug: Curcumin|Drug: Placebo oral tablet Compare overall survival and progression free survival|Compare the objective response rate using RECIST radiological criteria|Compare the disease control rate|Describe the safety of research therapy by classifying Common Terminology Criteria for Adverse Events (CTCAE) Female Phase 2 0 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment IX-023435 December 31, 2023

Carroquino-Garcia, P., et al. (2019). "Therapeutic Exercise in the Treatment of Primary Dysmenorrhea: A Systematic Review and Meta-Analysis." Physical Therapy 99(10): 1371-1380.
	Background: Dysmenorrhea is a health problem with a high impact on health and society. Some drugs have been shown to be effective at treating dysmenorrhea. Therapeutic exercise is another option for reducing the symptomatology of this health problem, with a low cost and the absence of side effects.; Purpose: The purposes of this review were to study the efficacy of physical exercise for pain intensity in primary dysmenorrhea and to assess its effectiveness in decreasing the duration of pain and improving quality of life.; Data Sources: Searches were conducted between February 2017 and May 2017 in the databases Web of Science, Physiotherapy Evidence Database (PEDro), PubMed, Scopus, CINAHL, and Dialnet, using the terms dysmenorrhea, exercise therapy, exercise movement technique, exercise, physical therapy, physical therapy speciality, treatment, primary dysmenorrhea, prevention, etiology, epidemiology, and pain.; Study Selection: We included randomized controlled trial studies conducted on women who were 16 to 25 years old and had primary dysmenorrhea, studies that included exercise as a type of therapy, studies that assessed the intensity and duration of pain and quality of life, and studies published in English or Spanish. Studies that included women with irregular cycles, women diagnosed with a gynecological disease, women who had had surgery, women with serious diseases, or women who used intracavitary or oral contraceptives were excluded. We started with 455 studies; 16 were included in the systematic review, and 11 were included in the 3 meta-analyses that were carried out.; Data Extraction: Two authors selected the studies and extracted their characteristics (participants, intervention, comparators, and outcomes) and results. The evaluation of the methodological quality of the studies was carried out by PEDro scale.; Data Synthesis: There was moderate evidence that therapeutic exercise can be considered a useful tool in the treatment of primary dysmenorrhea in terms of a reduction in pain intensity. Regarding the duration of pain and quality of life, there was low evidence and very low evidence, respectively. In the 3 meta-analyses, the results were significantly positive in favor of exercise for decreases in both the intensity and the duration of pain.; Limitations: Limitations of this study include the great heterogeneity of the interventions applied in the studies in terms of type of exercise, in combination or alone, and dosage. This review includes a small number of studies with risk of bias, so the present findings must be interpreted with caution.; Conclusions: Therapeutic exercise reduces pain intensity in patients with primary dysmenorrhea. (© 2019 American Physical Therapy Association.)

Carter, E., et al. (2023). "Single-incision sling operations for urinary incontinence in women." The Cochrane Database of Systematic Reviews 10(10): CD008709.
	BACKGROUND: Stress urinary incontinence imposes a significant health and economic burden on individuals and society. Single-incision slings are a minimally-invasive treatment option for stress urinary incontinence. They involve passing a short synthetic device through the anterior vaginal wall to support the mid-urethra. The use of polypropylene mesh in urogynaecology, including mid-urethral slings, is restricted in many countries. This is a review update (previous search date 2012). OBJECTIVES: To assess the effects of single-incision sling operations for treating urinary incontinence in women, and to summarise the principal findings of relevant economic evaluations. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from: CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, and two trials registers. We handsearched journals, conference proceedings, and reference lists of relevant articles to 20 September 2022. SELECTION CRITERIA: We included randomised or quasi-randomised controlled trials in women with stress (or stress-predominant mixed) urinary incontinence in which at least one, but not all, trial arms included a single-incision sling. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. The primary outcome was subjective cure or improvement of urinary incontinence. MAIN RESULTS: We included 62 studies with a total of 8051 women in this review. We did not identify any studies comparing single-incision slings to no treatment, conservative treatment, colposuspension, or laparoscopic procedures. We assessed most studies as being at low or unclear risk of bias, with five studies at high risk of bias for outcome assessment. Sixteen trials used TVT-Secur, a single-incision sling withdrawn from the market in 2013. The primary analysis in this review excludes trials using TVT-Secur. We report separate analyses for these trials, which did not substantially alter the effect estimates. We identified two cost-effectiveness analyses and one cost-minimisation analysis. Single-incision sling versus autologous fascial sling One study (70 women) compared single-incision slings to autologous fascial slings. It is uncertain if single-incision slings have any effect on risk of dyspareunia (painful sex) or mesh exposure, extrusion or erosion compared with autologous fascial slings. Subjective cure or improvement of urinary incontinence at 12 months, patient-reported pain at 24 months or longer, number of women with urinary retention, quality of life at 12 months and the number of women requiring repeat continence surgery or sling revision were not reported for this comparison. Single-incision sling versus retropubic sling Ten studies compared single-incision slings to retropubic slings. There may be little to no difference between single-incision slings and retropubic slings in subjective cure or improvement of incontinence at 12 months (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.91 to 1.07; 2 trials, 297 women; low-certainty evidence). It is uncertain whether single-incision slings increase the risk of mesh exposure, extrusion or erosion compared with retropubic minimally-invasive slings; the wide confidence interval is consistent with both benefit and harm (RR 1.55, 95% CI 0.24 to 9.82; 3 trials, 267 women; low-certainty evidence). It is uncertain whether single-incision slings lead to fewer women having postoperative urinary retention compared with retropubic slings; the wide confidence interval is consistent with possible benefit and harm (RR 0.47, 95% CI 0.12 to 1.84; 2 trials, 209 women; low-certainty evidence). The effect of single-incision slings on the risk of repeat continence surgery or mesh revision compared with retropubic slings is uncertain (RR 4.19, 95% CI 0.31 to 57.28; 2 trials, 182 women; very low-certainty evidence). One study reported quality of life, but not in a suitable format for analysis. Patient-reported pain at more than 24 months and the number of women with dyspareunia were not reported for this comparison. We downgraded the evidence due to concerns about risks of bias, imprecision and inconsistency. Single-incision sling versus transobturator sling Fifty-one studies compared single-incision slings to transobturator slings. The evidence ranged from high to low certainty. There is no evidence of a difference in subjective cure or improvement of incontinence at 12 months when comparing single-incision slings with transobturator slings (RR 1.00, 95% CI 0.97 to 1.03; 17 trials, 2359 women; high-certainty evidence). Single-incision slings probably have a reduced risk of patient-reported pain at 24 months post-surgery compared with transobturator slings (RR 0.12, 95% CI 0.02 to 0.68; 2 trials, 250 women; moderate-certainty evidence). The effect of single-incision slings on the risk of dyspareunia is uncertain compared with transobturator slings, as the wide confidence interval is consistent with possible benefit and possible harm (RR 0.78, 95% CI 0.41 to 1.48; 8 trials, 810 women; moderate-certainty evidence). There are a similar number of mesh exposures, extrusions or erosions with single-incision slings compared with transobturator slings (RR 0.61, 95% CI 0.39 to 0.96; 16 trials, 2378 women; high-certainty evidence). Single-incision slings probably result in similar or reduced cases of postoperative urinary retention compared with transobturator slings (RR 0.68, 95% CI 0.47 to 0.97; 23 trials, 2891 women; moderate-certainty evidence). Women with single-incision slings may have lower quality of life at 12 months compared to transobturator slings (standardised mean difference (SMD) 0.24, 95% CI 0.09 to 0.39; 8 trials, 698 women; low-certainty evidence). It is unclear whether single-incision slings lead to slightly more women requiring repeat continence surgery or mesh revision compared with transobturator slings (95% CI consistent with possible benefit and harm; RR 1.42, 95% CI 0.94 to 2.16; 13 trials, 1460 women; low-certainty evidence). We downgraded the evidence due to indirectness, imprecision and risks of bias. AUTHORS' CONCLUSIONS: Single-incision sling operations have been extensively researched in randomised controlled trials. They may be as effective as retropubic slings and are as effective as transobturator slings for subjective cure or improvement of stress urinary incontinence at 12 months. It is uncertain if single-incision slings lead to better or worse rates of subjective cure or improvement compared with autologous fascial slings. There are still uncertainties regarding adverse events and longer-term outcomes. Therefore, longer-term data are needed to clarify the safety and long-term effectiveness of single-incision slings compared to other mid-urethral slings.

Caruso, S., et al. (2022). "Randomized study on the effectiveness of nomegestrol acetate plus 17β-estradiol oral contraceptive versus dienogest oral pill in women with suspected endometriosis‑associated chronic pelvic pain." BMC Women's Health 22(1): 146.
	Background: To evaluate the effects of a combined oral contraceptive containing 1.5 mg 17b-estradiol (E2) and 2.5 mg nomegestrol acetate (NOMAC) or 2 mg/daily dienogest (DNG) oral progestin on endometriosis-associated chronic pelvic pain (CPP) and on the quality of life (QoL) and sexual function, by a randomized study design.; Methods: The E2/NOMAC group and DNG group included 99 and 98 women, respectively. The levels of CPP were measured by the visual analogic scale (VAS). The QoL scores were investigated by the Short Form-36 questionnaire (SF-36). Finally, sexual function was studied using the Female Sexual Function Index (FSFI), while sexual distress was studied by the Female Sexual Distress Scale (FSDS). The study had 3, 6 and 12-month follow-ups.; Results: The intra-group analysis showed an improvement of the VAS score from baseline to the 12-month follow-up in the women of both groups (p < 0.001). The inter-group comparison showed a similar improvement of CPP (p = 0.06). Women on DNG had better SF-36 somatic (p < 0.01) and FSFI scores (p < 0.006) than women on E2/NOMAC at the 6- and 12-month follow-ups.; Conclusions: The results support the efficacy of both hormonal treatments, even if DNG was more effective than E2/NOMAC in a limited intergroup comparison. (© 2022. The Author(s).)

Casteleijn, F. M., et al. (2021). "Urethral bulking therapy for treating stress urinary incontinence in women." The Cochrane Database of Systematic Reviews(2).
	- Objectives This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of urethral bulking injections for treating stress urinary incontinence in women; and summarise the principal findings of relevant economic evaluations.

Cedillo, S., et al. (2023). "Cost-effectiveness of olaparib plus bevacizumab versus bevacizumab monotherapy in the maintenance of patients with homologous recombination deficiency-positive advanced ovarian cancer after response to first-line platinum-based chemotherapy." International Journal of Gynecological Cancer.
	Objective: The PAOLA-1 trial confirmed that adding olaparib to bevacizumab significantly increased clinical benefit following response to platinum-based chemotherapy in homologous recombination deficiency-positive ovarian cancer. The objective of this analysis was to determine the cost-effectiveness of olaparib plus bevacizumab compared with bevacizumab alone as maintenance treatment for patients with homologous recombination deficiency-positive advanced ovarian cancer from the Spanish National Health System perspective.; Methods: A lifetime partitioned survival model with four health states (progression-free, post-progression 1, post-progression 2, and death) and monthly cycles was developed. Long-term survival, defined as 60 months, was included as a landmark to extrapolate progression-free survival from PAOLA-1. Weibull distribution was selected as the most accurate survival model for progression-free survival extrapolation. Time to second progression and overall survival were extrapolated using parametric survival models. Mortality was obtained from the overall survival and adjusted by Spanish women mortality rates. Health state utilities and utility decrements for adverse events were included. An expert panel validated data and assumptions. Direct costs (in 2021 euros (€)) were obtained from local sources and included drug acquisition and administration, subsequent therapies, monitoring costs, adverse events, and palliative care. A 3% annual discount rate was applied to costs and outcomes. The incremental cost-effectiveness ratio was calculated as cost per quality-adjusted life-years (QALYs) gained. Deterministic and probabilistic sensitivity analyses were performed.; Results: Compared with bevacizumab alone, olaparib plus bevacizumab increased QALYs and life-years by 2.39 and 2.77, respectively, at an incremental cost of €58 295.31, resulting in an incremental cost-effectiveness ratio of €24 371/QALY. Probabilistic sensitivity analysis demonstrated that olaparib plus bevacizumab had a 49.5% and 90.3% probability of being cost-effective versus bevacizumab alone at a willingness-to-pay threshold of €25 000 and €60 000 per QALY gained, respectively.; Conclusion: For patients with homologous recombination deficiency-positive advanced ovarian cancer, olaparib plus bevacizumab is a cost-effective maintenance therapy compared with bevacizumab alone in Spain.; Competing Interests: Competing interests: SC is an employee of AstraZeneca. CG and SA are employees of Outcomes’10, an independent consultancy that received fees from AstraZeneca for medical writing. Authors LM, ACCL, PVB, AC, and JAPF report personal fees from AstraZeneca, during the conduct of the study. (© IGCS and ESGO 2023. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)

Celenay Seyda, T. (2022). "Comparison of Aerobic Exercise and Spinal Stabilization Exercises in Women With Primary Dysmenorrhea." ClinicalTrials.gov.
	PD is the cramping pain that comes before or during a period. Different exercise approaches have positive effects in PD. Comparing the effects of these exercise approaches is needed to determine the effects on PD.

Celenay Seyda, T. (2022). "Comparison of Stabilization Exercises and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence." ClinicalTrials.gov.
	Stress urinary incontinence is involuntary urinary incontinence with increased intraabdominal pressure. Different exercise approaches such as pelvic floor exercises and stabilization exercises are used in these patients. There is a need for studies comparing the effects of these exercises.

Celenay Seyda, T. (2022). "The Effects Of Relaxation Training In Women With Primary Dysmenorrhea." ClinicalTrials.gov.
	PD is the cramping pain that comes before or during a menstrual period. Relaxation training contributes to the reduction of stress and pain. Thus, there is a need to investigate the effects of relaxation training in dysmenorrhea.

Celenay Seyda, T., et al. (2023). "Comparison of Connective Tissue Massage and Classic Massage in Women With Primary Dysmenorrhea: A Randomized Clinical Trial." Journal of Manipulative & Physiological Therapeutics 46(5): 305-314.
	
Celenay, S. T., et al. (2022). "A comparison of Kinesio taping and external electrical stimulation in addition to pelvic floor muscle exercise and sole pelvic floor muscle exercise in women with overactive bladder: a randomized controlled study." Disability and Rehabilitation 44(18): 5124-5132.
	PURPOSE: To compare the effects of Kinesio taping® (KT) and external electrical stimulation (ES) in addition to pelvic floor muscle exercise (PFME) and sole PFME in women with overactive bladder (OAB). MATERIAL AND METHODS: Patients with OAB were randomly allocated into PFME, PFME + KT, PFME + ES groups. All treatments were carried out for 6 weeks. OAB symptoms with voiding diary and Overactive Bladder-Version8 (OAB-V8), pelvic floor muscle strength (PFMS) with perineometer, quality of life with King's Health Questionnaire (KHQ) were assessed before (BT) and after treatment (AT). AT, the perception of improvement was inquired. RESULTS: AT, OAB symptoms and KHQ scores decreased and PFMS improved in all groups (p < 0.05). The intergroup comparisons revealed a further decrease in voids/day, voids/night, OAB-V8, and some KHQ scores, and a further increase in the perception of improvement in the PFME + KT and PFME + ES groups compared to the PFME group (p < 0.05). In the PFME + ES group, there was a further decrease in numbers of incontinence compared to the PFME group, and in severity measures scores compared to the other groups (p < 0.05). CONCLUSION: KT and external ES in addition to PFME were more effective than PFME alone in the treatment of OAB.IMPLICATIONS FOR REHABILITATIONPelvic floor muscle exercise was found to be effective in reducing overactive bladder symptoms and increasing quality of life.Kinesio taping or external electrical stimulation in addition to pelvic floor muscle exercise is more effective in improving overactive bladder symptoms, quality of life, and perception of improvement than pelvic floor muscle exercise alone.Kinesio taping and external electrical stimulation can be used as a complementary application in the treatment of overactive bladder.Pelvic floor muscle exercise, pelvic floor muscle exercise + Kinesio taping, and pelvic floor muscle exercise + electrical stimulation applications should be included in conservative treatment options in patients with overactive bladder to reduce symptoms and cost, and improve quality of life.

Celenay, S. T., et al. (2022). "Effects of Pelvic Floor Muscle Training on Sexual Dysfunction, Sexual Satisfaction of Partners, Urinary Symptoms, and Pelvic Floor Muscle Strength in Women With Overactive Bladder: A Randomized Controlled Study." The Journal of Sexual Medicine 19(9): 1421-1430.
	BACKGROUND: In women with overactive bladder (OAB), sexual dysfunctions and sexual satisfaction of their partners have been problems that are as important as urinary symptoms. AIM: To investigate the effects of pelvic floor muscle training (PFMT) on sexual dysfunction, sexual satisfaction of partners, urinary symptoms, and pelvic floor muscle strength (PFMS) in women with OAB. METHODS: Women with OAB were randomized into 2 groups: 6-week PFMT (n = 21) (home exercise program) and a control group (n = 22) (did not receive any treatment for OAB). OUTCOMES: Sexual dysfunction, sexual satisfaction of partner, urinary symptoms, and PFMS were assessed at baseline and after 6 weeks with the Female Sexual Function Index (FSFI), a Visual Analogue Scale (VAS), the OAB-Version8 (OAB-V8), and the Modified Oxford Scale (MOS), respectively. RESULTS: After 6 weeks, there was an increase in FSFI domains [desire (95% CI: 0.18 to 0.64; P:.001, d: 0.88); arousal (95% CI: 0.42 to 1.24, P:<.001, d: 1.17); orgasm (95% CI:0.85 to 1.47; P:<.001, d:1.89); satisfaction (95% CI: 0.85 to 1.44; P:<.001, d: 2.29); sexual pain (95% CI:0.80 to 1.52; P:<.001, d:1.47); total score (95% CI: 3.70 to 5.94; P:<.001, d: 2.55)], sexual satisfaction of partners (95% CI: 1.80 to 2.85; P:<.001, d:2.83) and PFMS scores (95% CI: 1.10 to 1.55; P:<.001, d:3.18), and a decrease in the OAB-V8 score (95% CI: -13.01 to -7.10; P:<.001, d:2.19) in the PFMT group compared to the control group. There was a significant decrease in sexual dysfunction in the PFMT group compared to the control group (P:.046). CLINICAL IMPLICATIONS: In order to improve sexual function, sexual satisfaction of the partners, urinary symptoms, and PFMS in women with OAB, PFMT should be added to the rehabilitation program in clinics. STRENGTHS & LIMITATIONS: The strength of this study was that it is a randomized controlled trial investigating the effect of PFMT in improving sexual function in OAB. The limitations of our study were the lack of a long-term (6 months-1 year) follow-up and the inability to blind. CONCLUSION: PFMT was effective in improving sexual dysfunction, sexual satisfaction of partners, urinary symptoms, and PFMS in women with OAB. Celenay ST, Karaaslan Y, Ozdemir E. Effects of Pelvic Floor Muscle Training on Sexual Dysfunction, Sexual Satisfaction of Partners, Urinary Symptoms, and Pelvic Floor Muscle Strength in Women With Overactive Bladder: A Randomized Controlled Study. J Sex Med 2022;19:1421-1430.

Celenay, S. T., et al. (2023). "Effects of spinal stabilization exercises focusing on the pelvic floor in women with overactive bladder." International Urogynecology Journal.
	INTRODUCTION AND HYPOTHESIS: The objective was to investigate the effects of spinal stabilization exercises (SSEs) focusing on the pelvic floor with regard to urinary symptoms, pelvic floor muscle strength (PFMS), core stability, quality of life (QoL), and perception of subjective improvement (PSI) in women with overactive bladder (OAB). METHODS: Patients were randomly divided into SSE (n=23) and control (n=24) groups. The SSE group received SSEs focusing on the pelvic floor for 3 days a week for 8 weeks and recommendation. The control group received only recommendation. Before (BT) and after treatment (AT), urinary symptoms were evaluated with Overactive Bladder Questionnaire-Version 8 (OAB-V8) and bladder diary. PFMS, core stability, and QoL were assessed using the Modified Oxford Scale (MOS), Sharman test, and King's Health Questionnaire (KHQ) respectively. AT, PSI with a Likert-type scale, and compliance with recommendations using a visual analog scale were assessed. RESULTS: The OAB-V8 and the KHQ scores, the number of voids per day and voids per night decreased and the MOS and the Sharman scores increased in the SSE group (p<0.05). In the control group, the OAB-V8 and incontinence effect, social limitations, emotional state, and sleep sub-dimension scores related to KHQ decreased (p<0.05). The OAB-V8, role and physical limitations, emotional state, and sleep sub-dimension scores decreased more, and the MOS, the Sharman, the PSI, and the compliance with recommendations scores increased more in the SSE group than in the control group (p<0.05). CONCLUSIONS: The SSEs focusing on the pelvic floor improved urinary symptoms, PFMS, core stability, QoL, and PSI. This exercise approach may be beneficial in the management of OAB.

Çelik, A. S. and S. E. Apay (2021). "Effect of progressive relaxation exercises on primary dysmenorrhea in Turkish students: A randomized prospective controlled trial." Complementary Therapies in Clinical Practice 42: 101280.
	BACKGROUND: A randomized prospective controlled study was conducted concerning the effects of progressive relaxation exercises on the reduction of pain in primary dysmenorrhea. MATERIALS AND METHODS: The research control group (CG) consisted of 60 students while the experimental group (EG) consisted of 64 students. The progressive relaxation exercises were self-administered via compact disc (CD) by participants for two menstrual cycles. A descriptive information form, a visual analog scale (VAS) and a dysmenorrhea monitoring form (DMF) were used for data collection. RESULTS: The difference between the average first and final post-exercise measurements of the VAS scores of students in the experimental group was statistically significant (p < 0.001), whereas the difference in the control group was not statistically significant (p > 0.05). CONCLUSION: Progressive relaxation exercises are an effective method for reducing dysmenorrhea when they are performed on a regular basis.

Centro Hospitalar e Universitário de Coimbra, E. P. E. (2024). "Effects of Resveratrol Supplementation on Oocyte Quality." ClinicalTrials.gov.
	No Results Available Dietary Supplement: Resveratrol|Dietary Supplement: Folic acid Number of good-quality embryos|Number of oocytes and mature oocytes|Fertilization rate|Cleavage rate|Biochemical pregnancy rate|Clinical pregnancy rate per cycle|Clinical pregnancy rate per embryo transfer|Ongoing pregnancy rate|Cumulate live birth rate Female Not Applicable 88 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment RA-01-23 December 2025

Cervantes Graziele, V., et al. (2023). "Sexual Function of Patients with Deep Endometriosis after Surgical Treatment: A Systematic Review." Revista Brasileira de Ginecologia e Obstetricia 45(11): e729-e744.
	Objective: To review the current state of knowledge on the impact of the surgical treatment on the sexual function and dyspareunia of deep endometriosis patients.; Data Source: A systematic review was conducted in accordance with the Meta-Analysis of Observational Studies in Epidemiology (MOOSE) guidelines. We conducted systematic searches in the PubMed, EMBASE, LILACS, and Web of Science databases from inception until December 2022. The eligibility criteria were studies including: preoperative and postoperative comparative analyses; patients with a diagnosis of deep endometriosis; and questionnaires to measure sexual quality of life.; Study Selection: Two reviewers screened and reviewed 1,100 full-text articles to analyze sexual function after the surgical treatment for deep endometriosis. The risk of bias was assessed using the Newcastle-Ottawa scale for observational studies and the Cochrane Collaboration's tool for randomized controlled trials. The present study was registered at the International Prospective Register of Systematic Reviews (PROSPERO; registration CRD42021289742).; Data Collection: General variables about the studies, the surgical technique, complementary treatments, and questionnaires were inserted in an Microsoft Excel 2010 (Microsoft Corp., Redmond, WA, United States) spreadsheet.; Synthesis of Data: We included 20 studies in which the videolaparoscopy technique was used for the excision of deep infiltrating endometriosis. A meta-analysis could not be performed due to the substantial heterogeneity among the studies. Classes III and IV of the revised American Fertility Society classification were predominant and multiple surgical techniques for the treatment of endometriosis were performed. Standardized and validated questionnaires were applied to evaluate sexual function.; Conclusion: Laparoscopic surgery is a complex procedure that involves multiple organs, and it has been proved to be effective in improving sexual function and dyspareunia in women with deep infiltrating endometriosis.; 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/).)

Chakrabarti, M., et al. (2022). "Debulking hysterectomy followed by chemoradiotherapy versus chemoradiotherapy for FIGO stage (2019) IB3/II cervical cancer." The Cochrane Database of Systematic Reviews 9: CD012246.
	Background: With an estimated 570,000 new cases reported globally in 2018, and increasing numbers of new cases in countries without established human papillomavirus (HPV) vaccination programmes, cervical cancer is the third most common cancer in women worldwide. The majority of global disease burden (around 85%) is in low-and middle-income countries (LMICs), with estimates of cervical cancer being the second most common cancer in women in such regions. As it commonly affects younger women, cervical cancer has the greatest impact on years of life lost (YLL) and adverse socioeconomic outcomes compared to all other cancers in women. Management of cervical cancer depends on tumour stage. Radical hysterectomy with lymphadenectomy is the standard primary treatment modality for International Federation of Gynecology and Obstetrics (FIGO) stage (2019) 1B1 to 1B3 disease. However, for larger primary tumours, radical hysterectomy is less commonly recommended. This is mainly due to a high incidence of unfavourable histopathological parameters, which require adjuvant concurrent chemoradiotherapy (CCRT) (chemotherapy given with radiotherapy treatment). CCRT is the standard of care and is widely used as first-line treatment for cervical cancer considered to be not curable with surgery alone (i.e.those with locally advanced disease). However, a sizable cohort of women managed with primary CCRT will have residual disease within the cervix following treatment. Debulking' hysterectomy to remove (debulk) the primary tumour in locally advanced disease, prior to CCRT, may be an alternative management strategy, avoiding the potential need for surgery for residual cervical disease following CCRT, which may be more extensive, or have increased morbidity due to CCRT. However, this strategy may subject more women to unnecessary surgery and its inherent risks.; Objectives: To assess the efficacy and harms of debulking hysterectomy (simple or radical) followed by chemoradiotherapy (CCRT) versus CCRT alone for FIGO (2019) stage IB3/II cervical cancer.; Search Methods: We systematically searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2021, Issue 4), MEDLINE via Ovid (1946 to 12 April 2021) and Embase via Ovid (1980 to 12 April 2021). We also searched other registers of clinical trials, abstracts of scientific meetings and reference lists up to 12 April 2021.; Selection Criteria: We searched for randomised controlled trials (RCTs), quasi-RCTs or non-randomised studies (NRSs) comparing debulking hysterectomy followed by CCRT versus CCRT alone for locally advanced FIGO (2019) stage IB3/II cervical malignancy.; Data Collection and Analysis: We applied Cochrane methodology, with two review authors independently assessing whether potentially relevant studies met the inclusion criteria. We planned to apply standard Cochrane methodological procedures to analyse data and risk of bias.; Main Results: We did not find any evidence for or against debulking hysterectomy followed by CCRT versus CCRT alone for FIGO (2019) stage IB3/II cervical cancer. We did not identify any studies assessing the validity of debulking hysterectomy for these women. AUTHORS' CONCLUSIONS: There was no evidence for or against debulking hysterectomy followed by CCRT versus CCRT alone for FIGO (2019) stage IB3/II cervical cancer. (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Chan Vivien Kin, Y., et al. (2022). "Cost-Effectiveness of Poly ADP-Ribose Polymerase Inhibitors in Cancer Treatment: A Systematic Review." Frontiers in Pharmacology 13: 891149.
	Background: PARP inhibitors have shown significant improvement in progression-free survival, but their costs cast a considerable financial burden. In line with value-based oncology, it is important to evaluate whether drug prices justify the outcomes. Objectives: The aim of the study was to systematically evaluate PARP inhibitors on 1) cost-effectiveness against the standard care, 2) impact on cost-effectiveness upon stratification for genetic characteristics, and 3) identify factors determining their cost-effectiveness, in four cancer types. Methods: We systematically searched PubMed, EMBASE, Web of Science, and Cochrane Library using designated search terms, updated to 31 August 2021. Trial-based or modeling cost-effectiveness analyses of four FDA-approved PARP inhibitors were eligible. Other studies known to authors were included. Reference lists of selected articles were screened. Eligible studies were assessed for methodological and reporting quality before review. Results : A total of 20 original articles proceeded to final review. PARP inhibitors were not cost-effective as recurrence maintenance in advanced ovarian cancer despite improved performance upon genetic stratification. Cost-effectiveness was achieved when moved to upfront maintenance in a new diagnosis setting. Limited evidence indicated non-cost-effectiveness in metastatic breast cancer, mixed conclusions in metastatic pancreatic cancer, and cost-effectiveness in metastatic prostate cancer. Stratification by genetic testing displayed an effect on cost-effectiveness, given the plummeting ICER values when compared to the "treat-all" strategy. Drug cost was a strong determinant for cost-effectiveness in most models. Conclusions : In advanced ovarian cancer, drug use should be prioritized for upfront maintenance and for patients with BRCA mutation or BRCAness at recurrence. Additional economic evaluations are anticipated for novel indications.; 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 Chan, Yang, Wong and Li.)

Chang, C.-L., et al. (2022). "An updated systematic review and network meta-analysis comparing open, laparoscopic and robotic-assisted sacrocolpopexy for managing pelvic organ prolapse." Journal of Robotic Surgery 16(5): 1037-1045.
	Abdominal sacrocolpopexy is considered as the gold standard treatment for pelvic organ prolapse. Sacrocolpopexy can be performed using open (OSC), laparoscopic (LSC), and robotic-assisted (RSC) approaches. The aim of this study is to compare the outcomes between these three approaches for managing pelvic organ prolapse by conducting a systematic review and network meta-analysis. A systematic search was performed in different databases from their earliest records to April 2021 with no restriction on languages. Only randomized controlled trials that compared the outcomes between OSC, LSC, and RSC were included in this study. A total of 6 studies with 486 participants were included in this study. Operative time was significantly shorter in OSC than in RSC and LSC. The probability rank showed less estimated blood loss in RSC and lowest overall postoperative complications in LSC. Probability scores also showed best anatomical outcomes for postoperative points C and Bp in RSC and for point Ba in LSC. Despite significantly longer operative time, RSC and LSC may provide better anatomical outcomes, less estimated blood loss, and less overall postoperative complications than OSC. However, this study did not find significant differences between RSC and LSC in efficacy and safety. (© 2021. The Author(s), under exclusive licence to Springer-Verlag London Ltd., part of Springer Nature.)

Chang, J., et al. (2023). "The efficacy of levonorgestrel releasing intrauterine system(LNG-IUS) combined with gonadotropin releasing hormone(GnRH) agonists in the treatment of adenomyosis or endometriosis: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Chang, O. H., et al. (2022). "Impact of the availability of midurethral slings on treatment strategies for stress urinary incontinence: a cost-effectiveness analysis." BJOG 129(3): 500-508.
	Objective: To perform a cost-effectiveness analysis for the surgical and non-surgical management of stress urinary incontinence (SUI) with and without the availability of midurethral sling. Design(s): Cost-effectiveness analysis. Setting(s): USA, 2019. Population: Women with stress urinary incontinence. Method(s): We modelled SUI treatment pathways with and without the availability of midurethral slings, including no treatment, incontinence pessary, pelvic floor muscle physical therapy, urethral bulking injection, open and laparoscopic Burch colposuspension, and pubovaginal autologous sling. Time horizon was 2 years after initial treatment. Main Outcome Measure(s): Costs (2019 US$) included index surgery, surgical retreatment, and complications including urinary retention, de novo urgency and mesh exposure. The incremental cost-effectiveness ratio (ICER) was calculated for non-dominated treatment strategies. Result(s): The least costly treatment strategies were incontinence pessary, pelvic floor physical therapy, no treatment and midurethral sling, respectively. Midurethral slings had the highest effectiveness. The strategy with the lowest effectiveness was no treatment. The three cost-effective strategies included pessary, pelvic floor muscle physical therapy and midurethral slings. No other surgical options were cost-effective. If midurethral slings were not available, all other surgical options were still dominated by pelvic floor muscle physical therapy. Multiple one-way sensitivity analyses confirmed model robustness. The only reasonable threshold in which outcomes would change, was if urethral bulking costs decreased 12.6%. Conclusion(s): The midurethral sling is the most effective SUI treatment and the only cost-effective surgical option. Tweetable abstract: Midurethral sling is the only cost-effective surgical treatment option for stress urinary incontinence.Copyright © 2021 John Wiley & Sons Ltd.

Chang, O. H., et al. (2023). "Surgical correction of the genital hiatus at the time of sacrocolpopexy - a 7-year Markov analysis: a cost-effectiveness analysis." International Urogynecology Journal 34(12): 2969-2975.
	Introduction and hypothesis: 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. We hypothesize it is not cost-effective to perform a posterior colporrhaphy. Method(s): We used TreeAge Pro to construct a decision model with Markov modeling to compare sacrocolpopexy with and without concurrent posterior repair (SCP and SCP+PR) over a time horizon of 7 years. Outcomes included probability and costs associated with prolapse recurrence, prolapse retreatment, and complications including rectal injury, rectovaginal hematoma requiring reoperation, and postoperative dyspareunia. Cost-effectiveness was defined as an incremental cost-effectiveness ratio (ICER) calculated as costs / effectiveness and the willingness to pay (WTP) was set at $100,000/QALY. Result(s): Our model showed that SCP was the dominant strategy, with lower costs (-$ 2681.06) and higher effectiveness (+0.10) compared to SCP+PR over the 7-year period. 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 at least 29.7% 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 was lower than the rate of SCP alone. 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.Copyright © 2023, The International Urogynecological Association.

Chang-He, Y., et al. (2023). "Manual therapy for Primary dysmenorrhea: a systematic reviews and meta analysis." PROSPERO International prospective register of systematic reviews.
	
Charlotte, H., et al. (2023). "Clinical efficacy of oral flurbiprofen, fenoprofen, ketoprofen, diclofenac and acetylsalicylic acid versus placebo and/or paracetamol in primary dysmenorrhea: a systematic review and meta-analysis of randomized controlled trials, an update of the 2015 COCHRANE systematic review." PROSPERO International prospective register of systematic reviews.
	
Charlotte, H., et al. (2023). "Clinical efficacy of oral paracetamol in primary dysmenorrhea: a systematic review and meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Charlton, W. (2022). "A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens." ClinicalTrials.gov.
	This is a phase 2 study to evaluate the efficacy, safety and tolerability of 3 doses of tildacerfont in approximately 39 women with PCOS and elevated adrenal androgens assessed by elevated DHEAS levels. Subjects will be randomized 2:1 (tildacerfont:placebo) at baseline. The study will consist of 3 consecutive 4‐week treatment periods at each dose level. Duration of participation is approximately 25 weeks.

Charnsiri, S., et al. (2023). "The effects of yoga on sleep quality and menopausal symptoms in menopausal women: a systematic review and meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Chemo Research, S. L. (2021). "A clinical study in women suffering from endometriosis to test the drug LPRI-CF113 (drospirenone) during 6 months of treatment." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Drospirenone Product Code: LPRI‐CF113 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: DROSPIRENONE CAS Number: 67392‐87‐4 Current Sponsor code: LPRI‐CF113 Other descriptive name: DROSPIRENONE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 2.8‐4 Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Endometriosis ; MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis 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 demonstrate the efficacy of LPRI‐CF113 in the management of Endometriosis Associated Pelvic Pain (EAPP) as assessed on a numeric rating scale (NRS). Primary end point(s): Changes from baseline in EAPP by the assessment of subject reported pain score on an NRS after 3 medication cycles.; ; Intercurrent events (ICEs) and strategies; • Change in rescue medication during 3 medication cycles compared to baseline. ; • Treatment non‐compliance (< 80% or > 120%).; • Discontinuation of treatment (due to lack of efficacy, adverse events [AEs] or safety concerns).; Secondary Objective: To assess the efficacy of LPRI‐CF113 versus placebo in terms of response to treatment.; To assess the safety and tolerability of LPRI‐CF113 in comparison to placebo. Timepoint(s) of evaluation of this end point: Number of days corresponding to subjects average menstruation cycle duration, prior to and including Day 28 of medication cycle 3 (or last intake of IP in case of early discontinuation). SECONDARY OUTCOME: Secondary end point(s): 1. Changes after 1, 3 and 6 medication cycle(s) compared to baseline in dysmenorrhoea (assessed via NRS pain score).; 2. Changes after 1, 3 and 6 medication cycle(s) compared to baseline in NMPP (assessed via NRS pain score).; 3. Changes after 1, 3 and 6 medication cycle(s) compared to baseline in rescue medication intake.; 4. Changes after 1 and 6 medication cycle(s) compared to baseline in EAPP (assessed via an NRS pain score).; 5. Changes after 1, 3 and 6 medication cycle(s) compared to baseline in dyspareunia.; 6. Number and percentage of subjects with amenorrhoea.; 7. Vaginal bleeding pattern; 8. The number and percentage of responders at 3 months (responder will be defined by a 50% EAPP reduction measured through an NRS).; 9. Withdrawals due to lack of efficacy (pain relief).; 10. Changes after 3 and 6 medication cycles compared to baseline in quality of life (30‐item Endometriosis Health Profile Questionnaire [EHP‐30]).; 11. Patient’s Global Impression of Change (PGIC).; 12. Adverse events.; 13. Mean absolute and relative changes in laboratory values. ; 14. Vital signs. Timepoint(s) of evaluation of this end point: 1, 3 and 6 medication cycles, respectively INCLUSION CRITERIA: 1. Postmenarcheal and premenopausal female subjects = 15 and = 45 years of age at screening, not seeking pregnancy. 2. Endometriosis was diagnosed histologically in the period from 3 months to 10 years before screening. 3. EAPP of = 3 points on an NRS during the last 3 months before screening. 4. Be able and willing to provide written informed consent or assent before any trial‐related procedure will be performed. 5. In females not using a hormonal contraceptive at screening: regular menstrual cycles (i.e. cycle length between 21 and 35 days) during the last 3 months before screening. 6. Willing to agree to one wash‐out cycle of hormonal therapies, if applicable. 7. Willing to use one agreed NSAID as rescue medication throughout the trial. No switching or start of an additional pain killer should be planned after Visit 1a until the end of the trial. 8. Systolic blood pressure = 140 mmHg and diastolic blood pressure = 90 mmHg at screening, i

Chemo Research, S. L. (2021). "A clinical study in women suffering from polycystic ovary syndrome (PCOS) to test the drug LPRI-424 (dienogest/ethinyl estradiol) during 9 months of treatment." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Dienogest 2.00 mg / Ethinyl Estradiol 0.02 mg Product Code: LPRI‐424 Pharmaceutical Form: Prolonged‐release tablet INN or Proposed INN: DIENOGEST CAS Number: 65928‐58‐7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2‐ INN or Proposed INN: ETHINYLESTRADIOL CAS Number: 57‐63‐6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.02‐ Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use CONDITION: Hirsutism related to Polycystic Ovarian Syndrome ; MedDRA version: 21.1 Level: PT Classification code 10036049 Term: Polycystic ovaries 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 demonstrate the efficacy of LPRI‐424 on hirsutism, measured by an adapted modified Ferriman‐Gallwey (mFG) score based on the investigator decision against placebo Primary end point(s): Changes from baseline in adapted mFG Secondary Objective: To assess the safety of LPRI‐424, bleeding pattern and health‐related quality of life Timepoint(s) of evaluation of this end point: After trial termination SECONDARY OUTCOME: Secondary end point(s): Changes in laboratory parameters from baseline; Adverse events (AEs); Vital signs; Clinical laboratory parameters; Physical examination; Electrocardiogram (ECG); Gynaecological examination; Cervical cytology; Changes in weight and waist ; Change in bleeding pattern from baseline ; Number of subjects with prolonged bleeding/spotting > 10 days ; IP acceptability based on IP satisfaction and wellbeing ; Changes in quality of life based on the Polycystic Ovarian Syndrome Questionnaire (PCOSQ) from baseline Timepoint(s) of evaluation of this end point: After trial termination INCLUSION CRITERIA: 1. Two years postmenarcheal women of any ethnic origin between 15 and 40 years (inclusive at the time of enrolment), not seeking pregnancy. Female subjects at risk of pregnancy aged between 15 and 17 years (inclusive) provided that a. Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services, b. All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed. 2. Diagnosed with PCOS according to the following criteria: a. Presence of hirsutism measured using an adapted mFG with a cut‐off value of = 7 (at V1a only based on patient’s history or interview; to be determined only at Visit 1b) and b. Presence of one of the following criteria: 1. Oligomenorrhea (= 6 menses per year) while not using hormonal contraceptives 2. Polycystic ovaries defined as presence of 12 or more follicles

Chen, F., et al. (2023). "Moxifloxacin monotherapy for treatment of uncomplicated pelvic inflammatory disease: A systematic review and meta-analysis with trial sequential analysis of randomized controlled trials." Pharmacoepidemiology and Drug Safety 32(11): 1189-1199.
	Purpose: The aim of this study was to evaluate the efficacy and safety of moxifloxacin monotherapy for the treatment of uncomplicated pelvic inflammatory disease (uPID).; Methods: The literatures from PubMed, ScienceDirect, Google Scholar, Cochrane library and the http://clinicaltrials.gov/ were retrieved until February 2023. Only randomized controlled trials (RCTs) comparing the efficacy and safety of moxifloxacin with other antibiotics for treating uPID were included. The primary outcomes were clinical cure rate (CCR), bacteriological success rates (BSR) and risk of drug-related adverse events (AEs). We used random-effects modelled meta-analysis, trial sequential analysis, and the Grading of Recommendations Assessment, Development, and Evaluation. This study was registered in the International Prospective Register of Systematic Reviews (registration number: CRD42023428751).; Results: A total of four RCTs that enrolled 3201 women patients with uPID were included. In the per-protocol populations, no significant difference was observed between patients given moxifloxacin and those given other antibiotics with regard to CCR at test-of-cure (TOC) (2485 patients, odds ratio [OR] = 0.84, 95% confidence interval [CI] 0.68-1.04, p = 0.12). Similarly, there was no statistically significant difference between patients given moxifloxacin and those given other antibiotics in terms of BSR at TOC (471 patients, OR = 1.17, 95% CI 0.70-1.96, p = 0.56) in the microbiologically valid population. However, drug-related AEs occurred less frequently with moxifloxacin than with other antibiotics (2973 patients, OR = 0.74, 95% CI 0.64-0.86, p < 0.0001), especially gastrointestinal AEs (2973 patients, OR = 0.59, 95% CI 0.47-0.74, p < 0.00001).; Conclusions: In the treatment of uPID, moxifloxacin monotherapy can achieve similar efficacy as other combination therapy regimens. Moreover, moxifloxacin had a better safety profile than that of comparators. Based on its additional advantages (i.e., better safety profile, no dosage adjustment and better compliance), moxifloxacin may be a more fascinating option compared with the currently used regimens. (© 2023 John Wiley & Sons Ltd.)

Chen, H., et al. (2020). "Efficacy and Safety of Bevacizumab-Combined Chemotherapy for Advanced and Recurrent Endometrial Cancer: A Systematic Review and Meta-Analysis." Balkan Medical Journal.
	BACKGROUND: Bevacizumab-combined chemotherapy is a new regimen for advanced/recurrent endometrial cancer. AIMS: This study aimed to evaluate the efficacy and safety of bevacizumab-combined chemotherapy in advanced/recurrent endometrial cancer. STUDY DESIGN: This is a systematic review and meta-analysis of clinical trials. METHOD(S): Eligible studies were retrieved form Embase, PubMed, and Cochrane Library. The data of primary outcomes including progression-free 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 versus other treatments in patients with advanced/recurrent endometrial cancer. RESULT(S): Two randomized-controlled and five 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 (Hazards ratio, HR=0.82, 95% CI 0.70, 0.97) and overall survival rate (HR=0.83, 95% CI 0.70, 0.98) as compared with chemotherapy alone. The rates of overall, complete, and partial response to bevacizumab-combined chemotherapy were 76%, 22%, and 21%, respectively. The six and 12-month disease-free progression rate 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 following bevacizumab-combined chemotherapy. CONCLUSION(S): This study suggested that bevacizumab-combined chemotherapy may have a higher efficacy in improving the overall and progression-free survival in patients with advanced/recurrent endometrial cancers as compared with chemotherapy alone.

Chen, I., et al. (2020). "Pre- and postsurgical medical therapy for endometriosis surgery." The Cochrane Database of Systematic Reviews 11: CD003678.
	Background: Endometriosis is a common gynaecological condition affecting 10% to 15% of reproductive-age women and may cause dyspareunia, dysmenorrhoea, and infertility. One treatment strategy is combining surgery and medical therapy to reduce the recurrence of endometriosis. Though the combination of surgery and medical therapy appears to be beneficial, there is a lack of clarity about the appropriate timing of when medical therapy should be used in relation with surgery, that is, before, after, or both before and after surgery, to maximize treatment response.; Objectives: To determine the effectiveness of medical therapies for hormonal suppression before, after, or both before and after surgery for endometriosis for improving painful symptoms, reducing disease recurrence, and increasing pregnancy rates.; Search Methods: We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and two trials registers in November 2019 together with reference checking and contact with study authors and experts in the field to identify additional studies.; Selection Criteria: We included randomized controlled trials (RCTs) which compared medical therapies for hormonal suppression before, after, or before and after, therapeutic surgery for endometriosis.; Data Collection and Analysis: Two review authors independently extracted data and assessed risk of bias. Where possible, we combined data using risk ratio (RR), standardized mean difference or mean difference (MD) and 95% confidence intervals (CI). Primary outcomes were: painful symptoms of endometriosis as measured by a visual analogue scale (VAS) of pain, other validated scales or dichotomous outcomes; and recurrence of disease as evidenced by EEC (Endoscopic Endometriosis Classification), rAFS (revised American Fertility Society), or rASRM (revised American Society for Reproductive Medicine) scores at second-look laparoscopy.; Main Results: We included 26 trials with 3457 women with endometriosis. We used the term "surgery alone" to refer to placebo or no medical therapy. Presurgical medical therapy compared with placebo or no medical therapy Compared to surgery alone, we are uncertain if presurgical medical hormonal suppression reduces pain recurrence at 12 months or less (dichotomous) (RR 1.10, 95% CI 0.72 to 1.66; 1 RCT, n = 262; very low-quality evidence) or whether it reduces disease recurrence at 12 months - total (AFS score) (MD -9.6, 95% CI -11.42 to -7.78; 1 RCT, n = 80; very low-quality evidence). We are uncertain if presurgical medical hormonal suppression decreases disease recurrence at 12 months or less (EEC stage) compared to surgery alone (RR 0.88, 95% CI 0.78 to 1.00; 1 RCT, n = 262; very low-quality evidence). We are uncertain if presurgical medical hormonal suppression improves pregnancy rates compared to surgery alone (RR 1.16, 95% CI 0.99 to 1.36; 1 RCT, n = 262; very low-quality evidence). No trials reported pelvic pain at 12 months or less (continuous) or disease recurrence at 12 months or less. Postsurgical medical therapy compared with placebo or no medical therapy We are uncertain about the improvement observed in pelvic pain at 12 months or less (continuous) between postsurgical medical hormonal suppression and surgery alone (MD -0.48, 95% CI -0.64 to -0.31; 4 RCTs, n = 419; I 2 = 94%; very low-quality evidence). We are uncertain if there is a difference in pain recurrence at 12 months or less (dichotomous) between postsurgical medical hormonal suppression and surgery alone (RR 0.85, 95% CI 0.65 to 1.12; 5 RCTs, n = 634; I 2 = 20%; low-quality evidence). We are uncertain if postsurgical medical hormonal suppression improves disease recurrence at 12 months - total (AFS score) compared to surgery alone (MD -2.29, 95% CI -4.01 to -0.57; 1 RCT, n = 51; very low-quality evidence). Disease recurrence at 12 months or less may be reduced with postsurgical medical hormonal suppression compared to surgery alone (RR 0.30, 95% CI 0.17 to 0.54; 4 RCTs, n = 433; I 2 = 58%; low-quality evidence). We are certain about the reduction observed in disease recurrence at 12 months or less (EEC stage) between postsurgical medical hormonal suppression and surgery alone (RR 0.80, 95% CI 0.70 to 0.91; 1 RCT, n = 285; very low-quality evidence). Pregnancy rate is probably increased with postsurgical medical hormonal suppression compared to surgery alone (RR 1.22, 95% CI 1.06 to 1.39; 11 RCTs, n = 932; I 2 = 24%; moderate-quality evidence). Pre- and postsurgical medical therapy compared with surgery alone or surgery and placebo There were no trials identified in the search for this comparison. Presurgical medical therapy compared with postsurgical medical therapy We are uncertain about the difference in pain recurrence at 12 months or less (dichotomous) between postsurgical and presurgical medical hormonal suppression therapy (RR 1.40, 95% CI 0.95 to 2.07; 2 RCTs, n = 326; I 2 = 2%; low-quality evidence). We are uncertain about the difference in disease recurrence at 12 months or less (EEC stage) between postsurgical and presurgical medical hormonal suppression therapy (RR 1.10, 95% CI 0.95 to 1.28; 1 RCT, n = 273; very low-quality evidence). We are uncertain about the difference in pregnancy rate between postsurgical and presurgical medical hormonal suppression therapy (RR 1.05, 95% CI 0.91 to 1.21; 1 RCT, n = 273; very low-quality evidence). No trials reported pelvic pain at 12 months or less (continuous), disease recurrence at 12 months - total (AFS score) or disease recurrence at 12 months or less (dichotomous). Postsurgical medical therapy compared with pre- and postsurgical medical therapy There were no trials identified in the search for this comparison. Serious adverse effects for medical therapies reviewed There was insufficient evidence to reach a conclusion regarding serious adverse effects, as no studies reported data suitable for analysis.; Authors' Conclusions: Our results indicate that the data about the efficacy of medical therapy for endometriosis are inconclusive, related to the timing of hormonal suppression therapy relative to surgery for endometriosis. In our various comparisons of the timing of hormonal suppression therapy, women who receive postsurgical medical therapy compared with no medical therapy or placebo may experience benefit in terms of disease recurrence and pregnancy. There is insufficient evidence regarding hormonal suppression therapy at other time points in relation to surgery for women with endometriosis. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Chen, J., et al. (2023). "Low-molecular-weight heparin in thrombophilic women receiving in vitro fertilization/intracytoplasmic sperm injection: A meta-analysis." Acta Obstetricia et Gynecologica Scandinavica 102(11): 1431-1439.
	Introduction: This meta-analysis aimed to evaluate the efficacy and safety of low-molecular-weight heparin (LMWH) on pregnancy outcomes in thrombophilic women receiving in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI).; Material and Methods: A systematic literature search of PubMed, EMBASE, the Cochrane Library, and China National Knowledge Infrastructure was performed to identify randomized controlled trials (RCTs) comparing LMWH with no treatment or placebo published from database inception until February 19, 2023. Primary outcomes were the clinical pregnancy rate and implantation rate, and secondary outcomes were the live birth rate, miscarriage rate, and the risk of bleeding events. The certainty of the evidence was rated using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system. Meta-analysis was conducted using STATA 14.0.; Results: Five RCTs involving 1094 thrombophilic women receiving IVF/ICSI were finally included. Administration of LMWH was associated with statistically higher clinical pregnancy rate (4 RCTs, risk ratio [RR] 1.50, 95% confidence interval [CI] 1.23-1.82, p < 0.001, low certainty evidence), implantation rate (5 RCTs, RR 1.49, 95% CI 1.25-1.78, p < 0.001, very low certainty evidence), and live birth rate (2 RCTs, RR 2.15, 95% CI 1.60-2.89, p < 0.001, very low certainty evidence), but with statistically lower miscarriage rate (2 RCTs, RR 0.36, 95% CI 0.15-0.86, p = 0.021, very low certainty evidence). However, using LMWH was linked to a higher risk of bleeding events (2 RCTs, RR 2.36, 95% CI 1.49-3.74, p < 0.001, very low certainty evidence).; Conclusions: Very low certainty evidence suggests that administration of LMWH may benefit pregnancy outcomes in thrombophilic women receiving IVF/ICSI treatment, although it may also increase the risk of bleeding events. However, before putting our findings into practice, healthcare professionals should conduct an in-depth evaluation of the available evidence and specific patient situations. Furthermore, due to the low methodological quality of the included studies, more high-quality studies are needed to validate our findings in the future. (© 2023 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Chen, J., et al. (2021). "The effects of statins on hyperandrogenism in women with polycystic ovary syndrome: a systematic review and meta-analysis of randomized controlled trials." Reproductive Biology and Endocrinology 19(1): 189.
	Several clinical studies showed that statins were potential to treat polycystic ovary syndrome (PCOS). Through comprehensive search PubMed, EMBASE, the Web of Science, BIOSIS, the ClinialTrails.gov, and the Cochrane Library database up to 14 Feb 2020, we identified the randomized controlled trials about the treatment of statins on hyperandrogenism in PCOS women, and performed a systematic review and meta-analysis. The quality of the included studies was assessed by the Cochrane risk of bias tool and the Jadda score. Subgroup analysis and sensitivity analysis were conducted to analyze the pooled results. Nine trials included 682 PCOS patients were identified. Statins showed a significant potential to reduce testosterone (SMD = -0.47; 95% CI, - 0.76-- 0.18; P = 0.002) and dehydroepiandrosterone (SMD = -0.51; 95% CI, - 0.97-- 0.05; P = 0.03) levels, compared to the control treatments. The cutaneous symptoms hirsutism (SMD = -0.61; 95% CI, - 1.13-- 0.10; P = 0.02) and acne (SMD = -0.92; 95% CI, - 1.49-- 0.34; P = 0.002) were significantly improved by statins in PCOS women. Subgroup analysis showed that the two types of statins, and the different control treatments as well, presented no significantly different effect on testosterone and dehydroepiandrosterone. Sensitivity analysis confirmed the stability of the findings from the meta-analysis. In conclusion, statin treatment could significantly reduce androgen levels and improve cutaneous manifestations of hyperandrogenism of PCOS. (© 2021. The Author(s).)

Chen, J., et al. (2023). "Efficacy and Safety of PARP Inhibitor Therapy in Advanced Ovarian Cancer: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials." Current computer-aided drug design.
	Aims: This study aims to evaluate the efficacy and safety of PARP inhibitor therapy in advanced ovarian cancer and identify the optimal treatment for the survival of patients.; Background: The diversity of PARP inhibitors makes clinicians confused about the optimal strategy and the most effective BRCAm mutation-based regimen for the survival of patients with advanced ovarian cancer.; Objectives: The objective of this study is to compare the effects of various PARP inhibitors alone or in combination with other agents in advanced ovarian cancer.; Methods: PubMed, Embase, Cochrane Library, and Web of Science were searched for relevant studies on PARP inhibitors for ovarian cancer. Bayesian network meta-analysis was performed using Stata 15.0 and R 4.0.4. The primary outcome was the overall PFS, and the secondary outcomes included OS, AE3, DISAE, and TFST.; Results: Fifteen studies involving 5,788 participants were included. The Bayesian network metaanalysis results showed that olaparibANDAI was the most beneficial in prolonging overall PFS and non-BRCAm PFS, followed by niraparibANDAI. However, for BRCAm patients, olaparibTR might be the most effective, followed by niraparibANDAI. Olaparib was the most effective for the OS of BRCAm patients. AI, olaparibANDAI, and veliparibTR were more likely to induce grade 3 or higher adverse events. AI and olaparibANDAI were more likely to cause DISAE.; Conclusion: PARP inhibitors are beneficial to the survival of patients with advanced ovarian cancer. The olaparibTR is the most effective for BRCAm patients, whereas olaparibANDAI and niraparibANDAI are preferable for non-BRCAm patients. Other: More high-quality studies are desired to investigate the efficacy and safety of PARP inhibitors in patients with other genetic performances. (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Chen, L., et al. (2022). "Menopausal hormone therapy does not improve some domains of memory: A systematic review and meta-analysis." Frontiers in Endocrinology 13: 894883.
	Background: Aged women appear to be at a higher risk of developing memory impairment than men. Whether menopausal hormone therapy (MHT) could improve memory in postmenopausal women remains unclear. We thus conducted a meta-analysis to investigate the potential effect of MHT on memory, especially verbal memory, in postmenopausal women.; Methods: PubMed, Cochrane, Embase, Chinese Biomedical Literature Database, and web of ClinicalTrials.gov were systematically searched for randomized controlled trials comparing MHT versus placebo in postmenopausal women. Our primary outcome of interest is memory function.; Results: We included 10 studies with 2,818 participants in the final analysis. There was no significant differences in immediate recall (weighted mean difference [WMD] 0.34, 95% confidence interval [CI]: -0.73, 1.40), delayed recall (WMD 0.99, 95% CI: -0.51, 2.48), short-delay (WMD -0.00, 95% CI: -0.37, 0.37), and long-delay (WMD -0.19, 95% CI: -0.69, 0.31) recall between WMT and placebo. WMT was associated with a lower digit span forward (mean reduction -0.20, 95% CI: -0.36, -0.03). In women within 5 years of menopause, MHT did not differ in immediate (0.45, 95% CI: -0.75, 1.65) or delayed recall (1.03, 95% CI: -0.93, 3.00), and digit span forward (-0.11, 95% CI: -0.72, 0.50), when compared with placebo.; Conclusion: This meta-analysis suggested that MHT had no effect on verbal memory in postmenopausal women, and may impair some domains of short-term memory. Current available evidence does not support MHT for improving memory in women less than 60 years, even in recently menopausal women.; Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO, identifier CRD42021233255.; 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, Zheng, Chen, Liu, Yao and Chen.)

Chen, L.-L. and J.-H. Zheng (2021). "Effects of atorvastatin on the insulin resistance in women of polycystic ovary syndrome: A systematic review and meta-analysis." Medicine 100(24): e26289.
	Background: Atorvastatin treatment has been suggested as a therapeutic method for women with polycystic ovary syndrome (PCOS) in many clinical studies. Nonetheless, the effects of atorvastatin on insulin resistance in PCOS patients still remain controversial.; Objective: The aim of this report was to evaluate the effects of atorvastatin therapy on the insulin resistance in the treatment of PCOS compared to that of placebo, in order to confer a reference for clinical practice.; Methods: Randomized controlled trials (RCTs) of atorvastatin for PCOS published up to August, 2020 were searched. Standardized mean difference (SMD) and 95% confidence interval (CI) were calculated, and heterogeneity was measured by the I2 test. Sensitivity analysis was also carried out. The outcomes of interest were as follows: fasting glucose concentration, fasting insulin level, homeostasis model assessment of insulin resistance (HOMA-IR) or body mass index (BMI) value.; Results: Nine RCTs with 406 participants were included. The difference of fasting glucose concentration in PCOS patients between atorvastatin group and placebo group was not statistically significant (8 trials; SMD -0.06, 95% CI -0.31 to 0.20, P = .66). PCOS patients in atorvastatin group had lower fasting insulin level than those in placebo group (7 trials; SMD -1.84, 95% CI -3.06 to -0.62, P < .003). The homeostasis model assessment of insulin resistance (HOMA-IR) value showed significant decrease in the atorvastatin therapy compared to placebo (6 trials; SMD -4.12, 95% CI -6.00 to -2.23, P < .0001). In contrast to placebo, atorvastatin therapy did not decrease the BMI value significantly in PCOS patients (7 trials; SMD 0.12, 95% CI -0.07 to 0.31, P = .22).; Conclusions: Atorvastatin therapy can reduce insulin resistance in the treatment of patients with PCOS. In addition, further large-sample, multi-center RCTs are needed to identify these findings.; Competing Interests: The authors have no funding and conflicts of interests to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Chen, R., et al. (2022). "Probiotics are a good choice for the treatment of bacterial vaginosis: a meta-analysis of randomized controlled trial." Reproductive Health 19(1): 137.
	Background: Bacterial vaginosis (BV) is one of the most common vaginal infectious diseases in female reproductive period. Although the existing view is that probiotic treatment may be one of the feasible methods for the treatment of BV, different intervention methods lead to different treatment results. Therefore, up-to-date and comprehensive evidence in this regard is essential for the development of intervention strategies.; Objective: This meta-analysis aims to systematically evaluate the role of probiotics in the treatment of BV in adult women.; Methods: We searched the databases of Embase, Cochrane Library, PubMed, Web of Science and ClinicalTrials.gov for Randomized Controlled Trials published until November 7, 2021. Meta-analysis was performed by Revman5.3 software to systematically evaluate the clinical efficacy of probiotics adjunctive therapy in the treatment of BV. The literatures were screened and evaluated according to the inclusion and exclusion criteria. Chi-square test was used to test the heterogeneity between trials. Random or Fixed effect models were used to analyze the cure rate of BV.; Results: Fourteen randomized controlled trials compared the efficacy of probiotics with antibiotic therapy (probiotics + antibiotics group) versus antibiotics alone or plus placebo (antibiotics (+ placebo) group) for BV [Risk Ratios (RR) = 1.23, 95% CI (1.05, 1.43), P = 0.009]. Three compared the efficacy of probiotics regimen (probiotics group) and antibiotics (antibiotics group) in the treatment of BV [RR = 1.12, 95% CI (0.60, 2.07), P = 0.72]. Another Three compared the efficacy of probiotics regimen (probiotics group) with placebo (placebo group) [RR = 15.20, 95% CI (3.87, 59.64), P < 0.0001].; Conclusion: Our meta-analysis suggests probiotics may play a positive role in the treatment of BV, but more strong evidence is needed. (© 2022. The Author(s).)

Chen, R. and J. You (2022). "Comparison of hysterectomy and uterine artery embolization in the treatment of symptomatic uterine fibroids: A protocol for systematic review and meta-analysis." Medicine 101(52): e32440.
	Background: Uterine fibroids are common benign tumors in premenopausal women. Surgery is the preferred treatment for symptomatic uterine fibroids. An alternative of hysterectomy to manage symptomatic uterine fibroids is selective uterine artery embolization. We performed a protocol for systematic review and meta-analysis to assess the effectiveness of uterine artery embolization for treating symptomatic uterine fibroids compared with hysterectomy.; Methods: The current systematic review and meta-analysis will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol. This review protocol has been registered in the International Prospective Register of systematic reviews. Its registration number is CRD42022371866. Only randomized controlled trials (RCTs) are included in our study.Two independent reviewers will search for databases including PubMed, Embase, Cochrane Library website, ClinicalTrials.gov databases, Chinese National Knowledge Infrastructure Database, Wanfang database, and VIP database. The risk of bias in each included study will be assessed utilizing the Cochrane Collaboration's risk of bias tool. The RevMan 5.3 software (Cochrane Collaboration, Oxford, UK) will be used to conduct the meta-analyses.; Results: The results of this systematic review will be published in a peer-reviewed journal.; Conclusion: This systematic review will provide high quality evidence to judge whether uterine artery embolization is an effective surgical method for patients with symptomatic uterine fibroids.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Chen, T.-L., et al. (2021). "Effectiveness of mindfulness-based interventions on quality of life and menopausal symptoms in menopausal women: A meta-analysis." Journal of Psychosomatic Research 147: 110515.
	Objective: Menopause is a normal physiological process experienced by women, but it is often accompanied by physical and emotional symptoms that may negatively affect quality of life. This meta-analysis aimed to evaluate the effectiveness of mindfulness-based interventions on quality of life and menopausal symptoms by examining randomized controlled trials.; Methods: A systematic search was conducted across six electronic databases to collect relevant articles published up to June 30, 2020. The articles' quality was assessed using the modified Jadad scale. We performed a meta-analysis with Review Manager 5.3, calculating 95% confidence intervals and standardized mean differences, and conducted sensitivity analyses.; Results: The meta-analysis of five randomized controlled trials included 475 participants. The results indicated that the mindfulness-based intervention groups showed significant improvements in total quality of life and vasomotor and physical quality of life, compared to control groups (standardized mean differences range: from -0.48 to -0.68, all ps < 0.05). After the sensitivity analyses, evidence of heterogeneity remained. Insufficient data prevented conducting a meta-analysis with the sexual subscale of MENQOL or on vasomotor symptoms of menopause.; Conclusion: For menopausal women, mindfulness-based interventions may improve quality of life (except for psychological and sexual subscales). However, there is insufficient evidence to analyze whether such interventions can reduce vasomotor-related menopausal symptoms. Although heterogeneity should be carefully assessed, mindfulness-based interventions may be a novel approach for improving women's overall quality of life during menopause. However, further research is needed to verify these effects. (Copyright © 2021 Elsevier Inc. All rights reserved.)

Chen, W. and W. Fang (2022). "A systematic review and network meta-analysis of efficacy in patients with chronic endometritis." PROSPERO International prospective register of systematic reviews.
	
Chen, W., et al. (2022). "Pharmacological interventions for the prevention of Unexplained Recurrent Spontaneous Abortion: protocol for a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Chen, Y., et al. (2022). "Effect of the enhanced recovery after surgery protocol on recovery after laparoscopic myomectomy: a systematic review and meta-analysis." Gland Surgery 11(5): 837-846.
	Background: Surgery is the recommended treatment for uterine leiomyoma but it still has issues like postoperative complications and slow recovery. The enhanced recovery after surgery (ERAS) protocol could probably reduce traumatic stress and promote the rapid postoperative recovery of patients, but there are controversies for the results of different studies. This meta-analysis was performed to resolve the controversies and provide evidence for the application of ERAS in gynecology.; Methods: The PubMed, Embase, Ovid, CNKI (China), Wanfang Data (China), and Google Scholar databases were searched to recruit all studies on the application of ERAS in laparoscopic myomectomy up to November 2021. The inclusion criteria of studies was established according to the PICOS principles. the Cochrane RoB 2.0 and Newcastle-Ottawa Scale (NOS) scale were used to assess the bias of the studies, RevMan 5.3 software was used for meta-analysis.; Results: Ten studies that met the criteria were finally included with 1,441 participants. Eight of them were randomized controlled trials (RCTs) and two were cohort studies, all of them were with low level of bias. Meta-analysis showed that ERAS protocol after laparoscopic myomectomy could significantly shorten the first time getting out of bed after surgery [mean difference (MD) =-4.85; 95% confidence interval (CI): (-7.35, -2.36); P=0.0001], the first defecation time after surgery [MD =-4.69; 95% CI: (-5.68, -3.69); P<0.00001], and the postoperative hospital stay [MD =-1.32, 95% CI: (-2.08, -0.56); P=0.0007]. It could also markedly reduce the patient readmission rate [odds ratio (OR) =0.42; 95% CI: (0.23, 0.76); P=0.004], and notably reduced the incidence of complications [OR =0.37; 95% CI: (0.22, 0.61); Z=3.82; P=0.0001]. Yet, the cost of the ERAS protocol was not significantly different from that of routine care [MD =-127.76, 95% CI: (-997.19, 741.66); P=0.77].; Discussion: The application of ERAS protocol after gynecological laparoscopic myomectomy can shorten the first defecation time, first time out of bed, hospital stay, and reduce the readmission rate as well as the incidence of postoperative complications, without additional costs. But still there was heterogeneity among the studies, the topic still deserved further exploration.; Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://gs.amegroups.com/article/view/10.21037/gs-22-168/coif). The authors have no conflicts of interest to declare. (2022 Gland Surgery. All rights reserved.)

Chen, Y., et al. (2022). "Sacrospinous Ligament Fixation vs Uterosacral Ligaments Suspension for Pelvic Organ Prolapse: A Systematic Review and Meta-Analysis." Urology 166: 133-139.
	Objective: To compare the effectiveness and safety of sacrospinous ligament fixation (SSLF) and uterosacral ligaments suspension (ULS) for surgical correction of pelvic organ prolapse (POP).; Methods: Comparative studies were identified in PubMed, EMBASE, MEDLINE, Cochrane library, Medicine and clinicaltrials.gov databases. Randomized controlled trials, prospective and retrospective cohort studies were included. Primary outcomes were collected including anatomical success rate (Defined as anterior or posterior vaginal wall beyond the hymen), surgical success rate, recurrence and total complication rate, while secondary outcomes were specific complications rates. Data were analyzed using Revman (Version 5.4).; Results: After searching databases and removing the duplicate studies, a total of 57 articles had entered the screening stage. Finally, 9 moderate and high quality studies (4 randomized controlled trials and 5 retrospective studies) with 4516 participants were included. For primary outcomes, there was no statistical difference between the 2 groups regarding surgical success rate (RR = 1.00; 95% CI: 0.91-1.01; I 2 = 0%; P =.98), anatomical success (RR = 0.90; 95% CI: 0.78-1.05; I 2 = 61%; P =.19), recurrence rate (RR = 1.26; 95% CI: 0.85-1.87; I 2 = 75%; P =.24) and total complication rate (RR = 1.07; 95% CI: 0.89-1.28; I 2 = 33%; P =.47). Subgroup analysis regarding different follow-up times (1,2 and 5 years) and stages (Stage 2 and stage 3-4) found similar results in primary outcomes.; Conclusion: In conclusion, SSLF and ULS have the same efficacy and safety for patients. However, SSLF seems to have lower complication rates of vaginal granulation tissue and urethral injury and is gradually favored by surgeons because of its short operation time and simple operation. We still need more high-quality research, especially in terms of the incidence of complications. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Chen, Y., et al. (2024). "Long-term outcomes of surgical interventions for stress urinary incontinence: a systematic review and network meta-analysis." International Journal of Surgery 110(1): 520-528.
	BACKGROUND: Stress urinary incontinence is common among women, and surgical interventions have significantly improved patients' symptoms. The long-term effectiveness of these surgeries is increasingly drawing attention, yet it remains sparsely documented in the literature. OBJECTIVE(S): To compare the long-term effectiveness and safety of retropubic tension-free vaginal tape (TVT-RP), tension-free vaginal tape-obturator (TVT-O), transobturator tape (TOT), single-incision sling (SIS), Burch colposuspension, and pubovaginal sling (PVS). METHOD(S): A comprehensive and systematic literature review was conducted in PubMed, EMBASE, MEDLINE, Cochrane Library, Medicine, and clinicaltrials.gov from inception to May 2023. Selected trials were evaluated for potential bias using the Cochrane tool. Treatment modalities were compared using network meta-analysis to assess objective success rate, subjective success rate, and complications as outcomes. RESULT(S): A total of 37 studies involving 5720 patients were included. No significant statistical differences were found among the interventions regarding objective success rate. PVS had the highest surface under the cumulative ranking curve SUCRA value (93.1). For subjective success rate, TVT-RP, TVT-O, and PVS demonstrated superiority over SIS, with PVS having the highest SUCRA value (80.1). SIS had lower overall complication and pain rates compared to other methods, with statistical significance. There were no differences in reoperation rate, exposure rate, and urinary tract infection occurrence among the surgical approaches. CONCLUSION(S): In terms of long-term effectiveness and safety, TVT-RP and TVT-O appear to be the preferred options for patients opting for synthetic slings, while for patients seeking nonsynthetic slings, PVS may represent the optimal choice.Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.

Chen, Y.-C., et al. (2023). "Effect of Vitamin D Supplementation on Primary Dysmenorrhea: A Systematic Review and Meta-Analysis of Randomized Clinical Trials." Nutrients 15(13).
	Dysmenorrhea causes pain and inconvenience during menstruation. In addition to medication, natural compounds are widely used to relieve various types of pain. In this study, we aimed to assess the effects of vitamin D (vit. D) supplementation in relieving the symptoms of primary dysmenorrhea. A comprehensive systematic database search of randomized controlled trials (RCTs) was performed. Oral forms of vit. D supplementation were included and compared with a placebo or standard care. The degree of dysmenorrhea pain was measured with a visual analogue scale or numerical rating scale. Outcomes were compared using the standardized mean difference (SMD) and 95% confidence intervals (CIs) in a meta-analysis. RCTs were assessed using the Cochrane risk-of-bias v2 (RoB 2) tool. The meta-analysis included 8 randomized controlled trials involving 695 participants. The results of the quantitative analysis showed a significantly lower degree of pain in the vit. D versus placebo in those with dysmenorrhea (SMD: -1.404, 95% CI: -2.078 to -0.731). The results of subgroup analysis revealed that pain lessened when the average weekly dose of vit. D was over 50,000 IU, in which dysmenorrhea was relieved regardless of whether vit. D was administered for more or less than 70 days and in any dose interval. The results revealed that vit. D treatment substantially reduced the pain level in the primary dysmenorrhea population. We concluded that vit. D supplementation is an alternative treatment for relieving the pain symptoms of dysmenorrhea.

Chen, Y.-Y., et al. (2021). "Estrogen for the prevention of recurrent urinary tract infections in postmenopausal women: a meta-analysis of randomized controlled trials." International Urogynecology Journal 32(1): 17-25.
	Introduction and Hypothesis: Recurrent urinary tract infections (rUTIs) are commonly encountered in postmenopausal women. Optimal non-antimicrobial prophylaxis for rUTIs is an important health issue. The aim of this study was to evaluate the use of estrogen in the prevention of rUTIs versus placebo.; Methods: Eligible studies published up to December 2019 were retrieved through searches of MEDLINE, Embase, and Cochrane Central Register of Controlled Trials and Database of Systematic Reviews. We included randomized controlled trials of estrogen therapies versus placebo regarding the outcomes of preventing rUTIs. Changes in vaginal pH and estrogen-associated adverse events were also analyzed.; Results: Eight studies including 4702 patients (2367 who received estrogen and 2335 who received placebo) were identified. Five studies including 1936 patients evaluated the use of vaginal estrogen, which resulted in a significant reduction in rUTIs (relative risk, 0.42; 95% CI, 0.30-0.59). Three studies including 2766 patients evaluated the outcomes of oral estrogen in the prevention of UTIs and showed no significant difference in the number of rUTIs compared to treatment with placebo (relative risk, 1.11; 95% CI, 0.92-1.35). Two studies reviewed changes in vaginal pH and showed a lower pH (mean difference, -1.81; 95% CI, -3.10--0.52) after vaginal estrogen therapy. Adverse events associated with vaginal estrogen were reported, including vaginal discomfort, irritation, burning, and itching. There was no significance increase in the vaginal estrogen group (relative risk, 3.06; 95% CI, 0.79-11.90).; Conclusions: Compared with placebo, vaginal estrogen treatment could reduce the number of rUTIs and lower the vaginal pH in postmenopausal women.

Chen, Z. and Z. Cai (2022). "Effects of oral contraceptives plus orlistat in patients with polycystic ovary syndrome and overweight/obesity: A meta-analysis." The Journal of Obstetrics and Gynaecology Research 48(6): 1399-1408.
	Aim: This meta-analysis was conducted to compare the effect and safety of oral contraceptive pills (OCP) plus orlistat with OCP alone in clinical, hormonal, and lipid metabolism outcomes in patients with polycystic ovary syndrome (PCOS) and overweight/obesity.; Methods: Pubmed, Embase, Web of Science, Chinese National Knowledge Infrastructure (CNKI), and SinoMed were systematically reviewed. A random-effects or fixed-effects model was used to pool the estimate.; Results: Eight studies were included in this meta-analysis. Significant reductions in BMI, WHR, and waist circumference were observed in combination group as compared with OCP alone group. Regarding the hormonal outcome, T, SHBG, FAI, LH, DHEAS, FSH, and E2 levels were significantly improved in combination group compared with OCP alone group. However, the TT and FT did not change significantly between the two groups. Regarding the lipid metabolism outcomes, TC, LDL-C, and TG levels were reduced and HDL-C level was increased in the combination group. Regarding the insulin metabolism outcomes, FINS and HOMA-IR levels were reduced in combination group than in OCP group. The ovulation rate, pregnancy rate, and overall effective rate were significantly higher in combination group than in OCP alone group. Fewer complications were observed in the combination group than in OCP group, and the difference between them was significant.; Conclusion: This combination treatment of OCP and orlistat was more effective than OCP alone in reducing the weight, hormonal, lipid, and insulin metabolism profiles, as well as improving the ovulation rate, pregnancy rate, and overall effective rate, as compared with OCP alone. (© 2022 Japan Society of Obstetrics and Gynecology.)

Chen, Z., et al. (2022). "Oral traditional Chinese patent medicines combined with non-steroidal anti-inflammatory drugs for primary dysmenorrhea: A protocol for Bayesian network meta-analysis and systematic review." PloS One 17(10): e0276129.
	Introduction: Primary dysmenorrhea (PD) was the most common gynecological disorder, with an increasingly high prevalence worldwide. PD often accompanied other dysmenorrhea-associated symptoms to trigger exacerbations, and even cause depression and anxiety for patients. As the effective first-line medication, non-steroidal anti-inflammatory drugs (NSAIDs) have become widespread across China and combined with oral traditional Chinese patent medicines (TCPMs) for PD in clinical practice. We hope to provide better efficacy and safety evidence about oral TCPMs combined with NSAIDs (oral TCPMs+NSAIDs) for patients with PD by this network meta-analysis.; Methods and Analysis: We will perform a Bayesian network meta-analysis of all oral TCPMs+NSAIDs for clinical diagnosis as PD. PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform, VIP information resource integration service platform databases, and clinical registers will be searched from the database inception to June 30, 2022 to find randomized controlled trials. Two reviewers will independently screen and check titles and abstracts and read the full text. Data extraction with the same criteria will be conducted by two researchers, including study characteristics, participant characteristics, interventions and comparators, and outcomes. We will perform the network meta-analysis by the Bayesian random method to analyze the direct and indirect comparisons. Meta-regression with multiple covariates will be conducted to find the potential heterogeneity. We will perform the sensitivity analysis to identify the potential effect on the robustness of our results. Evidence certainty of all interventions in outcomes will be identified and assessed by Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) assessment. Funnel plots with Egger test and Begg's test to detect the potential publication bias.; Trial Registration: PROSPERO registration number: CRD42021265675.; Competing Interests: The authors have declared that no competing interests exist.

Cheng, H., et al. (2021). "Poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors as maintenance therapy in women with newly diagnosed ovarian cancer: a systematic review and meta-analysis." Archives of Gynecology and Obstetrics 304(2): 285-296.
	Purpose: To investigate the efficacy and safety of poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors (including their different types) as maintenance therapy in women with newly diagnosed ovarian cancer, and to explore whether this therapy produces a survival benefit in a subgroup population with specific clinical characteristics.; Methods: We searched MEDLINE, EMBASE, the Cochrane Library, Web of Science and relevant clinical research registry platforms on October 1, 2019, and included randomized controlled trials (RCTs) that compared PARP inhibitors with placebo in women (aged ≥ 18 years) with newly diagnosed epithelial ovarian cancer.; Results: We identified four RCTs with 3,070 participants. Compared with placebo, PARP inhibitor maintenance therapy showed a clinically significant benefit on progression free survival (PFS) in homologous recombination deficiency (HRD) positive population (hazard ratio [HR], 0.39; 95% confidence interval [CI], 0.29-0.53). In contrast, no clear differences were identified between the groups in the HRD negative population (HR, 0.83; 95% CI 0.67-1.03). Further, there was no clear difference between the groups in terms of other outcomes (overall survival, health-related quality of life, and adverse events).; Conclusions: PARP inhibitor maintenance therapy significantly prolongs the PFS of patients with newly diagnosed ovarian cancer, especially in HRD positive patients. The diagnostic test used to determine HRD status plays an important role in guiding PARP inhibitor maintenance therapy. Compared with placebo, the effect of PARP inhibitors on ovarian cancer was probably not affected by the International Federation of Gynecology and Obstetrics stage status, response to first-line chemotherapy, and residual macroscopic disease after debulking surgery. (© 2021. The Author(s).)

Cheng, J., et al. (2021). "Effectiveness comparisons of various therapies for FIGO stage IB2/IIA2 cervical cancer: a Bayesian network meta-analysis." BMC Cancer 21(1): 1078.
	Background: Cervical cancer is a common malignancy of the female genital tract. Treatment options for cervical cancer patients diagnosed at FIGO (2009) stage IB2 and IIA2 remains controversial.; Methods: We perform a Bayesian network meta-analysis to directly or indirectly compare various interventions for FIGO (2009) IB2 and IIA2 disease, in order to improve our understand of the optimal treatment strategy for these women. Three databases were searched for articles published between 1971 and 2020. Data on included study characteristics, outcomes, and risk of bias were abstracted by two reviewers.; Results: Seven thousand four hundred eighty-six articles were identified. Thirteen randomized controlled trials of FIGO (2009) IB2 and IIA2 cervical cancer patients were included in the final analysis. These trials used six different interventions: concomitant chemoradiotherapy (CCRT), radical surgery (RS), radical surgery following chemoradiotherapy (CCRT+RS), neoadjuvant chemotherapy followed by radical surgery (NACT+RS), adjuvant radiotherapy followed by Radical surgery (RT + RS), radiotherapy alone (RT).SUCRA ranking of OS and Relapse identified CCRT+RS and CCRT as the best interventions, respectively. Systematic clustering analysis identified the CCRT group as a unique cluster.; Conclusion: These data suggest that CCRT may be the best approach for improving the clinical outcome of cervical cancer patients diagnosed at FIGO (2009) stage IB2/IIA2. Phase III randomized trials should be performed in order to robustly assess the relative efficacy of available treatment strategies in this disease context. (© 2021. The Author(s).)

Cheng, Y.-S., et al. (2020). "Serotonergic antidepressants for sleep disturbances in perimenopausal and postmenopausal women: a systematic review and meta-analysis." Menopause 28(2): 207-216.
	Importance: Although previous meta-analyses mainly focused on the effects of hormonal treatment against menopausal sleep disturbances, the therapeutic role of antidepressants has not been systematically addressed.; Objective: To study the therapeutic benefit and safety of antidepressants in menopausal sleep disturbances.; Evidence Review: Randomized controlled trials assessing the therapeutic effects of antidepressants against menopausal sleep problems were identified from the PubMed, Cochrane Library, and Science Direct databases from inception to March 1, 2020. Studies that were clinical trials with placebo controls were included. Subgroup analyses were conducted according to a random effects model.; Findings: Analysis of seven eligible randomized controlled trials including a total of 1,949 perimenopausal and postmenopausal women showed the effectiveness of serotonergic antidepressants against sleep disturbances despite the small effect size (Hedge g = 0.24, 95% CI = 0.11-0.38). The efficacy remained significantly better than that of placebo for postmenopausal women (Hedge g = 0.25, 95% CI = 0.04-0.45), participants with hot flashes (Hedge g = 0.18, 95% CI = 0.02-0.34), and those without diagnosis of major depressive disorder (Hedge g = 0.23, 95% CI = 0.06-0.40). There was no difference in therapeutic benefit between sedating and nonsedating serotonergic antidepressants. Besides, the dropout rate did not differ between antidepressant and placebo groups.; Conclusions and Relevance: Our results showed that serotonergic antidepressants were effective against sleep disturbances in perimenopausal and postmenopausal women. The efficacy remained significant for women without major depressive disorder. The dropout rates were also comparable between serotonergic antidepressants and placebo groups.; Competing Interests: Financial disclosure/conflicts of interest: None reported. (Copyright © 2020 by The North American Menopause Society.)

Cheng, Y.-S., et al. (2021). "Pharmacologic and hormonal treatments for menopausal sleep disturbances: A network meta-analysis of 43 randomized controlled trials and 32,271 menopausal women." Sleep Medicine Reviews 57: 101469.
	This network meta-analysis aimed at investigating efficacy/tolerability of pharmacologic/hormonal interventions for menopausal sleep disturbances. Major databases were searched for randomized controlled trials (RCTs) examining pharmacologic or hormonal interventions with either placebo or active controlled designs. Primary outcomes were improvements in sleep disturbance severity/tolerability (i.e., overall dropout rates), whereas secondary outcome was adverse event-related discontinuation rates. Analysis of 43 RCTs with 25 treatment arms involving 32,271 women during/after menopausal transition (age: 61.24 ± 4.23, duration: 90.83 ± 66.29 wks) showed therapeutic effect of melatonin-fluoxetine [SMD = -2.47 (95% CI:-4.19-0.74)] against sleep disturbances compared to placebo. Subgroup analysis of 15 RCTs on vasomotor symptoms demonstrated superior benefits of gabapentin [SMD = -1.04 (95% CI:-1.90-0.18)], oral combined hormone therapy [SMD = -0.62 (95% CI:-1.06-0.18)], and bazedoxifene-conjugated estrogens [SMD = -0.50 (95% CI:-0.96-0.04)] to placebo/control. Despite benefits of raloxifene-only [SMD = -1.86 (95% CI:-3.09-0.63)] and raloxifene-oral estrogen [SMD = -2.64 (95% CI:-4.64-0.63)], patient selection may be a confounder. Dropout rates were comparable between interventions and placebo/control. Eszopiclone [RR = 3.84 (95% CI: 1.14-12.87)] and oral combined hormone therapy [RR = 2.51 (95% CI: 1.04-6.07)] were associated with higher rates of adverse event-related discontinuation. The results support combined estrogen-progesterone therapy for menopausal sleep disturbances associated with vasomotor symptoms but showed no significant effects of hypnotics in this clinical setting.; Competing Interests: Conflicts of interest The authors do not have any conflicts of interest to disclose. (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Chien, Y., et al. (2021). "Estrogen supplement improves bone mineral density in oligomenorrhea or amenorrhea athletes." PROSPERO International prospective register of systematic reviews.
	
Chieng Wei, K., et al. (2022). "Probiotics, a promising therapy to reduce the recurrence of bacterial vaginosis in women? a systematic review and meta-analysis of randomized controlled trials." Frontiers in Nutrition 9: 938838.
	Introduction: The evidence for probiotic efficacy in preventing bacterial vaginosis (BV) recurrences among women aged 18 years and above is sparse. We aimed to ascertain the efficacy of probiotics in preventing BV recurrences after at least one menstrual cycle in this population.; Methods: We conducted a systematic literature search using PubMed, MEDLINE (Ovid interface), Web of Science (WoS), Scopus, Embase, ProQuest Dissertations and Theses Global, Cochrane Library databases and registries comprised of Open Science Framework (OSF) preprints registry, the ClinicalTrials.gov (USA), WHO International Clinical Trials Registry Platform (WHO-ICTRP), International Standard RCT Number (ISRCTN) registry, limited to randomized clinical trials (RCTs) in English published between January 2000 and December 2021. The inclusion criteria were trials that administered probiotics to BV-positive women in an experimental arm of at least 20 samples. The usage of probiotics should be preceded with standard antibiotic regimen and followed by a reassessment of BV status after at least a single menstrual cycle. Risk of bias assessment was completed using revised Cochrane risk-of-bias tool for randomized trials (RoB 2). The PROSPERO registration number of the review is CRD42022302044.; Results: From 8,162 identified records, we included 10 studies ( n = 1,234 participants) for final analysis; 7 trials compared probiotics vs. placebo, whereas 3 trials compared probiotics vs. metronidazole alone. Using random-effects meta-analysis, probiotics were shown to reduce the risk of BV recurrences by 45% compared to either placebo or metronidazole [14.8 vs. 25.5%, RR: 0.55 (95%CI: 0.33, 0.91), p = 0.03, I 2 = 45.4% (95%CI: 0, 73.7%)]. Sensitivity analysis revealed the robustness of results upon removal of studies with high risk of bias [RR: 0.54 (95%CI: 0.38, 0.77), p = 0.006] and reporting bias (RR: 0.53, 95%CI: 0.39, 0.74, p = 0.002). Meta-regression demonstrated that the route of administration ( p vaginal = 0.67; p oral = 0.44), the total dosage of probiotics ( p = 0.17), cumulative days of probiotic administration ( p = 0.76), and the number of species in probiotic preparation ( p = 0.40) were not linked to BV recurrences.; Interpretation: Probiotics were associated with more than twofold reduction in BV recurrences when BV status was assessed after at least 1-month postintervention. Further high-quality and methodologically standardized RCTs should evaluate probiotic efficacy for BV prevention in a diverse community setting.; Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/display&#95;record.php?ID=CRD42021290613], identifier [CRD42021290613].; 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 Chieng, Abdul Jalal, Bedi, Zainuddin, Mokhtar, Abu, Chew and Nur Azurah.)

Cho, A., et al. (2021). "Efficacy of Daily Intake of Dried Cranberry 500 mg in Women with Overactive Bladder: A Randomized, Double-Blind, Placebo Controlled Study." The Journal of Urology 205(2): 507-513.
	PURPOSE: We sought to determine the efficacy of dried cranberry on reducing symptoms of overactive bladder in women. MATERIALS AND METHODS: Eligible women aged 18 or older with overactive bladder were randomized to either daily dried cranberry powder (500 mg) or placebo (500 mg) and followed for 24 weeks. Efficacy was measured by 3-day voiding diaries and Overactive Bladder Questionnaire Short Form, Patient Perception of Bladder Condition, Sexual Quality of Life-Female and Pelvic Floor Distress Inventory surveys. Statistical analyses were performed by BIOFORTIS using SAS® software version 9.4. RESULTS: Of the 98 women who were randomized 77 completed all the visits and 60 were included in the per protocol analysis. Compared to placebo using per protocol analysis the cranberry group showed a significant reduction of daily micturitions (-1.91, 95% CI -3.74--0.88, p=0.0406), urgency episodes (-2.81, 95% CI -4.82--0.80, p=0.0069), and Patient Perception of Bladder Condition scores (-0.66, 95% CI -1.23-0.08, p=0.0258) at 24 weeks of followup. Mean volume per micturition, nocturia and the remaining survey outcomes did not differ significantly between the groups (p >0.05). CONCLUSIONS: Daily intake of dried cranberry powder reduced daily micturition by 16.4%, urgency episodes by 57.3% and patient perception of bladder condition by 39.7%. However, an intent-to-treat analysis showed no statistically significant difference between the groups for these measurements (p >0.05). Future larger studies with longer followup periods are needed to further determine the long-term effect of cranberry on overactive bladder.

Cho, B. (2022). "A human study to evaluate the efficacy and safety of herbal complex extract NS2107 on climacteric symptoms in menopausal women." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Dietary Supplement : Subjects will be randomly allocated to placebo or experimental group and take 2 tablets once a day for 12 weeks. CONDITION: Diseases of the genitourinary system PRIMARY OUTCOME: biochemical markers hot flush questionnaire Kupperman index MENQOL SECONDARY OUTCOME: Safety markers INCLUSION CRITERIA: 1) Subject who agrees to participate in the study and signs the informed consent form 2) Women aged 45–65 years 3) Post‐menopausal (amenorrhea = 12 months) or peri‐menopausal (amenorrhea = 3 month & follicle stimulating hormone (FSH) > 30 IU/L) 4) Moderate or severe menopausal symptoms (Kupperman inde Xscore = 15) 5) Subject with an average daily hot flash score of 10 or higher for the past 1 week

Cho, H.-W. (2023). "Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance." ClinicalTrials.gov.
	The primary objective is to find out whether the CRS is beneficial in patients who have progressed on PARPi maintenance.

Cho Hyun, W. (2023). "A randomized phase II study of secondary cytoreductive surgery in patients with relapsed ovarian cancer who have progressed on PARP inhibitor maintenance." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Drug, Procedure/Surgery : 1) Experimental Group Liposomal doxorubicin plus carboplatin and bevacizumab chemotherapy after secondary cytoreductive surgery ‐ Liposomal doxorubicin, 30mg/m2, IV, q4w, 6 ‐ Carboplatin, AUC 5, IV, q4w, 6 ‐ Bevacizumab, 10mg/kg, IV, q2w, 6 ‐> Bevacizumab maintenance, 15mg/kg, IV, q3w (Until PD) 2) Control Group Liposomal doxorubicin plus carboplatin and bevacizumab chemotherapy without surgery ‐ Liposomal doxorubicin, 30mg/m2, IV, q4w, 6 ‐ Carboplatin, AUC 5, IV, q4w, 6 ‐ Bevacizumab, 10mg/kg, IV, q2w, 6 ‐> Bevacizumab maintenance, 15mg/kg, IV, q3w (Until PD) CONDITION: Neoplasms PRIMARY OUTCOME: PFS(Progression‐free survival) SECONDARY OUTCOME: Complication rate associated with surgery until definitive hospital discharge OS(Overall Survival) Predictive and prognostic value of CA‐125, duration of PARPi maintenance, BRCA status QoL(Quality of Life) Rate of complete resection as prognostic factor INCLUSION CRITERIA: ‐ Patients with first recurrence of platinum sensitive, invasive epithelial ovarian‐, fallopian tube‐ or primary peritoneal cancer of any initial stage. ‐ Progression‐free interval of at least 6 months after end of last platinum‐ containing therapy, ‐ Progressed during PARP inhibitor maintenance or treatment free interval biologic agent (TFIb) < 3 months ‐ Women aged = 19 years ‐ Complete resection of the tumor by median laparotomy seems possible (estimated by an experienced surgeon). Intra‐abdominal disease has to be excluded by MRI/CT, if other surgical approaches for isolated extra‐abdominal recurrences are planned 1. A positive AGO‐score and/or iMODEL+PET/CT 2. Patients who are likely to be completely resected according to the investigator's judgment will be allowed by consensus between PI(surgeon) and designated radiologist even if AGO or iMODEL+PET/CT negative. ‐ Patients who have given their signed and written informed consent and

Choi, S. J., et al. (2022). "Randomized, single-blind, placebo-controlled trial on Hominis placenta extract pharmacopuncture for hot flashes in peri- and post-menopausal women." Integrative Medicine Research 11(4): 100891.
	Background: Hominis placenta pharmacopuncture is widely used for climacteric symptoms. This study examined the efficacy and safety of pharmacopuncture with PLC (the extract of Hominis placenta) on hot flashes for perimenopausal and postmenopausal women. Method(s): This study was a randomized placebo-controlled single-blind trial, which recruited 128 perimenopausal and postmenopausal women, randomly assigned to receive pharmacopuncture with PLC or normal saline (NS) for eight weeks. The primary outcome was the mean changes in the hot flash score (HFS) and the secondary outcomes were the mean changes in the Menopause Rating Scale (MRS), follicle-stimulating hormone (FSH) levels, and estradiol (E2) levels from baseline to eight weeks. Missing values were imputed using the last-observation-carried-forward method. Result(s): After treatment (week 9), the HFS decreased significantly in both groups (p = 0.000). The residual HFS was 47.09 +/- 41.39% and 56.45 +/- 44.92 % in the PLC and control groups, respectively (p = 0.262). One month after the treatment (week 13), the score of the PLC group was reduced, but the score increased in the control group (p = 0.077). There were no statistically significant differences in the mean changes in MRS, FSH, and E2 between the two groups. No serious adverse events related to this trial were noted. Conclusion(s): In this study, Hominis placenta extract pharmacopuncture did not differ significantly from NS in reducing the hot flash score. While this therapy appears safe, the potential for long-term effect of PLC extract needs to be examined in a large randomized controlled trial with appropriate controls.Copyright © 2022

Christiansen, M. (2021). "Patient-Reported Outcomes Among Women Wtih Gynecological Cancer (The CONNECT Study)." ClinicalTrials.gov.
	No Results Available Other: Nurse-led consultations based on electronic patient-reported outcomes Change from baseline in Quality of life measured by EORTC QLQ C-30 until 9 months.|Change from baseline in disease-specific Quality of life using the EORTC QLQ-OV28 Ovarian Module until 9 months.|Change from baseline in disease-specific Quality of life using the EORTC QLQ-EN24 Endometrial Module until 9 months.|Change from baseline in Hospital Anxiety and Depression Scale (HADS) until 9 months.|Change from baseline in Self-efficacy for managing chronic disease 6-item scale until 9 months.|Common Terminology Criteria for Adverse Events (CTCAE), an objective grading of the patients symptoms. Female Not Applicable 130 Other Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care Copenhagen University Hospital February 1, 2024

Chuai, Y., et al. (2021). "Vascular endothelial growth factor (VEGF) targeting therapy for persistent, recurrent, or metastatic cervical cancer." The Cochrane Database of Systematic Reviews 3: CD013348.
	Background: Cervical cancer ranks as the fourth leading cause of death from cancer in women. Historically, women with metastatic or recurrent cervical cancer have had limited treatment options. New anti-angiogenesis therapies, such as vascular endothelial growth factor (VEGF) targeting agents, offer an alternative strategy to conventional chemotherapy; they act by inhibiting the growth of new blood vessels, thereby restricting tumour growth by blocking the blood supply.; Objectives: To assess the benefits and harms of VEGF targeting agents in the management of persistent, recurrent, or metastatic cervical cancer.; Search Methods: We performed searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, online registers of clinical trials, and abstracts of scientific meetings up until 27 May 2020.; Selection Criteria: We examined randomised controlled trials (RCTs) that evaluated the use of VEGF targeting agents alone or in combination with conventional chemotherapy or other VEGF targeting agents.; Data Collection and Analysis: Three review authors independently screened the results of search strategies, extracted data, assessed risk of bias, and analysed data according to the standard methods expected by Cochrane. The certainty of evidence was assessed via the GRADE approach.; Main Results: A total of 1634 records were identified. From these, we identified four studies with a total of 808 participants for inclusion. We also identified two studies that were awaiting classification and nine ongoing studies. Bevacizumab plus chemotherapy versus chemotherapy Treatment with bevacizumab plus chemotherapy may result in lower risk of death compared to chemotherapy alone (hazard ratio (HR) 0.77, 95% confidence interval (CI) 0.62 to 0.95; 1 study, 452 participants; low-certainty evidence). However, there are probably more specific adverse events when compared to chemotherapy alone, including gastrointestinal perforations or fistulae (risk ratio (RR) 18.00, 95% CI 2.42 to 133.67; 1 study, 440 participants; moderate-certainty evidence); serious thromboembolic events (RR 4.5, 95% CI 1.55 to 13.08; 1 study, 440 participants; moderate-certainty evidence); and hypertension (RR 13.75, 95% CI 5.07 to 37.29; 1 study, 440 participants; moderate-certainty evidence). There may also be a higher incidence of serious haemorrhage (RR 5.00, 95% CI 1.11 to 22.56; 1 study, 440 participants; low-certainty evidence). In addition, the incidence of serious adverse events is probably higher (RR 1.44, 95% CI 1.16 to 1.79; 1 study, 439 participants; moderate-certainty evidence). The incremental cost-effectiveness ratio was USD 295,164 per quality-adjusted life-year (1 study, 452 participants; low-certainty evidence). Cediranib plus chemotherapy versus chemotherapy Treatment with cediranib plus chemotherapy may or may not result in similar risk of death when compared to chemotherapy alone (HR 0.94, 95% CI 0.53 to 1.65; 1 study, 69 participants; low-certainty evidence). We found very uncertain results for the incidences of specific adverse events, including gastrointestinal perforations or fistulae (RR 3.27, 95% CI 0.14 to 77.57; 1 study, 67 participants; very low-certainty evidence); serious haemorrhage (RR 5.45, 95% CI 0.27 to 109.49; 1 study, 67 participants; very low-certainty evidence); serious thromboembolic events (RR 3.41, 95% CI 0.14 to 80.59; 1 study, 60 participants; very low-certainty evidence); and serious hypertension (RR 0.36, 95% CI 0.02 to 8.62; 1 study, 67 participants; very low-certainty evidence). In addition, there may or may not be a similar incidence of serious adverse events compared to chemotherapy alone (RR 1.15, 95% CI 0.75 to 1.78; 1 study, 67 participants; low-certainty evidence). Apatinib plus chemotherapy or chemotherapy/brachytherapy versus chemotherapy or chemotherapy/brachytherapy Treatment with apatinib plus chemotherapy or chemotherapy/brachytherapy may or may not result in similar risk of death compared to chemotherapy alone or chemotherapy/brachytherapy alone (HR 0.90, 95% CI 0.51 to 60; 1 study, 52 participants; low-certainty evidence). However, hypertension events may occur at a higher incidence as compared to chemotherapy alone or chemotherapy/brachytherapy alone (RR 5.14, 95% CI 1.28 to 20.73; 1 study, 52 participants; low-certainty evidence). Pazopanib plus lapatinib versus lapatinib Treatment with pazopanib plus lapatinib may result in higher risk of death compared to lapatinib alone (HR 2.71, 95% CI 1.16 to 6.31; 1 study, 117 participants; low-certainty evidence). We found very uncertain results for the incidences of specific adverse events, including gastrointestinal perforations or fistulae (RR 2.00, 95% CI 0.19 to 21.59; 1 study, 152 participants; very low-certainty evidence); haemorrhage (RR 2.00, 95% CI 0.72 to 5.58; 1 study, 152 participants; very low-certainty evidence); and thromboembolic events (RR 3.00, 95% CI 0.12 to 72.50; 1 study, 152 participants; very low-certainty evidence). In addition, the incidence of hypertension events is probably higher (RR 12.00, 95% CI 2.94 to 49.01; 1 study, 152 participants; moderate-certainty evidence). There may or may not be a similar incidence of serious adverse events as compared to lapatinib alone (RR 1.45, 95% CI 0.94 to 2.26; 1 study, 152 participants; low-certainty evidence). Pazopanib versus lapatinib Treatment with pazopanib may or may not result in similar risk of death as compared to lapatinib (HR 0.96, 95% CI 0.67 to 1.38; 1 study, 152 participants; low-certainty evidence). We found very uncertain results for the incidences of specific adverse events, including gastrointestinal perforations or fistulae (RR 1.03, 95% CI 0.07 to 16.12; 1 study, 150 participants; very low-certainty evidence); haemorrhage (RR 1.03, 95% CI 0.31 to 3.40; 1 study, 150 participants; very low-certainty evidence); and thromboembolic events (RR 3.08, 95% CI 0.13 to 74.42; 1 study, 150 participants; very low-certainty evidence). In addition, the incidence of hypertension events is probably higher (RR 11.81, 95% CI 2.89 to 48.33; 1 study, 150 participants; moderate-certainty evidence). The risk of serious adverse events may or may not be similar as compared to lapatinib (RR 1.31, 95% CI 0.83 to 2.07; 1 study, 150 participants; low-certainty evidence).; Authors' Conclusions: We found low-certainty evidence in favour of the use of bevacizumab plus chemotherapy. However, bevacizumab probably increases specific adverse events (gastrointestinal perforations or fistulae, thromboembolic events, hypertension) and serious adverse events. We found low-certainty evidence that does not support the use of cediranib plus chemotherapy, apatinib plus chemotherapy, apatinib plus chemotherapy/brachytherapy, or pazopanib monotherapy. We found low-certainty evidence suggesting that pazopanib plus lapatinib worsens outcomes. The VEGF inhibitors apatinib and pazopanib may increase the probability of hypertension events. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Cianci, S., et al. (2020). "Hyperthermic intraperitoneal chemotherapy (HIPEC) for ovarian cancer recurrence: systematic review and meta-analysis." Gland Surgery 9(4): 1140-1148.
	Background: Ovarian cancer is the first cause of death among gynecological malignancies with a high incidence of recurrence. Different treatment options are suitable to prolong the survival rate of these patients. Over the last years, one of the most intriguing methods, adopted in different oncologic centers worldwide, is the hyperthermic intraperitoneal chemotherapy (HIPEC).; Methods: A meta-analysis was performed to value the role of HIPEC for ovarian cancer recurrence. Search strategy was conducted with a combination of the following keywords: "ovarian recurrence, ovarian cancer recurrence, peritoneal cancer recurrence, ovarian recurrence AND HIPEC, secondary cytoreduction HIPEC". Seven studies were selected for analysis.; Results: In women with recurrent ovarian cancer (ROC), the use of HIPEC in addition to cytoreductive surgery and chemotherapy significantly improved 1-year overall survival (OS) when compared to protocols without HIPEC (OR 2.42; 95% CI, 1.06-5.56; P=0.04; I 2 =4%). The improvement in OS was maintained significant also after 2, 3 and 5 years respectively (OR 3.33; 95% CI, 1.81-6.10; P<0.01; I 2 =0%), (OR 4.22; 95% CI, 2.07-8.60; P<0.01; I 2 =52%), (OR 5.17; 95% CI, 1.40-19.09; P=0.01; I 2 =82%).; Conclusions: HIPEC seems to have an effective role to prolong survival in patients affected by ROC.; Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/gs-20-335). The series “Ovarian Cancer Recurrence” was commissioned by the editorial office without any funding or sponsorship. SC served as the unpaid Guest Editor of the series and serves as an unpaid editorial board member of Gland Surgery from Aug 2019 to Jul 2021. The authors have no other conflicts of interest to declare. (2020 Gland Surgery. All rights reserved.)

Cibula, D. (2021). "Intermediate Risk Cervical Cancer: radical Surgery +/- Adjuvant Radiotherapy." ClinicalTrials.gov.
	The role of adjuvant (chemo)radiotherapy in intermediate risk (IR) cervical cancer patients is controversial, supported by single randomised GOG 92 study performed more than 20 years ago. Intermediate‐risk group is defined as lymph node negative but with a combination of negative prognostic factors (tumour size >2 cm, lymphovascular space invasion, deep stromal invasion >2/3). Recent retrospective studies showed excellent local control in intermediate risk group patients after radical surgery with no additional adjuvant treatment. CERVANTES trial is designed to bring level A evidence on the role of adjuvant treatment in IR patients in an international, prospective, randomised study. Patients will be registered into the trial before surgery and randomised after the final pathology report has been received into ARM A, with no additional treatment, and ARM B, receiving adjuvant (chemo)radiotherapy. Quality assurance program will be in place for both, radical surgery and adjuvant treatment.

Cibula, D., et al. (2022). "CERVANTES: an international randomized trial of radical surgery followed by adjuvant (chemo) radiation versus no further treatment in patients with early-stage, intermediate-risk cervical cancer (CEEGOG-CX-05; ENGOT-CX16)." International Journal of Gynecological Cancer.
	Background: The role of adjuvant treatment in the intermediate-risk group of patients with early-stage cervical cancer is controversial and is supported by a single randomized Gynecologic Oncology Group (GOG) 92 study performed more than 20 years ago. Recent retrospective studies have shown excellent local control in this group of patients after radical surgery with no additional adjuvant treatment.; Primary Objective: To evaluate if adjuvant (chemo)radiation is associated with a survival benefit after radical surgery in patients with intermediate-risk cervical cancer.; Study Hypothesis: Radical surgery alone is non-inferior to the combined treatment of radical surgery followed by adjuvant (chemo)radiation in disease-free survival in patients with intermediate-risk cervical cancer.; Trial Design: This is a phase III, international, multicenter, randomized, non-inferiority trial in which patients with intermediate-risk cervical cancer will be randomized 1:1 into arm A, with no additional treatment after radical surgery, and arm B, receiving adjuvant external beam radiotherapy±brachytherapy ± concomitant chemotherapy. Patient data will be collected over 3 years post-randomization of the last enrolled patient for primary endpoint analysis or for 6 years for the overall survival analysis.; Major Inclusion/exclusion Criteria: Patients with intermediate-risk early-stage cervical cancer (IB1-IIA), defined as lymph node-negative patients with a combination of negative prognostic factors (tumor size >4 cm; tumor size >2 cm and lymphovascular space invasion; deep stromal invasion >2/3; or tumor-free distance <3 mm) with squamous cell carcinoma or human papillomavirus (HPV)-related adenocarcinoma, are eligible for the trial.; Primary Endpoint: Disease-free survival defined as time from randomization to recurrence diagnosis.; Sample Size: 514 patients from up to 90 sites will be randomized.; Estimated Dates for Completing Accrual and Presenting Results: It is estimated that the accrual will be completed by 2027 (with 3 additional years of follow-up) and primary endpoint results will be published by 2031. Estimated trial completion is by 2034.; Trial Registration: NCT04989647.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Cinar, E. (2023). "Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder." ClinicalTrials.gov.
	Idiopathic overactive bladder is defined the presence of a sense of urgency with or without accompanying urinary incontinence without an organic pathology or urinary infection. Its prevalence was reported to be between 7.7 to 31 % in women. In this prospective randomized controlled study, we aim to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder.

Cindy, T., et al. (2024). "Unveiling The Impact of Prophylactic Para-Aortic Lymph Nodes Irradiation in Cervical Cancer: Meta-Analysis of Randomized Controlled Trials." PROSPERO International prospective register of systematic reviews.
	
Ciortea, R., et al. (2023). "Comparison of laparoscopic sacrocolpopexy with vaginal reconstructive procedures and abdominal sacrocolpopexy for the surgical management of vaginal vault prolapse: a systematic review and meta-analysis." Frontiers in Medicine 10: 1269214.
	Introduction: Vaginal vault prolapse, also known as apical prolapse, is a distressing condition that may affect women following hysterectomy, necessitating surgical intervention when conservative measures prove ineffective. The surgical management of apical compartment prolapse includes procedures such as laparoscopic sacrocolpopexy (LSCP), abdominal sacrocolpopexy (ASCP) or vaginal reconstructive procedures (VRP). This systematic review and meta-analysis aims to compare the outcomes of these interventions.; Methods: A comprehensive search of electronic databases was conducted to identify eligible studies. Fourteen studies comprising a total of 1,289 women were included. The selected studies were analyzed to evaluate outcomes such as duration of surgery, length of hospital stay, blood loss, complication rates, and patient satisfaction.; Results: LSCP did not demonstrate significant advantages over VRP in terms of perioperative or long-term outcomes. However, when compared to ASCP, LSCP showed shorter hospital stay, reduced blood loss, decreased postoperative pain, and lower rates of ileus.; Discussion: This systematic review contributes to evidence-based decision-making for the surgical treatment of vaginal vault prolapse. While LSCP did not exhibit substantial benefits over VRP, it emerged as a preferable option compared to ASCP due to shorter hospital stays and reduced postoperative complications. The findings from this study provide valuable insights for clinicians and patients in selecting the most appropriate surgical approach for vaginal vault prolapse. However, future research should focus on long-term follow-ups, standardizing outcomes, and outcome measures, and evaluating cost-effectiveness to further enhance clinical practice.; 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 Ciortea, Roman, Măluțan, Bucuri, Ormindean, Nati and Mihu.)

Claire, A., et al. (2023). "Do psychological interventions improve the health-related quality of life of women with polycystic ovary syndrome? A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Claire, C., et al. (2023). "Impact of alternative treatments on endometriosis-related symptoms: a systematic review with meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Clemence, N., et al. (2023). "Olaparib versus Bevacizumab for Platinum-resistant or Recurrent Ovarian/Fallopian Tube/Peritoneal Cancer: Clinical Benefits and Risk- Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Cohen Paul, A., et al. (2022). "Getting the MOST out of follow-up: a randomized controlled trial comparing 3 monthly nurse led follow-up via telehealth, including monitoring CA125 and patient reported outcomes using the MOST (Measure of Ovarian Symptoms and Treatment concerns) with routine clinic based or telehealth follow-up, after completion of first line chemotherapy in patients with epithelial ovarian cancer." International Journal of Gynecological Cancer 32(4): 560-565.
	Background: Physical symptoms, anxiety, depression, fear of recurrence, sexual dysfunction, and social withdrawal are common in women after treatment for ovarian cancer. Most patients would like and need help dealing with these symptoms. The traditional model of follow-up care is unstructured and largely focused on diagnosing recurrent disease, and most oncologists lack skills to identify and manage psychosocial issues. No high quality prospective clinical trials have been conducted to determine the optimal follow-up regimen or the cost effectiveness of ovarian cancer surveillance strategies.; Primary Objectives: To assess emotional wellbeing, acceptability, safety, and cost effectiveness of nurse led follow-up via telehealth for women with ovarian cancer following completion of primary treatment.; Study Hypothesis: We hypothesize that compared with routine clinic based follow-up, nurse led follow-up via telehealth, including serum CA125 monitoring and completion of a patient reported outcome instrument, the Measure of Ovarian Symptoms and Treatment concerns-Surveillance (MOST-S26), will improve emotional wellbeing in women with ovarian cancer; be feasible, safe, acceptable, and not delay the time to diagnosis of recurrent disease; will result in greater patient satisfaction; will identify more patients with psychological distress, lead to better care, and improved psychological outcomes; and be cost-effective.; Trial Design: Phase II multicenter randomized trial comparing 3 monthly nurse led telehealth consultations that include serum CA125 monitoring and completion of the MOST-S26, with routine clinic based follow-up. The allocation ratio will be 1:1.; Major Inclusion/exclusion Criteria: Eligible patients will be women with high grade epithelial ovarian cancer who have normalized serum CA125 (to <35 kU/L) at completion of first line chemotherapy.; Primary Endpoints: Emotional wellbeing at 12 months.; Sample Size: 150 patients.; Estimated Dates for Completing Accrual and Presenting Results: July 2023. Results expected in 2025, 24 months after the last participant is enrolled.; Trial Registration: ACTRN12620000332921.; Competing Interests: Competing interests: PAC reports honoraria from Seqirus and Astra Zeneca unrelated to the submitted work. AO reports grants, personal fees, and other funding from SurgicalPerformance PTY Ltd, and grants from Medtronic, not directly related to the subject of this manuscript; consultancy fees from Baxter Healthcare Australia and New Zealand and Astra Zeneca Australia, not directly related to the subject of this manuscript; and a trademark licensed to SurgicalPerformance Pty Ltd. PB reports honoraria from GSK. MF reports grants from Astra Zeneca, Novartis, and Beigene; consulting fees from Astra Zeneca, Novartis, GSK, MSF, Takeda, and Lilly; honoraria from Astra Zeneca, GSK, and ACT Genomics; and support for travel from Astra Zeneca, unrelated to the submitted work. MK, MF, PMW, RC, and PAC developed the MOST-S26. (© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Cokorda Istri Agung, A., et al. (2023). "Platelet-rich Plasma Administration for Women Undergoing In Vitro Fertilization (IVF): A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Colbert, L. (2021). "Single Fraction or Multi-fraction Palliative Radiation Therapy for the Improvement of Quality of Life in Patients With Metastatic Gynecologic Cancers." ClinicalTrials.gov.
	No Results Available Radiation: 3-Dimensional Conformal Radiation Therapy|Radiation: Intensity-Modulated Radiation Therapy|Other: Quality-of-Life Assessment|Other: Questionnaire Administration|Radiation: Volume Modulated Arc Therapy Absolute change in index value of EuroQol 5 Dimensions - 5 Levels (EQ-5D-5L) score|Absolute change in mobility|Absolute change in self-care|Absolute change in activity|Absolute change in pain|Absolute change in anxiety|>= 6 point increase in EuroQol-Visual Analogue Scale|Decrease in Symptom Inventory (SIS)|Incidence of adverse events Female Phase 2 108 Other|NIH Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2020-0517|NCI-2020-05684 December 31, 2025

Colella, C., et al. (2022). "The effect of mother-infant group music classes on postnatal depression-A systematic review protocol." PloS One 17(10): e0273669.
	Background: Postnatal mental health problems affect 10-15% of women and can adversely impact on mother-infant interactions and bonding, the mother's mood, and feelings of competence. There is evidence that attending performing arts activities, such as singing, dancing, and listening to music, may improve maternal mental health with potential for an effect on postnatal depression.; Methods: A systematic review will be conducted to assess the effect of mother-infant group music classes on postnatal depression compared to standard care, no control or wait list control. Studies will be included that report on postnatal depression. Further outcomes of interest include anxiety, stress, parenting competence, confidence and self-efficacy, perceived social support and mother-infant bonding. Infant and child outcomes measuring cognitive development, behaviour and social and emotional development will be included. Search databases to be used will be Medline, EMBASE, CINAHL, PsycINFO, Scopus, CENTRAL, Web of Science, Maternity and Infant Care and discipline-specific journals for music. The Cochrane's Template for Intervention description and replication (TIDieR) checklist and guide will be utilised to aid a detailed description, standardised assessment and quality assurance. Risk of bias will be assessed by the authors using the Cochrane Handbook for Systematic Reviews of Interventions risk of bias tool. If sufficient studies are available, meta-analyses will be conducted to combine, compare and summarise the results of the studies for more precise estimates of effects. Where meta-analysis is not possible, results for each individual study will be reported through qualitative narrative data synthesis.; Discussion: This systematic review will identify and synthesise evidence of the measured effect of postnatal mother-infant interventions involving music on maternal psychological and psychosocial outcomes and infant/child outcomes.; Systematic Review Registration: This protocol was registered with Prospero on 18 October 2021 (registration number CRD42021283691). https://www.crd.york.ac.uk/prospero/display&#95;record.php?ID=CRD42021283691.; Competing Interests: The authors have declared that no competing interests exist.

Coleridge Sarah, L., et al. (2019). "Chemotherapy versus surgery for initial treatment in advanced ovarian epithelial cancer." The Cochrane Database of Systematic Reviews 2019(10).
	Background: Epithelial ovarian cancer presents at an advanced stage in the majority of women. These women require surgery and chemotherapy for optimal treatment. Conventional treatment has been to perform surgery first and then give chemotherapy. However, there may be advantages to using chemotherapy before surgery.; Objectives: To assess whether there is an advantage to treating women with advanced epithelial ovarian cancer with chemotherapy before debulking surgery (neoadjuvant chemotherapy (NACT)) compared with conventional treatment where chemotherapy follows debulking surgery (primary debulking surgery (PDS)).; Search Methods: We searched the following databases on 11 February 2019: CENTRAL, Embase via Ovid, MEDLINE (Silver Platter/Ovid), PDQ and MetaRegister. We also checked the reference lists of relevant papers that were identified to search for further studies. The main investigators of relevant trials were contacted for further information.; Selection Criteria: Randomised controlled trials (RCTs) of women with advanced epithelial ovarian cancer (Federation of International Gynaecologists and Obstetricians (FIGO) stage III/IV) who were randomly allocated to treatment groups that compared platinum-based chemotherapy before cytoreductive surgery with platinum-based chemotherapy following cytoreductive surgery.; Data Collection and Analysis: Two review authors independently extracted data and assessed risk of bias in each included trial.; Main Results: We found 1952 potential titles, with a most recent search date of February 2019, of which five RCTs of varying quality and size met the inclusion criteria. These studies assessed a total of 1713 women with stage IIIc/IV ovarian cancer randomised to NACT followed by interval debulking surgery (IDS) or PDS followed by chemotherapy. We pooled results of the three studies where data were available and found little or no difference with regard to overall survival (OS) (1521 women; hazard ratio (HR) 1.06; 95% confidence interval (CI) 0.94 to 1.19, I 2 = 0%; moderate-certainty evidence) or progression-free survival in four trials where we were able to pool data (1631 women; HR 1.02; 95% CI 0.92 to 1.13, I 2 = 0%; moderate-certainty evidence). Adverse events, surgical morbidity and quality of life (QoL) outcomes were poorly and incompletely reported across studies. There may be clinically meaningful differences in favour of NACT compared to PDS with regard to serious adverse effects (SAE grade 3+). These data suggest that NACT may reduce the risk of need for blood transfusion (risk ratio (RR) 0.80; 95% CI 0.64 to 0.99; four studies,1085 women; low-certainty evidence), venous thromboembolism (RR 0.28; 95% CI 0.09 to 0.90; four studies, 1490 women; low-certainty evidence), infection (RR 0.30; 95% CI 0.16 to 0.56; four studies, 1490 women; moderate-certainty evidence), compared to PDS. NACT probably reduces the need for stoma formation (RR 0.43, 95% CI 0.26 to 0.72; two studies, 581 women; moderate-certainty evidence) and bowel resection (RR 0.49, 95% CI 0.26 to 0.92; three studies, 1213 women; moderate-certainty evidence), as well as reducing postoperative mortality (RR 0.18; 95% CI 0.06 to 0.54:five studies, 1571 women; moderate-certainty evidence). QoL on the EORTC QLQ-C30 scale produced inconsistent and imprecise results in two studies (MD -1.34, 95% CI -2.36 to -0.32; participants = 307; very low-certainty evidence) and use of the QLQC-30 and QLQC-Ov28 in another study (MD 7.60, 95% CI 1.89 to 13.31; participants = 217; very low-certainty evidence) meant that little could be inferred.; Authors' Conclusions: The available moderate-certainty evidence suggests there is little or no difference in primary survival outcomes between PDS and NACT. NACT may reduce the risk of serious adverse events, especially those around the time of surgery, and the need for bowel resection and stoma formation. These data will inform women and clinicians and allow treatment to be tailored to the person, taking into account surgical resectability, age, histology, stage and performance status Data from an unpublished study and ongoing studies are awaited. (Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Colombo, G. E., et al. (2020). "Efficacy and safety of expectant management in the treatment of tubal ectopic pregnancy: A systematic review and meta-analysis." Human Reproduction Open 2020(4).
	STUDY QUESTION: Is expectant management (EM) of tubal ectopic pregnancy (EP) an effective and safe treatment strategy when compared to alternative interventions? SUMMARY ANSWER: There is insufficient evidence to conclude EM yields a difference in the resolution of tubal EP, the avoidance of surgery or time to resolution of tubal EP when compared to intramuscular methotrexate in stable patients with b-hCG <1500 IU/l. WHAT IS ALREADY KNOWN: The utilisation of medical and surgical management for EP is well established. EM aims to allow spontaneous resolution of the EP without intervention. STUDY DESIGN, SIZE, AND DURATION: We performed a systematic review and meta-analysis, searching Ovid MEDLINE, Embase, PsycINFO, CINAHL, Web of Science, OpenGrey.eu, Google Scholar, cross-referencing citations and trial registries to 15 December 2019. There were no limitations placed on language or publication date. Search terms included tubal EP and EM as well as variations of these terms. PARTICIPANTS/MATERIALS, SETTING AND METHOD: We considered studies that included patients with tubal EP, EM as a comparator, and that were randomised controlled trials (RCTs). The primary outcome was resolution of tubal EP. Secondary outcomes included avoidance of surgery and the time to resolution of EP. Two reviewers independently selected the studies, assessed bias and extracted data. Relative risk (RR) and mean difference with 95% CI were assessed using a random effects model. The certainty of evidence was scored according to Grading of Recommendations Assessment, Development and Evaluation guidelines. MAIN RESULTS AND THE ROLE OF CHANCE: In total, 920 studies were screened. Five studies were eligible for inclusion in the systematic review. Two RCTs comparing methotrexate to EM were identified as being eligible for inclusion in meta-analysis. No RCTs comparing surgery to EM were identified. Compared with EM, there was insufficient evidence that methotrexate yields a difference on resolution of tubal EP (RR 1.04, 95% CI 0.88-1.23, P 1/4 0.67; two RCTs, moderate-certainty evidence), avoiding surgery (RR 1.10, 95% CI 0.94-1.29, P 1/4 0.25; two RCTs, low-certainty evidence) or the time to resolution of tubal EP (-2.56 days (favouring EM), 95% CI -7.93-2.80, P 1/4 0.35; two RCTs, low-certainty evidence). LIMITATIONS, REASONS FOR CAUTION: Only two RCTs with a total of 103 patients were eligible for inclusion in this meta-analysis. Further RCTs comparing EM to medical and surgical management are needed and these should also report adverse events. Patient preference should also be evaluated. WIDER IMPLICATIONS OF THE FINDINGS: We found insufficient evidence of differences in terms of resolution, avoidance of surgery and time to resolution between expectant and medical management. Given the imprecision in the effect estimates as demonstrated by the wide CIs, resulting in the downgrading of certainty of evidence for all outcomes in this meta-analysis, larger RCTs comparing interventions for tubal EP are needed. Caution should be exercised when trying to decide between EM and methotrexate to treat tubal EP. STUDY FUNDING/COMPETING INTEREST(S): There was no funding for this study. NICM receives funding from various sources; none specifically supported this research. M.L. reports grants from Australian Women and Children's Research Foundation, outside the submitted work. M.A.: As a medical research institute, NICM Health Research Institute receives research grants and donations from foundations, universities, government agencies and industry. Sponsors and donors provide untied and tied funding for work to advance the vision and mission of the Institute. This systematic review was not specifically supported by donor or sponsor funding to NICM. M.A. reports a partnership grant with Metagenetics outside the submitted work. G.C. reports grants from Australian Women and Children's Research Foundation, personal fees from Roche and GE Healthcare, outside the submitted work. The remaining authors report no conflicts of interest.Copyright © The Author(s) 2020. Publ shed by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.

Colombo, N., et al. (2021). "Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer." New England Journal of Medicine 385(20): 1856‐1867.
	BACKGROUND: Pembrolizumab has efficacy in programmed death ligand 1 (PD‐L1)‐positive metastatic or unresectable cervical cancer that has progressed during chemotherapy. We assessed the relative benefit of adding pembrolizumab to chemotherapy with or without bevacizumab. METHODS: In a double‐blind, phase 3 trial, we randomly assigned patients with persistent, recurrent, or metastatic cervical cancer in a 1:1 ratio to receive pembrolizumab (200 mg) or placebo every 3 weeks for up to 35 cycles plus platinum‐based chemotherapy and, per investigator discretion, bevacizumab. The dual primary end points were progression‐free survival and overall survival, each tested sequentially in patients with a PD‐L1 combined positive score of 1 or more, in the intention‐to‐treat population, and in patients with a PD‐L1 combined positive score of 10 or more. The combined positive score is defined as the number of PD‐L1‐staining cells divided by the total number of viable tumor cells, multiplied by 100. All results are from the protocol‐specified first interim analysis. RESULTS: In 548 patients with a PD‐L1 combined positive score of 1 or more, median progression‐free survival was 10.4 months in the pembrolizumab group and 8.2 months in the placebo group (hazard ratio for disease progression or death, 0.62; 95% confidence interval [CI], 0.50 to 0.77; P<0.001). In 617 patients in the intention‐to‐treat population, progression‐free survival was 10.4 months and 8.2 months, respectively (hazard ratio, 0.65; 95% CI, 0.53 to 0.79; P<0.001). In 317 patients with a PD‐L1 combined positive score of 10 or more, progression‐free survival was 10.4 months and 8.1 months, respectively (hazard ratio, 0.58; 95% CI, 0.44 to 0.77; P<0.001). Overall survival at 24 months was 53.0% in the pembrolizumab group and 41.7% in the placebo group (hazard ratio for death, 0.64; 95% CI, 0.50 to 0.81; P<0.001), 50.4% and 40.4% (hazard ratio, 0.67; 95% CI, 0.54 to 0.84; P<0.001), and 54.4% and 44.6% (hazard ratio, 0.61; 95% CI, 0.44 to 0.84; P?=?0.001), respectively. The most common grade 3 to 5 adverse events were anemia (30.3% in the pembrolizumab group and 26.9% in the placebo group) and neutropenia (12.4% and 9.7%, respectively). CONCLUSIONS: Progression‐free and overall survival were significantly longer with pembrolizumab than with placebo among patients with persistent, recurrent, or metastatic cervical cancer who were also receiving chemotherapy with or without bevacizumab. (Funded by Merck Sharp and Dohme; KEYNOTE‐826 ClinicalTrials.gov number, NCT03635567.).

Colombo, N., et al. (2023). "INOVATYON/ ENGOT-ov5 study: Randomized phase III international study comparing trabectedin/pegylated liposomal doxorubicin (PLD) followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line." British Journal of Cancer 128(8): 1503-1513.
	Background: This trial investigated the hypothesis that the treatment with trabectedin/PLD (TP) to extend the platinum-free interval (TFIp) can improve overall survival (OS) in patients with recurrent ovarian cancer (OC).; Methods: Patients with OC (up to two previous platinum-based lines), with a TFIp of 6-12 months, were randomised to receive carboplatin/PLD (CP) or TP followed by platinum therapy at relapse. The primary endpoint was OS (HR: 0.75).; Results: The study enrolled 617 patients. The median TFIp was 8.3 months and 30.3% of patients had received two previous platinum lines. 74% and 73.9% of patients, respectively, received a subsequent therapy (ST) in the CP and TP arm; in the latter TP arm 87.2% of ST was platinum-based, as per protocol. The median OS was 21.4 for CP and 21.9 months for TP (HR 1.13; 95% CI: 0.94-1.35; p = 0.197). Grade 3-5 adverse reactions occurred in 37.1% of patients in the CP arm and 69.7% of patients in the TP arm, and the most frequent were neutropenia (22.8% CP, 39.5% TP), gastrointestinal (7.1% CP, 17.4% TP), hepatic (0.7% CP, 19.1% TP).; Conclusions: This study did not meet the primary endpoint. CP combination remains the standard for patients with recurrent OC and a 6-12 months TFIp; TP is an effective treatment in patients suffering from persistent platinum toxicities.; Clinical Trial Registration: ClinicalTrials.gov, number NCT01379989. (© 2023. The Author(s).)

Colombo, N., et al. (2022). "Randomized phase II trial of weekly paclitaxel vs. cediranib-olaparib (continuous or intermittent schedule) in platinum-resistant high-grade epithelial ovarian cancer." Gynecologic Oncology 164(3): 505-513.
	Background: Previous findings showed that cediranib-olaparib increased PFS in women with recurrent platinum-sensitive ovarian cancer compared to olaparib alone.; Methods: BAROCCO trial randomized 123 patients: 80mg/m2 paclitaxel weekly up to 24 weeks (control), olaparib 300mg tablets twice daily together with 20mg cediranib daily (continuous schedule) or with 20mg cediranib 5 days/week (intermittent schedule) until progression. The primary objective was the PFS comparison between each experimental arm and the control (alpha one-sided 5%; power 80%; HR 0.5).; Results: The median platinum-free interval was 1.9 months, 60% of patients had been pretreated with 3 or more chemotherapy lines. Median PFS for paclitaxel, the continuous, and the intermittent schedules were 3.1, 5.6, and 3.8 months. The HR for PFS in the continuous arm vs control was 0.76 (90% CI: 0.50-1.14, p = 0.265). The HR for PFS in the intermittent arm vs control was 1.03 (90% CI: 0.68-1.55, p = 0.904). Treatment was discontinued due to adverse events in 15%, 20%, and 5% of patients in the control, continuous and intermittent arms. Grade ≥ 3 anemia and diarrhea and hypertension of any grade occurred only in the experimental arms, and peripheral neuropathies and alopecia only in the control arm. Five serious adverse drug reactions occurred and two were fatal: one in the control and one in the continuous arm.; Conclusions: The combination of cediranib-olaparib was not superior to chemotherapy in terms of PFS in heavily pretreated platinum-resistant ovarian cancer patients. However, this oral doublet, is active and may offer a non-chemotherapy option in this difficult to treat population.; Clinical Trial Identification: IRFMN-OVA-7289, EudraCT: 2016-003964-38, NCT03314740. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Conforti, A., et al. (2021). "Recombinant human luteinizing hormone co-treatment in ovarian stimulation for assisted reproductive technology in women of advanced reproductive age: a systematic review and meta-analysis of randomized controlled trials." Reproductive Biology and Endocrinology 19(1): 91.
	Introduction: Several studies suggest that luteinizing hormone (LH) could improve IVF outcome in women of advanced reproductive age by optimizing androgen production. In this review, we assessed the role of recombinant-human LH (r-hLH) and recombinant human follicle stimulating hormone (r-hFSH) co-treatment in ovarian stimulation for assisted reproductive technology in women of advanced reproductive age candidates for assisted reproduction.; Material and Methods: Using a preregistered protocol we systematically searched Medline/PubMed, Scopus and the ISI Web of Science databases to identify randomized controlled trials in which r-hFSH monotherapy protocols were compared with r-hFSH/r-hLH co-treatment in women ≥35 years undergoing fresh IVF cycles. We calculated the pooled odds ratio (OR) for dichotomous data and the weight mean difference (WMD) for continuous data with an associated 95% confidence interval (CI). The meta-analyses were conducted using the random-effect model. P values < 0.05 were considered statistically significant. Subgroup analyses of all primary and secondary outcomes were performed only in women aged 35-40 years.; Results: Twelve studies were identified. In women aged between 35 and 40 years, r-hFSH/r-hLH co-treatment was associated with higher clinical pregnancy rates (OR 1.45, CI 95% 1.05-2.00, I 2 = 0%, P = 0.03) and implantation rates (OR 1.49, CI 95% 1.10-2.01, I 2 = 13%, P = 0.01) versus r-hFSH monotherapy. Fewer oocytes were retrieved in r-hFSH/r-hLH-treated patients than in r-hFSH-treated patients both in women aged ≥35 years (WMD -0.82 CI 95% -1.40 to - 0.24, I 2 = 88%, P = 0.005) and in those aged between 35 and 40 years (WMD -1.03, CI - 1.89 to - 0.17, I 2 = 0%, P = 0.02). The number of metaphase II oocytes, miscarriage rates and live birth rates did not differ between the two groups of women overall or in subgroup analysis.; Conclusion: Although more oocytes were retrieved in patients who underwent r-hFSH monotherapy, this meta-analysis suggests that r-hFSH/r-hLH co-treatment improves clinical pregnancy and implantation rates in women between 35 and 40 years of age undergoing ovarian stimulation for assisted reproduction technology. However, more RCTs using narrower age ranges in advanced age women are warranted to corroborate these findings.

Conforti, A., et al. (2022). "Does Intrauterine Injection of hCG Improve IVF Outcome? A Systematic Review and a Meta-Analysis." International Journal of Molecular Sciences 23(20).
	Various interventions have been proposed to improve embryo implantation in IVF. Among these, intrauterine injections of human chorionic gonadotropin seem to have promising results. Consequently, we conducted a review and meta-analysis to assess IVF outcomes by comparing couples who underwent intrauterine hCG injection transfer versus those who underwent embryo transfer with intrauterine injection of placebo, or without any additional intervention. The primary outcome was the clinical pregnancy rate. Secondary outcomes were the implantation rate, miscarriage rate, and live birth rate. A meta-analysis was conducted using the random effects model, while bias within studies was detected using the Cochrane risk of bias tool. Ectopic pregnancies and stillbirths were also assessed. The clinical pregnancy (RR 1.38, 95% CI 1.17−1.62, p < 0.0001) and implantation rate (RR 1.40, 95% CI 1.12−1.75, p = 0.003) were significantly higher in women who underwent hCG injection than in the control group. These significant effects persisted only in women who underwent cleavage-stage embryo transfer. No significant differences between groups were observed in the other secondary outcomes. In conclusion, our systematic review and meta-analysis demonstrate that intrauterine injection of hCG could be a valuable approach in women who undergo cleavage-stage embryo transfer. Given the lack of data about the live birth rate, caution should be exercised in interpreting these data.

Cong, C., et al. (2023). "The effects of acupuncture for the treatment of endometriosis-related pain: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Consortium, R. R. (2022). "Refining adjuvant treatment in endometrial cancer based on molecular features: the RAINBO clinical trial program." International Journal of Gynecological Cancer.
	Background: The endometrial cancer molecular classification has been integrated into the 2020 World Health Organization (WHO) diagnostic classification and European treatment guidelines, and provides direction towards more effective and less toxic adjuvant treatment strategies for women with endometrial cancer.; Primary Objectives: The RAINBO program of clinical trials will investigate four molecular class-directed adjuvant treatment strategies following surgical resection to either increase cure rates through the addition of novel targeted therapies or safely reduce toxicity and improve quality of life through treatment de-escalation.; Study Hypothesis: Molecular-directed adjuvant treatment strategies will improve clinical outcomes and reduce toxicity of unwarranted therapies in women with endometrial cancer. The overarching and translational research RAINBO program will advance knowledge of predictive and prognostic (bio)markers that will improve prognostication and treatment allocation.; Trial Design: The RAINBO program is a platform of four international clinical trials and an overarching research program. The randomized phase III p53abn-RED trial for women with invasive stage I-III p53abn endometrial cancer compares adjuvant chemoradiation followed by olaparib for 2 years with adjuvant chemoradiation alone. The randomized phase III MMRd-GREEN trial for women with stage II (with lymphovascular space invasion (LVSI)) or stage III mismatch repair-deficient (MMRd) endometrial cancer compares adjuvant radiotherapy with concurrent and adjuvant durvalumab for 1 year to radiotherapy alone. The randomized phase III NSMP-ORANGE trial is a treatment de-escalation trial for women with estrogen receptor positive stage II (with LVSI) or stage III no specific molecular profile (NSMP) endometrial cancer comparing radiotherapy followed by progestin for 2 years to adjuvant chemoradiation. The POLE mut-BLUE trial is a phase II trial in which the safety of de-escalation of adjuvant therapy is investigated for women with stage I-III POLE mut endometrial cancer: no adjuvant therapy for lower-risk disease and no adjuvant therapy or radiotherapy alone for higher-risk disease. The overarching RAINBO program will combine data and tumor material of all participants to perform translational research and evaluate molecular class-based adjuvant therapy in terms of efficacy, toxicity, quality of life, and cost-utility.; Major Inclusion/exclusion Criteria: Inclusion criteria include a histologically confirmed diagnosis of endometrial cancer treated by hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy or sentinel lymph node biopsy, with no macroscopic residual disease after surgery and no distant metastases, and molecular classification according to the WHO 2020 algorithm.; Primary Endpoints: Recurrence-free survival at 3 years in the p53abn-RED, MMRd-GREEN, and NSMP-ORANGE trials and pelvic recurrence at 3 years in the POLE mut-BLUE trial.; Sample Size: The p53abn-RED trial will include 554 patients, the MMRd-GREEN trial 316, the NSMP-ORANGE trial 600, and the POLE mut-BLUE trial 145 (120 for lower-risk disease and approximately 25 for higher-risk disease). The overarching research program will pool the four sub-trials resulting in a total sample size of around 1600.; Estimated Dates for Completing Accrual and Presenting Results: The four clinical trials will have different completion dates; main results are expected from 2028.; Trial Registration Number: The RAINBO program is registered at clinicaltrials.gov (NCT05255653).; Competing Interests: Competing interests: J Alexandre reports grants paid to his institution by MSD and Janssen; consulting fees to him by MSD, AstraZeneca, GSK, Eisai, and Janssen; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events to him by MSD, AstraZeneca, GSK, Clovis, and Novartis; support for attending meetings and/or travel to him by AstraZeneca and Novartis. SM de Boer reports a research grant paid to her institution by Varian Medical Systems. T Bosse reports research project funding by the Dutch Cancer Society (KWF). DN Church has participated in an advisory board for MSD and has received research funding from HalioDx (on behalf of the TransSCOT consortium). CL Creutzberg reports research grants from the Dutch Cancer Society (KWF) for the conduct of the PORTEC trials and the RAINBO program. JL Ethier reports payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events by Merck, GSK and AstraZeneca and participation in these companies’ Advisory Boards. JS Frenel reports having personally received consulting fees and support for attending meetings and/or travel by Pfizer, Lilly, Novartis, AstraZeneca, Clovis Oncology, GSK, Gilead, Daiichi Sankyo, and Seagan. Payment or honoraria were personally received for lectures, presentations, speaker bureaus, manuscript writing or educational events from Lilly, Novartis, AstraZeneca, Gilead, Daiichi Sankyo, and Seagen. C Gordon reports being a member of the Canadian Cancer Clinical Trials Group as member of the Patients’ Representatives Committee on a volunteer basis. K Han reports research grants from the Canadian Institutes of Health Research Project Grant and Princess Margaret Hospital Foundation, participating on the Astra Zeneca Cervical Cancer Radiation Oncology Advisory Board (October 2021), and being Endometrial Cancer Working Group Co-Chair of the Canadian Cancer Trials Group. N Horeweg reports research grants paid to her institution from the Dutch Cancer Society (KWF) and an unrestricted research grant by Varian for the RAINBO program and other unrelated research projects. VH Koelzer is principal investigator in a public-private partnership with Roche unrelated to the topic of this manuscript, received research funding from the Image Analysis Group unrelated to the topic of this manuscript, served as an invited speaker on behalf of Indica Labs, and is participant of a patent application co-owned by the Netherlands Cancer Institute (NKI-AVL) and the University of Basel on the assessment of cancer immunotherapy biomarkers by digital pathology. JR Kroep reports having received study drugs and an unrestricted research grant from AstraZeneca for the conduct of the MMRd-GREEN trial, as well as a research grants from the Dutch Cancer Society and WCRF. Consulting fees were paid to the researcher’s institution by AstraZeneca, MSD, GSK, Novartis and Eisai, as well as payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events by MSD and GSK. Participation on a Data Safety Monitoring Board or Advisory Board without payment for the TEIPP trial and the ALISON trial were reported. J McGrane reports having received consulting fees for participation in advisory boards of GSK, MSD and Ipsen and honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events, and for attending meetings and/or travel. A Taylor reports participation in the advisory board of MSD. (© IGCS and ESGO 2022. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)

Cooke, G., et al. (2022). "Treatment for recurrent vulvovaginal candidiasis (thrush)." The Cochrane Database of Systematic Reviews 1: CD009151.
	Background: Recurrent vulvovaginal candidiasis (RVVC) affects up to 5% of women. No comprehensive systematic review of treatments for RVVC has been published.; Objectives: The primary objective was to assess the effectiveness and safety of pharmacological and non-pharmacological treatments for RVVC. The secondary objective was to assess patient preference of treatment options.; Search Methods: We conducted electronic searches of bibliographic databases, including CENTRAL, MEDLINE, Embase, and CINAHL (search date 6 October 2021). We also handsearched reference lists of identified trials and contacted authors of identified trials, experts in RVVC, and manufacturers of products for vulvovaginal candidiasis.; Selection Criteria: We considered all published and unpublished randomised controlled trials evaluating RVVC treatments for at least six months, in women with four or more symptomatic episodes of vulvovaginal candidiasis in the past year. We excluded women with immunosuppressive disorders or taking immunosuppressant medication. We included women with diabetes mellitus and pregnant women. Diagnosis of RVVC must have been confirmed by presence of symptoms and a positive culture and/or microscopy. We included all drug and non-drug therapies and partner treatment, assessing the following primary outcomes: • number of clinical recurrences per participant per year (recurrence defined as clinical signs and positive culture/microscopy); • proportion of participants with at least one clinical recurrence during the treatment and follow-up period; and • adverse events.; Data Collection and Analysis: Two authors independently reviewed titles and abstracts to identify eligible trials. Duplicate data extraction was completed independently by two authors. We assessed risk of bias as described in the Cochrane Handbook for Systematic Reviews of Interventions. We used the fixed-effects model for pooling and expressed the results as risk ratio (RR) with 95% confidence intervals (CI). Where important statistical heterogeneity was present we either did not pool data (I 2 > 70%) or used a random-effects model (I 2 40-70%). We used the GRADE tool to assess overall certainty of the evidence for the pooled primary outcomes.; Main Results: Studies: Twenty-three studies involving 2212 women aged 17 to 67 years met the inclusion criteria. Most studies excluded pregnant women and women with diabetes or immunosuppression. The predominant species found on culture at study entry was Candida albicans. Overall, the included studies were small (<100 participants). Six studies compared antifungal treatment with placebo (607 participants); four studies compared oral versus topical antifungals (543 participants); one study compared different oral antifungals (45 participants); two studies compared different dosing regimens for antifungals (100 participants); one study compared two different dosing regimens of the same topical agent (23 participants); one study compared short versus longer treatment duration (26 participants); two studies assessed the effect of partner treatment (98 participants); one study compared a complementary treatment (Lactobacillus vaginal tablets and probiotic oral tablets) with placebo (34 participants); three studies compared complementary medicine with antifungals (354 participants); two studies compared 'dermasilk' briefs with cotton briefs (130 participants); one study examined Lactobacillus vaccination versus heliotherapy versus ciclopyroxolamine (90 participants); one study compared CAM treatments to an antifungal treatment combined with CAM treatments (68 participants). We did not find any studies comparing different topical antifungals. Nine studies reported industry funding, three were funded by an independent source and eleven did not report their funding source. Risk of bias: Overall, the risk of bias was high or unclear due to insufficient blinding of allocation and participants and poor reporting. Primary outcomes: Meta-analyses comparing drug treatments (oral and topical) with placebo or no treatment showe there may be a clinically relevant reduction in clinical recurrence at 6 months (RR 0.36, 95% CI 0.21 to 0.63; number needed to treat for an additional beneficial outcome (NNTB) = 2; participants = 607; studies = 6; I² = 82%; low-certainty evidence) and 12 months (RR 0.80, 95% CI 0.72 to 0.89; NNTB = 6; participants = 585; studies = 6; I² = 21%; low-certainty evidence). No study reported on the number of clinical recurrences per participant per year. We are very uncertain whether oral drug treatment compared to topical treatment increases the risk of clinical recurrence at 6 months (RR 1.66, 95% CI 0.83 to 3.31; participants = 206; studies = 3; I² = 0%; very low-certainty evidence) and reduces the risk of clinical recurrence at 12 months (RR 0.95, 95% CI 0.71 to 1.27; participants = 206; studies = 3; I² = 10%; very low-certainty evidence). No study reported on the number of clinical recurrences per participant per year. Adverse events were scarce across both treatment and control groups in both comparisons. The reporting of adverse events varied amongst studies, was generally of very low quality and could not be pooled. Overall the adverse event rate was low for both placebo and treatment arms and ranged from less than 5% to no side effects or complications.; Authors' Conclusions: In women with RVVC, treatment with oral or topical antifungals may reduce symptomatic clinical recurrences when compared to placebo or no treatment. We were unable to find clear differences between different treatment options (e.g. oral versus topical treatment, different doses and durations). These findings are not applicable to pregnant or immunocompromised women and women with diabetes as the studies did not include or report on them. More research is needed to determine the optimal medication, dose and frequency. (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Cooper, K. (2022). "Comparing medical management with laparoscopic surgery for the treatment of deep endometriosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Women with deep endometriosis will be invited to take part. Women with deep endometriosis will be referred by their GP to specialist endometriosis centres and will be invited to take part in DIAMOND by the endometriosis team. Potentially eligible women will be given information about the study. Those who are interested in taking part will be asked to sign a consent form. They can do this at their outpatient appointment or at home after the appointment. Women will have the option to complete either a paper consent form or complete the consent form electronically. Consent forms that are returned by post are checked, signed and dated with the date of receipt by someone who is listed on the delegation log with appropriate delegated responsibilities. Participant completed e‐consent forms will be checked, and electronically counter‐signed by someone listed on the delegation log with appropriate delegated responsibilities. The countersignature will only be recorded after a discussion has taken place with the participant about the study and any questions have been answered. Only once both patient and clinician signatures are present will informed consent be considered to have been obtained. Any e‐consent obtained will be verbally confirmed by the site at any future communication. Participants will be sent a copy of the paper consent or e‐consent form for their own records and a copy will be retained in the investigator site file and TMF. After a woman consents to the DIAMOND study, baseline data will be collected, and women will be asked to complete a questionnaire about their condition and their quality of life. Then, women will be randomised CONDITION: Deep infiltrating endometriosis ; Urological and Genital Diseases ; Endometriosis PRIMARY OUTCOME: ; Primary clinical outcome:; Endometriosis‐associated pain measured using the pain domain of the condition‐specific Endometriosis Health Profile‐30 (EHP‐30) at 18 months post‐randomisation; ; Primary economic outcome:; Incremental cost per quality‐adjusted life‐year (QALY) gained from a health service perspective, measured using self‐completed questionnaires and case note reviews at 18 months post‐randomisation; INCLUSION CRITERIA: 1. Women aged 18–49 years old seeking treatment for pain 2. Laparoscopically confirmed deep endometriosis +/‐ radiological imaging 3. Suitable for either medical or surgical management 4. Able and willing to give informed consent to participate and to participate in study procedures SECONDARY OUTCOME: ; Patient‐reported outcomes measured using self‐completed questionnaires at 3, 12, 18 months post‐randomisation, unless stated otherwise:; 1. Satisfaction with treatment measured on a six‐point scale from ‘totally satisfied’ to ‘totally dissatisfied’; 2. Endometriosis‐associated pain measured using the pain domain of EHP‐30; 3. Generic and condition‐specific quality of life measured using EQ‐5D and EHP‐30; 4. Need for further medical treatment and/or gynaecological surgery measured using self‐completed questionnaires and case note review at 18 months post‐randomisation; 5. Serious adverse events and major surgical complications assessed using self‐completed questionnaires, site‐completed case report forms and case note reviews at 18 months post‐randomisation; 6. Discontinuation of randomised treatment assessed using self‐completed questionnaires and case note review at 18 months post‐randomisation; 7. Occupational outcomes assessed using the Work Productivity and Activity Impairment Questionnaire: General Health V2.0; 8. Sexual health measured using the EHP‐30 sexual health module; 9. Pregnancy measured using patient self‐report and case note review at 18 months;

Cope, A. G., et al. (2020). "Nonextirpative treatments for uterine fibroids: measuring success." Journal of Minimally Invasive Gynecology 28(3): 442-452.e444.
	OBJECTIVE: To analyze outcomes of nonextirpative treatments for uterine fibroids compared to myomectomy. DATA SOURCES: A systematic search of the following databases from inception to January 2020 was performed: Ovid Medline, Embase, PubMed, and Cochrane Controlled Register of Trials. METHODS OF STUDY SELECTION: Two authors reviewed titles and abstracts for relevance, and full articles were obtained and evaluated for inclusion. Studies were included if they compared nonextirpative interventions for uterine fibroids to myomectomy and reported at least one outcome of interest. TABULATION, INTEGRATION, AND RESULTS: Of the 2010 articles identified and reviewed, 125 full text articles were reviewed and 22 were ultimately included in the analysis. Nonextirpative treatments reviewed included uterine artery embolization (UAE, 16 studies, n= 9555 subjects), focused ultrasound (FUS, 4 studies, n=1516), laparoscopic radiofrequency ablation (RFA, 3 studies, n=49). UAE, FUS, and laparoscopic RFA groups were compared to patients undergoing myomectomy (n=34872, n=20677, n=47 respectively). In comparison to myomectomy, UAE had similar quality of life scores, symptom severity scores, sexual function scores, ovarian function, and miscarriage rates following intervention. There was lower likelihood of achieving pregnancy after UAE and a higher rate of reintervention after UAE compared to myomectomy. FUS had similar post-procedure sexual function scores and reintervention rates compared to myomectomy. Laparoscopic RFA had similar quality of life scores, symptom severity scores, sexual function scores, reintervention rates, and pregnancy rates following the procedure compared to myomectomy. CONCLUSION: Nonextirpative treatments for uterine fibroids have similar outcomes to myomectomy in multiple domains, with most available evidence comparing UAE to myomectomy.

Copeland Larry, J., et al. (2022). "Phase III Randomized Trial of Maintenance Taxanes Versus Surveillance in Women With Advanced Ovarian/Tubal/Peritoneal Cancer: A Gynecologic Oncology Group 0212:NRG Oncology Study." Journal of Clinical Oncology 40(35): 4119-4128.
	Purpose: To compare taxane maintenance chemotherapy, paclitaxel (P) and paclitaxel poliglumex (PP), with surveillance (S) in women with ovarian, peritoneal, or fallopian tube (O/PC/FT) cancer who attained clinical complete response after first-line platinum-taxane therapy.; Methods: Women diagnosed with O/PC/FT cancer who attained clinical complete response after first-line platinum-taxane-based chemotherapy were randomly allocated 1:1:1 to S or maintenance, P 135 mg/m 2 once every 28 days for 12 cycles, or PP at the same dose and schedule. Overall survival (OS) was the primary efficacy end point.; Results: Between March 2005 and January 2014, 1,157 individuals were enrolled. Grade 2 or worse GI adverse events were more frequent among those treated with taxane (PP: 20%, P: 27% v S: 11%). Grade 2 or worse neurologic adverse events occurred more often with taxane treatment (PP: 46%, P: 36% v S: 14%). At the fourth scheduled interim analysis, both taxane regimens passed the OS futility boundary and the Data Monitoring Committee approved an early release of results. With a median follow-up of 8.1 years, 653 deaths were reported; none were attributed to the study treatment. Median survival durations were 58.3, 56.8, and 60.0 months for S, P, and PP, respectively. Relative to S, the hazard of death for P was 1.091 (95% CI, 0.911 to 1.31; P = .343) and for PP, it was 1.033 (95% CI, 0.862 to 1.24; P = .725). The median times to first progression or death (PFS) were 13.4, 18.9, and 16.3 months for S, P, and PP, respectively. Hazard ratio = 0.801; 95% CI, 0.684 to 0.938; P = .006 for P and hazard ratio = 0.854; 95% CI, 0.729 to 1.00; P = .055 for PP.; Conclusion: Maintenance therapy with P and PP did not improve OS among patients with newly diagnosed O/tubal/peritoneal cancer, but may modestly increase PFS. GI and neurologic toxicities were more frequent in the taxane treatment arms.

Corbett, G. A., et al. (2021). "Probiotic therapy in couples with infertility: A systematic review." European Journal of Obstetrics, Gynecology, and Reproductive Biology 256: 95-100.
	The reproductive microbiome is becoming increasingly recognised for its influence on fertility. While there has been much work to investigate the treatment of bacterial vaginosis and disordered microbiomes in optimizing outcomes in Assisted Reproductive Technology (ART), the role of routinely prescribed probiotics is yet to be established. The therapeutic potential of probiotic therapy remains an exciting opportunity in ART and this review endeavours to summarise its evidence to date. A systematic review of MEDLINE (Pubmed), Allied Health Literature (CINAHL), EMBASE, Web of Science and the Cochrane database was performed on 7th May 2019, and repeated on 26th August 2019. The search was built using the terms 'subfertility;' 'probiotic therapy;' 'clinical pregnancy rate' and 'assisted reproductive outcomes.' The primary outcome was change in clinical pregnancy rate. Secondary outcomes included improvements in male and female fertility parameters and microbial assessment. The initial search found 882 articles, of which 26 full manuscripts were reviewed. Four articles were eligible for inclusion. Of the two studies that reported the primary outcome, only one study found probiotics increased the clinical pregnancy rate non-significantly (48.0%-58.8%, p = 0.47). It also found higher miscarriage rate (30 % vs 16.6 %, p = 0.47) in the group treated with probiotics. Both studies on males with oral probiotic found significantly improved sperm motility. While benefit in sperm motility has been observed with male probiotic therapy, there is conflicting evidence on the efficacy of probiotic therapy for women undergoing assisted reproduction. High quality randomized studies are needed to definitively examine probiotic therapy and establish its benefit for couples undergoing assisted reproduction.; Competing Interests: Declaration of Competing Interest The authors reported no declarations of interest. (Copyright © 2020 Elsevier B.V. All rights reserved.)

Cornell, U. (2022). "Effect of 'Cramp Bites' on Period Cramps in Women Aged 18-25." ClinicalTrials.gov.
	No Results Available Dietary Supplement: Cramp Bites by Aunt Flo's Kitchen Visual Analogue Scale for Spasmodic Cramps|Visual Analogue Scale for Congestive Cramps|Menstrual Symptom Questionnaire (MSQ) Female Phase 2|Phase 3 12 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment IRB0145243 October 31, 2022

Correa, N., et al. (2024). "Personalizing the first dose of FSH for IVF/ICSI patients through machine learning: a non-inferiority study protocol for a multi-center randomized controlled trial." Trials 25(1): 38.
	Background: Adequately selecting the initial follicle-stimulating hormone (FSH) dose during controlled ovarian stimulation (COS) is key for success in assisted reproduction. The objective of COS is to obtain an optimal number of oocytes to increase the chances of achieving a pregnancy, while avoiding complications for the patient. Current clinical protocols do achieve good results for the majority of patients, but further refinements in individualized FSH dosing may reduce the risk of poor ovarian response while also limiting the risk of ovarian hyperstimulation syndrome (OHSS) risk. Models to select the first FSH dose in COS have been presented in literature with promising results. However, most have only been developed and tested in normo-ovulatory women under the age of 40 years. Method(s): This is a randomized, controlled, multicenter, single blinded, clinical trial. This study will be performed in 236 first cycle in vitro fertilization (IVF) and/or ICSI (intracytoplasmic sperm injection) patients, randomized 1:1 in two arms. In the intervention arm, the dose of FSH will be assigned by a machine learning (ML) model called IDoser, while in the control arm, the dose will be determined by the clinician following standard practice. Stratified block randomization will be carried out depending on the patient being classified as expected low responder, high responder, or normo-responder. Patients will complete their participation in the trial once the first embryo transfer result is known. The primary outcome of the study is the number of metaphase II (MII) oocytes retrieved at ovarian pick up (OPU) and the hypothesis of non-inferiority of the intervention arm compared to the control. Secondary outcomes include the number of cycle cancelations (due to low response or no retrieval of mature oocytes), risk of ovarian hyperstimulation syndrome (OHSS), and clinical pregnancy and live birth rates per first transfer. Discussion(s): To our knowledge, this is the first randomized trial to test clinical performance of an all-patient inclusive model to select the first dose of FSH for COS. Prospective trials for machine learning (ML) models in healthcare are scarce but necessary for clinical application. Trial registration: ClinicalTrials.gov, NCT05948293 . Registered on 14 July 2023.Copyright © 2024, The Author(s).

Corrêa Thayane, D., et al. (2020). "Use of GnRH Analogues in the Reduction of Submucous Fibroid for Surgical Hysteroscopy: A Systematic Review and Meta-Analysis." Revista Brasileira de Ginecologia e Obstetricia 42(10): 649-658.
	Objective: Gonadotropin-releasing hormone analogues (GnRH-a) have been used preoperatively before hysteroscopic myomectomy to decrease the size and vascularization of the myomas, but evidence to support this practice is weak. Our objective was to analyze the use of GnRH-a in the reduction of submucous fibroid as a facilitator for surgical hysteroscopy from published clinical trials.; Data Sources: Studies from electronic databases (Pubmed, Scielo, EMBASE, Scopus, PROSPERO), published between 1980 and December 2018. The keywords used were fibroid , GnRH analogue , submucous , histeroscopy , histeroscopic resection and their correspondents in Portuguese.; Study Selection: The inclusion criteria were controlled trials that evaluated the GnRH-a treatment before hysteroscopic resection of submucous myomas. Four clinical trials were included in the meta-analysis.; Data Collection: Two review authors extracted the data without modification of the original data, using the agreed form. We resolved discrepancies through discussion or, if required, we consulted a third person.; Data Synthesis: The present meta-analysis included a total of 213 women and showed no statistically significant differences in the use of GnRH-a compared with the control group for complete resection of submucous myoma (relative risk [RR]: 0.94; 95% confidence interval [CI]: 0.80-1.11); operative time (mean difference [MD]: - 3.81; 95%CI : - 3.81-2.13); fluid absorption (MD: - 65.90; 95%CI: - 9.75-2.13); or complications (RR 0.92; 95%CI: 0.18-4.82).; Conclusion: The present review did not support the routine preoperative use of GnRH-a prior to hysteroscopic myomectomy. However, it is not possible to determine its inferiority when compared with the other methods due to the heterogeneity of existing studies and the small sample size.; Competing Interests: The authors have no conflict of interests to declare. (The Author(s). 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/).)

Correyero-León, M. (2021). "Transcutaneous Tibial Nerve Stimulation as Treatment for Women With Primary Dysmenorrhea." ClinicalTrials.gov.
	The goal of this study is to verify whether transcutaneous stimulation of the posterior tibial nerve improves pain, quality of life and sleep deficiency in patients with pain related to their menstrual period in the short and medium‐long term. The hypothesis of the study states that by applying that method to the patients, a decrease or disappearance of pain in menstruation should happen, as well as an improvement in quality of life and sleep deficiency. The study will consist of: ‐ An interview, lasting 30 minutes, in which the characteristics of the study will be explained. In case of wishing to participate, it will be required to sign the informed consent document and to fill out the medical history sheet. ‐ An evaluation phase: in which it will be necessary to fill out a number of questionnaires during two consecutive menstrual periods. ‐ An intervention phase: consisting of 12 30‐minute treatment sessions, once a week. The patients will be randomly assigned to one of the two groups. In both groups, a current will be applied to different locations on the legs. The technique will be performed through four/two electrodes leg attached to the skin. This stimulation will not be painful at any time nor will it have harmful effects on the patients health. In this phase, the individual should continue filling out the questionnaires provided in each period. On the last day of treatment, a scale of satisfaction with the treatment will be retrieved. ‐ A re‐evaluation phase: in which the individual shall fill out a number of questionnaires a month, 3 and 6 months after finishing the treatment.

Correyero-León, M., et al. (2023). "Transcutaneous Tibial Nerve Stimulation for Primary Dysmenorrhea: A Protocol for a Randomized Controlled Trial." Healthcare 11(11).
	Primary dysmenorrhea (PD) is a painful menstruation that can persist for the duration of a woman's fertile life. Non-steroidal anti-inflammatory drugs, hormonal therapy, physiotherapy techniques, etc., are the main treatments. The main objective of this study is to evaluate the effectiveness of transcutaneous posterior tibial nerve stimulation (TTNS) in PD patients. The study will consist of a single-blind randomized clinical trial, parallel-assigned with two arms. Women with PD (18-43 years) with regular menstrual cycles and at least 4 points in VAS will be randomly divided into experimental (TTNS) and placebo (simulated stimulation) groups during 12 treatment sessions (1 session/week) and several follow-ups: monthly during treatment and 1, 3 and 6 months after. Maximum and mean pain intensity, pain duration, pain severity, number of anti-inflammatory drugs, quality of life, sleep quality, overall improvement, treatment satisfaction and secondary effects will be measured once a month every 6 months and at 3 and 6 months. The Student's t -test for independent samples or the Mann-Whitney U test will be used. The literature shows effective physiotherapeutic techniques for PD in the short term, which do not act on causes and have limitations. The TTNS technique can be used in transcutaneous and percutaneous modalities, with similar effectiveness, but the transcutaneous causes less discomfort. TTNS modulates pain, and long-term benefits could be achieved at low cost and without patient discomfort.

Cottrell Angela, M., et al. (2020). "Benefits and Harms of Electrical Neuromodulation for Chronic Pelvic Pain: A Systematic Review." European Urology Focus 6(3): 559-571.
	Context: Patients with chronic pelvic pain (CPP) may have pain refractory to conventional pain management strategies. Neuromodulation could provide relief of pain.; Objective: To evaluate the benefits and harms of neuromodulation for CPP.; Evidence Acquisition: A comprehensive search of EMBASE, PUBMED, and SCOPUS was performed for the entire database to January 2018. Studies were selected, data were extracted, and quality was assessed by two independent reviewers. A meta-analysis was used to combine randomized controlled trials (RCTs); otherwise, a narrative analysis was used.; Evidence Synthesis: After screening 1311 abstracts, 36 studies including eight RCTs were identified, enrolling 1099 patients. Studies covered a broad range in terms of phenotypes of CPP and methods of neuromodulation. A meta-analysis was possible for percutaneous tibial nerve stimulation and transcutaneous electrical nerve stimulation, which showed improvement in pain. Only narrative synthesis was possible for other modalities (sacral nerve stimulation, spinal cord stimulation, intravaginal electrical stimulation, and pudendal nerve stimulation) which appeared to reduce pain in patients with CPP. Treatments generally improved quality of life but with variable reporting of adverse events. Many studies showed high risks of bias and confounding.; Conclusions: While electrical neuromodulation may improve symptoms in CPP, further work is needed with high-quality studies to confirm it.; Patient Summary: Neuromodulation may be useful in reducing pain and improving quality of life in patients with chronic pelvic pain, but more research is needed. (Copyright © 2019 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Coyle Meaghan, E., et al. (2021). "Acupuncture versus placebo acupuncture for in vitro fertilisation: a systematic review and meta-analysis." Acupuncture in Medicine 39(1): 20-29.
	Objective: To evaluate the efficacy of acupuncture compared to placebo acupuncture for women undergoing in vitro fertilisation (IVF) in a systematic review and meta-analysis.; Methods: A search was conducted in seven English-language biomedical databases from their inception to 3 April 2019 to identify studies evaluating acupuncture as an adjunct to IVF treatment. Randomised controlled trials (RCTs) that compared acupuncture with placebo acupuncture using a non-invasive placebo acupuncture device in women undergoing a fresh or frozen IVF cycle were eligible, as were studies that tested placebo acupuncture as the intervention. Outcomes were clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate, live birth rate and adverse events.; Results: Eight RCTs involving 3607 women were included. Studies were judged to be low risk for most of the risk of bias domains. Acupuncture around the time of embryo transfer was not significantly different to placebo acupuncture in terms of the clinical pregnancy rate (6 RCTs, 2473 women, risk ratio (RR) = 0.99 (95% confidence interval (CI) = 0.88, 1.11), I 2 = 51%, moderate certainty evidence), ongoing pregnancy rate (4 RCTs, 1459 women, RR = 0.88 (95% CI = 0.75, 1.02), I 2 = 50%, moderate certainty evidence), miscarriage rate (4 RCTs, 502 women, RR = 1.23 (95% CI = 0.89, 1.71), I 2 = 30%, high certainty evidence) or live birth rate (4 RCTs, 1835 women, RR = 0.87 (95% CI = 0.75, 1.01), I 2 = 0%, high certainty evidence). Outcomes with placebo acupuncture were not significantly different to usual care. Adverse events relating to acupuncture, such as discomfort and bruising, were mild to moderate.; Conclusion: Acupuncture administered around the time of embryo transfer did not have a statistically significant effect on IVF outcomes compared with placebo acupuncture.

Cozzolino, M., et al. (2020). "Growth hormone cotreatment for poor responders undergoing in vitro fertilization cycles: a systematic review and meta-analysis." Fertility and Sterility 114(1): 97-109.
	Objective: To evaluate the effectiveness of growth hormone (GH) supplementation in improving the in vitro fertilization (IVF) outcomes of poor responders.; Design: Systematic review and meta-analysis.; Setting: Not applicable.; Patient(s): Poor ovarian responders undergoing conventional IVF or intracytoplasmic sperm injection (ICSI).; Intervention(s): Randomized controlled trials (RCTs) of poor ovarian responders undergoing a single IVF/ICSI cycle with GH supplementation versus conventional controlled ovarian stimulation. This review was registered in the PROSPERO database before starting data extraction (CRD42020151681).; Main Outcome Measure(s): Primary outcome was live birth rate. Clinical pregnancy rate, miscarriage rate, ongoing pregnancy rate, number of oocytes, number of mature (metaphase II [MII]) oocytes and the number of embryos available to transfer were considered as secondary outcomes.; Result(s): Twelve RCTs were included; 586 women were assigned to the intervention group and 553 to the control group. The analysis revealed that patients receiving GH supplementation did not show an increased live birth rate, miscarriage rate, or ongoing pregnancy rate. However, GH supplementation in poor responders increased clinical pregnancy rate, number of oocytes retrieved (mean difference 1.62), number of MII oocytes (mean difference 2.06), and number of embryos available to transfer (mean difference 0.76). Sensitivity and subgroup analyses did not provide statistical changes to pooled results.; Conclusion(s): The present meta-analysis provides evidence that GH supplementation may improve some reproductive outcomes in poor responders, but not live birth rates. (Copyright © 2020 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Cozzolino, M., et al. (2019). "Bed rest after an embryo transfer: a systematic review and meta-analysis." Archives of Gynecology and Obstetrics 300(5): 1121-1130.
	Introduction: Bed rest for the variable duration is commonly recommended after an embryo transfer (ET) carried out during an in vitro fertilization (IVF). This is based on beliefs that supine position and the reduction of physical activity-to the minimum-might prevent the risk of embryo expulsion once is transferred to the uterus. Therefore, we have designed a meta-analysis based exclusively on evidence from published randomized controlled trials (RCTs), in the attempt to analyze the effectiveness of bed rest after an ET to improve the chance for success in vitro fertilization.; Methods: The review protocol was registered in PROSPERO (CRD42019122758), and data extraction started before protocol publication. Five RCTs were included; 499 women were assigned to the intervention group and 503 to the control group.; Results: The analysis of 1002 women did not show any significant change in clinical pregnancy rate between groups [RR 0.86, 95% CI (0.74-1.00), p = 0.06, I 2 = 0%]. Likewise, no difference was found in live birth [RR 0.93, 95% CI (0.51-1.69) p = 0.81, I 2 = 68%], ongoing pregnancy rate [RR 0.84, 95% CI (0.60-1.20), p = 0.34, I 2 = 63%], miscarriage rate [RR 1.08, 95% CI (0.46-2.57), p = 0.86, I 2 = 64%], multiple pregnancy rate [RR 0.08, 95% CI (0.50-1.04), p = 0.71, I 2 = 0%] or implantation rate [RR 0.90, 95% CI (0.72-1.13), p = 0.38, I 2 = 0%]. Subgroup analyses-considering only immediate mobilization or bed rest 24 h-did not show significant differences regarding the outcome.; Conclusion: Our findings showed that immediate mobilization after an ET does not have a negative influence over the success rates of IVF. Therefore, bed rest should not be recommended.

Cozzolino, M., et al. (2019). "Corifollitropin alfa for ovarian stimulation in in vitro fertilization: a systematic review and meta-analysis of randomized controlled trials." Fertility and Sterility 111(4): 722-733.
	Objective: To evaluate the effectiveness of corifollitropin alfa in improving the success of IVF.; Design: Systematic review and meta-analysis.; Setting: Not applicable.; Patient(s): Infertile women undergoing conventional IVF or intracytoplasmic sperm injection (ICSI).; Intervention(s): Randomized controlled trials (RCTs) of infertile women undergoing a single IVF/ICSI cycle with either corifollitropin alfa or a conventional ovarian stimulation protocol based on daily injections. The review protocol was registered in PROSPERO before starting the data extraction (CRD42018088605).; Main Outcome Measure(s): Primary outcomes were live birth rate and/or ongoing pregnancy rate. Clinical pregnancy rate, miscarriage rate, multiple pregnancies, number of oocytes and embryos obtained, cancellation rate, and rate of ovarian hyperstimulation syndrome and ectopic pregnancy were considered as secondary outcomes.; Result(s): Eight randomized controlled trials were included; 2,345 women were assigned to the intervention group and 1,995 to the control group. The analysis of 4,340 IVF cycles did not reveal any difference in live birth rate and/or ongoing pregnancy rate between groups (risk ratio [RR], 0.92; 95% confidence interval [CI], 0.80-1.05). Similarly, no difference was found in clinical pregnancy rate (RR, 0.96; 95% CI, 0.88-1.05; I 2 = 0%), miscarriage rate (RR, 0.94; 95% CI, 0.71-1.25; I 2 = 0%), or multiple pregnancy rate (RR, 1.22; 95% CI, 0.99-1.50; I 2 = 0%). Also, the rates of cycle cancellation, ovarian hyperstimulation syndrome, and ectopic pregnancy were similar in both groups. Sensitivity and subgroup analyses did not provide statistical changes to pooled results.; Conclusion(s): Corifollitropin alfa seems to be an alternative for daily recombinant FSH injections in normal and poor responder patients undergoing ovarian stimulation in IVF/ICSI treatment cycles. (Copyright © 2018 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Craciunas, L., et al. (2021). "Oxytocin antagonists for assisted reproduction." The Cochrane Database of Systematic Reviews 9: CD012375.
	Background: Embryo transfer (ET) is a crucial step of in vitro fertilisation (IVF) treatment, and involves placing the embryo(s) in the woman's uterus. There is a negative association between endometrial wave-like activity (contractile activities) at the time of ET and clinical pregnancy, but no specific treatment is currently used in clinical practice to counteract their effects. Oxytocin is a hormone produced by the hypothalamus and released by the posterior pituitary. Its main role involves generating uterine contractions during and after childbirth. Atosiban is the best known oxytocin antagonist (and is also a vasopressin antagonist), and it is commonly used to delay premature labour by halting uterine contractions. Other oxytocin antagonists include barusiban, nolasiban, epelsiban, and retosiban. Administration of oxytocin antagonists around the time of ET has been proposed as a means to reduce uterine contractions that may interfere with embryo implantation. The intervention involves administering the medication before, during, or after the ET (or a combination).; Objectives: To evaluate the effectiveness and safety of oxytocin antagonists around the time of ET in women undergoing assisted reproduction.; Search Methods: We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and two trials registers in March 2021; and checked references and contacted study authors and experts in the field to identify additional studies.; Selection Criteria: We included randomised controlled trials (RCTs) of the use of oxytocin antagonists for women undergoing ET, compared with the non-use of this intervention, the use of placebo, or the use of another similar drug.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. Primary review outcomes were live birth and miscarriage; secondary outcomes were clinical pregnancy and other adverse events.; Main Results: We included nine studies (including one comprising three separate trials, 3733 women analysed in total) investigating the role of three different oxytocin antagonists administered intravenously (atosiban), subcutaneously (barusiban), or orally (nolasiban). We found very low- to high-certainty evidence: the main limitations were serious risk of bias due to poor reporting of study methods, and serious or very serious imprecision. Intravenous atosiban versus normal saline or no intervention We are uncertain of the effect of intravenous atosiban on live birth rate (risk ratio (RR) 1.05, 95% confidence interval (CI) 0.88 to 1.24; 1 RCT, N = 800; low-certainty evidence). In a clinic with a live birth rate of 38% per cycle, the use of intravenous atosiban would be associated with a live birth rate ranging from 33.4% to 47.1%. We are uncertain whether intravenous atosiban influences miscarriage rate (RR 1.08, 95% CI 0.75 to 1.56; 5 RCTs, N = 1424; I² = 0%; very low-certainty evidence). In a clinic with a miscarriage rate of 7.2% per cycle, the use of intravenous atosiban would be associated with a miscarriage rate ranging from 5.4% to 11.2%. Intravenous atosiban may increase clinical pregnancy rate (RR 1.50, 95% CI 1.18 to 1.89; 7 RCTs, N = 1646; I² = 69%; low-certainty evidence), and we are uncertain whether multiple or ectopic pregnancy and other complication rates were influenced by the use of intravenous atosiban (very low-certainty evidence). Subcutaneous barusiban versus placebo One study investigated barusiban, but did not report on live birth or miscarriage. We are uncertain whether subcutaneous barusiban influences clinical pregnancy rate (RR 0.96, 95% CI 0.69 to 1.35; 1 RCT, N = 255; very low-certainty evidence). Trialists reported more mild to moderate injection site reactions with barusiban than with placebo, but there was no difference in severe reactions. They reported no serious drug reactions; and comparable neonatal outcome between groups. Oral nolasiban versus placebo Nolasiban does not increase live birth rate (RR 1.13, 95% CI 0.99 to 1.28; 3 RCTs, N = 1832; I² = 0%; high-certainty evidence). In a clinic with a live birth rate of 33% per cycle, the use of oral nolasiban would be associated with a live birth rate ranging from 32.7% to 42.2%. We are uncertain of the effect of oral nolasiban on miscarriage rate (RR 1.45, 95% CI 0.73 to 2.88; 3 RCTs, N = 1832; I² = 0%; low-certainty evidence). In a clinic with a miscarriage rate of 1.5% per cycle, the use of oral nolasiban would be associated with a miscarriage rate ranging from 1.1% to 4.3%. Oral nolasiban improves clinical pregnancy rate (RR 1.15, 95% CI 1.02 to 1.30; 3 RCTs, N = 1832; I² = 0%; high-certainty evidence), and probably does not increase multiple or ectopic pregnancy, or other complication rates (moderate-certainty evidence).; Authors' Conclusions: We are uncertain whether intravenous atosiban improves pregnancy outcomes for women undergoing assisted reproductive technology. This conclusion is based on currently available data from seven RCTs, which provided very low- to low-certainty evidence across studies. We could draw no clear conclusions about subcutaneous barusiban, based on limited data from one RCT. Further large well-designed RCTs reporting on live births and adverse clinical outcomes are still required to clarify the exact role of atosiban and barusiban before ET. Oral nolasiban appears to improve clinical pregnancy rate but not live birth rate, with an uncertain effect on miscarriage and adverse events. This conclusion is based on a phased study comprising three trials that provided low- to high-certainty evidence. Further large, well-designed RCTs, reporting on live births and adverse clinical outcomes, should focus on identifying the subgroups of women who are likely to benefit from this intervention. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Cremieux, F. (2024). "PREVenting-ENvIronment-Reprotoxic Exposures Before In Vitro Fertilization (PREVENIR-FIV)." ClinicalTrials.gov.
	No Results Available Behavioral: Visioconsulation|Behavioral: self-assessment questionnaire|Biological: hair sampling|Behavioral: self-assessment questionnaire on dedicated application|Behavioral: Specialized follow-up|Behavioral: self-assessment questionnaire for follow-up Clinical live birth rate|Clinical pregnancy rate|Embryology markers|Pregnancy markers|Newborn health|Behavior changes|qualitative analysis All Not Applicable 4224 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Other RCAPHM21_0387|2022-A01017-36 June 2028

Cristian, D., et al. (2021). "The role of ovulation triggers in women with unexplained or anovulatory infertility undergoing ovulation induction: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Cross, D., et al. (2023). "Effectiveness of supervised Kegel exercises using bio-feedback versus unsupervised Kegel exercises on stress urinary incontinence: a quasi-experimental study." International Urogynecology Journal 34(4): 913-920.
	Introduction and hypothesis: The objective was to investigate and compare the efficacy of supervised Kegel exercises with bio-feedback on stress urinary incontinence (SUI) and pelvic floor muscle strength (PFMS) compared with unsupervised Kegel exercises. Method(s): Matched-group quasi-experimental study of 29 female participants divided into two groups (supervised and non-supervised) was conducted over 12 weeks. Baseline measurements of PFMS were undertaken by a women's health physiotherapist and a Kegel exercise regime bespoke designed for each participant. The supervised group visited the physiotherapist monthly for bio-feedback training (BT); the unsupervised group continued at home with their individualised Kegel exercises. Data were collected via a perineometer (PeritronTM) and self-reporting responses to questionnaires. All participants received a final PFMS measurement on completion of the study. Result(s): Overall Incontinence Severity index (ISI) score was significantly lower in the supervised group post-intervention. Wilcoxon signed-rank tests indicated that supervised Kegel exercises significantly reduced frequency (p= 0.002) and severity (p= 0.020) of overall ISI. Analysis of PFMS were not significantly different, despite an increase in maximum voluntary contraction or pelvic floor muscle strength (PFMS) (p= 0.032) in the supervised group. Of the questionnaires, results of Wilcoxon signed-rank tests indicated that "total bother" was significantly reduced (p= 0.005) in the supervised group. The correlation analysis between PFMS and ISI did not reveal any significant results. Conclusion(s): The study confirmed that supervised BT is more effective in reducing SUI than unsupervised Kegel exercises, and that this reduction in ISI score did not correlate with the improvement in PFMS.Copyright © 2022, Crown.

Cruff, J. and S. Khandwala (2021). "A Double-Blind Randomized Sham-Controlled Trial to Evaluate the Efficacy of Fractional Carbon Dioxide Laser Therapy on Genitourinary Syndrome of Menopause." Journal of Sexual Medicine 18(4): 761‐769.
	Background: Despite some prospective case series showing effectiveness of vaginal laser to treat genitourinary syndrome of menopause (GSM), there is a paucity of placebo‐controlled level one evidence. Aim: To assess the effect of fractional carbon dioxide (CO2) laser therapy to treat GSM against a sham comparator. Methods: We conducted a parallel, randomized, double‐blind, sham‐controlled trial to compare menopausal women treated with fractional CO2 laser against sham treatment for improvement in GSM‐related dyspareunia. Three treatments were given 6 weeks apart, and participants attended a 6‐month visit from study start for primary (proportion improved) and secondary (vaginal health index, VHI; visual analogue scale, VAS; modified global assessment, PGI‐I; Female Sexual Function Index, FSFI; Day‐to‐Day Impact of Vaginal Aging, DIVA; Urinary Distress Inventory short‐form, UDI‐6) assessments. Outcomes: The primary endpoint was a 2‐stage improvement in GSM‐related dyspareunia from baseline to 6 months determined by a severity scale, and the proportion of subjects who achieved this were compared between groups. Results: Thirty participants were randomized to laser (n = 14) or sham (n = 16). In the treatment arm, 13 attended all treatments, and 1 attended at least 2 while in the sham arm, 14 attended all treatments, and 2 attended at least 2 treatments. Twelve (86%) in the treatment arm and 16 (100%) in the sham arm attended the 6‐month visit. There were no differences in the proportion improved between treatments and controls (64% vs. 67%, respectively, P = 1.000). Both arms showed significant within‐group improvements based on VHI and VAS, but not between groups. Similar findings were observed on sexual impact questionnaires with improvements within both groups from baseline to 6 months but not by median differences between the groups at 6 months. There were no adverse events in either of the arms. Clinical Implications: Further well‐powered research is needed to determine efficacy of fractional CO2 laser for the treatment of GSM, especially in light of a potential placebo effect. Strengths & Limitations: We present a sham‐controlled double‐blinded randomized trial using validated tools; the main limitation included an underpowered proportion of sexually active participants for the primary outcome. Conclusion: This study was underpowered to draw conclusions regarding the efficacy of fractional CO2 laser therapy in the treatment of GSM. We did observe improvements in the sham‐arm to suggest a possible placebo contribution. Further well‐powered level one research is needed to demonstrate the therapeutic effect of this novel modality. Cruff J, Khandwala S, A Double‐Blind Randomized Sham‐Controlled Trial to Evaluate the Efficacy of Fractional Carbon Dioxide Laser Therapy on Genitourinary Syndrome of Menopause. J Sex Med 2021;18:761–769.

Csirzo, A., et al. (2024). "Robot-assisted laparoscopy does not have demonstrable advantages over conventional laparoscopy in endometriosis surgery: a systematic review and meta-analysis." Surgical Endoscopy 38(2): 529-539.
	Background: Endometriosis is a chronic condition affecting 6-10% of women of reproductive age, with endometriosis-related pain and infertility being the leading symptoms. Currently, the gold standard treatment approach to surgery is conventional laparoscopy (CL); however, the increasing availability of robot-assisted surgery is projected as a competitor of CL. This study aimed to compare the perioperative outcomes of robot-assisted laparoscopy (RAL) and CL in endometriosis surgery. Objective(s): We aimed to compare the effectiveness and safety of these two procedures. Method(s): A systematic search was conducted in three medical databases. Studies investigating different perioperative outcomes of endometriosis-related surgeries were included. Results are presented as odds ratios (OR) or mean differences (MD) with 95% confidence intervals (CI). Result(s): Our search yielded 2,014 records, of which 13 were eligible for data extraction. No significant differences were detected between the CL and RAL groups in terms of intraoperative complications (OR = 1.07, CI 0.43-2.63), postoperative complications (OR = 1.3, CI 0.73-2.32), number of conversions to open surgery (OR = 1.34, CI 0.76-2.37), length of hospital stays (MD = 0.12, CI 0.33-0.57), blood loss (MD = 16.73, CI 4.18-37.63) or number of rehospitalizations (OR = 0.95, CI 0.13-6.75). In terms of operative times (MD = 28.09 min, CI 11.59-44.59) and operating room times (MD = 51.39 min, CI 15.07-87.72;), the RAL technique remained inferior. Conclusion(s): RAL does not have statistically demonstrable advantages over CL in terms of perioperative outcomes for endometriosis-related surgery. Graphical abstract: [Figure not available: see fulltext.].Copyright © 2023, The Author(s).

Cui, L., et al. (2022). "A meta-analysis evaluating efficacy and safety of enema for chronic pelvic pain in women." PROSPERO International prospective register of systematic reviews.
	
Cui, Y., et al. (2023). "The Efficacy and Safety of Acupuncture in Treating Stress Urinary Incontinence in Women from a Meta-Analysis of Four Randomized Controlled Trials." Archivos Espanoles de Urologia 76(1): 40-49.
	PURPOSE: To verify the efficacy and safety of acupuncture in treating stress urinary incontinence (SUI) in women in a single treatment cycle lasting at least 6 weeks. METHOD(S): A preferred reporting items for systematic reviews and meta-analyses (PRISMA) summary was followed correctly. Through the use of EMBASE, Cochrane Library databases, and PubMed (until July 2021), we looked for randomized controlled trials. In addition, the included articles' original references were looked up as well. RESULT(S): Totally, we analyzed four studies including 690 patients. Compared with the sham acupuncture group, this analysis verified that acupuncture was critically better result in decreasing mean urine leakage (p = 0.04), 1-hour pad test (p = 0.04), 72-hour incontinence episodes (p < 0.00001), International Consultation on Incontinence Questionnaire-Short Form scores (p = 0.0005) and improving patient self-evaluation (All p < 0.05). However, two groups had no statistical significance in improving pelvic floor muscle strength. In the matter of safety, mainly adverse events, especially with respect to pain, both groups showed no statistical difference. CONCLUSION(S): Acupuncture is more beneficial to patients with stress urinary incontinence in women with no critical difference in the incidence of advent events than sham acupuncture.

Cuijpers, P., et al. (2023). "Psychological treatment of perinatal depression: a meta-analysis." Psychological Medicine 53(6): 2596-2608.
	BACKGROUND: Depression during pregnancy and after the birth of a child is highly prevalent and an important public health problem. Psychological interventions are the first-line treatment and, although a considerable number of randomized trials have been conducted, no recent comprehensive meta-analysis has evaluated treatment effects. METHOD(S): We used an existing database of randomized controlled trials of psychotherapies for adult depression and included studies aimed at perinatal depression. Random effects models were used in all analyses. We examined the effects of the interventions in the short and long term, and also examined secondary outcomes. RESULT(S): Forty-three studies with 49 comparisons and 6270 participants between an intervention and control group were included. The overall effect size was g = 0.67 [95% confidence interval (CI) 0.45~0.89; numbers needed-to-be-treated = 4.39] with high heterogeneity (I2 = 80%; 95% CI 75~85). This effect size remained largely unchanged and significant in a series of sensitivity analyses, although some publication bias was found. The effects remained significant at 6-12 months follow-up. Significant effects were also found for social support, anxiety, functional limitations, parental stress and marital stress, although the number of studies for each outcome was low. All results should be considered with caution because of the high levels of heterogeneity in most analyses. CONCLUSION(S): Psychological interventions are probably effective in the treatment of perinatal depression, with effects that last at least up to 6-12 months and probably also have effects on social support, anxiety, functional impairment, parental stress, and marital stress.

Curfs, M. H. J. M., et al. (2023). "A multicentre double-blinded randomized controlled trial on the efficacy of laser-assisted hatching in patients with repeated implantation failure undergoing IVF or ICSI." Human Reproduction 38(10): 1952-1960.
	Study Question: Does assisted hatching increase the cumulative live birth rate in subfertile couples with repeated implantation failure? Summary Answer: This study showed no evidence of effect for assisted hatching as an add-on in subfertile couples with repeated implantation failure. What is Known Already: The efficacy of assisted hatching, with regard to the live birth rate has not been convincingly demonstrated in randomized trials nor meta-analyses. It is suggested though that especially poor prognosis women, e.g. women with repeated implantation failure, might benefit most from assisted hatching. Study Design, Size, Duration: The study was designed as a double-blinded, multicentre randomized controlled superiority trial. In order to demonstrate a statistically significant absolute increase in live birth rate of 10% after assisted hatching, 294 participants needed to be included per treatment arm, being a total of 588 subfertile couples. Participants were included and randomized from November 2012 until November 2017, 297 were allocated to the assisted hatching arm of the study and 295 to the control arm. Block randomization in blocks of 20 participants was applied and randomization was concealed from participants, treating physicians, and laboratory staff involved in the embryo transfer procedure. Ovarian hyperstimulation, oocyte retrieval, laboratory procedures, embryo selection for transfer and cryopreservation, the transfer itself, and luteal support were performed according to local protocols and were identical in both the intervention and control arm of the study with the exception of the assisted hatching procedure which was only performed in the intervention group. The laboratory staff performing the assisted hatching procedure was not involved in the embryo transfer itself. Participants/Materials, Setting, Methods: Participants were eligible for inclusion in the study after having had either at least two consecutive fresh IVF or ICSI embryo transfers, including the transfer of frozen and thawed embryos originating from those fresh cycles, and which did not result in a pregnancy or as having had at least one fresh IVF or ICSI transfer and at least two frozen embryo transfers with embryos originating from that fresh cycle which did not result in a pregnancy. The study was performed at the laboratory sites of three tertiary referral hospitals and two university medical centres in the Netherlands. Main Results and The Role of Chance: The cumulative live birth rate per started cycle, including the transfer of fresh and subsequent frozen/thawed embryos if applicable, resulted in 77 live births in the assisted hatching group (n = 297, 25.9%) and 68 live births in the control group (n = 295, 23.1%). This proved to be statistically not significantly different (relative risk: 1.125, 95% CI: 0.847 to 1.494, P = 0.416). Limitations, Reasons for Caution: There was a small cohort of subfertile couples that after not achieving an ongoing pregnancy, still had cryopreserved embryos in storage at the endpoint of the trial, i.e. 1 year after the last randomization. It cannot be excluded that the future transfer of these frozen/thawed embryos increases the cumulative live birth rate in either or both study arms. Next, at the start of this study, there was no international consensus on the definition of repeated implantation failure. Therefore, it cannot be excluded that assisted hatching might be effective in higher order repeated implantation failures. Wider Implications of the Findings: This study demonstrated no evidence of a statistically significant effect for assisted hatching by increasing live birth rates in subfertile couples with repeated implantation failure, i.e. the couples which, based on meta-analyses, are suggested to benefit most from assisted hatching. It is therefore suggested that assisted hatching should only be offered if information on the absence of evidence of effect is provided, at no extra costs and preferably only in the setting of a clinical trial taking cost-effectiveness into account.Copyrig t © 2023 The Author(s).

Da Silva Ana, S. (2023). "RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women With Recurrent Urinary Tract Infections." ClinicalTrials.gov.
	No Results Available Device: Deka SmartXide Touch C60 (MonaLisa Touch)|Device: Sham To determine and compare the incidence of symptomatic antibiotic-treated UTI during the 6-month follow-up period after completion of allocated treatment|UTI history diary|Vaginal Health Index Score (VHIS)|King's Health Questionnaire (KHQ)|International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)|International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)|10 cm Visual Analogue Scale for Symptoms (VAS)|Urinary Tract Infection Symptom Assessment Questionnaire (UTISA)|Female Sexual Function Index Scoring (FSFI)|Health Service Utilisation Questionnaire (HSU-Q)|Treatment satisfaction questionnaire for laser (TSQ-L)|Vulvoscopic Genital Tissue Appearance Scale (VGTA)|Adverse event recording|Dipstick urine analysis|Standard urine culture|Expanded Quantitative Urine Culture (EQUC)|16S rRNA rapid Next-generation Gene Sequencing|Shotgun metagenomic sequencing Female Not Applicable 48 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 302037 October 1, 2026

Dagli, S. S. and R. Dagli (2023). "Pain relief effects of aromatherapy with rose oil (Rosa damascena Mill.) inhalation in patients with primary dysmenorrhea: A randomized controlled clinical trial." Journal of Herbal Medicine 38: 100637.
	Introduction: Pharmacological agents, such as non-steroidal anti-inflammatory drugs (NSAIDs), and non-pharmacological techniques, including acupuncture and aromatherapy, are commonly used for the management of abdominal pain in patients with primary dysmenorrhea. Essential rose oil obtained from Rosa Mill (RDM) is often used in aromatherapy for the treatment of many diseases. This study was aimed at using visual analog scale (VAS) pain scores and total analgesic consumption to evaluate the effects of adding RDM essential oil inhalation to the standard treatment (NSAID) of primary dysmenorrhea. Method(s): In this prospective randomized controlled clinical trial, 86 patients were randomized into groups R and C. The patients in group C only used standard analgesics (50 mg diclofenac sodium enteric film tablets). In group R, patients used both standard analgesics and RDM inhalation aromatherapy. A 10-point VAS was used to determine the pain values of the patients and was recorded as pre-treatment (VAS-0) and post-treatment (VAS-60). The analgesic consumption by the patients was recorded for 24 h. Result(s): In both groups, there was a significant decrease in VAS scores after treatment. The VAS-60 scores in group R were significantly lower than those in group C (2 [1-4] vs. 5 [2-5], respectively; P = 0.013). Analgesic consumption in group R was significantly lower than in group C (50 [50-100] mg vs. 100 [50-100] mg, respectively; p = 0.003). Conclusion(s): Inhalational rose oil aromatherapy is a good self-treatment option for primary dysmenorrhea.Copyright © 2023 Elsevier GmbH

Daiichi, S. (2023). "A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer." ClinicalTrials.gov.
	This study will focus on R‐DXd in participants with platinum‐resistant, high‐grade ovarian, primary peritoneal, or fallopian tube cancer. R‐DXd is an antibody‐drug conjugate that specifically binds to CDH6, which is overexpressed in tumor cells. The Phase 2 dose‐optimization part of the study (Part A) intends to define the recommended dose based on safety and efficacy, while the Phase 3 (Part B) part of the study will compare R‐DXd with Investigator's choice of chemotherapy and further evaluate efficacy.

Daily James, W., et al. (2019). "Equol Decreases Hot Flashes in Postmenopausal Women: A Systematic Review and Meta-Analysis of Randomized Clinical Trials." Journal of Medicinal Food 22(2): 127-139.
	Soy isoflavones may benefit some, but not all, menopausal women, and the ability of the women to produce equol may be the major determinant of effectiveness. We assessed the efficacy of soy isoflavones and equol for alleviating menopausal symptoms, especially vasomotor symptoms, in postmenopausal women who were equol producers and nonproducers by using systematic review and meta-analysis of randomized clinical trials (RCTs). We searched 12 English, Korean, and Chinese language scientific and medical databases. We selected all available RCTs that assessed the effect of equol, either equol itself or soy isoflavone in equol producers, on menopausal symptoms in peri- or postmenopausal women. The primary outcome was the effect on hot flashes. The severity of hot flashes was determined by the scores, and sensitivity and risk of bias analyses were conducted. Other outcomes of the review, but not meta-analysis, included depression and adverse events. Six studies (779 total subjects) met all criteria for the systematic review, 5 of those could be included in the meta-analysis (728 total subjects). Two studies included in the meta-analysis reported no statistically significant benefits of equol; the other three did report significant benefits of equol. Meta-analysis revealed a significant benefit of equol for lowering hot flash scores and revealed a generally low risk of bias. In conclusion, this study found that supplementing equol to equol nonproducers significantly lowered the incidence and/or severity of hot flashes in menopausal women.

Dal Farra, F., et al. (2022). "Effectiveness of Myofascial Manual Therapies in Chronic Pelvic Pain Syndrome: A Systematic Review and Meta-Analysis." International Urogynecology Journal 33(11): 2963-2976.
	Introduction and Hypothesis: Chronic pelvic pain syndrome (CPPS) is defined as the occurrence of chronic pelvic pain (CPP) in the absence of a specific cause. People typically refer to pain associated with urological, gynaecological, and sexual dysfunction, affecting the quality of life. Therefore, we assessed the effectiveness of myofascial manual therapies (MMT) for pain and symptom impact.; Methods: A systematic review and meta-analysis were conducted. Findings were reported following the 2020 PRISMA statement. Five databases were searched for RCTs. Studies were independently assessed through a standardized form, and their internal validity was evaluated using the Cochrane risk of bias (RoB) tool. Effect sizes (ES) were calculated post-treatment, and the quality of evidence was assessed through GRADE criteria.; Results: Seven articles were included in the review, five of these in the meta-analysis. None of these studies were completely judged at low RoB. MMT was revealed to be not significantly superior for pain reduction [ES: -0.54 (-1.16; 0.08); p = 0.09], for symptom impact [ES: -0.37 (-0.87; 0.13); p = 0.15], and for quality of life [ES: -0.44 (-1.22, 0.33), p = 0.26] compared to standard care. The quality of evidence was "very low". Other results were presented in a qualitative synthesis.; Conclusions: In patients with CPP/CPPS, MMT is not considered superior to other interventions for pain reduction and symptom impact improvements. However, a positive trend was detected, and we should find confirmation in the future. Further high-quality, double-blinded, sham-controlled RCTs are first necessary to confirm these positive effects and to improve the quality of evidence. (© 2022. The International Urogynecological Association.)

Damm, T., et al. (2019). "Continuous vs. cyclic combined hormonal contraceptives for treatment of dysmenorrhea: a systematic review." Contraception: X 1: 100002.
	Objective: This systematic review aims to evaluate the benefits of oral continuous combined hormonal contraceptives (CHCs) in managing dysmenorrhea by comparing randomized controlled trials (RCTs) evaluating the efficacy of continuous vs. cyclic CHC use for the following outcomes: (a) reducing dysmenorrhea duration and frequency, (b) severity, (c) recurrence and (d) interference with daily activity.; Study Design: Cochrane, PUBMED and Popline databases were searched from 1934 to 2018 for all relevant studies evaluating CHC for treatment of dysmenorrhea. A study was selected if it (a) compared continuous regimen vs. cyclic regimen of oral CHC, (b) measured dysmenorrhea as a primary or secondary outcome, (c) was an RCT and (d) was published in English. Due to differences in CHC used and outcome measurement, a systematic analysis of individual study results and a limited meta-analysis were conducted.; Results: Of 780 studies that were screened by title and abstract, 8 were included in the final analysis; 6 evaluated cyclic vs. continuous CHC, and 2 evaluated cyclic vs. extended/flexible CHC use. Quality of evidence was low for all outcome measures. Overall, compared to cyclic use, flexible/extended CHC resulted in 4 fewer days of dysmenorrhea. Studies revealed conflicting results for interference with daily activity, pain severity and pain recurrence. Side effects were few in both comparison groups.; Conclusions: Continuous or extended/flexible CHC use may reduce dysmenorrhea duration compared to cyclic regimen; however, more rigorous research is needed.; Implications: This systematic review shows that continuous CHC use may reduce dysmenorrhea duration compared to cyclic regimen, although the quality of evidence is low. Future double-blinded RCTs with more rigorous study design, consistent outcome measures and comprehensive outcome reporting are needed.

Danhof, N. A., et al. (2020). "IUI for unexplained infertility - A network meta-analysis." Human Reproduction Update 26(1): 1-15.
	BACKGROUND: IUI for unexplained infertility can be performed in a natural cycle or in combination with ovarian stimulation. A disadvantage of ovarian stimulation is an increased risk of multiple pregnancies with its inherent maternal and neonatal complication risks. Stimulation agents for ovarian stimulation are clomiphene citrate (CC), Letrozole or gonadotrophins. Although studies have compared two or three of these drugs to each other in IUI, they have never been compared to one another in one analysis. OBJECTIVE AND RATIONALE: The objective of this network meta-analysis was to compare the effectiveness and safety of IUI with CC, Letrozole or gonadotrophins with each other and with natural cycle IUI. SEARCH METHOD(S): We searched PubMed, MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, CENTRAL and the Clinical Trial Registration Database indexed up to 16 August 2018. We included randomized controlled trials that compared a stimulation regimen with CC, Letrozole or gonadotrophins to each other or to natural cycle IUI among couples with unexplained infertility. We performed the network meta-analysis within a multivariate random effects model. OUTCOME(S): We identified 26 studies reporting on 5316 women. The relative risk (RR) for live birth/ongoing pregnancy rates comparing IUI with CC to natural cycle IUI was 1.05 (95% CI 0.63-1.77, low quality of evidence), while comparing IUI with Letrozole to natural cycle IUI was 1.15 (95% CI 0.63-2.08, low quality of evidence) and comparing IUI with gonadotrophins to natural cycle IUI was 1.46 (95% CI 0.92-2.30, low quality of evidence). The RR for live birth/ongoing pregnancy rates comparing gonadotrophins to CC was 1.39 (95% CI 1.09-1.76, moderate quality of evidence), comparing Letrozole to CC was 1.09 (95% CI 0.76-1.57, moderate quality of evidence) and comparing Letrozole to gonadotrophins was 0.79 (95% CI 0.54-1.15, moderate quality of evidence). We did not perform network meta-analysis on multiple pregnancy due to high inconsistency. Pairwise meta-analyses showed an RR for multiple pregnancy rates of 9.11(95% CI 1.18-70.32) comparing IUI with gonadotrophins to natural cycle IUI. There was no data available on multiple pregnancy rates following IUI with CC or Letrozole compared to natural cycle IUI. The RR for multiple pregnancy rates comparing gonadotrophins to CC was 1.42 (95% CI 0.68-2.97), comparing Letrozole to CC was 0.97 (95% CI 0.47-2.01) and comparing Letrozole to gonadotrophins was 0.29 (95% CI 0.14-0.58). In a meta-analysis among studies with adherence to strict cancellation criteria, the RR for live births/ongoing pregnancy rates comparing gonadotrophins to CC was 1.20 (95% CI 0.95-1.51) and the RR for multiple pregnancy rates comparing gonadotropins to CC was 0.80 (95% CI 0.38-1.68). WIDER IMPLICATION(S): Based on low to moderate quality of evidence in this network meta-analysis, IUI with gonadotrophins ranked highest on live birth/ongoing pregnancy rates, but women undergoing this treatment protocol were also at risk for multiple pregnancies with high complication rates. IUI regimens with adherence to strict cancellation criteria led to an acceptable multiple pregnancy rate without compromising the effectiveness. Within a protocol with adherence to strict cancellation criteria, gonadotrophins seem to improve live birth/ongoing pregnancy rates compared to CC. We, therefore, suggest performing IUI with ovarian stimulation using gonadotrophins within a protocol that includes strict cancellation criteria. Obviously, this ignores the impact of costs and patients preference.Copyright © The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved.

Daniels, J., et al. (2022). "Uterine artery embolisation versus myomectomy for premenopausal women with uterine fibroids wishing to avoid hysterectomy: the FEMME RCT." Health Technology Assessment 26(22): 1-74.
	Background: Uterine fibroids are the most common tumour in women of reproductive age and are associated with heavy menstrual bleeding, abdominal discomfort, subfertility and reduced quality of life. For women wishing to retain their uterus and who do not respond to medical treatment, myomectomy and uterine artery embolisation are therapeutic options.; Objectives: We examined the clinical effectiveness and cost-effectiveness of uterine artery embolisation compared with myomectomy in the treatment of symptomatic fibroids.; Design: A multicentre, open, randomised trial with a parallel economic evaluation.; Setting: Twenty-nine UK hospitals.; Participants: Premenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolisation were recruited. Women were excluded if they had significant adenomyosis, any malignancy or pelvic inflammatory disease or if they had already had a previous open myomectomy or uterine artery embolisation.; Interventions: Participants were randomised to myomectomy or embolisation in a 1 : 1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic. Embolisation of the uterine arteries was performed under fluoroscopic guidance.; Main Outcome Measures: The primary outcome was the Uterine Fibroid Symptom Quality of Life questionnaire (with scores ranging from 0 to 100 and a higher score indicating better quality of life) at 2 years, adjusted for baseline score. The economic evaluation estimated quality-adjusted life-years (derived from EuroQol-5 Dimensions, three-level version, and costs from the NHS perspective).; Results: A total of 254 women were randomised - 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolisation (98 underwent embolisation). Information on the primary outcome at 2 years was available for 81% ( n = 206) of women. Primary outcome scores at 2 years were 84.6 (standard deviation 21.5) in the myomectomy group and 80.0 (standard deviation 22.0) in the uterine artery embolisation group (intention-to-treat complete-case analysis mean adjusted difference 8.0, 95% confidence interval 1.8 to 14.1, p = 0.01; mean adjusted difference using multiple imputation for missing responses 6.5, 95% confidence interval 1.1 to 11.9). The mean difference in the primary outcome at the 4-year follow-up time point was 5.0 (95% CI -1.4 to 11.5; p = 0.13) in favour of myomectomy. Perioperative and postoperative complications from all initial procedures occurred in similar percentages of women in both groups (29% in the myomectomy group vs. 24% in the UAE group). Twelve women in the uterine embolisation group and six women in the myomectomy group reported pregnancies over 4 years, resulting in seven and five live births, respectively (hazard ratio 0.48, 95% confidence interval 0.18 to 1.28). Over a 2-year time horizon, uterine artery embolisation was associated with higher costs than myomectomy (mean cost £7958, 95% confidence interval £6304 to £9612, vs. mean cost £7314, 95% confidence interval £5854 to £8773), but with fewer quality-adjusted life-years gained (0.74, 95% confidence interval 0.70 to 0.78, vs. 0.83, 95% confidence interval 0.79 to 0.87). The differences in costs (difference £645, 95% confidence interval -£1381 to £2580) and quality-adjusted life-years (difference -0.09, 95% confidence interval -0.11 to -0.04) were small. Similar results were observed over the 4-year time horizon. At a threshold of willingness to pay for a gain of 1 QALY of £20,000, the probability of myomectomy being cost-effective is 98% at 2 years and 96% at 4 years.; Limitations: There were a substantial number of women who were not recruited because of their preference for a particular treatment option.; Conclusions: Among women with symptomatic uterine fibroids, myomectomy resulted in greater improvement in quality of life than did uterine artery embolisation. The differences in costs and quality-adjusted life-years are very small. Future research should involve women who are desirin pregnanc .; Trial Registration: This trial is registered as ISRCTN70772394.; Funding: This study was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme, and will be published in full in Health Technology Assessment ; Vol. 26, No. 22. See the NIHR Journals Library website for further project information.

Danielsson Kristina, G. (2023). "Mifepristone and Letrozole in Ectopic Pregnancy (MILE)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Mifegyne 200 mg tabletter,Product Code: PRD8503344,Pharmaceutical Form: TABLET,Other descriptive name: ,Strength: Mifepristone 200mg,Product Name: Methotrexate Teva 100 mg/ml koncentrat till infusionsvätska, lösning,Product Code: PRD667056,Pharmaceutical Form: INJECTION,Other descriptive name: ,Strength: Methotrexate 100mg,Product Name: Letrozole Sandoz 2,5 mg filmdragerade tabletter,Product Code: PRD747119,Pharmaceutical Form: FILM‐COATED TABLET,Other descriptive name: ,Strength: Letrozole 2.5mg CONDITION: Ectopic pregnancy Therapeutic area: Diseases [C] ‐ Female Urogenital Diseases and Pregnancy Complications [C13] PRIMARY OUTCOME: Main Objective:To evaluate if the combination of mifepristone and letrozole is non‐inferior to methotrexate in treating ectopic pregnancy within a non‐inferiority margin of 10%. Primary end point(s):The primary endpoint is the proportion of patients who have a successful treatment response defined as decline of serum hCG to < 2 IU/L without the need for any additional medical or surgical intervention within 60 days of treatment. Secondary Objective:To evaluate if there is any difference in treatment related side effects when using the combination of mifepristone and letrozole compared to methotrexate.,To evaluate if there are differences in the proportion of patients who need additional medical and/or surgical interventions between the groups.,To evaluate if there is difference in time to treatment response between the groups.,To evaluate if there is difference in post treatment pregnancy rate and ovarian reserve between the groups.,To evaluate if there are biomarkers for ectopic versus intrauterine pregnancy that can be identified.,To evaluate if there are background factors that are associated with successful treatment. SECONDARY OUTCOME: Secondary end point(s):AMH‐levels at baseline, 1 month and 3 months after treatment. We will also assess time to pregnancy (days) and pregnancy rates (%) within the first year after treatment. Secondary end point(s):Comparison of background factors between patients that have successful and unsuccessful treatment. Secondary end point(s):Micro RNAs (analyzed by single cell sequencing) profiles and CA‐125 (patients receiving treatment for ectopic pregnancy versus patients with ultrasound confirmed intrauterine pregnancy within the same period of gestation). Secondary end point(s):The proportion of patients in both groups with adverse events (AE) and serious adverse events (SAE) classified as related or possibly related to treatment as judged by the investigators. Secondary end point(s):The proportion of patients who need additional medical or surgical interventions in each group. Secondary end point(s):Time to resolution (days) of ectopic pregnancy from start of medical treatment to resolution defined as hCG <2 IU/L. INCLUSION CRITERIA: Confirmed ectopic pregnancy, or high suspicion thereof*, in need of treatment. *i.e. empty uterus, pathological hCG dynamic.,18 years old or above,Able to understand verbal and written patient information,Given written consent to participate in the trial

Danxue, H. and K. Liyuan (2023). "Efficacy and safety of immune checkpoint inhibitors for ovarian cancer: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Danxue, H. and K. Liyuan (2023). "Efficacy and safety of immunotherapy for Cervical cancer: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Daré Bioscience, I. (2023). "A Study of Diclofenac Gel in Women With Primary Dysmenorrhea." ClinicalTrials.gov.
	The goal of this clinical trial is to compare 1% and 3% diclofenac gel (DARE‐PDM1) to placebo in women with symptomatic primary dysmenorrhea. The main question it aims to answer are: Is DARE‐PDM1 1%, 3% diclofenac gel systemically safe? What are the systemic levels of DARE‐PDM1 1%, 3% diclofenac gel in plasma and vaginal fluid following 1 dose and 3 doses. Participants will be seen for routine safety evaluations and complete a daily diary recording dysmenorrhea associated pain.

Darici, E., et al. (2022). "Different segmental resection techniques and postoperative complications in patients with colorectal endometriosis: A systematic review." Acta Obstetricia et Gynecologica Scandinavica 101(7): 705-718.
	Introduction: The aim of this study was to analyze the available literature by conducting a systematic review to assess the possible effects of nerve-sparing segmental resection and conventional bowel resection on postoperative complications for the treatment of colorectal endometriosis.; Material and Methods: Pubmed, Clinical Trials.gov, Cochrane Library, and Web of Science were comprehensively searched from 1997 to 2021 in order to perform a systematic review. Studies including patients undergoing segmental resection for colorectal endometriosis including adequate follow-up, data on postoperative complications and postoperative sequelae were enrolled in this review. Selected articles were evaluated and divided in two groups: Nerve-sparing resection (NSR), and conventional segmental resection not otherwise specified (SRNOS). Within the NSRs, studies mentioning preservation of the rectal artery supply (artery and nerve-sparing SR - ANSR) and not reporting preservation of the artery supply (NSR not otherwise specified - NSRNOS) were further analyzed.; Prospero Id: CRD42021250974.; Results: A total of 7549 patients from 63 studies were included in the data analysis. Forty-three of these publications did not mention the preservation or the removal of the hypogastric nerve plexus, or main rectal artery supply and were summarized as SRNOS. The remaining 22 studies were listed under the NSR group. The mean size of the resected deep endometriosis lesions and patients' body mass index were comparable between SRNOS and NSR. A mean of 3.6% (0-16.6) and 2.3% (0-10.5%) of rectovaginal fistula development was reported in patients who underwent SRNOS and NSR, respectively. Anastomotic leakage rates varied from 0% to 8.6% (mean 1.7 ± 2%) in SRNOS compared with 0% to 8% (mean 1.7 ± 2%) in patients undergoing NSR. Urinary retention (4.5% and 4.9%) and long-term bladder catheterization (4.9% and 5.6%) were frequently reported in SRNOS and NSR. There was insufficient information about pain or the recurrence rates for women undergoing SRNOS and NSR.; Conclusions: Current data describe the outcomes of different segmental resection techniques. However, the data are inhomogeneous and not sufficient to reach a conclusion regarding a possible advantage of one technique over the other. (© 2022 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Datta Adrija, K., et al. (2021). "Mild versus conventional ovarian stimulation for IVF in poor, normal and hyper-responders: a systematic review and meta-analysis." Human Reproduction Update 27(2): 229-253.
	Background: Mild ovarian stimulation has emerged as an alternative to conventional IVF with the advantages of being more patient-friendly and less expensive. Inadequate data on pregnancy outcomes and concerns about the cycle cancellation rate (CCR) have prevented mild, or low-dose, IVF from gaining wide acceptance.; Objective and Rationale: To evaluate parallel-group randomised controlled trials (RCTs) on IVF where comparisons were made between a mild (≤150 IU daily dose) and conventional stimulation in terms of clinical outcomes and cost-effectiveness in patients described as poor, normal and non-polycystic ovary syndrome (PCOS) hyper-responders to IVF.; Search Methods: Searches with no language restrictions were performed using Medline, Embase, Cochrane central, Pre-Medicine from January 1990 until April 2020, using pre-specified search terms. References of included studies were hand-searched as well as advance access articles to key journals. Only parallel-group RCTs that used ≤150 IU daily dose of gonadotrophin as mild-dose IVF (MD-IVF) and compared with a higher conventional dose (CD-IVF) were included. Studies were grouped under poor, normal or hyper-responders as described by the authors in their inclusion criteria. Women with PCOS were excluded in the hyper-responder group. The risk of bias was assessed as per Cochrane Handbook for the included studies. The quality of evidence (QoE) was assessed according to the GRADE system. PRISMA guidance was followed for review methodology.; Outcomes: A total of 31 RCTs were included in the analysis: 15 in the poor, 14 in the normal and 2 in the hyper-responder group. Live birth rates (LBRs) per randomisation were similar following use of MD-IVF in poor (relative risk (RR) 0.91 (CI 0.68, 1.22)), normal (RR 0.88 (CI 0.69, 1.12)) and hyper-responders (RR 0.98 (CI 0.79, 1.22)) when compared to CD-IVF. QoE was moderate. Cumulative LBRs (5 RCTs, n = 2037) also were similar in all three patient types (RR 0.96 (CI 0.86 1.07) (moderate QoE). Risk of ovarian hyperstimulation syndrome was significantly less with MD-IVF than CD-IVF in both normal (RR 0.22 (CI 0.10, 0.50)) and hyper-responders (RR 0.47 (CI 0.31, 0.72)), with moderate QoE. The CCRs were comparable in poor (RR 1.33 (CI 0.96, 1.85)) and hyper-responders (RR 1.31 (CI 0.98, 1.77)) but increased with MD-IVF among normal responders (RR 2.08 (CI 1.38, 3.14)); all low to very low QoE. Although fewer oocytes were retrieved and fewer embryos created with MD-IVF, the proportion of high-grade embryos was similar in all three population types (low QoE). Compared to CD-IVF, MD-IVF was associated with less gonadotrophin use and lower cost.; Wider Implications: This updated review provides reassurance on using MD-IVF not only for the LBR per cycle but also for the cumulative LBR, with moderate QoE. With risks identified with 'freeze-all' strategies, it may be time to recommend mild-dose ovarian stimulation for IVF for all categories of women i.e. hyper, poor and normal responders to IVF. (© The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Datta Niloy, R., et al. (2019). "Efficacy and Safety Evaluation of the Various Therapeutic Options in Locally Advanced Cervix Cancer: A Systematic Review and Network Meta-Analysis of Randomized Clinical Trials." International Journal of Radiation Oncology, Biology, Physics 103(2): 411-437.
	Treatment options in locally advanced cervix cancer (LACC) have evolved around radiation therapy (RT) and/or chemotherapy (CT), hypoxic cell sensitizers, immunomodulators (Imm), and locoregional moderate hyperthermia (HT). A systematic review and network meta-analysis was conducted to synthesize the evidence for efficacy and safety in terms of long-term locoregional control (LRC), overall survival (OS), and grade ≥3 acute morbidity (AM) and late morbidity (LM). Five databases were searched, and 6285 articles (1974-2018) were screened per the Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. Fifty-nine randomized trials in untreated LACC without surgical intervention were shortlisted. These used 13 different interventions: RT alone and/or neoadjuvant CT (NACT), adjuvant CT (ACT), concurrent chemoradiation therapy (CTRT) (weekly cisplatin [CDDP]/3-weekly CDDP/combination CT with CDDP/non-CDDP-based CT), hypoxic cell sensitizers, Imm, or HT. Odds ratios (ORs) using random effects network meta-analysis were estimated. Interventions for each endpoint were ranked according to their corresponding surface under cumulative ranking curve values. Of the 9894 patients evaluated, the total events reported for LRC, OS, AM, and LM were 5431 of 8197, 4482 of 7958, 1710 of 7183, and 441 of 6333, respectively. ORs and 95% credible intervals (CrIs) for the 2 best strategies were HT + RT versus CTRT + ACT (OR, 1.23; 95% CrI, 0.49-3.19) for LRC, CTRT (3-weekly CDDP) versus HTCTRT (OR, 1.14; 95% CrI, 0.35-3.65) for OS, RT + ACT versus RT (OR, 0.01; 95% CrI, 0.00-1.04) for AM, and NACT + RT + ACT versus RT + Imm (OR, 0.42; 95% CrI, 0.02-7.39) for LM. The 3 interventions with the highest cumulative surface under cumulative ranking curve values for all 4 endpoints were HTRT, HTCTRT, and CTRT (3-weekly CDDP). Articles with low risk of bias and those published during 2004 to 2018 also retained these interventions as the best. Two-step cluster analysis grouped these 3 modalities in a single distinctive cluster. HTRT, HTCTRT, and CTRT with 3-weekly CDDP were identified as therapeutic modalities with the best comprehensive impact on key clinical endpoints in LACC. This warrants a phase 3 randomized trial among these strategies for a head-to-head comparison and additional validation. (Copyright © 2018 Elsevier Inc. All rights reserved.)

Davenport Margie, H., et al. (2019). "Exercise for the prevention and treatment of low back, pelvic girdle and lumbopelvic pain during pregnancy: a systematic review and meta-analysis." British Journal of Sports Medicine 53(2): 90-98.
	Objective: The purpose of this review was to investigate the relationship between prenatal exercise, and low back (LBP), pelvic girdle (PGP) and lumbopelvic (LBPP) pain.; Design: Systematic review with random effects meta-analysis and meta-regression.; Data Sources: Online databases were searched up to 6 January 2017.; Study Eligibility Criteria: Studies of all designs were eligible (except case studies and reviews) if they were published in English, Spanish or French, and contained information on the population (pregnant women without contraindication to exercise), intervention (subjective or objective measures of frequency, intensity, duration, volume or type of exercise, alone ["exercise-only"] or in combination with other intervention components [eg, dietary; "exercise + co-intervention"]), comparator (no exercise or different frequency, intensity, duration, volume and type of exercise) and outcome (prevalence and symptom severity of LBP, PGP and LBPP).; Results: The analyses included data from 32 studies (n=52 297 pregnant women). 'Very low' to 'moderate' quality evidence from 13 randomised controlled trials (RCTs) showed prenatal exercise did not reduce the odds of suffering from LBP, PGP and LBPP either in pregnancy or the postpartum period. However, 'very low' to 'moderate' quality evidence from 15 RCTs identified lower pain severity during pregnancy and the early postpartum period in women who exercised during pregnancy (standardised mean difference -1.03, 95% CI -1.58, -0.48) compared with those who did not exercise. These findings were supported by 'very low' quality evidence from other study designs.; Conclusion: Compared with not exercising, prenatal exercise decreased the severity of LBP, PGP or LBPP during and following pregnancy but did not decrease the odds of any of these conditions at any time point.; Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

David, V.-C., et al. (2022). "Para-aortic lymph node dissection in patients with locally advanced cervical cancer: A Systematic review." PROSPERO International prospective register of systematic reviews.
	
Davies, M. (2023). "Oxybutynin or venlafaxine for hot flushes in women who cannot or prefer not to use hormone replacement therapy." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: To compare the relative clinical and cost‐effectiveness of extended‐release oxybutynin compared to low‐dose modified‐release venlafaxine in controlling VMS after 3 months of treatment, separately, in two populations of women with menopausal VMS: (a) those that are unable to take HRT, and (b) those who prefer not to use HRT. Participants will be recruited from secondary care clinics (which include gynaecology, specialist menopause, oncology), social media and GP/hospital database searches, throughout the UK. During the recruitment process, eligibility will be checked, and consent will be obtained (either electronically or face to face). As part of the eligibility checks, participants will self‐complete a hot flush diary, and report the number and severity of hot flushes every day, for 7 days, and only those with a mean of = 5 moderate/severe hot flushes per day will be eligible to take part. Baseline data will be recorded, which will include demographics, body mass index, when hot flushes started, history of hysterectomy, reason for contraindication to HRT (Group A), lifestyle factors, use of medication, complementary and supplements. Participants will also be sent baseline questionnaires to self‐complete about their quality of life, hot flushes, overall health and wellbeing, urinary symptoms, sleep, and work productivity. Eligible participants who consent will be individually randomised on a 1:1 ratio, separately for the two participant groups, using an online randomisation system, minimised in a secure online algorithm by recruitment site, body mass index, and use of anti‐oestrogens (group A) or recent hormone (HRT) use (group B), and retaining a random element. Investigators and participants will not be blinded. CONDITION: Women experiencing menopausal and peri menopausal hot flushes ; Urological and Genital Diseases PRIMARY OUTCOME: The average Hot Flush (HF) score (frequency x severity) over one week, at week 12 SECONDARY OUTCOME: ; All measured at baseline, week 12, and 6 and 12 months and additional stated timepoints:; 1. Average HF score (also in weeks 4 and 8); 2. Frequency and severity (individually) of hot flushes/night sweats (also in weeks 4 and 8); 3. Individual domains and total score of MENQOL‐I (also at week 4); 4. Hot Flush Related Daily Interference Scale (HFRDIS) (also at week 4); 5. Health related quality of life (EQ‐5D‐5L) and capability‐wellbeing (ICECAP‐A); 6. Participant acceptability and satisfaction with treatment (also at week 4); 7. Participant‐reported global impression of change on VMS and overall wellbeing; 8. Urinary urgency, frequency and incontinence (ICIQ‐OAB); 9. Sleep quality (PSQI); 10. Work Productivity and Activity Impairment Questionnaire‐ general (WPAI); 11. Pregnancy and pregnancy outcomes (participant reported and/or patient records); 12. Common known side‐effects of each treatment (participant reported via questionnaires); 13. Change or cessation of treatment, and for breast cancer population, continuation of endocrine therapy (participant reported via questionnaires); 14. Resource Use (participant reported via questionnaires ); INCLUSION CRITERIA: Group A (HRT contraindicated) 1. Women for whom HRT is contraindicated, e.g. women with breast cancer treated with adjuvant endocrine therapy. 2. =5 moderate/ severe menopausal hot flushes daily average, collected over a week, prior to randomisation. 3. Written/electronic informed consent. Group B (prefer not to use HRT) 1. Diagnosis of menopause or perimenopause 2. Age > 45 years 3. =5 moderate/ severe menopausal hot flushes daily average, collected over a week, prior to randomisation. 4. Not intending to use HRT within 12 months. 5. Written/electronic informed consent.

Dawkhar Shekhar, S. (2021). "Effect of Durvalumab and/or Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention1: Arm C (durvalumab, olaparib): Platinum‐based chemotherapy (175 mg/m2 paclitaxel [intravenous (IV)] and AUC5 or AUC6 carboplatin [IV]) every 3 weeks (Q3W) for 6 cycles with durvalumab 1120 mg Q3W IV during the chemotherapy phase. Patients will receive durvalumab 1500 mg every 4 weeks (Q4W) (IV) with olaparib 300 mg tablets twice daily (oral) in the maintenance phase until disease progression. Intervention2: Arm B (durvalumab, placebo): Platinum‐based chemotherapy (175 mg/m2 paclitaxel [IV] and AUC5 or AUC6 carboplatin [IV]) every 3 weeks (Q3W) for 6 cycles with durvalumab 1120 mg Q3W (IV) during the chemotherapy phase. Patients will receive durvalumab 1500 mg Q4W (IV) with olaparib placebo tablets twice daily (oral) in the maintenance phase until disease progression. Control Intervention1: Arm A (control): Platinum‐based chemotherapy (175 mg/m2 paclitaxel [IV] and AUC5 or AUC6 carboplatin [IV]) for 6 cycles with durvalumab placebo Q3W (IV) every 3 weeks (Q3W) during the chemotherapy phase. Patients will receive durvalumab placebo Q4W (IV) with olaparib placebo tablets twice daily (oral) in the maintenance phase until disease progression. CONDITION: Health Condition 1: C55‐ Malignant neoplasm of uterus, partunspecified PRIMARY OUTCOME: Progression‐free survival (PFS) (per RECIST 1.1 as assessed by investigator)Timepoint: Q9W for the first 18 weeks relative to randomisation and then Q12W until RECIST 1.1‐defined radiological progression (PD) SECONDARY OUTCOME: PFS (per RECIST 1.1 as assessed by investigator)Timepoint: Q9W for the first 18 weeks relative to randomisation and then Q12W until RECIST 1.1‐defined radiological progression (PD) PK and immunogenicity of durvalumab and durvalumab in combination with olaparib through assessment of: ; 1) Serum concentrations of durvalumab ; 2) Anti‐drug antibodies (ADA) to durvalumabTimepoint: 1) PK blood sample: Chemotherapy phase cycle 5 day 1 (C5D1), maintenance phase C9D1 and 3 months post last IP dose ; 2) ADA blood sample: Chemotherapy phase (C1D1, C5D1), maintenance phase C9D1 and 3, 6 months post last IP dose Second progression‐free survival (PFS2), overall survival (OS), objective response rate (ORR), duration of response (DoR), time to first subsequent therapy or death (TFST), time to second subsequent therapy or death (TSST), and time to study treatment discontinuation or ; death (TDT)Timepoint: Survival status will be assessed 1, 2, 3, 4, 6, 8 and 10 months (every 2 months subsequently) post the last IP dose. ; ; Q9W for the first 18 weeks relative to randomisation and then Q12W until RECIST 1.1‐defined radiological progression (PD) ; ; Following RECIST 1.1‐defined radiological progression, patients will be assessed Q12W for a second progression Symptoms, functioning and overall health‐related quality of life (HRQoL) through assessment of: ; 1) European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ‐C30) ; 2) European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Endometrial Cancer 24 (EORTC QLQ‐EN24)Timepoint: Q3W for the first 18 weeks relative to C1D1, and then Q4W until PFS2 INCLUSION CRITERIA: 1) Capable of giving signed informed consent; 2) Histologically confirmed diagnosis of epithelial endometrial carcinoma; 3) Patient must have endometrial cancer in categories as specified in protocol; 4) Naïve to first‐line systemic anti‐cancer treatment; 5) A formalin‐fixed, paraffin‐embedded (FFPE) tumour sample from the locoregional or a metastatic site must be available and must be suitable for mismatch repair (MMR) status evaluation; 6) Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment; 7) Must have a life expectancy of at least 16 weeks; 8) Postmenopausal or evidence of nonchildbearing status for women of childbearing potential; 9) Body weight >30 kg; 10) Adequate organ and bone marrow function within 28 days prior to administration of Cycle 1 Day 1 as d ined in protocol; 11) Measure

de Bruijn, L., et al. (2020). "Treatment of posttraumatic stress disorder following childbirth." Journal of Psychosomatic Obstetrics and Gynaecology 41(1): 5-14.
	Aim: The aim of this systematic review is to give an overview of the literature on treatment options for posttraumatic stress disorder (PTSD) following childbirth and to assess their efficacy. Method: PubMed, Embase, Web of Science, Cochrane and PsycINFO were searched using "PTSD", "childbirth" and "therapy" as terms for studies in English language published between 2000 and 2017. Additional studies were identified by checking reference lists. Studies were included when presence of PTSD was confirmed prior to treatment and childbirth was the traumatic event focused on. All studies were reviewed on sample size, study design, used instruments, sample characteristics, type of treatment and the result of treatment regarding PTSD (symptoms). Results: Six studies met the inclusion criteria. One study on debriefing, three studies on cognitive behavioral therapy (CBT) and two studies on eye movement desensitization and reprocessing (EMDR) were identified. Both EMDR and CBT appear to be promising therapies for PTSD following childbirth. Debriefing seems to be beneficial when women request it themselves. Conclusions: EMDR and CBT seem to be effective as therapy for PTSD following childbirth. However, evidence is still limited and more controlled trials are needed to draw conclusive results.

de Carvalho, S. F. C., et al. (2023). "Pelvic venous reflux embolization in the treatment of symptomatic pelvic congestive syndrome: A systematic review with meta-analysis." Journal of Vascular Surgery: Venous and Lymphatic Disorders 11(2): 412-421.e416.
	Objective: The objective of this study was to objectively evaluate the improvement of chronic pelvic pain in patients with congestive pelvic syndrome undergoing pelvic venous embolization treatment through the Visual Analog Scale (VAS) measurement. Method(s): This is a meta-analysis conducted by evaluating descriptors indexed in the Medical Subject Heading platform and variable terms in the following databases: PubMed, ScienceDirect, LILACS, Cochrane Library, and CINAHL up until March 2021. The study was registered in the PROSPERO platform with reference number CRD42021246488. Result(s): A total of 1426 patients (age range, 31-49 years; 100% female), included in 19 studies (range, 11-520 patients), met the inclusion criteria. All studies showed a decrease in mean VAS scores after pelvic venous embolization (P <.001). There was a reduction of 5.15 points (95% confidence interval [CI], 4.44-5.86; I2 = 97%) in VAS considering a meta-analysis with random effects. Dyspareunia, dysuria, and dysmenorrhea symptoms improved in 79.8% (n = 401), 77.3% (n = 205), and 46.7% (n = 303) of symptomatic patients, respectively. Studies that evaluated associated symptoms through the VAS also reported a decrease in mean scores for dyspareunia (1.8 points; 95% CI, 1.07-2.53; I2 = 0%), dysuria (1.63 points; 95% CI 0.84-2.41; I2 = 0%), and dysmenorrhea (2.7 points; 95% CI 1.87-3.53; I2 = 0%). The procedure was mostly performed in gonadal and hypogastric veins (72.5%), followed by left ovarian vein alone (18.7%) and bilateral gonadal veins (7%). Embolizing agents used were coils and/or vascular plugs (76.5%), liquid (4%), or combined (19.4%) agents, with clinical improvement maintained during a mean follow-up period of 21.7 months. Regarding recurrence of symptoms, pelvic pain was the most reported, with 52 recurrences (6.1%) in a mean time of 8.5 to 21 months, followed by lower limb varicosities with 43 recurrences (16.6%). Coil migration was the most common major complication with 29 occurrences (2%), followed by thrombosis with one occurrence (0.07%). Conclusion(s): Pelvic venous embolization is efficient in reducing chronic pelvic pain secondary to the symptomatic pelvic congestive syndrome and its related symptoms objectively evaluated by the VAS. Studies with greater follow-up that promote comparison between techniques to treat symptomatic patients are required.Copyright © 2022 Society for Vascular Surgery

de Leeuw, M. (2023). "EASYlight study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Ketanest® S 5 mg/ml ‐ Ampullen,Product Code: PRD392897,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Esketamine Hydrochloride 5.77mg,Product Name: Ondansetron 2 mg/ml Solution for Injection,Product Code: PRD10011746,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Ondansetron 2mg,Product Name: SODIUM CHLORIDE,Product Code: SUB12581MIG,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: 0.9%,Pharmaceutical form of the placebo: SOLUTION FOR INJECTION,Route of administration of the placebo: INTRAVENOUS,Product Name: Ondansetron Morningside 4 mg orodispergeerbare tabletten,Product Code: PRD10416608,Pharmaceutical Form: ORODISPERSIBLE TABLET,Other descriptive name: ,Strength: Ondansetron 4mg CONDITION: Endometriosis Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03]‐Diseases [C] ‐ Female Urogenital Diseases and Pregnancy Complications [C13] PRIMARY OUTCOME: Main Objective:The primary aim of the EASYlight study is to assess the effect of 8 hour esketamine infusion versus placebo (saline) on the numeric rating scale score (NRS score) for chronic pelvic pain in patients with chronic pain associated with endometriosis. Primary end point(s):NRS score for chronic pelvic pain 4 weeks after the 8 hour infusion treatment Secondary Objective:Treatment experience,NRS scores for dysmenorrhea, dysuria, dyschezia, dyspareunia and chronic pelvic pain,Depressive symptoms,Quality of life,Pain coping and cognition,Work productivity,Health care utilization SECONDARY OUTCOME: Secondary end point(s):Cost‐effectiveness (adjusted iPCQ, adjusted iMCQ) Secondary end point(s):Depressive symptoms (HADS) Secondary end point(s):Pain coping and cognition (PCCL) Secondary end point(s):Pain scores (NRS scores for dysmenorrhea, dyschezia, dysuria, dyspareunia and chronic pelvic pain) Secondary end point(s):Quality of life (EHP‐30, EQ‐5D‐5L) Secondary end point(s):Treatment experience (including side‐effects) (Bond&Ladder questionnaire, Bowdle questionnaire, treatment experience rating (on a scale of 0‐10) INCLUSION CRITERIA: All pre‐menopausal women aged above 18 years,Women (endometriosis is a condition exclusive to females),‐ Diagnosed with endometriosis (ultrasound, MRI or previous laparoscopic and/or diagnostic surgery) according to the #Enzian classification. This means that endometriosis is present in the following compartments: Rectovaginal space (minimal A1) and/or Sacrouterine ligaments, cardinal ligaments, pelvic sidewall (minimal B1) and/or Rectum (minimal C1) and/or Endometriosis of the intestines, diaphragm and/or Adenomyosis (according to the morphological uterus sonographic assessment (MUSA) or evident adenomyosis on the MRI) and/or Peritoneal / superficial endometriosis (diagnosed laparoscopically and not treated during surgery).,‐Mild to severe chronic pelvic pain (NRS scale >= 6). The 11‐point NRS scale ranges from ‘0’ representing no pain to ‘10’ representing the worst pain imaginable.,‐Resistant to current recommended lines of analgesics (paracetamol, NSAIDs),‐Usage

de Moraes Francisco Cezar, A., et al. (2023). "PD-1/PD-L1 inhibitors plus carboplatin and paclitaxel compared with carboplatin and paclitaxel in primary advanced or recurrent endometrial cancer: a systematic review and meta-analysis of randomized clinical trials." BMC Cancer 23(1): 1166.
	Background: Paclitaxel and carboplatin is the standard chemotherapy for the treatment of advanced or recurrent endometrial cancer. However, the benefit of adding programmed cell death 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors to chemotherapy is still unclear.; Method: We searched PubMed, Scopus, Cochrane, and Web of Science databases for randomized controlled trials that investigated PD-1/PD-L1 inhibitors plus carboplatin and paclitaxel compared with carboplatin and paclitaxel in primary advanced or recurrent endometrial cancer. We computed hazard ratios (HRs) or risk ratios (RRs) for binary endpoints, with 95% confidence intervals (CIs). We used DerSimonian and Laird random-effect models for all endpoints. Heterogeneity was assessed using I 2 statistics. R, version 4.2.3, was used for statistical analyses.; Results: A total of three studies and 1,431 patients were included. Compared with carboplatin plus paclitaxel-based chemotherapy, progression-free survival (PFS) rate (HR 0.32; 95% CI 0.23-0.44; p < 0.001) and overall survival (OS) at 30 months (RR 3.13; 95% CI 1.26-7.78; p = 0.01) were significant in favor of the PD-1/PD-L1 inhibitors plus carboplatin and paclitaxel group in the mismatch repair-deficient subgroup. However, there were no significant differences in the mismatch repair-proficient subgroup for PFS (HR 0.74; 95% CI 0.50-1.08; p = 0.117) or OS at 30 months (RR 2.24; 95% CI 0.79-6.39; p = 0.13).; Conclusion: Immunotherapy plus carboplatin-paclitaxel increased significantly PFS and OS among patients with advanced or recurrent endometrial cancer, with a significant benefit in the mismatch repair-deficient and high microsatellite instability population. (© 2023. The Author(s).)

De Neubourg, D., et al. (2021). "Live birth after additional tubal flushing with oil-based contrast versus no additional flushing: a randomised, multicentre, parallel-group pragmatic trial in infertile women with at least one patent tube at hysterosalpingo-foam sonography (HYFOIL study)." BMJ Open 11(11): e054845.
	INTRODUCTION: Tubal patency testing is an essential part in the fertility workup of many subfertile women. Hysterosalpingography (HSG) has long been the test of choice in many clinics. There is evidence from a large randomised multicentre trial and from a recent meta‐analysis that women who had HSG using oil soluble contrast medium (OSCM) had higher rates of ongoing pregnancy compared with women who underwent this procedure using water contrast. However, the field is moving away from HSG and nowadays hysterosalpingo‐foam sonography (Hyfosy) using ultrasound guidance is considered as the first line office tubal patency test. Therefore, a large multicentre randomised clinical trial (RCT) will be initiated to evaluate if flushing the fallopian tubes with OSCM after a normal Hyfosy showing at least one patent fallopian tube will increase the live birth rate as compared with no flushing. METHODS AND ANALYSIS: We plan a multicentre two arm, 1:1 randomised, open‐label pragmatic comparative trial in 12 Belgian centres. After informed consent, we will randomise infertile women between 18 and 40 years of age, undergoing Hyfosy as part of the fertility workup to Hyfosy with additional tubal flushing with OSCM versus Hyfosy without additional flushing. Infertility is defined as lack of conception despite 12 months of unprotected intercourse, or three cycles of donor insemination without pregnancy or three ovulatory ovulation induction cycles without pregnancy, all three in combination with at least one patent tube on Hyfosy. Primary endpoint will be live birth with conception within 6 months after randomisation. ETHICS AND DISSEMINATION: Approval on 11 May 2021 by the Ethics Committee from ZNA Hospital Antwerp who was the central Ethics Committee for the Clinical Trial Regulation Pilot (Pilot 412) in the 12 centres. The findings from this RCT will be disseminated in peer‐reviewed publications and presentations at scientific international meetings. TRIAL REGISTRATION NUMBERS: EudraCT number: 2020‐002135‐30 and NCT04379973.

De Souza, M. J., et al. (2021). "Randomised controlled trial of the effects of increased energy intake on menstrual recovery in exercising women with menstrual disturbances: the 'REFUEL' study." Human Reproduction 36(8): 2285‐2297.
	STUDY QUESTION: Does increased daily energy intake lead to menstrual recovery in exercising women with oligomenorrhoea (Oligo) or amenorrhoea (Amen)? SUMMARY ANSWER: A modest increase in daily energy intake (330 ± 65 kcal/day; 18 ± 4%) is sufficient to induce menstrual recovery in exercising women with Oligo/Amen. WHAT IS KNOWN ALREADY: Optimal energy availability is critical for normal reproductive function, but the magnitude of increased energy intake necessary for menstrual recovery in exercising women, along with the associated metabolic changes, is not known. STUDY DESIGN, SIZE, DURATION: The REFUEL study (trial # NCT00392873) is the first randomised controlled trial to assess the effectiveness of 12 months of increased energy intake on menstrual function in 76 exercising women with menstrual disturbances. Participants were randomised (block method) to increase energy intake 20‐40% above baseline energy needs (Oligo/Amen + Cal, n = 40) or maintain energy intake (Oligo/Amen Control, n = 36). The study was performed from 2006 to 2014. PARTICIPANTS/MATERIALS, SETTING, METHODS: Participants were Amen and Oligo exercising women (age = 21.0 ± 0.3 years, BMI = 20.8 ± 0.2 kg/m2, body fat = 24.7 ± 0.6%) recruited from two universities. Detailed assessment of menstrual function was performed using logs and measures of daily urinary ovarian steroids. Body composition and metabolic outcomes were assessed every 3 months. MAIN RESULTS AND THE ROLE OF CHANCE: Using an intent‐to‐treat analysis, the Oligo/Amen + Cal group was more likely to experience menses during the intervention than the Oligo/Amen Control group (P = 0.002; hazard ratio [CI] = 1.91 [1.27, 2.89]). In the intent‐to‐treat analysis, the Oligo/Amen + Cal group demonstrated a greater increase in energy intake, body weight, percent body fat and total triiodothyronine (TT3) compared to the Oligo/Amen Control group (P < 0.05). In a subgroup analysis where n = 22 participants were excluded (ambiguous baseline menstrual cycle, insufficient time in intervention for menstrual recovery classification), 64% of the Oligo/Amen + Cal group exhibited improved menstrual function compared with 19% in the Oligo/Amen Control group (χ2, P = 0.001). LIMITATIONS, REASONS FOR CAUTION: While we had a greater than expected dropout rate for the 12‐month intervention, it was comparable to other shorter interventions of 3‐6 months in duration. Menstrual recovery defined herein does not account for quality of recovery. WIDER IMPLICATIONS OF THE FINDINGS: Expanding upon findings in shorter, non‐randomised studies, a modest increase in daily energy intake (330 ± 65 kcal/day; 18 ± 4%) is sufficient to induce menstrual recovery in exercising women with Oligo/Amen. Improved metabolism, as demonstrated by a modest increase in body weight (4.9%), percent body fat (13%) and TT3 (16%), was associated with menstrual recovery. STUDY FUNDING/COMPETING INTEREST(S): This research was supported by the U.S. Department of Defense: U.S. Army Medical Research and Material Command (Grant PR054531). Additional research assistance provided by the Penn State Clinical Research Center was supported by the National Center for Advancing Translation Sciences, National Institutes of Health, through Grant UL1 TR002014. M.P.O. was supported in part by the Loretta Anne Rogers Chair in Eating Disorders at University of Toronto and University Health Network. All authors report no conflict of interest. TRIAL REGISTRATION NUMBER: NCT00392873. TRIAL REGISTRATION DATE: October 2006. DATE OF FIRST PATIENT’S ENROLMENT: September 2006.

de Souza Pinto Luiz, P., et al. (2023). "Evaluation of safety and effectiveness of gestrinone in the treatment of endometriosis: a systematic review and meta-analysis." Archives of Gynecology and Obstetrics 307(1): 21-37.
	Purpose: Endometriosis is a common chronic gynecological disease defined as the presence of endometrial glands and stroma tissue outside the uterus. Gestrinone is an effective antiestrogen that induces endometrial atrophy and/or amenorrhea. The purpose of this systematic review is to provide an evaluation of safety and effectiveness of gestrinone for the treatment of endometriosis.; Methods: We performed a search in six electronic databases: PubMed, MEDLINE (ovid), Embase, Cochrane CENTRAL (clinical trials), Web of Science and Scopus. Our selected primary outcomes were the changes in dysmenorrhea, pain relief including pelvic pain and dyspareunia. The secondary outcomes embrace hormones parameters, pregnancy rate and adverse events.; Results: Of 3269 references screened, 16 studies were included involving 1286 women. All studies compared gestrinone with other drugs treatments (placebo, Danazol, Mifepristone tablets, Leuprolide acetate, Quyu Jiedu Recipe) during 6 months. When compared with other drugs treatments, gestrinone relieved dysmenorrhea, pelvic pain, and morphologic response in the ovary. There was an increase on the pregnancy rate. Regarding the side effects observed, gestrinone showed the same adverse events and increased the risk of acne and seborrhea when compared to other treatments. Even if there was any difference in efficacy between gestrinone, danazol, leuprolide acetate, or Quyu Jiedu Recipe Chinese Medicine, it remains unclear due to insufficient data.; Conclusion: Based limited evidence available suggests that gestrinone appeared to be safe and may have some efficacy advantages over danazol, as well as other therapeutic interventions for treating endometriosis. However, this conclusion should be interpreted with caution, due the quality of the evidence provided is generally very low or unclear.; Trial Registration: CRD42021284148. (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

de Tayrac, R., et al. (2022). "Urinary and sexual impact of pelvic reconstructive surgery for genital prolapse by surgical route. A randomized controlled trial." International Urogynecology Journal 33(7): 2021-2030.
	Introduction and Hypothesis: The main objective of the study was to evaluate the rates of de novo stress urinary (SUI) and postoperative dyspareunia after both sacrocolpopexy/hysteropexy (SCP) and vaginal mesh surgery.; Methods: A prospective, multicenter, randomized, open-label study with two parallel groups treated by either SCP or Uphold Lite vaginal mesh was carried out. Study participants were ≥ 50 and < 80 years old patients with Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 who were considered eligible for reconstructive surgery and who were sexually active with no dyspareunia and free from bothersome SUI at presentation. Women were assessed before surgery and at 4-8 weeks and 11-13 months after using validated measures including POP-Q, Pelvic Floor Disability Index (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), and Patient Global Impression of Improvement (PGI-I). Data were also collected for health economics evaluation.; Results: Of the required sample of 156 women, 42 women (19 SCP and 23 vaginal mesh) were only recruited owing to the discontinuation of vaginal mesh worldwide. The median follow-up was 376 days. The rates of bothersome de novo SUI were similar in the SCP and Uphold vaginal mesh groups (15.79 vs 15.00%, OR 0.95 [95% CI 0.22-4.14]). Among 30 sexually active patients at follow-up, the rates of women reporting de novo dyspareunia "usually or always" were 6.7% after SCP vs 13.3% after vaginal mesh (p = 1). Health economics evaluation showed a cost saving of 280€ in favor of the Uphold vaginal mesh technique, but no significant difference in the total cost (2,934.97€ for SCP vs 3,053.26€ for Uphold vaginal mesh).; Conclusions: Bothersome de novo SUI and de novo dyspareunia occurred in approximately 15% and 23% of our study cohorts, with no significant difference between sacrocolpopexy/hysteropexy and anterior/apical vaginal mesh surgery. However, these results should be interpreted with caution owing to the small sample size. (© 2022. The International Urogynecological Association.)

De Vos, M. (2021). "Optimising Preconceptual Health in Subfertile PCOS Patients Using a Lifestyle Modification Program." ClinicalTrials.gov.
	When allocated to the control arm patients will receive the standard of care combined with the foreseen questionnaires and bio‐electric impedance analysis for body composition and ergospirometry. When the patient is allocated to the interventional arm she will receive a 12‐week lifestyle modification program prior to her fertility treatment. The lifestyle modification program will consist of dietary advice, advice for physical activity and emotional support. After the 12‐week program the fertilty treatment will start as per routine practice. Questionnaires, ergospirometry and bio‐electric impedance analysis will also be performed at the foreseen moments.

Dean, G., et al. (2021). "Treatment of mild-to-moderate pelvic inflammatory disease with a short-course azithromycin-based regimen versus ofloxacin plus metronidazole: results of a multicentre, randomised controlled trial." Sexually Transmitted Infections 97(3): 177-182.
	OBJECTIVE: A multicentre, randomised non-inferiority trial compared the efficacy and safety of 14 days of ofloxacin and metronidazole (standard-of-care (SoC)) versus a single dose of intramuscular ceftriaxone followed by 5 days of azithromycin and metronidazole (intervention arm (IA)) in women with mild-to-moderate pelvic inflammatory disease (PID). METHODS: Women with a clinical diagnosis of PID presenting at sexual health services were randomised to the SoC or IA arms. Treating clinicians and participants were not blinded to treatment allocation but the clinician performing the assessment of primary outcome was blinded. The primary outcome was clinical cure defined as ≥70% reduction in the modified McCormack pain score at day 14-21 after starting treatment. Secondary outcomes included adherence, tolerability and microbiological cure. RESULTS: Of the randomised population 72/153 (47.1%) reached the primary end point in the SoC arm, compared with 68/160 (42.5%) in the IA (difference in cure 4.6% (95% CI -15.6% to 6.5%). Following exclusion of 86 women who were lost to follow-up, attended outside the day 14-21 follow-up period, or withdrew consent, 72/107 (67.3%) had clinical cure in the SoC arm compared with 68/120 (56.7%) in the IA, giving a difference in cure rate of 10.6% (95% CI -23.2% to 1.9%). We were unable to demonstrate non-inferiority of the IA compared with SoC arm. Women in the IA took more treatment doses compared with the SoC group (113/124 (91%) vs 75/117 (64%), p=0.0001), but were more likely to experience diarrhoea (61% vs 24%, p<0.0001). Of 288 samples available for analysis, Mycoplasma genitalium was identified in 10% (28/288), 58% (11/19) of which had baseline antimicrobial resistance-associated mutations. CONCLUSION: A short-course azithromycin-based regimen is likely to be less effective than the standard treatment with ofloxacin plus metronidazole. The high rate of baseline antimicrobial resistance supports resistance testing in those with M. genitalium infection to guide appropriate therapy. TRIAL REGISTRATION NUMBER: 2010-023254-36.

DeCensi, A. (2022). "Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)." ClinicalTrials.gov.
	Primary objective: To determine if letrozole is superior to standard chemotherapy in terms of progression‐free survival (PFS) in the first line treatment of patients with advanced low‐grade serous epithelial ovarian carcinoma positive for estrogen and/or progesterone receptors. Secondary objectives: ‐ to evaluate the response of tumor to letrozole compared with standard chemotherapy in terms of objective response rate (ORR); ‐ to test the predictive effect of ER and PgR on response to letrozole in terms of PFS and ORR; ‐ to evaluate the possible negative association between the effect of letrozole, in terms of PFS and ORR, and the proliferative index Ki67; ‐ to evaluate the impact of letrozole compared with the impact of standard chemotherapy on patients' health related quality of life evaluated by Menopausal Quality of Life Questionnaire (MENQOL); ‐ to evaluate the impact of letrozole compared with standard chemotherapy on patients' musculoskeletal pain evaluated by Brief Pain Inventory ‐ Short Form (BPISF); ‐ to evaluate the effect on overall survival (OS). As most patients will recur and will be switched to chemotherapy and vice versa, OS is not expected to be significantly different; ‐ to evaluate the safety of letrozole compared with standard chemotherapy according to CTCAE v 5.0. Translational objectives: ‐ to characterize the mutational profile and gene expression of the disease by NGS (next‐generation sequencing) methodology on tissue samples; ‐ to evaluate the circulating tumor DNA (ctDNA) on liquid biopsies as a tool to monitor the disease response.

Deehan, C., et al. (2023). "Endometrial ablation and resection versus hysterectomy for heavy menstrual bleeding: an updated systematic review and meta-analysis of effectiveness and complications." Obstetrics & Gynecology Science 66(5): 364-384.
	To evaluate the clinical efficacy, safety, and cost-effectiveness of endometrial ablation or resection (E:A/R) compared to hysterectomy for the treatment of heavy menstrual bleeding. Literature search was conducted, and randomized control trials (RCTs) comparing (E:A/R) versus hysterectomy were reviewed. The search was last updated in November 2022. Twelve RCTs with 2,028 women (hysterectomy: n=977 vs. [E:A/R]: n=1,051) were included in the analyzis. The meta-analysis revealed that the hysterectomy group showed improved patient-reported and objective bleeding symptoms more than those of the (E:A/R) group, with risk ratios of (mean difference [MD], 0.75; 95% confidence intervals [CI], 0.71 to 0.79) and (MD, 44.00; 95% CI, 36.09 to 51.91), respectively. Patient satisfaction was higher post-hysterectomy than (E:A/R) at 2 years of follow-up, but this effect was absent with long-term follow-up. (E:A/R) is considered an alternative to hysterectomy as a surgical management for heavy menstrual bleeding. Although both procedures are highly effective, safe, and improve the quality of life, hysterectomy is significantly superior at improving bleeding symptoms and patient satisfaction for up to 2 years. However, it is associated with longer operating and recovery times and a higher rate of postoperative complications. The initial cost of (E:A/R) is less than the cost of hysterectomy, but further surgical requirements are common; therefore, there is no difference in the cost for long-term follow-up.

Deenadayalan, B., et al. (2023). "Is Acupuncture or Acupressure on Sanyinjiao (SP6) Acupoint effective for the management of Primary Dysmenorrhea: An updated systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Dekel, S., et al. (2024). "Preventing posttraumatic stress disorder following childbirth: a systematic review and meta-analysis." American Journal of Obstetrics and Gynecology.
	Objective: Women can develop posttraumatic stress disorder in response to experienced or perceived traumatic, often medically complicated, childbirth; the prevalence of these events remains high in the United States. Currently, no recommended treatment exists in routine care to prevent or mitigate maternal childbirth-related posttraumatic stress disorder. We conducted a systematic review and meta-analysis of clinical trials that evaluated any therapy to prevent or treat childbirth-related posttraumatic stress disorder. Data Sources: PsycInfo, PsycArticles, PubMed (MEDLINE), ClinicalTrials.gov, CINAHL, ProQuest, Sociological Abstracts, Google Scholar, Embase, Web of Science, ScienceDirect, Scopus, and the Cochrane Central Register of Controlled Trials were searched for eligible trials published through September 2023. Study Eligibility Criteria: Trials were included if they were interventional, if they evaluated any therapy for childbirth-related posttraumatic stress disorder for the indication of symptoms or before posttraumatic stress disorder onset, and if they were written in English. Method(s): Independent coders extracted the sample characteristics and intervention information of the eligible studies and evaluated the trials using the Downs and Black's quality checklist and Cochrane's method for risk of bias evaluation. Result(s): A total of 41 studies (32 randomized controlled trials, 9 nonrandomized trials) were reviewed. They evaluated brief psychological therapies including debriefing, trauma-focused therapies (including cognitive behavioral therapy and expressive writing), memory consolidation and reconsolidation blockage, mother-infant-focused therapies, and educational interventions. The trials targeted secondary preventions aimed at buffering childbirth-related posttraumatic stress disorder usually after traumatic childbirth (n=24), tertiary preventions among women with probable childbirth-related posttraumatic stress disorder (n=14), and primary prevention during pregnancy (n=3). A meta-analysis of the combined randomized secondary preventions showed moderate effects in reducing childbirth-related posttraumatic stress disorder symptoms when compared with usual treatment (standardized mean difference, -0.67; 95% confidence interval, -0.92 to -0.42). Single-session therapy within 96 hours of birth was helpful (standardized mean difference, -0.55). Brief, structured, trauma-focused therapies and semi-structured, midwife-led, dialogue-based psychological counseling showed the largest effects (standardized mean difference, -0.95 and -0.91, respectively). Other treatment approaches (eg, the Tetris game, mindfulness, mother-infant-focused treatment) warrant more research. Tertiary preventions produced smaller effects than secondary prevention but are potentially clinically meaningful (standardized mean difference, -0.37; -0.60 to -0.14). Antepartum educational approaches may help, but insufficient empirical evidence exists. Conclusion(s): Brief trauma-focused and non-trauma-focused psychological therapies delivered early in the period following traumatic childbirth offer a critical and feasible opportunity to buffer the symptoms of childbirth-related posttraumatic stress disorder. Future research that integrates diagnostic and biologic measures can inform treatment use and the mechanisms at work.Copyright © 2024 The Authors

Del Forno, S., et al. (2021). "Assessment of levator hiatal area using 3D/4D transperineal ultrasound in women with deep infiltrating endometriosis and superficial dyspareunia treated with pelvic floor muscle physiotherapy: randomized controlled trial." Ultrasound in Obstetrics & Gynecology 57(5): 726‐732.
	OBJECTIVES: Deep infiltrating endometriosis (DIE) is associated with chronic pelvic pain, dyspareunia and pelvic floor muscle hypertonia. The primary aim of this study was to evaluate the effect of pelvic floor physiotherapy (PFP) on the area of levator ani hiatus during Valsalva maneuver, assessed using transperineal ultrasound, in women with DIE suffering from superficial dyspareunia. METHOD(S): This was a randomized controlled trial of 34 nulliparous women diagnosed with DIE and associated superficial dyspareunia. After an initial clinical examination, all patients underwent three‐dimensional/four‐dimensional (3D/4D) transperineal ultrasound to measure the levator hiatal area (LHA) at rest, on maximum pelvic floor muscle contraction and on maximum Valsalva maneuver, and were asked to rate their pain symptoms using a numerical rating scale (NRS). Eligible women were assigned randomly (1:1 ratio) to no intervention (control group, 17 women) or treatment with five individual sessions of PFP (study group, 17 women). Four months after the first examination, all women underwent a second evaluation of pain symptoms and LHA on transperineal ultrasound. The primary outcome measure was the percentage change in LHA on maximum Valsalva maneuver between the baseline and follow‐up examinations. The percentage changes in pain symptoms between the two examinations, including superficial and deep dyspareunia, dysmenorrhea, chronic pelvic pain, dysuria and dyschezia, were also evaluated. RESULT(S): Thi women, comprising 17 in the study group and 13 in the control group, completed the study and were included in the analysis. The percentage change in LHA on maximum Valsalva maneuver between the two examinations was higher in the study group than in the control group (20.0+/‐24.8% vs ‐0.5+/‐3.3%; P=0.02), indicating better pelvic floor muscle relaxation. After PFP treatment, the NRS score for superficial dyspareunia remained almost unchanged in the control group (median change in NRS (DELTA‐NRS), 0 (interquartile range (IQR), 0‐0)) while a marked reduction was observed in the study group (median DELTA‐NRS, ‐3 (IQR, ‐4 to ‐2); P<0.01). Moreover, there was a significant difference between the PFP and control groups with regards to the change in chronic pelvic pain (median DELTA‐NRS, 0 (IQR, ‐2 to 0) vs 0 (IQR, 0‐1); P=0.01). CONCLUSION(S): In women with DIE, PFP seems to result in increased LHA on Valsalva maneuver, as observed by 3D/4D transperineal ultrasound, leading to improved superficial dyspareunia, chronic pelvic pain and pelvic floor muscle relaxation.

Deligiannidis, K. M., et al. (2021). "Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial." JAMA Psychiatry 78(9): 951-959.
	IMPORTANCE: Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy, negatively affecting both mother and child. OBJECTIVE: To demonstrate the efficacy and safety of zuranolone, a neuroactive steroid γ-aminobutyric acid receptor-positive allosteric modulator, in PPD. DESIGN, SETTING, AND PARTICIPANTS: This phase 3, double-blind, randomized, outpatient, placebo-controlled clinical trial was conducted between January 2017 and December 2018 in 27 enrolling US sites. Participant were women aged 18 to 45 years, 6 months or fewer post partum, with PPD (major depressive episode beginning third trimester or ≤4 weeks postdelivery), and baseline 17-item Hamilton Rating Scale for Depression (HAMD-17) score of 26 or higher. Analysis was intention to treat and began December 2018 and ended March 2019. INTERVENTIONS: Randomization 1:1 to placebo:zuranolone, 30 mg, administered orally each evening for 2 weeks. MAIN OUTCOMES AND MEASURES: Primary end point was change from baseline in HAMD-17 score for zuranolone vs placebo at day 15. Secondary end points included changes from baseline in HAMD-17 total score at other time points, HAMD-17 response (≥50% score reduction) and remission (score ≤7) rates, Montgomery-Åsberg Depression Rating Scale score, and Hamilton Rating Scale for Anxiety score. Safety was assessed by adverse events and clinical assessments. RESULTS: Of 153 randomized patients, the efficacy set comprised 150 patients (mean [SD] age, 28.3 [5.4] years), and 148 (98.7%) completed treatment. A total of 76 patients were randomized to placebo, and 77 were randomized to zuranolone, 30 mg. Zuranolone demonstrated significant day 15 HAMD-17 score improvements from baseline vs placebo (-17.8 vs -13.6; difference, -4.2; 95% CI, -6.9 to -1.5; P = .003). Sustained differences in HAMD-17 scores favoring zuranolone were observed from day 3 (difference, -2.7; 95% CI, -5.1 to -0.3; P = .03) through day 45 (difference, -4.1; 95% CI, -6.7 to -1.4; P = .003). Sustained differences at day 15 favoring zuranolone were observed in HAMD-17 response (odds ratio, 2.63; 95% CI, 1.34-5.16; P = .005), HAMD-17 score remission (odds ratio, 2.53; 95% CI, 1.24-5.17; P = .01), change from baseline for Montgomery-Åsberg Depression Rating Scale score (difference, -4.6; 95% CI, -8.3 to -0.8; P = .02), and Hamilton Rating Scale for Anxiety score (difference, -3.9; 95% CI, -6.7 to -1.1; P = .006). One patient per group experienced a serious adverse event (confusional state in the zuranolone group and pancreatitis in the placebo group). One patient in the zuranolone group discontinued because of an adverse event vs none for placebo. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, zuranolone improved the core symptoms of depression as measured by HAMD-17 scores in women with PPD and was generally well tolerated, supporting further development of zuranolone in the treatment of PPD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02978326.

Deligiannidis Kristina, M., et al. (2023). "Zuranolone for the Treatment of Postpartum Depression." The American Journal of Psychiatry 180(9): 668-675.
	Objective: Postpartum depression (PPD) is a common perinatal complication with adverse maternal and infant outcomes. This study investigated the efficacy and safety of zuranolone, a positive allosteric modulator of synaptic and extrasynaptic GABA A receptors and neuroactive steroid, as an oral, once-daily, 14-day treatment course for patients with severe PPD.; Methods: In this double-blind phase 3 trial, women with severe PPD were randomized in a 1:1 ratio to receive zuranolone 50 mg/day or placebo for 14 days. The primary endpoint was change from baseline in total score on the 17-item Hamilton Depression Rating Scale (HAM-D) at day 15; key secondary endpoints were change from baseline in HAM-D score at days 3, 28, and 45 and change from baseline in Clinical Global Impressions severity (CGI-S) score at day 15. Adverse events were monitored.; Results: Among 196 patients randomized (zuranolone, N=98; placebo, N=98), 170 (86.7%) completed the 45-day study. Treatment with zuranolone compared with placebo resulted in statistically significant improvement in depressive symptoms at day 15 (least squares mean [LSM] change from baseline in HAM-D score, -15.6 vs. -11.6; LSM difference, -4.0, 95% CI=-6.3, -1.7); significant improvement in depressive symptoms was also reported at days 3, 28, and 45. CGI-S score at day 15 significantly improved with zuranolone compared with placebo. The most common adverse events (≥10%) with zuranolone were somnolence, dizziness, and sedation. No loss of consciousness, withdrawal symptoms, or increased suicidal ideation or behavior were observed.; Conclusions: In this trial, zuranolone demonstrated significant improvements in depressive symptoms and was generally well tolerated, supporting the potential of zuranolone as a novel, rapid-acting oral treatment for PPD.; Competing Interests: Dr. Deligiannidis has served as a consultant for Brii Biosciences, Gerbera Therapeutics, GH Research, Neuroscience Software, Reunion Neuroscience, and Sage Therapeutics; she has received grants from Sage Therapeutics, awarded to Zucker Hillside Hospital/Feinstein Institutes for Medical Research (related to clinical trials of brexanolone and zuranolone), and grants from NIH and Vorso Corporation; and she has received royalties from an NIH employee invention. Dr. Meltzer-Brody has received grant funding from Janssen, awarded to the University of North Carolina Chapel Hill, grants from NIH and the Patient-Centered Outcomes Research Institute, and grants and other research funding from Sage Therapeutics, awarded to the University of North Carolina at Chapel Hill; and she has received personal fees from WebMD/Medscape. Dr. Maximos has received grants from Sage Therapeutics related to the zuranolone clinical trial; he has served as a consultant for Evofem Biosciences; and he may hold stock in Sage Therapeutics. Dr. Peeper holds stock in Sage Therapeutics. Dr. Freeman conducts research with the Massachusetts General Hospital (MGH) National Pregnancy Registry and, as an employee of MGH, works with the MGH Clinical Trials Network and Institute, which received research funding from multiple pharmaceutical companies and NIMH; current sponsors of the MGH National Pregnancy Registry include Alkermes, Eisai, Johnson & Johnson/Janssen Pharmaceuticals, Otsuka America Pharmaceutical, Sage Therapeutics, Sunovion Pharmaceuticals, Supernus Pharmaceuticals, and Teva Pharmaceutical Industries; she is a research investigator for Sage Therapeutics; she serves on advisory boards for independent data safety and monitoring committees for Beckley Psytech, Brainify, Eliem, Everly Health, Janssen (Johnson & Johnson), Neurocrine, Novartis, Relmada, Sage Therapeutics, and Tibi Health; she has participated in Everly Health Educational activities (speaking, planning): WebMD, Medscape, Pri-Med, and Postpartum Support International; and she has received royalties from the MGH Scale and the Massachusetts General Hospital Female Reproductive Lifecycle and Hormones Questionnaire. Dr. Lasser, Dr. Bullock, Ms. Li, and Dr. Doherty are employees of Sag Therapeutics, and may hold stock and/or stock options. Dr. Rana and Dr. Garcia were employees of Sage Therapeutics at the time of the study and development of the manuscript, and may hold stock and/or stock options. Dr. Kotecha, Ms. Forrestal, and Dr. Leclair are employees of Biogen, and may hold stock.

Demirci, N. (2024). "The Effect of the Self-Care Support Program on Women With Endometriosis." ClinicalTrials.gov.
	No Results Available Behavioral: Endometriosis Self-care Support Program Self-Care Behaviors Scale in Endometriosis|Endometriosis Health Profile|Depression, Anxiety and Stress Scale|Numerical Pain Scale Female Not Applicable 58 Other Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Supportive Care 150 December 2024

Demirtas, B. (2024). "The The Effect of Planned Behavior Theory-Based Education on Physical Activity and Dysmenorrhea." ClinicalTrials.gov.
	No Results Available Behavioral: Theory of Planned Behavior Based Training Program Visual Analog Scale (VAS)|Dysmenorrhea Impact Scale-Short Form|Physical Activity Scale|The Self-Effıcacy Scale|Daily Step Tracking Female Not Applicable 68 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care AnkaraU-HEM-RK-01 January 2024

Denison Hayley, J., et al. (2020). "Oral versus intra-vaginal imidazole and triazole anti-fungal treatment of uncomplicated vulvovaginal candidiasis (thrush)." The Cochrane Database of Systematic Reviews 8: CD002845.
	Background: Anti-fungals are available for oral and intra-vaginal treatment of uncomplicated vulvovaginal candidiasis.; Objectives: The primary objective of this review is to assess the relative effectiveness (clinical cure) of oral versus intra-vaginal anti-fungals for the treatment of uncomplicated vulvovaginal candidiasis. Secondary objectives include the assessment of the relative effectiveness in terms of mycological cure, in addition to safety, side effects, treatment preference, time to first relief of symptoms, and costs.; Search Methods: We searched CENTRAL, MEDLINE, Embase, and two trials registers on 29 August 2019 together with reference checking and citation searching.; Selection Criteria: We included randomised controlled trials published in any language comparing at least one oral anti-fungal with one intra-vaginal anti-fungal in women (aged 16 years or over) with a mycological diagnosis (positive culture, microscopy for yeast, or both) of uncomplicated vulvovaginal candidiasis. We excluded trials if they solely involved participants who were HIV positive, immunocompromised, pregnant, breast feeding or diabetic.; Data Collection and Analysis: We used standard methodological procedures as recommended by Cochrane.; Main Results: This review includes 26 trials (5007 participants). Eight anti-fungals are represented. All but three trials included participants with acute vulvovaginal candidiasis. Trials were conducted in Europe: UK (3), Croatia (2). Finland (2), the Netherlands (2), Germany (1), Italy (1), Sweden (1) and one trial across multiple European countries, USA (7) Thailand (2), Iran (2), Japan (1) and Africa (Nigeria) (1). The duration of follow-up varied between trials. The overall risk of bias of the included trials was high. There was probably little or no difference shown between oral and intra-vaginal anti-fungal treatment for clinical cure at short-term follow-up (OR 1.14, 95% CI 0.91 to 1.43; 13 trials; 1859 participants; moderate-certainty evidence) and long-term follow-up (OR 1.07, 95% CI 0.77 to 1.50; 9 trials; 1042 participants; moderate-certainty evidence). The evidence suggests that if the rate of clinical cure at short-term follow-up with intra-vaginal treatment is 77%, the rate with oral treatment would be between 75% and 83%; if the rate of clinical cure at long term follow-up with intra-vaginal treatment is 84%, the rate with oral treatment would be between 80% and 89%. Oral treatment probably improves mycological cure over intra-vaginal treatment at short term (OR 1.24, 95% CI 1.03 to 1.50: 19 trials; 3057 participants; moderate-certainty evidence) and long-term follow-up (OR 1.29, 95% CI 1.05 to 1.60; 13 trials; 1661 participants; moderate-certainty evidence). The evidence suggests that if the rate of mycological cure at short-term follow-up with intra-vaginal treatment is 80%, the rate with oral treatment would be between 80% and 85%; if the rate of mycological cure at long-term follow-up with intra-vaginal treatment is 66%, the rate with oral treatment would be between 67% and 76%. In terms of patient safety, there is a low risk of participants withdrawing from the studies due to adverse drug effects for either treatment (23 trials; 4637 participants; high-certainty evidence). Due to the low certainty of evidence, it is undetermined whether oral treatments reduced the number of side effects compared with intra-vaginal treatments (OR 1.04, 95% CI 0.84 to 1.29; 16 trials; 3155 participants; low-certainty evidence). The evidence suggests that if the rate of side effects with intra-vaginal treatment is 12%, the rate with oral treatment would be between 10% and 15%. We noted that the type of side effects differed, with intra-vaginal treatments being more often associated with local reactions, and oral treatments being more often associated with systemic effects including gastro-intestinal symptoms and headaches. Oral treatment appeared to be the favoured treatment preference over intra-vaginal treatment or no preference (12 trials; 2206 participants), however the data were poorly reported and the certainty of the evidence was low. There was little or no difference in time to first relief of symptoms between oral and intra-vaginal treatments: four trials favoured the oral treatment, four favoured intra-vaginal, one study reported no difference and one was unclear. The measurements varied between the 10 trials (1910 participants) and the certainty of the evidence was low. Costs were not reported in any of the trials.; Authors' Conclusions: Oral anti-fungal treatment probably improves short- and long-term mycological cure over intra-vaginal treatment for uncomplicated vaginal candidiasis. Oral treatment was the favoured treatment preference by participants, though the certainty of this evidence is low. The decision to prescribe or recommend an anti-fungal for oral or intra-vaginal administration should take into consideration safety in terms of withdrawals and side effects, as well as cost and treatment preference. Unless there is a previous history of adverse reaction to one route of administration or contraindications, women who are purchasing their own treatment should be given full information about the characteristics and costs of treatment to make their own decision. If health services are paying the treatment cost, decision-makers should consider whether the higher cost of some oral anti-fungals is worth the gain in convenience, if this is the patient's preference. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Deshmukh, H., et al. (2023). "The Effect of a Very-Low-Calorie Diet (VLCD) vs. a Moderate Energy Deficit Diet in Obese Women with Polycystic Ovary Syndrome (PCOS)-A Randomised Controlled Trial." Nutrients 15(18).
	We performed an open-label, randomised controlled trial to compare the effects of a very-low-calorie diet (VLCD) vs. moderate energy deficit approach on body weight, body composition, free androgen index (FAI), and metabolic markers in obese women with polycystic ovary syndrome (PCOS). Forty eligible patients were randomly assigned to a VLCD ( n = 21) or a conventional energy deficit approach ( n = 19) over the same period. After eight weeks, both groups experienced significant weight loss; however, this was greater in the VLCD arm (-10.9% vs. -3.9%, p < 0.0001). There was also a trend towards a reduction in FAI in the VLCD group compared to the energy deficit group (-32.3% vs. -7.7%, p = 0.07). In the VLCD arm, two women (18%) had a biochemical remission of PCOS (FAI < 4); this was not the case for any of the participants in the energy deficit arm. There was a significant within-group increase in the sex-hormone-binding globulin ( p = 0.002) and reductions in fasting blood glucose ( p = 0.010) and waist to hip ratio ( p = 0.04) in the VLCD arm, but not in the energy deficit arm. The VLCD resulted in significantly greater weight reduction and was accompanied by more pronounced improvements in hyperandrogenaemia, body composition, and several metabolic parameters in obese women with PCOS as compared to the energy deficit approach.

Deslypere, J.-P. (2021). "Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis." ClinicalTrials.gov.
	Females aged 18‐50 years with a clinical diagnosis of an acute VVC episode at Screening Visit will be randomly assigned to either miconazole nitrate 2% + low or high dose of domiphen bromide vaginal cream or to the comparator product Gyno‐Daktarin® vaginal cream (miconazole nitrate 2%). The creams will be applied for 7 days and subjects will be followed up for 12 weeks.

Devakumar, H., et al. (2023). "Dexamethasone administration to improve patient recovery in ambulatory vaginal reconstructive surgery: a randomized prospective trial." International Urogynecology Journal 34(8): 1781-1788.
	Introduction and hypothesis: Dexamethasone is a potent glucocorticoid that may improve quality of recovery (QoR). We hypothesized that standard administration of dexamethasone at induction may improve QoR compared to placebo in subjects undergoing ambulatory vaginal reconstructive surgeries. Method(s): This was a randomized prospective clinical trial on subjects scheduled for ambulatory vaginal reconstructive surgery for prolapse and/or urinary incontinence. Intervention arm subjects were administered dexamethasone and the control group, a placebo (normal saline). Timing of administration, anesthesia medications, postoperative pain medications, and antiemetics were standardized. Primary outcome was difference in QoR (QoR-40) scores 24-48 h after surgery. Power analysis estimated that 27 subjects were required in each group to detect a difference in QoR-40 scores with 80% power and an alpha of 0.05. Result(s): Fifty-one subjects were enrolled and randomized. 4 withdrew, 1 was excluded, and 46 were analyzed. For the primary outcome, there was no difference in the QoR-40 between the dexamethasone and placebo group (--13.5 vs -19.6, p=0.24). Postoperative nausea vomiting intensity scores were not different (8.33 vs 9.09, p=1). Pain scores were similar in the two groups (6.0 vs 4.7, p=0.12). Although not statistically significant, surgical satisfaction at 6 weeks was better with dexamethasone (23.5 vs 26.9, p=0.09). Conclusion(s): Based on this study, a single dose of dexamethasone at the time of induction prior to ambulatory vaginal reconstructive surgery was not associated with improved QoR. Standardized anesthesia protocols may play a role in postoperative nausea, pain control, and thereby QoR in patients undergoing ambulatory vaginal reconstructive surgeries.Copyright © 2023, The International Urogynecological Association.

Devall, A., et al. (2021). "Mifepristone and misoprostol versus placebo and misoprostol for resolution of miscarriage in women diagnosed with missed miscarriage: The MifeMiso RCT." Health Technology Assessment 25(68): i-113.
	Background Miscarriage is the most common complication of pregnancy. As many as 15-25% of pregnancies end in a miscarriage, and the number of miscarriages in England is estimated to be approximately 125,000 per year. Management of miscarriage can be expectant (i.e. waiting for natural miscarriage), medical (i.e. with drugs) or surgical. About 25% of women opt for medical management; however, there is uncertainty about the optimal drug regimens for medical management. Before National Institute for Health and Care Excellence (NICE) guideline CG154 was published in 2012, it was common practice to use a combination of mifepristone (Mifegyne, Exelgyn, Paris, France) and misoprostol. The 2012 guideline, however, recommended that misoprostol alone should be given to women having medical management. This recommendation was based on very limited evidence, from one study of 115 women, which found no difference between a combination of mifepristone and misoprostol and misoprostol alone. Recognising the limited available evidence, NICE and the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) called for a trial. Objectives The primary objective was to test the hypothesis that treatment with mifepristone plus misoprostol is superior to treatment with misoprostol alone for the resolution of miscarriage within 7 days in women diagnosed by pelvic ultrasound scan with a missed miscarriage in the first 14 weeks of pregnancy. The key secondary objective aimed to test the hypothesis that the addition of mifepristone reduces the need for surgical intervention to resolve the miscarriage. Other secondary objectives aimed to evaluate if the addition of mifepristone reduces the need for further doses of misoprostol, to evaluate if the addition of mifepristone improves other clinical outcomes [including surgical intervention up to and including 7 days post randomisation and after 7 days post randomisation, duration of bleeding, infection, negative pregnancy test at 21 days post randomisation, time from randomisation to discharge from early pregnancy unit (EPU) care, side effects and complications], to evaluate if the addition of mifepristone improves patient satisfaction and acceptability of management and to assess the cost-effectiveness of the combination of mifepristone and misoprostol in the medical management of missed miscarriage. Methods Participants were randomised online in a 1: 1 ratio via a secure internet facility through an Integrated Trial Management System. Minimisation was implemented for maternal age (< 30 or >= 30 years), body mass index (< 35 or >= 35 kg/m2), previous parity (nulliparous or parous women), gestational age (< 70 or >= 70 days), amount of bleeding (Pictorial Blood loss Assessment Chart score; <= 2 or >= 3) and randomising centre. Clinical data were collected up to discharge from EPU care. Participants who agreed to participate in the qualitative study were interviewed by telephone or videoconference or face to face within approximately 6 weeks of their discharge date. The primary analysis was by intention to treat. A withintrial cost-effectiveness study and a nested qualitative study were also conducted as part of the trial. Results A total of 711 women, from 28 hospitals in the UK, received either mifepristone plus misoprostol (357 women) or placebo plus misoprostol (354 women). The follow-up rate for the primary outcome was 98% (696 of 711 women). The risk of failure to pass the gestational sac within 7 days was 17% (59 of 348 women) in the mifepristone plus misoprostol group, compared with 24% (82 out of 348 women) in the placebo plus misoprostol group [risk ratio (RR) 0.73, 95% confidence interval (CI) 0.54 to 0.98; p = 0.04]. Surgical intervention to resolve the miscarriage was needed in 17% (62 out of 355 women) in the mifepristone plus misoprostol group, compared with 25% (87 out of 353 women) in the placebo plus misoprostol group (RR 0.70, 95% CI 0.52 to 0.94; p = 0.02). There was no evidence of a difference in the incidence of adverse events between the two groups. A t tal of 42 women, 19 in the mifepristone plus misoprostol group and 23 in the placebo plus misoprostol group, took part in an interview.Women appeared to have a preference for active management of their miscarriage, to help bring a timely resolution to the physical process. Overall, when women experienced care that supported their psychological well-being throughout the care pathway, and information was delivered in a skilled and sensitive manner such that women felt informed and in control, they were more likely to express satisfaction with medical management. The within-trial cost-effectiveness analysis found that the use of mifepristone and misoprostol resulted in an absolute effect difference of 6.6% (95% CI 0.7% to 12.5%). The average cost per woman was lower in the mifepristone and misoprostol (MifeMiso) group than in the placebo and misoprostol group, with a cost saving of 182 (95% CI 26 to 338). Hence the use of mifepristone and misoprostol for the medical management of a missed miscarriage dominated the use of misoprostol alone. The modelbased analysis, that compared the trial intervention with other existing possible interventions for the management of miscarriage not analysed in the trial, showed that the MifeMiso intervention is dominant when compared with expectant management and the current medical management strategy. However, the intervention is a less effective, although less costly, strategy than surgical management. Conclusions Our trial showed that pre-treatment with mifepristone followed by misoprostol resulted in a higher rate of resolution of missed miscarriage than misoprostol treatment alone. Women were largely satisfied with medical management of missed miscarriage and would choose it again.Copyright © 2021 Devall et al.

Devall Adam, J., et al. (2021). "Progestogens for preventing miscarriage: a network meta-analysis." The Cochrane Database of Systematic Reviews 4: CD013792.
	Background: Miscarriage, defined as the spontaneous loss of a pregnancy before 24 weeks' gestation, is common with approximately 25% of women experiencing a miscarriage in their lifetime, and 15% to 20% of pregnancies ending in a miscarriage. Progesterone has an important role in maintaining a pregnancy, and supplementation with different progestogens in early pregnancy has been attempted to rescue a pregnancy in women with early pregnancy bleeding (threatened miscarriage), and to prevent miscarriages in asymptomatic women who have a history of three or more previous miscarriages (recurrent miscarriage).; Objectives: To estimate the relative effectiveness and safety profiles for the different progestogen treatments for threatened and recurrent miscarriage, and provide rankings of the available treatments according to their effectiveness, safety, and side-effect profile.; Search Methods: We searched the following databases up to 15 December 2020: Cochrane Central Register of Controlled Trials, Ovid MEDLINE(R), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP), and reference lists of retrieved studies.; Selection Criteria: We included all randomised controlled trials assessing the effectiveness or safety of progestogen treatment for the prevention of miscarriage. Cluster-randomised trials were eligible for inclusion. Randomised trials published only as abstracts were eligible if sufficient information could be retrieved. We excluded quasi- and non-randomised trials.; Data Collection and Analysis: At least two review authors independently assessed the trials for inclusion and risk of bias, extracted data and checked them for accuracy. We performed pairwise meta-analyses and indirect comparisons, where possible, to determine the relative effects of all available treatments, but due to the limited number of included studies only direct or indirect comparisons were possible. We estimated the relative effects for the primary outcome of live birth and the secondary outcomes including miscarriage (< 24 weeks of gestation), preterm birth (< 37 weeks of gestation), stillbirth, ectopic pregnancy, congenital abnormalities, and adverse drug events. Relative effects for all outcomes are reported separately by the type of miscarriage (threatened and recurrent miscarriage). We used the GRADE approach to assess the certainty of evidence.; Main Results: Our meta-analysis included seven randomised trials involving 5,682 women, and all provided data for meta-analysis. All trials were conducted in hospital settings. Across seven trials (14 treatment arms), the following treatments were used: three arms (21%) used vaginal micronized progesterone; three arms (21%) used dydrogesterone; one arm (7%) used oral micronized progesterone; one arm (7%) used 17-α-hydroxyprogesterone, and six arms (43%) used placebo. Women with threatened miscarriage Based on the relative effects from the pairwise meta-analysis, vaginal micronized progesterone (two trials, 4090 women, risk ratio (RR) 1.03, 95% confidence interval (CI) 1.00 to 1.07, high-certainty evidence), and dydrogesterone (one trial, 406 women, RR 0.98, 95% CI 0.89 to 1.07, moderate-certainty evidence) probably make little or no difference to the live birth rate when compared with placebo for women with threatened miscarriage. No data are available to assess the effectiveness of 17-α-hydroxyprogesterone or oral micronized progesterone for the outcome of live birth in women with threatened miscarriage. The pre-specified subgroup analysis by number of previous miscarriages is only possible for vaginal micronized progesterone in women with threatened miscarriage. In women with no previous miscarriages and early pregnancy bleeding, there is probably little or no improvement in the live birth rate (RR 0.99, 95% CI 0.95 to 1.04, high-certainty evidence) when treated with vaginal micronized progesterone compared to placebo. However, for women with one or more previous miscarriages and early pregnancy bleeding, vaginal micronized progesterone increases the live bi th rate compared to placebo (RR 1.08, 95% CI 1.02 to 1.15, high-certainty evidence). Women with recurrent miscarriage Based on the results from one trial (826 women) vaginal micronized progesterone (RR 1.04, 95% CI 0.95 to 1.15, high-certainty evidence) probably makes little or no difference to the live birth rate when compared with placebo for women with recurrent miscarriage. The evidence for dydrogesterone compared with placebo for women with recurrent miscarriage is of very low-certainty evidence, therefore the effects remain unclear. No data are available to assess the effectiveness of 17-α-hydroxyprogesterone or oral micronized progesterone for the outcome of live birth in women with recurrent miscarriage. Additional outcomes All progestogen treatments have a wide range of effects on the other pre-specified outcomes (miscarriage (< 24 weeks of gestation), preterm birth (< 37 weeks of gestation), stillbirth, ectopic pregnancy) in comparison to placebo for both threatened and recurrent miscarriage. Moderate- and low-certainty evidence with a wide range of effects suggests that there is probably no difference in congenital abnormalities and adverse drug events with vaginal micronized progesterone for threatened (congenital abnormalities RR 1.00, 95% CI 0.68 to 1.46, moderate-certainty evidence; adverse drug events RR 1.07 95% CI 0.81 to 1.39, moderate-certainty evidence) or recurrent miscarriage (congenital abnormalities 0.75, 95% CI 0.31 to 1.85, low-certainty evidence; adverse drug events RR 1.46, 95% CI 0.93 to 2.29, moderate-certainty evidence) compared with placebo. There are limited data and very low-certainty evidence on congenital abnormalities and adverse drug events for the other progestogens.; Authors' Conclusions: The overall available evidence suggests that progestogens probably make little or no difference to live birth rate for women with threatened or recurrent miscarriage. However, vaginal micronized progesterone may increase the live birth rate for women with a history of one or more previous miscarriages and early pregnancy bleeding, with likely no difference in adverse events. There is still uncertainty over the effectiveness and safety of alternative progestogen treatments for threatened and recurrent miscarriage. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Devine, K., et al. (2021). "Intramuscular progesterone optimizes live birth from programmed frozen embryo transfer: a randomized clinical trial." Fertility and Sterility 116(3): 633-643.
	OBJECTIVE: To determine whether vaginal progesterone for programmed endometrial preparation is noninferior to intramuscular progesterone in terms of live birth rates from frozen embryo transfer (FET). DESIGN: Three-armed, randomized, controlled noninferiority trial. SETTING: Multicenter fertility clinic. PATIENT(S): A total of 1,346 volunteer subjects planning vitrified-warmed transfer of high-quality nonbiopsied blastocysts were screened, of whom 1,125 subjects were ultimately enrolled and randomly assigned to treatment. INTERVENTION(S): The subjects were randomly assigned to receive, in preparation for FET, 50 mg daily of intramuscular progesterone (control group), 200 mg twice daily of vaginal micronized progesterone plus 50 mg of intramuscular progesterone every third day (combination treatment), or 200 mg twice daily of vaginal micronized progesterone. MAIN OUTCOME MEASURE(S): The primary outcome was live birth rate per vitrified-warmed embryo transfer. The secondary outcomes were a positive serum human chorionic gonadotropin test 2 weeks after FET, biochemical pregnancy loss, clinical pregnancy, clinical pregnancy loss, total pregnancy loss, serum luteal progesterone concentration 2 weeks after FET, and patient's experience and attitudes regarding the route of progesterone administration, on the basis of a survey administered to the subjects between FET and pregnancy test. RESULT(S): A total of 1,060 FETs were completed. The live birth rate was significantly lower in women receiving only vaginal progesterone (27%) than in women receiving intramuscular progesterone (44%) or combination treatment (46%). Fifty percent of pregnancies in women receiving only vaginal progesterone ended in miscarriage. CONCLUSION(S): The live birth rate after vaginal-only progesterone replacement was significantly reduced, due primarily to an increased rate of miscarriage. Vaginal progesterone supplemented with intramuscular progesterone every third day was noninferior to daily intramuscular progesterone, offering an effective alternative regimen with fewer injections. CLINICAL TRIAL REGISTRATION NUMBER: NCT02254577.

Devranoğlu, B. (2021). "Comparison of the Effect of Cervical Mucus Cleaning Method Applied Before Embryo Transfer on Pregnancy Rates." ClinicalTrials.gov.
	No Results Available Procedure: Cotton swab|Procedure: Cannula Detecting pregnancy after embryo transfer.|Confirmation of fetal cardiac activity in detected pregnancy.|Success of embryo transfer during intervention. Female Not Applicable 183 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 90-07.April.2021 July 8, 2022

Devranoğlu, B. (2021). "Comparison of the Effect of Cervical Mucus Removal With Cotton Swab or Cannula on Pregnancy Rates Before Embryo Transfer." ClinicalTrials.gov.
	All patients will be informed about the study and those who give written consent will be included in the study. Women undergoing good quality embryo transfer will be assigned to one of the 3 arms of the study according to the previously determined randomization chart. The first evaluation of the patient will be made on the 12th day after embryo transfer. Pregnancy status will be evaluated with serum βhcg value. If pregnancy is confirmed by serum βhcg value, fetal viability will be evaluated by ultrasound 4 weeks after transfer.

Dhariwal, L. (2023). "Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension." ClinicalTrials.gov.
	Patient demographics, previous medical and surgical history, baseline physical exam including POP‐Q will be collected from the electronic medical record following enrollment. This information will be stored in REDCap which is a secure database system. Patients will be randomized by in REDCap system with the sequence of 1:1 with blocks of 6. Patients and assessors will be blinded to the type of suture that was used. The surgeons will not be blinded. All procedures will be performed by a fellowship‐trained, Female Pelvic Medicine and Reconstructive Surgery board‐certified surgeon. Sacrospinous ligament suspension (SSLS) procedure with the assigned suture and any scheduled concomitant prolapse and anti‐incontinence procedures will be performed. Follow up exams will occur at 2‐4 weeks, 12 weeks and 12 months post‐operatively. The follow up visits will include a POP��Q exam at 12 weeks and 12 months. The 12 months follow up visit will include a PGI‐I questionnaire. All participants will also be assessed for any suture‐related complications. 12 month POP‐Q exam will be completed by one of the providers who will be blinded to the suture type. There will be no additional follow up visits for participation in the study. The follow up appointments at 2‐4 weeks, 12 weeks and 12 months are the times of usually scheduled post‐operative follow up.

Di Donato, V., et al. (2019). "Ospemifene for the treatment of vulvar and vaginal atrophy: A meta-analysis of randomized trials. Part II: Evaluation of tolerability and safety." Maturitas 121: 93-100.
	Objective: To evaluate the tolerability and safety of ospemifene in treating dyspareunia associated with postmenopausal vulvo- vaginal atrophy (VVA). Method(s): The literature was searched through to 31 July 2018 to identify randomized controlled trials comparing ospemifene 60 mg against placebo for the treatment of VVA. Two groups of outcomes were selected: 1) side-effects, including hot flushes, urinary tract infection (UTI), headache, deep venous thrombosis (DVT), coronary heart disease (CHD), cardiovascular event (CVE), discontinuation due to side-effects, serious adverse event (SAE); 2) Safety, in relation to endometrial thickness, vaginal bleeding, breast tenderness, breast and endometrial cancer. A random-effects model was used in the meta-analysis. Study quality and bias risk were assessed with the Cochrane tool. Result(s): In the group of patients treated with ospemifene, there was a slightly higher rate of hot flushes (OR:2.36, 95% CI 1.26-4.42; p = 0.007) and UTI (OR:1.97, 95% CI 1.23-3.14, p = 0.005) at 12 weeks of treatment, but no differences were noted after 52 weeks. The incidence of headaches, DVT, CHD, CVE, discontinuation of treatment, and SAEs was not significantly different between groups. Ospemifene treatment was statistically associated with a greater endometrial thickness in women with an intact uterus both at 12 weeks (SMD: 0.40, (95% CI 0.17 to 0.63, p < 0.0005) and at 52 weeks (SMD: 0.62, 95% CI 0.23-1.01, p = 0.002); however, this increase was not clinically relevant. The incidence of vaginal bleeding, endometrial cancer, breast tenderness, breast and endometrial cancer was not significantly different between groups. Conclusion(s): This meta-analysis suggests that ospemifene treatment is well tolerated and presents a good safety profile. Long-term safety studies with larger samples, which include patients at high risk, are warranted.Copyright © 2018

Di Donato, V., et al. (2019). "Ospemifene for the treatment of vulvar and vaginal atrophy: A meta-analysis of randomized trials. Part I: Evaluation of efficacy." Maturitas 121: 86-92.
	Objective: To evaluate the efficacy of ospemifene in treating dyspareunia associated with postmenopausal vulvo-vaginal atrophy (VVA).; Methods: A structured search was carried out in PubMed-Medlin, Embase, Cochrane Controlled Trials Register databases through to 31 July 2018. The search included the following terms: "Ospemifene", "vulvovaginal atrophy", "dyspareunia", "SERM" and "randomized controlled trial" (RCTs). Four outcomes were selected: vaginal pH; proportions of parabasal and superficial vaginal cells; and perception of the most bothersome symptom (vaginal dryness or dyspareunia). A random-effects model was used in the meta-analysis. Study quality and bias risk were assessed with the Cochrane tool.; Results: Six RCTs comparing the efficacy of ospemifene against placebo after 12 and 52 weeks of treatment were included in the meta-analysis. At 12 weeks, changes in vaginal Ph (SMD: -0.96, 95% CI:-1.12 to -0.81; p < 0.0001), parabasal cells (SMD: -36.84 95% CI -46.95 to -26.72; p < 0.0001), superficial cells (SMD: 8.23, 95% CI 3.73-12.74, p < 0.0003), and dyspareunia (SMD= - 2.70, 95% CI - 2.88 to -2.52, p < 0.0001) indicated that ospemifene was more effective than placebo.; Conclusion: The present meta-analysis suggests that ospemifene 60 mg is associated with significant improvement in the morphological and physiological features of the vaginal mucosa that correlate with the symptoms associated with postmenopausal VVA. (Copyright © 2018. Published by Elsevier B.V.)

Di Spiezio Sardo, A., et al. (2023). "Hysteroscopic resection vs ultrasound-guided dilation and evacuation for treatment of cesarean scar ectopic pregnancy: a randomized clinical trial." American Journal of Obstetrics and Gynecology 229(4): 437.e431-437.e437.
	Background: Cesarean scar ectopic pregnancy is a type of ectopic pregnancy in which the fertilized egg is implanted in the muscle or fibrous tissue of the scar after a previous cesarean delivery. The condition can be catastrophic if not managed on time and can lead to significant morbidity and mortality. Several approaches have been studied for the management of cesarean scar ectopic pregnancy in women who opted for termination of pregnancy with no consensus on the best treatment modality reached so far.; Objective: This study aimed to compare the success rate of hysteroscopic resection vs ultrasound-guided dilation and evacuation for the treatment of cesarean scar ectopic pregnancy.; Study Design: This was a parallel group, nonblinded, randomized clinical trial conducted at a single center in Italy. Women with singleton gestations at <8 weeks and 6 days of gestation were included in the study. Inclusion criteria were women with a cesarean scar ectopic pregnancy with positive embryonic heart activity who opted for termination of pregnancy. Patients were randomized 1:1 to receive either hysteroscopic resection (ie, intervention group) or ultrasound-guided dilation and evacuation (ie, control group). Both groups received 50 mg/m 2 of methotrexate intramuscularly at the time of randomization (day 1) and another dose at day 3. A third dose of methotrexate was planned in case of persistence of positive fetal heart activity at day 5. Participants received either ultrasound-guided dilation and evacuation or hysteroscopic resection from 1 to 5 days after the last dose of methotrexate. Hysteroscopic resection was performed under spinal anesthesia using a 15 Fr bipolar mini-resectoscope. Dilation and evacuation were performed by vacuum aspiration with a Karman cannula, followed by sharp curettage, if necessary, under ultrasound guidance. The primary outcome was the success rate of the treatment protocol, defined as no further treatment required until the complete resolution of the cesarean scar ectopic pregnancy. Resolution of the cesarean scar ectopic pregnancy was evaluated based on decline of beta-hCG and the absence of residual gestational material in the endometrial cavity. Treatment failure was defined as the necessity for further treatment required until the complete resolution of the cesarean scar ectopic pregnancy. A sample size calculation indicated that 54 participants were required to test the hypothesis RESULTS: A total of 54 women were enrolled and randomized. Number of previous cesarean deliveries ranged from 1 to 3. Overall, 10 women received a third dose of methotrexate with 7 of 27 (25.9%) participants in the hysteroscopic resection group and 3 of 27 (11.1%) in the dilation and evacuation group. The success rate was 100% (27/27) in the hysteroscopic resection group and 81.5% (22/27) in the dilation and evacuation group (relative risk, 1.22; 95% confidence interval, 1.01-1.48). Additional procedures were required in 5 cases of the control group, namely 3 hysterectomies, 1 laparotomic uterine segmental resection, and 1 hysteroscopic resection. The length of stay in the hospital was 9.0±2.9 days in the intervention group and 10.0±3.5 days in the control group (mean difference, -1.00 days; 95% confidence interval, -2.71 to 0.71). No cases of admission to intensive care unit or maternal death were reported.; Conclusion: Hysteroscopic resection was associated with an increased success rate in the treatment of cesarean scar ectopic pregnancy when compared with ultrasound-guided dilation and evacuation. (Copyright © 2023. Published by Elsevier Inc.)

Di, W. and H. Jianrong (2023). "Quality of life in ovarian cancer patients treated with PARP inhibitors: a meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Dian, F., et al. (2024). "Oral gonadotropin-releasing hormone antagonist for treating symptomatic uterine fibroid: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Dias, C. (2022). "Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy." ClinicalTrials.gov.
	Randomized, double‐blind, placebo‐controlled, parallel‐designed, multiple‐site, bioequivalence study with clinical endpoints.

DÍAz-Arribas MarÍA, J. (2024). "Efficacy of Radiofrequency in Primary Dysmenorrhea." ClinicalTrials.gov.
	No Results Available Device: Transabdominal radiofrecuency application|Device: Intracavitary radiofrequency application Dysmenorrheal pain intensity|Quality of life during menstruation.|Quality of life (General)|Pressure Pain Threshold|Number and quantity of drugs. Female Not Applicable 45 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Investigator, Outcomes Assessor)|Primary Purpose: Treatment UCompluMadrid May 20, 2024

Diaz-Garcia, C., et al. (2022). "Follicular activation in women previously diagnosed with poor ovarian response: a randomized, controlled trial." Fertility and Sterility 117(4): 747-755.
	Objective: To investigate whether ovarian fragmentation for follicular activation (OFFA) improves ovarian reserve markers and in vitro fertilization (IVF) outcomes in women with poor ovarian response (POR). Design(s): Randomized, controlled trial, with parallel assignment. Setting(s): University hospital. Patient(s): Thirty-four women with POR according to the European Society of Human Reproduction and Embryology criteria. Intervention(s): Women with POR were randomly allocated to receive ovarian fragmentation in 1 ovary or to no intervention (control group). Ovarian reserve markers were followed at 2-week intervals for 6 months. In vitro fertilization cycles were initiated when the antral follicle count (AFC) doubled or at the end of follow-up. Main Outcome Measure(s): The primary outcome was the number of metaphase II (MII) oocytes obtained. Antral follicle count, antimullerian hormone level, and reproductive outcomes were recorded as secondary outcomes. Exploratory outcomes included surgical results and analysis of protein and gene expression. Result(s): Ovarian fragmentation for follicular activation resulted in an increase in AFC in the intervention ovary compared with the control ovary and an increase in total AFC in the OFFA group compared with controls. Serum antimullerian hormone and follicle-stimulating-hormone levels did not improve in the OFFA group throughout the follow-up period. Fifteen patients from each arm underwent IVF. In the control group, 33 MII oocytes were retrieved and 18 embryo transfers were performed, with a 20% pregnancy rate and an 18.7% live birth rate per cycle. In the OFFA group, 23 MII oocytes were retrieved and 11 embryo transfers were performed, with a 13.3% pregnancy rate and a 6.7% live birth rate per cycle. Reproductive outcomes did not significantly differ between the groups. Hippo pathway inhibition was confirmed by an 18.8% reduction in the phospho-YAP/YAP (Yes-associated protein 1) ratio and BIRC and CCN overexpression after fragmentation. Conclusion(s): Ovarian fragmentation for follicular activation in women with POR resulted in an increase in AFC but did not modify IVF outcomes when compared with controls. Clinical Trial Registration Number: NCT02354963.Copyright © 2021 American Society for Reproductive Medicine

Dincer, Y. and U. Oskay (2023). "The Effect of Acupressure Applied to Sanyinjiao (SP6) on Primary Dysmenorrhea." Alternative Therapies in Health and Medicine 29(1): 16-22.
	Context: With the technological developments and advancement of scientific knowledge in the field of health, healthcare professionals are now expected to identify strategies for the use of complementary therapies and to guide healthy and ill individuals in their correct and effective use. Acupressure-a simple, effective, safe, and economical therapy-may reduce the pain caused by dysmenorrhea.; Objective: The aim of the study was to determine the benefits of acupressure applied to the Sanyinjiao (SP6) acupressure point for treatment of primary dysmenorrhea.; Design: The research team designed a randomized controlled trial.; Setting: The study took place at the Health Services Vocational School at Duzce University in Duzce, Turkey.; Participants: Participants were 67 students with dysmenorrhea, who were studying business administration at the university between October 2016 and January 2018.; Intervention: Participants were randomly assigned to one of two groups, in compliance with the study's criteria. The acupressure group pressed the SP6 acupressure point on each leg once a day for 10 minutes, for the first three days of each menstrual period for three months. The students in the acupressure and placebo group have been followed up for a total of four cycles. The participants in the acupressure group have been advised to press to the SP6 acupressure point for ten minutes every day on each leg for the first three days of each menstruation period for three months; the participants in the placebo group have been recommended to scrub the sham-acupressure point for ten minutes every day on each leg for the first three days of each menstruation period for three months. Within the last month(Month 4), evaluation forms have been applied without any further practices. The control group rubbed a false acupressure point on each leg once a day for ten minutes, for the same period.; Outcome Measures: A diagnostic form was used to collect the study's data and to determine participants' demographic characteristics. A visual analogue scale (VAS) and the Brief Pain Inventory (BPI) were used to evaluate dysmenorrhea pain. A satisfaction form was used to evaluate participants' satisfaction.; Results: On the VAS, the severity of pain was lower in the acupressure group than in the control group. On the BPI, the scores were lower and the pain caused less discomfort in the acupressure group than in the control group. Moreover, both groups were satisfied with the practices.; Conclusions: Acupressure can be used as an effective and reliable method for the management of primary dysmenorrhea.

Ding, H., et al. (2022). "Cost-effectiveness of PARP inhibitors in malignancies: A systematic review." PloS One 17(12): e0279286.
	Objectives: Poly (ADP-ribose) polymerase inhibitor (PARPi) have become a mainstay for the treatment of BRCA-mutant malignancies. PARPis are likely to be more effective but also bring an increase in costs. Thus, we aimed at evaluating the cost effectiveness of PARPis in the treatment of malignancies.; Methods: Studies of cost effectiveness of PARPis were searched from PubMed, Web of Science, and Cochrane Library. Key information was extracted from the identified studies and reviewed. Quality of the included studies was evaluated using Quality of Health Economic Studies (QHES) instrument. Modeling techniques, measurement of parameters and uncertainty analysis were analyzed across studies. Interventions and cost-effectiveness results were reported stratified by patient population.; Results: Among the 25 studies identified, we included 17 on ovarian cancer, 2 on breast cancer, 3 on pancreatic cancer, and 3 on prostate cancer that involved olaparib, niraparib, rucaparib, and talazoparib. All studies had a QHES score of above 75. In the maintenance therapy of ovarian cancer, additional administration of olaparib was cost-effective for newly diagnosed patients after first-line platinum-based chemotherapy but was not cost-effective for platinum-sensitive recurrent patients in majority studies. However, the economic value of other PARPis in ovarian cancer as well as all PARPis in other tumors remained controversial. Cost-effectiveness of PARPi was primarily impacted by the costs of PARPi, survival time, health utility and discount rate. Moreover, genetic testing improved the cost-effectiveness of PARPi treatment.; Conclusions: PARPi is potentially cost-effective for patients with ovarian, pancreatic, or prostate cancer. Genetic testing can improve the cost-effectiveness of PARPi.; Competing Interests: The authors have declared that no competing interests exist. (Copyright: © 2022 Ding 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.)

Ding, T., et al. (2021). "The survival outcome and complication of secondary cytoreductive surgery plus chemotherapy in recurrent ovarian cancer: a systematic review and meta-analysis." Journal of Ovarian Research 14(1): 93.
	Objective: The aim of this meta-analysis was to assess the effectiveness and safety of secondary cytoreductive surgery plus chemotherapy (SCS + CT) in recurrent ovarian cancer (ROC). Our secondary purpose was to analyze whether patients could benefit from complete resection.; Methods: We searched EMBASE, MEDLINE, the Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials, from inception to April 2021. We used appropriate scales to assess the risk of bias. Data from included studies that reported median PFS or OS were weighted by individual study sample size, and aggregated for meta-analysis. We calculated the pooled proportion of complications within 30 days after surgery.; Results: We identified 13 articles, including three RCTs and ten retrospective cohort studies. A total of 4572 patients were included, of which 916 patients achieved complete resection, and all patients were comparable at baseline. Compared with chemotherapy alone, SCS + CT significantly improved the PFS (HR = 0.54, 95% CI: 0.43-0.67) and OS (HR = 0.60, 95% CI: 0.44-0.81). Contrary to the results of cohort studies, the meta-analysis of RCTs showed that SCS + CT could not bring OS benefits (HR = 0.93, 95% CI: 0.66-1.3). The subgroup analysis showed the prognostic importance of complete resection. Compared with chemotherapy alone, complete resection was associated with longer PFS (HR = 0.53, 95% CI: 0.45-0.61) and OS (HR = 0.56, 95% CI: 0.39-0.81), while incomplete resection had no survival benefit. Additionally, complete resection could maximize survival benefit compared with incomplete resection (HR = 0.56, 95% CI: 0.46-0.69; HR = 0.61, 95% CI: 0.50-0.75). The pooled proportion for complications at 30 days was 21% (95% CI: 0.12-0.30), and there was no statistical difference in chemotherapy toxicity between the two groups.; Conclusion: The review indicated that SCS + CT based regimens was correlated with better clinical prognosis for patients with recurrent ovarian cancer, but the interpretation of OS should be cautious. The meta-analysis emphasizes the importance of complete resection, suggesting that the potential benefits of prolonging survival may outweigh the disadvantages of any short-term complications associated with surgery. (© 2021. The Author(s).)

Dinoi, G., et al. (2024). "Robotic-assisted versus conventional laparoscopic surgery in the management of obese patients with early endometrial cancer in the sentinel lymph node era: A randomized controlled study (RObese)." International Journal of Gynecological Cancer: ijgc-2023.
	Background: Nearly 65% of patients with endometrial cancer who undergo primary hysterectomy have concurrent obesity. Retrospective data show advantages in using robotic surgery in these patients compared with conventional laparoscopy, namely lower conversion rate, increased rate of same-day discharge, and reduced blood loss. Nevertheless, to date no prospective randomized controlled trials have compared laparoscopic surgery versus robotic-assisted surgery in morbidly obese patients. Primary Objective: The robotic-assisted versus conventional laparoscopic surgery in the management of obese patients with early endometrial cancer in the sentinel lymph node era: a randomized controlled study (RObese) trial aims to find the most appropriate minimally invasive surgical approach in morbidly obese patients with endometrial carcinoma. Study Hypothesis: Robotic surgery will reduce conversions to laparotomy in endometrial cancer patients with obesity compared with those who undergo surgery with conventional laparoscopy. Trial Design: This phase III multi-institutional study will randomize consecutive obese women with apparent early-stage endometrial cancer to either laparoscopic or robot-assisted surgery. Major Inclusion/Exclusion riteria: The RObese trial will include obese (BMI>=30 kg/m2) patients aged over 18 years with apparent 2009 Federation of Gynecology and Obstetrics (FIGO) stage IA-IB endometriod endometrial cancer. Primary Endpoint: Conversion rate to laparotomy between laparoscopic surgery versus robot-assisted surgery. Sample Size: RObese is a superiority trial. The clinical superiority margin for this study is defined as a difference in conversion rate of -6%. Assuming a significance level of 0.05 and a power of 80%, the study plans to randomize 566 patients. Estimated Dates for Completing Accrual and Presenting Results: Patient recruitment will be completed by 2026, and follow-up will be completed by 2029 with presentation of data shortly thereafter. Two interim analyses are planned: one after the first 188 and the second after 376 randomized patients. Trial Registration: NCT05974995 Copyright © IGCS and ESGO 2024. No commercial re-use. See rights and permissions. Published by BMJ.

Dioun, S., et al. (2024). "Cost-effectiveness of lenvatinib plus pembrolizumab versus chemotherapy for recurrent mismatch repair-proficient endometrial cancer after platinum-based therapy." Gynecologic Oncology 182: 70-74.
	Objective: The recent Study 309-KEYNOTE-775 showed improved survival for lenvatinib plus pembrolizumab compared to chemotherapy in patients with recurrent endometrial cancer. We created a decision model to compare the cost-effectiveness of lenvatinib plus pembrolizumab in patients with recurrent mismatch repair-proficient (pMMR) endometrial cancer who had progressed after first-line chemotherapy. Method(s): A Markov model was created to simulate the clinical trajectory of 10,000 patients with recurrent pMMR endometrial cancer. The initial decision point in the model was treatment with ether lenvatinib plus pembrolizumab or chemotherapy (doxorubicin or dose-dense paclitaxel). Model probabilities, utility values and costs were derived with assumptions drawn from published literature. A cycle length of 3 months and a time horizon of 2 years was used. The effectiveness was calculated in terms of average quality adjusted life years (QALYs) gained. The primary outcome was incremental cost-effectiveness ratios (ICERs), expressed in 2020 US dollars/QALYs. One-way, two-way and probabilistic sensitivity analyses were performed. Result(s): Chemotherapy was the least costly strategy at $66,693 followed by lenvatinib plus pembrolizumab ($193,590). Lenvatinib plus pembrolizumab resulted in more patients being alive at 2 years (lenvatinib plus pembrolizumab: 367, chemotherapy: 109). Chemotherapy was cost-effective compared with lenvatinib plus pembrolizumab (ICER: $164,493/QALYs). Lenvatinib plus pembrolizumab became cost-effective when its cost was reduced by $1553 per month (7.8% reduction). Conclusion(s): For patients with recurrent pMMR endometrial cancer Lenvatinib plus pembrolizumab is associated with greater survival but is more costly than chemotherapy. The cost of lenvatinib and pembrolizumab would have to be reduced by approximately 7% to be considered cost-effective.Copyright © 2023 Elsevier Inc.

Dioun, S., et al. (2023). "Dostarlimab for recurrent mismatch repair-deficient endometrial cancer: A cost-effectiveness study." BJOG 130(2): 214-221.
	Objective: Patients with recurrent endometrial cancer treated with carboplatin and paclitaxel whose disease progresses have few effective treatment options. Based on promising clinical trial data, the anti-programmed cell death 1 (anti-PD-1) antibody dostarlimab was recently granted accelerated approval for endometrial cancer by the US Food and Drug Administration. We developed a decision model to examine the cost-effectiveness of dostarlimab for patients with progressive/recurrent deficient mismatch repair (dMMR) endometrial cancer whose disease has progressed with first-line chemotherapy. Design(s): Cost-effectiveness study. Population: Hypothetical cohort of 6000 women with progressive/recurrent dMMR endometrial cancer. Method(s): The initial decision point in the Markov model was treatment with dostarlimab, pembrolizumab or pegylated liposomal doxorubicin (PLD). Model probabilities, and cost and utility values were derived with assumptions drawn from published literature. Effectiveness was estimated as average quality-adjusted life years (QALYs) gained. One-way, two-way and probabilistic sensitivity analyses were performed to vary the assumptions across a range of plausible values. Main Outcome Measure(s): The primary outcome was the incremental cost-effectiveness ratio (ICER). Result(s): Pegylated liposomal doxorubicin (PLD) was the least costly strategy, at $55,732, followed by dostarlimab ($151,533) and pembrolizumab ($154,597). Based on a willingness-to-pay threshold of $100,000/QALY, PLD was cost-effective compared with dostarlimab, with an ICER of $331,913 per QALY gained for dostarlimab, whereas pembrolizumab was ruled out by extended dominance (less effective, more costly), compared with dostarlimab. In one-way sensitivity analyses, dostarlimab was cost-effective when its cost was reduced to $4905 (52% reduction). These results were robust in a variety of sensitivity analyses. Conclusion(s): Dostarlimab is associated with greater survival compared with other treatments for women with recurrent dMMR endometrial cancer. Although the agent is substantially more costly, dostarlimab became cost-effective when its cost was reduced to $5489 per cycle.Copyright © 2022 John Wiley & Sons Ltd.

Dioun, S., et al. (2022). "Minimally invasive surgery for suspected early-stage ovarian cancer; a cost-effectiveness study." BJOG 129(5): 777-784.
	Objective: While there are a number of benefits to minimally invasive surgery (MIS) for women with ovarian cysts, there is an increased risk of ovarian capsule rupture during the procedure, which could potentially seed the abdominal cavity with malignant cells. We developed a decision model to compare the risks, benefits, effectiveness and cost of MIS versus laparotomy in women with ovarian masses.; Design: Cost-effectiveness study POPULATION: Hypothetical cohort of 10 000 women with ovarian masses who were undergoing surgical management.; Methods: The initial decision point in the model was performance of surgery via laparotomy or a MIS approach. Model probabilities, costs and utility values were derived from published literature and administrative data sources. Extensive sensitivity analyses were conducted to assess the robustness of the findings.; Main Outcome Measures: The primary outcome was the cost-effectiveness of MIS versus laparotomy for women with a pelvic mass measured by incremental cost-effectiveness ratios (ICERs).; Results: MIS was the least costly strategy at $7,732 per women on average, compared with $17,899 for laparotomy. In our hypothetical cohort of 10 000 women, there were 64 cases of ovarian rupture in the MIS group and 53 in the laparotomy group, while there were 26 cancer-related deaths in the MIS group and 25 in the laparotomy group. MIS was more effective than laparotomy (188 462 QALYs for MIS versus 187 631 quality adjusted life years [QALYs] for laparotomy). Thus, MIS was a dominant strategy, being both less costly and more effective than laparotomy. These results were robust in a variety of sensitivity analyses.; Conclusion: MIS constitutes a cost-effective management strategy for women with suspicious ovarian masses.; Tweetable Abstract: MIS is a cost-effective management strategy for women with suspicious ovarian masses. (© 2021 John Wiley & Sons Ltd.)

DiVasta, A. (2021). "IUD and Norethindrone Acetate for Treatment of Endometriosis." ClinicalTrials.gov.
	Endometriosis is a major source of morbidity for U.S. females, affecting 49% of adolescents with chronic pelvic pain and 10% of all women of reproductive age. This percentage translates into approximately 176 million women worldwide who may suffer from endometriosis. Annual health care costs are estimated to be over $22 billion in the US alone. Over 50% of adults with endometriosis report onset of severe pelvic pain during their adolescence. Symptoms result in decreased quality of life, negative socioeconomic consequences, impaired reproductive potential, and diminished mental health. Endometriosis is a chronic disease that progresses over time in more than half of patients. Endometriosis has no cure. For adolescents in particular, this means that the impact of endometriosis and its symptoms can last for decades. Appropriate management involves not only prompt initiation of therapy, but also the maintenance of therapy for a protracted length of time. Medical therapy for endometriosis typically includes oral progestins or contraceptive pills. Though often effective, these options are associated with systemic side‐effects which may further affect compliance and preclude long‐term use. Furthermore, the need for repeated or regular administration compromises compliance and therefore efficacy. The levonorgestrel‐releasing intrauterine system (LNG‐IUD) has been evaluated as a promising treatment for endometriosis in adult women. The LNG‐IUD 52 mg (Mirena) delivers levonorgestrel (LNG) to the uterine cavity at a steady rate of 20 µg/day over 5 to 6 years. The LNG causes atrophy and pseudo decidualization of the uterine lining, along with apoptosis of endometrial glands and stroma. As the LNG‐IUD requires no further patient action following insertion, patient compliance is excellent. While continuation of the device is generally very good in adults, unfavorable uterine bleeding patterns are the most frequent reason for early device removal, particularly within the first 6 months. Anecdotal clinical experience suggests that combining use of the LNG‐IUD with low‐dose oral progestin therapy may maximize effectiveness and continuation of the LNG‐IUD device in adolescents. The investigators will recruit 80 adolescents for participation in a double‐blind, randomized trial of NETA (n=40) vs. placebo (control group, n=40) for adjunct treatment to the levonorgestrel‐containing IUD for pelvic pain due to endometriosis. It is believed that a combination of the locally‐acting LNG‐IUD plus systemic NETA may be the optimal combination to effectively treat endometriosis pain, minimize side effects, provide contraception, and control bleeding for adolescents with endometriosis.

Diyuan, M., et al. (2022). "Herbal therapy for treating stress urinary incontinence in women." PROSPERO International prospective register of systematic reviews.
	
Diz-Teixeira, P., et al. (2023). "Update on Physiotherapy in Postpartum Urinary Incontinence. A Systematic Review." Archivos Espanoles de Urologia 76(1): 29-39.
	BACKGROUND: Urinary incontinence in the postpartum period is related to biomechanical and hormonal changes that occur during the obstetric period and also related to perineal trauma during childbirth. Physiotherapy is currently presented as one of the conservative options for the treatment of urinary incontinence at this stage, so this review aims to go over scientific literature to assess the effect of physiotherapy on postpartum urinary incontinence. MATERIAL AND METHODS: In February 2022, a bibliographic search was carried out in PubMed, Scopus, Medline, PeDRO and Sport Discuss databases. Studies published within the last 10 years and randomized clinical trials that used physiotherapy techniques for the treatment of postpartum urinary incontinence were identified, but those articles that differ from the objective of the work and those that were duplicated in the databases were excluded. RESULT(S): Out of the 51 articles identified, 8 were finally included that fit the criteria and the subject of the study. Regarding the intervention, we have found that all the articles refer to pelvic floor muscle training. In addition to urinary incontinence, these studies evaluated other variables such as strength, resistance, quality of life and sexual function, obtaining significant results in 6 out of all the studies consulted. CONCLUSION(S): Pelvic floor muscle training is beneficial for the treatment of urinary incontinence in the postpartum period, then supervised and controlled exercise combined with a home training routine is recommended. It is not clear whether the benefits are maintained over time.

Djian, M.-c. (2021). "Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation." ClinicalTrials.gov.
	No Results Available Device: Transcutaneous Auricular Vagus Nerve Stimulation Change of symptoms related to the pelvic pain|Efficacy on pain|Efficacy on severity of patient's symptoms|Efficacy on quality of life|Efficacy on Anxiety|Efficacy on gynecological and pelvic pain symptoms|General efficacy of the device Transcutaneous Electronic Neuro Stimulation TENS Eco Plus|Collection of possible side effects Female Not Applicable 72 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2019-0057 February 2025

Dmochowski, R. R., et al. (2021). "A randomized, placebo-controlled clinical development program exploring the use of litoxetine for treating urinary incontinence." Neurourology and Urodynamics 40(6): 1515‐1523.
	Aims: To investigate the safety and efficacy of litoxetine, a serotonin reuptake inhibitor, in treating urinary incontinence (UI) and mixed urinary incontinence (MUI). Methods: Two randomized, double‐blind, placebo‐controlled clinical trials (RCT1 and RCT2) were conducted. RCT1, which included 196 women aged 18–75 with MUI randomized 1:1:1:1 to receive 10, 20, or 40 mg litoxetine or placebo orally twice daily (BID) for 12 weeks, investigated the efficacy (including changes in patient reported outcomes) and safety of litoxetine compared to placebo. RCT2, which included 82 men and women aged 18–70 with any UI type randomly assigned 2:1 to receive 30 mg litoxetine or placebo orally BID for 8 weeks including a 2 week dose titration period, investigated the safety (including psychiatric safety) and efficacy of litoxetine compared to placebo. Efficacy was measured as the change in number of incontinence episodes per week and assessed using an analysis of covariance with missing data imputed by Predictive Mean Matching. Safety was assessed by adverse events (AEs) and physical examinations and analyzed using descriptive statistics. Results: The 30‐mg and placebo groups in RCT2 showed no difference in frequency of AEs, and litoxetine reduced the number of incontinence episodes per week compared to placebo. Although RCT1 suffered an unexpectedly high placebo response, and therefore did not meet the primary efficacy endpoint, 71% of participants receiving 40 mg litoxetine reported a clinically meaningful improvement in the King's Health Questionnaire. Conclusions: Litoxetine may be a safe, effective and well‐tolerated treatment for patients with UI.

Dobó, N., et al. (2023). "Laparoscopic natural orifice specimen extraction (NOSE) colectomy versus conventional laparoscopic colorectal resection in patients with rectal endometriosis: a randomized, controlled trial." International Journal of Surgery.
	BACKGROUND: The conventional laparoscopic approach for the surgical management of deep endometriosis (DE) infiltrating the rectum appears to ensure improved digestive functional outcomes. The natural orifice specimen extraction (NOSE) technique for the treatment of colorectal DE can significantly accelerate postoperative recovery; however, data on gastrointestinal function following conventional laparoscopic segmental bowel resection (CLR) compared with NOSE-colectomy (NC) for DE are sparse. MATERIALS AND METHODS: Between September 30, 2019, and December 31, 2020, a randomized, open-label, two-arm, parallel-group controlled trial with women aged 18-45 years was conducted at University Hospital.91 patients were randomized to CLR or NC, with DE infiltrating at least the muscular layer, at least 50% of the circumference of the bowel, up to 15 cm from the anal verge, exhibiting pain and bowel symptoms and/or infertility. The primary endpoint was bowel function, represented by Low Anterior Resection Syndrome (LARS). Secondary parameters included the Endometriosis Health Profile 30 (EHP30), Gastrointestinal Quality of Life Index (GIQLI), Visual Analog Scale (VAS) scores preoperatively and at set times (one and six months, one year) following surgery. RESULTS: No significant differences were observed in the postoperative LARS scores, VAS, EHP30, and GIQLI between the NC and CLR groups. LARS scores did not reveal significant differences 12 months postoperatively compared to the preoperative values in both groups (CLR-group P=0.93 versus NC-group, P=0.87). GIQLI scores were significantly improved 12 months after the operation compared with baseline values in the CLR-group (P=0.002) and NC-group (P=0.001). Pain symptoms and quality of life scores significantly improved 12 months postoperatively in both groups. CONCLUSIONS: NC is a feasible surgical approach for treating patients with rectal DE. Our study did not show a statistically significant difference between CLR and NC techniques in mid-term digestive and pain outcomes.

Dolors, T., et al. (2023). "Live birth rates following low molecular weight heparin prophylaxis compared to no antithrombotic treatment in pregnant women with previous recurrent miscarriages and negative for antiphospholipid antibodies: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Domar, A. (2021). "The Impact of the SPIKES Protocol With IVF Patients." ClinicalTrials.gov.
	No Results Available Behavioral: Spikes-focused bad news protocol Assess if the SPIKES-based nursing script is associated with a difference in perceived nursing compassion|Assess patient distress after receiving the negative pregnancy test phone call|Assess patient depression after receiving the negative pregnancy test phone call Female Not Applicable 136 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Supportive Care BN2021 May 24, 2022

Donat Lindsay, C. (2023). "Mindful Movement for Pelvic Pain." ClinicalTrials.gov.
	Chronic pelvic pain (CPP) is defined as the sensation of pain arising from the lower urinary tract, bowel, pelvic floor, myofascial, and reproductive structures and includes cyclic pain and pain with intercourse, when the condition adversely affects a patient's wellbeing. Chronic pelvic pain is often associated with negative cognitive, behavioral,sexual and emotional consequences, which can include physical deconditioning, pain catastrophizing, kinesiophobia, and depression. CPP has been estimated to affect between 5.7%‐26.6% of women. Treatments for pelvic pain include management of peripheral pain sources, as well as targeting the centrally mediated response to pain. The use of centrally acting pain medications, including opioids, is common in patients with pelvic pain. There is increasing literature recommending against the use of opioids for chronic pain, citing risks of dependence, addiction, and over‐dose related death. Therefore, it is critical to look for safe alternatives to manage chronic pelvic pain. Exercise has been targeted as a treatment strategy for chronic pain conditions, improving both pain intensity and physical function. Multiple studies have demonstrated that yoga, Zumba®, and treadmill walking can improve menstrual‐related pain in young women with dysmenorrhea. In addition to pain reduction, studies have also demonstrated improvement in quality of life. Mindfulness is the non‐judgmental acceptance and investigation of present experience, including body sensations, internal mental states, thoughts, emotions, impulses, and memories to reduce suffering or distress and to increase well‐being. Prior research by our group has demonstrated efficacy of mindfulness meditation in reducing pain and improving quality of life in women with chronic pelvic pain. Mindful movement is putting attention into what the body is feeling as it moves. It involves paying attention movement that feels good as well as to early warning signs that an exercise may be too intense or may cause a pain flare. This study is a 12‐week program of aerobic exercise and stretching for patients with CPP that applies mindful movement practices. Patients will be randomized to weekly classes versus routine recommendations for exercise. We will measure pain reduction, improvement in quality of life, and reduction in pain catastrophizing and kinesiophobia. We will enroll patients with chronic pelvic pain of at least 6‐months duration who have not engaged in regular physical activity in the prior 3 months. Patients aged 18 or older receiving care in the Pelvic Pain Program at the WMC will be invited to take part in the study. Records for patients in the pelvic pain program who are presenting for care will be reviewed for eligibility and approached prior to their visit about potentially participating in the study. Additionally, charts for patients active in the pelvic pain program will be reviewed for eligibility and the research assistant contact participants about participation in the study. If patients are interested in the study and do not have an upcoming office visit, they will be scheduled to come in to meet with the research assistant and be consented for the study. Subjects will also be consented at the time of their office visits. Study methods: 1. 60 patients with a history of CPP who meet the inclusion and exclusion criteria will be recruited and randomly assigned to the mindful movement program (N=30) or routine care (N=30). 2. All subjects will watch a video, created by our program for the pelvic pain population, which will review safety measures for starting an exercise program. The video includes how to start and gently increase duration of exercise and modifications that can be used to safely exercise with pain. All subjects will receive a step tracker and a study journal. 3. Patients randomized to the study arm will get a prescription for aerobic mindful exercise and stretching 4 days a week. They will view additional videos, created by our program, about mindful movement, awareness of body cues, intentiona ovement, and body scans. The scripts for the videos are submitted to the IRB for approval. They will have access to exercise classes as described below that are geared toward participants with physical limitations. All classes will incorporate reminders regarding mindful movement practices, as teachers will be selected who have an understanding of this principle. Participants will be instructed to attend an in person or virtual class at least once a week. A variety of 20‐60 minute classes will be available. Participants will be reminded to listen to their body's cues and be given options to modify their movement. Additionally, participants will work towards completing at least 20 minutes of walking followed by 5‐10 minutes of stretching 3 days a week. Participants can attend additional classes instead of walking. Participants are instructed to work toward a goal of at least. 80 minutes of cardiovascular exercise along with stretching each week. Participants will be required to track their activity with a study journal and step tracker provided through the study. a. Walking exercise with stretching: Participants will be recommended to walk on a treadmill, outside, or indoor location for at least 20 minutes, at a pace brisk enough to elevate ones heart rate. Participants are instructed to gently stretch their muscles following this activity for approximately 5‐10 minutes. b. Yoga is a physical and mental practice with ancient roots. Modern yoga generally intends to build strength, stamina, flexibility, coordination and balance through a series of poses. c. Shake your Soul® is a movement practice that was developed with mindfulness practices in mind. It incorporates fluid dance repertoire set to world music. Classes cannot be recorded. d. Zumba® is a dance exercise class that features Latin and World rhythms. It provides a total workout, combining cardio, muscle conditioning, balance, and flexibility. Lower impact versons, such as Zumba Gold® have been designed to meet the needs of seniors and others who need lower impact activity. Classes cannot be recorded 4. Weekly phone calls with the research assistant will include collection of pain scores and will review barriers to exercise, pain issues related to the exercise and mindful approach to exercise. If a participant feels they may have an injury or are unable to continue the program, Dr. Clark Donat or Dr. Fox will be notified and follow up accordingly. 5. Patients randomized to the control arm will receive routine care within the pelvic pain program. As part of routine care, patients are counseled on the importance of movement and encouraged to engage in gentle activity. They will be given access to the introductory video. Participants will be encouraged to walk or engage in some form of cardiovascular exercise for at least 20 minutes a day, 4 days a week, and gently stretch for 5‐10 minutes after their exercise. Participants are instructed to increase work toward a goal of at least. 80 minutes of cardiovascular exercise along with stretching each week. Participants will be encouraged to reach out to the study team if they feels they may have an injury or are unable to continue the program, Dr. Clark Donat or Dr. Fox will be notified and follow up accordingly. 6. Pain scores will be obtained using an 11‐point NPS by the research assistant at the initial visit and during weekly phone check‐ins. 7. Quality of life will be assessed using the World Health Organization Quality of Life ‐BREF questionnaire, a 26‐item validated tool that addresses 4 domains: physical health, psychological health, social relationships, and environmental health [21]. Kinesiophobia will be assessed using the validated Tampa Scale for Kinesiophobia, a 17‐item tool that indicates the level of fear associated with movement [22]. Pain catastrophizing will be assessed using the Pain Catastrophizing Scale, a validated 13‐ item tool that examines three subscales: magnification, rumination and helplessness [23]. These tools will be administered at enrollment and week 12. 8. Patient c arts will be reviewed for demographics information, pain diagnoses and treatments, and medical and surgical history. Summary Study Outline following randomization Study Arm (1) vs. Control Arm (2) Initial exercise video 1. Yes‐ prior to initiation of 12 week program 2. Yes‐ prior to initiation of 12 week program Step tracker and study journal 1. Yes‐ prior to initiation of 12 week program 2. Yes‐ prior to initiation of 12 week program Mindful Movement video 1. Yes‐ prior to initiation of 12 week program 2. No Prescription for weekly exercise 1. Yes‐ 4 days a week with a goal of 80 minutes of cardiovascular exercise plus stretching a week: including at least one class 2. No, but participants will be encouraged to exercise 4 days a week with a goal of 80 minutes of cardiovascular exercise plus stretching each week. Weekly Phone calls by research assistant 1. Yes‐ with follow up by Drs. Clark Donat or Fox as indicated 2. No Assessment of Pain scores 1. Yes‐ at intake and weekly by RA 2. Yes‐ at intake and at conclusion of study Questionnaires 1. Yes‐ At enrollment and week 12 via RedCap 2. Yes‐ At enrollment and week 12 via RedCap Benefits: Study subjects may benefit from improved pain levels, improved quality of life, and increased fitness level. They may also benefit from developing increased insight about how movement helps their pain and how to understand their bodies signal in relationship to exercise. Risks: There is limited risk to the subjects who choose to participate in this study. All recruited patients will already be undergoing care for their chronic pelvic pain, and therefore being counseled generally on the importance of gentle exercise and movement. New exercise can be associated with musculoskeletal soreness or injury, some participants may notice changes in their bowel or bladder habits, and participants could experience dehydration. To minimize these risks and prepare participants for these side effects, the exercise will be slow and gentle with incorporated stretching, participants will be counseled on adequate hydration, and made aware that bowel and bladder changes may be encountered. As part of the weekly check in calls the research assistant will screen for possible side effects from exercise and provide appropriate information or alter the providers to contact the patient. Potential Obstacles: Studies of patients with CPP often have a low completion rate because of chronic pain and life stressors [16]. We hope that this program of mindful movement, with a slow and gentle increase in duration, will help to allow more subjects to continue this program. In addition, we will be providing a small stipend to help encourage completion of the study. Since much of the exercise will be available virtually, there may be a barrier with poor access to the internet. However, patients will be given the option of a walking program that can be completed independently. Lastly, pain catastrophizing and kinesiophobia may also be barriers for this study. We hope that our gentle approach to exercise will allow patient to engage in the program. Additionally, we will monitor patient experience with pain catastrophizing and kinesiophobia as a study outcome. Confidentiality of Data: Medical records of all patients enrolling in the study will be reviewed for demographic and health related information. Protected Health Information (PHI) obtained will include patient's name and date of birth. Additionally, information from the questionnaires will be obtained. All information will be kept in a REDCAP database. Responses to the questionnaires will be put into the database, and all hard copies will be discarded. After data collection is complete, all data will be de‐identified and a key to allow the information to be linked to the appropriate patient will be kept in a separate, password‐protected database on a Lifespan computer. The de‐identified database will be used for statistical analysis and presentation of data to the team, in order to maintain HIPPA compliance. Hard copies of the consent forms il be kept in a locked file cabinet in Dr. Sarah Fox's office. The final data will be analyzed and published in a group format, and will not be traceable to specific patients. No information about sensitive or illegal behavior will be obtained. Participate compensation: All subjects will be given a fitness tracker valued at $30, They will also be compensated $25 for completion of the surveys at 6 and 12 weeks. Additionally, participants who are randomized to the study arm will receive access to virtual and in person exercise classes free of charge. Timeline: In preparation for this application, the PI reviewed records of the patients seen in the Pelvic Pain Program for the month of September 2021. 27 patients seen in that month would have been eligible for the study. For this reason, we are confident that we would be able to recruit and randomize our target of 60 patients within 6 months of beginning recruitment. Research Team:The investigators all have extensive experience caring for patients with chronic pain conditions. We have worked together clinically for up to 12 years and have been actively involved in research on mindfulness for the past 4 years. The current research team previously studied mindfulness meditation for CPP so they have experience with this patient population and have already established successful collaboration [16].

Döner Şerife, İ., et al. (2023). "The effect of aromatherapy massage with lemon and peppermint essential oil on menopausal symptoms: A double-blinded, randomized placebo controlled clinical trial." Explore.
	Objectives: Menopausal and postmenopausal women experience many physical and psychological symptoms. The positive effects of aromatherapy sessions with different oils on menopausal symptoms are well known. The aim of this study was to investigate the effect of an aromatherapy massage with peppermint and lemon essential oil on menopausal symptoms.; Methods: Total 63 menopausal and postmenopausal women were included in this study. Participants were randomly divided into three groups: Menta peppermint (n = 21), Citrus lemon (n = 21), and Placebo (n = 21). The peppermint and lemon essential oils of the intervention groups were diluted with 1.5 % sweet almond oil. Pure sweet almond oil was used in the placebo group. Each participant in the massage groups received a hand and arm massage with the selected oil twice a week for 4 weeks in 30-min sessions. Participants' menopausal symptoms were assessed before and after application using the Menopause Symptoms Rating Scale (MRS).; Results: When the differences in the treatment groups according to time were examined, it was found that there were statistically significant differences in lemon (F = 9.561, p = 0.003, η 2 = 0.139) and peppermint essential oil (F = 15.687, p = 0.001, η 2 = 0.210) groups according to time. The peppermint essential oil group was more effective than the lemon group. In addition, both peppermint and lemon essential oils were effective for somatic symptoms (p < 0.05). For psychological symptoms, only the lemon oil (p = 0.011) proved effective, and for urogenital symptoms, only the peppermint essential oil (p = 0.001).; Conclusion: The study found that aromatherapy massage with peppermint and lemon essential oil effectively reduced menopausal symptoms. Peppermint essential oil was more effective than lemon essential oil in reducing the menopausal symptoms.; The Clinical Trial Registration Number: NCT05677698. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Dong, S.-Q., et al. (2021). "Comparative efficacy and safety of complementary and alternative therapies for tubal obstructive infertility: A protocol for network meta-analysis." Medicine 100(7): e24810.
	Background: Infertility is a kind of global disease. Fallopian tubal obstruction is one of the most important causes of female infertility. Complementary and alternative therapies are effective in treating tubal obstructive infertility, but there is no study on a comprehensive comparison among them. So, the purpose of this paper is to evaluate the efficacy and safety of different complementary and alternative therapies for tubal obstructive infertility.; Methods: We will search for randomized controlled trials (RCTs) from the following databases: PubMed, Cochrane Library, EMBASE, Web of Science, Chinese Biomedical Literature Database (SinoMed), Chinese National Knowledge Infrastructure (CNKI), Wanfang database, and VIP database. We will assess the risk of bias of the included studies with the Cochrane tool, and the strength of evidence with the GRADE approach. Both pairwise meta-analyses and network meta-analyses will be performed to examine the relative efficacy and safety of complementary and alternative therapies in the treatment of tubal obstructive infertility.; Conclusion: Our findings will provide clear evidence based on current available studies, which may lead to some proposals for both patients and researchers.; Inplasy Registration Number: INPLASY202110076.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Dong-A St Co, L. (2022). "A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder." ClinicalTrials.gov.
	This study will evaluate the efficacy and safety of DA‐8010 in patients with overactive bladder.

Donovan Heidi, S., et al. (2022). "Effects of the WRITE Symptoms Interventions on Symptoms and Quality of Life Among Patients With Recurrent Ovarian Cancers: An NRG Oncology/GOG Study (GOG-0259)." Journal of Clinical Oncology 40(13): 1464-1473.
	Purpose: GOG-259 was a 3-arm randomized controlled trial of two web-based symptom management interventions for patients with recurrent ovarian cancer. Primary aims were to compare the efficacy of the nurse-guided (Nurse-WRITE) and self-directed (SD-WRITE) interventions to Enhanced Usual Care (EUC) in improving symptoms (burden and controllability) and quality of life (QOL).; Methods: Patients with recurrent or persistent ovarian, fallopian, or primary peritoneal cancer with 3+ symptoms were eligible for the study. Participants completed baseline (BL) surveys (symptom burden and controllability and QOL) before random assignment. WRITE interventions lasted 8 weeks to develop symptom management plans for three target symptoms. All women received EUC: monthly online symptom assessment with provider reports; online resources; and every 2-week e-mails. Outcomes were evaluated at 8 and 12 weeks after BL. Repeated-measures modeling with linear contrasts evaluated group by time effects on symptom burden, controllability, and QOL, controlling for key covariates.; Results: Participants (N = 497) reported mean age of 59.3 ± 9.2 years. At BL, 84% were receiving chemotherapy and reported a mean of 14.2 ± 4.9 concurrent symptoms, most commonly fatigue, constipation, and peripheral neuropathy. Symptom burden and QOL improved significantly over time ( P < .001) for all three groups. A group by time interaction ( P < .001) for symptom controllability was noted whereby both WRITE intervention groups had similar improvements from BL to 8 and 12 weeks, whereas EUC did not improve over time.; Conclusion: Both WRITE Intervention groups showed significantly greater improvements in symptom controllability from BL to 8 and BL to 12 weeks compared with EUC. There were no significant differences between Nurse-WRITE and SD-WRITE. SD-WRITE has potential as a scalable intervention for a future implementation study.; Competing Interests: Lari B. WenzelConsulting or Advisory Role: Array BioPharma Robert P. EdwardsResearch Funding: Merck Mary C. RobergeResearch Funding: Clovis Oncology (Inst) Teresa H. ThomasConsulting or Advisory Role: Healthline Media, Mashup Media David G. MutchConsulting or Advisory Role: Lilly Carolyn Y. MullerResearch Funding: AstraZeneca (Inst), Genmab (Inst), VBL Therapeutics (Inst), Roche/Genentech (Inst), TapImmune Inc (Inst), Linnaeus Therapeutics (Inst), Agenus (Inst), Incyte (Inst), Merck (Inst)Patents, Royalties, Other Intellectual Property: Have a pending patent on the cancer use for R-ketorolac—not yet its own new drug (Inst)Other Relationship: NCI, Department of DefenseNo other potential conflicts of interest were reported.

Dos, S., et al. (2021). "Hyaluronic Acid in Postmenopause Vaginal Atrophy: A Systematic Review." The Journal of Sexual Medicine 18(1): 156-166.
	Background: The decline in postmenopausal serum estrogen concentration results in several changes in the vulvovaginal and vesicourethral areas, resulting in the genitourinary syndrome of menopause, including symptoms such as vaginal atrophy.; Aim: To evaluate the effects of hyaluronic acid in vaginal atrophy.; Methods: A search strategy was developed using the following terms: "Hyaluronic Acid vaginal gel," "vaginal estrogens," "Vaginitis, Atrophic," and "Postmenopause." This strategy was used in major databases such as MEDLINE, EMBASE, Scopus, Cochrane library, Web of Science, Virtual Health Library (BVS), Congress Abstracts, and Gray Literature (Google Scholar and British Library) for studies published until June 2020.; Outcomes: A systematic review was carried out to assess the results of atrophic vaginitis/vaginal dryness, dyspareunia, vaginal pH, and cell maturation of the studies found by the search strategy.; Results: A total of 833 studies were identified, 528 studies were directed for reading titles and abstracts, and 515 were excluded for not meeting the selection criteria. A total of 13 studies were selected for reading the full text. 5 primary studies involving 335 women met the criteria and were included. The studies were published between the years 2011 and 2017. It was not possible to perform meta-analysis owing to the substantial heterogeneity present in the studies. The results presented suggest that treatment with hyaluronic acid, when compared with the use of estrogens, does not present a significant difference in the results obtained for the outcomes: epithelial atrophy, vaginal pH, dyspareunia, and cell maturation.; Clinical Translation: Hyaluronic acid appears to be an alternative to non-hormonal treatments for the signs of vaginal atrophy and dyspareunia.; Strengths & Limitations: The analysis of the studies in this systemic review suggests that hyaluronic acid has efficacy similar to vaginal estrogens for the treatment of the signs of vaginal atrophy and dyspareunia. However, the included studies measured the data in different ways, causing the performance of meta-analysis to be impaired.; Conclusion: The comparisons presented suggest that hyaluronic acid has a profile of efficacy, safety, and tolerability comparable with vaginal estrogens for the treatment of symptoms of vaginal atrophy. It is a possible alternative for women who cannot use hormonal treatment. dos Santos CCM, Uggioni MLR, Colonetti T, et al. Hyaluronic Acid in Postmenopause Vaginal Atrophy: A Systematic Review. J Sex Med 2021;18:156-166. (Copyright © 2020 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Dos, S., et al. (2020). "The effect of exercise as an intervention for women with polycystic ovary syndrome: A systematic review and meta-analysis." Medicine 99(16): e19644.
	Background: Polycystic ovary syndrome (PCOS) affects reproductive-aged women and is associated with increased prevalence of serious clinical problems including: reproductive implications, metabolic dysfunction, and cardiovascular risk. Physical activity offers several health benefits for women with PCOS. The aim of this systematic review was to synthesize evidence on the effect of different types of exercise on reproductive function and body composition for women with PCOS.; Methods: This was a systematic review and meta-analysis of randomized controlled trials (RCTs) following recommended review methods. We searched 6 databases: Cumulative Index of Nursing and Allied Health Literature; Embase; MEDLINE (via Ovid); PubMed; Sport Discus; and Web of Science; and we developed search strategies using a combination of Medical Subject Headings terms and text words related to exercise interventions for women with PCOS. There was no restriction on language or publication year. The search was conducted on April 16, 2019 and updated on November 15, 2019. Two authors independently screened citations, determined risk of bias and quality of evidence with Grading of Recommendations Assessment, Development and Evaluation. We conducted meta-analyses following recommended guidelines, and report results using standardized mean difference (SMD).; Results: Ten RCTs (n = 533) were included in this review. Studies tested the following interventions: aerobic, resistance, and combined (aerobic/resistance) training programs. Most studies were small (average 32, range 15-124 participants), and of relatively short duration (8-32 weeks). There was high heterogeneity for outcomes of reproductive function (menstrual cycle, ovulation, and fertility). We noted low certainty evidence for little to no effect of exercise on reproductive hormones and moderate certainty evidence that aerobic exercise reduced body mass index (BMI) in women with PCOS: BMI SMD -0.35, 95% confidence interval -0.56 to -0.14, P = .001.; Conclusion: For women with PCOS, evidence is limited to discern the effect of exercise on major health outcomes (e.g., reproductive function). There is moderate certainty evidence that aerobic exercise alone is beneficial for reducing BMI in women with PCOS. Future studies should be conducted with longer duration, larger sample sizes, and should provide detailed information on menstrual cycle and fertility outcomes.PROSPERO Systematic review registration: 2017 CRD42017058869.

Doust, A. (2021). "ESPriT2 – a multicentre clinical trial to determine whether surgical removal of superficial peritoneal endometriosis improves pain symptoms and quality of life." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Participants will be randomised at time of laparoscopy if superficial peritoneal endometriosis only is found. Randomisation will be to either remove the lesions by excision/ablation/both (depending on operating surgeon's preference) or to diagnostic laparoscopy alone. Randomisation is via an on‐line database and will take place during laparoscopy once eligibility has been confirmed. Follow‐up will be at 30 days, 3, 6 months and 12 month post‐operatively. We will also carry out a data linkage follow‐up of up to 5 years. CONDITION: Women with isolated superficial peritoneal endometriosis ; Urological and Genital Diseases ; Endometriosis of pelvic peritoneum PRIMARY OUTCOME: Pain at 12 months post randomisation as defined by the ‘pain domain’ of the EHP‐30 questionnaire SECONDARY OUTCOME: ; 1. Time off work and presenteeism defined by the WPAIQ at 12 months; 2. Need for hormonal medication for endometriosis related symptoms at 3, 6 and 12 months; 3. Need for analgesics for endometriosis related symptoms at 3, 6 and 12 months; 4. Pain domain of the EHP‐30 at 3 and 6 months; 5. Total score of EHP‐30 at 3, 6 and 12 months; 6. Fatigue symptoms defined by the BFI at 12 months; 7. Neuropathic pain symptoms defined by PainDETECT™ at 12 months; 8. Urinary symptoms defined by PUF 12 months; 9. Irritable bowel symptoms defined by the ROME IV criteria at 12 months; 10. Pain catastrophizing defined by PCQ at 12 months; 11. Fibromyalgia defined by FS at 12 months; 12. Specific patient reported symptoms defined by MYMOP2; 13. Post operative pain and analgesic requirements by patient reported diary; 14. Length of hospital stay measured using patient records; 15. Surgical complications at 30 days measured using patient records; 16. Adverse events related to surgery at 30 days measured using patient records; 17. Need for further surgery for endometriosis related symptoms at 12 months measured using patient records; 18. Pregnancy events at 3, 6 and 12 months; ; Economic Outcomes; 19. Quality of life defined by EQ5D‐5L at 3, 6, and 12 months; 20. General wellbeing defined by ICECAP‐A at 3, 6 and 12 months; 21. Costs and resource use at 3, 6 and 12 months (primary and secondary care) collected via a telephone call and completion of a data collection form; 22. Impacts on employment, caregiving, and other usual activities (e.g. education) collected via a telephone call and completion of a data collection form; INCLUSION CRITERIA: 1. Aged over 16 2. Undergoing laparoscopy for the investigation of chronic pelvic pain 3. In order to be randomised, isolated superficial peritoneal endometriosis (SPE) must be identified at laparoscopy (macroscopically) 4. Able to give informed consent

Doyle, N., et al. (2022). "Effect of Timing by Endometrial Receptivity Testing vs Standard Timing of Frozen Embryo Transfer on Live Birth in Patients Undergoing In Vitro Fertilization: A Randomized Clinical Trial." JAMA 328(21): 2117-2125.
	Importance: Endometrial receptivity testing is purported to improve live birth following frozen embryo transfer by identifying the optimal embryo transfer time for an individual patient; however, data are conflicting.; Objective: To compare live birth from single euploid frozen embryo transfer according to endometrial receptivity testing vs standardized timing.; Design, Setting, and Participants: Double-blind, randomized clinical trial at 30 sites within a multicenter private fertility practice in the Eastern US. Enrollment was from May 2018 to September 2020; follow-up concluded in August 2021. Participants underwent in vitro fertilization, preimplantation genetic testing for aneuploidy, endometrial receptivity testing, and frozen embryo transfer. Those with euploid blastocyst(s) and an informative receptivity result were randomized. Exclusion criteria included recurrent pregnancy loss, recurrent implantation failure, surgically aspirated sperm, donor egg(s), and unmitigated anatomic uterine cavity defects.; Interventions: The intervention group (n = 381) underwent receptivity-timed frozen embryo transfer, with adjusted duration of progesterone exposure prior to transfer, if indicated by receptivity testing. The control group (n = 386) underwent transfer at standard timing, regardless of receptivity test results.; Main Outcomes and Measures: The primary outcome was live birth. There were 3 secondary outcomes, including biochemical pregnancy and clinical pregnancy.; Results: Among 767 participants who were randomized (mean age, 35 years), 755 (98%) completed the trial. All randomized participants were analyzed. The primary outcome of live birth occurred in 58.5% of transfers (223 of 381) in the intervention group vs 61.9% of transfers (239 of 386) in the control group (difference, -3.4% [95% CI, -10.3% to 3.5%]; rate ratio [RR], 0.95 [95% CI, 0.79 to 1.13]; P = .38). There were no significant differences in the intervention vs the control group for the prespecified secondary outcomes, including biochemical pregnancy rate (77.2% vs 79.5%, respectively; difference, -2.3% [95% CI, -8.2% to 3.5%]; RR, 0.97 [95% CI, 0.83 to 1.14]; P = .48) and clinical pregnancy rate (68.8% vs 72.8%, respectively; difference, -4.0% [95% CI, -10.4% to 2.4%]; RR, 0.94 [95% CI, 0.80 to 1.12]; P = .25). There were no reported adverse events.; Conclusions and Relevance: Among patients for whom in vitro fertilization yielded a euploid blastocyst, the use of receptivity testing to guide the timing of frozen embryo transfer, compared with standard timing for transfer, did not significantly improve the rate of live birth. The findings do not support routine use of receptivity testing to guide the timing of embryo transfer during in vitro fertilization.; Trial Registration: ClinicalTrials.gov Identifier: NCT03558399.

Du, X. (2021). "Efficacy and Safety of a Repurposed Drug Added to the Combination of Len Plus Pem in Advanced Endometrial Cancer." ClinicalTrials.gov.
	This is a Phase 3, multicenter, randomized, open‐label trial to evaluate whether EG‐007 plus Len+Pem is superior to Len+Pem alone in patients with advanced endometrial cancer (Stage III or IV). This trial will be preceded by a safety lead‐in study with up to 28 patients (the safety lead‐in is a separate, free‐standing protocol). Approximately 450 patients will be randomized equally (1:1) to receive EG‐007 plus Len+Pem or Len+Pem alone. The randomization will be stratified by the following stratification factors: ‐ Diagnosis Classification (advanced Stage III/IV vs. recurrent endometrial cancer) ‐ ECOG score at baseline (0 vs 1) ‐ Geographic region (Asia vs ROW)

Dubernard, G. (2023). "Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms." ClinicalTrials.gov.
	No Results Available Device: HIFU treatment in rectal Endometriosis|Device: SHAM HIFU procedure Comparison of the evolution in the level of acute pelvic pain compared to the sham intervention group.|Adverse Events occurrence and comparison between the two groups|Symptoms evolution evaluation|Evaluation of anal continence|Evaluation of constipation|Evaluation of urinary symptoms|Evaluation of sexual fonction|Quality of life evoluation|Volume lesion evaluation|Post treatment medication rate|Post treatment pain rate|Overall recovery time evaluation Female Not Applicable 60 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment HIFU/F/21.12 February 1, 2024

Dudoniene, V., et al. (2023). "Pelvic Floor Muscle Training versus Functional Magnetic Stimulation for Stress Urinary Incontinence in Women: A Randomized Controlled Trial." Journal of Clinical Medicine 12(9): 3157.
	Background: There is strong evidence that specific pelvic floor muscle training (PFMT) reduces stress urinary incontinence (SUI), but the application of functional magnetic stimulation (FMS) is still under discussion. Objective(s): To evaluate and compare the effects of FMS and PFMT on pelvic floor muscle function, urinary incontinence symptoms and quality of life (QoL) in women with SUI. Method(s): A randomized controlled, parallel-group trial was executed in an outpatient physical medicine and rehabilitation centre. The study included 68 women and was fully completed by 48 women (n = 24 in each group) aged 29-49 years, with SUI, who were randomly assigned to PFMT and FMS groups. The symptoms of urinary incontinence and their impact on quality of life were assessed with two questionnaires: the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and the Incontinence Impact Questionnaire-Short Form (IIQ-7). Perineometer (Pelvexiser) was used to measure the resting vaginal pressure, pelvic floor muscle (PFM) strength and endurance. All outcome measures were taken at baseline and after 6 weeks of interventions. Cohen's effect size (d) was calculated. Result(s): A significant improvement (p < 0.05) of ICIQ-SF and IIQ-7 was observed in both groups with a high effect size in the PFMT group (d = 1.56 and d = 1.17, respectively) and the FMS group (d = 1.33 and d = 1.45, respectively). ICIQ-SF and IIQ-7 scores did not differ significantly between groups after the 6-week treatment period. Resting vaginal pressure, PFM strength and endurance increased (p < 0.05) in both groups with a medium (d = 0.52) to large (d = 1.56) effect size. Conclusion(s): No significant difference between groups was found in any measurement of perineometry. PFMT and FMS significantly improved SUI symptoms and the quality of life of the study participants. None of the applied interventions was superior to the other in the short-term effect.Copyright © 2023 by the authors.

Duffecy, J. (2021). "Caria: digital Intervention for Menopause Symptom." ClinicalTrials.gov.
	Menopause is the time of life when menstrual cycles cease. Women typically spend 30‐40% of their lives in menopause. Individual experiences of menopause vary and although some women do not experience any significant symptoms, common symptoms include vasomotor dysfunction, vaginal dryness, mood changes, sleep disturbances, urinary incontinence, cognitive changes, somatic complaints and sexual dysfunction. Reduced quality of life can occur as a result of these symptoms. A mobile app has been developed to reduce the impact of these symptoms using a variety of behavioral change techniques including education, goal setting, motivational enhancement, social support and cognitive behavioral approaches. Participants will complete self report assessments of women's symptoms and QOL at baseline, 3 weeks and 6 weeks of app use.

Dufour, S., et al. (2021). "Impact of a Pozzi tenaculum forceps use on the success rate of intrauterine insemination (IUI) : protocol for a randomised control trial." BMJ Open 11(3): e043230.
	INTRODUCTION: A therapeutic option frequently proposed for infertility is to proceed first with intrauterine insemination (IUI) cycles. Little is known on the effect of uterine contractions on IUI success rates. We postulated that uterine contractions may help with sperm migration in the women's genital tract. Our objective is to compare the efficacy of IUI when performed with and without a tenaculum forceps on the cervix. METHODS AND ANALYSIS: We are conducting a randomised controlled trial with women aged 18-40 years old, diagnosed with primary or secondary infertility due to endometriosis, mild to moderate male factor, unexplained infertility or ovulatory dysfunction, receiving IUI treatments. On the day of their IUI, women will receive standard care treatment plus or minus the planned use of a Pozzi tenaculum forceps on the cervix. Each of the 800 women will be randomised only once for their first three IUI. They will be randomised in one of the following sequences: tenaculum-no tenaculum-tenaculum or, no tenaculum-tenaculum-no tenaculum. We will compare the live birth rate (primary outcome) and the clinical pregnancy rate (secondary outcome) after IUI treatment. We also plan on assessing global satisfaction of women, pain levels felt during IUI and discrepancies in primary and secondary outcomes in interventions performed by attendings compared with trainees. ETHICS AND DISSEMINATION: This research project was approved by the Centre Hospitalier Universitaire de Québec's ethics review board (no 2018-4084). Pozzi tenaculum application is associated with mild pain, estimated at 33 on a Visual Analogue Scale ranging from 0 to 100. We plan on publishing an article to present our findings in a peer-reviewed journal as well as presenting the research abstract at conferences. TRIAL REGISTRATION NUMBER: NCT03435809.

Dunivan, G. (2021). "The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)." ClinicalTrials.gov.
	No Results Available Drug: Cannabidiol vaginal suppository|Drug: Placebo vaginal suppository Urinary Pain Severity Scores|Urinary Symptom Severity Scores|Marijuana Urine Drug Test Female Phase 1 0 Other Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 00-000 September 2022

Duraes, M. (2023). "Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention." ClinicalTrials.gov.
	Introduction: Incomplete early miscarriage is defined as early miscarriage with persistent intrauterine material on ultrasound. Intrauterine retention of trophoblastic debris is not an uncommon phenomenon. These retentions may initially be asymptomatic but are often responsible for persistent metrorrhagia and endometritis. This symptomatology often accentuates the psychological distress of patients mourning the pregnancy. Incomplete miscarriages are mainly managed by the gynecological emergency department. The recommendations of the Collège National des Gynécologues et Obstétriciens Français (CNGOF) suggest as a first line of treatment: either surgical management or expectant care. The choice between the two is left to the discretion of the doctor and the patient. there are no clear recommendations as to the choice between hysteroscopy and aspiration. Within the teams, the choice is often made according to the habits and protocols of the service, according to the equipment available and the skills of the gynaecologists. Aim: The main objective is to compare the efficacy of management by endo‐uterine aspiration versus management by hysteroscopy of trophoblastic retention after early miscarriage, at 6 weeks after surgery, by endovaginal ultrasound. The secondary objectives are: ‐ the comparison of the rate of complications of the two techniques, during and after surgery ‐ the comparison of the rate of recourse to a second line surgical management between the two arms, ‐ the comparison of the rate of synechiae diagnosed by hysterosonography between the two techniques at 6 weeks after surgery, ‐ the comparison of the time to conception in the two arms during the 2 years after surgery ‐ the comparison of the fertility rate at 2 years after surgery in the two arms. Methods: This is a prospective, multicenter, randomized, open‐label, two‐arms, parallel therapeutic clinical trial comparing hysteroscopy versus endouterine aspiration for the management of trophoblastic retention after spontaneous miscarriage. Patients will be randomized (110 per arm) after verification of eligibility criteria and signature of consent, on the day of the operation: ‐ Arm A: 110 patients treated by operative hysteroscopy ‐ Arm B: 110 patients treated by endo‐uterine aspiration Randomization will be stratified by center, age (<35 years, 35 years and over), size of trophoblastic retention (<30mm, 30mm and over) and scheduled by random size block. It will be centralized (Ennov‐clinical software) and parameterized by the Unité́ de Recherche Clinique & Biostatistiques of the Montpellier University Hospital. Statistics: The effectiveness of operative hysteroscopy is expected to be 100%, and that of aspiration 90%. To show this difference with an alpha risk of 5%, and with a power of 90%, 98 patients per arm will have to be analysed (exact binomial distribution calculation, epiR package of R implemented in biostatgv). To take into account a 10% loss of sight rate, 220 patients will be recruted. Patients will be included in the study on the morning of the procedure, after verification of the selection criteria. The expected number of lost to follow‐up is estimated at 10%; in fact, the main criterion is evaluated relatively early (6 weeks), in patients having a desire for pregnancy and therefore relatively compliant, the rate of lost to follow‐up will be a fairly low. A flow‐chart will be constructed to describe the evolution of the populations during the study. It will detail the causes of non‐inclusion and the causes of loss to follow‐up. All study data will be described according to the randomization arm, in the randomized population: mean, standard deviation, median and quartiles, extrema and number of missing data for quantitative variables, numbers and percentages of each modality for qualitative data. The clinical comparability of the randomized population and the ITT population for the primary endpoint will be assessed. Primary analysis: The uterine vacuity rate will be compared between the two arms in th

Duygu, V. Y. (2021). "The Effect of Acupressure Applied to Menopausal Women on Menopausal Symptoms and Quality of Life." ClinicalTrials.gov.
	Parallel to the increase in life expectancy by years, the population of women living in the post‐menopausal period is also increasing. In order to have a healthy menopause, which is an important part of women's life, it is thought that the acupressure without health risks by women may be effective in reducing the symptoms of menopause experienced by women and quality of life. In line with this information, it was aimed to determine the effect of acupressure on menopausal symptoms and quality of life and the relationship between menopausal symptoms and quality of life. The study will be carried out with menopausal women between the ages of 40‐60 in Mersin province in Turkey. Therefore, in the study, 46 women in the menopausal period between the ages of 40‐60 will be randomly assigned to acupressure and control groups. The study group (n = 23) will be applied to the determined points in a certain order. Sequence of application Large intestine 4th point (LI 4), Heart 7th point (HT 7), Triple warmer point 23 (TE 23), Stomach 36th point (ST 36), Spleen 6th point (SP 6) and Liver The 3rd point is (LV 3). Acupressure application for 20‐25 minutes three times a week for four weeks will be applied individually to the study group. No intervention will be made to the control group for a period of four weeks. The primary expected outcome of the research is the effect of acupressure on menopausal symptoms of menopausal women. The second expected result of the study is to determine the effect of acupressure on quality of life. Results will be applied three times in total, before the study and control application, two weeks and 4 weeks later.

Düz Senem, A. (2021). "The Effect of Polycystic Ovary Syndrome Treatment on Metabolomics." ClinicalTrials.gov.
	No Results Available Drug: Yasmin|Drug: Diane-35 Metabolomics|hirsutism score|fasting serum insulin levels|low density lipoprotein|body mass index|clinical findings Female Not Applicable 42 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2021/28 June 2023

Dymond, A., et al. (2021). "Economic Evaluation of Senshio (Ospemifene) for the Treatment of Vulvovaginal Atrophy in Scotland." Applied Health Economics and Health Policy 19(1): 123-132.
	Background: Local oestrogens, the current treatment for vulvar and vaginal atrophy (VVA), are not suitable for all women. Standard of care (SoC) consists of over-the-counter lubricants and moisturisers. Senshio (ospemifene) provides a treatment option for postmenopausal women who are not candidates for local vaginal oestrogen therapy who would otherwise have an unmet clinical need. Objective(s): The aim of this study was to estimate the cost-effectiveness of ospemifene, a selective oestrogen receptor modulator, for the treatment of moderate to severe symptomatic VVA in postmenopausal women who are not candidates for local vaginal oestrogen therapy. Method(s): The Scottish Medicines Consortium (SMC) recently evaluated the clinical and cost-effectiveness evidence of ospemifene plus SoC compared with SoC alone. A cost-effectiveness study, from a National Health Service (NHS) Scotland perspective over a lifetime time horizon, was submitted to the SMC. The cohort-based Markov model used robust clinical evidence from two large pivotal phase III randomised controlled studies and included four health states classified by dyspareunia symptom severity: none, mild, moderate and severe. The movement of women between health states was dependent on the effectiveness of treatment in reducing dyspareunia. Extensive sensitivity analyses were undertaken to assess the level of confidence associated with the base-case results. Result(s): Treatment with ospemifene was associated with an additional cost of 847 per patient and an increase in quality-adjusted life-years (QALY) of 0.06 per patient. Ospemifene had an incremental cost-effectiveness ratio of 14,138 per QALY. In the probabilistic sensitivity analysis, there was a probability of 89% that ospemifene was cost-effective at a threshold of 20,000 per QALY gained. Ospemifene remained cost-effective under all scenario analyses. The SMC reviewed the clinical and economic evidence and judged that the evidence demonstrated a robust case to support prescribing ospemifene in NHS Scotland. Conclusion(s): Ospemifene is a cost-effective intervention that has recently been accepted by the SMC for the treatment of postmenopausal women with moderate to severe VVA who are not candidates for local oestrogen.Copyright © 2020, Springer Nature Switzerland AG.

Earl Rachel, A. and M. Grivell Rosalie (2021). "Nifedipine for primary dysmenorrhoea." The Cochrane Database of Systematic Reviews 12: CD012912.
	Background: Dysmenorrhoea (period pain) is a common condition with a substantial impact on the well-being and productivity of women. Primary dysmenorrhoea is defined as recurrent, cramping pelvic pain that occurs with periods, in the presence of a normal uterus, ovaries and fallopian tubes. It is thought to be caused by uterine contractions (cramps) associated with a high level of production of local chemicals such as prostaglandins. The muscle of the uterus (the myometrium) responds to these high levels of prostaglandins by contracting forcefully, causing low oxygen levels and consequently pain. Nifedipine is a calcium channel blocker in widespread clinical use for preterm labour due to its ability to inhibit uterine contractions in that setting. This review addresses whether this effect of nifedipine also helps with relief of the uterine contractions during menstruation OBJECTIVES: To assess the effectiveness and safety of nifedipine for primary dysmenorrhoea.; Search Methods: We searched for all published and unpublished randomised controlled trials (RCTs) of nifedipine for dysmenorrhoea, without language restriction and in consultation with the Cochrane Gynaecology and Fertility Group (CGF) Information Specialist. The following databases were searched to 25 November 2021: the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase, PsycINFO, and CINAHL. Also searched were the international trial registers: ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal, the Web of Science, OpenGrey, LILACS database, PubMed and Google Scholar. We checked the reference lists of relevant articles.; Selection Criteria: We included RCTs comparing nifedipine with placebo for the treatment of primary dysmenorrhoea.; Data Collection and Analysis: The primary outcomes to be assessed were pain, and health-related quality of life. Secondary outcomes were adverse effects, satisfaction, and need for additional medication. The two review authors independently assessed the included trials. There were insufficient data to allow meaningful meta-analysis.; Main Results: The evidence assessed was of very low quality overall. We examined three small RCTs, with a total of 106 participants. Data for analysis could be extracted from only two of these trials (with a total of 66 participants); two trials were published in the 1980s, and the third in 1993. Nifedipine may be effective for "any pain relief" compared to placebo in women with primary dysmenorrhoea (odds ratio (OR) 9.04, 95% confidence interval (CI) 2.61 to 31.31; 2 studies, 66 participants; very low-quality evidence). The evidence suggests that if the rate of pain relief using placebo is 40%, the rate using nifedipine would be between 64% and 95%. For the outcome of "good" or "excellent" pain relief, nifedipine may be more effective than placebo; the confidence interval was very wide (OR 43.78, 95% CI 5.34 to 259.01; 2 studies, 66 participants; very low-quality evidence). We are uncertain if the use of nifedipine was associated with less requirement for additional analgesia use than placebo (OR 0.54, 95% CI 0.07 to 4.20, 1 study, 42 participants; very low-quality evidence). Participants indicated that they would choose to use nifedipine over their previous analgesic if the option was available. There were similar levels of adverse effects and menstruation-related symptoms in the placebo and intervention groups (OR 0.94, 95% CI 0.08 to 10.90; 1 study, 24 participants; very low-quality evidence); if the chance of adverse effects with placebo is 80%, the rate using nifedipine would be between 24% and 98%. There were no results regarding formal assessment of health-related quality of life.; Authors' Conclusions: The evidence is insufficient to confirm whether nifedipine is a possible medical treatment for primary dysmenorrhoea. The trials included in this review had very low numbers and were of low quality. Notably, there was a large imbalance in number randomised between placebo and treatment groups in one of the two trials with data available for analysis. While there was no evidence of a difference noted in adverse effects between groups, more data from larger participant numbers are needed for this outcome. Larger, more well-conducted trials are required to elucidate the potential role of nifedipine in the treatment of this common condition, as it could be a useful addition to the therapeutic options available if shown to be well tolerated and effective. The safety of nifedipine in women of reproductive age is well established from trials of its use in preterm labour, and clinicians are accustomed to off-label use for this indication. The drug is inexpensive and readily available. Other options for relief of primary dysmenorrhoea are not suitable for all women; NSAIDs and the oral contraceptive pill (OCP) are contraindicated for some women, and the OCP is not suitable for women who are trying to conceive. In addition, the trials examined suggest there may be a participant preference for nifedipine. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Eckel, F., et al. (2024). "Dequalinium Chloride for the Treatment of Vulvovaginal Infections: A Systematic Review and Meta-Analysis." Journal of Lower Genital Tract Disease 28(1): 76-83.
	Objective/Purpose: Women at reproductive age frequently experience vulvovaginal infections and vaginitis. The most common etiologies are vulvovaginal candidiasis (VVC), bacterial vaginosis (BV), desquamative inflammatory vaginitis/aerobic vaginitis, and trichomoniasis. Various treatment options are available for these infections, such as specific antimicrobial or antiseptic agents. Dequalinium chloride (DQC) is a local antiseptic agent with a broad antimicrobial and antifungal spectrum. Multiple studies suggest that DQC is an efficient treatment for vaginal infections; however, it is not widely recommended as a first-line treatment. This systematic review and meta-analysis aims to evaluate the efficacy of DQC compared with that of standard treatment. Method(s): Our systematic review was conducted according to the PRISMA guidelines. PubMed/MEDLINE, EMBASE, CENTRAL, and clinicaltrials.org were searched to retrieve relevant reports up to October 2022. Result(s): Four randomized controlled studies and 1 observational study were included in this review. Overall, DQC showed noninferiority to the reference treatments for BV and VVC, and to the evaluated treatment options for desquamative inflammatory vaginitis/aerobic vaginitis. For BV and VVC, this could also be confirmed in a meta-analysis including 3 randomized controlled studies. No serious adverse events were reported in any of these studies. Conclusion(s): Dequalinium chloride offers a safe, well-tolerated, and efficient treatment option for vulvovaginal infections of different etiologies. However, further studies are needed to confirm our findings and allow inclusion of DQC as a first-line treatment into guidelines.Copyright © 2023 Lippincott Williams & Wilkins.

Ekersund, J., et al. (2022). "A mobile app for the treatment of female mixed and urgency incontinence: a cost-effectiveness analysis in Sweden." International Urogynecology Journal 33(5): 1273-1282.
	Introduction and hypothesis: A previous randomized controlled trial (RCT) demonstrated that the app Tat II, for self-management of mixed urinary incontinence (MUI) and urgency urinary incontinence (UUI), yielded significant, clinically relevant improvements in symptom severity and quality of life (QoL) compared with a control group. We aimed to assess the cost-effectiveness of Tat II. Method(s): A cost-utility analysis with a 1-year societal perspective was carried out, comparing Tat II with an information app. Data were collected alongside an RCT: 122 community-dwelling women aged >=18 years with MUI or UUI >=2 times/week were randomized to 3 months of Tat II treatment focused on pelvic floor muscle training (PFMT) and bladder training (BT; n = 60), or to an information app (n = 62). Self-assessed data from validated questionnaires were collected at baseline and at 3-month and 1-year follow-ups. Costs for assessment, treatment delivery, incontinence aids, laundry, and time for PFMT and BT were included. We calculated quality-adjusted life-years (QALYs) using the International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life. The incremental cost-effectiveness ratio (ICER) between the groups was our primary outcome. Sensitivity analyses were performed. Result(s): The mean age was 58.3 (SD = 9.6) years. Annual overall costs were 738.42 in the treatment group and 605.82 in the control group; annual QALY gains were 0.0152 and 0.0037 respectively. The base case ICER was 11,770.52; ICERs in the sensitivity analyses ranged from -9,303.78 to 22,307.67. Conclusion(s): The app Tat II is a cost-effective treatment method for women with MUI and UUI.Copyright © 2022, The Author(s).

Eleje George, U., et al. (2019). "Palliative interventions for controlling vaginal bleeding in advanced cervical cancer." The Cochrane Database of Systematic Reviews 3: CD011000.
	Background: This is an updated version of the original Cochrane review published in Issue 5, 2015.Cervical cancer is the fourth most common cancer among women worldwide, with estimated 569,847 new diagnoses and 311,365 deaths per year. However, incidence and stage at diagnosis vary greatly between geographic areas and are largely dependent on the availability of a robust population screening programme. For example, in Nigeria, advanced-stage disease at presentation is common (86% to 89.3% of new cases), whereas in the UK, only 21.9% of women present with International Federation of Gynaecology and Obstetrics (FIGO) stage II+ disease. Women with advanced cancer of the cervix often need palliation for distressing symptoms, such as vaginal bleeding. Vaginal bleeding can be life threatening in advanced disease, with an incidence ranging from 0.7% to 100%. Bleeding is the immediate cause of death in 6% of women with cervical cancer and its management often poses a challenge.Thus, vaginal bleeding remains a common consequence of advanced cervical cancer. Currently, there is no systematic review that addresses palliative interventions for controlling vaginal bleeding caused by advanced cervical cancer. A systematic evaluation of the available palliative interventions is needed to inform decision-making.; Objectives: To evaluate the efficacy and safety of tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions compared with radiotherapy for palliative treatment of vaginal bleeding in women with advanced cervical cancer.; Search Methods: The search for the original review was run in 23 March 2015, and subsequent searches for this update were run 21 March 2018. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 3) in the Cochrane Library; MEDLINE via Ovid to March week 2, 2018; and Embase via Ovid to March week 12, 2018. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of review articles, and contacted experts in the field. We handsearched citation lists of relevant studies.; Selection Criteria: We searched for randomised and non-randomised comparative studies that evaluated the efficacy and safety of tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions compared with radiotherapy techniques for palliative treatment of vaginal bleeding in women with advanced cervical cancer (with or without metastasis), irrespective of publication status, year of publication or language in the review.; Data Collection and Analysis: Two review authors independently assessed whether potentially relevant studies met the inclusion criteria. We found no studies for inclusion and, therefore, we analysed no data.; Main Results: The search strategy identified 1522 unique references of which we excluded 1330 on the basis of title and abstract. We retrieved the remaining 22 articles in full, but none satisfied the inclusion criteria. We identified only observational data from single-arm studies of women treated with formalin-soaked packs, interventional radiology or radiotherapy techniques for palliative control of vaginal bleeding in women with cervical cancer.; Authors' Conclusions: Since the last version of this review we found no new studies. There is no evidence from controlled trials to support or refute the use of any of the proposed interventions compared with radiotherapy. Therefore, the choice of intervention will be based on local resources. Radiotherapy techniques for managing vaginal bleeding are not readily available in resource-poor settings, where advanced cases of cervical cancer are predominant. Thus, this systematic review identified the need for a randomised controlled trial assessing the benefits and risks of palliative treatments for vaginal bleeding in women with advanced cervical cancer.

Elena, P., et al. (2023). "Effectiveness of exercise treatment and manipulation in management of pelvic pain and quality of life in women with endometriosis: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Elers, J., et al. (2021). "TVT or TVT-O? - A systematic review and meta-analysis comparing efficacy, complications and re-operations." European Journal of Obstetrics and Gynecology and Reproductive Biology 258: 146-151.
	Objectives: To compare the efficacy, complications and re-operations after bottom-up tension-free vaginal tape (TVT) and inside-out tension-free vaginal tape - obturator (TVT-O) in the treatment of stress urinary incontinence (SUI) in adult women. Study design: A systematic literature search and review was performed limited to randomized controlled trials. We searched Medline, Embase, Cochrane Library, Cinahl, Guideline International network (GIN), Trip Database and NICE (UK). The certainty in the estimates of the included outcomes was rated using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) method. Result(s) and Conclusion(s): We included 22 randomized controlled trials. The overall certainty in the evidence was moderate across all outcomes. TVT and TVT-O significantly improved the incontinence regarding number of incontinence episodes, subjective patient reported effect and incontinence related quality of life, and there was no difference between TVT and TVT-O. Leg or groin pain was significantly less common 6 months after TVT than TVT-O with RR 0.27 (CI 95 % 0.11 - 0.66), 9 studies, n = 1312. In absolute numbers 83 patients more developed chronic leg or groin pain per 1000 operations with TVT-O compared to TVT. We found no statistically significant differences between chronic pelvic or lower abdominal pain 6 months after TVT and TVT-O. Bladder perforations were significantly more common after TVT with RR 4.53 (CI 95 % 2.32-8.86), 21 studies, n = 3308. In absolute numbers this meant 5 more bladder perforations after TVT per 1000 operations. No statistically significant differences were noted in de novo urgency, re-operations, infection, hematoma, pain during sexual intercourse or sexual function. Bottom-up TVT and inside-out TVT-O showed equal efficacy, but leg and groin pain were much more common with TVT-O. The authors would recommend TVT instead of TVT-O as first line operation in patients who need surgery for SUI.Copyright © 2020 Elsevier B.V.

Elia, R. and C. Ekaterina (2021). "Honey for the treatment of vulvovaginal candidiasis." PROSPERO International prospective register of systematic reviews.
	
Elisa, G., et al. (2023). "Systematic review of adjuvant radiotherapy on groin node metastases in patients treated surgically for vulvar cancer." PROSPERO International prospective register of systematic reviews.
	
Elizabeth, F., et al. (2021). "Effectiveness of different electrostimulation protocols compared to pelvic floor exercises in urinary incontinence symptoms: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Elkind-Hirsch Karen, E., et al. (2022). "Liraglutide 3 mg on weight, body composition, and hormonal and metabolic parameters in women with obesity and polycystic ovary syndrome: a randomized placebo-controlled-phase 3 study." Fertility and Sterility 118(2): 371-381.
	Objective: To study the efficacy and safety of the GLP-1 analog liraglutide 3 mg (LIRA 3 mg) vs. placebo (PL) for reduction of body weight (BW) and hyperandrogenism in women with obesity and polycystic ovary syndrome (PCOS).; Design: Randomized, double-blind, placebo-controlled trial.; Setting: Hospital-based outpatient endocrine and metabolic center.; Patient(s): Women diagnosed with PCOS (NIH criteria) were randomly assigned to LIRA 3 mg (n = 55) or PL (n = 27) once daily for 32 weeks with lifestyle intervention.; Intervention(s): Study visits at baseline and 32 weeks included BW and body composition by dual-energy x-ray absorptiometry. Oral glucose tolerance tests were done with sex steroids, free androgen index (FAI), and lipids measured in the fasting sample.; Main Outcome Measure(s): The primary end points were changes in BW and FAI. Safety was assessed in all patients who received at least one dose of the study drug.; Result(s): Change in BW from baseline to week 32 was -5.7% (±0.75) with LIRA 3 mg vs. -1.4% (±1.09) with PL. At week 32, more participants on LIRA 3 mg than on PL achieved at least 5% weight reductions (25 of 44 vs. 5 of 23). Free androgen index significantly reduced with LIRA 3 mg compared with the PL where the mean FAI slightly increased. Gastrointestinal events, which were mostly mild to moderate, were reported in 58.2% of the LIRA 3 mg-subjects and 18.5% of PL subjects.; Conclusion(s): LIRA 3 mg once daily appears superior to PL in reducing BW and androgenicity and improving cardiometabolic parameters in women with PCOS and obesity.; Clinical Trial Registration Number: NCT03480022. (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Eman, Y., et al. (2023). "A systematic review and meta-analysis to assess the effectiveness of vitamin D as an alternative to FDA-approved treatment and other therapies for managing vulvovaginal atrophy and sexual inactivity in postmenopausal women." PROSPERO International prospective register of systematic reviews.
	
Emmanuel, K., et al. (2023). "The Efficacy and Safety of Pembrolizumab and Dostarlimab in Advanced Endometrial Carcinoma: A Systematic Review." PROSPERO International prospective register of systematic reviews.
	
Enklaar Rosa, A., et al. (2023). "Manchester Procedure vs Sacrospinous Hysteropexy for Treatment of Uterine Descent: A Randomized Clinical Trial." JAMA 330(7): 626-635.
	Importance: In many countries, sacrospinous hysteropexy is the most commonly practiced uterus-preserving technique in women undergoing a first operation for pelvic organ prolapse. However, there are no direct comparisons of outcomes after sacrospinous hysteropexy vs an older technique, the Manchester procedure.; Objective: To compare success of sacrospinous hysteropexy vs the Manchester procedure for the surgical treatment of uterine descent.; Design, Setting, and Participants: Multicenter, noninferiority randomized clinical trial conducted in 26 hospitals in the Netherlands among 434 adult patients undergoing a first surgical treatment for uterine descent that did not protrude beyond the hymen.; Interventions: Participants were randomly assigned to undergo sacrospinous hysteropexy (n = 217) or Manchester procedure (n = 217).; Main Outcomes and Measures: The primary outcome was a composite outcome of success, defined as absence of pelvic organ prolapse beyond the hymen in any compartment evaluated by a standardized vaginal support quantification system, absence of bothersome bulge symptoms, and absence of prolapse retreatment (pessary or surgery) within 2 years after the operation. The predefined noninferiority margin was 9%. Secondary outcomes were anatomical and patient-reported outcomes, perioperative parameters, and surgery-related complications.; Results: Among 393 participants included in the as-randomized analysis (mean age, 61.7 years [SD, 9.1 years]), 151 of 196 (77.0%) in the sacrospinous hysteropexy group and 172 of 197 (87.3%) in the Manchester procedure group achieved the composite outcome of success. Sacrospinous hysteropexy did not meet the noninferiority criterion of -9% for the lower limit of the CI (risk difference, -10.3%; 95% CI, -17.8% to -2.8%; P = .63 for noninferiority). At 2-year follow-up, perioperative outcomes and patient-reported outcomes did not differ between the 2 groups.; Conclusions: Based on the composite outcome of surgical success 2 years after primary uterus-sparing pelvic organ prolapse surgery for uterine descent, these results support a finding that sacrospinous hysteropexy is inferior to the Manchester procedure.; Trial Registration: TrialRegister.nl Identifier: NTR 6978.

Enríquez-Sánchez Luis, B. (2024). "To Study the Effect of SC-FOS Prebiotics in Women With Polycystic Ovary Syndrome." ClinicalTrials.gov.
	No Results Available Dietary Supplement: Short Chain Fructooligosaccharides|Dietary Supplement: Placebo Group Score of Bristol Scale|Score Short Form Health Survey (SF-36) Female Not Applicable 40 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 030C-06/23 May 30, 2025

Ente Ospedaliero Ospedali, G. (2022). "Phase III trial on hormonal therapy versus standard chemotherapy for Estrogen/Progesterone Receptor positive low-grade serous Epithelial ovarian cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: LETRIX ‐ 2.5 MG COMPRESSE RIVESTITE CON FILM 30 COMPRESSE IN BLISTER AL/PVDC/PVC/PE/PVDC Product Name: Letrix Product Code: [Letrix] Pharmaceutical Form: Tablet INN or Proposed INN: LETROZOLO CAS Number: 112809‐51‐5 Current Sponsor code: IMP 1 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2500‐ Product Name: Carboplatino Product Code: [na] Pharmaceutical Form: Solution for infusion INN or Proposed INN: CARBOPLATINO CAS Number: 41575‐94‐4 Current Sponsor code: na Other descriptive name: Carboplatin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ Trade Name: Paclitaxel Product Name: Paclitaxel Product Code: [na] Pharmaceutical Form: Solution for infusion INN or Proposed INN: PACLITAXEL CAS Number: 33069‐62‐4 Current Sponsor code: na Other descriptive name: Paclitaxel Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6‐ CONDITION: Patients with a low‐grade serous epithelial carcinoma of the ovary (LGSCO) including cancer of fallopian tube and peritoneum, FIGO III‐IV stage and with ER+ and/or PgR+ after primary surgery are eligible. ; 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] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: The primary objective is to determine if letrozole is superior to standard chemotherapy in terms of progression‐free survival (PFS) in patients with advanced low‐grade serous epithelial ovarian carcinoma positive for estrogen and/or progesterone receptors. Secondary Objective: • to evaluate the response of tumor to letrozole compared with standard chemotherapy in terms of objective response rate (ORR);; • To test the predictive effect of ER, PgR on response to letrozole in terms of PFS and ORR;; • to evaluate the possible negative association between the effect of letrozole, in terms of PFS and ORR, and the proliferative index Ki67;; • to evaluate the impact of letrozole compared with the impact of standard chemotherapy on patients’ health related quality of life evaluated by MENQOL;; • to evaluate the impact of letrozole compared with standard chemotherapy on patients’ musculoskeletal pain evaluated by BPI‐SF;; • to describe the OS according to randomization arm.; • to evaluate the safety of letrozole compared with standard chemotherapy. Primary end point(s): The primary endpoint is PFS, defined for each patient as the time from the date of randomization to the date of local or regional relapse, distant metastasis, or death from any cause, whichever comes first. Timepoint(s) of evaluation of this end point: Tumor assessments should be performed by radiological assessment and CA‐125 every 6 months until PD. SECONDARY OUTCOME: Secondary end point(s): Objective Response Rate (ORR), defined as the percentage of patients with an objective response determined by a complete response (CR) or a partial response (PR) as determined by RECIST 1.1.; Clinical Benefit (CB), defined as the percentage of patients who will experience a CR or PR or stable disease (SD).; OS, defined for each patient as the time from the date of randomization to the date of death from any cause.; Health‐related QoL assessed by the Menopause Quality of Life questionnaire (MENQOL) questionnaire.; Musculoskeletal Pain assessed by BPI‐SF questionnaire. Timepoint(s) of evaluation of this end point: Tumor assessments should be performed by radiological assessment and CA‐125 every 6 months until PD.; Tumor assessments should be performed by radiological assessment and CA‐125 every 6 months until PD.; Tumor assessments should be performed by radiological ssessment and CA‐125 every 6 months until PD.; The evaluation will be performed at visit at 3 months and at disease progression (Both arms).; The evaluation will be performed at visit at 3 months and at disease progression (Both arms). INCLUSION CRITERIA: 1. Age = 18 years. 2. Newly diagnosed, low‐grade serous carcinoma of the ovary including cancer of fallopian tube and peritoneum (invasive micropapillary serous carcinoma or invasive grade 1 serous carcinoma). This is to be confirmed by a central pathology review performed at the Coordinating Centre. 3. Immunohistochemically determined positivity (= 10%) for PgR and/or ER expression. This is to be confirmed by centralized review. 4. Patients must have undergone an upfront surgery with maximal cytoreductive effort, with either optimal or suboptimal residual disease status. 5. Stage III‐IV according to 2018 FIGO classification. 6. Postmenopausal status (>12 consecutive months without menstruation) or patients who have undergone a bilateral salpingo‐oophorectomy. 7. Randomization must take place within 60 days of primary cytoreductive surgery. 8. Eastern Cooperative Oncology Group ‐ performance status (ECOG‐PS) 0‐1. 9. To be able to take ora

Erduran, B. and Y. Sözbir Şengül (2023). "Effects of intermittent kangaroo care on maternal attachment, postpartum depression of mothers with preterm infants." Journal of Reproductive and Infant Psychology 41(5): 556-565.
	Purpose: To reveal the effect of intermittent kangaroo care on maternal attachment, postpartum depression of mothers with preterm infants.; Methods: The study was conducted as a single centre randomised controlled study with sixty mothers whose newborns were hospitalised in the NICU due to prematurity. The data were collected by the questionnaire form, Edinburgh Postnatal Depression Scale (EPDS) and the Maternal Attachment Inventory (MAI). 'Intermittent kangaroo care' was applied for 30 minutes once a day for 10 days to the experimental group. Women were completed the EPDS and the MAI in postpartum 30-40th days.; Results: The median of the total score of EPDS in the experimental group was 7, and in the control group was 9 (p > 0.05). The median of the total score of MAI in the experimental group was 99, and in the control group was 97 (p <0.05) and it was determined that the effect size of the difference between the groups was medium (1-β: 0.65, Cohen's d: 0.532).; Conclusion: It was determined that mothers who received intermittent kangaroo care had higher scores that can be interpreted as higher maternal attachment than others and the postpartum depression scores did not differ between experimental and control group.

Erel Cemal, T. (2023). "Elastographic Improvement of Vaginal Atrophy Treated by Erbium Yag Laser." ClinicalTrials.gov.
	No Results Available Device: Fotona Dynamis Er:YAG Laser System|Device: Sham Efficacy: Rate of improvement in vaginal atrophy|Efficacy:Rate of improvement in sexual function|Efficacy: Rate of improvement in pain|Safety:Incidence and severity of device related Adverse Events Female Not Applicable 40 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 689852 December 2023

Erickson Britt, K. (2022). "Testing the Addition of Trastuzumab or Trastuzumab/Pertuzumab to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma." ClinicalTrials.gov.
	PRIMARY OBJECTIVES: I. To evaluate the efficacy of trastuzumab and hyaluronidase‐oysk (HERCEPTIN HYLECTA) and pertuzumab, trastuzumab, and hyaluronidase‐zzxf (PHESGO) in combination with paclitaxel/carboplatin in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. (Phase II) II. To evaluate the efficacy of trastuzumab and hyaluronidase‐oysk (HERCEPTIN HYLECTA) and pertuzumab, trastuzumab, and hyaluronidase‐zzxf (PHESGO) in combination with paclitaxel/carboplatin in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. (Phase III) SECONDARY OBJECTIVES: I. To evaluate the overall response rate (ORR) in patients with measurable disease. II. To evaluate the duration of objective response in patients with measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. III. To determine the nature, frequency and degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 for each treatment arm. IV. To compare quality of life (QOL), as measured by Functional Assessment of Cancer Therapy ‐ Endometrial Trial Outcome Index (FACT‐En‐TOI), in the experimental versus control arms. V. To compare patient‐reported treatment‐associated symptoms (diarrhea and rash) as measured with the Patient Reported Outcomes (PRO) ‐ CTCAE, patient‐reported fatigue as measured with the Patient Reported Outcomes Measurement Information System (PROMIS)‐Fatigue short form, and other concerning side effects of treatment as measured by the item 'bothered by side effect', in the FACT‐En TOI, respectively, in the experimental and control arms. VI. To assess the correlation of HER2 immunohistochemistry (IHC) expression and in situ hybridization (ISH) amplification with clinical outcome and response to HER2 targeted therapies. EXPLORATORY OBJECTIVE: I. To explore time to sustained deterioration in quality of life, as measured by a drop in the FACT‐En‐TOI by 6 or more points lasting for more than one PRO time point, in the experimental and control arms. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30‐60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease (SD) or partial response (PR) who still have measurable disease after completion of cycle 6 may receive 4 additional cycles of this treatment at the discretion of the treating physician. ARM II: Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30‐60 minutes, and trastuzumab/hyaluronidase‐oysk subcutaneously (SC) over 2‐5 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease after completion of cycle 6 may receive 4 additional cycles of this treatment at the discretion of the treating physician. MAINTENANCE: Patients receive trastuzumab/hyaluronidase‐oysk SC over 2‐5 minutes on day 1 of each cycle. Cycles repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients with SD or PR may continue maintenance therapy for up to 3 years from the start of treatment. ARM III: Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30‐60 minutes, and pertuzumab/trastuzumab/hyaluronidase‐zzxf SC over 5‐8 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease after completion of cycle 6 may receive 4 additional cycles of this treatment at the discretion of the treating physician. MAINTENANCE: Patients receive pertuzumab/trastuzumab/ hyaluronidase‐zzxf SC over 5 minutes on day 1. Cycles repeat every 3 weeks for up to 1 year in absence of disease progression or unacceptable toxicity. Patien with SD or PR may continue maintenance for up to 3 years from the start of treatment. Patients undergo echocardiogram (ECHO) or multigated acquisition scan (MUGA) scan at end of treatment and every 6 months for 2 years. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Eryilmaz, S. (2021). "The Effect of Acupressure and Massage on Pain in Primary Dysmenorrhea." ClinicalTrials.gov.
	Purpose of the Research: The aim of the study is to determine the effect of acupressure and massage on pain severity, menstrual symptoms and quality of life in students with primary dysmenorrhea. Research Hypotheses: H1: Students who have been treated with acupressure and massage in dysmenorrhea have lower pain levels than the control group. H2: Pain levels of students who have been treated with acupressure and massage in dysmenorrhea are lower than those who have only been massaged. H3: The menstrual symptom intensity of students undergoing acupressure and massage in dysmenorrhea is lower than in the control group. H4: In menstrual symptom intensity of students who have been treated with acupressure and massage in dysmenorrhea is lower than those who have been massaged only. H5: The quality of life of students undergoing acupressure and massage in dysmenorrhea is higher than the control group. H6: The quality of life of students who have been treated with acupressure and massage in dysmenorrhea is higher than those who have been massaged only. Materıal Method Type of the Study The research was planned as a randomized controlled trial. Place and Time of the Study The research will be carried out between September 2020 and June 2021 in the Faculty of Education randomly selected among the faculties located on the campus of Kırşehir Ahi Evran University. There are 7 departments in the Faculty of Education: computer and instructional technology education, educational sciences, mathematics and science education, turkish and social sciences education, basic education, special education, foreign language education. As of 2019‐2020 academic year, the total number of female students in the faculty is 1574. There is no course in the curriculum of the departments of the faculty that includes dismenor, including health information lessons. The Universe and the Sample of the Research The universe of the research will be female students studying at the Education Faculty of Kırşehir Ahi Evran University (N = 1574). The sample of the research will be students who study at Kırşehir Ahi Evran University Faculty of Education, experience dysmenorrhea and have criteria for recruitment. For the power analysis of the study, based on the fact that Uçar et al. (2018) had a mean score of 7.44 (Standard deviation 2.0) in university students experiencing primary dysmenorrhea, assuming that the intensity of pain would be 6.6 points in 95% confidence interval, with 80% strength. the size was determined to be at least 89 for each group. (89 acupressure + massage group, 89 massage group, 89 control groups). The number of students to be taken from the departments in the faculty will be determined by proportioning the weights of the departments in the universe. For this, the number of students in each department will be requested from the faculty. Then, the Random Integer Generator method will be used to separate the experimental and control groups. For this, 267 students will be listed, and students from 3 columns in random.org will be divided into groups according to their numbers. In the study, dysmenorrhea was defined as the pain during menstrual bleeding. The criteria included in the scope of pain in dysmenorrhea are pain in the waist, groin or abdomen that started in the first 6‐12 hours and lasted for 8‐72 hours in the last 12 months (Ambresin et al., 2012). Data Collection Tools Personal Information Form (Appendix‐1) in collecting data, Visual Analogue Scale (VAS) (Appendix‐2), Daily Menstrual Symptom Evaluation Scale (Appendix‐3), Quality of Life Scale Short Form SF‐12 (Appendix‐4) in the evaluation of dysmenorrhea pain It will be used. Personal Information Form (Annex‐1) The questions in the form were prepared by the researcher in line with the literature information. In this form, students; The questions questioning the characteristics (age, department, number of class), and the features associated with the menstrual cycle (age of menarche, bleeding time, pain duration, etc.) were included. Visual Analog Scale V S) (Annex‐2) VAS is used to measure perceived pain. Painlessness on one end and 10 cm on the other for the most severe pain. On a (100 mm.) Ruler, the patient expresses his pain by drawing a line, marking or pointing. The length of the distance from where there is no pain to the point marked by the patient is measured in centimeters, and the numerical value found indicates the pain intensity of the patient. Daily Menstrual Symptom Evaluation Scale (GMSSS) (Annex‐3) GMSSS was developed by Jenni W. Taylor (1979) to evaluate the symptoms and intensity of symptoms that occurred during menstruation. The Turkish validity and reliability of the scale was performed by Oskay et al. The intensity of each symptom is scored between 0 and 5 on a scale of 17 symptoms. Increased score indicates that the intensity of symptoms increases. In the study of Oskay et al. (2008), Cronbach's alpha value of the scale was found to be 0.88. Quality of Life Scale Short Form SF‐12 (Annex‐4) A shorter form SF‐12 Short Health Scale was created by taking 12 different items from 8 different subtitles of SF‐36. SF‐12 has a physical (SF12‐PCS) and mental (SF12‐MCS) status assessment scale with regression analysis applied in the general population. SF‐12 was developed and version 2.0 (SF‐12v2) was created. Words are shortened and simplified, questions and answers are made easier to read to prevent missing answers, 6‐step answer categories are reduced to 5 by reducing complexity, and answers are simplified by printing in a horizontal (left to right) form. SF‐12 is an easy‐to‐apply survey, obtained by shortening and simplifying SF‐36, with proven reliability and validity. It is used in the evaluation of physical and mental health, which are two main components of general health status. The T‐score used when calculating scoring in SF‐36 is not used in SF‐12. Instead, it is not possible to calculate if there is missing data in SF‐12, which has a different scoring rule. Research Variables Independent Variables: Acupressure and massage treatments applied to students experiencing dysmenorrhoea Dependent Variables: Pain severity, menstrual symptoms, quality of life levels of students experiencing dysmenorrhea

Escriva, G. (2023). "The CRESCENDO Program (inCRease Physical Exercise and Sport to Combat ENDOmetriosis)." ClinicalTrials.gov.
	No Results Available Behavioral: Physical activity|Behavioral: Physical activity and education Change in Perceived pain and fatigue|Change in Perceived Quality of life; Endometriosis Health Profile 30|Change in Physical activity (PA) ; International Physical Activity Questionnaire & International Sedentary Assessment Tool|Change in self image|Change in perceived social support|Change in stereotype|Change in motivation All Not Applicable 200 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Outcomes Assessor)|Primary Purpose: Other ANR-22-CE36-0002-01 December 2024

Escriva-Boulley, G., et al. (2023). "Effects of a physical activity and endometriosis-based education program delivered by videoconference on endometriosis symptoms: the CRESCENDO program (inCRease physical Exercise and Sport to Combat ENDOmetriosis) protocol study." Trials 24(1): 759.
	Background: Endometriosis is a chronic disease characterized by growth of endometrial tissue outside the uterine cavity which could affect 200 million women (The term "woman" is used for convenience. Individuals gendered as man or as nonbinary can also suffer from this disease) worldwide. One of the most common symptoms of endometriosis is pelvic chronic pain associated with fatigue. This pain can cause psychological distress and interpersonal difficulties. As for several chronic diseases, adapted physical activity could help to manage the physical and psychological symptoms. The present study will investigate the effects of a videoconference-based adapted physical activity combined with endometriosis-based education program on quality of life, pain, fatigue, and other psychological symptoms and on physical activity.; Methods: This multicentric randomized-controlled trial will propose to 200 patients with endometriosis to be part of a trial which includes a 6-month program with 45 min to more than 120 min a week of adapted physical activity and/or 12 sessions of endometriosis-based education program. Effects of the program will be compared to a control group in which patients will be placed on a waiting list. All participants will be followed up 3 and 6 months after the intervention. None of the participants will be blind to the allocated trial arm. The primary outcome measure will be quality of life. Secondary outcomes will include endometriosis-related perceived pain, fatigue, physical activity, and also self-image, stereotypes, motivational variables, perceived support, kinesiophobia, basic psychological need related to physical activity, and physical activity barriers. General linear models and multilevel models will be performed. Predictor, moderator, and mediator variables will be investigated.; Discussion: This study is one of the first trials to test the effects of a combined adapted physical activity and education program for improving endometriosis symptoms and physical activity. The results will help to improve care for patients with endometriosis.; Trial Registration: ClinicalTrials.gov, NCT05831735 . Date of registration: April 25, 2023. (© 2023. The Author(s).)

Eskander Ramez, N., et al. (2023). "Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer." The New England Journal of Medicine 388(23): 2159-2170.
	Background: Standard first-line chemotherapy for endometrial cancer is paclitaxel plus carboplatin. The benefit of adding pembrolizumab to chemotherapy remains unclear.; Methods: In this double-blind, placebo-controlled, randomized, phase 3 trial, we assigned 816 patients with measurable disease (stage III or IVA) or stage IVB or recurrent endometrial cancer in a 1:1 ratio to receive pembrolizumab or placebo along with combination therapy with paclitaxel plus carboplatin. The administration of pembrolizumab or placebo was planned in 6 cycles every 3 weeks, followed by up to 14 maintenance cycles every 6 weeks. The patients were stratified into two cohorts according to whether they had mismatch repair-deficient (dMMR) or mismatch repair-proficient (pMMR) disease. Previous adjuvant chemotherapy was permitted if the treatment-free interval was at least 12 months. The primary outcome was progression-free survival in the two cohorts. Interim analyses were scheduled to be triggered after the occurrence of at least 84 events of death or progression in the dMMR cohort and at least 196 events in the pMMR cohort.; Results: In the 12-month analysis, Kaplan-Meier estimates of progression-free survival in the dMMR cohort were 74% in the pembrolizumab group and 38% in the placebo group (hazard ratio for progression or death, 0.30; 95% confidence interval [CI], 0.19 to 0.48; P<0.001), a 70% difference in relative risk. In the pMMR cohort, median progression-free survival was 13.1 months with pembrolizumab and 8.7 months with placebo (hazard ratio, 0.54; 95% CI, 0.41 to 0.71; P<0.001). Adverse events were as expected for pembrolizumab and combination chemotherapy.; Conclusions: In patients with advanced or recurrent endometrial cancer, the addition of pembrolizumab to standard chemotherapy resulted in significantly longer progression-free survival than with chemotherapy alone. (Funded by the National Cancer Institute and others; NRG-GY018 ClinicalTrials.gov number, NCT03914612.). (Copyright © 2023 Massachusetts Medical Society.)

Eskisehir Osmangazi, U. (2023). "Abdominal-Kegel Exercise and the Effect of Telemedicine in Stress Urinary Incontinence." ClinicalTrials.gov.
	No Results Available Other: Group administered to individual telemedicine Telemedicine success|Quality of life score Female Not Applicable 100 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment EskisehirOU/03.03.2022-20 July 30, 2024

Espiño-Albela, A., et al. (2022). "Effects of Pelvic-Floor Muscle Training in Patients with Pelvic Organ Prolapse Approached with Surgery vs. Conservative Treatment: A Systematic Review." Journal of Personalized Medicine 12(5).
	The aim of this systematic review was to explore the effectiveness of pelvic-floor muscle training (PFMT) in the treatment of women with pelvic organ prolapse (POP) who had undergone either surgery or only conservative treatment, based on a selection of randomized clinical trials (RCT). The search was carried out in PubMed, Cochrane, Scopus, CINAHL, and PEDro databases between April 2021 and October 2021 using the following MeSH terms or keywords: "pelvic organ prolapse", "POP", "pelvic floor muscle training", "pelvic floor muscle exercise", "kegel exercise", and "surgery". The methodological quality of the studies was assessed using the PEDro scale. Eighteen RCTs were included in this review. The findings showed improvements in symptoms associated with POP, in pelvic-floor function, and in quality of life in women who performed a PFMT protocol. However, PFMT did not produce significant changes in sexual function, and the results of the change in POP stage were inconclusive. When viewing PFMT as a complementary treatment to surgery, no significant improvements were observed in any of the analyzed variables. In conclusion, a PFMT program is an effective way to improve the pelvic, urinary, and intestinal symptoms associated with POP; function of the pelvic floor; and quality of life. PFMT as an adjunct to surgery does not seem to provide a greater benefit than surgical treatment alone. RCTs of higher methodological quality, with a larger sample size and a longer follow-up, are needed to confirm the results.

Espinós Juan, J., et al. (2020). "The Effect of Lifestyle Intervention on Pregnancy and Birth Outcomes on Obese Infertile Women: A Systematic Review and Meta-Analysis." International Journal of Fertility & Sterility 14(1): 1-9.
	Obesity has been associated with negative effects on natural fertility and poor prognosis when assisted reproductive technologies (ART) are performed. Patients attending for fertility treatments are often advised to optimize their weights to improve the outcomes. There is lack of enough information on how weight-loss would be effective for improving fertility in women who are overweight or obese. We conducted a systematic review to evaluate whether weight-loss achieved by lifestyle program improves natural or assisted reproduction in obese infertile women. We searched CENTRAL, MEDLINE, and EMBASE up to March 2018. Two reviews were selected as randomised trials assessing a lifestyle intervention in women with obesity before receiving treatments for infertility and appraised their risk of bias. We extracted data on pregnancy, birth, and miscarriage rates as the primary outcomes and pooled effect estimates using a random effects model. The primary outcome was the live birth rate. We reported summary measures as the relative risk (RR), 95% confidence interval (CI), and percentage of heterogeneity (I 2 ). We included eight randomised trials with 1175 women. Lifestyle programmes, improved pregnancy rates (RR: 1.43, CI: 95% 1.02 to 2.01; I 2 =60%; 8 RCTs; N=1098) but had no impact on live births (RR: 1.39, CI: 95% 0.90 to 2.14; I 2 =64%; 7RCTs; N=1034). Our findings suggest that women participating in lifestyle interventions had an increased risk of miscarriage (RR: 1.50, CI: 95% 1.04 to 2.16; I 2 =0; 6RCTs; N=543). We rated the quality of evidence for these outcomes as the moderate-to-low. Lifestyle interventions slightly increased the pregnancy rate, while it would be uncertain whether it can improve the live birth. Lifestyle interventions can increase the risk of miscarriage. More research is needed to further explore lifestyle interventions on reproductive outcomes in obese infertile women.; Competing Interests: The authors declare no conflicts of interest. (Copyright© by Royan Institute. All rights reserved.)

Estevao, C., et al. (2021). "SHAPER-PND trial: clinical effectiveness protocol of a community singing intervention for postnatal depression." BMJ Open 11(11): e052133.
	Introduction: Postnatal depression (PND) affects approximately 13% of new mothers. Community-based activities are sought after by many mothers, especially mothers that prefer not to access pharmacological or psychological interventions. Singing has shown positive effects in maternal mood and mother-child bonding. The Scaling-Up Health-Arts Programmes: Implementation and Effectiveness Research-Postnatal Depression study will analyse the clinical and implementation effectiveness of 10-week singing sessions for PND in new mothers. This protocol paper will focus on the clinical effectiveness of this trial.; Methods and Analysis: A total of 400 mothers with PND (with a score of at least 10 on the Edinburgh Postnatal Depression Scale) and their babies will be recruited for this hybrid type II randomised controlled trial. The intervention group will attend 10 weekly singing sessions held at community venues or online, facilitated by the arts organisation, Breathe Arts Health Research (Breathe). A control group will be encouraged to attend non-singing sessions in the community or online for 10 weeks. A package of assessments will be collected from participants for clinical, mechanistic and implementation outcomes, at different stages of the trial. Clinical assessments will include questionnaires and interviews for demographics, mental health and social measures, together with biological samples for measurement of stress markers; the study visits are at baseline, week 6 (mid-trial) and week 10 (end of trial), with follow ups at weeks 20 and 36. Multiple imputation will be used to deal with possible missing data and multivariable models will be fitted to assess differences between groups in the outcomes of the study.; Ethics and Dissemination: Ethical approval has been granted by the London-West London and GTAC Research Ethics Committee, REC reference: 20/PR/0813.; Trial Registration Number: NCT04834622; Pre-results.; Competing Interests: Competing interests: NS is the director of the London Safety and Training Solutions, which offers training in patient safety, implementation solutions and human factors to healthcare organisations. DF is a non-executive board director for Breathe Arts Health Research but she receives no financial compensation for her involvement. TS received funding for training cancer multidisciplinary teams in the assessment and quality improvement methods in the United Kingdom. TS serves as a consultant to F. Hoffmann-La Roche Diagnostics providing advisory research services in relation to innovations for cancer multidisciplinary teams and their care planning meetings in the United States of America. CP has received research and consultation funding from Boehringer Ingelheim and Johnson & Johnson for research on depression and inflammation, and by a Wellcome Trust strategy award to the Neuroimmunology of Mood Disorders and Alzheimer’s Disease (NIMA) Consortium (104025), which is also funded by Janssen, GlaxoSmithKline, Lundbeck and Pfizer; the work presented in this paper is unrelated to this funding. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Evans, R., et al. (2021). "Safety, tolerability, and efficacy of LiRIS 400 mg in women with interstitial cystitis/bladder pain syndrome with or without Hunner lesions." Neurourology and Urodynamics 40(7): 1730‐1739.
	Aims: Two phase 2 studies were conducted to assess the efficacy and safety of lidocaine‐releasing intravesical system (LiRIS) in patients with interstitial cystitis/bladder pain syndrome (IC/BPS) with (Study 001; NCT02395042) or without, (Study 002; NCT02411110) Hunner lesions (HL). Methods: Both were multicenter, randomized, double‐blind, placebo‐controlled, and enrolled women aged ≥18 years. In Study 001, patients were randomized 2:1:1 to LiRIS 400 mg/LiRIS 400 mg, placebo/LiRIS 400 mg, or placebo/placebo for a continuous 28 (2 × 14)‐day period. In Study 002, patients were randomized 1:1 to LiRIS 400 mg or placebo for a continuous (single treatment) 14‐day period. Results: In total, 59 and 131 patients received treatment in Studies 001 and 002, respectively. There was no statistically significant difference in the primary endpoint, the change from baseline to Week 4 of follow‐up post‐removal in mean daily average bladder numeric rating scale (NRS) pain score in either study (Study 001: placebo/placebo, −1.6; LiRIS/LiRIS, −2.7, p = 0.142; placebo/LiRIS, −2.5, p = 0.319; Study 002: LiRIS −1.2; placebo, −1.5, p = 0.505). There was no statistically significant difference between groups in daily worst NRS pain score, number of micturitions/day or urgency episodes/day. There was no clear trend for reduction in number of HL for LiRIS vs placebo. The frequency of treatment‐emergent adverse events was similar between treatment groups in both studies; most were mild or moderate intensity. Conclusion: These studies did not demonstrate a treatment effect of LiRIS 400 mg compared with placebo, either in patients with IC/BPS with HL, or in those without HL.

Evans, S. (2023). "Randomized E-Hypnotherapy for Chronic Pelvic Pain Syndrome Trial (REST)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: The study intervention is e‐Hypnotherapy: participants randomised to e‐Hypnotherapy will first receive one session of Chronic Pelvic Pain Syndrome (CPPS) and hypnosis education. Education will consist of information regarding pathophysiology of the pain process, specifically chronic pelvic pain, along with the impact that complimentary therapies such as hypnotherapy can have on pain. Education will be delivered via the website and will consist of short videos, animations and informative text sections to read. Following week one education, participants will need to listen to e‐Hypnotherapy recordings at least once a week for seven weeks. The group will also be instructed to continue listening to recordings from the weeks prior whilst progressing. Each weekly recording will go for approximately one hour, with the total weekly time commitment being no more than three hours. The active control is relaxation: participants randomised to relaxation will first receive one session of Chronic Pelvic Pain Syndrome (CPPS) similar to the hypnosis. Following week one education, participants will need to listen to relaxation recordings at least once a week for seven weeks. The group will also be instructed to continue listening to recordings from the weeks prior whilst progressing. Each weekly recording will go for approximately one hour, with the total weekly time commitment being no more than three hours. CONDITION: Anaesthesiology ‐ Pain management Chronic pelvic pain; ; Chronic pelvic pain Oral and Gastrointestinal ‐ Crohn's disease Oral and Gastrointestinal ‐ Inflammatory bowel disease Renal and Urogenital ‐ Other renal and urogenital disorders Renal and Urogenital ‐ Pelvic inflammatory disease Reproductive Health and Childbirth ‐ Menstruation and menopause PRIMARY OUTCOME: The primary outcome measure will be pain severity at post‐treatment (8 weeks) measured by the Brief Pain Inventory (BPI), which has good validity and reliability[8 weeks (primary outcome), 6 months and 12 months post‐intervention] INCLUSION CRITERIA: ‐ Patients diagnosed with CPPS with persistent pain for at least 6 months, supported by a letter from treating physician or other evidence confirming the above. ‐ At least 18 years of age. ‐ Capacity to provide informed consent. ‐ English speaking, or sufficient level of English to understand the trial intervention, answer relevant questionnaires and participate in a group context. ‐ Access to internet. ‐ Residing in Australia. SECONDARY OUTCOME: Acceptability of e‐Hypnotherapy and Relaxation: will be measured with a treatment satisfaction scale at 8‐weeks[8 weeks post‐intervention] Fatigue will be measured by the Fatigue Symptom Inventory (FSI)[8 weeks, 6 months and 12 months post‐intervention] Health utilisation and cost data will be collected via a patient health service utilisation and employment questionnaire administered at all time‐points.[8 weeks, 6 months and 12 months post‐intervention] Pain catastrophizing will be measured with the Pain Catastrophizing Scale (PCS)[8 weeks, 6 months and 12 months post‐intervention] Psychological symptoms will be measured by the Depression Anxiety Stress Scale (DASS‐21)[8 weeks, 6 months and 12 months post‐intervention] Quality of Life (QOL) will be measured with the EQ5D5L[8 weeks, 6 months and 12 months post‐intervention] Safety of e‐Hypnotherapy and Relaxation: will be established with weekly check‐ins by the trial manager to understand whether any adverse events (e.g., increased anxiety) have occurred.[Weekly throughout 8‐week intervention] Self‐efficacy will be measured with the Pain Self‐Efficacy Questionnaire (PSEQ).[8 weeks, 6 months and 12 months post‐intervention] Sleep quality will be measured with the Jenkins Sleep Scale[8 weeks, 6 months and 12 months post‐intervention] Suggestibility in e‐Hypnotherapy participants will be assessed using the Short Suggestibility Scale (SSS) and include in our sensitivity analyses.[Weekly throughout 8‐week intervention] The secondary out ome measures include: Pain Interference as assessed with the Brief Pain Inventory (BPI) [8 weeks, 6 months and 12 months post‐intervention]

Evans, S., et al. (2019). "Psychological and mind-body interventions for endometriosis: A systematic review." Journal of Psychosomatic Research 124: 109756.
	Endometriosis is a common gynecological condition associated with debilitaing pain and poor mental health. This review examines the evidence for psychological and mind-body (PMB) interventions to improve endometriosis pain, psychological distress, sleep and fatigue. Electronic databases searched included PsychINFO, MEDLINE, CINAHL, EMBASE, Cochrane Library, Scopus, and PubMed. Inclusion criteria were women with endometriosis, and interventions that used psychological or mind-body interventions; there were no exclusion criteria regarding study design. Studies were identified and coded using standard criteria, and risk of bias was assessed with established tools relevant to the study design. A total of 12 publications relating to 9 separate studies were identified:- 3 randomized controlled trials, 1 controlled trial, 2 single-arm studies, 1 retrospective cohort study, and 2 case series. Interventions included yoga, mindfulness, relaxation training, cognitive behavioural therapy combined with physical therapy, Chinese medicine combined with psychotherapy, and biofeedback. Results indicate that no studies have yet used gold-standard methodology and, thus, definitive conclusions cannot be offered about PMB efficacy. However, the results of these pilot studies suggest that PMB interventions show promise in alleviating pain, anxiety, depression, stress and fatigue in women with endometriosis, and future well-designed RCTs including active control groups are warranted. (Copyright © 2019 Elsevier Inc. All rights reserved.)

Evans-Hoeker, E., et al. (2022). "Dietary and/or physical activity interventions in women with overweight or obesity prior to fertility treatment: protocol for a systematic review and individual participant data meta-analysis." BMJ Open 12(11): 065206.
	Introduction Dietary and/or physical activity interventions are often recommended for women with overweight or obesity as the first step prior to fertility treatment. However, randomised controlled trials (RCTs) so far have shown inconsistent results. Therefore, we propose this individual participant data meta-analysis (IPDMA) to evaluate the effectiveness and safety of dietary and/or physical activity interventions in women with infertility and overweight or obesity on reproductive, maternal and perinatal outcomes and to explore if there are subgroup(s) of women who benefit from each specific intervention or their combination (treatment-covariate interactions). Methods and analysis We will include RCTs with dietary and/or physical activity interventions as core interventions prior to fertility treatment in women with infertility and overweight or obesity. The primary outcome will be live birth. We will search MEDLINE, Embase, Cochrane Central Register of Controlled Trials and trial registries to identify eligible studies. We will approach authors of eligible trials to contribute individual participant data (IPD). We will perform risk of bias assessments according to the Risk of Bias 2 tool and a random-effects IPDMA. We will then explore treatment-covariate interactions for important participant-level characteristics. Ethics and dissemination Formal ethical approval for the project (Venus-IPD) was exempted by the medical ethics committee of the University Medical Center Groningen (METc code: 2021/563, date: 17 November 2021). Data transfer agreement will be obtained from each participating institute/hospital. Outcomes will be disseminated internationally through the collaborative group, conference presentations and peer-reviewed publication. PROSPERO registration number CRD42021266201.Copyright © 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.

Evripidis, T., et al. (2022). "Perineal procedures for full thickness rectal prolapse in adults." PROSPERO International prospective register of systematic reviews.
	
Ewelina, R., et al. (2023). "Effect of fertility-sparing treatments for heavy menstrual bleeding due to uterine fibroids: a systematic review, pairwise and network meta-analysis of aggregate data." PROSPERO International prospective register of systematic reviews.
	
Ewies, A., et al. (2021). "Folic acid supplementation in postmenopausal women with hot flushes: phase III randomised double-blind placebo-controlled trial." BJOG 128(12): 2024‐2033.
	OBJECTIVE: To assess whether folic acid supplementation ameliorates hot flushes. DESIGN: Double‐blind, placebo‐controlled randomised trial. SETTING: Nine hospitals in England. POPULATION: Postmenopausal women experiencing ≥50 hot flushes weekly. METHODS: Women (n = 164) were randomly assigned in a 1:1 ratio to receive folic acid 5 mg tablet or placebo daily for 12 weeks. Participants recorded frequency and severity of hot flushes in a Sloan Diary daily and completed Greene Climacteric and Utian Quality of Life (UQoL) Scales at 4‐week intervals. MAIN OUTCOME MEASURES: The change in daily Hot Flush Score at week 12 from randomisation based on Sloan Diary Composite Score B calculation. RESULTS: Data of 143 (87%) women were available for the primary outcome. The mean change (SD) in Hot Flush Score at week 12 was ‐6.98 (10.30) and ‐4.57 (9.46) for folic acid and placebo group, respectively. The difference between groups in the mean change was ‐2.41 (95% CI ‐5.68 to 0.87) (P = 0.149) and in the adjusted mean change ‐2.61 (95% CI ‐5.72 to 0.49) (P = 0.098). Analysis of secondary outcomes indicated an increased benefit in the folic acid group regarding changes in total and emotional UQoL scores at week 8 when compared with placebo. The difference in the mean change from baseline was 5.22 (95% CI 1.16‐9.28) and 1.88 (95% CI 0.23‐3.52) for total and emotional score, respectively. CONCLUSIONS: The study was not able to demonstrate that folic acid had a statistically significant greater benefit in reducing Hot Flush Score over 12 weeks in postmenopausal women when compared with placebo. TWEETABLE ABSTRACT: Folic acid may ameliorate hot flushes in postmenopausal women but confirmation is required from a larger study.

Facchinetti, F., et al. (2019). "Short-term effects of metformin and myo-inositol in women with polycystic ovarian syndrome (PCOS): a meta-analysis of randomized clinical trials." Gynecological Endocrinology 35(3): 198-206.
	Metformin (MET), the most commonly used insulin sensitizer, is the reference off-label drug for the treatment of polycystic ovary syndrome (PCOS), worldwide. However, its use may be limited mainly by gastrointestinal adverse effects. Myo-inositol (MI), a well-recognized food supplement, also represents an evidence-based treatment for PCOS women, popular in many countries. Our aim is to provide a systematic review of the literature and a meta-analysis which compares these two treatments, for their short-term efficacy and safety in PCOS patients. Systematic review and meta-analysis of randomized clinical trials (RCTs). RCTs were identified from 1994 through 2017 using MEDLINE, Cochrane Library, PubMed, and ResearchGate. Included studies were limited to those one directly comparing MET to MI on several hormones changes. Standardized mean difference (SMD) or risk ratios (RRs) with 95% CIs were calculated. Changes in fasting insulin was the main outcome of measure. Six trials with a total of 355 patients were included. At the end of treatment, no difference between MET and MI was found on fasting insulin (SMD=0.08 µU/ml, 95% CI: -0.31-0.46, p=.697), HOMA index (SMD =0.17, 95% CI: -0.53-0.88, p=.635), testosterone (SMD= -0.01, 95% CI: -0.24-0.21, p=.922), SHBG levels (SMD= -0.50 nmol/l, 95% CI: -1.39-0.38, p=.263) and body mass index (BMI) (SMD= -0.22, 95% CI: -0.60-0.16, p=.265). There was strong evidence of an increased risk of adverse events among women receiving MET compared to those receiving MI (RR =5.17, 95% CI: 2.91-9.17, p<.001). No differences were found in the effect of MET and MI on short-term hormone changes. The better tolerability of MI makes it more acceptable for the recovery of androgenic and metabolic profile in PCOS women.

Faisal, A., et al. (2022). "The efficacy of fish oil supplementation to treat primary dysmenorrhea: a systematic review and meta-analysis study." PROSPERO International prospective register of systematic reviews.
	
Falconer, L., et al. (2022). "What is the evidence of effectiveness of non-pharmaceutical, non-surgical, biopsychosocial interventions for body image and pain management in individuals with endometriosis? A systematic review." Journal of Endometriosis and Pelvic Pain Disorders 14(4): 206-216.
	Aim: To identify and review the success of non-pharmaceutical, non-surgical biopsychosocial interventions in individuals with endometriosis, in managing pain and improving body image. Method(s): Cochrane, EBSCO, IBSS, NICE, Open Grey, OVID, Proquest, Scopus and Science Direct were searched in April 2021, using inclusion and exclusion criteria. Data Collection and Analysis: Five randomised control trials, and one controlled clinical trial resulted from the search. Study quality was assessed using the Effective Public Health Practice Project (EPHPP) Quality Assessment Tool. Studies were synthesised by intervention type, into physical only, and physical and psychological. Result(s): Across the six papers, 323 participants were recruited, through medical records or self-referral, and treatments largely administered by specialist practitioners. From the EPHPP quality assessment,2 weak quality papers, and four moderate quality papers found improvements to pain, with large effect sizes in four papers. No studies used established body image measures to examine intervention effects on body image, and all lacked health psychology theoretical basis. There were common issues in selection bias, confounders and blinding. Conclusion(s): Without gold-standard methodology, evidence of effectiveness cannot be concluded. However, there is promising rationale if these issues are addressed.Copyright © The Author(s) 2022.

Fan, Y., et al. (2023). "Brief and long co-incubation of sperm and oocytes for in vitro fertilization: a meta-analysis of randomized controlled trials." BMC Pregnancy and Childbirth 23(1): 200.
	Background: There is still no consensus on the optimal time of oocyte-sperm co-incubation during in vitro fertilization and embryo transfer (IVF-ET). The aim of this meta-analysis was to compare the effects of brief (1-6 h) and long (16-24 h) gametes co-incubation time on IVF outcomes.; Methods: The study protocol was registered online through PROSPERO (CRD42022337503) and PRISMA guidelines were followed in the present study. The following databases were searched from inception to May 2022 for randomized controlled trials (RCTs): PubMed, Embase, Cochrane library, Web of Science, using search terms related to IVF, gametes, time of co-incubation and reproductive outcome measure. Studies comparing outcomes of brief co-incubation to that of long co-incubation during IVF, and reporting primary outcome (live birth rate), secondary outcomes (clinical pregnancy rate; ongoing pregnancy rate; miscarriage rate; normal fertilization rate; polyspermy rate; top-quality embryo rate; implantation rate) were searched. A total of 11 studies were included in the meta-analysis. Combined odds ratio (OR) and 95% confidence interval (CI) were calculated for the data. Statistical heterogeneity analysis between studies was assessed by Cochran Q and I 2 statistic with a significant threshold of P < 0.05. Methodologic quality assessment of RCTs was made for potential risk of bias with Cochrane Risk of Bias Tool.; Results: Compared to long-term co-incubation, brief co-incubation had an advantage in increasing implantation rate (OR: 1.97, 95% CI: 1.52-2.57), ongoing pregnancy rate (OR: 2.18, 95% CI: 1.44-3.29) and top-quality embryo rate (OR: 1.17, 95% CI: 1.02-1.35). However, brief co-incubation of gametes had no advantages in the live-birth rate (OR: 1.09, 95% CI: 0.72-1.65), miscarriage rate (OR: 1.32, 95% CI: 0.55-3.18), clinical pregnancy rate (OR: 1.36, 95% CI: 0.99-1.87) and polyspermy rate (OR: 0.80, 95% CI: 0.48-1.33) than long-term co-incubation. Additionally, the brief co-incubation was associated with lower normal fertilization rate (OR: 0.89, 95% CI: 0.80-0.99), compared with long co-incubation.; Conclusions: Brief co-incubation of gametes had the advantages in increasing implantation rate, ongoing pregnancy rate and top-quality embryo rate than long-term co-incubation. However, the live-birth rate displayed no difference between the two in vitro fertilization methods. Gametes co-incubation time should be individualized according to each patient's IVF history, infertility causes and the semen parameters. (© 2023. The Author(s).)

Fang-fang, H., et al. (2022). "Acupuncture-related therapies for uterine fibroids: A protocol for systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Fang-fang, H., et al. (2022). "Effectiveness and safety of moxibustion for uterine fibroids: a protocol for systematic reviews and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Fanghui, F. and X. Yuanfang (2023). "The efficacy of minimally invasive radical hysterectomy for cervical cancer: a protocol for systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Fangyi, D., et al. (2022). "Comparative efficacy of Pharmacologic and Nonpharmacologic Interventions for the treatment of Insomnia Symptoms in Postmenopausal Women: a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Farag, F., et al. (2023). "What Are the Short-term Benefits and Potential Harms of Therapeutic Modalities for the Management of Overactive Bladder Syndrome in Women? A Review of Evidence Under the Auspices of the European Association of Urology, Female Non-neurogenic Lower Urinary Tract Symptoms Guidelines Panel." European Urology 84(3): 302-312.
	Context: Overactive bladder syndrome (OAB) is highly prevalent among women and has a negative impact on their quality of life. The current available treatments for OAB symptoms include conservative, pharmacological, or surgical modalities. Objective(s): To provide an updated contemporary evidence document regarding OAB treatment options and determine the short-term effectiveness, safety, and potential harms of the available treatment modalities for women with OAB syndrome. Evidence Acquisition: The Medline, Embase, and Cochrane controlled trial databases and clinicaltrial.gov were searched for all relevant publications up to May 2022. The risk of bias assessment followed the recommended tool in the Cochrane Handbook for Systematic Reviews of Interventions, and quality of evidence was assessed using the modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. A meta-analysis was performed where appropriate. Evidence Synthesis: Antimuscarinics and beta-3 agonists were significantly more effective than placebo across most outcomes, with beta-3 agonists being more effective at reducing nocturia episodes and antimuscarinics causing significantly higher adverse events. Onabotulinumtoxin-A (Onabot-A) was more effective than placebo across most outcomes, but with significantly higher rates of acute urinary retention/clean intermittent self-catheterisation (six to eight times) and urinary tract infections (UTIs; two to three times). Onabot-A was also significantly better than antimuscarinics in the cure of urgency urinary incontinence (UUI) but not in the reduction of mean UUI episodes. Success rates of sacral nerve stimulation (SNS) were significantly higher than those of antimuscarinics (61% vs 42%, p = 0.02), with similar rates of adverse events. SNS and Onabot-A were not significantly different in efficacy outcomes. Satisfaction rates were higher with Onabot-A, but with a higher rate of recurrent UTIs (24% vs 10%). SNS was associated with 9% removal rate and 3% revision rate. Conclusion(s): Overactive bladder is a manageable condition, with first-line treatment options including antimuscarinics, beta-3 agonists, and posterior tibial nerve stimulation. Second-line options include Onabot-A bladder injections or SNS. The choice of therapies should be guided by individual patient factors. Patient Summary: Overactive bladder is a manageable condition. All patients should be informed and advised on conservative treatment measures in the first instance. The first-line treatment options for its management include antimuscarinics or beta-3 agonists medication, and posterior tibial nerve stimulation procedures. The second-line options include onabotulinumtoxin-A bladder injections or sacral nerve stimulation procedure. The therapy should be chosen based on individual patient factors.Copyright © 2023 European Association of Urology

Fasero, M. (2023). "Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness." ClinicalTrials.gov.
	This is a prospective, multicenter, randomized, controlled, double‐blind clinical investigation to evaluate the safety and efficacy of a new hyaluronic acid‐based vaginal moisturizer gel (medical device class IIb) in women with symptoms of vaginal atrophy and dryness, compared to a commonly used marketed vaginal moisturizer in gynecology clinics (Cumluade Hidratante Interno®), with a 1‐month follow‐up. The participants will apply the single dose of vaginal moisturizer 3 times per week, every other day, preferably in the evening. The investigators will monitor the evolution of vaginal symptoms, vaginal health using the Vaginal Health Index (VHI), sexual function using the Female Sexual Function Index (FSFI) questionnaire, and the safety and tolerability of the new class IIb medical device.

Fatemeh, A. and M. Narges (2022). "Surgery versus medical for the treatment of endometriosis: A protocol for systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Fatima, K., et al. (2023). "Effects of myo-inositol vs. metformin on hormonal and metabolic parameters in women with PCOS: a meta-analysis." Irish Journal of Medical Science 192(6): 2801-2808.
	Objective: Polycystic Ovary Syndrome is the most prevalent hormonal disorder in females. Over the years, metformin (MET) has become the first-line choice of treatment; however, due to its gastrointestinal side effects, a more recent drug, myo-inositol (MI), has been introduced. We aim to conduct a systematic review and meta-analysis to compare the effects of MET and MI on hormonal and metabolic parameters.; Materials and Methods: Authors extensively searched PubMed, Scopus, Cochrane Library, Google Scholar, and Web of Science for randomized clinical trials (RCTs) until August 2021. Eight (n = 8) articles were included, with a total sample size of 1088, of which 460 patients received MET, 436 received MI, and 192 received a combination of both. Standard mean differences (SMDs) and Confidence Intervals (CIs) were used for data synthesis, and forest plots were made using Review Manager 5.4 for Statistical Analysis using the random-effect model.; Results: The meta-analysis indicates that there is no significant difference between MET and MI in terms of their effects on BMI (SMD = 0.16, 95% CI: - 0.11 to 0.43, p = 0.24), fasting insulin (SMD = 0.00, 95% CI: - 0.26 to 0.27, p = 0.97), fasting blood sugar (SMD = 0.11, 95% CI: - 0.31to 0.53, p = 0.60), HOMA index (SMD = 0.09, 95% CI: - 0.20 to 0.39, p = 0.50), and LH/FSH (SMD = 0.20, 95% CI: - 0.24 to 0.64, p = 0.37). BMI, fasting blood sugar, and LH/FSH ratio reported moderate heterogeneity because of the varying number of study participants.; Conclusion: Our meta-analysis comparing hormonal and metabolic parameters between MET and MI did not show much significant difference, indicating both drugs are equally beneficial in improving metabolic and hormonal parameters in patients with PCOS. (© 2023. The Author(s), under exclusive licence to Royal Academy of Medicine in Ireland.)

Fatima, K., et al. (2021). "The Use of Combined Oral Contraceptives in the Symptomatic Treatment of Endometriosis." PROSPERO International prospective register of systematic reviews.
	
Faustino, R. P.-L., et al. (2021). "Systematic review and meta-analysis on the effect of vaginal estrogen or laser on vulvovaginal atrophy." PROSPERO International prospective register of systematic reviews.
	
Fawcett, K., et al. (2021). "Effect of a dietary and exercise intervention in women with overweight and obesity undergoing fertility treatments: protocol for a randomized controlled trial." BMC Nutrition 7(1): 51.
	BACKGROUND: Distinct molecular, inflammatory, and metabolic signatures are present in oocytes and follicular fluid derived from women with obesity when compared to those derived from normal weight women, which suggest existing signals that may program future offspring for metabolic diseases. This study aims to assess the feasibility and efficacy of a peri-conception nutrition and exercise intervention on mitigating obesity-associated changes in oocyte gene expression profiles and follicular fluid metabolites. METHODS: This single blinded randomized control trial will include 120 women with a BMI of 25-45 kg/m2, ≥21 years of age, and undergoing in vitro fertilization (IVF) treatments. Participants will be randomized to standard of care (N = 60) or an intervention group (N = 60) in a block design by polycystic ovary syndrome status. The intervention will combine a dietary component (Mediterranean meal plan) with exercise prescription following the Physical Activity Guidelines for Americans. Participants will be assessed pre- and post-intervention. The standard of care group will be offered to join the intervention group if the IVF treatments are unsuccessful as a cross over design. Recruitment is anticipated to start in July of 2021. Primary outcomes will include single oocyte gene expression profiles and follicular fluid metabolites. Mann-Whitney U nonparametric tests will be used to assess potential differences for each stratum. Follicular fluid and serum metabolites will be analyzed using a one-factor Analysis of Covariance (ANCOVA) at four levels, pair-wise comparisons using Tukey-Kramer post-hoc tests will be used to identify groups whose means differ significantly while retaining the family-wise error rate at 5%. When the design is balanced, two-way Analysis of Variance (ANOVA), or non-parametric Friedman test will be used in data analysis. Additionally, general linear models and ANCOVA may be used to control for covariates. Significance will be set at p < 0.05. Findings will be disseminated via peer-reviewed manuscripts and presentations at scientific conferences. DISCUSSION: This study will provide novel data and key information on the impact of a dietary and exercise intervention on oocyte gene expression and follicular fluid content. Results will demonstrate the potential of such intervention in mitigating obesity-induced changes in oocyte gene expression and follicular fluid metabolites. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT04273048 ): submitted November 13, 2019; posted February 17, 2020.

Feduniw, S., et al. (2022). "The Effect of Vitamin E Supplementation in Postmenopausal Women-A Systematic Review." Nutrients 15(1).
	Menopause is a physiological change in any woman. Nevertheless, its symptoms could be difficult to accept, and hormone therapy can be sometimes unattractive or contraindicated. Vitamin E components are phytoestrogens, so they are believed to be useful in some indications including menopause. This review aimed to assess the available evidence on the effectiveness of vitamin E in alleviating menopausal symptoms. The Pubmed/MEDLINE, Cochrane Library and Scopus databases were screened. All types of studies that assessed the effectiveness of vitamin E in alleviating menopausal symptoms were included. The PICO question was: "How does vitamin E supplementation affect menopausal symptom occurrence?" The PROSPERO ID number of this review is CRD42022328830. After quality assessment, 16 studies were included in the analysis. The studies were divided into three groups in which the influence of vitamin E on the genital syndrome of menopause, vasomotor symptoms and vascular and metabolic changes were assessed. Vitamin E influences postmenopausal hot flashes, vascular modulation, plasma lipid profile level and vaginal changes. Compared to vitamin E, estrogen administration leads to better clinical effects. Nevertheless, vitamin E might serve as additive to hormone therapy and its alternative in women with contraindications to estrogens. More quality data are necessary to draw final conclusions.

Feldthusen, C., et al. (2021). "Effects of a New Mattress and Pillow and Standard Treatment for Nightly Pelvic Girdle Pain in Pregnant Women: A Randomised Controlled Study." International Journal of Women's Health 13: 1251-1260.
	OBJECTIVE: To evaluate the efficacy of a memory-foam mattress and pillow plus standard treatment for nightly pelvic girdle pain (PGP) during pregnancy. METHOD: In this randomised controlled study conducted at a tertiary-care hospital, 66 pregnant women who had nightly PGP were enrolled to receive standard treatment with the mattress and pillow (intervention group, n = 34) or solely standard treatment (control group, n = 32). The primary outcome was change in nightly posterior PGP on a visual analogue scale, VAS from baseline to 4 weeks. Secondary outcomes include nightly anterior PGP, the evening PGP score, estimated sleep duration, number of nightly wake-ups, daytime sleepiness (Epworth sleepiness scale), function (Pelvic Girdle Questionnaire), health-related quality of life, and pain catastrophizing. RESULTS: Forty-four women (67%) completed the treatment. The difference in nightly posterior pain intensity was significantly different in favour of the intervention group (VAS, 16.5 mm (95% CI 1.4:31.6) p = 0.028). Sleep duration increased within both groups (intervention group: 26 min, p = 0.022; control group: 14 min, p = 0.014) and the difference between groups was significant (p = 0.046). In addition, the intervention group indicated a decreased evening PGP intensity (p = 0.008) and fewer nightly wake-ups (p = 0.049). The control group showed a deterioration in function (Pelvic Girdle Questionnaire) (p = 0.018) and an increase in daytime sleepiness (Epworth sleepiness scale) (p = 0.021) from baseline to 4 weeks. CONCLUSION: In conclusion, significantly lower nightly posterior PGP intensity was noted after the use of a mattress and pillow as an adjunct to standard treatment. Nightly PGP can have adverse effects on various aspects of the health and quality of life of pregnant women, and although the results of this study should be interpreted with caution considering the high drop-out rate and the inadequate statistical power, the findings indicate the potential for the use of such interventions to improve PGP in pregnant women.

Felipe, G., et al. (2023). "Ibrexafungerp for vulvovaginal candidiasis: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Feng, Y. and L. Fei (2022). "Laparoscopic-assisted vaginal hysterectomy for benign uterine disease: a meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Feng, Z., et al. (2022). "Immunotherapy for recurrent reproductive failure (RRF) patients with abnormal natural killer cell levels/activity: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Fengyi, W., et al. (2022). "Efficacy and Safety of Fu's Subcutaneous Needling for Primary Dysmenorrhea: A Systematic Review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Fernández-Pérez, P., et al. (2023). "Effectiveness of physical therapy interventions in women with dyspareunia: a systematic review and meta-analysis." BMC Women's Health 23(1): 387.
	BACKGROUND: Dyspareunia is defined as the occurrence of pain during or after sexual intercourse, which directly affects physical, sexual, and mental health. This condition can lead to depression, anxiety, and low self-esteem in women who experience it. OBJECTIVES: The aim of this research was to evaluate the effectiveness of physical therapy interventions for the treatment of female dyspareunia. DESIGN: A systematic review and meta-analysis was conducted. METHOD: Search of publications was conducted in Scopus, Medline, Pubmed, Cinahl and Web of Science. Treatment effects were defined as standardized mean difference and their 95% confidence intervals. Statistical heterogeneity was assessed using Crohan's Q test and quantified using the I2 index. RESULTS: Of the 19 articles selected, six applied multimodal physiotherapy treatments; five, electrotherapy; three, Thiele's massage; two, interdisciplinary interventions or pelvic floor muscle training; and one, extracorporeal shockwave therapy. The meta-analysis showed significant results for the variables pain and quality of life with the interventions based on electrotherapy and electrotherapy combined with pelvic floor muscle training. These interventions did not show significant results for the improvement of sexual function. CONCLUSIONS: Physiotherapy techniques are effective and procedures have been identified with reliable results in improving pain and quality of life in patients with dyspareunia. One of the most important aspects is the strengthening of the perineal musculature and the application of Transcutaneous Electrical Nerve Stimulation. Furthermore, manual trigger point release therapy and Thiele massage, optimize and guarantee the reduction of pain intensity. PROSPERO REGISTRATION: CRD42021236155.

Fernando, S.-J., et al. (2022). "The use of Punica granatum L. (pomegranate) for the treatment of Candida vulvovaginitis: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Fernando Soares da Silva, N., et al. (2021). "Effects of muscle training on dyspareunia." PROSPERO International prospective register of systematic reviews.
	
Ferrante, K. L., et al. (2021). "Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women: a Randomized Clinical Trial." Female Pelvic Medicine & Reconstructive Surgery 27(2): 112‐117.
	OBJECTIVES: We aimed to compare the efficacy of 2 commonly used contemporary vaginal estrogen administrations versus placebo for the prevention of urinary tract infection (UTI) in postmenopausal women with a clinical diagnosis of recurrent UTI (rUTI). METHODS: This was an investigator‐initiated, multicenter, single‐blind, randomized, placebo‐controlled trial of vaginal estrogen (delivered via ring or cream) compared with placebo. Postmenopausal women with documented rUTI were randomized to receive either vaginal estrogen (via ring or cream) or placebo cream in a 1:1:1 fashion. The primary outcome was occurrence of UTI at 6 months. After 6 months, open‐label use of ring or active cream was offered to all participants for an additional 6 months. Because of slower than expected recruitment, sample size calculations and block randomization schema were revised to combine estrogen groups (ring or cream) for statistical comparisons to placebo cream in a 1:1 fashion. RESULTS: Thirty‐five women were randomized with 9 dropouts (1 ring, 2 cream, and 6 placebo) prior to the 6 months. Intention‐to‐treat analysis (assuming dropouts as failures) revealed fewer women treated with vaginal estrogen had a UTI within 6 months versus placebo (11/18 vs 16/17, respectively; P = 0.041). Per‐protocol analysis revealed fewer subjects treated with vaginal estrogen had a UTI at 6 months (8/15 vs 10/11, respectively; P = 0.036). CONCLUSIONS: Commonly prescribed forms of vaginal estrogen with contemporary dosing schedules prevent UTIs in postmenopausal women with an active diagnosis of rUTI.

Ferrario, L., et al. (2022). "Innovative and conventional "conservative" technologies for the treatment of uterine fibroids in Italy: a multidimensional assessment." Health Economics Review 12(1): 21.
	Background: To evaluate the potential benefits of the Magnetic Resonance-guided high intensity Focused Ultrasound (MRgFUS) introduction in the clinical practice, for the treatment of uterine fibroids, in comparison with the standard "conservative" procedures, devoted to women who wish to preserve their uterus or enhance fertility: myomectomy and uterine artery embolization (UAE). Method(s): A Health Technology Assessment was conducted, assuming the payer's perspective (Italian National Healthcare Service). The nine EUnetHTA Core Model dimensions were deeply investigated, by means of i) a literature review; ii) the implementation of health economics tools (useful for uterine fibroids patients' clinical pathway economic evaluation, and budget impact analysis), to define MRgFUS economic and organizational sustainability, and iii) administration of specific questionnaires filled by uterine fibroids' experts, to gather their perceptions on the three possible conservative approaches (MRgFUS, UAE and myomectomy). Result(s): Literature revealed that MRgFUS would generate several benefits, from a safety and an efficacy profile, with significant improvement in symptoms relief. Advantages emerged concerning the patients' perspective, thus leading to a decrease both in the length of hospital stay (p-value< 0.001), and in patients' productivity loss (p-value = 0.024). From an economic point of view, the Italian NHS would present an economic saving of - 6.42%. A positive organizational and equity impact emerged regarding the capability to treat a larger number of women, thus performing, on average, 131.852 additional DRGs. Conclusion(s): Results suggest that MRgFUS could be considered an advantageous technological alternative to adopt within the target population affected by uterine fibroids, demonstrating its economic and organisational feasibility and sustainability, with consequent social benefits.Copyright © 2022, The Author(s).

Ferring, P. (2021). "A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation." ClinicalTrials.gov.
	Hormone preparations like REKOVELLE and GONAL‐F are used to make the body produce multiple egg sacs, allowing more eggs to be collected from women undergoing infertility treatment. The main purpose of this trial is to see how many eggs are produced with a starting dose of 15 µg REKOVELLE compared to a starting dose of 225 IU GONAL‐F. This research is intended to provide more knowledge about REKOVELLE, including the doses given in the trial.

Ferring, P. (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." ClinicalTrials.gov.
	No Results Available Drug: FE 999302|Drug: Ovitrelle|Drug: Novarel Number of metaphase II (MII) oocytes|Number of oocytes retrieved|Number of fertilised (2 pronuclei) oocytes|Number and quality of embryos on day 3 after oocyte retrieval|Number and quality of blastocysts on day 5 after oocyte retrieval|Serum hormone concentrations of progesterone|Serum hormone concentrations of 17-OH-progesterone|Serum hormone concentrations of estradiol|Serum hormone concentrations of follicle stimulating hormone (FSH)|Serum hormone concentrations of luteinising hormone (LH)|Positive βhCG (positive serum βhCG test 13-15 days after transfer)|Clinical pregnancy (at least one gestational sac 5-6 weeks after transfer)|Vital pregnancy (at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer)|Ongoing pregnancy (at least one intrauterine viable fetus 10-11 weeks after transfer)|Serum hCG concentrations 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)|Ovarian hyperstimulation syndrome (OHSS), overall and by timing, grade, and severity|Injection site reactions (redness, pain, itching, swelling, and bruising) assessed by the subject following administration of investigational medicinal product (IMP)|Treatment-induced anti-hCG antibodies, overall as well as with neutralising capacity|Multi-fetal gestation|Biochemical pregnancy|Spontaneous abortion|Ectopic pregnancy (with and without medical/surgical intervention)|Vanishing twins Female Phase 2 0 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Investigator, Outcomes Assessor)|Primary Purpose: Treatment 000298 June 25, 2024

Ferron, G., et al. (2023). "Neoadjuvant chemotherapy with or without nintedanib for advanced epithelial ovarian cancer: Lessons from the GINECO double-blind randomized phase II CHIVA trial." Gynecologic Oncology 170: 186-194.
	Aim: The oral anti-angiogenic therapy nintedanib prolongs progression-free survival (PFS) when combined with chemotherapy after primary surgery for advanced epithelial ovarian cancer. The randomized phase II CHIVA trial evaluated the impact of combining nintedanib with neoadjuvant chemotherapy (NACT) for epithelial ovarian cancer.; Methods: Patients with newly diagnosed unresectable FIGO stage IIIC-IV epithelial ovarian cancer received 3-4 cycles of carboplatin plus paclitaxel every 3 weeks as NACT before interval debulking surgery (IDS), followed by 2-3 post-operative cycles. Patients were randomized 2:1 to receive either nintedanib 200 mg twice daily or placebo on days 2-21 every 3 weeks during NACT (omitting peri-operative cycles), and then as maintenance therapy for up to 2 years. The primary endpoint was PFS.; Results: Between January 2013 and May 2015, 188 patients were randomized (124 to nintedanib, 64 to placebo). PFS was significantly inferior with nintedanib (median 14.4 versus 16.8 months with placebo; hazard ratio 1.50, p = 0.02). Overall survival (OS) was also inferior (median 37.7 versus 44.1 months, respectively; hazard ratio 1.54, p = 0.054). Nintedanib was associated with increased toxicity (grade 3/4 adverse events: 92% versus 69%, predominantly hematologic and gastrointestinal), lower response rate by RECIST (35% versus 56% before IDS), and lower IDS feasibility (58% versus 77%) versus placebo.; Conclusions: Adding nintedanib to chemotherapy and in maintenance as part of NACT for advanced epithelial ovarian cancer cannot be recommended as it increases toxicity and compromises chemotherapy efficacy (IDS, PFS, OS).; Clinicaltrials: govregistration: NCT01583322.; Competing Interests: Declaration of Competing Interest Gwénaël Ferron: Advisory boards (Clovis, AstraZeneca, GSK, MSD, Roche, RanD Biotech, Olympus), lectures/symposia (AstraZeneca, Clovis, GSK, MSD, PharmaMar). Nicolas Delanoy: Advisory boards/honoraria (GSK, AstraZeneca, MSD, Clovis Oncology). Florence Joly: Advisory boards (Clovis, AstraZeneca, GSK, MSD, Seagen), lectures/symposia (AstraZeneca, Clovis, GSK, MSD); non-gynecology: Ipsen, Janssen, Sanofi, Bayer, Astellas, Pfizer, Amgen. Alain Lortholary: Advisory board fees (AstraZeneca, MSD Tesaro), speaker honoraria (Clovis Oncology, Roche), congress participation (Novartis, Pfizer, MSD, Lilly, Roche), member of CS3 sein UNICANCER. Benoît You: Consulting (MSD, AstraZeneca, GSK–Tesaro, Bayer, Roche/Genentech, ECS Progastrin, Novartis, LEK, Amgen, Clovis Oncology, Merck Serono, BMS, Seagen, Myriad). Nadine Dohollou: Consulting/expert (Daiichi, Lilly, Roche, Seagen), conferences/training (Daiichi, Lilly, Roche, Seagen), research grants/clinical trials (AstraZeneca, BMS, Boehringer Ingelheim, Genomic Health, Lilly, MSD, Novartis, Pfizer, Roche). Anne Floquet: Advisory boards (MSD, AstraZeneca, GSK, Clovis Oncology), congress participation (AstraZeneca, GSK, MSD, PharmaMar, Roche). Michel Fabbro: AstraZeneca, GSK, Clovis. Jérôme Alexandre: AstraZeneca, GSK, Clovis, MSD, Eisai, Novartis. Isabelle Ray-Coquard: Advisory/consultancy (Amgen, AstraZeneca, Clovis Oncology, Genmab, GSK, ImmunoGen, Mersana, Deciphera, Novocure, Eisai, Sutro Pharma, Merck Sharp & Dohme, Pfizer/Merck Serono, PharmaMar, Roche), research grant/funding (Roche, BMS, MSD, GSK), travel/accommodation/expenses (AstraZeneca, Roche, GSK, Clovis). (Copyright © 2023. Published by Elsevier Inc.)

Field, A., et al. (2023). "Assessing obstetric outcomes: A systematic review and meta-analysis comparing fresh, artificial, and natural thaw embryo transfer cycles." The Australian & New Zealand Journal of Obstetrics & Gynaecology.
	Background: The increasing utilisation of in vitro fertilisation (IVF) has prompted significant interest in determining the optimal endometrial environment to increase pregnancy rates and minimise the obstetric complications associated with various embryo transfer strategies.; Aims: To determine which cycle is associated with increased obstetric complications: fresh embryo transfer (FreshET), natural thaw (NatThawET) or artificial thaw (ArtThawET). Outcomes of interest included: hypertensive disorders of pregnancy (HDP), gestational diabetes (GD), pre-term birth (PTB), post-partum haemorrhage (PPH) and large for gestational age (LGA).; Materials and Methods: A comprehensive search of MEDLINE, EMBASE, CENTRAL, and PUBMED was conducted from 1947 to May 17, 2022. Two independent reviewers carried out the screening, and data extraction for the following comparisons: ArtThawET vs NatThawET, ArtThawET vs FreshET, and NatThawET vs FreshET. Meta-analysis was conducted using a fixed-effect Mantel-Haenszel model. The quality of the studies was assessed using GRADEpro.; Results: A total of 23 studies were included in this review. ArtThawET was associated with a significantly increased odds of HDP (odds ratio (OR) 1.76, confidence interval (CI) 1.66-1.86), PTB (OR 1.18, CI 1.13-1.23), PPH (OR 2.61, CI 2.3-2.97) and LGA (OR 1.11, CI 1.07-1.15), compared to NatThawET. ArtThawET was also associated with increased odds of HDP (OR 2.13, CI 1.89-2.4), PPH (OR 3.52, CI 3.06-4.04) and LGA (OR 2.12, CI 1.77-2.56), compared to FreshET. Furthermore, NatThawET demonstrated increased odds of HDP (OR 1.20, CI 1.11-1.29), PPH (OR 1.25, CI 1.14-1.38) and LGA (OR 1.85, CI 1.66-2.07) compared to FreshET.; Conclusion: When clinically feasible, ArtThawET should be avoided as a first-line option for IVF to reduce the risk of obstetric complications. An adequately powered, multicentre randomised controlled trial is necessary to confirm these findings and investigate the underlying pathophysiology. (© 2023 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology published by John Wiley & Sons Australia, Ltd on behalf of Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Filis, P., et al. (2022). "Hyperthermic intraperitoneal chemotherapy (HIPEC) for the management of primary advanced and recurrent ovarian cancer: a systematic review and meta-analysis of randomized trials." ESMO Open 7(5): 100586.
	Introduction: Ovarian cancer is the most lethal gynecologic malignancy. Although treatment with hyperthermic intraperitoneal chemotherapy (HIPEC) has shown promising results, its role remains elusive. The aim of this study was to assess the comprehensive randomized evidence for the use versus non-use of HIPEC in primary and recurrent ovarian cancer.; Materials and Methods: The Medline, Embase and Cochrane databases, as well as the European Society for Medical Oncology (ESMO) and American Society of Clinical Oncology (ASCO) conference abstracts of the last 5 years, were scrutinized in January 2022 for randomized, controlled trials that studied the use of HIPEC in ovarian cancer. Overall survival (OS), disease-free survival (DFS) and progression-free survival, as well as post-operative morbidity were the outcomes of interest. This study was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline.; Results: Six randomized, controlled trials that randomized 737 patients were included in our analysis; of these, four studies (519 patients) were in primary and two (218 patients) in recurrent settings. In primary ovarian cancer, the combination of HIPEC with interval cytoreductive surgery (CRS) and neoadjuvant chemotherapy significantly improved the 5-year OS [393 patients, risk ratio (RR) = 0.77; 95% confidence interval (CI) 0.67-0.90; P value = 0.001] and DFS (hazard ratio = 0.60; 95% CI 0.41-0.87; P value = 0.008) compared with standard treatment alone. In the absence of neoadjuvant chemotherapy, the use of HIPEC + CRS was not associated with any survival advantage (126 patients, 4-year OS, RR = 0.93; 95% CI 0.57-1.53; P value = 0.781), but the sample size was smaller in this subset. Use of HIPEC in recurrent ovarian cancer did not provide any survival advantage (5-year OS: 218 patients, RR = 0.85; 95% CI 0.45-1.62; P value = 0.626). The risk for grade ≥3 adverse events was similar between HIPEC and no HIPEC (RR = 1.08; 95% CI 0.98-1.18; P value = 0.109).; Conclusions: In primary ovarian cancer the combination of HIPEC with interval CRS and neoadjuvant chemotherapy is a safe option that significantly improved 5-year OS and DFS. Its use in other settings should continue to be considered investigational.; Competing Interests: Disclosure The authors have declared no conflicts of interest. Data sharing All data generated or analysed during this study are included in this published article (and its supplementary information files). (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Fiorentino, F., et al. (2022). "DICE: Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian cancer resistant to standard treatment-a study protocol for a randomised trial investigating a novel therapy called TAK228." Trials 23(1): 261.
	Background: The standard initial treatment for ovarian cancer is surgery and platinum-based chemotherapy and potentially maintenance therapy with avastin or inhibitors of poly-ADP ribose polymerase (PARP). While a proportion of women are cured by this approach, the vast majority will relapse and become resistant to platinum chemotherapy either initially or on subsequent treatment. There is an unmet need to improve response to treatment and quality of life in these women. TAK228 is a novel therapy that can be added to standard treatment in the participant population and the aim of the DICE trial is to assess its effectiveness. Laboratory and clinical research has shown that these ovarian cancers may respond to the molecular target of a drug such as TAK228, and there have been studies using it in other advanced solid tumours including endometrial cancer.; Methods: One hundred twenty-four eligible women will be recruited from participating research sites in the United Kingdom (UK) and Germany. Randomised participants will receive either weekly paclitaxel alone (standard treatment, n = 62) or TAK228 plus weekly paclitaxel (n = 62) until the cancer significantly worsens; there are significant adverse events or any other protocol-defined stopping criteria. Participants will be monitored for response to treatment (using radiological imaging), adverse events and quality of life during both randomised treatment and subsequent follow-up.; Discussion: The primary objective/endpoint of the study is to compare the two treatments in terms of progression-free survival, or the length of time that each participant is alive without the cancer significantly worsening according to defined assessment criteria. If the addition of TAK228 to weekly paclitaxel chemotherapy is shown to significantly improve this statistically, and adverse events and quality of life are not significantly worse than standard treatment, then TAK228 plus weekly paclitaxel could potentially be taken forward within the context of a larger phase III trial.; Trial Registration: ClinicalTrials.gov NCT03648489 . Registered on 27 August 2018. (© 2022. The Author(s).)

Fitz, V., et al. (2024). "Inositol for Polycystic Ovary Syndrome: a systematic review and meta-analysis to inform the 2023 update of the International Evidence-Based PCOS Guidelines." The Journal of Clinical Endocrinology and Metabolism.
	CONTEXT: Insulin resistance is common in women with Polycystic Ovary Syndrome (PCOS). Inositol may have insulin sensitising effects; however, its efficacy in the management of PCOS remains indeterminate. OBJECTIVE(S): To inform the 2023 International Evidence-based Guidelines in PCOS, this systematic review and meta-analysis evaluated the efficacy of inositol, alone or in combination with other therapies, in the management of PCOS. DATA SOURCES: Medline, PsycInfo, EMBASE, All EBM, and CINAHL from inception until August 2022. STUDY SELECTION: Thirty trials (n=2230; 1093 intervention, 1137 control), with 19 pooled in meta-analyses were included. DATA EXTRACTION: Data were extracted for hormonal, metabolic, lipids, psychological, anthropometric, reproductive outcomes and adverse effects by one reviewer, independently verified by a second. DATA SYNTHESIS: Thirteen comparisons were assessed, with three in meta-analyses. Evidence suggests benefits for myo-inositol or D-chiro-inositol (DCI) for some metabolic measures and potential benefits from DCI for ovulation but inositol may have no effect on other outcomes. Metformin may improve waist-hip ratio and hirsutism compared to inositol but there is likely no difference for reproductive outcomes, and the evidence is very uncertain for BMI. Myo-inositol likely causes fewer gastrointestinal adverse events compared with metformin; however, these are typically mild and self-limited. CONCLUSION(S): The evidence supporting the use of inositol in the management of PCOS is limited and inconclusive. Clinicians and their patients should consider the uncertainty of the evidence together with individual values and preferences when engaging in shared decision-making regarding the use of inositol for PCOS.Copyright © The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society.

Fitzgerald Jocelyn, J. (2022). "A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain." ClinicalTrials.gov.
	Objectives: The goals of this research program are to evaluate the patient‐reported outcomes of a multimodal care bundle for patients presenting to a multidisciplinary chronic pelvic pain clinic compared to "usual care" in an Urogynecology clinic. Primary Aim: To compare pre and post intervention self‐evaluation of pain and function scores in women with chronic pain syndromes with a primary finding of urinary/bladder pain symptoms with or without levator spasm who undergo multi‐disciplinary, bundled care compared with usual care in a Urogynecology clinic setting. Secondary Aims: a) To identify and phenotype "non‐responders" to a bundled approach to Interstitial Cystitis/Painful Bladder Syndrome/Chronic Pelvic Pain (IC/PBS/CPP). Hypothesis: We hypothesize that a bundled, multidisciplinary care approach will significantly improve patient scores on validated outcomes questionnaires compared to usual care. Methods: All treatment plans, medications, and procedures recommended for patients involved in this study are within the current standards of care for IC/PBS/CPP, regardless of treatment arm and are known to be safe interventions. Study Design: Single center, randomized pre‐post intervention/prospective cohort study32 of usual FPMRS care vs. multimodal, multidisciplinary care bundle (MMCB). Setting: Patients will be recruited from an outpatient Urogynecology clinic. They will subsequently be randomized to a Multidisciplinary chronic pelvic pain clinic at an alternate site vs. continuing usual outpatient care in Urogynecology as above.

Fitzsimmons, T. S., et al. (2023). "Immune checkpoint inhibitors efficacy across solid cancers and the utility of PD-L1 as a biomarker of response: a systematic review and meta-analysis." Frontiers in Medicine 10: 1192762.
	Background: Immune checkpoint inhibitors (ICPI) are a tumor agnostic treatment. However, trials of their use have been site specific. Here we summarize the trial data and explore the utility of programmed death-ligand 1 (PD-L1) expression as a biomarker to direct their pan-cancer use. Method(s): A systematic review of literature, following PRISMA guidelines, was performed. Medline, Embase, Cochrane CENTRAL, NHS Health and Technology, and Web of Science were searched from their conception to June 2022 limited to the English language. The search terms and method were devised by a specialist medical librarian. Studies were limited to adults with solid cancers (excluding melanomas) treated with ICPIs. Only phase III randomized control trials (RCT) were included. The primary outcome was overall survival and secondary outcomes were progression free survival, PD-L1 expression, quality of life outcomes and adverse event data. Where present in eligible clinical trials, hazard ratios (HR), risk ratios (RR), standard error (SE) and 95% confidence intervals (CI) were extracted or calculated. Heterogeneity across studies was described with the use of an I2 score (Low: 25, 50%: moderate, 75% low heterogeneity). HR pools inverse variance methods were adopted by Random Effects (RE). Means were standardized across any heterogenous scale limits. Result(s): In total 46,510 participants were included in the meta-analysis. Overall, meta-analysis favored the use of ICPIs with an overall survival (OS) HR of 0.74 (95% CI 0.71 to 0.78). Lung cancers showed the most benefit in OS [HR 0.72 (95% 0.66-0.78)] followed by head and neck cancers [HR 0.75 (95% CI 0.66-0.84)] and gastroesophageal junction cancers [HR 0.75 (95% CI 0.61-0.92)]. ICPIs seem to be efficacious at both primary presentation and recurrence [OS HR 0.73 (95% CI 0.68-0.77)] vs. [OS HR 0.79 (95% CI 0.72 to 0.87)] respectively. Interestingly, subgroup analysis comparing studies in which most cancers demonstrated PD-L1 expression vs. those studies in which a minority of cancer demonstrated PD-L1 expression reported similar effect of ICPI use on OS; oddly the data favored ICPI use in studies with a minority of PD-L1 expression. Specifically, studies with minority PD-L1 expression had an HR 0.73 (95% CI 0.68-0.78) vs. studies with majority PD-L1 expression HR 0.76 (95% CI 0.70-0.84). This was maintained even when studies exploring the same cancer site were directly compared. Subgroup analysis was performed comparing the impact on OS subdivided by the specific ICPI used. Where meta-analysis was performed, Nivolumab led to the greatest impact [HR 0.70 (95% CI 0.64-0.77)] with Avelumab failing to reach significance [HR 0.93 (95% CI 0.80-1.06)]. However, overall heterogenicity was high (I2 = 95%). Finally, the use of ICPIs led to an improved side effect profile when compared with standard chemotherapy [RR 0.85 (95% CI 0.73-0.98)]. Conclusion(s): ICPIs improve survival outcomes in all cancer types. These effects are seen in the primary, recurrent, chemotherapy sensitive, chemotherapy resistant disease. These data support their use as a tumor agnostic therapy. Furthermore, they are well tolerated. However, PD-L1 as a biomarker for the targeting of ICPI use seems problematic. Other biomarkers such as mismatch repair or tumor mutational burden should be explored in randomized trials. In addition, there are still limited trials looking at ICPI use outside of lung cancer.Copyright © 2023 Fitzsimmons, Singh, Walker, Newton, Evans, Crosbie and Ryan.

Florou, P., et al. (2020). "Does coenzyme Q 10 supplementation improve fertility outcomes in women undergoing assisted reproductive technology procedures? A systematic review and meta-analysis of randomized-controlled trials." Journal of Assisted Reproduction and Genetics 37(10): 2377-2387.
	Objective: Increased oxidative stress has been identified as a pathogenetic mechanism in female infertility. However, the effect of specific antioxidants, such as coenzyme Q 10 (CoQ 10 ), on the outcomes after assisted reproductive technologies (ART) has not been clarified. The aim of this study was to systematically review and meta-analyze the best available evidence regarding the effect of CoQ 10 supplementation on clinical pregnancy (CPR), live birth (LBR), and miscarriage rates (MR) compared with placebo or no-treatment in women with infertility undergoing ART.; Methods: A comprehensive literature search was conducted in PubMed (MEDLINE), Cochrane, and Scopus, from inception to March 2020. Data were expressed as odds ratio (OR) with 95% confidence intervals (CI). The I 2 index was employed for heterogeneity.; Results: Five randomized-controlled trials fulfilled eligibility criteria (449 infertile women; 215 in CoQ 10 group and 234 in placebo/no treatment group). Oral supplementation of CoQ 10 resulted in an increase of CPR when compared with placebo or no-treatment (28.8% vs. 14.1%, respectively; OR 2.44, 95% CI 1.30-4.59, p = 0.006; I 2 32%). This effect remained significant when women with poor ovarian response and polycystic ovarian syndrome were analyzed separately. No difference between groups was observed regarding LBR (OR 1.67, 95% CI 0.66-4.25, p = 0.28; I 2 34%) and MR (OR 0.61, 95% CI 0.13-2.81, p = 0.52; I 2 0%).; Conclusions: Oral supplementation of CoQ 10 may increase CPR when compared with placebo or no-treatment, in women with infertility undergoing ART procedures, without an effect on LBR or MR.

Flynn, J., et al. (2021). "Robotic versus laparoscopic ventral mesh rectopexy: a systematic review and meta-analysis." International Journal of Colorectal Disease 36(8): 1621-1631.
	Introduction: Ventral mesh rectopexy is frequently performed as a means of improving the quality of life for sufferers of rectal prolapse. The minimally invasive approach is highly desirable but can be technically difficult to achieve in the narrow confines of the pelvis. The robotic platform is becoming a more common means of overcoming these difficulties, but evidence of an objective benefit over standard laparoscopy is scarce. This study seeks to review and analyse the data comparing outcomes after robotic and laparoscopic ventral mesh rectopexy.; Method: We searched MEDLINE, EMBASE and the Cochrane database for papers comparing robotic to laparoscopic ventral mesh rectopexy. Comparable data was pooled for meta-analysis.; Results: Six studies compared outcomes between robotic and laparoscopic ventral mesh rectopexy. Sample sizes were relatively small, and only two of the studies were randomised. Pooled analysis was possible for data on operating time, complication rates, conversion rates and length of stay in hospital. This showed a non-significant trend towards longer operating times and a statistically significant reduction in length of stay after robotic procedures. There was no significant difference in complication and conversion rates.; Conclusion: The frequent finding of longer operating time for robotic surgery was not confirmed in this study. Shorter length of stay in hospital was seen, with other post-operative outcomes showing no significant difference. More data is needed with cost-benefit analyses to show whether the robotic platform is justified. (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Fondazione Policlinico Universitario Agostino Gemelli Irccs Universita, C. (2021). "PERSONALIZED MOLECULAR DRIVEN SURGERY ACCORDING TO BRCA MUTATIONAL STATUS IN ADVANCED EPITHELIAL OVARIAN CANCER PATIENTS WITH HIGH TUMOR LOAD." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: LYNPARZA Product Name: OLAPARIB Product Code: [L01XX46] Pharmaceutical Form: Tablet INN or Proposed INN: OLAPARIB CAS Number: 763113‐22‐0 Current Sponsor code: AZD 2281 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Trade Name: LYNPARZA Product Name: OLAPARIB Product Code: [L01XX46] Pharmaceutical Form: Tablet INN or Proposed INN: OLAPARIB CAS Number: 763113‐22‐0 Current Sponsor code: AZD 2281 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Product Name: CISPLATINO Product Code: [L01XA01] Pharmaceutical Form: Solution for infusion INN or Proposed INN: CISPLATINO CAS Number: 15663‐27‐1 Current Sponsor code: 2019‐0024‐30 Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 75‐ CONDITION: ADVANCED OVARIAN CARCINOMA ; MedDRA version: 21.1 Level: PT Classification code 10054913 Term: Serous cystadenocarcinoma ovary System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: Overall, we want to find out whether up front treatments could be associated with different survival outcomes according to the BRCA mutational status.; To demonstrate the efficacy of PDS versus NACT for increasing the PFS. Primary end point(s): PFS Secondary Objective: • Median OS; • Quality of life assessment ; • Optimal cytoreduction rate; • Time to starting second‐line chemotherapy; • General immune status and tumor‐derived apoptotic body generation; • Biomarkers; • Radiomics features. Timepoint(s) of evaluation of this end point: 5 years SECONDARY OUTCOME: Secondary end point(s): • OS; • QoL ; • Cytoreduction rate; • Time to starting second‐line chemotherapy; • General immune status and tumor‐derived apoptotic body generation; • Biomarkers; • Radiomics features. Timepoint(s) of evaluation of this end point: 5 years. INCLUSION CRITERIA: 1. Diagnosis of advanced epithelial ovarian cancer (FIGO stage III B‐IV) 2. high tumor load assessed by laparoscopy according to the Fagotti’s score (PIV 8‐12) 3. age between 18 and 80 4. Performance Status (ECOG) = 2, an adequate respiratory, hepatic, cardiac, bone marrow, liver and renal function (Creatinine Clearance > 60 mL/min according to Cockroft formula) 5. sBRCA‐wt 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Fondazione Policlinico Universitario Agostino Gemelli Irccs Universita, C. (2021). "RANDOMIZED PHASE III MULTICENTRE STUDY INVESTIGATING THE ROLE OF LETROZOLE IN HEAVILY PRETREATED RECURRENT OVARIAN CANCER." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Letrozolo Product Code: [L02BG04] Pharmaceutical Form: Tablet INN or Proposed INN: Letrozolo CAS Number: 112809‐51‐5 Current Sponsor code: CGS 20267 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2500‐ CONDITION: ADVANCED OVARIAN CANCER ; MedDRA version: 21.1 Level: PT Classification code 10054913 Term: Serous cystadenocarcinoma ovary System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: Proportion of patient alive at 12 months Primary end point(s): Proportion of patient alive at 12 months Secondary Objective: PFS; OS; ORR (according to RECIST criteria version 1.1); TPST; TSST; Toxicity profile (evaluated according to NCI‐CTCAE version 4.0); Quality of Life (QoL) (evaluated by EORTC QLQ‐C30/ QLQ‐OV28 questionnaire, FACT Ovarian Symptom Index (FOSI), FACT‐ES and Activity daily living (ADL) and instrumental ADL (IADL) scales) Timepoint(s) of evaluation of this end point: 30 months INCLUSION CRITERIA: • Female of 18 years of age or older • Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer • Platinum resistant or refractory disease (patients who did not respond to last platinum‐based therapy or with last relapse occurred < 6 months from the last dose of platinum) or patients not amenable of platinum treatment • >3 previous chemotherapy lines • ECOG performance status 0 ‐2 • Measurable and evaluable disease according to RECIST criteria confirmed by radiological imaging: at least one lesion of = 1.0 cm for non‐lymph nodes or = 1.5 cm in short‐axis diameter for lymph nodes at CT scan (Subjects with isolated rising CA‐125 without radiologically visible disease are excluded) • Left Ventricular Ejection Fraction (LVEF) = institutional lower limit normal • Estimated life expectancy = 16 weeks • Adequate functions evidenced by: ¬ Hemoglobin 10.0 g/dl ¬

Forleo, F., et al. (2024). "Efficacy and safety of vaginal formulations with tyndallized ferments in subjects with nonspecific vulvovaginitis: A randomized study in Italy." Journal of Obstetrics and Gynaecology Research.
	Aim: In this study, we tested the efficacy, safety, and tolerability of vaginal ovules and a vaginal douche containing tyndallized ferments in women affected by nonspecific vulvovaginitis, with or without the human papillomavirus (HPV). Method(s): The study included 91 female patients and had a randomized, controlled sequential design, with parallel groups. Ovules and douche were tested and compared to a control group treated with sterile physiological solution. Total symptom score (TSS), individual signs and symptoms, therapeutic success were evaluated, as well as safety and tolerability. Result(s): The tyndallized ferments formulations (ovules and douche) had a safe and tolerable profile, and resulted in a significant decrease in TSS in patients affected by nonspecific vulvovaginitis, both at 5 and 10 days of treatment, when compared to a control group. The treatment was more effective than the control in reducing symptoms such as vulvar erythema, vulvar edema, itching, and burning. Patients affected by vulvovaginitis and HPV-positive received a 30 days treatment either with ovules or ovules + douche, and we observed an improvement at Day 30 compared to Day 0, for both regimens. Conclusion(s): Our study suggests that topical treatment with tyndallized ferments is a safe and effective strategy to reduce symptoms of nonspecific vulvovaginitis.Copyright © 2024 Japan Society of Obstetrics and Gynecology.

Forman, A. (2022). "Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?" ClinicalTrials.gov.
	The trial seeks to test effect of laparoscopic excision of peritoneal endometriosis on pelvic pain. Data will also be gathered on quality of life and neuropathic pain. Patients will be randomized to one of three groups: 1) laparoscopy with excision of endometrial tissue, 2) laparoscopy without excision of endometrial tissue and 3) waiting list control. Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Masking : Quadruple (Participant Care Provider Investigator Outcomes Assessor) Outcome Measure: Pelvic pain measured using NRS with 6 secondary measures

Forslund, M., et al. (2023). "Combined oral contraceptive pill compared with no medical treatment in the management of polycystic ovary syndrome: A systematic review." Clinical Endocrinology 99(1): 79-91.
	Objective: As part of the update of the International Evidence-Based Guidelines for the Assessment and Management of polycystic ovary syndrome (PCOS), a systematic review was performed to inform evidence-based recommendations.; Design: Systematic review. Only randomised controlled trial were included.; Patients: Women with PCOS; the use of combined oral contraceptive pills (COCP) was compared with no medical treatment.; Measurements: Outcomes were designed in collaboration with clinical experts, researchers, and consumers. Critical outcomes included hirsutism, irregular cycles, quality of life, body mass index (BMI), and weight.; Results: 1660 publications were identified, but only four studies were included. No studies could be combined for meta-analysis. COCP treatment improved cycle regularity compared with no medical treatment (100% vs. 0%, with low certainty of evidence). COCP showed no difference in improvement of hirsutism or BMI compared with placebo or lifestyle; a lower weight after COCP compared with no treatment (mean difference [MD] -8.0 (95% confidence interval, CI -11.67); -4.33 kg); and improvement in quality of life (MD 1.2 [95% CI 0.96]; 1.44), but these results were all very low certainty of evidence.; Conclusion: Results show that COCP benefit cycle regulation, but other benefits or potential adverse effects were only identified with very low certainty of evidence. The COCP is frontline medical treatment in PCOS, but this is still based on established efficacy in the broader general population. Our results show that research in PCOS is seriously lacking and should be prioritised to capture core reproductive, metabolic and psychological outcomes important in PCOS. (© 2023 The Authors. Clinical Endocrinology published by John Wiley & Sons Ltd.)

Forslund, M., et al. (2023). "Different kinds of oral contraceptive pills in polycystic ovary syndrome: a systematic review and meta-analysis." European Journal of Endocrinology 189(1): S1-S16.
	Objective: To compare between different combined oral contraceptive pills (COCPs) as part of the update of the International Evidence-Based Guidelines on the Assessment and Management of polycystic ovary syndrome (PCOS).; Design: A systematic review and meta-analysis was performed, Prospero CRD42022345640.; Methods: MEDLINE, EMBASE, All EBM, CINAHL, and PsycINFO was searched on July, 8, 2022, for studies including women with PCOS, comparing 2 different COCPs in randomized controlled trials.; Results: A total of 1660 studies were identified, and 19 randomized controlled trials (RCTs) were included.Fourth-generation COCP resulted in lower body mass index (BMI) (mean difference [MD] 1.17 kg/m2 [95% confidence interval {CI} 0.33; 2.02]) and testosterone (MD 0.60 nmol/L [95% CI 0.13; 1.07]) compared with third-generation agents, but no difference was seen in hirsutism.Ethinyl estradiol (EE)/cyproterone acetate (CPA) was better in reducing hirsutism as well as biochemical hyperandrogenism (testosterone [MD 0.38 nmol/L {95% CI 0.33-0.43}]) and BMI (MD 0.62 kg/m2 [95% CI 0.05-1.20]) compared with conventional COCPs.There was no difference in hirsutism between high and low EE doses. No evidence regarding natural estrogens in COCP was identified.; Conclusion: With current evidence, combined regimens containing an antiandrogen (EE/CPA) may be better compared with conventional COCPs in reducing hyperandrogenism, but EE/CPA will not be recommended as a first-line COCP treatment by the pending PCOS guideline update, due to higher venous thrombotic events (VTE) risk in the general population. Later-generation progestins offer theoretical benefits, but better evidence on clinical outcomes is needed in women with PCOS.; Trial Registration: The protocol for the systematic review was registered prospectively in Prospero, CRD42022345640. (© The Author(s) 2023. Published by Oxford University Press on behalf of European Society of Endocrinology.)

Fort, D., et al. (2023). "Tackling childbirth-related intrusive memories with a single-session behavioural intervention involving a visuospatial task: Protocol for a single-blind, waitlist-controlled randomised trial." BMJ Open 13(5): e073874.
	Introduction Approximately 12.3% of mothers experience childbirth-related post-traumatic stress symptoms (CB-PTSS). However, evidence-based interventions to treat CB-PTSS are lacking. Intrusive memories (IM), a key CB-PTSS, are distressing and can trigger other PTSS by reliving the traumatic event. Emerging evidence shows that a behavioural intervention involving a visuospatial task (BI-VT) can reduce the number of IM and PTSS, supposedly by interfering with the reconsolidation of the trauma memory. This study aims to test the efficacy of a single-session BI-VT targeting IM to reduce the number of childbirth-related (CB-)IM and PTSS, in comparison to a waitlist control group (WCG). Methods and analysis In this multicentre, single-blind, randomised controlled trial being undertaken at one regional and one university hospital in Switzerland, 60 participants will be allocated to the Immediate Intervention Group (IIG), receiving the immediate intervention on day 15, and 60 participants to the WCG receiving the delayed intervention on day 30. All participants will report their CB-IM during the 2 weeks preimmediate and postimmediate intervention in diaries. The IIG will additionally report their CB-IM over weeks 5 and 6 postimmediate intervention. Self-report questionnaires will assess CB-PTSS at 2 weeks preimmediate and postimmediate intervention in both groups, and at 6 weeks postimmediate intervention in the IIG. A feedback questionnaire will evaluate the intervention acceptability. The primary outcome will be group differences in the number of CB-IM between the 2 weeks preimmediate and postimmediate intervention. Secondary outcomes will be CB-PTSS at 2 and 6 weeks postimmediate intervention, the number of CB-IM at weeks 5 and 6 postimmediate intervention, and intervention acceptability. Ethics and dissemination Ethical approval was granted by the Human Research Ethics Committee of the Canton of Vaud (study number 202200652). Participants will provide an informed consent before study participation. Results will be presented in peer-reviewed journals and at conferences. Trial registration number NCT05381155.Copyright © 2023 BMJ Publishing Group. All rights reserved.

Fraison, E., et al. (2020). "Metformin versus the combined oral contraceptive pill for hirsutism, acne, and menstrual pattern in polycystic ovary syndrome." The Cochrane Database of Systematic Reviews 8: CD005552.
	Background: Metformin has been proposed as possibly a safer and more effective long-term treatment than the oral contraceptive pill (OCP) in women with polycystic ovary syndrome (PCOS). It is important to directly compare the efficacy and safety of metformin versus OCP in the long-term treatment of women with PCOS. This is an update of a Cochrane Review comparing insulin sensitising agents with the OCP and only includes studies on metformin.; Objectives: To assess the effectiveness and safety of metformin versus the OCP (alone or in combination) in improving clinical, hormonal, and metabolic features of PCOS.; Search Methods: In August 2019 we searched the Cochrane Gynaecology and Fertility Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and CINAHL, the trial registers, handsearched references of the identified articles, and contacted experts in the field to identify additional studies.; Selection Criteria: We included randomised controlled trials (RCTs) of the use of metformin versus the OCP (alone or in combination) for women with PCOS.; Data Collection and Analysis: We used standard methods recommended by Cochrane. The primary review outcomes were the clinical parameters of hirsutism and adverse events, both severe (requiring stopping of medication), and minor. In the presence of substantial heterogeneity (I 2 statistic > 50), which could be explained by pre-specified subgroup analyses on the basis of BMI, we reported the subgroups separately.; Main Results: This is a substantive update. We identified 38 additional studies. We included 44 RCTs (2253 women), which comprised 39 RCTs on adult women (2047 women) and five RCTs on adolescent women (206 women). Evidence quality ranged from very low to low. The main limitations were risk of bias, imprecision and inconsistency. Metformin versus the OCP In adult women, we are uncertain of the effect of metformin compared to the OCP on hirsutism in subgroup body mass index (BMI) < 25 kg/m 2 (mean difference (MD) 0.38, 95% confidence interval (CI) -0.44 to 1.19, 3 RCTs, n = 134, I 2 = 50%, very low-quality evidence) and subgroup BMI > 30 kg/m 2 (MD -0.38, 95% CI -1.93 to 1.17; 2 RCTs, n = 85, I 2 = 34%, low-quality evidence). Metformin may be less effective in improving hirsutism compared to the OCP in the subgroup BMI 25 kg/m 2 to 30 kg/m 2 (MD 1.92, 95% CI 1.21 to 2.64, 5 RCTs, n = 254, I 2 = 0%, low-quality evidence). Metformin may increase severe gastro-intestinal adverse events rate compared to the OCP (Peto odds ratio (OR) 6.42, 95% CI 2.98 to 13.84, 11 RCTs, n = 602, I 2 = 0%, low-quality evidence). Metformin may decrease the incidence of severe other adverse events compared to the OCP (Peto OR 0.20, 95% CI 0.09 to 0.44, 8 RCTs, n = 363, I 2 = 0%, low-quality evidence). There were no trials reporting on minor adverse events. In adolescents, we are uncertain whether there is a difference between Metformin and the OCP, on hirsutism and adverse events. Metformin versus metformin combined with the OCP In adult women, metformin may be less effective in improving hirsutism compared to Metformin combined with the OCP (MD 1.36, 95% CI 0.62 to 2.11, 3 RCTs, n = 135, I 2 = 9%, low-quality evidence). We are uncertain if there was a difference between metformin and metformin combined with the OCP for severe gastro-intestinal adverse events (OR 0.74, 95% CI 0.21 to 2.53, 3 RCTs, n = 171, I 2 = 0%, low-quality evidence), or for severe other adverse events (OR 0.56, 95% CI 0.11 to 2.82, 2 RCTs, n = 109, I 2 = 44%, low-quality evidence). There were no trials reporting on minor adverse events. In adolescents, there were no trials for this comparison. The OCP versus metformin combined with the OCP In adult women, the OCP may be less effective in improving hirsutism compared to metformin combined with the OCP (MD 0.54, 95% CI 0.20 to 0.89, 6 RCTs, n = 389, I 2 = 1%, low-quality evidence). The OCP may decrease the incidence of severe gastro-intestinal adverse events compared to metformin combined with the OCP (OR 0.20, 95% CI 0.06 to 0.72 5 RCTs, n = 228, I 2 = 0%, low-quality evidence). We are uncertain if there is a difference between the OCP and metformin combined with the OCP for severe other adverse events (OR 1.61, 95% CI 0.49 to 5.37, 4 RCTs, n = 159, I 2 = 12%, low-quality evidence). The OCP may decrease the incidence of minor (gastro-intestinal) adverse events compared to metformin combined with the OCP (OR 0.06, 95% CI 0.01 to 0.44, 2 RCTs, n = 98, I 2 = 0%, low-quality evidence). In adolescents, we are uncertain whether there is a difference between the OCP, compared to metformin combined with the OCP, on hirsutism or adverse events.; Authors' Conclusions: In adult women with PCOS, metformin may be less effective in improving hirsutism compared to the OCP in the subgroup BMI 25 kg/m 2 to 30 kg/m 2 but we are uncertain if there was a difference between metformin and the OCP in subgroups BMI < 25 kg/m 2 and BMI > 30kg/m 2 . Compared to the OCP, metformin may increase the incidence of severe gastro-intestinal adverse events and decrease the incidence of severe other adverse events with no trials reporting on minor adverse events. Either metformin alone or the OCP alone may be less effective in improving hirsutism compared to metformin combined with the OCP. We are uncertain whether there is a difference between the OCP alone and metformin alone compared to metformin combined with the OCP for severe or minor adverse events except for the OCP versus metformin combined with the OCP where the OCP may decrease the incidence of severe and minor gastro-intestinal adverse events. In adolescent women with PCOS, we are uncertain whether there is a difference between any of the comparisons for hirsutism and adverse events due to either no evidence or very low-quality evidence. Further large well-designed RCTs that stratify for BMI are needed to evaluate metformin versus the OCP and combinations in women with PCOS, in particular adolescent women. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

France-Ratcliffe, M., et al. (2024). "Evaluating a multi-behavioural home-based intervention for reducing depressive symptoms in postnatal women : The food, move, sleep (FOMOS) for postnatal mental health randomised controlled trial protocol." Contemporary Clinical Trials 136: 107383.
	Background: Postnatal depression (PND) is a leading cause of illness and death among women following childbirth. Physical inactivity, sedentary behaviour, poor sleep, and sub-optimal diet quality are behavioural risk factors for PND. A feasible, sustainable, and scalable intervention to improve healthy behaviours and reduce PND symptoms among women at postpartum is needed. This study aims to examine the effectiveness of a multi-behavioural home-based program Food, Move, Sleep (FOMOS) for Postnatal Mental Health designed to improve PND symptoms in women at postpartum. Method(s): This randomised clinical trial will recruit 220 Australian women (2-12 months postpartum) experiencing heightened PND symptoms (Edinburgh Postnatal Depression Scale score >= 10). Participants will be randomised to FOMOS or wait-list control receiving standard clinical care. FOMOS is a 6-month mobile health (mHealth) intervention targeting diet quality, physical activity, sedentary behaviour, sleep, and mental health. The intervention, informed by the Social Cognitive Theory and incorporating behaviour change techniques defined in the CALO-RE taxonomy and Cognitive Behavioural Treatment of Insomnia, provides exercise equipment, and educational/motivational material and social support via mHealth and social media. Data collection pre-intervention and at 3, 6 and 12 months will assess the primary outcome of PND symptoms and secondary outcomes (diet quality, physical activity, sitting time, sleep quality) using self-report and device measures. Process evaluation will explore acceptability, appropriateness, cost-effectiveness, feasibility, and sustainability via analytic tools, record keeping, interviews, and surveys. Discussion(s): If effective, FOMOS could be a feasible and potentially scalable management strategy to support improvement of health behaviours and mental health for women with PND symptoms. Trial registration: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12622001079730pCopyright © 2023

Franco Rafael Ruiz, E., et al. (2022). "Systematic review of the treatment of recurrent ovarian granulosa cell tumor (GCT) in adult women." PROSPERO International prospective register of systematic reviews.
	
Frangou, E., et al. (2021). "OVPSYCH2: A randomized controlled trial of psychological support versus standard of care following chemotherapy for ovarian cancer." Gynecologic Oncology 162(2): 431-439.
	BACKGROUND: Fear of disease progression (FOP) is a rational concern for women with Ovarian Cancer (OC) and depression is also common. To date there have been no randomized trials assessing the impact of psychological intervention on depression and FOP in this patient group. PATIENTS AND METHODS: Patients with primary or recurrent OC who had recently completed chemotherapy were eligible if they scored between 5 and 19 on the PHQ-9 depression and were randomized 1:1 to Intervention (3 standardized CBT-based sessions in the 6-12 weeks post-chemotherapy) or Control (standard of care). PHQ-9, FOP-Q-SF, EORTC QLQ C30 and OV28 questionnaires were then completed every 3 months for up to 2 years. The primary endpoint was change in PHQ-9 at 3 months. Secondary endpoints were change in other scores at 3 months and all scores at later timepoints. RESULTS: 182 patients registered; 107 were randomized; 54 to Intervention and 53 to Control; mean age 59 years; 75 (70%) had completed chemotherapy for primary and 32 (30%) for relapsed OC and 67 patients completed both baseline and 3-month questionnaires. Improvement in PHQ-9 was observed for patients in both study arms at three months compared to baseline but there was no significant difference in change between Intervention and Control. A significant improvement on FOP-Q-SF scores was seen in the Intervention arm, whereas for those in the Control arm FOP-Q-SF scores deteriorated at 3 months (intervention effect = -4.4 (-7.57, -1.22), p-value = 0.008). CONCLUSIONS: CBT-based psychological support provided after chemotherapy did not significantly alter the spontaneously improving trajectory of depression scores at three months but caused a significant improvement in FOP. Our findings call for the routine implementation of FOP support for ovarian cancer patients.

Franik, S., et al. (2022). "Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome." The Cochrane Database of Systematic Reviews 9: CD010287.
	Background: Polycystic ovary syndrome (PCOS) is the most common cause of infrequent periods (oligomenorrhoea) and absence of periods (amenorrhoea). It affects about 5% to 20% of women worldwide and often leads to anovulatory infertility. Aromatase inhibitors (AIs) are a class of drugs that were introduced for ovulation induction in 2001. Since about 2001 clinical trials have reached differing conclusions as to whether the AI, letrozole, is at least as effective as the first-line treatment clomiphene citrate (CC), a selective oestrogen receptor modulator (SERM).; Objectives: To evaluate the effectiveness and safety of AIs (letrozole) (with or without adjuncts) compared to SERMs (with or without adjuncts) for infertile women with anovulatory PCOS for ovulation induction followed by timed intercourse or intrauterine insemination.; Search Methods: We searched the following sources, from their inception to 4 November 2021, to identify relevant randomised controlled trials (RCTs): the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase and PsycINFO. We also checked reference lists of relevant trials, searched the trial registers and contacted experts in the field for any additional trials. We did not restrict the searches by language or publication status.; Selection Criteria: We included all RCTs of AIs used alone or with other medical therapies for ovulation induction in women of reproductive age with anovulatory PCOS.; Data Collection and Analysis: Two review authors independently selected trials, extracted the data and assessed risks of bias using RoB 1. We pooled trials where appropriate using a fixed-effect model to calculate odds ratios (ORs) and 95% confidence intervals (CIs) for most outcomes, and risk differences (RDs) for ovarian hyperstimulation syndrome (OHSS). The primary outcomes were live birth rate and OHSS rate. Secondary outcomes were clinical pregnancy, miscarriage and multiple pregnancy rates. We assessed the certainty of the evidence for each comparison using GRADE methods.; Main Results: This is a substantive update of a previous review; of six previously included trials, we excluded four from this update and moved two to 'awaiting classification' due to concerns about validity of trial data. We included five additional trials for this update that now includes a total of 41 RCTs (6522 women). The AI, letrozole, was used in all trials. Letrozole compared to SERMs with or without adjuncts followed by timed intercourse Live birth rates were higher with letrozole (with or without adjuncts) compared to SERMs followed by timed intercourse (OR 1.72, 95% CI 1.40 to 2.11; I 2 = 0%; number needed to treat for an additional beneficial outcome (NNTB) = 10; 11 trials, 2060 participants; high-certainty evidence). This suggests that in women with a 20% chance of live birth using SERMs, the live birth rate in women using letrozole with or without adjuncts would be 27% to 35%. There is high-certainty evidence that OHSS rates are similar with letrozole or SERMs (0.5% in both arms: risk difference (RD) -0.00, 95% CI -0.01 to 0.01; I 2 = 0%; 10 trials, 1848 participants; high-certainty evidence). There is evidence for a higher pregnancy rate in favour of letrozole (OR 1.69, 95% CI 1.45 to 1.98; I 2 = 0%; NNTB = 10; 23 trials, 3321 participants; high-certainty evidence). This suggests that in women with a 24% chance of clinical pregnancy using SERMs, the clinical pregnancy rate in women using letrozole with or without adjuncts would be 32% to 39%. There is little or no difference between treatment groups in the rate of miscarriage per pregnancy (25% with SERMs versus 24% with letrozole: OR 0.94, 95% CI 0.66 to 1.32; I 2 = 0%; 15 trials, 736 participants; high-certainty evidence) and multiple pregnancy rate (2.2% with SERMs versus 1.6% with letrozole: OR 0.74, 95% CI 0.42 to 1.32; I 2 = 0%; 14 trials, 2247 participants; high-certainty evidence). However, a funnel plot showed mild asymmetry, indicating that some trials in favour of SERMs might be missing. Letrozole compared to la a oscopic ovarian drilling (LOD) One trial reported very low-certainty evidence that live birth rates may be higher with letrozole compared to LOD (OR 2.07, 95% CI 0.99 to 4.32; 1 trial, 141 participants; very low-certainty evidence). This suggests that in women with a 22% chance of live birth using LOD with or without adjuncts, the live birth rate in women using letrozole with or without adjuncts would be 24% to 47%. No trial reported OHSS rates. Due to the low-certainty evidence we are uncertain if letrozole improves pregnancy rates compared to LOD (OR 1.47, 95% CI 0.95 to 2.28; I² = 0%; 3 trials, 367 participants; low-certainty evidence). This suggests that in women with a 29% chance of clinical pregnancy using LOD with or without adjuncts, the clinical pregnancy rate in women using letrozole with or without adjuncts would be 28% to 45%. There seems to be no evidence of a difference in miscarriage rates per pregnancy comparing letrozole to LOD (OR 0.65, 95% CI 0.22 to 1.92; I² = 0%; 3 trials, 122 participants; low-certainty evidence). This also applies to multiple pregnancies (OR 3.00, 95% CI 0.12 to 74.90; 1 trial, 141 participants; very low-certainty evidence).; Authors' Conclusions: Letrozole appears to improve live birth rates and pregnancy rates in infertile women with anovulatory PCOS, compared to SERMs, when used for ovulation induction, followed by intercourse. There is high-certainty evidence that OHSS rates are similar with letrozole or SERMs. There was high-certainty evidence of no difference in miscarriage rate and multiple pregnancy rate. We are uncertain if letrozole increases live birth rates compared to LOD. In this update, we added good quality trials and removed trials with concerns over data validity, thereby upgrading the certainty of the evidence base. (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Frankowska, K., et al. (2024). "The Efficacy and Safety of Transvaginal Ethanol Sclerotherapy in the Treatment of Endometrial Cysts-A Systematic Review." International Journal of Molecular Sciences 25(2): 1337.
	Endometriosis, as a chronic disorder that is a source of severe pain ailments and infertility, requires a comprehensive therapeutic approach. Sclerotherapy, consisting of the administration of sclerosing agents into the cyst, is a constantly evolving minimally invasive treatment method for this disease. Hence, the main objective of this systematic review was to evaluate the impact of its most often used variant, transvaginal ethanol sclerotherapy, on endometriosis-related symptoms, endometrial cyst recurrence rate, ovarian reserve, assisted reproductive technology (ART) outcomes, and pregnancy outcomes, as well as to assess potential complications resulting from this treatment. This systematic review was undertaken using PubMed, Scopus, Web of Science, and Cochrane Library databases on 24 November 2023. The risk of bias in included studies was assessed with the use of the Newcastle-Ottawa scale (NOS) and the revised Cochrane risk of bias 2.0 tool for randomized controlled trials. From the 1141 records obtained from all databases, 16 studies have been included in this review. The use of ethanol sclerotherapy was characterized by a low rate of post-procedural complications. The recurrence rate of endometrial cysts after the procedure depended on the ethanol instillation time within the cyst. Although ethanol sclerotherapy had negligible influence on ovarian reserves when compared to laparoscopic cystectomy, the effects of both these methods on pregnancy outcomes were comparable. This review identifies that sclerotherapy is safe, provides significant relief of symptoms, and does not impair the reproductive potential of the patients.Copyright © 2024 by the authors.

Frederice Claudia, P., et al. (2021). "Interventional treatment for myofascial pelvic floor pain in women: systematic review with meta-analysis." International Urogynecology Journal 32(5): 1087-1096.
	Introduction and Hypothesis: Female myofascial pain (MFP) of the pelvic floor muscles (PFM) is a subtype of chronic pelvic pain associated with urinary, anorectal, and sexual symptoms, such as dyspareunia. Treatment remains poorly discussed, and we hypothesized that different treatments could improve outcomes versus placebo or no treatment.; Methods: A systematic review (CRD 42020201419) was performed in June 2020 using the following databases: PubMed, Cochrane Library, Web of Science, Embase, Scopus, BVSalud, Clinicaltrials.gov , and PEDro, including randomized clinical trials related to MPF of PFM. Primary outcome was pain after treatment, and secondary outcomes were quality of life and sexual function. Risk of bias and quality of evidence (GRADE criteria) were evaluated. Meta-analysis for continuous variables was performed (mean difference between baseline and treatment and post-treatment mean between groups).; Results: Five studies were included (n = 218). Final mean VAS score (GRADE: very low) after 4 weeks of treatment (p = 0.14) and the mean difference from baseline and 4 weeks (p = 0.66) between groups were not different between the intervention and control groups. Quality of life according to the SF-12 questionnaire (GRADE: very low) followed the same pattern. However, sexual function (GRADE: low) according to the total FSFI score (MD = -5.07 [-8.31, -1.84], p < 0.01, i 2 = 0%) and the arousal, orgasm, and pain domains improved in the intervention groups when the mean difference from baseline and 4 weeks was compared with controls.; Conclusion: Pain and quality of life after 4 weeks of heterogeneous intervention differed between the intervention and control groups in sexual function: FSFI in studies improved in almost all domains. VAS (in three studies) and SF-12 (in two studies) failed to demonstrate differences.

Freites, J., et al. (2019). "Laparoscopic colposuspension for urinary incontinence in women." The Cochrane Database of Systematic Reviews 2019(12): CD002239.
	Background: Laparoscopic colposuspension was one of the first minimal access operations for treating stress urinary incontinence in women, with the presumed advantages of shorter hospital stays and quicker return to normal activities. This Cochrane Review was last updated in 2010. Objective(s): To assess the effects of laparoscopic colposuspension for urinary incontinence in women; and summarise the principal findings of relevant economic evaluations of these interventions. Search Method(s): We searched the Cochrane Incontinence Specialised Register (22 May 2019), which contains trials identified from CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings. Selection Criteria: Randomised controlled trials of women with urinary incontinence that included laparoscopic surgery in at least one arm. Data Collection and Analysis: We independently extracted data from eligible trials, assessed risk of bias and implemented GRADE. Main Result(s): We included 26 trials involving 2271 women. Thirteen trials (1304 women) compared laparoscopic colposuspension to open colposuspension and nine trials (412 women) to midurethral sling procedures. One trial (161 women) compared laparoscopic colposuspension with one suture to laparoscopic colposuspension with two sutures; and three trials (261 women) compared laparoscopic colposuspension with sutures to laparoscopic colposuspension with mesh and staples. The majority of trials did not follow up participants beyond 18 months. Overall, there was unclear risk of selection, performance and detection bias and generally low risk of attrition and reporting bias. There is little difference between laparoscopic colposuspension using sutures and open colposuspension for subjective cure within 18 months (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.99 to 1.08; 6 trials, 755 women; high-quality evidence). We are uncertain whether laparoscopic colposuspension using mesh and staples is better or worse than open colposuspension for subjective cure within 18 months (RR 0.75, 95% CI 0.61 to 0.93; 3 trials, 362 women; very low-quality evidence) or whether there is a greater risk of repeat continence surgery with laparoscopic colposuspension. Laparoscopic colposuspension may have a lower risk of perioperative complications (RR 0.67, 95% CI 0.47 to 0.94; 11 trials, 1369 women; low-quality evidence). There may be similar or higher rates of bladder perforations with laparoscopic colposuspension (RR 1.72, 95% CI 0.90 to 3.29; 10 trials, 1311 women; moderate-quality evidence). Rates for de novo detrusor overactivity (RR 1.29, 95% CI 0.72 to 2.30; 5 trials, 472 women) and voiding dysfunction (RR 0.81, 95% CI 0.50 to 1.31; 5 trials, 507 women) may be similar but we are uncertain due to the wide confidence interval. Five studies reported on quality of life but we could not synthesise the data. There may be little difference between laparoscopic colposuspension using sutures and tension-free vaginal tape (TVT) for subjective cure within 18 months (RR 1.01, 95% CI 0.88 to 1.16; 4 trials, 256 women; low-quality evidence) or between laparoscopic colposuspension using mesh and staples and TVT (RR 0.71, 95% CI 0.55 to 0.91; 1 trial, 121 women; low-quality evidence). For laparoscopic colposuspension compared with midurethral slings, there may be lower rates of repeat continence surgery (RR 0.40, 95% CI 0.04 to 3.62; 1 trial, 70 women; low-quality evidence) and similar risk of perioperative complications (RR 0.99, 95% CI 0.60 to 1.64; 7 trials, 514 women; low-quality evidence) but we are uncertain due to the wide confidence intervals. There may be little difference in terms of de novo detrusor overactivity (RR 0.80, 95% CI 0.34 to 1.88; 4 trials, 326 women; low-quality evidence); and probably little difference in terms of voiding dysfunction (RR 1.06, 95% CI 0.47 to 2.41; 5 trials, 412 women; moderate-quality evidence) although we are uncertain due to the wide confidence interval. Five studies reported on q ality of life but we could not synthesise the data. No studies reported on bladder perforations. Low-quality evidence indicates that there may be higher subjective cure rates within 18 months with two sutures compared to one suture (RR 1.37, 95% CI 1.14 to 1.64; 1 trial, 158 women). Comparing one suture and two sutures, one suture may have lower rates of repeat continence surgery (RR 0.35, 95% CI 0.01 to 8.37; 1 trial, 157 women) and similar risk of perioperative complications (RR 0.88, 95% CI 0.45 to 1.70) but we are uncertain due to the wide 95% CIs. There may be higher rates of voiding dysfunction with one suture compared to two sutures (RR 2.82; 95% CI 0.30 to 26.54; 1 trial, 158 women; low-quality evidence), but we are uncertain due to the wide confidence interval. This trial did not report bladder perforations, de novo detrusor overactivity or quality of life. We are uncertain whether laparoscopic colposuspension with sutures is better or worse for subjective cure within 18 months compared to mesh and staples (RR 1.24, 95% CI 0.96 to 1.59; 2 trials, 180 women; very low-quality evidence) or in terms of repeat continence surgery (RR 0.97, 95% CI 0.06 to 14.91; 1 trial, 69 women; very low-quality evidence). Laparoscopic colposuspension with sutures may increase the number of perioperative complications compared to mesh and staples (RR 1.94, 95% CI 1.09 to 3.48; 3 trials, 260 women; low-quality evidence) but rates of de novo detrusor overactivity may be similar (RR 0.72, 95% CI 0.17 to 3.06; 2 trials, 122 women; low-quality evidence), however, we are uncertain due to the wide confidence interval. None of the studies reported bladder perforations, voiding dysfunction or quality of life. Authors' conclusions: The data indicate that, in terms of subjective cure of incontinence within 18 months, there is probably little difference between laparoscopic colposuspension and open colposuspension, or between laparoscopic colposuspension and midurethral sling procedures. Much of the evidence is low quality, meaning that a considerable degree of uncertainty remains about laparoscopic colposuspension. Future trials should recruit adequate numbers, conduct long-term follow-up and measure clinically important outcomes. A brief economic commentary identified three studies. We have not quality-assessed them and they should be interpreted in light of the findings on clinical effectiveness.Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Freund-Levi, Y. (2022). "Can the Use of Uricap Female Device Lead to Better Care for Women > 75+Years?" ClinicalTrials.gov.
	The aim is to improve the care for female patients in long‐term nursing homes who suffer from UI and to prevent recurrent urinary tract infections (UTIs). The project organization consist of researchers within primary care, geriatrics and nursing sciences. The investigators will recruit study participants with UI from long‐term nursing homes in Örebro County that will be randomized in an open randomised controlled trial to an intervention or a control group. The intervention will last for 3 months. The study participants will receive a structured medical assessment before and after the intervention, including assessment of the patient's cognitive functions, genital skin status, neuropsychiatric symptoms and quality of life (QoL). The uridome is changed daily while the control group will receive usual incontinence treatment. The investigators will study the number of UTIs during the intervention period, analyze inflammatory cytokines in urine using OLINK proteomics and ELISA to study inflammation. Health economic analysis will be performed. The investigators believe that treatment with Uricap Female will be more effective in preventing recurrent UTIs, improve genital skin status, cognitive status and neuropsychiatric symptoms and QoL for the women. This will directly lead to individualised care and less strain on primary care resources.

Freyer, G. (2021). "Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer." ClinicalTrials.gov.
	Phase II, randomized, open label, multicenterstudy. Randomization on a 1:1 ratio, stratification performed according to: BRCA status (local assessment) FIGO stage at diagnosis (IIIA versus IIIB/IIIC) Previous hyperthermic intraperitoneal chemotherapy (yes/no).

Frydman, N. (2021). "Efficiency of Comprehensive Chromosomal Testing of Trophectoderm Biopsies of Blastocysts in In Vitro Fertilization." ClinicalTrials.gov.
	No Results Available Procedure: Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts (CTTEB) Number of live birth|Number of live birth taking in consideration further single frozen-thawed blastocyst cycles|Biological ICSI parameters|Pregnancy outcome|Ratio between the proportion of women with live birth and days after randomization|Cost of the procedure|Efficiency of non-invasive chromosomal testing|obstetrical parameters|Perinatal parameters: All Not Applicable 700 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment APHP 200006 January 2026

Fu, L.-L., et al. (2023). "Efficacy of granulocyte colony-stimulating factor for infertility undergoing IVF: a systematic review and meta-analysis." Reproductive Biology and Endocrinology 21(1): 34.
	Objective: This study aimed to evaluate the effectiveness of granulocyte colony-stimulating factor (G-CSF) for infertility and recurrent spontaneous abortion.; Methods: Existing research was searched in PubMed, Embase and Cochrane Library till Dec 2021. Randomized control trials (RCTs) that compared G-CSF administration with the control group in infertility women undergoing IVF were included. The primary outcomes included clinical pregnancy rate; the secondary outcomes included live birth rate, abortion ratebiochemical pregnancy rate, embryo implantation rate, as well as endometrial thickness.; Result(s): 20 RCTs were included in this study. G-CSF increased the clinical pregnancy rate (RR = 1.85; 95% CI: 1.07, 3.18) and the endometrial thickness (MD = 2.25; 95% CI: 1.58,2.92;) in patients with thin endometrium undergoing IVF. G-CSF increased the biochemical pregnancy rate (RR = 2.12; 95% CI: 1.54, 2.93), the embryo implantation rate (RR = 2.51; 95% CI: 1.82, 3.47) and the clinical pregnancy rate (RR = 1.93; 95% CI: 1.63, 2.29) in patients with a history of repeated implantation failure undergoing IVF. No differences were found in pregnancy outcomes of general IVF patients.; Conclusions: Granulocyte colony-stimulating factor is likely to be a potential option for infertility women undergoing IVF with thin endometrium or recurrent implantation failure .; Trial Registration: Retrospectively registered (The PROSPERO registration number: CRD42022360161). (© 2023. The Author(s).)

Fu, P., et al. (2022). "treatments for women with cesarean scar pregnancy: a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Fuentes-Aparicio, L., et al. (2023). "The effect of an abdominopelvic exercise program alone VS in addition to postural instructions on pelvic floor muscle function in climacteric women with stress urinary incontinence. A randomized controlled trial." Physiotherapy Theory and Practice 39(4): 738-749.
	INTRODUCTION: Scarce literature exists regarding the influence of posture-based interventions for the treatment of stress urinary incontinence (SUI). OBJECTIVE(S): The aim of this randomized controlled trial with two parallel groups was to investigate whether the addition of postural instructions to a 12-week abdominopelvic exercise program is superior to an abdominopelvic exercise program alone, in terms of PFMs function and symptoms in climacteric women with SUI. METHOD(S): Climacteric women aged between 40-75 years old who presented with SUI were included in this parallel study (NCT03727945). Two randomized groups performing one 40-minutes session per week for 12-weeks were compared: one performing an abdominopelvic exercise program (AEP) and a second one performing the same intervention with the addition of postural instructions (AEPPI). PFMs electromyographical (EMG) activity and strength (Oxford Grading Scale) were quantified during a maximal voluntary contraction. SUI symptoms were assessed using a 3-day bladder diary. These outcomes were collected at baseline, immediately after intervention, and 3-months after the intervention. RESULT(S): A total of 47 women were included in the study (AEP [n = 23], AEPPI [n = 24]). Between-group analysis showed significant differences for post-intervention EMG and strength values, showing higher values for the AEPPI compared to the AEP group. At 3-months follow-up, statistically significant differences were only obtained in strength, with higher values in the AEPPI group. No significant differences were obtained in terms of UI symptoms. CONCLUSION(S): A 12-session abdominopelvic exercise program supplemented with postural instructions is superior to an abdominopelvic exercise program alone in terms of PFMs function in women with SUI.

Fufeng, L. and G. Zhijuan (2022). "Diffrent ovarian stimulation protocols in diminished ovarian reserve patients undergoing IVF/ICSI: a network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Fufeng, L. and G. Zhijuan (2022). "Effects of Zishen Yutai Pills for patients with diminished ovarian reserve: a meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Fujia, J., et al. (2022). "Effect of Chinese herbal medicine for promoting circulation on dysmenorrhea: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Fundació Sant Joan de, D. (2021). "A Phase II, randomised, multi-centric, multi-national clinical trial to evaluate the efficacy, tolerability, and safety of a fixed dose combination of Spironolactone, Pioglitazone & Metformin (SPIOMET) for adolescent girls and young adult women (AYAs) with polycystic ovary syndrome (PCOS)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: SPIOMET Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Spironolactone CAS Number: 52‐01‐7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ INN or Proposed INN: Pioglitazone CAS Number: 111025‐46‐8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7.5‐ INN or Proposed INN: Metformin CAS Number: 657‐24‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 850‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: SPIO Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Spironolactone CAS Number: 52‐01‐7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ INN or Proposed INN: Pioglitazone CAS Number: 111025‐46‐8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7.5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: PIO Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Pioglitazone CAS Number: 111025‐46‐8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7.5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Polycystic Ovary Syndrome (PCOS) ; MedDRA version: 21.1 Level: LLT Classification code 10065161 Term: Polycystic ovarian syndrome 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 test the efficacy of SPIOMET in normalising ovulation in adolescents and young adult women with PCOS. Primary end point(s): On‐treatment and post‐treatment ovulation rate. Secondary Objective: To test the efficacy of SPIOMET in normalising the endocrine‐metabolic status, body composition and abdominal fat distribution, on‐treatment and post‐treatment; to assess the safety of SPIOMET and the; adherence and subjective acceptability, and the quality of life of participating subjects. Timepoint(s) of evaluation of this end point: Following end of each two 12‐week on‐treatment periods (month 0‐3 and month 9‐12), and following the end of post‐treatment period (month 12‐15) SECONDARY OUTCOME: Secondary end point(s): 1. Clinical variables: hirsutism (modified Ferriman & Gallwey score), Acne (evaluated using the Leeds Acne Grading Scale), menstrual regularity (3,17); 2. Endocrine‐metabolic variables:; • Circulating androgens: total testosterone, SHBG, free androgen index (FAI),; androstenedione;; • Lipids ‐ total cholesterol, low‐density lipoprotein (LDL‐cholesterol), high‐density lipoprotein; (HDL‐ cholesterol), triglycerides; ; • Insulinaemia: fasting and 2 hours after a 75‐gr oral glucose load [oral glucose tolerance test (oGTT). Estimation of insulin resistance from fasting insulin and glucose levels using the homeostasis model assessment (HOMA);; • Markers of inflammation & insulin sensitivity: ultra‐sensitive C‐reactive protein (us‐CRP); growth‐and‐ differentiation factor‐15 (GDF15); high molecular weight adiponectin (HMW‐adip), C‐X‐C motif chemokine ligand 14 (CXCL14) (69,81);; 3. Epigenetic variable: circulating microRNA 451‐a; (miR‐451a) concentrations (88);; 4. Imaging variables:; • Cardiovascular risk – cIMT (ultrasound);; • Body composition: dual‐energy X‐ray absorptiometry (DXA);; • Abdominal fat distribution (subcutaneous and; visceral) and hepatic fat (MRI);; 5. Lifestyle assessment:; • Body composition, abdominal fat distribution (waist circumference, Waist to hip ratio (WHR), and hepatic fat by MRI) and weight status;; • Improvement of co‐morbidities and health behaviour (SF‐36, PCOSQ, modified self reported health ; ehaviour in school‐aged children questionnaire (HBSC‐Q); • Minimisation of ad rse side effects (i.e., “Sick‐Control‐One‐Fat‐Food” (SCOFF) + Binge; Eating Disorder Screener 7 (BEDS‐7) questionnaires to assess the risk of eating disorders; of risk confirmed, then, the EDE‐Q will be used); • Improvement of HRQoL;; 6. Safety variables:; • Blood count, electrolyte panel, urea, alanine transaminase (ALT), aspartate transaminase (AST), gamma‐glutamyltransferase (GGT), creatinine, vitamin B12 and folic acid;; • Report of AEs;; 7. Adherence and acceptability:; • Adherence will be calculated as the ratio between the number of tablets prescribed and dispensed for the period between hospital appointments and the number of tablets returned by the patient at the following appointment;; • Acceptability of the tablet by the study patients;; 8. PROMs & HRQoL: generic (SF‐36) and specific (PCOSQ) questionnaires Timepoint(s) of evaluation of this end point: As defined per protocol. INCLUSION CRITERIA: 1. Age range within the AYAs category (> 12.0 years and = 23.9 years at study start); 2. Gynaecological age of 2 years or more; 3. Clinical androgen excess, as defined by the presence of hirsutism (modified Ferriman‐Gallwey score = 4) and/or inflammatory acne (Leeds scale) unresponsive to medications. The scarce normative data existing in adolescents suggest that an adult level of hirsutism is reached around 2 years after menarche; 4. Biochemical androgen excess, as defined by increased total testosterone (=50 ng/dL), and/or a FAI higher than 3.5 [FAI, total testosterone (nmol/L) x 100/SHBG (nmol/L)], in the follicular phase of the cycle (days 3–7) or after 2 months of amenorrhea; 5. Menstrual irregularity, as defined by = 8 menses per year corresponding to an average intermenstrual time of =45 days; 6. Written informed consent obtained from the patient, or assent from the patient and consent by the parents or the legally acceptable representative

Furusawa, A., et al. (2021). "A randomized phase III trial of adjuvant chemotherapy versus concurrent chemoradiotherapy for postoperative cervical cancer: Japanese Gynecologic Oncology Group study (JGOG1082)." International Journal of Gynecological Cancer 31(4): 623-626.
	BACKGROUND: The standard treatment for stage IB-IIB cervical cancer is radiotherapy or radical hysterectomy; after radical hysterectomy, adjuvant concurrent chemoradiotherapy is recommended for patients with high risk factors. However, adjuvant concurrent chemoradiotherapy can cause severe gastrointestinal and urinary toxicity. PRIMARY OBJECTIVE: To assess whether postoperative adjuvant chemotherapy is not inferior to adjuvant concurrent chemoradiotherapy for overall survival in patients with high risk cervical cancer. STUDY HYPOTHESIS: Adjuvant chemotherapy is not inferior to adjuvant concurrent chemoradiotherapy for overall survival and will reduce severe toxicities. TRIAL DESIGN: Patients with high risk factors after radical hysterectomy will be randomized 1:1 to receive adjuvant concurrent chemoradiotherapy or adjuvant chemotherapy. Treatment will be started within 6 weeks of surgery. The concurrent chemoradiotherapy group will receive whole pelvis irradiation (50.4 Gy) and cisplatin (40 mg/m2/week). The chemotherapy group will receive paclitaxel (175 mg/m2) plus cisplatin (50 mg/m2) or carboplatin (AUC=6) every 3 weeks for six cycles. MAJOR INCLUSION/EXCLUSION CRITERIA: Patients with high risk stage IB-IIB cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma) who underwent radical hysterectomy are eligible for the study. High risk is defined as the presence of pelvic lymph node metastasis and/or parametrial invasion. PRIMARY ENDPOINT: The primary endpoint is overall survival. SAMPLE SIZE: 250 patients in total are required. ESTIMATED DATES FOR COMPLETING ACCRUAL: This study began in November 2019, and 250 patients will be accrued within 5 years. TRIAL REGISTRATION NUMBER: The study has been registered with the Japan Registry of Clinical Trials (jRCTs041190042).

Gabby, S., et al. (2022). "A systematic review and meta-analysis of ingested complementary, alternative, and traditional remedies to improve the symptoms of endometriosis." PROSPERO International prospective register of systematic reviews.
	
Gabriel, L., et al. (2021). "Intrauterine manipulator and oncological outcome in endometrial cancer surgery: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Gabriela, P., et al. (2021). "Nutritional strategies to treat exercise-induced menstrual disturbance: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Gaddam Neha, G. (2023). "PRP Injections for Genitourinary Syndrome of Menopause." ClinicalTrials.gov.
	Platelet‐rich plasma (PRP) is autologous blood which has been centrifuged to separate the supernatant resulting in a solution with high concentration of platelets. Injection of PRP stimulates cell growth and can has been proven safe and effective for uses in orthopedics, dermatology, and gynecology. Despite the relative paucity of data, the use of PRP as a therapy for sexual dysfunction and genitourinary symptoms in the setting of menopause has been patented as the O‐Shot and V‐Shot. This is a single‐blinded randomized control trial to determine if PRP injections into the anterior vaginal wall improve sexual functioning in women diagnosed with the genitourinary syndrome of menopause (GSM) characterized by vaginal dryness/irritation.

Gaetano, R., et al. (2023). "Ovarian suppression protocols before assisted reproduction techniques in women with endometriosis: systematic review and network meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Gaillard, S., et al. (2021). "Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL)." Gynecologic Oncology 163(2): 237-245.
	OBJECTIVE: The randomized phase 3 CORAIL trial evaluated whether lurbinectedin improved progression-free survival (PFS) compared to pegylated liposomal doxorubicin (PLD) or topotecan in patients with platinum-resistant ovarian cancer. METHODS: Patients were randomly assigned (1:1) to lurbinectedin 3.2 mg/m2 1-h i.v. infusion q3wk (experimental arm), versus PLD 50 mg/m2 1-h i.v. infusion q4wk or topotecan 1.50 mg/m2 30-min i.v. infusion Days 1-5 q3wk (control arm). Stratification factors were PS (0 vs. ≥1), prior PFI (1-3 months vs. >3 months), and prior chemotherapy lines (1-2 vs. 3). The primary endpoint was PFS by Independent Review Committee in all randomized patients. This study was registered with ClinicalTrials.gov, NCT02421588. RESULTS: 442 patients were randomized: 221 in lurbinectedin arm and 221 in control arm (127 PLD and 94 topotecan). With a median follow-up of 25.6 months, median PFS was 3.5 months (95% CI, 2.1-3.7) in the lurbinectedin arm and 3.6 months (95% CI, 2.7-3.8) in the control arm (stratified log-rank p = 0.6294; HR = 1.057). Grade ≥ 3 treatment-related adverse events (AEs) were most frequent in the control arm: 64.8% vs. 47.9% (p = 0.0005), mainly due to hematological toxicities. The most common grade ≥ 3 AEs were: fatigue (7.3% of patients) and nausea (5.9%) with lurbinectedin; mucosal inflammation (8.5%) and fatigue (8.0%) in the control arm. CONCLUSIONS: The primary endpoint of improvement in PFS was not met. Lurbinectedin showed similar antitumor efficacy and was better tolerated than current standard of care in patients with platinum-resistant ovarian cancer.

Gaitskell, K., et al. (2023). "Angiogenesis inhibitors for the treatment of epithelial ovarian cancer." The Cochrane Database of Systematic Reviews 4: CD007930.
	Background: Many women, and other females, with epithelial ovarian cancer (EOC) develop resistance to conventional chemotherapy drugs. Drugs that inhibit angiogenesis (development of new blood vessels), essential for tumour growth, control cancer growth by denying blood supply to tumour nodules.; Objectives: To compare the effectiveness and toxicities of angiogenesis inhibitors for treatment of epithelial ovarian cancer (EOC).; Search Methods: We identified randomised controlled trials (RCTs) by searching CENTRAL, MEDLINE and Embase (from 1990 to 30 September 2022). We searched clinical trials registers and contacted investigators of completed and ongoing trials for further information.; Selection Criteria: RCTs comparing angiogenesis inhibitors with standard chemotherapy, other types of anti-cancer treatment, other angiogenesis inhibitors with or without other treatments, or placebo/no treatment in a maintenance setting, in women with EOC. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Our outcomes were overall survival (OS), progression-free survival (PFS), quality of life (QoL), adverse events (grade 3 and above) and hypertension (grade 2 and above).; Main Results: We identified 50 studies (14,836 participants) for inclusion (including five studies from the previous version of this review): 13 solely in females with newly-diagnosed EOC and 37 in females with recurrent EOC (nine studies in platinum-sensitive EOC; 19 in platinum-resistant EOC; nine with studies with mixed or unclear platinum sensitivity). The main results are presented below. Newly-diagnosed EOC Bevacizumab, a monoclonal antibody that binds vascular endothelial growth factor (VEGF), given with chemotherapy and continued as maintenance, likely results in little to no difference in OS compared to chemotherapy alone (hazard ratio (HR) 0.97, 95% confidence interval (CI) 0.88 to 1.07; 2 studies, 2776 participants; moderate-certainty evidence). Evidence is very uncertain for PFS (HR 0.82, 95% CI 0.64 to 1.05; 2 studies, 2746 participants; very low-certainty evidence), although the combination results in a slight reduction in global QoL (mean difference (MD) -6.4, 95% CI -8.86 to -3.94; 1 study, 890 participants; high-certainty evidence). The combination likely increases any adverse event (grade ≥ 3) (risk ratio (RR) 1.16, 95% CI 1.07 to 1.26; 1 study, 1485 participants; moderate-certainty evidence) and may result in a large increase in hypertension (grade ≥ 2) (RR 4.27, 95% CI 3.25 to 5.60; 2 studies, 2707 participants; low-certainty evidence). Tyrosine kinase inhibitors (TKIs) to block VEGF receptors (VEGF-R), given with chemotherapy and continued as maintenance, likely result in little to no difference in OS (HR 0.99, 95% CI 0.84 to 1.17; 2 studies, 1451 participants; moderate-certainty evidence) and likely increase PFS slightly (HR 0.88, 95% CI 0.77 to 1.00; 2 studies, 2466 participants; moderate-certainty evidence). The combination likely reduces QoL slightly (MD -1.86, 95% CI -3.46 to -0.26; 1 study, 1340 participants; moderate-certainty evidence), but it increases any adverse event (grade ≥ 3) slightly (RR 1.31, 95% CI 1.11 to 1.55; 1 study, 188 participants; moderate-certainty evidence) and may result in a large increase in hypertension (grade ≥ 3) (RR 6.49, 95% CI 2.02 to 20.87; 1 study, 1352 participants; low-certainty evidence). Recurrent EOC (platinum-sensitive) Moderate-certainty evidence from three studies (with 1564 participants) indicates that bevacizumab with chemotherapy, and continued as maintenance, likely results in little to no difference in OS (HR 0.90, 95% CI 0.79 to 1.02), but likely improves PFS (HR 0.56, 95% CI 0.50 to 0.63) compared to chemotherapy alone. The combination may result in little to no difference in QoL (MD 0.8, 95% CI -2.11 to 3.71; 1 study, 486 participants; low-certainty evidence), but it increases the rate of any adverse event (grade ≥ 3) slightly (RR 1.11, 1.07 to 1.16; 3 studies, 1538 participants; high-certainty evidenc ). Hypertension (grade ‰¥ 3) was more common in arms with bevacizumab (RR 5.82, 95% CI 3.84 to 8.83; 3 studies, 1538 participants). TKIs with chemotherapy may result in little to no difference in OS (HR 0.86, 95% CI 0.67 to 1.11; 1 study, 282 participants; low-certainty evidence), likely increase PFS (HR 0.56, 95% CI 0.44 to 0.72; 1 study, 282 participants; moderate-certainty evidence), and may have little to no effect on QoL (MD 6.1, 95% CI -0.96 to 13.16; 1 study, 146 participants; low-certainty evidence). Hypertension (grade ≥ 3) was more common with TKIs (RR 3.32, 95% CI 1.21 to 9.10). Recurrent EOC (platinum-resistant) Bevacizumab with chemotherapy and continued as maintenance increases OS (HR 0.73, 95% CI 0.61 to 0.88; 5 studies, 778 participants; high-certainty evidence) and likely results in a large increase in PFS (HR 0.49, 95% CI 0.42 to 0.58; 5 studies, 778 participants; moderate-certainty evidence). The combination may result in a large increase in hypertension (grade ≥ 2) (RR 3.11, 95% CI 1.83 to 5.27; 2 studies, 436 participants; low-certainty evidence). The rate of bowel fistula/perforation (grade ≥ 2) may be slightly higher with bevacizumab (RR 6.89, 95% CI 0.86 to 55.09; 2 studies, 436 participants). Evidence from eight studies suggest TKIs with chemotherapy likely result in little to no difference in OS (HR 0.85, 95% CI 0.68 to 1.08; 940 participants; moderate-certainty evidence), with low-certainty evidence that it may increase PFS (HR 0.70, 95% CI 0.55 to 0.89; 940 participants), and may result in little to no meaningful difference in QoL (MD ranged from -0.19 at 6 weeks to -3.40 at 4 months). The combination increases any adverse event (grade ≥ 3) slightly (RR 1.23, 95% CI 1.02 to 1.49; 3 studies, 402 participants; high-certainty evidence). The effect on bowel fistula/perforation rates is uncertain (RR 2.74, 95% CI 0.77 to 9.75; 5 studies, 557 participants; very low-certainty evidence).; Authors' Conclusions: Bevacizumab likely improves both OS and PFS in platinum-resistant relapsed EOC. In platinum-sensitive relapsed disease, bevacizumab and TKIs probably improve PFS, but may or may not improve OS. The results for TKIs in platinum-resistant relapsed EOC are similar. The effects on OS or PFS in newly-diagnosed EOC are less certain, with a decrease in QoL and increase in adverse events. Overall adverse events and QoL data were more variably reported than were PFS data. There appears to be a role for anti-angiogenesis treatment, but given the additional treatment burden and economic costs of maintenance treatments, benefits and risks of anti-angiogenesis treatments should be carefully considered. (Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Gaitzsch, H., et al. (2020). "The effect of mind-body interventions on psychological and pregnancy outcomes in infertile women: a systematic review." Archives of Women's Mental Health 23(4): 479-491.
	Preliminary evidence suggests that mind-body interventions, including mindfulness-based interventions and yoga, may be effective in reducing mental health difficulties and psychological distress in infertile patients undergoing fertility treatments. We systematically reviewed and synthesized current medical literature of the effectiveness of mind-body interventions in reducing the severity of psychological distress and improving marital function and pregnancy outcomes in infertile women/couple. Databases including PsychINFO, PubMed, EMBASE, and the Cochrane Library were searched for relevant studies. Manual searches were conducted in relevant articles. We included 12 studies that met the inclusion criteria. Four studies were randomized controlled trials (RCT), 4 non-randomized controlled trial (NRCT), and 4 uncontrolled studies (UCT). Participation in a mind-body intervention was associated with reduced anxiety trait and depression scores. The reduction was of low or moderate amplitude in most studies. Our review offers evidence for the effectiveness of mind-body interventions in reducing anxiety state and depression in infertile women and a possible improvement in pregnancy rate. Further RCTs with a precise timing of intervention are needed.

Gan, J., et al. (2022). "Treatment outcomes of blastocysts thaw cycles, comparing the presence and absence of a corpus luteum: a systematic review and meta-analysis." BMJ Open 12(4): e051489.
	Purpose: This study aims to review the literature and perform a meta-analysis to determine if the presence of a corpus luteum has an impact on treatment outcomes in thaw cycles, where blastocyst embryos are transferred.; Method: PUBMED, EMBASE, CENTRAL and CINAHL were searched for papers published between January 2017 and 27 July 2020. Additional articles were selected from the reference list of the results and previous reviews. Three reviewers independently reviewed and extracted data. The meta-analysis was conducted though RevMan V.5.4.1. Studies were quality assessed with the Cochrane risk of bias tool and the Newcastle-Ottawa Scale.; Results: Nine publications were included for data extraction and subsequent meta-analysis. Two studies were randomised controlled trials, and seven were cohort studies. Subgroup analysis of the different study designs was performed. While the rates of positive human chorionic gonadotropin results (relative risk, RR 1.0, 95% CI 0.95 to 1.05) and clinical pregnancies (RR 1.06, 95% CI 0.96 to 1.18) were comparable between the two groups, the rates of live births were higher in thaw cycles with a corpus luteum (RR 1.14, 95% CI 1.06 to 1.22). Analysis of pregnancy losses demonstrated that both biochemical pregnancy (early miscarriage) (RR 0.71, 95% CI 0.62 to 0.82) and miscarriages (RR 0.72, 95% CI 0.62 to 0.83) were increased in cycles without a corpus luteum.; Conclusion: Where clinically appropriate, the use of cycle types that have a functional corpus luteum should be favoured. There were several limitations to this study, including the quality of studies and the inherent bias of retrospective cohort studies. Further, high-quality research, particularly randomised controlled trials with blastocysts embryos, is required to further explore these findings.; Prospero Registration Number: CRD42020209583.; 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.)

Gan, R., et al. (2023). "Time interval between hCG administration and oocyte retrieval and ART outcomes: an updated systematic review and meta-analysis." Reproductive Biology and Endocrinology 21(1): 61.
	Research Question: To explore whether prolonged hCG-ovum pickup interval improves assisted reproductive technology outcomes.; Design: CENTRAL, CNKI, Cochrane Systematic Reviews, EMBASE, MEDLINE, PUBMED, and Web of Science up to May 13 2023 were searched for studies reporting associations between hCG-ovum pickup intervals and assisted reproductive technology outcomes. Intervention types included short (≤ 36 h) and long (> 36 h) hCG-ovum pickup intervals in assisted reproductive technology cycles. All outcomes were based upon only fresh embryo transfers. Primary outcome is defined as the clinical pregnancy rate. Data were pooled using random-effects models. Heterogeneity was assessed using the I 2 statistics.; Results: Twelve studies were included in the meta-analysis, including five retrospective cohort studies, one prospective cohort study, and six randomized or quasi-randomized controlled trials. The short and long interval groups had similar oocyte maturation rates, fertilization rate and high-quality embryo rate (OR, 0.69; 95% CI, 0.45-1.06; I 2 = 91.1%, OR, 0.88; 95% CI, 0.77-1.0; I 2 = 44.4% and OR, 1.05; 95% CI, 0.95-1.17; I 2 = 8.6%, respectively). The clinical pregnancy rates in the long retrieval group were significantly higher than in the short retrieval group (OR, 0.66; 95% CI, 0.45-0.95; I 2 = 35.4%). The groups had similar miscarriage and live birth rates (OR, 1.92; 95% CI, 0.66-5.60; I 2 = 0.0% and OR, 0.50; 95% CI, 0.24-1.04; I 2 = 0.0%, respectively).; Conclusions: The clinical pregnancy rates can be increased by prolonging the hCG-ovum pickup interval, which would help us develop more reasonable time schedules for fertility centers and patients.; Meta-Analysis Registration: PROSPERO CRD42022310006 (28 Apr 2022). (© 2023. The Author(s).)

Gao, H., et al. (2021). "Uterine artery embolization, surgery and high intensity focused ultrasound in the treatment of uterine fibroids: a network meta-analysis." Quantitative Imaging in Medicine and Surgery 11(9): 4125-4136.
	Background: To systematic review the safety and effectiveness between uterine artery embolization (UAE), surgery and high intensity focused ultrasound (HIFU) in the treatment of uterine fibroids.; Methods: The PubMed, EMbase, The Cochrane Library, Web of Science, Wanfang Data, and CNKI were electronically searched to collect relevant studies on comparing the safety and effectiveness of UAE, surgery and HIFU in the treatment of uterine fibroids from January 2000 to August 2019. After two reviewers independently screened the literature, extracted the data and evaluated the risk of bias of included studies, network meta-analysis was performed by ADDIS 1.16.8 and Stata 14 software.; Results: A total of 11 studies (22 articles) involving 3,646 patients were included. Compared with surgery, UAE and HIFU patients had higher quality of life (1-year follow-up) improvement, and UAE was higher than HIFU. Network meta-analysis show that patients treated with HIFU had the lowest incidence of major complications within 1 year, followed by UAE, and the highest surgery. Patients treated with HIFU and UAE have shorter hospital stays and quicker recovery time than surgery. The rate of further intervention after surgery treatment might be lower than that of UAE and HIFU.; Conclusions: UAE has the highest quality of life improvement (1-year follow-up) for uterine fibroids. HIFU and UAE are safer with shorter hospital stays and quicker recovery time compared with surgery. However, both UAE and HIFU have the risks of re-treatment. However, limited by the number and quality of included studies, the above conclusions need to be verified through more high-quality studies.; Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/qims-20-1331). The authors have no conflicts of interest to declare. (2021 Quantitative Imaging in Medicine and Surgery. All rights reserved.)

Gao, H., et al. (2021). "The Effect of Vitamin D Supplementation on Blood Lipids in Patients with Polycystic Ovary Syndrome: A Meta-Analysis of Randomized Controlled Trials." International Journal of Endocrinology 2021: 8849688.
	Purpose. Studies have found that vitamin D supplementation may improve blood lipids in patients with polycystic ovary syndrome, but the results are controversial, so this study will further analyze the effect of vitamin D supplementation on blood lipids in patients with polycystic ovary syndrome. Methods. PubMed, Embase, Cochrane Library, CNKI, and Wanfang databases were searched up to May 2020, to identify randomized controlled trials of the effect of vitamin D supplementation on blood lipids in patients with polycystic ovary syndrome. The Cochrane risk of bias tool was applied to assess the risk of bias, and RevMan5.3 software was used for statistical analysis. Results. Ten studies were included in this study, including 543 subjects. The results of the meta-analysis showed that, compared with placebo, vitamin D supplementation can significantly reduce total cholesterol level (WMD =-11.32, 95% CI = [-14.51,-8.41], P<0.00001), low-density lipoprotein cholesterol level (WMD =-4.83, 95% CI = [-7.52,-2.14], P=0.0004), and triglyceride level (WMD =-8.23, 95% CI = [-13.08,-3.38], P=0.0009, but the effect on high-density lipoprotein cholesterol level is not statistically significant (WMD =-0.32, 95%CI = [-1.24, 0.60], P=0.50). Conclusion. Vitamin D supplementation can significantly reduce total cholesterol, low-density lipoprotein cholesterol, and triglycerides in patients with polycystic ovary syndrome. However, it has no significant effect on high-density lipoprotein cholesterol.Copyright © 2021 Hong Gao et al.

Gao, L., et al. (2021). "Quantitative Analysis of the Efficacy of PARP Inhibitors as Maintenance Therapy in Recurrent Ovarian Cancer." Frontiers in Pharmacology 12: 771836.
	Objective: This study aimed to establish a pharmacodynamic model and to screen reasonable covariates to quantitatively describe the efficacy of poly (ADP-ribose) polymerase inhibitors (PARPis) as maintenance treatment for recurrent ovarian cancer (ROC). Method(s): The log normal hazard function model was established by using progression-free survival (PFS) data of 1,169 patients from published randomized trials on FDA-approved PARP inhibitors (olaparib, niraparib, and rucaparib). Monte Carlo simulation was used to compare PFS values in different scenarios, such as monotherapy (administered alone) and combination therapy (PARPis combined with chemo- or target-therapies), different biomarker statuses, and different PARP inhibitors. PFS was also estimated. Result(s): The study showed that the median PFS was 8.5 months with monotherapy and 16.0 months with combination therapy. The median PFS of patients with the BRCA mutation, BRCA wild-type, and HRD-positivity were 11.0, 7.5, and 9.0 months in monotherapy, respectively, and 23.0, 14.0 and 17.5 months, in combination therapy, respectively. In addition, the median PFS of olaparib, niraparib, and rucaparib monotherapy were about 9.5, 10.5, and 12.0 months, respectively, and about 19.0, 20.0, and 25 months, respectively, in combination therapy. The median PFS values in combination with cediranib, bevacizumab, and chemotherapy were approximately 17.0, 12.5 and 19.5 months, respectively. Conclusion(s): PARPi combination therapy is more effective as maintenance treatment for ROC than monotherapy, and the efficacy of PARPis in combination with chemotherapy is higher than that of the combination with antiangiogenic drugs. We found that the PFS of BRCA wild-type was similar to that of HRD-positive patients, and there was no significant difference in PFS between olaparib, niraparib, and rucaparib, which provides necessary quantitative information for the clinical practice of PARPis in the treatment of ROC.© Copyright © 2021 Gao, Chen, Li, Li and Zheng.

Gao, M., et al. (2019). "Intrauterine injection of human chorionic gonadotropin before embryo transfer can improve in vitro fertilization-embryo transfer outcomes: a meta-analysis of randomized controlled trials." Fertility and Sterility 112(1): 89.
	Objective: To evaluate whether intrauterine injection of hCG before embryo transfer can improve IVF-ET outcomes.; Design: Meta-analysis.; Setting: Not applicable.; Patient(s): Infertile women who underwent IVF-ET and received an intrauterine injection of hCG before ET.; Intervention(s): Infertile women treated with or without intrauterine hCG injection before ET.; Main Outcome Measure(s): The primary outcomes were live birth rate (LBR), ongoing pregnancy rate (OPR), and clinical pregnancy rate (CPR), and the secondary outcomes were implantation rate (IR) and miscarriage rate (MR). Odds ratios with 95% confidence intervals (CIs) and successful ET rates were pooled to determine the effects of hCG on IVF-ET outcomes.; Result(s): Fifteen randomized controlled trials (RCTs) with a total of 2,763 participants were included. Infertile women in the experimental group (treated with intrauterine hCG injection before ET) exhibited significantly higher LBR (44.89% vs. 29.76%), OPR (48.09% vs. 33.42%), CPR (47.80% vs. 32.78%), and IR (31.64% vs. 22.52%) than those in the control group (intrauterine injection of placebo or no injection). Furthermore, MR was significantly lower (12.45% vs. 18.56%) in the experimental group than in the control group.; Conclusion(s): The findings of this meta-analysis indicate that intrauterine injection of hCG can improve LBR, OPR, CPR, and IR after IVF-ET cycles. In addition, different timing and dosages of hCG administration may exert different effects on IVT-ET outcomes. Notably, infertile women treated with 500 IU hCG within 15 minutes before ET can achieve optimal IVF-ET outcomes. (Copyright © 2019 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Gao, W., et al. (2020). "A Critical Appraisal and Recommendations for Cost-Effectiveness Studies of Poly(ADP-Ribose) Polymerase Inhibitors in Advanced Ovarian Cancer." PharmacoEconomics 38(11): 1201-1218.
	Background: Ovarian cancer is the fifth leading cause of cancer death in women in the US. With poly(ADP-ribose) polymerase (PARP) inhibitors having shown promising results in ongoing trials, there is interest in better understanding their economic value.; Objective: This study aimed to review and evaluate the quality of published cost-effectiveness analyses (CEAs), and provide recommendations for CEAs in this setting.; Methods: A systematic literature review of the MEDLINE and EMBASE databases was conducted in June 2019 to identify CEAs of PARP inhibitors in treating advanced ovarian cancer from peer-reviewed journals and conferences. Key information from the identified publications were extracted and reviewed. The quality of full-text studies was assessed using the Quality of Health Economic Studies instrument. Recommendations for future CEAs were developed based on the findings from the literature review.; Results: Eighteen CEAs (five in full texts) met the inclusion criteria. Most adopted a US healthcare or societal perspective. The majority of the studies did not clearly display the economic model structure. No studies reported the validation of model projections based on internal or external data. Surrogate outcomes such as incremental costs per progression-free life-year gained were the most common outcomes reported. The majority of studies drew their conclusions based on surrogate outcomes, even with no theoretical or empirical threshold for cost effectiveness. All five full-text studies included some type of sensitivity or scenario analyses. The key drivers of the incremental cost-effectiveness ratio were treatment duration, effects, and costs, health utility, and prevalence of BRCA mutations.; Conclusion: In the existing CEAs for PARP inhibitors, there were uncertainties and challenges leading to variation in quality. We provided recommendations to improve consistency and quality of CEAs in this setting, which will help to better understand the value of PARP inhibitors, improve decision making, and reduce potential misallocation of resources.

Gao, X., et al. (2023). "Systematic Review and Meta-Analysis: Impact of Various Hemostasis Methods on Ovarian Reserve Function in Laparoscopic Cystectomy for Ovarian Endometriomas." Alternative Therapies in Health and Medicine.
	Background: Ovarian endometriomas, resulting from the invasion of endometriosis into ovarian tissue, can significantly affect ovarian reserve, potentially leading to infertility. When conservative treatments fail, it may further aggravate ovarian reserve decline by invading the ovarian cortex and, in severe cases, result in premature ovarian failure and infertility.; Objective: This study aimed to investigate the impact of various hemostasis methods on ovarian reserve function in cases of laparoscopic cystectomy for ovarian endometriomas.; Methods: We conducted a systematic review and meta-analysis to assess the effects of different hemostasis techniques used during laparoscopic cystectomy for ovarian endometriomas. A comprehensive analysis of relevant literature was performed, focusing on the impact of bipolar electrocoagulation, ultrasonic scalpel, and suture hemostasis on ovarian reserve function. The evaluation criteria included Anti-Müllerian hormone levels and antral follicle counts.; Results: Our analysis revealed significant variations in the impact of hemostasis methods on ovarian reserve function. While all methods aimed to stop bleeding during surgery, the thermal damage to surrounding tissues differed. Bipolar electrocoagulation, ultrasonic scalpel, and suture hemostasis showed varying effects on ovarian reserve, with implications for post-operative fertility.; Conclusions: The choice of the hemostasis method in laparoscopic cystectomy for ovarian endometriomas has a crucial influence on ovarian reserve function. Our findings emphasize the need to consider the potential consequences of thermal damage when selecting a hemostasis technique. Clinicians should weigh the benefits and risks of each method to protect ovarian reserve function effectively. This study offers valuable insights for guiding clinical practice, ensuring optimal outcomes for patients facing endometrioma-related fertility challenges.

Gao, X., et al. (2022). "Effects of ovarian endometrioma aspiration on in vitro fertilization-intracytoplasmic sperm injection and embryo transfer outcomes: a systematic review and meta-analysis." Archives of Gynecology and Obstetrics 306(1): 17-28.
	Purpose: To evaluate the effect of ovarian endometrioma aspiration on IVF/ICSI outcomes.; Methods: The PubMed, EMBASE, Web of Science, China National Knowledge Infrastructure, and Wanfang databases were searched to identify studies related to the treatment of endometrioma up to October 1, 2020, and the data of 1207 patients from 10 studies were analyzed using STATA.; Results: The 10 studies in our analysis included 7 comparing aspiration and surgery and 6 comparing aspiration with no intervention. In the aspiration versus surgery groups, live birth rate [OR 0.97 (95% CI 0.51, 1.85), P = 0.925] and clinical pregnancy rate [OR 1.30 (95% CI 0.95, 1.80), P = 0.105] showed no significant difference between the two groups. Abortion rate [OR 4.26 (95% CI 1.38, 13.08), P = 0.011], the number of oocytes retrieved [mean difference 1.95 (95% CI 0.10, 3.81), P = 0.039], and the estradiol peak on hCG day [mean difference 392.16 (95% CI 230.14, 554.18), P < 0.001] were significantly higher in the aspiration group compared to the surgical group. In the aspiration versus the no intervention group, live birth rate [OR 0.84 (95% CI 0.45, 1.59), P = 0.602] and clinical pregnancy rate [OR 1.25 (95% CI 0.88, 1.77), P = 0.206] were not significantly different between the two groups. The abortion rate [OR 0.31 (95% CI 0.11, 0.88), P = 0.028] and the number of gonadotropin ampoules [mean difference - 3.13 ampoules (95% CI - 4.90, - 1.37), P < 0.001] were significantly lower in the aspiration group compared to the no intervention group.; Conclusion: Compared with surgical treatment or no intervention treatment, aspiration has less effect on ovarian response, ovarian reserve, and pregnancy outcomes. (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Gao, Y., et al. (2021). "Tamoxifen and aromatase inhibitors for relapse of tubo-ovarian high-grade serous cancer." The Cochrane Database of Systematic Reviews 2021(4): CD014757.
	Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To evaluate the effectiveness and safety of tamoxifen and aromatase inhibitors for women with recurrent high-grade serous tubo-ovarian cancer where further conventional chemotherapy or molecular-targeted cytotoxic drugs are not available or would not be tolerated.Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Garcia Alexandra, N. (2022). "Vaginal Estradiol Use in Pessary Care." ClinicalTrials.gov.
	The purpose of the study is to investigate the effects of vaginal estradiol cream on pessary care. All patients presenting to the University of South Florida Urogynecology clinic for pessary fitting for pelvic organ prolapse and/or urinary incontinence are screened as potential study participants. After being informed of risks and benefits of participations and consent is obtained, patients that have been successfully fitted for a pessary and agree to participate will be separated into two groups: the control group or treatment group. The treatment group will be provided with a prescription for vaginal estradiol cream. Vaginal estradiol cream is FDA approved and is the first line treatment for vaginal atrophy, also known as dryness. The study will be unblinded and randomized, neither the participant nor the study doctor will choose which group the will be participant will be placed in. The participant will have an equal chance of being given either treatment. The treatment group will be asked to apply vaginal estradiol cream nightly for two weeks and then twice weekly thereafter. All participants will have 2 study visits over a 6‐month period which is standard for pessary care: a regular follow up pessary check visit two weeks after pessary fitting and second visit 6 months later. At these visits, questions regarding symptoms including vaginal bleeding, vaginal discharge, and discomfort with pessary will be assessed and a physical exam will be performed as is standard for all pessary users.

Garcia de Arriba, S., et al. (2022). "Vaginal hormone-free moisturising cream is not inferior to an estriol cream for treating symptoms of vulvovaginal atrophy: Prospective, randomised study." PloS One 17(5): e0266633.
	This prospective, open-label, multicentre, multinational, randomised trial investigated the non-inferiority of treatment with a vaginal hormone-free moisturising cream compared to a vaginal estriol (0.1%) cream in a panel of post-menopausal women suffering from symptoms of vulvovaginal dryness in a parallel group design. In total, 172 post-menopausal women were randomly allocated to either one of the two treatments, each administered for 43 days. The primary endpoint was the total severity score of subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) of the respective treatment period. Secondary endpoints were severity of single subjective symptoms (including dyspareunia if sexually active), impairment of daily life, Vaginal Health Index, as well as assessment of safety. In both groups, women treated with hormone-free moisturising cream and those treated with estriol cream, total severity score improved significantly compared to baseline by 5.0 (from 6.1 to 1.1) and by 5.4 (from 6.0 to 0.6), respectively, after 43 days of treatment (p < 0.0001). One-sided test of baseline differences (for a clinically relevant difference Δ = 1.5) confirmed the hormone-free moisturising cream to be non-inferior to the estriol cream. Severity of dyspareunia as well as impairment of daily life due to subjective symptoms, significantly improved for both treatment groups (p<0.0001). Subgroup analysis of women with mild or moderate impairment of daily life at baseline caused by "vaginal dryness" symptoms benefited from both creams, while women with severe impairment showed a significantly greater benefit from the estriol cream (p = 0.0032). Both treatments were well tolerated with no serious adverse events occurring. This study provides clinical evidence that a hormone-free vaginal moisturising cream cannot only improve vaginal dryness compared to an 0.1% estriol cream but also can relieve dyspareunia as well as improve woman's impairment of daily life, justifying its use as a first choice for mild or moderate vulvovaginal dryness symptoms.; Competing Interests: The authors have read the journal’s policy. SGdA, LG, MH, and CM, have the following competing interest: They work for the company Dr. August Wolff GmbH & Co. KG Arzneimittel (Bielefeld, Germany) which is interested in developing products regarding treatment of vulvovaginal atrophy/ vaginal dryness symptoms. The principal investigator of the study [PS] as well as the statistical specialist [TWM] were also sponsored by Dr. August Wolff GmbH & Co. KG Arzneimittel. This does not alter the authors adherence to PLOS ONE policies on sharing data and materials.

Garcia Miguel, M. (2022). "Effect of contact diathermy on pain and quality of life in women with Primary Chronic Pelvic Pain Syndrome: a randomized placebo-controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention Arm: Subjects in this group will receive 6 CRet sessions over a period of 6 weeks (one session per week). CRet will be delivered using a “FisioWarm Pure” (Golden Star Srl, Roma, Italy) device, capable of delivering a peak power of 300 W when is set to continuous wave radiofrequency emission. Each session will consist on the application of 30 minutes of CRet using the resistive modality (non‐isolated metallic electrodes) and an output frequency set at 500 kHz. Each session will be divided into an extra‐vaginal treatment and a subsequent intra‐vaginal treatment. The first 15 minutes will involve a fixed static application using 4 small, round metallic electrodes positioned over the suprapubic area. A high conductivity cream will be used as a coupling medium between the resistive electrodes and the skin surface. The second 15 minutes will consist on the delivery of radiofrequency energy through the application of an intracavitary resistive electrode. For both applications, the return (neutral) plate will be placed under the subject’s lumbosacral area. The intensity of the application will be constantly monitored and adjusted by the therapist according to patients’ feedback, trying to maintain a moderate heating sensation, always within their comfort limits. Each attendance will be registered both manually in the appropriate Case Report Form (CRF) and electronically. CONDITION: Primary Chronic Pelvic Pain Syndrome; ; Primary Chronic Pelvic Pain Syndrome Anaesthesiology ‐ Pain management PRIMARY OUTCOME: Pain rating Index (PRI) as measured by the McGill Pain Questionnaire[Baseline, one week (primary timepoint) and 6 weeks after completing treatment protocol.] Pain intensity with 100 mm visual analogue scale (VAS).[Baseline, before each CRet session, one week (primary timepoint) and 6 weeks after intervention is finished.] SECONDARY OUTCOME: Quality of Life (QoL) using the WHOQOL‐BREF questionnaire.[Baseline, one week and 6 weeks after completing study protocol.] Sexual Function as measured by the Female Sexual Function Index (FSFI).[Baseline, one week and 6 weeks after completing study protocol.] Average electromyographic (EMG) activity of pelvic floor muscles (PFM), over a minimum period of 100 seconds will be measured in µV at rest, with participants in a crook lying supine position.[Baseline, one week and 6 weeks after completing study protocol.] Global Response Assessment (GRA), using a 7‐item Likert‐type scale.[6 weeks after completion of study protocol.] INCLUSION CRITERIA: ‐ Women diagnosed of CPPS according to the definition by the European Urology Association (EUA). ‐ Presence of tenderness on palpation of Levator Ani (LA) muscle during vaginal examination. ‐ Presence of abnormal tension at rest within the PFM as indicated by surface electromyographic (EMG) signal (for the purpose of this study, this is defined as mean PFM EMG resting activity above 5 microV over a minimum period of 100 secs). ‐ Pharmacological treatment had remained stable for a minimum of 4 weeks prior to initiation of CRet therapy. ‐ Able and willing to provide informed consent. ‐ CRet treatment naive.

Garcia-Beltran, C., et al. (2023). "SPIOMET4HEALTH-efficacy, tolerability and safety of lifestyle intervention plus a fixed dose combination of spironolactone, pioglitazone and metformin (SPIOMET) for adolescent girls and young women with polycystic ovary syndrome: study protocol for a multicentre, randomised, double-blind, placebo-controlled, four-arm, parallel-group, phase II clinical trial." Trials 24(1): 589.
	Background: Polycystic ovary syndrome (PCOS) is the most prevalent, chronic endocrine-metabolic disorder of adolescents and young women (AYAs), affecting 5-10% of AYAs worldwide. There is no approved pharmacological therapy for PCOS. Standard off-label treatment with oral contraceptives (OCs) reverts neither the underlying pathophysiology nor the associated co-morbidities. Pilot studies have generated new insights into the pathogenesis of PCOS, leading to the development of a new treatment consisting of a fixed, low-dose combination of two so-called insulin sensitisers [pioglitazone (PIO), metformin (MET)] and one mixed anti-androgen and anti-mineralocorticoid also acting as an activator of brown adipose tissue [spironolactone (SPI)], within a single tablet (SPIOMET). The present trial will evaluate the efficacy, tolerability and safety of SPIOMET, on top of lifestyle measures, for the treatment of PCOS in AYAs.; Methods: In this multicentre, randomised, double-blind, placebo-controlled, four-arm, parallel-group, phase II clinical trial, AYAs with PCOS will be recruited from 7 clinical centres across Europe. Intention is to randomise a total of 364 eligible patients into four arms (1:1:1:1): Placebo, PIO, SPI + PIO (SPIO) and SPI + PIO + MET (SPIOMET). Active treatment over 12 months will consist of lifestyle guidance plus the ingestion of one tablet daily (at dinner time); post-treatment follow-up will span 6 months. Primary endpoint is on- and post-treatment ovulation rate. Secondary endpoints are clinical features (hirsutism, menstrual regularity); endocrine-metabolic variables (androgens, lipids, insulin, inflammatory markers); epigenetic markers; imaging data (carotid intima-media thickness, body composition, abdominal fat partitioning, hepatic fat); safety profile; adherence, tolerability and acceptability of the medication; and quality of life in the study participants. Superiority (in this order) of SPIOMET, SPIO and PIO will be tested over placebo, and if present, subsequently the superiority of SPIOMET versus PIO, and if still present, finally versus SPIO.; Discussion: The present study will be the first to evaluate-in a randomised, double-blind, placebo-controlled way-the efficacy, tolerability and safety of SPIOMET treatment for early PCOS, on top of a lifestyle intervention.; Trial Registration: EudraCT 2021-003177-58. Registered on 22 December 2021. https://www.clinicaltrialsregister.eu/ctr-search/search?query=%092021-003177-58 . (© 2023. BioMed Central Ltd., part of Springer Nature.)

Garcia-Duran, C., et al. (2022). "ATOMICC trial: a randomized, open-label, phase II trial of anti-PD1, dostarlimab, as maintenance therapy for patients with high-risk locally advanced cervical cancer after chemoradiation." International Journal of Gynecological Cancer.
	Background: Currently, women diagnosed with high-risk locally advanced cervical cancer are at high risk of recurrence after treatment with concurrent chemoradiation and represent a population with high unmet need.; Primary Objective: The primary objective is to evaluate the progression-free survival of high-risk locally advanced cervical cancer patients who have achieved a partial or complete response after chemoradiation after receiving dostarlimab as maintenance therapy.; Study Hypothesis: The study aims to demonstrate that the use of dostarlimab, as maintenance therapy, would significantly increase progression-free survival in these patients.; Trial Design: ATOMICC trial is a phase II, randomized, open-label, multicenter study to assess the efficacy and safety of anti-PD1, dostarlimab, as maintenance therapy in patients with high-risk locally advanced cervical cancer who have achieved a partial or complete response after chemoradiation. The control arm entails a clinical and radiological follow-up, with no further treatment (current standard of care). ATOMICC trial is an investigator-driven trial sponsored by GEICO (Grupo Español de Investigación en Cáncer de Ovario) and supported by GlaxoSmithKline (GSK).; Major Inclusion/exclusion Criteria: Women aged over 18 years with a biopsy-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix meeting the following staging criteria: International Federation of Gynecology and Obstetrics (FIGO) 2009 stages IB2, IIA2, IIB with pelvic lymph node involvement, FIGO stages IIIA, IIIB, IVA, and any FIGO 2009 stage with para-aortic lymph node involvement are eligible for the trial. All patients must have achieved a partial or complete response after definitive concurrent chemoradiation. Women diagnosed with FIGO stage IVB, having undergone a previous hysterectomy, or having a history of active autoimmune disease will not be considered eligible.; Primary Endpoint: Progression-free survival defined as the time from the date of randomization to the date of first disease progression or death due to any cause, whichever occurs first.; Sample Size: A total of 132 patients are expected to be recruited in the study, using a 1:2 (control:experimental arm) randomization allocation ratio.; Estimated Dates for Completing Accrual and Presenting Results: The trial was launched in Q2-2019 and the trial is estimated to be closed for recruitment in Q3-2022. Results are expected to be released in Q3-2024.; Trial Registration: The trial is registered at ClinicalTrials.gov (NCT03833479).; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Garcia-Sanchez, E., et al. (2019). "What pelvic floor muscle training load is optimal in minimizing urine loss in women with stress urinary incontinence? A systematic review and meta-analysis." International Journal of Environmental Research and Public Health 16(22): 4358.
	Pelvic floor muscle training is commonly used for urine loss. However, research studies have not determined which training load is the most effective for women with stress urinary incontinence (SUI). Moreover, none of the previous reviews or studies have described the total effectiveness of pelvic floor muscle training (PFMT) with an objective test such as the pad test. The objectives were to analyze the effectiveness of pelvic floor muscle training in women with SUI and to determine which training load produces the greatest adaptations for decreasing urine loss. The search was conducted in three databases (PubMed, Web of Science and Cochrane), for randomized controlled trials (RCTs) that evaluated the effects of PFMT. Studies were included if they met the following criteria: participants were women; were older than 18; had SUI; were treated with PFMT; and the assessments of the effects were measured with a pad test. Finally, 10 articles (293 women) analyzed the pad test in women with SUI who performed PFMT. The meta-analysis showed that PFMT, independent of the protocol used in the study, resulted in decreased urine loss in women suffering from SUI. However, for large effects, the program should last 6-12 weeks, with >3 sessions/week and a length of session <45 min.Copyright © 2019 by the authors. Licensee MDPI, Basel, Switzerland.

Gayathri, D., et al. (2022). "Systematic review and meta-analysis of the effectiveness of HRT use among menopausal women." PROSPERO International prospective register of systematic reviews.
	
Ge, J., et al. (2021). "Pelvic floor muscle training in the treatment of pelvic organ prolapse: A meta-analysis of randomized controlled trials." Actas Urologicas Espanolas 45(1): 73-82.
	Background: We aimed to assess the overall effect of pelvic muscle training (PFMT) on patients with pelvic organ prolapse (POP) based on eligible randomized controlled trials (RCT).; Methods: We searched the following databases, such as PubMed, Cochrane, and Embase, to identify eligible RCT based on the index words updated to December 2018. We also searched the publications related to the present study. Odds rations (OR), and mean difference (MD) along with 95% confidence interval (95% CI) were used to analyze the main outcomes.; Results: In this meta-analysis, 15 RCTs were included with a total of 1309 patients in the PFMT group and a total of 1275 patients in the control group. The overall results showed no significant difference in the incidence of add 2 POP-Q stages (RR: 0.55, 95%CI: 0.19-1.63), add 1 POP-Q stages (RR: 1.04, 95%CI: 0.69-1.57), no POP-Q stages change (RR: 0.94, 95%CI: 0.81-1.09), reduce 2 POP-Q stages (RR: 1.72, 95%CI: 0.79-3.76), self-reported same symptom change (RR: 0.70, 95%CI: 0.45-1.09), and self-reported worse symptom change (RR: 0.67, 95%CI: 0.22-2.03) between the 2groups. Besides, the incidence of reduce 1 POP-Q stages was significantly higher in the PFMT group than that of the control group (RR: 1.80, 95%CI: 1.20-2.69), and the PFMT significantly changed the self-reported symptoms with better outcomes when compared with the control group (RR: 2.90, 95%CI: 1.72-4.89). However, after the therapy, the PFMT group decreased the POP-SS (SMD: -0.24, 95%CI: -0.71-0.22), POPDI-6 (SMD: -0.14, 95%CI: -0.43-0.15), CRADI-8 (SMD: -0.03, 95%CI: -0.16-0.11), and UDI-6 (SMD: -0.17, 95%CI: -0.43-0.10) versus the control group, but without statistical significance.; Conclusion: PMFT showed better effect in reducing 1 POP-Q stages, changing the self-reported symptoms with better outcomes, decreasing the score of POP-SS, POPDI-6, CRADI-8, and UDI-6 in women with POP versus the control group. However, more high-quality multicenter RCTs with a larger sample size are needed to confirm the present conclusions. (Copyright © 2020 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.)

Ge, J. J., et al. (2022). "The effectiveness and safety of liraglutide in treating overweight/obese patients with polycystic ovary syndrome: a meta-analysis." Journal of endocrinological investigation 45(2): 261-273.
	Purpose: The purpose of this study is to evaluate the effectiveness and safety of liraglutide/liraglutide + metformin in overweight/obese women with polycystic ovary syndrome (PCOS).; Methods: The related literatures published until April 2021 were searched in PubMed, Cochrane Library, MEDLINE and EmBase.; Results: Six randomized controlled trials of 127 related articles were obtained through searching. Three articles compared liraglutide with metformin, and four articles compared liraglutide combined with metformin with metformin. Our meta-analysis suggests that liraglutide was superior to metformin only in weight loss [MD = - 2.74, 95% CI (- 4.29, - 1.18), P = 0.0006]. Compared with metformin group, the combination group had significant advantages in weight loss [MD = - 3.81, 95% CI (- 5.16, - 2.46), P < 0.001], BMI [MD = - 2.59, 95% CI (- 3.12, - 2.07), P < 0.001], waist circumference [MD = - 6.26, 95% CI (- 7.79, - 4.72), P < 0.001], fasting blood glucose [MD = - 0.59, 95% CI (- 0.74, - 0.44), P < 0.001] and fasting insulin [MD = - 1.52, 95% CI (- 2.69, - 0.35), P = 0.01], while the incidence of adverse reactions was relatively high [RR = 2.91, 95% CI (1.55, 5.46), P = 0.00009].; Conclusion: The present results indicate that liraglutide and metformin have the similar effects in the treatment of overweight/obese PCOS patients. Liraglutide combined with metformin is more effective than metformin in improving PCOS, but it is necessary to master the correct medication method to reduce the occurrence of adverse reactions. (© 2021. Italian Society of Endocrinology (SIE).)

Ge, S., et al. (2021). "Effect of traditional Chinese medicine (TCM) on survival, quality of life, and immune function in patients with ovarian carcinoma: A protocol for systematic review and meta analysis." Medicine 100(2): e23904.
	Background: Traditional Chinese medicine (TCM) has been widely applied as promising adjunctive drugs for ovarian carcinoma (OC) in China and other Asian countries. However, its exact clinical efficacy and safety is still not well investigated. In this study, we aimed to summarize the efficacy of TCM on survival, quality of life (QoL), and immune function in patients with OC through the meta-analysis.; Methods: Relevant clinical trials of TCM for the treatment OC patients will be searched in Cochrane Library, Web of Science, Google Scholar, PubMed, Medline, Embase, China Scientific Journal Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and Wanfang Database from their inception to November 2020. Two researchers will perform data extraction and risk of bias assessment independently. The clinical outcomes, including overall survival (OS), QoL, immune function, tumor markers, and adverse events, were systematically evaluated by using Review Manager 5.3 and Stata 14.0 statistical software.; Results: The results of this study will provide high-quality evidence for the effect of TCM on survival, QoL and immune function in patients with OC.; Conclusion: The conclusions of this meta-analysis will be published in a peer-reviewed journal, and draw an objective conclusion of the efficacy of TCM on survival, QoL, and immune function in patients with OC.; Trial Registration Number: INPLASY2020110104. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Geary, O., et al. (2023). "The effectiveness of mother-led infant massage on symptoms of maternal postnatal depression: A systematic review." PloS One 18(12): e0294156.
	Introduction: Postnatal depression is a significant public health issue which may escalate and lead to adverse outcomes for women, infants, their family and the wider society. The aim of this review was to examine the effectiveness and experiences of mother-led infant massage on symptoms of maternal postnatal depression and to synthesise these findings to inform policy, practice and further research.; Methods: A systematic search of five academic databases was conducted: CINAHL, MEDLINE, EMBASE, PsycINFO and Allied and Complementary Medicine Database in February 2023 with no date or geographic limiters set owing to the paucity of research on this subject area. Quality appraisal was undertaken using the Joanna Briggs Institute quality appraisal tools and all included RCT's were assessed separately using the Cochrane Risk of Bias Tool. Narrative synthesis was used to analyse the data.; Findings: A total of (n = 323) studies were returned of which (n = 8) met the inclusion criteria for the review. This review identified a total sampling of (n = 521) women with maternal postnatal depression. The results are presented under three themes: 1) the effectiveness of mother-led infant massage on symptoms of postnatal depression; 2) women's experiences of mother-led infant massage; and 3) the effects of mother-led infant massage on the mother-infant relationship.; Discussion: The review highlights women who used infant massage displayed a reduction in symptoms of postnatal depression, improved mother-infant interactions and improved self-efficacy in addition to benefits for infants. Public Health Nurse/Community Midwife-led infant massage may help to relieve such symptoms and empower women.; Competing Interests: The author(s) have declared no competing interests. (Copyright: © 2023 Geary 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.)

Gemma, M. and S. Rachel (2022). "Availability and effectiveness of Pain Management Programmes for the treatment of endometriosis." PROSPERO International prospective register of systematic reviews.
	
Genelux, C. (2022). "Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Platinum-doublet + Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (OnPrime, GOG-3076)." ClinicalTrials.gov.
	Olvi‐Vec (olvimulogene nanivacirepvec, aka GL‐ONC1, laboratory name: GLV‐1h68) is an oncolytic vaccinia virus‐based immunotherapy. This study is to test the hypothesis that the combination of Olvi‐Vec followed by further chemotherapy is particularly effective against established tumors by virus‐mediated immune activation and re‐sensitization of tumor cells to chemotherapy. Participant population includes histologically confirmed non‐resectable platinum‐resistant/refractory ovarian cancer (PRROC). Determination of progression‐free survival, safety and overall survival are key objectives. Participants randomized into the Experimental Arm will receive a single‐cycle (2 infusions on two consecutive days) of Olvi‐Vec through an intraperitoneal catheter. The catheter is then removed, and patients receive systemically administered platinum‐doublet chemotherapy and bevacizumab. The control arm receives the same platinum‐doublet chemotherapy and bevacizumab at the same dose and schedule. Biological samples will be obtained from some Experimental Arm participants for virus‐shedding testing. Assessment of response to treatment in both arms will be by RECIST 1.1 and iRECIST. Maintenance/continued treatment with non‐platinum chemotherapy and bevacizumab is dependent on a participant being clinically stable until confirmed progressive disease by iRECIST or can no longer tolerate therapy. Dr. Robert W. Holloway (AdventHealth Cancer Institute, Orlando, FL) will serve as the National Principal Investigator for this Phase 3 study in PRROC.

Geng, T., et al. (2020). "The effect of ICSI in infertility couples with non-male factor: a systematic review and meta-analysis." Journal of Assisted Reproduction and Genetics 37(12): 2929-2945.
	Purpose: We performed a systematic review and meta-analysis of available literature to investigate the efficacy of the intracytoplasmic sperm injection (ICSI) in couples with non-male factor with respect to the clinical outcomes.; Methods: The literature search was based on EMBASE, PubMed, and the Cochrane Library. All studies published after 1992 until February 2020 and written in English addressing patients in the presence of normal semen parameters subjected to ICSI and in vitro fertilization (IVF) were eligible. Reference lists of retrieved articles were hand-searched for additional studies. The primary outcomes were fertilization rate, clinical pregnancy rate, and implantation rate; the secondary outcomes were good-quality embryo rate, miscarriage rate, and live birth rate.; Results: Four RCTs and twenty-two cohort studies fulfilling the inclusion criteria were included. Collectively, a meta-analysis of the outcomes in RCTs showed that compared to IVF, ICSI has no obvious advantage in fertilization rate (RR = 1.16, 95% CI: 0.83-1.62), clinical pregnancy rate (RR = 1.04, 95% CI: 0.66-1.64), implantation rate (RR = 1.12, 95% CI: 0.67-1.86), and live birth rate (RR = 1.17, 95% CI: 0.43-3.15). Pooled results of cohort studies demonstrated a statistically significant higher fertilization rate (RR = 1.16, 95% CI: 1.03-1.31) and miscarriage rate (RR = 1.04, 95% CI: 1.01-1.06) in the ICSI group; furthermore, higher clinical pregnancy rate (RR = 0.85, 95% CI: 0.77-0.94), implantation rate (RR = 0.78, 95% CI: 0.65-0.95), and live birth rate (RR = 0.86, 95% CI: 0.79-0.94) was founded in the IVF group; no statistically significant difference was observed in good-quality embryo rate (RR = 0.98, 95% CI: 0.93-1.04).; Conclusion: ICSI has no obvious advantage in patients with normal semen parameters. Enough information is still not available to prove the efficacy of ICSI in couples with non-male factor infertility comparing to IVF.

Gentilleau, C. (2023). "Early Intervention to Protect the Mother-Child Relationship After Postpartum Depression." ClinicalTrials.gov.
	No Results Available Behavioral: HUGS|Behavioral: Playtime Mother-infant interaction|Mothers' stress Female Not Applicable 104 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Supportive Care RC31/21/0166 December 2026

George, K., et al. (2023). "Effectiveness of therapeutic exercise on pregnancy-related low back pain, pelvic girdle pain, disability, and quality of life. A Systematic Review And Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
George, K., et al. (2021). "The effect of conventional physiotherapy interventions or no intervention at all in comparison with alternative physiotherapy interventions for the treatment of urinary incontinence in men and women: A systematic review and narrative synthesis." PROSPERO International prospective register of systematic reviews.
	
Georgia, K. and K. Richard (2023). "The effect of vitamin D supplementation on markers of insulin resistance in women with polycystic ovarian syndrome: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Georgiou Ektoras, X., et al. (2019). "Long-term GnRH agonist therapy before in vitro fertilisation (IVF) for improving fertility outcomes in women with endometriosis." The Cochrane Database of Systematic Reviews 2019(11).
	Background: Endometriosis is known to have an impact on fertility and it is common for women affected by endometriosis to require fertility treatments, including in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI), to improve the chance of pregnancy. It has been postulated that long-term gonadotrophin-releasing hormone (GnRH) agonist therapy prior to IVF or ICSI can improve pregnancy outcomes. This systematic review supersedes the previous Cochrane Review on this topic (Sallam 2006).; Objectives: To determine the effectiveness and safety of long-term gonadotrophin-releasing hormone (GnRH) agonist therapy (minimum 3 months) versus no pretreatment or other pretreatment modalities, such as long-term continuous combined oral contraception (COC) or surgical therapy of endometrioma, before standard in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) in women with endometriosis.; Search Methods: We searched the following electronic databases from their inception to 8 January 2019: Cochrane Gynaecology and Fertility Specialised Register of Controlled Trials, CENTRAL via the Cochrane CENTRAL Register of Studies ONLINE (CRSO), MEDLINE, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL). We searched trial registries to identify unpublished and ongoing trials. We also searched DARE (Database of Abstracts of Reviews of Effects), Web of Knowledge, OpenGrey, Latin American and Caribbean Health Science Information Database (LILACS), PubMed, Google and reference lists from relevant papers for any other relevant trials.; Selection Criteria: Randomised controlled trials (RCTs) involving women with surgically diagnosed endometriosis that compared use of any type of GnRH agonist for at least three months before an IVF/ICSI protocol to no pretreatment or other pretreatment modalities, specifically use of long-term continuous COC (minimum of 6 weeks) or surgical excision of endometrioma within six months prior to standard IVF/ICSI. The primary outcomes were live birth rate and complication rate per woman randomised.; Data Collection and Analysis: Two independent review authors assessed studies against the inclusion criteria, extracted data and assessed risk of bias. A third review author was consulted, if required. We contacted the study authors, as required. 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 and presented with 95% CIs. We studied heterogeneity of the studies via the I 2 statistic. We assessed the quality of evidence using GRADE criteria.; Main Results: We included eight parallel-design RCTs, involving a total of 640 participants. We did not assess any of the studies as being at low risk of bias across all domains, with the main limitation being lack of blinding. Using GRADE methodology, the quality of the evidence ranged from very low to low quality. Long-term GnRH agonist therapy versus no pretreatment We are uncertain whether long-term GnRH agonist therapy affects the live birth rate (RR 0.48, 95% CI 0.26 to 0.87; 1 RCT, n = 147; I 2 not calculable; very low-quality evidence) or the overall complication rate (Peto OR 1.23, 95% CI 0.37; to 4.14; 3 RCTs, n = 318; I 2 = 73%; very low-quality evidence) compared to standard IVF/ICSI. Further, we are uncertain whether this intervention affects the clinical pregnancy rate (RR 1.13, 95% CI 0.91 to 1.41; 6 RCTs, n = 552, I 2 = 66%; very low-quality evidence), multiple pregnancy rate (Peto OR 0.14, 95% CI 0.03 to 0.56; 2 RCTs, n = 208, I 2 = 0%; very low-quality evidence), miscarriage rate (Peto OR 0.45, 95% CI 0.10 to 2.00; 2 RCTs, n = 208; I 2 = 0%; very low-quality evidence), mean number of oocytes (MD 0.72, 95% CI 0.06 to 1.38; 4 RCTs, n = 385; I 2 = 81%; very low-quality evidence) or mean number of embryos (MD -0.76, 95% CI -1.33 to -0.19; 2 RCTs, n = 267; I 2 = 0%; ry low-quality evidence). Long-term GnRH agonist therapy versus long-term continuous COC No studies reported on this comparison. Long-term GnRH agonist therapy versus surgical therapy of endometrioma No studies reported on this comparison.; Authors' Conclusions: This review raises important questions regarding the merit of long-term GnRH agonist therapy compared to no pretreatment prior to standard IVF/ICSI in women with endometriosis. Contrary to previous findings, we are uncertain as to whether long-term GnRH agonist therapy impacts on the live birth rate or indeed the complication rate compared to standard IVF/ICSI. Further, we are uncertain whether this intervention impacts on the clinical pregnancy rate, multiple pregnancy rate, miscarriage rate, mean number of oocytes and mean number of embryos. In light of the paucity and very low quality of existing data, particularly for the primary outcomes examined, further high-quality trials are required to definitively determine the impact of long-term GnRH agonist therapy on IVF/ICSI outcomes, not only compared to no pretreatment, but also compared to other proposed alternatives to endometriosis management. (Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Georgiou Ektoras, X., et al. (2022). "Follicular flushing during oocyte retrieval in assisted reproductive techniques." The Cochrane Database of Systematic Reviews 11: CD004634.
	Background: Follicular aspiration under transvaginal ultrasound guidance is routinely performed as part of assisted reproductive technology (ART) to retrieve oocytes for in vitro fertilisation (IVF). The process involves aspiration of the follicular fluid followed by the introduction of flush, typically culture media, back into the follicle followed by re-aspiration. However, there is a degree of controversy as to whether this intervention yields a larger number of oocytes and is hence associated with greater potential for pregnancy than aspiration only.; Objectives: To assess the safety and efficacy of follicular flushing as compared with aspiration only performed in women undergoing ART.; Search Methods: We searched the following electronic databases up to 13 July 2021: the Cochrane Gynaecology and Fertility Specialised Register of Controlled Trials, CENTRAL (containing output from two trial registries and CINAHL), MEDLINE, Embase, and PsycINFO. We also searched LILACS, Google Scholar, and Epistemonikos. We reviewed the reference lists of relevant papers and contacted experts in the field to identify further relevant studies.; Selection Criteria: We included randomised controlled trials (RCTs) that compared follicular aspiration and flushing with aspiration alone in women undergoing ART using their own gametes. Primary outcomes were live birth rate and miscarriage rate per woman randomised.; Data Collection and Analysis: Two review authors independently assessed studies identified by search against the inclusion criteria, extracted data, and assessed risk of bias. A third review author was consulted if required. We contacted study authors as needed. We analysed dichotomous outcomes using Mantel-Haenszel odds ratios (ORs), 95% confidence intervals (CIs), and a fixed-effect model, and we analysed continuous outcomes using mean differences (MDs) between groups presented with 95% CIs. We examined the heterogeneity of studies via the I 2 statistic. We assessed the certainty of evidence using the GRADE approach.; Main Results: We included 15 studies with a total of 1643 women. Fourteen studies reported outcomes per woman randomised, and one study reported outcomes per ovary. No studies were at low risk of bias across all domains; the main limitation was lack of blinding. The certainty of the evidence ranged from moderate to very low, and was downgraded for risk of bias, imprecision, and inconsistency. We are uncertain of the effect of follicular flushing on live birth rate compared to aspiration alone (OR 0.93, 95% CI 0.59 to 1.46; 4 RCTs; n = 467; I 2 = 0%; moderate-certainty evidence). This suggests that with a live birth rate of approximately 30% with aspiration alone, the equivalent live birth rate with follicular flushing lies between 20% and 39%. We are uncertain of the effect of follicular flushing on miscarriage rate compared to aspiration alone (OR 1.98, 95% CI 0.18 to 22.22; 1 RCT; n = 164; low-certainty evidence). This suggests that with a miscarriage rate of approximately 1% with aspiration alone, the equivalent miscarriage rate with follicular flushing lies between 0% and 22%. We are uncertain of the effect of follicular flushing on oocyte yield (MD -0.47 oocytes, 95% CI -0.72 to -0.22; 9 RCTs; n = 1239; I 2 = 61%; very low-certainty evidence); total number of embryos (MD -0.10 embryos, 95% CI -0.34 to 0.15; 2 RCTs; n = 160; I 2 = 58%; low-certainty evidence); and clinical pregnancy rate (OR 1.12, 95% CI 0.85 to 1.51; 7 RCTs; n = 939; I 2 = 46%; low-certainty evidence). The duration of the retrieval process may be longer with flushing (MD 175.44 seconds, 95% CI 152.57 to 198.30; 7 RCTs; n = 785; I 2 = 87%; low-certainty evidence). It was not possible to perform a meta-analysis for adverse events, although individual studies reported on outcomes ranging from depression and anxiety to pain and pelvic organ injury.; Authors' Conclusions: The effect of follicular flushing on both live birth and miscarriage rates compared with aspiration alone is uncertain. Although the evidence does not permit any firm concl s ons on the impact of follicular flushing on oocyte yield, total number of embryos, number of cryopreserved embryos, or clinical pregnancy rate, it may be that the procedure itself takes longer than aspiration alone. The evidence was insufficient to permit any firm conclusions with respect to adverse events or safety. (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Gerli, S., et al. (2022). "Biological and clinical effects of a resveratrol-based multivitamin supplement on intracytoplasmic sperm injection cycles: a single-center, randomized controlled trial." The Journal of Maternal-fetal & Neonatal Medicine 35(25): 7640-7648.
	Background: Resveratrol display's positive effects on follicle growth and development in preclinical studies while there is scantly information from clinical trials. The aim of this study was to evaluate the biological and clinical impact of a resveratrol-based multivitamin supplement on intracytoplasmatic sperm injection (ICSI) cycles.; Methods: A randomized, single-center controlled trial conducted at the University Center of Assisted Reproductive Technologies involving 101 women infertile women undergoing ICSI cycles was conducted. A pretreatment with a daily resveratrol based nutraceutical was administered to the Study Group; Control Group received folic acid. The primary outcomes were the number of developed mature follicles (>16 mm), total oocytes and MII oocytes recovered, the fertilization rate and the number of cleavage embryos/blastocysts obtained. Secondary endpoints were the duration and dosage of gonadotropins, the number of embryos for transfer, implantation, biochemical, clinical pregnancy rates, live birth and miscarriage rates.; Results: A significantly higher number of oocytes and MII oocytes were retrieved in the Study Group than in Control Group ( p = .03 and p = .04, respectively). A higher fertilization rate ( p = .004), more cleavage embryos/patient ( p = .01), blastocytes/patients ( p = .01) and cryopreserved embryos ( p = .03) were obtained in the Study Group. No significant differences in biochemical or clinical pregnancy, live birth, and miscarriage rates were revealed, but a trend to a higher live birth rate was revealed in the Study Group.; Conclusions: A 3 months period of dietary supplementation with a resveratrol-based multivitamin nutraceutical leads to better biological effects on ICSI cycles.; Trial Registration Number: ClinicalTrials.gov registration identifier: NCT04386499.

Geynisman-Tan, J. (2021). "REDUCE Trial- Reducing Prolapse Recurrence." ClinicalTrials.gov.
	The decision to perform a posterior colpoperineorrhaphy at the time of sacrocolpopexy is controversial. Based on cohort data, some surgeons advocate that sacrocolpopexy alone is effective at treating posterior vaginal wall prolapse and the addition of posterior colpoperineorrhaphy only increases the likelihood of pain with defecation and dyspareunia. Experts theorize that placement of posterior vaginal mesh down to the perineal body provides adequate posterior support and reduces genital hiatus size. Others argue that placement of mesh too low on the posterior vagina may be associated with increased mesh exposure and pain secondary to mesh stiffness. No randomized trials exist comparing prolapse outcomes using new, ultra‐light polypropylene mesh with and without posterior colpoperineorrhaphy. The investigators hypothesize that there will be no difference in prolapse outcomes after sacrocolpopexy using Restorelle mesh with and without posterior colpoperineorrhaphy. However, patients with a posterior colpoperineorrhaphy will be more likely to report pain with defecation and dyspareunia. This will be the first multicenter randomized trial comparing outcomes of sacrocolpopexy with and without posterior colpoperineorrhaphy.

Ghaderi, F., et al. (2023). "Physiotherapy in Patients with Stress Urinary Incontinence: A Systematic Review and Meta-analysis." Urology Research & Practice 49(5): 293-306.
	Physiotherapy is the most commonly used treatment for stress urinary incontinence including pelvic floor muscle training, biofeedback, and electrical stimulation. This systematic review evaluated the effects of physiotherapy in patients with stress urinary incontinence compared with no treatment, placebo, sham, surgery, or other inactive control treatments. MEDLINE (via PubMed), The Cochrane Library (CENTRAL), Embase, Scopus, Web of Science, PEDro, and Trip Database were explored using applicable vocabularies for all English and Persian language investigations released from inception to January 2021. On one side, trials including physiotherapy of pelvic floor muscle training, biofeedback, and electrical stimulation and on the other, either no treatment, placebo, sham, surgery, or other inactive control treatments were included. Studies were assessed for appropriateness and methodological excellence. Two authors extracted data. Disagreements were resolved by a third opinion. Data were processed as described in the Joanna Briggs Institute Handbook. Twenty-nine trials with 2601 participants were found, but only 16 were included because of data heterogeneity. The results showed that physiotherapy interventions are better than no treatment in terms of urine leakage, but no difference was found for urinary incontinence severity. Also, physiotherapy showed favorable results over comparison groups for International Consultation on Incontinence Questionnaire, pad test, pelvic floor muscle function, and improvement outcomes. This systematic review supports the widespread use of pelvic physiotherapy as the first-line treatment for adult patients with stress urinary incontinence.

Ghanbari, Z., et al. (2022). "Quality of Life Following Pelvic Organ Prolapse Treatments in Women: A Systematic Review and Meta-Analysis." Journal of Clinical Medicine 11(23): 7166.
	Introduction: Quality of life (QoL) improvement is one of the main outcomes in the management of pelvic organ prolapse as a chronic illness in women. This systematic review aimed to investigate the impact of surgical or pessary treatment for pelvic organ prolapse (POP) on quality of life. Method(s): Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was applied. Electronic databases, including PubMed, Scopus, and Web of Science, were searched for original articles that evaluated the QoL before and after surgical interventions or pessary in pelvic organ prolapse from 1 January 2012 until 30 June 2022 with a combination of proper keywords. Included studies were categorized based on interventions, and they were tabulated to summarize the results. Result(s): Overall, 587 citations were retrieved. Of these, 76 articles were found eligible for final review. Overall, three categories of intervention were identified: vaginal surgeries (47 studies), abdominal surgeries (18 studies), and pessary intervention (11 studies). Almost all interventions were associated with improved quality of life. The results of the meta-analysis showed a significant association between the employment of surgical approach techniques (including vaginal and abdominal surgeries) and the quality of life (Pelvic Floor Distress Inventory (PFDI) (MD: -48.08, 95% CI: -62.34 to -33.77, p-value < 0.01), Pelvic Floor Impact Questionnaire (PFIQ) (MD: -33.41, 95% CI: -43.48 to -23.34, p < 0.01)) and sexual activity of patients with pelvic organ prolapse (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) (MD: 4.84, 95% CI: 1.75 to 7.92, p < 0.01)). Furthermore, narrative synthesis for studies investigating the effect of the pessary approach showed a positive association between the use of this instrument and improvement in the quality of life and sexual activity. Conclusion(s): The results of our study revealed a significant improvement in the women's quality of life following abdominal and vaginal reconstructive surgery. The use of pessary was also associated with increased patient quality of life.Copyright © 2022 by the authors.

Ghonim, M., et al. (2019). "A systematic review and meta-analysis of ulipristal acetate for symptomatic uterine fibroids." International Journal of Gynaecology and Obstetrics 146(2): 141-148.
	Background: Uterine fibroids cause menorrhagia and adversely affect quality of life. Ulipristal acetate (UPA) can improve fibroid symptoms.; Objectives: To assess the effectiveness of UPA in women with symptomatic uterine fibroids.; Search Strategy: We searched CENTRAL, MEDLINE, Embase, and CINHAL on December 31, 2018, using relevant search terms. Clinical trials registries were searched for ongoing trials and there were no language restrictions.; Selection Criteria: We included randomized controlled trials (RCTs) comparing UPA with placebo/no treatment/any pharmacological intervention for symptomatic uterine fibroids.; Data Collection and Analysis: Two authors independently screened trials, extracted data, and assessed the risk of bias in included studies. We used risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, plus their 95% confidence intervals (CIs).; Main Results: We identified six RCTs (1121 participants). Five studies (882 participants) compared UPA with placebo. UPA significantly achieved amenorrhea (RR 24.54; 95% CI, 10.82-55.64), reduced blood loss, and improved quality of life with insufficient evidence from RCTs for adverse events. There was insufficient evidence for improved outcomes when UPA was compared with leuprolide acetate.; Conclusion: Compared with placebo, oral UPA significantly induces amenorrhea, reduces heavy menses, and improves quality-of-life in women with uterine fibroids. (© 2019 International Federation of Gynecology and Obstetrics.)

Ghorbani, Z. and M. Mirghafourvand (2021). "The efficacy and safety of intravaginal oxytocin on vaginal atrophy: A systematic review." Post Reproductive Health 27(1): 30-41.
	Genitourinary syndrome of menopause is a major issue in menopausal health. Because unlike vasomotor symptoms, it has a progressive trend. In this regard we conducted a systematic review to evaluate the efficacy of intravaginal oxytocin on postmenopausal vaginal atrophy. A search was performed for published studies in Cochrane Library, MEDLINE, Web of Science, Embase, Scopus, ProQuest, Google Scholar and Persian databases without time and language limitations. Only randomized controlled trials that compared intravaginal oxytocin with placebos were included. The outcome measures were objective and subjective assessed symptoms of vaginal atrophy. Statistical heterogeneity was evaluated using the I 2 . The standardized mean differences were pooled the fixed effects model. Of the five included studies, four studies meta-analysed. The meta-analysis in terms of the cytological analysis (standardized mean difference: 35.13, 95% confidence interval: 32.59-37.67, n = 218, I 2 = 96%) was statistically significant. In terms of histological assessments (standardized mean difference: -0.38, 95% confidence interval: -0.94 to 0.17, n = 38, I 2 = 0%) and endometrial thickness (standardized mean difference: 0.05, 95% confidence interval: -0.20 to -0.31, n = 95, I 2 = 0%), there were no statistically significant differences between the groups. Three studies reported a statistically significant improvement in the subjective symptoms; however, we were unable to perform a meta-analysis. Four of the included studies assessed side effects, but only two studies reported them. Oxytocin as a nonestrogenic compound can be a suitable alternative for the treatment of vaginal atrophy, especially in women with contraindications for using estrogenic compounds. Further good quality clinical trials with long-term follow-ups are recommended to demonstrate the effects of intravaginal gel in the treatment of vaginal atrophy.

Gia-Han, L., et al. (2024). "Examining the safety and effectiveness of immunomodulating therapies in women with recurrent pregnancy loss." PROSPERO International prospective register of systematic reviews.
	
Gianfilippo, R., et al. (2023). "The role of different medical therapy in the management of adenomyosis: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Giannini, A., et al. (2023). "PARP Inhibitors in Newly Diagnosed and Recurrent Ovarian Cancer." American Journal of Clinical Oncology 46(9): 414-419.
	Ovarian cancer is the most lethal gynecologic malignancy, characterized by a high death-to-incidence ratio. Platinum-based chemotherapy is the mainstay of treatment for newly diagnosed and platinum-sensitive recurrent ovarian cancer. Poly (ADP-ribose) polymerase inhibitors (PARP inhibitors) have been incorporated into the treatment strategy for ovarian cancer. PARP inhibitors showed particular benefit for patients harboring defects in DNA repair pathways. Accumulating evidence showed that PARP inhibitors provide a benefit in newly diagnosed advanced ovarian cancer, even in the absence of BRCA mutation, as reported in the PRIMA, PRIME, and ATHENA-mono trials. Interestingly, the PAOLA-1 study provides another important finding, supporting the adoption of olaparib plus bevacizumab in patients with homologous recombination deficiency. Although those results are exciting, several patients develop resistance to PARP inhibitors. Hence, new combinations are under investigation to identify new treatment strategies to overcome this resistance. Currently, researchers are focused on the possibility to adopt PARP inhibitors even in the setting of platinum-resistant disease. The present critical review aims to report the current landscape and further perspective for strengthening PARP inhibitors' effectiveness in newly diagnosed and recurrent ovarian cancer.; Competing Interests: The authors declare no conflicts of interest. (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Gibbons, T., et al. (2021). "Levonorgestrel-releasing intrauterine device (LNG-IUD) for symptomatic endometriosis following surgery." The Cochrane Database of Systematic Reviews 12: CD005072.
	Background: Endometriosis is a condition characterised by the presence of ectopic deposits of endometrial-like tissue outside the uterus, usually in the pelvis. The impact of laparoscopic treatment on overall pain is uncertain and a significant proportion of women will require further surgery. Therefore, adjuvant medical therapies following surgery, such as the levonorgestrel-releasing intrauterine device (LNG-IUD), have been considered to reduce recurrence of symptoms. OBJECTIVES: To determine the effectiveness and safety of post-operative LNG-IUD in women with symptomatic endometriosis.; Search Methods: We searched the following databases from inception to January 2021: The Specialised Register of the Cochrane Gynaecology and Fertility Group, CENTRAL (which now includes records from two trial registries), MEDLINE, Embase, PsycINFO, LILACS and Epistemonikos. We handsearched citation lists of relevant publications, review articles, abstracts of scientific meetings and included studies. We contacted experts in the field for information about any additional studies.; Selection Criteria: We included randomised controlled trials (RCTs) comparing women undergoing surgical treatment of endometriosis with uterine preservation who were assigned to LNG-IUD insertion, versus control conditions including expectant management, post-operative insertion of placebo (inert intrauterine device), or other medical treatment such as gonadotrophin-releasing hormone agonist (GnRH-a) drugs.; Data Collection and Analysis: Two review authors independently selected studies for inclusion, and extracted data to allow for an intention-to-treat analysis. For dichotomous data, we calculated the risk ratio (RR) and 95% confidence interval (CI) using the Mantel-Haenszel fixed-effect method. For continuous data, we calculated the mean difference (MD) and 95% CI using the inverse variance fixed-effect method.; Main Results: Four RCTs were included, with a total of 157 women. Two studies are ongoing. The GRADE certainty of evidence was very low to low. The certainty of evidence was graded down primarily for serious risk of bias and imprecision. LNG-IUD versus expectant management Overall pain: No studies reported on the primary outcome of overall pain. Dysmenorrhoea: We are uncertain whether LNG-IUD improves dysmenorrhoea at 12 months. Data on this outcome were reported on by two RCTs; meta-analysis was not possible (RCT 1: delta of median visual analogue scale (VAS) 81 versus 50, P = 0.006, n = 55; RCT 2: fall in VAS by 50 (35 to 65) versus 30 (25 to 40), P = 0.021, n = 40; low-certainty evidence). Quality of life: We are uncertain whether LNG-IUD improves quality of life at 12 months. One trial demonstrated a change in total quality of life score with postoperative LNG-IUD from baseline (mean 61.2 (standard deviation (SD) 14.8) to 12 months (mean 70.3 (SD 16.2) compared to expectant management (baseline 55.1 (SD 17.0) to 57.0 (SD 33.2) at 12 months) (n = 55, P = 0.014, very low-certainty evidence). Patient satisfaction: Two studies found higher rates of satisfaction with LNG-IUD compared to expectant management; however, combining the studies in meta-analysis was not possible (n = 95, very low-certainty evidence). One study found 75% (15/20) of those given post-operative LNG-IUD were "satisfied" or "very satisfied", compared to 50% (10/20) of those in the expectant management group (RR 1.5, 95% CI 0.90-2.49, 1 RCT, n=40, very low-certainty evidence). The second study found that fewer were "very satisfied" in the expectant management group when compared to LNG, but there were no data to include in a meta-analysis. Adverse events: One study found a significantly higher proportion of women reporting melasma (n = 55, P = 0.015, very low-certainty evidence) and bloating (n = 55, P = 0.021, very low-certainty evidence) following post-operative LNG-IUD. There were no differences in other reported adverse events, such as weight gain, acne, and headaches. LNG-IUD versus GnRH-a Overall pain: No studies reported on the primary outcome of overall pain. hronic pelvic pain: We are uncertain whether LNG-IUD improves chronic pelvic pain at 12 months when compared to GnRH-a (VAS pain scale) (MD -2.0, 95% CI -20.2 to 16.2, 1 RCT, n = 40, very low-certainty evidence). Dysmenorrhoea: We are uncertain whether LNG-IUD improves dysmenorrhoea at six months when compared to GnRH-a (measured as a reduction in VAS pain score) (MD 1.70, 95%.CI -0.14 to 3.54, 1 RCT, n = 18, very low-certainty evidence). Adverse events: One study suggested that vasomotor symptoms were the most common adverse events reported with patients receiving GnRH-a, and irregular bleeding in those receiving LNG-IUD (n = 40, very low-certainty evidence) AUTHORS' CONCLUSIONS: Post-operative LNG-IUD is widely used to reduce endometriosis-related pain and to improve operative outcomes. This review demonstrates that there is no high-quality evidence to support this practice. This review highlights the need for further studies with large sample sizes to assess the effectiveness of post-operative adjuvant hormonal IUD on the core endometriosis outcomes (overall pain, most troublesome symptom, and quality of life). (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Gibbons, T., et al. (2023). "Timed intercourse for couples trying to conceive." The Cochrane Database of Systematic Reviews 9(9): CD011345.
	BACKGROUND: Many factors influence fertility, one being the timing of intercourse. The 'fertile window' describes a stage in the cycle when conception can occur and is approximately five days before to several hours after ovulation. 'Timed intercourse' is the practice of prospectively identifying ovulation and, thus, the fertile window to increase the likelihood of conception. Methods of predicting ovulation include urinary hormone measurement (luteinising hormone (LH) and oestrogen), fertility awareness-based methods (FABM) (including tracking basal body temperatures, cervical mucus monitoring, calendar charting/tracking apps), and ultrasonography. However, there are potentially negative aspects associated with ovulation prediction, including stress, time consumption, and cost implications of purchasing ovulation kits and app subscriptions. This review considered the evidence from randomised controlled trials (RCTs) evaluating the use of timed intercourse (using ovulation prediction) on pregnancy outcomes. OBJECTIVES: To evaluate the benefits and risks of ovulation prediction methods for timing intercourse on conception in couples trying to conceive. SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility (CGF) Group Specialised Register, CENTRAL, MEDLINE, and Embase in January 2023. We also checked the reference lists of relevant studies and searched trial registries for any additional trials. SELECTION CRITERIA: We included RCTs that compared methods of timed intercourse using ovulation prediction to other forms of ovulation prediction or intercourse without ovulation prediction in couples trying to conceive. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane to select and analyse studies in this review. The primary review outcomes were live birth and adverse events (such as depression and stress). Secondary outcomes were clinical pregnancy, pregnancy (clinical or positive urinary pregnancy test not yet confirmed by ultrasound), time to pregnancy, and quality of life. We assessed the overall quality of the evidence for the main comparisons using GRADE methods. MAIN RESULTS: This review update included seven RCTs involving 2464 women or couples. Four of the five studies from the previous review were included in this update, and three new studies were added. We assessed the quality of the evidence as moderate to very low, the main limitations being imprecision, indirectness, and risk of bias. Urinary ovulation tests versus intercourse without ovulation prediction Compared to intercourse without ovulation prediction, urinary ovulation detection probably increases the chance of live birth in couples trying to conceive (risk ratio (RR) 1.36, 95% confidence interval (CI) 1.02 to 1.81, 1 RCT, n = 844, moderate-quality evidence). This suggests that if the chance of a live birth without urine ovulation prediction is 16%, the chance of a live birth with urine ovulation prediction is 16% to 28%. However, we are uncertain whether timed intercourse using urinary ovulation detection resulted in a difference in stress (mean difference (MD) 1.98, 95% CI -0.87 to 4.83, I² = 0%, P = 0.17, 1 RCT, n = 77, very low-quality evidence) or clinical pregnancy (RR 1.09, 95% CI 0.51 to 2.31, I² = 0%, 1 RCT, n = 148, low-quality evidence). Similar to the live birth result, timed intercourse using urinary ovulation detection probably increases the chances of clinical pregnancy or positive urine pregnancy test (RR 1.28, 95% CI 1.09 to 1.50, I² = 0, 4 RCTs, n = 2202, moderate-quality evidence). This suggests that if the chance of a clinical pregnancy or positive urine pregnancy test without ovulation prediction is assumed to be 18%, the chance following timed intercourse with urinary ovulation detection would be 20% to 28%. Evidence was insufficient to determine the effect of urine ovulation tests on time to pregnancy or quality of life. Fertility awareness-based methods (FABM) versus intercourse without ovulation prediction Due to insufficient evidence, we are uncertain whether timed intercourse using FABM resulted in a difference in live birth rate compared to intercourse without ovulation prediction (RR 0.95, 95% CI 0.76 to 1.20, I² = 0%, 2 RCTs, n = 157, low-quality evidence). We are also uncertain whether FABM affects stress (MD -1.10, 95% CI -3.88 to 1.68, 1 RCT, n = 183, very low-quality evidence). Similarly, we are uncertain of the effect of timed intercourse using FABM on anxiety (MD 0.5, 95% CI -0.52 to 1.52, P = 0.33, 1 RCT, n = 183, very low-quality evidence); depression (MD 0.4, 95% CI -0.28 to 1.08, P = 0.25, 1 RCT, n = 183, very low-quality evidence); or erectile dysfunction (MD 1.2, 95% CI -0.38 to 2.78, P = 0.14, 1 RCT, n = 183, very low-quality evidence). Evidence was insufficient to detect a benefit of timed intercourse using FABM on clinical pregnancy (RR 1.13, 95% CI 0.31 to 4.07, 1 RCT, n = 17, very low-quality evidence) or clinical or positive pregnancy test rates (RR 1.08, 95% CI 0.89 to 1.30, 3 RCTs, n = 262, very low-quality evidence). Finally, we are uncertain whether timed intercourse using FABM affects the time to pregnancy (hazard ratio 0.86, 95% CI 0.53 to 1.38, 1 RCT, n = 140, low-quality evidence) or quality of life. No studies assessed the use of timed intercourse with pelvic ultrasonography. AUTHORS' CONCLUSIONS: The new evidence presented in this review update shows that timed intercourse using urine ovulation tests probably improves live birth and pregnancy rates (clinical or positive urine pregnancy tests but not yet confirmed by ultrasound) in women under 40, trying to conceive for less than 12 months, compared to intercourse without ovulation prediction. However, there are insufficient data to determine the effects of urine ovulation tests on adverse events, clinical pregnancy, time to pregnancy, and quality of life. Similarly, due to limited data, we are uncertain of the effect of FABM on pregnancy outcomes, adverse effects, and quality of life. Further research is therefore required to fully understand the safety and effectiveness of timed intercourse for couples trying to conceive. This research should include studies reporting clinically relevant outcomes such as live birth and adverse effects in fertile and infertile couples and utilise various methods to determine ovulation. Only with a comprehensive understanding of the risks and benefits of timed intercourse can recommendations be made for all couples trying to conceive.

Giese, N., et al. (2023). "Acupuncture for endometriosis: A systematic review and meta-analysis." Integrative Medicine Research 12(4): 101003.
	Background: Current endometriosis treatments do not always provide symptom relief, with many using complementary approaches. This study examined the effectiveness of acupuncture on pain and quality of life in people with endometriosis.; Methods: Searches were conducted on Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Allied and Complementary Medicine Database (AMED) and Embase (Ovid), Epistemonikos, and Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCOhost) on 20 March 2023. Trials were included if they used penetrating acupuncture. Risk of bias was assessed with Cochrane RoB2 and GRADE for overall evidence certainty. Random-effects meta-analyses were undertaken, using Hedges' g or mean difference (MD) both with 95 % confidence intervals (CI).; Results: Six studies involving a total of 331 participants were included. Evidence for benefit was found for acupuncture compared to non-specific acupuncture on overall pelvic pain ( g = 1.54, 95 % CI 0.92 to 2.16, 3 RCTs, n = 231, low certainty evidence, p <0.001), menstrual pain ( g = 1.67, 95 % CI 1.23 to 2.12, 1 RCT, n = 106, moderate certainty evidence, p <0.001), and non-specified pelvic pain (MD -2.77, 95 % CI 2.15 to 3.38, 2 RCTs, n = 125, low certainty evidence, p <0.001), and compared to usual care on menstrual pain ( g = 0.9, 95 % CI 0.15 to 1.64, 1 RCT, n = 19, very low certainty evidence, p = 0.02). Most studies reported low rates of adverse events.; Conclusion: Acupuncture treatment for endometriosis demonstrated clinically relevant improvements in pelvic pain and should be considered as a potential treatment intervention.; Study Registration: PROSPERO ID: CRD42023408700. (© 2023 Korea Institute of Oriental Medicine. Published by Elsevier B.V.)

Gilbert, L., et al. (2023). "Safety and efficacy of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients with platinum-resistant ovarian cancer." Gynecologic Oncology 170: 241-247.
	Purpose: Evaluate the antitumor activity and safety profile of the combination of mirvetuximab soravtansine and bevacizumab in patients with platinum-resistant ovarian cancer.; Methods: Patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, whose most recent platinum-free interval was ≤6 months, were administered mirvetuximab soravtansine (6 mg/kg adjusted ideal body weight) and bevacizumab (15 mg/kg), intravenously, once every 3 weeks. Eligibility included FRα expression by immunohistochemistry (IHC; ≥25% of cells with ≥2+ intensity). Prior bevacizumab and/or PARP inhibitor (PARPi) treatment were permitted. The primary endpoint was confirmed objective response rate (ORR). Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and safety.; Results: Ninety-four patients received combination treatment with mirvetuximab soravtansine and bevacizumab. Median age was 62 years (range, 39-81). Fifty-two percent had ≥3 prior therapies; 59% had prior bevacizumab; and 27% had prior PARPi. ORR was 44% (95% CI 33, 54) with 5 complete responses, median DOR 9.7 months (95% CI 6.9, 14.1), and median PFS 8.2 months (95% CI 6.8, 10.0). Treatment-related adverse events were consistent with the profiles of each agent, with the most common being blurred vision (all grades 57%; grade 3, 1%), diarrhea (54%; grade 3, 1%), and nausea (51%; grade 3, 1%).; Conclusion: The mirvetuximab soravtansine plus bevacizumab doublet is an active and well-tolerated regimen in patients with FRα-expressing platinum-resistant ovarian cancer. Promising activity was observed for patients regardless of level of FRα expression or prior bevacizumab. These data underscore the potential for mirvetuximab soravtansine as the combination partner of choice for bevacizumab in this setting.; Competing Interests: Declaration of Competing Interest LG reports personal fees from Merck and GSK; advisory board participation with AstraZeneca, Alkermes, Merck, Eisai, Eisai-Merck, GSK, and Novocure; institutional funding from OncoQuest Pharmaceuticals, Novocure GmbH, Alkermes Inc., ImmunoGen Inc., AstraZeneca, Esperas Pharma Inc., K-Group Beta Inc., Merck Sharp & Dohme, Roche, Karyopharm, Tesaro, and IMV Inc. AO reports personal fees from AstraZeneca, Doctaforum Servicios S.L, Edizioni Minerva Medica SpA, ESMO, PharmaMar, and Roche; advisory board participation with Agenus, AstraZeneca, Clovis Oncology, Inc., Corcept Therapeutics, Deciphera Pharmaceutical, Eisai Europe Limited, EMD Serono, Inc., F. Hoffmann-La Roche, GlaxoSmithKline, ImmunoGen, KL Logistics, Medison Pharma, Merck Sharp & Dohme de España, Mersana Therapeutics, Novocure GmbH, PharmaMar, prIME Oncology, ROCHE FARMA, Sattucklabs, and Sutro Biopharma, Inc.; funding from AbbVie Deutschland Gmbh & Co Hg, Ability Pharmaceuticals, Advaxis, Agenus, Aprea Therapeutics AB, AstraZeneca AB, Beigene USA, Inc., Belgian Gynaecological Oncology Group (BGOG), Bristol-Myers Squibb International Corporation, Clovis Oncology, Corcept Therapeutics, Eisai, Eli Lilly and Company, F. Hoffmann-La Roche, Grupo Español de Investigación en Cáncer de Ovario (GEICO), ImmunoGen, Iovance Biotherapeutics, Medimmune, Merck Healthcare, Merck Sharp & Dohme, Millennium Pharmaceuticals, Mundipharma Research, Novartis Farmacéutica, Regeneron Pharmaceuticals, Seagen, Seattle Genetics, Sutro Biopharma, Tesaro, University Health Network, and Verastem. UAM reports consulting fees from Merck, GSK, and AstraZeneca; personal fees from Med Learning Group; advisory board participation with 2× Oncology, NextCure, Trillium, Agenus, ImmunoGen, Novartis, Boehringer Ingelheim, Rivkin Foundation, Ovarian Cancer Research Alliance, Clearity Foundation, and Morphosys; data safety monitoring board participation with Alkermes and Symphogen. GMMS reports advisory board participation with ImmunoGen. PCL reports no disclosures. CMC reports personal fees from Qiagen, Inc., Teladoc Health, and InfiniteMD. DP reports no disclosures. SM reports no disclosures. MM reports employment and stock tions with ImmunoGen Inc. JW reports employment and stock options with ImmunoGen Inc. KNM reports personal fees from AbbVie, Alkemeres, Aravive, AstraZeneca, Blueprint Pharma, Bristol Myers Squibb, Eisai, Elevar, GSK/Tesaro, Genentech/Roche, iMab, ImmunoGen, Merck, Mereo, Mersana, Myriad, OncXerna, Oncomed, Rubius, Sorrento, Tarveda, Vavotar, and VBL Therapeutics; advisory board participation with Abbvie, Alkemeres, Aravive, AstraZeneca, Blueprint Pharmaceuticals, Eisai, Elevar, Genetech/Roche, GSK/Tesaro, ImmunoGen, Merck, Mereo, Mersana, Myriad, Onco Med, OncXerna, Rubius, Sorrento, Tarveda, Vavotar, VBL Therapeutics; funding from Genentech/Roche, GSK/Tesaro, ImmunoGen, Lilly, Merck, and PTC Therapeutics. DMO reports receiving grants or contracts from AbbVie Inc., Agenus Inc., Ajinomoto Co Inc., Amgen Inc., Array BioPharma Inc., AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Clovis Oncology, Dare Bioscience, Eisai Inc., EMD Serono Inc., Ergomed Plc, Genentech, Genmab, GOG Foundation Inc., ImmunoGen Inc., Iovance Biotherapeutics, Janssen Biotech Inc., Johnson & Johnson Pharmaceuticals, Ludwig Institute for Cancer Research Ltd., Merck, Merck Serono, Mersana Therapeutics, New Mexico Cancer Care Alliance, Novocure Inc., PRA Health Sciences, Regeneron Pharmaceuticals Inc., Seagen Inc., Stemcentrx, Sumitomo, Dainippon Pharma Oncology Inc., Syneos Health, Tesaro, TRACON Pharmaceuticals, VentiRX Pharmaceuticals Inc., and Yale University; data safety monitoring board and/or advisory board participation with AbbVie Inc., Ambry Genetics, Amgen Inc., Arquer Diagnostics, AstraZeneca Pharmacueticals LP, Celsion Corporation, Clovis Oncology, Corcept Therapeutics, Eisai Inc., Elevar Therapeutics, Genentech, GOG Foundation Inc., ImmunoGen Inc., InxMed, Iovance Biotherapeutics, Janssen Biotech Inc., Johnson and Johnson Pharmaceuticals, Merck, Mersana Therapeutics Inc., Novartis, Novocure Inc., Regeneron Pharmaceuticals Inc., Roche Diagnostics MSA, Seagen Inc., Sorrento Therapeutics, Sumitomo Danippon Pharma Oncology Inc., Takeda Pharmaceuticals USA Inc., Tesaro, and Tora; other financial or nonfinancial interests with Agenus Inc., Myriad Genetic Laboratories Inc., Rubis, and Tarveda Therapeutics. (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Giles, J. (2024). "Usefulness of Corifollitropin α as Alternative to Conventional Daily rFSH Protocols in Oocyte Donors Undergoing Pituitary Suppression With Medroxiprogesterona Acetate (MPA)." ClinicalTrials.gov.
	No Results Available Drug: Corifolitropin Alfa|Drug: Folitropin Beta To compare the number of total oocytes obtained after controlled ovarian stimulation with α-Corifolitropin vs. β-Folitropin in donors in whom medroxyprogesterone acetate (MPA) was used to prevent early luteinization.|To compare the number of metaphase II (MII) oocytes obtained after controlled ovarian stimulation with α-Corifolitropin vs. β-Folitropin in donors in whom medroxyprogesterone acetate (MPA) was used to prevent early luteinization.|Incidence of early luteinization|Medication tolerance: pain, abdominal distension, ovarian hyperstimulation syndrome (OHSS), etc.|Controlled ovraian stimulation duration|Total cost of each stimulation type. Female Not Applicable 318 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2304-VLC-051-JG December 31, 2025

Gil-Ibañez, B. (2023). "Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients." ClinicalTrials.gov.
	validated screening scales used: Gynecologic Cancer Lymphedema Questionnaire (GCLQ) Hospital Anxiety and Depression Scale (HADS) Sexual Function Abbreviated Index (IFSFA‐6) Short Nutritional Assessment Questionnaire (SNAQ) Sarcopenia Formulary (SARC‐F) along with self‐perceived quality of life questionnaires from EORTC: QLQ‐C30 EN‐24 or OV‐28 or CX‐24

Gil-Ibáñez, B. (2023). "A Multimodal Intervention Program to Improve Sexual Health and Self-perceived Quality of Life in Patients Treated for Cervical Cancer (PROVIDENCE)." ClinicalTrials.gov.
	Cervical cancer treatment, both radical hysterectomy and chemoradiotherapy, can impair all scopes of daily life and, beyond the physical changes caused by treatment, has psychological and social implications that influence health‐related quality of life (HR‐QoL). Patients undergoing treatment for cervical cancer have shown to score less in HR‐QoL scales compared to healthy women. More than half of women with gynecological cancer experience sexual dysfunction, especially those affected by cervical cancer. In spite of the latest 2023 ESGO/ESTRO/ESP recommendations on the management of cervical cancer, several observational studies indicate that the percentage of cervical cancer patients receiving information and treatment for early menopause and sexual dysfunction, especially regarding hormone replacement therapy, does not exceed 50%. The PROVIDENCE trial is a multi‐institutional, national, randomized clinical trial which aims to demonstrate that a multimodal intervention including patient education on sexuality and healthy habits and the prevention of vaginal dysfunction reduces sexual disfunction and HR‐QoL impairment in patients treated for cervical cancer. The recruitment period is scheduled from January 2024 to December 2026 and will be held in Gynecology Oncology Units of referral hospitals in Spain. Patients will be randomized 1:1 at diagnosis of cervical cancer to control arm or intervention arm. After treatment for initial or locally advanced cervical cancer, patients in the control arm will undergo the standard follow‐up and treatment of post‐treatment morbidity will be performed following the standard procedures as determined by their referring physician. The proposed multimodal intervention for patients assigned to the intervention group (detailed below) includes education on healthy habits, the prevention of vaginal dysfunction using vaginal moisturizers and topical estrogens, and a systematic evaluation of the need of hormone replacement therapy.

Girdler, S. (2022). "Estrogen Variability and Irritability During the Menopause Transition." ClinicalTrials.gov.
	No Results Available Drug: Estradiol Patch, 0.1 mg/24 Hours Weekly Transdermal Film, Extended Release|Drug: Placebo|Drug: Progesterone 200 mg Mean IDAS Ill Temper Scale Score Over Time|Theta Oscillatory Activity (4-8 Hz) In Response To Dot Probe Task (Indexing Threat) Over Time|Beta Oscillatory Activity (13-30 Hz) In Response To Affective Posner Paradigm (probing Frustration) Over Time Female Phase 4 50 Other|NIH Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Basic Science 21-3395|R21MH128241 December 2024

Giulia, D., et al. (2022). "MIS in high grade endometrial cancer: laparoscopic versus robotic outcomes. A systematic review and metanalysis." PROSPERO International prospective register of systematic reviews.
	
Giulia, S., et al. (2024). "Physiotherapy in the treatment of Genito-pelvic pain/penetration disorder: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Giuliani, J., et al. (2023). "Cost-effectiveness of poly-(ADP-ribose) polymerase (PARP)-inhibitors for the maintenance treatment after responding to first- and second-line chemotherapy in advanced ovarian cancer." Journal of Oncology Pharmacy Practice 29(2): 457-464.
	The introduction of inhibitors of poly-(ADP-ribose) polymerase (PARP) for the treatment of women with epithelial ovarian cancers (EOC) has radically changed the treatment in maintenance setting after responding to first- and second-line chemotherapy. The aim of this paper was to assess the pharmacological costs of PARP inhibitors (olaparib, niraparib, rucaparib and veliparib) in maintenance treatment after responding to first-line chemotherapy in EOC. Incremental cost-effectiveness ratio (ICER) was calculated as the ratio between the difference of the costs in the intervention and in the control groups (pharmacy costs) and the difference between the effect in the intervention and in the control groups (progression-free survival (PFS)). We have considered the pivotal phase III randomized controlled trials (RCTs). Three different populations were considered: the overall population, patients with germline BRCA mutation (gBRCA) and homologous recombination deficiency (HRD) patients non-gBRCA mutation. Three thousand four hundred and twenty patients and 1209 patients were considered in maintenance treatment after responding to first- and second-line chemotherapy in EOC, respectively. At the actual price, the treatment with PARP inhibitors is not cost-effective in maintenance treatment after responding to first-line and second-line chemotherapy in EOC. A reduction in pharmacological costs is mandatory.Copyright © The Author(s) 2022.

Giusto, L. L., et al. (2022). "Telemedicine follow-up is safe and efficacious for synthetic midurethral slings: a randomized, multi-institutional control trial." International Urogynecology Journal 33(4): 1007‐1015.
	Introduction and hypothesis: The objective was to assess whether telemedicine‐based follow‐up is equivalent to office‐based follow‐up in the early postoperative period after routine synthetic midurethral sling placement. Methods: This is a prospective, international, multi‐institutional, randomized controlled trial. Patients undergoing synthetic midurethral sling placement were randomized to 3‐week postoperative telemedicine versus office‐based follow‐up. The primary outcome was the rate of unplanned events. Secondary outcomes included patient satisfaction, crossover from telemedicine to office‐based follow‐up, and compliance with 3‐ to 5‐month office follow‐up. Results: We included 238 patients (telemedicine: 121 vs office: 117). No differences in demographics or medical comorbidities were noted between the study groups (p = 0.09–1.0). No differences were noted in unplanned events: hospital admission, emergency department visit, or unplanned office visit or call (14% vs 12.9%, p = 0.85) or complications (9.9% vs 8.6%, p = 0.82). Both groups were equally “very satisfied” with their surgical outcomes (71.1% vs 69%, p = 0.2). Telemedicine patients were more compliant with 3‐ to 5‐month office follow‐up (90.1% vs 79.3%, p = 0.04). Conclusions: After synthetic midurethral sling placement, telemedicine follow‐up is a safe patient communication option in the early postoperative period. Telemedicine patients reported no difference in satisfaction compared with office‐based follow‐up but had greater compliance with 3‐ to 5‐month follow‐up.

GlaxoSmithKline, S. A. (2021). "OPAL Master Protocol Phase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments and/or Combinations of Treatments in Participants with Ovarian Cancer (OPAL). OPAL-Supplement C Cohort C: open-Label Phase 2, Randomized, Controlled Multicenter Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants with Homologous Recombination-Deficient Stage III/IV Ovarian Cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: Zejula Product Name: Niraparib Product Code: GSK3985771 Pharmaceutical Form: Capsule INN or Proposed INN: niraparib CAS Number: 1038915‐60‐4 Current Sponsor code: GSK3985771 Other descriptive name: NIRAPARIB TOSILATE MONOHYDRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ CONDITION: Ovarian 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) ; MedDRA version: 24.0 Level: PT Classification code 10084789 Term: Homologous recombination deficiency positive advanced 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: To evaluate the efficacy of neoadjuvant niraparib compared with neoadjuvant platinum‐taxane doublet chemotherapy after 1 induction cycle of; carboplatin‐paclitaxel per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in participants with confirmed HRd Stage III to IV OC Primary end point(s): Primary efficacy analysis is pre‐IDS overall response rate (ORR; defined as the percentage of participants with unconfirmed complete or partial response) per RECIST v1.1 by investigator assessment. Secondary Objective: • To evaluate clinical benefit by Gynecological Cancer InterGroup (GCIG) cancer antigen 125 (CA‐125) response criteria; • To evaluate clinical benefit as measured by progression‐free survival (PFS) per RECIST v1.1 by investigator assessment; • To evaluate participants’ reported overall tolerability toward treatment, overall health status, OC‐specific health‐related quality of life (HRQoL) & symptoms, and work productivity; • To evaluate clinical benefit as measured by OS; • To evaluate clinical benefit as measured by time to first subsequent treatment (TFST); • To evaluate the safety and tolerability of neoadjuvant niraparib and neoadjuvant platinum‐taxane doublet chemotherapy Timepoint(s) of evaluation of this end point: Q3 2024 SECONDARY OUTCOME: Secondary end point(s): Secondary endpoints include CA‐125 progression by GCIG CA‐125 response criteria; PFS; patient‐reported outcomes to evaluate overall tolerability to treatment, overall health status, OC‐specific health‐related quality of life and symptoms, and work productivity; OS; TFST; and safety and tolerability Timepoint(s) of evaluation of this end point: Q1 2026 INCLUSION CRITERIA: C1. Participant must be female =18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent. C2. Participant must have measurable disease according to RECIST v1.1. C3. Participant has an ECOG performance status of 0 to 2. C4. Participant has adequate organ function, defined as follows: a. Absolute neutrophil count =1500/µL, without growth factor support (granulocyte colony‐stimulating factor or granulocyte‐macrophage colony‐stimulating factor administration is not permitted within 2 weeks of Screening) b. Platelets =100,000/µL without platelet transfusion support within 2 weeks prior to Screening c. Hemoglobin =9 g/dL without transfusion or growth factor (recombinant erythropoietin) within 2 weeks of Screening d. Serum creatinine =1.5× upper limit of normal (ULN) or calculated creatinine clearance =50 mL/min using Cockcroft‐Gault equation e. Total bilirubin =1.5× UL

Glazener, C., et al. (2020). "Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT)." BJOG 127(8): 1002-1013.
	Objective: To compare standard (native tissue) repair with synthetic mesh inlays or mesh kits.; Design: Randomised controlled trial.; Setting: Thirty-three UK hospitals.; Population: Women having surgery for recurrent prolapse.; Methods: Women recruited using remote randomisation.; Main Outcome Measures: Prolapse symptoms, condition-specific quality-of-life and serious adverse effects.; Results: A Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference [MD] -0.41, 95% CI -2.92 to 2.11: standard 6.6 versus mesh kit 5.9, MD -1.21 , 95% CI -4.13 to 1.72) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05 [0.66-1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49 [0.11-2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%), of whom two required surgical revision.; Conclusions: We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis.; Tweetable Abstract: There is not enough evidence to support use of synthetic mesh inlay or mesh kits for repeat prolapse surgery. (© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.)

Gloria, G.-M. and R. Petronila Oliva (2021). "Effectiveness of physiotherapy in dyspareunia. Systematic Review." PROSPERO International prospective register of systematic reviews.
	
Glujovsky, D., et al. (2023). "Personalized embryo transfer guided by endometrial receptivity analysis: a systematic review with meta-analysis." Human Reproduction 38(7): 1305-1317.
	Study Question: Does a personalized embryo transfer (pET) guided by tests for endometrial receptivity (TER) increase the effectiveness of ART procedures?; Summary Answer: The use of TER-guided pET is not supported by current published evidence in women without repeated implantation failure (RIF), while in women with RIF more research is needed to assess a potential benefit.; What Is Known Already: Implantation rates are still far from ideal, especially in some patients that have RIF with good-quality embryos. As a potential solution, a wide range of diverse TER use different sets of genes to identify displacements of the window of implantation to adjust the individual length of progesterone exposure in a pET.; Study Design, Size, Duration: A systematic review with meta-analysis was performed. Search terms included endometrial receptivity analysis, ERA, personalized embryo transfer. CENTRAL, PubMed, Embase, reference lists, clinical trials registers, and conference proceedings (search date October 2022) were searched, with no language restrictions.; Participants/materials, Setting, Methods: Randomized controlled trials (RCTs) and cohort studies comparing a pET guided by TER vs standard embryo transfer (sET) in different subgroups that undergo ART were identified. We also investigated pET in non-receptive-TER vs sET in receptive-TER, and pET in a specific population vs sET in a general population. Risk of bias (RoB) was assessed with the Cochrane tool and ROBINS-I. Only those with low/moderate RoB underwent meta-analysis. The GRADE approach was used to evaluate the certainty of evidence (CoE).; Main Results and the Role of Chance: We screened 2136 studies and included 35 (85% used ERA and 15% used other TER). Two studies were RCTs comparing endometrial receptivity analysis (ERA)-guided pET vs sET in women with no history of RIF. In women without RIF, no important differences (moderate-CoE) were found in live birth rates and clinical pregnancy rates (CPR). We also performed a meta-analysis of four cohort studies that were adjusted for confounding. In agreement with the RCTs, no benefits were found in women without RIF. However, in women with RIF, low CoE suggests that pET might improve the CPR (OR 2.50, 95% CI 1.42-4.40).; Limitations, Reasons for Caution: We found few studies with low RoB. Only two RCTs in women without RIF were published, and none in women with RIF. Furthermore, the heterogeneity observed in populations, interventions, co-interventions, outcomes, comparisons, and procedures limited the pooling of many of the included studies.; Wider Implications of the Findings: In the population of women without RIF, in agreement with previously published reviews, pET did not prove to be more effective than sET and, therefore, it precludes the routine use of this strategy in this population until more evidence is available. However, more research is advisable in women with RIF as low-certainty evidence from observational studies adjusted for confounders suggests that the CPR might be higher with pET guided by TER in this population. Although this review presents the best available evidence, it is still insufficient to change current policies.; Study Funding/competing Interest(s): No specific funding was obtained for this study. There are no conflicts of interest to declare.; Registration Number: PROSPERO CRD42022299827. (© 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.)

Glujovsky, D., et al. (2023). "Progestogens for prevention of luteinising hormone (LH) surge in women undergoing controlled ovarian hyperstimulation as part of an assisted reproductive technology (ART) cycle." The Cochrane Database of Systematic Reviews(11).
	- Background Currently, gonadotrophin releasing hormone (GnRH) analogues are used to prevent premature ovulation in ART cycles. However, their costs remain high, the route of administration is invasive and has some adverse effects. Oral progestogens could be cheaper and effective to prevent a premature LH surge. Objectives To evaluate the effectiveness and safety of using progestogens to avoid spontaneous ovulation in women undergoing controlled ovarian hyperstimulation (COH). Search methods We searched the Cochrane Gynaecology and Fertility Group trials register, CENTRAL, MEDLINE, Embase and PsycINFO in Dec 2021. We contacted study authors and experts to identify additional studies. Selection criteria We included randomised controlled trials (RCTs) that included progestogens for ovulation inhibition in women undergoing controlled ovarian hyperstimulation (COH). Data collection and analysis We used standard methodological procedures recommended by Cochrane, including the risk of bias (RoB) assessment. The primary review outcomes were live birth rate (LBR) and oocyte pick‐up cancellation rate (OPCR). Secondary outcomes were clinical pregnancy rate (CPR), cumulative pregnancy, miscarriage rate (MR), multiple pregnancies, LH surge, total and MII oocytes, days of stimulation, dose of gonadotropins, and moderate/severe ovarian hyperstimulation syndrome (OHSS) rate. The primary analyses were restricted to studies at overall low and some concerns RoB, and sensitivity analysis included all studies. We used the GRADE approach to assess the certainty of evidence. Main results We included 14 RCTs (2643 subfertile women undergoing ART, 47 women used oocyte freezing for fertility preservation and 534 oocyte donors). Progestogens versus GnRH antagonists We are very uncertain of the effect of medroxyprogesterone acetate (MPA) 10 mg compared with cetrorelix on the LBR in poor responders (odds ratio (OR) 1.25, 95% confidence interval (CI) 0.73 to 2.13, one RCT, N = 340, very‐low‐certainty evidence), suggesting that if the chance of live birth following GnRH antagonists is assumed to be 18%, the chance following MPA would be 14% to 32%. There may be little or no difference in OPCR between progestogens and GnRH antagonists, but due to wide Cs (CIs), we are uncertain (OR 0.92, 95%CI 0.42 to 2.01, 3 RCTs, N = 648, I² = 0%, low‐certainty evidence), changing the chance of OPCR from 4% with progestogens to 2% to 8%. Given the imprecision found, no conclusions can be retrieved on CPR and MR. Low‐quality evidence suggested that using micronised progesterone in normo‐responders may increase by 2 to 6 the MII oocytes in comparison to GnRH antagonists. There may be little or no differences in gonadotropin doses. Progestogens versus GnRH agonists Results were uncertain for all outcomes comparing progestogens with GnRH agonists. One progestogen versus another progestogen The analyses comparing one progestogen versus another progestogen for LBR did not meet our criteria for primary analyses. The OPCR was probably lower in the MPA 10 mg in comparison to MPA 4 mg (OR 2.27, 95%CI 0.90 to 5.74, one RCT, N = 300, moderate‐certainty evidence), and MPA 4 mg may be lower than micronised progesterone 100 mg, but due to wide CI, we are uncertain of the effect (OR 0.81, 95%CI 0.43 to 1.53, one RCT, N = 300, low‐certainty evidence), changing the chance of OPCR from 5% with MPA 4 mg to 5% to22%, and from 17% with micronised progesterone 100 mg to 8% to 24%. When comparing dydrogesterone 20 mg to MPA, the OPCR is probably lower in the dydrogesterone group in comparison to MPA 10 mg (OR 1.49, 95%CI 0.80 to 2.80, one RCT, N = 520, moderate‐certainty evidence), and it may be lower in dydrogesterone group in comparison to MPA 4 mg but due to wide confidence interval, we are uncertain of the effect (OR 1.19, 95%CI 0.61 to 2.34, one RCT, N = 300, low‐certainty evidence), changing the chance of OPCR from 7% with dydrogesterone 20 to 6‐17%, and in MPA 4 mg from 12% to 8% to 24%. When comparing dydrogesterone 20 mg to micronised progest rone 100 g, the OPCR is probably lower in the dydrogesterone group (OR 1.54, 95%CI 0.94 to 2.52, two RCTs, N=550, I² = 0%, moderate‐certainty evidence), changing OPCR from 11% with dydrogesterone to 10% to 24%. We are very uncertain of the effect in normo‐responders of micronised progesterone 100 mg compared with micronised progesterone 200 mg on the OPCR (OR 0.35, 95%CI 0.09 to 1.37, one RCT, N = 150, very‐low‐certainty evidence). There is probably little or no difference in CPR and MR between MPA 10 mg and dydrogesterone 20 mg. There may be little or no differences in MII oocytes and gonadotropins doses. No cases of moderate/severe OHSS were reported in most of the groups in any of the comparisons. Authors' conclusions Little or no differences in LBR may exist when comparing MPA 4 mg with GnRH agonists in normo‐responders. OPCR may be slightly increased in the MPA 4 mg group, but MPA 4 mg reduces the doses of gonadotropins in comparison to GnRH agonists. Little or no differences in OPCR may exist between progestogens and GnRH antagonists in normo‐responders and donors. However, micronised progesterone could improve by 2 to 6 MII oocytes. When comparing one progestogen to another, dydrogesterone suggested slightly lower OPCR than MPA and micronised progesterone, and MPA suggested slightly lower OPCR than the micronised progesterone 100 mg. Finally, MPA 10 mg suggests a lower OPCR than MPA 4 mg. There is uncertainty regarding the rest of the outcomes due to imprecision and no solid conclusions can be drawn. Plain language summary Progestogens versus gonadotrophin‐releasing hormone (GnRH) agonists, GnRH antagonists and other progestogens for women undergoing assisted reproductive technology (ART) Review question Cochrane authors reviewed the evidence about the effect of progestogens versus gonadotrophin‐releasing (GnRH) agonists, GnRH antagonists and other progestogens in women undergoing assisted reproductive technology. Background GnRH agonists and antagonists are medications that affect hormones related to fertility. They are commonly used to prevent a hormone called luteinising hormone from causing a premature ovulation in women undergoing assisted reproductive technology treatments. This is important because spontaneous ovulation can lead to the cancellation of egg retrieval. However, these medications can be costly and need to be injected. An alternative approach is to use progestogens, which are steroid hormones, as they may be just as effective but are taken orally, which can reduce costs and increase patient satisfaction. We conducted a comparison of the benefits and risks of these two treatments, using different types of progestogens, such as medroxyprogesterone acetate, dydrogesterone and micronised progesterone. Study characteristics We found 14 studies comparing oral progestogens with GnRH agonists, antagonists and other progestogens in a total of 3224 women undergoing assisted reproductive technology. The evidence is current to December 2021. Key results Fourteen well‐designed studies were included in the analysis. Progestogens versus GnRH antagonists The evidence suggests that if the chance of live birth following GnRH antagonists is assumed to be 18%, the chance following medroxyprogesterone acetate (progestogen) would be between 14% and 32%. Cancellation rates may have no differences between progestogens and GnRH antagonists and may be slightly reduced in GnRH agonists in comparison to medroxyprogesterone acetate 4 mg. No conclusions can be retrieved regarding clinical pregnancy rate and miscarriage rate, when comparing progestogens with GnRH antagonists. In women with normal number of eggs (normo‐responders), micronised progesterone (progestogen) may increase by 2 to 6 the number of MII oocytes in comparison to GnRH antagonists. There may be little or no differences in gonadotropin doses. Progestogens versus GnRH agonists There may be no differences in live birth rate when comparing medroxyprogesterone acetate 4 mg (progestogen) to GnRH agonist in normo‐responders undergoing assi ted reprod ctive technology. The evidence suggests that if the chance of cycle cancellation following GnRH agonists is assumed to be 5%, the chance following medroxyprogesterone acetate 4 mg (progestogen) would be between 2% and 16%. No conclusions can be retrieved regarding clinical pregnancy rate and miscarriage rate when comparing progestogens with GnRH agonists. There may be little or no differences in MII oocytes. Medroxyprogesterone acetate 4 mg (progestogen) reduces the doses of gonadotropins in comparison to GnRH agonists. One progestogen versus another progestogen None of the studies that reported live birth rate were included in the primary analysis. ‐ Dydrogesterone probably decreases the cancellation rate in comparison to medroxyprogesterone acetate and micronised progesterone. ‐ Medroxyprogesterone acetate suggested a slightly lower cancellation rate in comparison to micronised progesterone 100 mg. ‐ Medroxyprogesterone acetate 10 mg probably suggests lower oocyte pick‐up cancellation rates than in medroxyprogesterone acetate 4 mg. ‐ Data were lacking on other unwanted effects. The evidence suggests that: ‐ if the chance of cancellation following medroxyprogesterone acetate 10 mg is assumed to be 5%, the chance following medroxyprogesterone acetate 4 mg would be between 5% and 22%; ‐ if the chance of cancellation following micronised progesterone 100 mg is assumed to be 17%, the chance following medroxyprogesterone acetate 4 mg would be between 8% and 24%; ‐ if the chance of cancellation following dydrogesterone 20 mg is assumed to be 7%, the chance following medroxyprogesterone acetate 10 mg would be between 6% and 17%; ‐ if the change of cancellation following dydrogesterone 20 mg is assumed to be 12%, the chance following medroxyprogesterone acetate 4 mg would be between 8% and 24% ‐ if the chance of cancellation following dydrogesterone 20 mg is assumed to be 11%, the chance following micronised progesterone 100 mg would be between 10% and 24%. There is probably little or no difference in clinical pregnancy rate and miscarriage rate between medroxyprogesterone acetate 10 mg (progestogen) and dydrogesterone 20 mg (progestogen). There may be little or no differences in MII oocytes and in gonadotropin doses. Evidence about other moderate or severe unwanted events was poorly reported and inconclusive for all the comparisons. What are the limitations of the evidence? There remains uncertainty about whether any progestogens compared among them or to GnRH antagonists or GnRH agonists changes the chance of having a baby. However, there may be little or no differences in the egg retrieval cancellation rate when compared to GnRH antagonists and progestogens may increase the risk of cancellation when compared to GnRH agonists. Among progestogens, cancellation rate may be lower in dydrogesterone in comparison to the rest, and medroxyprogesterone acetate 10 mg may be better than medroxyprogesterone acetate 4 mg and micronised progesterone. The certainty of the evidence was assessed as low. The reason for this is that most comparisons included only one study that did not recruit a large enough number of women to provide meaningful results. This means that results must be treated cautiously, and further studies are needed to confirm findings.

Glujovsky, D., et al. (2020). "How effective are the non-conventional ovarian stimulation protocols in ART? A systematic review and meta-analysis." Journal of Assisted Reproduction and Genetics 37(12): 2913-2928.
	Purpose: To compare the effectiveness of starting the ovarian stimulation on the early follicular phase ("Conventional") with the newer range of non-conventional approaches starting in the luteal phase ("Luteal"), random-start, and studies implementing them in DuoStim ("Conventional"+"Luteal").; Methods: Systematic review. We searched CENTRAL, PubMed, and Embase, on March 2020. We included randomized and non-randomized controlled trials that compared "Luteal," random-start ovarian stimulation or DuoStim with "Conventional"; we analyzed them by subgroups: oocyte freezing and patients undergoing ART treatments, both, in the general infertile population and among poor responders.; Results: The following results come from a sensitivity analysis that included only the low/moderate risk of bias studies. When comparing "Luteal" to "Conventional," clinically relevant differences in MII oocytes were ruled out in all subgroups. We found that "Luteal" probably increases the COH length both, in the general infertile population (OR 2.00 days, 95% CI 0.81 to 3.19, moderate-quality evidence) and in oocyte freezing cycles (MD 0.85 days, 95% CI 0.53 to 1.18, moderate-quality evidence). When analyzing DuoStim among poor responders, we found that it appears to generate a higher number of MII oocytes in comparison with a single "Conventional" (MD 3.35, 95%CI 2.54-4.15, moderate-quality evidence).; Conclusion: Overall, this systematic review of the available data demonstrates that in poor responders, general infertile population and oocyte freezing for cancer stimulation in the late follicular and luteal phases can be utilized in non-conventional approaches such as random-start and DuoStim cycles, offering similar outcomes to the conventional cycles but potentially with increased flexibility, within a reduced time frame. However, more well-designed trials are required to establish certainty.

Glujovsky, D., et al. (2020). "Endometrial preparation for women undergoing embryo transfer with frozen embryos or embryos derived from donor oocytes." The Cochrane Database of Systematic Reviews 10: CD006359.
	Background: A frozen embryo transfer (FET) cycle is when one or more embryos (frozen during a previous treatment cycle) are thawed and transferred to the uterus. Some women undergo fresh embryo transfer (ET) cycles with embryos derived from donated oocytes. In both situations, the endometrium is primed with oestrogen and progestogen in different doses and routes of administration.; Objectives: To evaluate the most effective endometrial preparation for women undergoing transfer with frozen embryos or embryos from donor oocytes with regard to the subsequent live birth rate (LBR).; Search Methods: The Cochrane Gynaecology and Fertility Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, LILACS, trials registers and abstracts of reproductive societies' meetings were searched in June 2020 together with reference checking and contact with study authors and experts in the field to identify additional studies.; Selection Criteria: Randomised controlled trials (RCTs) evaluating endometrial preparation in women undergoing fresh donor cycles and frozen embryo transfers.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. We analysed all available interventions versus placebo, no treatment, or between each other. The primary review outcome was live birth rate. Secondary outcomes were clinical and multiple pregnancy, miscarriage, cycle cancellation, endometrial thickness and adverse effects.; Main Results: Thirty-one RCTs (5426 women) were included. Evidence was moderate to very low-quality: the main limitations were serious risk of bias due to poor reporting of methods, and serious imprecision. Stimulated versus programmed cycle We are uncertain whether a letrozole-stimulated cycle compared to a programmed cycle, for endometrial preparation, improves LBR (odds ratio (OR) 1.26, 95% confidence interval (CI) 0.49 to 3.26; 100 participants; one study; very low-quality evidence). Stimulating with follicle stimulating hormone (FSH), letrozole or clomiphene citrate may improve clinical pregnancy rate (CPR) (OR 1.63, 95% CI 1.12 to 2.38; 656 participants; five studies; I 2 = 11%; low-quality evidence). We are uncertain if they reduce miscarriage rate (MR) (OR 0.79, 95% CI 0.36 to 1.71; 355 participants; three studies; I 2 = 0%; very low-quality evidence). Endometrial thickness (ET) may be reduced with clomiphene citrate (mean difference(MD) -1.04, 95% CI -1.59 to -0.49; 92 participants; one study; low-quality evidence). Other outcomes were not reported. Natural versus programmed cycle We are uncertain of the effect from a natural versus programmed cycle for LBR (OR 0.97, 95% CI 0.74 to 1.28; 1285 participants; four studies; I 2 = 0%; very low-quality evidence) and CPR (OR 0.79, 95% CI 0.62 to 1.01; 1249 participants; five studies; I 2 = 60%; very low-quality evidence), while a natural cycle probably reduces the cycle cancellation rate (CCR) (OR 0.60, 95% CI 0.44 to 0.82; 734 participants; one study; moderate-quality evidence). We are uncertain of the effect on MR and ET. No study reported other outcomes. Transdermal versus oral oestrogens From low-quality evidence we are uncertain of the effect transdermal compared to oral oestrogens has on CPR (OR 0.86, 95% CI 0.59 to 1.25; 504 participants; three studies; I 2 = 58%) or MR (OR 0.55, 95% CI 0.27 to 1.09; 414 participants; two studies; I 2 = 0%). Other outcomes were not reported. Day of starting administration of progestogen When doing a fresh ET using donated oocytes in a synchronised cycle starting progestogen on the day of oocyte pick-up (OPU) or the day after OPU, in comparison with recipients that start progestogen the day prior to OPU, probably increases the CPR (OR 1.87, 95% CI 1.13 to 3.08; 282 participants; one study, moderate-quality evidence). We are uncertain of the effect on multiple pregnancy rate (MPR) or MR. It probably reduces the CCR (OR 0.28, 95% CI 0.11 to 0.74; 282 participants; one study; moderate-quality evidence). No study reported other outcomes. Gonadotropin-releasing hormone (GnRH) agonist versus co trol A cycle with GnRH agonist compared to without may improve LBR (OR 2.62, 95% CI 1.19 to 5.78; 234 participants; one study; low-quality evidence). From low-quality evidence we are uncertain of the effect on CPR (OR 1.08, 95% CI 0.82 to 1.43; 1289 participants; eight studies; I 2 = 20%), MR (OR 0.85, 95% CI 0.36 to 2.00; 828 participants; four studies; I 2 = 0%), CCR (OR 0.49, 95% CI 0.21 to 1.17; 530 participants; two studies; I 2 = 0%) and ET (MD -0.08, 95% CI -0.33 to 0.16; 697 participants; four studies; I 2 = 4%). No study reported other outcomes. Among different GnRH agonists From very low-quality evidence we are uncertain if cycles among different GnRH agonists improves CPR or MR. No study reported other outcomes. GnRH agonists versus GnRH antagonists GnRH antagonists compared to agonists probably improves CPR (OR 0.62, 95% CI 0.42 to 0.90; 473 participants; one study; moderate-quality evidence). We are uncertain of the effect on MR and MPR. No study reported other outcomes. Aspirin versus control From very low-quality evidence we are uncertain whether a cycle with aspirin versus without improves LBR, CPR, or ET. Steroids versus control From very low-quality evidence we are uncertain whether a cycle with steroids compared to without improves LBR, CPR or MR. No study reported other outcomes.; Authors' Conclusions: There is insufficient evidence on the use of any particular intervention for endometrial preparation in women undergoing fresh donor cycles and frozen embryo transfers. In frozen embryo transfers, low-quality evidence showed that clinical pregnancy rates may be improved in a stimulated cycle compared to a programmed one, and we are uncertain of the effect when comparing a programmed cycle to a natural cycle. Cycle cancellation rates are probably reduced in a natural cycle. Although administering a GnRH agonist, compared to without, may improve live birth rates, clinical pregnancy rates will probably be improved in a GnRH antagonist cycle over an agonist cycle. In fresh synchronised oocyte donor cycles, the clinical pregnancy rate is probably improved and cycle cancellation rates are probably reduced when starting progestogen the day of or day after donor oocyte retrieval. Adequately powered studies are needed to evaluate each treatment more accurately. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Glujovsky, D., et al. (2022). "Cleavage‐stage versus blastocyst‐stage embryo transfer in assisted reproductive technology." The Cochrane Database of Systematic Reviews(5).
	- Background Advances in embryo culture media have led to a shift in in vitro fertilisation (IVF) practice from cleavage‐stage embryo transfer to blastocyst‐stage embryo transfer. The rationale for blastocyst‐stage transfer is to improve both uterine and embryonic synchronicity and enable self selection of viable embryos, thus resulting in better live birth rates. Objectives To determine whether blastocyst‐stage (day 5 to 6) embryo transfer improves the live birth rate (LBR) per fresh transfer, and other associated outcomes, compared with cleavage‐stage (day 2 to 3) embryo transfer. Search methods We searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL, MEDLINE, Embase, PsycINFO, and CINAHL, from inception to October 2021. We also searched registers of ongoing trials and the reference lists of studies retrieved. Selection criteria We included randomised controlled trials (RCTs) which compared the effectiveness of IVF with blastocyst‐stage embryo transfer versus IVF with cleavage‐stage embryo transfer. Data collection and analysis We used standard methodological procedures recommended by Cochrane. Our primary outcomes were LBR per fresh transfer and cumulative clinical pregnancy rates (cCPR). Secondary outcomes were clinical pregnancy rate (CPR), multiple pregnancy, high‐order multiple pregnancy, miscarriage (all following first embryo transfer), failure to transfer embryos, and whether supernumerary embryos were frozen for transfer at a later date (frozen‐thawed embryo transfer). We assessed the overall quality of the evidence for the main comparisons using GRADE methods. Main results We included 32 RCTs (5821 couples or women). The live birth rate following fresh transfer was higher in the blastocyst‐stage transfer group (odds ratio (OR) 1.27, 95% confidence interval (CI) 1.06 to 1.51; I 2 = 53%; 15 studies, 2219 women; low‐quality evidence). This suggests that if 31% of women achieve live birth after fresh cleavage‐stage transfer, between 32% and 41% would do so after fresh blastocyst‐stage transfer. We are uncertain whether blastocyst‐stage transfer improves the cCPR. A post hoc analysis showed that vitrification could increase the cCPR. This is an interesting finding that warrants further investigation when more studies using vitrification are published. The CPR was also higher in the blastocyst‐stage transfer group, following fresh transfer (OR 1.25, 95% CI 1.12 to 1.39; I 2 = 51%; 32 studies, 5821 women; moderate‐quality evidence). This suggests that if 39% of women achieve a clinical pregnancy after fresh cleavage‐stage transfer, between 42% and 47% will probably do so after fresh blastocyst‐stage transfer. We are uncertain whether blastocyst‐stage transfer increases multiple pregnancy (OR 1.05, 95% CI 0.83 to 1.33; I 2 = 30%; 19 studies, 3019 women; low‐quality evidence) or miscarriage rates (OR 1.12, 95% CI 0.90 to 1.38; I 2 = 24%; 22 studies, 4208 women; low‐quality evidence). This suggests that if 9% of women have a multiple pregnancy after fresh cleavage‐stage transfer, between 8% and 12% would do so after fresh blastocyst‐stage transfer. However, a sensitivity analysis restricted only to studies with low or 'some concerns' for risk of bias, in the subgroup of equal number of embryos transferred, showed that blastocyst transfer probably increases the multiple pregnancy rate. Embryo freezing rates (when there are frozen supernumerary embryos for transfer at a later date) were lower in the blastocyst‐stage transfer group (OR 0.48, 95% CI 0.40 to 0.57; I 2 = 84%; 14 studies, 2292 women; low‐quality evidence). This suggests that if 60% of women have embryos frozen after cleavage‐stage transfer, between 37% and 46% would do so after blastocyst‐stage transfer. Failure to transfer any embryos was higher in the blastocyst transfer group (OR 2.50, 95% CI 1.76 to 3.55; I 2 = 36%; 17 studies, 2577 women; moderate‐quality evidence). This suggests that if 1% of women have no embryos transferred in planned fres cleavage‐stage transfer, between 2% and 4% probably have no embryos transferred in planned fresh blastocyst‐stage transfer. The evidence was of low quality for most outcomes. The main limitations were serious imprecision and serious risk of bias, associated with failure to describe acceptable methods of randomisation. Authors' conclusions There is low‐quality evidence for live birth and moderate‐quality evidence for clinical pregnancy that fresh blastocyst‐stage transfer is associated with higher rates of both than fresh cleavage‐stage transfer. We are uncertain whether blastocyst‐stage transfer improves the cCPR derived from fresh and frozen‐thawed cycles following a single oocyte retrieval. Although there is a benefit favouring blastocyst‐stage transfer in fresh cycles, more evidence is needed to know whether the stage of transfer impacts on cumulative live birth and pregnancy rates. Future RCTs should report rates of live birth, cumulative live birth, and miscarriage. They should also evaluate women with a poor prognosis to enable those undergoing assisted reproductive technology (ART) and service providers to make well‐informed decisions on the best treatment option available. Plain language summary When trying to have a baby through assisted conception, is it better to transfer the embryo to the womb on day 3 or day 5? Background Many women and couples are unlikely to get pregnant and have a baby without medical treatment, due to infertility. Doctors have developed a variety of assisted reproductive technologies (ARTs), such as in vitro fertilisation (IVF), which involve the manipulation of eggs and sperm outside a woman's body, to try to increase her chances of getting pregnant. Typically, in assisted conception, doctors collect eggs from a woman and fertilise them in a laboratory, leading to the formation of embryos. An embryo is the early stage of human development. Doctors commonly transfer one or several embryos into a woman’s womb (uterus) at one of two stages of embryo development: either the cleavage stage, which is 2 or 3 days after egg collection when an embryo typically consists of between 2 and 128 cells; or the blastocyst stage, which is 5 or 6 days after egg collection when an embryo consists of between 70 and 100 cells. Until recently, doctors usually transferred embryos at the earlier, cleavage, stage. However, there has been a trend to transferring embryos at the later, blastocyst, stage. Researchers believe that only those embryos capable of surviving make it to the blastocyst stage; in other words, viable embryos will self‐select. So, it is thought that transferring embryos at the later stage may improve a woman's chances of becoming pregnant and having a healthy baby. Review question We wanted to find out if transferring embryos into a woman's womb at cleavage stage (day 2 to 3) or blastocyst stage (day 5 to 6) is better, in terms of: – number of babies born alive (live birth rate) following embryo transfers using only 'fresh' embryos; that is, embryos that have not been frozen and subsequently thawed; – total number of pregnancies achieved following embryo transfers using both 'fresh' and frozen then thawed embryos, collected from a single egg collection procedure (cumulative clinical pregnancy rate); – multiple pregnancy rate (when a woman is carrying more than one baby at a time); ‐ miscarriage rate (the loss of a pregnancy before the 20th week of development in the womb). Study characteristics We included 32 randomised controlled trials (studies in which participants are assigned randomly to 2 or more treatment groups), which included 5821 women or couples. The evidence is current to October 2021. Key results – Transferring 'fresh' embryos at the blastocyst stage (day 5 to 6) may lead to more live births than when 'fresh' embryos are transferred at the cleavage stage (day 2 to 3). This suggests that if 31% of women achieve live birth after 'fresh' cleavage‐stage embryo transfer, between 32% and 41% would do so after 'fresh' blastocyst‐sta e transfer. – Transferring 'fresh' embryos at the blastocyst stage probably leads to more clinical pregnancies – defined as evidence of fetal heart activity on an ultrasound scan – than when 'fresh' embryos are transferred at the cleavage stage. This suggests that if 39% of women achieve a clinical pregnancy after 'fresh' cleavage‐stage transfer, between 42% and 47% will probably do so after 'fresh' blastocyst‐stage transfer. – We are uncertain whether blastocyst‐stage transfer favors cumulative clinical pregnancy rates (i.e. pregnancies from both fresh and thawed cycles deriving from a single egg collection procedure). – We are uncertain whether blastocyst‐stage transfer increases multiple pregnancy rates compared to cleavage‐stage transfer, when we consider all the studies that reported information on this. – When we consider evidence only from higher‐quality studies and studies that transferred the same number of embryos in both embryo stages, we found that multiple pregnancy rate is probably higher in the blastocyst‐stage transfer group. – We are uncertain whether blastocyst‐stage transfer increases miscarriage rates compared to cleavage‐stage transfer. Future studies should report rates of live birth, cumulative live birth, and miscarriage, to enable women, couples and their doctors to make well‐informed decisions on the best treatment option available. Quality of the evidence We have low to moderate confidence in the quality of the evidence for most outcomes. The main limitation was the failure of some studies to describe acceptable methods of assigning women or couples at random to treatment groups.

Go Virginia Arlene, A., et al. (2020). "A systematic review of the psychosocial impact of fibroids before and after treatment." American Journal of Obstetrics and Gynecology 223(5): 674.
	Objective: Despite the high prevalence of uterine fibroids, the psychosocial impact of fibroids has not been evaluated across different quality of life indicators and compared with other chronic conditions. Here, we rigorously analyzed available evidence pertaining to the psychosocial burden of uterine fibroids in premenopausal women and compared validated quality of life and symptom scores before and after treatment.; Data Sources: We searched PubMed, PsycINFO, ClinicalTrials.gov, Embase, and Cochrane Library for publications from January 1990 to January 2020.; Study Eligibility Criteria: We considered English-language publications that evaluated the association between uterine fibroids diagnosed by imaging studies in premenopausal women and quality of life by standardized and validated questionnaires at baseline and after treatment. We used a detailed list of terms related to quality of life, questionnaires, and uterine fibroids to conduct the search.; Methods: Three reviewers screened titles and abstracts and then obtained full-text articles for further analysis. The reviewers assessed risk of bias using established Cochrane and Newcastle-Ottawa Scale guidelines. The quality of life scores of premenopausal women with fibroids were reviewed at baseline and compared with those of published quality of life scores in other disease populations in addition to after fibroid treatment.; Results: A total of 57 studies were included in the review: 18 randomized controlled trials and 39 observational studies. Of note, the 36-Item Short Form Survey and European Quality of Life Five-Dimension Scale questionnaires both indicated a diagnosis of uterine fibroids to have a disability score that was similar to or exceeded (was a greater psychosocial stressor) a diagnosis of heart disease, diabetes mellitus, or breast cancer. Quality of life scores were lower at baseline than after treatment in all instruments measuring these variables in women with uterine fibroids, indicating significantly impaired psychosocial functioning. Uterine fibroids were associated with significant patient-reported health disabilities related to bodily pain, mental health, social functioning, and satisfaction with sex life.; Conclusion: A diagnosis of uterine fibroids was a significant psychosocial stressor among women at baseline and relative to other diseases. Validated quality of life instruments indicated therapeutic success and the improvement of both physical and emotional symptoms after treatment. (Copyright © 2020. Published by Elsevier Inc.)

Gold, D. (2021). "IUL Study A Randomized Sham - Controlled Clinical Study." ClinicalTrials.gov.
	Background: Stress urinary incontinence (SUI) has a huge impact on the quality of life (QoL) in women and its treatment is challenging. Intraurethral laser may be an additional treatment option. Study aim: The aim is to study the effectiveness of intraurethral laser therapy in women with SUI. Design: randomized double blinded sham ‐ controlled clinical study Study population: women which have been diagnosed with SUI I‐II°, aged between 18‐80 years. Study groups: Participants will be randomized (1:1), without stratification. The Intervention group will receive 2 treatments of intraurethral laser therapy and the Control group will receive 2 treatments of intraurethral SHAM laser therapy. Sample size: A sample size of 20 women, 8 per group including a 20% Drop Out Rate, was calculated. Primary outcome: impact of SUI on the VAS scale 3 months after laser therapy versus sham laser therapy. Secondary study outcomes were defined as subjective SUI, objective SUI, QoL, treatment satisfaction, intraurethral microbiome, 3 months after laser therapy versus sham laser therapy.

Goldberg, A., et al. (2024). "Anti-obesity pharmacological agents for polycystic ovary syndrome: A systematic review and meta-analysis to inform the 2023 international evidence-based guideline." Obesity Reviews: e13704.
	This systematic review and meta-analysis evaluated the efficacy of anti-obesity agents for hormonal, reproductive, metabolic, and psychological outcomes in polycystic ovary syndrome (PCOS) to inform the 2023 update of the International Evidence-based Guideline on PCOS. We searched Medline, EMBASE, PsycInfo, and CINAHL until July 2022 with a 10-year limit to focus on newer agents. Eleven trials (545 and 451 participants in intervention and control arms respectively, 12 comparisons) were included. On descriptive analyses, most agents improved anthropometric outcomes; liraglutide, semaglutide and orlistat appeared superior to placebo for anthropometric outcomes. Meta-analyses were possible for two comparisons (exenatide vs. metformin and orlistat+combined oral contraceptive pill [COCP] vs. COCP alone). On meta-analysis, no differences were identified between exenatide versus metformin for anthropometric, biochemical hyperandrogenism, and metabolic outcomes, other than lower fasting blood glucose more with metformin than exenatide (MD: 0.10 mmol/L, CI 0.02-0.17, I2 =18%, 2 trials). Orlistat+COCP did not improve metabolic outcomes compared with COCP alone (fasting insulin MD: -8.65pmol/L, -33.55 to 16.26, I2 =67%, 2 trials). Published data examining the effects of anti-obesity agents in women with PCOS are very limited. The role of these agents in PCOS should be a high priority for future research.Copyright © 2024 The Authors. Obesity Reviews published by John Wiley & Sons Ltd on behalf of World Obesity Federation.

Gonzalez, M., et al. (2021). "A phase III, randomized, double blinded trial of platinum based chemotherapy with or without atezolizumab followed by niraparib maintenance with or without atezolizumab in patients with recurrent ovarian, tubal, or peritoneal cancer and platinum treatment free interval of more than 6 months: ENGOT-Ov41/GEICO 69-O/ANITA Trial." International Journal of Gynecological Cancer 31(4): 617-622.
	BACKGROUND: Platinum based chemotherapy is the treatment of choice for ovarian cancer patients with a platinum treatment free interval of >6 months. Niraparib is an oral poly (ADP-ribose) polymerase inhibitor approved as maintenance therapy after a response to platinum rechallenge, regardless of BRCA status. Atezolizumab is a humanized monoclonal antibody targeting programmed death-ligand 1 (PD-L1). A combination of poly (ADP-ribose) polymerase inhibitor and anti-PD-L1/programmed cell death protein 1 (PD-1) has shown synergy in preclinical models and promising clinical activity. PRIMARY OBJECTIVE: To determine whether the addition of atezolizumab to carboplatin based chemotherapy and to subsequent maintenance with niraparib improves progression free survival compared with placebo in patients with recurrent disease and a platinum treatment free interval of >6 months. TRIAL DESIGN: The Atezolizumab and NIraparib Treatment Association (ANITA) trial is a GEICO (Grupo Español de Investigación en Cáncer de Ovario) led phase III, randomized, double-blinded, multicenter European Network for Gynecological Oncological Trials (ENGOT) study. Patients will be randomized to arm A (control arm) consisting of platinum based chemotherapy (investigator's choice) plus a placebo of atezolizumab followed by maintenance niraparib plus a placebo of atezolizumab, or to arm B (experimental arm) consisting of platinum based chemotherapy (investigator's choice) plus atezolizumab followed by maintenance niraparib plus atezolizumab. MAJOR INCLUSION/EXCLUSION CRITERIA: Inclusion criteria are women aged over 18 years, diagnosed with relapsed high grade serous, endometrioid, or undifferentiated ovarian, fallopian tube, or primary peritoneal carcinoma. Patients are eligible if they received no more than two previous lines of chemotherapy, relapsed ≥6 months after the last platinum containing regimen, and have at least one measurable lesion according to the response evaluation criteria in solid tumors, version 1.1. PRIMARY ENDPOINT: The primary endpoint for this study is progression free survival. SAMPLE SIZE: Approximately 414 patients will be recruited and randomized in a 1:1 ratio, with the aim of demonstrating a benefit in progression free survival for the experimental arm with a hazard ratio of O.7, using a two sided alpha of 0.05 and a power of 80%. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: The trial was launched in the fourth quarter of 2018 and is estimated to close in the second quarter of 2021. Mature results for progression free survival are expected to be presented by 2023. TRIAL REGISTRATION: Clinicaltrials.gov NCT03598270.

González-Gutiérrez María, D., et al. (2022). "Effects of Non-Invasive Radiofrequency Diathermy in Pelvic Floor Disorders: A Systematic Review." Medicina 58(3).
	Background and Objectives : In recent years, the use of radiofrequency diathermy in pelvic floor disorders has grown proportionally to the interest in this specialty. Despite the common use of this therapy among pelvic floor physiotherapists, little is known about its effects and effectiveness in pelvic floor disorders. For this reason, the aim of the present review is to assess the effects of non-invasive 300 kHz-1 MHz radiofrequency diathermy in the treatment of pelvic floor disorders. Materials and Methods : A literature search was performed in PubMed, Scopus and Web of Science, searching for any type of study that included pelvic floor disorder participants and an experimental group treated with non-invasive nor ablative radiofrequency diathermy. Results : There were a total of 578 studies after removing duplicates. The inclusion and exclusion criteria were applied, resulting in a total of 15 studies, which were methodologically assessed with PEDro and the Newcastle and Ottawa scale. Conclusions : Despite the low quality of most of them, the studies showed improvements in urinary incontinence, pelvic pain conditions, pelvic floor muscles strength and sexual function. These findings must be considered with caution until more randomized clinical trials are performed to solve the biases detected.

Gonzalez-Isaza, P., et al. (2022). "Pulsed Magnetic Stimulation for Stress Urinary Incontinence and Its Impact on Sexuality and Health." Medicina 58(12).
	It is becoming increasingly common that patients' preferences move towards non-surgical approaches, such as pulsed magnetic stimulation, for female stress urinary incontinence. OBJECTIVE(S): We evaluated the efficacy and safety of a device that uses electromagnetic technology to treat urinary incontinence, with an emphasis on health-related quality of life. METHOD(S): A total of 47 female subjects from 18 to 80 years old were enrolled. After block randomization, treatment consisted of 2 pulsed planar magnetic stimulation sessions per week for 4 weeks (8 sessions). Validated questionnaires: Female Sexual Function Index, International Consultation on Incontinence Questionnaire for Urinary Incontinence: Short Form, and Pelvic Floor Bothersome. Follow-ups were performed at weeks 1, 9, and 14. RESULT(S): The present study is one of the first clinical trials published evaluating the efficacy and safety of the electromagnetism-based device with flat configuration in patients with stress urinary incontinence, showing a reduction in PFBQ, ICQSF, and Oxford test scores during follow-up, and significantly at week 14 of follow-up, which implied a favorable impact on clinical outcomes, quality of life, and sexuality. CONCLUSION(S): The improved results in the treatment group compared with the simulated group show that pulsed magnetic stimulation is a safe and attractive non-invasive alternative for patients who prefer non-surgical treatments.

González-Martín, A., et al. (2022). "Maintenance olaparib plus bevacizumab in patients with newly diagnosed advanced high-grade ovarian cancer: Main analysis of second progression-free survival in the phase III PAOLA-1/ENGOT-ov25 trial." European Journal of Cancer 174: 221-231.
	Background: PAOLA-1/ENGOT-ov25 (NCT02477644) demonstrated a significant progression-free survival (PFS) benefit with maintenance olaparib plus bevacizumab versus placebo plus bevacizumab in newly diagnosed, advanced ovarian cancer. We report the prespecified main second progression-free survival (PFS2) analysis for PAOLA-1.; Methods: This randomised, double-blind, phase III trial was conducted in 11 countries. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were in response after first-line platinum-based chemotherapy plus bevacizumab. Patients were randomised 2:1 to olaparib (300 mg twice daily) or placebo for up to 24 months; all patients received bevacizumab (15 mg/kg every 3 weeks) for up to 15 months. Primary PFS end-point was reported previously. Time from randomisation to second disease progression or death was a key secondary end-point included in the hierarchical-testing procedure.; Results: After a median follow-up of 35.5 months and 36.5 months, respectively, median PFS2 was 36.5 months (olaparib plus bevacizumab) and 32.6 months (placebo plus bevacizumab), hazard ratio 0.78; 95% confidence interval (CI) 0.64-0.95; P = 0.0125. Median time to second subsequent therapy or death was 38.2 months (olaparib plus bevacizumab) and 31.5 months (placebo plus bevacizumab), hazard ratio 0.78; 95% CI 0.64-0.95; P = 0.0115. Seventy-two (27%) patients in the placebo plus bevacizumab group received a poly(ADP-ribose) polymerase inhibitor as first subsequent therapy. No new safety signals were observed for olaparib plus bevacizumab.; Conclusion: In newly diagnosed, advanced ovarian cancer, maintenance olaparib plus bevacizumab provided continued benefit beyond first progression, with a significant PFS2 improvement and a time to second subsequent therapy or death delay versus placebo plus bevacizumab. (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

González-Martín, A., et al. (2023). "Progression-free survival and safety at 3.5years of follow-up: results from the randomised phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer." European Journal of Cancer 189: 112908.
	Purpose: To report updated long-term efficacy and safety from the double-blind, placebo-controlled, phase 3 PRIMA/ENGOT-OV26/GOG-3012 study (NCT02655016).; Methods: Patients with newly diagnosed advanced ovarian cancer with complete or partial response (CR or PR) to first-line platinum-based chemotherapy received niraparib or placebo once daily (2:1 ratio). Stratification factors were best response to first-line chemotherapy regimen (CR/PR), receipt of neoadjuvant chemotherapy (yes/no), and homologous recombination deficiency (HRD) status (deficient [HRd]/proficient [HRp] or not determined). Updated (ad hoc) progression-free survival (PFS) data (as of November 17, 2021) by investigator assessment (INV) are reported.; Results: In 733 randomised patients (niraparib, 487; placebo, 246), median PFS follow-up was 3.5years. Median INV-PFS was 24.5 versus 11.2months (hazard ratio, 0.52; 95% confidence interval [CI], 0.40-0.68) in the HRd population and 13.8 versus 8.2months (hazard ratio, 0.66; 95% CI, 0.56-0.79) in the overall population for niraparib and placebo, respectively. In the HRp population, median INV-PFS was 8.4 versus 5.4months (hazard ratio, 0.65; 95% CI, 0.49-0.87), respectively. Results were concordant with the primary analysis. Niraparib-treated patients were more likely to be free of progression or death at 4years than placebo-treated patients (HRd, 38% versus 17%; overall, 24% versus 14%). The most common grade ≥ 3 treatment-emergent adverse events in niraparib patients were thrombocytopenia (39.7%), anaemia (31.6%), and neutropenia (21.3%). Myelodysplastic syndromes/acute myeloid leukaemia incidence rate (1.2%) was the same for niraparib- and placebo-treated patients. Overall survival remained immature.; Conclusions: Niraparib maintained clinically significant improvements in PFS with 3.5years of follow-up in patients with newly diagnosed advanced ovarian cancer at high risk of progression irrespective of HRD status. No new safety signals were identified.; Competing Interests: Declaration of Competing Interest Dr. González-Martín reports support for the manuscript funding from GSK; grants or contracts from GSK and Roche; consulting fees from Alkermes, Amgen, AstraZeneca, Clovis Oncology, Genmab, GSK, ImmunoGen, Merck Sharp & Dohme, MacroGenics, Novartis, Oncoinvent, Pfizer/Merck, PharmaMar, Roche, Sotio, and Sutro; honoraria fees from AstraZeneca, Clovis, GSK, PharmaMar, and Roche; and support for attending meetings from AstraZeneca, GSK, PharmaMar, and Roche. Dr. Pothuri reports institutional grant support from AstraZeneca, Celsion, Genentech/Roche, Karyopharm, Merck, Mersana, GSK, Sutro, Toray, Incyte, Imab, Onconova, VBL Therapeutics, and Clovis Oncology; consulting fees from AstraZeneca, GSK, SeaGen, and Merck; advisory board fees from Eisai, Lily, Merck, Sutro Biopharma, Tesaro/GSK, Astra Zeneca, and GOG Foundation. Dr. Vergote reports institutional payments for corporate sponsorship research from Amgen and Roche and contracted research from Genmab and Oncoinvent AS; institutional consulting fee payments from Amgen (Europe) GmbH, AstraZeneca, Carrick Therapeutics, Clovis Oncology Inc, Deciphera Pharmaceuticals, Elevar Therapeutics, F. Hoffmann–La Roche Ltd, Genmab, GSK, Immunogen Inc, Mersana, Millennium Pharmaceuticals, MSD, Novocure, Oncoinvent AS, Octimet Oncology, Sotio, Verastem Oncology, and Zentalis; consulting fees from Deciphera Pharmaceuticals, Jazz Pharmaceuticals, and Oncoinvent AS; honoraria payments from Agenus, Aksebio, AstraZeneca, Bristol Myers Squibb, Deciphera Pharmaceuticals, Eisai, F. Hoffmann–La Roche Ltd, Genmab, GSK, Immunogen Inc, Jazz Pharmaceuticals, Karyopharm, MSD, Novartis, Novocure, Oncoinvent AS, Seagen, and Sotio; institutional travel support from Amgen, AstraZeneca, MSD, Roche, and Tesaro; advisory board fees from Agenus, AstraZeneca, Bristol Myers Squibb, Deciphera Pharmaceuticals (2021), Eisai, F. Hoffmann–La Roche Ltd, Genmab, GSK, Immunogen Inc, MSD, Novartis, Novocure, Seagen (2021), and Sotio. Dr. Graybill reports advisory board and speaker fees f om GSK. Dr. Lorusso reports personal fees from Amgen, AstraZeneca, Clovis Oncology, Genmab, Immunogen, Merck, and PharmaMar; and grants from Merck and PharmaMar. Dr. McCormick reports advisory role fees from AstraZeneca, Clovis, GSK, ImmunoGen, and Merck. Dr. Freyer reports personal fees from AstraZeneca, Biogaran, Bristol Myers Squibb, Clovis Oncology, MSD, Novartis, Pfizer Inc., Roche Holding AG, S.A.S., and Tesaro; grants from AstraZeneca, Mylan, and Roche Holding AG. Dr. Backes reports personal fees from Agenus, CEC Oncology, Clovis, Eisai, Merck, AstraZeneca and GSK. ImmunoGen, Myriad; grants from Clovis, Eisai, Immunogen, and Merck, Beigene, Natera. Dr. Heitz reports honoraria from Roche, AstraZeneca, GSK, NovoCure, and PharmaMar; advisory board fees from NovoCure; and leadership role with AGO study group. Dr. Redondo reports institutional grants from Eisai, PharmaMar, and Roche; honoraria fees from AstraZeneca, MSD, Clovis, GSK, PharmaMar, and Eisai; advisory board roles at AstraZeneca, MSD, Clovis, GSK, PharmaMar, and Eisai; and travel support from AstraZeneca, GSK, and PharmaMar. Dr. Moore reports personal fees from Abcodia Inc, Fujirebio Diagnostics Inc, and Humphries Pharmaceutical; and institutional grants from Angle Plc. Dr. Vulsteke reports medical writing support to GSK; consulting fees from Atheneum Partners, Bristol Myers Squibb, GSK, Janssen-Cilag, Leo-Pharma, Merck Sharp & Dohme, and Roche; advisory board fees from AstraZeneca, Bayer, GSK, Janssen-Cilag, Leo Pharma, Merck Sharp & Dohme; and travel support from Pfizer and Roche. Dr. O'Cearbhaill reports participating in advisory boards with 2seventy bio, Bayer, Carina Biotech, Fresenius Kabi, Immunogen, GSK, Miltenyi Biotec, Regeneron, and Seattle Genetics; personal fees from GOG Foundation; travel fees from Hitech Health and Gathering Around Cancer, Ireland; service as a noncompensated steering committee member for the PRIMA and Moonstone (niraparib) and DUO-O (olaparib) studies; institutional research support grants from Acrivon Therapeutics, AstraZeneca/Merck, Atara Biotherapeutics/Bayer, Genentech, Genmab, GSK, Gynecologic Oncology Group Foundation, Juno Therapeutics, Kite/Gilead, Ludwig Institute for Cancer Research, Lyell Immunopharma, Regeneron, Sellas Life Sciences, StemcentRx, Syndax, TapImmune Inc, and TCR2 Therapeutics. Drs. Malinowska and Shtessel are employees of GSK. Ms. Compton is a former employee of GSK and currently receiving consulting fees from GSK. Dr. Mirza reports consulting and advisory role fees from AstraZeneca, Biocad, GSK, Karyopharm, Merck, Roche, and Zai Lab; speakers’ bureau fees from AstraZeneca and GSK; institutional research funding from Apexigen, AstraZeneca, Deciphera (trial chair), GSK, and Ultimovacs; and personal financial interest in Karyopharm (stocks/shares, member of board of directors). Dr. Monk reports consulting fees from 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; and speakers’ bureau honoraria from AstraZeneca, Clovis, Eisai, Merck, Roche/Genentech, and Tesaro/GSK. (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

González-Ravina, C., et al. (2022). "Effect of Sperm Selection by Magnetic-Activated Cell Sorting in D-IUI: A Randomized Control Trial." Cells 11(11).
	Clinical outcome in assisted reproduction techniques (ARTs) is mainly influenced by the quality of gametes used. It is known that a high percentage of sperm DNA fragmentation (DNAf) decreases the success of ART clinical results. Therefore, techniques such as magnetic-activated cell sorting (MACS) help to improve results in cases of patients with a high percentage of DNAf. Cryopreservation of sperm in donor intrauterine insemination (D-IUI) treatments increases sperm DNAf, so patients using these sperm samples can benefit from using this technique. This prospective randomized national multicenter study analyzed clinical outcomes of 181 D-IUI treatments. MACS was performed after density gradient centrifugation (DGC) in 90 thawed semen donor samples (MACSG), whereas only DGC was performed in 91 thawed semen donor samples (CG). To our knowledge, this is the first study analyzing the effect of MACS on D-IUI cycles. Our results show no significant differences in gestation, live birth, or miscarriage rates between the two groups. We believe that further studies with a larger sample size are needed to evaluate the application of MACS in combination with standard IUI donor sperm preparations in fertility clinics.

Göral Türkcü, S. and S. Özkan (2021). "The effects of reflexology on anxiety, depression and quality of life in patients with gynecological cancers with reference to Watson's theory of human caring." Complementary Therapies in Clinical Practice 44: 101428.
	OBJECTIVES: This study aimed to examine the effects of reflexology based on Watson's theory of human caring on anxiety, depression, and quality of life in gynecological cancer patients. MATERIAL AND METHODS: The study was a prospective, single-blind, randomized controlled trial with a pretest-posttest and a control group. The clinical trial was conducted at a university hospital in the Aegean region between October 2016 and June 2018. It was completed with 62 women, of whom 31 were in the intervention group and 31 were in the control group. Data were collected by using a personal information form, the Beck Anxiety Inventory, the Beck Depression Inventory, and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-version 3.0. RESULTS: Anxiety and depression levels were lower in the intervention group than in the control group. Besides, the quality of life was higher in the intervention group than in the control group. Reflexology significantly reduced symptoms due to chemotherapy, such as fatigue, pain, insomnia, and loss of appetite. Although there was a decrease in symptoms, such as nausea, vomiting, diarrhea and constipation immediately after reflexology, an increase in symptoms was observed in the intervention group two weeks later. CONCLUSION: These results showed that reflexology based on Watson's theory of human caring is effective in reduction of anxiety and depression and improves the quality of life in gynecological cancer patients during chemotherapy. It can be suggested that offering reflexology at certain intervals during chemotherapy will increase the duration of its effect.

Gordon Jennifer, L. (2023). "Acceptance and Commitment Therapy (ACT) Adapted for Women With Infertility-related Distress." ClinicalTrials.gov.
	No Results Available Behavioral: Infertility ACTion Program Fertility Quality of Life tool (Fertiqol)|Psychological flexibility (MPFI)|Generalized Anxiety Disorder-7 (GAD-7)|Patient Health Questionnaire-9 (PHQ-9) Female Not Applicable 90 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment REB 2022-026 December 1, 2023

Gordon, J. L., et al. (2024). "Testing an Evidence-Based Self-Help Program for Infertility-Related Distress: Protocol for a Randomized Controlled Trial." JMIR Research Protocols 13: e52662.
	BACKGROUND: Infertility-the inability to achieve pregnancy despite ≥12 months of focused attempts to conceive-is experienced by 1 in 6 couples. Women typically carry a disproportionate share of the psychological burden associated with infertility, experiencing poor quality of life, and 30%-40% experiencing depressive mood or anxiety. Unfortunately, currently available psychological interventions targeting infertility-related distress are associated with modest effects. OBJECTIVE: Our team, in collaboration with patient advisors, has designed a self-help intervention for infertility-related distress involving 7 weekly 10-minute videos addressing the cognitive, behavioral, and interpersonal challenges associated with infertility, delivered through a mobile app. A feasibility study suggests that it is well accepted and highly effective in reducing symptoms of anxiety and depressed mood among distressed individuals dealing with infertility. This study represents the next step in this line of research: a fully powered randomized controlled trial comparing the intervention to a waitlist control group. METHODS: We will recruit 170 individuals struggling to become pregnant in Canada or the United States to be randomized to our 7-week self-help program or a treatment-as-usual condition. The primary outcome will be fertility quality of life, while secondary outcomes will include depressive symptoms, anxious symptoms, and relationship quality, assessed before and after the program as well as biweekly for 16 weeks following completion of the program. Self-reported health care use and the presence of diagnosed mood and anxiety disorders, assessed through a structured psychiatric interview, will also be assessed immediately following the intervention and at the 16-week follow-up assessment. Treatment adherence and retention will also be recorded throughout the intervention. Multilevel modeling will compare the intervention arm to the treatment-as-usual condition in terms of all continuous outcomes across the 9 measurement points. Logistic regression will be used to assess the occurrence of mood and anxiety disorders in the 2 treatment arms at the posttreatment assessment as well as at the 16-week follow-up. Sensitivity analyses will examine potential treatment moderators: membership in the LGBTQIA+ (lesbian, gay, bisexual, transgender, queer, intersex, and asexual) communities, baseline fertility quality of life, cultural background, disability status, and pursuit of conception through medical intervention. RESULTS: We expect our intervention to be more effective than treatment-as-usual in improving all mental health parameters assessed and decreasing health care use related to both mental and reproductive health. Effects are expected to be larger with decreasing baseline quality of life and equally effective regardless of membership in the LGBTQIA+ communities, cultural background, or disability status. CONCLUSIONS: If our intervention is successful, this would suggest that it should be scaled up and made publicly available. The availability of this program would fill an important gap in light of the high rates of psychopathology among those experiencing infertility and considering the current lack of effective psychotherapy approaches for infertility. TRIAL REGISTRATION: Clinicaltrials.gov NCT06006936; https://classic.clinicaltrials.gov/ct2/show/NCT06006936. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/52662.

Grand Tobias, S., et al. (2019). "The cost-effectiveness of oral contraceptives compared to 'no hormonal treatment' for endometriosis-related pain: An economic evaluation." PloS One 14(1): e0210089.
	Objective: To develop a preliminary cost-effectiveness model that compares oral contraceptives and 'no hormonal treatment' for the treatment of endometriosis-related pain.; Methods: A de novo preliminary state transition (Markov) model was developed. The model was informed by systematic literature review and expert opinion. The uncertainty around the results was assessed both by deterministic and probabilistic sensitivity analyses. The economic evaluation was conducted from National Health Service (NHS) England perspective. The main outcome measure was incremental cost per quality-adjusted life year (QALY), with cost-effectiveness plane and cost-effectiveness acceptability curves presented for alternative willingness-to-pay thresholds.; Results: Oral contraceptives dominated 'no hormonal treatment' and provided more QALYs at a lower cost than 'no hormonal treatment', with a cost-effectiveness probability of 98%. A one-way sensitivity analysis excluding general practitioner consultations showed that oral contraceptives were still cost-effective.; Conclusions: The analyses showed that oral contraceptives could be an effective option for the treatment of endometriosis, as this treatment was shown to provide a higher level of QALYs at a lower cost, compared to 'no hormonal treatment'. The results are subject to considerable parameter uncertainty as a range of assumptions were required as part of the modelling process.; Competing Interests: HB is employed by RTI Health Solutions (and formerly worked at the University of Birmingham). This commercial affiliation does not alter our adherence to all PLOS ONE policies on sharing data and materials.

Greg, M., et al. (2021). "Network Meta-Analysis of First and Second Generation Endometrial Ablation Devices." PROSPERO International prospective register of systematic reviews.
	
Griesing, G. (2022). "Ovarian PRP (Platelet Rich Plasma) Injection for Follicular Activation." ClinicalTrials.gov.
	Age‐related infertility and premature loss of ovarian reserve has become a major challenge for ART professionals as the the average age at first childwish has dramatically increased over time. Under physiological circumstances, most follicles in the human ovary remain dormant throughout the female life span and eventually become atretic, however, histological samples reveal that the follicular pool in the ovary is completely exhausted only as late as the early 70ies and that the ovary holds oogonial stem cells, which may have the ability to differentiate into functional follicles. The pressing problem for reproductive medicine is therefore the question how to reactivate some of the putative ovarian 'reproductive reserve' in those women with premature follicular depletion or those who wish to become pregnant at advanced age. Platelet rich plasma (PRP) is a blood‐derived product, characterized by high concentrations of growth factors and chemokines. PRP is produced by centrifuging a small quantity of the patient's own blood and extracting the active, platelet‐rich fraction. The platelet‐rich fraction is applied to the human body typically by injection. PRP is used for therapeutic purposes in different medical areas ranging from orthopedics to plastic surgery, for its putative ability to stimulate and facilitate cell proliferation and thereby tissue differentiation and regeneration. In the context of reproductive medicine, PRP has been proposed to increase pregnancy rates after uterine flushing in women with recurrent implantation failure or thin endometrium. Intra‐ovarian injection of PRP has been proposed to activate dormant ovarian follicles pre IVF‐treatment in cases of idiopathic low ovarian reserve, premature ovarian insufficiency or ovarian depletion because of advanced maternal age. To date, there is no randomized placebo‐controlled trial available that has evaluated intra‐ovarian PRP injection in terms of efficacy and safety for premature ovarian failure, and, more specifically, also not in patients with depleted ovarian reserve/poor ovarian response (POR) who constitute a significant proportion of patients undergoing assisted reproduction.

Grigoriadis, T., et al. (2024). "Platelet-Rich Plasma for the Treatment of Stress Urinary Incontinence-A Randomized Trial." Urogynecology 30(1): 42-49.
	Importance: Urinary incontinence affects millions of women worldwide. Objective(s): The aim of the current study was to evaluate the efficacy and safety of periurethral platelet-rich plasma (PRP) injections in women with stress urinary incontinence (SUI). Study Design: This was a single-center, double-blind, randomized sham-controlled trial. Fifty participants with SUI and urodynamic stress incontinence were randomized in 2 equally sized groups. Women in the PRP group received 2 PRP injections at 3 levels of the urethra at 4- to 6-week intervals. Women in the sham group were injected with sodium chloride 0.9%. At baseline, participants underwent urodynamic studies and a 1-hour pad test and completed the International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), the Patient Global Impression Scale of Improvement, and the King's Health Questionnaire. At follow-up visits (1, 3, and 6 months), women underwent the 1-hour pad test and completed the King's Health Questionnaire and the ICIQ-FLUTS. Primary outcome was the subjective evaluation as indicated by the response to question 11a of the ICIQ-FLUTS questionnaire. Secondary outcomes included scores of questionnaires and urine loss assessed on the 1-hour pad test. The level of discomfort during injections and any adverse events were also evaluated. Result(s): During follow-up, the mean score of the 11a question decreased significantly in the PRP group compared with sham. Subjective cure was significantly higher in the PRP group (32% vs 4%, P < 0.001). A significant reduction of urine loss assessed on the 1-hour pad test was observed in the PRP group compared with the sham group at 6-month follow-up. No adverse events were observed. Conclusion(s): Periurethral PRP injections were superior to sham injections in improving SUI symptoms with an excellent safety profile.Copyright © 2024 Urogynecology. All rights reserved.

Grinsfelder Michaela, O. (2022). "Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers." ClinicalTrials.gov.
	PRIMARY OBJECTIVES: I. Determine the toxicity of ipatasertib in combination with megestrol acetate in women with metastatic grade 1‐2 endometrioid endometrial cancer and establish the recommended phase II dose. (Phase I) II. Compare the progression free survival of the combination of ipatasertib with megestrol acetate to megestrol acetate alone among women with metastatic grade 1‐2 endometrioid adenocarcinoma of the endometrium. (Phase II) III. Compare the toxicity of the combination of ipatasertib with megestrol acetate to megestrol acetate alone. (Phase II) SECONDARY OBJECTIVES: I. Compare objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the two arms. II. Examine the pharmacokinetics of ipatasertib + megestrol acetate to assess potential drug‐drug interactions. III. Assess the association between biomarkers and response to therapy. EXPLORATORY OBJECTIVE: I. Explore whether pS6/total S6 and pPRAS40/total PRAS40 expression is impacted by the use of ipatasertib and megestrol acetate. OUTLINE: This is a phase Ib, dose de‐escalation study of ipatasertib followed by a phase II study. PHASE Ib: Patients receive megestrol acetate orally (PO) once daily (QD) and ipatasertib PO QD throughout the trial. Patients undergo a computed tomography (CT) or magnetic resonance imaging (MRI) during screening, on study, and during follow‐up. Patients also undergo collection of blood samples throughout the trial. PHASE II: Patients are randomized to 1 of 2 arms. ARM I: Patients receive megestrol acetate PO QD throughout the trial. Patients undergo a CT or MRI during screening, on study, and during follow‐up. Patients also undergo collection of blood samples throughout the trial. ARM II: Patients receive megestrol acetate PO QD and ipatasertib PO QD throughout the trial. Patients undergo a CT or MRI during screening, on study, and during follow‐up. Patients also undergo collection of blood samples throughout the trial.

Grisham, R. (2023). "A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer." ClinicalTrials.gov.
	This international, randomized, open‐label, Phase 3 study will compare the investigational combination of avutometinib plus defactinib versus Investigator's Choice of Treatments (ICT) in patients with recurrent LGSOC who have progressed on a prior platinum‐based therapy. Avutometinib and defactinib are both a type of drug called a kinase inhibitor. Kinase inhibitors block cancer cell growth. The study will compare the progression‐free survival (PFS) of the combination of avutometinib plus defactinib versus ICT. The study will also evaluate the effect of the combination on safety, overall survival, other efficacy endpoints, and health‐related quality of life and disease related symptoms. The study is being conducted by gynecological cancer specialists. Patients who are eligible and agree to participate in this study will be treated with either a combination of avutometinib with defactinib, or with one of five standard of care NCCN and ESMO treatment recommendations for recurrent LGSOC, and then with subsequent follow up appointments. Patients who originally received one of the standard of care treatments who are determined to have progressive disease may be eligible to crossover to receive the investigational combination avutometinib plus defactinib.Avutometinib and defactinib are investigational drugs that have not been approved by the U.S. Food and Drug Administration (FDA)

Grob, P. (2021). "Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis." ClinicalTrials.gov.
	No Results Available Drug: Dequalinium Chloride|Drug: Metronidazole Oral Clinical cure rate|Bacteriological cure rate|Therapeutic cure|Individual Amsel Criteria over time|Nugent score over time|Subjective assessment of efficacy|Subjective assessment of tolerability|Adverse events Female Phase 4 151 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment MNFM380119|2020-002489-15 August 25, 2022

Gruenwald, I., et al. (2021). "Low-Intensity Shockwave for Treatment of Vestibulodynia: A Randomized Controlled Therapy Trial." The Journal of Sexual Medicine 18(2): 347-352.
	BACKGROUND: Provoked vestibulodynia (PVD) is an exhausting pain syndrome that immensely affects quality of sexual life and consequently negatively affects quality of life. Low-intensity shock wave therapy produces physical forces that lead to pain relief. AIM: The aim of this study was to evaluate the feasibility, safety, and efficacy of low-intensity shockwave therapy in patients with provoked vestibulodynia. METHODS: This is a double-blinded, randomized, sham-controlled, prospective study of 32 women. The treatment protocol included a series of treatments, performed twice a week for 6 weeks. Each treatment consisted of 500 pulses of low intensity shockwaves (0.09 mJmm2) using the Medispec, ED-1000 shockwave generator or sham. Participants were assessed at the baseline, and at 1 and 3 months after completing all treatments. OUTCOMES: Pain was assessed by both subjective and objective measures. The primary outcome was a change in dyspareunia, as assessed by scores on the 10-point visual analog scale. Secondary outcome measures were changes in pain threshold and tolerance, assessed by a quantitative validated algometer test, the Wong-Baker pain FACES scale, the Female Sexual Function Index and the Patients' Global Impression of Change scale. RESULTS: From the baseline to 1 month and 3 months after completion of treatment, visual analog scale scores for dyspareunia decreased (8.0 ± 1.4, 5.7 ± 2.3, and 4.4 ± 2.5, respectively, P < .005). For these respective time points, Wong-Baker scores decreased (4.0 ± 0.6, 2.9 ± 1.2, 2.5 ± 1.3, respectively, P < .05); and total Female Sexual Function Index increased (17.9 ± 6.3, 20.9 ± 6.2, 22.5 ± 8, respectively, P < .002). Pain threshold and tolerance measured by the algometer were increased 3 months after completion of the treatment compared with the baseline (69.8 mmHg ± 11.8 vs 22.9 mmHg ± 9.0, P < .01 and 87.7 mmHg ± 35.7 vs 43.3 mmHg ± 14.7, P < .0001, respectively). No changes were observed in any of the measures assessed in the sham group. CLINICAL IMPLICATIONS: We found a new effective treatment for alleviating the most bothersome symptom in PVD, pain during penetration and intercourse. This resulted in improved sexual function. STRENGTHS & LIMITATIONS: The strengths of this study are the randomized controlled design, the correlated subjective questionnaires, and the use of semiquantitative algometer methodology. The limitations are the relative low number of participants in a single center. CONCLUSION: For women with PVD, low-intensity shockwave therapy applied at the introitus is a feasible, safe, and effective treatment option that may have a beneficial effect in pain relief and in sexual function. Gruenwald I, Gutzeit O, Petruseva A, et al. Low-Intensity Shockwave for Treatment of Vestibulodynia: A Randomized Controlled Therapy Trial. J Sex Med 2021;18:347-352.

Guan, S., et al. (2021). "Progestin-Primed Ovarian Stimulation Protocol for Patients in Assisted Reproductive Technology: A Meta-Analysis of Randomized Controlled Trials." Frontiers in Endocrinology 12: 702558.
	Objectives: Progestin-primed ovarian stimulation (PPOS) is a new ovarian stimulation protocol that can block the luteinizing hormone (LH) surge through progesterone instead of traditional down regulating or gonadotropin-releasing hormone (GnRH) antagonist, and in order to achieve multi-follicle recruitment. This paper aims to investigate the effectiveness of PPOS and its suitability for infertile patients with different ovarian reserve functions.; Methods: We searched published randomized controlled trials (RCTs) about PPOS on Cochrane Library, PubMed, Embase, and Web of Science. The search period spanned from January 1, 2015 to November 16, 2020. The data were extracted, and the meta-analysis was performed on ovarian stimulation as well as embryological and clinical outcomes. The outcomes were pooled by a random effects model, and the risk of heterogeneity was evaluated. Subgroup analysis was performed for different ovarian reserve patients.; Results: The clinical pregnancy rates and live birth or ongoing pregnancy rates with the PPOS protocol were not different from those with the control group. In the diminished ovarian reserve (DOR) subgroup, the PPOS protocol had a lower rate of premature LH surge [RR = 0.03, 95% CI = 0.01 to 0.13, p < 0.001]. The PPOS protocol had a lower rate of ovarian hyperstimulation syndrome (OHSS) [RR = 0.52, 95% CI = 0.36 to 0.76, p < 0.001, I 2 = 0.00%]. The secondary outcomes showed that the number of oocytes retrieved, MII oocytes, and viable embryos was higher than that of the control protocol in DOR patients [(MD = 0.33, 95% CI = 0.30 to 0.36, p < 0.001), (MD = 0.30, 95% CI = 0.27 to 0.33, p < 0.001), (MD = 0.21, 95% CI = 0.18 to 0.24, p < 0.001)] and normal ovarian reserve (NOR) patients [(MD = 1.41, 95% CI = 0.03 to 2.78, p < 0.001), (MD = 1.19, 95% CI = 0.04 to 2.35, p < 0.001), (MD = 1.01, 95% CI = 0.21 to 1.81, p = 0.01)].; Conclusion: The findings suggest that PPOS is an effective ovarian stimulation protocol and is beneficial for patients with different ovarian reserve functions, which needs to be validated in more RCTs with larger samples.; 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 Guan, Feng, Huang and Huang.)

Guan, Y., et al. (2020). "The Effect of Metformin on Polycystic Ovary Syndrome in Overweight Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." International Journal of Endocrinology 2020: 5150684.
	Objective: Metformin is an important component of PCOS treatment. At present, the effect of metformin in overweight women with PCOS has not been evaluated. Therefore, we conducted a systematic review to assess the effects of metformin in overweight women with PCOS and to analyze the effects of metformin in overweight women with PCOS.; Methods: We searched the PubMed, Cochrane Library, Embase, CNKI, VIP, and Wanfang databases for studies published before March 2020. Randomized controlled trials were identified to study the effects of metformin in overweight women with PCOS. Data from studies including body mass index (BMI), waist circumference (WC), follicle-stimulating hormone (FSH), homeostasis model assessment of insulin resistance (HOMA-IR), luteinizing hormone (LH), sex hormone-binding globulin (SHBG), high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total cholesterol (TC), triglycerides (TG), fasting blood glucose (FBG), fasting insulin, testosterone, and androstenedione were pooled. Qualified trials were selected, and methodological quality was strictly assessed. Two reviewers chose the studies independently of each other.; Results: Twelve trials were included. The intervention group and the control group had significant differences in the changes in body mass index (BMI) (WMD = -1.25, 95% CI (-1.60, -0.91), p < 0.00001) and waist circumference (WC) (WMD = -1.41, 95% CI (-2.46, -0.37), p =0.008) after metformin. The comprehensive results show that, in all studies, overweight women with polycystic ovary syndrome treated with metformin had significantly improved endocrine and metabolic indicators, including testosterone, follicle-stimulating hormone, luteinizing hormone, and low-density lipoprotein cholesterol. However, metformin did not regulate the secretion indexes of fasting insulin, homeostasis model assessment of insulin resistance, sex hormone-binding globulin, high-density lipoprotein cholesterol, total cholesterol, triglycerides, fasting blood glucose, and androstenedione.; Conclusions: Compared with control interventions, metformin appears to be an effective intervention for overweight women with PCOS.; Competing Interests: The authors declare no conflicts of interest. (Copyright © 2020 Yuanyuan Guan et al.)

Guan-hua, Z., et al. (2023). "The effectiveness of nutrition supplements in improving in women with polycystic ovary syndrome: A systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Gueli, A., et al. (2021). "A Multicentric Randomized Trial to Evaluate the ROle of Uterine MANipulator on Laparoscopic/Robotic HYsterectomy for the Treatment of Early-Stage Endometrial Cancer: The ROMANHY Trial." Frontiers in Oncology 11: 720894.
	OBJECTIVE: This prospective randomized trial aimed to assess the impact of the uterine manipulator in terms of lymph vascular space invasion (LVSI) in patients undergoing minimally invasive staging for early-stage endometrial cancer. METHODS: In this multicentric randomized trial, enrolled patients were randomly allocated in two groups according to the no use (arm A) or the use (arm B) of the uterine manipulator. Inclusion criteria were G1-G2 early-stage endometrial cancer at preoperative evaluation. The variables collected included baseline demographic characteristics, perioperative data, final pathology report, adjuvant treatment, and follow-up. RESULTS: In the study, 154 patients (76 in arm A and 78 in arm B) were finally included. No significant differences were recorded regarding the baseline characteristics. A statistically significant difference was found in operative time for the laparoscopic staging (p=0.005), while no differences were reported for the robotic procedures (p=0.419). The estimated blood loss was significantly lower in arm A (p=0.030). No statistically significant differences were recorded between the two study groups in terms of peritoneal cytology, LVSI (p=0.501), and pattern of LVSI (p=0.790). No differences were detected in terms of overall survival and disease-free survival (p=0.996 and p=0.480, respectively). Similarly, no differences were recorded in the number of recurrences, 6 (7.9%) in arm A and 4 (5.2%) in arm B (p=0.486). The use of the uterine manipulator had no impact on DFS both at univariable and multivariable analyses. CONCLUSIONS: The intrauterine manipulator does not affect the LVSI in early-stage endometrial cancer patients undergoing laparoscopic/robotic staging. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov, identifier (NCT: 02762214).

Guevara James, P., et al. (2023). "Social Media-based Parenting Program for Women With Postpartum Depressive Symptoms: An RCT." Pediatrics 151(3).
	Objectives: To test effects of a social media-based parenting program for mothers with postpartum depressive symptoms.; Methods: We conducted a randomized controlled trial from December 2019 to August 2021 of a parenting program using Facebook. Women with mild-to-moderate depressive symptoms (Edinburgh Postnatal Depression Scale [EPDS] 10-19) were randomized to the program, plus online depression treatment or depression treatment alone for 3 months. Women completed the EPDS monthly and the Parent-Child Early Relational Assessment, Parenting Stress Index-Short Form, and Parenting Sense of Competence pre- and postintervention. Differences among groups were assessed using intention-to-treat analysis.; Results: Seventy-five women enrolled and 66 (88%) completed the study. Participants were predominantly Black (69%), single (57%), with incomes <$55 000 (68%). The parenting group reported a more rapid decline in depressive symptoms than the comparison group (adjusted EPDS difference, -2.9; 95% confidence interval, -4.8 to -1.0 at 1 month). There were no significant group X time interactions for the Parent-Child Early Relational Assessment, Parenting Stress Index-Short Form, or Parenting Sense of Competence scores. Forty-one percent of women sought mental health treatment for worsening symptoms or suicidality. Women in the parenting group who exhibited greater engagement or reported mental health treatment had greater parenting responsiveness.; Conclusions: A social media-based parenting program led to more rapid declines in depressive symptoms but no differences in responsive parenting, parenting stress, or parenting competence relative to a comparison group. Social media can provide parenting support for women with postpartum depressive symptoms, but greater attention to engagement and treatment access are needed to improve parenting outcomes. (Copyright © 2023 by the American Academy of Pediatrics.)

Guillot-Tantay, C., et al. (2023). "Long-term Safety of Synthetic Midurethral Sling Implantation for the Treatment of Stress Urinary Incontinence in Adult Women: A Systematic Review." European Urology Open Science 54: 10-19.
	Context: Midurethral slings (MUSs) are the most used therapy for the treatment of stress urinary incontinence (SUI). While warning signals about potential complications have been raised worldwide, there is a lack of safety data especially in the long term. Objective(s): Our objective was to evaluate synthetic MUS safety outcomes at long term in adult women. Evidence Acquisition: We included all studies evaluating MUSs in adult women with SUI. All synthetic MUSs have been considered: tension-free vaginal tape (TVT), transobturator tape (TOT), and mini-slings. The primary outcome was the reoperation rate at 5 yr. Evidence Synthesis: Of 5586 references screened after duplicate removal, 44 studies (8218 patients) were included. Among these, nine were randomized controlled trials and 35 were cohort studies. The overall reoperation rates at 5 yr varied between 0% and 19% for TOT (11 studies), 0% and 13% for TVT (17 studies), and 0% and 19% for mini-slings (two studies). The overall reoperation rates at 10 yr varied between 5% and 15% for TOT (four studies) and between 2% and 17% for TVT (four studies). There were few safety data beyond 5 yr: 22.7% of the articles reported a follow-up at >=10 yr and 2.3% at >=15 yr. Conclusion(s): The incidence rates of reoperations and complications are heterogeneous, and data beyond 5 yr are rare. Patient Summary: There is an urgent need to improve safety monitoring of mesh as our review highlights that available safety data are heterogeneous and of insufficient quality to guide the decision.Copyright © 2023 The Authors

Gulia, S., et al. (2022). "Maintenance therapy with a poly(ADP-ribose) polymerase inhibitor in patients with newly diagnosed advanced epithelial ovarian cancer: individual patient data and trial-level meta-analysis." ESMO Open 7(5): 100558.
	Background: We synthesize the efficacy and toxicity of poly(ADP-ribose) polymerase inhibitors (PARPis) in patients with newly diagnosed advanced ovarian cancer.; Patients and Methods: We manually extracted individual patient data (IPD) for progression-free survival (PFS) from published survival curves of randomized controlled trials (RCTs) that compared PARPi versus placebo as maintenance therapy in first-line treatment, for whole study populations and subgroups, based on BRCA1/BRCA2 mutation (germline and/or somatic) and homologous recombination deficiency (HRD) status, using WebPlotDigitizer software. The respective PFS curves for each study and combined population were reconstructed from extracted IPD. The primary outcome was PFS in combined whole population and subgroups.; Results: In IPD analysis of combined population from three RCTs, with 2296 patients and 1287 events, PFS was significantly longer in PARPi versus placebo [median 20.4 (95% confidence interval (CI) 18.6-21.9) versus 14.9 (95% CI 13.9-16.5) months, respectively; hazard ratio (HR) 0.67, 95% CI 0.60-0.75; P < 0.001]. In IPD subgroup analyses from four eligible RCTs (2687 patients and 1485 events), median PFS was significantly longer in PARPi versus placebo arm, in the BRCA-mutated (45.7 versus 17.7 months, respectively; HR 0.38, 95% CI 0.32-0.46; P < 0.001), HRD-positive including BRCA-mutated (34.7 versus 17.9 months, respectively; HR 0.45, 95% CI 0.38-0.54; P < 0.001), and HRD positive excluding BRCA-mutated (22.3 versus 13.1 months, respectively; HR 0.47, 95% CI 0.34-0.65; P < 0.001) subgroups, but not in the HRD-negative (15.0 versus 11.3 months, respectively; HR 0.90, 95% CI 0.76-1.05; P = 0.75) subgroup. Results of trial-level meta-analysis were concordant with IPD analysis in whole population and subgroups.; Conclusions: Among newly diagnosed ovarian cancer patients, PARPi maintenance therapy significantly improves PFS in those with germline and/or somatic BRCA mutation and/or HRD-positive tumor but not in those with HRD-negative tumor.; Competing Interests: Disclosure SeG is supported by Eli Lilly, Pfizer Inc, Celltrion. Kendle India Pvt Ltd, Zydus (institutional financial interest for the conducted research); serves on the advisory boards of Novartis and Eisai (nonremunerated). SR reports support from AstraZeneca, JSS clinical research (institutional financial interest for the conducted research). SG reports participating in lectures, presentations, speaking assignments (honoraria to author’s institution) for Seoul National University Hospital, Lupin Limited, Roche, Novartis, Eli Lilly, Nag Foundation, Eisai, Omnicuris, Cipla, Cadila Pharmaceuticals, and Intas Pharmaceuticals; serves on the advisory boards (honoraria to author’s institution) of Novartis, AstraZeneca, and Eli Lilly; is a member on the national committee (honorarium to author), including Indian Council of Medical Research, Government of India, Council of Scientific and Industrial Research, Government of India, Department of Biotechnology, Government of India, India Alliance; played a key role in clinical trials (institutional financial interest) funded by F. Hoffmann-La Roche Ltd, EirGenix Inc., Novartis Healthcare Pvt. Ltd., AstraZeneca Pharma India limited., Glenmark Pharmaceuticals Ltd., Roche Products (India) Pvt. Ltd., HLL Lifecare Limited (A Government of India Enterprises), Intas Pharmaceuticals Ltd. All remaining authors have declared no conflicts of interest. (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Gulley, L. (2022). "Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome." ClinicalTrials.gov.
	The main purpose of this study is to find out whether taking part in a group‐based interpersonal psychotherapy (IPT) program designed to improve mood and lessen stress in girls with PCOS will improve depression, unhealthy eating behaviors, weight, and insulin resistance.

Gümüsburun, N., et al. (2023). "Triple vs. single uterine tourniquet to reduce hemorrhage at myomectomy: a randomized trial." Archives of Gynecology and Obstetrics 308(6): 1811-1816.
	Purpose: This study aimed to compare the effect of triple uterine tourniquet and single tourniquet on intraoperative blood loss during open myomectomy.; Methods: Women were randomized to undergo open myomectomy with a triple (n = 30) or single uterine tourniquet (n = 30). All symptomatic women aged 18-48 who had three or more myomas or at least one myoma greater than 8 cm if there were less than three myomas were eligible for the study. The primary outcome variable was the volume of intraoperative blood loss. The sample size was set to detect a 240 ml difference in blood loss with 80% power at α = 0.05, with an effect size of 0.8. The rate of transfusions, change in hemoglobin, volume of drains, operation time, tourniquet time, and perioperative complications were secondary outcomes.; Results: We found no significant difference in intraoperative blood loss between triple and single uterine tourniquets (527 [102-2931]) ml vs. 508 [172-2764] ml, p = 0.238). Between the single and triple tourniquet groups, the median weight of myoma (379 [136-3850] vs. 330 [140-1636] g, p = 0.451) and median number (1 [1-18] vs. 2 (1-13), p = 0.214), total operation time (84 ± 31 min vs. 79 ± 27 min, p = 0.503), ischemia time (35 ± 21 min vs. 30 ± 14 min., p = 0.238), drain volume at 48th hour (196 ± 89)ml vs. 243 ± 148 ml, p = 0.144) and decrease in hemoglobin (2.3 ± 1.8 g/dl vs. 2.8 ± 1.4 g/dl, p = 0.437) were similar. Eight (27%) patients in the triple tourniquet group and 12 (40%) patients in the single tourniquet group were transfused (p = 0.273). One patient underwent hysterectomy 6-8 h after myomectomy in a single tourniquet group.; Conclusion: There was no clinically significant difference in intraoperative blood loss between triple and single uterine tourniquets during open myomectomy.; Clinical Trial Registration Number and Date of Registration: ClinicalTrials.gov ID: NCT02392585, 03/13/2015. (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Gumussoy, S., et al. (2021). "Effects of Biofeedback-Guided Pelvic Floor Muscle Training With and Without Extracorporeal Magnetic Innervation Therapy on Stress Incontinence: A Randomized Controlled Trial." Journal of Wound, Ostomy, and Continence Nursing 48(2): 153-161.
	PURPOSE: We evaluated the effects of biofeedback-guided pelvic floor muscle training (EMG-BF), with and without extracorporeal magnetic innervation (EMG-BF+ExMI) therapy on lower urinary tract symptoms based on frequency of stress urinary incontinence (SUI) and grams of urine loss, health-related quality of life, and sexual function in women with SUI. DESIGN: This was a randomized controlled trial. SUBJECTS AND SETTING: The sample comprised 51 adult women with SUI. Their mean age was 50.92 years (SD 8.88). Twenty-six were randomly allocated to EMG-BF alone and 25 were allocated to undergo EMG-BF+ExMI. METHODS: This study's main outcome was lower urinary tract symptoms measured via the 1-hour pad test (grams of urine loss) and a 3-day bladder diary (frequency of stress incontinence episodes). Additional outcome measures were health-related quality of life measured with the Incontinence Quality of Life (I-QOL) questionnaire, sexual function evaluated via the Female Sexual Function Index (FSFI), and pelvic floor muscle contraction force measured via a perineometer and Modified Oxford Scale (MOS). All participants underwent biofeedback-enhanced pelvic floor muscle training using EMG during 20-minute sessions twice weekly for a period of 8 weeks. In addition to the EMG-BF+ExMI group, ExMI was applied during 20-minute sessions twice weekly for a period of 8 weeks. Participants from both groups were asked to perform pelvic floor muscle exercises at home (60 pelvic floor muscle contractions daily, divided into 3 sessions of 20 contractions each). Outcome measures were made at baseline and repeated at the end of treatment. RESULTS: Fifteen (57.7%) in the EMG-BF group and 13 (52.0%) in the EMG-BF+ExMI group achieved dryness. Four participants (15.4%) in the EMG-BF group and 5 (20%) in the EMG-BF+ExMI group experienced improvement. Seven patients (26.9%) in the EMG-BF group and 7 (28%) in the EMG-BF+ExMI group did not benefit from the treatments. There was no statistically significant difference between the groups in terms of cure and improvement (P = .895). CONCLUSIONS: Findings indicate that use of magnetic innervation does not improve lower urinary tract symptoms, health-related quality of life, sexual function, and pelvic floor muscle strength when compared to pelvic floor muscle training alone.

Gunawan Yuliana, W. and Y. Erlina (2023). "Efficacy and safety of carbon dioxide laser therapy compared with sham for genitourinary syndrome of menopause management: a meta-analysis of randomized clinical trials." Menopause 30(9): 980-987.
	Importance: Data on whether the carbon dioxide (CO 2 ) laser is useful for treatment of genitourinary syndrome of menopause (GSM) are inconsistent.; Objective: This meta-analysis evaluated the benefits and safety of CO 2 laser compared with sham treatment of GSM.; Evidence Review: A relevant literature search of Europe PMC, MEDLINE, Scopus, and ClinicalTrials.gov databases using specific keywords was conducted. The results of continuous variables were pooled into the standardized mean difference (SMD), whereas dichotomous variables were pooled into odds ratio with 95% confidence intervals (95% CI) using random-effects models. A funnel plot was used to assess for the presence of publication bias.; Findings: A total of six randomized clinical trials were included. Pooled analysis revealed that CO 2 laser therapy was associated with a higher reduction in the Vaginal Assessment Scale (SMD, -0.81 [95% CI, -1.59 to -0.04]; P = 0.04; I2 = 88%) and Urinary Distress Inventory short form (SMD, -0.45 [95% CI, -0.84 to -0.06]; P = 0.02; I2 = 0%), and greater patient satisfaction rate (odds ratio, 5.46 [95% CI, 2.23 to 13.37]; P = 0.0002; I2 = 0%) when compared with sham-only treatment. Meanwhile, the Female Sexual Function Index, Vaginal Health Index, and Patient Global Impression Improvement did not differ significantly between groups. Adverse events were only mild with no serious adverse events reported.; Conclusions and Relevance: CO 2 laser therapy may improve the overall treatment of GSM with a relatively good safety profile. However, further randomized clinical trials with larger sample sizes are still needed to confirm the results of this study.; Competing Interests: Financial disclosure/conflicts of interest: None reported. (Copyright © 2023 by The North American Menopause Society.)

Guo, C., et al. (2021). "The efficacy and toxicity of angiogenesis inhibitors for ovarian cancer: a meta-analysis of randomized controlled trials." Archives of Gynecology and Obstetrics 303(2): 285-311.
	Purpose: To evaluate the efficacy and toxicity of angiogenesis inhibitors for the treatment of ovarian cancer patients, we conducted a meta-analysis of the published literature on this subject.; Methods: In this meta-analysis, we searched PubMed, EMBASE, Web of Science, and Cochrane Library databases for randomized controlled trials (RCTs). The literature search was performed up to August 12, 2019. The risk of bias of the included studies was evaluated using The Cochrane Collaboration's tool, and the statistical analyses were performed using RevMan 5.3 software. The sensitivity analysis was performed with Stata 12.0 software.; Results: 22 RCTs with 11,254 patients were included. Our meta-analysis demonstrates that angiogenesis inhibitors therapy can significantly improve progression-free survival (PFS) (hazard ratio [HR] 0.71, 95% CI 0.63-0.79, I 2 = 80%, P < 0.00001) and overall survival (OS) (HR 0.95, 95% CI 0.90-0.99, I 2 = 0%, P = 0.03) in ovarian cancer patients. The subgroups results suggest differences in the benefit in OS in first-line treatment (HR 1.00, 95% CI 0.93-1.08, I 2 = 0%, P = 0.90) compared with treatment at relapse (HR 0.87, 95% CI 0.81-0.95, I 2 = 0%, P = 0.0008). The PFS improved both in first-line treatment (HR 0.87, 95% CI 0.79-0.95, I 2 = 60%, P = 0.003) and recurrent treatment (HR 0.60, 95% CI 0.53-0.67, I 2 = 57% P < 0.0001) patients. The PFS and OS in recurrent group were prolonged both in the platinum-resistant group(PFS: HR 0.50, 95% CI 0.42-0.60, I 2 = 0%, P < 0.00001; OS: HR 0.76, 95% CI 0.62-0.93, I 2 = 0%, P = 0.007) and the platinum-sensitive group (PFS: HR 0.58, 95% CI 0.49-0.69, I 2 = 64%, P < 0.00001; OS: HR 0.88, 95% CI 0.79-0.99, I 2 = 0%, P = 0.03). However, this therapy is associated with a higher risk of common adverse events of grade ≥ 3 (risk ratio [RR]: 1.12; 95% CI 1.07-1.17; I 2 = 0%, P = 0.68) such as arterial thromboembolic disease, ascites, diarrhea, gastrointestinal perforations, headache, hemorrhagic, hypertension, hypokalemia, leucopenia, pain, proteinuria, thrombocytopenia, and thrombosis or embolism.; Conclusion: This meta-analysis suggests angiogenesis inhibitors may significantly improve PFS and OS of ovarian cancer patients and increase the incidence of common adverse events.

Guo, J., et al. (2022). "Evaluation of the efficiency and safety of adjuvant chemotherapy alone for patients with advanced endometrial carcinoma: A protocol for systematic review and meta-analysis." Medicine 101(28): e29156.
	Background: Endometrial cancer is a tumor that affects many women. Essentially, patients who have high-risk endometrial cancer tend to have a disproportionately high rate of metastasis as well as relapse than the general population. Regardless of complete resection, individuals who are having stages III or IV cancer appear to be at substantial risk of recurrence, either locally or distantly. Chemotherapy and radiation therapy are examples of systemic adjuvant treatment. However, the ideal scheduling strategy remains a mystery. Undertaking this research can help in examining the efficacy as well as safety of adjuvant chemotherapy alone in patients with advanced endometrial cancer in the future.; Methods: To recognize all randomized controlled trials evaluating the efficacy and safety of adjuvant chemotherapy alone in those patients with advanced endometrial carcinoma, a comprehensive systematic review along with meta-analysis were undertaken in PubMed, EMBASE, Cochrane Library, Web of Science, Wanfang, China National Knowledge Infrastructure (CNKI), and Chinese Biological Medical Database (CBM). In accordance with traditional Cochrane methodology, 2 independent authors will review search results, choose studies for inclusion, extract study characteristics and outcome data, and examine the risk of bias in the researches they pick. The P values and the I² statistic shall be employed in determining the levels of heterogeneity. Meanwhile, the heterogeneity will be explored via the use of sensitivity analyses, and the meta-analysis will be conducted utilizing the RevMan 5.3 software package.; Results: Patients with advanced endometrial cancer will benefit from this research since it will offer a high-quality synthesis of existing information on the utilization of adjuvant chemotherapy alone.; Conclusion: The outcomes of the proposed investigation will summarize the current evidence of adjuvant chemotherapy alone for patients with advanced endometrial carcinoma.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Guo, S., et al. (2020). "Vitamin D Supplementation Ameliorates Metabolic Dysfunction in Patients with PCOS: A SystematicReview of RCTs and Insight into the Underlying Mechanism." International Journal of Endocrinology 2020: 7850816.
	Objective. Evidence suggests that vitamin D deficiency correlated with metabolic disorders in women with polycystic ovary syndrome (PCOS). We conducted this systematic review and meta-analysis to evaluate the impact of vitamin D supplementation alone on glucose, lipid, and androgen parameters and inflammation biomarkers in women with PCOS. Methods. Literature research was conducted in Pubmed, Embase, Web of Science, Clinical Trials, and Cochrane Library to identify relevant randomized controlled trials (RCTs) up to March 2020. The effect of vitamin D supplementation alone on women with PCOS was compared with administration of placebo. The systematic review and meta-analysis protocol was registered in the International Prospective Register of Systematic Reviews (Prospero) as number CRD42020157444. Results. Thirteen randomized controlled trials with 824 patients in total were included. Serum FPG, fasting insulin, HOMA-IR, and VLDL-C were significantly decreased in the vitamin D group versus placebo. Vitamin D supplementation group also showed a significantly elevated level of QUICKI. No significant impact was seen on serum triglyceride, total-C, LDL-C, HDL-C, total testosterone, DHEAS, SHBG, or hs-CRP. Subgroup analysis demonstrated that oral vitamin D intake had significantly decreased serum triglyceride and total-C level in women with PCOS who have vitamin D deficiency (serum vitamin D < 20 ng/ml). Conclusion. The findings of the present meta-analysis indicate that vitamin D supplementation exerted favorable effects among women with PCOS on glucose metabolism and lipid metabolism, especially in vitamin D deficient women, but had no significant effect on the androgenic profile or inflammation status.Copyright © 2020 Shan Guo et al.

Guo, Y., et al. (2021). "Recombinant Human Adenovirus-p53 Therapy for the Treatment of Cervical Cancer: A Meta-Analysis." Frontiers in Oncology 11: 748681.
	Objectives: To evaluate the clinical curative effects and toxicity of recombinant human adenovirus-p53 injection (rAd-p53) plus chemotherapy (CT), radiotherapy (RT), or concurrent chemoradiotherapy (CRT) for the treatment of cervical cancer.; Methods: We identified 14 eligible studies in the PubMed, Web of Science, Cochrane Library, Embase, CNKI, Wangfangdate, CBM, and VIP databases from their inception to May 2021 and performed meta-analyses using RevMan version 5.3.; Results: This analysis included 14 studies involving 737 patients. The results of the meta-analysis results showed significantly improved complete remission (odds ratio [OR] = 2.54, 95% confidence interval [CI]: 1.74-3.70, p < 0.00001), partial remission (OR = 1.56, 95% CI: 1.14-2.14, p = 0.006), and object response (OR = 4.47, 95% CI: 3.02-6.60, p < 0.00001) rates in the rAd-p53 combination therapy group compared to those in the CT/RT/CRT group. The results of subgroup analyses of CT/RT/CRT were consistent with the overall results. Regarding the incidence of adverse reactions, only the occurrence rate of fever (OR = 18.21, 95% CI: 10.54-31.47, p < 0.00001) in the rAd-p53 combination group was higher than that in the CT/RT/CRT group. No other significant differences were observed in other adverse reactions.; Conclusion: RAd-p53 combined with CT/RT/CRT for the treatment of cervical cancer showed significant advantages in efficacy and safety compared to those in the CT/RT/CRT group. Therefore, rAd-p53 has great potential as an effective therapy for cervical cancer.; Systematic Review Registration: https://inplasy.com/inplasy-2021-5-0058/.; 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, Chen, Zhang, Fang, Xu, Zhang, Rao and Xin.)

Gustavo, C., et al. (2023). "Phytoestrogens for Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Guy, H., et al. (2022). "Systematic literature review of efficacy and safety of first-line maintenance therapy trials in advanced ovarian cancer." Future Oncology 18(30): 3435-3447.
	Aim: To review safety and efficacy outcomes in studies of first-line maintenance therapies for advanced ovarian cancer. Methods: A systematic literature review was performed (27 February 2020) to identify clinical outcomes including progression-free survival (PFS), overall survival (OS) and Grade ≥3 adverse events. Results: Overall 50 references met prespecified criteria; 18 studies evaluated 10 different agents, including PARP inhibitors. PFS was an end point in 16 trials and OS in 12 trials. PARP inhibitors reported better PFS hazard ratios (HRs: 0.59-0.68) compared with other classes; no mature OS data were identified. Safety reporting was inconsistent. Conclusion: Reported PFS HRs were better for PARP inhibitors than for other ovarian cancer maintenance therapies; overall survival data remain immature.

Guy, M., et al. (2022). "Transcutaneous electrical neurostimulation relieves primary dysmenorrhea: A randomized, double-blind clinical study versus placebo." Progres en Urologie 32(7): 487-497.
	Introduction: This randomized, crossover, double-blind, controlled trial evaluates the efficacy and safety of a preprogrammed transcutaneous electrical nerve stimulation (TENS) device versus placebo (SHAM) in women with primary dysmenorrhea (PD).; Material: Forty women suffering from significant dysmenorrhea requiring the use of analgesics and/or non-steroidal anti-inflammatory drugs self-apply to the abdominal or lumbar region depending on the location of the pain, alternately according to randomization, the TENS device then the SHAM (dummy device) or conversely SHAM then TENS. The primary endpoint compares the evolution of pain intensity before and after application of TENS and SHAM. The speed of action, the persistence of the analgesic effect and the therapeutic savings are also evaluated. Adverse events (AEs) are collected.; Results: A statistically and clinically significant decrease in the pain of 53% (P<0.0001) is observed during the first 2 applications of TENS versus no analgesic effect (-5%, P=0.318) with SHAM. Over all 197 applications of TENS, the reduction of menstrual pain intensity by more than half is confirmed. The rapid relief, less than 20 minutes in 74% of cases, lasts on average more than 7 hours. A difference in analgesic consumption of -93% is observed in favor of TENS (P<0.01). Seven participants reported 10 non-serious AEs, 2 of which were possibly related to TENS.; Conclusion: The TENS device tested represents a well-tolerated, rapidly and lastingly effective non-pharmacological analgesic solution, capable of replacing or being combined with analgesics in the management of PD. (Copyright © 2022 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.)

Ha, J.-Y. and S.-H. Ban (2021). "Effects of Mind-Body Programs on Infertile Women: A Systematic Review and Meta-analysis of Randomized Controlled Trials." Asian Nursing Research 15(2): 77-88.
	Purpose: This study was to systematically review randomized controlled trials and conduct a meta analysis. The results of randomized controlled trials were integrated and analyzed to assess the effects of mind-body programs on anxiety, depression, quality of life, and pregnancy rate in infertile women.; Methods: Using electronic databases (i.e., Research Information Sharing Service, Korean Studies Information Service System, Korean Medical Database, National Digital Science Library, Cochrane Library, PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature, and PsycARTICLES), 10 of 2,259 studies were included for meta-analysis. To estimate the effect size, a meta-analysis of the studies was performed using RevMan 5.3.; Results: The mind-body program was effective in relieving anxiety [standardized mean difference (SMD) = -3.44; 95% confidence interval (CI) = -5.94, -0.95; p = .007; I 2 = 69%] and depression (SMD = -5.79; 95% CI = -10.36, -1.22; p = .010; I 2 = 86%). Furthermore, it was effective in enhancing the quality of life (SMD = 7.40; 95% CI = 2.92, 11.88; p = .001; I 2 = 53%) and pregnancy rate (SMD = 2.06; 95% CI = 1.08, 3.95; p = .030; I 2 = 73%). The mind-body program was found to relieve anxiety and depression in infertile women and improve their quality of life, thereby positively affecting the pregnancy rate.; Conclusion: The mind-body program was found to relieve anxiety and depression in infertile women and improve their quality of life, thereby positively affecting the pregnancy rate. The mind-body program needs to be considered to a wider audience for positive effects on emotions and pregnancy outcomes of infertile women.; Competing Interests: Conflict of interest The authors declared no conflict of interest. (Copyright © 2021. Published by Elsevier B.V.)

Ha, J.-Y., et al. (2023). "Efficacy of psychosocial interventions for pregnancy rates of infertile women undergoing in vitro fertilization: a systematic review and meta-analysis." Journal of Psychosomatic Obstetrics and Gynaecology 44(1): 2142777.
	Purpose: This study aimed to analyze the efficacy of psychosocial interventions for improving pregnancy rates in infertile women undergoing in vitro fertilization (IVF) treatment through a systematic review and meta-analysis.; Methods: Twelve studies were included in the meta-analysis. To estimate the effect size, a meta-analysis of the studies was performed using RevMan 5.3. The possibility of publication bias was evaluated using funnel plots and Egger's method.; Results: A statistically significant effect size (standardized mean difference [SMD] = 1.39; 95% confidence interval [CI] = 1.11-1.71; p = 0.004; I 2 = 19%) was found for the 12 studies that investigated the effects of psychosocial interventions on clinical pregnancy rates. The psychosocial interventions that had a significant effect on pregnancy rates were mind-body interventions (SMD = 1.37; 95% CI = 1.01-1.85; p = 0.040; I 2 = 0%) and cognitive behavioral therapy (SMD = 2.19; 95% CI = 1.17-4.13; p = 0.010).; Conclusions: The results suggest that psychosocial interventions affect pregnancy rates. Moreover, they indicate that mind-body interventions and cognitive behavioral therapy are beneficial for improving the pregnancy outcome in infertile women undergoing IVF.

Haas David, M., et al. (2019). "Progestogen for preventing miscarriage in women with recurrent miscarriage of unclear etiology." The Cochrane Database of Systematic Reviews 2019(11).
	Background: Progesterone, a female sex hormone, is known to induce secretory changes in the lining of the uterus essential for successful implantation of a fertilized egg. It has been suggested that a causative factor in many cases of miscarriage may be inadequate secretion of progesterone. Therefore, clinicians use progestogens (drugs that interact with the progesterone receptors), beginning in the first trimester of pregnancy, in an attempt to prevent spontaneous miscarriage. This is an update of a review, last published in 2013. Since publication of the 2018 update of this review, we have been advised that the Ismail 2017 study is currently the subject of an investigation by the Journal of Maternal-Fetal & Neonatal Medicine. We have now moved this study from 'included studies' to 'Characteristics of studies awaiting classification' until the outcome of the investigation is known.; Objectives: To assess the efficacy and safety of progestogens as a preventative therapy against recurrent miscarriage.; Search Methods: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (6 July 2017) and reference lists from relevant articles, attempting to contact trial authors where necessary, and contacted experts in the field for unpublished works.; Selection Criteria: Randomized or quasi-randomized controlled trials comparing progestogens with placebo or no treatment given in an effort to prevent miscarriage.; Data Collection and Analysis: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two reviewers assessed the quality of the evidence using the GRADE approach.; Main Results: Twelve trials (1,856 women) met the inclusion criteria. Eight of the included trials compared treatment with placebo and the remaining four trials compared progestogen administration with no treatment. The trials were a mix of multicenter and single-center trials, conducted in India, Jordan, UK and USA. In five trials women had had three or more consecutive miscarriages and in seven trials women had suffered two or more consecutive miscarriages. Routes, dosage and duration of progestogen treatment varied across the trials. The majority of trials were at low risk of bias for most domains. Ten trials (1684 women) contributed data to the analyses. The meta-analysis of all women, suggests that there may be a reduction in the number of miscarriages for women given progestogen supplementation compared to placebo/controls (average risk ratio (RR) 0.73, 95% confidence interval (CI) 0.54 to 1.00, 10 trials, 1684 women, moderate-quality evidence). A subgroup analysis comparing placebo-controlled versus non-placebo-controlled trials, trials of women with three or more prior miscarriages compared to women with two or more miscarriages and different routes of administration showed no clear differences between subgroups for miscarriage. None of the trials reported on any secondary maternal outcomes, including severity of morning sickness, thromboembolic events, depression, admission to a special care unit, or subsequent fertility. There was probably a slight benefit for women receiving progestogen seen in the outcome of live birth rate (RR 1.07, 95% CI 1.00 to 1.13, 6 trials, 1411 women, moderate-quality evidence). We are uncertain about the effect on the rate of preterm birth because the evidence is very low-quality (RR 1.13, 95% CI 0.53 to 2.41, 4 trials, 256 women, very low-quality evidence). No clear differences were seen for women receiving progestogen for the other secondary outcomes including neonatal death, fetal genital abnormalities or stillbirth. There may be little or no difference in the rate of low birthweight and trials did not report on the secondary child outcomes of teratogenic effects or admission to a special care unit.; Authors' Conclusions: For women with unexplained recurrent miscarriages, supplementation with progestogen therapy may reduce the rate of misca riage in subsequent pregnancies. (Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Haas, J., et al. (2021). "The role of ICSI vs. conventional IVF for patients with advanced maternal age-a randomized controlled trial." Journal of Assisted Reproduction and Genetics 38(1): 95‐100.
	Objectives: This study aimed to evaluate the role of intracytoplasmic sperm injection (ICSI) in the treatment of non‐male factor infertile patients aged ≥ 39. Methods: This is a single‐center, prospective, randomized controlled clinical trial, between March 2018 and December 2019. Sixty‐nine patients were recruited, and sixty patients participated in the study. Their ovaries were randomized prior to the beginning of the ovarian stimulation: the oocytes from one side (n = 257) were allocated to the ICSI (ICSI arm), while those of the contralateral side (n = 258) were allocated to conventional insemination (IVF arm). The fertilization rate per oocyte retrieved, number of zygotes (2PN), and cleavage‐stage embryos were assessed and compared between the two study groups. Results: The average number of zygotes (3.1 vs. 2.7 p = 0.45), the fertilization rate (72.4% vs. 65.1% p = 0.38), the average number of cleavage‐stage (2.8 vs. 2.4 p = 0.29), and the average top‐quality embryos (TQE) cleavage‐stage embryos (1.7 vs. 1.6 p = 0.94) were comparable between the two groups. The TQE rate per randomized oocyte (41.2% vs. 41% p = 0.8) was also similar in both groups. Conclusions: ICSI does not improve the reproductive outcomes of advanced‐age patients undergoing conventional insemination for non‐male factor infertility. Trial registration: NCT03370068

Hade, J. (2023). "Ovarian PRP for Diminished Ovarian Reserve." ClinicalTrials.gov.
	A randomized, double‐blind, placebo‐controlled trial comparing ovarian injection of platelet‐rich plasma vs. placebo in women diagnosed with diminished ovarian reserve at risk for a poor ovarian response (POR) between 35 to 42 years of age. Participants for this study include patients who are planning to undergo IVF with preimplantation genetic testing for aneuploidy (PGT‐A) followed by a frozen embryo transfer (FET) cycle. Only patients with either a euploid embryo or eligible mosaic embryo (following consultation with a geneticist), as determined by PGT‐A, will be allowed to proceed with a single blastocyst FET cycle All patients will have a baseline ultrasound and blood work at the time of menses, approximately one month prior to starting their initial IVF cycle. Routine monitoring will be required to determine the day of ovulation. Once an LH surge is detected or if a lead follicle on pelvic ultrasound is deemed large enough to induce ovulation, a "trigger" shot with 250 mcg/0.5 mL of Ovidrel® will be self‐administered subcutaneously (SQ). Based upon the patient's randomization, either oPRP or ovarian Serum (oS) injections will be performed under anesthesia and within 72 hours from the day of ovulation. Following their ovarian injections, all patients will return for monitoring with the onset of menses approximately 14 to 16 days from the date of ovulation. A medication protocol will be determined at the start of each IVF cycle. Either a natural (nIVF), mild (mIVF) or conventional (cIVF) IVF protocol will be chosen by the treating physician. This determination will be based on findings from the repeat pelvic ultrasound with AFC and blood work for anti‐mullerian hormone (AMH), follicle stimulating hormone (FSH), lutenizing hormone (LH), estradiol (E2), progesterone (P4), and beta‐human chorionic gonadotrophin (B‐hCG). Natural IVF will be considered for patients with only 1‐2 antral follicles, mIVF for patients with 2‐4 antral follicles observed, and cIVF for patients with four or more antral follicles visualized at the time stimulation started. Patients will begin their designated protocol and return four to five days following medication start. A repeat pelvic ultrasound will be performed to measure the growth and size of all follicles visualized along with the endometrial thickness. Also, blood work for E2, FSH, LH, and P4 will be obtained. Monitoring for follicular and endometrial development will continue routinely and as needed, until the majority of all follicles observed have a mean diameter between 15 to 22 mm. Induction of ovulation will commence 35 and a half hours prior to oocyte retrieval, by self‐administration of 10,000 IU hCG SQ. The patient will receive deep IV sedation anesthesia by a board‐certified anesthesiologist for her oocyte retrieval and placement of either her second oPRP or oS injections. Using transvaginal ultrasound guidance, all follicles visualized under ultrasound will be aspirated using standard practices by patients undergoing IVF at GNF. Aspirates will be collected in 10 ml test tubes. All oocytes will be assessed at the time of retrieval for maturity. All oocytes that are deemed mature (MII) will undergo intracytoplasmic sperm injection (ICSI), to maximize fertilization rates, 2‐4 hours after identification of the first polar body. All immature (non MII) oocytes will be isolated under a stereomicroscope and transferred into maturation media and incubated further in a triple gas mixture (90% N2, 5% CO2, and 5% O2) for up to 24 hours to allow maturation prior to ICSI. Following the oocyte retrieval, either oPRP or oS will be performed as described previously. Monitoring will recommence two weeks following the first oocyte retrieval to identify if any residual follicles or ovarian cysts are present. If the ovaries are deemed resting and no active ovarian cysts persist, then the patient will begin her second IVF cycle. Again, the medication protocol will be determined by findings observed on pelvic ultrasound including AFC and ovarian hormone testing. f the patient is deemed ineligible to start another IVF cycle, then she will return with the following menstrual period to begin her second IVF cycle. The process of monitoring patients, inducing ovulation and collecting oocytes will be identical to the first oocyte retrieval. However, no additional oPRP or oS injections will be performed.

Hadizadeh-Talasaz, Z., et al. (2019). "Effect of pelvic floor muscle training on postpartum sexual function and quality of life: A systematic review and meta-analysis of clinical trials." Taiwanese Journal of Obstetrics & Gynecology 58(6): 737-747.
	There are a weakness and laxity in pubourethral and external urethral ligaments during postpartum which has an important role in the females' sexual function and quality of life. Some evidences showed that pelvic floor muscle training can strength pelvic muscles and prevent sexual dysfunction. Therefore, current study aimed to review the effect of pelvic floor exercise on female sexual function and quality of life in the postpartum period. PubMed, CINAHL, Medline, Scopus, Google scholar citations, Persian databases including SID and Iran Medex were searched using MeSH-based keywords to find published articles. Experimental and quasi-experimental studies in Persian and English were included. Data extracted was done in pre-defined checklist by two independent researchers. Risk of bias was assessed using the Cochrane Risk of Bias tool. Meta-Analysis of the data was carried out by "Comprehensive Meta-analysis Version 2" (CAM). The search resulted in 347 titles and abstracts, which were narrowed down to 12 potentially eligible articles. Pooled standardized differences in means (SMD) of sexual function in both pelvic floor exercise and control group were 0.462 [0.117 to 0.806], p = 0.009. The pooled SMD was 1.294 [0.926 to 1.663], p < 0001 for sexual quality of life. The pooled SMD was 0.232 [0.038-0.426], p = 0.019 for general quality of life. Evidences showed that pelvic floor muscle training in primi or multi-parous women can boost sexual function and quality of life in postpartum. Although the majority of studies and the result of meta-analysis reported positive results, more high-quality RCTs are needed in this area. One limitation of our study is significant heterogeneity because of different intervention method.

Hafidh, B., et al. (2023). "CO2 laser therapy for management of stress urinary incontinence in women: a systematic review and meta-analysis." Therapeutic Advances in Urology 15.
	Background: Carbon dioxide (CO2) laser therapy is an emerging treatment for women with stress urinary incontinence (SUI). Objective(s): To examine the efficacy of CO2 laser therapy for management of SUI-related symptoms in women. Design(s): A systematic review and meta-analysis of randomized controlled trials and cohort studies. Data sources and methods: Four databases were screened until January 2023. All efficacy continuous endpoints were assessed via subtraction of the posttreatment from pretreatment values. The data were summarized as mean difference (MD) with 95% confidence interval (CI) using the random-effects model. Result(s): A total of 15 studies with 700 patients were analyzed. CO2 laser therapy significantly decreased the 1-h pad weights at 3 months [n = 5 studies, MD = -3.656 g, 95% CI (-5.198, -2.113), p < 0.001], 6 months [n = 6 studies, MD = -6.583 g, 95% CI (-11.158, -2.008), p = 0.005], and 12 months [n = 6 studies, MD = -3.726 g, 95% CI (-6.347, -1.106), p = 0.005]. Moreover, CO2 laser therapy significantly decreased the International Consultation of Incontinence Questionnaire-Urinary Incontinence Short Form Scores at 3 months [n = 10 studies, MD = -4.805, 95% CI (-5.985, -3.626), p < 0.001] and 12-months [n = 6 studies, MD = -3.726, 95% CI (-6.347, -1.106), p = 0.005]. Additionally, CO2 laser therapy significantly decreased the Pelvic Floor Impact Questionnaire scores at 6 months [n = 2 studies, MD = -11.268, 95% CI (-18.671, -3.865), p = 0.002] and 12 months [n = 2 studies, MD = -10.624, 95% CI (-18.145, -3.103), p = 0.006]. Besides, CO2 laser therapy significantly decreased the Urogenital Distress Inventory-6 scores at 3 months [n = 2 studies, MD = -21.997, 95% CI (-32.294, -11.699), p < 0.001], but not at 6 months [n = 3 studies, MD = -3.034, 95% CI (-7.357, 1.259), p = 0.169]. Lastly, CO2 laser therapy significantly increased the Vaginal Health Index Score at 6 months [n = 2 studies, MD = 2.826, 95% CI (0.013, 5.638), p = 0.047] and 12 months [MD = 1.553, 95% CI (0.173, 2.934), p = 0.027]. Conclusion(s): CO2 laser therapy improved the SUI-related symptoms in women. To obtain solid conclusions, future studies should be well-designed with standardized settings, consistent therapeutic protocols, and long-term follow-up periods.Copyright © The Author(s), 2023.

Hagen, S., et al. (2023). "Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial." EClinicalMedicine 66: 102326.
	Background: Prolapse affects 30-40% of women. Those using a pessary for prolapse usually receive care as an outpatient. This trial determined effectiveness and cost-effectiveness of pessary self-management (SM) vs clinic-based care (CBC) in relation to condition-specific quality of life (QoL). Method(s): Parallel-group, superiority randomised controlled trial, recruiting from 16 May 2018 to 7 February 2020, with follow-up to 17 September 2021. Women attending pessary clinics, >=18 years, using a pessary (except Shelf, Gellhorn or Cube), with pessary retained >=2 weeks were eligible. Limited manual dexterity; cognitive deficit; pregnancy; or requirement for non-English teaching were exclusions. SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received usual routine appointments. The primary clinical outcome was pelvic floor-specific QoL (PFIQ-7), and incremental net monetary benefit for cost-effectiveness, 18 months post-randomisation. Group allocation was by remote web-based application, minimised on age, user type (new/existing) and centre. Participants, intervention deliverers, researchers and the statistician were not blinded. The primary analysis was intention-to-treat based. Trial registration: https://doi.org/10.1186/ISRCTN62510577. Finding(s): The requisite 340 women were randomised (169 SM, 171 CBC) across 21 centres. There was not a statistically significant difference between groups in PFIQ-7 at 18 months (mean SM 32.3 vs CBC 32.5, adjusted mean difference SM-CBC -0.03, 95% CI -9.32 to 9.25). SM was less costly than CBC. The incremental net benefit of SM was 564 (SE 581, 95% CI -576 to 1704). A lower percentage of pessary complications was reported in the SM group (mean SM 16.7% vs CBC 22.0%, adjusted mean difference -3.83%, 95% CI -6.86% to -0.81%). There was no meaningful difference in general self-efficacy. Self-managing women were more confident in self-management activities. There were no reported suspected unexpected serious adverse reactions, and 31 unrelated serious adverse events (17 SM, 14 CBC). Interpretation(s): Pessary self-management is cost-effective, does not improve or worsen QoL compared to CBC, and has a lower complication rate. Funding(s):National Institute for Health and Care Research, Health Technology Assessment Programme (16/82/01).Copyright © 2023 The Authors

Hakbilen Hilal, G. (2022). "Comfort Theory-Based Nursing Interventions in Women With Stress Urinary Incontinence." ClinicalTrials.gov.
	Urinary incontinence (UI) is seen as a common health problem among adult women. UI, defined as unconscious urinary incontinence, is not a disease, but a symptom that develops due to damage to the bladder, sphincter mechanism, or pelvic floor muscles. Different rates are expressed regarding the incidence of UI in the world. When population studies conducted in many countries are evaluated, it has been determined that the incidence of UI varies between 5% and 70%. Population‐based studies have reported that UI is more common in women than men, and approximately 10% of all adult women experience UI. Urinary incontinence can be classified as urge incontinence (UII) (involuntary leakage accompanied by urgency), stress incontinence (SUI) (involuntary leakage upon exertion or sneezing or coughing), or mixed incontinence (MUI) (involuntary leakage associated with urgency and effort, sneezing or coughing). In a prevalence study, the prevalence of any type of UI among women was found to be 53%; according to UI subtypes, 16% of women had MUI, 26% had SUI and 10% had UUI. Although many adult women experience SUI today, they see this as a natural consequence of birth and aging and do not think that it is a serious health problem. As a result of this situation, women do not attempt to apply for health services for UI. However, although UI is not life‐threatening, it imposes significant limitations on women's activities of daily living and sexual and interpersonal relationships. Emotional problems such as embarrassment, depression, sadness, and low body image that UI brings with it cause a negative effect on quality of life. Pharmacological, surgical, and behavioral treatment methods can be applied in the treatment of UI, which causes significant negative effects on quality of life. One of the behavioral treatment methods that can provide therapeutic benefits for urinary incontinence is yoga. Yoga is an ancient medical practice used to maintain bodily health and heal many types of diseases. Recently, yoga has become a new option to strengthen the pelvic floor muscles and treat symptoms related to pelvic floor dysfunctions. When the literature is examined, the results of studies showing that yoga practice is very effective in the treatment of UI have been found. Unlike most UI treatments, yoga can be practiced by women without constant supervision from healthcare providers, thus offering an accessible and cost‐effective self‐management strategy for large numbers of women in the community. Nurses have important roles and responsibilities in the diagnosis, treatment, and care process of UI. Nurses need to plan and implement a care that will increase the quality of life and provide comfort for patients with UI. The word comfort, which we often use in our daily life, expresses a basic human need. Comfort is a nursing function, initiative, and also the intended outcome of most nursing interventions in the field of nursing. Kolcaba created the taxonomic structure of Comfort Theory, consisting of three levels and four dimensions, in 1988. The 3 levels within the scope of the theory were created depending on the intensity of meeting the individual comfort needs of the patients. In other words, the level of meeting the patients' needs for comfort created 3 levels of the Comfort Theory. These levels are respectively; relief, relief, and superiority. Kolcaba handled Comfort Theory in 4 dimensions taxonomically. These dimensions are based on a holistic philosophy, that is, a holistic perspective, and are named physical comfort, psychospiritual comfort, sociocultural comfort, and environmental comfort. When the taxonomic structure of Comfort Theory is evaluated, it is seen that all its components are interconnected. For example; physical comfort is related to bodily perceptions. When the individual's needs for physical responses to various stimuli are met, the individual will get rid of the distress of these responses and reach the desired comfort level. Kolcaba emphasized that comfort care is a process as an attempt to achieve comfor and that increasing comfort level is a product. In the literature, no randomized controlled study was found in which nursing interventions based on Comfort Theory were applied to female patients with SUI. In this study, it is aimed to evaluate the effect of nursing interventions based on Comfort Theory applied to female patients with SUI on UI, quality of life, and comfort level. In addition, it is thought that the results obtained from this study will increase awareness of practices such as yoga, meditation, and breathing exercises as an effective, applicable, and easily adaptable behavioral treatment method in female patients with a diagnosis of SUI. AIM OF THE STUDY The aim of this study; To examine the effects of nursing interventions based on Comfort Theory applied to female patients with SUI on UI, quality of life and comfort levels. HYPOTHESES OF THE STUDY 1. H1: Nursing interventions based on Comfort Theory have an effect on the UI level of female patients with SUI. 2. H1: Nursing interventions based on Comfort Theory have an effect on the quality of life of female patients with SUI. 3. H1: Nursing interventions based on Comfort Theory have an effect on the comfort level of female patients with SUI.

Halic, U. (2023). "SuJok Massage Dismenorea Painful Menstruation." ClinicalTrials.gov.
	This study was performed in a single‐blind, randomized controlled type to examine the effect of Su Jok and massage on pain and quality of life in women with primary dysmenorrhea.The sample size in this study was G*Power 3.1.9.2. In the program, 5% first type error, 0.30 standardized effect size, 1:1 distribution ratio, 80% power, and the minimum sample size required for the three groups were calculated as 111 women and 37 women for each group. Considering that there may be losses, 40 women and a total of 120 women were randomized to each group. "Data Collection Form", "Visiual Analog Scale (VAS)", "Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale", "SF‐36, Quality of Life Scale" were used to obtain data.Intervention and Data Collection Stage 1: VAS was applied to the women who volunteered to participate in the study on the first day of menstruation, and women with a mean score of 5 and above and meeting the sample selection criteria were randomized into three separate groups as A, B, and C. The researcher who performed the randomization ensured that the women were assigned to the control and experimental groups and did not share this information with the other researchers. Data Collection Form, Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale, SF‐36 Quality of Life Scale were applied to all women on the first day of the next menstruation. Since the data collection tools were based on self‐report, the woman was allowed to answer in a calm environment and alone. The environment where the applications will be held was arranged in such a way that the researcher and the participant could sit opposite each other with two chairs and an application table. Entry and exit to the room was prevented until the application was over. The environment was quiet. Stage 2 Su Jok Experimental Group (A): In this study, the seed therapy technique was applied using live buckwheat seeds. Hands were used because it was reported in the literature that hands were used for gynecological pain and were more suitable.The acupuncture point, which is the reflection of the painful area, was determined on the women's hands. This point was massaged for a few minutes by the researcher, and then the buckwheat seed was fixed to this point with a bandage and the area where the seed was applied was massaged for 30 minutes. After each application, VAS evaluation was taken from the women. Su Jok was applied to women in the first three days of menstruation for three cycles.Experimental Group (B) to whom massage was applied: Massage application determined by scanning the literature and taking expert opinion classical massage techniques (eufluorage, petrissage, friction, tapotman, vibration) was used. Massage was attempted for a total of 20 minutes, 10 minutes on the back and waist, and 10 minutes on the abdominal region, in the first three days of the three cycles. Massage application was started from the back and waist region. Efflorage, petrissage, friction, vibration, taputman and efflorage for one minute were applied to this area, respectively. Afterwards, three minutes of efflorage, petrissage, friction, and one‐minute efflorage were applied to the abdominal region, respectively. Odorless, lubricating gel was used during the application. After each application, VAS evaluation was taken from the women. Massage was applied to the women in the first three days of menstruation for three cycles. Control Group (C): VAS assessment was obtained for the first three days during three cycles. Stage 3 Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale and SF‐36 Quality of Life Scale were applied to all women included in the study on the third day of the third cycle.

Haller, H., et al. (2019). "Craniosacral therapy for chronic pain: a systematic review and meta-analysis of randomized controlled trials." BMC Musculoskeletal Disorders 21(1): 1.
	Objectives: To systematically assess the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain.; Methods: PubMed, Central, Scopus, PsycInfo and Cinahl were searched up to August 2018. Randomized controlled trials (RCTs) assessing the effects of CST in chronic pain patients were eligible. Standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated for pain intensity and functional disability (primary outcomes) using Hedges' correction for small samples. Secondary outcomes included physical/mental quality of life, global improvement, and safety. Risk of bias was assessed using the Cochrane tool.; Results: Ten RCTs of 681 patients with neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain were included. CST showed greater post intervention effects on: pain intensity (SMD = -0.32, 95%CI = [- 0.61,-0.02]) and disability (SMD = -0.58, 95%CI = [- 0.92,-0.24]) compared to treatment as usual; on pain intensity (SMD = -0.63, 95%CI = [- 0.90,-0.37]) and disability (SMD = -0.54, 95%CI = [- 0.81,-0.28]) compared to manual/non-manual sham; and on pain intensity (SMD = -0.53, 95%CI = [- 0.89,-0.16]) and disability (SMD = -0.58, 95%CI = [- 0.95,-0.21]) compared to active manual treatments. At six months, CST showed greater effects on pain intensity (SMD = -0.59, 95%CI = [- 0.99,-0.19]) and disability (SMD = -0.53, 95%CI = [- 0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. Sensitivity analyses revealed robust effects of CST against most risk of bias domains. Five of the 10 RCTs reported safety data. No serious adverse events occurred. Minor adverse events were equally distributed between the groups.; Discussion: In patients with chronic pain, this meta-analysis suggests significant and robust effects of CST on pain and function lasting up to six months. More RCTs strictly following CONSORT are needed to further corroborate the effects and safety of CST on chronic pain.; Protocol Registration at Prospero: CRD42018111975.

Hamanishi, J., et al. (2021). "Nivolumab Versus Gemcitabine or Pegylated Liposomal Doxorubicin for Patients With Platinum-Resistant Ovarian Cancer: open-Label, Randomized Trial in Japan (NINJA)." Journal of Clinical Oncology 39(33): 3671‐3681.
	PURPOSE: This phase III, multicenter, randomized, open‐label study investigated the efficacy and safety of nivolumab versus chemotherapy (gemcitabine [GEM] or pegylated liposomal doxorubicin [PLD]) in patients with platinum‐resistant ovarian cancer. MATERIALS AND METHODS: Eligible patients had platinum‐resistant epithelial ovarian cancer, received ≤ 1 regimen after diagnosis of resistance, and had an Eastern Cooperative Oncology Group performance score of ≤ 1. Patients were randomly assigned 1:1 to nivolumab (240 mg once every 2 weeks [as one cycle]) or chemotherapy (GEM 1000 mg/m2 for 30 minutes [once on days 1, 8, and 15] followed by a week's rest [as one cycle], or PLD 50 mg/m2 once every 4 weeks [as one cycle]). The primary outcome was overall survival (OS). Secondary outcomes included progression‐free survival (PFS), overall response rate, duration of response, and safety. RESULTS: Patients (n = 316) were randomly assigned to nivolumab (n = 157) or GEM or PLD (n = 159) between October 2015 and December 2017. Median OS was 10.1 (95% CI, 8.3 to 14.1) and 12.1 (95% CI, 9.3 to 15.3) months with nivolumab and GEM or PLD, respectively (hazard ratio, 1.0; 95% CI, 0.8 to 1.3; P = .808). Median PFS was 2.0 (95% CI, 1.9 to 2.2) and 3.8 (95% CI, 3.6 to 4.2) months with nivolumab and GEM or PLD, respectively (hazard ratio, 1.5; 95% CI, 1.2 to 1.9; P = .002). There was no statistical difference in overall response rate between groups (7.6% v 13.2%; odds ratio, 0.6; 95% CI, 0.2 to 1.3; P = .191). Median duration of response was numerically longer with nivolumab than GEM or PLD (18.7 v 7.4 months). Fewer treatment‐related adverse events were observed with nivolumab versus GEM or PLD (61.5% v 98.1%), with no additional or new safety risks. CONCLUSION: Although well‐tolerated, nivolumab did not improve OS and showed worse PFS compared with GEM or PLD in patients with platinum‐resistant ovarian cancer.

Hamel, C., et al. (2021). "Mifepristone followed by misoprostol compared with placebo followed by misoprostol as medical treatment for early pregnancy loss (the Triple M trial): A double-blind placebo-controlled randomised trial." EClinicalMedicine 32: 100716.
	BACKGROUND: Worldwide, millions of women seek treatment for early pregnancy loss (EPL) annually. Medical management with misoprostol is widely used, but only effective 60% of the time. Pre-treatment with mifepristone prior to misoprostol might improve the success rate of medical management. METHODS: This was a multi-centre, double-blind, placebo-controlled randomised trial in 17 Dutch hospitals. Women with a non-viable pregnancy between 6 and 14 weeks of gestation were eligible for inclusion after at least one week of expectant management. Participants were randomised (1:1) between oral mifepristone 600 mg or an oral placebo tablet. Participants took 400 μg misoprostol orally, repeated after four hours on day two and, if necessary, day three. Primary outcome was expulsion of gestational sac and endometrial thickness <15 mm after 6-8 weeks. Analyses were done according to intention-to-treat principles. This trial is registered with ClinicalTrials.gov, NCT03212352. FINDINGS: Between June 28th 2018 and January 8th 2020, 175 women were randomised to mifepristone and 176 to placebo, including 344 in the intention-to-treat analysis. In the mifepristone group 136 (79•1%) of 172 participants reached complete evacuation compared to 101 (58•7%) of 172 participants in the placebo group (p<0•0001, RR 1•35, 95% CI 1•16-1•56). Incidence of serious adverse events was significantly lower in the mifepristone group with 24 (14%) patients affected versus 55 (32%) in the placebo group (p = 0•0005) (Table 3). INTERPRETATION: Pre-treatment with mifepristone prior to misoprostol was more effective than misoprostol alone in managing EPL. FUNDING: Healthcare Insurers Innovation Foundation, Radboud University Medical Centre, Canisius Wilhelmina Hospital.

Hamel Charlotte, C., et al. (2022). "Economic evaluation of a randomized controlled trial comparing mifepristone and misoprostol with misoprostol alone in the treatment of early pregnancy loss." PloS One 17(2): e0262894.
	Background: In case of early pregnancy loss (EPL) women can either choose for expectant, medical or surgical management. One week of expectant management is known to lead to spontaneous abortion in approximately 50% of women. Medical treatment with misoprostol is known to be safe and less costly than surgical management, however less effective in reaching complete evacuation of the uterus. Recently, a number of trials showed that prompt treatment with the sequential combination of mifepristone with misoprostol is superior to misoprostol alone in reaching complete evacuation. In this analysis we evaluate whether the sequential combination of mifepristone with misoprostol is cost-effective compared to misoprostol alone, in the treatment of EPL.; Methods and Findings: A cost-effectiveness analysis (CEA) from a healthcare perspective was performed alongside a randomised controlled trial (RCT) in which standard treatment with misoprostol only was compared with a combination of mifepristone and misoprostol, in women with EPL after a minimum of one week of unsuccessful management. A limited societal perspective scenario was added. This RCT, the Triple M trial, was a multicentre, randomized, double-blinded, placebo-controlled trial executed at 17 hospitals in the Netherlands. The trial started on June 27th 2018, and ended prematurely in January 2020 due to highly significant outcomes from the predefined interim-analysis. We included 351 women with a diagnosis of EPL between 6 and 14 weeks gestation after at least one week of unsuccessful expectant management. They were randomized between double blinded pre-treatment with oral mifepristone 600mg (N = 175) or placebo (N = 176) taken on day one, both followed by misoprostol orally. In both groups, an intention-to-treat analysis was performed for 172 patients, showing a significant difference in success rates between participants treated with mifepristone and misoprostol versus those treated with misoprostol alone (79.1% vs 58.7% respectively). In this cost-effective analysis we measured the direct, medical costs related to treatment (planned and unplanned hospital visits, medication, additional treatment) and indirect costs based on the IMTA Productivity Cost Questionnaire (iPCQ). Quality Adjusted Life Years (QALY's) were calculated from participants' scores on the SF-36 questionnaires sent digitally at treatment start, and one, two and six weeks later. We found medical treatment with placebo followed by misoprostol to be 26% more expensive compared to mifepristone followed by misoprostol (p = 0.001). Mean average medical costs per patient were significantly lower in the mifepristone group compared to the placebo group (€528.95 ± 328.93 vs €663.77 ± 456.03, respectively; absolute difference €134.82, 95% CI 50,46-219,18, p = 0.002). Both indirect costs and QALY's were similar between both groups.; Conclusion: The sequential combination of mifepristone with misoprostol is cost-effective compared with misoprostol alone, for treatment of EPL after a minimum of one week of unsuccessful expectant management.; Competing Interests: The authors have declared that no competing interests exist.

Hamerlynck, T. (2021). "Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial." ClinicalTrials.gov.
	Design : RCT ‐ Multicenter ‐ Randomized controlled ‐ Parallel group design ‐ Superiority trial ‐ Non‐blinded Primary Objective To compare the effectiveness in terms of time to next pregnancy between operative hysteroscopy and expectant management in patients with sonographic evidence of RPOC after primary non‐surgical management of miscarriage. Secondary Objectives 1. Effectiveness objectives To compare the effectiveness between operative hysteroscopy and expectant management with respect to: ‐ Generic quality of life (QOL) (as measured by SF‐36, HADS (Hospital Anxiety and Depression Scale)) and EQ‐5D‐5L 6 months after randomization ‐ Course of pregnancy in those women who have an ongoing pregnancy after randomization during the study follow‐up period (including miscarriage, ectopic pregnancy and live birth) 2. Safety objectives To compare the safety between operative hysteroscopy and expectant management with respect to: ‐ Necessity for additional treatment ‐ Out‐of‐protocol/unscheduled visits to the outpatient clinic or general practitioner ‐ Complications 3. Cost‐effectiveness objectives To compare the health related costs between operative hysteroscopy and expectant management.

Hampshire Hospitals, N. H. S. F. T. (2023). "VESPER: Pelvic Organ Prolapse Study." ClinicalTrials.gov.
	No Results Available Procedure: Laser therapy Pelvic Organ Prolapse Quantification Score (POP-Q) between baseline and 6 months after treatment.|Pelvic Organ Prolapse Quantification Score (POP-Q) between baseline and 12 months after treatment.|Change in mean International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) test scores from baseline to 6 months post treatment|Change in mean International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) test scores from baseline to 12 months post treatment|Patient's Global Impression of Improvement (PGI-I) at 6 months|Patient's Global Impression of Improvement (PGI-I) at 12 months|Change in mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) scores|Pain visual analogue scale Female Not Applicable 25 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 2019-FAM-02 April 30, 2026

Hamulyák Eva, N., et al. (2020). "Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss." The Cochrane Database of Systematic Reviews 5: CD012852.
	Background: Aspirin and heparin are widely used as preventive strategy to reduce the high risk of recurrent pregnancy loss in women with antiphospholipid antibodies (aPL). This review supersedes a previous, out-of-date review that evaluated all potential therapies for preventing recurrent pregnancy loss in women with aPL. The current review focusses on a narrower scope because current clinical practice is restricted to using aspirin or heparins, or both for women with aPL in an attempt to reduce pregnancy complications.; Objectives: To assess the effects of aspirin or heparin, or both for improving pregnancy outcomes in women with persistent (on two separate occasions) aPL, either lupus anticoagulant (LAC), anticardiolipin (aCL) or aβ 2 -glycoprotein-I antibodies (aβ 2 GPI) or a combination, and recurrent pregnancy loss (two or more, which do not have to be consecutive).; Search Methods: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (3 June 2019), and reference lists of retrieved studies. Where necessary, we attempted to contact trial authors.; Selection Criteria: Randomised, cluster-randomised and quasi-randomised controlled trials that assess the effects of aspirin, heparin (either low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH]), or a combination of aspirin and heparin compared with no treatment, placebo or another, on pregnancy outcomes in women with persistent aPL and recurrent pregnancy loss were eligible. All treatment regimens were considered.; Data Collection and Analysis: Two review authors independently assessed trials for inclusion criteria and risk of bias. Two review authors independently extracted data and checked them for accuracy and the certainty of the evidence was assessed using the GRADE approach.; Main Results: Eleven studies (1672 women) met the inclusion criteria; nine randomised controlled trials and two quasi-RCTs. The studies were conducted in the USA, Canada, UK, China, New Zealand, Iraq and Egypt. One included trial involved 1015 women, all other included trials had considerably lower numbers of participants (i.e. 141 women or fewer). Some studies had high risk of selection and attrition bias, and many did not include sufficient information to judge the risk of reporting bias. Overall, the certainty of evidence is low to very low due to the small numbers of women in the studies and to the risk of bias. The dose and type of heparin and aspirin varied among studies. One study compared aspirin alone with placebo; no studies compared heparin alone with placebo and there were no trials that had a no treatment comparator arm during pregnancy; five studies explored the efficacy of heparin (either UFH or LMWH) combined with aspirin compared with aspirin alone; one trial compared LMWH with aspirin; two trials compared the combination of LMWH plus aspirin with the combination of UFH plus aspirin; two studies evaluated the combination of different doses of heparin combined with aspirin. All trials used aspirin at a low dose. Aspirin versus placebo We are very uncertain if aspirin has any effect on live birth compared to placebo (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.71 to 1.25, 1 trial, 40 women, very low-certainty evidence). We are very uncertain if aspirin has any effect on the risk of pre-eclampsia, pregnancy loss, preterm delivery of a live infant, intrauterine growth restriction or adverse events in the child, compared to placebo. We are very uncertain if aspirin has any effect on adverse events (bleeding) in the mother compared with placebo (RR 1.29, 95% CI 0.60 to 2.77, 1 study, 40 women). The certainty of evidence for these outcomes is very low because of imprecision, due to the low numbers of women involved and the wide 95% CIs, and also because of risk of bias. Venous thromboembolism and arterial thromboembolism were not reported in the included studies. Heparin plus aspirin versus aspirin alone Heparin plus aspirin may increase the number of live bi ths (RR 1.27, 95% CI 1.09 to 1.49, 5 studies, 1295 women, low-certainty evidence). We are uncertain if heparin plus aspirin has any effect on the risk of pre-eclampsia, preterm delivery of a live infant, or intrauterine growth restriction, compared with aspirin alone because of risk of bias and imprecision due to the low numbers of women involved and the wide 95% CIs. We are very uncertain if heparin plus aspirin has any effect on adverse events (bleeding) in the mother compared with aspirin alone (RR 1.65, 95% CI 0.19 to 14.03, 1 study, 31 women). No women in either the heparin plus aspirin group or the aspirin alone group had heparin-induced thrombocytopenia, allergic reactions, or venous or arterial thromboembolism. Similarly, no infants had congenital malformations. Heparin plus aspirin may reduce the risk of pregnancy loss (RR 0.48, 95% CI 0.32 to 0.71, 5 studies, 1295 women, low-certainty evidence). When comparing LMWH plus aspirin versus aspirin alone the pooled RR for live birth was 1.20 (95% CI 1.04 to 1.38, 3 trials, 1155 women). In the comparison of UFH plus aspirin versus aspirin alone, the RR for live birth was 1.74 (95% CI 1.28 to 2.35, 2 trials, 140 women).; Authors' Conclusions: The combination of heparin (UFH or LMWH) plus aspirin during the course of pregnancy may increase live birth rate in women with persistent aPL when compared with aspirin treatment alone. The observed beneficial effect of heparin was driven by one large study in which LMWH plus aspirin was compared with aspirin alone. Adverse events were frequently not, or not uniformly, reported in the included studies. More research is needed in this area in order to further evaluate potential risks and benefits of this treatment strategy, especially among women with aPL and recurrent pregnancy loss, to gain consensus on the ideal prevention for recurrent pregnancy loss, based on a risk profile. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Han, A. L., et al. (2022). "Evaluation of the Effectiveness of Fermented Soybean-Lettuce Powder for Improving Menopausal Symptoms." Nutrients 14(14).
	Menopause syndrome causes a decline in the quality of life of postmenopausal women. Hormone therapy is recommended for the treatment of menopausal syndromes. However, it has several side effects. Soybean has been safely used to relieve the symptoms of menopause. Lettuce has antidiabetic and anti-inflammatory effects and improves sleep quality. Natural nitric oxide metabolites are produced through fermentation, which increases the effectiveness of the functional substances. This study assessed the alleviation of menopausal syndrome symptoms by natural nitric oxide-containing soybean lettuce extract using the Kupperman index. This study included adult women with menopausal syndrome and a Kupperman index of ≥15. After a four-week study with 40 participants, the final analysis included 39 participants in the experimental group ( n = 19) and the placebo group ( n = 20). Body mass index, waist circumference, and the total cholesterol, low-density and high-density lipoprotein cholesterol, and triglyceride levels were not altered before and after treatment in both groups. There was a significant decrease in the Kupperman index after treatment in the experimental group, but no significant change was observed in the placebo group. Soybean lettuce extract alleviates menopause syndrome without any special side effects.

Han, E. J., et al. (2021). "Efficacy of intralipid administration to improve in vitro fertilization outcomes: A systematic review and meta-analysis." Clinical and Experimental Reproductive Medicine 48(3): 203-210.
	We performed a systematic review and meta-analysis to evaluate whether intralipid administration improved the outcomes of in vitro fertilization. Online databases (PubMed, Cochrane Library, Medline, and Embase) were searched until March 2020. Only randomized controlled trials (RCTs) that assessed the role of intralipid administration during in vitro fertilization were considered. We analyzed the rates of clinical pregnancy and live birth as primary outcomes. Secondary outcomes included the rates of chemical pregnancy, ongoing pregnancy, and missed abortion. We reviewed and assessed the eligibility of 180 studies. Five RCTs including 840 patients (3 RCTs: women with repeated implantation failure, 1 RCT: women with recurrent spontaneous abortion, 1 RCT: women who had experienced implantation failure more than once) met the selection criteria. When compared with the control group, intralipid administration significantly improved the clinical pregnancy rate (risk ratio [RR], 1.48; 95% confidence interval [CI], 1.23-1.79), ongoing pregnancy rate (RR, 1.82; 95% CI, 1.31-2.53), and live birth rate (RR, 1.85; 95% CI, 1.44-2.38). However, intralipid administration had no beneficial effect on the miscarriage rate (RR, 0.75; 95% CI, 0.48-1.17). A funnel plot analysis revealed no publication bias. Our findings suggest that intralipid administration may benefit women undergoing in vitro fertilization, especially those who have experienced repeated implantation failure or recurrent spontaneous abortion. However, larger, well-designed studies are needed to confirm these findings.

Han, K. (2022). "Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER." ClinicalTrials.gov.
	No Results Available Radiation: Vaginal brachytherapy|Radiation: Adjuvant radiotherapy (EBRT +/- brachytherapy)|Other: Observation Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status|Estimate the rate of isolated vaginal recurrence at 3 years|Estimate the rate of para-aortic recurrence at 3 years|Estimate the rate of distant metastasis at 3 years|Estimate recurrence-free survival|Estimate endometrial cancer-specific survival|Estimate overall survival|Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory Female Phase 2 325 Other Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment EN10 June 30, 2029

Han, K. (2022). "Catheter-directed Sclerotherapy Versus Surgical Resecction: randomized Controlled Trial Comparing Ovarian Function and Therapeutic Efficacy After Treatment of Ovarian Endometrioma." ClinicalTrials.gov.
	Screening ‐ History, Physical examination ‐ Vital signs ‐ Laboratory test (Serum AMH, CA‐125, HE‐4) / EKG / MRI ‐ EHP‐30 Intervention ‐ Surgical enucleation or catheter‐directed sclerotherapy ‐ Laboratory test / EKG ‐ Adverse event monitoring Follow‐up visit #1 (1 month) ‐ Vital signs ‐ Lab test (AMH, CA‐125) / Ultrasound ‐ Adverse event monitoring Follow‐up visit #2 (6 months) ‐ Vital signs ‐ Lab test (AMH, CA‐125) / Ultrasound / Contrast‐enhanced MRI ‐ EHP‐30 Follow‐up visit #3 (12months) ‐ Vital signs ‐ Lab test (AMH, CA‐125) / Ultrasound ‐ EHP‐30

Han Sileny, N., et al. (2023). "A randomized phase 2 study of sapanisertib in combination with paclitaxel versus paclitaxel alone in women with advanced, recurrent, or persistent endometrial cancer." Gynecologic Oncology 178: 110-118.
	Objective: This phase 2 study investigated sapanisertib (selective dual inhibitor of mTORC1/2) alone, or in combination with paclitaxel or TAK-117 (a selective small molecule inhibitor of PI3K), versus paclitaxel alone in advanced, recurrent, or persistent endometrial cancer.; Methods: Patients with histologic diagnosis of endometrial cancer (1-2 prior regimens) were randomized to 28-day cycles on four treatment arms: 1) weekly paclitaxel 80 mg/m 2 (days 1, 8, and 15); 2) weekly paclitaxel 80 mg/m 2 + oral sapanisertib 4 mg on days 2-4, 9-11, 16-18, and 23-25; 3) weekly sapanisertib 30 mg, or 4) sapanisertib 4 mg + TAK-117 200 mg on days 1-3, 8-10, 15-17, and 22-24.; Results: Of 241 patients randomized, 234 received treatment (paclitaxel, n = 87 [3 ongoing]; paclitaxel+sapanisertib, n = 86 [3 ongoing]; sapanisertib, n = 41; sapanisertib+TAK-117, n = 20). The sapanisertib and sapanisertib+TAK-117 arms were closed to enrollment after futility analyses. After a median follow-up of 14.4 (paclitaxel) versus 17.2 (paclitaxel+sapanisertib) months, median progression-free survival (PFS; primary endpoint) was 3.7 versus 5.6 months (hazard ratio [HR] 0.82; 95% confidence interval [CI] 0.58-1.15; p = 0.139); in patients with endometrioid histology (n = 116), median PFS was 3.3 versus 5.7 months (HR 0.66; 95% CI 0.43-1.03). Grade ≥ 3 treatment-emergent adverse event rates were 54.0% with paclitaxel versus 89.5% paclitaxel+sapanisertib.; Conclusions: Our findings support inclusion of chemotherapy combinations with investigational agents for advanced or metastatic disease. The primary endpoint was not met and toxicity was manageable.; Trial Registration: ClinicalTrials.gov number, NCT02725268.; Competing Interests: Declaration of Competing Interest Ana Oaknin reports receiving institutional funding from Abbvie Deutschland, Advaxis Inc., Aeterna Zentaris, Amgen, Aprea Therapeutics AB, Bristol Myers Squibb, Clovis Oncology, Eisai Co., Ltd., F. Hoffmann–La Roche Ltd., Immunogen Inc., Merck Sharp & Dohme de España SA, Millennium Pharmaceuticals Inc., PharmaMar SA, Regeneron Pharmaceuticals and Tesaro Inc.; personal fees for travel and/or accommodation from AstraZeneca, PharmaMar and Roche; personal fees for advisory board membership from Agenus, AstraZeneca, Clovis Oncology, Corcept Therapeutics, Deciphera Pharmaceuticals, Eisai Co., Ltd., EMD Serono, F. Hoffmann–La Roche Ltd., Genmab, GSK, ImmunoGen, Itheos, Merck Sharp & Dohme de España, SA, Mersana Therapeutics, Novocure, PharmaMar, Sattucklabs, Seagen, and Sutro Biopharma; membership for ASCO, GOG, and SEOM; a non-remunerated role (member and Cervix Cancer Chair on behalf of GEICO) for GCIG; and being an unpaid member, Officer, Co-Chair of the ESMO Gynaecological Cancers Congress 2023–2025, Chair of the Gynaecological Track ESMO 2019, Scientific Track Member Gynaecological Cancers ESMO 2018, ESMO 2020, and ESMO 2022, member of the Gynaecological Cancers Faculty, and Subject Editor for the Gynaecological Clinical Practice Guidelines. Francesco Raspagliesi has received payment or honoraria from GSK, MSD, and AstraZeneca as well as support for attending meetings and/or travel from GSK. Robert M. Wenham reports receiving personal and institutional fees from Merck and Ovation Diagnostics; institutional clinical trial fees from AstraZeneca, Abbvie, Regeneron, and Eisai Co., Ltd.; personal consulting fees from Merck, Legend Biotech, Novacure, Genentech, GSK/Tesaro, AstraZeneca, Abbvie, Ovation Diagnostics, Regeneron, Seagen, Shattuck Labs, Eisai Co., Ltd., and Immunogen; speakers fees from Clovis Oncology; support for attending meetings and/or travel as part of the consulting, board participation, or abstract preparation, not in isolation; travel fees from Sonnet Biotherapeutics and Eisai Co., Ltd.; personal/DSMB fees from Seagen and GSK/Tesaro; personal/scientific advisory board fees from Sonnet Biotherapeutics; and personal stock or stock options for Ovation Diagnostics. Elena Ioana Braicu reports receiving research funding from Bayer and Tesaro; er onal fees from Clovis Oncology, Tesaro, Eisai Co., Ltd., and RochePharma; and both research funding and personal fees from Roche Diagnostics, GSK, and AstraZeneca. Vicky Makker reports research funding (institution) from AstraZeneca, Bayer, Bristol Myers Squibb, Clovis Oncology, Duality, Eisai Co., Ltd., Faeth Therapeutics, Karyopharm Therapeutics, Lilly, MSD, Takeda, and Zymeworks; an unpaid consulting or advisory role for ArQule, AstraZeneca, Clovis Oncology, Duality, Eisai Co., Ltd., Faeth Therapeutics, GlaxoSmithKline, IBM, Immunocore, ITeos Therapeutics, Kartos Therapeutics, Karyopharm Therapeutics, Lilly, MSD, Moreo, Morphosys, Novartis, Takeda, and Zymeworks; support for travel, accommodations, and/or expenses from Eisai Co., Ltd. and MSD. Eva María Guerra Alía reports advisory/consultancy honorarium from AstraZeneca-MSD, Clovis Oncology, GSK-Tesaro, PharmaMar, and Roche; speaker bureau/expert testimony honorarium from AstraZeneca-MSD, PharmaMar, Roche, and GSK-Tesaro; and support for travel, accommodation, and/or expenses from Roche, GSK-Tesaro, and Baxter. Zhenqiang Su is an employee of Takeda. Sylvie Vincent is an employee of Takeda. Farhad Sedarati is an employee of Takeda. Douglas V. Faller reports consulting fees from Viracta Therapeutics, Briacell Therapeutics, and Molecular Partners; equity from Oryzon Genomics, Phoenicia Biosciences, Viracta Therapeutics, and Briacell Therapeutics; and employment at Oryzon Genomics, Phoenicia Biosciences, and Takeda Pharmaceuticals (ended in 2022). Sileny N. Han, Amit Oza, Nicoletta Colombo, Andrea Jewell, Jonathan Krell, Jean- François Baurain, Rachel Neuwirth, and Giovanni Scambia have no disclosures to report. (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Han, X., et al. (2022). "Efficacy and safety of electrical stimulation for stress urinary incontinence in women: a systematic review and meta-analysis [see note]." International Urogynecology Journal 33(4): 789-799.
	Introduction and hypothesis: This systematic review and meta-analysis was aimed at investigating the safety and short- and long-term efficacy of electrical stimulation (ES) in women with stress urinary incontinence (SUI). Method(s): PubMed, Embase, and the Cochrane database were searched for randomized controlled trials (RCTs) conducted up to 2020. Studies comparing ES with sham ES or no intervention were included. Standardized mean differences (SMDs), weighted mean differences (WMDs), relative risks (RR), and 95% confidence intervals (CIs) were calculated. Result(s): This study included 9 RCTs, involving a total of 982 patients, of whom 520 received ES. Our results showed that in the short term (< 3 months), compared with sham ES or no intervention, ES significantly improved incontinence-specific quality of life (IQOL) (p = 0.003; SMD = 0.90 [95% CI, 0.30 to 1.50]; I2 = 88%) and reduced urine leakage (p < 0.00001; WMD = -6.15 [95% CI, -8.29 to -4.01]; I2 = 0%) but did not significantly reduce the frequency of incontinence episodes (p = 0.34; WMD = -0.98 [95% CI, -2.99 to 1.04]; I2 = 85%). In the long term (3-7.5 months), ES significantly improved IQOL (p = 0.0009; SMD = 1.14 [95% CI, 0.47 to 1.81]; I2 = 91%) and reduced the frequency of incontinence episodes (p = 0.0009; WMD = -2.45 [95% CI, -3.90 to -1.01]; I2 = 79%) but did not significantly reduce urine leakage (p = 0.27; WMD = -9.21 [95% CI, -25.57 to 7.14]; I2 = 71%). There was no significant difference in adverse events between ES and sham ES or no intervention (p = 0.36; RR = 1.34 [95% CI, 0.72 to 2.50]; I2 = 0%). A test for subgroup differences showed that electroacupuncture (EA) improved long-term IQOL to a greater extent than vaginal ES (VES), whereas there was no significant difference in efficacy between EA and VES in short- or long-term reduction of urine leakage, frequency of incontinence episodes, or short-term IQOL improvement. Conclusion(s): ES may improve short- and long-term IQOL for women with SUI, but it appears to provide only short-term reduction in urine leakage and long-term reduction in frequency of incontinence episodes. However, we cannot draw any conclusion on the safety between ES and sham ES or no intervention because of the rarity of adverse events. It is still uncertain whether EA is comparable or superior to VES owing to an insufficient number of studies and patients. The conclusions should be considered carefully because of the limited quality and quantity of the RCTs included. Further rigorous RCTs with adequate sample sizes and long follow-up are necessary to fully validate our findings.Copyright © 2021, The International Urogynecological Association.

Han, Y., et al. (2023). "Effect of vitamin D supplementation on hormones and menstrual cycle regularization in polycystic ovary syndrome women: A systemic review and meta-analysis." The Journal of Obstetrics and Gynaecology Research 49(9): 2232-2244.
	Aim: Polycystic ovary syndrome (PCOS) is a prevalent endocrine disease among women of childbearing age. Women with PCOS frequently experience reproductive complications, which are closely associated with the concentration of vitamin D. This systemic review and meta-analysis were conducted to elucidate the possible effect of vitamin D supplementation in PCOS women on hormones, including Luteinizing hormone (LH), follicle-stimulating hormone (FSH), the ratio of LH and FSH (LH/FSH), and the menstrual cycle regularization.; Methods: We searched PubMed, Web of Science, Ovid MEDLINE, Cochrane Library, and EMBASE for the relevant articles published up to January 2022. The pooled estimates were calculated using RevMan 5.4 software.; Results: Twelve studies involving 849 PCOS patients were included. Our study indicated that vitamin D supplementation could reduce serum LH (standard mean difference [SMD]: -0.41; 95% confidence interval [CI]: -0.54, -0.28; p < 0.01). Subgroup analysis identified that the supplementation of vitamin D ≤4000 IU/day (SMD: -0.69; 95% CI: -1.15, -0.23; p < 0.01), treatment time ≤8 weeks (SMD: -0.61; 95% CI: -0.95, -0.26; p < 0.01), and vitamin D co-supplementation (SMD: -0.37; 95% CI: -0.65, -0.10; p < 0.01) were related to reduce serum LH level. In addition, vitamin D supplementation improved the regularity of menstrual cycle significantly (risk ratio [RR]: 1.35; 95% CI: 1.18, 1.54; p < 0.01). In stratified analysis, the significant effects only existed in dosage of vitamin D >4000 IU (RR: 1.62; 95% CI: 1.02, 2.57; p < 0.01), treatment time >8 weeks (RR: 1.41; 95% CI: 1.06, 1.87; p = 0.02) and vitamin D co-supplementation (RR: 1.18; 95% CI: 1.03, 1.35; p = 0.02). However, vitamin D might have no effects on serum FSH (SMD: -0.05; 95% CI: -0.42, 0.32; p = 0.79) and LH/FSH (SMD: -0.24; 95% CI: -0.55, 0.08; p = 0.14) in PCOS patients.; Conclusions: Evidence from the existing randomized controlled trials indicated that vitamin D supplementation might improve the LH level and the menstrual cycle regularization but did not have any effect on FSH and LH/FSH levels in PCOS patients. (© 2023 Japan Society of Obstetrics and Gynecology.)

Han, Y., et al. (2023). "The Effectiveness of progestin-primed ovarian stimulation (PPOS) on patients with Endometriosis underwent in vitro fertilization-embryo transfer (IVF/ICSI): A systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Han, Y., et al. (2019). "GLP-1 receptor agonists versus metformin in PCOS: a systematic review and meta-analysis." Reproductive Biomedicine Online 39(2): 332-342.
	This meta-analysis aimed to evaluate the efficacy and safety of glucagon-like peptide 1 (GLP-1) receptor agonists for women with polycystic ovary syndrome (PCOS) by comparing their effect with that of metformin. Electronic databases (PubMed, EMBASE, Cochrane Library, WanFang Database, CNKI) dating from their establishment to June 2018 were searched to find all randomized controlled trials (RCTs) reporting the efficacy of GLP-1 receptor agonists versus metformin for patients with PCOS. Therapeutic variables included menstrual cycle, sex hormone and clinical manifestations, glucose metabolism and other metabolic indexes. Eight RCTs among 462 related articles were included in the meta-analysis. Compared with metformin, GLP-1 receptor agonists were more effective in improving insulin sensitivity (standard mean difference [SMD] -0.40, 95% confidence interval [CI] -0.74 to -0.06, P = 0.02) and reducing body mass index (SMD -1.02, 95% CI -1.85 to -0.19, P = 0.02) and abdominal girth (SMD -0.45, 95% CI -0.89 to -0.00, P = 0.05). GLP-1 receptor agonists were associated with a higher incidence of nausea and headache than metformin, but there were no significant differences in other data. Therefore, compared with metformin, GLP-1 receptor agonists might be a good choice for obese patients with PCOS, especially those with insulin resistance. The available evidence is, however, inconclusive given its moderate to low quality. More high-quality research is needed to assess the efficacy of a GLP-1 receptor agonist on women with PCOS. (Copyright © 2019 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Han, Y., et al. (2021). "Non-pharmacological interventions for overweight/obese women with polycystic ovary syndrome on ovulation and pregnancy outcomes: a protocol for systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Han, Y., et al. (2021). "The dose-related efficacy and safety of acupuncture therapies in women with polycystic ovary syndrome undergoing in vitro fertilization and embryo transfer: a protocol for systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Hana, A., et al. (2021). "The effectiveness of combining Metformin with Oral contraceptive pills to treat Polycystic ovarian syndrome in adults and adolescents and their impact on inflammatory markers: Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Hanna, J., et al. (2024). "Efficacy of embolotherapy for the treatment of pelvic congestion syndrome: A systematic review." Irish Journal of Medical Science.
	Pelvic congestion syndrome (PCS) poses a significant health, diagnostic, and economic challenges. Transcatheter embolisation has emerged as a promising treatment for PCS. A systematic review was performed in order to assess the safety and efficacy of transcatheter embolisation in the treatment of PCS. A systematic search of electronic databases was performed using 'PubMed', 'Embase', 'Medline (OVID)', and 'Web of Science', for articles pertaining to efficacy of embolotherapy for the treatment of pelvic congestion syndrome. A total of 25 studies were included in this systematic review with a combined total of 2038 patients. All patients included were female with a mean average age of 37.65 (31-51). Of the 25 studies, 18/25 studies reported pre- and post-procedural pelvic pain outcomes using a visual analogue scale (VAS). All studies showed a reduction in VAS post-procedure. Transcatheter embolisation had a high technical success rate (94%) and an overall complication rate of 9.0%, of which 10.4% were major and 89.6% were minor. Fifteen out of 19 (78.9%) major complications required a subsequent intervention. Transcatheter embolisation using various techniques is effective and safe in treating PCS. A low quality of evidence limits the currently available literature; however, embolisation has shown to improve symptoms in the majority of patients with low complication rates and recurrence rates. (© 2024. The Author(s).)

Hansen, K. (2024). "The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System." ClinicalTrials.gov.
	No Results Available Device: May Health System Ovulation occurrence|Adverse event collection|Cumulative ovulation rate at 6 months without 1st-line|Cumulative ovulation rate at 6 months with 1st-line|Time to ovulation|Documented pregnancy|Hormone serum concentrations|Pain level after procedure|Performance of activities of daily living|Procedure times|Time to discharge|Post Anesthetic Discharge Scoring System (PADSS) Female Not Applicable 195 Industry Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CR003 May 2028

Hansen, K. E., et al. (2023). "Psychological interventions improve quality of life despite persistent pain in endometriosis: results of a 3-armed randomized controlled trial." Quality of Life Research 32(6): 1727-1744.
	Purpose: Despite standard medical treatment endometriosis is often associated with disabling pain and poor quality of life (QoL). Studies indicate that psychological interventions (PIs) may improve pain and QoL, yet studies on the effects of PIs for women with endometriosis are sparse and limited by low-quality study designs. Therefore, this study aimed, in a rigorous three-armed design, to evaluate the effect of PIs on chronic pelvic pain (CPP) and QoL in women with endometriosis.; Methods: This three-armed parallel, multi-center randomized controlled trial included fifty-eight endometriosis patients reporting severe CPP [≥ 5 for pain intensity measured on a 0-10-point numeric rating scale (NRS)]. Patients were randomly assigned to (1) Specific mindfulness- and acceptance-based psychological intervention (MY-ENDO), (2) Carefully matched non-specific psychological intervention (Non-specific), or (3) A wait-list control group (WL). The primary outcome was pelvic pain intensity/unpleasantness measured on NRS. Secondary outcomes included endometriosis-related quality of life, workability, pain acceptance, and endometriosis-related symptoms. Differences in outcomes between groups at post-treatment follow-up were analyzed using mixed linear models. Analyses were performed on an intention-to-treat basis.; Results: Compared to WL, psychological intervention (MY-ENDO + Non-specific) did not significantly reduce pain. However, psychological intervention did significantly improve the QoL-subscales 'control and powerlessness', 'emotional well-being', and 'social support' as well as the endometriosis-related symptoms 'dyschezia' and 'constipation'. MY-ENDO was not superior to Non-specific.; Conclusions: Women with endometriosis may have significant and large effects of psychological intervention on QoL despite an ongoing experience of severe CPP.; Trial Registration: 12 April 2016, clinicaltrials.gov (NCT02761382), retrospectively registered. (© 2023. The Author(s).)

Hansrani, V., et al. (2023). "Transvenous occlusion of incompetent pelvic veins to treat chronic pelvic pain in women: A randomised controlled trial." BJOG 130(11): 1362-1369.
	Objective: To investigate the effectiveness of transvenous occlusion of incompetent pelvic veins in women presenting with chronic pelvic pain (CPP) in improving symptoms and quality of life.; Design: Patient-blinded randomised controlled trial with objective outcome measures. Results were analysed on an intention-to-treat basis.; Setting: Gynaecology and Vascular Surgery Services of two teaching hospitals in northwest England.; Population: Sixty women aged 18-54 years presenting with CPP after exclusion of other pathology, and who were found to have pelvic vein incompetence.; Methods: Participants were randomised and assigned to contrast venography alone or contrast venography plus transvenous occlusion of the incompetent pelvic veins.; Main Outcome Measure: The primary outcome was change in pain score measured using the short-form McGill Pain Score (SF-MPQ) and the Visual Analogue Score (VAS) recorded at 12 months post-randomisation. Secondary outcomes included quality of life using the EQ-5D instrument, symptomatic improvement and procedure-related complications.; Results: Sixty participants were randomised to transvenous occlusion of incompetent pelvic veins or venography only. At 12 months, median pain scored 2 (3-10) in the intervention group versus 9 (5-22) in controls (p = 0.016). Pain on the VAS scored 15 (0-3) versus 53 (20-71), respectively (p = 0.002). Median EQ-5D improved after intervention from 0.79 (0.74-0.84) to 0.84 (0.79-1.00; p = 0.008) over 12 months. No major complications were reported.; Conclusion: Transvenous occlusion of pelvic vein incompetence reduced pain scores, improved quality of life and diminished symptom burden with no major reported complications.; Trial Registration: ISRCTN 15091500. (© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Hanzhi, Z., et al. (2023). "A comparison of the efficacy in the acupuncture-related therapies for disorders associated with ovarian insufficiency: a Bayesian network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Hao, J., et al. (2021). "Efficacy and safety of PARP inhibitors in the treatment of advanced ovarian cancer: An updated systematic review and meta-analysis of randomized controlled trials." Critical Reviews in Oncology/Hematology 157: 103145.
	Background: Poly-ADP-ribose polymerase (PARP) inhibitors have emerged as a novel class of therapeutics for ovarian cancer (OC); however, PARP inhibitors present a class effect adverse-event profile.; Methods: A comprehensive literature review was performed for phase II or III randomized controlled trials (RCTs) published up to and including January 2020. We analyzed relevant clinical trials reporting the efficacy and toxicity profile of PARP inhibitors in patients with advanced OC. We estimated hazard ratios (HRs), incidences, risk ratios (RRs) and relative 95 % confidence intervals (95 % CI) for progression-free survival (PFS) and selected adverse events, using Stata 12.0 software package.; Results: The systematic review process yielded 10 eligible trials comprising 4,241 patients with advanced OC for survival analysis and 4553 patients for evaluation of toxicity profile. The pooled HR (PARP inhibitor vs control group) for PFS was 0.41 (95 % CI, 0.35-0.50) in overall patients, 0.51 (95 % CI, 0.40-0.64) in unselected setting, 0.32 (95 % CI, 0.26-0.39) in BRCA mutation setting, and 0.57 (95 % CI, 0.41-0.78) in wild-type setting. Patients treated with PARP inhibitors exhibited higher risks of all-grade and high-grade haematological toxicities, including anemia, leucopenia, neutropenia, thrombocytopenia (P < 0.05), and also presented higher risks of all-grade gastrointestinal side effects, including constipation, diarrhea, nausea, and vomiting as well as high-grade nausea and vomiting (P < 0.05).; Conclusions: This study indicated that the use of PARP inhibitor provided substantial progression-free survival (PFS) benefits, irrespective of BRCA mutation status; however, treatment with PARP inhibitor was associated with increased risks of selected treatment-related adverse events. (Copyright © 2020 Elsevier B.V. All rights reserved.)

Hao, S., et al. (2022). "Comparative Efficacy of Different Interventions Alone or in Combination Administration on Clinical Outcomes in Women with Repeated Embryo Implantation Failure: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials." PROSPERO International prospective register of systematic reviews.
	
Hao, S.-L., et al. (2023). "Comparison of different drug for reducing testosterone levels in women with polycystic ovary syndrome: A systematic review and network meta-analysis." Medicine 102(41): e35152.
	Background: The optimal drug for treatment with polycystic ovary syndrome (PCOS) was in debate. We did this network meta-analysis to assess the efficacy and safety of different drugs for reducing testosterone levels in women with PCOS.; Methods: We searched studies from inception until January 10, 2023, through PubMed, Embase, and Cochrane Library database. All studies comparing different drugs for reducing testosterone levels in women with polycystic ovary syndrome were included in this network meta-analysis. Outcomes were total testosterone levels, free testosterone levels, and withdraw due to adverse events. We calculated the surface under the cumulative ranking curve (SUCRA) for each treatment.; Results: Finally, a total of 13 studies were finally included in this network meta-analysis. In head-to-head comparison, atorvastatin (WMD -3.1, 95% CrI: -3.7 to -2.5), metformin (WMD -2.6, 95% CrI: -3.5 to -1.6), metformin + simvastatin (WMD -2.8, 95% CrI: -4.1 to -1.5), simvastatin (WMD -2.7, 95% CrI: -4.2 to -1.3), spironolactone (WMD -3.1, 95% CrI: -4.3 to -1.9), spironolactone + metformin (WMD -3.2, 95% CrI: -4.5 to -2.0) were all more effective than the placebo, and the difference was statistically significant (P < .05). The SUCRA shows that spironolactone + metformin ranked first (SUCRA, 85.0%), Atorvastatin ranked second (SUCRA, 77.7%), Spironolactone ranked third (SUCRA, 77.2%), and metformin + simvastatin ranked the fourth. The SUCRA of different drugs for free testosterone levels shows that atorvastatin ranked first (SUCRA, 75.0%), spironolactone + metformin ranked second (SUCRA, 5.3%), metformin + simvastain ranked third (SUCRA, 62.6%), and spironolactone ranked the fourth (SUCRA, 56.4%). No statistically significant differences were found between the 2 treatment groups for withdrawn due to adverse events (P > .05).; Conclusions: Considering the network meta-analysis and rankings, atorvastatin was recommended to be the optimal drug for treatment PCOS. However, the optimal dose of atorvastatin was unknown and should be verified by more randomized controlled trials.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.)

Harada, T. and M. Momoeda (2021). "Efficacy of cyclic and extended regimens of ethinylestradiol 0.02 mg -levonorgestrel 0.09 mg for dysmenorrhea: A placebo-controlled, double-blind, randomized trial." Reproductive Medicine and Biology 20(2): 215-223.
	PURPOSE: We aimed to evaluate the efficacy and safety of 28-day Cyclic and 84-day Extended regimens of NPC-16 (ethinylestradiol 0.02 mg plus levonorgestrel 0.09 mg) in patients with dysmenorrhea. METHODS: This was a placebo-controlled, double-blind, randomized trial conducted in Japan. A total of 251 primary and secondary dysmenorrhea patients were randomly assigned to the NPC-16-Cyclic group, NPC-16-Extended group, or the Placebo group. The primary end point was a comparison of the efficacy and safety of the Cyclic and Extended NPC-16 regimen for the treatment of dysmenorrhea relative to the Placebo. MAIN FINDINGS: Significantly greater reductions in total dysmenorrhea score and visual analog scale score were observed in the Cyclic and Extended groups compared with the Placebo group. Compared with the Cyclic regimen as a secondary end point, the Extended regimen exhibited greater efficacy in the treatment of dysmenorrhea over the course of the study period, particularly in patients with severe dysmenorrhea. The incidence of adverse drug reactions (ADRs) was significantly higher in the Cyclic and Extended groups than in the Placebo group. CONCLUSION: The Cyclic and Extended regimens of NPC-16 significantly reduced dysmenorrhea severity compared to placebo. The Extended regimen was superior to cyclic regimen in reducing the dysmenorrhea.

Harada, T., et al. (2022). "Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain compared with leuprorelin in Japanese women: a phase 3, randomized, double-blind, noninferiority study." Fertility and Sterility 117(3): 583-592.
	Objective: To evaluate the efficacy and safety of 40-mg relugolix (REL) compared with those of leuprorelin (LEU) in women with endometriosis-associated pain.; Design: Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study in Japanese patients.; Setting: Hospitals and clinics.; Patient(s): Women aged ≥20 years with regular menstrual cycles (25-38 days) experiencing endometriosis or ovarian endometrioma and reporting pelvic pain.; Intervention(s): In the REL group, 40 mg of REL was orally administered once a day for 24 weeks. In the LEU group, 3.75 or 1.88 mg of LEU was subcutaneously injected every 4 weeks for 24 weeks.; Main Outcome Measure(s): The primary endpoint was the change in the maximum visual analog scale score for pelvic pain from baseline until 28 days before the end of treatment.; Result(s): Changes in the maximum visual analog scale score were -52.6 ± 1.3 for REL and -57.5 ± 1.4 for LEU. Ovarian endometrioma decreased by 12.26 ± 17.52 cm 3 for REL and 14.10 ± 18.81 cm 3 for LEU. Drug-related treatment emergent adverse events with an incidence of >10% for both groups were hot flush, metrorrhagia, headache, and genital hemorrhage. Discontinuations from treatment emergent adverse events were 2.9% for REL and 4.3% for LEU.; Conclusion(s): Relugolix was noninferior to LEU for treating endometriosis-associated pelvic pain. Safety profiles of both medications were comparable, although menses returned earlier in patients taking REL, a huge benefit for women who plan to conceive after treatment.; Clinical Trial Registration Number: ClinicalTrials.gov: NCT03931915. (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Haraldson, P., et al. (2022). "Botulinum Toxin A for Provoked Vestibulodynia: 12 Months' Follow-up of a Randomized Controlled Trial." The Journal of Sexual Medicine 19(11): 1670-1679.
	Background: Provoked vestibulodynia (PVD) is a common pain disorder afflicting primarily young women, and botulinum toxin A (BTA) has been to a limited extent tested as a treatment.; Aim: Evaluate outcome 12 months after injection with BTA as a treatment for PVD.; Methods: We conducted a double-blinded, placebo-controlled trial of twice repeated injections of 50 units of BTA or placebo in the bulbocavernosus muscles, 3 months apart, in women with PVD. Treatment outcome after six months', failed to show any significant difference in pain reduction between the groups, as previously reported. Here, we report treatment outcomes 12 months after the first injections. In addition to injections, participants where instructed to perform pelvic floor exercises during month 6-12. 38 participants/group was calculated to achieve a statistical power of 80% based on an effect size of 20 VAS units (mean score range 56-76±31 SD).; Outcomes: Primary outcome was self-reported dyspareunia or pain at tampon use, using a visual analogue scale (VAS) 0-100. Secondary outcomes were vaginal pressure measurements, psychological health, sexual function and distress.; Results: From the initial 88 randomized women with PVD, 75 remained at 12 months; 38 in the BTA and 37 in the placebo group. There was no significant difference in primary outcome between the groups. Vaginal pressure in the BTA group had been restored to pre-treatment levels, with no differences between the groups at 12 months. There was an increase in sexual function in the BTA group, with a Female Sexual Function Index of 22.8 (±4.8) compared to the placebo group to 19.7 (±5.0), P=.048. No differences were observed in sexual distress, stress and anxiety. There was an increase in number of women attempting intercourse in the BTA group (74%) compared with placebo (43%), P=.005. Too few patients performed the pelvic floor exercises for this intervention to be analyzed.; Clinical Implications: This study highlights BTA as a safe treatment option for patients with PVD.; Strengths and Limitations: The randomized, double-blinded design and repeated treatments are the major strengths of this study and it is the first study to objectively evaluate muscular effect after BTA injections. The major shortcoming is that few participants performed the pelvic floor exercises, preventing analyses.; Conclusion: At 12 months' follow up, no significant difference in reduction of dyspareunia or pain at tampon use was observed. Women receiving BTA attempted intercourse more often and improved their sexual function compared with women receiving placebo. Haraldson P, Mühlrad H, Heddini U, et al. Botulinum Toxin A for Provoked Vestibulodynia: 12 Months' Follow-up of a Randomized Controlled Trial. J Sex Med 2022;19:1670-1679. (Copyright © 2022 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Harter, P. (2021). "Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer." ClinicalTrials.gov.
	No Results Available Drug: Carboplatin|Drug: Pegylated liposomal doxorubicin (PLD)|Drug: Gemcitabine|Drug: Paclitaxel|Drug: Mirvetuximab Soravtansine Progression free survival (PFS) defined as the time from randomization to progressive disease (PD) or death, whichever occurs earlier. PD is based on investigator assess-ment using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).|OS|ORR|Efficacy regarding PFS|Efficacy regarding OS|Efficacy regarding ORR|Serological progressive disease|Time to first subsequent treatment (TFST)|Time to second subsequent treatment (TSST)|Patient-reported outcomes|Safety and tolerability Female Phase 2 136 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment AGO-OVAR 2.34|2018-004207-39 December 2026

Harter, P. (2021). "Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer." ClinicalTrials.gov.
	Eligible patients will be those patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III/IV, except FIGO stage IIIA2 without nodal involvement) invasive high grade epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer, who have either undergone upfront primary surgery or plan to undergo chemotherapy with interval debulking surgery (IDS). In addition, patients should not have any medical contraindications that would exclude treatment with bevacizumab and/or niraparib. All eligible patients will receive the first cycle of chemotherapy (carboplatin area under curve [AUC] 5 and paclitaxel 175 mg/m²) as part of Study Run‐In‐Period (cycle 1). In parallel, central laboratory will determine the breast cancer (BRCA) status in tumor tissue (tBRCA). All patients with a valid central tBRCA test result will be randomized prior to day 1 of cycle 2 in a 1:1 ratio in the following treatment arms: Arm 1: Patients will receive further 5 cycles of carboplatin and paclitaxel q21d followed by niraparib once daily for up to a total of 3 years Arm 2: Patients will receive further 5 cycles of carboplatin and paclitaxel plus bevacizumab q21d followed by bevacizumab q21d (for up to 1 year) and niraparib once daily for up to a total of 3 years. The study aims to investigate, if the treatment strategy of carboplatin / paclitaxel / bevacizumab / niraparib is superior to the treatment of carboplatin / paclitaxel / niraparib‐Inhibitor in an all‐comer population.

Harter, P., et al. (2022). "Efficacy of maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed, advanced ovarian cancer in the phase III PAOLA-1/ENGOT-ov25 trial." Gynecologic Oncology 164(2): 254-264.
	Objectives: Adding maintenance olaparib to bevacizumab provided a significant progression-free survival (PFS) benefit in patients with newly diagnosed, advanced ovarian cancer in the randomized, double-blind PAOLA-1/ENGOT-ov25 trial (NCT02477644). We analyzed PFS by clinical risk and biomarker status.; Methods: Patients received olaparib 300 mg twice daily for up to 24 months plus bevacizumab 15 mg/kg every 3 weeks for up to 15 months in total, or placebo plus bevacizumab. This post hoc exploratory analysis evaluated PFS in patients classified as higher risk (stage III with upfront surgery and residual disease or neoadjuvant chemotherapy; stage IV) or lower risk (stage III with upfront surgery and no residual disease), and by biomarker status.; Results: Of 806 randomized patients, 74% were higher risk and 26% were lower risk. After a median 22.9 months of follow-up, PFS favored olaparib plus bevacizumab versus placebo plus bevacizumab in higher-risk patients (hazard ratio [HR] 0.60; 95% confidence interval [CI] 0.49-0.74) and lower-risk patients (0.46; 0.30-0.72). Olaparib plus bevacizumab provided a substantial PFS benefit versus bevacizumab alone in the homologous recombination deficiency (HRD)-positive subgroup (higher risk: HR 0.39; 95% CI 0.28-0.54 and lower risk: 0.15; 0.07-0.30), with 24-month PFS rates in lower-risk patients of 90% versus 43%, respectively (Kaplan-Meier estimates).; Conclusions: In PAOLA-1, maintenance olaparib plus bevacizumab provided a substantial PFS benefit in HRD-positive patients with a reduction of risk of progression or death of 61% in the higher-risk group and of 85% in the lower-risk group compared with bevacizumab alone.; Competing Interests: Declaration of Competing Interest Philipp Harter reports grant support from AstraZeneca, Roche, GlaxoSmithKline, Boehringer Ingelheim, Medac, and Genmab; and consulting fees from Amgen, AstraZeneca, Roche, Tesaro, GlaxoSmithKline, Sotio, Zai Lab, Merck Sharp & Dohme, Clovis Oncology, and Immunogen. Marie Ange Mouret-Reynier has nothing to disclose. Sandro Pignata reports honoraria from AstraZeneca, Roche, Merck Sharp & Dohme, Pfizer, Tesaro, Clovis Oncology and PharmaMar. Claire Cropet has nothing to disclose. Antonio González-Martín reports grants from Roche and GSK (funding for ENGOT ov-41 trial and ANITA); consulting fees from Alkermes, Amgen, AstraZeneca, Clovis Oncology, GSK, Genmab, Mersana, Roche, Immunogen, MSD, Oncoinvent, PharmaMar, Sotio, and Takeda; honoraria from AstraZeneca, Clovis Oncology, GSK, Roche, and MSD; support for attending meetings and/or travel from AstraZeneca, GSK, Roche, MSD and PharmaMar; and being the Chairman of GEICO and Chairman of ENGOT (2018–2020). Gerhard Bogner reports advisory board fees from AstraZeneca and Roche. Keiichi Fujiwara reports consulting fees and grant support from Pfizer, Eisai, Merck Sharp & Dohme, Taiho, Zeria, Chugai Pharmaceutical, Genmab and Takeda Pharmaceutical Company, receiving grant support from Immunogen, Oncotherapy and Regeneron, and receiving consulting fees from Novartis, Kyowa Hakko Kirin, Daiichi Sankyo, Mochida Pharmaceutical and NanoCarrier. Ignace Vergote reports grant support from Amgen and Roche; research support from Oncoinvent AS and Genmab; consulting fees from Aksebio, Amgen (Europe) GmbH, AstraZeneca, Bristol Myers Squibb, Carrick Therapeutics, Clovis Oncology, Deciphera Pharmaceuticals, Eisai, Elevar Therapeutics, F. Hoffman-La Roche Ltd., Genmab, GSK, Immunogen Inc., Jazz Pharma, Karyopharm, Mersana, Millennium Pharmaceuticals, MSD, Novocure, Novartis, Octimet Oncology NV, Oncoinvent AZ, Seagen, Sotio a.s., Verastem Oncology, Zentalis; and support for attending meetings and travel from Amgen, AstraZeneca, MSD, Roche, Tesaro. Nicoletta Colombo reports research grants from AstraZeneca, PharmaMar and Roche; honoraria for lectures from AstraZeneca, Tesaro, Novartis, Clovis Oncology, Merck Sharp and Dohme, GlaxoSmithKline and Eisai; honoraria for advisory boards from Roche, PharmaMar, AstraZeneca, Clovis Oncology, Merck Sharp and Dohme, GlaxoSmithKline, T saro, Pfizer, BioCad, Immunogen, Mersana, Eisai and Oncxema; and is a Steering Committee member on ESMO clinical guidelines and a Scientific Committee Chair for Acto Onlus. Trine Jakobi Nøttrup has nothing to disclose. Anne Floquet reports support for attending meetings and travel from AstraZeneca, GSK and PharmaMar. Ahmed El-Balat reports an advisory role for Roche, Clovis Oncology and Tesaro; lecture honoraria from Roche, Astra Zeneca and Olympus; travel support from AstraZeneca, PharmaMar and Teva. Giovanni Scambia reports grants/research support from MSD Italia S.r.l.; consulting fees from Johnson & Johnson, and TESARO Bio Italy S.r.l; and speaker's bureau fees from Clovis Oncology Italy Srl and MSD Italia Srl. Eva Maria Guerra Alia reports consulting fees from Roche, Clovis Oncology, GSK-Tesaro, PharmaMar, AstraZeneca and MSD; travel support from Roche, Baxter and GSK-Tesaro; participation on a data safety monitoring board or advisory board for Roche, Clovis Oncology, GSK-Tesaro, PharmaMar, AstraZeneca and MSD. Michel Fabbro reports honoraria from Astra Zeneca and GSK. Barbara Schmalfeldt reports consulting fees from AstraZeneca, Roche and MSD; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, Roche, Tesaro, GSK, MSD, and Clovis Oncology; travel support from AstraZeneca and Roche; participation on a data safety monitoring board or advisory board for AstraZeneca, Roche, GSK, MSD; and leadership or fiduciary role for Deutsche Gesellschaft für Gynäkologie und Geburtshilfe. Anne-Claire Hardy-Bessard reports consulting and advisory board fees from AstraZeneca, Clovis Oncology, GSK, Novartis, Pfizer, Roche and Seagen. Ingo Runnebaum reports lecture and advisory board fees from AstraZeneca, Tesaro, Clovis Oncology, and GlaxoSmithKline. Eric Pujade-Lauraine reports lecture fees and speaker's bureau fees from AstraZeneca, GSK, Tesaro, and Roche; lecture fees from Clovis and Pfizer; expert testimony fees from AstraZeneca; travel support from AstraZeneca and GSK; participation on a data safety monitoring board or advisory board from AstraZeneca, Roche and Incyte; and is employed by ARCAGY Research. Isabelle Ray-Coquard reports honoraria (self) from Abbvie, Agenus, Advaxis, BMS, PharmaMar, Genmab, Pfizer, AstraZeneca, Roche, GSK, MSD, Deciphera, Mersena, Merck Sereno, Novartis, Amgen, Tesaro and Clovis; honoraria (institution) from GSK, MSD, Roche and BMS; advisory/consulting fees from Abbvie, Agenus, Advaxis, BMS, PharmaMar, Genmab, Pfizer, AstraZeneca, Roche/Genentech, GSK, MSD, Deciphera, Mersana, Merck Sereno, Novartis, Amgen, Tesaro and Clovis; research grant/funding (self) from MSD, Roche and BMS; research grant/funding (institution) from MSD, Roche, BMS, Novartis, Astra Zeneca and Merck Sereno; and travel support from Roche and AstraZeneca and GSK. (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Harter, P., et al. (2021). "Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer." The New England Journal of Medicine 385(23): 2123-2131.
	BACKGROUND: Treatment for patients with recurrent ovarian cancer has been mainly based on systemic therapy. The role of secondary cytoreductive surgery is unclear. METHODS: We randomly assigned patients with recurrent ovarian cancer who had a first relapse after a platinum-free interval (an interval during which no platinum-based chemotherapy was used) of 6 months or more to undergo secondary cytoreductive surgery and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Patients were eligible if they presented with a positive Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) score, defined as an Eastern Cooperative Oncology Group performance-status score of 0 (on a 5-point scale, with higher scores indicating greater disability), ascites of less than 500 ml, and complete resection at initial surgery. A positive AGO score is used to identify patients in whom a complete resection might be achieved. The primary end point was overall survival. We also assessed quality of life and prognostic factors for survival. RESULTS: A total of 407 patients underwent randomization: 206 were assigned to cytoreductive surgery and chemotherapy, and 201 to chemotherapy alone. A complete resection was achieved in 75.5% of the patients in the surgery group who underwent the procedure. The median overall survival was 53.7 months in the surgery group and 46.0 months in the no-surgery group (hazard ratio for death, 0.75; 95% confidence interval, 0.59 to 0.96; P = 0.02). Patients with a complete resection had the most favorable outcome, with a median overall survival of 61.9 months. A benefit from surgery was seen in all analyses in subgroups according to prognostic factors. Quality-of-life measures through 1 year of follow-up did not differ between the two groups, and we observed no perioperative mortality within 30 days after surgery. CONCLUSIONS: In women with recurrent ovarian cancer, cytoreductive surgery followed by chemotherapy resulted in longer overall survival than chemotherapy alone. (Funded by the AGO Study Group and others; DESKTOP III ClinicalTrials.gov number, NCT01166737.).

Harvie, H. S., et al. (2024). "Trial Design for Mixed Urinary Incontinence: Midurethral Sling Versus Botulinum Toxin A." Urogynecology.
	IMPORTANCE: Mixed urinary incontinence (MUI) is common and can be challenging to manage. OBJECTIVE(S): We present the protocol design and rationale of a trial comparing the efficacy of 2 procedures for the treatment of women with MUI refractory to oral treatment. The Midurethral sling versus Botulinum toxin A (MUSA) trial compares the efficacy of intradetrusor injection of 100 U of onabotulinimtoxinA (an office-based procedure directed at the urgency component) versus midurethral sling (MUS) placement (a surgical procedure directed at the stress component). STUDY DESIGN: The MUSA is a multicenter, randomized trial of women with MUI electing to undergo procedural treatment for MUI at 7 clinical centers in the NICHD Pelvic Floor Disorders Network. Participants are randomized to either onabotulinumtoxinA 100 U or MUS. OnabotulinimtoxinA recipients may receive an additional injection between 3 and 6 months. Participants may receive additional treatment (including crossover to the alternative study intervention) between 6 and 12 months. The primary outcome is change from baseline in Urogenital Distress Inventory (UDI) at 6 months. Secondary outcomes include change in UDI at 3 and 12 months, irritative and stress subscores of the UDI, urinary incontinence episodes, predictors of poor treatment response, quality of life and global impression outcomes, adverse events, use of additional treatments, and cost effectiveness. RESULT(S): Recruitment and randomization of 150 participants is complete and participants are currently in the follow-up phase. CONCLUSION(S): This trial will provide information to guide care for women with MUI refractory to oral treatment who seek surgical treatment with either onabotulinumtoxinA or MUS.Copyright © 2024 American Urogynecologic Society. All rights reserved.

Harvie, H. S., et al. (2021). "Cost-effectiveness of behavioral and pelvic floor muscle therapy combined with midurethral sling surgery vs surgery alone among women with mixed urinary incontinence: results of the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence randomized trial." American Journal of Obstetrics and Gynecology 225(6): 651.e651-651.e626.
	Background: Urinary incontinence is prevalent among women, and it has a substantial economic impact. Mixed urinary incontinence, with both stress and urgency urinary incontinence symptoms, has a greater adverse impact on quality of life and is more complex to treat than either stress or urgency urinary incontinence alone. Studies evaluating the cost-effectiveness of treating both the stress and urgency urinary incontinence components simultaneously are lacking. Objective(s): Cost-effectiveness was assessed between perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery and midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. The impact of baseline severe urgency urinary incontinence symptoms on cost-effectiveness was assessed. Study Design: This prospective economic evaluation was performed concurrently with the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence randomized trial that was conducted from October 2013 to April 2016. Participants included 480 women with moderate-to-severe stress and urgency urinary incontinence symptoms and at least 1 stress urinary incontinence episode and 1 urgency urinary incontinence episode on a 3-day bladder diary. The primary within-trial analysis was from the healthcare sector and societal perspectives, with a 1-year time horizon. Costs were in 2019 US dollars. Effectiveness was measured in quality-adjusted life-years and reductions in urinary incontinence episodes per day. Incremental cost-effectiveness ratios of combined treatment vs midurethral sling surgery alone were calculated, and cost-effectiveness acceptability curves were generated. Analysis was performed for the overall study population and subgroup of women with Urogenital Distress Inventory irritative scores of >=50th percentile. Result(s): The costs for combined treatment were higher than the cost for midurethral sling surgery alone from both the healthcare sector perspective ($5100 [95% confidence interval, $5000-$5190] vs $4470 [95% confidence interval, $4330-$4620]; P<.01) and the societal perspective ($9260 [95% confidence interval, $8590-$9940] vs $8090 [95% confidence interval, $7630-$8560]; P<.01). There was no difference between combined treatment and midurethral sling surgery alone in quality-adjusted life-years (0.87 [95% confidence interval, 0.86-0.89] vs 0.87 [95% confidence interval, 0.86-0.89]; P=.90) or mean reduction in urinary incontinence episodes per day (-4.76 [95% confidence interval, -4.51 to 5.00] vs -4.50 [95% confidence interval, -4.25 to 4.75]; P=.13). When evaluating the overall study population, from both the healthcare sector and societal perspectives, midurethral sling surgery alone was superior to combined treatment. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone is <=28% from the healthcare sector and <=19% from the societal perspectives for a willingness-to-pay value of <=$150,000 per quality-adjusted life-years. For women with baseline Urogenital Distress Inventory irritative scores of >=50th percentile, combined treatment was cost-effective compared with midurethral sling surgery alone from both the healthcare sector and societal perspectives. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone for this subgroup is >=90% from both the healthcare sector and societal perspectives, at a willingness-to-pay value of >=$150,000 per quality-adjusted life-years. Conclusion(s): Overall, perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery was not cost-effective compared with midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. However, combined treatment was of good value compared with midurethral sling surgery alone for women with baseline severe urgency urinary incontinence symptoms.Copyright © 2021 Elsevier Inc.

Hasan Kalyoncu, U. (2023). "Clinical Pilates and Aerobic Exercise in Menopause." ClinicalTrials.gov.
	Menopause is defined as the time in a woman's life when there is a decrease in ovarian function and permanent cessation of reproductive function. Identification of the healthcare needs of menopausal women requires special attention. During menopause, hormonal, physical and emotional changes occur as a result of decreased estrogen levels. Psychological, somatic and atrophic changes occur in the early stages of menopause and cardiovascular disease and osteoporosis during late menopause. Due to the complex nature of menopause, various approaches are employed in the treatment of menopausal symptoms. Hormone Replacement Therapy (HRT) is one of them. However, prolonged use of combined estrogen/progesterone therapy may increase the risk of breast cancer. Among the conservative treatment methods, exercise is the most reliable and effective approach. Exercise provides similar benefits as HRT. The effects of exercise may vary with the initiation and type of exercise and the individual level of adherence to exercise. During exercise, cardiovascular, respiratory and musculoskeletal systems work together. In the short‐term, regular exercise increases endurance, reduces stress and encourages better sleep patterns in a short period of time. In the longer term, exercise can reduce the risk of coronary artery disease (CAD), hypertension (HT) and type 2 diabetes. Various exercise approaches are employed including aerobic exercise, yoga, pilates and relaxation exercises. Mixed findings on the outcomes of exercise have been reported in published studies. In a study examining the effects of aerobic exercise, yoga and diet on vasomotor symptoms (VMS) in menopausal women, exercise and diet were found to have no effect, whereas yoga showed beneficial effects on VMS. 12‐week yoga and aerobic exercises were not effective in improving actigraphic sleep parameters in menopausal women with hot flashes. Contrastingly, a 6‐week walking exercise program was demonstrated to improve sleep quality of postmenopausal women. A study evaluating the effects of aerobic exercise on estrogen level, fat mass and muscle mass versus resistance exercises in postmenopausal women found that resistance exercises were more effective in improving these parameters. Usgu et al. reported that 8‐week aerobic walking exercises provided a reduction in somatic and psychological complaints, had no effect on urogenital symptoms but improved quality of life in premenopausal women. A meta‐analysis of randomized trials aiming to determine the impact of low‐to‐moderate‐intensity exercises on depressive symptoms in middle‐aged and older women found that both types of exercises were effective in alleviating depressive symptoms. Moderate‐intensity (VO2 max 60%) walking exercises practiced for 4 months showed greater effects on menopausal symptoms, physical activity, depression, satisfaction with life, self‐esteem and feelings of loneliness compared to control. On the other hand, Pilates is an exercise modality in which postural muscles are worked out with various body movements, and involves multi‐muscle synergies that improve spinal stabilization, flexibility and endurance. The biopsychosocial effects of Pilates in menopausal women have been shown in many studies. Positive effects of a 12‐week Pilates training on sleep quality, depression, fatigue and anxiety in postmenopausal women were previously demonstrated. An 8‐week Pilates training was found to reduce depression by improving quality of life in menopausal women. A systematic review of published studies on the efficacy of Pilates exercises in the rehabilitation of several conditions including postmenopausal osteoporosis concluded that Pilates can be prescribed for effective management of postmenopausal osteoporosis. In a meta‐analysis of the trials examining the effect of exercise on women with depression, Pilates training was shown to reduce depressive symptoms in postmenopausal women compared to control group in one study included in the analysis. In the same meta‐analysis involving 25 studi , aerobic exercise training was found to provide similar effects on depressive symptoms when compared with other exercise methods. To the best of our knowledge, there is no study in the literature that examined the effects of clinical Pilates training on vasomotor symptoms, quality of life, depression, and sleep problems versus aerobic exercises in menopausal women. This study aimed to investigate the effects of clinical Pilates training and aerobic exercises on menopausal symptoms, depression and quality of life and sleep quality in menopausal women.

Hasegawa, K. (2022). "NIRVANA-1." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Patients will be included after surgery and will be randomized after cycle 1 (carboplatin AUC 5‐6 + paclitaxel 175 mg/m2), using an Interactive Voice Response System / Interactive Web Response System (IWRS) in a 1:1 ratio to the treatments as specified below: ‐ Arm A: carboplatin AUC 5‐6 + paclitaxel 175 mg/m2 q3w, 5 cycles, followed by niraparib 200* or 300 mg/d for 2 years. ‐ Arm B: carboplatin AUC 5‐6 + paclitaxel 175 mg/m2 + bevacizumab 15 mg/kg q3w, 5 cycles, followed by bevacizumab 15 mg/kg q3w for 15 months + niraparib 200* or 300 mg/d for 2 years. * Patients < 77 kg and/or platelets < 150 G/l, as measured prior to dosing at D1 of the Maintenance Treatment Period, will receive niraparib 200 mg/d. CONDITION: ovarian cancer PRIMARY OUTCOME: Progression‐Free Survival rate at 24 months 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 BRCA1 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 carboplatin

Haydock, R., et al. (2022). "The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis." Trials 23(1): 1040.
	Background: Bacterial vaginosis (BV) is the most common cause of vaginal discharge in women of reproductive age, and it is estimated that up to a third of women will experience it at some point in their lives. BV produces an offensive vaginal odour and it is associated with serious sequelae. The most frequently prescribed treatment for BV in the UK is 7-day oral metronidazole but recurrences are common following it. Dequalinium chloride (Fluomizin©) is an anti-infective, antiseptic agent administered as a vaginal tablet. Small studies have shown this to be an effective alternative to antibiotics as a BV treatment. This trial aims to investigate whether dequalinium is as effective as current antibiotic treatments for the treatment of BV 1 month after treatment start.; Methods: DEVA is a multi-centre, randomised, open-label, parallel group, non-inferiority trial of dequalinium chloride versus usual care antibiotics for the treatment of BV. Recruitment will take place in 15 GUM clinics in the UK with Leeds Sexual Health also managing remote recruitment via the trial website. Women will be randomised 1:1 to receive dequalinium or usual care antibiotics. The primary outcome is to determine if the proportion of women reporting resolution of BV symptoms 4 weeks after treatment (without the need for additional treatment) is not worse in women treated with dequalinium chloride compared to usual care antibiotics. Questionnaire follow-up will take place 4 and 12 weeks after starting treatment, and remotely recruited patients will also provide a week 4 BV vaginal smear. The sample size is 904.; Discussion: This trial will provide high-quality evidence on the use of dequalinium chloride as a BV treatment, which could result in patients reducing the number of antibiotics they take.; Trial Registration: ISRCTN ISRCTN91800263. Prospectively registered on 20 January 2020. (© 2022. The Author(s).)

Hayes, S., et al. (2023). "Exercise during CHemotherapy for Ovarian cancer (ECHO) trial: design and implementation of a randomised controlled trial." BMJ Open 13(4): e067925.
	Introduction: Epidemiological evidence supports an association between higher levels of physical activity and improved cancer survival. Trial evidence is now needed to demonstrate the effect of exercise in a clinical setting. The E xercise during CH emotherapy for O varian cancer (ECHO) trial is a phase III, randomised controlled trial, designed to determine the effect of exercise on progression-free survival and physical well-being for patients receiving first-line chemotherapy for ovarian cancer.; Methods and Analysis: Participants (target sample size: n=500) include women with newly diagnosed primary ovarian cancer, scheduled to receive first-line chemotherapy. Consenting participants are randomly allocated (1:1) to either the exercise intervention (plus usual care) or usual care alone, with stratification for recruitment site, age, stage of disease and chemotherapy delivery (neoadjuvant vs adjuvant). The exercise intervention involves individualised exercise prescription with a weekly target of 150 minutes of moderate-intensity, mixed-mode exercise (equivalent to 450 metabolic equivalent minutes per week), delivered for the duration of first-line chemotherapy through weekly telephone sessions with a trial-trained exercise professional. The primary outcomes are progression-free survival and physical well-being. Secondary outcomes include overall survival, physical function, body composition, quality of life, fatigue, sleep, lymphoedema, anxiety, depression, chemotherapy completion rate, chemotherapy-related adverse events, physical activity levels and healthcare usage.; Ethics and Dissemination: Ethics approval for the ECHO trial (2019/ETH08923) was granted by the Sydney Local Health District Ethics Review Committee (Royal Prince Alfred Zone) on 21 November 2014. Subsequent approvals were granted for an additional 11 sites across Queensland, New South Wales, Victoria and the Australian Capital Territory. Findings from the ECHO trial are planned to be disseminated via peer-reviewed publications and international exercise and oncology conferences.; Trial Registration Number: Australian New Zealand Clinical Trial Registry (ANZCTRN12614001311640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367123&isReview=true).; 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.)

Hazel, A., et al. (2022). "Effectiveness of conservative treatments for endometriosis-associated pain: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
He, J., et al. (2024). "Efficacy of antioxidant supplementation in improving endocrine, hormonal, inflammatory, and metabolic statuses of PCOS: a meta-analysis and systematic review." Food & Function 15(4): 1779-1802.
	Background and aim: A large number of recent studies have reported on the use of antioxidants in patients with polycystic ovary syndrome (PCOS). This study aimed to evaluate the antioxidant effects on PCOS. Method(s): We searched PubMed, Embase, Web of Science, and The Cochrane Library to identify randomized controlled trials investigating the use of antioxidants in treating PCOS. Statistical analysis was performed using Review Manager 5.4. Stata17.0 software was used to conduct sensitivity analyses. Result(s): This meta-analysis included 49 articles and 62 studies. The sample comprised 1657 patients with PCOS from the antioxidant group and 1619 with PCOS from the placebo group. The meta-analysis revealed that the fasting blood glucose levels [standardized mean difference (SMD): -0.31, 95% confidence interval (CI): -0.39 to -0.22, P < 0.00001], the homeostatic model assessment of insulin resistance (SMD: -0.68, 95% CI: -0.87 to -0.50], P < 0.00001), and insulin levels (SMD: -0.68, 95% CI: -0.79 to -0.58, P < 0.00001) were significantly lower in patients with PCOS taking antioxidants than those in the placebo group. Further, total cholesterol levels (SMD: -0.38, 95% CI: -0.56 to -0.20, P < 0.001), low-density lipoprotein cholesterol levels (SMD: -0.24, 95% CI: -0.37 to -0.10, P = 0.0008), and very low-density lipoprotein levels (SMD: -0.53, 95% CI: -0.65 to -0.41, P < 0.00001) were lower in patients with PCOS taking antioxidant supplements compared with the placebo group. Total testosterone (TT) level (SMD: -0.78, 95% CI: -1.15 to -0.42, P < 0.0001), dehydroepiandrosterone level (SMD: -0.42, 95% CI: -0.58 to -0.25, P < 0.00001), and mean standard deviation modified Ferriman-Gallway (MF-G scores) (SMD: -0.63, 95% CI: -0.98 to -0.28, P = 0.0004) were lower in patients taking antioxidant supplements. C-reactive protein (CRP) levels (SMD: -0.48, 95% CI: -0.63 to -0.34, P < 0.000001), body mass index [mean difference (MD): -0.27, 95% CI: -0.50 to -0.03, P = 0.03], weight (MD: -0.73, 95% CI: -1.35 to -0.11, P = 0.02), and diastolic blood pressure (MD: -3.78, 95% CI: -6.30 to -1.26, P = 0.003) were significantly lower. Moreover, the levels of sex hormone-binding protein (SMD: 0.23, 95% CI: 0.07-0.38, P = 0.004), high-density lipoprotein cholesterol (SMD: 0.11, 95% CI: 0.01-0.20, P = 0.03), total antioxidant capacity (SMD: 0.59, 95% CI: 0.31-0.87, P < 0.0001), and quantitative insulin sensitivity index (SMD: 0.01, 95% CI: 0.01-0.02, P < 0.00001) were higher in patients with PCOS who took antioxidant supplements compared with the placebo group. Antioxidant supplements did not affect other analyzed parameters in these patients, including follicle-stimulating hormone, free androgen index, nitric oxide, glutathione, malondialdehyde, and diastolic blood pressure. Conclusion(s): Antioxidants are beneficial in treating PCOS. Our study might provide a new treatment strategy for patients with clinical PCOS. We hope that more high-quality studies evaluating the effects of antioxidants on patients with PCOS will be conducted in the future. Registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42023448088.

He, L., et al. (2022). "Hysteropreservation versus hysterectomy in uterine prolapse surgery: a systematic review and meta-analysis." International Urogynecology Journal 33(7): 1917-1925.
	Introduction and Hypothesis: Hysteropreservation and hysterectomy for uterine prolapse have been compared in several randomized controlled trials (RCTs), as the best treatment has not been definitively determined. This study aimed to summarize the available evidence in RCTs of hysteropreservation versus hysterectomy.; Methods: We performed electronic searches in the PubMed, Embase, Cochrane Library, and China National Knowledge Infrastructure databases for eligible RCTs from inception to June 2020. The relative risks (RRs) and weighted mean differences (WMDs) with corresponding 95% confidence intervals (CIs) were calculated for categorical and continuous variables using random-effects models.; Results: Twelve RCTs involving 1177 patients were selected for meta-analysis. There were no significant differences between hysteropreservation and hysterectomy for the incidences of recurrence (RR, 0.55; 95% CI, 0.26-1.19; P = 0.130) and reoperation (RR, 1.15; 95% CI, 0.56-2.37; P = 0.705). Moreover, neither hysteropreservation nor hysterectomy had any significant effect on the risk of constipation (RR, 0.72; 95% CI, 0.15-3.46; P = 0.681), voiding dysfunction (RR, 0.99; 95% CI, 0.54-1.84; P = 0.981), intraoperative bleeding (RR, 0.35; 95% CI, 0.05-2.26; P = 0.271), upper leg dullness (RR, 0.70; 95% CI, 0.15-3.17; P = 0.643), dyspareunia (RR, 1.47; 95% CI, 0.69-3.13; P = 0.317), and wound infection (RR, 1.38; 95% CI, 0.24-7.80; P = 0.714). Furthermore, hysteropreservation was associated with less intraoperative blood loss (WMD, -25.68; 95% CI, -44.39 to -6.96; P = 0.007), shorter duration of surgery (WMD, -11.30; 95% CI, -19.04 to -3.55; P = 0.004), and shorter duration of hospitalization (WMD, -0.63; 95% CI, -1.10 to -0.16; P = 0.009) compared with hysterectomy.; Conclusion: This study found that both hysteropreservation and hysterectomy have similar effects on recurrence and reoperation rates, while hysteropreservation was superior to hysterectomy in reducing intraoperative blood loss and shortening the duration of surgery and hospitalization. (© 2021. The International Urogynecological Association.)

He, L., et al. (2023). "The impact of physical activity intervention on perinatal depression: A systematic review and meta-analysis." Journal of Affective Disorders 321: 304-319.
	Background: No meta-analysis has analyzed the effect of physical activity level, period of physical activity intervention, and duration of intervention, on perinatal depression. This study was to evaluate the impact of physical activity intensity, dose, period, and duration on perinatal depression.; Methods: The literature was searched via the PubMed, Embase, Cochrane Library, and Web of Science databases. Weighted mean difference (WMD) or the risk ratio (RR) was used as the effect indicator, and the effect size was represented by the 95 % confidence interval (CI). Subgroup analysis based on the perinatal stage, physical activity intensity, physical activity equivalent, and intervention duration was performed.; Results: Totally, 35 studies including 5084 women were included. Physical activity could reduce the incidence and severity of depression in perinatal women. Among depressed women with prenatal depression, low-intensity physical activity, with metabolic equivalents (METs)-min/week being <450, was associated with lower levels of depression. In the general population, the risk of postpartum depression was lower in the physical activity group when the duration of intervention was ≥12 weeks, being II, III stage, and ≥450 METs-min/week. Both low and moderate-intensity physical activity were beneficial to an improved depression severity among depressed women with postpartum depression, and moderate exercise intervention could decrease the risk of postpartum depression in general pregnant women.; Limitations: Different types of physical activities may affect the effectiveness of interventions.; Conclusion: Our study indicated physical activity specifically targeted at pregnant women could reduce depression risk and severity.; 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.)

He, P., et al. (2021). "Systematic review and meta-analysis of the efficacy of tension-free vaginal tape on pelvic organ prolapse complicated by stress urinary incontinence." Annals of Palliative Medicine 10(12): 12589-12597.
	Background: Patients with pelvic organ prolapse combined with stress urinary incontinence (SUI) require pelvic floor repair and surgical treatment; however, there is currently no systematic evaluation of the treatment effect.; Methods: PubMed, Medline, Embase, Elsevier, The Cochrane Library, Web of science, and other databases were searched for randomized controlled trials (RCTs) published between January 2000 and December 2020 regarding tension-free vaginal tape (TVT) treatment of pelvic organ prolapse combined with SUI. Quality evaluation of the articles included in this study was conducted in accordance with the Cochrane Work Manual (5.3), and RevMan 5.3 software was used to conduct meta-analysis of the data extracted from literature meeting the requirements.; Results: A total of 10 articles were included, involving a total of 1,361 subjects, including 553 in the control group (a different surgical treatment) and 808 in the observation group (single TVT or TVT combined with pelvic floor repair). The bias evaluation results showed that all of the included literature was rated as level B, so there was no need for sensitivity analysis. The meta-analysis showed that the combined effect size of the clinical cure rate was {odds ratio (OR) [95% confidence interval (CI)]: 3.82 (1.39, 10.52); Z=2.59, P=0.010}, and the combined effect size of the clinical complication rate was [risk difference (RD) (95% CI): -0.09 (-0.16, -0.02); Z=2.38; P=0.02]. The results showed that the clinical cure rate of the observation group was significantly higher than that of the control group, while the clinical complication rate was significantly lower than that of the control group (P<0.05).; Discussion: TVT surgery or TVT combined with pelvic floor repair surgery can significantly improve the cure rate of patients with pelvic organ prolapse combined with SUI, and reduce the incidence of postoperative complications. Therefore, TVT is a suitable surgical method for the treatment of patients with pelvic organ prolapse combined with SUI.

He, Y., et al. (2023). "Comparative effectiveness and safety of 36 therapies or interventions for pregnancy outcomes with recurrent implantation failure: a systematic review and network meta-analysis." Journal of Assisted Reproduction and Genetics 40(10): 2343-2356.
	Purpose: To investigate the effectiveness and safety of 36 different therapies for recurrent implantation failure (RIF) patients.; Methods: We searched PubMed, Embase, the Cochrane Library (CENTRAL), Web of Science, and China National Knowledge Internet (CNKI) from inception to August 24, 2022, with language in both English and Chinese. Randomized controlled trials (RCTs) and observational studies that provided data with one of pregnancy outcomes on RIF patients were included in the network meta-analysis (NMA). The odds ratios (OR) and 95% credible interval (CrI) on pregnancy outcomes were summarized by NMA with a random-effects model. We also analyzed data from only RCTs and compared whether the optimal treatment is the same for different failed embryo transfer attempts.; Results: The total of 29,906 RIF patients from 154 clinical studies (74 RCTs and 80 non-RCTs) were included in the NMA. In terms of implantation rate (IR), growth hormone (GH) (OR: 3.32, 95% CrI: 1.95-5.67) is the best treatment in all included studies; IVIG+PBMC (5.84, 2.44-14.1) is the best for clinical pregnancy rate (CPR); hyaluronic acid (HA) (12.9, 2.37-112.0) for live birth rate (LBR); and aspirin combined with glucocorticoids (0.208, 0.0494-0.777) for miscarriage rate (MR). The two-dimensional graphs showed that GH could maximize IR and CPR simultaneously; HA and GH could simultaneously increase IR and LBR to a large extent; HA could maximize IR and minimize MR.; Conclusion: IVIG+PBMC, GH, and embryo medium enriched with HA could significantly improve pregnancy outcomes in patients with RIF. It appears that combination therapy is a potential administration strategy.; Trial Registration: This study has been registered on PROSPERO (CRD42022353423). (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

He, Y., et al. (2022). "Is gabapentin effective and safe in the treatment of chronic pelvic pain in women: a systematic review and meta-analysis." International Urogynecology Journal 33(5): 1071-1081.
	Introduction and Hypothesis: Chronic pelvic pain (CPP) affects 2.1-24% of women, causing physical and psychological damage to women around the world. Based on the efficacy of gabapentin in the treatment of chronic pain, we conducted this study to evaluate the efficacy and safety of gabapentin in reducing pain in women with CPP.; Methods: Systematic searches were performed in the electronic databases of PubMed, Embase, Web of Science, Scopus, Cochrane, and Clinicalkey databases. Studies focused on comparing the efficacy of gabapentin and placebo in the treatment of female CPP patients were included. RevMan 5.4 was used to analyze the results and risk of bias. Two investigators independently selected eligible studies and extracted related pain scores and side effects for meta-analysis.; Results: In total, 4 RCTs were enrolled in the meta-analysis, totaling 425 patients. Among patients receiving gabapentin, the average pain scores in 3 and 6 months were significantly lower than those in the placebo group(p < 0.00001). The results showed that there was no statistical difference between gabapentin and placebo in the reduction of pain scores from baseline(p = 0.41). The incidence of side effects in the gabapentin group was significantly higher than that in the placebo group (p < 0.00001).; Conclusion: This systematic review and meta-analysis demonstrated that for women with CPP, gabapentin was significantly different from placebo in average pain scores at 3 and 6 months. However, the two drugs did not differ in the reduction in pain scores from baseline. Gabapentin can bring more significant side effects, whether they are common side effects or serious side effects. (© 2021. The International Urogynecological Association.)

Healey, M. (2022). "I-PRP-FET Trial: intrauterine Platelet-Rich-Plasma Infusion Prior to Frozen Embryo Transfer in Women Undergoing In Vitro Fertilisation (IVF)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: All participants will undergo a transabdominal ultrasound performed to measure endometrial thickness 2‐3 days prior to the embryo transfer. This is a baseline measure for post‐intervention assessment of changes in endometrial thickness. Participants randomized to Platelet rich plasma (PRP) infusion will undergo venepuncture 2‐3 days prior to planned embryo transfer. The 10 ml whole blood sample taken will be prepared on site to yield autologous PRP. The sample will be centrifuged on a Scanfuge Maxi by Origio, first spin at 300g and second spin at 700g. An hour after the blood collection the participant will then have the PRP sample infused into the uterine cavity by a fertility specialist. This procedure will take approximately 10 minutes to complete and will be delivered only once, it will be assumed complete once the PRP injection is complete. There will not be a post procedure ultrasound. Administering the PRP solution: (1) The subject is placed in a lithotomy position (2) A speculum is inserted into the vagina and the cervix visualized (3) Any mucus or vaginal discharge is wiped from the cervix (4) A Cook catheter is gently inserted along the cervical canal and just beyond the internal os (5) A Cook catheter is then gently inserted into the uterine cavity and 0.5‐1.0 mL of the PRP solution is slowly injected over about 15‐30 seconds using minimal pressure. (6) The catheters and speculum are then removed. CONDITION: Recurrent embryo implantation failure;Infertility; ; Recurrent embryo implantation failure ; Infertility Reproductive Health and Childbirth ‐ Fertility including in vitro fertilisation PRIMARY OUTCOME: Chemical pregnancy – defined as a serum beta human chorionic gonadotrophin level >25 IU/L at 11 days post‐transfer[11 days post embryo transfer] Clinical pregnancy – defined as the presence of a gestational sac on transvaginal ultrasound (USS) at 7 weeks gestation[5 weeks following embryo transfer] SECONDARY OUTCOME: Live birth, defined as the birth of a live born neonate >20 weeks gestational age. This will be assessed via outcome data routinely collected by the IVF clinic for all patients available on their electronic record.[Delivery of pregnancy (within 40 weeks of embryo transfer)] The change in endometrial thickness on transabdominal ultrasound from 2 days prior to transfer to time of embryo transfer. [From 2 days prior to transfer to time of embryo transfer. ] The concentration of platelets in the autologous samples prepared for injection[Time of Platelet rich plasma preparation] INCLUSION CRITERIA: i. Women <40yo planned to undergo embryo transfer without pre‐implantation genetic testing (PGT) who have had 1 or more consecutive previously failed embryo transfers (negative pregnancy test) ii. Women of any age planning to undergo embryo transfer with PGT performed who have had 1 or more consecutive previously failed embryo transfers (negative pregnancy test)

Heba, A., et al. (2022). "Atosiban effect on pregnancy outcomes in women undergoing IVF or ICSI : A Systematic Review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Hegila da Silva, D., et al. (2023). "Efficacy of Non-Pharmacological Therapies in Chronic Pelvic Pain of Endometriosis: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Heitz, F., et al. (2023). "AGO-OVAR 28/ENGOT-ov57. Niraparib alone versus niraparib in combination with bevacizumab in patients with carboplatin-taxane-based chemotherapy in advanced ovarian cancer: a multicenter randomized phase III trial." International Journal of Gynecological Cancer 33(12): 1966-1969.
	Background: Phase III trial data have shown a significant benefit by the addition of a maintenance treatment with niraparib, irrespective of BRCA or HRD status, in patients with advanced high-grade ovarian cancers; and, a significant benefit of the combination of olaparib and bevacizumab compared with bevacizumab monotherapy in HRD positive patients. However, it is unclear whether a PARP inhibitor monotherapy is sufficient, or if the addition of bevacizumab is needed.; Primary Objectives: This trial will investigate if the treatment strategy of carboplatin/paclitaxel/bevacizumab/niraparib is superior to the treatment of carboplatin/paclitaxel/niraparib in an all-comer population.; Study Hypothesis: Adding bevacizumab to chemotherapy followed by niraparib maintenance improves progression-free survival in patients with newly diagnosed advanced ovarian cancer.; Trial Design: AGO-OVAR 28/ENGOT-ov57 is an international, multicenter, randomized, prospective phase III trial within the the European Network for Gynecological Oncological Trial (ENGOT), led by the Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) study group. All patients should have completed the first cycle of chemotherapy (carboplatin and paclitaxel) as part of the Study Run-In-Period. Prior to day 1 of cycle 2, patients with a valid central tumor BRCA (tBRCA) test result were randomized in a 1:1 ratio into either: Arm 1, to receive five additional cycles of carboplatin and paclitaxel q21d, followed by niraparib for up to 3 years; or Arm 2, to receive five additional cycles of carboplatin and paclitaxel plus bevacizumab q21d, followed by bevacizumab q21d (for up to 1 year), and niraparib for up to 3 years.; Major Inclusion/exclusion Criteria: The trial population is composed of adult patients with newly diagnosed, advanced high-grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer FIGO III/IV (except FIGO IIIA2 without nodal involvement). Patients who are scheduled for neoadjuvant chemotherapy and interval debulking surgery are also eligible for the trial.; Primary Endpoint: The primary endpoint is progression-free survival.; Sample Size: The study plans to recruit 970 patients (485 patients in each arm).; Estimated Dates for Completing Accrual and Presenting Results: The Last-Patient-In is expected to be enrolled in September 2024, with presentation of the primary endpoint in 2028.; Trial Registration: NCT05009082; EudraCT Number: 2021-001271-16.; Competing Interests: Competing interests: Grants or contracts from any entity is reported by PH (AstraZeneca, Roche, GSK, Genmab, Immunogen, Seagen, Clovis, and Novartis (all institutional)), by JS (Roche, MSD, GSK, Tesaro, AstraZeneca, MSD, Eisai, Merck, and Novocure), and by NC (Roche, GSK, and AstraZeneca). Consulting fees are reported by FH (NovoCure, PharmaMar, AstraZeneca, Roche, Tesaro, GSK, Clovis, and Amedes), by CM (MSD, Roche, GSK, Seagen, Novartis, and PharmaMar), by LG (GSK, MSD, AstraZeneca, PharmaMar, and Clovis Oncology), by BS (GSK, AstraZeneca, Roche Pharma, MSD, and Eisai), by AH (AstraZeneca, Celgen, GSK, LEO Pharma, MedConcept GmbH, Med update GmbH, Medicultus, Pfizer, Promedicis GmbH, Softconsult, Roche Pharma AG, and Streamedup!GmbH), by PH (AstraZeneca, Roche, GSK, Clovis, Immunogen, MSD, Miltenyi, Novartis, and Eisai), by JS (Immunogen, Incyte, GSK, AstraZeneca, Clovis, Novocure, MSD Eisai, and Merck), and by NC (AstraZeneca, Clovis Oncology, Eisai, GSK, Immunogen, Mersana, MSD/Merck, Nuvation Bio, Onxerna, Pfizer, Pieris, and Roche). Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events are reported by FH (NovoCure, PharmaMar, AstraZeneca, Roche, Tesaro, GSK, Clovis, and Amedes), by CM (GSK, AstraZeneca, and MSD), by BS (GSK, AstraZeneca, Roche, MSD, and Eisai), by PW (AstraZeneca, Roche, MSD, Eisai, Lilly, GSK, and Daiichi Sankyo), by NDG (Roche, AstraZeneca, Clovis Myriad, Novartis, GSK, and MSD), by PH (Amgen, AstraZeneca, GSK, Roche, Sotio, Stryker, Zai Lab, MSD, Clovis, Eisai, Mersana, and Ex cientia), by JS (Immunogen, Incyte, GSK, AstraZeneca, Clovis, Novocure, Bristol Myers Squibb, Eisai, and Novartis), and by NC (AstraZeneca, Novartis, Clovis Oncology, GSK, and MSD/Merck). Participation on a Data Safety Monitoring Board or Advisory Board is reported by CM (GSK and Karypharma), by BS (GSK, AstraZeneca, Roche, MSD, and Eisai), by JS (Immunogen, Incyte, GSK, AstraZeneca, Clovis, Novocure, Bristol Myers Squibb, MSD, Merck, Bayer, and PharmaMar), and by NC (AstraZeneca, Clovis Oncology, Eisai, GSK, Immunogen, Mersana, MSD/Merck, Nuvation Bio, Onxerna, Pfizer, Pieris, and Roche). Support for attending meetings and/or travel is reported by LG (GSK, MSD, AstraZeneca, and Clovis Oncology) by BS (GSK, AstraZeneca, and Roche) by NDG (AstraZeneca), by PW (Gilead, Novartis, Roche, MSD, AstraZeneca, Lilly, Eisai, Pfizer, GSK, and Daiichi Sankyo), by PH (AstraZeneca), and by JS (GSK, AstraZeneca, Roche, Novocure, Immunogen, Incyte, MSD, and Eisei). Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid is reported by BS (Deutsche Gesellschaft für Gynäkologie und Geburtshilfe), JS (ENGAGE, ESGO, ASCO, ESGO, GCIG, Deutsche Stiftung Eierstockkrebs). AGOJS reports receipt of equipment, materials, drugs, medical writing, gifts, or other services. Medical writing services by MSD. SH reports none; AR reports none; DC reports none; MGM reports none; PCS reports none; EH reports none; SP reports none. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Helali Aya, E., et al. (2022). "A comprehensive systematic review and network meta-analysis: the role of anti-angiogenic agents in advanced epithelial ovarian cancer." Scientific Reports 12(1): 3803.
	The efficacy of anti-angiogenic agents (AAAs) in epithelial ovarian cancer (EOC) remains unclear. Therefore, we conducted a systematic review and network meta-analysis (NMA) to synthesize evidence of their comparative effectiveness for improving overall survival (OS) among EOC patients. We searched six databases for randomized controlled trials (RCTs) from their inception to February 2021. We performed an NMA with hazard ratios (HRs) and 95%-confidence intervals (CIs) to evaluate comparative effectiveness among different AAAs in chemotherapy-naïve and recurrent EOC. P-score was used to provide an effectiveness hierarchy ranking. Sensitivity NMA was carried out by focusing on studies that reported high-risk chemotherapy-naïve, platinum-resistant, and platinum-sensitive EOC. The primary outcome was OS. We identified 23 RCTs that assessed the effectiveness of AAAs. In recurrent EOC, concurrent use of trebananib (10 mg/kg) with chemotherapy was likely to be the best option (P-score: 0.88, HR 1.67, 95% CI 0.94; 2.94). The NMA indicated that bevacizumab plus chemotherapy followed by maintenance bevacizumab (P-score: 0.99) and pazopanib combined with chemotherapy (P-score: 0.79) both had the highest probability of being the best intervention for improving OS in high-risk chemotherapy-naïve and platinum-resistant EOC, respectively. AAAs may not play a significant clinical role in non-high-risk chemotherapy-naïve and platinum-sensitive EOC. (© 2022. The Author(s).)

Hendrikse, C. S. E., et al. (2023). "The potential of RAS/RAF/MEK/ERK (MAPK) signaling pathway inhibitors in ovarian cancer: A systematic review and meta-analysis." Gynecologic Oncology 171: 83-94.
	Background: The RAS/RAF/MEK/ERK (MAPK) pathway plays a role in ovarian carcinogenesis. Low-grade serous ovarian carcinoma (LGSOC) frequently harbors activating MAPK mutations. MAPK inhibitors have been used in small subsets of ovarian carcinoma (OC) patients to control tumor growth. Therefore, we performed a meta-analysis to evaluate the effectiveness of MAPK inhibitors in OC patients. We aimed to determine the clinical benefit rate (CBR), the subgroup of MAPK inhibitors with the best CBR and overall response rate (ORR), and the most common adverse events.; Methods: We conducted a search in PubMed, Embase via Ovid, the Cochrane library and clinicaltrials.gov on studies evaluating the efficacy of single MAPK pathway inhibition with MAPK pathway inhibitors in OC patients. Our primary outcome included the CBR, defined by the proportion of patients with stable disease (SD), complete (CR) and partial response (PR). Secondary outcomes included the ORR (including PR and CR) and grade 3 and 4 adverse events. Meta-analysis was performed using a random-effects model.; Results: We included nine studies with a total of 319 OC patients, for which we determined a pooled CBR of 63% (95%-CI 39-84%, I 2 = 92%). Combined treatment with Raf- and MEK inhibitors in in BRAF v600 mutated LGSOC (n = 6) had the greatest efficacy with a CBR of 100% and ORR of 83%. MEK inhibitors had the best efficacy as a single agent. Subgroup analysis by tumor histology demonstrated a significantly higher CBR and ORR in patients with LGSOC, with a pooled CBR and ORR of 87% (95%-CI 81-92%, I 2 = 0%) and 27% (95%-CI 10-48%, I 2 = 77%) respectively. Adverse events of grade 3 or higher were reported frequently: 123 in 167 patients.; Conclusions: MEK inhibitors are the most promising single agents in (LGS)OC. However, dual MAPK pathway inhibition should be considered in patients with a BRAF v600 mutation, or non-mutated OC with depleted treatment options due indications of higher efficacy and tolerable toxicity profiles.; Competing Interests: Declaration of Competing Interest CSEH and PvdP are employed by the Catharina Hospital. The other authors declare no competing interests. (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Hengjie, C., et al. (2023). "Does acupuncture improves the response to ovarian rejuvenation in women with primary ovarian insufficiency (POI)?" PROSPERO International prospective register of systematic reviews.
	
Hengxiang, S. and M. Ke (2021). "Does adjuvant growth hormone improve IVF/ICSI outcomes for poor ovarian responsers?" PROSPERO International prospective register of systematic reviews.
	
Hengxiang, S. and M. Ke (2021). "The effect of endometrial receptivity analysis for patients with recurrent implantation failure." PROSPERO International prospective register of systematic reviews.
	
Hengxiang, S. and M. Ke (2021). "The effect of inositol supplementation for patients with polycystic ovary syndrome undergoing assisted reproductive techniques." PROSPERO International prospective register of systematic reviews.
	
Hengxiang, S. and M. Ke (2021). "The efficacy and safety of acupuncture to endometriosis-associated pelvic pain: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Hengxiang, S. and M. Ke (2021). "High intensity interval training on depressive and anxiety symptoms of patients with PCOS: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Hengxiang, S. and M. Ke (2021). "High intensity interval training on hormonal profile, metabolic parameters and body composition for patients with PCOS: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Hengxiang, S. and M. Ke (2021). "High intensity interval training on reproductive outcomes for patients with PCOS——a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Hengxiang, S. and M. Ke (2021). "Non-pharmaceutical therapies on the management of primary dysmenorrhea: a network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Henrique Graf, P., et al. (2022). "Gonadotropin-Releasing Hormone Receptor Antagonists with or without Hormonal Add-Back Therapy for Uterine Fibroids: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Henrique Graf, P. and B. Caroline Cristine Almeida (2023). "Progesterone for Women with Threatened Miscarriage: A Systematic Review and Network Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Henrique Graf, P. and B. Caroline Cristine Almeida (2023). "Safety and Efficacy of Clinical Treatment in Symptomatic Uterine Fibroids: A Systematic Review and Network Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Henrique Graf, P. and B. Caroline Cristine Almeida (2023). "Treatment of bacterial vaginosis during pregnancy to reduce miscarriage: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Henrique Graf, P., et al. (2022). "Treatment of Uterine Fibroids-Related Pain with Relugolix: a Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Hernandez-Zepeda, M. L., et al. (2023). "Ovarian preservation compared to oophorectomy in premenopausal women with early-stage, low-grade endometrial Cancer: A cost-effectiveness analysis." Gynecologic Oncology 173: 8-14.
	Objectives: Standard treatment for endometrial cancer is a hysterectomy, bilateral salpingo-oophorectomy, and lymph node assessment. In premenopausal women, removal of the ovaries may not be necessary and could increase the risk of all-cause mortality. We sought to estimate the outcomes, costs, and cost-effectiveness of oophorectomy versus ovarian preservation in premenopausal women with early-stage, low-grade endometrial cancer. Method(s): A decision-analytic model was designed using TreeAge software comparing oophorectomy to ovarian preservation in premenopausal women with early-stage, low-grade endometrial cancer. We used a theoretical cohort of 10,600 women to represent our population of interest in the United States in 2021. Outcomes included cancer recurrences, ovarian cancer diagnoses, deaths, rates of vaginal atrophy, costs, and quality-adjusted life years (QALYs). The cost-effectiveness threshold was set at $100,000/QALY. Model inputs were derived from the literature. Sensitivity analyses were conducted to evaluate the robustness of the results. Result(s): Oophorectomy resulted in more deaths and higher rates of vaginal atrophy, while ovarian preservation resulted in 100 cases of ovarian cancer. Ovarian preservation resulted in lower costs and higher QALYs making it cost effective when compared to oophorectomy. Sensitivity analyses demonstrated the probability of cancer recurrence after ovarian preservation and probability of developing ovarian cancer were the most impactful variables in our model. Conclusion(s): Ovarian preservation is cost-effective in premenopausal women with early-stage, low-grade endometrial cancer when compared to oophorectomy. Ovarian preservation may prevent surgical menopause, which may improve quality of life and overall mortality without compromising oncologic outcomes, and should be strongly considered in premenopausal women with early stage disease.Copyright © 2023 Elsevier Inc.

Herzog Thomas, J., et al. (2023). "ARTISTRY-7: phase III trial of nemvaleukin alfa plus pembrolizumab vs chemotherapy for platinum-resistant ovarian cancer." Future Oncology 19(23): 1577-1591.
	Standard single-agent nonplatinum chemotherapy provides only modest benefit in a small proportion of patients with platinum-resistant/-refractory ovarian cancer, with objective response rates of 6-20% and progression-free survival of ≈3-4 months. Nemvaleukin alfa (nemvaleukin, ALKS 4230) is a novel cytokine designed to capture and expand the therapeutic potential of high-dose interleukin-2 (IL-2) while mitigating its associated toxicity issues. Nemvaleukin preferentially activates cytotoxic CD8 + T cells and natural killer cells with minimal, non-dose-dependent effects on CD4 + regulatory T cells. The global, randomized, open-label, phase III ARTISTRY-7 trial will compare efficacy and safety of nemvaleukin plus pembrolizumab with chemotherapy in patients with platinum-resistant ovarian cancer. The primary end point is investigator-assessed progression-free survival. Clinical Trial Registration : GOG-3063; ENGOT-OV68; NCT05092360 (ClinicalTrials.gov).

Herzog Thomas, J., et al. (2023). "Randomized phase II trial of farletuzumab plus chemotherapy versus placebo plus chemotherapy in low CA-125 platinum-sensitive ovarian cancer." Gynecologic Oncology 170: 300-308.
	Objective: The primary purpose of this study was to determine if farletuzumab, an antifolate receptor-α monoclonal antibody, improved progression-free survival (PFS) versus placebo when added to standard chemotherapy regimens in patients with platinum-sensitive recurrent ovarian cancer (OC) in first relapse (platinum-free interval: 6-36 months) with low cancer antigen 125 (CA-125) levels.; Methods: Eligibility included CA-125 ≤ 3 x upper limit of normal (ULN, 105 U/mL), high-grade serous, platinum-sensitive recurrent OC, previous treatment with debulking surgery, and first-line platinum-based chemotherapy with 1st recurrence between 6 and 36 months since frontline platinum-based treatment. Patients received investigator's choice of either carboplatin (CARBO)/paclitaxel (PTX) every 3 weeks or CARBO/pegylated liposomal doxorubicin (PLD) every 4 weeks x6 cycles in combination with either farletuzumab [5 mg/kg weekly] or placebo randomized in a 2:1 ratio. Maintenance treatment with farletuzumab (5 mg/kg weekly) or placebo was given until disease progression or intolerance.; Results: 214 patients were randomly assigned to farletuzumab+chemotherapy (142 patients) versus placebo+chemotherapy (72 patients). The primary efficacy endpoint, PFS, was not significantly different between treatment groups (1-sided α = 0.10; p-value = 0.25; hazard ratio [HR] = 0.89, 80% confidence interval [CI]: 0.71, 1.11), a median of 11.7 months (95% CI: 10.2, 13.6) versus 10.8 months (95% CI: 9.5, 13.2) for farletuzumab+chemotherapy and placebo+chemotherapy, respectively. No new safety concerns were identified with the combination of farletuzumab+chemotherapy.; Conclusions: Adding farletuzumab to standard chemotherapy does not improve PFS in patients with OC who were platinum-sensitive in first relapse with low CA-125 levels. Folate receptor-α expression was not measured in this study. (Clinical Trial Registry NCT02289950).; Competing Interests: Declaration of Competing Interest TH reports medical writing support; consulting fees from Astra Zeneca (AZ), Caris, Clovis, Genentech, Gradalis, Epsilogen, Merck (MSD), Eisai, Seagen; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AZ, Clovis, GlaxoSmithKline (GSK); participation on a Data Safety Monitoring Board or Advisory Board from Incyte, Corcept; Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid as Treasurer GOG Foundation and Associate Director GOG-P. SP reports no conflicts of interest. SG reports payments for clinical trial conduct from Eisai; grants or contracts for clinical trial conduct from GSK, Merck, Mersana, Jounce, AZ, Seagen, Clovis; consulting fees from Seagen; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Eisai and GSK; Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid as GOG foundation, GASCO, National Cancer Institute Cervix committee. MR reports no conflicts of interest. KF reports grants and contracts from Eisai; consulting fees from Eisai. CV reports medical writing support from Eisai; consulting fees from Janssen-Cilag, Roche, GSK, Atheneum Partners, Astellas Pharma, MSD, Bristol Myers Squibb (BMS), Leo-Pharma; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Janssens Cilag, Leo Pharma, Bayer; support for attending meetings and/or travel from Roche and Pfizer. DA reports clinical trial support from Eisai. JS reports consulting fees from Eisai, Roche, Novocure, AZ, GSK, Tesaro, Pfizer, MSD, Merck, Clovis; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Eisai, Roche, Novocure, AZ, GSK, Tesaro, Pfizer, MSD, Merck; payment for expert testimony from Eisai, Roche, Novocure, AZ, GSK, Tesaro, Pfizer, MSD, Merck; support for attending meetings and/or travel from GSK, Roche, AZ; participation on a Data Safety Monitoring Board Advisory Board from Eisai, Roche, Novocure, AZ, GSK, Tesaro, Pfizer, MSD, Merck, Clovis; Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid as ESGO council, NOGGO council, AGO Executive Board, GCIG member; RC reports grants or contracts from AZ, Clovis, Genelux, Genmab, Merck, Immunogen Janssen, Roche/Genentech; consulting fees from Agenus, Alkermes, AZ, Clovis, Deciphera, Genelux, Genmab, GSK, Immunogen, Janssen, OncoQuest, Onxeo, Onxerna, Regeneron, Roche/Genentech, Novocure, Merck, Abbvie; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AZ, Clovis, Roche/Genentech, Merck; participation on a Data Safety Monitoring Board or Advisory Board from VBL Therapeutics. HG reports no conflicts of interest. GS reports grants or contracts from MSD Italia; consulting fees from Tesaro Bio Italy srl, Johnson and Johnson; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Clovis Oncology Italy srl. BM reports consulting fees from Acrivon, Adaptimune, Agenus, Akeso Bio, Amgen, Aravive, AZ, Bayer, Clovis, Eisai, Elevar, EMD Merck, Genmab/Seagen, GOG Foundation, Gradalis, Heng Rui, ImmunoGen, Karyopharm, Lovance, Laekna, Macrogenics, Merck, Mersana, Myriad, Novartis, Novocure, OncoC4, Panavance, Pieris, Pfizer, Puma, Regeneron, Roche/Genentech, Sorrento, Tesaro/GSK, US Oncology Research, VBL, Verastem, Zentalis; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AZ, Clovis, Eisai, Merck, Myriad, Roche/Genentech, Tesaro/GSK. JA reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from BMS, Merck, Astellas, Eisai, Ipsen, Pfizer; support for attending meetngs and/or travel from Ipsen. KU reports grants or contracts from Eisai. RH reports grants or contracts from AZ, Clovis, GSK; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AZ, Clovis, GSK; multiple cases for medicolegal expert witness; participation on a Data Safety Monitoring Board or Advisory Board from AZ, Clovis, GSK. CZ reports grants or contracts from Novartis; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Roche, Novartis, Pfizer, Lilly, AstraZeneca, MSD, Eisai, GSK; support for attending meetings or travel from Roche, Novartis, Pfizer, Lilly, AstraZeneca, MSD, Eisai, GSK, ExactSciences, Clovis; participation on a Data Safety Monitoring Board or Advisory Board from Roche, Novartis, Pfizer, Lilly, AstraZeneca, MSD, Eisai, GSK, DaichiSankyo. RW reports support for medical writing from Eisai; grants or contracts from OnTarget Labs, Merck, Anixa Bioscience; consulting fees from Novocure, Mersana, AZ, Ovation Diagnostics, Sonnet Biotherapeutics, Shattuck Labs, Clovis, Abbvie, Tesaro/GSK, Seagen, Genentech, Merck, Regeneron, Legend Biotech, Eisai; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AZ and GSK; support for attending meetngs and/or travel from Sonnet Biotherapeutics and Tapimmune; participation on a Data Safety Monitoring Board or Advisory Board from Tesaro, Seagen; stock or stock options from Ovation Diagnostics; AG reports grants or contracts from Roche and Tesaro/GSK; consulting fees from AZ, Genmab, MSD, Oncoinvent, PharmaMar, SOTIO, Clovis, Immunogen, Amgen Merck/Pfizer, Roche, GSK/Tesaro; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Roche, Tesaro/GSK, Clovis, Immunogen, Pfizer, Amgen, SOTIO, Marcrogenics, AZ, MSD, Genmab, Oncoinvent, EMD Serono, Mersana, SUTRO, PharmaMar; support for attending meetngs and/or travel from Roche, PharmaMar, AZ, Tesaro/GSK; BS reports consulting fees from AZ, Clovis, GSK, Merck, Eisai, Lilly, Novartis, Immunogen, Seagen, Genmab, Genentech; YJ reports employment from Eisai; LR re rts employment from Eisai. KT reports support for the manuscript from Eisai; consulting fees from Merck, GSK, Clovis, AZ, Regeneron, Eisai, Seagen; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Merck, GSK, Clovis, AZ, Regeneron, Eisai, Seagen; participation on a Data Safety Monitoring Board or Advisory Board from Lovance. SW reports employment from Eisai. IV reports grants or contracts from Oncoinvent, AS, Amgen, Roche; consulting fees from Agenus, Akesobio, AZ BMS, Deciphera Pharmaceuticals, Eisai, Elevar Therapeutics, Exelixis, F. Hoffmann-La Roche, Genmab, GSK, Immunogen, Jazzpharma, Karyopharm, Mersana, MSD, Novocure, Novartis, Oncoinvent, OncXerna, Regeneron, Sanofi, Seagen, Sotio, Verastem Oncology, Zentalis; support for attending meetngs and/or travel from Karyopharm, Genmab, Novocure. (Copyright © 2023. Published by Elsevier Inc.)

Heshmati, J., et al. (2021). "The effect of cinnamon supplementation on glycemic control in women with polycystic ovary syndrome: A systematic review and meta-analysis." Journal of Food Biochemistry 45(1): e13543.
	Several clinical trials have identified glycemic-lowering effects of cinnamon, while other studies have reported conflicting findings. A comprehensive systematic search on Embase, PubMed, Scopus, Web of Science, and Cochrane Library was conducted using defined keywords in any language through June 2020. Studies that compared the effect of cinnamon with placebo on insulin resistance (IR) indices, as the primary outcome, in women with polycystic ovary syndrome (PCOS) were considered eligible. Standard Mean difference (SMD) (with 95% confidence intervals) for endpoints were calculated using the random-effects model. Finally, five RCTs which met the criteria were included in the meta-analysis. After pooling data, cinnamon supplementation significantly reduced homeostatic model assessment for insulin resistance (HOMA-IR) scores in women with PCOS (SMD: -0.84, 95% CI: -1.52, -0.16, p = .010). Cinnamon supplementation likely improves certain IR markers in patients with PCOS. PRACTICAL APPLICATIONS: There are controversies reports for cinnamon intake, which animal models have suggested that it decreases IR via promotion of insulin action, stimulating insulin signaling pathways, and enhancing insulin sensitivity. This study provides comprehensive information about the effect of cinnamon on insulin resistance (IR) indices in women with PCOS. In this regard, our results indicated that cinnamon supplementation significantly reduced homeostatic model assessment for insulin resistance (HOMA-IR) scores in women with PCOS. Therefore, consumption of cinnamon can be safe and this can be a useful recommendation for improving IR and promotion of healthy life which indeed are the potential or actual uses of this research. (© 2020 Wiley Periodicals LLC.)

Hess Engström, A., et al. (2023). "Health economic evaluation of a randomized controlled trial (EMBLA study), an internet-based treatment for provoked vulvodynia." Scientific Reports 13(1): 6242.
	Internet-based treatment (IBT) for provoked vulvodynia (PVD) may reduce pain during intercourse and increases pain acceptance. However, a there is still a knowledge gap regarding the cost-effectiveness of IBT for PVD. The aim of this study was to perform a health economic evaluation of guided internet-based intervention for PVD as an addition to standard treatment. The sample consisted of 99 women with a PVD diagnosis. Healthcare related costs, health-related quality of life, and quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio (ICER) were analyzed. After the IBT, the intervention group had fewer visits to a midwife than the control group (p=0.03), but no between-group differences were found for visits to other professionals, treatment length, health-related quality of life, QALYs, and costs for treatment. It was estimated a cost of 260.77 for a clinical meaningful change in pain acceptance. Internet-based treatment as add-on to clinical treatment may lower number of visits to a healthcare.Copyright © 2023. The Author(s).

Hess Engström, A., et al. (2022). "Internet-based Treatment for Vulvodynia (EMBLA) - A Randomized Controlled Study." The Journal of Sexual Medicine 19(2): 319-330.
	Background: Internet-based ACT (Acceptance and commitment therapy) treatment may improve accessibility and reduce stigma related to seeking health care, but there are a lack of studies investigating internet-based treatment using ACT principles for women with vulvodynia.; Aim: The aim of this study was to investigate the effects of an internet-based treatment of pain during intercourse for women with provoked vulvodynia compared with no intervention during the waiting period before clinical treatment.; Methods: A multicenter randomized controlled trial was conducted during 2016 to 2020, in which 99 participants were included. Participants were randomized to either a 6 week guided internet-based treatment using ACT principles or usual care. Data were collected at baseline, 6 weeks after baseline, and approximately 10 months after baseline.; Outcomes: Pain-related (pain during intercourse, tampon test, impact of pain on sexual function) and pain behavior-related outcomes (attempts at intercourse, sexual activities besides intercourse, willingness to perform the tampon test, chronic pain acceptance questionnaire) were used as outcomes.; Results: Treatment was efficacious in what concerns pain during intercourse and pain acceptance. Less pain during intercourse among women in the intervention group was observed at both post-treatment (primary endpoint, P = .01, Cohen's d = 1.4, 95% CI = 0.33, 2.4), and follow-up (P = .04). Absolut mean difference between groups for pain during intercourse at post-treatment was -2.84, (95 % CI = -4.91, -0.78), and -1.58 at follow-up, (95 % CI = -3.17, 0.02), where the intervention group rated less pain than controls. No differences between groups over time were found for tampon test measures or impact of pain on sexual function. There was a significant difference between groups at all timepoints indicating fewer attempts at intercourse among participants in the intervention group. At post-treatment, women who underwent internet-based treatment reported higher pain acceptance and a rise in activity engagement compared with the control group.; Clinical Implications: There is an indication that internet-based treatment could be incorporated into clinical practice as a complement to clinical treatment.; Strengths & Limitations: Study strengths included using several forms of recruitment and an intervention built by different professions with long experience of treating patients with vulvodynia. High dropout rate was a limitation of this study.; Conclusion: Internet-based treatment may have an impact on pain during intercourse and positive effects on pain acceptance. However, conclusions must be drawn with caution due to the small sample size. Engström AH, Bohm-Starke N, Kullinger M, et al. Internet-based Treatment for Vulvodynia (EMBLA) - A Randomized Controlled Study. J Sex Med 2022;19:319-330. (Copyright © 2021 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Heudel, P., et al. (2022). "Safety and Efficacy of the mTOR Inhibitor, Vistusertib, Combined With Anastrozole in Patients With Hormone Receptor-Positive Recurrent or Metastatic Endometrial Cancer: The VICTORIA Multicenter, Open-label, Phase 1/2 Randomized Clinical Trial." JAMA Oncology 8(7): 1001-1009.
	Importance: Endometrial cancer is often hormone-dependent and treated with aromatase inhibitors. The PI3K-AKT-mTOR pathway deregulation observed in endometrial cancer drives hormonal resistance, thus supporting the rationale of combining mTOR inhibitor with endocrine therapy.; Objective: To evaluate the safety and efficacy of vistusertib in combination with anastrozole in the treatment of women with hormone receptor-positive recurrent or metastatic endometrial cancer.; Design, Settings, and Participants: The VICTORIA study was a multicenter, open-label, randomized clinical trial that accrued 75 patients with hormone receptor-positive recurrent or metastatic endometrial cancer from 12 cancer centers in France in April 2016 to October 2019. After a safety run-in period, a Simon 2-stage design was used. Data analyses were performed from December 11, 2020, to March 11, 2021.; Interventions: Patients were randomized in a 2:1 ratio to oral vistusertib (125 mg twice daily 2 days per week) and oral anastrozole (1 mg daily) in the combination vistusertib with anastrozole arm (V+A arm) or oral anastrozole alone (A arm).; Main Outcomes and Measures: The primary end point was serious adverse events for the safety run-in period and progression-free rate at 8 weeks (8wk-PFR)-assessed with a blinded independent central review in phase 2. The secondary end points were objective response rate, duration of response, progression-free survival (PFS), overall survival, and incidence of adverse events.; Results: Of the 75 patients who were randomized, 73 (median [range] age, 69.5 [37-88] y; all female) were treated: V+A arm, 49 patients; A arm, 24 patients. In the V+A arm, the 8wk-PFR was 67.3% (unilateral 95% CI, 54.7%) and in the A arm, 39.1% (unilateral 95% CI, 22.2%). No significant serious adverse events were reported during the safety run-in period (n = 6 in V+A arm). The overall response rate was 24.5% (95% CI, 13.3%-38.9%) in the V+A arm vs 17.4% (95% CI, 5.0%-38.8%) in the A arm. With a median follow-up of 27.7 months, median PFS was 5.2 (95% CI, 3.4-8.9) in the V+A arm and 1.9 (95% CI, 1.6-8.9) months in the A arm. Fatigue, lymphopenia, hyperglycemia, and diarrhea were the most common (grade ≥2) adverse events associated with vistusertib.; Conclusions and Relevance: This multicenter, open-label, phase 1/2 randomized clinical trial demonstrated that adding vistusertib to anastrozole improved 8wk-PFR, overall response rate, and PFS for patients with endometrial cancer and had manageable adverse events. Identification of molecular subgroups would allow for more precise selection of patients who may be most likely to experience favorable outcomes.; Trial Registration: ClinicalTrials.gov Identifier: NCT02730923.

Heuer Christopher, W. (2021). "Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome." ClinicalTrials.gov.
	Background/significance: Overactive Bladder Syndrome (OAB) is defined as urinary urgency, with or without urgency incontinence, and usually accompanied by frequency and nocturia. OAB remains an increasingly more prevalent disease, affecting over 45% of postmenopausal women over the age 65 within the United States. Epidemiological research continues to consistently highlight OAB's impact on patience's mental health, sleep quality, physical activity, occupational productivity and overall quality of life. OAB's economic burden cannot be overstated as well as a US cost‐of‐illness study reported a total cost of $66 billion in 2007 and estimated cost of over $82 billion in 2021. Mainstay first‐line forms of management for OAB include behavioral modifications such as bladder training (timed voiding, urge suppression techniques), pelvic floor physical therapy, fluid management and bladder irritant restrictions. Second‐line forms of management consistent of pharmacotherapy including oral anticholinergics or beta‐3 adrenoreceptor agonists. Multiple studies have shown that vaginal estrogen improves symptoms of urinary urgency and frequency in postmenopausal women. Limited data currently exist comparing beta‐3 antagonists to vaginal estrogen use for overactive bladder syndrome as well as the combination of both. Purpose: This study aims to compare the efficacy of vaginal estradiol with that of oral mirabegron in the treatment of overactive bladder in postmenopausal women and characterize outcomes in women undergoing combined therapy. Study design: This is a single site, double‐blinded, randomized controlled trial for 152 postmenopausal women with urinary frequency, urgency, nocturia with or without urgency urinary incontinence symptoms. Patient's will be randomized between 0.01% vaginal estradiol cream 1/2 gram once nightly for two weeks then three times per week or 50 milligrams oral Mirabegron once a night. Procedures: Postmenopausal women with bothersome OAB symptoms will be eligible for the study. OAB symptoms will be based on the OAB‐q (SF) symptom bother questionnaire with an initial score greater than 20. Other inclusion criteria include ability to speak English. Exclusion criteria include: Post void residual >200mL or >1/3 patient's total bladder volume, currently on or previously taking anticholinergic or beta‐ 3 antagonists within the past 1 month, untreated, symptomatic pelvic organ prolapse greater than Stage 2, contraindication to vaginal estrogen therapy, contraindication to Mirabegron, undiagnosed postmenopausal vaginal bleeding within the past 12 months, current diagnosis of a condition which explains their overactive bladder or incontinence symptoms. Participants who elect to enroll will have a post‐void residual determined, a demographic sheet, the OAB‐q (SF) health‐related quality of life (HRQL) questionnaire, a 24‐hour voiding diary and Patient Global Impression of Severity (PGI‐S). Participants will be randomized via random allocation rule fixed blocking in a 1:1 ratio to either vaginal estrogen or oral Mirabegron. After 12 weeks of single therapy, the patients will be contacted for follow up to complete all previous questionnaires, a 24‐hour voiding diary as well as the PGI‐I questionnaire. After the initial 12‐weeks, single therapy follow up appointment, participants will be offered dual treatment (both vaginal estrogen and Mirabegron same doses/frequencies.) If the patient agrees she will receive dual treatment for 12 weeks and follow up with the same questionnaires.

Hexiang, P., et al. (2023). "Effect of GnRH agonist on the cycles of in vitro fertilization/intracytoplasmic sperm injection in patients with adenomyosis: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Heydarpour, F., et al. (2020). "Effects of cinnamon on controlling metabolic parameters of polycystic ovary syndrome: A systematic review and meta-analysis." Journal of Ethnopharmacology 254: 112741.
	Ethnopharmacological Relevance: Cinnamon as a traditional medicine has been widely used in various disorders such as headache, toothache, common cold, diarrhea, flatulence, fever, amenorrhea frigidity. However, the effect of cinnamon supplementation on metabolic parameters of polycystic ovary syndrome (PCOS) patients has not been fully assessed.; Aim of the Study: Clinical trials have shown contradictory effects of cinnamon supplementation on metabolic parameters of polycystic PCOS patients. Therefore, we evaluated the effect of cinnamon supplementation on metabolic parameters of PCOS patients through a systematic review and meta-analysis of clinical trials.; Materials and Methods: PubMed, Embase, the Cochrane library, Scopus and Web of Science databases (until August 2019) were searched to identify potential clinical trials with information on cinnamon supplementation on metabolic parameters among PCOS patients. Weighted Mean Differences was pooled using a random-effects model. Standard methods were used for assessment of heterogeneity, publication bias and sensitivity analysis.; Results: Pooling five clinical trials (five treatment arms) together did not show any significant effect on body weight (WMD: -0.74 kg, 95% CI: -3.17 to 1.69) and body mass index (BMI) (WMD: -1.47, 95% CI: -4.07 to 1.12). Our results illustrated that a significant decrease of fasting blood sugar (WMD: -5.32, mg/dL95% CI: -10.46 to -0.17), fasting insulin (WMD: -4.10, μIU/dL95% CI: -6.76 to -0.144) and HOMA-IR (WMD: -0.69 95% CI: -1.37 to -0.004) were observed after cinnamon treatment. Moreover, our findings demonstrated that oral cinnamon supplementation in PCOS patients led to significant reduction of serum level of LDL-C, total cholesterol, and triacylglycerol. Besides, an improvement of serum concentration of HDL-C was shown by cinnamon supplementation.; Conclusion: Generally, present study indicated that cinnamon supplementation may help PCOS patients to manage their metabolic parameters. Future prospective randomized clinical trials with longer intervention duration are warranted to obtain a precise conclusion.; Competing Interests: Declaration of competing interest No potential competing interests. (Copyright © 2020. Published by Elsevier B.V.)

Heymann, D., et al. (2020). "Hyaluronic acid in embryo transfer media for assisted reproductive technologies." The Cochrane Database of Systematic Reviews 9: CD007421.
	Background: This is an update of a Cochrane Review first published in the Cochrane Library (2010, Issue 7). To increase the success rate of assisted reproductive technologies (ARTs), adherence compounds such as hyaluronic acid (HA) have been introduced into subfertility management. Adherence compounds are added to the embryo transfer medium to increase the likelihood of embryo implantation, with the potential for higher clinical pregnancy and live birth rates.; Objectives: To determine whether adding adherence compounds to embryo transfer media could improve pregnancy outcomes, including improving live birth and decreasing miscarriage, in women undergoing assisted reproduction.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group Trials Register, CENTRAL, MEDLINE, Embase, and PsycINFO electronic databases on 7 January 2020 for randomised controlled trials that examined the effects of adherence compounds in embryo transfer media on pregnancy outcomes. Furthermore, we communicated with experts in the field, searched trials registries, checked reference lists of relevant studies, and conference abstracts were handsearched.; Selection Criteria: Only truly randomised controlled trials comparing embryo transfer media containing functional concentrations of adherence compounds to media with no or low adherence compound concentrations were included.; Data Collection and Analysis: Two review authors selected trials for inclusion according to the above criteria, after which the same two review authors independently extracted data for subsequent analysis. Statistical analysis was performed according to the guidelines developed by Cochrane. We combined data to calculate pooled risk ratios (RRs) and 95% confidence intervals (CIs). We assessed statistical heterogeneity using the I² statistic. We used GRADE methods to assess the overall quality of evidence for the main comparisons.; Main Results: We analysed 26 studies with a total of 6704 participants. Overall, the certainty of evidence was low to moderate: the main limitations were imprecision and/or heterogeneity. Compared to embryos transferred in media containing no or low (0.125 mg/mL) HA, the addition of functional (0.5 mg/mL) HA concentrations to the transfer media probably increases the live birth rate (RR 1.21, 95% CI 1.1 to 1.31; 10 RCTs, N = 4066; I² = 33%; moderate-quality evidence). This suggests that if the chance of live birth following no HA addition in media is assumed to be 33%, the chance following HA addition would be between 37% and 44%. The addition of HA may slightly decrease miscarriage rates (RR 0.82, 95% CI 0.67 to 1.00; 7 RCTs, N = 3091; I² = 66%; low-quality evidence). Nevertheless, when only studies with low risk of bias were included in the analysis, there was no conclusive evidence of a difference in miscarriage rates (RR 0.96, 95% CI 0.75 to 1.23; N = 2219; I² = 36%). Adding HA to transfer media probably results in an increase in both clinical pregnancy (RR 1.16, 95% CI 1.09 to 1.23; 17 studies, N = 5247; I² = 40%; moderate-quality evidence) and multiple pregnancy rates (RR 1.45, 95% CI 1.24 to 1.70; 7 studies, N = 3337; I² = 36%; moderate-quality evidence). We are uncertain of the effect of HA added to transfer media on the rate of total adverse events (RR 0.86, 95% CI 0.40 to 1.84; 3 studies, N = 1487; I² = 0%; low-quality evidence).; Authors' Conclusions: Moderate-quality evidence shows improved clinical pregnancy and live birth rates with the addition of HA as an adherence compound in embryo transfer media in ART. Low-quality evidence suggests that adding HA may slightly decrease miscarriage rates, but when only studies at low risk of bias were included in the analysis, the results were inconclusive. HA had no clear effect on the rate of total adverse events. The increase in multiple pregnancy rates may be due to combining an adherence compound and transferring more than one embryo. Further studies of adherence compounds with single embryo transfer need to be undertaken. (Copyright © 2020 The Cochrane Collaboration Published by John Wiley & Sons, Ltd.)

Hideaki, Y., et al. (2023). "Antidepressants and hormone-modulating therapies for premenstrual syndrome and premenstrual dysphoric disorder: A systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Hijaz, A. (2021). "Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse." ClinicalTrials.gov.
	This is a multi‐site, randomized controlled trial, where women with the confirmed diagnosis of uterovaginal prolapse will be randomized in a 1:1 ratio to either A) a minimally invasive supracervical hysterectomy with sacrocolpopexy (MI‐SCH+SCP) or B) total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS). After surgery, participants will be followed for 3 years including physical pelvic exams and validated symptom questionnaires to assess for the primary and secondary outcomes. A subset of participants will participate in semi‐structured interviews, before surgery and through 2 years after surgery, that will assess patient recovery, satisfaction with care, and calibrate surveyed and clinically assessed outcomes to the daily life experiences of women.

Hirschberg Angelica, L. (2022). "Micronized Progesterone Versus Norethisterone Acetate in Combination With Estrogen as Menopausal Hormone Therapy." ClinicalTrials.gov.
	Postmenopausal women with climacteric symptoms will be randomized (1:1) to double blind treatment with oral mP or NETA in combination with oral estradiol. For the breast part, a power analysis revealed that 91 women/group would be sufficient to detect a significant difference in mammographic breast density between the groups at the 5%‐level (two‐sided) with 80% power. Considering the estimated rate of discontinuation and incomplete data, the target sample for the breast part is 260 patients. For the endometrial part, it is estimated that two or less women with serious adverse endometrial outcomes would result in an annual incidence of endometrial pathology of 0.67% or less with an upper bound of the one‐sided 95% CI of 2.08% or less. Considering the estimated rate of discontinuation and incomplete data in the mP + estradiol group, the target sample for this part of the study is 390 patients. Mammography at baseline and after 12 months of treatment will be assessed by independent radiologists at the Karolinska University Hospital blinded to treatment. In addition to visual judgment, a computer based quantitative assessment will be performed. All mammograms will be anonymous so that the operator will be unaware of the patient's identity and type of treatment. Percentage change in mammographic density will be evaluated and compared between the groups. Endometrial biopsies at baseline and after 12 months of treatment will be evaluated by two independent pathologists at the Karolinska University Hospital for the incidence of endometrial pathology (hyperplasia or cancer) in the mP + estradiol group. Furthermore, immunostaining of the proliferation marker Ki‐67, and other markers related to proliferation and apoptosis will be analyzed and compared between groups. Different validated self‐assessment questionnaires will be used for screening of mood disorders like depression and anxiety, as well as quality of life and menopausal symptoms. The Patient Health Questionnaire (PHQ‐9) is a tool for screening, diagnosing, and measuring the severity of depression. The Hospital Anxiety and Depression Scale (HADS) is an instrument for detecting states of depression and anxiety in the setting of a hospital or medical outpatient clinic. Health related quality of life is measured using the Psychological General Well‐Being Index (PGWB). The Women's Health Questionnaire (WHQ) measures menopausal symptoms. The change in scores will be compared between the groups. Blood lipid profile, serum hormones, growth and metabolic factors, and coagulation factors will be analyzed. The gut‐ and vaginal microbiome will be characterized and compared between groups.

Hirte, H., et al. (2021). "Neoadjuvant and adjuvant systemic therapy for newly diagnosed stage II- IV epithelial ovary, fallopian tube, or primary peritoneal carcinoma: A systematic review." Critical Reviews in Oncology/Hematology 162: 103324.
	Background: To systematically review neoadjuvant and adjuvant therapy options for women with newly diagnosed stage II-IV ovarian cancer.; Methods: Phase III trials were searched using MEDLINE, EMBASE, and Cochrane Library. Maintenance therapies were excluded.; Results: Thirty-three trials were included. For women with high-risk profiles that would contraindicate upfront cytoreductive surgery, neoadjuvant chemotherapy can be an option. In the post-surgical adjuvant setting, the three-weekly regimen consisting of paclitaxel and carboplatin remains the standard of care. Docetaxel may be offered to those who are unable to tolerate paclitaxel. Intraperitoneal cisplatin and paclitaxel increased OS for stage III optimally debulked women (GOG 172). The intraperitoneal regimens in GOG 252 offered no survival benefit and some harms in terms of toxicity and quality of life.; Conclusions: There is no evidence to support adding a third agent to the standard carboplatin and paclitaxel. Results of the iPocc study will clarify the role of intraperitoneal chemotherapy. (Copyright © 2021 Elsevier B.V. All rights reserved.)

Hirte, H., et al. (2021). "Consolidation or maintenance systemic therapy for newly diagnosed stage II, III, or IV epithelial ovary, fallopian tube, or primary peritoneal carcinoma: A systematic review." Critical Reviews in Oncology/Hematology 162: 103336.
	Backgrounds: To systematically review the effectiveness and harm of consolidation or maintenance therapy in patients with newly diagnosed stage II-IV EOC.; Methods: MEDLINE, EMBASE, PubMed, Cochrane Library, and PROSPERO databases, and four relevant conferences were systematically searched. We adhered to PRISMA guidelines, and used the GRADE approach to aggregate data.; Results: Among 12,675 citations, 28 comprising 16,310 patients were analyzed. The certainty of aggregated study evidence ranged from high to low.; Conclusions: The existing evidence does not find overall survival benefit for consolidation therapy with chemotherapy. For maintenance therapy, comparing with placebo, olaparib, niraparib, veliparib, and bevacizumab are effective as maintenance therapy for certain patients with newly diagnosed stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma respectively without reducing quality of life. Longer follow-up with more mature results of overall survival will better define the effect of these agents. (Copyright © 2021 Elsevier B.V. All rights reserved.)

Hiu, S., et al. (2022). "Ultra-radical (extensive) surgery versus standard surgery for the primary cytoreduction of advanced epithelial ovarian cancer." The Cochrane Database of Systematic Reviews 8: CD007697.
	Background: Ovarian cancer is the seventh most common cancer among women and the leading cause of death in women with gynaecological malignancies. Opinions differ regarding the role of ultra-radical (extensive) cytoreductive surgery in ovarian cancer treatment.; Objectives: To evaluate the effectiveness and morbidity associated with ultra-radical/extensive surgery in the management of advanced-stage epithelial ovarian cancer.; Search Methods: We searched CENTRAL (2021, Issue 11), MEDLINE Ovid and Embase Ovid up to November 2021. We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field.; Selection Criteria: Randomised controlled trials (RCTs) or non-randomised studies (NRS), analysed using multivariate methods, that compared ultra-radical/extensive and standard surgery in women with advanced primary epithelial ovarian cancer.; Data Collection and Analysis: Two review authors independently assessed whether potentially relevant studies met the inclusion criteria, abstracted data and assessed the risk of bias. We identified three NRS and conducted meta-analyses where possible.; Main Results: We identified three retrospective observational studies for inclusion in the review. Two studies included women exclusively undergoing upfront primary debulking surgery (PDS) and the other study including both PDS and interval debulking surgical (IDS) procedures. All studies were at critical risk of bias due to retrospective and non-randomised study designs. Meta-analysis of two studies, assessing 397 participants, found that women who underwent radical procedures, as part of PDS, may have a lower risk of mortality compared to women who underwent standard surgery (adjusted HR 0.60, 95% CI 0.43 to 0.82; I 2 = 0%; very low-certainty evidence), but the evidence is very uncertain. The results were robust to a sensitivity analysis including women with more-extensive disease (carcinomatosis) (adjusted HR 0.61, 95% CI 0.44 to 0.85; I 2 = 0%; n = 283, very low-certainty evidence), but the evidence is very uncertain. One study reported a comparison of radical versus standard surgical procedures associated with both PDS and IDS procedures, but a multivariate analysis was only undertaken for disease-free survival (DFS) and therefore the certainty of the evidence was not assessable for overall survival (OS) and remains very low. The lack of reporting of OS meant the study was at high risk of bias for selective reporting of outcomes. One study, 203 participants, found that women who underwent radical procedures as part of PDS may have a lower risk of disease progression or death compared to women who underwent standard surgery (adjusted HR 0.62, 95% CI 0.42 to 0.92; very low-certainty evidence), but the evidence is very uncertain. The results were robust to a sensitivity analysis in one study including women with carcinomatosis (adjusted HR 0.52, 95% CI 0.33 to 0.82; n = 139; very low-certainty evidence), but the evidence is very uncertain. A combined analysis in one study found that women who underwent radical procedures (using both PDS and IDS) may have an increased chance of disease progression or death than those who received standard surgery (adjusted HR 1.60, 95% CI 1.11 to 2.31; I 2 = 0%; n = 527; very low-certainty evidence), but the evidence is very uncertain. In absolute and unadjusted terms, the DFS was 19.3 months in the standard surgery group, 15.8 in the PDS group and 15.9 months in the IDS group. All studies were at critical risk of bias and we only identified very low-certainty evidence for all outcomes reported in the review. Perioperative mortality, adverse events and quality of life (QoL) outcomes were either not reported or inadequately reported in the included studies. Two studies reported perioperative mortality (death within 30 days of surgery), but they did not use any statistical adjustment. In total, there were only four deaths within 30 days of surgery in both studies. All were observed in the standard surgery group, but we did not report a risk ratio (RR) to avoid potentially misleading results with so few deaths and very low-certainty evidence. Similarly, one study reported postoperative morbidity, but the authors did not use any statistical adjustment. Postoperative morbidity occurred more commonly in women who received ultra-radical surgery compared to standard surgery, but the certainty of the evidence was very low.; Authors' Conclusions: We found only very low-certainty evidence comparing ultra-radical surgery and standard surgery in women with advanced ovarian cancer. The evidence was limited to retrospective, NRSs and so is at critical risk of bias. The results may suggest that ultra-radical surgery could result in improved OS, but results are based on very few women who were chosen to undergo each intervention, rather than a randomised study and intention-to-treat analysis, and so the evidence is very uncertain. Results for progression/DFS were inconsistent and evidence was sparse. QoL and morbidity was incompletely or not reported in the three included studies. A separate prognostic review assessing residual disease as a prognostic factor in this area has been addressed elsewhere, which demonstrates the prognostic effect of macroscopic debulking to no macroscopic residual disease. In order to aid existing guidelines, the role of ultra-radical surgery in the management of advanced-stage ovarian cancer could be addressed through the conduct of a sufficiently powered, RCT comparing ultra-radical and standard surgery, or well-designed NRSs, if this is not possible. (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Höder, A., et al. (2023). "Pelvic floor muscle training with biofeedback or feedback from a physiotherapist for urinary and anal incontinence after childbirth - a systematic review." BMC Women's Health 23(1): 618.
	Background: Childbirth is one of the biggest risk factors for incontinence. Urinary and anal incontinence can cause pain and social limitations that affect social life, cohabitation, and work. There is currently no up-to-date literature study on the effect of pelvic floor muscle training with feedback from a physiotherapist, which involves verbal instructions based on vaginal and anal digital palpation, compared to treatment without feedback (e.g., recommendations for pelvic floor muscle training).; Aim: The objective of this systematic review was to examine the scientific evidence regarding the impact of pelvic floor muscle training (PFMT) with feedback from a physiotherapist and/or biofeedback on urinary and anal incontinence in women during the first six months following vaginal delivery, compared to treatment without feedback.; Methods: The literature search was conducted in the databases PubMed, Cochrane, and CINAHL. In addition, a manual search was conducted. The search terms consisted of MeSH terms and synonyms in the respective search block including population, intervention, and study design, as well as the terms pelvic floor and postpartum. An evaluation of each included study was conducted for methodological quality, evidence value, and clinical relevance.; Results: Eight studies were included, three of which showed a significant difference between groups, in favor of the intervention group that received pelvic floor muscle training with feedback from a physiotherapist and/or biofeedback. Due to the varying results and insufficient quality for the majority of the studies, the scientific basis was considered insufficient.; Conclusion: The scientific evidence for pelvic floor muscle training with feedback from a physiotherapist or biofeedback on postpartum urinary and anal incontinence compared to treatment without feedback is considered insufficient. Further research on the subject is needed. The study is registered in PROSPERO CRD42022361296. (© 2023. The Author(s).)

Hodgson Ruth, M., et al. (2020). "Interventions for endometriosis-related infertility: a systematic review and network meta-analysis." Fertility and Sterility 113(2): 374.
	Objective: To compare the effectiveness of different treatments for women with endometriosis-related infertility.; Design: A systematic review and network meta-analysis of randomized controlled trials (RCTs).; Setting: Not applicable.; Patient(s): Women with endometriosis confirmed by laparoscopy with associated infertility.; Intervention(s): An extensive electronic search of the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, ClinicalTrials.gov, and Embase.; Main Outcome Measure(s): Clinical pregnancy, live birth rate, miscarriage, and adverse events.; Result(s): A total of 4,252 trials/abstracts were identified through the literature search, of which we included 36 trials in the systematic review and 26 trials reporting on 2,245 women with endometriosis-related infertility in the network meta-analysis. Network meta-analysis showed that compared with placebo, surgical laparoscopy alone (odds ratio = 1.63; 95% confidence interval, 1.13-2.35) or GnRH agonist alone (odds ratio = 1.68; 95% confidence interval, 1.07-2.46) results in higher odds of pregnancy. The evidence on the other interventions versus placebo or on the secondary outcomes including live birth, miscarriage, and adverse events is insufficient.; Conclusion(s): The most important conclusion is that more RCTs are needed to clarify the relative effectiveness of treatments for endometriosis-related infertility, ideally comparing interventions to existing recommended interventions such as surgical laparoscopy. In addition, further RCTs comparing IVF and IUI to other treatments are essential.; Registration Number: PROSPERO registration number, CRD42018087572. (Copyright © 2019 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Holloway Robert, W., et al. (2023). "A phase III, multicenter, randomized study of olvimulogene nanivacirepvec followed by platinum-doublet chemotherapy and bevacizumab compared with platinum-doublet chemotherapy and bevacizumab in women with platinum-resistant/refractory ovarian cancer." International Journal of Gynecological Cancer 33(9): 1458-1463.
	Background: Treatment options for patients with platinum-resistant/refractory ovarian cancers are limited and only marginally effective. The development of novel, more effective therapies addresses a critical unmet medical need. Olvimulogene nanivacirepvec (Olvi-Vec), with its strong immune modulating effect on the tumor microenvironment, may provide re-sensitization to platinum and clinically reverse platinum resistance or refractoriness in platinum-resistant/refractory ovarian cancer.; Primary Objective: The primary objective is to evaluate the efficacy of intra-peritoneal Olvi-Vec followed by platinum-based chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer.; Study Hypothesis: This phase III study investigates Olvi-Vec oncolytic immunotherapy followed by platinum-based chemotherapy and bevacizumab as an immunochemotherapy evaluating the hypothesis that such sequential combination therapy will prolong progression-free survival (PFS) and bring other clinical benefits compared with treatment with platinum-based chemotherapy and bevacizumab.; Trial Design: This is a multicenter, prospective, randomized, and active-controlled phase III trial. Patients will be randomized 2:1 into the experimental arm treated with Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab or the control arm treated with platinum-doublet chemotherapy and bevacizumab.; Major Inclusion/exclusion Criteria: Eligible patients must have recurrent, platinum-resistant/refractory, non-resectable high-grade serous, endometrioid, or clear-cell ovarian, fallopian tube, or primary peritoneal cancer. Patients must have had ≥3 lines of prior chemotherapy.; Primary Endpoint: The primary endpoint is PFS in the intention-to-treat population.; Sample Size: Approximately 186 patients (approximately 124 patients randomized to the experimental arm and 62 to the control arm) will be enrolled to capture 127 PFS events.; Estimated Dates for Completing Accrual and Presenting Results: Expected complete accrual in 2024 with presentation of primary endpoint results in 2025.; Trial Registration: NCT05281471.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Holm Anna-Clara, S. (2023). "Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women." ClinicalTrials.gov.
	The overall aim is to investigate the efficacy of and compare two modes of physical exercise (strength training and high‐intensity aerobic exercise) to unchanged physical activity on vasomotor symptoms (VMS), as well as secondary outcomes such as health‐related quality of life, sleep quality, physical activity levels, clinical outcomes, biomarkers, perceptions of and adherence to the interventions. In a longer perspective, the goal is to find evidence‐based treatment options for VMS in postmenopausal women that are safe and effective, and have positive effects on health and quality of life after menopause. Our hypothesis is that strength training and high‐intensity aerobic exercise will reduce VMS in postmenopausal women and improve quality of life as well as clinical outcomes more than in a control group with unchanged physical activity. We also hypothesize that strength training and high‐intensity aerobic training will have the same effect on the primary outcome (change in VMS) and that most of the changes in secondary outcomes will be superior in the high‐intensity aerobic training group compared to the strength training group. This is an open, two‐centre, parallel, randomized controlled study performed according to the SPIRIT and CONSORT statements Recruitment will take place by advertising on social media, in local newspapers and in the Women's clinics and primary care centers in Linköping and Kalmar. Women who respond to the advertisements will be contacted by a member of the research group or research nurse to receive information about the study and screen for inclusion and exclusion criteria. Women who are possibly eligible will be invited to a screening visit for further information and informed consent. At the visit, inclusion and exclusion criteria will be checked by a physician, and a clinical examination will be performed. Eligible participants will receive a VMS screening diary and invited to a second visit 2‐3 weeks later where inclusion and randomization will be performed if the VMS inclusion criteria are fulfilled. Randomization An allocation sequence using a computerized random number generator will be prepared by a statistician not involved in recruitment. Opaque sealed and sequentially numbered envelopes with group allocation will be prepared and opened in the presence of the participant upon inclusion and randomization. Power analysis: A sample size calculation was made based on the results of our previous study on strength training for VMS (Berin et al 2019) and showed that to detect a 50% difference in moderate and severe hot flushes with 80% power and expected dropout rate of 20% 40 participants in total would be needed. For this three‐armed set‐up we estimate that 20 participants in each group will be needed, i.e. 60 in total. To also achieve sufficient power for some of the secondary outcomes the intended sample size is increased to 30 per group, 90 in total. Data analysis: The primary analysis will be performed according to the intention‐to‐treat principle, including all participants who provided more than baseline data for the primary outcome. For quantitative interval data mixed design ANOVAs will be used to analyze the effect over time between and within groups. For the between‐group comparisons effect sizes will be calculated. For ordinal data, such as the questionnaires, Kruskal‐Wallis and Friedman test will be used for statistical analysis of the effect. Participants who complete two or more training sessions per week will be considered adherent with their assigned intervention and included in a per‐protocol analysis. Detailed description of adherence, such as the fidelity with the training interventions, will be presented descriptively.

Holt, C., et al. (2021). "Improving the mother-infant relationship following postnatal depression: a randomised controlled trial of a brief intervention (HUGS)." Archives of Women's Mental Health 24(6): 913-923.
	Postnatal depression (PND) disrupts the crucial mother-infant relationship on which optimal child development depends. However, few well-evaluated, brief mother-infant interaction interventions exist. This randomised controlled trial (RCT) aimed to evaluate the effect of a 4-session, group-based mother-infant interaction intervention ('HUGS'), compared to a control playgroup, both following cognitive-behavioural therapy for PND, on mother-infant relationships and early child development. It was hypothesised that dyads receiving the HUGS intervention would show larger improvements than control dyads. Mothers (n = 77; M age = 32 years) diagnosed with major or minor depressive disorder using the Structured Clinical Interview for the DSM-IV participated with their infants (<12 months). Primary outcomes were observed mother-infant interactions using the Parent Child Early Relational Assessment (ERA) and maternal parenting stress using the Parenting Stress Index (PSI). Data were collected at baseline, post-PND treatment, post-HUGS intervention and 6-month post-HUGS follow-up. Seventy-four percent of HUGS dyads attended at least half of the HUGS sessions (≥2). Significant group differences emerged at the 6-month follow-up (but were not significant immediately post-HUGS). At 6-month follow-up, HUGS dyads showed significantly improved parental positive affective involvement and verbalisation (ERA; F1, 47 = 4.96, p = .03, ηp2 = .10) and less impaired bonding (F1, 45 = 4.55, p = .04, ηp2 = .09) than control dyads. No differences were found on the PSI or on child development outcomes. Both groups improved substantially (around 30 points) on the PSI following PND treatment, so that average scores were below the clinically significant threshold when beginning HUGS and the control playgroup. Findings suggest that incorporating HUGS intervention following PND treatment is effective for improving mother-infant relationships. A longer-term follow-up and larger sample size may be needed for improved mother-infant relationships to show an impact on observable child developmental outcomes. Registered with the Australian New Zealand Clinical Trials Registry (ACTRN12612001110875).

Hongbo, Y., et al. (2023). "Study on improvement of fertility following laparoscopic segmental bowel resection for colorectal endometriosis." PROSPERO International prospective register of systematic reviews.
	
Hongchun, Z. and X. Zhen (2023). "Effectiveness of omega-3 in the treatment of endometriosis." PROSPERO International prospective register of systematic reviews.
	
Hongjuan, W., et al. (2023). "Effects of mind–body exercises on women with menopause: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Hongxiao, L., et al. (2021). "Efficacy and safety of acupuncture on premature ovarian insufficiency: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Hong-Yu, L., et al. (2023). "Evaluating the Outcomes of Maintenance or Consolidation Therapy in Epithelial Ovarian Cancer: A Comprehensive Network Meta-Analysis of Survival, Adverse Events, and Quality of Life." PROSPERO International prospective register of systematic reviews.
	
Hope Medicine Nanjing) Co, L. (2021). "A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain." ClinicalTrials.gov.
	This study aims to evaluate the safety and efficacy of HMI‐115 versus a placebo in pre‐menopausal women with moderate to severe Endometriosis associated pain. Part 1 of the study will determine the safety and efficacy of HMI 115 at 3 dose levels. Part 2 will detect a higher dose and might be conducted after Part 1.

Horeweg, N., et al. (2021). "Adjuvant Systemic Therapy after Chemoradiation and Brachytherapy for Locally Advanced Cervical Cancer: A Systematic Review and Meta-Analysis." Cancers 13(8).
	Background: Standard of care for locally advanced cervical cancer is chemoradiation and brachytherapy. The addition of adjuvant systemic treatment may improve overall survival. A systematic review and meta-analysis was conducted to summarize evidence on survival outcomes, treatment completion and toxicity.; Methods: PubMed, EMBASE and Web of Science were systematically searched for relevant prospective and retrospective studies. Two authors independently selected studies, extracted data and assessed study quality. Pooled hazard ratios for survival endpoints were estimated using random effect models. Weighted averages of treatment completion and toxicity rates were calculated and compared by the Fisher exact test.; Results: The search returned 612 articles; 35 articles reporting on 29 different studies on adjuvant chemotherapy or immunotherapy were selected for systematic review. Twelve studies on an adjuvant platinum-pyrimidine antagonist or platinum-taxane were included for meta-analysis. The pooled hazard ratios for overall survival were 0.76 (99%CI: 0.43-1.34, p = 0.22) and 0.47 (99%CI: 0.12-1.86, p = 0.16) for the addition of, respectively, a platinum-pyrimidine antagonist or platinum-taxane to chemoradiation and brachytherapy. Completion rates were 82% (95%CI: 76-87%) for platinum-pyrimidine antagonist and 74% (95%CI: 63-85%) for platinum-taxane. Severe acute hematological and gastro-intestinal toxicities were significantly increased by adding adjuvant chemotherapy to chemoradiation and brachytherapy.; Conclusions: The addition of adjuvant platinum-pyrimidine antagonist or platinum-taxane after chemoradiation and brachytherapy does not significantly improve overall survival, while acute toxicity is significantly increased. These adjuvant treatment strategies can therefore not be recommended for unselected patients with locally advanced cervical cancer.

Horeweg, N., et al. (2022). "A systematic review and meta-analysis of adjuvant chemotherapy after chemoradiation for locally advanced cervical cancer." Critical Reviews in Oncology/Hematology 172: 103638.
	We investigated whether the addition of adjuvant chemotherapy to chemoradiation improves overall survival (OS) and progression-free survival (PFS) by conducting a systematic review and meta-analysis. Systematic searches in the databases of PubMed, Embase and Web of Science yielded 881 articles. Two reviewer authors independently selected 31 articles for full text review and deemed eight studies eligible for inclusion. Two were randomised controlled trials (RCT), one was a large (n = 609) matched-case study and the remaining were small retrospective cohort studies; in total 2150 patients. Risk of bias assessment showed that the RCTs were at low risk and all other studies were at high risk of bias. Pooled hazard ratios for OS and PFS were 0.78 (95%CI 0.45-1.33, p = 0.36) and 0.85 (95%CI 0.65-1.10, p = 0.22), respectively. Analysis stratified by study design and sensitivity analysis showed similar results. Funnel plots showed significant publication bias due to a lack of small studies with negative outcomes. (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Horne, A. W., et al. (2023). "Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial." Lancet 401(10377): 655‐663.
	BACKGROUND: Tubal ectopic pregnancies can cause substantial morbidity or even death. Current treatment is with methotrexate or surgery. Methotrexate treatment fails in approximately 30% of women who subsequently require rescue surgery. Gefitinib, an epidermal growth factor receptor inhibitor, might improve the effects of methotrexate. We assessed the efficacy of oral gefitinib with methotrexate, versus methotrexate alone, to treat tubal ectopic pregnancy. METHODS: We performed a multicentre, randomised, double‐blind, placebo‐controlled trial across 50 UK hospitals. Participants diagnosed with tubal ectopic pregnancy were administered a single dose of intramuscular methotrexate (50 mg/m2) and randomised (1:1 ratio) to 7 days of additional oral gefitinib (250 mg daily) or placebo. The primary outcome, analysed by intention to treat, was surgical intervention to resolve the ectopic pregnancy. Secondary outcomes included time to resolution of ectopic pregnancy and serious adverse events. This trial is registered at the ISRCTN registry, ISCRTN 67795930. FINDINGS: Between Nov 2, 2016, and Oct 6, 2021, 328 participants were allocated to methotrexate and gefitinib (n=165) or methotrexate and placebo (n=163). Three participants in the placebo group withdrew. Surgical intervention occurred in 50 (30%) of 165 participants in the gefitinib group and in 47 (29%) of 160 participants in the placebo group (adjusted risk ratio 1·15, 95% CI 0·85 to 1·58; adjusted risk difference ‐0·01, 95% CI ‐0·10 to 0·09; p=0·37). Without surgical intervention, median time to resolution was 28·0 days in the gefitinib group and 28·0 days in the placebo group (subdistribution hazard ratio 1·03, 95% CI 0·75 to 1·40). Serious adverse events occurred in five (3%) of 165 participants in the gefitinib group and in six (4%) of 162 participants in the placebo group. Diarrhoea and rash were more common in the gefitinib group. INTERPRETATION: In women with a tubal ectopic pregnancy, adding oral gefitinib to parenteral methotrexate does not offer clinical benefit over methotrexate and increases minor adverse reactions. FUNDING: National Institute of Health Research.

Horsch, A. (2022). "Tackling Intrusive Traumatic Memories After Childbirth." ClinicalTrials.gov.
	This single‐blind waitlist randomized controlled trial aims to investigate the efficacy of a single‐session behavioral intervention composed of a brief evocation of the childbirth memory followed by a visuospatial task (the computer game "Tetris"), on childbirth‐related intrusive traumatic memories (CB‐ITM) and other childbirth‐related posttraumatic stress disorder (CB‐PTSD) symptoms. Women who report CB‐ITM after 6 weeks postpartum can be included in the study. Participants will be randomly allocated to either the immediate treatment (IT) group or to the waitlist (WL) group. Women in the IT group will first report their CB‐ITM in a daily diary during 2 weeks (diary 1). On the 15th day, they will meet a psychologist to receive the single‐session behavioral intervention. They will then complete a daily diary during the 2 weeks post‐intervention (diary 2) and during the 5th and 6th weeks post‐intervention (diary 3). Women in the WL group will report their CB‐ITM continuously during 4 weeks in diary 1 and 2 before receiving the same intervention on the 30th day. They will also complete a last diary during the 2 weeks post‐intervention (diary 3). It is expected that women in the immediate treatment group (IT group) will have fewer CB‐ITM in diary 2, in comparison to the WL group, for which we expect no significant change in the number of CB‐ITM between diary 1 and 2. This study will contribute to the development of a single‐session behavioral intervention to reduce CB‐ITMs and other CB‐PTSD symptoms, which would reduce the distress experienced by mothers and may improve the well‐being of the whole family.

Hoshiai, H., et al. (2021). "Relugolix for oral treatment of uterine leiomyomas: a dose-finding, randomized, controlled trial." BMC Women's Health 21(1): 375.
	BACKGROUND: Uterine leiomyomas are the most common neoplasm affecting women and frequently cause heavy menstrual bleeding and pain. Gonadotropin-releasing hormone (GnRH) receptor antagonists provide fast symptom relief and show promise as a medical (non-surgical) treatment option and as a presurgical treatment to reduce leiomyoma size. The aim of this study was to evaluate the efficacy and safety of three dose levels of oral relugolix, a small molecule GnRH receptor antagonist, in Japanese women with uterine leiomyomas and heavy menstrual bleeding. METHODS: This phase 2, multicenter, double-blind, parallel-group study was conducted at 36 sites in Japan in women with uterine leiomyomas and heavy menstrual bleeding, defined as a pictorial blood loss assessment chart (PBAC) score of ≥ 120 in one menstrual cycle. Patients were randomized 1:1:1:1 to relugolix 10, 20, or 40 mg, or placebo, orally once daily for 12 weeks. The primary endpoint was the proportion of patients with a total PBAC score of < 10 from week 6 to 12. A sample size of 50 patients per group was estimated to provide ≥ 95% power, based on the comparison of relugolix 40 mg with placebo using a chi-square test with a significance level of 5% (two-sided). RESULTS: From November 2011 to September 2012, 216 patients were randomized and 214 patients (99.1%) were analyzed. The proportion (difference vs. placebo) of patients that achieved the primary endpoint in the placebo and 10-, 20-, and 40-mg relugolix groups were 0%, 20.8% (95% confidence interval [CI]: 9.3-32.3, P < .001), 42.6% (95% CI: 29.4-55.8, P < .001), and 83.3% (95% CI: 73.4-93.3, P < .001), respectively. Though treatment-emergent adverse events were similar between the 20- and 40-mg groups, the incidence rates were more frequent compared with the placebo group. Most of these adverse events were mild or moderate in intensity. CONCLUSIONS: Relugolix decreased menstrual blood loss in women with uterine leiomyomas in a dose-response manner, and was generally well tolerated. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT01452659 , NCT01452659 (registered 17/10/2011); JAPIC Clinical Trial Information, https://www.clinicaltrials.jp , JapicCTI-111590 (registered 31/08/2011).

Hou, J. H., et al. (2024). "Outpatient hysteroscopy impact on subsequent assisted reproductive technology: a systematic review and meta-analysis in patients with normal transvaginal sonography or hysterosalpingography images." Reproductive Biology and Endocrinology 22(1): 18.
	Background: Standard management for intrauterine lesions typically involves initial imaging followed by operative hysteroscopy for suspicious findings. However, the efficacy of routine outpatient hysteroscopy in women undergoing assisted reproductive technology (ART) remains uncertain due to a lack of decisive high-quality evidence. This study aimed to determine whether outpatient hysteroscopy is beneficial for infertile women who have unremarkable imaging results prior to undergoing ART. Method(s): A systematic review and meta-analysis were conducted following PRISMA guidelines, incorporating data up to May 31, 2023, from databases such as PubMed, Embase, and the Cochrane Library. The primary outcome assessed was the live birth rate, with secondary outcomes including chemical pregnancy, clinical pregnancy rates, and miscarriage rates. Statistical analysis involved calculating risk ratios with 95% confidence intervals and assessing heterogeneity with the I2 statistic. Result(s): The analysis included ten randomized control trials. Receiving outpatient hysteroscopy before undergoing ART was associated with increased live birth (RR 1.22, 95% CI 1.03-1.45, I2 61%) and clinical pregnancy rate (RR 1.27 95% CI 1.10-1.47, I2 53%). Miscarriage rates did not differ significantly (RR 1.25, CI 0.90-1.76, I2 50%). Subgroup analyses did not show a significant difference in clinical pregnancy rates when comparing normal versus abnormal hysteroscopic findings (RR 1.01, CI 0.78-1.32, I2 38%). We analyzed data using both intention-to-treat and per-protocol approaches, and our findings were consistent across both analytical methods. Conclusion(s): Office hysteroscopy may enhance live birth and clinical pregnancy rates in infertile women undergoing ART, even when previous imaging studies show no apparent intrauterine lesions. Treating lesions not detected by imaging may improve ART outcomes. The most commonly missed lesions are endometrial polyps, submucosal fibroids and endometritis, which are all known to affect ART success rates. The findings suggested that hysteroscopy, given its diagnostic accuracy and patient tolerability, should be considered in the management of infertility. Database registration: The study was registered in the International Prospective Register of Systemic Review database (CRD42023476403).Copyright © 2024, The Author(s).

Hou, W. H., et al. (2020). "Effects of extracorporeal magnetic stimulation on urinary incontinence: A systematic review and meta-analysis." Journal of Advanced Nursing 76(9): 2286-2298.
	AIMS: To examine the effectiveness of extracorporeal magnetic stimulation for treatment of stress urinary incontinence. DESIGN: Systematic review and meta-analysis. DATA RESOURCES: Four electronic databases from inception to 18 May 2019. REVIEW METHODS: Two authors independently performed the search, assessed the methodological quality, and extracted data. The final studies included in the analysis were selected after reaching consensus with the third author. RESULT(S): A total of 20 studies were included in the systematic review and 12 of these in the meta-analysis. Quality assessment indicated that only 8 of 17 randomized controlled trials had low risk in overall risk of bias, whereas all controlled trials had serious risk of bias. The weighted mean effect size of magnetic stimulation on quality of life, number of leakages, pad test outcomes, and number of incontinence events was 1.045 (95% CI: 0.409-1.681), -0.411 (95% CI: 0.178-0.643), -0.290 (95% CI: 0.025-0.556), and -0.747 (95% CI: -1.122 to -0.372), respectively. Subgroup analysis revealed a significant difference in the type of quality of life measurement used. Sensitivity analyses revealed that a high degree of heterogeneity persisted even after omitting studies individually. CONCLUSION(S): Extracorporeal magnetic stimulation may be effective in treating urinary incontinence and improving quality of life without major safety concerns. However, because of a high degree of heterogeneity among studies, inferences from the results must be made with caution. IMPACT: We recommend that clinical nurses apply extracorporeal magnetic stimulation to treat stress urinary incontinence among female patients and encourage researchers to conduct further qualitative and quantitative studies to develop consistent content and dosage for the intervention. STUDY REGISTRATION: The review protocol was registered a priori and published online in the PROSPERO database of systematic reviews (www.crd.york.ac.uk/Prospero with the registration number #CRD42019138835).Copyright © 2020 John Wiley & Sons Ltd.

Hou, Y., et al. (2022). "Effect of pelvic floor muscle training using mobile health applications for stress urinary incontinence in women: a systematic review." BMC Women's Health 22(1): 400.
	Background: Pelvic floor muscle training (PFMT) is the first-line treatment for urinary incontinence, but adherence to PFMT is generally poor. Currently, a number of novel strategies exist to facilitate adherence of PFMT. We sought to determine effectiveness of mHealth app-based PFMT for treating stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (MUI) in women. The primary objective was to assess the effects of mHealth app-based PFMT and usual treatment on severity of the symptom, the quality of life (QoL) of users and the patient's global impression of improvement. The secondary objective was to assess how mHealth app use affects adherence of PFMT. Method(s): All randomized controlled trials and quasi-randomized controlled trials aimed at evaluating the effects of mHealth app-based PFMT in women with SUI or stress-predominant MUI were included. Twelve electronic databases, namely the Cochrane Library, PubMed, CINAHL, Embase, Web of science, OVID, SciELO, REHABDATA, PEDro database, Chinese CNKI and Wanfang and the Open Grey databases were used as search sources. The protocol was registered in PROSPERO (CRD 42020183515). This systematic review was developed following the PRISMA 2020 Checklist. The Cochrane Handbook for Systematic Reviews of Interventions for Randomized Controlled Trials was used to assess risk of bias in included studies. Two authors extracted the data into a standardized spreadsheet. Result(s): Six studies that met the eligibility criteria were included. The full sample included 439 patients with treatment via mHealth app and 442 controls of usual treatment. ICIQ-UI SF, ICIQ-VS, and QUID scores decreased after follow-up in the mHealth app and control groups in six studies. ICIQ-LUTS QoL scores decreased after follow-up in the mHealth app and control groups in three studies. In only one study, ICIQ-VS QoL scores decreased after 1 month and 2 months of follow-up in the mHealth app group, but increased abruptly after 3 months of follow-up. EQ5D-VAS scores increased in both groups in one study. The percentage of PGI-I increased in the mHealth app group in three studies after follow-up. After follow-up in three studies, BPMSES scores and self-reported adherence scores increased in the mHealth app group relative to the initial time point, but in one study, at 6 months compared with 3 months of follow-up, adherence scores decreased slightly in the mHealth app group. Conclusion(s): This systematic review determined that mHealth app-based PFMT showed promise from the perspective of improving both outcomes and exercise adherence.Copyright © 2022, The Author(s).

Hou, Z., et al. (2021). "What is the impact of granulocyte colony-stimulating factor (G-CSF) in subcutaneous injection or intrauterine infusion and during both the fresh and frozen embryo transfer cycles on recurrent implantation failure: a systematic review and meta-analysis?" Reproductive Biology and Endocrinology 19(1): 125.
	Background: Among recurrent implantation failure (RIF) patients, the rate of successful implantation remains relatively low due to the complex etiology of the condition, including maternal, embryo and immune factors. Effective treatments are urgently needed to improve the outcomes of embryo transfer for RIF patients. In recent years, many researchers have focused on immunotherapy using granulocyte colony-stimulating factor (G-CSF) to regulate the immune environment. However, the study of the G-CSF for RIF patients has reached conflicting conclusions. The aim of this systematic review and meta-analysis was performed to further explore the effects of G-CSF according to embryo transfer cycle (fresh or frozen) and administration route (subcutaneous injection or intrauterine infusion) among RIF patients.; Method: The PubMed, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched for literature published from the initial to October 2020. The meta-analysis, random-effects model and heterogeneity of the studies with I 2 index were analyzed. Stata 15 was used for statistical analysis.; Results: A total of 684 studies were obtained through the databases mentioned above. Nine RCTs included 976 RIF patients were enrolled in this meta-analysis. Subgroup analysis indicated that G-CSF improved the clinical pregnancy rate for both the fresh and frozen embryo transfer cycles (fresh RR: 1.74, 95% CI: 1.27-2.37, I 2 = 0.0%, n = 410; frozen RR: 1.44, 95% CI: 1.14-1.81, I 2 = 0.0.%, n = 366), and for both subcutaneous injection and intrauterine infusion (subcutaneous RR: 1.73, 95% CI: 1.33-2.23, I 2 = 0.0%, n = 497; intrauterine RR: 1.39, 95% CI: 1.09-1.78, I 2 = 0.0%, n = 479), but the biochemical pregnancy rate of the RIF group was also higher than that of the control group (RR: 1.85, 95% CI: 1.28-2.68; I 2 = 20.1%, n = 469). There were no significant differences in the miscarriage rate (RR: 1.13, 95% CI: 0.25-5.21: I 2 = 63.2%, n = 472) and live birth rate (RR: 1.43, 95% CI: 0.86-2.36; I 2 = 52.5%; n = 372) when a random-effects model was employed.; Conclusion: The administration of G-CSF via either subcutaneous injection or intrauterine infusion and during both the fresh and frozen embryo transfer cycles for RIF patients can improve the clinical pregnancy rate. However, whether G-CSF is effective in improving livebirth rates of RIF patients is still uncertain, continued research on the utilization and effectiveness of G-CSF is recommended before G-CSF can be considered mainstream treatment for RIF patients. (© 2021. The Author(s).)

Hsia, L.-H., et al. (2023). "Dual trigger improves the pregnancy rate in fresh in vitro fertilization (IVF) cycles compared with the human chorionic gonadotropin (hCG) trigger: a systematic review and meta-analysis of randomized trials." Journal of Assisted Reproduction and Genetics 40(9): 2063-2077.
	Propose: The purpose of this study was to assess whether the implementation of a "dual trigger" approach, utilizing gonadotropin-releasing hormone agonist (GnRHa) and human chorionic gonadotropin (hCG) in the GnRH antagonist protocol for in vitro fertilization (IVF), leads to improved pregnancy outcomes compared to the conventional hCG trigger alone. Previous meta-analyses have not provided sufficient evidence to support the superiority of the dual trigger over the hCG trigger in fresh or frozen embryo transfer cycles. Thus, a systematic review and meta-analysis of randomized trials were conducted to provide a comprehensive evaluation of the impact of the dual trigger on pregnancy outcomes in fresh or frozen embryo transfer cycles.; Method: A systematic review and meta-analysis of randomised controlled trials (RCTs) were conducted. We searched the Medline and Embase databases for articles up to 2023 by using search terms: "dual trigger," "GnRHa," "hCG," "IVF." Eligible RCTs comparing the dual trigger with the hCG trigger were included. The primary outcome was the live birth rate (LBR) per cycle. The secondary outcomes were the number of oocytes retrieved, number of mature oocytes retrieved, implantation rate, biochemical pregnancy rate, CPR, miscarriage rate and ovarian hyperstimulation syndrome (OHSS) rate per started cycle We compared the oocyte maturation and pregnancy outcomes in the dual trigger and hCG trigger groups. In patients undergoing fresh embryo transfer (ET) and frozen-thawed ET, we also conducted a subgroup analysis to evaluate whether dual trigger improves the clinical pregnancy rate (CPR).; Results: We included 10 randomised studies, with 825 participants in the dual trigger group and 813 in the hCG trigger group. Compared with the hCG trigger, dual trigger was associated with a significant increase in the LBR per cycle (odds ratio (OR) = 1.61[1.16, 2.25]), number of oocytes retrieved (mean difference [MD] = 1.05 [0.43, 1.68]), number of mature oocytes retrieved (MD = 0.82 [0. 84, 1.16]), and CPR (OR = 1.48 [1.08, 2.01]). Subgroup analyses revealed that dual trigger was associated with a significantly increased CPR in patients who received fresh ET (OR = 1.68 [1.14, 2.48]). By contrast, the dual trigger was not associated with an increased CPR in the patient group with frozen-thawed ET (OR = 1.15 [0.64, 2.08]).; Conclusion: The dual trigger was associated with a significantly higher number of retrieved oocytes, number of mature oocytes, CPR, and LBR in IVF than the hCG trigger. The beneficial effect for fresh ET cycles compared with frozen-thawed ET might be associated with increased endometrial receptivity.; Relevance: After dual trigger, delaying ET due to the concern of endometrial receptivity might not be needed. (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Hu, C., et al. (2022). "Does completion of radical hysterectomy improve oncological outcomes of women with clinical early-stage cervical cancer and intraoperative detection of nodal involvement?: protocol for a systematic review and meta-analysis." BMJ Open 12(7): e056848.
	Introduction: The management of women with clinical early-stage cervical cancer and lymph node involvement detected intraoperatively is heterogeneous and controversial. This paper presents the protocol of a systematic review and meta-analysis regarding the management of this specific population of patients. This proposed study aims to answer the question: does completion of radical hysterectomy improve the oncological outcomes of women with clinical early-stage cervical cancer and intraoperatively detected nodal involvement?; Methods and Analysis: This protocol is drafted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines, and the proposed study will be conducted in accordance with the standard guidelines of 'Preferred Reporting Items for Systematic Reviews and Meta-Analyses' and 'Meta-analysis of Observational Studies in Epidemiology reporting guideline'. Comprehensive literature searches will be performed in PubMed, Embase, Scopus, and Web of Science. The screening of the eligible studies, the extraction of data of interest, and the quality assessment of the included studies will all be independently performed by different members of our team. The primary outcome of this proposed study will be comparing the risk of recurrence or death from cervical cancer and the risk of all-cause death in patients with two different treatments (completion of radical hysterectomy or abandonment of radical hysterectomy); the secondary outcome of this proposed study will be comparing the risk of the grade 3/4 toxicities associated with the two types of management. Given the clinical heterogeneity among the included studies, data on outcomes will be pooled by random-effects models. Heterogeneity will be evaluated using the I 2 statistic. The risk of bias for the included studies will be evaluated using the Newcastle-Ottawa Scale or the Cochrane collaboration's tool. The grade of evidence will be evaluated by two independent members of our team using the Grading of Recommendations, Assessment, Development and Evaluations approach.; Ethics and Dissemination: Ethical approval is not required because there will no primary data collected. The findings of this proposed study will be published in an international peer-reviewed journal.; Prospero Registration Number: CRD42021273527.; 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.)

Hu, K.-L., et al. (2020). "Melatonin Application in Assisted Reproductive Technology: A Systematic Review and Meta-Analysis of Randomized Trials." Frontiers in Endocrinology 11: 160.
	Objective: To study whether melatonin treatment can increase clinical pregnancy rate and live birth rate in assisted reproductive technology (ART) cycles. Methods: Literature searches were conducted to retrieve randomized trials that reported the effect of melatonin treatment on ART outcomes. Databases searched included PubMed, EMBASE, Cochrane Library, Web of Science, and Google Scholar. Results: Ten studies matched the inclusion criteria. Clinical pregnancy was reported in all of the included studies and live birth was reported in three studies. Melatonin treatment significantly increased the clinical pregnancy rate [OR = 1.43 (1.11, 1.86), power = 0.98, 10 RCTs, low-quality evidence] but not the live birth rate [OR = 1.38 (0.78, 2.46), power = 0.34, 3 RCTs, low-quality evidence]. Melatonin treatment increased the number of oocyte collected [SMD = 0.34 (0.01, 0.67), 7 RCTs, low-quality evidence], the number of maturated oocyte [SMD = 0.56 (0.27, 0.85), 7 RCTs, low-quality evidence], and the number of good quality embryo [MD = 0.36 (0.18, 0.55), 3 RCTs, low-quality evidence]. Melatonin treatment significantly increased the biochemical pregnancy rate [OR = 1.65 (1.14, 2.38), 6 RCTs, low-quality evidence] and had no significant effect on the miscarriage rate [OR = 1.28 (0.65, 2.51), 5 RCTs, low-quality evidence]. Conclusion: Melatonin treatment significantly increases the clinical pregnancy rate but not live birth rate in ART cycles. Melatonin treatment also increases the number of oocyte collected, maturated oocyte, and good quality embryo. No clear evidence suggested that melatonin treatment increased the adverse events in ART cycles. The actual findings may be compromised due to the wide heterogeneity of the included IVF patients, from PCOS to low ovarian reserve. (Copyright © 2020 Hu, Ye, Wang and Zhang.)

Hu, X., et al. (2023). "Comparison of nutritional supplements in improving glycolipid metabolism and endocrine function in polycystic ovary syndrome: a systematic review and network meta-analysis." PeerJ 11: e16410.
	Objective: To explore the comparative effectiveness of nutritional supplements in improving glycolipid metabolism and endocrine function in patients with polycystic ovary syndrome (PCOS).; Method: Randomized controlled clinical trials on the effects of nutritional supplements in PCOS patients were searched in PubMed, Embase, Cochrane Library, and Web of Science from their establishments to March 15, 2023. Then, literature screening, data extraction, and network meta-analysis were performed. This study was registered at PROSPERO (registration number CRD 42023441257).; Result: Forty-one articles involving 2,362 patients were included in this study. The network meta-analysis showed that carnitine, inositol, and probiotics reduced body weight and body mass index (BMI) compared to placebo, and carnitine outperformed the other supplements (SUCRAs: 96.04%, 97.73%, respectively). Omega-3 lowered fasting blood glucose (FBG) (SUCRAs: 93.53%), and chromium reduced fasting insulin (FINS) (SUCRAs: 72.90%); both were superior to placebo in improving insulin resistance index (HOMA-IR), and chromium was more effective than Omega-3 (SUCRAs: 79.99%). Selenium was potent in raising the quantitative insulin sensitivity index (QUICKI) (SUCRAs: 87.92%). Coenzyme Q10 was the most effective in reducing triglycerides (TG), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) levels (SUCRAs: 87.71%, 98.78%, and 98.70%, respectively). Chromium and probiotics decreased TG levels, while chromium and vitamin D decreased TC levels. No significant differences were observed in high-density lipoprotein cholesterol (HDL-C), total testosterone (TT), sex-hormone binding globulin (SHBG), and C-reactive protein (CRP) between nutritional supplements and placebo.; Conclusion: Carnitine was relatively effective in reducing body mass, while chromium, Omega-3, and selenium were beneficial for improving glucose metabolism. Meanwhile, coenzyme Q10 was more efficacious for improving lipid metabolism. However, publication bias may exist, and more high-quality clinical randomized controlled trials are needed.; Competing Interests: The authors declare that they have no competing interests. (© 2023 Hu et al.)

Hu, Y., et al. (2023). "Comparison of exenatide alone or combined with metformin versus metformin in the treatment of polycystic ovaries: a systematic review and meta-analysis." BMC Endocrine Disorders 23(1): 250.
	Background: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility in women of childbearing age. Randomized controlled trials (RCTs) have reported that exenatide and metformin are effective in the treatment of PCOS. In this meta-analysis, we aimed to compare the effectiveness and safety of exenatide alone or in combination with metformin versus metformin in patients suffering from PCOS.; Methods: RCTs of exenatide therapy were identified through a search of electronic databases in November 2022 and updated in October 2023. Eligible studies were identified independently by the reviewers. Outcomes were analysed with Revman 5.4.; Results: Nine RCTs among 214 studies on 1059 women with PCOS were included in the analysis, and among the nine RCTs, eight studies compared exenatide with metformin. Our meta-analysis demonstrated that exenatide was more effective than metformin in terms of pregnancy rate (RR 1.85 [95% CI 1.19,2.86] P = 0.006), sex hormone-binding globulin (SHBG) (MD 5 [95% CI 3.82,6.18] P < 0.001), and follicle-stimulating hormone (FSH) (MD 0.82 [95% 0.41,1.24] P < 0.001). The reductions in total testosterone (TT) (SMD -0.43 [95% CI -0.84, -0.03] P = 0.04) was more significant after treatment with exenatide than after treatment with metformin. In terms of safety, exenatide had a lower diarrhea rate (RR 0.11 [95% CI 0.01, 0.84]) than metformin. In the other three studies, exenatide plus metformin was compared with metformin. Exenatide combined with metformin was more effective in improving SHBG (MD 10.38[95%CI 6.7,14.06] P < 0.001), Matsuda index (MD 0.21[95%CI 0.05,0.37]) and reducing free androgen index (FAI) (MD -3.34 [-4.84, -1.83] P < 0.001), Weight (MD -2.32 [95%CI -3.89, -0.66]) and WC (MD-5.61[95%CI -8.4, -2.82] P < 0.001). The incidence of side effects between exenatide plus metformin and metformin was not statistically significant.; Conclusions: Exenatide alone or in combination with metformin is more effective than metformin for women with PCOS. Considering the evidence on effectiveness and safety, exenatide alone or in combination with metformin may be a better treatment approach than metformin for women with PCOS.; Trial Registration: INPLASY https://inplasy.com/inplasy-protocols/ ID: 10.37766/inplasy2022.11.0055. (© 2023. The Author(s).)

Hua, L. and C. Wang (2023). "Recombinant-luteinzing hormone supplementation in women during IVF/ICSI cycles with GNRH-antagonist protocol: A systematic review and meta-analysis." European Journal of Obstetrics, Gynecology, and Reproductive Biology 283: 43-48.
	The objective of this meta-analysis is to determine the beneficial effect of recombinant-luteinizing Hormone (r-LH) addition in women undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) with gonadotropin-releasing hormone (GnRH) antagonist protocol and whether an optimal time of Recombinant-Luteinizing Hormone (r-LH) supplementation exist during the controlled of stimulation (COS). The primary outcomes are clinical Pregnancy rate and the number of oocytes retrieved. Secondary outcomes are the number of metaphase II oocytes, miscarriage rate and live birth rate. Results show that supplementation of LH generated a greater number of oocytes retrieved than patients who did not receive LH supplementation, but it did not help with other pregnancy outcomes. Furthermore, the result of the subgroup analysis revealed no significant difference in the outcomes with different LH addition times.; 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 Authors. Published by Elsevier B.V. All rights reserved.)

Huang, A. J., et al. (2023). "TReating Incontinence for Underlying Mental and Physical Health (TRIUMPH): a study protocol for a multicenter, double-blinded, randomized, 3-arm trial to evaluate the multisystem effects of pharmacologic treatment strategies for urgency-predominant urinary incontinence in ambulatory older women." Trials 24(1): 287.
	Background: Urgency-type urinary incontinence affects one in four older community-dwelling women and overlaps with other common aging-associated health syndromes such as cognitive impairment, physical mobility impairment, and depression. Observational studies have raised concern about potentially higher rates of delirium and dementia in older adults taking anticholinergic bladder medications, but few prospective data are available to evaluate the effects of these and other pharmacologic treatments for urgency incontinence on cognition and other multisystem functional domains important to older women. Method(s): The TRIUMPH study is a randomized, double-blinded, 3-arm, parallel-group trial comparing the multisystem effects of anticholinergic versus beta-3-adrenergic agonist bladder therapy and versus no active bladder anti-spasmodic pharmacotherapy in older women with urgency incontinence. Women aged 60 years and older (target N = 270) who have chronic urgency-predominant urinary incontinence and either normal or mildly impaired cognition at baseline are recruited from the community by investigators based in northern California, USA. Participants are randomized in equal ratios to take identically encapsulated oral anticholinergic bladder therapy (in the form of tolterodine 2 mg extended release [ER]), oral beta-3 adrenergic agonist bladder therapy (mirabegron 25 mg ER), or placebo daily for 24 weeks, with the option of participant-directed dose titration (to tolterodine 4 mg ER, mirabegron 50 mg ER, or matching placebo daily). Participants also receive patient-oriented information and instructions about practicing first-line behavioral management strategies for incontinence. The primary outcome is change in composite cognitive function over 24 weeks assessed by a comprehensive battery of cognitive tests, with a secondary exploration of the persistence of change at 36 weeks. Secondary outcomes include changes over 24 and 36 weeks in domain-specific cognitive function; frequency, severity, and impact of urgency-associated urinary symptoms; physical function and balance; sleep quality and daytime sleepiness; psychological function; and bowel function. Discussion(s): The TRIUMPH trial addresses the need for rigorous evidence to guide counseling and decision-making for older women who are weighing the potential multisystem benefits and risks of pharmacologic treatments for urgency incontinence in order to preserve their day-to-day functioning, quality of life, and independence in older age. Trial registration: ClinicalTrials.gov NCT05362292. Registered on May 5, 2022.Copyright © 2023, The Author(s).

Huang Alison, J., et al. (2023). "Efficacy of Continuous Transdermal Nitroglycerin for Treating Hot Flashes by Inducing Nitrate Cross-tolerance in Perimenopausal and Postmenopausal Women: A Randomized Clinical Trial." JAMA Internal Medicine 183(8): 776-783.
	Importance: Due to the potential risks of long-term systemic estrogen therapy, many menopausal women are interested in nonhormonal treatments for vasomotor symptoms. Physiologic studies indicate that nitric oxide plays a key role in mediating hot flash-related vasodilation, suggesting that nonhormonal medications that induce nitrate tolerance in the vasculature may offer therapeutic benefit for vasomotor symptoms.; Objective: To determine whether uninterrupted administration of transdermal nitroglycerin (NTG) to induce nitrate cross-tolerance decreased the frequency or severity of menopause-related hot flashes.; Design, Setting, and Participants: This randomized, double-blinded, placebo-controlled clinical trial included perimenopausal or postmenopausal women reporting 7 or more hot flashes per day who were recruited from northern California by study personnel at a single academic center. Patients were randomized between July 2017 and December 2021, and the trial ended in April 2022 when the last randomized participant completed follow-up.; Interventions: Uninterrupted daily use of transdermal NTG (participant-directed dose titration from 0.2-0.6 mg/h) or identical placebo patches.; Main Outcome Measures: Validated symptom diaries assessing changes in any hot flash frequency (primary outcome) and moderate-to-severe hot flash frequency over 5 and 12 weeks.; Results: Among the 141 randomized participants (70 NTG [49.6%], 71 placebo [50.4%]; 12 [85.8%] Asian, 16 [11.3%] Black or African American, 15 [10.6%] Hispanic or Latina, 3 [2.1%] multiracial, 1 [0.7%] Native Hawaiian or Pacific Islander, and 100 [70.9%] White or Caucasian individuals), a mean (SD) of 10.8 (3.5) hot flashes and 8.4 (3.6) moderate-to-severe hot flashes daily was reported at baseline. Sixty-five participants assigned to NTG (92.9%) and 69 assigned to placebo (97.2%) completed 12-week follow-up (P = .27). Over 5 weeks, the estimated change in any hot flash frequency associated with NTG vs placebo was -0.9 (95% CI, -2.1 to 0.3) episodes per day (P = .10), and change in moderate-to-severe hot flash frequency with NTG vs placebo was -1.1 (95% CI, -2.2 to 0) episodes per day (P = .05). At 12 weeks, treatment with NTG did not significantly decrease the frequency of any hot flashes (-0.1 episodes per day; 95% CI, -1.2 to 0.4) or moderate-to-severe hot flashes (-0.5 episodes per day; 95% CI, -1.6 to 0.7) relative to placebo. In analyses combining 5-week and 12-week data, no significant differences in change in the frequency of any hot flashes (-0.5 episodes per day; 95% CI, -1.6 to 0.6; P = .25) or moderate-to-severe hot flashes (-0.8 episodes per day; 95% CI, -1.9 to 0.2; P = .12) were detected with NTG vs placebo. At 1 week, 47 NTG (67.1%) and 4 placebo participants (5.6%) reported headache (P < .001), but only 1 participant in each group reported headache at 12 weeks.; Conclusions and Relevance: This randomized clinical trial found that continuous use of NTG did not result in sustained improvements in hot flash frequency or severity relative to placebo and was associated with more early but not persistent headache.; Trial Registration: Clinicaltrials.gov Identifier: NCT02714205.

Huang, C., et al. (2023). "Platelet-Rich Plasma Intrauterine Infusion as Assisted Reproduction Technology (ART) to Combat Repeated Implantation Failure (RIF): A Systematic Review and Meta-Analysis." Iranian Journal of Public Health 52(8): 1542-1554.
	Background: Repeated implantation failure (RIF) is considered one of the major challenges facing clinician in assisted reproduction technologies (ART) despite the significant advances that have been made in this field. Platelet rich plasma (PRP), also known as autologous conditioned plasma, is a protein concentrate with anti-inflammatory and pro-regenerative characteristics. The use of PRP in women undergoing ART has been studied in the past, with varying degrees of success. The goal of this trial was to see if injecting PRP into the uterus improves pregnancy outcomes in women receiving ART.; Methods: PubMed, Embase, Scopus, Web of Science, and the Cochrane Database of Clinical Trials were among the databases searched (CENTRAL), from 2015 to 2021. The pooled estimates were calculated using a meta-analysis with a random-effects model. There were 14 studies with a total of 1081 individuals (549 cases and 532 controls).; Results: There was no difference in miscarriage rates between women who got PRP and those who received placebo ( P≤0.90 ). Chemical pregnancy ( P≤0.00 ), clinical pregnancy (P ≤0.001 ), and implantation rate ( P≤ 0.001 ) were all significantly higher in women. Endometrial thickness increased in women who got PRP vs women who received placebo after the intervention ( P ≤0.001 ).; Conclusion: PRP may be an alternate therapeutic approach for individuals with thin endometrium and RIF, according to the findings of this comprehensive study. To determine the subgroup that would benefit the most from PRP, more prospective, big, and high-quality randomized controlled trials (RCTs) are needed. (Copyright © 2023 Huang et al. Published by Tehran University of Medical Sciences.)

Huang, D., et al. (2024). "Efficacy and safety of VEGF/VEGFR inhibitors for platinum-resistant ovarian cancer: a systematic review and meta-analysis of randomized controlled trials." BMC Women's Health 24(1): 34.
	Background: Almost all patients with ovarian cancer will experience relapse and eventually develop platinum-resistant. The poor prognosis and limited treatment options have prompted the search for novel approaches in managing platinum-resistant ovarian cancer (PROC). Therefore, a meta-analysis was conducted to evaluate the efficacy and safety of combination therapy with vascular endothelial growth factor (VEGF) /VEGF receptor (VEGFR) inhibitors for PROC. Method(s): A comprehensive search of online databases was conducted to identify randomized clinical trials published until December 31, 2022. Pooled hazard ratios (HR) was calculated for overall survival (OS) and progression-free survival (PFS), while pooled odds ratio (OR) was calculated for objective response rate (ORR) and treatment-related adverse events (TRAEs). Subgroup analysis was further performed to investigate the source of heterogeneity. Result(s): In total, 1097 patients from eight randomized clinical trials were included in this meta-analysis. The pooled HRs of OS (HR = 0.72; 95% CI: 0.62-0.84, p < 0.0001) and PFS (HR = 0.52; 95% CI: 0.45-0.59, p < 0.0001) demonstrated a significant prolongation in the combination group compared to chemotherapy alone for PROC. In addition, combination therapy demonstrated a superior ORR compared to monotherapy (OR = 2.34; 95%CI: 1.27-4.32, p < 0.0001). Subgroup analysis indicated that the combination treatment of VEGF/VEGFR inhibitors and chemotherapy was significantly more effective than monochemotherapy in terms of OS (HR = 0.71; 95% CI: 0.61-0.84, p < 0.0001), PFS (HR = 0.49; 95% CI: 0.42-0.57, p < 0.0001), and ORR (OR = 2.97; 95% CI: 1.89-4.67, p < 0.0001). Although the combination therapy was associated with higher incidences of hypertension, mucositis, proteinuria, diarrhea, and hand-foot syndrome compared to monochemotherapy, these toxicities were manageable and well-tolerated. Conclusion(s): The meta-analysis demonstrated that combination therapy with VEGF/VEGFR inhibitors yielded better clinical outcomes for patients with PROC compared to monochemotherapy, especially when combined with chemotherapy. This analysis provides more treatment options for patients with PROC. Systematic review registration: [ https://www.crd.york.ac.uk/PROSPERO ], Prospective Register of Systematic Reviews (PROSPERO), identifier: CRD42023402050.Copyright © 2024, The Author(s).

Huang, J., et al. (2023). "Efficacy and safety of vaginal electrical stimulation as an alternative or adjunct treatment for overactive bladder syndrome in women: a meta-analysis of randomized controlled trials." International Urogynecology Journal 34(10): 2345-2357.
	Introduction and hypothesis: The objective was to evaluate the efficacy and safety of vaginal electrical stimulation (VES) as an alternative or adjunct treatment for overactive bladder (OAB) syndrome in women. Method(s): Five English-language databases and four Chinese-language databases were searched to identify relevant studies. Studies comparing VES (VES alone or VES plus other interventions) with other interventions (medicines, bladder training, or PFMT) were included. Voiding diary, quality of life (QoL), and adverse events were extracted from the included studies for comparison. Result(s): Seven trials with 601 patients in total were reviewed. The results showed that when compared with other interventions, VES alone significantly improved urgency episodes (p = 0.0008) and voiding frequency (p = 0.01), but did not significantly reduce nocturia (p = 0.85), urinary incontinence episodes (p = 0.90) and number of pads (p = 0.87). When VES plus other interventions was compared with other interventions, the former significantly improved voiding frequency (p < 0.00001), nocturia (p < 0.00001), and number of pads (p = 0.03), but it did not significantly reduce urinary incontinence episodes (p = 0.24). Both VES alone (p < 0.00001) and VES plus other interventions (p = 0.003) showed significant benefit on QoL. Conclusion(s): This study demonstrated that VES alone decreased urgency episodes and QoL better than other therapies. Although VES alone reduced voiding frequency better and VES plus other therapies decreased nocturia, number of pads, urgency episodes, and QoL better than other therapies, the results should be interpreted with caution for clinical practice because some of the RCTs included were of low quality and because of the small number of studies included.Copyright © 2023, The International Urogynecological Association.

Huang, L., et al. (2022). "Effectiveness and toxicity of metronomic oral cyclophosphamide for recurrent or platinum-refractory ovarian cancer: A meta-analysis." Heliyon 8(8): e10399.
	PURPOSE: To systematically assess the effectiveness and toxicity of metronomic oral cyclophosphamide (MOC) on recurrent or platinum-refractory ovarian cancer. METHODS: We searched the Cochrane Library, Embase, PubMed, CNKI, Weipu, and Wanfang databases for eligible studies. A descriptive statistical method was used to analyze the pooled results. Ratios and means were merged to analyze the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and the rate of serious adverse events (SAEs). Subgroup analysis, sensitivity analysis, and examination of publication bias were conducted for heterogeneity test and quality assurance of the results. RESULTS: The ORR and DCR by MOC were 25% (95% CI 12-41) and 61% (95% CI 43-77), respectively. The median PFS and OS were 4.29 months (95% CI 2.62-5.97) and 11.26 months (95% CI 8.13-14.39), respectively. The rate of SAEs was 41% (95% CI 30-52). The most frequent SAEs were gastrointestinal toxicity 6% (95% CI 1-12), lymphopenia 6% (95% CI 1-13), and neutropenia 5% (95% CI 2-9). In the subgroup analysis, the ORR and DCR in the subgroup of MOC combined with bevacizumab/pazopanib were 42% (95% CI 26-58) and 82% (95% CI 63-95), respectively. The median PFS and OS were 7.32 months (95% CI 5.93-8.70) and 17.35 months (95% CI 12.89-21.82), respectively. CONCLUSION: MOC has a certain effect in clinical response on patients with recurrent or platinum-refractory ovarian cancers, especially when MOC combined with bevacizumab/pazopanib. However, there is a high risk of SAEs.

Huang, X., et al. (2022). "Effects of the non-pharmacological interventions of traditional Chinese medicine on postpartum depression: A protocol for systematic review and network meta-analysis." Medicine 101(9): e28939.
	Background: Postpartum depression (PPD) has become one of the common disorders during the postpartum period. The non-pharmacological interventions of traditional Chinese medicine (TCM) have achieved good results in the treatment of PPD. However, the efficacy of different non-pharmacological interventions of TCM for PPD has not been fully elucidated. Due to the large number of non-pharmacological intervention of TCM modalities, the selection of appropriate non-pharmacological interventions of TCM has become an urgent clinical problem. The aim of this network meta-analysis was to explore the best choice for different non-pharmacological interventions of TCM for PPD.; Methods: PubMed, Web of Science, Scopus, Cochrane Library, Embase, China Scientific Journal Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and Wanfang Data were searched to identify the randomized controlled trials of non-pharmacological interventions of TCM for PPD from the inception to February 2022. Two researchers will be independently responsible for literature screening, data extraction, and assessment of their quality. Standard pair-wise and Bayesian network meta-analysis will be performed to compare the efficacy of different non-pharmacological interventions of TCM for PPD via Stata 14.0 and WinBUGS1.4 software.; Results: The results of this meta-analysis will be submitted to a peer-reviewed journal for publication.; Conclusions: The conclusion of this systematic review will provide evidence for the selection of an optimal non-pharmacological interventions of TCM for PPD.; Ethics and Dissemination: Ethical approval is not required for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences, and shared on social media platforms.; Osf Registration Number: DOI 10.17605/OSF.IO/TM96G.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Huang, Y., et al. (2024). "Assessing the Efficacy of Clotrimazole and Metronidazole Combined Treatment in Vaginitis: A Meta-Analysis." Alternative Therapies in Health and Medicine 30(1): 186-191.
	Objective: This meta-analysis aims to assess the efficacy of combining clotrimazole and metronidazole in the treatment of mixed infectious vaginitis (VA). The goal is to provide clinical guidance for future medication strategies. Method(s): We conducted a comprehensive search of the literature database for studies involving the use of clotrimazole combined with metronidazole in the treatment of mixed infectious VA. After rigorous screening, eligible studies were subjected to meta-analysis using RevMan 5.3 software. Outcome measures included cure rates, recurrence rates, and the incidence of adverse reactions. Result(s): Six randomized controlled trials (RCTs) were included, comprising 160 patients in the test group (treated with clotrimazole combined with metronidazole) and 160 patients in the control group (treated with alternative regimens). All selected studies were of high quality and possessed significant reference value. Meta-analysis results indicated that, in comparison to the control group, the test group exhibited a comparable incidence of adverse reactions (P > .05), higher cure rates, increased treatment satisfaction, and a lower recurrence rate (P < .05). Conclusion(s): The combination of clotrimazole and metronidazole is an effective treatment option for mixed infectious vaginitis, thus warranting recommendation.

Huang, Y. and X. Zhang (2023). "Meta-analysis of the efficacy of omega-3 polyunsaturated fatty acids when treating patients with polycystic ovary syndrome." Medicine 102(39): E35403.
	Objective: To systematically assess the efficacy of omega-3 polyunsaturated fatty acids (PUFAs) when treating polycystic ovary syndrome (PCOS). Method(s): 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 omega-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. Result(s): Our meta-analysis included 7 clinical control studies comprising 574 samples to evaluate the impact of omega-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 omega-3 PUFAs could be beneficial in managing specific metabolic markers in PCOS, although the results showed marked heterogeneity. Conclusion(s): In PCOS patients, PUFAs can enhance reproductive endocrine, glucose, and lipid levels. However, additional research and extended follow-up are required to confirm this.Copyright © 2023 Lippincott Williams and Wilkins. All rights reserved.

Huang, Z., et al. (2020). "Efficacy of telemedicine for urinary incontinence in women: a systematic review and meta-analysis of randomized controlled trials." International Urogynecology Journal 31(8): 1507-1513.
	Objectives: The systematic review and meta-analysis were performed to summarize the available evidence and assess the efficacy of telemedicine for urinary incontinence in women. Method(s): PUBMED, EMBASE, Web of Science, The Cochrane Library, CBM, CNKI, WanFang, and VIP databases were electronically searched to identify eligible studies updated to February 2020 to collect RCTs regarding the efficacy of telemedicine for urinary incontinence in women. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of included studies with the Cochrane Handbook for Systematic Reviews of Interventions. A meta-analysis was performed using RevMan 5.3. Result(s): Seven studies involving a total of 836 patients were included in the systematic review and meta-analysis. The results of the meta-analysis showed that compared with usual care, telemedicine intervention significantly reduced the UI severity (SMD = -0.90, 95% CI, -1.73 - -0.07, P = 0.003) and improved QOL (SMD = 0.71, 95% CI, 0.21-1.20, P = 0.005). The results of the descriptive analysis indicated that telemedicine intervention can also reduce the patients' anxiety and depression, improving patients' self-efficacy and their impression of improvement. Conclusion(s): The systematic review and meta-analysis demonstrate that telemedicine can reduce the UI severity and anxiety and depression, improving QOL, self-efficacy, and impression of improvement for women with urinary incontinence. Due to the limited quality and quantity of the included studies, rigorous studies with adequate sample sizes are required to conclude with more confidence.Copyright © 2020, The International Urogynecological Association.

Huang, Z., et al. (2021). "Regenerated Cell Therapy for Stress Urinary Incontinence: A Meta-Analysis." Journal of Investigative Surgery 34(12): 1366-1376.
	Purpose: To evaluate the efficacy and safety of regenerated cell therapy for stress urinary incontinence (UI) in humans. Method(s): We searched articles from PubMed, Embase, and the Cochrane Library database published before February 24, 2020. Of 396 records identified, 23 articles on human clinical research met our criteria, including a total of 890 patients. Stata/SE12.0 software was used to analyze cure, efficiency (cure rate plus improvement rate), and complication rates. Result(s): No significant differences in cure rates and effective rates were observed for any cell type in males. However, in females, the myocytes with fibroblasts subgroup (82%) and nucleated cells with platelets subgroup (89%) exhibited significantly higher cure rates compared with the other two subgroups (25% and 36%). Pooled effective rates of myocytes and fibroblasts (92%) and nucleated cells with platelets (97%) were also higher compared with the other two subgroups (72% and 60%). Pooled complication rates were 23% and 26% in males and females, respectively, and there were some differences among subgroups. Although some studies reported postoperative complications, no serious complications were reported and most recovered within 1-2 weeks. Conclusion(s): Limited studies have indicated the safety and effectiveness of regenerated cells for treating stress UI in the follow-up period, which may be an ideal method to treat stress UI in the future. Moreover, nucleated cells with platelets and myocytes with fibroblasts were markedly effective, but whether cell injection therapies elicit superior effects need further confirmation.Copyright © 2020 Taylor & Francis Group, LLC.

Huchon, C., et al. (2023). "Operative Hysteroscopy vs Vacuum Aspiration for Incomplete Spontaneous Abortion: A Randomized Clinical Trial." JAMA 329(14): 1197-1205.
	Importance: Vacuum aspiration is commonly used to remove retained products of conception in patients with incomplete spontaneous abortion. Scarring of the uterine cavity may occur, potentially impairing future fertility. A procedural alternative, operative hysteroscopy, has gained popularity with a presumption of better future fertility.; Objective: To assess the superiority of hysteroscopy to vacuum aspiration for subsequent pregnancy in patients with incomplete spontaneous abortion who intend to have future pregnancy.; Design, Setting, and Participants: The HY-PER randomized, controlled, single-blind trial included 574 patients between November 6, 2014, and May 3, 2017, with a 2-year duration of follow-up. This multicenter trial recruited patients in 15 French hospitals. Individuals aged 18 to 44 years and planned for surgery for an incomplete spontaneous abortion with plans to subsequently conceive were randomized in a 1:1 ratio.; Interventions: Surgical treatment by hysteroscopy (n = 288) or vacuum aspiration (n = 286).; Main Outcomes and Measures: The primary outcome was a pregnancy of at least 22 weeks' duration during 2-year follow-up.; Results: The intention-to-treat analyses included 563 women (mean [SD] age, 32.6 [5.4] years). All aspiration procedures were completed. The hysteroscopic procedure could not be completed for 19 patients (7%), 18 of which were converted to vacuum aspiration (8 with inability to completely resect, 7 with insufficient visualization, 2 with anesthetic complications that required a shortened procedure, 1 with equipment failure). One hysteroscopy failed due to a false passage during cervical dilatation. During the 2-year follow-up, 177 patients (62.8%) in the hysteroscopy group and 190 (67.6%) in the vacuum aspiration (control) group achieved the primary outcome (difference, -4.8% [95% CI, -13% to 3.0%]; P = .23). The time-to-event analyses showed no statistically significant difference between groups for the primary outcome (hazard ratio, 0.87 [95% CI, 0.71 to 1.07]). Duration of surgery and hospitalization were significantly longer for hysteroscopy. Rates of new miscarriages, ectopic pregnancies, Clavien-Dindo surgical complications of grade 3 or above (requiring surgical, endoscopic, or radiological intervention or life-threatening event or death), and reinterventions to remove remaining products of conception did not differ between groups.; Conclusions and Relevance: Surgical management by hysteroscopy of incomplete spontaneous abortions in patients intending to conceive again was not associated with more subsequent births or a better safety profile than vacuum aspiration. Moreover, operative hysteroscopy was not feasible in all cases.; Trial Registration: ClinicalTrials.gov Identifier: NCT02201732.

Huddleston, H. (2022). "Restoring Metabolic and Reproductive Health With Sleep in PCOS Study, CPAP Trial." ClinicalTrials.gov.
	No Results Available Device: Continuous Positive Airway Pressure Device (CPAP)|Other: Delayed Continuous Positive Airway Pressure Device (CPAP) Number of participants showing a change in fractional de novo lipogenesis (DNL, %)|Number of participants showing a change in free testosterone (pg/mL)|Number of participants showing a change in insulin secretion rate (picomol/min) Female Not Applicable 20 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 22-36861 April 30, 2024

Huddleston Heather, G. (2023). "Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome." ClinicalTrials.gov.
	Study synopsis: Recruitment: ‐ PCOS participants will be recruited from those who are being seen or have previously been seen at the UCSF multidisciplinary PCOS clinic. ‐ Non‐PCOS participants will be recruited from patients being seen at the UCSF Center for Reproductive Health for other clinical evaluations or research projects. Study protocol: Aim 1: Pre‐DEXCOM evaluation: PCOS participants: ‐ As part of routine clinical care all PCOS participants will have had the following procedures completed: ‐ Blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17‐OH‐Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D. ‐ Screening questionnaires on physical exercise using validated International Physical Activity Questionnaire ‐ In person clinical evaluation including physical exam and history. ‐ In person transvaginal ultrasound assessment. ‐ The above are part of standard of care screening for patients with concern for PCOS and are currently routinely completed at the UCSF Center for Reproductive Health in this setting. ‐ Participants will also be asked to complete a 10 question validated fatigue assessment scale (FAS) Non‐PCOS participants: ‐ Participants will have blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17‐OH‐ Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D obtained. ‐ Screening questionnaires on physical exercise using validated International Physical Activity Questionnaire will be obtained. ‐ Participants will be asked to complete the same intake questionnaires that PCOS participants complete as part of standard of care practices in the UCSF multidisciplinary PCOS clinic, which include questions on ethnicity, family, medical, and social history. ‐ If blood work was not completed as part of standard of care for routine clinical evaluation or as part of a previously completed research study in which the patient provided consent for their data to be used in other trials, the above labs will be collected and paid for by the research protocol. ‐ Participants will also be asked to complete a 10 question validated fatigue assessment scale (FAS) Procedures: DEXCOM evaluation: ‐ PCOS and non‐PCOS participants will be given a DEXCOM CGM to wear for 10 days. During this time they will be blinded to the results of the DEXCOM. ‐ Participants will be asked to complete the automated self‐administered 24‐hour dietary assessment (ASA24) tool, which is a web based, validated 24 hour dietary record program, produced by the National Cancer Institute (NCI)/Nation Institute of Health and made available free of charge to researchers. ‐ As part of the ASA24 participants will also be asked about their sleep quality the night prior to their dietary record. See attached module. ‐ All participants will be asked to complete the ASA24 during a 24 hour period while wearing the CGM. Aim 2: Recruitment: ‐ From those participants with PCOS recruited for Aim 1, a subgroup with evidence of dysglycemia (as outlined in the inclusion criteria) will be recruited for aim 2. ‐ Participants will be randomized in a 3:1 fashion to intervention with CGM vs control. Procedures: Intervention group: ‐ All participants will receive standard of care nutrition and exercise advice from a trained registered dietician. ‐ Participants randomized to the intervention arm will also receive education on how to use and monitor blood glucose using the DEXCOM G7 CGM and associated phone application. ‐ Participants will be asked to use a CGM continuously for 90 days. ‐ After 90 days blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17‐OH‐Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D will be obtained. ‐ After 90 days participants will also be asked to repeat a 10 question vali ted fatigue assessment scale (FAS) ‐ After 90 days participants will be asked about their menstrual cycle pattern over the 90 day period Control group: ‐ All participants will receive standard of care nutrition and exercise advice from a trained registered dietician. ‐ After 90 days blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17‐OH‐Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D will be obtained. ‐ After 90 days, participants in the control group will be given the opportunity to receive CGM devices to monitor blood glucose up to 30 days with education on how to use the device and associated phone application to monitor blood glucose. ‐ After 90 days participants will also be asked to repeat a 10 question validated fatigue assessment scale (FAS) ‐ After 90 days participants will be asked about their menstrual cycle pattern over the 90 day period Data Management: Clinical and laboratory data will be stored in a Research Electronic Data Capture (REDCap) system designed by Dr. Huddleston and research staff. Fields will be designed by study coordinators with input from key investigators. Our team has extensive experience with REDCap architecture and utilization.

Huh, K., et al. (2023). "Online Public Health Nurse-Delivered Group Cognitive Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial During the COVID-19 Pandemic." The Journal of Clinical Psychiatry 84(5).
	Objective: Rates of postpartum depression (PPD) increased during the COVID-19 pandemic, further highlighting the need for effective, accessible treatments for PPD. While public health nurses (PHNs) can be trained to help treat PPD, it is not known if they can effectively deliver evidence-based psychotherapies online to those with PPD.; Methods: Mothers (n = 159) living in Ontario, Canada, with an Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10 and an infant < 12 months of age were randomized to receive a 9-week group cognitive behavioral therapy (CBT) intervention delivered by PHNs over Zoom, between October 2020 and November 2021. Experimental group participants received CBT plus treatment as usual (TAU), and control participants received TAU alone. Participants were assessed at baseline (T1), 9 weeks later (T2), and 6 months after T2 (T3). Primary outcomes were changes in EPDS score and current major depressive disorder (MDD) as measured by the Mini International Neuropsychiatric Interview. Secondary outcomes included worry, social support, the mother-infant relationship, and infant temperament.; Results: At T2, experimental group participants showed clinically and statistically significant reductions on the EPDS ( d = 0.65) and decreases in postpartum worry ( d = 0.38) and rejection and pathological anger toward their infant ( d = 0.44). They were also less likely to meet diagnostic criteria for current MDD compared to control participants (OR = 5.09; 95% CI, 1.18-21.98; number needed to treat [NNT: 3.7]). These improvements remained stable 6 months later (T3).; Conclusions: PHNs can be trained to deliver effective online group CBT for PPD to reduce depression and worry and improve aspects of the mother-infant relationship, and they represent an important way to increase access to effective treatment for PPD.; Trial Registration: ClinicalTrials.gov identifier: NCT04928742. (© Copyright 2023 Physicians Postgraduate Press, Inc.)

Hui, H., et al. (2022). "Acupuncture combined with Metformin to improve metabolic prognosis in Polycystic Ovary Syndrome patients with Obesity:a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Huimin, Z., et al. (2023). "Effects of electroacupuncture on the pregnancy outcomes in patients undergoing assisted reproduction: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Huiyan, F., et al. (2021). "Clotrimazole vs fluconazole for the treatment of vulvovaginal candidiasis: a meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Hülya, K., et al. (2023). "The Effect of Soya Isoflavones Given to Women in Climacteric Period on Menopausal Symptoms and Quality of Life: Systematic Review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Hunter, E., et al. (2021). "The effectiveness of weight-loss lifestyle interventions for improving fertility in women and men with overweight or obesity and infertility: A systematic review update of evidence from randomized controlled trials." Obesity Reviews 22(12): e13325.
	Being overweight or obese can have a negative impact on fertility outcomes. This systematic review updates randomized controlled trial (RCT) findings on the effectiveness of weight loss interventions in reducing weight and improving reproductive outcomes of women and men with overweight or obesity and infertility. Eligible studies, published since the last review, were identified by searching databases from March 20, 2016 until March 31, 2020. RCTs involving any type of lifestyle intervention were considered. Eight RCTs were identified and aggregated with seven RCTs included in our previous review. Meta-analyses revealed that women randomized to a combined diet and exercise intervention were more likely to become pregnant, risk ratio (RR) = 1.87 (95% CI 1.20, 2.93) and achieve a live birth RR = 2.20 (95% CI 1.23, 3.94), compared to women in control groups who received no or minimal intervention. This pattern was not replicated in trials where control groups received immediate access to assisted reproductive technology (ART). No eligible randomized trials involving men were identified. Data were largely obtained from small scale studies. Better designed, adequately powered, robust randomized trials are needed to better understand the effect of weight loss interventions on reproductive outcomes in both women and men.Copyright © 2021 World Obesity Federation

Huo, G., et al. (2024). "Cost-effectiveness of tisotumab vedotin as a second- or third-line therapy for cervical cancer." Journal of Gynecologic Oncology.
	OBJECTIVE: To evaluate the cost-effectiveness of tisotumab vedotin to treat recurrent or metastatic cervical cancer in second- or third-line from the U.S. payer perspective. METHODS: A Markov model with three-state was employed to simulate recurrent or metastatic cervical cancer patients who were administered either tisotumab vedotin or investigator's choice of chemotherapy based on the phase II, open-labeled innovaTV 301 randomized clinical trial. The data on cost and health preferences were collected from the literature. RESULTS: Tisotumab vedotin generated an additional 0.25 quality-adjusted life-years (QALYs) compared to chemotherapy, but at an additional cost of $206,779. This results in incremental cost-effectiveness ratios of 839,107.88 per QALY. The results of the univariate sensitivity analysis indicated that cost of tisotumab vedotin, utility of progressive disease and progression-free survival had the greatest impacts on the outcomes. Probability sensitivity analysis showed that tisotumab vedotin had a 0% chance of being considered cost-effective. CONCLUSION: Tisotumab vedotin was unlikely cost-effective compared to chemotherapy for recurrent or metastatic cervical cancer patients at a willingness-to-pay threshold of $150,000/QALY from the perspective of a U.S. payer. Lowering the prices of tisotumab vedotin could potentially enhance its cost-effectiveness.

Hurt, K., et al. (2021). "Extracorporeal shock wave therapy for treating dyspareunia: a prospective, randomized, double-blind, placebo-controlled study." Annals of Physical and Rehabilitation Medicine 64(6): 101545.
	BACKGROUND: Dyspareunia is a genital pain during or after penile‐vaginal sexual intercourse. It is a painful spasm of the pelvic muscles that partly or entirely disables vaginal penetration. OBJECTIVES: We examined the effect of extracorporeal shock wave therapy (ESWT) on idiopathic non‐organic dyspareunia in women. A prospective, randomized, double‐blind, placebo‐controlled study was conducted. METHODS: The study included 62 women who reported dyspareunia. Patients in the treatment and placebo groups received ESWT perineally weekly for 4 consecutive weeks; placebo patients received placebo stand‐off treatment. The grade of dyspareunia was estimated by using the Marinoff Dyspareunia Scale and subjective pain intensity on a visual analog scale (VAS) before and after treatment. Follow‐ups were conducted 1, 4 and 12 weeks after the final ESWT session. RESULTS: The study included 61 women. The treatment but not placebo group differed by the Marinoff Dyspareunia Scale and VAS. Differences before and after treatment within groups were all p<0.001 and between groups, p<0.001. Pain reduction was always >30%. The effect sizes were both large: Marinoff 0.825 and VAS 0.883. CONCLUSIONS: ESWT significantly reduced subjective pain in our women treated for dyspareunia.

Hurtaud, A. (2023). "Interest of a Short Early Psychological Care in Women With Miscarriage." ClinicalTrials.gov.
	No Results Available Other: short early psychological care associated with encouragement of early support consultation with generalist practitioner or midwife|Other: encouragement of early support consultation with generalist practitioner or midwife anxiety|depression Female Not Applicable 932 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2022_RIPH_003_MisTher December 1, 2026

Husain, N., et al. (2022). "Multicentre randomised controlled trial of a group psychological intervention for postnatal depression in British mothers of South Asian origin (ROSHNI-2): Study protocol." BJPsych Open 8(1): A404.
	Background In the UK, postnatal depression is more common in British South Asian women than White Caucasion women. Cognitive-behavioural therapy (CBT) is recommended as a first-line treatment, but there is little evidence for the adaptation of CBT for postnatal depression to ensure its applicability to different ethnic groups. Aims To evaluate the clinical and cost-effectiveness of a CBT-based positive health programme group intervention in British South Asian women with postnatal depression. Method We have designed a multicentre, two-arm, partially nested, randomised controlled trial with 4- and 12-month follow-up, comparing a 12-session group CBT-based intervention (positive health programme) plus treatment as usual with treatment as usual alone, for British South Asian women with postnatal depression. Participants will be recruited from primary care and appropriate community venues in areas of high South Asian density across the UK. It has been estimated that randomising 720 participants (360 into each group) will be sufficient to detect a clinically important difference between a 55% recovery rate in the intervention group and a 40% recovery rate in the treatment-as-usual group. An economic analysis will estimate the cost-effectiveness of the positive health programme. A qualitative process evaluation will explore barriers and enablers to study participation and examine the acceptability and impact of the programme from the perspective of British South Asian women and other key stakeholders.Copyright © The Author(s), 2021. Published by Cambridge University Press on behalf of the Royal College of Psychiatrists.

Huser, M., et al. (2023). "Safety and Efficacy of Single Incision Sling Versus Midurethral Sling in the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial." Urogynecology 29(2): 113-120.
	Importance: This study compares the long-term efficacy and safety of an innovative single-incision sling (SIS) with the inside-out transobturator tape (TOT) sling in the treatment of female stress urinary incontinence. Objective(s): Women with urodynamic stress urinary incontinence were randomized to either SIS or TOT groups and followed up for 4 years. The primary outcome was objective cure defined with a negative cough stress test result. Secondary outcomes involved subjective cure reported via patient's satisfaction scale, surgery complications, postoperative de novo urgency, and patient's life quality. Study Design: This is a randomized noninferiority controlled trial. Result(s): A total of 168 women were randomized (84 in both groups). After 4-year follow-up, 130 patients were analyzed (66 in the SIS group and 64 in the TOT group). The objective (86.4% vs 84.4%; risk difference [95% confidence interval], 0.020 [-0.101 to 0.141]; P = 0.807) and subjective cure rates (83.3% vs 81.3%; risk difference [95% confidence interval], 0.020 [-0.111 to 0.151]; P = 0.821) were similar with the SIS and TOT groups. Both procedures were associated with low complication rates. Repeated surgery rates were 7.6% in the SIS group and 6.3% in the TOT groups. The mesh exposure rate was 1.5% for the SIS group and 3.1% for the TOT group. Incidence of de novo urgency did not vary between TOT and SIS patients. Both groups registered significant life quality improvement. Conclusion(s): After long-term follow-up, anti-incontinence SIS surgery proved noninferior to the inside-out TOT procedure in terms of objective and subjective cure rates.Copyright © 2023 by the Author(s).

Hwang, S. I., et al. (2023). "Acupuncture Treatment for Emotional Problems in Women with Infertility: A Systematic Review and Meta-Analysis." Healthcare 11(20).
	This systematic review and meta-analysis aimed to evaluate the efficacy and safety of acupuncture in treating emotional problems in women with infertility. We searched for randomized controlled trials using acupuncture treatment for emotional problems in women with infertility using 11 databases from their inception to 30 June 2023. The control intervention included no treatment, sham acupuncture treatment, and conventional treatment. The primary outcome was emotion-related rating scales, and the secondary outcomes were total effectiveness rate, quality of life, clinical pregnancy rate, and adverse events. Twelve randomized controlled trials involving 1930 participants were included. A meta-analysis of these studies indicated that, as compared to the control treatment, acupuncture significantly improved the State-Trait Anxiety Inventory, Self-rating Anxiety Scale, Amsterdam Preoperative Anxiety and Information Scale, and Self-rating Depression Scale scores, which were the primary emotion-related outcomes. Furthermore, the meta-analysis demonstrated that acupuncture treatment had a significant effect on the clinical pregnancy rate, which was the secondary outcome. No adverse events were reported in any of the studies. Our findings demonstrate the potential of acupuncture for treating emotional problems in women with infertility. However, well-designed and high-quality randomized clinical trials are required to confirm the effectiveness and safety of acupuncture treatment. The protocol of the current study was registered in PROSPERO (registration number: CRD42020166119).

Hwang, U. J., et al. (2021). "Effect of pelvic floor electrical stimulation on diaphragm excursion and rib cage movement during tidal and forceful breathing and coughing in women with stress urinary incontinence: A randomized controlled trial." Medicine 100(1): e24158.
	BACKGROUND: The pelvic floor muscle (PFM) is associated with respiratory function. We investigated the effects of PFM training by pelvic floor electrical stimulation (PFES) on PFM strength, diaphragm excursion, and upper rib cage movement during tidal and forceful breathing and coughing in women with stress urinary incontinence (SUI). METHODS: In total, 33 participants with SUI were divided into PFES and control groups. The two groups were measured pre- and post-8 weeks of training. Diaphragm excursion and upper rib cage movement during tidal and forceful breathing and coughing and PFM strength were measured using sonography, electromagnetic sensors, and perineometry. RESULTS: There were significant difference of main effect between pre- and post-training and between groups in PFM strength (between groups: P = .001, between time: P < .001) and diaphragm excursion during forceful breathing (between groups: P = .015, between time: P = .026) and coughing (between groups: P = .035, between time: P = .006). There were significant differences in diaphragm excursion during tidal (P = .002) and forceful breathing (P = .005) and coughing (P < .001) between pre- and post-training in the PFES group. Elevation of the upper rib cage during tidal (P < .001) and forceful breathing (P = .001) was significantly decreased after 8 weeks of training in the PFES group. Widening in the horizontal plane in the upper rib cage during forceful breathing (P < .001) was significantly increased after 8 weeks of training in the PFES group. PFM strength (P < .001) was significantly increased after 8 weeks of training in the PFES group. CONCLUSIONS: Pelvic floor muscles training by electrical stimulation can improve diaphragm excursion and breathing patterns in women with SUI.

Hwang, U. J., et al. (2023). "Effect of pelvic floor muscle electrical stimulation on lumbopelvic control in women with stress urinary incontinence: randomized controlled trial." Physiotherapy Theory and Practice 39(10): 2077-2086.
	INTRODUCTION: The pelvic floor muscle (PFM) plays a role not only in lumbopelvic stabilization, but also in incontinence and sexual function. OBJECTIVE(S): This study aimed to determine the effectiveness of PFM training by electrical stimulation (ES) on urinary incontinence, PFM performance (i.e. strength and power), lumbopelvic control, and abdominal muscle thickness in women with stress urinary incontinence (SUI). METHOD(S): Participants were randomized into ES and control groups. The ES group underwent PFM ES for 8 weeks, whereas the control group underwent only a walking program. The impact of urinary incontinence on quality of life was assessed by the Incontinence Impact Questionnaire (IIQ)-7. PFM strength and power were measured using a perineometer. Lumbopelvic control was measured by one and double-leg-lowering tests. Abdominal muscle thickness was measured by sonography. RESULT(S): The ES group showed significantly improved IIQ-7 scores and PFM performance, and had significantly higher values in both one and double-leg lowering tests (p < .05) after 8 weeks of training, indicating significant improvement from pre-session values (p < .005). There were no significant between- or within-group differences at rest in abdominal muscle thickness. CONCLUSION(S): PFM ES could improve lumbopelvic control and PFM performance, and reduce subjective symptoms of urinary incontinence in women with SUI.

Hwang, W. Y., et al. (2024). "Minimally Invasive Sacrohysteropexy Versus Vaginal Hysterectomy with Uterosacral Ligament Suspension for Pelvic Organ Prolapse: a Prospective Randomized Non-Inferiority Trial." Journal of Minimally Invasive Gynecology.
	Study Objective: To investigate whether minimally invasive Sacrohysteropexy (SH) is non-inferior to vaginal hysterectomy (VH) with uterosacral ligament suspension (USLS) in women with symptomatic uterovaginal prolapse. Design(s): Prospective, randomized, non-inferiority study. Setting(s): Tertiary university-based hospital. Patient(s): A total of 146 patients with uterovaginal prolapse between July 2016 and August 2019. Intervention(s): Patients were randomly assigned in a 1:1 ratio to either laparoscopic or robotic SH surgery or VH with USLS surgery. Measurements and Main Results: The primary outcome was prolapse recurrence at 1 year after surgery, defined as prolapse >= stage 2 evaluated using the pelvic organ prolapse quantification system, bothersome vaginal bulge symptoms, or retreatment for prolapse. The secondary outcomes included operation time, estimated blood loss, hospital stay, operation-related complications, pain intensity, quality of life, and activities of daily living. Of 146 women who underwent randomization, 73 in the SH group and 73 in the VH with USLS group were analyzed. SH was non-inferior for recurrence compared with VH with USLS (16.4% vs 15.8%, 95% confidence interval: -13.0% to 14.2%). Operating duration and transvaginal length were significantly longer in the SH group, while there were no significant differences in the estimated blood loss, length of hospital stay, or postoperative complication rates. Although perioperative pain intensity was greater from 1 week to 1 month in the SH group, the quality of life and activities of daily living did not differ between the groups throughout postoperative year 1. Conclusion(s): Laparoscopic or robotic SH was non-inferior to VH with USLS for the recurrence of pelvic organ prolapse at the 1-year follow-up.Copyright © 2024 AAGL

Hwang, W. Y., et al. (2022). "Efficacy and safety of skin-adhesive low-level light therapy for overactive bladder: a Phase III study." International Urogynecology Journal 33(12): 3573-3580.
	Introduction and hypothesis: Overactive bladder (OAB) is a common condition that remains challenging to treat. We hypothesized that skin-adhesive low-level light therapy (LLLT) would be an effective treatment for OAB caused by bladder muscle contraction. Accordingly, we aimed to evaluate the efficacy and safety of an LLLT device for the treatment of OAB. Method(s): This prospective, randomized, double-blind, placebo-controlled, multicenter trial included patients with a clinical diagnosis of OAB who were treated at either of two university hospitals. Patients were instructed to apply an LLLT device (Color DNA-WSF) or a sham device at home three times daily for 12 weeks. The primary outcome was the change in the mean daily number of urge urinary incontinence (UUI) episodes between baseline and 12 weeks. The secondary outcomes were the mean changes in incontinence, voiding, and nocturia episodes from baseline and the likelihood of achieving a > 50% reduction in UUI and incontinence episodes after 12 weeks. All patients completed the Overactive Bladder Symptom Score (OABSS), Urogenital Distress Inventory-6 (UDI-6), and Impact Urinary Incontinence-7 (IIQ-7) questionnaires. Safety parameters included treatment-emergent adverse events. Result(s): Compared with those in the sham group, the numbers of UUI and urinary incontinence episodes in the LLLT group were significantly decreased at week 12 (UUI, (-1.0 +/- 1.7 vs. -0.4 +/- 2.5, P = 0.003; urinary incontinence, -1.1 +/- 1.9 vs. -0.5 +/- 2.9, P=0.002). Furthermore, the OABSS, UDI-6, and IIQ-7 scores at week 12 tended to be better in the LLLT group than in the sham group. The incidence of device-related treatment-emergent adverse events was similar between groups. Conclusion(s): LLLT may be clinically useful and safe for the treatment of OAB.Copyright © 2022, The Author(s).

Hyewon, A., et al. (2022). "Electroacupuncture for management of endometriosis : A Systematic Review of Randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Hyun Sun, H., et al. (2022). "Safety of red ginseng and herb extract complex (RHC) in menopausal women: A randomized, double-blind, placebo-controlled trial." Journal of Ginseng Research 46(4): 601-608.
	Background: Various treatments are used to relieve menopausal symptoms for women. However, herbal substances are frequently used as complementary and alternative therapies as other treatments can increase ovarian and breast cancer risk. While the herbal substances' therapeutic effect is essential, the safety of their use is considered more important. This study aims to confirm the safety of red ginseng and herb extract complex (RHC), which are used to relieve menopausal symptoms.; Methods: This randomized, double-blind, placebo-controlled clinical study recruited and divided 120 women experiencing menopausal symptoms into the RHC and placebo groups (60 women per group). Subjects were administered with 2 g RHC or placebo daily for 12 wk. Adverse reactions, female hormonal changes, and uterine thickness were observed and recorded on wk 0, 6, and 12. Hematologic and blood chemistry tests were also conducted.; Results: The reactions of the subjects who received RHC or placebo at least once were analyzed. A total of six adverse reactions occurred in the RHC group, while nine occurred in the placebo group; common reactions observed in both groups were genital, subcutaneous tissue, and vascular disorders. However, there was no statistically significant difference between the administration groups (p = 0.5695), and no severe adverse reactions occurred in both groups.; Conclusion: This study confirms the safety of daily intake of 2 g of RHC for 12 wk by menopausal women. (© 2022 The Korean Society of Ginseng. Publishing services by Elsevier B.V.)

Iakovidou Maria, C., et al. (2023). "The role of endometrial scratching prior to in vitro fertilization: an updated systematic review and meta-analysis." Reproductive Biology and Endocrinology 21(1): 89.
	Research Question: To evaluate the role of endometrial scratching performed prior to an embryo transfer cycle on the probability of pregnancy compared to placebo/sham or no intervention.; Design: A computerized literature (using a specific search strategy) search was performed across the databases MEDLINE, EMBASE, COCHRANE CENTRAL, SCOPUS and WEB OF SCIENCE up to June 2023 in order to identify randomized controlled trials (RCTs) evaluating the effect of endometrial scratching prior to an embryo transfer cycle on the probability of pregnancy, expressed either as live birth, ongoing pregnancy or clinical pregnancy (in order of significance) compared to placebo/sham or no intervention. Data were pooled using random-effects or fixed-effects model, depending on the presence or not of heterogeneity. Heterogeneity was assessed using the I 2 statistic. Subgroup analyses were performed based on the population studied in each RCT, as well as on the timing and method of endometrial biopsy. Certainty of evidence was assessed using the GRADEPro tool.; Results: The probability of live birth was significantly higher in embryo transfer cycles after endometrial scratching as compared to placebo/sham or no intervention (relative risk-RR: 1.12, 95% CI: 1.05-1.20; heterogeneity: I 2 =46.30%, p<0.001, 28 studies; low certainty). The probability of ongoing pregnancy was not significantly difference between the two groups (RR: 1.07, 95% CI: 0.98-1.18; heterogeneity: I 2 =27.44%, p=0.15, 11 studies; low certainty). The probability of clinical pregnancy was significantly higher in embryo transfer cycles after endometrial scratching as compared to placebo/sham or no intervention (RR: 1.12, 95% CI: 1.06-1.18; heterogeneity: I 2 =47.48%, p<0.001, 37 studies; low certainty). A subgroup analysis was performed based on the time that endometrial scratching was carried out. When endometrial scratching was performed during the menstrual cycle prior to the embryo transfer cycle a significantly higher probability of live birth was present (RR: 1.18, 95% CI:1.09-1.27; heterogeneity: I 2 =39.72%, p<0.001, 21 studies; moderate certainty). On the contrary, no effect on the probability of live birth was present when endometrial injury was performed during the embryo transfer cycle (RR: 0.87, 95% CI: 0.67-1.15; heterogeneity: I 2 =65.18%, p=0.33, 5 studies; low certainty). In addition, a higher probability of live birth was only present in women with previous IVF failures (RR: 1.35, 95% CI: 1.20-1.53; heterogeneity: I 2 =0%, p<0.001, 13 studies; moderate certainty) with evidence suggesting that the more IVF failures the more likely endometrial scratching to be beneficial (p=0.004). The number of times endometrial scratching was performed, as well as the type of instrument used did not appear to affect the probability of live birth.; Conclusions: Endometrial scratching during the menstrual cycle prior to an embryo transfer cycle can lead to a higher probability of live birth in patients with previous IVF failures.; Prospero Registration: PROSPERO CRD42023433538 (18 Jun 2023). (© 2023. BioMed Central Ltd., part of Springer Nature.)

Ibañez, L. (2022). "A Clinical Trial to Evaluate the Efficacy, Tolerability, and Safety of a Fixed Dose Combination of Spironolactone, Pioglitazone & Metformin (SPIOMET) in Polycystic Ovary Syndrome (PCOS)." ClinicalTrials.gov.
	This is a multi‐centre, multi‐national, double‐blinded, placebo‐controlled, parallel, randomised Phase II clinical trial to evaluate the efficacy, tolerability, and safety of a fixed dose combination of Spironolactone, Pioglitazone and Metformin (SPIOMET) for adolescent girls and young adult women (AYAs) with polycystic ovary syndrome (PCOS). Study description: Currently, there is no European Medicines Agency (EMA)/U.S. Food and Drug Administration (FDA)‐approved therapy for PCOS in AYAs. Oral contraceptives (OCs) are prescribed off‐label to approximately 98% of AYAs with PCOS, including those without pregnancy risk. OCs alleviate key symptoms by inducing a pharmacological combination of anovulatory subfertility, regular pseudo‐menses, and extreme elevations of sex hormone‐binding globulin (SHBG), but OCs do not revert the underlying pathophysiology, and patients remain at risk for post‐treatment subfertility and possibly, for lifelong co‐morbidities. Given the key role of hepato‐visceral fat excess in the pathogenesis of PCOS, the prime aim of the treatment should be to achieve a preferential loss of central fat, which should in turn normalise the entire PCOS phenotype. Recent evidence disclosed that a treatment consisting of a fixed low‐dose combination of two insulin sensitisers [pioglitazone (PIO) and metformin (MET), with different modes of action], and one mixed anti‐androgen and anti‐mineralocorticoid (spironolactone), was superior to an OC in normalising the PCOS phenotype, including ovulation rates and hepato‐visceral fat.

Ibrahim Ezzeldin, M., et al. (2020). "Poly(ADP-ribose) polymerase inhibitors as maintenance treatment in patients with newly diagnosed advanced ovarian cancer: a meta-analysis." Future Oncology 16(10): 585-596.
	Aim: Poly(ADP-ribose) polymerase inhibitors (PARPIs) improved progression-free survival among patients with recurrent ovarian cancer. This meta-analysis examined the effectiveness of PARPIs as maintenance strategy for newly diagnosed patients with advanced high-grade ovarian cancer with or without mutations. Materials & methods: Using defined selection criteria, a literature search identified four eligible randomized clinical trials involving 2386 patients. Results: Compared with placebo maintenance, PARPIs achieved a 46% reduction in the risk of progression or death as compared with placebo (hazard ratio: 0.54; 95% CI: 0.39-0.73; p < 0.0001). That benefit was shown in all clinical subgroups: among those with BRCA mutation, with negative/unknown BRCA mutation, and in those with homologous recombination deficient tumors. Data about the effect on overall survival are still premature. Conclusion: In patients with newly diagnosed advanced ovarian cancer, PARPIs maintenance after standard therapy achieved a significant improvement in progression-free survival as compared with placebo, overall and in all subgroups.

Imogen, S. and J. Kannamannadiar (2021). "Does embryoglue transfer medium increase In Vitro Fertilisation (IVF) success rate?" PROSPERO International prospective register of systematic reviews.
	
Indra Adi, S., et al. (2023). "Systematic Review & Meta-Analysis Study of the Effectiveness of Dienogest Therapy Versus Combination Contraceptive Pills in Cases of Post-Intraoperative Endometriosis: A Study of VAS Scores for Dysmenorrhea, Dyschesia and Dysparenia." PROSPERO International prospective register of systematic reviews.
	
Inoguchi, A. (2023). "First-in-Human Study of DS-3939a in Subjects with Advanced Solid Tumors." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Generic name etc : DS‐3939a Dosage and Administration for Investigational material : Dose Escalation Part : IV solution (Once every 3 weeks, initial dose 1 mg /kg), Dose Expansion Part : IV solution (Once every 3 weeks, recommended dose for expansion part) CONDITION: Locally advanced, metastatic, or unresectable solid tumors PRIMARY OUTCOME: Dose‐limiting toxicities (DLT); Adverse events (AEs); Objective Response Rate (Part 2) SECONDARY OUTCOME: Overall Response Rate: ORR; Duration of Response: DoR; Disease Control Rate: DCR; Time to Response: TTR; Progression‐free Survival: PFS; Overall Survival: OS; TA‐MUC1 Expression by Immunohistochemistry; PK; ADAs for DS‐3939a (status and titers) INCLUSION CRITERIA: 1. Sign and date the Informed Consent Form (ICF), prior to the start of any study‐specific qualification procedures. 2. Adults >= 18 years of age on the day of signing the ICF. 3. Has a left ventricular ejection fraction (LVEF) >= 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) within 28 days of enrollment. 4. Has adequate organ function 5. Measurable disease based on RECIST V1.1. 6. ECOG performance status score of 0 or 1. Additional inclusion criteria for Part 1 ‐ Has a histologically or cytologically documented locally advanced, metastatic, or unresectable urothelial, non‐small cell lung, breast, ovarian, or biliary tract cancers, or pancreatic ductal adenocarcinoma, regardless of any molecular subtypes. Additional inclusion criteria for Part 2 ‐ Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria and documented radiographic disease

Inonu, U. (2021). "The Effect of Acupressure, Laughter Yoga and Mindfulness on Menopausal Symptoms and Quality of Life." ClinicalTrials.gov.
	On average, one third of a woman's life passes during menopause. The menopausal period is an important period that brings many physical and psychological changes with it and significantly affects the disease process and the family and society. Cultural and ethnic characteristics of the society are among the important factors that affect women's attitudes towards menopause and the meaning of middle age for women.women seek ways to deal with menopausal symptoms. women prefer drug‐free coping methods. Mindfulness stress reduction program, yoga and laughter yoga are an alternative way to reduce menopausal symptoms.. These methods can reduce the complaints and increase the quality of life. For this reason, the effect should be determined in the menopausal period.

Inonu, U. (2023). "The Effects of Reiki on Menopausal Symptoms and Depression Levels." ClinicalTrials.gov.
	Design This study was designed as a randomized controlled trial in which participants were randomly assigned to Reiki or control groups. Location and time The study was conducted with postmenopausal women registered at a Family Health Center (FHC) located in the center of a province in eastern Türkiye between May 2023 and July 2023. The center is a primary healthcare institution that provides general healthcare services and reproductive healthcare services (such as family planning, education, and counseling). There is no application specific to the menopausal period in the center. This center was randomly selected considering its socioeconomic level, proximity to the city center, and the number of women registered in the center. The center serves approximately 15.000 individuals, of which approximately 5100 are women. In addition, there was a quiet and calm hall in the center where Reiki could be practiced. Population and sample of the study The population of the study consisted of postmenopausal women registered to the determined FHC. Women who applied to the FHC for any reason, agreed to participate voluntarily, and met the inclusion criteria were included in the study. The criteria for inclusion in the study were as follows: Those who were between the ages of 45‐55, did not have hearing problems, did not have any psychiatric diseases, were in a natural menopause period, and did not take hormone replacement therapy. A web‐based software was used to determine the sample size. Priori‐power analysis was performed to estimate the appropriate sample size. In the literature, the mean score of menopausal symptoms, which is the primary result of the study, was found to be 16.6 (standard deviation 8.9). The sample size was calculated as 41 for each group (41 Reiki group, 41 control group), assuming a 5% error level, bidirectional significance level, 95% confidence interval, 80% representation of the population, and assuming to create a decrease in the post‐intervention menopausal symptoms mean score by 5 points. To reach the sample size, 140 women were evaluated in terms of eligibility criteria. 47 women who did not meet the inclusion criteria and 19 women who refused to participate in the study were excluded from the study. 7 out of 50 women included in the Reiki group were excluded from the study because they did not continue the sessions after the second Reiki session. Seven of the 53 women included in the control group were excluded from the study because they did not want to continue the study. The research was completed with a total of 82 women, 41 of them in the Reiki group and 41 of them in the control group. Randomization The allocation of women to the Reiki and control groups in the study was done by simple randomization. For randomization, using the random number generation method available on the random.org site, numbers in which the numbers 1 and 2 are randomly sorted were created in the system. Women who accepted to participate in the study and met the inclusion criteria were randomly assigned to number 1 or 2 according to the order of arrival at the FHC. Which number would be the Reiki or control group was determined by drawing lots before starting the study. Number 1 formed the Reiki group, number 2 formed the control group. The same method was continued until the women in the Reiki and control groups reached the sample size. Data collection tools In the study, data were collected with a sociodemographic questionnaire including questions about age, last menstrual period, education level and income level, Menopause Rating Scale (MRS), Beck Depression Inventory (BDI), and a question investigating the level of being affected by menopause complaints. The question investigating the level of being affected by menopause is: "At which level do menopause complaints affect you?". Women answered this question on a scale of 0 (very little/very slightly) to 10 (extreme/very much). The Menopause Rating Scale (MRS) was developed to assess the severity of menopausal symptoms. The Turkish validity and reliability f the scale was performed in 2005. The scale consists of 11 items and 3 subscales. These 3 subscales are called somato‐vegetative complaints (such as night sweating and hot flush), psychological complaints (such as anxiety and depression), and urogenital complaints (such as urethral syndrome and vaginal dryness). The scale is in the form of a 5‐point Likert type and each item is graded between zero (no complaints) and four (severe symptoms) points. The total score that can be obtained from the scale varies between 0‐44 points. An increase in the total score obtained from the scale indicates that the menopausal complaints experienced are intensified. The Cronbach's alpha reliability coefficient of the scale was calculated as 0.84. Beck Depression Inventory (BDI) is used to have information about depressive symptoms and attitudes by evaluating the findings of emotional, cognitive, and motivational symptoms that can be seen in depression. The Turkish validity and reliability study of the inventory was carried out. Depressive symptoms and attitudes were collected under 21 headings (moodiness, pessimism, sense of failure, joylessness, sense of guilt, sense of punishment, self‐blame, suicidal ideation, desire to cry, level of irritability, social loneliness, indecision, change in body image, inability to work, sleep disorder, fatigue, loss of appetite, weight loss, somatic complaints, and loss of libido). Each item is scored between 0 (not at all) and 3 (severe) according to the severity of the displayed behavior. The lowest score that can be obtained from the inventory is 0, and the highest score is 63. A high total score indicates a high level of depression severity. The Cronbach's alpha reliability coefficient of the scale was determined as 0.80. Data collection In the study, data were collected from women who applied to the FHC for general healthcare services after receiving service. After being informed about the research by the researcher ESB, data collection tools were applied to the volunteer women in a hall in the FHC by face‐to‐face interview method. Four weeks after the data collection tools used in the research were filled in as a pre‐test, post‐test data were obtained with the same measurement tools. Intervention The Reiki intervention was administered free of charge by the ESB from researchers holding a Usui Shiki Ryoho Reiki 1 (Degree 1) in the study. The researcher received training and certification in Reiki techniques before starting the study. After completing the training program, the researcher applied Reiki to the Reiki group once a week for 4 weeks. The sessions were held individually in a hall in the ASM, taking into account the times available to the women in the sample. Each session lasted 30‐40 minutes. The Reiki application in the study was based on the First Degree Reiki (Reiki I) protocol. In Reiki I, the "aura attunement" between the practitioner and the person provides healing by touching or holding the hands a few cm above the body. The following sequence is generally applied in the Reiki protocol. 1. Before starting Reiki, the jewelry on the practitioner and the participant is removed. 2. The person sits or lies down in a comfortable position. The arms and legs remain open so that they do not touch each other. 3. Keeping the practitioner's fingers in a comfortable position, energy is sent to each chakra or area on the body for 3‐5 minutes. 6. Hands are washed. In addition to the general protocol of reiki, the practitioner preferred a quiet room and dimmed the light of the room to prevent distraction and practiced in a dim environment. No intervention was applied to the control group by the researcher. Women in the control group received the service they needed from ASM.

Instituto Superior de Investigación en Estética Médica, N. y. A. (2021). "Effects of Intermittent Fasting on Polycystic Ovary Syndrome (PCOS) Compared to Standard Treatment." ClinicalTrials.gov.
	No Results Available Behavioral: Time restricted eating PCOS Rotterdam criteria|Insulin resistance (IR) Female Not Applicable 16 Other Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment AYUSOP22 October 11, 2022

International, E. Q. and Inc (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." ClinicalTrials.gov.
	No Results Available Drug: Lerociclib|Drug: Letrozole 2.5mg|Drug: Placebo Progression Free Survival (PFS)|Overall Survival (OS)|Progression Free Survival (PFS) by Investigator|Patient Reported Outcomes/Quality of Life|Safety/Tolerability Female Phase 3 0 Industry|Other Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment EQ132-303|GOG-3075|ENGOT-EN17 March 2025

Intzes, S., et al. (2021). "Hold your needles in women with recurrent pregnancy losses with or without hereditary thrombophilia: Meta-analysis and review of the literature." Journal of Gynecology Obstetrics and Human Reproduction 50(4): 101935.
	Objectives: The use of antithrombotic prophylaxis in women with recurrent pregnancy losses (RPL) remains controversial.; Methods: We performed meta-analysis of randomized controlled trials (RCTs) comparing low molecular weight heparin (LMWH) versus No LMWH in women with or without hereditary thrombophilia and RPL. Twelve RCTs met our inclusion criteria and 2298 women were included in this meta-analysis. Our primary end point was live birth and odds ratio (OR) for live birth are reported.; Results: In women with thrombophilia the benefit of LMWH on live birth is not significant but heterogeneity of the studies is significant (OR, 2.09; 95 % CI, 0.58-7.57; p = 0.26; I 2 = 86 %, p = 0.0001). Considering women without thrombophilia there is no benefit of LMWH in OR of live birth and data from studies have low heterogeneity (OR, 1.25; 95 % CI, 0.88-1.78; p = 0 0.21; I 2 = 44 %, p = 0.07).; Conclusions: Hold your needles in women with RPL. Probably in some hereditary thrombophilic defects LMWH has a positive effect on OR for live birth.; Competing Interests: Declaration of Competing Interest The authors report no declarations of interest. (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Iqbal Ayesha, Z., et al. (2023). "Effects of Omega-3 Polyunsaturated Fatty Acids Intake on Vasomotor Symptoms, Sleep Quality and Depression in Postmenopausal Women: A Systematic Review." Nutrients 15(19).
	The menopausal transition is often accompanied with distressing manifestations, such as vasomotor symptoms, sleep disruptions, and depressive syndrome. Omega-3 polyunsaturated fatty acids ( n -3 PUFAs) have emerged as a potential intervention to alleviate these symptoms. This review aimed to comprehensively assess the impact of n -3 PUFAs supplementation on vasomotor symptoms, sleep quality, and depression among postmenopausal women. We conducted a systematic literature search of randomized controlled trials across the Cochrane Library, Web of Science, PubMed, CINAHL, EMBASE, and SCOPUS databases from inception to August 2023. Among the initial pool of 163 identified studies, nine studies met the inclusion criteria and were incorporated into this systematic review. Notably, four studies detected potential benefits of n -3 PUFAs in improving hot flashes and night sweats. On the contrary, sleep quality outcomes displayed heterogeneity across the studies. Incorporating diverse scales, such as the Hamilton Depression Rating Scale-21, the Patient Health Questionnaire depression scale, and Generalized Anxiety Disorder-7 for depression outcomes, we found inconclusive evidence of n -3 PUFA's impact on depression. Overall, the combined analysis of these studies did not provide substantial evidence to support the efficacy of n -3 PUFAs in improving vasomotor symptoms, sleep quality, and depression. Further well-designed randomized clinical trials with larger participant groups are crucial to validate and generalize these results. Review Registration: PROSPERO registration no: CRD42023421922.

Irfan, A., et al. (2023). "Efficacy of the Combination of Hyaluronic Acid and Chondroitin Sulfate in the Treatment of Interstitial Cystitis/Bladder Pain Syndrome: A Systematic Review." PROSPERO International prospective register of systematic reviews.
	
Iris, Z., et al. (2023). "Vitamin D for endometriosis and primary dysmenorrhea related Pain – A systematic review of registered RCTs." PROSPERO International prospective register of systematic reviews.
	
Ironwood Pharmaceuticals, I. (2023). "Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome." ClinicalTrials.gov.
	No Results Available Drug: IW-3300 rectal foam|Drug: Placebo Change from baseline (CFB) in weekly average of daily bladder pain (which can include sensations like burning, pressure, and/or discomfort) at its worst at Week 12|CFB in weekly average of a burning sensation in the bladder at its worst at Week 12|CFB in weekly average of a pressure sensation in the bladder at its worst at Week 12|CFB in weekly average of discomfort in the bladder at its worst at Week 12|CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12|Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects|Overall frequency of TEAEs by severity grade All Phase 2 300 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment C3300-201 November 2025

Isabel, M. and S. Moniek (2022). "What is the effect of physiotherapy on the quality of life and pain experienced by woman with symptoms associated with endometriosis?" PROSPERO International prospective register of systematic reviews.
	
Isabela Godoy, M., et al. (2022). "A sistematic review comparing two Apical Pelvic Organ Prolapse correction techniques: Uterosacral Ligament Suspension for Vaginal Vault Fixation versus Sacrospinous Ligament Fixation." PROSPERO International prospective register of systematic reviews.
	
Isenlik Bekir, S., et al. (2023). "Comparison of laparoscopic lateral suspension and laparoscopic sacrocolpopexy with concurrent total laparoscopic hysterectomy for the treatment of pelvic organ prolapse: a randomized controlled clinical trial." International Urogynecology Journal 34(1): 231-238.
	Introduction and Hypothesis: We compared the outcomes of women who underwent laparoscopic lateral suspension with concurrent total laparoscopic hysterectomy (LLS-TLH) with those of women who underwent laparoscopic sacrocolpopexy with concurrent total laparoscopic hysterectomy (LSC-TLH) for apical and/or anterior vaginal wall prolapse.; Methods: Eighty women underwent LLS-TLH or LSC-TLH operations. According to the Pelvic Organ Prolapse Quantification System (POP-Q), women with symptomatic pelvic organ prolapse of stage 2 or higher apical and/or anterior compartment prolapse were enrolled in the study. The objective cure rate according to the POP-Q system was the primary (objective) outcome. The International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and Patient Global Impression of Improvement (PGI-I) questionnaire scores were the secondary (subjective) outcomes. The primary and secondary outcomes were evaluated at 1 year after surgery.; Results: The primary and secondary outcomes indicated significant improvements in both groups (p < 0.05). The objective cure rate was 92.5% for apical and 78.6% for anterior compartment prolapse in the LLS-TLH group; the respective rates were 100% and 74.1% in the LSC-TLH group. The subjective cure rate was 87.5% for the LLS-TLH group and 90% for the LSC-TLH group. No statistically significant differences between groups were found in the objective cure rate, subjective cure rate, or ICIQ-VS, ICIQ-SF, or PGI-I scores at 1 year (p > 0.05).; Conclusions: LLS-TLH can serve as a safe, effective, and feasible alternative to LSC-TLH, with low complication rates and similar short-term objective and subjective outcomes. (© 2022. The International Urogynecological Association.)

Ishikawa, H. (2023). "Study on the efficacy and safety of AT-04 for endometriosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: After obtaining consent, eligibility for this study will be confirmed by screening tests, and central enrollment and randomized assignment to minimize bias will be conducted at the data center on a 1:1 basis. The actual treatment group will receive AT‐04 for 16 weeks. The control group will also be treated with S‐02, a sham machine, for 16 weeks. At the 16‐week visit, subjects will be asked to bring their equipment and replace it with new equipment (all actual equipment). After the 16‐week period, to ensure blinding after the replacement of the actual device, we will explain at the time of obtaining consent to participate in this study that the feeling of use may vary depending on the device under study. The pads will be applied to at least two sites on the lower abdomen, including the uterine and ovarian areas, and if there are other painful areas, two additional sites (maximum 4 sites) will be applied to those areas. D055909 magnetic field therapy CONDITION: D004715 dysmenorrhea heavy menstrual bleeding endometriosis ; dysmenorrhea heavy menstrual bleeding PRIMARY OUTCOME: Change in Numeric Rating Scale (NRS) score from collected at each visit for endometriosis‐related pain at the end of the double‐blind period (after 16 weeks) compared to baseline before the start of treatment SECONDARY OUTCOME: Secondary efficacy endpoints ; 1Change in NRS score for endometriotic pelvic pain interviewed at the visit (4,8,12, and 20 weeks) compared to baseline before treatment initiation during the treatment period; 2Change in NRS score for menstrual pain and endometriotic pelvic pain during the menstrual period compared to baseline before treatment initiation during the treatment period by eRPO (Electronic Patient‐Reported Outcomes).; 3 Change in NRS score for endometriosis pelvic pain other than menstrual periods during the treatment period compared to baseline before treatment initiation by ePRO.; 4 Biberoglu & Behrman (B&B) score at the visit (4,8,12,16 and 20 weeks) compared to before treatment initiation; 5 Endometriosis Health Profile‐30 (EHP‐30) score at the visit (4,8,12,16 and20 weeks) compared to before treatment initiation; 6 Health‐related quality of life (EQ‐5D) at the visit (4,8,12,16 and 20 weeks) compared to before treatment initiation; 7 Change in ovarian chocolate cyst size at the end of the treatment period (16 weeks) compared to baseline before treatment initiation; ; Secondary safety endpoints; Frequency and rate of occurrence of investigational device failure and adverse events INCLUSION CRITERIA: (1) Patients 18 years of age or older at the time consent is obtained (2) Premenopausal female patients (3) Patients with endometriosis (patients must meet one of the following conditions. In addition, if the disease recurs after surgery, the patient must be diagnosed again with one of the following) (1) Patients diagnosed with endometriosis by laparotomy or laparoscopy performed within 5 years prior to the start of treatment. (2) Patients with endometriosis detected by MRI or ultrasonography (transvaginal, transabdominal, or transrectal) performed within 1 year prior to the start of treatment, including ovarian chocolate cysts. (3) Patients with a diagnosis of clinical endometriosis based on either Douglas fossa induration, limited uterine mobility, or pelvic tenderness by internal or rectal examination performed prior to the start of treatment. (4) Patients with dysmenorrhea or pelvic pain that is thought to be derived from endometriosis, at leas

Ishikawa, H., et al. (2024). "Efficacy and safety of a novel pain management device, AT-04, for endometriosis-related pain: study protocol for a phase III randomized controlled trial." Reproductive Health 21(1): 12.
	Background: Endometriosis-related pain encompassing dysmenorrhea, dyspareunia, and chronic pelvic pain, reduces the quality of life in premenopausal women. Although treatment options for endometriosis alleviate this pain, approximately one-third of women still experience pain even after receiving treatment, indicating the need for novel approaches to pain relief in those women. The Angel Touch device (AT-04) is a portable magnetic fields irradiation device that incorporates a combination of mixed alternative magnetic fields at 2 kHz and 83.3 MHz. A phase III trial confirmed the efficacy and safety of AT-02, a prototype of AT-04, for pain relief in patients with fibromyalgia. Method(s): This is a phase III, multicenter, prospective, randomized, sham device-controlled, double-blind, parallel study. The participants will be premenopausal women aged > 18 years who have endometriosis-related pain with at least moderate severity. Considering dropouts, 50 participants have been deemed appropriate. Eligible women will be centrally registered, and the data center will randomly allocate them in a 1:1 ratio to the intervention and control groups. Women in the intervention group will receive electromagnetic wave irradiation generated by AT-04 and those who in the control group will wear a sham device for 16 weeks, and both groups will wear AT-04 for another 4 weeks. The primary outcome measure is the change in the Numeric Rating Scale score at 16 weeks compared with the baseline. Secondary outcome measures are efficacy for pelvic pain including dysmenorrhea and non-menstrual pain, and chronic pelvic pain not related to menstruation, dysmenorrhea, and dyspareunia, and improvement of quality of life during the study period. Safety will be evaluated by device defects and the frequency of adverse events. The study protocol has been approved by the Clinical Study Review Board of Chiba University Hospital, Chiba, Japan, and will be conducted in accordance with the principles of the Declaration of Helsinki and the Japanese Clinical Trials Act and relevant notifications. Discussion(s): This study aims to develop a novel method of managing endometriosis-related pain. The AT-04 is an ultralow-invasive device that can be used without inhibiting ovulation, suggesting potential benefits to women of reproductive-age. Trial registration number Japan Registry of Clinical Trials (jRCTs032230278).Copyright © 2024, The Author(s).

Ishikawa, M., et al. (2023). "Final analysis of a randomized phase II/III trial of conventional paclitaxel and carboplatin with or without bevacizumab versus dose-dense paclitaxel and carboplatin with or without bevacizumab, in stage IVB, recurrent, or persistent cervical carcinoma (JCOG1311)." International Journal of Gynecological Cancer 33(5): 692-700.
	Objective: To assess the efficacy of dose-dense weekly paclitaxel plus carboplatin in metastatic or recurrent cervical carcinoma, we conducted a phase II/III randomized controlled study comparing dose-dense paclitaxel and carboplatin with or without bevacizumab to conventional paclitaxel and carboplatin with or without bevacizumab. However, at the primary analysis of the phase II part, the response rate in the dose-dense arm was not higher than in the conventional arm and the study was terminated early before starting phase III. After a further 2 years of follow-up, we conducted this final analysis.; Methods: 122 patients were enrolled and randomly assigned to either the conventional or dose-dense arm. After bevacizumab was approved in Japan, patients in both arms received bevacizumab if not contraindicated. In the final analysis, overall survival, progression-free survival, and adverse events were updated.; Results: The median follow-up of surviving patients was 34.8 months (range 19.2-64.8). Median overall survival in the conventional arm was 17.7 months and in the dose-dense arm 18.5 months (p=0.71). Median progression-free survival in the conventional arm was 7.9 months and in the dose-dense arm 7.2 months (p=0.64). A platinum-free interval within 24 weeks and treatment without bevacizumab were identified as prognostic factors for overall and progression-free survival. Grade 3 to 4 non-hematologic toxicity occurred in 46.7% of patients who received the conventional regimen and in 43.3% of patients who received the dose-dense regimen. Adverse events related to bevacizumab in 82 patients included fistula in five (6.1%) and gastrointestinal perforation in three (3.7%).; Conclusions: It was confirmed that dose-dense paclitaxel plus carboplatin for metastatic or recurrent cervical carcinoma is not superior to conventional paclitaxel and carboplatin. Patients who had early refractory disease after prior chemoradiotherapy had the poorest prognosis. The development of treatments that improve the prognosis of such patients remains an important issue.; Clinical Trial Information: jRCTs031180007.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Işik Emir, İ., et al. (2024). "Investigation of The Efficacy of the Relaxation Technique on Primary Dysmenorrhea and Menstrual Symptoms: A Randomized Controlled Longitudinal Trail." Gevher Nesibe Journal of Medical and Health Sciences 9(1): 103-110.
	Aim: The aim of this study is to examine the effectiveness of Mitchell's relaxation technique applied to young women with primary dysmenorrhea (PD) on dysmenorrhea and menstrual symptoms in long-term follow-ups. Methods: This is a randomized-controlled intervention trial. A total of 76 students, 37 in the intervention and 39 in the control group, were included in the study. Data collection tools were a Descriptive Information Form, the Visual Analog Scale (VAS), and the Menstrual Symptom Scale (MSS). The intervention group was followed during five menstrual cycles, four of which were consecutive. During a total of three menstrual cycles, 30-minute educational video lessons were given every day on menstrual days or at least three times a week. It was determined that the groups were independent and homogeneous in terms of the specified characteristics. Results: There was no statistically significant difference between the groups in terms of VAS and MSS scores in the first follow-up, but differences were found in the 2nd, 3rd, 4th, and 5th follow-ups (p&lt;0.05). It was determined that the 2nd, 3rd, 4th, and 5th follow-up VAS and MSS scores of the intervention group were significantly lower than those of the control group. Conclusion: Mitchell's relaxation education has positive effects on dysmenorrhea and menstrual symptoms. Women can receive this education and include it in their daily life.

Isikoglu, M., et al. (2021). "Conventional IVF revisited: Is ICSI better for non-male factor infertility? Randomized controlled double blind study." Journal of Gynecology Obstetrics and Human Reproduction 50(7): 101990.
	STUDY QUESTION: Is ICSI better than conventional IVF for non-male factor infertility? SUMMARY ANSWER: IVF should be the choice of assisted reproductive technique in non-male factor infertility cases. WHAT IS ALREADY KNOWN: Although total fertilization failure is a major concern for patients and professionals, the overall risk/benefit analysis favors conventional IVF in non-male factor infertility cases. However, according to the ESHRE EIM database pertaining to 1997-2012, the use of IVF has been continuously decreasing in favor of ICSI. STUDY DESIGN, SIZE, DURATION: Randomized controlled double-blind study involving 138 women undergoing ART in a private Center. PARTICIPANTS/MATERIALS, SETTING, METHODS: All couples with a female partner ≤42 years of age and without severe male factor (total progressive motile sperm with normal morphology >10.000) were included in the study. Exclusion criteria were: history of total fertilization failure, less than 6 cumulus oocyte complexes (COC) available for fertilization, prenatal genetic testing (PGT) cycles, unwillingness to participate and couples undergoing total cryopreservation for any indication. On the day of oocyte pick up, sibling COCs were randomly allocated to fertilization with IVF or denudation followed by ICSI to MII oocytes. The decision to transfer IVF or ICSI embryo(s) depended on embryo quality. Women receiving two embryos were given only IVF or ICSI embryos. Neither the clinician performing the transfer nor the patients were aware of the fertilization method used to generate the embryos transferred. Main outcome parameters were fertilization, clinical pregnancy, implantation and miscarriage rates. MAIN RESULTS AND THE ROLE OF CHANCE: Demographic variables, ovarian reserve and infertility etiology, duration of stimulation, total gonadotropin consumption, peak estradiol levels were similar for IVF-ET and ICSI-ET groups. Mean number of COCs (18.95 vs 19.24), number of embryos transferred (1,81 vs 1,81), the ratio of good quality embryos/total embryos (56.89 % and 55.97 %), clinical pregnancy rates (63 % vs 49 %), implantation rates (31 % vs 28 %), and abortion rates (12,5 % vs 8,1 %) were also similar. A total of 1306 COCs were allocated for IVF while 1331 COCs were denuded for ICSI. Fertilization rate per inseminated oocyte was significantly higher in ICSI group (56,20 % vs 63,78 %). There were ten cases of total fertilization failure, all in the IVF group. Although overall fertilization rate was higher for ICSI, it was similar in both groups when cases with total fertilization failure were excluded. LIMITATIONS, REASONS FOR CAUTION: The non-availability of live birth rates is a limitation. Randomization of sibling oocytes, not patients requires careful interpretation of pregnancy and implantation rates. WIDER IMPLICATIONS OF THE FINDINGS: Lower cost, ease of application and similar clinical outcome makes IVF the choice of fertilization method in non-male factor infertility cases.

Istituto Nazionale Tumori, I. F. P. (2022). "MITO END-3: a randomized phase II trial of Carboplatin+Paclitaxel compared to Carboplatin+Paclitaxel+Avelumab in advanced (stage III-IV) or recurrent endometrial cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: AVELUMAB Product Code: [MSB0010718C] Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: AVELUMAB Current Sponsor code: MSB0010718C Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ Trade Name: PACLITAXEL ACCORD HEALTHCARE ITALIA ‐ 6 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 300MG/50ML Product Name: PACLITAXEL Product Code: [PACLITAXEL] Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: PACLITAXEL CAS Number: 33069‐62‐4 Current Sponsor code: paclitaxel Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6‐ Trade Name: CARBOPLATINO SANDOZ GMBH ‐ 10MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 60ML Product Name: CARBOPLATINO Product Code: [CARBOPLATINO] Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: CARBOPLATINO CAS Number: 41575‐94‐4 Current Sponsor code: CARBOPLATINO Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ CONDITION: advanced (stage III‐IV) or recurrent endometrial cancer ; MedDRA version: 21.0 Level: LLT Classification code 10007342 Term: Carcinoma endometrial System Organ Class: 100000004864 Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: To compare progression‐free survival (PFS) of patients with advanced or recurrent endometrial cancer when treated with Carboplatin+Paclitaxel vs Carboplatin+Paclitaxel+Avelumab Primary end point(s): To evaluate the effect of Carboplatin+Paclitaxel+Avelumab vs Carboplatin+Paclitaxel on PFS in patients with advanced or recurrent endometrial cancer. The trial will test the hypothesis that Carboplatin+Paclitaxel+Avelumab treatment will improve the PFS of treated patients in comparison to those treated with standard Carboplatin‐Paclitaxel. Secondary Objective: •overall survival; •best response rate; •Quality of Life; •safety and tolerability; •patient reported symptomatic toxicities (Italian PRO‐CTCAE); ; Exploratory Objectives:; •To investigate the relationship between PD‐L1 expression and response to Avelumab treatment utilizing archival FFPE tumor tissue; •To assess patients for microsatellite instability (MSI) phenotype using mismatch repair (MMR) immunohistochemistry (IHC) testing and/or MSI test ; •To assess patients for mutations in the in the exonuclease domain of POLE, analyzing exons 9 and 13 (mutational hot spots); •To assess the relationship between MMR deficiency and POLE mutations with survival (PFS and OS) and response rates and between other biomarkers predicting response to Avelumab treatment using archival FFPE tumor tissue and blood samples (if applicable); Timepoint(s) of evaluation of this end point: Disease response will be assessed according to RECIST v1.1 criteria every nine weeks. SECONDARY OUTCOME: Secondary end point(s): Secondary Objectives:; • To compare the overall survival (OS) of patients receiving Carboplatin+Paclitaxel vs Carboplatin+Paclitaxel +Avelumab; • To compare the best response rate of patients receiving Carboplatin+Paclitaxel vs Carboplatin+Paclitaxel+Avelumab (RECIST 1.1 criteria); • To assess the safety and tolerability of Carboplatin+Paclitaxel+Avelumab in this population; • To assess changes in Quality of Life parameters in patients treated with Carboplatin+Paclitaxel+Avelumab compared to the standard treatment; • To describe patient reported symptomatic toxicities in both treatment arms (Italian PRO‐CTCAE); ; Exploratory Objectives:; • To investigate the relationship between PD‐L1 expression and response to Avelumab treatment utilizing archival FFPE tumor tissue; ; • To assess patients for microsatellite instability (MSI) phenotype using mismatch repair (MMR) immunohistochemistry (IHC) testing and/or MSI test ; • To assess patients for mutations in the in the exonuclease domain of POLE, analyzing exons 9 and 13 ( tational hot spots); • To assess the relationship between MMR deficiency and POLE mutations with survival (PFS and OS) and response rates; • To investigate the relationship between other biomarkers predicting response to Avelumab treatment using archival FFPE tumor tissue and blood samples (if applicable) Timepoint(s) of evaluation of this end point: The total estimated duration of the trial is 60 months, including 24 months to accrue patients, and follow‐up of 36 months from randomization of last patient for survival INCLUSION CRITERIA: 1. Female aged ³ 18 years on day of signing informed consent 2. ECOG Performance Status of 0–1 3. Patients with newly diagnosed or recurrent EC FIGO stage III‐IV and histologically‐confirmed (any histology except sarcoma and carcinosarcoma) 4. Patients may have received adjuvant treatment (platinum‐based cytotoxic chemotherapy and/or radiotherapy). Patients having received prior chemotherapy must have completed their treatment at least 6 months prior to registration for protocol therapy. Patients having received prior radiotherapy must have completed their treatment at least 28 days prior to registration for protocol therapy 5. Have measurable disease based on RECIST v1.1 criteria 6. Availability of tumor samples for biomarker analysis 7. Endometrial cancer will include all carcinomas, including endometrioid carcinoma, papillary serous carcinoma, clear cell carcinoma 8. Adequate hematological function defined by

István, B., et al. (2022). "Investigating the efficacy and safety of anti-VEGF plus PARP inhibitor combination for the treatment of ovarian cancer." PROSPERO International prospective register of systematic reviews.
	
Ito, S. (2021). "Effectiveness of behavioral self-management intervention on female urinary incontinence patients." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Questionnaire survey, physical function test, Behavior modification counseling, self‐monitoring Questionnaire survey, physical function test CONDITION: urinary incontinence PRIMARY OUTCOME: urinary incontinence symptoms INCLUSION CRITERIA:

Ivánková, K. (2023). "Laparoscopic Therapy of Endometrioma: Sclerotherapy vs Cystectomy in Patients With Unfinished Reproductive Plans." ClinicalTrials.gov.
	No Results Available Procedure: laparoscopic ethanol sclerotherapy|Procedure: laparoscopic cystectomy of endometrioma AMH dynamics|endometrioma recurrence|complications|Asissted reproduction methods succes rate|pregnancy rate|deliveries Female Not Applicable 160 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment AMHstudy January 1, 2025

Iwata, M., et al. (2022). "Efficacy of Low-Dose Estrogen-Progestins and Progestins in Japanese Women with Dysmenorrhea: A Systematic Review and Network Meta-analysis." Advances in Therapy 39(11): 4892-4909.
	Introduction: Although several studies suggest beneficial effects of low-dose estrogen-progestins (LEPs) and progestins on dysmenorrhea in Japanese women, the difference in efficacy between drugs remains unknown.; Methods: We identified studies by searching the MEDLINE, Cochrane Library, and ICHUSHI databases and included randomized controlled trials (RCTs) that used total dysmenorrhea score and visual analogue scale (VAS) as outcome measures to evaluate LEPs and progestins for primary and secondary dysmenorrhea. We analyzed results by meta-analysis and network meta-analysis (NMA).; Results: We identified 10 articles on eight RCTs and included seven drugs (six LEPs and one progestin, i.e., dienogest) and placebo in the analysis. Meta-analysis showed improvements in total dysmenorrhea score and VAS for almost all drugs compared with placebo. In NMA, VAS in secondary dysmenorrhea improved more with dienogest than with norethisterone/ethinylestradiol (mean difference - 25.84 [95% CrI - 44.46 to - 7.15]). In the comparison of administration regimens, VAS improved more with progestin-continuous than LEP-cyclic and the surface under the cumulative ranking (SUCRA) of LEP-extended and progestin-continuous appeared to be higher than that of LEP-cyclic.; Conclusions: We confirmed that LEPs and dienogest are effective for primary and secondary dysmenorrhea and suggest that continuous regimens may be more effective than cyclic regimens in improving outcomes. (© 2022. The Author(s).)

Jacoby, V. (2023). "Prescription of Letrozole for Uterine Myoma." ClinicalTrials.gov.
	The PLUM Study is a randomized, double‐blinded, 2‐arm, parallel‐group, placebo‐controlled trial is designed to compare the efficacy of letrozole versus placebo on leiomyoma‐related symptoms and quality of life as well as leiomyoma and uterine size.

Jade, T., et al. (2021). "Effect of the uterine artery embolization for symptomatic leiomyomas: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jadine, S. and T. Kathryn (2022). "The effect of weight-loss interventions on polycystic ovarian syndrome (PCOS): a systematic review of randomised controlled trials." PROSPERO International prospective register of systematic reviews.
	
Jafarzade, A., et al. (2024). "A comparison of hyaluronic acid and estradiol treatment in vulvovaginal atrophy." European Review for Medical and Pharmacological Sciences 28(2): 571-576.
	OBJECTIVE: This study aims to compare the effects of vaginal estrogen and hyaluronic acid on vulvovaginal atrophy. PATIENTS AND METHODS: This randomized controlled study included a total of 300 patients, with 150 patients in each group (Group E and Group H). The VHI score was determined based on a pre-treatment evaluation conducted by a gynecologist. After one month of receiving vaginal estrogen in Group E and vaginal hyaluronic acid in Group H, the patients were re-evaluated by their physicians. RESULT(S): A statistically significant difference was found between the pre- and post-treatment VHI scores in Group E and Group H (p = 0.000; p = 0.000). No statistical difference was found between Group E and Group H in terms of treatment efficacy (p = 0.712). The pre- and post-treatment complaints of dryness, itching, dyspareunia, burning, and dysuria were found to be statistically significant in Group E and Group H (p = 0.000; p = 0.000; p = 0.000; p = 0.000; p = 0.000 in Group E, respectively) (p = 0.000; p = 0.000; p = 0.000; p = 0.000; p = 0.000 in Group H, respectively). No statistical difference was observed regarding dyspareunia, dysuria, and burning complaints (p = 0.632; p = 0.106; p = 0.128, respectively). However, hyaluronic acid was found to be significantly more effective for itching complaints (p = 0.002), while estrogen was found to be significantly more effective for dryness complaints (p = 0.012). CONCLUSION(S): Hyaluronic acid and estrogen were equally effective in vaginal treatment. Hyaluronic acid may be preferred for patients in whom hormonal therapy is contraindicated or for those who prefer non-hormonal therapy.Copyright © 2024 Verduci Editore s.r.l. All rights reserved.

Jamal, W. (2022). "Rescue Progesterone Supplementation During Frozen Embryo Transfer." ClinicalTrials.gov.
	No Results Available Drug: Progesterone Effervescent Vaginal Tablet Evaluate the ongoing pregnancy rate|Evaluate the miscarriage rate|Evaluate progesterone levels|Evaluate the rate of biochemical pregnancy Female Phase 2 150 Industry Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IIS-1032 June 30, 2026

James, E., et al. (2021). "A systematic review of findings from controlled trials of psychological interventions for dysmenorrhea (menstrual pain)." PROSPERO International prospective register of systematic reviews.
	
Jamieson, A. (2022). "STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision." ClinicalTrials.gov.
	Purpose: The aim of this prospective study is to determine if implementation of HPV(p16) and p53 stratified management algorithms will improve outcomes for women with VSCC. Hypothesis: Primary: Molecular stratification of VSCC, using margin status for both HPV and p53 pathology to direct surgical management, will improve clinical outcomes. Patient Reported Outcomes (PRO) Hypothesis: In women with HPV‐associated (HPV‐A) VSCC who undergo less radical surgery, treatment‐related side effects will be reduced, health‐related quality of life will be improved, and fear of cancer recurrence will not be increased, when compared to patients who undergoing standard surgery. PROs that are expected to be improved in this subgroup are: satisfaction with body image, frequency and enjoyment of sexual activity, urinary symptoms, and genital pain. In women with HPV‐independent (HPV‐I) VSCC, the expected PRO/HRQL (Health‐related quality of life) trajectory is expected to remain unchanged in the intervention group compared to the observation group, and fear of recurrence will be decreased. Justification: Most VSCC guidelines today recommend tumour‐free pathological margins of 8mm or more to adequately treat the primary tumour. These guidelines are based on retrospective data which did not stratify patients based on HPV or TP53 mutation status. HPV‐I VSCC: there is now data suggesting investigators are undertreating these patients and that surgical margins defined by proximity of invasive disease, presence of preinvasive disease and p53 IHC (Immunohistochemistry) status will guide the need for re‐excision and optimize local disease control. Goal in HPV‐I VSCC = demonstrating re‐excision to achieve clear margins will improve outcomes. HPV‐A VSCC: there is data supporting that investigators are likely overtreating these patients, and the absence of invasive disease at the resection margin will be sufficient without loss of local control and will improve patient reported outcomes. Goal in HPV‐A VSCC= demonstrating de‐escalation of surgery is safe(and will improve QoL). Objectives: Primary Objective: To determine if implementation of HPV and p53 stratified algorithms to guide surgical management will improve outcomes in patients with VSCC; based on 3‐year local recurrence rates in both HPV‐I and HPV‐A disease Secondary Objectives: 1. Determine the health economic impact (EQ‐5D) of implementation of HPV and p53 stratified treatment algorithms 2. Determine the patient reported outcomes (EORTC QLQ (Quality of Life Questionnaire) ‐C30 and EORTC QLQ‐VU34), patient decisional conflict, patient satisfaction /acceptance with HPV and p53 stratified care in VSCC 3. Determine the disease specific survival (DSS) and overall survival (OS) for HPV‐I and HPV‐A VSCC managed per algorithms 4. Determine the feasibility of implementation of routine p16 and p53 IHC reporting in VSCC pathology (proportion of patients who had p53 and p16 IHC successfully performed in an acceptable turnaround time ie >85% of patients within 21 days of surgery) RESEARCH DESIGN: The HPV‐I arm of the study will be conducted as a phase II, randomised control trial and the HPV‐A arm of the study will be a prospective trial. STATISTICAL ANALYSIS: The Kaplan‐Meier method will be used to estimate 3‐year rates of recurrence‐free survival, vulvar cancer‐specific survival, and overall survival and associated 95% confidence interval with the events defined as any recurrence or death for recurrence‐free survival, death due to vulvar cancer for vulvar cancer‐specific survival, and death due to any cause for overall survival. Women without the event observed at the time of analysis will be censored at the last follow‐up.

Janaina, S. and C. Hilton (2022). "Efficacy and safety of ovarian stem cell transplantation in patients with primary ovarian insufficiency and poor responders: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Jang, Y.-C., et al. (2022). "Comparison of Severity of Genitourinary Syndrome of Menopause Symptoms After Carbon Dioxide Laser vs Vaginal Estrogen Therapy: A Systematic Review and Meta-analysis." JAMA Network Open 5(9): e2232563.
	Importance: Vaginal estrogen for genitourinary syndrome of menopause (GSM) should be used with caution in women with contraindications, highlighting the need for effective treatment alternatives.; Objective: To compare the severity of GSM after vaginal laser vs estrogen therapy.; Data Sources: The PubMed, Embase, and Cochrane Library databases were searched for articles published from database inception to April 8, 2022, with no language restrictions. Reference lists were also searched.; Study Selection: Randomized clinical trials (RCTs) that compared the use of lasers with vaginal estrogen in adults were selected.; Data Extraction and Synthesis: Two investigators independently extracted data from included studies. The Cochrane risk of bias tool for RCTs was used to assess risk of bias of each study. A random-effects model was used to pool mean differences (MDs) with 95% CIs.; Main Outcomes and Measures: Primary outcomes were Vaginal Analog Scale (VAS; higher scores indicate severer symptoms), Vaginal Health Index (VHI; higher scores indicate better vaginal health), Vaginal Maturation Index (VMI; higher scores indicate higher estrogen effect on the vaginal epithelium), Female Sexual Function Index (FSFI; higher scores indicate better female sexual function), and Sexual Quotient-Female (SQ-F; higher scores indicate better female sexual function) questionnaire scores. Urinary symptoms were assessed as an additional outcome. Data analyses were performed from April 9 to 12, 2022.; Results: A total of 6 RCTs with 270 women with GSM were included (135 were randomized to laser therapy and 135 to estrogen therapy; mean age ranged from 54.6 to 61.0 years). No significant differences were found between carbon dioxide laser and vaginal estrogen from baseline to the end of follow-up in overall VAS scores (MD, -0.16; 95% CI, -0.67 to 0.36; I2, 33.31%), VHI (MD, 0.20; 95% CI, -0.56 to 0.97; I2, 83.25%), VMI (MD, -0.56; 95% CI, -1.14 to 0.02; I2, 35.07%), FSFI (MD, -0.04; 95% CI, -0.45 to 0.36; I2, 41.60%), and SQ-F (P = .37 based on 1 study). Other questionnaire-based outcome measures demonstrated no difference between groups from baseline to the end of follow-up for changes in urinary symptoms.; Conclusions and Relevance: This systematic review and meta-analysis of RCTs found that vaginal laser treatment is associated with similar improvement in genitourinary symptoms as vaginal estrogen therapy. Further research is needed to test whether vaginal laser therapy could be a potential treatment option for women with contraindications to vaginal estrogen.

javad, H. and A. Ahmed (2023). "The Positive Effects of Zinc Supplements on the Improvement of Primary Dysmenorrhea and Premenstrual Symptoms: A systematic review and meta-analysis of randomized clinical trials." PROSPERO International prospective register of systematic reviews.
	
javad, H. and M. Mojgan (2021). "Effect of L-carnitine supplementation on body weight and insulin resistance in women with polycystic ovary syndrome: systematic review and meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
javad, H. and M. Mojgan (2021). "A systematic review and meta-analysis of the green tea effects on anthropomethric parameters of PCOS patients." PROSPERO International prospective register of systematic reviews.
	
Javad, H. and Z. Somayeh (2023). "A systematic review and meta-analysis of the Melatonin effects on metabolic parameters of PCOS patients." PROSPERO International prospective register of systematic reviews.
	
Javanbakht, M., et al. (2020). "Surgical treatments for women with stress urinary incontinence: A systematic review of economic evidence." Systematic Reviews 9(1): 85.
	Background: Surgical interventions for the treatment of stress urinary incontinence (SUI) in women are commonly employed following the failure of minimally invasive therapies. Due to the limited information available on the relative cost-effectiveness of available surgeries for treating SUI, a de novo economic analysis was conducted to assess costs and effects of all relevant surgeries. To inform the economic analysis, the objective of this review was to identify and assess the quality of existing economic evaluation studies on different surgical interventions for the treatment of SUI in women. Method(s): The following databases were searched during the review process: Medical Literature Analysis and Retrieval System Online (MEDLINE), MEDLINE In-Process, Excerpta Medica Database (Embase), National Health Service Economic Evaluation Database (NHS EED), and Health Management Information Consortium and Cost-Effectiveness Analysis Registry (CEA registry). The key criteria for inclusion were that the study population included women with SUI and that the surgical interventions considered were utilised as either a primary or a follow-up surgery. The review included only full economic evaluations. Studies were quality assessed using the Drummond checklist for economic evaluations. No quantitative synthesis of the results by meta-analysis was conducted due to the high methodological heterogeneity. Result(s): Twenty-six economic evaluations were included, of which 13 were model-based analyses. Surgical treatments assessed most frequently were mid-urethral slings and open and laparoscopic colposuspension. There were some differences in the methodological approaches taken, including differences in type of economic analysis, perspective, time horizon, types of resource use, and costs and outcomes that were included in the analysis. The majority of studies conducted a cost-utility analysis from a health system perspective and applied a time horizon of between 1 and 5 years. The cost-effectiveness results suggest that single-incision mini-sling and mid-urethral slings are among the most cost-effective options. Conclusion(s): The review has shown that methods used for the economic evaluation of surgical treatments for SUI vary widely in terms of study design, analysis type, compared alternatives, time horizon, costing methodologies and effect outcomes. Future economic evaluation studies on surgical treatments for SUI may be improved by the application of available guidelines. Systematic review registration: Registered in PROSPERO in 2016, CRD42016049339Copyright © 2020 The Author(s).

Jazaeri, A. (2023). "Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer." ClinicalTrials.gov.
	This is a 1:1 randomized, open label, multi‐center phase I/II trial to evaluate the safety, dosing, efficacy, and biological activity of adding IMNN‐001 to chemotherapy + BEV compared to chemotherapy + BEV alone. The chemotherapy (NACT & adjuvant) will be a standard regimen of carboplatin + paclitaxel administered every three weeks for a total of 7‐9 cycles. The protocol requires at least 4 cycles of NACT and allows up to 2 additional cycles of neoadjuvant therapy at the Investigator's discretion based on response and other clinical considerations. ICS will take place 3‐4 weeks from last dose of NACT. Following at least a 4‐week recovery from ICS, 3 additional adjuvant cycles of study treatments will be administered. The minimum time interval between surgery and BEV administration will be 4 weeks for safety. BEV will be included at Cycles 2, 3, 6, and 7. BEV may be substituted by an FDA approved biosimilar. The experimental arm will add IMNN‐001 weekly to each cycle of chemotherapy + BEV beginning with cycle 1 day 15 and continue weekly through the last cycle of adjuvant therapy.

Jeng, C.-J., et al. (2020). "Comparison of magnetic resonance-guided high-intensity focused ultrasound with uterine artery embolization for the treatment of uterine myoma: A systematic literature review and meta-analysis." Taiwanese Journal of Obstetrics & Gynecology 59(5): 691-697.
	Objective: This study aimed to compare the outcomes of magnetic resonance-guided (MR-g) high-intensity focused ultrasound (HIFU) with uterine artery embolization (UAE) for the treatment of uterine myoma.; Materials and Methods: A systematic literature review and meta-analysis was conducted using database searches of Medline, Cochrane, EMBASE, and Google Scholar. Articles were searched through March 25, 2020. Outcomes of interest were Symptom Severity Score (SSS), Health-related Quality of Life (HRQoL), re-intervention rate, and rate of adverse reactions in patients with uterine myoma.; Results: Four studies were included with a total of 207 patients with uterine myomas who received MR-g HIFU and 201 who received UAE. UAE was associated with a greater reduction in SSS, improved HRQoL, and a significantly lower re-intervention rate compared with MR-g HIFU in 3 of 4 included studies. No significant differences were found in the incidence and severity of adverse events between treatment arms in one study, but differences were observed in the percentage of adverse reactions in another.; Conclusion: Published evidence suggests that the efficacy of MR-g HIFU may not be superior to that of UAE in the treatment of uterine myoma.; Competing Interests: Declaration of Competing Interest The authors declare that they have no conflicts of interest and nothing to disclose. (Copyright © 2020. Published by Elsevier B.V.)

Jeng, H.-S., et al. (2020). "Treating vaginitis with probiotics in non-pregnant females: A systematic review and meta-analysis." Experimental and Therapeutic Medicine 20(4): 3749-3765.
	Vaginitis, also known as vulvovaginitis, is an inflammation of the vagina and vulva and a common disease in females. It is thought to be caused by vaginal dysbiosis and improved by probiotics. Bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) are the major types of vaginal infections. The present systematic review and meta-analysis aimed to clarify the efficacy of probiotics in the treatment of common vaginal infections in non-pregnant females. Literature on randomized controlled trials and two-armed prospective studies on any intervention with probiotics published until December 24th, 2018 was searched in the PubMed, Cochrane and EMBASE databases. The outcomes of interest were recurrence rate, cure rate, remission rate and normal vaginal flora restoration. Finally, a total of 30 studies on bacterial vaginosis (BV) and/or VVC were included and stratified into 3 study types based on treatment design as follows: Type I, antibiotic/probiotics vs. antibiotics/antifungals (22 studies); Type II, probiotics vs. placebo (5 studies); Type III, probiotics vs. antibiotics (3 studies). The type I studies comprised 1,788 non-pregnant females and had the highest inter-study comparability in post-treatment follow-up design and meta-analysis outcome data. Probiotics interventions were significantly associated with a lower recurrence rate of vaginitis [pooled odds ratio (OR)=0.27, 95% CI: 0.18-0.41, P<0.001] and higher cure/remission rate (pooled OR=2.28, 95% CI: 1.20-4.32, P=0.011). However, a significant increase in normal vaginal flora after probiotic treatment was observed only in BV (pooled OR=4.55, 95% CI: 1.44-14.35, P=0.01). In addition, supportive but heterogeneous results were obtained from the 6-month follow-up data of Type-I studies, different infection types and supplementary analysis of Type-II studies. In conclusion, probiotics have a significant short-term effect in the treatment of common vaginal infections in non-pregnant females. In order to evaluate the long-term effects of probiotics in common vaginal infections, it is worthwhile to perform higher-quality clinical trials in the future. (Copyright: © Jeng et al.)

Jennifer, W., et al. (2022). "The effectiveness of lumbopelvic support garments in the reduction of pregnancy related pelvic girdle pain: A systematic review." PROSPERO International prospective register of systematic reviews.
	
Jensen, K. H. K., et al. (2021). "Meditation and mindfulness reduce perceived stress in women with recurrent pregnancy loss: a randomized controlled trial." Reproductive Biomedicine Online 43(2): 246‐256.
	Research question: Can participating in a tailored 7‐week meditation and mindfulness programme with additional standard supportive care versus standard supportive care only reduce perceived stress for women with recurrent pregnancy loss (RPL)? Design: A two‐armed randomized controlled trial (RCT) with 12‐month follow‐up. In total 76 patients were enrolled and randomly assigned to either standard supportive care or to a 7‐week meditation and mindfulness programme led by an instructor in addition to standard supportive care. Results: At intervention completion (after 7 weeks), perceived stress decreased significantly both in the intervention group (P = 0.001) and in the control group (P = 0.006). The decrease in perceived stress in the intervention group was significantly larger (P = 0.027) compared with the control group. At the 12‐month follow‐up perceived stress was still significantly decreased in both groups compared with baseline (P < 0.0001 in the intervention group and P = 0.002 in the control group). Conclusion: This first RCT of a tailored meditation and mindfulness intervention for women with RPL documents that a 7‐week daily at‐home meditation and mindfulness programme combined with group sessions reduced perceived stress significantly more than a standard supportive care programme. Future studies should address the most effective format and the ‘dose’ needed for an impact on perceived stress levels.

Jensterle, M., et al. (2023). "Semaglutide delays 4-hour gastric emptying in women with polycystic ovary syndrome and obesity." Diabetes, Obesity & Metabolism 25(4): 975-984.
	Aim: To evaluate the effect of once-weekly subcutaneous semaglutide 1.0 mg on the late digestive period of gastric emptying (GE) after ingestion of a standardized solid test meal by using technetium scintigraphy, the reference method for this purpose.; Methods: We conducted a single-blind, placebo-controlled trial in 20 obese women with polycystic ovary syndrome (PCOS; mean [range] age 35 [32.3-40.8] years, body mass index 37 [30.7-39.8] kg/m 2 ) randomized to subcutaneous semaglutide 1.0 mg once weekly or placebo for 12 weeks. GE was assessed after ingestion of [ 99mT c] colloid in a pancake labelled with radiopharmaceutical by scintigraphy using sequential static imaging and dynamic acquisition at baseline and at Week 13. Estimation of GE was obtained by repeated imaging of remaining [ 99mT c] activity at fixed time intervals over the course of 4 hours after ingestion.; Results: From baseline to the study end, semaglutide increased the estimated retention of gastric contents by 3.5% at 1 hour, 25.5% at 2 hours, 38.0% at 3 hours and 30.0% at 4 hours after ingestion of the radioactively labelled solid meal. Four hours after ingestion, semaglutide retained 37% of solid meal in the stomach compared to no gastric retention in the placebo group (P = 0.002). Time taken for half the radiolabelled meal to empty from the stomach was significantly longer in the semaglutide group than the placebo group (171 vs. 118 min; P < 0.001).; Conclusion: Semaglutide markedly delayed 4-hour GE in women with PCOS and obesity. (© 2022 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Jessica, L., et al. (2022). "Comparison of lifestyle modification vs no intervention on polycystic ovarian syndrome characteristics in the adolescent population: a protocol for a systematic review." PROSPERO International prospective register of systematic reviews.
	
Jia, C. and J. Song (2023). "Efficacy of biofeedback electrical stimulation combined with pelvic floor muscle training in postpartum stress urinary incontinence: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jia, Y. U., et al. (2023). "Comparative effectiveness of non-pharmacological interventions on sleep in perimenopausal and postmenopausal women&#xff1a;A systematic review with network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jian, Z. and B. A. I. Shou-Min (2023). "Efficacy and toxicity of nimotuzumab in combination with chemoradiotherapy in the treatment of locally advanced cervical cancer." PROSPERO International prospective register of systematic reviews.
	
Jiang, C., et al. (2021). "Chinese herbal medicine for immune infertility: A protocol for systematic review and meta-analysis." Medicine 100(5): e24248.
	Background: Infertility is a reproductive disorder caused by multiple causes and is an adverse event of reproductive health for couples in the reproductive period. Women who do not avoid sex for at least 12 months and are not pregnant are said to be infertile. 10% to 20% of infertility is caused by immune factors. At present, there is no unified diagnostic standard for immunological infertility. Clinically, it is considered that abnormal ovulation and reproductive system function of women are excluded, and no obvious pathogenic factors occur; routine examination of male semen is normal, but there is evidence of anti-reproductive immunity, thus causing infertility is immunological infertility. Traditional Chinese medicine (TCM) has a long history of treating infertility and has remarkable curative effect. It plays an important role in the treatment of gynecological and obstetrical diseases in China. The purpose of this study is to evaluate the efficacy and safety of traditional Chinese medicine for the treatment of immune infertility.; Method: we searched the literature from following databases: Cochrane Library, PubMed, China Biomedical Literature Database (CB), EMBASE, Chinese Journal of Science and Technology (VIP), China National Knowledge Infrastructure Database (CNKI) and Wanfang Database were searched. All the databases mentioned above will be searched from the start date to the latest version. A manual search of all references to the included trials, published randomized controlled trials (RCTs) whether blind or unblind, any languages and length of follow up were included. Treatments included Chinese medicinal herbs (single or compound). Controlls were placebo and western medicine, or no intervention. Key outcomes will include pregnancy rates, the efficiency of Chinese herbal medicine (at least one negative antibody for infertility), birth rates (the ratio of the number of pregnant women giving birth to their babies normally after herbal treatment to the total number of patients treated), recurrence rate and safety index. Two evaluators independently retrieved and extracted data and import it into Endnote X8. Then they conduct methodological evaluation on the quality of the included studies, and meta-analysis was conducted with RevMan 5.3 and Stata 13.0 software. We will use the Cochrane risk analysis tool to assess the risk of bias. Differences will be resolved by consensus or through the participation of third parties. All analysis will be performed based on the Cochrane Handbook for Systematic Reviews of Interventions.; Results: The purpose of this study is to evaluate the efficacy and safety of traditional Chinese herb medicine in the treatment of immune infertility.; Conclusion: This meta-analysis can provide evidence for clinicians to help patients make better choices.; Trial Registration Number: INPLASY2020120073.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Jiang, J., et al. (2022). "Evaluation on curative effects of adjuvant chemotherapy alone in treating with advanced endometrial carcinoma: A protocol for systematic review and meta-analysis." Medicine 101(9): e28817.
	Background: Endometrial carcinoma is classified as a gynecological cancer with high incidence. However, comparatively, only a small percentage of patients associated with it experience the condition progress to advanced disease or face recurring conditions. In the event where the condition progresses or recurs, the existing prognosis is poor and the most efficient form of treatment has not been established. Traditional methods to treat advanced endometrial carcinoma involves cytoreductive surgical intervention and radiation therapy, or chemotherapy, or a combination. Currently, there is controversy regarding the safest and most effective form of treatment. Therefore, the aim of conducting this protocol is to systematically review and provide meta-analyses on the curative effects of only using adjuvant chemotherapy to treat advanced endometrial carcinoma.; Methods: A systematic search will be performed in 6 online-based databases, including WanFang, PubMed, Web of Science, EMBASE, and Cochrane Library, China National Knowledge Infrastructure databases. All related studies until December 22, 2021 will be considered in the search. Moreover, Google Scholar will be used as a source for grey literature. Two independent authors will screen the titles and abstracts. We will use the revised Cochrane risk of bias tool for performing an assessment of the risk of bias in randomized controlled trials. Additionally, Begg test statistics and Egger regression test will be employed to objectively detect the publication bias.; Ethics and Dissemination: Not required.; Osf Registration: 10.17605/OSF.IO/JA48Q.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Jiang, Y., et al. (2023). "The effect of progesterone supplementation for luteal phase support in natural cycle frozen embryo transfer: a systematic review and meta-analysis based on randomized controlled trials." Fertility and Sterility 119(4): 597-605.
	Importance: The necessity of progesterone supplementation for luteal phase support (LPS) in natural cycle frozen embryo transfer (NC-FET) cycles warrants further confirmation.; Objective: To investigate the effect of progesterone supplementation for LPS on the reproductive outcomes of patients undergoing NC-FET cycles.; Data Sources: The PubMed, Ovid-Embase, Cochrane Library, Web of Science, CNKI, Wanfang, VIP, and CBM were electronically searched. The search time frame was from inception up to September 2022.; Study Selection and Synthesis: Randomized controlled trials (RCTs) that used progesterone for LPS in NC-FET cycles, including true NC-FET cycles (tNC-FET) and modified NC-FET cycles (mNC-FET), were included. The counted data were analyzed using relative risk (RR) as the effect-size statistic, and each effect size was assigned its 95% confidence interval (CI).; Main Outcome Measures: The primary outcomes were the live birth rate (LBR) and the clinical pregnancy rate (CPR), and the secondary outcome was the miscarriage rate.; Results: Four RCTs were included, which involved 1116 participants. The results of the meta-analysis showed that progesterone supplementation was associated with increased LBR (RR, 1.42; 95% CI, 1.15-1.75; I 2 = 0%, moderate-quality evidence) and CPR (RR, 1.30, 95% CI, 1.07-1.57; I 2 = 0%, moderate-quality evidence) in patients undergoing NC-FET cycles. Subgroup analysis showed that progesterone supplementation was associated with higher LBR and CPR in tNC-FET cycles. However, no association was found between increased LBR and CPR in mNC-FET cycles. In addition, only one RCT reported that oral dydrogesterone had similar CPR and miscarriage rate compared with vaginal progesterone in mNC-FET cycles.; Conclusion(s): Overall, moderate-quality evidence suggested that progesterone supplementation for LPS was associated with increased LBR and CPR in NC-FET cycles. Progesterone supplementation was associated with a higher LBR and CPR in tNC-FET cycles. However, the effectiveness of progesterone supplementation in mNC-FET cycles should be further verified by larger RCTs. Low to very low-quality evidence indicated that oral dydrogesterone and vaginal progesterone have similar reproductive outcomes in mNC-FET cycles, which requires further study, especially in tNC-FET cycles.; Registration Number: PROSPERO CRD42022355550 (https://www.crd.york.ac.uk/prospero/display&#95;record.php?RecordID=355550) was registered on September 3, 2022. (Copyright © 2022 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Jiang, Y., et al. (2023). "The effect of embryo selection using time-lapse monitoring on IVF/ICSI outcomes: A systematic review and meta-analysis." The Journal of Obstetrics and Gynaecology Research 49(12): 2792-2803.
	Aim: To explore the effect of embryo selection using the time-lapse monitoring (TLM) system compared with conventional morphological selection (CMS) on in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes.; Methods: We searched PubMed, Ovid-Embase, and The Cochrane Library for the following studies: At Comparison 1, embryo selection using TLM images in a TLM incubator based on morphology versus embryo selection using CMS in a conventional incubator based on morphology; at Comparison 2, embryo selection using TLM based on morphokinetics versus embryo selection using CMS based on morphology. The primary outcomes were the live birth rate (LBR), ongoing pregnancy rate (OPR), clinical pregnancy rate (CPR), and implantation rate (IR), and the secondary outcome was the miscarriage rate (MR).; Results: A total of 14 randomized control trials (RCTs) were included. Both based on morphology, TLM incubators increased the IR (risk ratio [RR]: 1.10; 95% confidence interval [CI]: 1.01, 1.18; I 2 = 0%, moderate-quality evidence) compared to conventional incubators. Low- to moderate-quality evidence suggests that TLM incubators did not improve LBR, OPR, CPR, and MR compared to conventional incubators. In addition, low- to moderate-quality evidence indicates that embryo selection using TLM based on morphokinetics did not improve LBR, OPR, CPR, IR, or MR compared to CMS based on morphology.; Conclusions: Low- to moderate-quality evidence suggests that neither TLM incubators nor embryo selection using TLM based on morphokinetics improved clinical outcomes (LBR, OPR, CPR, and MR) compared with CMS based on morphology. TLM is still an investigational procedure for IVF/ICSI practice. (© 2023 Japan Society of Obstetrics and Gynecology.)

Jiang, Y., et al. (2020). "Evaluation of the Efficacy and Safety of PARP Inhibitors in Advanced-Stage Epithelial Ovarian Cancer." Frontiers in Oncology 10: 954.
	Purpose: PARP inhibitors are a novel targeted anti-cancer drug and a large number of clinical studies on PARP inhibitors have been accomplished. This updated meta-analysis was conducted to evaluate the efficacy and safety of PARP inhibitors in advanced-stage epithelial ovarian cancer. Methods: Medline (PubMed), Embase, Cochrane Central Register of Controlled Trials, Web of Science, and Scopus were searched to identify the eligible trials up to April 2020. ClinicalTrials.gov was also screened for additional unpublished trials. Data extraction and risk of bias assessment were performed by two independent investigators, respectively. The hazard ratios (HRs) and its 95% confidence intervals (CI) for time-to-event data of progression-free survival (PFS) and overall survival (OS), and the risk ratios (RRs) with 95% CI for dichotomous data of overall response rate (ORR) and occurrence of adverse events (AEs) were calculated by Review Manager 5.3 and Stata 12.0 software. Results: A total of 12 trials with 5,347 patients were included in this meta-analysis. Compared with the control group, PARP inhibitors significantly improved PFS (HR, 0.51; 95% CI, 0.40-0.65; P < 0.00001) and ORR (RR, 1.26; 95% CI, 1.11-1.43; P = 0.0003). Specifically, PFS was improved regardless of BRCA genes mutations and homologous-recombination status. However, no difference was observed in OS between the PARP inhibitors group and the control group (95% CI, 0.73-1.01; P = 0.06). PARP inhibitors were associated with a statistically significant higher risk of hematologic events and different PARP inhibitors had different toxicities profiles. Conclusion: PARP inhibitors are an effective and well-tolerated treatment for patients with advanced-stage epithelial ovarian cancer. (Copyright © 2020 Jiang, Zhao, Zhang, Tian, Yang, Wang, Zhao, Yang, Wang and Yang.)

Jiang, Y., et al. (2020). "Treatment of G-CSF in unexplained, repeated implantation failure: A systematic review and meta-analysis." Journal of Gynecology Obstetrics and Human Reproduction 49(10): 101866.
	Backgroud: Repeated implantation failure (RIF) is a stressful situation for subfertile women undergoing in vitro fertilisation (IVF) treatment and caregivers. Granulocyte-colony stimulating factor (G-CSF) seems to play an important role in assisted reproductive techniques. However, it is currently unknown whether G-CSF is effective in improving results for patients with RIF. Objective(s): To describe and summarize current evidence of the effect of the granulocyte colony stimulating factor (G-CSF) in treating RIF. Method(s): Relevant scientific literature was thoroughly searched by computer in domestic and foreign database from the inceptions to November 2019. And relevant randomized controlled trials (RCTs) assessing the efficacy of G-CSF in unexplained RIF were included. The meta-analysis was conducted by Stata 12. 0 software, and we estimated relative risks (RRs) and associated 95 % confidence intervals (CIs) of G-CSF on implantation rate (IR), the clinical pregnancy rate (CPR), the abortion rate (AR) in patients with unexplained RIF using fixed-effect model. Besides, Subgroup analysis was performed according to the different administration methods. Result(s): A total of eleven articles were included for the final meta-analysis with sample sizes ranging from 13 to 107 patients. The G-CSF was associated with an increased IR [RR = 2.346, 95 %CI (1.615-3.409), I2 = 0. 0%] and CPR [RR = 1.910, 95 %CI (1.562-2.337), I2 = 0.0 %] in patients with unexplained RIF. When further stratified by the method of administration, the subgroup analysis revealed that both intrauterine injection and subcutaneous injection are capable of improving IR[subcutaneous injection:RR = 2.400, 95 %CI (1. 268-4. 542), I2 = 0.0 %; intrauterine injection:RR = 2.317, 95 %CI (1.462-3.673), I2 = 0.0 %] and CPR[subcutaneous injection: RR = 2. 022, 95 %CI (1.443-2.832), I2 = 0. 0%; intrauterine injeciton: RR = 1.848, 95 %CI (1.438-2.376), I2 = 0. 0%]. G-CSF was not associated with AR in patients with unexplained RIF [RR = 2.092, 95 %CI (0.815-5.369), I2 = 0.0 %]. Conclusion(s): The current evidence support G-CSF's positive effect on the implantation rate and clinical pregnancy rate of patients with unexplained RIF, especially when administrated by subcutaneous injection. There is no conclusive evidence for the association between G-CSF and the abortion rate. Moreover, few of the included articles reported side effects of G-CSF, so its safety remains to be investigated.Thus, future research should evaluate.Copyright © 2020 Elsevier Masson SAS

Jianyu, Y. and Z. Zhigang (2024). "Moxibustion for endometriosis-related pain: protocol for a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jianyu, Y., et al. (2023). "Acupuncture for endometriosis-related pain: protocol for a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jiaqi, Y., et al. (2021). "Efficacy and safety of apatinib in the treatment of ovarian cancer(OC): a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jiaqi, Z., et al. (2021). "SGLT-2i's for improving the endocrine and metabolic profile in obese/overweight individuals with PCOS: protocol for systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jicheng, L. and G. Feng (2023). "Comparsion of hysterectomy and uterus preservation in the treatment of pelvic organ prolapse by pelvic floor reconstructive surgery with transvaginal mesh: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jidong Dung, E., et al. (2021). "Psychological interventions for maternal depression among women of African and Caribbean origin: a systematic review." BMC Women's Health 21(1): 83.
	Background: Maternal depression is a leading cause of disease burden for women worldwide; however, there are ethnic inequalities in access to psychological interventions in high-income countries (HICs). Culturally appropriate interventions might prove beneficial for African and Caribbean women living in HICs as ethnic minorities.; Methods: The review strategy was formulated using the PICo (Population, phenomenon of Interest, and Context) framework with Boolean operators (AND/OR/NOT) to ensure rigour in the use of search terms ("postpartum depression", "maternal depression", "postnatal depression", "perinatal depression" "mental health", "psychotherapy" "intervention", "treatment", "black Caribbean", "black African", "mothers" and "women"). Five databases, including Scopus, PsycINFO, Applied Social Science Index and Abstracts (ASSIA), ProQuest Central and Web of Science, were searched for published articles between 2000 and July 2020. 13 studies met the inclusion criteria, and the relevant data extracted were synthesised and thematically analysed.; Results: Data syntheses and analyses of included studies produced four themes, including (1) enhance parenting confidence and self-care; (2) effective mother-child interpersonal relationship; (3) culturally appropriate maternal care; and (4) internet-mediated care for maternal depression.; Conclusion: In the quest to address maternal mental health disparities among mothers of African and Caribbean origin in HICs, the authors recommend culturally adapted psychological interventions to be tested in randomised control trials.

Jie, C., et al. (2024). "Comparative effects of progestin-based combination therapy for endometrial cancer or atypical endometrial hyperplasia: A systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jimenez, S. (2022). "Therapeutic Exercise and Education in Neurophysiology of Pain in the Quality of Life of Women With Endometriosis." ClinicalTrials.gov.
	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.

Jímenez, S. (2022). "THERAPEUTIC EXERCISE AND EDUCATION IN PAIN NEUROPHYSIOLOGY TO IMPROVE PAIN INTENSITY IN WOMEN WITH ENDOMETRIOSIS. CLINICAL TRIAL." ClinicalTrials.gov.
	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.

Jin, B., et al. (2020). "Influence of vitamin D supplementation on lipid levels in polycystic ovary syndrome patients: a meta-analysis of randomized controlled trials." The Journal of International Medical Research 48(8): 300060520935313.
	Objective: Observational studies have shown that circulating vitamin D (VitD) deficiency is associated with atherogenic lipid patterns among polycystic ovary syndrome (PCOS) patients. However, interventional studies have shown inconsistent results. The aim of this meta-analysis was to investigate how VitD supplementation influences lipid indices in PCOS patients.; Methods: The authors searched four electronic databases through August 2019 to identify randomized controlled trials (RCTs) that assessed the effect of VitD intervention on serum lipids among PCOS patients. Mean differences were generated for statistical evaluation.; Results: We included eight studies and performed nine comparisons across 467 participants. VitD supplementation reduced serum triglyceride levels (-11.88 mg/dL; 95% confidence interval [CI]: -17.03 to -6.73), total cholesterol (-9.09 mg/dL; 95% CI: -14.90 to -3.29), low-density lipoprotein cholesterol (-5.22 mg/dL; 95% CI: -10.32 to -0.13), and very-low-density lipoprotein cholesterol (-2.43 mg/dL; 95% CI: -3.69 to -1.17) compared with no VitD supplementation. However, high-density lipoprotein cholesterol levels showed no differences with or without VitD supplementation (-0.39 mg/dL; 95% CI: -1.39 to 0.61).; Conclusions: VitD supplementation improved serum lipid levels among PCOS patients, but serum high-density lipoprotein cholesterol levels were not changed. VitD intervention might benefit PCOS patients who are at high risk of an atherogenic lipid profile.

Jin, J. and Z. Jianing (2022). "Assessment of the effectiveness and safety of combination of contrast-enhanced ultrasound (CEUS) and high-intensity focused ultrasound (HIFU) for uterine fibroids: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jin, X., et al. (2021). "Pregnancy Outcome Difference between Fresh and Frozen Embryos in Women without Polycystic Ovary Syndrome: a Systematic Review and Meta-Analysis." Reproductive Sciences 28(5): 1267-1276.
	The purpose of this study is to identify that the advantages of frozen embryos are not evident in ovulatory women or women with non-polycystic ovary syndrome (non-PCOS) by meta-analysis. An exhaustive literature search of PubMed (MEDLINE), Embase, and Cochrane Library databases was performed until March 20, 2020 (limited to articles published in English). We included randomized clinical trials comparing the results of frozen and fresh embryo transfers. The primary outcomes were live birth rate and birth weight. The fixed effect model was used when a significant heterogeneity was observed. Otherwise, a random effect model was used. In 511 identified studies, 4 were eligible and were included in this review. There was no difference in live birth rate, singleton birth weight, clinical pregnancy, ongoing pregnancy, gestational diabetes, and gestational hypertension between frozen and fresh embryos. In frozen embryos, the relative risk of moderate or severe ovarian hyperstimulation syndrome (OHSS) was lower, the incidence rate of pre-eclampsia higher, and the standardized mean difference of twin birth weight higher than in fresh embryos. There is no significant difference between frozen embryo transfer (FET) and fresh embryo transfer in ovulatory women or women with non-PCOS. We recommend that the transfer depends on the actual situation in the patient in clinical practice, rather than the "freeze all" policy and thawing FET.

Jin Xin, H., et al. (2022). "Intrauterine interventions for women with two or more implantation failures: A systematic review and network meta-analysis." Frontiers in Endocrinology 13: 959121.
	Objective: To compare the effectiveness of different intrauterine interventions for women with two or more unexplained implantation failures.; Design: A systematic review and network meta-analysis of randomized controlled trials (RCTs).; Patients: Women with two or more implantation failures undergoing fresh or frozen embryo transfer (ET).; Interventions: An electronic search of the following databases: Pubmed, Cochrane Central Register of Controlled Trials (CENTRAL), and Embase.; Main Outcome Measures: Clinical pregnancy, live birth/ongoing pregnancy, and miscarriage.; Results: We included 21 RCTs(3079 women) in the network meta-analysis. The network meta-analysis showed that compared with control treatment, platelet-rich plasma(PRP), peripheral blood mononuclear cells (PBMC), granulocyte colony-stimulating factor(G-CSF), human chorionic gonadotropin(HCG), and endometrial scratch(ES) significantly increased clinical pregnancy(OR 3.78, 95% CI 2.72 to 5.25; 2.79, 95% CI 1.75 to 4.45; 1.93, 95% CI 1.37 to 2.72; 1.80, 95% CI 1.18 to 2.72; 1.75, 95% CI 1.29 to 2.36, respectively). PRP ranked the highest in improving clinical pregnancy, followed by PBMC, G-CSF, HCG, and ES. Compared with control treatment, PRP, PBMC, and ES significantly increased live birth/ongoing pregnancy (OR 5.96, 95% CI 3.38 to 10.52; OR 2.55, 95% CI 1.27 to 5.11; OR 1.70, 95% CI 1.07 to 2.69, respectively). PRP ranked the highest in improving live birth/ongoing pregnancy, followed by PBMC, and ES.; Conclusions: PRP is the most effective intrauterine intervention in improving pregnancy outcome in women with two or more implantation failures.; 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 Jin, Li and Li.)

Jing, C. and S. Ai Shun (2021). "Meta-analysis of the curative effect of dienogest on the prevention of postoperative recurrence of endometriosis." PROSPERO International prospective register of systematic reviews.
	
Jing, W. and L. Weihong (2022). "Efficacy and Safety of Acupoint Catgut Embedding Therapy for Polycystic Ovary Syndrome (PCOS): A Systematic Review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jingjing, H., et al. (2019). "Adjuvant chemoradiotherapy vs. radiotherapy alone in early-stage high-risk endometrial cancer: a systematic review and meta-analysis." European Review for Medical and Pharmacological Sciences 23(2): 833-840.
	Objective: The benefits of adjuvant chemoradiotherapy (CRT) in patients with International Federation of Gynecology and Obstetrics (FIGO) stages I-II high-risk endometrial cancer remain controversial. We undertook a systematic review and meta-analysis to assess the efficacy of CRT over radiotherapy (RT) in patients with early-stage high-risk endometrial cancer.; Patients and Methods: We searched MEDLINE (from 1946 to May 2018), EMBASE (from 1966 to May 2018), and the Cochrane Library database for randomized controlled trials (RCTs) conducted for endometrial cancer comparing CRT to RT alone. The outcomes were overall survival (OS), failure-free survival (FFS), local recurrence rates (LRR) and the distant metastasis rate (DMR).; Results: Three eligible studies with 1120 participants were included in the meta-analysis. All studies were published from 1990 to 2018. The OS rates were 82.5% for the patients in the CRT group and 84.4% for patients in the RT group. The included three RCTs showed no significant difference of OS between the CRT and RT groups (odd ratio 0.98, 95% CI 0.93 to 1.02, p=0.35) with no heterogeneity (I2=0%, p=0.47). Two studies reported 382 FFS events in 469 patients with CRT treatment (81.4%) and 376 events of the 470 patients with RT treatment (80.0%). Overall, CRT group didn't provide any benefit over RT alone (1.02, 0.95 to 1.08, p=0.62; I2 = 0%, p=0.55) in FFS. 39 patients in CRT group (10.2%) vs. 16 patients in RT group (4.3%) were diagnosed with local recurrence. LRR was significantly more common in patients receiving adjuvant chemoradiotherapy compared with adjuvant radiotherapy (2.29, 1.31 to 3.98, p=0.004; I²=0%, p=0.33). The distant metastasis occurred in 20 patients (5.2%) treated with CRT and 26 patients (7.0%) treated with RT. The effect of reducing DMR was equivocal between the CRT group and the RT group, with an OR of 0.74 (0.43-1.27, p=0.28; I²=0%, p=0.87).; Conclusions: This study demonstrates that adjuvant chemoradiotherapy has no advantage over radiotherapy alone for overall survival and failure-free survival in high-risk patients with FIGO stages I-II endometrial cancer. In addition, CRT is associated with a high risk of local recurrences.

Jingnan, L., et al. (2023). "The efficacy and safety of massage in primary dysmenorrhea&#xff1a;A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jingning, S. and Z. Nan (2023). "Electro-acupuncture therapy for dysmenorrhea with syndrome of phlegm-dampness blocking collaterals: a systematic review and meta-analysis protocol." PROSPERO International prospective register of systematic reviews.
	
Jingran, G., et al. (2023). "Pregnancy outcomes of acupuncture for Polycystic Ovary Syndrome undergoing in vitro fertilization." PROSPERO International prospective register of systematic reviews.
	
jingya, L., et al. (2023). "Effects of different mind-body therapies on quality of life in perimenopausal women: a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jingyi, W., et al. (2023). "Acupuncture for high-quality embryos in women undergoing in vitro fertilization: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jingyu, X., et al. (2023). "Creative art therapy for postpartum depression: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jinno, M., et al. (2021). "Trapa bispinosa Roxb. extract lowers advanced glycation end-products and increases live births in older patients with assisted reproductive technology: a randomized controlled trial." Reproductive Biology and Endocrinology 19(1): 149.
	BACKGROUND: Advanced glycation end-products (AGE), which accumulate with insulin resistance and aging, impair folliculogenesis and may decrease endometrial receptivity. Hishi (Trapa bispinosa Roxb.) extract, a safe herbal medicine, strongly inhibits AGE formation in vitro. We determined whether Hishi lowers AGE and increases live births in older assisted reproductive technology (ART) patients. METHODS: This prospective randomized open-label controlled trial included 64 patients 38 to 42 years old undergoing ART with or without Hishi extract between June 11, 2015 and July 12, 2019. None had over 2 ART failures, diabetes, uterine anomalies, or exhausted ovarian reserve. After allocation, the Hishi group received Hishi extract (100 mg/day) until late pregnancy or failure. The control group received no extract. Both groups underwent 1 cycle of conventional infertility treatment; 1 long-protocol cycle of ovarian stimulation, oocyte retrieval, in vitro fertilization/intracytoplasmic sperm injection, and fresh embryo transfer (ET); and, if needed, cryopreserved ET until live birth or embryo depletion. Serum AGE were measured before and during ART, as were AGE in follicular fluid (FF). RESULTS: Cumulative live birth rate among 32 Hishi patients was 47%, significantly higher than 16% among 31 controls (p<0.01; RR, 4.6; 95% CI, 1.4 - 15.0; 1 control dropped out). Live birth rate per ET, including fresh and cryopreserved, was significantly higher with Hishi (28% in 47 ET vs. 10% in 49 ET; p<0.05; RR, 3.4; 95% CI, 1.1-10.4). Among variables including age, day-3 FSH, anti-Müllerian hormone, and Hishi, logistic regression identified only Hishi as significantly associated with increased cumulative live birth (p<0.05; OR, 5.1; 95% CI, 1.4 - 18.3). Hishi significantly enhanced oocyte developmental potential, improved endometrial receptivity in natural cycles, and decreased AGE in serum and FF. Larger serum AGE decreases with Hishi were associated with more oocytes becoming day-2 embryos. CONCLUSIONS: Hishi decreased AGE in serum and FF and improved oocyte developmental potential and endometrial receptivity, increasing live births in older patients. Treatment of infertility by AGE reduction represents a new addition to infertility treatment. Therapeutic trials of Hishi for other AGE-associated diseases might be considered. TRIAL REGISTRATION: UMIN registration in Japan ( UMIN000017758 ) on June 1, 2015. https://www.umin.ac.jp/ctr/index.htm.

Jinno, M., et al. (2023). "Granulocyte colony-stimulating factor priming improves embryos and pregnancy rate in patients with poor ovarian reserve: a randomized controlled trial." Reproductive Biology and Endocrinology 21(1): 29.
	Background: Granulocyte colony-stimulating factor (G-CSF) administration increased ovarian preantral follicles and anti-Mullerian hormone (AMH) in animal models with diminished ovarian reserve. We investigated whether G-CSF priming before treatment with assisted reproductive technology (ART) improved embryo development and pregnancy rate while increasing serum AMH in patients with poor ovarian reserve. Method(s): In this prospective randomized open-label controlled trial, 100 patients 20 to 42 years old with AMH below 2 ng/mL were randomized to priming or control groups (50 patients each). None had over 1 ART failure, day-3 follicle-stimulating hormone (FSH) above 30 IU/L, uterine anomalies, or a partner with azoospermia. All patients initially underwent conventional infertility treatment for 2 consecutive cycles in which the priming group but not controls received a subcutaneous G-CSF priming injection during the early luteal phase. Each group then underwent 1 cycle of in vitro fertilization/intracytoplasmic sperm injection and fresh embryo transfer (IVF/ICSI-fresh ET), followed by cryopreserved ET if needed until live birth or embryo depletion. AMH was measured before and after priming. Result(s): Fertilization rate, embryonic development, and implantation rate by fresh ET were significantly improved by priming. Clinical and ongoing pregnancy rates by IVF/ICSI-fresh ET were significantly higher with priming (30% and 26% in 47 ART patients; 3 delivered with conventional treatment) than in controls (12% and 10% in 49 ART patients; 1 dropped out). With priming, significantly more patients achieved cryopreservation of redundant blastocysts. The cumulative live birth rate was 32% in 50 patients with priming, significantly higher than 14% in 49 controls (relative risk, 2.8; 95% confidence interval, 1.04-7.7). Infants derived from priming had no congenital anomalies, while infant weights, birth weeks, and Apgar scores were similar between groups. Among 4 variables (age, day-3 FSH, AMH, and priming), logistic regression significantly associated age and priming with cumulative live birth. Priming significantly increased serum AMH. No adverse effects of priming were observed. Conclusion(s): G-CSF priming improved embryonic development and pregnancy rate during ART treatment and increased AMH in patients with poor ovarian reserve. Enhanced preantral follicle growth likely was responsible. Trial registration: UMIN registration in Japan (UMIN000013956) on May 14, 2014. https://www.umin.ac.jp/ctr/index.htm.Copyright © 2023, The Author(s).

Jiskoot, G., et al. (2022). "Changes in eating behavior through lifestyle treatment in women with polycystic ovary syndrome (PCOS): a randomized controlled trial." Journal of Eating Disorders 10(1): 69.
	Background: Eating behaviors like emotional eating, external eating and restrained eating play an important role in weight gain and weight loss in the general population. Improvements in eating behavior are important for long-term weight. This has not yet been studied in women with Polycystic Ovary Syndrome (PCOS). The aim of this study is to examine if a three-component lifestyle intervention (LI) is effective for improving disordered eating behavior in women with PCOS.; Methods: Women diagnosed with PCOS (N = 183), with a body mass index (BMI) > 25 kg/m 2 and trying to achieve a pregnancy were either assigned to 1 year of 20 group sessions of cognitive behavioral therapy (CBT) combined with nutritional advice and exercise with or without additional feedback through Short Message Service (SMS) or Care As Usual (CAU), which includes the advice to lose weight using publicly available services.; Results: The Eating Disorder Examination Questionnaire (EDEQ) scores worsened in CAU (47.5%) and improved in the LI (4.2%) at 12 months. The difference between the LI and CAU was significant (P = 0.007) and resulted in a medium to large effect size (Cohen's d: - 0.72). No significant differences were observed in EDEQ scores between LI with SMS compared to LI without SMS (Cohen's d: 0.28; P = 0.399). Also, weight loss did not mediate the changes in eating behavior. An overall completion rate of 67/183 (36.6%) was observed.; Conclusions: A three-component CBT lifestyle program resulted in significant improvements in disordered eating behavior compared to CAU. Changes in disordered eating behavior are important for long-term weight loss and mental health.; Trial Registration: NTR, NTR2450. Registered 2 August 2010, https://www.trialregister.nl/trial/2344. (© 2022. The Author(s).)

Joao, F., et al. (2022). "Intrauterine Administration of Activated Peripheral Blood Mononuclear Cells in Intrauterine Insemination: A Prospective Double-Blind Randomized Clinical Trial." Journal of Obstetrics and Gynaecology Canada 44(4): 383-389.
	OBJECTIVE: To evaluate the effect of intrauterine administration of activated peripheral blood mononuclear cells (PBMC) on intrauterine insemination (IUI) success rates. METHODS: This prospective double-blind randomized parallel clinical trial included 213 patients undergoing IUI at the Fertilys clinic. PBMC were isolated on the day of ovulation (day 0; D0) and stimulated with phytohemagglutinin (PHA) and human chorionic gonadotropin (hCG) for 48 hours (day 2; D2). Patients in the PBMC group (n = 108) underwent in utero administration of 1.106 cells on D2, while patients in the control group (n = 105) were administered sperm-washing medium. Distribution of CD4 T lymphocyte populations (n = 61) was assessed on D0 and D2. Pregnancy and live birth rates were also evaluated. RESULTS: Demographic and clinical characteristics, pregnancy rates, and live birth rates were not significantly different between the PBMC and control groups. Significantly higher levels of T helper (Th) 2, Th22, and T regulatory cells (P < 0.0001) and lower levels of Th17 cells were observed in hCG-activated PBMC at D2 than at D0. CONCLUSION: Intrauterine administration of PBMC was not beneficial in IUI patients. New clinical approaches to better identify patients requiring endometrium immunomodulation needs to be addressed.

Johnson, J. E., et al. (2022). "Protocol for the Healing After Loss (HeAL) Study: a randomised controlled trial of interpersonal psychotherapy (IPT) for major depression following perinatal loss." BMJ Open 12(4): e057747.
	Introduction: This protocol describes a study testing the efficacy of interpersonal psychotherapy (IPT) for major depressive disorder following perinatal loss (early and late fetal death and early neonatal death). Perinatal loss is associated with elevated risk of major depressive disorder and post-traumatic stress disorder (PTSD). Perinatal loss conveys specific treatment needs. The trial will be the first fully powered randomised trial of treatment for any psychiatric disorder following perinatal loss. Methods and analysis: A sample of 274 women in Flint and Detroit areas in Michigan who experience a major depressive episode following a perinatal loss will be randomised to group IPT for perinatal loss or to group coping with depression. We anticipate that 50% of the sample will have co-occurring PTSD. Assessments occur at baseline, mid-treatment (8 weeks), post-treatment (16 weeks) and follow-up (28 weeks). Clinical outcomes include time to recovery from major depressive episode (primary), depressive symptoms, PTSD symptoms and time to recovery from PTSD. Additional outcomes include social support, social role functioning (including parental functioning for those with living children), well-being, grief (including complicated grief and fault beliefs) and fear of subsequent pregnancies. Social support and grief are hypothesised mediators of IPT effects on time to recovery from major depressive episode. Ethics and dissemination: The trial was approved by Michigan State University's Biomedical Institutional Review Board. It has a data and safety monitoring board and has been submitted to the community-based organisation partners community ethics review board. Written operating procedures outline methods for protecting confidentiality, monitoring and recording adverse events, and safeguarding participants. We will share study results with research and clinical communities, community organisations through which we recruited, and will offer results to study participants. Deidentified datasets will be available through the National Institute of Mental Health Data Archive and to qualified investigators on request.Copyright © 2022 Author(s) (or their employer(s)).

Johnson Kimball, A., et al. (2023). "Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT." The Journal of Clinical Endocrinology and Metabolism 108(8): 1981-1997.
	Context: Vasomotor symptoms (VMS) are common, bothersome, and can persist for years before and after menopause.; Objective: We aimed to assess efficacy/safety of fezolinetant for treatment of moderate to severe VMS associated with menopause.; Methods: In this double-blind, placebo-controlled, 12-week phase 3 trial with a 40-week active treatment extension (NCT04003142; SKYLIGHT 2), women aged 40 to 65 years with minimum average 7 moderate to severe VMS/day were randomized to 12 weeks of once-daily placebo, fezolinetant 30 mg, or fezolinetant 45 mg. Completers were rerandomized to fezolinetant 30/45 mg for 40 additional weeks. Coprimary efficacy endpoints were mean daily change from baseline to week 4 (W4) and W12 in VMS frequency and severity. Safety was also assessed.; Results: Both fezolinetant doses statistically significantly reduced VMS frequency/severity at W4 and W12 vs placebo. For VMS frequency, W4 least squares mean (SE) reduction vs placebo: fezolinetant 30 mg, -1.82 (0.46; P < .001); 45 mg, -2.55 (0.46; P < .001); W12: 30 mg, -1.86 (0.55; P < .001); 45 mg, -2.53 (0.55; P < .001). For VMS severity, W4: 30 mg, -0.15 (0.06; P < .05); 45 mg, -0.29 (0.06; P < .001); W12: 30 mg, -0.16 (0.08; P < .05); 45 mg, -0.29 (0.08; P < .001). Improvement in VMS frequency and severity was observed by W1 and maintained through W52. Serious treatment-emergent adverse events were infrequent, reported by 2%, 1%, and 0% of those receiving fezolinetant 30 mg, fezolinetant 45 mg, and placebo, respectively.; Conclusion: Daily fezolinetant 30 and 45 mg were efficacious and well tolerated for treating moderate to severe VMS associated with menopause. (© The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society.)

Joly, F. (2021). "Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line." ClinicalTrials.gov.
	Phase III, randomized, open label, multi‐centre study. Randomization on a 1:1 ratio, stratification performed according to: ‐ Prior adjuvant chemotherapy (yes or no) ‐ Prior pelvic radiotherapy (yes or no) ‐ Disease status: newly diagnosed advanced / metastatic disease versus relapse

Joly, F., et al. (2022). "Paclitaxel with or without pazopanib for ovarian cancer relapsing during bevacizumab maintenance therapy: The GINECO randomized phase II TAPAZ study." Gynecologic Oncology 166(3): 389-396.
	Background: Anti-angiogenic rechallenge with bevacizumab plus chemotherapy is effective in recurrent ovarian cancer (rOC); however, data are limited on tyrosine kinase inhibitors after progression on maintenance bevacizumab.; Methods: In the randomized phase II TAPAZ trial, patients with rOC during the first year of bevacizumab maintenance therapy were assigned 2:1 to either weekly paclitaxel 65 mg/m 2 plus pazopanib 600-800 mg daily or standard weekly paclitaxel 80 mg/m 2 . The primary endpoint was 4-month progression-free survival (PFS) rate.; Results: Overall, 116 patients were randomized and treated: 79 with combination therapy and 37 with single-agent paclitaxel. Median follow-up was 13.1 months. There was no difference between treatment arms in 4-month PFS rate (61% [95% CI, 51-73%] with the combination versus 68% [95% CI, 54-85%] with paclitaxel alone), median PFS (4.9 [95% CI, 4.1-6.1] versus 5.8 [95% CI, 4.8-7.4] months, respectively) or median overall survival (13.6 versus 12.9 months, respectively). The combination was associated with more grade 3/4 toxicities (87% versus 70%, respectively) and toxicity-related paclitaxel discontinuations (22% versus 11%). Pazopanib was discontinued for toxicity in 44% of patients, most commonly for gastrointestinal and vascular events. There were two treatment-related deaths, both in the combination arm (pulmonary embolism and gastrointestinal perforation). At month 4, patient-reported outcomes deteriorated from baseline in the combination arm, particularly for abdominal/gastrointestinal symptoms, which showed a clinically important difference versus paclitaxel alone.; Conclusions: In rOC progressing during maintenance bevacizumab, adding pazopanib to paclitaxel did not improve efficacy, increased toxicity, and compromised chemotherapy delivery.; Clinicaltrials: govregistration:NCT02383251. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Jonasson, A. F., et al. (2021). "A Vaginal Inlay for Reduction of Stress Urinary Incontinence: Outcome of a Randomized Clinical Trial and Four User Acceptance Studies." Advances in Urology 2021: 8822186.
	A multicenter, randomized, controlled clinical trial and four postmarket user acceptance investigations were carried out to document the safety, performance, and user acceptance of Efemia Bladder Support, a novel vaginal inlay for the temporary reduction of stress urinary incontinence (SUI). The clinical investigation enrolled 97 women diagnosed with SUI, randomized 3 : 1 to either treatment or standard care (control). The primary endpoint was reduction of urine leakage, measured as change in pad weight baseline week compared with treatment week. Secondary endpoints were treatment success, calculated as the percentage of subjects with >70% reduction in pad weight, reduction in incontinence episodes, and quality of life (QoL). 75 women (77%) completed the clinical investigation. No serious adverse events occurred. The treatment group reached a 55% (p < 0.001) mean reduction of total leakage compared to the control arm. A subanalysis, involving only leakage during provocation testing (coughing and jumping), showed a 67% (p < 0.001) mean reduction of leakage. No significant effect on QoL could be observed. 51% of the women answered "yes" to the question if they would use the device to reduce SUI. The user acceptance of the device was further investigated in four postmarket studies, using an improved device design with a slimmer centerpiece and a thinner handle, while keeping the effect achieving parts of the device unchanged. An average of 74% of the 102 participants in the postmarket studies reported that they were likely to continue using Efemia. The highest user satisfaction was seen in the two studies evaluating the use of Efemia during exercise, where 83% and 88% of the women were likely to continue using Efemia. It can be concluded that Efemia is a safe, well-tolerated, and effective alternative for reducing SUI, both in everyday life and during physical exercise.

Jonasson Aino, F. (2021). "Evaluation of VagiVitalAC for Treatment of Candida Vulvovaginitis." ClinicalTrials.gov.
	Candidiasis is an infection caused by a yeast (a type of fungus) called Candida. Candidiasis in the vagina is commonly called a "vaginal yeast infection." Another names for this infection is "vaginal candidiasis". The symptoms of vaginal candidiasis include: Vaginal itching or soreness, Pain during sexual intercourse, Pain or discomfort when urinating and Abnormal vaginal discharge. VagiVitalAC is a modified version of the existing gel VagiVital, formulated to act as a treatment for fungal infections. This clinical investigation is a two‐part study consisting of a pilot part followed by a randomized part. The aim of the pilot part is to evaluate if VagiVitalAC is able to cure the vulvovaginal candidiasis in at least 70% of the patients after 7 days treatment. If the proportion of cured patients is at least 70 %, the next part, the randomized part, will be performed. In the randomized part, the treatment efficacy and safety of VagiVitalAC on candida vulvovaginitis will be evaluated by comparing a treatment group with a control group receiving no treatment.

Jonasson Aino, F. (2023). "A Randomised, Partly-blinded Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Bacterial Vaginosis Compared With an Untreated Control Group." ClinicalTrials.gov.
	No Results Available Device: pHyph Clinical cure rate on Day 7|Proportion of patients that do not have the symptom "fishy odour" on Days 1 to 7 after start of treatment, compared to Day 0, measured by using a patient questionnaire administered via mobile application.|Proportion of patients that do not have the symptom "fishy odour" on Day 7 after start of treatment, compared to Day 0, as assessed by the Investigator as part of the Amsel criteria.|Proportion of patients having a reduction in each of 3 BV symptoms scores on Days 1 to 7 after start of treatment, compared to Day 0, measured by using a patient questionnaire administered via mobile application.|Safety and local tolerability of pHyph for patients receiving daily treatment for 6 days, based on the reported treatment-emergent AEs up until Day 7 after start of treatment.|Clinical cure rate on Day 7 after start of treatment, defined as clinical cure according to secondary endpoint 1 and Nugent score <4, i.e., both criteria have to be fulfilled.|Clinical cure rate on Day 7 after start of treatment, defined as Nugent score <4.|Usability measured using a patient questionnaire administered via mobile application on Day 7 and Day 25.|Difference between Day 0, Day 7, and Day 25 after start of treatment in the occurrence of anaerobic vaginal dysbiosis, as assessed by analysis of the vaginal microbiome.|Difference between Day 0, Day 7, and Day 25 after start of treatment in the occurrence of vaginal yeasts, as assessed by analysis of the vaginal microbiome.|For the subgroup of patients with a Nugent score ≥7 on Day 0: Primary endpoint and secondary endpoints 1-4, and 6.|Proportion of patients that do not have the symptom "fishy odour" on Day 25 after start of treatment, as assessed by the Investigator as part of the Amsel criteria.|Proportion of patients that do not have the symptom fishy "odour" on Day 25 after start of treatment, as assessed by the Investigator as part of the Amsel criteria, and Nugent score <4, i.e., both criteria have to be fulfilled.|Clinical cure rate on Day 25 after start of treatment, defined as clinical cure according to the primary endpoint.|Clinical cure rate on Day 25 after start of treatment, defined as clinical cure according to the primary endpoint and Nugent score <4, i.e., both criteria have to be fulfilled.|Proportion of patients having a reduction in pH on Day 7 after start of treatment compared to Day 0.|Recurrence from day 25, as defined by vaginal dysbiosis|Recurrence from day 7, as defined by clinical assessment|Recurrence from day 25, as defined by clinical assessment|Safety and local tolerability for patients receiving preventive treatment: Female Not Applicable 92 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Investigator)|Primary Purpose: Treatment CL3-2 December 2024

Jones, S. (2023). "Pressurised IntraPeritoneal Aerosolised Chemotherapy (PIPAC) in the management of cancers of the bowel, ovary and stomach: a randomised controlled trial of efficacy in peritoneal metastases." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: The trial will test a new method to deliver chemotherapy as a spray, directly into the peritoneal cavity, for whether this improves survival in patients with peritoneal metastases, compared to conventional intravenous chemotherapy. This randomised controlled trial will be open to patients with bowel, ovarian or stomach cancer. Each cancer type will have individual eligibility criteria and protocols to allow for the necessary variations in treatment. In all cancer types, patients will be randomised to receive either standard chemotherapy delivered via the bloodstream or a combination of standard chemotherapy (SACT) and/or Pressurised IntraPeritoneal Aerosolised Chemotherapy (PIPAC), where three PIPAC procedures are performed (ovarian intervention arm receives PIPAC with no SACT). This trial design enables the variation required to include patients with different cancer types and the ability to stop the trial for any one cancer type if it is not working whilst continuing with the others. Prior to randomisation, the treating Investigator will select the SACT regimen most appropriate to the individual patient from treatment options available for the patient’s disease group. Following randomisation, treatment will commence within two weeks for all participants other than those in the ovarian intervention arm, for whom the first PIPAC should take place within three weeks. There is no trial‐specific drug provision, all drugs used in the trial will be taken from local hospital supplies. Each disease group has specific options for the chemotherapy dose and frequency which we have represented in our protocol with 3 separate schemas and tables for treatment options (these can be viewed in the attached synopsis). All participants will be followed up to the point of peritoneal disea CONDITION: Colorectal, ovarian and stomach cancer with peritoneal metastasis ; Cancer PRIMARY OUTCOME: Peritoneal progression‐free survival (pPFS) measured using Response Evaluation Criteria in Solid Tumours (RECIST) V1.1 criteria based on CT scans performed at baseline, prior to each cycle of chemotherapy, prior to each cycle of PIPAC, 30 days after each PIPAC, every two months for the first year after of trial treatment and every three months thereafter until the end of the trial SECONDARY OUTCOME: 1. Oncology patients' core quality of life measures using the EORTC QLQ C30 questionnaire at baseline, after each PIPAC cycle, 2 months follow up, 4 monthly thereafter; 2. Safety and surgical complication rates measured using 2.1 and 2.1.1 below prior to and post each PIPAC cycle:; 2.1. Toxicity and grade according to NCI Common Terminology Criteria for Adverse Events (CTCAE) V5.0; 2.1.1. Episodes of neutropenic sepsis; 2.2. Clavien Dindo Classification (within 30 days of each PIPAC) ; 2.3. Incidence of radiologically proven bowel obstruction every 2 months in the first year then every 3 months; 3. Proportion of patients completing 3 PIPAC procedures, and reasons why not if <3 completed; 4. Number of conversions to operable disease in the stomach or colorectal cancer; 5. OS, defined as days from randomisation to death for any reason; 6. PFS. This is defined as the time from the date of randomisation to the date of progression (anywhere in the patient) or death from any cause; 6.1. Extraperitoneal PFS (ePFS), defined as the time from the date of randomisation to the date of progression (outside of the peritoneum) or death from any cause; 6.2. Episodes of therapeutic ascitic drainages (in ovarian cancer); 7. Peritoneal specific ORR observed at any time during treatment and follow‐up; 8. Peritoneal‐specific DCR, defined as the proportion of patients with complete response, partial response or stable disease maintained at the end of treatment scan (i.e. 3rd scan) INCLUSION CRITERIA: All disease groups: 1. 16 years and older 2. Visible (measurable or non‐measurable) peritoneal lesion(s) on computerised tomography (CT) imaging as per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 3. Eastern Cooperative Oncology Group (E G) performance status 0–1 4. Adequate bone marrow, liver and kidney function (within 7 days prior to randomisation): 4.1. Neutrophil =1.5×10^9/L 4.2. White blood cells =3.0 X10^9/L 4.3. Platelets =100×10^9/L 4.4. Haemoglobin =90 g/l 4.5. Serum bilirubin =3 XULN 4.6. ALT/AST =2.5 XULN (if both done, both must meet criteria) 4.7. Creatinine clearance =60 ml/min 5. Fit enough to receive full dose of systemic anti‐cancer therapy (SACT) in cycle 1 as defined in the protocol. 6. Ability to provide informed consent obtained prior to any trial‐specific screening procedures. Colorectal group only: 1. PM from histologically proven primary adenocarcinoma of the colorectum.<br

Jonsdottir, G., et al. (2022). "Ultrasound guided microwave ablation compared to uterine artery embolization treatment for uterine fibroids - a randomized controlled trial." International Journal of Hyperthermia 39(1): 341-347.
	Objective: To evaluate the efficacy, feasibility and acceptability of microwave ablation (MWA) compared to uterine artery embolization (UAE) as treatment for uterine fibroids.; Method: A randomized controlled superiority trial, including premenopausal women 30-55 years, with symptomatic uterine fibroids without any single fibroid exceeding mean diameter of eight centimeters. Patients were randomized to receive microwave ablation, performed abdominally or vaginally, or to uterine artery embolization. The primary outcome was volume difference of the three largest fibroids at 6 months post treatment evaluated by magnetic resonance imaging (MRI) by a blinded radiologist analyzed by Mann-Whitney U -test. Secondary outcomes included symptom severity score (SSS), health related quality of life (HR-QoL), amount of menstrual bleeding, postoperative pain, length of hospitalization, need for additional treatment, adverse events and if patients would recommend the treatment to a friend.; Results: Patients were recruited from 30 January 2017 to 12 September 2019, with a total of 17 patients treated in each group from May 2017 to December 2019. Superiority of MWA could not be established. The volume reduction was 41.8% (Interquartile range, IQR, 14-63) in the MWA group compared to 62.2% (IQR 34.9-80.1) in the UAE group ( p = 0.29). Effects on symptoms, HR-QoL and acceptability did not differ between groups. Days of hospitalization and sick leave were significantly fewer in the MWA group ( p < 0.001 and p = 0.001).; Conclusions: Although superiority of MWA could not be established, it is a promising technique for treating uterine fibroids. It was well tolerated and associated with lower use of health care resources. Trial registration: NCT02942537, www.clincialtrials.gov.

Juhasz, A. E., et al. (2024). "Ranking the dietary interventions by their effectiveness in the management of polycystic ovary syndrome: a systematic review and network meta-analysis." Reproductive Health 21(1): 28.
	Introduction: Polycystic ovary syndrome (PCOS) is a common condition in women, characterised by reproductive and metabolic dysfunction. While dietary approaches have been evaluated as a first-line treatment for patients with PCOS, there is limited evidence to support preference for a specific dietary composition. This systematic review and network meta-analysis was performed with the objective of comparing different dietary interventions in terms of positive impact. Metformin, the currently preferred treatment, was also compared. Method(s): The latest systematic search was performed on the 20th of March, 2023. Eligible randomised controlled trials (RCTs) included patients with PCOS and compared the dietary approach with another intervention or a standard diet. Outcomes were expressed via anthropometric measurements and hormonal, glycemic, and lipid levels. The Bayesian method was used to perform a network meta-analysis and to calculate the surface under the cumulative ranking curve (SUCRA) values in order to rank the dietary interventions. The overall quality of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation system. Result(s): 19 RCTs were identified, comprising data from 727 patients who were variously treated with 10 types of dietary interventions and metformin. The Dietary Approaches to Stop Hypertension (DASH) diet was the most effective in reducing Homeostatic Model Assessment of Insulin Resistance (SUCRA 92.33%), fasting blood glucose (SUCRA 85.92%), fasting insulin level (SUCRA 79.73%) and triglyceride level (SUCRA 82.07%). For body mass index (BMI), the most effective intervention was the low-calorie diet (SUCRA 84.59%). For weight loss, the low-calorie diet with metformin (SUCRA 74.38%) was the most effective intervention. Metformin produced the greatest reductions in low-density lipoprotein cholesterol (SUCRA 78.08%) and total testosterone levels (SUCRA 71.28%). The low-carb diet was the most effective intervention for reducing cholesterol levels (SUCRA 69.68%), while the normal diet (SUCRA 65.69%) ranked first for increasing high-density lipoprotein cholesterol levels. Conclusion(s): Dietary interventions vary in their effects on metabolic parameters in women with PCOS. Based on our results, the DASH diet is the most effective dietary intervention for treating PCOS. Registration PROSPERO ID CRD42021282984Copyright © The Author(s) 2024.

Jun, T., et al. (2023). "Clinical efficacy and safety of different drugs after laparoscopic fertility preservation surgery for endometriosis: a network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jung, E.-S. (2022). "A 12-week randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of HX112 on menopausal symptoms." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Dietary Supplement : *HX112 high dose group • Main Component: HX112 345mg/tablet • Weight: 700mg/tablet • Usage and Capacity: Intake 2 tablets /time and twice a day • Intake period: 12‐weeks * HX112 low dose group • Main Component: HX112 187.5mg/tablet • Weight: 700mg/tablet • Usage and Capacity: Intake 2 tablets /time and twice a day • Intake period: 12‐weeks * Placebo • Main Component: crystalline cellulose • Weight: 700mg/tablet • Usage and Capacity: Intake 2 tablets /time and twice a day • Intake period: 12‐weeks CONDITION: Diseases of the genitourinary system PRIMARY OUTCOME: Kupperman Index SECONDARY OUTCOME: Estradiol, FSH lipid profiles MENQOL‐K INCLUSION CRITERIA: 1) Postmenopause(passed one year since the last menstrual period) woman aged between 45 and 60 years. 2) FSH > 30 mIU/mL 3) Kupperman Inde Xscore = 20 4) Woman who has agreed to participate in this study and written an informed consent

Junior Jose, E., et al. (2023). "Probiotics for the treatment of bacterial vaginosis: a systematic review and meta-analyses." PROSPERO International prospective register of systematic reviews.
	
Junqian, L., et al. (2022). "Efficacy of Acupuncture and Moxibustion in patients with poor ovarian response on in vitro fertilization and embryo transfer: a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Junyue, Z. and Z. Tianzhe (2021). "Comparison of the efficacy of different postoperative adjuvant treatments for early-stage cervical cancer: a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Jürgen, A. (2022). "Pain control in patients with endometriosis through relaxation methods and activity exercises supported by "virtual reality" technology." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention 1: Each of the 24 patients will be assigned to a program (A, B, C) for 4 weeks, so that 8 patients each start with either HypnoVR relaxation module (A), the activity module SyncVR Fit (B), or the Control phase (C). After a washout phase of 1 week all patients are assigned to the next program, which again takes 4 weeks and is then completed by a second washout phase. After three rotations (14 weeks) all patients have participated in all three programs Patients in Arm1 first undergo the HypnoVR relaxation module (A), then the SyncVR‐Fit activity module (B) or control phase (C), and as the third phase, the control phase (C) or SyncVR‐Fit activity module (B). The documentation of the questionnaires (NRS, PDI, PCS, MOS‐SS, SF‐36, DASS) takes place on the Unipark® platform (https://www.unipark.com/). Questionnnaires will be answered on each presence visit (start of the intervention phase, 4 weeks, 9 weeks, 14 weeks). Intervention 2: Each of the 24 patients will be assigned to a program (A, B, C) for 4 weeks, so that 8 patients each start with either HypnoVR relaxation module (A), the activity module SyncVR Fit (B), or the Control phase (C). After a washout phase of 1 week all patients are assigned to the next program, which again takes 4 weeks and is then completed by a second washout phase. After three rotations (14 weeks) all patients have participated in all three programs Patients in Arm2 first undergo the SyncVR‐Fit activity module (B), then the control phase (C) or the HypnoVR relaxation module (A), and as a third phase the HypnoVR relaxation module (A) or the control phase (C). The documentation of the questionnaires (NRS, PDI, PCS, MOS‐SS, SF‐36, DASS) takes place on the Unipark® platform (https://www.unipark.com/). Questionnnaires will be answered CONDITION: N80 ‐ Endometriosis PRIMARY OUTCOME: The average pain intensity during the day and the maximum pain intensity during the day measured by the NRS scale from 0‐10 ; Daily, throughout the entire study period (14 week of intervention): Daily record (the average pain intensity, max. pain intensity, on‐ demand medication), using the pain e‐diary SECONDARY OUTCOME: 1. Pain‐related impairment as measured by the PDI score improves by 20%; 2. Improvement in general health‐related quality of life measured by the SF 12 ; 3. Sleep quality improves as measured by the MOS‐SS INCLUSION CRITERIA: ‐ Age over 18. ‐ Severe pain reported in clinical routine (minimum of 5 points on NRS scale). ‐ Willingness not to schedule surgery or start a new analgesic (non‐opioid and opioid analgesics) during participation in the study (except for established emergency medication). ‐ Willingness not to start a new non‐drug treatment such as acupuncture, behavioral therapy, massage. If such therapy exists, it should be continued unchanged ‐ Signed patient information and consent form ‐ Understanding of the German language, ability to consent and compliance ‐ The patient has understood the principle of the patient diary and agrees to keep it according to the instructions and to use the VR glasses according to the instructions.

Kabisch, S. (2022). "kontina(R) for the self-management of patients with overactive bladder." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention 1: The intervention group uses kontina(R) for 12 weeks. The follow‐up will also be 12 weeks. Intervention 2: The control group will receive information on overactive bladder, behavioural therapy, lifestyle changes and pelvic floor muscle training from the investigator according to usual care. After 12 weeks subjects will get access to kontina(R) as well. CONDITION: N32.8 ‐ Other specified disorders of bladder N39.42 ‐ [generalization N39.4: Other specified urinary incontinence] PRIMARY OUTCOME: 1. Change from baseline in OAB‐related HRQoL (OAB‐q) at week 12; 2. Change from baseline in mean number of micturitions/ 24 hrs at week 12 SECONDARY OUTCOME: 1. Change from baseline in OAB‐related HRQoL at week 6; 2. Change from baseline in mean number of micturitions/24 hrs at week 6; 3. Change from baseline in OAB‐related symptom bother at weeks 6 and 12; 4. Change from baseline in ICIQ‐UI SF in patients with urinary incontinence at weeks 6 and12; 5. Change from baseline in mean number of urgency episodes/24 hrs at weeks 6 and 12; 6. Change from baseline in mean number of urinary incontinence/24 hrs in patients with urinary incontinence at weeks 6 and 12 INCLUSION CRITERIA: 1) Male and female subjects aged at least 18 years 2) Subjects with OAB ‐ with or without urgency urinary incontinence (UUI) OR ‐ with or without mixed urinary incontinence (MUI) for which the investigator determines that UUI is predominant to the subject 3) Subjects with a history of symptoms of OAB (at least three months) who are treatment‐naïve or stopped prior OAB treatment at least four weeks ago and for whom behavioral therapy, lifestyle interventions or physiotherapy measures are indicated 4) At least eight micturitions in 24 hrs 5) BMI from 18 to less than 40 kg/m2 6) Subjects who have access to a mobile device and are skilled in the use of it 7) Subjects who are able to understand, read and write German 8) Willing and capable of providing informed consent to use kontina® and participate in all assessments associated with the clinical study 9) In possession of a smartphone and willing and able to use it for study purposes

Kachnowski, S. (2023). Curio Digital Therapy for the Treatment of Post-partum Depression.
	Primary Objective: Evaluate the clinical effectiveness of the MamaLift Plus app compared to control (digital sham plus treatment as usual) for the management of PPD in the observed population for a period of 9 calendar weeks. It is hypothesized that women who use the MamaLift Plus APP will experience less severe symptoms of depression in post-partum period than comparable women who do not and receive their usual care from health providers. Detailed Description Women between 18 and 50 years of age who have had a live birth within 3 months prior to study start date and have a diagnosis of mild to moderate PPD. A total of 200 women will be recruited to volunteer in the study with 166 assigned to the intervention arm and 37 assigned to the control group.

Kadoura, S., et al. (2022). "Conventional GnRH antagonist protocols versus long GnRH agonist protocol in IVF/ICSI cycles of polycystic ovary syndrome women: a systematic review and meta-analysis." Scientific Reports 12(1): 4456.
	Gonadotropin-releasing hormone (GnRH) analogues are commonly used in clinical practice to prevent premature luteinizing hormone (LH) surge during In-Vitro Fertilization/ Intra-Cytoplasmic Sperm Injection (IVF/ICSI) cycles. This review aimed to summarize the available evidence comparing the effects of conventional GnRH antagonist protocols, the most commonly used GnRH antagonist protocols, and GnRH agonist protocols on IVF/ICSI outcomes in women with polycystic ovary syndrome (PCOS). A comprehensive electronic search was carried out in Pubmed, Cochrane CENTRAL, Scopus, Web of Science, CINAHL, TRIP, ClinicalTrials.gov and ISRCTN registry from inception until 24 November 2020 without any language or date restrictions. In addition, reference lists of eligible studies and previous meta-analyses were hand-searched to identify relevant studies. Eligible randomized controlled trials were those designed to compare the effects of conventional GnRH antagonist protocols and GnRH agonist protocols on IVF/ICSI outcomes in PCOS subjects. The Cochrane ROB 2.0 tool was used to assess the risk of bias of each study, and the GRADE assessment was used to evaluate the overall quality of evidence. Data synthesis and analyses were done using Review Manager 5.3 with the assistance of Revman Web. A random-effects model was used for all meta-analysis. Dichotomous outcomes were reported as Relative Risk (RR) and continuous outcomes as Weighted Mean Difference (WMD), both with 95% CIs. The primary outcomes were Live birth rate, Ongoing pregnancy rate, and Ovarian hyperstimulation syndrome (OHSS) rate. Other IVF outcomes were considered secondary outcomes. We included ten studies with 1214 randomized PCOS women. Using GnRH antagonist protocols led to a significantly lower OHSS rate (RR = 0.58; 95% CI: [0.44 to 0.77], P = 0.0002), shorter stimulation duration (WMD = - 0.91; 95% CI: [-1.45 to - 0.37] day, P = 0.0009), lower gonadotropin consumption (WMD = - 221.36; 95% CI: [- 332.28 to - 110.45] IU, P < 0.0001), lower E2 levels on hCG day (WMD = - 259.21; 95% CI: [- 485.81 to - 32.60] pg/ml, P = 0.02), thinner endometrial thickness on hCG day (WMD = - 0.73; 95% CI: [- 1.17 to - 0.29] mm, P = 0.001), and lower number of retrieved oocytes (WMD = - 1.82; 95% CI: [- 3.48 to - 0.15] oocytes, P = 0.03). However, no significant differences in live birth rate, ongoing pregnancy rate, clinical pregnancy rate, multiple pregnancy rate, miscarriage rate and cycle cancellation rate were seen between the GnRH antagonist protocols and the long GnRH agonist one. Although more cycles were cancelled due to poor ovarian response in the GnRH antagonist protocol (RR = 4.63; 95% CI: [1.49 to 14.41], P = 0.008), similar rates of cancellation due to risk of OHSS were noticed in both groups. The differences in IVF/ICSI outcomes may arise from the different patterns of gonadotropins suppression that the GnRH analogues exhibit during the early follicular phase of IVF/ICSI cycles and the divergent direct impacts of these analogues on ovaries and endometrial receptivity. The main evidence limitation was Imprecision. Conventional GnRH antagonist protocols represent a safer and more cost-effective treatment choice for PCOS women undergoing IVF/ICSI cycles than the standard long GnRH agonist protocol without compromising the IVF/ICSI clinical outcomes. The study had no sources of financial support and was prospectively registered at PROSPERO (International Prospective Register of Systematic Reviews) under registration number (CRD42021242476). (© 2022. The Author(s).)

Kahleova, H. (2021). "Nutritional Intervention for Endometriosis." ClinicalTrials.gov.
	Endometriosis is a chronic, painful condition that affects 5‐10% of reproductive aged women. It is characterized by the presence of endometrial cells outside the uterus, causing pain and infertility. Current therapies to temporarily control symptoms include surgery and medical options with significant side effects. Women with endometriosis may have several surgeries by their mid‐20s. The medical costs associated with endometriosis in the US alone are about $3.6 billion annually, and the total annual health care cost associated with endometriosis in 2002 was $22 billion, one‐third of which is direct health care costs, with two‐thirds attributed to loss of productivity. Diet may play important roles in endometriosis through its effect on circulating estrogen concentrations and inflammatory processes. Reduced fat intake and increased fiber intake have been shown to reduce estrogen levels, a key determinant of endometriosis activity. Some evidence suggests a pathogenic role for the gut microbiome, which influences the mucosal immune system and pelvic inflammation. The microbiome is responsive to short term dietary intervention, although long term changes have not been well characterized. Therefore, the investigators propose a novel intervention strategy using a plant‐based diet to improve pain, inflammation, and quality of life. The morbidity caused by endometriosis is substantial in terms of pain, reduced quality of life, lost productivity, and effects on relationships. Current medical therapies are limited in efficacy and have major side effects. Typical palliative surgery does not cure endometriosis. Better understanding of diet's ability to influence the disease process has the potential to improve quality of life and daily functioning without the cost and side effects of current therapies.

Kähnert, H. (2023). "Intensified aftercare preparation for oncological rehab patients: development and evaluation of a sequential blended learning concept for rehabilitation and aftercare." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group 1: IG‐1 Rehab program (treatment as usual) Access to OV‐rehab (2 Weeks) including OV‐training (45 min.) and individual counseling 'aftercare goals' (60 min.) Access to OV‐aftercare (6 months) including OV‐training (45 min.) Group 2: IG‐3 Rehab program (treatment as usual) Access to OV‐aftercare (6 months) including OV‐training (45 min.) and individual counseling 'aftercare goals' (60 min.) Group 3: CG Rehab program (treatment as usual) Training on the use of the Internet for researching health information (45 min.) CONDITION: ; C50 ; C81‐C96 ; D05 ; C51‐C58 C51‐C58 C81‐C96 Carcinoma in situ of breast Malignant neoplasm of breast Malignant neoplasms of female genital organs Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue PRIMARY OUTCOME: Measuring time: at the beginning and end of rehab, 3‐, 6‐ and 9 months after discharge; Health‐related quality of life (EORTC‐QLQ‐C30) SECONDARY OUTCOME: Measuring time: at the beginning and end of rehab, 3‐, 6‐ and 9 months after discharge ; 1. Goal attainment scaling ; 2. Restrictions on participation (IMET, German version) ; 3. Anxiety and depression scale (PHQ4‐scale) ; 4. Distress thermometer (DT) ; 5. Exercise and sport questionnaire (BSA‐ questionnaire) ; 6. Subjective prognosis of gainful employment (SPE‐scale) INCLUSION CRITERIA: Oncological rehab patients (ICD‐10: C50, D05; ICD‐10: C51‐C58; ICD‐10: C81‐C96) Age: > 18 years Use of mobile end devices Sufficient German language skills Informed consent is available in writing

Kai, Y., et al. (2023). "The effectiveness of digital psychosocial interventions to improve psychological outcomes of gynecological cancer patients: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Kalaitzopoulos Dimitrios, R., et al. (2022). "Effects of vitamin D supplementation in endometriosis: a systematic review." Reproductive Biology and Endocrinology 20(1): 176.
	Background: There is a growing body of human, animal and in vitro studies on vitamin D (vit D) substitution in endometriosis. The aim of this systematic review is to critically appraise and qualitatively synthesize the results of the available studies that examine the supplementation of vit D for endometriosis treatment.; Methods: A systematic search of the literature was conducted in four electronic databases (Medline, Cochrane, Scopus, Embase) and grey literature for original research articles on humans, animals and in vitro models published in any language.; Results: Four human studies, four animal studies and four in vitro studies were included. Quantitative synthesis of human studies showed no significant effect of vit D intake for dysmenorrhea (2 studies, 44 vit D vs 44 placebo, mean -0.71, 95% CI -1.94, 0.51) and non-cyclic pelvic pain (2 studies, 42 vit D vs 38 placebo, mean 0.34, 95% CI -0.02, 0.71). Regarding reproductive outcomes in women with endometriosis after in vitro fertilization, the only available study showed no differences between women taking vit D and women taking placebo. Three of the four included animal studies showed regression of endometriotic implants when treated with vit D. The in vitro studies demonstrated that vit D decreases invasion and proliferation of endometriotic lesions without affecting apoptosis.; Conclusions: Although in vitro and animal studies suggest regression of the endometriotic implants and decrease of invasion and proliferation after vit D supplementation, this was not reflected in the results of the meta-analysis, which showed no benefit of vit D supplementation in patients with endometriosis and dysmenorrhea or non-cyclic pelvic pain as well as on the outcome of IVF treatment. However, given the heterogeneity and the diversity of the available studies, more research is required to shed light on the role of vit D supplementation in women with endometriosis. (© 2022. The Author(s).)

Kalaitzopoulos Dimitrios, R., et al. (2024). "Fertility, pregnancy and perioperative outcomes after operative hysteroscopy for uterine septum: a network meta-analysis." Archives of Gynecology and Obstetrics 309(3): 731-744.
	Introduction: Septate uterus is a congenital malformation associated with adverse reproductive and pregnancy outcomes. It remains controversial whether hysteroscopic septoplasty should be recommended for the treatment of septate uterus, and it is also unclear if different hysteroscopic methods have more favorable outcomes. This study aims to compare the available hysteroscopic techniques of septoplasty for fertility, reproductive, and perioperative outcomes.; Methods: This systematic review and meta-analysis was conducted following PRISMA guidelines. We searched Medline, Scopus, and Cochrane databases up to April 2023 without language restrictions. Eligible studies had to compare two or more different methods of hysteroscopic septoplasty in women with septate uterus and report on fertility and pregnancy outcomes after a follow-up. Perioperative outcomes were also examined. Data extraction was performed by two independent reviewers using a standardized form. Risk of bias was assessed using the Newcastle-Ottawa Quality Assessment Form and Revised Cochrane risk-of-bias tool (RoB 2).; Results: Out of 561 studies identified, 9 were included in the systematic review and meta-analysis. The comparison of different hysteroscopic septoplasty techniques based on the energy used showed higher pregnancy rates after mechanical septoplasty in comparison to electrosurgery, while miscarriage and live birth rates were comparable. Laser vs. electrosurgery and mechanical techniques of septoplasty had comparable pregnancy, miscarriage, and live birth rates. The network meta-analysis after comparing every different method used showed significantly higher clinical pregnancy rate in scissor group in comparison to resectoscope. No significant differences were found among the techniques regarding miscarriage rate and live birth rate.; Conclusion: In summary, this systematic review and network meta-analysis suggests that hysteroscopic septoplasty with scissors is associated with higher pregnancy rates compared to resectoscope. However, the limited evidence available and small sample sizes in the included studies indicate that these findings should be interpreted with caution. Further studies are required to determine the effectiveness of various hysteroscopic techniques and guide clinical decision-making in the management of this condition. (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Kalis, V. (2022). "Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS." ClinicalTrials.gov.
	Pelvic organ prolapse (POP) has a negative impact on the quality of life of affected women and anterior compartment defects remain the most challenging to repair. It was reported that a women has almost a 1 in 5 risk of needing any kind of POP surgery in her lifetime, with anterior wall repair accounting for 40.6% of all of these. Depending on the structures affected, cystocele can be secondary to defects at: A) Level I vaginal support, provided by the uterosacral and cardinal ligaments or B) Level II vaginal support, mainly provided by the pubocervical fascia. Level II defects can be midline or lateral (paravaginal) depending on whether the fascia is weak at the midline or detached from its lateral attachment to the arcus tendineus fasciae pelvis (ATFP). Clinically, these defects are often combined and/or may be bilateral. Hence, careful assessment and individualized planning of the surgical procedure is essential to optimize cystocele repair outcome. Several surgical techniques and approaches have been used for cystocele repair. These involve native tissue and the use of mesh implanted transvaginally and / or transabdominally.The mainstay for the vaginal repair of a level I defects is to anchor the uterine cervix or vaginal vault to the sacrospinous or the anterior longitudinal ligaments. However, proper restoration of a level II defect is more complex. Although, a classical anterior colporrhaphy might be suitable to correct an isolated midline weakness in the endopelvic fascia, it is suboptimal, on its own, for the repair an associated lateral defect, which is a common association. Indeed, De Lancey reported that paravaginal defects (PVDs) were diagnosed in 89% of women undergoing surgery for cystocele and stress urinary incontinence. Although a variety of techniques for paravaginal defect repair (PVDR) have been suggested, several of these are now not feasible in many countries following the FDA's ban on transvaginal mesh manufacture, sale and distribution. Therefore, currently there are attempts to utilize minimally invasive approaches and modern devices in PVDR native tissue repair. Applying this principle, e.g. Capio Suture Capturing Device (Boston Scientific) has been proposed to re‐attach the vagina to the ATFP using two to four non‐absorbable sutures. However, based on anatomical observation, the ATFP is thin its superior part and thicker inferiorly. This is an issue that might affect the reliability of identifying and ensuring a secure anchorage to the ATFP when solely using a transvaginal route. Recently a novel. Technique of PVDR, called transobturator cystocele repair has been published. However, as the technique was described recently, no follow‐up data have been reported to support its practice. The aim of this randomized controlled trial (RCT) is to compare the novel TOCR and standard anterior colporrhaphy (AR) regarding their safety, efficacy and quality‐of‐life improvement in a one‐year follow‐up.

Kamali, S., et al. (2023). "The effect of e-pelvic floor muscle training on symptoms in women with stress urinary incontinence: a randomized controlled trial." Women & Health 63(6): 473-483.
	The aim of this study was to investigate how e-pelvic floor muscle training (e-PFMT) affected urinary incontinence (UI) symptoms and quality of life (QoL) in women with stress urinary incontinence (SUI). Fifty-five women with SUI symptoms were randomly assigned to the intervention (n=27) or the control (n=28) group. Both groups were given lifestyle advice about SUI. The intervention group performed e-PFMT three days a week, one day via videoconference, and was supervised by a physiotherapist for eight weeks. UI symptoms were assessed by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), the Incontinence Severity Index (ISI), the Urinary Distress Inventory-6 (UDI-6), and QoL was assessed by the King's Health Questionnaire (KHQ) before and after intervention. After intervention, the Patient Global Impression of Improvement (PGI-I) scale was used to assess improvement, and the Visual Analogue Scale (VAS) was used to assess adherence. While the intervention group's ICIQ-UI SF, ISI, and UDI-6 scores improved (p<.001), there was no change in the control group (p>.05). Except for personal relationship limitations, all KHQ scores improved in the intervention group. The control group's role limitations and sleep/energy disturbances scores worsened. ICIQ-UI SF (p=.004), ISI (p<.001), and UDI-6 (p<.001) scores of the intervention group were improved compared to the control group. PGI-I and adherence were found to be higher in the intervention group compared to the control group. e-PFMT performed via videoconference to women with SUI, was found to be effective in improving UI symptoms and QoL as compared to lifestyle instructions only.

Kamath Mohan, S., et al. (2019). "Screening hysteroscopy in subfertile women and women undergoing assisted reproduction." The Cochrane Database of Systematic Reviews 4: CD012856.
	Background: Screening hysteroscopy in infertile women with unexplained infertility, or prior to intrauterine insemination (IUI) or in vitro fertilisation (IVF) may reveal intrauterine pathology that may not be detected by routine transvaginal ultrasound. Hysteroscopy, whether purely diagnostic or operative may improve reproductive outcomes.; Objectives: To assess the effectiveness and safety of screening hysteroscopy in subfertile women undergoing evaluation for infertility, and subfertile women undergoing IUI or IVF.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL CRSO, MEDLINE, Embase, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (September 2018). We searched reference lists of relevant articles and handsearched relevant conference proceedings.; Selection Criteria: Randomised controlled trials comparing screening hysteroscopy versus no intervention in subfertile women wishing to conceive spontaneously, or before undergoing IUI or IVF.; Data Collection and Analysis: We independently screened studies, extracted data, and assessed the risk of bias. The primary outcomes were live birth rate and complications following hysteroscopy. We analysed data using risk ratio (RR) and a fixed-effect model. We assessed the quality of the evidence by using GRADE criteria.; Main Results: We retrieved 11 studies. We included one trial that evaluated screening hysteroscopy versus no hysteroscopy, in women with unexplained subfertility, who were trying to conceive spontaneously. We are uncertain whether ongoing pregnancy rate improves following a screening hysteroscopy in women with at least two years of unexplained subfertility (RR 4.30, 95% CI 2.29 to 8.07; 1 RCT; participants = 200; very low-quality evidence). For a typical clinic with a 10% ongoing pregnancy rate without hysteroscopy, performing a screening hysteroscopy would be expected to result in ongoing pregnancy rates between 23% and 81%. The included study reported no adverse events in either treatment arm. We are uncertain whether clinical pregnancy rate is improved (RR 3.80, 95% CI 2.31 to 6.24; 1 RCT; participants = 200; very low-quality evidence), or miscarriage rate increases (RR 2.80, 95% CI 1.05 to 7.48; 1 RCT; participants = 200; very low-quality evidence), following screening hysteroscopy in women with at least two years of unexplained subfertility.We included ten trials that included 1836 women who had a screening hysteroscopy and 1914 women who had no hysteroscopy prior to IVF. Main limitations in the quality of evidence were inadequate reporting of study methods and higher statistical heterogeneity. Eight of the ten trials had unclear risk of bias for allocation concealment.Performing a screening hysteroscopy before IVF may increase live birth rate (RR 1.26, 95% CI 1.11 to 1.43; 6 RCTs; participants = 2745; I² = 69 %; low-quality evidence). For a typical clinic with a 22% live birth rate, performing a screening hysteroscopy would be expected to result in live birth rates between 25% and 32%. However, sensitivity analysis done by pooling results from trials at low risk of bias showed no increase in live birth rate following a screening hysteroscopy (RR 0.99, 95% CI 0.82 to 1.18; 2 RCTs; participants = 1452; I² = 0%).Only four trials reported complications following hysteroscopy; of these, three trials recorded no events in either group. We are uncertain whether a screening hysteroscopy is associated with higher adverse events (Peto odds ratio 7.47, 95% CI 0.15 to 376.42; 4 RCTs; participants = 1872; I² = not applicable; very low-quality evidence).Performing a screening hysteroscopy before IVF may increase clinical pregnancy rate (RR 1.32, 95% CI 1.20 to 1.45; 10 RCTs; participants = 3750; I² = 49%; low-quality evidence). For a typical clinic with a 28% clinical pregnancy rate, performing a screening hysteroscopy would be expected to result in clinical pregnancy rates between 33% and 40%.There may be little or no difference in miscarriage rate foll wing screening hysteroscopy (RR 1.01, 95% CI 0.67 to 1.50; 3 RCTs; participants = 1669; I² = 0%; low-quality evidence).We found no trials that compared a screening hysteroscopy versus no hysteroscopy before IUI.; Authors' Conclusions: At present, there is no high-quality evidence to support the routine use of hysteroscopy as a screening tool in the general population of subfertile women with a normal ultrasound or hysterosalpingogram in the basic fertility work-up for improving reproductive success rates.In women undergoing IVF, low-quality evidence, including all of the studies reporting these outcomes, suggests that performing a screening hysteroscopy before IVF may increase live birth and clinical pregnancy rates. However, pooled results from the only two trials with a low risk of bias did not show a benefit of screening hysteroscopy before IVF.Since the studies showing an effect are those with unclear allocation concealment, we are uncertain whether a routine screening hysteroscopy increases live birth and clinical pregnancy, be it for all women, or those with two or more failed IVF attempts. There is insufficient data to draw conclusions about the safety of screening hysteroscopy.

Kamath Mohan, S., et al. (2020). "Granulocyte-colony stimulating factor administration for subfertile women undergoing assisted reproduction." The Cochrane Database of Systematic Reviews 1: CD013226.
	Background: Granulocyte-colony stimulating factor (G-CSF) seems to play an important role in the process of embryo implantation and continuation of pregnancy. It has been used during in vitro fertilisation (IVF) treatment for subfertile women with chronically thin endometrium and those with previous multiple IVF failures. It is currently unknown whether G-CSF is effective in improving results following assisted reproductive technology (ART).; Objectives: To evaluate the effectiveness and safety of G-CSF in women undergoing ART.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform in February 2019. We searched reference lists of relevant articles and handsearched relevant conference proceedings.; Selection Criteria: Randomised controlled trials (RCTs) comparing G-CSF administration versus no treatment or placebo in subfertile women undergoing IVF treatment.; Data Collection and Analysis: Two review authors independently screened studies, extracted data, and assessed risk of bias. The primary outcomes were live-birth rate and miscarriage rate following G-CSF administration. We have reported ongoing pregnancy rate in cases where studies did not report live birth but reported ongoing pregnancy. Secondary outcomes were clinical pregnancy rate, multiple pregnancy rate, adverse events, ectopic pregnancy rate, small for gestational age at birth, abnormally adherent placenta, and congenital anomaly rate. We analysed data using risk ratio (RR), Peto odds ratio and a fixed-effect model. We assessed the quality of the evidence using the GRADE criteria.; Main Results: We included 15 trials involving 622 women who received G-CSF and 631 women who received placebo or no additional treatment during IVF. The main limitations in the quality of the evidence were inadequate reporting of study methods and high risk of performance bias due to lack of blinding. We assessed only two of the 15 included trials as at a low risk of bias. None of the trials reported the primary effectiveness outcome of live-birth rate. We are uncertain whether G-CSF administration improves ongoing pregnancy rate compared to control in subfertile women undergoing ART (RR 1.42, 95% confidence interval (CI) 0.83 to 2.42; 2 RCTs; participants = 263; I² = 0%; very low-quality evidence). For a typical clinic with 14% ongoing pregnancy rate, G-CSF administration would be expected to result in ongoing pregnancy rates between 12% and 35%. We are uncertain whether G-CSF administration reduces miscarriage rate (Peto odds ratio 0.55, 95% CI 0.17 to 1.83; 3 RCTs; participants = 391; I² = 0%; very low-quality evidence) compared to the control group in subfertile women undergoing ART. We are uncertain whether G-CSF administration improves overall clinical pregnancy rate compared to control in subfertile women undergoing ART (RR 1.63, 95% CI 1.32 to 2.01; 14 RCTs; participants = 1253; I² = 13%; very low-quality evidence). For a typical clinic with 17% clinical pregnancy rate, G-CSF administration would be expected to result in clinical pregnancy rates between 23% and 35%. In the unselected IVF population, we are uncertain whether G-CSF administration improves clinical pregnancy rate compared to the control group (RR 1.11, 95% CI 0.77 to 1.60; 3 RCTs; participants = 404; I² = 0%; low-quality evidence). G-CSF administration may improve clinical pregnancy rate in women with two or more previous IVF failures compared to the control group (RR 2.11, 95% CI 1.56 to 2.85; 7 RCTs; participants = 643; I² = 0%; low-quality evidence). In subfertile women with thin endometrium undergoing ART, we are uncertain whether G-CSF administration improves clinical pregnancy rate compared to the control group (RR 1.58, 95% CI 0.95 to 2.63; 4 RCTs; participants = 206; I² = 30%; low-quality evidence). No study reported on multiple pregnancy rate. Only four trials reported adverse events as an outcome, and none of them reported any major adverse events following either G-CSF administration or placebo/no treatment.; Authors' Conclusions: In subfertile women undergoing ART, we are uncertain whether the administration of G-CSF improves ongoing pregnancy or overall clinical pregnancy rates or reduces miscarriage rate compared to no treatment or placebo, whether in all women or those with thin endometrium, based on very low-quality evidence. Low-quality evidence suggests that G-CSF administration may improve clinical pregnancy rate in women with two or more IVF failures, but the included studies had unclear allocation concealment or were at high risk of performance bias. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Kamath Mohan, S., et al. (2020). "Number of embryos for transfer following in vitro fertilisation or intra-cytoplasmic sperm injection." The Cochrane Database of Systematic Reviews 8: CD003416.
	Background: Transfer of more than one embryo during in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) increases multiple pregnancy rates resulting in an increased risk of maternal and perinatal morbidity. Elective single embryo transfer offers a means of minimising this risk, but this potential gain needs to be balanced against the possibility of jeopardising the overall live birth rate (LBR).; Objectives: To evaluate the effectiveness and safety of different policies for the number of embryos transferred in infertile couples undergoing assisted reproductive technology cycles.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group specialised register of controlled trials, CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform from inception to March 2020. We handsearched reference lists of articles and relevant conference proceedings. We also communicated with experts in the field regarding any additional studies.; Selection Criteria: We included randomised controlled trials (RCTs) comparing different policies for the number of embryos transferred following IVF or ICSI in infertile women. Studies of fresh or frozen and thawed transfer of one to four embryos at cleavage or blastocyst stage were eligible.; Data Collection and Analysis: Two review authors independently extracted data and assessed trial eligibility and risk of bias. The primary outcomes were LBR and multiple pregnancy rate. The secondary outcomes were clinical pregnancy and miscarriage rates. We analysed data using risk ratios (RR), Peto odds ratio (Peto OR) and a fixed effect model.; Main Results: We included 17 RCTs in the review (2505 women). The main limitation was inadequate reporting of study methods and moderate to high risk of performance bias due to lack of blinding. A majority of the studies had low numbers of participants. None of the trials compared repeated single embryo transfer (SET) with multiple embryo transfer. Reported results of multiple embryo transfer below refer to double embryo transfer. Repeated single embryo transfer versus multiple embryo transfer in a single cycle Repeated SET was compared with double embryo transfer (DET) in four studies of cleavage-stage transfer. In these studies the SET group received either two cycles of fresh SET (one study) or one cycle of fresh SET followed by one frozen SET (three studies). The cumulative live birth rate after repeated SET may be little or no different from the rate after one cycle of DET (RR 0.95, 95% CI (confidence interval) 0.82 to 1.10; I² = 0%; 4 studies, 985 participants; low-quality evidence). This suggests that for a woman with a 42% chance of live birth following a single cycle of DET, the repeated SET would yield pregnancy rates between 34% and 46%. The multiple pregnancy rate associated with repeated SET is probably reduced compared to a single cycle of DET (Peto OR 0.13, 95% CI 0.08 to 0.21; I² = 0%; 4 studies, 985 participants; moderate-quality evidence). This suggests that for a woman with a 13% risk of multiple pregnancy following a single cycle of DET, the risk following repeated SET would be between 0% and 3%. The clinical pregnancy rate (RR 0.99, 95% CI 0.87 to 1.12; I² = 47%; 3 studies, 943 participants; low-quality evidence) after repeated SET may be little or no different from the rate after one cycle of DET. There may be little or no difference in the miscarriage rate between the two groups. Single versus multiple embryo transfer in a single cycle A single cycle of SET was compared with a single cycle of DET in 13 studies, 11 comparing cleavage-stage transfers and three comparing blastocyst-stage transfers.One study reported both cleavage and blastocyst stage transfers. Low-quality evidence suggests that the live birth rate per woman may be reduced in women who have SET in comparison with those who have DET (RR 0.67, 95% CI 0.59 to 0.75; I² = 0%; 12 studies, 1904 participants; low-quality evidence). Thus, for a woman with a 46% chance of live b rth following a single cycle of DET, the chance following a single cycle of SET would be between 27% and 35%. The multiple pregnancy rate per woman is probably lower in those who have SET than those who have DET (Peto OR 0.16, 95% CI 0.12 to 0.22; I² = 0%; 13 studies, 1952 participants; moderate-quality evidence). This suggests that for a woman with a 15% risk of multiple pregnancy following a single cycle of DET, the risk following a single cycle of SET would be between 2% and 4%. Low-quality evidence suggests that the clinical pregnancy rate may be lower in women who have SET than in those who have DET (RR 0.70, 95% CI 0.64 to 0.77; I² = 0%; 10 studies, 1860 participants; low-quality evidence). There may be little or no difference in the miscarriage rate between the two groups.; Authors' Conclusions: Although DET achieves higher live birth and clinical pregnancy rates per fresh cycle, the evidence suggests that the difference in effectiveness may be substantially offset when elective SET is followed by a further transfer of a single embryo in fresh or frozen cycle, while simultaneously reducing multiple pregnancies, at least among women with a good prognosis. The quality of evidence was low to moderate primarily due to inadequate reporting of study methods and absence of masking those delivering, as well as receiving the interventions. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Kamphuis, D. (2023). "The Cost-effectiveness of Hysterosalpingography Versus Hysterosalpingo-foam Sonography During Fertility Work-up." ClinicalTrials.gov.
	Background: The diagnostic work‐up for infertility generally includes estimating the risk for tubal pathology and if indicated assessing tubal patency. Traditionally, tubal patency testing during the fertility work‐up is performed with hysterosalpingography (HSG). In previous studies it has been demonstrated that tubal flushing with oil‐based contrast during HSG resulted in more ongoing pregnancies than when HSG is performed with water‐based contrast. HyFoSy is a more patient friendly alternative for HSG. Up till now, the fertility enhancing effect of tubal flushing with ExEm Foam during HyFoSy has only been studied in relatively small and observational studies. Objectives:The main objective of this study is to determine whether tubal flushing with oil‐based contrast during HSG results into more pregnancies leading to live births when compared to tubal flushing with ExEm Foam during HyFoSy, and whether this approach is cost‐effective. In this study the safety of both strategies will also be compared. Rationale: The hypothesis is that tubal flushing with oil‐based contrast during HSG leads to more live births compared to tubal flushing with ExEm Foam during HyFoSy in women with an indication for tubal patency testing. If more live births are achieved, expensive fertility treatments will be less needed, which makes tubal flushing with oil‐based contrast during HSG a cost‐effective strategy. Study design: This study is a multicenter randomized controlled trial with an economic analysis alongside it. Women with indication for tubal patency testing will be randomized to tubal flushing with oil‐based contrast during HSG and tubal flushing with ExEm Foam during HyFoSy.

Kanadys, W., et al. (2021). "Evaluation of Clinical Meaningfulness of Red Clover ( Trifolium pratense L.) Extract to Relieve Hot Flushes and Menopausal Symptoms in Peri- and Post-Menopausal Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." Nutrients 13(4).
	The meta-analysis presented in this article covered the efficacy of red clover isoflavones in relieving hot flushes and menopausal symptoms in perimenopausal and postmenopausal women. Studies were identified by MEDLINE (PubMed), Embase, and the Cochrane Library searches. The quality of the studies was evaluated according to Cochrane criteria. A meta-analysis of eight trials (ten comparisons) demonstrated a statistically significant reduction in the daily incidence of hot flushes in women receiving red clover compared to those receiving placebo: weighted mean difference (WMD-weighted mean difference) -1.73 hot flushes per day, 95% CI (confidence interval) -3.28 to -0.18; p = 0.0292. Due to 87.34% homogeneity, the performed analysis showed substantive difference in comparisons of postmenopausal women with ≥5 hot flushes per day, when the follow-up period was 12 weeks, with an isoflavone dose of ≥80 mg/day, and when the formulations contained a higher proportion of biochanin A. The meta-analysis of included studies assessing the effect of red clover isoflavone extract on menopausal symptoms showed a statistically moderate relationship with the reduction in the daily frequency of hot flushes. However, further well-designed studies are required to confirm the present findings and to finally determine the effects of red clover on the relief of flushing episodes.

Kan-Chu, L., et al. (2023). "Effects of Vitamin D supplement on patients with dysmenorrhea: a systematic review and meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Kaneko, M. (2022). "Effect of PARP Inhibitors as Maintenance Treatment on Restricted Mean Survival Time in Platinum-Sensitive Recurrent Ovarian Cancer: A Systematic Review and Meta-analysis." The Annals of Pharmacotherapy 56(1): 27-34.
	Background: Earlier trials on the efficacy of poly (ADP-ribose) polymerase (PARP) inhibitors in platinum-sensitive relapsed ovarian cancer used the hazard ratio (HR) as an efficacy parameter.; Objective: The present meta-analysis was focused on improving the robustness and clinical interpretability of the efficacy evaluation of PARP inhibitors using the restricted mean survival time (RMST).; Methods: A search for relevant studies published up to July 31, 2020, was performed in electronic databases to identify eligible trials comparing PARP inhibitors with placebo. The difference in RMST was used as a PARP inhibitor efficacy parameter. Combined differences in RMST with 95% CIs across studies were calculated using a random-effects model.; Results: Four trials (6 articles) were assessed, including 1079 patients treated with PARP inhibitors and 598 with placebo. The combined RMST differences for up to 360 days (PARP inhibitors minus placebo: point estimate and 95% CI) among all patients and the patients of subgroups with BRCA mutations, homologous recombination-deficient (HRD) carcinoma, and BRCA wild-type carcinoma were 87 days (95% CI = 71, 102), 112 days (95% CI = 96, 129), 99 days (95% CI = 80, 119), and 69 days (95% CI = 47, 92), respectively. The combined RMST differences for up to 660 and 720 days were also larger among patients with BRCA mutations than among those with HRD carcinoma.; Conclusion and Relevance: Based on using the RMST difference as an alternative measure to the HR, this meta-analysis suggests that PARP inhibitors are the most effective for patients with BRCA mutations, followed by patients with HRD carcinoma.

Kang, I., et al. (2022). "Effect of isoflavone supplementation on menopausal symptoms: a systematic review and meta-analysis of randomized controlled trials." Nutrition Research and Practice 16(Suppl 1): S147-S159.
	Background/objectives: Complementary and alternative medicines can be used to alleviate climacteric symptoms that significantly affect the quality of life of postmenopausal women. Isoflavones are the most common plant-based therapies for postmenopausal changes, but the results of previous studies have been controversial.; Materials/methods: To investigate whether isoflavones would affect menopausal symptoms as well as ovarian hormones, we performed a systematic review and meta-analysis. The PubMed and EMBASE databases were used to perform the systematic search. Included studies were limited to randomized controlled trials (RCTs) assessing the impact of isoflavone supplementation on menopausal symptoms.; Results: Eleven studies were included for the final quantitative assessment. Isoflavone intervention was varied between 49.3 and 135 mg of isoflavones per day for 12 wk-2 yrs. The meta-analysis showed that supplementation of isoflavones significantly increased the estradiol levels (standardized mean difference [SMD] = 0.615, P = 0.035) and Kupperman index (SMD = 3.121, P = 0.003) but had no significant effect on hot flashes, follicle-stimulating hormone, and luteinizing hormone. However, both estradiol and the Kupperman index showed significant heterogeneity among studies (I 2 = 94.7%, P < 0.001 and I 2 = 98.1%, P < 0.001, respectively).; Conclusions: Although the results showed a significant SMD in estradiol and the Kupperman index, the results should be interpreted with caution due to the high heterogeneity. Further validation with a larger RCT will be necessary. Overall, isoflavone supplementation has distinct effects on the climacteric symptoms and hormonal changes in postmenopausal women.; Competing Interests: Conflict of Interest: The authors declare no potential conflicts of interests. (©2022 The Korean Nutrition Society and the Korean Society of Community Nutrition.)

Kang, Y., et al. (2022). "Impact of endometrial scratching on reproductive outcome in patients: A systematic review and meta-analysis." Medicine 101(33): e30150.
	Background: Endometrial scratching (ES) has demonstrated initial success in women with recurrent implantation failure, but the effect in women with 1 previous assisted reproductive technology (ART) failure is unknown. This meta-analysis aimed to evaluate the impact of ES as a treatment in clinical outcomes for women with at least 1 failed in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI)/Intrauterine Insemination (IUI).; Methods: PubMed, Medline, Embase, Cochrane Library, Web of Science, CNKI, and EMCC databases were searched for randomized controlled trial studies utilizing endometrial scratching for infertility women with at least 1 failed assisted reproductive technology (ART) to collect pregnancy outcomes, including clinical pregnancy rate (CPR), embryo implantation rate (IR), miscarriage rate (MR), live birth rate (LBR), and multiple pregnancy rate (MPR).; Results: Sixteen randomized controlled trial (RCT) studies were included in this meta-analysis, including 1770 women in the intervention group and 1934 women in the control group. Overall, the CPR, IR and LBR were significantly higher in the intervention group than in the control group (for CPR, n = 1430, 16 studies, P = .0002, risk ratio (RR) = 1.59, 95% confidence interval [CI] [1.24, 2.03]; for IR, n = 859, 10 studies, P = .0003, RR = 1.67, 95% CI [1.26, 2.21]; for LBR, n = 156, 6 studies, P = .0005, RR = 1.59, 95% CI [1.22, 2.06]). Nonetheless, there was no significant difference in MR (n = 344, 11 studies, P = .62, risk ratio (RR) = 0.92, 95% confidence interval [CI] [0.66, 1.29]) and MPR (n = 98, 3 studies, P = .39, risk ratio (RR) = 0.81, 95% confidence interval [CI] [0.51, 1.30]) between the intervention group and the control group.; Conclusion: Endometrial scratching is considered to enhance the reproductive outcomes of embryo implantation. Additional randomized controlled studies are recommended to identify the appropriate time of invasion and the applicable population to confirm whether it can become a routine operation. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Kanuni Sultan Suleyman, T. and H. Research (2022). "Comparison of Suturing Technique Types on Pubocervical Fascia at Colpographhy Anterior for Cystocele Repair." ClinicalTrials.gov.
	Primary and secondary endpoints: Primary outcome measures will be the subjective cure of prolapse ("absence or presence of a bulge in the vagina"), objective success with anatomic absence of advanced prolapse at POP‐Q sites Ba, C and Bp defined as less than 1 cm individually and as a total. Secondary outcome measures include all other parameters such as perioperative outcomes, patient satisfaction, quality of life outcomes, complications, scores on questionnaires, and reoperations. The study protocol will be submitted to the institutional review boards of every participating study site and written informed consent will be obtained from all participants on enrolment. Project design: The investigators will perform an international singlecentre single‐blind randomized controlled trial by participating in our tertiary referral hospital.

Kapil, K., et al. (2023). "Day 3 versus day 5 embryo transfer: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Karabuk, U. (2024). "Effect of Emotional Freedom Technique on Symptoms in Dysmenorrhea." ClinicalTrials.gov.
	No Results Available Other: EFT group Examining the Effect of Emotional Freedom Technique on Quality of Life and Symptoms in Dysmenorrhea Female Not Applicable 64 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Prevention E-77192459-050.99-232650 April 15, 2024

Karaca, A. (2023). "Prolonged Grief and Perception of Femininity in Gynecological Cancer Patients." ClinicalTrials.gov.
	No Results Available Behavioral: Such as art therapy, play therapy, breathing techniques Prolonged Grief Disorder Score Female Not Applicable 80 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Supportive Care AfyonkarahisarHSU-KPAMUK-1 September 18, 2023

Karacay Basak, C. (2022). "Effect of EMG Biofeedback in Female Patients With Stress Urinary Incontinence." ClinicalTrials.gov.
	Urogynecological complaints have medical and social aspects that negatively affect quality of life. are problems. depression, anxiety, low productivity at work, social isolation and associated with sexual dysfunction. Urinary incontinence (UI), which has serious negative effects on people's quality of life, psychological state and physical health, and especially affects older women, stands out as an important public health problem with the prolongation of the average life expectancy. The two most common types of UI in women are stress urinary incontinence (SUI) and urge urinary incontinence (UI). While SUI is the involuntary leakage of urine typically during coughing, sneezing and other physical activities; UUI is defined as urinary incontinence associated with urgency with a sudden and forced need to urinate. The simultaneous presence of SUI and UUI symptoms is defined as mixed urinary incontinence (MUI). Treatment options of SUI, which are divided into conservative and surgical treatment, are conservative treatment options; behavioral therapy (changing lifestyle and dietary habits and bladder training) and PTC rehabilitation (PTK exercises, biofeedback, electrical stimulation, electromagnetic stimulation, neuromodulation and vaginal issues). With PTK exercises, it is aimed to work the levator ani muscle group. These exercises are described as contractions and relaxation periods lasting 10 seconds. It is recommended to be applied in 3 different positions while lying, sitting and standing. Increasing the number of contractions gradually and reaching 60 repetitions per day is targeted in the treatment (1). One of the ways to teach PTK exercises is "biofeedback" (BF). This method provides visual and auditory feedback while teaching the correct contraction of the muscles (2). Since it is an active method, it is thought that the increase in PTK power is higher. Superficial or internal electrodes can be used (3). The investigators will use surface electrodes in our project. In a recent meta‐analysis in the literature (4); In the current meta‐analysis on the effectiveness of EMG biofeedback in patients with SUI, it was reported that pelvic floor muscle training combined with EMG‐BF achieved better results than pelvic floor muscle training alone in the management of SUI, but randomized studies are still needed to confirm the results. To determine the effectiveness of EMG biofeedback method on pelvic floor muscle strength, severity of complaints, pad test and quality of life in women with stress urinary incontinence (SUI) by comparing them with pelvic floor muscle (PTK) exercises and Sham EMG biofeedback group. In our project, the investigators will be able to determine whether the EMG biofeedback exercise performed with the device is really superior to the exercise performed by the patient himself, using the Sham group. Thus, the results of our project; It will provide scientific data for teaching patients about pelvic floor muscle training in the clinic and for use in urinary rehabilitation of SUI patients.

Karadag, B., et al. (2023). "McCall culdoplasty vs. vaginally assisted laparoscopic sacrocolpopexy in the treatment of advanced uterine prolapse: A randomized controlled study." Taiwanese Journal of Obstetrics & Gynecology 62(2): 325-329.
	Objective: The primary aim of this study was to compare the anatomic outcomes of vaginally assisted laparoscopic sacrocolpopexy (VALS) with those of McCall culdoplasty (McCC) in patients undergoing concurrent vaginal hysterectomy.; Materials and Methods: This randomized controlled study presents the outcomes of 68 patients who underwent hysterectomy and vaginal suspension for apical prolapse ≥ Stage III according to the Pelvic Organ Prolapse Quantification (POP-Q) system between October 2017 and December 2020. Among these patients, 33 underwent VALS and 35 underwent McCC. Clinical features, surgical data, concomitant surgical procedures, postoperative complications, and recurrence rates were assessed. Before and after one year of surgery, the short form of the Pelvic Floor Impact Questionnaire and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire were used to evaluate subjective symptoms. Patient Global Impression of Improvement Questionnaire was used to assess patient satisfaction.; Results: The mean follow-up durations were 25.5 ± 7.63 months and 25.6 ± 5.96 months in the VALS and McCC groups, respectively. Prolapse recurrence occurred in 3 (9.1%) women in the VALS group versus 12 (34.3%) women in the McCC group (p = 0.031).; Conclusion: The McCC operation was associated with a shorter operation time, whereas the VALS operation had a significantly higher objective success rate. Based on this study, it may be concluded that McCC is not an effective procedure for advanced uterine prolapse.; Competing Interests: Declaration of Competing Interest The authors declared no conflict of interest. (Copyright © 2023. Published by Elsevier B.V.)

Karadeniz, O. (2021). "Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair." ClinicalTrials.gov.
	Primary and secondary endpoints: Primary outcome measures will be the subjective cure of prolapse ("absence or presence of a bulge in the vagina"), objective success with anatomic absence of advanced prolapse at POP‐Q sites Ba, C and Bp defined as less than 1 cm individually and as a total. Secondary outcome measures include all other parameters such as perioperative outcomes, patient satisfaction, quality of life outcomes, complications, scores on questionnaires, and reoperations. The study protocol will be submitted to the institutional review boards of every participating study site and written informed consent will be obtained from all participants on enrolment. Project design: The investigators will perform an international multicentre single‐blind randomized controlled trial with participating our tertiary referral hospital.

Karalis, T., et al. (2023). "Surgical results in POP/UI surgery after using PVDF compared to other materials. A systematic review and meta-analysis." European Journal of Obstetrics, Gynecology, and Reproductive Biology 284: 110-119.
	Objectives: Synthetic materials have been used for the surgical treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). During the last 25 years, these materials were composed mostly of polypropylene (PP), whereas recently the use of polyvinylidene difluoride (PVDF) is of increasing interest due to its characteristics. This study aimed to compare the results after SUI/POP surgery using PVDF versus PP materials by synthesizing the data of relevant existing literature.; Study Design: This systematic review and meta-analysis included clinical trials, case-control studies, or cohort studies written in the English language. The search strategy included the electronic databases MEDLINE, EMBASE, and Cochrane, and grey literature (congresses IUGA, EUGA, AUGS, FIGO). All studies have to provide numeric data or odds ratios (OR) of developing a specific outcome in surgeries with PVDF compared with outcomes of other used materials. No restrictions of race or ethnicity were applied, nor chronological restrictions. Exclusion criteria were studies that included patients with cognitive impairment, dementia, stroke, or central nervous system trauma. All studies were screened by two reviewers, initially by title and abstract, and afterward by full text. Disagreements were resolved through mutual consent. All studies were assessed for their quality and bias risk. Data were extracted using a data extraction form formulated in a Microsoft Excel spreadsheet. Our results were divided into studies dealing only with SUI patients, studies dealing only with POP patients, and cumulative analysis of variables expressed in both SUI and POP surgery. The primary outcomes were the rates of post-operative recurrence, mesh erosion, and postoperative pain after surgery with PVDF compared to PP. The secondary outcomes were post-operative sexual dissatisfaction, overall satisfaction rates, hematoma, urinary tract infection, de novo urge incontinence, and reoperation rate.; Results: No differences in the post-operative rates of SUI/POP recurrence, mesh erosion, and pain were found after surgery with PVDF vs surgery with PP. Patients after SUI surgery with PVDF tapes had statistically significant lower rates of de-novo urgency compared to the PP group [OR = 0.38 (0.18, 0.88), p = 0.01]; patients after POP surgery with PVDF materials had statistically significant lower rates of de-novo sexual dysfunction compared to the PP group [OR = 0.12 (0.03, 0.46), p = 0.002].; Conclusions: This study provided evidence that the use of PVDF in SUI/POP surgeries could be a valid alternative to PP. However our results are limited by uncertainty due to the overall low quality of the existent data. Further research and validation would contribute to better surgical techniques.; 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.)

Karimi, A., et al. (2022). "The therapeutic effects and mechanisms of action of resveratrol on polycystic ovary syndrome: A comprehensive systematic review of clinical, animal and in vitro studies." Clinical and Experimental Pharmacology & Physiology 49(9): 935-949.
	Polycystic ovary syndrome (PCOS) is one of the most important and common polygenic endocrine disorders among women of reproductive age. Resveratrol, a natural phenol, is involved in various biological activities, including antioxidant, antiseptic, anti-inflammatory, anti-ageing and anti-cancer effects. This systematic review aimed to investigate the therapeutic effects and mechanisms of actions of resveratrol in PCOS. The present study was conducted according to the guidelines of the Preferred Reporting Items for Systematic Review and Meta-Analysis statements. We searched PubMed, Science Direct, Google Scholar, Scopus, ISI Web of Science, ProQuest and Embase databases up to August 2021 by using the relative keywords. Original studies published in the English language that assessed the effects of resveratrol on PCOS and its associated complications were considered. Out of 417 records screened, only 24 articles met the inclusion criteria: 10 in vitro, 10 animal and 4 human studies. The results obtained in the present study showed that resveratrol supplementation might be effective in improving PCOS-related symptoms by reducing insulin resistance, alleviating dyslipidaemia, improving ovarian morphology and anthropometric indices, regulating the reproductive hormones and reducing inflammation and oxidative stress by affecting biological pathways. According to the available evidence, resveratrol may reduce the complications of PCOS. However, further studies are recommended for a comprehensive conclusion on the exact mechanism of resveratrol in PCOS patients. (© 2022 John Wiley & Sons Australia, Ltd.)

Karina, R.-C., et al. (2021). "Dietary interventions in polycystic ovary syndrome: A network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Karine, E., et al. (2023). "Letrozole and clomiphene versus letrozole alone for ovulation induction in women with polycystic ovary syndrome: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Karolinska University, H. (2021). "Safety of oral micronized progesterone versus norethisterone acetate in continuous combination with oral estrogen as menopausal hormone therapy – a double-blind randomized study- PROBES study (Progesterone Breast Endometrial Safety study)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: Utrogestan Product Name: Micronized progesterone Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Activelle Product Name: Activelle Pharmaceutical Form: Capsule Trade Name: Estrofem Product Name: Estrofem Pharmaceutical Form: Capsule CONDITION: Climacteric symptoms Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] PRIMARY OUTCOME: Main Objective: To compare the effects of one‐year treatment with mP versus NETA, both in combination with estradiol, on; mammographic breast density. Primary end point(s): ‐Percentage change in mammographic density compared between the groups. Secondary Objective: To compare the effects of one‐year treatment with mP versus NETA, both in combination with estradiol, on; the secondary outcomes below:; ‐ Breast cell proliferation; ‐ Endometrial cell proliferation; ‐ Endometrial thickness using ultrasound; ‐ Bleeding pattern; Gene and protein expression of growth factors and apoptosis markers in breast and endometrial tissue; ‐ Depression and anxiety symptoms (PHQ‐9, HADS); ‐ Health‐related quality of life (PGWB); ‐ Women’s Health Questionnaire (WHQ); ‐ Blood lipid profile, serum hormones, growth and metabolic factors; ; Timepoint(s) of evaluation of this end point: After 12 months of treatment SECONDARY OUTCOME: Secondary end point(s): ‐ Incidence of endometrial proliferation (proliferation marker (Ki67); ‐ Endometrial thickness on ultrasound; ‐ Bleeding pattern as documented in a bleeding diary; ‐ Gene and protein expression of growth factors and apoptosis markers in breast and endometrial tissue; ‐ Depression and anxiety symptoms (Patient Health Questionnaire (PHQ‐9), Hospital Anxiety and Depression; Scale (HADS)); ‐ Health���related quality of life (Psychological General Well‐Being Index (PGWB)); ‐ Women’s Health Questionnaire (WHQ); ‐ Blood lipid profile, serum hormones, growth and metabolic factors (follicle‐stimulating hormone, luteinizing; hormone, estradiol, progesterone, testosterone, sex hormone‐binding globulin, IGF–I and its binding proteins). ; ; Incidence of endometrial hyperplasia and cancer. ; Timepoint(s) of evaluation of this end point: After 12 months of treatment INCLUSION CRITERIA: ‐ Healthy and naturally postmenopausal women (more than one year since last menstruation or FSH > 40 IE/L) with climacteric symptoms (sweating, hot flush and sleep problems) that adversely affect quality of life. ‐ Age 45‐60 years ‐ BMI > 19 kg/m2 and = 32 kg/m2 ‐ Intact uterus ‐ In case of previous MHT use, washout 8 weeks for oral MHT and 4 weeks for transdermal MHT or local estrogen treatment before screening ‐ Written informed consent 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 520 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Karolinska University, H. (2023). "A randomized double blind, multicenter trial to assess time-interval between cytoreductive surgery and adjuvant chemotherapy after administration of local anesthetic intraperitoneally/perioperatively in advanced epithelial ovarian cancer - IPLA-OVCA." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: ROPIVACAINE HYDROCHLORIDE,Product Code: SUB04264MIG,Pharmaceutical Form: INFUSION,Other descriptive name: ,Strength: 2mg,Product Name: SODIUM CHLORIDE,Product Code: SUB12581MIG,Pharmaceutical Form: SOLUTION FOR INFUSION,Other descriptive name: ,Strength: 0.9%,Pharmaceutical form of the placebo: SOLUTION FOR INFUSION,Route of administration of the placebo: INTRAPERITONEAL USE CONDITION: Advanced epithelial ovarian cancer stage III‐IV ; MedDRA version: 20.0Level: PTClassification code: 10033128Term: Ovarian cancerSystem Organ Class: 100000004864 MedDRA version: 20.0Level: PTClassification code: 10033128Term: Ovarian cancerSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] ‐ Neoplasms [C04] PRIMARY OUTCOME: Main Objective:To investigate whether Ropivacaine 0.2% administered intraperitoneally during surgery and intermittently thereafter for up to 72 h in patients with stage III‐IV epithelial ovarian cancer undergoing cytoreductive surgery leads to earlier start of adjuvant chemotherapy. Primary end point(s):Time (days) to start of adjuvant chemotherapy after cytoreductive surgery Secondary Objective:To evaluate postoperative complications and morbidity, quality of recovery and overall survival. SECONDARY OUTCOME: Secondary end point(s):Postoperative complications, postoperative morbidity, quality of recovery, cardiac and renal impairment and overall survival INCLUSION CRITERIA: Women > 18 years,ASA I‐III,Scheduled for upfront cytoreductive surgery for stage III or IV epithelial ovarian cancer,Signed written informed consent

Kartal Yasemin, A. (2024). "The Effect of Mindfulness-based Stress Reduction Programme Given to Infertile Women." ClinicalTrials.gov.
	No Results Available Other: mindfulness-based stress reduction Informed Voluntary Consent Form (Annex 1)|Identifying Characteristics Information Form (Annex 2)|Perceived Stress Scale (Appendix 3):|Depression-Anxiety-Stress Scale (Appendix 4)|Collection and study of salivary cortisol samples Female Not Applicable 86 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Other RojdaBAYARYILDIRIM June 10, 2025

Karyopharm Therapeutics, I. (2022). "A MULTICENTER TRIAL OF SELINEXOR IN MAINTENANCE THERAPY FOR PATIENTS WITH ENDOMETRIAL CARCINOMA." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: NEXPOVIO Product Name: Selinexor Product Code: KPT‐330 Pharmaceutical Form: Coated tablet INN or Proposed INN: Selinexor Current Sponsor code: KPT‐330 Other descriptive name: SELINEXOR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use CONDITION: Selinexor/placebo will be given as maintenance therapy after combination chemotherapy for patients with p53 wild‐type, advanced or recurrent endometrial cancer ; 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 10014734 Term: Endometrial cancer metastatic System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) ; MedDRA version: 21.0 Level: PT Classification code 10014736 Term: Endometrial 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 evaluate the efficacy of selinexor compared to placebo as maintenance therapy Primary end point(s): Investigator assessed PFS per Response Evaluation Criteria in Solid Tumors (RECIST); v1.1 in the ITT population (tumor protein 53 wild‐type [TP53 wt] by central next generation; sequencing [NGS] testing) Secondary Objective: To compare overall survival OS in selinexor and placebo arms; To evaluate the safety and tolerability of selinexor; To compare selinexor and placebo for time to first subsequent therapy; To compare selinexor and placebo for time to second subsequent therapy; To compare selinexor and placebo for time until second progression; To assess the efficacy of selinexor compared to placebo, as assessed by a blinded independent central review (BICR); To evaluate health‐related quality of life (HR‐QoL) outcomes Timepoint(s) of evaluation of this end point: July 2024 SECONDARY OUTCOME: Secondary end point(s): • OS; • The safety and tolerability of study drug (selinexor and placebo) will be evaluated; based on adverse event (AE) reports, physical examination results (including vital signs), and clinical laboratory results by means of the occurrence, nature, and severity of AEs via; Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0; • TFST; • TSST; • Time from randomization until the second progression event (PFS2) or death due to any; cause, whichever occurs first; • PFS, as assessed by a BICR, per RECIST v1.1; • European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life; Questionnaire EuroQol‐5 Dimensions‐5 Levels (EQ‐5D‐5L) Timepoint(s) of evaluation of this end point: August 2025 INCLUSION CRITERIA: 1. At least 18 years of age at the time of signing informed consent. 2. Histologically confirmed EC including: endometrioid, serous, undifferentiated, and carcinosarcoma. 3. TP53 wt assessed by NGS, evaluated by a central vendor. 4. Completed a single line, at least 12 weeks of platinum‐based therapy (not including adjuvant or neoadjuvant therapy for Stage I‐III disease) and achieved confirmed partial or complete response (PR or CR) by imaging, according to RECIST version 1.1. The patients should have received treatment for: Primary Stage IV disease, defined as: a. had a primary or later debulking surgery during first‐line platinum‐based therapy with R0 resection (R0 resection indicates a macroscopic complete resection of all visible tumor) and achieved CR after at least 12 weeks platinum‐based therapy, OR b. had a primary or later debulking surgery during first‐line platinum‐based therapy with R1 resection (R1 resection indicates incomplet

Karyopharm Therapeutics, I. (2022). "Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma." ClinicalTrials.gov.
	The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum‐based therapy. A total of 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.

Kasaven Lorraine, S., et al. (2023). "Systematic review and meta-analysis: does pre-implantation genetic testing for aneuploidy at the blastocyst stage improve live birth rate?" Journal of Assisted Reproduction and Genetics 40(10): 2297-2316.
	Purpose: To establish if preimplantation genetic testing for aneuploidy (PGT-A) at the blastocyst stage improves the composite outcome of live birth rate and ongoing pregnancy rate per embryo transfer compared to conventional morphological assessment.; Methods: A systematic literature search was conducted using PubMed, EMBASE and Cochrane database from 1st March 2000 until 1st March 2022. Studies comparing reproductive outcomes following in vitro fertilisation using comprehensive chromosome screening (CCS) at the blastocyst stage with traditional morphological methods were evaluated.; Results: Of the 1307 citations identified, six randomised control trials (RCTs) and ten cohort studies fulfilled the inclusion criteria. The pooled data identified a benefit between PGT-A and control groups in the composite outcome of live birth rate and ongoing pregnancy per embryo transfer in both the RCT (RR 1.09, 95% CI 1.02-1.16) and cohort studies (RR 1.50, 95% CI 1.28-1.76). Euploid embryos identified by CCS were more likely to be successfully implanted amongst the RCT (RR 1.20, 95% CI 1.10-1.31) and cohort (RR 1.69, 95% CI 1.29-2.21) studies. The rate of miscarriage per clinical pregnancy is also significantly lower when CCS is implemented (RCT: RR 0.73, 95% CI 0.56-0.96 and cohort: RR 0.48, 95% CI 0.32-0.72).; Conclusions: CCS-based PGT-A at the blastocyst biopsy stage increases the composite outcome of live births and ongoing pregnancies per embryo transfer and reduces the rate of miscarriage compared to morphological assessment alone. In view of the limited number of studies included and the variation in methodology between studies, future reviews and analyses are required to confirm these findings. (© 2023. The Author(s).)

Kasper-Jedrzejewska, M., et al. (2024). "The effects of one-time soft tissue therapy on pelvic floor muscle electromyographic signals in women with urinary incontinence: A randomized intervention trial." Neurourology and Urodynamics 43(2): 320-328.
	Aims: To investigate the effects of one-time soft tissue therapy (STT) on pelvic floor muscle (PFM) electromyographic signals in women with stress and/or mixed urinary incontinence. Method(s): An intervention study conducted with 63 women with stress and/or mixed urinary incontinence. Participants were randomly assigned to either the one-time STT group (experimental group) or the control group. The same teaching model for voluntary contraction and relaxation of the PFM was used for all participants. Electromyographic signals from the PFM during functional tasks were the primary clinical outcome measures at baseline and immediately after the intervention. Electromyographic signals were analyzed using root mean square amplitude. Result(s): There was no significant difference between groups in electromyographic PFM signals in prebaseline rest (mean difference: -0.146 [95% confidence interval (CI): -0.44 to 0.148; p = 0.470]), phasic contractions (mean difference: 0.807 [95% CI: 0.123-1.491; p = 0.459]), tonic contractions (mean difference: 1.06 [95% CI: 0.255-1.865; p = 0.302]), endurance contractions (mean difference: 0.896 [95% CI: 0.057-1.735; p = 0.352]) and postbaseline rest (mean difference: -0.123 [95% CI: -0.406 to 0.16; p = 0.591]) immediately after the one-time STT intervention. Conclusion(s): A one-time STT intervention does not appear to effectively alter electromyographic signal of the PFM in women with urinary incontinence. Due to the limitations of the study, further research is needed to confirm these results.Copyright © 2023 Wiley Periodicals LLC.

Kasrie, J. (2023). "A Trial of Sperm Injection (PICSI) on Miscarriage Rates in Assisted Conception." ClinicalTrials.gov.
	No Results Available Procedure: PICSI Miscarriage rate|Fertilisation rates|Embryo development and quality|Blastocyst development and quality|Implantation rate|Biochemical pregnancy rate|Live birth rate All Not Applicable 140 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 46341 September 1, 2023

Katja Haemmerli, K. (2022). "Mind-body Online Therapy in Gynecological Oncology." ClinicalTrials.gov.
	In this randomized‐controlled two‐arm monocentric study with three measurement time points, the effectiveness and feasibility of an internet‐based, therapist‐guided mind‐body self‐help intervention for gynecological cancer patients with primary diagnoses is examined. Different modules (e.g., relaxation, mindfulness, stress management, disease management, nutrition and exercise behaviors) with a mind‐body focus are available for the patients. The goal of the intervention is to improve or maintain the quality of life.

Katsika, E. T., et al. (2023). "Higher live birth rate following transdermal testosterone pretreatment in poor responders: a systematic review and meta-analysis." Reproductive Biomedicine Online 46(1): 81-91.
	A systematic review and meta-analysis was performed aiming to identify good-quality randomized controlled trials (RCT) evaluating testosterone pretreatment in poor responders. Eight RCTs were analysed, evaluating 797 women. Transdermal testosterone gel was used in all studies, with a dose ranging from 10 to 12.5 mg/day for 10-56 days. The main outcome measure was achievement of pregnancy, expressed as clinical pregnancy or live birth. Testosterone pretreatment was associated with a significantly higher live birth (risk ratio [RR] 2.07, 95% confidence interval [CI] 1.09-3.92) and clinical pregnancy rate (RR 2.25, 95% CI 1.54-3.30), as well as a significant increase in the number of cumulus-oocyte complexes retrieved. Significantly fewer days to complete ovarian stimulation, a lower total dose of gonadotrophins, a lower cancellation rate due to poor ovarian response and a thicker endometrium on the day of triggering of final oocyte maturation were observed. No significant differences were observed in oestradiol concentration, the numbers of follicles ≥17 mm, metaphase II oocytes, two-pronuclear oocytes and embryos transferred, and the proportion of patients with embryo transfer. The current study suggests that the probability of pregnancy is increased in poor responders pretreated with transdermal testosterone who are undergoing ovarian stimulation for IVF.

Kawabata, H., et al. (2022). "Intravenous ferric derisomaltose versus saccharated ferric oxide for iron deficiency anemia associated with menorrhagia: a randomized, open-label, active-controlled, noninferiority study." International Journal of Hematology 116(5): 647-658.
	A multicenter, randomized, open-label, phase III study was conducted to compare the efficacy and safety of intravenous ferric derisomaltose (FDI) versus saccharated ferric oxide (SFO) in Japanese patients with iron deficiency anemia associated with menorrhagia. FDI can be administered as a single dose up to 1000 mg, whereas SFO has a maximum single dose of 120 mg. The primary endpoint, which was the maximum change in hemoglobin concentration from baseline, was noninferior for the FDI group compared with the SFO group. The incidence of treatment-emergent adverse events was lower in the FDI group (66.2%) than in the SFO group (90.8%). Notably, the incidence of serum phosphorus level < 2.0 mg/dL was significantly lower in the FDI group (8.4%) than in the SFO group (83.2%), and severe hypophosphatemia (≤ 1.0 mg/dL) occurred in 6.7% of SFO‑treated patients compared with none in the FDI group. The percentage of patients who achieved the cumulative total iron dose during the 8-week treatment period was higher in the FDI group (92.8%) than in the SFO group (43.2%). The study met its primary endpoint, and also demonstrated the tolerability of a high dose of FDI per infusion, with a lower incidence of hypophosphatemia. (© 2022. The Author(s).)

Kawahara, N., et al. (2024). "The clinical trial of alternative relugolix administration for uterine leiomyoma prior to surgically treatment: a study protocol for Non-Adverse Relugolix Administration (NARA) trial." Trials 25(1): 68.
	Background: Uterine leiomyomas are common for reproductive-aged women and affect women's quality of life due to heavy menstrual bleeding or dysmenorrhea. Leiomyomas grow according to estradiol exposure and decrease after post-menopause. In case serious symptoms are caused by leiomyomas, pharmacotherapy or surgical treatment is proposed. Prior to surgical treatment, pharmacotherapies aimed at the reduction of leiomyoma and uterine volume or improvement of anemia are introduced to conduct minimum invasive surgery (i.e., to reduce blood loss or surgical duration). Recently, relugolix (40 mg orally once daily) as a gonadotropin-releasing hormone (GnRH) receptor antagonist has proved its sufficient efficacy in suppressing estradiol levels without the transient estradiol flare-up compared with GnRH agonist. However, long-term administration should not be permitted liable to for climacteric disorder or osteoporosis, and evidence is lacking on the actual efficacy and extent of adverse effects of the every-other-day dosing regimen. This trial aimed to prove non-inferiority in volume reduction effect on leiomyoma and safety (i.e., reduction of adverse effects) by every-other-day administration after 2 months of everyday administration compared to daily administration throughout the duration. Method(s): A minimization adaptive randomized control trial (RCT) will be conducted. Patients (over 20 years old) harboring leiomyoma who will be undergoing surgical treatment will be invited to participate. Patients who are enrolled in the intervention group will receive every-other-day administration for 16 weeks after 8 weeks of daily administration. Patients who are enrolled in the control group will receive daily throughout the 24 weeks. The primary outcome is the leiomyoma volume reduction, and the secondary endpoints are the reduction of uterine volume, the occurrence of the climacteric disorder, genital bleeding days, change rate of serum hormone or bone turnover markers, and bone mineral density after 24 weeks compared to before administration. Discussion(s): This study aims to prove both the non-inferiority in leiomyoma volume reduction and superiority in adverse effects occurrence reduction, which will provide a novel method to escape adverse effects while maintaining the effect of leiomyoma reduction. Trial registration: Japan Registry of Clinical Trials jRCTs051230078. Registered on 26 July 2023.Copyright © 2024, The Author(s).

Kazemi, M., et al. (2021). "Effects of Dietary Glycemic Index and Glycemic Load on Cardiometabolic and Reproductive Profiles in Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis of Randomized Controlled Trials." Advances in Nutrition 12(1): 161-178.
	Women with polycystic ovary syndrome (PCOS) exhibit cardiometabolic (e.g., insulin resistance) and associated reproductive disruptions. Lifestyle modification (e.g., diet) is recommended as the first-line therapy to manage PCOS; however, a favorable dietary regimen remains unclear beyond energy restriction. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to summarize evidence on impacts of dietary glycemic index (GI) or glycemic load (GL) on cardiometabolic and reproductive profiles to update the International Evidence-based Guideline for the Assessment and Management of PCOS. Databases of MEDLINE, Cochrane, Web of Science, and Scopus were searched through 30 October 2019, and confirmed on 25 March 2020, to identify RCTs (≥8 wk) comparing the effects of diets with lower (LGI/LGL) and higher (HGI/HGL) GI/GL on glucoregulatory outcomes, lipid profile, anthropometrics, and androgen status in PCOS. The primary outcome was HOMA-IR. Data were pooled by random-effects models and expressed as weighted mean differences and 95% CIs. The risk of bias was assessed by the Cochrane tool. Ten RCTs (n = 403) were eligible. Eight evaluated LGI and 2 LGL diets. LGI diets decreased HOMA-IR (-0.78; -1.20, -0.37; I2 = 86.6%), fasting insulin (-2.39; -4.78, 0.00 μIU/mL; I2 = 76.8%), total cholesterol (-11.13; -18.23, -4.04 mg/dL; I2 = 0.0%), LDL cholesterol (-6.27; -12.01, -0.53 mg/dL; I2 = 0.0%), triglycerides (-14.85; -28.75, -0.95 mg/dL; I2 = 31.0%), waist circumference (-2.81; -4.40, -1.23 cm; I2 = 53.9%), and total testosterone (-0.21; -0.32, -0.09 nmol/L; I2 = 8.6%) compared with HGI diets (all: P ≤ 0.05) without affecting fasting glucose, HDL cholesterol, weight, or free androgen index (all: P ≥ 0.07). Some results were contradictory and only described narratively for 2 RCTs that evaluated LGL diets, since inclusion in meta-analyses was not possible. LGI diets improved glucoregulatory outcomes (HOMA-IR, insulin), lipid profiles, abdominal adiposity, and androgen status, conceivably supporting their inclusion for dietary management of PCOS. Further RCTs should confirm these observations and address whether LGI diets improve more patient-pressing complications, including ovulatory cyclicity, infertility, and cardiovascular disease risk in this high-risk population. This review was registered at www.crd.york.ac.uk/PROSPERO as CRD42020175300. (Copyright © The Author(s) on behalf of the American Society for Nutrition 2020.)

Ke, H., et al. (2021). "Elagolix for endometriosis: a systematic review and meta analysis." PROSPERO International prospective register of systematic reviews.
	
Keckstein Julia, S., et al. (2023). "Hybrid argon plasma coagulation (HybridAPC) versus sharp excision for the treatment of endometriosis: a prospective randomized clinical trial." Archives of Gynecology and Obstetrics 307(1): 187-194.
	Purpose: Endometriosis is a benign, but potentially serious gynaecological condition in terms of abdominal pain and impaired fertility. Laparoscopic excision techniques are considered the therapeutic standard. HybridAPC is presented as a novel technique for the non-contact thermal ablation of peritoneal endometriosis with simultaneous protection of the underlying thermosensitive structures by creating a needle-free elevated fluid cushion which enables a safer exposure and distance, as well as potentially improved peritoneal conditioning prior to APC.; Methods: In this prospective randomized clinical trial, 39 patients with 132 superficial endometriotic lesions in total were treated with HybridAPC or sharp excision in an initial laparoscopic procedure according to randomization. In a second-look laparoscopy, adhesion formation was rated macroscopically. Histologic samples were taken from previously treated areas for evaluation of eradication rate.; Results: The eradication rate was not significantly different between HybridAPC treatment and sharp excision (65 vs. 81%, p = .55). Adhesions formed in 5% of HybridAPC-treated lesions and in 10% after sharp excision (p = .49). HybridAPC treatment was significantly faster than sharp excision (69 vs. 106 s, p < .05). No intra- and postoperative complications were registered.; Conclusion: This clinical trial demonstrates the feasibility of this novel surgical technique with a promising impact on adhesion prevention. Compared to sharp excision, HybridAPC is likely to be a safe, tissue-preserving, and fast method for the treatment of peritoneal endometriosis. (© 2022. The Author(s).)

Kemeng, X. and c. limin (2022). "Chinese herbal medicine Danggui Sini decoction for primary dysmenorrhea: A protocol for systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Kemeng, X. and C. Limin (2022). "Chinese herbal medicine Gexia Zhuyu decoction for primary dysmenorrhea: A protocol for systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Kemin, L., et al. (2022). "PARP inhibitors for treating recurrent ovarian cancer: Network meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Kennelly, M. J., et al. (2021). "Efficacy of Vibegron and Mirabegron for Overactive Bladder: A Systematic Literature Review and Indirect Treatment Comparison." Advances in Therapy 38(11): 5452-5464.
	Background: In the absence of head-to-head trials, we performed an indirect treatment comparison of the beta3-adrenergic agonists vibegron and mirabegron in the treatment of overactive bladder (OAB). Method(s): PubMed, Embase, and Cochrane Library were searched for articles related to phase 3, double-blind, controlled trials of vibegron 75 mg and mirabegron 25/50 mg in patients with OAB. Efficacy outcomes included change from baseline at weeks 4, 12, and 52 in mean daily number of total urinary incontinence episodes and micturitions and mean volume voided/micturition. Effect size was computed as placebo-subtracted change from baseline (weeks 4, 12) or active control (tolterodine)-subtracted change from baseline (week 52) for each treatment group. Adverse events (AEs) are presented descriptively. Result(s): After removal of duplicates, 49 records were identified, and after screening 9 met inclusion criteria for analysis. Vibegron showed significantly greater reduction in mean daily number of total incontinence episodes than mirabegron 25 mg at week 4, mirabegron 50 mg (weeks 4, 52), and tolterodine (weeks 4, 12) (P < 0.05, each) and significantly greater improvement in volume voided versus mirabegron 25 mg (week 12), mirabegron 50 mg (weeks 12, 52), and tolterodine (week 4) (P < 0.05, each). Confidence intervals of point estimates overlapped zero for all other comparisons of vibegron and mirabegron (25 or 50 mg) or tolterodine, indicating no significant differences between treatments for these time/endpoints. Urinary tract infection, hypertension, and dry mouth were the most commonly occurring AEs for vibegron, mirabegron, and tolterodine, respectively, in the short-term trials; hypertension was the most commonly occurring AE with all three treatments in the long-term trials. Conclusion(s): Vibegron was associated with significant improvement in total incontinence episodes versus mirabegron at 4 and 52 weeks and volume voided at 12 and 52 weeks. Improvement in micturitions was similar between vibegron and mirabegron or tolterodine. Incidence of AEs was generally comparable between vibegron and mirabegron.Copyright © 2021, The Author(s).

Kenter Gemma, G., et al. (2023). "Randomized Phase III Study Comparing Neoadjuvant Chemotherapy Followed by Surgery Versus Chemoradiation in Stage IB2-IIB Cervical Cancer: EORTC-55994." Journal of Clinical Oncology 41(32): 5035-5043.
	Purpose: This multicenter trial by the European Organisation for Research and Treatment of Cancer Gynecological Cancer Group was motivated by conflicting evidence on the value of neoadjuvant chemotherapy before surgery compared with concomitant chemoradiotherapy (CCRT) in stage IB2-IIB cervical carcinoma.; Methods: Between May 2002 and January 2014, 626 patients with International Federation of Gynecology and Obstetrics stage IB2-IIb were randomly assigned between neoadjuvant chemotherapy followed by surgery (NACT-S; n = 314) and standard CCRT (n = 312). The primary end point was 5-year overall survival (OS) rate. Secondary end points were progression-free survival, OS, toxicity, and health-related quality of life (HRQOL).; Results: After a median follow-up of 8.7 years, 198 patients (31.6%) died. Age, stage, and cell type were balanced in both arms. Protocol treatment was completed in 223 of 314 (71%) patients in NACT-S and 257 of 312(82%) in CCRT arms. Main reasons for incomplete protocol treatment were toxicity (30 of 314; 9.6%) and progressive disease (21 of 314; 6.7%) in the NACT-S arm and toxicity (23 of 312; 7.4%) and patient refusal (13 of 312; 4.2%) in the CCRT arm. Additional radiotherapy after completed NACT-S was given to 107 patients (48%), and additional surgery to 20 patients (8%) after completed CCRT. Short-term adverse events (AEs) ≥grade 3 occurred more frequently with NACT-S (41% v 23%), and long-term AEs ≥grade 3 more often with CCRT (21% v 15%). The 5-year OS was not significantly different between NACT-S (72%; 95% CI, 66 to 77) and CCRT (76%; 95% CI, 70 to 80).; Conclusion: This trial failed to demonstrate superiority in favor of the NACT-S arm but resulted in acceptable morbidity and HRQOL in both arms.

Keyan, M. and Z. Hui (2023). "Effects of different hemostatic approaches to endometriosis cysts on anti-Müllerian hormone levels : a systematic review and reticular meta-analysis based on an RCT study." PROSPERO International prospective register of systematic reviews.
	
Keyang, L. and D. Ailin (2023). "Sildenafil citrate on uterine blood flow in subfertile women: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Keye, C., et al. (2023). "The impact of menopause education on quality of life among menopausal women: a systematic review with meta-analysis." Climacteric 26(5): 419-427.
	A systematic review with meta-analysis was conducted to establish the impact of menopause health education on quality of life (QoL) among menopausal women. Research suggests that specific educational programs can support and enable women during the physical and emotional transition through menopause. The CINAHL, Medline, APA, Embase and Google Scholar databases were searched between 30 November 2021 and 9 January 2022 using the PRISMA guidelines. The Cochrane risk of bias tool was used to critically evaluate the included studies. Review Manager software was used to conduct the meta-analysis of suitable studies. Eight papers were eligible for this review. The participants were aged between 40 and 60 years, with diagnosis of menopause stemming from changes in the menstrual cycle to a last menstrual period of 7 years. Follow-up data were collected between 1 and 4 months post education. Meta-analysis of both the primary outcome (QoL) and secondary outcome (symptom control) demonstrated statistically significant improvements post intervention. Papers not suitable for meta-analysis were reviewed narratively; two papers assessing the primary outcome (QoL) demonstrated an improvement, but only one to a statistically significant level. Secondary outcomes revealed improvements, with all bar one paper doing so to statistical significance. Menopause health education demonstrated an improvement in both QoL and symptom control in menopausal women; however, given some weaknesses in the included studies, further research is justified. Limitations include participants' level of education, geographical location, risk of bias, that only half of the papers addressed participant use of hormone replacement therapy and length of follow-up.

Khalid, K., et al. (2023). "Effects of Ketogenic Diet on Reproductive Hormones in Women With Polycystic Ovary Syndrome." Journal of the Endocrine Society 7(10): bvad112.
	Context: Ketogenic diet has recently made a comeback as a part of lifestyle and dietary modifications in patients with polycystic ovary syndrome (PCOS). Despite studies suggesting its beneficial effects in reversing hormonal imbalance in women with PCOS, evidence has been patchy and derived from small populations under varying conditions.; Objective: To pool evidence from clinical trials to study the effects of ketogenic diet on reproductive hormones (LH/FSH ratio, free testosterone, serum progesterone) and observe evidence of weight change.; Methods: PubMed, ScienceDirect, Scopus, and Web of Science core collection were searched for clinical trials evaluating the effects of ketogenic diet in established PCOS women consistent with the Rotterdam classification. Single- or double-arm studies that included an outcome of interest were included. Two investigators worked independently to screen potential articles and a designated investigator extracted data on study characteristics and evaluated the outcomes. Data were pooled using a random-effects model. The quality of selected studies was assessed using the Cochrane Risk of Bias Tool.; Results: Following ≥45 days of intervention with ketogenic diet among women with PCOS, significant improvement was observed in reproductive hormone levels, with reduced LH/FSH ratio ( d -0.851; 95% CI -1.015, -0.686; P < .001), reduced serum free testosterone ( d - 0.223; 95% CI -0.328, -0.119; P < .001), and an increased in serum sex hormone binding globulin (SHBG) ( d 9.086; 95% CI 3.379, 14.792; P = .002). Significant weight loss was unanimously observed in all included studies ( d -11.56; 95% CI -14.97, -8.15; P < .001).; Conclusion: Short-term ketogenic diet potentially improved hormonal imbalances commonly associated with PCOS. (© The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society.)

Khamis, Y., et al. (2021). "Vaginal CO2 laser therapy versus sham for genitourinary syndrome of menopause management: a systematic review and meta-analysis of randomized controlled trials." Menopause 28(11): 1316-1322.
	Importance: The research of new therapeutic modalities, especially with energy-based devices, has been increasing nowadays for genitourinary syndrome of menopause (GSM) management. Microablative fractional CO2 laser has been used for pelvic floor dysfunction management.; Objective: To conduct a systematic review and meta-analysis of randomized controlled trials to compare fractional CO2 laser therapy versus sham therapy for GSM management.; Evidence Review: We searched for the available randomized clinical trials in Cochrane Library, PubMed, ISI web of science, and Scopus during March 2021. We included randomized clinical trials that compared CO2 laser to sham among postmenopausal women with GSM diagnosis. We extracted the available data from included studies and pooled them in a meta-analysis model using RevMan software. Our main outcomes were total vaginal score assessment using the Vaginal Assessment Scale, sexual function using the Female Sexual Function Index, urinary symptoms using the Urogenital Distress Inventory-6, and satisfaction.; Findings: Three studies met our inclusion criteria with a total number of 164 women. The CO2 laser was linked to a significant reduction in Vaginal Assessment Scale score when compared with the sham group (mean difference [MD] = -0.49, 95% CI [-0.75 to -0.22], P = 0.004). The CO2 laser was associated with a significant improvement in Female Sexual Function Index score in comparison with sham group (MD = 9.37, 95% CI [6.59-12.14], P < 0.001). In addition, a significant reduction in Urogenital Distress Inventory-6 score was reported among the CO2 laser group (MD = -6.95, 95% CI [-13.24 to -0.67], P = 0.03). More women were significantly satisfied among the CO2 laser group (risk ratio = 1.98, 95% CI [1.36-2.89], P = 0.004).; Conclusions and Relevance: CO2 laser therapy is a promising alternative for GSM management. Further randomized trials with larger sample sizes are required to confirm our findings.; Competing Interests: Financial disclosures/conflicts of interest: None reported. (Copyright © 2021 by The North American Menopause Society.)

Kharaji, G., et al. (2023). "Supervised versus unsupervised pelvic floor muscle training in the treatment of women with urinary incontinence - a systematic review and meta-analysis." International Urogynecology Journal 34(7): 1339-1349.
	Introduction and hypothesis: This study synthesized the effects of supervised and unsupervised pelvic floor muscle training (PFMT) programs on outcomes relevant to women's urinary incontinence (UI). Method(s): Five databases were searched from inception to December 2021, and the search was updated until June 28, 2022. Randomized and non-randomized control trials (RCTs and NRCTs) comparing supervised and unsupervised PFMT in women with UI and reported urinary symptoms, quality of life (QoL), pelvic floor muscles (PFM) function/ strength, the severity of UI, and patient satisfaction outcomes were included. Risk of bias assessment of eligible studies was performed by two authors through Cochrane risk of bias assessment tools. The meta-analysis was conducted using a random effects model with the mean difference or standardized mean difference. Result(s): Six RCTs and one NRCT study were included. All RCTs were assessed as "high risk of bias", and the NRCT study was rated as "serious risk of bias" for almost all domains. The results showed that supervised PFMT is better than unsupervised for QoL and PFM function of women with UI. There was no difference between supervised and unsupervised PFMT for urinary symptoms and improvement of the severity of UI. Results of patient satisfaction were inconclusive due to the sparse literature. However, supervised and unsupervised PFMT with thorough education and regular reassessment showed better results than those for unsupervised PFMT without educating patients about correct PFM contractions. Conclusion(s): Supervised and unsupervised PFMT programs can both be effective in treating women's UI if training sessions and regular reassessments are provided.Copyright © 2023, The International Urogynecological Association.

Khatib, G. (2021). "Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery." ClinicalTrials.gov.
	No Results Available Procedure: Rectosigmoid resection Local pelvic recurrence|Recurrence-free survival|Cancer specific survival|Surgery related morbidities|Health related Quality of life|Overall survival Female Not Applicable 120 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 105/17- Ov01 December 2026

Khatlani, K., et al. (2019). "Effect of Lifestyle Intervention on Cardiometabolic Risk Factors in Overweight and Obese Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis." Metabolic Syndrome and Related Disorders 17(10): 473-485.
	The effects of lifestyle interventions (LSIs) on cardiometabolic risk factors in women with polycystic ovary syndrome (PCOS) are controversial. We conducted a systematic review and meta-analysis to assess the effectiveness of LSI on cardiometabolic risk in women with PCOS. We reviewed five databases for randomized controlled trials (RCTs) published between 2012 and December 2016, evaluating the effect of LSI among adult, reproductive age group, overweight, and obese women with PCOS. Outcome measures included weight change, homeostatic model assessment-insulin resistance index (HOMA-IR), total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL), and high-density lipoprotein (HDL). A total of 564 studies were screened; 35 full text studies assessed for eligibility, 20 excluded with reasons, 15 included in the systematic review, and 9 studies from 8 RCTs included in a meta-analysis. LSI resulted in significant reduction in weight in sensitivity analyses [study 5 dietary arm as intervention: standardized mean difference (SMD) = -0.81 (95% confidence interval {CI} = -1.24 to -0.39); study 5 combination arm as intervention: SMD = -0.85 (95% CI = -1.26 to -0.45)], HOMA-IR overall [study 5 dietary arm: SMD = -1.46 (95% CI = -2.72 to -0.20); study 5 combination arm SMD = -1.50 (95% CI = -2.76 to -0.23)], and LDL overall [SMD = -1.06 (95% CI = -2.00 to -0.12)]. LSI was more beneficial than Metformin in decreasing LDL [SMD = -2.60 (95% CI = -5.15 to -0.05)] but similar to comparator group in terms of TC, TG, and HDL ( P > 0.05). Short-term LSI can effectively improve weight, insulin resistance, and lipid profile and could be recommended as first-line therapy in overweight and obese PCOS women to reduce cardiometabolic risk.

Khemka, V. (2022). "Pembrolizumab vs Platinum Doublet Chemotherapy in Participants with dMMR Advanced or Recurrent Endometrial Carcinoma in the First-line Setting." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: KEYTRUDA® Pharmaceutical Form: Solution for infusion INN or Proposed INN: Pembrolizumab CAS Number: 1374853‐91‐4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25‐ Trade Name: Carboplatin Bendalis Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Carboplatin CAS Number: 41575‐94‐4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ Trade Name: Carboplatin Kabi Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Carboplatin CAS Number: 41575‐94‐4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ Trade Name: Cisplatin Teva Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Cisplatin CAS Number: 15663‐27‐1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ Trade Name: Paclitaxel EVER Pharma Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Paclitaxel CAS Number: 33069‐62‐4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6‐ Trade Name: Docetaxel EVER Valinject Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Docetaxel CAS Number: 114977‐28‐5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ Trade Name: Docetaxel AqVida Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Docetaxel CAS Number: 114977‐28‐5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ Trade Name: Docetaxel cell pharm Pharmaceutical Form: Concentrate for solution f CONDITION: First‐line treatment of participants with dMMR advanced or recurrent EC ; MedDRA version: 21.1 Level: LLT Classification code 10014747 Term: Endometrial carcinoma recurrent System Organ Class: 100000004864 Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Secondary Objective: 1. To compare pembrolizumab to chemotherapy with respect to ORR per RECIST 1.1 by BICR in participants with measurable disease at study entry; 2. To compare pembrolizumab to chemotherapy with respect to DCR per RECIST 1.1 by BICR in participants with measurable disease at study entry; 3. To compare pembrolizumab to chemotherapy with respect to DOR per RECIST 1.1 by BICR in participants with measurable disease at study entry; 4. To compare pembrolizumab to chemotherapy with respect to PFS per RECIST 1.1 as assessed by the investigator; 5. To compare pembrolizumab to chemotherapy with respect to PFS2 per RECIST 1.1 as assessed by the investigator; 6. To compare the safety and tolerability of pembrolizumab to chemotherapy; 7. To compare pembrolizumab to chemotherapy with respect to change from baseline score and TTD in the EORTC QLQ‐C30 GHS/QoL; Main Objective: 1. To compare pembrolizumab to chemotherapy with respect to PFS per RECIST 1.1 as assessed by BICR; 2. To compare pembrolizumab to chemotherapy with respect to OS; Primary end point(s): 1. Progression‐Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR); 2. Overall survival (OS); Timepoint(s) of evaluation of this end point: 1. Up to approximately 30 months ; 2. Up to approximately 49 months; SECONDARY OUTCOME: Timepoint(s) of evaluation of this end point: 1. Up to approximately 30 months ; 2. Up to approximately 30 months ; 3. Up to approximately 30 months ; 4. Up to approximately 30 months ; 5. Up to approximately 30 months ; 6. Up to approximately 27 months; 7. Up to approximately 24 months; 8. Baseline and up to approximately 25 months; 9. Baseline and up to approximately 25 months; 10. Up to approximately 25 months; 11. Up to approximately 25 months Secondary end point(s): 1. Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR; 2 isease Control Rate (DCR) per RECIST 1.1 as Assessed by BICR; 3. Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR; 4. PFS per RECIST 1.1 as Assessed by Investigator; 5. Progression‐Free Survival 2 (PFS2) per RECIST 1.1 as Assessed by Investigator; 6. Number of Participants Who Experience at Least One Adverse Event (AE); 7. Number of Participants Who Discontinue Study Treatment Due to an AE; 8. Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire‐Core 30 (EORTC QLQ‐C30) Global Health Status (GHS) (Item 29) And Quality of Life (QoL) (Item 30) Combined Score; 9. Change From Baseline in EORTC QLQ‐C30 Physical Functioning (Items 1‐5) Combined Score; 10. Time to Deterioration (TTD) in EORTC QLQ‐C30 GHS (Item 29) And QoL (Item 30) Combined Score; 11. TTD in EORTC QLQ‐C30 Physical Functioning (Items 1‐5) Combined Score INCLUSION CRITERIA: 1.Has a histologically confirmed diagnosis of Stage III or IV or recurrent EC or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR. 2.Has radiographically evaluable disease, either measurable or nonmeasurable per RECIST 1.1, as assessed by the investigator. Prior Therapy 3.Has received no prior systemic therapy for advanced EC. 4.Is female, at least 18 years of age at the time of signing the informed consent (either Authorization for Release of Tumor Tissue or main study consent). 5.Has ECOG performance status of 0 or 1 within 7 days before randomization. 6.A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: ‐Is not a WOCBP OR ‐Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferre

Kiel Ida, A., et al. (2022). "High-Intensity Interval Training in Polycystic Ovary Syndrome: A Two-Center, Three-Armed Randomized Controlled Trial." Medicine and Science in Sports and Exercise 54(5): 717-727.
	Purpose: Exercise training is recommended to improve cardiometabolic health and fertility in women with polycystic ovary syndrome (PCOS), yet there are few randomized controlled trials on the effects of different exercise protocols on clinical reproductive outcomes. Our aim was to determine the effect of high-intensity interval training (HIT) on menstrual frequency, as a proxy of reproductive function, in women with PCOS.; Methods: The IMPROV-IT study was a two-center randomized controlled trial undertaken in Norway and Australia. Women with PCOS were eligible for inclusion. After stratification for body mass index <27 or ≥27 kg·m-2 and study center, participants were randomly allocated (1:1:1) to high-volume HIT (HV-HIT), low-volume HIT (LV-HIT), or a control group. Measurements were assessed at baseline, after the 16-wk exercise intervention, and at 12-month follow-up. The primary outcome was menstrual frequency after 12 months. Secondary outcomes included markers of cardiometabolic and reproductive health, quality of life, and adherence to and enjoyment of HIT.; Results: We randomly allocated 64 participants to the HV-HIT (n = 20), LV-HIT (n = 21), or control group (n = 23). There were no differences in menstrual frequency at 12 months between the LV-HIT and control groups (frequency ratio, 1.02; 95% confidence interval [CI], 0.73-1.42), the HV-HIT and control groups (frequency ratio, 0.93; 95% CI, 0.67-1.29), or the LV-HIT and HV-HIT groups (frequency ratio, 1.09; 95% CI, 0.77-1.56). Menstrual frequency increased in all groups from baseline to 12 months. More participants became pregnant in the LV-HIT group (n = 5) than in the control group (n = 0, P = 0.02).; Conclusions: A semisupervised HIT intervention did not increase menstrual frequency in women with PCOS.Clinical Trial Registration Number:ClinicalTrials.gov (NCT02419482). (Copyright © 2022 by the American College of Sports Medicine.)

Kietpeerakoo, C., et al. (2019). "Nerve-sparing radical hysterectomy compared to standard radical hysterectomy for women with early stage cervical cancer (stage Ia2 to IIa)." The Cochrane Database of Systematic Reviews 2019(2): CD012828.
	Radical hysterectomy is one of the standard treatments for stage Ia2 to IIa cervical cancer. Bladder dysfunction caused by disruption of the pelvic autonomic nerves is a common complication following standard radical hysterectomy and can affect quality of life significantly. Nerve-sparing radical hysterectomy is a modified radical hysterectomy, developed to permit resection of oncologically relevant tissues surrounding the cervical lesion, while preserving the pelvic autonomic nerves. Objectives To evaluate the benefits and harms of nerve-sparing radical hysterectomy in women with stage Ia2 to IIa cervical cancer. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 4), MEDLINE via Ovid (1946 to May week 2, 2018), and Embase via Ovid (1980 to 2018, week 21). We also checked registers of clinical trials, grey literature, reports of conferences, citation lists of included studies, and key textbooks for potentially relevant studies. Selection criteria We included randomised controlled trials (RCTs) evaluating the efficacy and safety of nerve-sparing radical hysterectomy compared to standard radical hysterectomy for women with early stage cervical cancer (stage Ia2 to IIa). Data collection and analysis We applied standard Cochrane methodology for data collection and analysis. Two review authors independently selected potentially relevant RCTs, extracted data, evaluated risk of bias of the included studies, compared results and resolved disagreements by discussion or consultation with a third review author, and assessed the certainty of evidence.Copyright © 2019 The Cochrane Collaboration. Published by JohnWiley & Sons, Ltd.

Kikuno, K. (2021). "The efficacy and safety of long-term low-dose Dienogest in patients with dysmenorrhea due to endometriosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: 0.5 mg group: Dienogest 0.5 mg twice daily, 1 tablet at a time for 48 weeks. 1 mg group: Dienogest 1 mg twice daily, 1 tablet at a time for 48 weeks. CONDITION: dysmenorrhea due to endometriosis ; endometriosis dysmenorrhea PRIMARY OUTCOME: Changes in VAS 48 weeks after baseline administration SECONDARY OUTCOME: 1.Incidence of low estrogen symptoms during reserch treatment(quantified using menopausal score); 2.Changes in dysmenorrhea score 48 weeks after dosing from baseline; 3.Changes in menopausal score 48 weeks after dosing from baseline; 4.Rate of reduction in ovarian endometriotic cyst size 48 weeks after baseline administration; 5.Change in bone mineral density 48 weeks after administration from baseline; 6.Primary endopoints and secondary endopoints above at 12,24,and 36 weeks. INCLUSION CRITERIA: 1.Patients who have been diagnosed with endometriosis (ovarian endometriotic cyst) and do not plan to undergo surgery 2. Patients with dysmenorrhea 3. Patients who plan to continue using Dienogest for more than 48 weeks. 4.Patients over 20years old to premenopausal at the time of consent 5.Patients who have written consent to participate in this study

Kiley, H., et al. (2023). "The role of prophylactic uterotonics, antifibrinolytic medications, and vasoconstrictive agents on second trimester abortion hemorrhage rates: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Kilinc, M. F., et al. (2022). "Long-term postoperative follow-up results of transobturator autologous rectus fascial sling versus transobturator tension-free vaginal tapes for female stress urinary incontinence: Randomized controlled clinical trial." Neurourology and Urodynamics 41(1): 281-289.
	Aims: To evaluate the outcomes of a new surgical technique for the treatment of stress urinary incontinence (SUI). Method(s): This randomized study included 132 index patients from January 2017 to May 2021, 60 applied with autologous facia and 60 with transobturator tension-free vaginal tape (TVT-O). The primary endpoint was dryness (negative stress test and 0 pad use per day) and this was assessed at 3, 6, 12, and 24 months. The secondary endpoints were the International Consultation on Incontinence Questionnaire short form (ICIQ-SF) and the urinary incontinence quality of life (QoL) at 3, 6, 12, and 24 months. Result(s): The dryness rate at 24 months was 92.4% (49/53) for patients with transobturator autologous rectus fascial sling (TO-AFS) and 94.6% (53/56) for those with TVT-O (p = 0.47). No difference was determined between the TO-AFS and TVT-O groups in respect of the ICIQ-SF and QoL scores at 2 years postoperatively (p = 0.87). There were five postoperative complications in the TO-AFS group (one urinary retention, one hematoma at suprapubic incision line, and three intermittent groin pains) and four in the TVT-O group (four persistent groin pain) (p = 0.98). Conclusion(s): The objective cure rates of the 24-month outcomes of TO-AFS indicate that this novel surgical technique seems to be a highly effective, safe, and feasible procedure for the treatment of SUI, but further studies including long-term follow-up are mandatory to confirm these preliminary data.Copyright © 2021 Wiley Periodicals LLC

Kim, A., et al. (2019). "Retropubic versus Transobturator Mid Urethral Slings in Patients at High Risk for Recurrent Stress Incontinence: A Systematic Review and Meta-Analysis." The Journal of Urology 202(1): 132-142.
	Purpose: The efficacy and safety of retropubic and transobturator tension-free vaginal tape mid urethral slings remain controversial in patients with stress urinary incontinence and risk factors for recurrence. We compared the techniques after initial mid urethral sling insertion in select groups, including patients with obesity, intrinsic sphincter deficiency, pelvic organ prolapse and recurrent stress urinary incontinence.; Materials and Methods: We used the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement to report the methods and results of the current review. Randomized controlled trials and observational studies were included. We assessed the objective and subjective cure rates, and the complication rate using the OR with the 95% CI. The protocol of the current meta-analysis was registered on PROSPERO (No. CRD42018102233).; Results: We retrieved 28 studies in a total of 2,607 patients to compare the efficacy and safety of retropubic vs transobturator tension-free vaginal tape in select groups (mean followup 26.9 months). Meta-analysis of the objective cure rate showed the significant superiority of retropubic compared to transobturator tension-free vaginal tape in patients overall (OR 3.37, 95% CI 2.55-4.43, p <0.00001, I 2 = 37%) and in each subpopulation. The subjective cure rate of retropubic tension-free vaginal tape was also significantly superior to that of transobturator tension-free vaginal tape in in patients overall (OR 2.01, 95% CI 1.45-2.80, p <0.0001, I 2 = 0%) and in those with intrinsic sphincter deficiency and recurrent stress urinary incontinence after mid urethral sling insertion. There was no significant difference in overall complications between retropubic and transobturator tension-free vaginal tape (OR 1.22, 95% CI 0.89-1.66, p = 0.21, I 2 = 0%).; Conclusions: The meta-analysis showed the superiority of retropubic tension-free vaginal tape over transobturator tension-free vaginal tape in terms of the objective and subjective cure rates in patients with obesity, intrinsic sphincter deficiency, pelvic organ prolapse and recurrent stress urinary incontinence after mid urethral sling insertion. Retropubic tension-free vaginal tape also has morbidity comparable to that of transobturator tension-free vaginal tape.

Kim, A., et al. (2019). "An Updated Systematic Review and Meta-analysis: Clinical Outcome of Single-Incision Slings Excluding TVT-Secur versus Standard Slings in Surgical Management of Stress Incontinence." BJU International 123(4): 566-584.
	OBJECTIVES: To assess and compare the long-term efficacy and safety of single-incision mini-slings (SIMS) except tension-free vaginal tape (TVT)-Secur with standard midurethral slings (SMUS) for female stress urinary incontinence through an updated systematic review and meta-analysis of randomized controlled trials (RCTs) comparing these 2 surgical methods. MATERIALS AND METHODS: A literature review of all RCTs comparing SIMS (Mini-Arc, Contasure-Needleless, Ophira, Tissue Fixation System, and Ajust) except TVT-Secur with SMUS was performed. The Medline, Embase, Scopus, Web of Science, and Cochrane Controlled Trial Register databases were reviewed. RESULTS: We retrieved 29 RCTs (N=2986) comparing SIMS except TVT-Secur with SMUS. Meta-analysis of long-term results showed no significant difference in the patient-reported cure rate (odds ratio [OD], 0.67; 95% confidence interval [CI], 0.44-1.60); however, we found that SMUS had a significantly superior objective cure rate (OD, 0.68; 95% CI, 0.47-0.99; p=0.04). SIMS were associated with a significantly shorter operation time, lower immediate postoperative pain based on the visual analog scale score, lower intraoperative blood loss, and lower postoperative voiding dysfunction. CONCLUSIONS: The meta-analysis showed clear evidence of the superiority of SMUS over SIMS except TVT-Secur, in terms of the objective cure rate, on long-term follow-up. However, SIMS are superior with respect to immediate postoperative pain, intraoperative blood loss, and postoperative voiding dysfunction. This article is protected by copyright. All rights reserved.

Kim, B. and H. Park (2024). "The Effects of Auricular Acupressure on Menopausal Symptoms, Stress, and Sleep in Postmenopausal Middle-Aged Women: A Randomized Single-Blind Sham-Controlled Trial." Journal of Midwifery and Women's Health 69(1): 41-51.
	Introduction: Middle-aged women in the postmenopausal period experience menopause symptoms, stress, and poor sleep quality due to hormonal changes. Nonetheless, most of them recognize such symptoms as an aging process without receiving proper treatment, and there are few nonpharmacologic interventions available. Method(s): This was a randomized single-masked, sham-controlled trial. For the intervention group, a vaccaria seed was applied to the auricular points of Shenmen, anterior lobe, adrenal glands, central rim, and endocrine that are related to the menopause symptoms, stress, and sleep while applying a seed to the auricular points not related to the forementioned symptoms to the control group. The Menopause Rating Scale (MRS), Perceived Stress Scale (PSS), heart rate variability, and electroencephalogram (EEG) were measured before the intervention, 4 weeks after the intervention, and 8 weeks after the intervention. Actigraphy was measured with a Fitbit, and the Pittsburgh Sleep Quality Index (PSQI) was measured before and after the intervention. The study was registered with the World Health Organization International Clinical Trials Registry Platform (KCT0007364). Result(s): The MRS showed significant differences over time in the intervention group (F, 22.057; P <.001). There was a significant difference over time in the PSS (F, 22.576; P <.001), stress index measured by heart rate variability (F, 14.027; P =.001), and antistress quotient of the right brain measured by EEG (F, 4.865; P =.033). Sleep quality, measured by the PSQI (t = -4.050, P <.001), and sleep efficiency measured by actigraphy (t = 5.996, P <.001) were found to be significantly different over time in the intervention group. Discussion(s): This study demonstrated that auricular acupressure is effective in improving menopause symptoms, stress, and sleep in postmenopausal middle-aged women. Therefore, auricular acupressure may be a useful nonpharmacologic intervention for alleviating these symptoms in this population.Copyright © 2023 by the American College of Nurse-Midwives.

Kim, C.-H. and S.-H. Lee (2022). "Effectiveness of Lifestyle Modification in Polycystic Ovary Syndrome Patients with Obesity: A Systematic Review and Meta-Analysis." Life 12(2).
	(1) Background: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility and endocrine disorders among women of reproductive age. Previous studies have employed lifestyle interventions to manage anovulatory infertility and endocrine disorders. However, the effect of lifestyle interventions on the metabolic index remains ambiguous; (2) Methods: Data were obtained through a systematic search of the Ovid-Medline, Ovid-EMBASE, and Cochrane Library databases. Two reviewers independently reviewed the literature in two stages. A consensus was achieved through discussions regarding the final selection of the literature; (3) Results: This study observed that the group that underwent lifestyle modifications displayed significant improvement in reproductive function compared to the control group. Combination therapy with diet and exercise resulted in improved fasting insulin levels, compared to monotherapy with diet or exercise. Moreover, moderate weight loss (a minimum of 5%) resulted in an improved metabolic index. The subgroup analysis revealed that the group that underwent lifestyle modifications had a significantly higher number of patients with improved menstrual cycles, compared to the control groups; (4) Conclusions: Lifestyle modification using combination therapy is a promising therapeutic approach that can be employed in the management of PCOS patients with obesity. This scenario warrants further studies with larger sample sizes to develop ideal treatment protocols.

Kim Chan, H., et al. (2020). "Effects of lifestyle modification in polycystic ovary syndrome compared to metformin only or metformin addition: A systematic review and meta-analysis." Scientific Reports 10(1): 7802.
	Polycystic ovary syndrome (PCOS) is a common disease that has an effect on approximately 10% of women of childbearing age. Although there is evidence regarding the role of lifestyle factors in the development of PCOS, the exact etiology remains unclear. Additionally, metformin is used in the treatment of PCOS but its role remains unclear. We compared the effects of lifestyle modification (LSM) + metformin and metformin alone on PCOS. We performed a systematic review by searching electronic databases for publications until December 2019. The primary endpoints were clinical outcomes, such as menstrual cycles and pregnancy rates, and the secondary endpoints were anthropometric, metabolic, and androgenic parameters. The meta-analysis revealed that there was no significant difference in the improvements in the menstrual cycles between LSM and metformin alone (weighted mean difference [MD] = 1.62) and between LSM + metformin and LSM (MD = 1.20). The pregnancy rates and body mass indices were not significantly different between LSM and metformin alone (MD = 1.44 and -0.11, respectively). LSM reduced insulin resistance (MD = -0.52) and increased serum levels of sex hormone-binding globulins (MD = 8.27) compared with metformin. Therefore, we suggest recommending lifestyle modifications actively to women with PCOS if they do not have indications for metformin.

Kim, D.-y. (2023). "A Phase III Randomized Clinical Trial of Laparoscopic or Robotic RH using cancer cell spillage minimizing techniques vs Abdominal RH In Patients with Early-Stage Cervical Cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Procedure/Surgery : ‐Laparoscopic or robotic radical hysterectomy and pelvic/paraaortic lymphadenectomy In the case of minimally invasive surgery, one or more of the following measures should be taken to minimize the leakage of cancer cells: Use an occlusive technique during colpotomy. Avoid the use of a manipulator. Perform vaginal closure prior to the main procedure. Close the cervi Xusing endoGIA (endoscopic stapler) before performing colpotomy. Perform vaginal suturing before performing colpotomy. Consider removing the main mass through conization before or during the surgery. ‐ Open radical hysterectomy and pelvic/para‐aortic lymphadenectomy CONDITION: Neoplasms PRIMARY OUTCOME: 5‐year disease‐free survival (5‐year DFS) SECONDARY OUTCOME: 3‐year progression free survival 5‐year overall survival Comparison of patients' quality of life after surgery Surgery‐related complications within 1 month after surgery, readmission rate, reoperation rate, mortality rate INCLUSION CRITERIA: 1) Patients aged 20‐80 years 2) Histologically confirmed adenocarcinoma, squamous cell carcinoma, or adenosquamous cell carcinoma of the cervi X 3) Patients who qualify for 2018 FIGO IA2 or IB1‐2 4) Patients undergoing type II or III radical hysterectomy (Piver Classification) 5) Patients with adequate bone marrow, kidney and liver function ? WBC = 3,000/mm3 ? Platelets = 100,000/mm3 ? Creatinine = 2.0 mg/dL ? Bilirubin = 1.5 Xinstitutional upper limit normal ? SGOT, SGPT, and ALP = 3 Xinstitutional upper limit normal 6) Performance status of ECOG 0‐1 7) Patients who voluntarily signed the research subject consent form

Kim Hee, s. (2021). "Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function." ClinicalTrials.gov.
	No Results Available Procedure: Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy|Procedure: suturing with barbed sutures during laparoscopic ovarian cystectomy Ovarian function preservation 12 weeks after surgery|Ovarian function preservation 48 weeks after surgery|The time required to finish hemostasis|the success rate of hemostasis within 10 minutes|Blood loss during operation|Hemoglobin|Transfusion during admission|Adverse events associated with operation, bleeding or transfusion|Hospitalization period|Operation running time Female Not Applicable 90 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2008-059-1147 December 31, 2026

Kim, H. I., et al. (2021). "Efficacy and Safety of a Standardized Soy and Hop Extract on Menopausal Symptoms: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial." Journal of Alternative and Complementary Medicine 27(11): 959-967.
	Objectives: Soy and hop extracts have been investigated as alternatives for hormone replacement therapy. However, their combined efficacy is not known. We investigated the efficacy and safety of a combined soy and hop extract on postmenopausal symptoms. Design: Double-blinded, randomized controlled trial. Settings/Location: Gynecological outpatient clinic of tertiary hospital. Subjects: Seventy-eight women with moderate or severe menopausal symptoms assessed as modified Kupperman Menopoausal Index (KMI) scores >20. Interventions: They received either a combined soy and hop extract (n = 38) or placebo (n = 40). Outcome measures: Menopausal symptoms were evaluated through self-reporting of modified Kupperman Menopausal Index (KMI) scores at baseline and after 6 and 12 weeks. We assessed serum levels of bone metabolism biomarkers, ultrasonographic parameters, hormone profiles, compliance, and safety. Results: After 12 weeks of the treatment, treatment group scores decreased by 20.61 points compared with 14.80 points in the placebo group (p < 0.05). Fatigue, paresthesia, arthralgia, and myalgia, palpitation and vaginal dryness significantly improved more in the treatment group compared with the placebo group after 12 weeks (p < 0.05). Urine N-telopeptide in participants ≥50 years in the treatment group showed a reduced increase. Endometrial thickness and hormonal profiles did not show significant changes in either group. No serious adverse events were reported. Conclusion: The results suggest that 190 mg of combined soy and hop extract is safe and effective for improvement of menopausal symptoms. CRIS No.: KCT0006019.

Kim, H. S., et al. (2021). "A multicentre, randomised, open-label, parallel-group Phase 2b study of belotecan versus topotecan for recurrent ovarian cancer." British Journal of Cancer 124(2): 375-382.
	BACKGROUND: This Phase 2b study compared the efficacy and toxicity of belotecan and topotecan in recurrent ovarian cancer. METHODS: Patients with platinum-sensitive recurrent or platinum-resistant recurrent ovarian cancer (PRROC) were randomised 1:1 to receive belotecan 0.5 mg/m2 or topotecan 1.5 mg/m2 for five consecutive days every 3 weeks. The primary endpoint was overall response rate (ORR); secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity. RESULTS: A total of 140 (belotecan, n = 71; topotecan, n = 69) and 130 patients (belotecan, n = 66; topotecan, n = 64) were included in the intention-to-treat (ITT) and per-protocol (PP) populations. ORR did not differ significantly between the belotecan and topotecan groups (ITT, 29.6% versus 26.1%; PP, 30.3% versus 25%). Although PFS did not differ between the groups, belotecan was associated with improved OS compared with topotecan in the PP population (39.7 versus 26.6 months; P = 0.034). In particular, belotecan showed longer OS in PRROC and non-high-grade serous carcinoma (non-HGSC; PP, adjusted hazard ratios, 0.499 and 0.187; 95% confidence intervals 0.255-0.977 and 0.039-0.895). Furthermore, there were no differences in toxicities between the two groups. CONCLUSIONS: Belotecan was not inferior to topotecan in terms of overall response for recurrent ovarian cancer. CLINICAL TRIAL REGISTRATION: NCT01630018.

Kim, J. H., et al. (2023). "Cost-effectiveness of hyperthermic intraperitoneal chemotherapy following interval cytoreductive surgery for stage III-IV ovarian cancer from a randomized controlled phase III trial in Korea (KOV-HIPEC-01)." Gynecologic Oncology 170: 19-24.
	Background: To evaluate the cost-effectiveness of the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) following interval cytoreductive surgery (ICS) for stage III-IV ovarian cancer from a randomized controlled phase III trial. Method(s): A comparative cost-effective analysis was performed using a Markov health-state transition model derived from the current trial cohort (ClinicalTrials.gov Identifier: NCT01091636). The incremental cost-effectiveness ratio (ICER) was evaluated by dividing the incremental costs by incremental quality-adjusted life-years (QALYs) with a time horizon of 10 years. Costs were calculated from the perspective of Korean healthcare, and health utility values were extracted from published sources. Result(s): Based on data from the trial, the mean QALY in the ICS group was 7.16 compared to 10.8 in ICS followed by the HIPEC group. With an incremental QALY of 3.64, the ICS followed by HIPEC, was estimated to obtain an ICER of KRW 954,598 (USD 708.3) per QALY. Conclusion(s): The findings of the study suggest that ICS followed by HIPEC, is cost-effective with a significant gain in QALYs. These results may support the current reimbursement of HIPEC from Korean insurance services and the management of long-term conditions.Copyright © 2023

Kim, J. H. and H. J. Yu (2024). "The Effectiveness of Cognitive Behavioral Therapy on Depression and Sleep Problems for Climacteric Women: A Systematic Review and Meta-Analysis." Journal of Clinical Medicine 13(2): 412.
	(1) Background: Women in their middle years undergoing perimenopause encounter a range of physical and psychological alterations attributed to hormonal changes. The prominent symptoms among menopausal women are depressive symptoms and sleep-related problems. The aim of this study was to conduct a meta-analysis examining the effects of Cognitive Behavioral Therapy (CBT) on women going through menopause, specifically focusing on depressive symptoms and sleep problems. We analyzed studies conducted both within the country and across international settings over the last decade. (2) Methods: A search of the literature was conducted-a targeted search, exclusively considering randomized controlled trials (RCTs) that were published within the timeframe spanning from 15 June 2013 to 15 June 2023. (3) Findings: Upon reviewing nine studies that satisfied our inclusion criteria and involved a total of 923 participants, it was noted that four of these studies incorporated diverse cognitive-behavioral strategies. Among the nine studies, a total of four were included in the meta-analysis: two measured depressive symptoms, and two measured sleep quality. The combined effect size for depressive symptoms was found to be 3.55 (95% confidence interval: -5.48, -1.61; p < 0.05), and for sleep quality, it was 0.78 (95% confidence interval: -1.32, -0.25; p = 0.004). (4) Conclusion(s): Our review emphasizes the necessity for conducting larger-scale studies focused on the application of CBT for women experiencing menopausal symptoms. Additionally, it is recommended to approach the interpretation of these results with caution due to discrepancies in methodology and the overall quality of the studies. Further clinical trials are necessary to establish the ideal number of CBT sessions needed for the effective treatment of depression in menopausal women. Future studies should cover a wider range of geographical locations, including more countries, and focus on various outcomes such as depressive symptoms and sleep quality.Copyright © 2024 by the authors.

Kim, M.-D. (2023). "Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis." ClinicalTrials.gov.
	No Results Available Procedure: Intrauterine device|Procedure: Uterine artery embolization Hemoglobin level|Pictorial blood loss assessment chart (PBAC)|Visual analogue scale|Symptom and quality of life score questionnaire|Uterine volume Female Not Applicable 56 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 4-2023-0729 July 2025

Kim Se, I., et al. (2022). "Hyperthermic intraperitoneal chemotherapy for epithelial ovarian cancer: A meta-analysis." Gynecologic Oncology 167(3): 547-556.
	Background: The value of hyperthermic intraperitoneal chemotherapy (HIPEC) at the time of cytoreductive surgery (CRS) for epithelial ovarian cancer (EOC) is controversial and its use remains experimental in most national and international guidelines. We wished to systematically evaluate all available evidence.; Methods: A comprehensive review of data from MEDLINE, EMBASE, and Cochrane Library databases was conducted from the first report on HIPEC in EOC till April 3, 2022. Progression-free survival (PFS) and overall survival (OS) were compared between the HIPEC and control groups. This meta-analysis was registered with PROSPERO (CRD42021265810).; Results: Fifteen studies (10 case-control studies and 5 randomized controlled trials [RCTs]) were included in the present meta-analysis. Based on the time interval between the last systemic chemotherapy exposure and timing of CRS +/- HIPEC, all studies and patients' cohorts we classified into recent (<6 months; n = 9 studies/patients cohorts) and non-recent (≥6 months, n = 8 studies/patients cohorts) chemotherapy exposure groups. In the recent chemotherapy exposure group, HIPEC was associated with improvement of both PFS (HR, 0.585; 95% CI, 0.422-0.811) and OS (HR, 0.519; 95% CI, 0.346-0.777). On the contrary, in the non-recent chemotherapy exposure group, HIPEC failed to significantly affect PFS (HR, 1.037; 95% CI, 0.684-1.571) or OS (HR, 0.932; 95% CI, 0.607-1.430). Consistent results were observed in subsequent sensitivity analyses.; Conclusion: Our present meta-analysis demonstrates that the value of HIPEC at CRS for EOC appears to depend on the timing of the last systemic chemotherapy exposure. Future trials are awaited to define the role of HIPEC in EOC.; Competing Interests: Declaration of Competing Interest Dr. Lim reported having a consulting or advisory role for AstraZeneca, Boryung, CKD Pharm, Genexine, Hospicare, GI Innovation, and Takeda and receiving research funding from AbbVie, Amgen, Astellas, AstraZeneca, BeiGene, Cellid, CKD Pharm, Clovis, Eisai, Genexine, GSK, Incyte, Merck, MSD, OncoQuest, Pfizer, and Roche outside the submitted work. Dr. Park reported having a consulting or advisory role for Boryung and Takeda and receiving research funding from AbbVie, Amgen, Astellas, AstraZeneca, BeiGene, Cellid, CKD Pharm, Clovis, Eisai, Genexine, GSK, Incyte, Merck, MSD, OncoQuest, Pfizer, and Roche outside the submitted work. No other disclosures were reported. Dr. Fotopoulou reported a consulting or advisory role for GlaxoSmithKline, Roche/Genentech, Clovis Oncology, AstraZeneca, Global Oncology One, Aptitude Health, Eisai, and research funding from Myrovlytis Charity Trust. Other authors declare they have no conflicts of interest relevant to this article. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Kim Seo, Y., et al. (2020). "Effectiveness of Non-Pharmacological Interventions for Overweight or Obese Infertile Women: A Systematic Review and Meta-Analysis." International Journal of Environmental Research and Public Health 17(20).
	Obesity is a well-known risk factor for infertility, and nonpharmacological treatments are recommended as effective and safe, but evidence is still lacking on whether nonpharmacological interventions improve fertility in overweight or obese women. The aim of this study was to systematically assess the current evidence in the literature and to evaluate the impact of nonpharmacological interventions on improving pregnancy-related outcomes in overweight or obese infertile women. Seven databases were searched for randomized controlled trials (RCTs) of nonpharmacological interventions for infertile women with overweight or obesity through August 16, 2019 with no language restriction. A meta-analysis was conducted of the primary outcomes. A total of 21 RCTs were selected and systematically reviewed. Compared to the control group, nonpharmacological interventions significantly increased the pregnancy rate (relative risk (RR), 1.37; 95% CI, 1.04-1.81; p = 0.03; I² = 58%; nine RCTs) and the natural conception rate (RR, 2.17, 95% CI, 1.41-3.34; p = 0.0004; I² = 19%, five RCTs). However, they had no significant effect on the live birth rate (RR, 1.36, 95% CI, 0.94-1.95; p =0.10, I² = 65%, eight RCTs) and increased the risk of miscarriage (RR: 1.57, 95% CI, 1.05-2.36; p = 0.03; I² = 0%). Therefore, nonpharmacological interventions could have a positive effect on the pregnancy and natural conception rates, whereas it is unclear whether they improve the live birth rate. Further research is needed to demonstrate the integrated effects of nonpharmacological interventions involving psychological outcomes, as well as pregnancy-related outcomes.; Competing Interests: The authors declare no conflicts of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Kim, S. I., et al. (2024). "Durvalumab with or without tremelimumab plus chemotherapy in HRR non-mutated, platinum-resistant ovarian cancer (KGOG 3045): A phase II umbrella trial." Gynecologic Oncology 182: 7-14.
	Aim: We investigated the efficacy and safety of durvalumab (D) with or without tremelimumab (T) in addition to single-agent chemotherapy (CT) in patients with platinum-resistant recurrent ovarian cancer (PROC) lacking homologous recombination repair (HRR) gene mutations. Patients and Methods: KGOG 3045 was an open-label, investigator-initiated phase II umbrella trial. Patients with PROC without HRR gene mutations who had received >=2 prior lines of therapy were enrolled. Patients with high PD-L1 expression (TPS >=25%) were assigned to arm A (D + CT), whereas those with low PD-L1 expression were assigned to arm B (D + T75 + CT). After completing arm B recruitment, patients were sequentially assigned to arms C (D + T300 + CT) and D (D + CT). Result(s): Overall, 58 patients were enrolled (5, 18, 17, and 18 patients in arms A, B, C, and D, respectively). The objective response rates were 20.0, 33.3, 29.4, and 22.2%, respectively. Grade 3-4 treatment-related adverse events were observed in 20.0, 66.7, 47.1, and 66.7 of patients, respectively, but were effectively managed. Multivariable analysis demonstrated that adding T to D + CT improved progression-free survival (adjusted HR, 0.435; 95% CI, 0.229-0.824; P = 0.011). Favorable response to chemoimmunotherapy was associated with MUC16 mutation (P = 0.0214), high EPCAM expression (P = 0.020), high matrix remodeling gene signature score (P = 0.017), and low FOXP3 expression (P = 0.047). Patients showing favorable responses to D + T + CT exhibited significantly higher EPCAM expression levels (P = 0.008) and matrix remodeling gene signature scores (P = 0.031) than those receiving D + CT. Conclusion(s): Dual immunotherapy with chemotherapy showed acceptable response rates and tolerable safety in HRR non-mutated PROC, warranting continued clinical investigation.Copyright © 2024 Elsevier Inc.

Kim Sun, M. (2022). "Development of Cognitive Behavior Therapy for Improving Mood and Psychosomatic Symptoms in Menopausal Women." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Others(cognitive behavioral therapy program ) : The intervention group participates in a cognitive behavioral therapy program for 60 minutes once a week for 8 weeks. The control group waits for 8 weeks without any intervention. CONDITION: Diseases of the genitourinary system PRIMARY OUTCOME: World health organization quality of life assessment instrument (WHOQOL‐BREF) SECONDARY OUTCOME: Generalized Anxiety Disorder‐7 Kupperman Index Menopause Emotional Symptoms Scale Menopause Rating Scale Patient Health Questionnaire‐15 Patient Health Questionnaire‐9 Subjective Memory Complaints Questionnaire INCLUSION CRITERIA: 1. menopause (the period from the onset of irregular menstrual cycles to one year after the last menstruation) women 2. 40 to 60 years old 3. Kupperman inde Xto assess the severity of menopause symptoms = 10

Kim, T. (2023). "A 12 week, Multi-Center, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of LG-CWHL on Menopausal Symptom." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Dietary Supplement : Take a total of 3 capsules once or twice a day of test food (300 mg/day as a comple Xsuch as Baeksuo extract) or placebo CONDITION: Diseases of the genitourinary system PRIMARY OUTCOME: Total score of KI SECONDARY OUTCOME: Blood ALP, OC, CT X blood lipid(Total Cholesterol, Triglyceride, HDL‐Cholesterol, LDLCholesterol) Individual item scores (11 items of KI, dry items) of Modified KI MENQOL‐K Upper body sweating (heat) score (number of symptoms, degree) Urine NTx INCLUSION CRITERIA: 1) a woman over forty and under sixty 2) A person who falls under one or more of the following criteria: ? Menopause (more than a year after the last period) ? Peripheral menopause (no menstruation for more than 3 months or FSH 30 mIU/mL) ? FSH not less than 30 mIU/mL (without uterus) 3) A person who has an MRS score of 9 points or more in visit 1 and has an average number of upper body fever (heat) symptoms per day in the period between visit 1 and visit 2 or more 4) A person who agrees to participate in the human body application test and signs a written consent form prior to the commencement of the human body application test

Kim, T.-H., et al. (2020). "Acupuncture in sham device controlled trials may not be as effective as acupuncture in the real world: a preliminary network meta-analysis of studies of acupuncture for hot flashes in menopausal women." Acupuncture in Medicine 38(1): 37-44.
	Background: Randomised controlled trials of acupuncture performed using sham interventions to control for the placebo effect have mostly used two types of sham techniques: techniques with minimal insertion of acupuncture needles with no additional stimulation (shallow needling control) and techniques with sham acupuncture devices that do not penetrate the skin (sham device control). To achieve successful blinding, sham device controlled acupuncture trials also use the acupuncture base unit in the verum acupuncture group, but in the shallow needling control trials this is not necessary for the verum acupuncture treatment.; Objective: In this study, we analysed the estimated comparative effectiveness of these two verum acupuncture modalities in studies of acupuncture for menopausal hot flashes that used two types of sham control treatments.; Methods: We conducted a network meta-analysis that included randomised controlled trials of acupuncture for hot flashes. Electronic databases, including Medline, Embase, Cochrane Library and AMED, were searched through March 2017. Data were extracted using a predefined data extraction tool by two independent reviewers. The risk of bias was assessed using the Cochrane risk of bias tool for randomised controlled trials. A five-node network meta-analysis was conducted based on the frequentist framework.; Results: Eight studies were included in this review. From the network meta-analysis, we found that verum acupuncture in the shallow needling controlled trials was more effective than verum acupuncture in the sham device controlled trials (SMD -7.27, 95% CI-9.11 to -5.43). Significant heterogeneity and inconsistency were not observed among the included studies or the comparisons.; Conclusions: From this preliminary analysis, we found that different types of verum acupuncture may have different effect sizes with respect to the severity of menopausal hot flashes.

Kim Yong, B., et al. (2023). "Study protocol for prospective multi-institutional phase III trial of standard of care therapy with or without stereotactic ablative radiation therapy for recurrent ovarian cancer (SABR-ROC)." BMC Cancer 23(1): 1014.
	Background: Efforts have been made to investigate the role of salvage radiotherapy (RT) in treating recurrent ovarian cancer (ROC). Stereotactic ablative radiation therapy (SABR) is a state-of-the-art therapy that uses intensity modulation to increase the fractional dose, decrease the number of fractions, and target tumors with high precision.; Methods: The SABR-ROC trial is a phase 3, multicenter, randomized, prospective study to evaluate whether the addition of SABR to the standard of care significantly improves the 3-year overall survival (OS) of patients with ROC. Patients who have completed the standard treatment for primary epithelial ovarian cancer are eligible. In addition, patients with number of metastases ≤ 10 and maximum diameter of each metastatic site of gross tumor ≤ 5 cm are allowed. Randomization will be stratified by (1) No. of the following clinical factors met, platinum sensitivity, absence of ascites, normal level of CA125, and ECOG performance status of 0-1; 0-3 vs. 4; (2) site of recurrence; with vs. without lymph nodes; and (3) PARP inhibitor; use vs. non-use. The target number of patients to be enrolled in this study is 270. Participants will be randomized in a 1:2 ratio. Participants in Arm 2 will receive SABR for recurrent lesions clearly identified in imaging tests as well as the standard of care (Arm 1) based on treatment guidelines and decisions made in multidisciplinary discussions. The RT fraction number can range from 1 to 10, and the accepted dose range is 16-45 Gy. The RT Quality Assurance (QA) program consists of a three-tiered system: general credentialing, trial-specific credentialing, and individual case reviews.; Discussion: SABR appears to be preferable as it does not interfere with the schedule of systemic treatment by minimizing the elapsed days of RT. The synergistic effect between systemic treatment and SABR is expected to reduce the tumor burden by eradicating gross tumors identified through imaging with SABR and controlling microscopic cancer with systemic treatment. It might also be beneficial for quality-of-life preservation in older adults or heavily treated patients.; Trial Registration: This trial was registered at ClinicalTrials.gov (NCT05444270) on June 29th, 2022. (© 2023. BioMed Central Ltd., part of Springer Nature.)

Kinjo, M., et al. (2023). "Comparison of mirabegron and vibegron in women with treatment-naive overactive bladder: a randomized controlled study." Urology 175: 67‐73.
	OBJECTIVE: To compare the efficacy and safety of mirabegron versus vibegron in postmenopausal women with treatment‐naïve overactive bladder (OAB). METHODS: We conducted a prospective randomized controlled study of women with treatment‐naïve OAB. The patients received mirabegron or vibegron at 50 mg daily for 12 weeks by a stratified randomized method. The OAB symptom score (OABSS) and quality of life (QOL) index were evaluated before and 4 and 12 weeks after the treatment. The patients' 3‐day voiding diary and postvoided residual urine volumes were evaluated before and 12 weeks after the treatment. RESULTS: Of 213 patients initially enrolled in this study, 199 patients were randomized to the mirabegron group (n = 97) or vibegron group (n = 102). Twelve weeks after the treatment, OABSS, QOL index, the numbers of micturition, urgency episodes, incontinence episodes, and voided volume per 24 hours were significantly improved compared with the baseline in both groups, and there was no significant difference in the rate of change in both groups. The postvoid residual urine volume was not significantly different in the 2 groups at 12 weeks. Discontinuation because of adverse effects was observed in 6.2% of patients in the mirabegron group and 6.8% in the vibegron group, with no significant difference between 2 groups. CONCLUSION: Both mirabegron at 50 mg and vibegron at 50 mg improved OAB symptoms and the parameters of voiding diary equally in postmenopausal women with treatment naïve OAB.

Kirca, N. and S. Celik Aslı (2023). "The effect of yoga on pain level in primary dysmenorrhea." Health Care for Women International 44(5): 601-620.
	This study was conducted to evaluate the effect of yoga on pain levels in female students with primary dysmenorrhea. This study is a randomized experimental study with control group and pretest post-test practice. This study included 60 volunteer female students (30 experimental and 30 control groups). The patients in the experimental group took part in the yoga program a total of 12 sessions, once per week for 12 weeks. "Personal Information Form", "Visual Analog Skala (VAS)" and "Dysmenorrhea Monitoring Form (DMF)" were used in data collection process. To measure dysmenorrhea pain, the students were requested to mark a number between 1 and 10 on the VAS scale according to the severity of their pain on the menstruation starting date. The yoga applications were used for three menstrual cycles. The mean age of the students in the experimental group was 20.30 ± 0.46, while the mean age of the students in the control group was 20.46 ± 0.50. The difference between the pain levels of the students in the experimental group in the first, second, third and fourth measurements was found to be statistically significant ( p < 0.001). It was determined that the difference between the pain levels of the students in the control group in the first, second, third and fourth measurements was not statistically significant ( p > 0.05). Yoga can be used as an effective intervention in reducing menstrual pain in women with primary dysmenorrhea.

Kirkman-Brown, J. (2024). "Comparing intrauterine insemination and in vitro fertilisation for unexplained infertility: a study on effectiveness and costs." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Couples who enter the trial will be randomised to receive either three cycles of letrozole stimulated Intra Uterine Insemination (IUI) or one cycle of In‐Vitro Fertilisation (IVF) with standard ovarian stimulation and first fresh or frozen embryo transfer. Couples will be randomised in a 1:1 ratio. A minimisation algorithm will ensure balance for the following variables: 1. Woman’s ethnicity (Asian, Black, Mixed, Other and White) 2. Woman’s Body Mass Inde X(BMI) (19.0 ‐ <24.90, 25.0 ‐ 29.9, 30.0 ‐ 34.9 kg/m²) 3. Woman’s age (18.0 ‐ <34.95, 35.0 ‐ 37.9, >38.0 ‐ 38.9 years) 4. Randomising centre Both interventions will be delivered in the fertility clinic the couples are attending. Data will be collected on adverse events and pregnancy rates throughout the study. Both partners will complete questionnaires to evaluate satisfaction with treatment, quality of life and resource use at 8, 18 and 24 months post‐trial entry. Sperm samples given by study participants will be included in the healthcare science sub‐study; which aims to assess the standardisation of semen quality assessment at different sites (NB participation in this sub‐study is not optional). Additionally, both partners and healthcare providers will be given the opportunity to discuss their experiences of study participation in the qualitative patient evaluation. The pilot study will run for the first 9 months of the trial; patients taking part in the pilot will follow the pathway described above. CONDITION: Unexplained infertility ; Pregnancy and Childbirth PRIMARY OUTCOME: The live birth of a baby at =34 weeks gestation, conceived within 240 days of randomisation (approximately 8 months). In line with the evaluation of treatment policy, initial or subsequent pregnancies may be included within this timeframe. This outcome will be assessed at 18 months post‐randomisation. INCLUSION CRITERIA: Couples with a diagnosis of unexplained infertility, referred to fertility centres for assisted conception, will be considered for the UNiTY trial. Unexplained fertility for the purpose of this trial is defined as the absence of the following fertility explanations after complete investigations: 1. Female infertility 1.1. Tubal disease 1.2. Deep endometriosis +/‐ ovarian endometriosis 1.3. Significant uterine abnormality requiring surgery (including cavity distorting fibroids, fibroids >5 cm or multiple fibroids) 1.4. Uterine septum with history of previous pregnancy loss 2. Male infertility 2.1. Total progressively motile sperm count less than 10M 2.2. Normal sperm morphology of 2% or less SECONDARY OUTCOME: ; Measured using patient records unless otherwise noted:; ; The following outcomes will be assessed at two timepoints: 18 months post‐randomisation to allow for pregnancy outcomes to be obtained and concern pregnancies conceived within 240 days (approximately 8 months) of randomisation; and 24 months post‐randomisation to allow for pregnancy outcomes to be obtained and concern pregnancies conceived within 420 days (approximately 14 months) of randomisation.; ; Pregnancy outcomes:; 1. Singleton live birth =37 weeks; 2. TTP leading to a live birth defined as time from randomisation to pregnancy in days (censored at 240 days); 3. Cycle cancellation and reason (failure to respond/over‐response); 4. Biochemical pregnancy; 5. Clinical pregnancy; 6. Ongoing pregnancy at 12 weeks (range 11 to 14 weeks); 7. Multiple pregnancy; 8. Ectopic pregnancy; 9. Miscarriage (defined as delivery before 24 weeks of gestation); 10. Stillbirth (defined as intrauterine death =24 weeks); 11. Termination; 12. Number of embryos remaining (IVF group); ; Outcomes in live births =24 weeks:; 1. Gestational age at delivery; 2. Gestation<28 weeks; 3. Gestation<32 weeks; 4. Gestation<37 weeks; 5. Birthweight, grams; 6. Small for gestational age (<10th centile); 7. Mode of birth (unassisted vaginal, instrumental vaginal, elective caesarean section, emergency caesarean section); 8. APGAR<7 out of 10 at 1 minute; 9. APGAR<7 out of 10 at 5 minutes; 10. P AR<7 out of 10 at 10 minutes; 11. Survival at 28 days (or discharge from hospital whichever is sooner); ; Complications:; The following outcomes will be assessed for the first IVF treatment within 420 days post‐randomisation.; 1. Maternal in IVF only; 1.1. Ovarian hyperstimulation syndrome – severe/critical OHSS; 1.2. Pelvic infection; 1.3. Bleeding post oocyte retrieval; 2. Admission to High Dependency Unit (HDU)/ Intensive Therapy Unit (ITU); ; The following outcomes will be assessed at 28 days post birth (or woman’s discharge date from hospital whichever is sooner).; 3. Antenatal; 3.1. Antepartum haemorrhage; 3.2. Pregnancy‐induced hypertension; 3.3. Pre‐eclampsia; 3.4. Obstetric cholestasis; 3.5. Preterm pre‐labour rupture of membranes; 3.6. Gestational diabetes; 4. Intrapartum; 4.1. Chorioamnionitis; 4.2. Intrauterine growth restriction; 4.3. Macrosomia; 5. Post‐partum; 5.1. Haemorrhage; ; The following outcomes will be assessed at 28 days post birth (or baby’s discharge date from the hospital, whichever is sooner).; 6. Neonatal; 6.1. Congenital or chromosomal abnormalities; 6.2. Admission to hospital; 6.3. Early infection (as assessed by the treating clinician); 6.4. Retinopathy of prematurity; 6.5. Necrotising enterocolitis; 6.6. Intraventricular haemorrhage; 6.7. Respiratory distress syndrome; 6.8. Ventilation or oxygen support; ; Patient‐reported outcomes:; 1. Health‐related quality of life (using the EQ‐5D‐5L questionnaire overall score and thermometer scale) measured at 8 and 18 months post‐randomisation; 2. Satisfaction with treatment and care provision (using the CSQ‐8) post‐treatment;

Kissinger, P. (2024). "Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole." ClinicalTrials.gov.
	No Results Available Drug: Metronidazole 500 mg|Drug: Secnidazole 2000 MG Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis All Phase 4 1200 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2024-101 July 31, 2029

Kiyak, S. and D. Kocoglu-Tanyer (2021). "Effectiveness of progressive muscle relaxation and laughter therapy on mental health and treatment outcomes in women undergoing in vitro fertilization: A randomized controlled trial." Research in Nursing & Health 44(6): 945-956.
	A majority of infertile women experience emotional problems, such as anxiety and depression. Nurses need nonpharmacological methods rather than drugs to address women's emotional distress during the in vitro fertilization (IVF) process. The purpose of this study was to examine the effect of progressive muscle relaxation exercises and laughter therapy on the mental health and treatment outcomes of women receiving IVF treatment. This parallel-group, randomized controlled trial was conducted in a private IVF center. Participants were randomly assigned to the intervention group (IG; n = 71) and control group (CG; n = 70). The IG received progressive muscle relaxation and laughter therapy for 40 min in each session for 3-4 sessions, whereas the CG received routine care. Data were obtained from the patient information form, State-Trait Anxiety Inventory, Beck Depression Inventory, and medical records. The questionnaire was completed at recruitment (T1) and oocyte pick-up day (T2). In the evaluation performed on the day of the oocyte pick-up, depression and trait anxiety scores of the IG were found to be lower than those in the CG, and the effect size was small. Group × time interaction was significant for depression (large effect size) and trait anxiety (small effect size). The estradiol levels, the number of oocytes, transfer status, and pregnancy rates (according to a blood test) were similar between groups. Women receiving IVF treatment who received progressive muscle relaxation and laughter therapy demonstrated psychological changes; however, the treatment did not affect medical outcomes.

Kızkın Zeynep, Y. (2023). "Effects of Transcutaneous Vagus Nerve Stimulation (taVNS) in Individuals With Primary Dysmenorrhea." ClinicalTrials.gov.
	In this study, which will be conducted over two menstrual cycles, 34 patients with PD will be randomised into two groups: taVNS and sham treatment. From the onset of pain during the menstrual cycle, taVNS or sham treatment will be applied for five days. Pain assessment will be conducted using the Numerical Rating Scale (NRS), pressure pain threshold with an algometer, menstrual symptoms using the Menstrual Symptom Scale (MSS) and the Functional and Emotional Measure of Dysmenorrhea (FEMD), anxiety using the Hamilton Anxiety Scale (HAM‐A), and physical performance using the 6‐Minute Walk Test (6MWT) during the first and second menstruation.

Klotz, S. G. R., et al. (2024). "The role of psychosocial factors in the interprofessional management of women with chronic pelvic pain: A systematic review." Acta Obstetricia et Gynecologica Scandinavica 103(2): 199-209.
	Introduction: Chronic pelvic pain (CPP) is a common pain disorder in women associated with negative biopsychosocial consequences. The multifactorial etiology and maintaining aspects of CPP logically require an interprofessional treatment approach. However, the effects of interprofessional treatment strategies on psychosocial factors remain unclear. The study aims to investigate how interprofessional therapy helps to treat psychosocial factors in women with CPP. The systematic review summarizes the current evidence of interprofessional treatment in women with CPP. Material(s) and Method(s): A systematic literature review was performed in six databases (Medline, Web of Science, Cochrane Library, PEDro, CINAHL, and PsycINFO) until February 2023. Studies were selected in a two-step approach applying as inclusion criteria the search combinations of Chronic Pelvic Pain and CPP, synonyms for interprofessional therapies, and for female patients. Studies were excluded if they were not quantitative primary research published in English, if CPP was not defined appropriately, if the study population was not female adult patients, if the interprofessional intervention was not operationalized appropriately, if they were single case studies, and if outcomes did not include at least one of the psychosocial factors pain, depressive symptoms, pain catastrophizing, fear, or anxiety. Risk of bias of the included studies was rated with the McMaster Critical Review Form. Studies were summarized narratively. The review is registered in PROSPERO (CRD42023391008). Result(s): Five studies with a total sample size of n = 186 women were included, three of them were uncontrolled retrospective before-after chart review. Only one study used a randomized controlled design, the other study used a non-randomized controlled group. The studies' methodological quality is adequate with perspective of study design. The multiprofessional treatment approaches used in the studies differed with regard to professions involved, therapy methods, and modalities. Psychosocial outcome measures were pain (five studies), depressive symptoms (three studies), and anxiety symptoms (four studies). Conclusion(s): Although interprofessional treatment strategies for women with CPP are recommended in existing guidelines, available evidence is scarce and does not allow for identification of the best interprofessional treatment approach. The effect on psychosocial factors remains unclear. More research is needed determining the best practice interprofessional treatment option for women with CPP.Copyright © 2023 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).

Klotz Susanne, G. R. M. P. T. H. S., et al. (2019). "Physiotherapy management of patients with chronic pelvic pain (CPP): A systematic review." Physiotherapy Theory and Practice 35(6): 516-532.
	Introduction: Chronic pelvic pain (CPP) is a common pain condition. However, treatment remains challenging. Musculoskeletal findings are frequent; therefore physiotherapy might be helpful. The purpose of this review was to evaluate the current evidence on physiotherapy in patients with CPP (PROSPERO registration number CRD42016037516).; Methods: Six databases were searched and additional hand searches were performed. Two reviewers independently conducted the database search and selected studies using a two-step approach. The methodological quality was assessed applying the Critical Review Form - Quantitative Studies.; Results: A total of eight studies were included. Trigger point therapy was examined in four studies; two of which were randomized controlled trials. All studies indicate a significant change in pain measurement. The other four studies evaluated the effect of biofeedback, Thiele massage, Mensendieck somatocognitive therapy and aerobic exercises, whereas the last two were tested in controlled trials. All studies showed significant improvements in pain assessment.; Conclusions: The evidence currently available is sparse with methodological flaws, making it difficult to recommend a specific physiotherapy option. There is an urgent need for high-quality randomized controlled trials to identify the most effective physiotherapy management strategy for patients with CPP.

Knapman, B. L., et al. (2024). "Botulinum Toxin for the Management of Pelvic Floor Tension Myalgia and Persistent Pelvic Pain: A Systematic Review and Meta-analysis." Obstetrics and Gynecology 143(1): E7-E17.
	OBJECTIVE:To systematically review the literature on use of botulinum toxin to treat pelvic floor tension myalgia and persistent pelvic pain.DATA SOURCES:The ClinicalTrials.gov, PubMed, EMBASE, and Scopus databases were searched from inception to November 2022 by two independent assessors (B.L.K. and F.G.L.). Identified studies were screened by title and abstract and included after full-text review. Data extraction was subsequently performed and recorded in Microsoft Excel. METHOD(S):This study was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines after registration in PROSPERO (CRD42022289132). All randomized studies, prospective studies with more than five participants, and retrospective studies with more than 10 participants published in English or French and assessing the use of botulinum toxin for the treatment of pelvic floor tension myalgia and persistent pelvic pain in women were included. Meta-analyses were performed on randomized data.TABULATION, INTEGRATION, AND RESULTS:Of 4,722 articles identified, 24 satisfied inclusion criteria. A meta-analysis of five randomized controlled trials totaling 329 participants demonstrated no differences in patient- and clinician-reported outcome measures, including pain, dyspareunia, sexual function, and vaginal manometry. Mean duration of follow-up was 6 months. A qualitative analysis of 14 prospective and four retrospective studies including 804 participants is supportive of botulinum toxin; however, the quality of data is low, and there is marked heterogeneity between studies. CONCLUSION(S):Meta-analyses of randomized data do not support the use of botulinum toxin to treat pelvic floor tension myalgia and persistent pelvic pain. Failure of these data to confirm the findings of nonrandomized prospective studies that suggest a treatment benefit may be attributable to the absence of placebo control and confounding outcomes obtained from an active comparator group. Further randomized controlled trials with true placebo are strongly recommended.SYSTEMATIC REVIEW REGISTRATION:PROSPERO, CRD42022289132.Copyright © 2024 Lippincott Williams and Wilkins. All rights reserved.

Ko, J. (2021). "A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer." ClinicalTrials.gov.
	Study team proposes to compare 2 standard doses of an anti‐cancer drug called bevacizumab, 7.5mg/kg per dose vs. 15mg/kg per dose, given in combination with chemotherapy in patients with ovarian cancer that progressed on platinum chemotherapy. Higher doses in cases of antibody‐based drugs like bevacizumab are not always better than lower doses, and in fact can cause more side effects without improving survival or shrinkage of cancer. Both 7.5 and 15mg/kg doses of bevacizumab every 3 weeks are used as standard protocol in BC Cancer for ovarian cancer patients, but only 15mg/kg doses are allowed for patients with ovarian cancer that progressed on platinum chemotherapy. This study is a pragmatic two‐arm blinded study in which 70 patients with platinum‐resistant ovarian cancer and eligible for bevacizumab + chemotherapy will be randomly assigned either to lower or higher standard dose of bevacizumab , combined with chemotherapy. Treating clinicians will decide how long the treatment will continue per standard of care. Duration of cancer control on CT scans, side effect profiles, and quality of life related to the two arms will be compared. If demonstrated, this finding will be practice‐changing, with comparable efficacy and quality of life, potentially improved safety profile, as well as reduced provincial drug costs.

Koçoğlu, F. and H. Zincir (2021). "The Effect of Reiki on Pain, Fatigue, and Quality of Life in Adolescents With Dysmenorrhea." Holistic Nursing Practice 35(6): 306-314.
	This randomized, single-blind, placebo-controlled study was conducted to evaluate the effect of Reiki applications on pain, fatigue, and quality of life in adolescents with dysmenorrhea. There were 38 patients in the Reiki group and 37 in the placebo-controlled group. Reiki was found to be effective on pain and fatigue in adolescents with dysmenorrhea but with no effect on the quality of life.

Kokka, F., et al. (2022). "Hysterectomy with radiotherapy or chemotherapy or both for women with locally advanced cervical cancer." The Cochrane Database of Systematic Reviews 8: CD010260.
	Background: This is an update of the Cochrane Review published in Issue 4, 2015. Cervical cancer is one of the most frequent cause of death from gynaecological cancers worldwide. Many new cervical cancer cases in low-income countries present at an advanced stage. Standard care in Europe and the US for locally advanced cervical cancer (LACC) is chemoradiotherapy. In low-income countries, with limited access to radiotherapy, LACC may be treated with chemotherapy and hysterectomy. It is not certain if this improves survival. It is important to assess the value of hysterectomy with radiotherapy or chemotherapy, or both, as an alternative.; Objectives: To determine whether hysterectomy, in addition to standard treatment with radiotherapy or chemotherapy, or both, in women with LACC (Stage IB 2 to III) is safe and effective compared with standard treatment alone.; Search Methods: We searched CENTRAL, MEDLINE via Ovid, Embase via Ovid, LILACS, trial registries and the grey literature up to 3 February 2022.; Selection Criteria: We searched for randomised controlled trials (RCTs) that compared treatments involving hysterectomy versus radiotherapy or chemotherapy, or both, in women with LACC International Federation of Gynecology and Obstetrics (FIGO) Stages IB 2 to III.; Data Collection and Analysis: We used standard methodological procedures expected by Cochrane. We independently assessed study eligibility, extracted data and assessed the risk of bias. Where possible, we synthesised overall (OS) and progression-free (PFS) or disease-free (DFS) survival in a meta-analysis using a random-effects model. Adverse events (AEs) were incompletely reported and we described the results of single trials in narrative form. We used the GRADE approach to assess the certainty of the evidence.; Main Results: From the searches we identified 968 studies. After deduplication, title and abstract screening, and full-text assessment, we included 11 RCTs (2683 women) of varying methodological quality. This update identified four new RCTs and three ongoing RCTs. The included studies compared: hysterectomy (simple or radical) with radiotherapy or chemoradiotherapy or neoadjuvant chemotherapy (NACT) versus radiotherapy alone or chemoradiotherapy (CCRT) alone or CCRT and brachytherapy. There is also one ongoing study comparing three groups: hysterectomy with CCRT versus hysterectomy with NACT versus CCRT. There were two comparison groups for which we were able to do a meta-analysis. Hysterectomy (radical) with neoadjuvant chemotherapy versus chemoradiotherapy alone Two RCTs with similar design characteristics (620 and 633 participants) found no difference in five-year OS between NACT with hysterectomy versus CCRT. Meta-analysis assessing 1253 participants found no evidence of a difference in risk of death (OS) between women who received NACT plus hysterectomy and those who received CCRT alone (HR 0.94, 95% CI 0.76 to 1.16; moderate-certainty evidence). In both studies, the five-year DFS in the NACT plus surgery group was worse (57%) compared with the CCRT group (65.6%), mostly for Stage IIB. Results of single trials reported no apparent difference in long-term severe complications, grade 3 acute toxicity and severe late toxicity between groups (very low-quality evidence). Hysterectomy (simple or radical) with neoadjuvant chemotherapy versus radiotherapy alone Meta-analysis of three trials of NACT with hysterectomy versus radiotherapy alone, assessing 571 participants, found that women who received NACT plus hysterectomy had less risk of death (OS) than those who received radiotherapy alone (HR 0.71, 95% CI 0.55 to 0.93; I 2 = 0%; moderate-quality evidence). However, a significant number of participants who received NACT plus hysterectomy also had radiotherapy. There was no difference in the proportion of women with disease progression or recurrence (DFS and PFS) between NACT plus hysterectomy and radiotherapy groups (RR 0.75, 95% CI 0.53 to 1.05; I 2 = 20%; moderate-quality evidence). The certainty of the evidence was low or very-low for all other mparisons for all outcomes. None of the trials reported quality of life outcomes.; Authors' Conclusions: From the available RCTs, we found insufficient evidence that hysterectomy with radiotherapy, with or without chemotherapy, improves the survival of women with LACC who are treated with radiotherapy or CCRT alone. The overall certainty of the evidence was variable across the different outcomes and was universally downgraded due to concerns about risk of bias. The certainty of the evidence for NACT and radical hysterectomy versus radiotherapy alone for survival outcomes was moderate. The same occurred for the comparison involving NACT and hysterectomy compared with CCRT alone. Evidence from other comparisons was generally sparse and of low or very low-certainty. This was mainly based on poor reporting and sparseness of data where results were based on single trials. More trials assessing medical management with and without hysterectomy may test the robustness of the findings of this review as further research is likely to have an important impact on our confidence in the estimate of effect. (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Kokkoni, K., et al. (2024). "Biosimilars versus originator recombinant follitropin alfa for ovarian stimulation in IVF/ICSI - a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Kolibianakis Efstratios, M. (2021). "The Effect of Ovamax on Oocyte Quality." ClinicalTrials.gov.
	No Results Available Other: Ova-max|Other: placebo Mean oocyte score|Percentage of mature oocytes|Percentage of fertilised oocytes|Blastulation rate|Pregnancy rate|Total number of COCs collected Female Not Applicable 158 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment UHR-17 June 30, 2024

Komar, A., et al. (2021). "Concurrent Retropubic Midurethral Sling and OnabotulinumtoxinA for Mixed Urinary Incontinence: A Randomized Controlled Trial." Obstetrics and Gynecology 137(1): 12-20.
	OBJECTIVE: To evaluate whether retropubic midurethral sling combined with onabotulinumtoxinA is more effective than sling alone in improving mixed urinary incontinence symptoms. METHODS: We conducted a prospective, double-blind, randomized, controlled trial of women with mixed urinary incontinence, planning to undergo midurethral sling. Women were randomly assigned to receive 100 unites of intradetrusor onabotulinumtoxinA or placebo during surgery. Participants completed the PGI-S (Patient Global Impression of Severity), the UDI-6 (Urinary Distress Inventory, Short Form), and the PFIQ-7 (Pelvic Floor Impact Questionnaire-Short Form 7) before and 3 months after surgery, and the primary outcome, PGI-I (Patient Global Impression of Improvement), 3 months postoperatively. Primary outcome was PGI-I score at 3 months for overall incontinence. We considered women "improved" with answers of "very much better" or "much better" on the PGI-I. Assuming a PGI-I response of "improved" in 66% of placebo and 93% of onabotulinumtoxinA participants, 68 women were needed to show a significant difference with 80% power at 0.05 significance level. RESULTS: From March 2016 to November 2019, 78 women completed a 3-month follow-up (onabotulinumtoxinA: 41; placebo: 37). Mean age was 51 years (±10). On the PGI-I, the number who "improved" did not differ between groups at 3 months (83% vs 84%, P=1.0). The onabotulinumtoxinA group had less severe urgency symptoms as indicated by median urgency PGI-S scores (1 [interquartile range 1-2] vs 2 [interquartile range 1-3], P=.033) and greater improvement in urgency symptoms based on median urgency PGI-I score (1 [interquartile range 1-3] vs 2 [interquartile range 2-4], P=.028). At 3 months, median UDI-6, PFIQ-7, and PGI-S scores improved significantly from baseline in both groups. Similarly, UDI-6 and PFIQ-7 scores did not differ between groups. More women in the onabotulinumtoxinA arm initiated intermittent self-catheterization, (3% placebo; 12% onabotulinumtoxinA, P=.20) and experienced urinary tract infections (5% placebo; 22% onabotulinumtoxinA, P=.051), but these did not differ statistically. CONCLUSION: Concurrent intradetrusor onabotulinumtoxinA injection did not improve overall incontinence symptoms at 3 months compared with placebo among women with mixed urinary incontinence undergoing midurethral sling placement. Women with mixed urinary incontinence undergoing sling report significant improvement in overall incontinence symptoms, regardless of the addition of onabotulinumtoxinA injections, but those receiving concurrent onabotulinumtoxinA injections reported less urgency severity and greater improvement in urgency symptoms at 3 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02678377.

Konecny, G. E., et al. (2021). "Results of TRIO-14, a phase II, multicenter, randomized, placebo-controlled trial of carboplatin-paclitaxel versus carboplatin-paclitaxel-ganitumab in newly diagnosed epithelial ovarian cancer." Gynecologic Oncology 163(3): 465-472.
	PURPOSE: Insulin-like growth factor (IGF) signaling is implicated in pathogenesis and chemotherapy resistance of epithelial ovarian cancer (EOC). We explored efficacy and safety of adding ganitumab, a monoclonal antibody targeting IGF-1R, to carboplatin/paclitaxel (CP) chemotherapy in patients with primary EOC. DESIGN: Patients were randomly assigned to receive CP/ganitumab (18 mg/kg q3w) or CP/placebo for 6 cycles followed by 6 cycles of single agent ganitumab/placebo maintenance therapy as front-line therapy. Primary endpoint was progression free survival. Secondary endpoints were time to progression and overall survival. Pretreatment samples were prospectively collected for retrospective biomarker analyses. RESULTS: 170 patients enrolled. 165 patients assessable for toxicity. Median PFS was 15.7 months with CP/ganitumab and 16.7 months with CP/placebo (HR 1.23; 95% CI 0.82-1.83, P = 0.313). All grade neutropenia (84.1% vs 71.4%), thrombocytopenia (75.3% vs 57.1%) and hyperglycemia (15.9% vs 2.6%) were more common in the ganitumab group compared to the placebo group. Ganitumab/placebo related serious adverse events were reported in 26.1% of the patients with ganitumab and in 6.5% with placebo. Non-progression related fatal events were more common with ganitumab (5 versus 2 patients). The ganitumab group experienced more dose delays which resulted in lower relative dose intensity of chemotherapy in the experimental group. In an exploratory model IGFBP2 expression was predictive of ganitumab response (treatment interaction; PFS, P = 0.03; OS, P = 0.01). CONCLUSION: Addition of ganitumab to CP chemotherapy in primary EOC did not improve PFS. Our results do not support further study of ganitumab in unselected EOC patients.

Kong, X., et al. (2023). "Effects of auricular acupressure on dysmenorrhea: A systematic review and meta-analysis of randomized controlled trials." Frontiers in Endocrinology 13: 1016222.
	Background: Auricular acupressure (AA) is widely used in treatment of dysmenorrhea, but the safety and efficacy of auricular acupressure on dysmenorrhoea are still lack of evidence-based basis.; Objective: The purpose of meta-analysis was to evaluate the effects of auricular acupressure on dysmenorrhea.; Data Sources: A systematic search was conducted in six electronic databases, including PubMed, Embase, Cochrane Central Register of Controlled Trials (CINAHL), Weipu (CQVIP), China National Knowledge Infrastructure (CNKI), and Wanfang databases, to retrieve studies published from the inception dates to June 10, 2022.; Study Selection: Randomized controlled trials (RCTs) that investigated the effectiveness of AA on dysmenorrhea were identified.; Data Extraction and Synthesis: The data extraction and quality assessment of the included studies were performed by two reviewers independently. Outcomes were abstracted to determine the effect measure by using mean differences (MD), standardized mean differences (SMD), or odds ratio (OR) from a random effects model.; Main Outcomes and Measures: Cure rate, total effective rate, and visual analogue scale (VAS) were described as primary outcomes; Short-form Menstrual Distress Questionnaire (MDQs), symptom scores, serum nitric oxide (NO) level, and adverse events were recorded as secondary outcomes.; Results: Thirty-five RCTs involving 3960 participants were included in this study. Our findings indicated that, overall, AA was associated with a significant benefit in cured rate (OR = 1.95, 95%CI: [1.34, 2.83], P=0.0004, I 2 = 75%), total effective rate (OR = 3.58, 95%CI: [2.92, 4.39], P<0.00001, I 2 = 67%), VAS score (MD = -1.45, 95%CI: [-1.73, -1.17], P<0.00001, I 2 = 67%), and symptom scores compared to the control group (SMD = -0.85, 95%CI: [-1.28, -0.43], P<0.0001, I 2 = 91%). However, no difference in serum NO (SMD = 0.77, 95%CI: [-0.39, 1.92], P = 0.19, I 2 = 89%) and MDQs (SMD = -0.58, 95%CI: [-1.26, 0.10], P = 0.10, I 2 = 79%) was found between the two groups. Furthermore, subgroup analysis results indicated that AA showed significant superiorities in increasing cured rate and total effective rate, and reducing VAS score and symptom scores when compared to analgesics and non-intervention. Moreover, AA presented the same superiorities when used as an adjunctive strategy to other therapy. However, these benefits were not detected in AA used alone when compared to the therapies, including Chinese herbs, acupuncture, external application of Chineseherbal medicine, moxibustion, auricular needle, and health education.; Conclusions: Overall, AA, as a potential safety therapy, is effective for the management of dysmenorrhea, such as increasing cured rate, total effective rate, VAS, and symptom scores. Nevertheless, AA showed no significant improvement in serum NO and MDQs. It is furtherly found that AA used alone is superior to analgesics and non-intervention regarding cured rate, total effective rate, VAS, and symptom scores. Furthermore, the same superiorities are observed when AA serves as an adjunctive strategy to other therapy. However, AA alone has little effect on them compared to other therapies, and there is no definite conclusion on the benefits of AA compared to placebo for patients with dysmenorrhea. Rigorous RCTs with blind method and placebo control are warranted to confirm these findings.; Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42022338524.; 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 Kong, Fang, Li, Zhang and Guo.)

Kong, X., et al. (2023). "Efficacy of intrauterine infusion therapy before embryo transfer in recurrent implantation failure: A systematic review and network meta-analysis." Journal of Reproductive Immunology 156: 103819.
	Previous studies of intrauterine infusion therapy in recurrent implantation failure (RIF) patients have shown conflicting results, and there is a lack of head-to-head horizontal comparisons between different drugs. This study aimed to assess the effectiveness of four intrauterine infusion drugs, including human chorionic gonadotropin (HCG), granulocyte colony-stimulating factor (G-CSF), peripheral blood mononuclear cells (PBMCs) and autologous platelet-rich plasma (PRP), in improving pregnancy outcomes in RIF patients through the network meta-analysis. Randomized controlled trials (RCTs) of preimplantation intrauterine infusion for RIF were searched in the Cochrane Library, Embase, Medline and CINAHL. Meanwhile, relevant data were extracted and Stata 15.0 software was applied to statistical analysis. A total of 21 studies with a sample size of 2917 cases were included in this study. Clinical pregnancy rate network meta-analysis showed that, intrauterine infusion of all four drugs is significantly better than the blank and placebo groups, while only PRP could significantly increase live birth rate compared with the blank and placebo groups. The SUCRA plots of clinical pregnancy and live birth rates showed a higher ranking of PRP and PBMCs. Early abortion intervention analysis found that only G-CSF is significantly better than the blank and placebo groups, and the SUCRA plot of G-CSF showed the highest ranking. All these findings confirmed that all four intrauterine infusion drugs can improve pregnancy outcomes in RIF patients to varying degrees, with PRP being the most effective. Further prospective, large-scale and high-quality RCTs are still necessary to determine the exact subgroups of benefit for the different drugs.Copyright © 2023 The Authors

Konstantinopoulos Panagiotis, A. (2022). "Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy." ClinicalTrials.gov.
	PRIMARY OBJECTIVE: I. To assess the clinical efficacy of the combination of copanlisib/olaparib, as measured by investigator‐assessed progression free survival (PFS), compared to standard chemotherapy in the setting of recurrent platinum resistant ovarian cancer that has progressed through prior PARP inhibitor therapy. SECONDARY OBJECTIVES: I. To assess the clinical efficacy of the combination of copanlisib/olaparib, as measured by objective response rate (ORR), per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. II. To assess the clinical efficacy of the combination of copanlisib/olaparib, as measured by overall survival (OS), compared to standard chemotherapy in the setting of recurrent platinum resistant ovarian cancer that has progressed through prior PARP inhibitor therapy. III. To determine the nature, frequency and degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5.0 for each treatment arm. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive either paclitaxel intravenously (IV) OR pegylated liposomal doxorubicin hydrochloride IV, OR topotecan hydrochloride IV while on study. ARM II: Patients receive copanlisib hydrochloride IV and olaparib orally (PO) while on study. Patients undergo computed tomography (CT) scan while on study and may undergo magnetic resonance imaging (MRI) throughout the study.

Konstantinopoulos Panagiotis, A., et al. (2022). "EPIK-O/ENGOT-OV61: alpelisib plus olaparib vs cytotoxic chemotherapy in high-grade serous ovarian cancer (phase III study)." Future Oncology 18(31): 3481-3492.
	Patients with platinum-resistant or -refractory high-grade serous ovarian cancer (HGSOC) have a poor prognosis, and their management represents a substantial unmet medical need. Preclinical data and results from a phase Ib trial demonstrated the efficacy and tolerability of the combination of the α-specific phosphatidylinositol-3-kinase (PI3K) inhibitor alpelisib plus the poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor olaparib in platinum-resistant, non- BRCA -mutated ovarian cancer. Here, we describe the study design and rationale for the phase III, multicenter, open-label, randomized, active-controlled EPIK-O/ENGOT-OV61 trial investigating alpelisib in combination with olaparib compared with standard-of-care chemotherapy in patients with platinum-resistant or -refractory HGSOC with no germline BRCA mutation. Progression-free survival (blinded independent review committee) is the primary end point. Overall survival is a key secondary end point. Clinical Trial Registration: : NCT04729387 (ClinicalTrials.gov).

Konya Meram State, H. (2022). "Comparison of Dydrogesterone and Micronized Progesterone Treatments in the Treatment of Threatened Miscarriage." ClinicalTrials.gov.
	About 140 pregnant women who applied to our clinic due to the threated miscarriage in the first trimester will be randomly given micronized progesterone to half and dydrogesterone to the other half. After the treatment, the miscarriage rates in the groups will be compared.

Korkut, Z., et al. (2023). "Effects of interferential current stimulation in women with pelvic organ prolapse: a prospective randomized sham-controlled study." International Urogynecology Journal 34(1): 279-289.
	Introduction and Hypothesis: The objective was to investigate the effects of interferential (IF) current stimulation on pelvic floor symptoms, prolapse stages, pelvic floor muscle (PFM) strength/endurance, quality of life (QoL), sexual function, perception of subjective improvement (PSI), and satisfaction in women with pelvic organ prolapse (POP).; Methods: The patients were randomly divided into the IF (n=13) and sham groups (n=12). Lifestyle advice was given in both groups. Active IF current was applied in the IF group and sham IF was applied in the sham group 3 days a week for 8 weeks. The following tools were used for data evaluation: pelvic floor symptom severity with the Pelvic Floor Distress Inventory-20 (PFDI-20), POP with the simplified POP-quantification system, PFM strength/endurance with a perineometer, QoL with the Prolapse Quality of Life Scale (P-QoL), and sexual function with the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Scale (PISQ-12). Evaluations were made before treatment (BT), mid-term (MT, 4th week), and after treatment (AT). PSI and satisfaction were evaluated AT with Likert-type scales.; Results: In the intergroup comparison AT, a greater increase in PFM strength/endurance, P-QoL-role limitations, P-QoL-sleep/energy scores, PSI, and satisfaction level, and a decrease in cystocele stages were observed in the IF group than in the sham group (p<0.05). Further, there was a greater increase in PFM endurance in the IF group in MT (p<0.05).; Conclusions: Interferential current stimulation was effective in improving POP stage, PFM strength/endurance, and QoL in women with POP. IF current stimulation can be used as a complementary treatment method in women with POP. (© 2022. The International Urogynecological Association.)

Kounidas, G., et al. (2021). "Efficacy of ulipristal acetate in women with fibroid induced menorrhagia: A systematic review and meta-analysis." Journal of Gynecology Obstetrics and Human Reproduction 50(9): 102173.
	Aim: To evaluate the efficacy of UPA in women with fibroid induced menorrhagia.; Methods: Embase, MEDLINE, CAB Abstracts, Cochrane Central Register of Controlled Trials, PsychInfo were searched up to 18th May 2020 and updated on 7th February 2021. Randomised controlled trials evaluating the efficacy of UPA in women with fibroid induced menorrhagia were included in the study.; Results: Two authors independently reviewed and extracted the study data. Statistical heterogeneity was quantified using I 2 statistics. Publication bias and data asymmetry was assessed by funnel plots. A meta-analysis was conducted where appropriate. Six studies were eligible for inclusion. UPA (5 mg and 10 mg) achieved statistically significant amenorrhoeic outcome when compared to placebo (p<0.00001). Increased adverse events (AE) profile was observed in the higher UPA dose, however, did not reach statistical significance.; Conclusions: This review demonstrates the efficacy of UPA in achieving amenorrhoea in women with fibroid induced menorrhagia. However, the favourable dose of UPA remains inconclusive when AE profile is taken into account. Evidence remains obscure regarding liver damage and further research is warranted to attain a conclusive outcome.; Competing Interests: Declaration of Competing Interest Authors have no competing interests to disclose. (Copyright © 2021 Elsevier Masson SAS. All rights reserved.)

Kovacs, P. (2021). "Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders." ClinicalTrials.gov.
	The investigators will enroll patients who, based on their initial evaluation, reproductive history or prior fertility treatment, have a proper indication to undergo in vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI) treatment. A basic infertility evaluation includes: 1.) hormonal evaluation of ovarian function, including ovarian reserve testing (anti‐Müllerian hormone [AMH] level, antral follicle count [AFC]), 2) transvaginal ultrasound evaluation of female internal genital organs, 3) evaluation of the uterine cavity (hysterosalpingogram, saline sonohysterogram or hysteroscopy), 4) cervical cancer screening, 5) cervical culture for Chlamydia, 6) serologic testing for HIV, hepatitis B, C, syphilis (both partners), 7) semen analysis, 8) male andrological exam, 9) if needed male hormonal +/‐ genetic testing. IVF‐ICSI treatment is started for advanced maternal age, diminished ovarian reserve (DOR), unexplained infertility after failed intrauterine inseminations, male factor infertility, endometriosis. The investigators plan to recruit: ‐ infertile patients between the ages of 18‐42 who require IVF‐ICSI treatment and are identified as poor responders based on: a) AMH: 0.3‐1.2 ng/ml or AFC <5, b) AMH>1.2 ng/ml or AFC≥5 but the retrieval of ≤ 4 oocytes during previous IVF treatment. (POSEIDON category III‐IV, Alviggi et al. Fertility Sterility 2016) Further inclusion criteria: ‐ regular menstrual cycles (24‐35 days) ‐ body mass index (BMI): 18‐35 kg/m2 ‐ no more than 3 previous failed IVF/ICSI treatments ‐ no more than 2 previous cancelled stimulations for IVF due to poor response ‐ motile sperm with normal morphology obtained from the ejaculate or from testicular biopsy ‐ intact uterine cavity Exclusion criteria: ‐ age <18 or >42 years ‐ short (<24 days), or long (>35 days) menstrual cycles ‐ irregular uterine cavity ‐ presence of hydrosalpinx ‐ positive HIV, hepatitis B, C screening tests ‐ BMI <18 or > 35 kg/m2 ‐ planned preimplantation genetic testing of the embryos ‐ planned elective cryopreservation ‐ medical, gynecologic or surgical contraindication to IVF treatment ‐ lack of consent Methods: prospective, multicenter (5 centers), randomized controlled trial comparing a higher or lower gonadotropin (Gn) dose treatment. In both the low and high groups two different drug regimens (follitropin alpha + hp human menopausal gonadotropin or follitropin delta + hp human menopausal gonadotropin) will be used. 150 IU follitropin alpha was shown to be equally effective to 10 mcg follitropin delta. Therefore, the investigators expect similar response (oocyte yield) with the two regimens within the high and low Gn dose groups but the study design still will allow the investigators to compare the two follitropin medications too, which is a secondary aim. Lower‐dose group: ‐ 150 IU follitropin alpha + 75 IU highly purified human menopausal gonadotropin (hpHMG) ‐ 10 mcg follitropin delta + 75 IU hpHMG Higher‐dose group: ‐ 225 IU follitropin alpha + 150 IU hpHMG ‐ 15 mcg follitropin delta + 150 IU hpHMG Treatment protocol: ‐ The stimulation will get started on day 2 or 3 of the spontaneous menstrual cycle, or on the 5th day after oral contraceptive pill use or after luteal estradiol pretreatment. ‐ During the stimulation ultrasound +/‐ serum hormone measurements will be used to monitor response. The first ultrasound is scheduled for day 5 or 6 of stimulation. At the time of the ultrasound blood test for serum estradiol is planned too. At the time of the last scan serum estradiol and progesterone levels will be measured. ‐ According to the study protocol the patient will continue with the assigned medication dose throughout her treatment. Dose increase is not allowed. If there is evidence for hyper‐response [estradiol level > 4000 pmol/l on day 6 or more than 15 follicles over 10 mm any time during the stimulation] the dose can be reduced. ‐ As soon as two or more follicles reach >17 mm in diameter human chorionic gonadotropin (hCG) r gonadotropin‐releasing hormone agonits [GnRH a] trigger injection will be used and 35‐36 hours later transvaginal ultrasound guided follicle aspiration will be performed. ‐ The luteal phase will be supported by vaginal progesterone starting on the day after the retrieval. ‐ IVF or ICSI fertilization will be performed based on the semen parameters or previous fertilization records. ‐ The day after the retrieval the success of fertilization will be checked and the embryo(s) will be transferred 2‐5 days after the retrieval. Embryo(s) will be transferred transcervically using soft transfer catheters under ultrasound guidance using the afterload technique. ‐ Surplus good quality embryos will be cryopreserved using vitrification. Elective cryopreservation (no transfer in the fresh cycle) will be performed if: 1) risk of ovarian hyperstimulation syndrome, 2) serum progesterone level over 1.5 ng/ml [5.5 nmol/l] prior to the oocyte collection, 3) any complications between the retrieval and planned fresh transfer (bleeding, infection, illness). ‐ 12‐14 days after the transfer serum human chorionic gonadotropin (HCG) measurement will determine whether implantation has occurred. If the test is positive in 2‐3 weeks a vaginal ultrasound will be done to determine the size, location and number of gestational sacs. Viable pregnancies will be referred to a formal prenatal care around week 8‐9 of pregnancy. Delivery and perinatal outcome data will be collected by phone call after the delivery. ‐ If the fresh IVF cycle is not successful but embryos have been cryopreserved then the patient will undergo a frozen embryo transfer treatment cycle either in her own cycle, or in a minimally stimulated or completely artificial cycle. The care of the patients will not differ from the care of non‐study patients in terms of potential medication dose, the number of clinic visits, retrieval and embryology procedures as well as prenatal care. Randomization: Randomization will be performed according to a computer generated list. (www.randomizer.org) The planned sample size is 700 patients (350 in both the low‐ and high‐dose groups). Sample size calculation: In order to determine the sample size, the investigators calculated with a 20% pregnancy rate in a patient population that fits the inclusion‐exclusion criteria. The investigators expect higher oocyte yield in the higher dose group that should result in more available embryos and therefore more frozen embryo transfers. The investigators calculate that this could increase the cumulative pregnancy rate by 50%. The investigators also believe that about 20% of the patients will drop out for various reasons. Therefore, 350 participants are needed in both arms of the study. Statistical analysis: After the enrollment of the first 350 patients, a planned interim analysis will be performed to decide whether the planned sample size is sufficient to achieve our goal. Logistic regression analysis using a generalized, mixed linear model will be used to assess the impact of various Gn doses on pregnancy rates. Chi‐square test will be used to test significance and OR will be calculated. Data will be collected for the following parameters: ‐ Age ‐ Cycle day 3 follicle stimulating hormone (FSH), estradiol level ‐ anti‐Müllerian hormone (AMH) ‐ antral follicle count (AFC) ‐ Indication for IVF: male, tubal, unexplained, endometriosis, diminished ovarian reserve ‐ Smoking (yes‐no) ‐ Body mass index ‐ Cycle number (fresh + frozen together) ‐ Estradiol level on day 6 ‐ Estradiol + progesterone level at the last scan ‐ Number of follicles >10 mm at the end of stimulation ‐ Stimulation duration ‐ Endometrial thickness ‐ Gn dose (daily, total) ‐ Trigger mechanism (HCG vs. GnRh agonist) ‐ Sperm parameters ‐ Oocyte number ‐ Mature (MII) oocyte number ‐ Proportion of mature oocytes (MII/ oocyte number) ‐ IVF vs. ICSI fertilization ‐ Number of fertilized (2 pronuclei (PN)) oocytes ‐ Fertilization rate per oocyte ‐ Fertilization rate per mature oc te ‐ The number of good quality embryos (morphology better than score "6B2" on day 3, or score >2BB on day 5) and proportion of good morphology embryos among all embryos ‐ Number of transferred embryos ‐ Number of cryopreserved embryos ‐ Pregnancy rate (positive hCG) ‐ Clinical pregnancy rate (sac with viable embryo in it) ‐ Cumulative pregnancy rate (fresh + frozen embryo transfers) ‐ Pregnancy/ neonatal outcome

Kowenski, K. (2023). "Effects of Flourish HEC Vaginal Care System on Birth-Related Pelvic Floor Disorders." ClinicalTrials.gov.
	No Results Available Device: Flourish HEC, which contains BioNourish|Other: Routine pelvic physical therapy Changes in vaginal microbiome over time|Changes in vaginal pH over time|Changes in pelvic floor muscle strength over time|Changes in pelvic floor muscle tension over time|Changes in vulvovaginal tissue inflammation over time|Changes in vulvovaginal symptoms over time|Time to resolution of most bothersome symptom (MBS) Female Not Applicable 1 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment PPT0922 March 29, 2023

Kozma, B. (2023). "Zinc-containing Vaginal Gel and Oral Fluconazole for Vulvovaginal Candidiasis." ClinicalTrials.gov.
	Randomized controlled trial will be conducted on 76 women with VVC, as confirmed by clinical and laboratory diagnosis. The participants will be allocated into two groups using blocked randomization method. In the control group participants will receive oral fluconazole treatment with a single dose of oral fluconazole (150 mg) while in the treatment group women will receive a single oral dose of fluconazole (150mg) followed by treatment with a zinc‐containing vaginal gel (daily for 2 weeks and twice per week thereafter). Vaginal samples will be collected (vaginal swab and cervicovaginal lavage) at baseline and 4‐8‐12 weeks after starting treatment. In addition, the clinical signs and symptoms will be assessed before the intervention and follow‐ups. Women will be asked to report any new symptoms of vaginal infections and will be asked to return for in‐office evaluation.

Kristeleit, R., et al. (2022). "Rucaparib versus standard-of-care chemotherapy in patients with relapsed ovarian cancer and a deleterious BRCA1 or BRCA2 mutation (ARIEL4): an international, open-label, randomised, phase 3 trial." The Lancet Oncology 23(4): 465-478.
	Background: Few prospective studies have compared poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitors to chemotherapy for the treatment of BRCA1-mutated or BRCA2-mutated ovarian carcinoma. We aimed to assess rucaparib versus platinum-based and non-platinum-based chemotherapy in this setting.; Methods: In this open-label, randomised, controlled, phase 3 study (ARIEL4), conducted in 64 hospitals and cancer centres across 12 countries (Brazil, Canada, Czech Republic, Hungary, Israel, Italy, Poland, Russia, Spain, Ukraine, the UK, and the USA), we recruited patients aged 18 years and older with BRCA1-mutated or BRCA2-mutated ovarian carcinoma, with an Eastern Cooperative Oncology Group performance status of 0 or 1, and who had received two or more previous chemotherapy regimens. Eligible patients were randomly assigned (2:1), using an interactive response technology and block randomisation (block size of six) and stratified by progression-free interval after the most recent platinum-containing therapy, to oral rucaparib (600 mg twice daily) or chemotherapy (administered per institutional guidelines). Patients assigned to the chemotherapy group with platinum-resistant or partially platinum-sensitive disease were given paclitaxel (starting dose 60-80 mg/m 2 on days 1, 8, and 15); those with fully platinum-sensitive disease received platinum-based chemotherapy (single-agent cisplatin or carboplatin, or platinum-doublet chemotherapy). Patients were treated in 21-day or 28-day cycles. The primary endpoint was investigator-assessed progression-free survival, assessed in the efficacy population (all randomly assigned patients with deleterious BRCA1 or BRCA2 mutations without reversion mutations), and then in the intention-to-treat population (all randomly assigned patients). Safety was assessed in all patients who received at least one dose of assigned study treatment. This study is registered with ClinicalTrials.gov, NCT02855944; enrolment is complete, and the study is ongoing.; Findings: Between March 1, 2017, and Sept 24, 2020, 930 patients were screened, of whom 349 eligible patients were randomly assigned to rucaparib (n=233) or chemotherapy (n=116). Median age was 58 years (IQR 52-64) and 332 (95%) patients were White. As of data cutoff (Sept 30, 2020), median follow-up was 25·0 months (IQR 13·8-32·5). In the efficacy population (220 patients in the rucaparib group; 105 in the chemotherapy group), median progression-free survival was 7·4 months (95% CI 7·3-9·1) in the rucaparib group versus 5·7 months (5·5-7·3) in the chemotherapy group (hazard ratio [HR] 0·64 [95% CI 0·49-0·84]; p=0·0010). In the intention-to-treat population (233 in the rucaparib group; 116 in the chemotherapy group), median progression-free survival was 7·4 months (95% CI 6·7-7·9) in the rucaparib group versus 5·7 months (5·5-6·7) in the chemotherapy group (HR 0·67 [95% CI 0·52-0·86]; p=0·0017). Most treatment-emergent adverse events were grade 1 or 2. The most common grade 3 or worse treatment-emergent adverse event was anaemia or decreased haemoglobin (in 52 [22%] of 232 patients in the rucaparib group vs six [5%] of 113 in the chemotherapy group). Serious treatment-emergent adverse events occurred in 62 (27%) patients in the rucaparib group versus 13 (12%) in the chemotherapy group; serious adverse events considered related to treatment by the investigator occurred in 32 (14%) patients in the rucaparib group and six (5%) in the chemotherapy group. Three deaths were considered to be potentially related to rucaparib (one due to cardiac disorder, one due to myelodysplastic syndrome, and one with an unconfirmed cause).; Interpretation: Results from the ARIEL4 study support rucaparib as an alternative treatment option to chemotherapy for patients with relapsed, BRCA1-mutated or BRCA2-mutated ovarian carcinoma.; Funding: Clovis Oncology.; Competing Interests: Declaration of interests RK has received institutional funding from Clovis Oncology for this clinical trial; reports clinical trial grants from Merck Sharp & Dohm ; has served as a consultant for Basilea Pharmaceutica and Shattuck Pharma; has received honoraria from Clovis Oncology, AstraZeneca, GlaxoSmithKline, and Incyte; received travelling support from AstraZeneca, GlaxoSmithKline, and Sierra Oncology; has served on data safety monitoring boards or advisory boards for Clovis Oncology, AstraZeneca, BeiGene, Eisai, GlaxoSmithKline, Incyte, iTeos Therapeutics, PharmaMar, and Roche. AF is currently at P A Herzen Cancer Research Institute, Moscow, Russia and delcares no competing interests. ACdM has received institutional funding from Clovis Oncology for this cl.inical trial; reports institutional clinical trial grants from Amgen, AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Regeneron, and Roche; has received honoraria for lectures from AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Roche, and Sanofi; has served on advisory boards for AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, and Roche. YS has received honoraria from AstraZeneca, Merck Sharp & Dohme, and Roche. NC reports grants from AstraZeneca and Roche; has served as a consultant for Clovis Oncology, AstraZeneca, BIOCAD, Eisai, GlaxoSmithKline, Immunogen, Merck Sharp & Dohme/Merck, Mersana, Oncxerna, Pfizer, Pharmamar, Roche, Takeda, and Tesaro; has received honoraria from Clovis Oncology, AstraZeneca, Eisai, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, and Tesaro; received traveling support from Tesaro; and has served on data safety monitoring boards or advisory boards for Clovis Oncology, AstraZeneca, BIOCAD, Eisai, GlaxoSmithKline, Immunogen, Merck Sharp & Dohme/Merck, Mersana Therapeutics, OncXerna, Pfizer, PharmaMar, Roche, Takeda, and Tesaro. DL has received institutional funding from Clovis Oncology for this clinical trial; reports institutional research grants from Clovis Oncology, GlaxoSmithKline, and Merck Sharp & Dohme; has served as a consultant for Merck Serono and ParmaMar; has served on advisory boards for Amgen, AstraZeneca, GlaxoSmithKline, Merck Sharp & Dohme, and PharmaMar; has received travelling support from AstraZeneca, GlaxoSmithKline, PharmaMar, and Roche; has served on data safety monitoring committee for Novartis; and has served on the board of directors for the Gynecological Cancer Academy, the Gynecological Cancer InterGroup, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies. GS reports grants and research support from Merck Sharp & Dohme Italia SRL; has served as a consultant for Tesaro Bio Italy SRL and Johnson & Johnson; and has received honoraria and served on a speakers' bureau for Clovis Oncology Italy SRL. DC has served as a consultant for Akeso Biopharma, AstraZeneca, GlaxoSmithKline, Merck Sharp & Dohme, Novocure, Roche, Seagen, and SOTIO. DT, KKL, KM, and SG are employees of Clovis Oncology, and have stock and stock options. AMO reports institutional research grants from AstraZeneca; has served on an advisory board (uncompensated) for GlaxoSmithKline; has served on advisory boards and steering committees (uncompensated) for Clovis Oncology and AstraZeneca; and has served as a principal investigator on investigator-initiated trials for Clovis Oncology, AstraZeneca, and GlaxoSmithKline. All other authors declare no competing interests. Authors received writing support from Clovis Oncology during the conduct of the study. RK is currently at the Department of Oncology, Guy's and St Thomas' NHS Foundation Trust, Great Maze Pond, London, UK. AL is currently at the Department of Oncology, Almazov National Medical Research Center, Saint Petersburg, Russia. DL is currently at Gynecologic Oncology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of Sacred Heart, Rome, Italy. (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Kuan Kevin, K. W., et al. (2023). "Comparing ART outcomes in women with endometriosis after GnRH agonist versus GnRH antagonist ovarian stimulation: a systematic review." Therapeutic Advances in Endocrinology and Metabolism 14: 20420188231173325.
	Background: Endometriosis is an oestrogen-dependent disease that can cause subfertility in women who may require assisted reproductive technology (ART) to achieve their pregnancy goals.; Objectives: The aim of this study was to compare ART outcomes in women with endometriosis following the long GnRH-agonist controlled ovarian stimulation (COS) protocol with those taking the GnRH-antagonist COS protocol.; Data Sources and Methods: MEDLINE, Embase and Web of Science were systematically searched in June 2022. Randomized controlled trials (RCTs) and observational studies comparing the long GnRH-agonist COS protocol and the GnRH-antagonist COS protocol in women with all stages/subtypes of endometriosis were included. Data were synthesized into comprehensive tables for systematic review. The Scottish Intercollegiate Guidelines Network (SIGN) checklists were used for the risk of bias assessment of non-randomized studies and randomized studies, and all the included studies were deemed to have acceptable quality.; Main Results: Eight studies (one RCT and seven observational) with 2695 patients (2761 cycles) were included. Most studies generally reported non-significant differences in clinical pregnancy or live birth rates regardless of the COS protocol used. However, the GnRH-agonist protocol may yield a higher total number of oocytes retrieved, especially mature oocytes. Conversely, the GnRH-antagonist protocol required a shorter COS duration and lower gonadotrophin dose. Adverse outcomes, such as rates of cycle cancellation and miscarriage, were similar between both COS protocols.; Conclusion: Both the long GnRH-agonist and GnRH-antagonist COS protocols generally yield similar pregnancy outcomes. However, the long GnRH-agonist protocol may be associated with a higher cumulative pregnancy rate due to the higher number of retrieved oocytes available for cryopreservation. The underlying mechanisms of the two COS protocols on the female reproductive tract remain unclear. Clinicians should consider treatment costs, stage/subtype of endometriosis and pregnancy goals of their patients when selecting a GnRH analogue for COS. A well-powered RCT is needed to minimize the risk of bias and compare the risk for ovarian hyperstimulation syndrome.; Registration: This review was prospectively registered at PROSPERO under Registration No. CRD42022327604.; Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. (© The Author(s), 2023.)

Kulaksiz, D., et al. (2023). "A modified mid-urethral sling technique for stress urinary incontinence: Three-year results of a prospective randomized trial in comparison with original transobturator tape procedure." International Urogynecology Journal 34(7): 1429-1436.
	Introduction and hypothesis: Stress urinary incontinence (SUI) is the most common subtype of urinary incontinence, which causes many social, psychological, and economic problems. Mid-urethral sling (MUS) surgery is popular worldwide for the treatment of SUI. We aimed to define a new modified mid-urethral sling technique (mMUS) in SUI treatment and to compare it with transobturator tape (TOT) surgery in terms of safety and efficiency. Method(s): A prospective, randomized study was planned with 126 women suffering from SUI. The patients were randomly divided into two groups, TOT and mMUS. In mMUS, the obturator membrane was not perforated. The objective and subjective symptoms, pain, quality-of-life measures, and side effect profiles were assessed in a 3-year follow-up. The visual analogue scale (VAS) was used for postoperative pain assessment. The International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) and Patient Global Impression of Improvement (PGI-I) were used for cure assessment scales. Result(s): In total, 96 patients completed 3-year follow-up (TOT, n = 49 and mMUS, n = 47). There was no statistical difference between the procedures in terms of cure rates (87.75% and 87.23%, respectively; p = 0.614). Mean VAS scores at 8 and 24 h postoperatively were significantly higher in the TOT group (p < 0.05). There was no significant difference between the groups in VAS scores after 24 h. There was no significant difference between groups in terms of pad test results, ICIQ, or PGI scores at baseline and 36 months after surgery. Conclusion(s): We showed that the mMUS procedure was as safe and effective as TOT, with less postoperative groin pain and complications.Copyright © 2022, The International Urogynecological Association.

Kulkarni, A., et al. (2024). "Treatment of Recurrent Low-grade Serous Ovarian Cancer with MEK Inhibitors: A Systematic Review." American Journal of Clinical Oncology 47(1): 11-16.
	Objective: Low-grade serous ovarian cancer (LGSC) represents 5% of all epithelial ovarian cancers. They are characterized by indolent growth and KRAS and BRAF mutations, differing from high-grade serous ovarian cancer both clinically and molecularly. LGSC has low response rates to traditional systemic therapies, including chemotherapy and hormonal therapy. The objective of this systematic review was to appraise the literature describing the efficacy of MEK inhibitors in the treatment of LGSC. Method(s): A comprehensive search was conducted of the following databases: Medline ALL, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Web of Sciences, ClinicalTrials.gov, International Clinical Trials Registry Platform (ICFRP), and International Standard Randomized Controlled Trials Number (ISRCTN) Registry. All studies investigating MEKi in the treatment of LGSC in the adjuvant or recurrent setting for patients 18 years of age or older were included. All titles/abstracts were then screened by 2 independent reviewers (A.K. and C.C.). The full-text articles were then screened. All disagreements were resolved by a third independent reviewer (T.Z.). Two independent reviewers (A.K. and C.C.) extracted data from the studies deemed eligible for final review. Result(s): A total of 2108 studies were identified in the initial search. Of these, a total of 4 studies met the eligibility criteria for systematic review. In these studies, 416 patients were treated with an MEKi alone. All patients included in the studies were being treated for LGSC in the recurrent setting. Varied results and efficacy of the MEKi were reported in each study. Conclusion(s): The results highlighted in this systematic review demonstrate varied responses to MEKi for recurrent LGSC. Further research is needed in this field comparing the efficacy to current therapies, as well as to further evaluate the safety and toxicity profile with long-term use of MEKi.Copyright © 2024 Lippincott Williams and Wilkins. All rights reserved.

Kumar, S., et al. (2019). "Quality of life outcomes following surgery for advanced ovarian cancer: a systematic review and meta-analysis." International Journal of Gynecological Cancer 29(8): 1285-1291.
	Background: Quality of life after ovarian cancer treatment is an important goal for patients. Complex debulking surgeries and platinum based chemotherapy are often required but quality of life after surgery is rarely reported.; Objectives: To describe quality of life outcomes after surgery for advanced ovarian cancer in a systematic review and meta-analysis.; Search Strategy: MEDLINE, EMBASE, and CENTRAL through March 2019 with no language restrictions.; Selection Criteria: Included studies reported quality of life in women diagnosed with primary advanced ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer undergoing cytoreduction surgery.; Data Collection and Analysis: Data on extent and timing of surgery, quality of life outcomes, and surgical complications were extracted and study quality assessed.; Results: Three randomized controlled trials comparing primary surgery to neoadjuvant chemotherapy had heterogeneous quality of life outcomes with no difference between arms, although there was a clinical improvement in global quality of life scores in both arms at 6 months compared with baseline. Data from two observational studies showed no meaningful difference in quality of life scores between patients undergoing standard or extensive surgery at 6 months.; Conclusions: There was no clinically important difference in the quality of life of patients undergoing either primary debulking surgery or neoadjuvant chemotherapy. There is insufficient evidence on quality of life outcomes of patients undergoing extensive or ultra-radical surgery compared with those undergoing less extensive surgery. Quality of life outcomes matter to patients, but there is little evidence to inform patient choice regarding the extent of surgery.; Competing Interests: Competing interests: The authors (SK, JL, SK and SS) declare that they have no competing interests. CC reports grants from the National Institute for Health and Care Excellence. SK reports other payments for lectures from Roche, others from Astra Zeneca, outside the submitted work. (© IGCS and ESGO 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Kumtepe, Y. (2022). "Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension." ClinicalTrials.gov.
	When the studies in the literature including the mini‐sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinery incontinence (SUI), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. The aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine SUI. Investigators planned to measure patients' Kings Health Questionary and Prolapse Quality of Life test at first and 6 months after the surgery and to determine how the operation affects the quality of life.

Kurt, G. (2023). "Effect of Lavender Inhalation on Dysmenorrhea." ClinicalTrials.gov.
	The research is a randomized controlled trial and an experimental research design will be used. The research will be carried out with two groups as experimental (lavender) and control (placebo) groups.

Kurtz, J.-E., et al. (2023). "Atezolizumab Combined With Bevacizumab and Platinum-Based Therapy for Platinum-Sensitive Ovarian Cancer: Placebo-Controlled Randomized Phase III ATALANTE/ENGOT-ov29 Trial." Journal of Clinical Oncology 41(30): 4768-4778.
	Purpose: Platinum-based doublets with concurrent and maintenance bevacizumab are standard therapy for ovarian cancer (OC) relapsing after a platinum-free interval (PFI) >6 months. Immunotherapy may be synergistic with bevacizumab and chemotherapy.; Patients and Methods: ATALANTE/ENGOT-ov29 (ClinicalTrials.gov identifier: NCT02891824), a placebo-controlled double-blinded randomized phase III trial, enrolled patients with recurrent epithelial OC, one to two previous chemotherapy lines, and PFI >6 months. Eligible patients were randomly assigned 2:1 to atezolizumab (1,200 mg once every 3 weeks or equivalent) or placebo for up to 24 months, combined with bevacizumab and six cycles of chemotherapy doublet, stratified by PFI, PD-L1 status, and chemotherapy regimen. Coprimary end points were investigator-assessed progression-free survival (PFS) in the intention-to-treat (ITT) and PD-L1-positive populations (alpha .025 for each population).; Results: Between September 2016 and October 2019, 614 patients were randomly assigned: 410 to atezolizumab and 204 to placebo. Only 38% had PD-L1-positive tumors. After 3 years' median follow-up, the PFS difference between atezolizumab and placebo did not reach statistical significance in the ITT (hazard ratio [HR], 0.83; 95% CI, 0.69 to 0.99; P = .041; median 13.5 v 11.3 months, respectively) or PD-L1-positive (HR, 0.86; 95% CI, 0.63 to 1.16; P = .30; median 15.2 v 13.1 months, respectively) populations. The immature overall survival (OS) HR was 0.81 (95% CI, 0.65 to 1.01; median 35.5 v 30.6 months with atezolizumab v placebo, respectively). Global health-related quality of life did not differ between treatment arms. Grade ≥3 adverse events (AEs) occurred in 88% of atezolizumab-treated and 87% of placebo-treated patients; grade ≥3 AEs typical of immunotherapy were more common with atezolizumab (13% v 8%, respectively).; Conclusion: ATALANTE/ENGOT-ov29 did not meet its coprimary PFS objectives in the ITT or PD-L1-positive populations. OS follow-up continues. Further research on biopsy samples is warranted to decipher the immunologic landscape of late-relapsing OC.

Kuwahara, C. (2023). "The Efficacy of DSG/EE 150/20 in Primary and Secondary Dysmenorrhea using a Flexible Extended Regimen." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: <Treatment, consisting of the efficacy phase (the equivalent of 3 conventional cycles)> participants will be randomized in a 3:1 ratio to DSG/EE 150/20 or to visually matching placebo. Participants will take one DSG/EE 150/20 or placebo tablet daily from Day 1 to any day between Day 24 and Day 80, followed by 4 consecutive days without tablet intake (tablet‐free interval, TFI). Scheduling the 4 days TFI depends on the participant s wish to schedule or postpone a withdrawal bleeding. 1 Cycle lengths range between 28 days (24/4) and 84 days (80/4). <treatment extension phase (up to the equivalent of 10 conventional cycles)> Participants will take one DSG/EE 150/20 tablet daily from Day 1 to any day between Day 24 and Day 80, followed by 4 consecutive days without tablet intake (tablet‐free interval, TFI). Scheduling the 4 days TFI depends on the participant s wish to schedule or postpone a withdrawal bleeding. 1 Cycle lengths range between 28 days (24/4) and 84 days (80/4). CONDITION: primary or secondary dysmenorrhea PRIMARY OUTCOME: Change from baseline through Day 84 in dysmenorrhea, as measured by the Total Dysmenorrhea Score. INCLUSION CRITERIA: 1. Aged 16 years or older at the time of obtaining consent ‐When the participant is below the age of 18 years, voluntary agreement shall be obtained from the participant and the representative or legal guardian, using the assent (for the minor) and ICF (for the representative or legal guardian). 2.Has a history of regular menstrual cycles of 28 +‐ 7 days when not using hormonal products 3.Diagnosed with moderate to severe primary or secondary dysmenorrhea: ‐Primary dysmenorrhea ‐secondary dysmenorrhea ruled out by interview, internal examination, and transvaginal ultrasonography ‐Secondary dysmenorrhea ‐Dysmenorrhea due to endometriosis, adenomyosis or uterine fibroids: ‐ confirmed diagnosis of endometriosis or adenomyosis by laparotomy or laparoscopy ‐ diagnosed with endometriosis (with ovarian chocolate cysts), adenomyosis or uterine fibroids by transvaginal ultrasonography (at the time of screening) 4.Has dysmenorrhea during th

Kwan, I., et al. (2021). "Monitoring of stimulated cycles in assisted reproduction (IVF and ICSI)." The Cochrane Database of Systematic Reviews(4).
	- Background Monitoring of in vitro fertilisation (IVF) and intra‐cytoplasmic sperm injection (ICSI) is necessary to detect as well as reduce the incidence and severity of ovarian hyperstimulation syndrome (OHSS) whilst achieving the optimal ovarian response needed for assisted reproduction treatment. Traditional monitoring of ovarian hyperstimulation during in vitro fertilisation IVF and ICSI treatment has included transvaginal ultrasonography (TVUS) plus serum estradiol levels. The need for combined monitoring (using TVUS and serum estradiol) during ovarian stimulation in assisted reproduction is controversial. It has been suggested that combined monitoring is time consuming, expensive and inconvenient for women and that simplification of IVF and ICSI therapy by using TVUS only should be considered. Objectives To assess the effect of monitoring controlled ovarian hyperstimulation (COH) in IVF and ICSI cycles in subfertile couples with TVUS only versus TVUS plus serum estradiol concentration, with respect to rates of live birth, pregnancy and OHSS. Search methods In this update conducted in March 2020, two review authors searched the Cochrane Gynaecology and Fertility Group's Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, the National Research Register, and web‐based trial registers. There was no language restriction applied. All references in the identified trials and background papers were checked and authors were contacted to identify relevant published and unpublished data. Selection criteria Only randomised controlled trials that compared monitoring with TVUS only versus TVUS plus serum estradiol concentrations in women undergoing COH for IVF and ICSI treatment were included. Data collection and analysis Two review authors (IK, AW) independently selected the studies, extracted data and assessed risk of bias. We resolved disagreements by discussion. Outcomes data were pooled and summary statistics were presented when appropriate. The quality of the evidence was rated using the GRADE methods. Main results We did not identify any new eligible studies in this update in 2020. The evidence based on the six trials identified in 2014 remained unchanged. They included 781 women undergoing monitoring of COH with either TVUS alone or a combination of TVUS and serum estradiol concentration during IVF or ICSI treatment. None of the six studies reported our primary outcome of live birth rate. Two studies presented pregnancy rate per initiated cycle and per embryo transfer, respectively. Four studies reported pregnancy rate per woman with pooled data; we are uncertain of the effect of monitoring with TVUS only versus combined monitoring on clinical pregnancy rate per woman (odds ratio (OR) 1.10; 95% confidence interval (CI) 0.79 to 1.54; four studies; N = 617; I² = 5%; low quality evidence). This suggests in women with a 36% chance of clinical pregnancy using monitoring with TVUS plus serum estradiol, the clinical pregnancy rate using TVUS only would be between 31% and 46%. We are uncertain of any effect in the mean number of oocytes retrieved per woman (mean difference (MD) 0.32; 95% CI ‐0.60 to 1.24; five studies; N = 596; I² = 17%; low quality evidence). We are uncertain whether monitoring with TVUS only versus combined monitoring affected the incidence of OHSS (OR 1.03; 95% CI 0.48 to 2.20; six studies; N = 781; I² = 0%; low quality evidence), suggesting that in women with a 4% chance of OHSS using monitoring with TVUS plus serum estradiol, the OHSS rate monitored by TVUS only would be between 2% and 8%. The cycle cancellation rate was similar in both arms of two studies (0/34 versus 1/31, 1/25 versus 1/25; OR 0.57; 95% CI 0.07 to 4.39; N = 115; I² = 0%; low quality evidence). The evidence was low quality for all comparisons. Limitations included imprecision and potential bias due to unclear randomisation methods, allocation concealment and blinding, as well as differences in treatment protocols. Quality assessment was hampered by the lack of methodological descriptions in sever l studies. A thors' conclusions This review update found no new randomised trials. Evidence from the six studies previously identified did not suggest that combined monitoring by TVUS and serum estradiol is more efficacious than monitoring by TVUS alone with regard to clinical pregnancy rates and the incidence of OHSS. The number of oocytes retrieved appeared similar for both monitoring protocols. The data suggest that both these monitoring methods are safe and reliable. However, these results should be interpreted with caution because the overall quality of the evidence was low. Results were compromised by imprecision and poor reporting of study methodology. The choice of one or the other method may depend upon the convenience of its use, and the associated costs. An economic evaluation of the costs involved with the two methods and the views of the women undergoing cycle monitoring would be welcome. Plain language summary Monitoring of stimulated cycles in fertility treatment involving in vitro fertilisation (IVF) and intra‐cytoplasmic sperm injection (ICSI) Review question: can ultrasound alone be used safely without adding estradiol blood test measurements to monitor women undergoing controlled ovarian hyperstimulation during IVF and ICSI? We reviewed the evidence on monitoring women undergoing controlled ovarian hyperstimulation as part of IVF or ICSI by transvaginal ultrasound (TVUS) only versus traditional combined monitoring (TVUS) and blood hormone (estradiol) levels. Background: Assisted reproduction techniques such as IVF and ICSI involve a process called controlled ovarian stimulation. The ovaries are artificially stimulated to produce follicles and then ovulation (release of a mature ovum or egg) is induced so that eggs can be retrieved for use in either IVF or ICSI to produce embryos in the laboratory. Traditionally women undergoing controlled ovarian hyperstimulation prior to ovulation induction have been monitored by TVUS and measurement of the hormone estradiol level in their blood. The aim of monitoring is to detect the optimum time to induce ovulation (by the administration of human chorionic gonadotrophin or luteinising hormone) and to determine an adequate response to ovarian hyperstimulation to allow egg retrieval, but importantly also to identify women at risk of the potentially serious rare condition of ovarian hyperstimulation syndrome (OHSS). It has been suggested that a simplified protocol of monitoring by TVUS alone may reduce unnecessary anxiety and operational costs during IVF and ICSI. Study characteristics: we included six randomised controlled trials conducted in the UK, France, Spain, Israel and the US, including 781 women. They compared monitoring with TVUS only versus TVUS plus serum estradiol concentration in women undergoing ovarian hyperstimulation for IVF and ICSI treatment. The evidence was current to March 2020. Key results: none of the six studies reported our primary outcome of live birth rate. Only four of the six studies reported pregnancy rate per woman; we are uncertain of the effect of monitoring with TVUS only versus TVUS plus estradiol measurement on clinical pregnancy rate per woman. Our findings suggest that in women with a 36% chance of clinical pregnancy using monitoring with TVUS plus serum estradiol, the clinical pregnancy rate using TVUS only would be between 31% and 46%. We are uncertain of any effect in the mean number of oocytes retrieved per woman. We are uncertain whether monitoring with TVUS only versus TVUS plus estradiol measurement affected the incidence of OHSS. The evidence suggested that in women with a 4% chance of OHSS using monitoring with TVUS plus serum estradiol, the OHSS rate monitored by TVUS only would be between 2% and 8%. The cycle cancellation rate was similar in both arms of two studies reporting this outcome. Quality of the evidence: the evidence was of low quality. Limitations included imprecision and potential bias due to unclear description of randomisation methods, allocation concealment and blinding, as well as differences in the treatment prot cols. Quality assessment was hampered by a lack of methodological descriptions in several studies. Two studies reported funding by pharmaceutical companies, whereas the remaining four studies did not report their sources of funding.

Kypriotis, K., et al. (2023). "A Study Protocol of Micro-Ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome." Cureus 15(11): e48645.
	INTRODUCTION: This is a presentation of a study protocol in order to evaluate whether the application of CO2 laser can additionally benefit the improvement of the symptoms of overactive bladder in postmenopausal women who have just started mirabegron as a treatment. MATERIALS AND METHODS: This is a study protocol of a randomized double-blind placebo-controlled trial. A total of 50 menopausal women will participate in the study. All patients will start treatment with mirabegron 50 mg and will be randomized into two groups. Women in group A (control) will undergo CO2 laser treatments while those in group B (placebo group) will receive placebo CO2 laser treatments. In total, three monthly sessions will be held in both groups. The monitoring and evaluation of the results will be carried out by completing a three-day urination diary, as well as by completing the Female Lower Urinary Tract Symptoms, Overactive Bladder Questionnaire, King's Health Questionnaire, Urinary Distress Inventory, Pelvic Floor Impact Questionnaire, Patient Global Impression of Improvement, before each session and a month after the last one. Differences between groups will be assessed at baseline and every month following the three laser therapies. RESULTS: This is an ongoing study protocol, and we are expecting the analysis of the results in 2024. CONCLUSIONS: The use of laser CO2 in postmenopausal women with overactive bladder syndrome may be a well-tolerated alternative treatment. The goal of our study is to evaluate the efficacy of laser treatment in combination with b3-adrenoreceptor agonist therapy.

La Rosa Valentina, L., et al. (2020). "Behavioral therapy versus drug therapy in individuals with idiopathic overactive bladder: A systematic review and meta-analysis." Journal of Health Psychology 25(5): 573-585.
	The aim of this study was to systematically review randomized clinical trials comparing the treatment of individuals with overactive bladder syndrome through the use of behavioral therapy versus drug therapy. A systematic electronic search of MEDLINE via PubMed, Embase, and Cochrane Library was performed, including studies indexed until August 2019. Five randomized clinical trials were included. The studies presented a high risk of bias. There was no significant difference between the evaluated treatments. Thus, behavioral therapy and drug therapy also promote the improvement of the symptoms of overactive bladder syndrome, and the behavioral therapy does not have significant adverse effects reported. Due to the high risk of bias in included studies, data should be interpreted with caution. Future studies with more comprehensive protocols may change the effect estimates of behavioral therapy on overactive bladder syndrome. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

Lacey, L., et al. (2021). "Assisted hatching on assisted conception (in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI))." The Cochrane Database of Systematic Reviews 3: CD001894.
	Background: Failure of implantation and conception may result from inability of the blastocyst to escape from its outer coat, which is known as the zona pellucida. Artificial disruption of this coat is known as assisted hatching and has been proposed as a method for improving the success of assisted conception by facilitating embryo implantation.; Objectives: To determine effects of assisted hatching (AH) of embryos derived from assisted conception on live birth and multiple pregnancy rates. SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility Group Specialised Register (until May 2020), the Cochrane Central Register of Controlled Trials (CENTRAL; until May 2020), in the Cochrane Library; MEDLINE (1966 to May 2020); and Embase (1980 to May 2020). We also searched trial registers for ongoing and registered trials (http://www.clinicaltrials.gov - a service of the US National Institutes of Health; http://www.who.int/trialsearch/Default.aspx - The World Health Organization International Trials Registry Platform search portal) (May 2020).; Selection Criteria: Two review authors identified and independently screened trials. We included randomised controlled trials (RCTs) of AH (mechanical, chemical, or laser disruption of the zona pellucida before embryo replacement) versus no AH that reported live birth or clinical pregnancy data.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. Two review authors independently performed quality assessments and data extraction.; Main Results: We included 39 RCTs (7249 women). All reported clinical pregnancy data, including 2486 clinical pregnancies. Only 14 studies reported live birth data, with 834 live birth events. The quality of evidence ranged from very low to low. The main limitations were serious risk of bias associated with poor reporting of study methods, inconsistency, imprecision, and publication bias. Five trials are currently ongoing. We are uncertain whether assisted hatching improved live birth rates compared to no assisted hatching (odds ratio (OR) 1.09, 95% confidence interval (CI) 0.92 to 1.29; 14 RCTs, N = 2849; I² = 20%; low-quality evidence). This analysis suggests that if the live birth rate in women not using assisted hatching is about 28%, the rate in those using assisted hatching will be between 27% and 34%. Analysis of multiple pregnancy rates per woman showed that in women who were randomised to AH compared with women randomised to no AH, there may have been a slight increase in multiple pregnancy rates (OR 1.38, 95% CI 1.13 to 1.68; 18 RCTs, N = 4308; I² = 48%; low-quality evidence). This suggests that if the multiple pregnancy rate in women not using assisted hatching is about 9%, the rate in those using assisted hatching will be between 10% and 14%. When all of the included studies (39) are pooled, the clinical pregnancy rate in women who underwent AH may improve slightly in comparison to no AH (OR 1.20, 95% CI 1.09 to 1.33; 39 RCTs, N = 7249; I² = 55%; low-quality evidence). However, when a random-effects model is used due to high heterogeneity, there may be little to no difference in clinical pregnancy rate (P = 0.04). All 14 RCTs that reported live birth rates also reported clinical pregnancy rates, and analysis of these studies illustrates that AH may make little to no difference in clinical pregnancy rates when compared to no AH (OR 1.07, 95% CI 0.92 to 1.25; 14 RCTs, N = 2848; I² = 45%). We are uncertain about whether AH affects miscarriage rates due to the quality of the evidence (OR 1.13, 95% CI 0.82 to 1.56; 17 RCTs, N = 2810; I² = 0%; very low-quality evidence).; Authors' Conclusions: This update suggests that we are uncertain of the effects of assisted hatching (AH) on live birth rates. AH may lead to increased risk of multiple pregnancy. The risks of complications associated with multiple pregnancy may be increased without evidence to demonstrate an increase in live birth rate, warranting careful consideration of the routine use of AH for couples undergoing in vitro fertilisa i n (IVF) or intracytoplasmic sperm injection (ICSI). AH may offer a slightly increased chance of achieving a clinical pregnancy, but data quality was of low grade. We are uncertain about whether AH influences miscarriage rates. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Laganà Antonio, S. (2022). "Laparoscopic Hysterectomy With Vaginal Vault Suspension to the Uterosacral Ligaments for Stage II-III Pelvic Organ Prolapse." ClinicalTrials.gov.
	No Results Available Procedure: Vaginal vault suspension to the uterosacral ligaments|Procedure: McCall culdoplasty Recurrence|Urinary impact questionnaire score (total score minimum: 0, maximum: 100)|Pelvic Organ Prolapse Impact Questionnaire (total score minimum: 0, maximum: 100)|Colorectal-Anal Impact questionnaire (total score minimum: 0, maximum: 100)|Prolapse/urinary incontinence sexual questionnaire score (total score minimum: 0, maximum: 48) Female Not Applicable 60 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention LULS-1 May 2024

Laganà Antonio, S. (2022). "Spontaneous Reproductive Outcomes After Oral Inositol Supplementation in Infertile Polycystic Ovarian Syndrome Women." ClinicalTrials.gov.
	No Results Available Dietary Supplement: Inositol + Folic acid|Dietary Supplement: Folic acid|Behavioral: Regular intercourses Clinical pregnancy rate|Miscarriage rate|Live birth rate|Spontaneous ovulation rate|Glucose metabolism|BMI|Lipid metabolism|Blood pressure|Androgens profile Female Not Applicable 80 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment IROP-1 December 31, 2024

Laganà Antonio, S. (2023). "Surgery and ART For Endometrioma." ClinicalTrials.gov.
	No Results Available Procedure: Laparoscopic enucleation of ovarian endometrioma.|Procedure: Prolonged pituitary downregulation|Procedure: Assisted Reproductive Technology (ART) Clinical pregnancy with fetal heartbeat|Biochemical pregnancy|Miscarriage|Live birth rate Female Not Applicable 100 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment SAFE-1 October 2027

Laganà Antonio, S. (2023). "Suture of the Ovary After Enucleation of Ovarian Endometrioma." ClinicalTrials.gov.
	No Results Available Procedure: Suture of the ovarian cortex|Procedure: No suture of the ovarian cortex Antral Follicle Count (AFC)|Pulsatility index, evaluated by Doppler flowmetry, of the ovarian artery|Resistive index, evaluated by Doppler flowmetry, of the ovarian artery|Ovarian volume Female Not Applicable 100 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment SOAVE-1 May 2027

Łagowska, K. and K. Kapczuk (2022). "Lactobacillus rhamnosus has no beneficial effect on anthropometric parameters, carbohydrate metabolism and androgen status in women with polycystic ovary syndrome." Women & Health 62(4): 336-347.
	The aim of this study was to assess the effect of a twenty-week weight-reducing diet with a low glycemic index and with or without Lactobacillus rhamnosus supplementation on changes in anthropometric, metabolic, and hormonal parameters in women with polycystic ovary syndrome (PCOS). The subjects were assigned to one of two intervention groups: the D group ( n = 21) received a weight-reduction diet with a low glycemic index, and the DP group ( n = 19) received a weight-reduction diet with a low glycemic index, as well as supplementation with Lactobacillus rhamnosus . Anthropometric, metabolic, and hormonal parameters were evaluated at baseline and after twenty weeks of intervention. After twenty weeks, significant reductions in weight, body mass index, fat mass, and waist circumference were seen in both groups, but no significant differences between the groups were observed. The intervention resulted in changes in glucose assessment after two hours in oral glucose tolerance test and in insulin assessment after two hours in oral glucose tolerance test. In the D group, the testosterone level and free androgen index decreased significantly. In overweight and obese women with PCOS, probiotic supplementation taken alongside a twenty-week low-glycemic-index weight-reduction diet has no additional beneficial effects on anthropometrical parameters, carbohydrate metabolism, or androgen status, compared with the low-glycemic-index weight-reduction diet alone.

Lai, T. (2022). "Value-based Integrated Recommendation Software Guiding Ovarian Cancer Treatment (VIRGO2)." ClinicalTrials.gov.
	The study will employ the complete utility of the mobile application by incorporating highly coordinated ovarian cancer care pathways, associated evidence‐based recommendations, and delivering these 'at the fingertips' of providers and patients when appropriate. The AI‐based mobile application requires both clinical data‐input as well as continuously captured patient‐reported outcome measures (PROMs) including those related to disease progression, medication side effects, medication adherence, anxiety and depression, and quality of life. The continuous assessment of outcome measures will provide ongoing monitoring that is delivered directly to the electronic medical record (EMR). This data allows abnormal outcome measures to trigger immediate expert‐based recommendations for care management with one click in the EMR through implementation of the AI‐driven ovarian cancer care pathways. Provider recommendations will be continuously generated for the optimization of care that is based upon individual risk profiles, disease stage, and health outcomes, resulting in dynamic and risk‐dependent recommendations. Remote patient monitoring will also allow for improved education and instruction, including appointment reminders and medication adherence optimization. The application will also provide nutritional support, mental support, and caregiver connectivity. Given ovarian cancer will be a chronic condition for 80% of patients, the critical challenge is to deliver high level care that improves patient outcomes while not increasing the cost of health care. This project will assess a process by which this can be done with the electronic medical record, a patient application, and AI‐generated patient care pathways. The development of such AI‐powered care pathways designed for ovarian cancer will be coordinated throughout the induction and maintenance treatment phases of ovarian cancer management.

Laidi, X., et al. (2021). "Impact of pharmacologic therapy improving glycolipid metabolism on IVF/ICSI outcomes among infertile women with polycystic ovary syndrome: a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Lainas, G. T., et al. (2023). "Follicular flushing increases the number of oocytes retrieved: a randomized controlled trial." Human Reproduction 38(10): 1927-1937.
	STUDY QUESTION: Does follicular flushing increase the number of cumulus-oocyte complexes (COCs) retrieved compared to single aspiration? SUMMARY ANSWER: Follicular flushing significantly increases the number of COCs retrieved compared to single aspiration. WHAT IS KNOWN ALREADY: On the basis of published meta-analyses, follicular flushing does not seem to increase the number of oocytes retrieved, the probability of clinical pregnancy, or that of live birth and has been associated with an increase in the duration of oocyte retrieval. It should be noted, however, that all the eligible randomized controlled trials (RCTs) in these meta-analyses have randomized patients into either single aspiration or follicular flushing. This study design might not allow the detection of the true effect of follicular flushing. Despite randomization, this might still be obscured, to an extent, by heterogeneity in patients, stimulation characteristics, and differences in the oocyte retrieval procedure. STUDY DESIGN, SIZE, DURATION: A prospective, single centre, RCT, including 105 patients was performed between July and December 2022. PARTICIPANTS/MATERIALS, SETTING, METHODS: Eligible patients were those undergoing oocyte retrieval for ICSI, aged <43 years, with BMI 18-35 kg/m2. Patients with all types of ovarian response (low-normal-high), as assessed on the day of triggering final oocyte maturation, were included. Random allocation of the ovaries of each patient to either single aspiration or follicular flushing was performed on the day of oocyte retrieval, using a computer-generated randomization list. Patients could enter the study only once. All follicles from ovaries allocated to either follicular flushing or single aspiration, were aspirated by the same 16G double lumen needle, with a constant aspiration pressure of 190 mmHg, resulting in flow rate of 0.42 ml/s. In the ovaries allocated to the follicular flushing group, if a COC was not recovered in the initial aspirate of each follicle, follicular flushing was performed until a COC was retrieved, up to a maximum of five times. The primary outcome measure was the number of COCs retrieved. Secondary outcomes were oocyte recovery rate, oocyte maturation rate, fertilization rate, and rate of good quality embryos on Day 2. Values are expressed as a median (inter-quartile range). MAIN RESULTS AND THE ROLE OF CHANCE: Significantly more COCs were retrieved in the follicular flushing as compared to the single aspiration group in all patients [5 (7) vs 2 (3), P < 0.001, respectively], as well as in patients with high [9 (3) vs 5 (4), P < 0.001, respectively], normal [5 (2) vs 2 (3), P < 0.001, respectively] and low [1 (1) vs 1 (1), P < 0.001, respectively] ovarian response. In patients with low ovarian response, no COCs were retrieved in 5.7% of the ovaries in the flushing group vs 42.8% of the ovaries in the single aspiration group (P < 0.001). The oocyte retrieval rate was significantly higher in the follicular flushing vs the single aspiration group, in all patients [88.9% (25.0) vs 45.5% (37.5), P < 0.001, respectively], as well as in patients with high [81.8% (15.9) vs 45.5% (22.2), P < 0.001, respectively], normal [85.7% (28.6) vs 40.0% (30.0), P < 0.001, respectively], and low [100% (0) vs 50.0% (100), P < 0.001, respectively] ovarian response. No significant difference was observed regarding maturation rate [85.2% (30.8) vs 100% (33.3), P = 0.78], fertilization rate [76.4% (50) vs 83.3% (50) P = 0.42], and the proportion of good quality embryos on Day 2 [83.3% (40) vs 100% (50), P = 0.62]. Similarly, no differences in the above variables were observed in patients with different types of ovarian response. Follicular flushing as compared to single aspiration was associated with a significant increase in the duration of oocyte retrieval in all patients [248 s (332) vs 135 s (164), respectively], as well as in patients with high [464 s (225) vs 237 s (89), P < 0.001, respectively], normal [248 s (108) vs 141 s (95) P < 0.001, respectively], and low [64 s (59) vs 48 s (10), P < 0.001, respectively] ovarian response. LIMITATIONS, REASONS FOR CAUTION: Although the current study design allows for a more accurate evaluation of the true effect of follicular flushing on the number of COCs retrieved, it does not permit the evaluation of its role on the probability of pregnancy. WIDER IMPLICATIONS OF THE FINDINGS: This is the first RCT to suggest that follicular flushing increases the number of COCs retrieved compared to single aspiration, independently of ovarian response. This implies that follicular flushing plays an important role in the optimization of oocyte retrieval. These results, however, need to be confirmed in future studies, in which an equal flow rate should be used during oocyte retrieval. STUDY FUNDING/COMPETING INTEREST(S): No external funding was obtained for this study. There are no conflicts of interest to declare. TRIAL REGISTRATION NUMBER: NCT05473455. TRIAL REGISTRATION DATE: 15 July 2022. DATE OF FIRST PATIENT’S ENROLMENT: 27 July 2022.

Lambaudie, E., et al. (2021). "TRAINING-Ovary 01 (connecTed pRehabiliAtIoN pelvIc caNcer surGery): multicenter randomized study comparing neoadjuvant chemotherapy for patients managed for ovarian cancer with or without a connected pre-habilitation program." International Journal of Gynecological Cancer 31(6): 920-924.
	BACKGROUND: Patients undergoing neoadjuvant chemotherapy before surgery for advanced ovarian cancer may have impaired functional capacity, nutritional status, and emotional well-being. PRIMARY OBJECTIVES: TRAINING-01 aims to determine if a connected pre-habilitation program during neoadjuvant chemotherapy for patients treated for an advanced ovarian cancer will improve physical capacity before major abdomino-pelvic surgery. STUDY HYPOTHESIS: A pre-habilitation program during neoadjuvant chemotherapy will bring a fitter patient to surgery and will decrease treatment morbidity and improve oncological outcomes. TRIAL DESIGN: This study is a prospective, multi-center, phase III study. The pre-habilitation program consists of providing multi-dimensional support during neoadjuvant chemotherapy using connected devices. The control group will receive usual care. MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients will be women with International Federation of Gynecology and Obstetrics stage III-IV advanced ovarian cancer undergoing neoadjuvant chemotherapy. Patients must be able to perform a cardiopulmonary exercise test. PRIMARY ENDPOINTS: The primary endpoint will be the comparison of the variation in maximum oxygen uptake (VO2 max) between baseline and surgery in the pre-habilitation group and control groups. SAMPLE SIZE: 136 patients (68 per arm) will be recruited to demonstrate a medium standardized effect d=0.5 in the variations of VO2 max between baseline and surgery. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: The duration of the study includes 24 months of recruitment and 5 years of follow up. We anticipate reporting primary endpoint results in 2024. TRIAL REGISTRATION: TRAINING-01-IPC 2018-039 (NCT04451369).

Lan, H., et al. (2024). "Effectiveness and Safety of Kidney-Tonifying Traditional Chinese Herbal Compound in Treating URSA: A Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Laniado, H. (2022). "Addition of Dydrogesterone to the Luteal Phase Support After Fresh Embryo Transfer." ClinicalTrials.gov.
	No Results Available Drug: Dydrogesterone 10mg Oral Tablet Live birth rate|Presence of fetal heartbeats at 12 weeks of gestation|Frequency of positive pregnancy tests on Day 14 after embryo transfer|Rates of obstetrical complications|Newborn outcomes|Newborn Weight|Rates of Newborn malformations Female Not Applicable 300 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 0003-20-LND May 31, 2023

Lankford, A. (2023). "PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer." ClinicalTrials.gov.
	This is a randomized, two‐arm study of PRGN‐2009 in patients with recurrent or metastatic cervical cancer who are pembrolizumab resistant. Patients meeting all eligibility criteria who consent to participate in the study will be randomized 1:1 to receive a combination of PRGN‐2009, plus pembrolizumab, or to receive pembrolizumab alone.

Lara Lucia, A., et al. (2023). "Hormone therapy for sexual function in perimenopausal and postmenopausal women." The Cochrane Database of Systematic Reviews 8: CD009672.
	Background: The perimenopausal and postmenopausal periods are associated with many symptoms, including sexual complaints. This review is an update of a review first published in 2013.; Objectives: We aimed to assess the effect of hormone therapy on sexual function in perimenopausal and postmenopausal women.; Search Methods: On 19 December 2022 we searched the Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS, ISI Web of Science, two trials registries, and OpenGrey, together with reference checking and contact with experts in the field for any additional studies.; Selection Criteria: We included randomized controlled trials that compared hormone therapy to either placebo or no intervention (control) using any validated assessment tool to evaluate sexual function. We considered hormone therapy: estrogen alone; estrogen in combination with progestogens; synthetic steroids, for example, tibolone; selective estrogen receptor modulators (SERMs), for example, raloxifene, bazedoxifene; and SERMs in combination with estrogen.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. We analyzed data using mean differences (MDs) and standardized mean differences (SMDs). The primary outcome was the sexual function score. Secondary outcomes were the domains of sexual response: desire; arousal; lubrication; orgasm; satisfaction; and pain. We assessed the certainty of the evidence using the GRADE approach.; Main Results: We included 36 studies (23,299 women; 12,225 intervention group; 11,074 control group), of which 35 evaluated postmenopausal women; only one study evaluated perimenopausal women. The 'symptomatic or early postmenopausal women' subgroup included 10 studies, which included women experiencing menopausal symptoms (symptoms such as hot flushes, night sweats, sleep disturbance, vaginal atrophy, and dyspareunia) or early postmenopausal women (within five years after menopause). The 'unselected postmenopausal women' subgroup included 26 studies, which included women regardless of menopausal symptoms and women whose last menstrual period was more than five years earlier. No study included only women with sexual dysfunction and only seven studies evaluated sexual function as a primary outcome. We deemed 20 studies at high risk of bias, two studies at low risk, and the other 14 studies at unclear risk of bias. Nineteen studies received commercial funding. Estrogen alone versus control probably slightly improves the sexual function composite score in symptomatic or early postmenopausal women (SMD 0.50, 95% confidence interval (CI) (0.04 to 0.96; I² = 88%; 3 studies, 699 women; moderate-quality evidence), and probably makes little or no difference to the sexual function composite score in unselected postmenopausal women (SMD 0.64, 95% CI -0.12 to 1.41; I² = 94%; 6 studies, 608 women; moderate-quality evidence). The pooled result suggests that estrogen alone versus placebo or no intervention probably slightly improves sexual function composite score (SMD 0.60, 95% CI 0.16 to 1.04; I² = 92%; 9 studies, 1307 women, moderate-quality evidence). We are uncertain of the effect of estrogen combined with progestogens versus placebo or no intervention on the sexual function composite score in unselected postmenopausal women (MD 0.08 95% CI -1.52 to 1.68; 1 study, 104 women; very low-quality evidence). We are uncertain of the effect of synthetic steroids versus control on the sexual function composite score in symptomatic or early postmenopausal women (SMD 1.32, 95% CI 1.18 to 1.47; 1 study, 883 women; very low-quality evidence) and of their effect in unselected postmenopausal women (SMD 0.46, 95% CI 0.07 to 0.85; 1 study, 105 women; very low-quality evidence). We are uncertain of the effect of SERMs versus control on the sexual function composite score in symptomatic or early postmenopausal women (MD -1.00, 95% CI -2.00 to -0.00; 1 study, 215 women; very low-quality evidence) and of their effect in unselected postmenopausal women (MD 2.2 , 95% 1.37 to 3.11 2 studies, 1525 women, I² = 1%, low-quality evidence). We are uncertain of the effect of SERMs combined with estrogen versus control on the sexual function composite score in symptomatic or early postmenopausal women (SMD 0.22, 95% CI 0.00 to 0.43; 1 study, 542 women; very low-quality evidence) and of their effect in unselected postmenopausal women (SMD 2.79, 95% CI 2.41 to 3.18; 1 study, 272 women; very low-quality evidence). The observed heterogeneity in many analyses may be caused by variations in the interventions and doses used, and by different tools used for assessment.; Authors' Conclusions: Hormone therapy treatment with estrogen alone probably slightly improves the sexual function composite score in women with menopausal symptoms or in early postmenopause (within five years of amenorrhoea), and in unselected postmenopausal women, especially in the lubrication, pain, and satisfaction domains. We are uncertain whether estrogen combined with progestogens improves the sexual function composite score in unselected postmenopausal women. Evidence regarding other hormone therapies (synthetic steroids and SERMs) is of very low quality and we are uncertain of their effect on sexual function. The current evidence does not suggest the beneficial effects of synthetic steroids (for example tibolone) or SERMs alone or combined with estrogen on sexual function. More studies that evaluate the effect of estrogen combined with progestogens, synthetic steroids, SERMs, and SERMs combined with estrogen would improve the quality of the evidence for the effect of these treatments on sexual function in perimenopausal and postmenopausal women. (Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Larik, M. O., et al. (2024). "Effects of resveratrol on polycystic ovarian syndrome: a systematic review and meta-analysis of randomized controlled trials." Endocrine 83(1): 51-59.
	Purpose: Polycystic ovarian syndrome (PCOS) is the heightened ovarian dysfunction associated with excessive androgen production, manifesting with hirsutism, abnormal menstrual cycle, and polycystic ovaries. In this systematic review and meta-analysis, the effect of resveratrol on laboratory parameters of PCOS women will be assessed. Method(s): An electronic search via PubMed, Cochrane Library, and Scopus was performed up to February 2023 for randomized controlled trials conforming to our pre-specified outcomes. A random-effects model was utilized, with cohorts compared using mean differences. Result(s): Three randomized controlled trials (RCTs) were included, reporting 84 patients receiving resveratrol, and 85 patients receiving placebo. It was observed that resveratrol significantly improved prolactin levels (P = 0.02), acne scores (P = 0.008), and total cholesterol (P = 0.02). However, there were no significant improvements observed with respect to total testosterone, follicle stimulating hormone (FSH), lutenizing hormone (LH), body mass index (BMI), hirsutism scores, triglycerides, high-density lipoprotein (HDL), and low-density lipoprotein (LDL). Conclusion(s): As per the results of our analysis, resveratrol demonstrates mild therapeutic potential for the sufferers of PCOS, and cannot replace the current established treatment guidelines. However, further comprehensive RCTs are required in order to assess the efficacy in long-term dosing and the safety profile of the use of resveratrol.Copyright © 2023, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Lashley, E. (2023). "Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages." ClinicalTrials.gov.
	Rationale: Recurrent miscarriage (RM) is defined as 2 or more spontaneous miscarriages. It affects 3% of all fertile couples and in less than 50% an underlying cause may be identified. Thus far, none of the therapies tested in women with unexplained RM showed improvement of the live birth rate (LBR). As the fetus is a semi‐allograft, which escapes maternal immune rejection in normal pregnancy, many studies proposed the involvement of immunological mechanism in RM. Glucocorticoids could have an effect on these mechanisms. Indeed, a recent meta‐analysis has shown a beneficial effect on live birth rate for treatment with prednisolone therapy (RR 1.58, 95% CI 1.23‐2.02). The included trials however were inadequately powered, differed in inclusion criteria or contained co‐intervention with heparin and aspirin. In addition, most patients were selected based on the natural killer cell density in prior uterine biopsy, though this has not yet proven to be a valid biomarker. Objectives: To assess the effectiveness of prednisolone administration, as compared to placebo, on the LBR in an unselected population of women with unexplained RM. Secondary, the effectiveness of prednisolone on the LBR in various subgroups, the tolerability and safety of prednisolone, the cost‐effectiveness and the effect on immune cell levels is studied. Main study parameters/endpoints: Primary outcome: live birth rate Secondary outcome: miscarriage rate, ongoing pregnancy rate, adverse events (including side effects and pregnancy complications), decidual immune cell level and direct costs. Trial design: Randomized double‐blind, placebo controlled multi‐center clinical trial. Follow up period ends 3 months after delivery (12 months after randomization). Trial population: Women with unexplained recurrent miscarriage, including at least 2 miscarriages, aged 18‐ 39 years are recruited in a new pregnancy with AD <7 weeks from 10 participating centers in the Netherlands (Coordinating center Leiden University Medical Centre, LUMC). Diagnosis unexplained recurrent miscarriages is based on latest ESHRE guideline. Intervention: After a complete diagnostic work‐up, eligible women will be asked to collect a sample of menstrual blood. Patients are then randomized for prednisolone or placebo in a subsequent pregnancy. Women are randomly assigned in a 1:1 ratio to prednisolone tablets (20 mg daily for 6 weeks, 10 mg daily for 1 week, 5 mg daily for 1 week) or identical placebo tablets. The participants will then receive prenatal visits according to standard care with their own treating physician. All patients will be asked to fill in questionnaires at randomization, and 3, 6 and 12 months after randomization. In a subgroup of patients participating in the LUMC and Radboud MC, additional analyses will be performed, aimed at elucidating the effect of prednisolone on level of different immune cell populations in miscarriage tissue or placenta. Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of patients represented by the trial subjects as well as the nature and extent of burden and risks: In the PREMI study the investigators will evaluate the effect of prednisolone on the live birth rate in patients with RM in a randomized, placebo‐controlled trial. The risks and burden of participating in the trial are estimated as small. The risk of participation is the risk of prednisolone use; substantial evidence exists that prednisolone in this dosage and usage in first trimester is safe for mother and fetus. Patients may however experience barriers for participation in this study, due to the possible assignment to the placebo‐arm (with a possible nil effect on pregnancy outcome), as well as potential side effects. Considering the latter, in a previous feasibility trial no side effects were severe enough for women to stop taking medication. Moreover, to establish the most valid results as possible, there is no other solid manner to answer this research question than by conducting a wel €designed double blinded placebo‐controlled RCT.

Lathi, R. (2023). "The Stanford Egg Freezing Study." ClinicalTrials.gov.
	No Results Available Procedure: Low-Intensity Egg Freezing Protocol|Procedure: High-Intensity Egg Freezing Protocol Oocyte yield per retrieval or egg freezing cycle|Mature oocytes cryopreserved per egg freezing cycle|Participant satisfaction with egg freezing experience and specific protocol (assessed using the Likert scale)|Out-of-pocket costs of the egg freezing cycle for the participant|Time off-work needed to complete the egg freezing cycle|Additional cost per additional oocytes retrieved Female Not Applicable 100 Other Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 69100 July 2025

Laughton, M., et al. (2021). "Comparison of Levonorgestrel-releasing Intrauterine System (LNG-IUS) against Laparoscopic Assisted Supracervical Hysterectomy (LASH) for menorrhagia treatment: An economic evaluation." Journal of Gynecology Obstetrics and Human Reproduction 50(10): 102229.
	Background: This economic evaluation and literature review was conducted with the primary aim to compare the cost-effectiveness of laparoscopic assisted supracervical hysterectomy (LASH) with NICE's gold-standard treatment of Levonorgestrel-releasing intrauterine system (LNG-IUS) for menorrhagia. Material(s) and Method(s): A cost-utility analysis was conducted from an NHS perspective, using data from two European studies to compare the treatments. Individual costs and benefits were assessed within one year of having the intervention. An Incremental Cost-Effectiveness Ratio (ICER) was calculated, followed by sensitivity analysis. Expected Quality Adjusted Life Years (QALYS) and costs to the NHS were calculated alongside health net benefits (HNB) and monetary net benefits (MNB). Result(s): A QALY gain of 0.069 was seen in use of LNG-IUS compared to LASH. This yielded a MNB between -44.99 and -734.99, alongside a HNB between -0.0705 QALYs and -0.106 QALYS. Using a 20,000-30,000/QALY limit outlined by NICE,this showed the LNG-IUS to be more cost-effective than LASH, with LASH exceeding the upper bound of the 30,000/QALY limit. Sensitivity analysis lowered the ICER below the given threshold. Conclusion(s): The ICER demonstrates it would not be cost-effective to replace the current gold-standard LNG-IUS with LASH, when treating menorrhagia in the UK. The ICER's proximity to the threshold and its high sensitivity alludes to the necessity for further research to generate a more reliable cost-effectiveness estimate. However, LASH could be considered as a first line treatment option in women with no desire to have children.Copyright © 2021 Elsevier Masson SAS

Laura, B. (2021). "Treatment of genitourinary syndrome of menopause. Systematic review and recommendations of the Spanish menopausal society." PROSPERO International prospective register of systematic reviews.
	
Lauren, C., et al. (2022). "Reproductive outcomes post in vitro maturation (IVM) in women with polycystic ovary syndrome (PCOS): A systematic review and meta-analyses." PROSPERO International prospective register of systematic reviews.
	
Laurentiu, C., et al. (2021). "Commercial endometrial transcriptomics tests of endometrial receptivity: present and future." PROSPERO International prospective register of systematic reviews.
	
Lauterbach, R., et al. (2022). "Maintenance Laser Treatment for Vaginal Looseness and Sexual Dysfunction: A Double-blinded Randomized Controlled Trial." The Journal of Sexual Medicine 19(9): 1404-1411.
	Background: Vaginal looseness and decreased sensation during intercourse is prevalent in up to 30%-55% of premenopausal women. The efficacy and safety of CO2 laser have been demonstrated for these indications; however, the effect is temporary, up to 6-12 months. No studies regarding the efficacy and safety of adjuvant laser treatments have been conducted to date.; Aim: To evaluate the efficacy and safety of a single maintenance CO 2 laser treatment in women with vaginal looseness and a concurrent decline in sexual sensation during intercourse.; Methods: This prospective double-blinded randomized controlled trial included premenopausal women who experienced significant temporary improvement in symptoms following previous treatment with CO2 laser due to the abovementioned indications. Participants were randomized to either a single CO2 laser treatment or a single sham treatment.; Outcomes: Treatment efficacy evaluated with the female sexual function index (FSFI) and the vaginal health index (VHI).; Results: Overall, 119 women were included in the study. Mean VHI and FSFI scores were significantly higher in the study group compared to the control group at three months post-treatment (17.34±1.39 vs 12.86±2.23, P = .023 and 30.93±1.79 vs 25.78±1.87, P = .044, respectively). In the study group, both VHI and FSFI returned to baseline at six months post-treatment. The median rate of sexual intercourse per month was increased in the study group at three months post-treatment (8 vs 4, P = .011), and returned to baseline at six months post-treatment.; Clinical Implications: Maintenance laser treatment provides a temporary non-surgical alternative for women with vaginal looseness and associated sexual dysfunction, though treatment effect seems to be limited to less than 6 months, requiring additional maintenance sessions.; Strengths and Limitations: The strengths of the current study include a randomized-sham controlled design. Furthermore, VHI was used as an objective evaluation tool, in addition to the FSFI, and assessment of the rate of sexual intercourse. The homogeneity and the relatively small sample size of the cohort is a limitation, and calls for caution in interpretation of the results, and the use of CO2 laser treatment in different age groups and populations.; Conclusion: A single maintenance laser treatment in women who previously underwent successful treatment with laser is an effective, well-tolerated, and safe procedure for treating symptoms of vaginal looseness and sexual dysfunction, though effects are temporary. Lauterbach R, Aharoni S, Farago N, et al. Maintenance Laser Treatment for Vaginal Looseness and Sexual Dysfunction: A Double-blinded Randomized Controlled Trial. J Sex Med 2022;19:1404-1411. (Copyright © 2022 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Lauterbach, R., et al. (2022). "The efficacy and safety of a single maintenance laser treatment for stress urinary incontinence: a double-blinded randomized controlled trial." International Urogynecology Journal 33(12): 3499-3504.
	Introduction and hypothesis: To evaluate the efficacy and safety of a single carbon dioxide (CO2) laser maintenance treatment in women previously treated successfully with laser for stress urinary incontinence (SUI), who have demonstrated a decline in treatment effect. Method(s): Women aged 40-70 years who experienced temporary significant improvement in symptoms following CO2 laser treatments for SUI were randomized to either the treatment group or the sham treatment control group. Cough test results, 1-h pad weights and scores on the Urogenital Distress Inventory (UDI6), the International Consultation of Incontinence Questionnaire (ICIQ-UI) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) were obtained at baseline and 3 and 6 months. Result(s): Of 183 women screened, 131 were included in the final analysis. Demographic characteristics and baseline measures in the outcome tests were similar between the groups. Statistically significant improvements were demonstrated in the study compared to the control group at 3 months post-treatment in positive cough test (44.4% vs. 79.4%, P = 0.002), mean pad weight test (2.3 g +/- 1.3 vs. 5.6 +/- 1.1, P < 0.001), mean UDI-6(24.7 +/- 12.1 vs. 45.1 +/- 13.6 SD, P = 0.004), mean ICIQ-UI (16.5 +/- 4.3 vs. 10.3 + 3.8, P = 0.003) and mean PISQ-12 (21.3 +/- 6.8 vs. 36.6 +/- 7.5, P = 0.003). However, values at 6 months post-treatment were similar to those at baseline. Conclusion(s): Our results suggest that a single maintenance laser treatment for reducing symptoms of SUI is transiently effective, well tolerated and safe. This treatment modality provides alternative non-surgical therapy for women with SUI.Copyright © 2022, The International Urogynecological Association.

Laveaux Obianuju Sandra, M. (2022). "Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)." ClinicalTrials.gov.
	In this project, the proposition is that the use of daily dosed Myfembree ( a combination of relugolix with estradiol and norethindrone acetate), FDA‐approved medication to treat heavy menses fibroid‐related symptoms, has the potential to delay the recurrence of fibroid symptoms, prolong the improved quality of life and delay the need for re‐intervention after uterine sparing surgery versus the routine standard of care.

Laven, J. (2022). "Online Brief CBT Intervention for Women With PCOS." ClinicalTrials.gov.
	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.

Lawrie Theresa, A., et al. (2019). "Robot-assisted surgery in gynaecology." The Cochrane Database of Systematic Reviews 4: CD011422.
	Background: This is an updated merged review of two originally separate Cochrane reviews: one on robot-assisted surgery (RAS) for benign gynaecological disease, the other on RAS for gynaecological cancer. RAS is a relatively new innovation in laparoscopic surgery that enables the surgeon to conduct the operation from a computer console, situated away from the surgical table. RAS is already widely used in the United States for hysterectomy and has been shown to be feasible for other gynaecological procedures. However, the clinical effectiveness and safety of RAS compared with conventional laparoscopic surgery (CLS) have not been clearly established and require independent review.; Objectives: To assess the effectiveness and safety of RAS in the treatment of women with benign and malignant gynaecological disease.; Search Methods: For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via Ovid, and EMBASE via Ovid, on 8 January 2018. We searched www.ClinicalTrials.gov. on 16 January 2018.; Selection Criteria: Randomised controlled trials (RCTs) comparing RAS versus CLS or open surgery in women requiring surgery for gynaecological disease.; Data Collection and Analysis: Two review authors independently assessed studies for inclusion and risk of bias, and extracted study data and entered them into an Excel spreadsheet. We examined different procedures in separate comparisons and for hysterectomy subgrouped data according to type of disease (non-malignant versus malignant). When more than one study contributed data, we pooled data using random-effects methods in RevMan 5.3.; Main Results: We included 12 RCTs involving 1016 women. Studies were at moderate to high overall risk of bias, and we downgraded evidence mainly due to concerns about risk of bias in the studies contributing data and imprecision of effect estimates. Procedures performed were hysterectomy (eight studies) and sacrocolpopexy (three studies). In addition, one trial examined surgical treatment for endometriosis, which included resection or hysterectomy. Among studies of women undergoing hysterectomy procedures, two studies involved malignant disease (endometrial cancer); the rest involved non-malignant disease.• RAS versus CLS (hysterectomy)Low-certainty evidence suggests there might be little or no difference in any complication rates between RAS and CLS (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.54 to 1.59; participants = 585; studies = 6; I² = 51%), intraoperative complication rates (RR 0.77, 95% CI 0.24 to 2.50; participants = 583; studies = 6; I² = 37%), postoperative complications (RR 0.81, 95% CI 0.48 to 1.34; participants = 629; studies = 6; I² = 44%), and blood transfusions (RR 1.94, 95% CI 0.63 to 5.94; participants = 442; studies = 5; I² = 0%). There was no statistical difference between malignant and non-malignant disease subgroups with regard to complication rates. Only one study reported death within 30 days and no deaths occurred (very low-certainty evidence). Researchers reported no survival outcomes.Mean total operating time was longer on average in the RAS arm than in the CLS arm (mean difference (MD) 41.18 minutes, 95% CI -6.17 to 88.53; participants = 148; studies = 2; I² = 80%; very low-certainty evidence), and the mean length of hospital stay was slightly shorter with RAS than with CLS (MD -0.30 days, 95% CI -0.53 to -0.07; participants = 192; studies = 2; I² = 0%; very low-certainty evidence).• RAS versus CLS (sacrocolpopexy)Very low-certainty evidence suggests little or no difference in rates of any complications between women undergoing sacrocolpopexy by RAS or CLS (RR 0.95, 95% CI 0.21 to 4.24; participants = 186; studies = 3; I² = 78%), nor in intraoperative complications (RR 0.82, 95% CI 0.09 to 7.59; participants = 108; studies = 2; I² = 47%). Low-certainty evidence on postoperative complications suggests these might be higher with RAS (RR 3.54, 95% CI 1.31 to 9.56; studies = 1; participants = 68). Researchers did not report blood transfusions and deaths up to days.Low-certainty evidence suggests that RAS might be associated with increased operating time (MD 40.53 min, 95% CI 12.06 to 68.99; participants = 186; studies = 3; I² = 73%). Very low-certainty evidence suggests little or no difference between the two techniques in terms of duration of stay (MD 0.26 days, 95% CI -0.15 to 0.67; participants = 108; studies = 2; I² = 0%).• RAS versus open abdominal surgery (hysterectomy)A single study with a total sample size of 20 women was included in this comparison. For most outcomes, the sample size was insufficient to show any possible differences between groups.• RAS versus CLS for endometriosisA single study with data for 73 women was included in this comparison; women with endometriosis underwent procedures ranging from relatively minor endometrial resection through hysterectomy; many of the women included in this study had undergone previous surgery for their condition. For most outcomes, event rates were low, and the sample size was insufficient to detect potential differences between groups.; Authors' Conclusions: Evidence on the effectiveness and safety of RAS compared with CLS for non-malignant disease (hysterectomy and sacrocolpopexy) is of low certainty but suggests that surgical complication rates might be comparable. Evidence on the effectiveness and safety of RAS compared with CLS or open surgery for malignant disease is more uncertain because survival data are lacking. RAS is an operator-dependent expensive technology; therefore evaluating the safety of this technology independently will present challenges.

Laxmi, S., et al. (2021). "Uterine septum management dilemma in women with recurrent miscarriages: systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Lazurko, C., et al. (2023). "Bevacizumab Treatment for Low-Grade Serous Ovarian Cancer: A Systematic Review." Current Oncology 30(9): 8159-8171.
	Serous epithelial ovarian cancer, classified as either high-grade (90%) or low-grade (10%), varies in molecular, histological, and clinicopathological presentation. Low-grade serous ovarian cancer (LGSOC) is a rare histologic subtype that lacks disease-specific evidence-based treatment regimens. However, LGSOC is relatively chemo-resistant and has a poor response to traditional treatments. Alternative treatments, including biologic therapies such as bevacizumab, have shown some activity in LGSOC. Thus, the objective of this systematic review is to determine the effect and safety of bevacizumab in the treatment of LGSOC. Following PRISMA guidelines, Medline ALL, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase all from the OvidSP platform, ClinicalTrials.gov, International Clinical Trials Registry Platform, International Standard Randomised Controlled Trial Number Registry were searched from inception to February 2022. Articles describing bevacizumab use in patients with LGSOC were included. Article screening, data extraction, and critical appraisal of included studies were completed by two independent reviewers. The effect of bevacizumab on the overall response rate, progression-free survival, overall survival, and adverse effects were summarized. The literature search identified 3064 articles, 6 of which were included in this study. A total of 153 patients were analyzed; the majority had stage IIIC cancer (56.2%). The overall median response rate reported in the studies was 47.5%. Overall, bevacizumab is a promising treatment for LGSOC, with response rates higher than traditional treatment modalities such as conventional chemotherapy, and is often overlooked as a treatment tool. A prospective clinical trial evaluating the use of bevacizumab in LGSOC is necessary to provide greater evidence and support these findings.

Leah, R., et al. (2022). "Future fertility and ectopic pregnancy recurrence in women of reproductive age with tubal ectopic pregnancy treated with expectant management, methotrexate or surgical intervention: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Leary, A. (2021). "OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC." ClinicalTrials.gov.
	The only therapeutic option for ovarian cancer patients presenting platinum sensitive relapse post‐ both bevacizumab and a PARPi is a platinum combination x 6 cycles followed by observation. There is no currently approved maintenance therapy in this setting. There is an urgent need for novel strategies for OC in relapse post bevacizumab and PARPi, in particular for novel maintenance strategies to prolong chemotherapy‐free intervals. One attractive strategy to turn OC from 'cold' tumors into a 'hot' tumor is via vaccination with tumor associated, or specific epitopes that have been modified to increase MHC and TCR binding. OSE2101 is a multi‐neoepitope vaccine covering relevant TAAs in OC, including p53 (mutated in 95% of high‐grade OC). In addition, the combination of OSE2101with an ICI may most effectively harness anti‐tumor immunity. If novel IO approaches are proposed in OC, they should be investigated early in the disease setting when host immunity is still robust, and with low tumor burden (platinum sensitive relapse and after 6 cycles of platinum chemotherapy). The hypothesis being tested is that OSE2101 alone or in combination with Pembrolizumab as maintenance treatment in patients with ovarian cancer platinum‐sensitive relapse could potentially bring benefit to subjects with high unmet medical need. A total of 180 patients with HLA‐A2 positive phenotype will be randomized using an Interactive Web Response System (IWRS) according to the following stratification factor: • Best response to platinum therapy: SD vs PR/CR In a 1:1:2 ration on the 3 study arms: ‐ Arm A (n=45): Observation/best supportive care ‐ Arm B (n=45): OSE2101: every 3 weeks until week 18, then every 6 weeks up to week 48, then every 12 weeks until disease progression, intolerance, patient withdrawal of consent or up to 2 years ‐ Arm C (n=90): OSE2101 + Pembrolizumab: OSE2101 same schedule as arm B plus pembrolizumab IV every 6 weeks until disease progression, intolerance, patient withdrawal of consent or up to 2 years Patient with phenotype HLA‐A2 negative will be followed in a separate cohort to record treatment and outcomes.

Leclair, C. (2022). "Vestibulectomy Surgical Techniques Comparison Study." ClinicalTrials.gov.
	No Results Available Other: Modified Technique|Other: Traditional Technique Change in Tampon Test pain scores from baseline to 3 months|Change in pain scores from baseline to 6 months|Change in pain scores from baseline to 12 months Female Not Applicable 118 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment OHSU IRB 24107 June 2025

Lederman, S., et al. (2023). "Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study." Lancet 401(10382): 1091-1102.
	Background: Neurokinin 3 receptor antagonists are potential non-hormonal therapies for the treatment of vasomotor symptoms in menopausal women as options are scarce for those who cannot or do not want to take hormone therapy. Fezolinetant is one of the first non-hormonal neurokinin 3 receptor antagonists in development for the treatment of vasomotor symptoms due to menopause. This study investigated the safety and efficacy of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.; Methods: SKYLIGHT 1 is a randomised, double-blind, placebo-controlled, 12-week, phase 3 trial with a 40-week active treatment extension. This trial was done at 97 facilities across the USA, Canada, Czech Republic, Hungary, Poland, Spain, and the UK. Women aged 40-65 years with an average of seven or more moderate-to-severe hot flashes per day were randomly assigned (1:1:1) to once-daily exact-matched placebo, fezolinetant 30 mg, or fezolinetant 45 mg. Randomisation was done using a web-based interactive response system and investigators, project team members, clinical staff, and participants were masked to treatment assignment. Coprimary endpoints were mean change in frequency and severity of vasomotor symptoms from baseline to weeks 4 and 12. The efficacy and safety analyses comprised all randomly assigned participants who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov (NCT04003155) and is completed.; Findings: Between July 11, 2019, and Aug 11, 2021, 2205 women were recruited of whom 175 were assigned to placebo, 176 to fezolinetant 30 mg, and 176 to fezolinetant 45 mg (175 in the placebo group, 174 in the fezolinetant 30 mg group, and 173 in the fezolinetant 45 mg received at least one dose [safety analysis set]). One participant randomly assigned to fezolinetant 45 mg received fezolinetant 30 mg in error, so the efficacy analysis set (full analysis set) consisted of 173 in the fezolinetant 30 mg group and 174 in the fezolinetant 45 mg group. 23 participants in the placebo group, 31 in the fezolinetant 30 mg group, and 13 in the fezolinetant 45 mg group discontinued treatment before week 12, mostly due to adverse events or participant withdrawal. Compared with placebo, fezolinetant 30 mg and fezolinetant 45 mg significantly reduced the frequency of vasomotor symptoms at week 4 (difference in change in least squares mean -1·87 [SE 0·42; p<0·001], -2·07 [SE 0·42; p<0·001]) and week 12 (-2·39 [SE 0·44; p<0·001], -2·55 [SE 0·43; p<0·001]). Compared with placebo, fezolinetant 30 mg and 45 mg significantly reduced the severity of vasomotor symptoms at week 4 (-0·15 [0·06; p=0·012], -0·19 [0·06; p=0·002]) and week 12 (-0·24 [0·08; p=0·002], -0·20 [0·08; p=0·007]). Improvements in frequency and severity of vasomotor symptoms were observed after 1 week and maintained over 52 weeks. During the first 12 weeks, treatment-emergent adverse events occurred in 65 (37%) of 174 women in the fezolinetant 30 mg group, 75 (43%) of 173 in the fezolinetant 45 mg group, and 78 (45%) of 175 in the placebo group. The incidence of liver enzyme elevations was low (placebo n=1; fezolinetant 30 mg n=2; fezolinetant 45 mg n=0) and these events were generally asymptomatic, transient, and resolved while on treatment or after treatment discontinuation.; Interpretation: Data support the clinical use of fezolinetant as a non-hormonal treatment for vasomotor symptoms associated with menopause. The study was placebo-controlled for 12 weeks followed by a 40-week blinded extension to assess the maintenance of effect. Furthermore, the population studied was diverse and representative of the potential target population for fezolinetant therapy. Further characterisation of the benefit of fezolinetant on quality of life, including on symptoms of mood and sexual wellbeing, merits investigation.; Funding: Astellas Pharma.; Competing Interests: Declaration of interests SL has received honoraria from AbbVie and research funding from AbbVie, Amgen, Aspira, Estetra, and Jans en. NS is a study investigator, member of the Scientific Advisory Board, and consultant for Astellas, a member of the Scientific Advisory Board for Amazon (Project Ember), Menogenix, and Que Oncology, a consultant for Ansh Labs, on the Program Committee for the North American Menopause Society (NAMS), past President of the Society for Reproductive Investigation, and is on the Nominating Committee for the Endocrine Society. RCT is a consultant and adviser for Astellas, a consultant for Bayer Healthcare, Happify Health, Pfizer, Procter and Gamble, and Vira Health, and is on the Board of Directors for NAMS. GN-P is a member of the Scientific Advisory Board for Astellas and Ferring Pharmaceuticals, has research funding from Merck, is Vice President of Diversity, Equity and Structural Change for the Society for Gynecological Investigations, and holds Committee Membership of the Endocrine Society. PS is a consultant for Astellas, board member for the European Menopause and Andropause Society (EMAS) and Deutsche Menopause Gesellschaft (DMG), and President of the Swiss Society for Gynecological Endocrinology and Menopause (SGEM). MS is on the advisory board or receives consulting fees or honoraria from Aspen, Astellas, BioSyent, Bayer, Duchesnay, GlaxoSmithKline, Merck, Mithra, Pfizer, Searchlight, Sprout, Sunovion, and Therapeutics MD, and fulfils a leadership or fiduciary role for the International Menopause Society, Terry Fox Research Institute, and Research Canada. AC is past President of the European Menopause and Andropause Society, and a consultant for Astellas, Theramex, and ItalFarmaco. FDO, ML, CF, and ME are employees of Astellas Pharma. (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Lederman Samuel, N. (2023). "Herbal Nutraceutical Supplementation on Vasomotor Symptoms in Menopausal Women." ClinicalTrials.gov.
	Menopause is characterized by the cessation of menstruation for 12 consecutive months. It is a natural phase in which a women's menstrual cycles permanently cease, with the transition often beginning around 50 years of age or older. Menopausal women often experience changes in vaginal health and sexuality, loss of bladder control, changes in mood, decreased sleep quality, changes in body composition, and vasomotor symptoms (VMS, including hot flashes and night sweats). VMS can have a negative impact on quality of life by disrupting both sleep and mood. Some management strategies for VMS include hypnosis, and supplementation of vitamin E, black cohosh, and phytoestrogens. However, hormone replacement therapy still remains the most common and effective treatment. Hormone replacement therapy, using estrogen or estrogen‐progestin containing products, reduces the frequency and severity of hot flashes by 75‐79%. Although hormone replacement therapy is generally well tolerated, it has been linked to an increased risk of breast cancer. Due to this concern it is recommended to use hormone replacement therapy for the shortest duration and lowest dose possible. There is a need for alternative options to help manage VMS in menopausal women, and dietary supplements may fill this role. The test product (TP) for this study is a dietary supplement containing a proprietary botanical blend containing polyphenols and flavonoids. These herbal ingredients have been previously investigated for various properties, which demonstrate the opportunity to support the quality of life of menopausal women experiencing VMS by improving sleep and mood. This randomized, double‐blind, placebo‐controlled, parallel study will be conducted to evaluate the TP for its impacts on healthy menopausal women with VMS.

Lee, B., et al. (2023). "Impact of PARP inhibitor maintenance therapy in newly diagnosed advanced epithelial ovarian cancer: A meta-analysis." PloS One 18(11): e0294647.
	Objectives: This meta-analysis was undertaken to systematically evaluate the effects of poly (ADP-ribose) polymerase inhibitor (PARPi) maintenance therapy on the survival of newly diagnosed advanced epithelial ovarian cancer (EOC) patients.; Methods/materials: A systematic literature search revealed 3,227 studies. A subsequent selection process identified seven suitable randomized studies that assessed the survival outcomes in newly diagnosed advanced EOC patients administered PARPi (n = 1921; the PARPi group) or placebo (n = 1150; the placebo group). The survival outcomes were compared with respect to the PARPi treatment regardless of bevacizumab maintenance therapy. All adverse events ≥ grade 3 were analyzed. Review Manager Version 5.4.1 software was used for the meta-analysis.; Results: The two-year progression-free survival (PFS) was significantly better in the PARPi group than the placebo (Hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.41 to 0.68). Furthermore, patients in the PARPi group with the BRCA1/2 mutation (BRCAm), BRCA wild type, homologous-recombination deficiency (HRD), or HRD without BRCAm, but not with homologous-recombination proficiency had a significantly better two-year PFS than the patients in the placebo group. The five-year overall survival (OS) was comparable in the two groups, but patients in the PARPi group with BRCAm had a significantly better five-year OS than those in the placebo group (HR, 0.57; 95% CI, 0.44 to 0.74). In addition, the adverse event rate (≥ grade 3) was significantly higher in the PARPi group than in the placebo group (HR, 2.94; 95% CI, 1.13 to 7.63).; Conclusions: In patients with newly diagnosed advanced EOC, PARPi maintenance therapy was significantly more effective in terms of survival than no PARPi treatment. However, the risk of serious adverse events was higher for patients who received PARPi maintenance therapy.; Competing Interests: The authors have declared that no competing interests exist. (Copyright: © 2023 Lee 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.)

Lee, E. and J. Zhang (2022). "Which assisted reproductive technology (ART) treatment strategy is the most clinically and cost-effective for women of advanced maternal age: a Markov model." BMC Health Services Research 22(1): 1197.
	Objective: To evaluate the clinical and cost-effectiveness of preimplantation genetic testing for aneuploidy, social freezing, donor and autologous assisted reproductive technology (ART) treatment strategies for women aged 35-45 following 6-12 months of infertility.; Methods: Four Markov decision-analytic models comprising: (i) Preimplantation genetic testing for aneuploidy (PGT-A); (ii) autologous ART from age 40 using oocytes cryopreserved at age 32 (social freezing); (iii) ART using donated oocytes (donor ART); (iv) standard autologous ART treatment (standard care) were developed for a hypothetical cohort of 35 to 45 years old ART naïve women with 6-12 months of infertility. Input probabilities for key parameters including live birth rates were obtained from the available literature. Deterministic and probabilistic sensitivity analyses were conducted to address uncertainty in estimating the parameters and around the model's assumptions. Cost effectiveness was assessed from both societal and patient perspectives .; Result(s): For infertile women at age 40 and above, social freezing is the most cost-saving strategy with the highest chance of a cumulative live birth at a lowest cost from a societal perspective. PGT-A and donor ART were associated with higher treatment costs and cumulative live-birth rates compared with the autologous ART. Among the four ART strategies, standard autologous ART has the lowest cumulative live birth rate of 45% at age 35 and decreasing to 1.6% by age 45 years. At a willingness-to-pay threshold of Australian dollars (A$)50,000, our model shows all alternative treatment strategies -PGT-A, social freezing and donor ART have a higher probability of being cost-effective compared to the standard autologous ART treatment. However, higher out-of-pocket expenditure may impede their access to these alternate strategies.; Conclusion: Given current evidence, all alternate strategies have a higher probability of being cost-effective compared to the standard autologous ART treatment. Whether this represents value for money depends on societal and individual's willingness-to-pay for children conceived with ART treatment. (© 2022. The Author(s).)

Lee, H. and S.-H. Lee (2023). "Effectiveness of an Integrated Mobile Application for Lifestyle Modifications in Overweight Women with Polycystic Ovarian Syndrome: A Randomized Controlled Trial." Life 13(7).
	Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women, characterized by hormonal imbalances and metabolic disturbances. Lifestyle modifications, including weight loss, are crucial for the management of PCOS symptoms. Mobile applications have emerged as promising tools to support lifestyle modifications. This study aimed to evaluate the effectiveness of a 12-week integrated lifestyle modification program, which used a mobile application, among overweight women with PCOS. A randomized controlled trial was conducted with 28 participants, who were assigned to either treatment group, which received a 12-week lifestyle modification program facilitated by a mobile application, or the control group, who were instructed to maintain their usual lifestyle and received an evidence-based leaflet containing information on PCOS. The primary outcome measure was a change in weight over 12 weeks. Insulin resistance, levels of sex hormones, hirsutism, acne, and depressive symptoms were measured as secondary outcomes. The results showed significant weight loss in the treatment group compared to the control group (3.19 vs. 0.79 kg; p < 0.05). Similarly, significant improvements were observed across time in postprandial insulin levels (22.25 vs. 9.29 μIU/mL), hirsutism (2.98 vs. -0.16 points), and depression (7.73 vs. 1.7 points) ( p < 0.05) between the two groups. This study highlights the potential benefits of using a mobile application to support lifestyle modifications, including weight loss and improvement in depressive symptoms, in overweight women with PCOS. Further research is needed to explore the long-term effects and incorporation of advanced technologies to enhance PCOS management outcomes. Mobile applications for lifestyle modifications offer a promising avenue for addressing the unique challenges faced by women with PCOS and provide accessible and personalized support for their health needs.

Lee, J. (2021). "A Clinical study for the evaluation of efficacy and safety of WMP-Pro on Menopausal symptom." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Dietary Supplement : WMP‐Pro group : Intake of WMP‐Pro(Probiotics complex 500mg/day) 1 capsule/day after meal for 12 weeks, Placebo : Intake of Placebo 1 capsule/day after meal for 12 weeks. CONDITION: Diseases of the genitourinary system PRIMARY OUTCOME: Kupperman Index SECONDARY OUTCOME: 1) Modified KI 2) MRS(Menopause Rating Scale) 3) MENQoL 4) Hot flushes 5) Waist circumference 6) Equol 7) BSALP, OC, CTx 8) Urine NTx 9) HDL‐C, LDL‐C, Triglyceride 10) Endothelin‐1, eNOS 11) Self‐assessment for improvement INCLUSION CRITERIA: 1) Woman aged between 45 and 60 years. 2) Woman who has passed one year since the last menstrual period or more than FSH 40 mIU / ml 3) Kupperman index score of 25 or higher 4) Woman who has agreed to participate in this study and written an informed consent

Lee, J. (2023). "A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-ov7/ ENGOT-ov80 Study)." ClinicalTrials.gov.
	Multicenter, randomized, open‐label, phase II clinical study comparing Dostarlimab +/‐ Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma. 198 subjects will be enrolled in this study and will be assigned to three groups in a 1:1:1 ratio. 1. Group A: Dostarlimab monotherapy ‐ First 3 cycles: Dostalimab 500mg every 3 weeks, IV ‐ 4 cycles up to 24 months: Dostalimab 1000mg every 6 weeks, IV 2. Group B: Dostarlimab + Bevacizumab combination therapy ‐ First 3 cycles: Dostalimab 500mg every 3 weeks, IV ‐ 4 cycles up to 24 months: Dostalimab 1000mg every 6 weeks, IV ‐ Bevacizumab administered IV at 15 mg/kg every 3 weeks until disease progression or unacceptable toxicity 3. Group C: General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)

Lee, J.-m. (2021). "Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents." ClinicalTrials.gov.
	PRIMARY OBJECTIVE: I. To assess the efficacy of the combinations durvalumab (MEDI4736) plus olaparib and cediranib, durvalumab (MEDI4736) plus cediranib, or olaparib and cediranib, as measured by progression‐free survival (PFS), as compared to physician's choice standard of care chemotherapy, in patients with recurrent platinum‐resistant ovarian, primary peritoneal or fallopian tube cancer who had prior bevacizumab. SECONDARY OBJECTIVES: I. To assess the efficacy of the combinations durvalumab (MEDI4736) plus olaparib and cediranib, durvalumab (MEDI4736) plus cediranib, or olaparib and cediranib, as measured by overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as compared to physician's choice standard of care chemotherapy, in patients with recurrent platinum‐resistant ovarian, primary peritoneal or fallopian tube cancer who had prior bevacizumab. II. To assess the efficacy of the combinations durvalumab (MEDI4736) plus olaparib and cediranib, durvalumab (MEDI4736) plus cediranib, or olaparib and cediranib, as measured by overall survival (OS), as compared to physician's choice standard of care chemotherapy, in patients with recurrent platinum‐resistant ovarian, primary peritoneal or fallopian tube cancer who had prior bevacizumab. OUTLINE: Patients are randomized to 1 of 4 arms. ARM I: Patients receive paclitaxel intravenously (IV) over 60 minutes on days 1, 8, and 15, or pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, or topotecan hydrochloride IV over 30 minutes on days 1, 8 and 15 or days 1‐5 per the discretion of the treating physician. Cycles repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening and as clinically indicated on study. Patients also undergo collection of blood and computed tomography (CT) with contrast during screening, and CT or magnetic resonance imaging (MRI) scans throughout the trial. ARM II: Patients receive durvalumab IV over 60 minutes on day 1, cediranib maleate orally (PO) once daily (QD) Monday through Friday, and olaparib PO twice daily (BID) on days 1‐28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial. ARM III: Patients receive durvalumab IV over 60 minutes on day 1 and cediranib maleate PO QD Monday through Friday. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial. ARM IV: Patients receive cediranib maleate PO QD on days 1‐28 and olaparib PO BID on days 1‐28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial. After completion of study treatment, patients are followed up periodically for up to 5 years.

Lee, J.-W. (2021). "Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer." ClinicalTrials.gov.
	No Results Available Drug: Metformin Treatment response rates Female Phase 3 77 Other Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment MetforminEndometrialCancer March 31, 2024

Lee, P. (2023). "Magnetic Stimulation as a Treatment for Stress Urinary Incontinence." ClinicalTrials.gov.
	A double‐blinded randomized controlled clinical trial with a treatment arm and a sham treatment arm will be conducted; followed by an open label trial at 3 months for any sham treatment arm participants who do not meet treatment success. The primary goal is to compare the subjective success rates for the resolution of stress urinary incontinence (SUI) for the magnetic stimulation treatment at 3 months. Secondary aims include an assessment of complications, resolution of SUI symptoms, patient bother from UI, quality of life and patient satisfaction. The proposed sample size is 158 patients. At the 3‐month post treatment evaluation, the treatment allocation will be unmasked. Patients will be followed post treatment up to 2 years.

Legro Richard, S., et al. (2022). "Effects of preconception lifestyle intervention in infertile women with obesity: The FIT-PLESE randomized controlled trial." PLoS Medicine 19(1): e1003883.
	Background: Women with obesity and infertility are counseled to lose weight prior to conception and infertility treatment to improve pregnancy rates and birth outcomes, although confirmatory evidence from randomized trials is lacking. We assessed whether a preconception intensive lifestyle intervention with acute weight loss is superior to a weight neutral intervention at achieving a healthy live birth.; Methods and Findings: In this open-label, randomized controlled study (FIT-PLESE), 379 women with obesity (BMI ≥ 30 kg/m2) and unexplained infertility were randomly assigned in a 1:1 ratio to 2 preconception lifestyle modification groups lasting 16 weeks, between July 2015 and July 2018 (final follow-up September 2019) followed by infertility therapy. The primary outcome was the healthy live birth (term infant of normal weight without major anomalies) incidence. This was conducted at 9 academic health centers across the United States. The intensive group underwent increased physical activity and weight loss (target 7%) through meal replacements and medication (Orlistat) compared to a standard group with increased physical activity alone without weight loss. This was followed by standardized empiric infertility treatment consisting of 3 cycles of ovarian stimulation/intrauterine insemination. Outcomes of any resulting pregnancy were tracked. Among 191 women randomized to standard lifestyle group, 40 dropped out of the study before conception; among 188 women randomized to intensive lifestyle group, 31 dropped out of the study before conception. All the randomized women were included in the intent-to-treat analysis for primary outcome of a healthy live birth. There were no significant differences in the incidence of healthy live births [standard 29/191(15.2%), intensive 23/188(12.2%), rate ratio 0.81 (0.48 to 1.34), P = 0.40]. Intensive had significant weight loss compared to standard (-6.6 ± 5.4% versus -0.3 ± 3.2%, P < 0.001). There were improvements in metabolic health, including a marked decrease in incidence of the metabolic syndrome (baseline to 16 weeks: standard: 53.6% to 49.4%, intensive 52.8% to 32.2%, P = 0.003). Gastrointestinal side effects were significantly more common in intensive. There was a higher, but nonsignificant, first trimester pregnancy loss in the intensive group (33.3% versus 23.7% in standard, 95% rate ratio 1.40, 95% confidence interval [CI]: 0.79 to 2.50). The main limitations of the study are the limited power of the study to detect rare complications and the design difficulty in finding an adequate time matched control intervention, as the standard exercise intervention may have potentially been helpful or harmful.; Conclusions: A preconception intensive lifestyle intervention for weight loss did not improve fertility or birth outcomes compared to an exercise intervention without targeted weight loss. Improvement in metabolic health may not translate into improved female fecundity.; Trial Registration: ClinicalTrials.gov NCT02432209.; Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: R.S.L reports consulting fees from InSupp, Ferring, Bayer, Abbvie and Fractyl and research sponsorship from Guerbet and the NIH (U10 HD38992). K.R.H. reports research support from Roche Diagnostics, Ferring and Ablacare and the NIH (U10HD077680). M.P.D reports institutional grants/contracts from Bayer, ObsEva, and AbbVie; serving as a member of the Board of Directors and a stockholder of Advanced Reproductive Care; and serving as a Consultant for Seikagaku, Actamax, AEGEA, Temple Therapeutics, and ARC Medical Devices as well as receiving funding from the NIH(U10 HD39005). A.Z.S. reports consulting fees from Seikagaku and Prima-Temp and research funding from the NIH. M.I.C. reports research funding from Ferring Pharmaceuticals and the NIH (U10HD077844). C.C. reports research funding from the NIH (U10 HD27049). R.A.W. reports Ablacare PCOS, Amgen Repatha in Pg and Partners Mass General Menopause Reviews, grants from NICHD. A.K. reports research grant from Merck. D.B.S. reports grants from National Institute of Diabetes, Digestive and Kidney Disease, National Institute of Dental and Craniofacial Research, Department of Defense and Commonwealth of Pennsylvania (PA CURE), consulting fees from Ethicon and NovoNordisk. N.S. reports consulting for Ansh Labs, and is a Scientific Advisor to Astellas and Menogenix, Inc. H.Z. reports research funding from the NIH (U10HD055925).

Lei, T., et al. (2023). "Clinical effect of integrated Chinese and Western medicine on infertility caused by polycystic ovary syndrome:a network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Leitch, J., et al. (2022). "Magnesium-Based Trigger Point Infiltrations Versus Local Anaesthetic Infiltrations in Chronic Pelvic Myofascial Pain: A Randomized, Double-Blind, Controlled Study." Journal of Obstetrics and Gynaecology Canada 44(8): 877-885.
	Objective: To determine if a novel, magnesium-based trigger point infiltration formulation is more effective in treating chronic myofascial pelvic pain than lidocaine-only infiltration.; Methods: This was a single-centre, double-blind, randomized controlled trial of women diagnosed with chronic pelvic myofascial pain associated with trigger points. We compared a novel magnesium-based infiltration formulation with lidocaine infiltration of trigger points and with a control group of participants who were waitlisted for a chronic pain clinic. Treatment groups completed a 12-week program that included 8 trigger point injection treatments and 9 visits during which pain scores were recorded and questionnaires administered. The primary outcome measure was change in mean pain score between baseline and the final visit. Secondary outcomes included pain with function scores, scores on the World Health Organization Quality of Life questionnaire, procedural pain, concomitant medication use, and complications.; Results: We assigned 44 women diagnosed with chronic myofascial pelvic pain associated with trigger points to either the magnesium-based infiltrate (n = 15), lidocaine infiltrate (n = 17), or waitlist (n = 12) group. In the intent-to-treat analysis, a clinically relevant decrease in mean pain score out of 10 was observed in the magnesium-based (-2.6 ± 3.2) and lidocaine (-2.9 ± 3.1) infiltration groups, but not in the waitlist group (-0.5 ± 2.3). The per protocol analysis post-hoc tests, adjusted for multiple comparisons, found a significant difference in the average change in pain score between the magnesium-based infiltrate and the waitlist groups (P = 0.045), while differences between the lidocaine infiltrate and waitlist groups approached statistical significance (P = 0.052). Both treatment groups saw improvements in pain with function and quality of life scores.; Conclusion: While this study is underpowered, it does not support the use of a magnesium-based trigger point infiltrate in the treatment of chronic myofascial pelvic pain over lidocaine-only infiltration. Nonetheless, these results are consistent with current management recommendations and suggest improvements in pain, pain with function, and quality of life scores with either magnesium-based or lidocaine-only infiltration. We outline an approach to assessment and treatment that can be adopted by general gynaecologists. (Copyright © 2022. Published by Elsevier Inc.)

Leme, N., et al. (2020). "Use of mobile apps for controlling of the urinary incontinence: A systematic review." Neurourology and Urodynamics 39(4): 1036-1048.
	OBJECTIVE: The primary objective was to evaluate the impact of app use on urinary incontinence control through pelvic floor muscle training when compared to the postal treatment plan. The secondary objectives were to evaluate how app use may affect the quality of life (QoL) of users and treatment adherence. MATERIAL AND METHODS: Eight databases (PubMed, SciELO, Embase, Web of Science, LILACS, Open Gray, Open Thesis, and OATD) were used as research sources. The protocol was registered in PROSPERO (CRD 42020145709). Randomized controlled trials assessing urinary incontinence (UI) control with app use, with no restriction of year, language, and status of publication were included. The JBI Systematic Reviews Checklist for Randomized Controlled Trials assessed the risk of bias of the studies selected. The mean scores of QoL between the pre- and postintervention periods were compared through standardized mean differences, which were weighted according to the number of months between the two periods. RESULTS: Only three studies met the eligibility criteria and were included. The methodological quality of the studies was from "low" to "moderate" risk of bias. The full sample included 203 patients with app-based treatment e 203 controls of postal treatment. All studies showed the reduction of urinary symptoms. In addition, two studies showed a reduction of QoL scores specific for the condition, while one study presented increased scores. CONCLUSION: Reminder therapy seems to be a promising strategy for controlling UI.

Lemi, B., et al. (2022). "The effectiveness and safety of alternative drugs compared to standard regimens for medical termination of pregnancy, a systematic review, and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Lemmers, M., et al. (2019). "Medical treatment for early fetal death (less than 24 weeks)." The Cochrane Database of Systematic Reviews 6: CD002253.
	Background: In most pregnancies that miscarry, arrest of embryonic or fetal development occurs some time (often weeks) before the miscarriage occurs. Ultrasound examination can reveal abnormal findings during this phase by demonstrating anembryonic pregnancies or embryonic or fetal death. Treatment has traditionally been surgical but medical treatments may be effective, safe, and acceptable, as may be waiting for spontaneous miscarriage. This is an update of a review first published in 2006.; Objectives: To assess, from clinical trials, the effectiveness and safety of different medical treatments for the termination of non-viable pregnancies.; Search Methods: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (24 October 2018) and reference lists of retrieved studies.; Selection Criteria: Randomised trials comparing medical treatment with another treatment (e.g. surgical evacuation), or placebo, or no treatment for early pregnancy failure. Quasi-randomised studies were excluded. Cluster-randomised trials were eligible for inclusion, as were studies reported in abstract form, if sufficient information was available to assess eligibility.; Data Collection and Analysis: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the quality of the evidence using the GRADE approach.; Main Results: Forty-three studies (4966 women) were included. The main interventions examined were vaginal, sublingual, oral and buccal misoprostol, mifepristone and vaginal gemeprost. These were compared with surgical management, expectant management, placebo, or different types of medical interventions were compared with each other. The review includes a wide variety of different interventions which have been analysed across 23 different comparisons. Many of the comparisons consist of single studies. We limited the grading of the quality of evidence to two main comparisons: vaginal misoprostol versus placebo and vaginal misoprostol versus surgical evacuation of the uterus. Risk of bias varied widely among the included trials. The quality of the evidence varied between the different comparisons, but was mainly found to be very-low or low quality.Vaginal misoprostol versus placeboVaginal misoprostol may hasten miscarriage when compared with placebo: e.g. complete miscarriage (5 trials, 305 women, risk ratio (RR) 4.23, 95% confidence interval (CI) 3.01 to 5.94; low-quality evidence). No trial reported on pelvic infection rate for this comparison. Vaginal misoprostol made little difference to rates of nausea (2 trials, 88 women, RR 1.38, 95% CI 0.43 to 4.40; low-quality evidence), diarrhoea (2 trials, 88 women, RR 2.21, 95% CI 0.35 to 14.06; low-quality evidence) or to whether women were satisfied with the acceptability of the method (1 trial, 32 women, RR 1.17, 95% CI 0.83 to 1.64; low-quality evidence). It is uncertain whether vaginal misoprostol reduces blood loss (haemoglobin difference > 10 g/L) (1 trial, 50 women, RR 1.25, 95% CI 0.38 to 4.12; very-low quality) or pain (opiate use) (1 trial, 84 women, RR 5.00, 95% CI 0.25 to 101.11; very-low quality), because the quality of the evidence for these outcomes was found to be very low.Vaginal misoprostol versus surgical evacuation Vaginal misoprostol may be less effective in accomplishing a complete miscarriage compared to surgical management (6 trials, 943 women, average RR 0.40, 95% CI 0.32 to 0.50; Heterogeneity: Tau² = 0.03, I² = 46%; low-quality evidence) and may be associated with more nausea (1 trial, 154 women, RR 21.85, 95% CI 1.31 to 364.37; low-quality evidence) and diarrhoea (1 trial, 154 women, RR 40.85, 95% CI 2.52 to 662.57; low-quality evidence). There may be little or no difference between vaginal misoprostol and surgical evacuation for pelvic infection (1 trial, 618 women, RR 0.73, 95% CI 0.39 to 1.37; low-quality evidence), blood loss (post-treatment haematocrit (%) (1 trial, 50 men, mean difference (MD) 1.40%, 95% CI -3.51 to 0.71; low-quality evidence), pain relief (1 trial, 154 women, RR 1.42, 95% CI 0.82 to 2.46; low-quality evidence) or women's satisfaction/acceptability of method (1 trial, 45 women, RR 0.67, 95% CI 0.40 to 1.11; low-quality evidence).Other comparisonsBased on findings from a single trial, vaginal misoprostol was more effective at accomplishing complete miscarriage than expectant management (614 women, RR 1.25, 95% CI 1.09 to 1.45). There was little difference between vaginal misoprostol and sublingual misoprostol (5 trials, 513 women, average RR 0.84, 95% CI 0.61 to 1.16; Heterogeneity: Tau² = 0.10, I² = 871%; or between oral and vaginal misoprostol in terms of complete miscarriage at less than 13 weeks (4 trials, 418 women), average RR 0.68, 95% CI 0.45 to 1.03; Heterogeneity: Tau² = 0.13, I² = 90%). However, there was less abdominal pain with vaginal misoprostol in comparison to sublingual (3 trials, 392 women, RR 0.58, 95% CI 0.46 to 0.74). A single study (46 women) found mifepristone to be more effective than placebo: miscarriage complete by day five after treatment (46 women, RR 9.50, 95% CI 2.49 to 36.19). However the quality of this evidence is very low: there is a very serious risk of bias with signs of incomplete data and no proper intention-to-treat analysis in the included study; and serious imprecision with wide confidence intervals. Mifepristone did not appear to further hasten miscarriage when added to a misoprostol regimen (3 trials, 447 women, RR 1.18, 95% CI 0.95 to 1.47).; Authors' Conclusions: Available evidence from randomised trials suggests that medical treatment with vaginal misoprostol may be an acceptable alternative to surgical evacuation or expectant management. In general, side effects of medical treatment were minor, consisting mainly of nausea and diarrhoea. There were no major differences in effectiveness between different routes of administration. Treatment satisfaction was addressed in only a few studies, in which the majority of women were satisfied with the received intervention. Since the quality of evidence is low or very low for several comparisons, mainly because they included only one or two (small) trials; further research is necessary to assess the effectiveness, safety and side effects, optimal route of administration and dose of different medical treatments for early fetal death.

Lenger Stacy, M., et al. (2023). "d-Mannose for Recurrent Urinary Tract Infection Prevention in Postmenopausal Women Using Vaginal Estrogen: A Randomized Controlled Trial." Urogynecology 29(3): 367-377.
	Importance: Further research is needed to determine whether d-mannose plus vaginal estrogen therapy (VET) is beneficial over VET alone for recurrent urinary tract infection (rUTI) prevention.; Objective: The aim of this study was to evaluate d-mannose efficacy for rUTI prevention in postmenopausal women using VET.; Study Design: We conducted a randomized controlled trial comparing d-mannose (2 g/d) with control. Participants were required to have a history of uncomplicated rUTIs and to remain on VET throughout the trial. They were followed up 90 days for incident UTIs. Cumulative UTI incidences were calculated by the Kaplan-Meier method and compared by Cox proportional hazards regression. For the planned interim analysis, P < 0.001 was considered statistically significant. Futility analysis was performed by generating post hoc conditional power for multiple scenarios.; Results: We evaluated 545 patients for frequent/recurrent UTIs from March 1, 2018, to January 18, 2020. Of these women, 213 had culture-proven rUTIs, 71 were eligible, 57 enrolled, 44 began their planned 90-day study period, and 32 completed the study. At interim analysis, the overall cumulative UTI incidence was 46.6%; 41.1% in the treatment arm (median time to first UTI, 24 days) and 50.4% in the control arm (median, 21 days); hazard ratio, 0.76; 99.9% confidence interval, 0.15-3.97. d-Mannose was well tolerated with high participant adherence. Futility analysis suggested the study lacked power to detect the planned (25%) or observed (9%) difference as statistically significant; the study was halted before conclusion.; Conclusions: d-Mannose is a well-tolerated nutraceutical, but further research is needed to determine whether d-mannose in combination with VET has a significant, beneficial effect beyond VET alone in postmenopausal women with rUTIs.; Competing Interests: The authors have declared they have no conflicts of interest. (Copyright © 2022 American Urogynecologic Society. All rights reserved.)

Lensen Sarah, F., et al. (2021). "Endometrial injury in women undergoing in vitro fertilisation (IVF)." The Cochrane Database of Systematic Reviews 6: CD009517.
	Background: Implantation of an embryo within the endometrial cavity is a critical step in the process of in vitro fertilisation (IVF). Previous research has suggested that endometrial injury (also known as endometrial scratching), defined as intentional damage to the endometrium, can increase the chance of pregnancy in women undergoing IVF.; Objectives: To assess the effectiveness and safety of endometrial injury performed before embryo transfer in women undergoing in vitro fertilisation (IVF) including intracytoplasmic sperm injection (ICSI) and frozen embryo transfer.; Search Methods: In June 2020 we searched the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, LILACS, DARE and two trial registries. We also checked the reference sections of relevant studies and contacted experts in the field for any additional trials.; Selection Criteria: Randomised controlled trials comparing intentional endometrial injury before embryo transfer in women undergoing IVF, versus no intervention or a sham procedure.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. Two independent review authors screened studies, evaluated risk of bias and assessed the certainty of the evidence by using GRADE (Grading of Recommendation, Assessment, Development and Evaluation) criteria. We contacted and corresponded with study investigators as required. Due to the high risk of bias associated with many of the studies, the primary analyses of all review outcomes were restricted to studies at a low risk of bias for selection bias and other bias. Sensitivity analysis was then performed including all studies. The primary review outcomes were live birth and miscarriage.; Main Results: Endometrial injury versus control (no procedure or a sham procedure) A total of 37 studies (8786 women) were included in this comparison. Most studies performed endometrial injury by pipelle biopsy in the luteal phase of the cycle before the IVF cycle. The primary analysis was restricted to studies at low risk of bias, and included eight studies. The effect of endometrial injury on live birth is unclear as the result is consistent with no effect, or a small reduction, or an improvement (odds ratio (OR) 1.12, 95% confidence interval (CI) 0.98 to 1.28; participants = 4402; studies = 8; I 2 = 15%, moderate-certainty evidence). This suggests that if the chance of live birth with IVF is usually 27%, then the chance when using endometrial injury would be somewhere between < 27% and 32%. Similarly, the effect of endometrial injury on clinical pregnancy is unclear (OR 1.08, 95% CI 0.95 to 1.23; participants = 4402; studies = 8; I 2 = 0%, moderate-certainty evidence). This suggests that if the chance of clinical pregnancy from IVF is normally 32%, then the chance when using endometrial injury before IVF is between 31% and 37%. When all studies were included in the sensitivity analysis, we were unable to conduct meta-analysis for the outcomes of live birth and clinical pregnancy due to high risk of bias and statistical heterogeneity. Endometrial injury probably results in little to no difference in chance of miscarriage (OR 0.88, 95% CI 0.68 to 1.13; participants = 4402; studies = 8; I 2 = 0%, moderate-certainty evidence), and this result was similar in the sensitivity analysis that included all studies. The result suggests that if the chance of miscarriage with IVF is usually 6.0%, then when using endometrial injury it would be somewhere between 4.2% and 6.8%. Endometrial injury was associated with mild to moderate pain (approximately 4 out of 10), and was generally associated with some minimal bleeding. The evidence was downgraded for imprecision due to wide confidence intervals and therefore all primary analyses were graded as moderate certainty. Higher versus lower degree of injury Only one small study was included in this comparison (participants = 129), which compared endometrial injury using two different instruments in the cycle prior to the IVF cycle: a pipelle catheter and a She ard catheter. This trial was excluded from the primary analysis due to risk of bias. In the sensitivity analysis, all outcomes reported for this study were graded as very-low certainty due to risk of bias, and as such we were not able to interpret the study results.; Authors' Conclusions: The effect of endometrial injury on live birth and clinical pregnancy among women undergoing IVF is unclear. The results of the meta-analyses are consistent with an increased chance, no effect and a small reduction in these outcomes. We are therefore uncertain whether endometrial injury improves the chance of live birth or clinical pregnancy in women undergoing IVF. Endometrial injury does not appear to affect the chance of miscarriage. It is a somewhat painful procedure associated with a small amount of bleeding. In conclusion, current evidence does not support the routine use of endometrial injury for women undergoing IVF. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Leonardi, M., et al. (2021). "Surgical interventions for the management of chronic pelvic pain in women." The Cochrane Database of Systematic Reviews 12: CD008212.
	Background: Chronic pelvic pain (CPP) is a common gynaecological condition accounting for 20% of all gynaecological referrals. There are wide ranges of causes with overlapping symptomatology, therefore the management of the condition is a formidable challenge for clinicians. The aetiology of CPP is heterogeneous and in many cases, no clear diagnosis can be reached. It is in this scenario that the label of chronic pelvic pain syndrome (CPPS) can be applied. We defined women with CPPS as having a minimum duration of pain of at least 6 months, including with a diagnosis of pelvic congestion syndrome, but excluding pain caused by a condition such as endometriosis. Many surgical interventions have been tried in isolation or in conjunction with non-surgical interventions in the management with variable results. Surgical interventions are invasive and carry operative risks. Surgical interventions must be evaluated for their effectiveness prior to their prevalent use in the management of women with CPPS.; Objectives: To review the effectiveness and safety of surgical interventions in the management of women with CPPS.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase and PsycINFO, on 23 April 2021 for any randomised controlled trials (RCT) for surgical interventions in women with CPPS. We also searched the citation lists of relevant publications, two trial registries, relevant journals, abstracts, conference proceedings and several key grey literature sources.; Selection Criteria: RCTs with women who had CPPS. The review authors were prepared to consider studies of any surgical intervention used for the management of CPPS. Outcome measures were pain rating scales, adverse events, psychological outcomes, quality of life (QoL) measures and requirement for analgesia.; Data Collection and Analysis: Two review authors independently evaluated studies for inclusion and extracted data using the forms designed according to Cochrane guidelines. For each included trial, we collected information regarding the method of randomisation, allocation concealment, blinding, data reporting and analyses. We reported pooled results as mean difference (MDs) or odds ratios (OR) and 95% confidence interval (CI) by the Mantel-Haenszel method. If similar outcomes were reported on different scales, we calculated the standardised mean difference (SMD). We applied GRADE criteria to judge the overall certainty of the evidence.; Main Results: Four studies met our inclusion criteria involving 216 women with CPP and no identifiable cause. Adhesiolysis compared to no surgery or diagnostic laparoscopy We are uncertain of the effect of adhesiolysis on pelvic pain scores postoperatively at three months (MD -7.3, 95% CI -29.9 to 15.3; 1 study, 43 participants; low-certainty evidence), six months (MD -14.3, 95% CI -35.9 to 7.3; 1 study, 43 participants; low-certainty evidence) and 12 months postsurgery (MD 0.00, 95% CI -4.60; 1 study, 43 participants; very low-certainty evidence). Adhesiolysis may improve both the emotional wellbeing (MD 24.90, 95% CI 7.92 to 41.88; 1 study, 43 participants; low-certainty evidence) and social support (MD 23.90, 95% CI -1.77 to 49.57; 1 study, 43 participants; low-certainty evidence) components of the Endometriosis Health Profile-30, and both the emotional component (MD 32.30, 95% CI 13.16 to 51.44; 1 study, 43 participants; low-certainty evidence) and the physical component of the 12-item Short Form (MD 22.90, 95% CI 10.97 to 34.83; 1 study, 43 participants; low-certainty evidence) when compared to diagnostic laparoscopy. We are uncertain of the safety of adhesiolysis compared to comparator groups due to low-certainty evidence and lack of structured adverse event reporting. No studies reported on psychological outcomes or requirements for analgesia. Laparoscopic uterosacral ligament ablation or resection compared to diagnostic laparoscopy/other treatment We are uncertain of the effect of laparoscopic uterosacral ligament/nerve ablat on (LUNA) or resection compared to other treatments postoperatively at three months (OR 1.26, 95% CI 0.40 to 3.93; 1 study, 51 participants; low-certainty evidence) and six months (MD -2.10, 95% CI -4.38 to 0.18; 1 study, 74 participants; very low-certainty evidence). At 12 months post-surgery, we are uncertain of the effect of LUNA on the rate of successful treatment compared to diagnostic laparoscopy. One study of 56 participants found no difference in the effect of LUNA on non-cyclical pain (P = 0.854) or dyspareunia (P = 0.41); however, there was a difference favouring LUNA on dysmenorrhea (P = 0.045) and dyschezia (P = 0.05). We are also uncertain of the effect of LUNA compared to vaginal uterosacral ligament resection on pelvic pain at 12 months (MD 2.00, 95% CI 0.47 to 3.53; 1 study, 74 participants; very low-certainty evidence). We are uncertain of the safety of LUNA or resection compared to comparator groups due to the lack of structured adverse event reporting. Women undergoing LUNA may require more analgesia postoperatively than those undergoing other treatments (P < 0.001; 1 study, 74 participants). No studies reported psychological outcomes or QoL.; Authors' Conclusions: We are uncertain about the benefit of adhesiolysis or LUNA in management of pain in women with CPPS based on the current literature. There may be a QoL benefit to adhesiolysis in improving both emotional wellbeing and social support, as measured by the validated QoL tools. It was not possible to synthesis evidence on adverse events as these were only reported narratively in some studies, in which none were observed. With the inadequate objective assessment of adverse events, especially long-term adverse events, associated with adhesiolysis or LUNA for CPPS, there is currently little to support these interventions for CPPS. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Leonardi, M., et al. (2020). "When to Do Surgery and When Not to Do Surgery for Endometriosis: A Systematic Review and Meta-analysis." Journal of Minimally Invasive Gynecology 27(2): 390.
	Objective: We performed a systematic review and meta-analysis with the aim to answer whether operative laparoscopy is an effective treatment in a woman with demonstrated endometriosis compared with alternative treatments. Moreover, we aimed to assess the risks of operative laparoscopy compared with those of alternatives. In addition, we aimed to systematically review the literature on the impact of patient preference on decision making around surgery.; Data Sources: We searched MEDLINE, Embase, PsycINFO, ClinicalTrials.gov, CINAHL, Scopus, OpenGrey, and Web of Science from inception through May 2019. In addition, a manual search of reference lists of relevant studies was conducted.; Methods of Study Selection: Published and unpublished randomized controlled trials (RCTs) in any language describing a comparison between surgery and any other intervention were included, with particular reference to timing and its impact on pain and fertility. Studies reporting on keywords including, but not limited to, endometriosis, laparoscopy, pelvic pain, and infertility were included. In the anticipated absence of RCTs on patient preference, all original research on this topic was considered eligible.; Tabulation, Integration, and Results: In total, 1990 studies were reviewed. Twelve studies were identified as being eligible for inclusion to assess outcomes of pain (n = 6), fertility (n = 7), quality of life (n = 1), and disease progression (n = 3). Seven studies of interest were identified to evaluate patient preferences. There is evidence that operative laparoscopy may improve overall pain levels at 6 months compared with diagnostic laparoscopy (risk ratio [RR], 2.65; 95% confidence interval [CI], 1.61-4.34; p <.001; 2 RCTs, 102 participants; low-quality evidence). Because the quality of the evidence was very low, it is uncertain if operative laparoscopy improves live birth rates. Operative laparoscopy probably yields little or no difference regarding clinical pregnancy rates compared with diagnostic laparoscopy (RR, 1.29; 95% CI, 0.99-1.92; p = .06; 4 RCTs, 624 participants; moderate-quality evidence). It is uncertain if operative laparoscopy yields a difference in adverse outcomes when compared with diagnostic laparoscopy (RR, 1.98; 95% CI, 0.84-4.65; p = .12; 5 RCTs, 554 participants; very-low-quality evidence). No studies reported on the progression of endometriosis to a symptomatic state or progression of extent of disease in terms of volume of lesions and locations in asymptomatic women with endometriosis. We found no studies that reported on the timing of surgery. No quantitative or qualitative studies specifically aimed at elucidating the factors informing a woman's choice for surgery were identified.; Conclusion: Operative laparoscopy may improve overall pain levels but may have little or no difference with respect to fertility-related or adverse outcomes when compared with diagnostic laparoscopy. Additional high-quality RCTs, including comparing surgery to medical management, are needed, and these should report adverse events as an outcome. Studies on patient preference in surgical decision making are needed (International Prospective Register of Systematic Review registration number: CRD42019135167). (Copyright © 2019 AAGL. Published by Elsevier Inc. All rights reserved.)

Leonardo, K., et al. (2022). "Biofeedback-assisted pelvic floor muscle training and pelvic electrical stimulation in women with overactive bladder: A systematic review and meta-analysis of randomized controlled trials." Neurourology and Urodynamics 41(6): 1258-1269.
	OBJECTIVE: This meta-analysis aims to compare biofeedback-assisted pelvic muscle floor training (PFMT) and pelvic electrical stimulation (ES) as an intervention group, with PFMT or bladder training (BT) as the control group, in women with an overactive bladder (OAB). METHOD: PubMed, Cochrane, CINAHL, EMBASE, and Scopus were systematically searched for randomized controlled trials (RCTs) published up to November 2021. The RCTs were screened for our eligibility criteria and quality was evaluated using the Cochrane Risk Index of Bias tools. The outcomes were changes in quality of life (QoL), episodes of incontinence, and the number of participants cured/improved. RESULTS: Eight studies involving 562 patients (comprising 204 patients with biofeedback-assisted PFMT, 108 patients with pelvic ES, and 250 patients who received PFMT alone or BT and lifestyle recommendations only, as the control group) were included. The ES group showed significant differences in terms of changes to QoL (mean difference [MD]: 7.41, 95% confidence interval [CI]: 7.90-12.92, p = 0.008), episodes of incontinence (MD: -1.33, 95% CI: -2.50 to -0.17, p = 0.02), and the number of participants cured or improved (risk ratio [RR]: 1.46, 95% CI: 1.14-1.87, p = 0.003), while the biofeedback group resulted in nonsignificant changes in QoL (MD: 0.13, 95% CI: 7.87-8.12, p = 0.98), episodes of incontinence (MD: 0.01, 95% CI: -0.89 to 0.90, p = 0.99), and the number of participants cured or improved (RR: 1.15, 95% CI: 0.99-1.33, p = 0.08), both compared to the control group respectively. CONCLUSION: This meta-analysis shows that low-frequency pelvic ES appears to be sufficient and effective as an additional intervention for women with OAB in clinical practice according to improvements in the subjects' QoL and reduction of symptoms. Meanwhile, biofeedback-assisted PFMT does not appear to be a significant adjuvant for conservative OAB therapy.

Leonardo, R., et al. (2023). "Efficacy and safety of adjuvant chemotherapy in early-stage endometrioid ovarian carcinoma: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Leppänen, R., et al. (2022). "Single-administered GnRH agonist as luteal phase support in insemination cycles: a randomized controlled trial." Gynecological Endocrinology 38(5): 438-442.
	Objective: To find out whether a single-administered GnRH agonist improves the live birth rate in real-life patients undergoing intrauterine insemination (IUI) cycles.; Study Design: A prospective, randomized controlled trial in a public single tertiary center in Tampere University Hospital, Finland. Altogether 251 IUI cycles in 163 patients were randomized to triptorelin and a control group between January 2017 and April 2019. In the triptorelin group, the participants had a single administration of a subcutaneous GnRH agonist triptorelin 0.1 mg at the time of implantation. In the control group, there was no luteal phase support. The primary outcome measure was the live birth rate (LBR). The secondary outcome measures were clinical pregnancy rate (CPR) and miscarriage rate.; Results: Overall, the live birth rate was lower in the triptorelin group compared to the control group (7.9 vs. 12.1%; p = .297). The clinical pregnancy rates were 12.6 and 13.7%, respectively. There were 2.4% miscarriages in the triptorelin group and no miscarriages in the control group. Ovarian stimulation with letrozole was associated with lower LBR among the triptorelin group, in comparison to the control group (0 vs. 14.7%, p = .020). In contrast, when gonadotrophin was added to the letrozole, LBR was almost doubled compared to the control group (15.9 vs. 8.3%, p = .341).; Conclusion: A single administration of GnRH agonist in the luteal phase does not improve LBR in IUI cycles.

Lessey Bruce, A. (2022). "Elagolix for Fertility Enhancement Clinical Trial." ClinicalTrials.gov.
	No Results Available Drug: Elagolix|Drug: Oral Contraceptive Ongoing pregnancy rate|Live birth rate|Number of subjects with categorical outcome of cancellation|Number of subjects with categorical outcome of not pregnant|Number of subjects with categorical outcome of biochemical pregnancy|Number of amniotic sacs|Miscarriage rate Female Phase 2 10 Other Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Treatment IRB00059474 August 9, 2023

Lessey Bruce, A. (2022). "SIRT-1 Antagonism for Endometrial Receptivity." ClinicalTrials.gov.
	No Results Available Drug: EX-527 (Selisistat)|Drug: Placebo Live birth rate|Pregnancy rate|Miscarriage rate Female Phase 2 0 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment BL5280 December 2023

Lethaby, A., et al. (2019). "Combined hormonal contraceptives for heavy menstrual bleeding." The Cochrane Database of Systematic Reviews 2: CD000154.
	Background: Menorrhagia or heavy menstrual bleeding (HMB) is an excessive blood loss that impairs a woman's quality of life, either physical, emotional, social or material. It is benign and not associated with pregnancy or any other gynaecological or systemic disease. Medical treatments used to reduce excessive menstrual blood loss (MBL) include prostaglandin synthetase inhibitors, antifibrinolytics, oral contraceptive pills, and other hormones. The combined oral contraceptive pill (COCP) is claimed to have a variety of beneficial effects, inducing a regular shedding of a thinner endometrium and inhibiting ovulation, thus having the effect of both treating HMB and providing contraception. More recently, a contraceptive vaginal ring (CVR) has been trialled to investigate whether this treatment can provide similar benefits to COCP while lessening hormonal systemic exposure. This review is an update of a review which originally focused on COCP alone. The scope of the review has been widened to consider other types of delivery of combined hormonal contraceptives for reduction of MBL.; Objectives: To determine the efficacy of combined hormonal contraceptives (pills, vaginal ring or patch) compared with other medical therapies, placebo, or no therapy in the treatment of HMB. A secondary objective was to compare the COCP with the CVR.; Search Methods: We searched the Gynecology and Fertility Group trials register, MEDLINE, Embase, CENTRAL, CINAHL and PsycINFO (search dates: Oct 1996, May 2002, June 2004, April 2006, June 2009, July 2017 and September 2018) for all randomised controlled trials (RCTs) of COCP and CVR for the treatment of HMB. We also searched trial registers and the reference lists of retrieved studies for additional trials.; Selection Criteria: We included randomised controlled trials (RCTs) of the use of COCP or CVR compared with no treatment, placebo, or other medical therapies for women with HMB and regular menstrual cycles.; Data Collection and Analysis: All assessments of trial quality and data extraction were performed unblinded by at least two review authors. Our primary review outcomes were treatment success, menstrual bleeding (assessed objectively, semi-objectively or subjectively), and participant satisfaction with treatment. Secondary outcomes were adverse events, quality of life, and haemoglobin level.; Main Results: We identified eight RCTs involving 805 participants. Two trials comparing COCP with placebo were considered to be moderate quality and the remaining studies were low to very low quality, mainly because of serious risk of bias from lack of blinding and concerns over precision.COCP versus placeboCOCP, with a step-down oestrogen and step-up progestogen regimen, improved response to treatment (return to menstrual 'normality') (OR 22.12, 95% CI 4.40 to 111.12; 2 trials; 363 participants; I 2 = 50%; moderate-quality evidence), and lowered MBL (OR 5.15, 95% CI 3.16 to 8.40; 2 trials; 339 participants; I 2 = 0%; moderate-quality evidence) when compared to placebo. The results suggested that, if the chance of 'successful' treatment was 3% in women taking placebo, then COCP increased this chance from 12% to 77% in women with unacceptable HMB. Minor adverse events, in particular breast pain, were more common with COCP. No study in this comparison reported semi-objectively assessed MBL or participant satisfaction with treatment.COCP versus other medical treatmentsNon-steroidal anti-inflammatory drugs (NSAIDs)There was insufficient evidence to determine whether the COCP reduced MBL when compared to NSAIDs (mefenamic acid and naproxen). No study in this comparison reported semi-objectively assessed MBL, subjectively assessed MBL, participant satisfaction with treatment or adverse events.Levonorgestrel-releasing intrauterine system (LNG IUS)The LNG IUS was more effective than COCP in reducing MBL (OR 0.21, 95% CI 0.09 to 0.48; 2 trials; 151 participants; I 2 = 0%; low-quality evidence) but it was not clear whether satisfaction with treatment or adverse effects varied according to which treatment was used. No study in this comparison reported semi-objectively assessed MBL or subjectively assessed MBL.Contraceptive vaginal ring (CVR) versus other medical treatmentsCOCP COCP was compared with CVR in two trials. There were discrepancies between some of the findings and there was no evidence of a benefit for one treatment compared to the other for response to treatment, MBL or participant satisfaction with treatment. There was a greater likelihood of nausea with COCP. No study in this comparison reported objectively assessed MBL or subjectively assessed MBL.ProgestogensCVR was compared to long course progestogens in one trial. It is possible that CVR increased the odds of satisfaction; but we are uncertain whether CVR improved MBL. The evidence was based on small numbers of participants and was very low quality, so definitive conclusions could not be reached. No study in this comparison reported objectively assessed MBL, subjectively assessed MBL, or adverse events.; Authors' Conclusions: Moderate-quality evidence suggests that the combined oral contraceptive pill over six months reduces HMB in women with unacceptable HMB from 12% to 77% (compared to 3% in women taking placebo). When compared with other medical options for HMB, COCP was less effective than the LNG IUS. Limited evidence suggested that COCP and CVR had similar effects. There was insufficient evidence to determine comparative efficacy of combined hormonal contraceptives with NSAIDs, or long course progestogens.

Leung, E. (2021). "Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II." ClinicalTrials.gov.
	No Results Available Radiation: Conventional Fractionation|Radiation: Hypofractionation Acute bowel toxicity|Acute bowel toxicities|Acute urinary toxicities through CTCAE|Acute urinary toxicities through EPIC|Local- regional failure|Disease-free survival|Quality of life using EORTC QLQ-30 and endometrial module (EN-24)|Correlation of GU toxicity, EORTC, and EPIC Female Not Applicable 50 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment SPARTACUS II June 1, 2023

Levi, M. (2022). "Biweekly Follow-Up and At-Home Ultrasound Reduce Anxiety in Women With Recurrent Pregnancy Loss." ClinicalTrials.gov.
	Background: Spontaneous pregnancy loss is a relatively common phenomenon, with 10‐15% of clinically recognized pregnancies ending in miscarriage.1 Recurrent pregnancy loss (RPL) is a disorder defined by two or more failed pregnancies2. According to various studies, pregnancy loss has been described as a traumatic event for couples even if the loss occurs at a very early stage of pregnancy.3‐5 Few controlled studies dealt with the effects of the miscarriage on the psychological condition of women during a subsequent pregnancy4,6‐8. These studies establish proof of considerably increased pregnancy specific anxiety in pregnant women with a history of spontaneous abortion, compared to pregnant women with no history of spontaneous abortion. As in the study of Bergner et al. women after early miscarriages are under pressure in a new pregnancy due to emotional disorders in the shape of pregnancy‐specific anxiety, mostly before the critical point in the pregnancy when the previous miscarriage took place is passed.6 In order to offer pregnant women who have previously suffered miscarriages, apart from adequate psychological support alongside workup to find the RPL etiology, some reassurance and comfort this study aimed to evaluate the effectiveness of "at home ultrasound" in addition to routine prenatal care in reducing maternal anxiety during pregnancy for patients with history of recurrent pregnancy loss. Study primary objectives/hypotheses: Of all interventions that can alleviate the stress during pregnancy, we wish to learn the effect of "at home ultrasound" used by patients and feedback by clinician. The aim of this study is to evaluate the effectiveness of "at home ultrasound" in addition to routine prenatal care in reducing maternal anxiety during pregnancy for patients with history of recurrent pregnancy loss. We hypothesize that couples would feel calmer and more reassured regarding their pregnancy. Administrative Organization: Department of Obstetrics and Gynecology at the Edith Wolfson Medical Center, Holon, Israel. Study population The study population includes gravid patients recruited between 12 weeks of gestation and 14 weeks. Eligible patients include women with recurrent pregnancy losses in first trimester. This is a randomized controlled prospective trial registered at TRIALS.GOV The study population will be recruited between 12 and 14 weeks of gestation. The study population will be subject to standard routine antenatal care per clinic protocol. In addition, these patients will be followed using a twice weekly virtual visit by a member of the study team. This visit will include a short survey of obstetrical complaints such as abdominal pain and vaginal bleeding, as well as a brief sonographic survey using the portable ultrasound device. The details and findings of the visit will be recorded in the medical charts. The portable device will be handed to the patient during the intake visit of the study. The patient will be instructed how to operate the device by a team member. Pulsenmore Specifications: Compatible with: Android mobile phones with USB type C connector (Samsung S8+, Nokia 8, Nokia 7.1) Application: PulseNmore ES™, downloadable from Google Play™ Store Network Connectivity: Wi‐Fi or cellular (via user's mobile phone) Data Upload: Secured cloud service compliant with formal information security standards and directives Probes used only for external use on intact skin without contamination of blood or bodily fluids and should be cleaned with low‐level disinfection between each use and sterilized prior patient exchange according to our departmental protocol. The control group: A population of patients between 12 and 22 weeks of gestation with history of recurrent pregnancy losses who will be subjected to routine antenatal care as per clinic protocol. These patients will not receive the additional intervention. i. Inclusion criteria: 1. Patients with recurrent pregnancy losses in first trimester 2. Current pregnancy gestational age 12‐14 week of gestation 3. Singleton pregnancy ii. xclusion criteria: 1. Female subjects who refuse to participate 2. Female subjects who don't speak Hebrew Methods: 1. Recruitment of eligible patients will be conducted during routine visits to the maternal fetal outpatient clinic. Patients will receive an explanation of the study protocol, purpose and methodology including the difference between the two study groups. Willing participants will sign an informed consent. 2. At the initiation visit, the patient will be randomly assigned to one of the two study groups. 3. Following the random assignment, all participants will complete 3 validated questionnaires. The first questionnaire, validated to a state of acute anxiety, termed STAI:Y‐1, The State‐Trait Anxiety Inventory. This version, includes 20 items representing anxiety related sensations. Patients will be instructed to scale on a range of 1 to 4, where 1 stands for strongly disagree and 4 for strongly agree, how do each of the items represent the current state of anxiety. The final grade for each questionnaire is obtained through summing all ranks. The scale is reversed for each item phrased in a positive note before summation. A higher grade correlates with greater anxiety. Addendum 1. The second questionnaire validated to the evaluation of maternal attachment to the fetus during pregnancy until the week of recruitment to the study. The questionnaire is termed: Maternal Antenatal Attachment Scale‐MAAS (female) Addendum 2. The third questionnaire, validated to evaluate the overall pregnancy experience: Revised Prenatal Distress Questionnaire (NUPDQ; Lobel et al., 2008) Addendum 3. After completion of the questionnaires, the patients will be instructed on the mode of operation of home ultrasound device (pulsenmore), the frequency and means of communication with the study team. The patient will receive a written manual of operation for the device and will sign a contract obligating to preserve and return the device at the end of the study period. 4. At 20‐22 weeks of gestation, the participants will complete again all the three questionnaires. During that visit, the patient will return the device to the present team member. 5. Collected data includes: 1. Demographic characteristics (age, BMI, smoking, number of pregnancies, number of deliveries, past obstetrical and medical history, use of medication) 2. Antenatal follow‐up 3. The results of the various questionnaires primary outcome The delta between The State‐Trait Anxiety Inventory (STAI:Y‐1) score filled at recruitment and at 20‐22 weeks of gestation (when patient start fill fetal movements). Secondary outcomes The delta between The Maternal Antenatal Attachment Scale MAAS and the Distress Questionnaire score filled at recruitment and at 20‐22 weeks of gestation. Number of obstetric ICU referrals Number of admissions for hospitalization during pregnancy Sample size For the purpose of calculating the sample size, suppose that The State‐Trait Anxiety Inventory (STAI: Y‐1) at the second trimester for a patient with reccurent pregnancy losses is 40 units with a standard deviation of 5 units based on previous work. 9 to demonstrate a decrease in the score) The State‐Trait Anxiety Inventory (STAI: Y‐1) in 8 units will need to recruit 50 women (25 per group) with 80 percent power and 0.05 alpha. Research funding ‐ The authors will not receive any financial support for the research. The devices are provided as a contribution for the research period by the Pulsenmore Company Study Duration ‐ 1 year.

Lheureux, S., et al. (2021). "Adavosertib plus gemcitabine for platinum-resistant or platinum-refractory recurrent ovarian cancer: a double-blind, randomised, placebo-controlled, phase 2 trial." Lancet 397(10271): 281-292.
	BACKGROUND: The Wee1 (WEE1hu) inhibitor adavosertib and gemcitabine have shown preclinical synergy and promising activity in early phase clinical trials. We aimed to determine the efficacy of this combination in patients with ovarian cancer. METHODS: In this double-blind, randomised, placebo-controlled, phase 2 trial, women with measurable recurrent platinum-resistant or platinum-refractory high-grade serous ovarian cancer were recruited from 11 academic centres in the USA and Canada. Women were eligible if they were aged 18 years or older, had an Eastern Cooperative Oncology Group performance status of 0-2, a life expectancy of more than 3 months, and normal organ and marrow function. Women with ovarian cancer of non-high-grade serous histology were eligible for enrolment in a non-randomised exploratory cohort. Eligible participants with high-grade serous ovarian cancer were randomly assigned (2:1), using block randomisation (block size of three and six) and no stratification, to receive intravenous gemcitabine (1000 mg/m2 on days 1, 8, and 15) with either oral adavosertib (175 mg) or identical placebo once daily on days 1, 2, 8, 9, 15, and 16, in 28-day cycles until disease progression or unacceptable toxicity. Patients and the team caring for each patient were masked to treatment assignment. The primary endpoint was progression-free survival. The safety and efficacy analysis population comprised all patients who received at least one dose of treatment. The trial is registered with ClinicalTrials.gov, NCT02151292, and is closed to accrual. FINDINGS: Between Sept 22, 2014, and May 30, 2018, 124 women were enrolled, of whom 99 had high-grade serous ovarian cancer and were randomly assigned to adavosertib plus gemcitabine (65 [66%]) or placebo plus gemcitabine (34 [34%]). 25 women with non-high-grade serous ovarian cancer were enrolled in the exploratory cohort. After randomisation, five patients with high-grade serous ovarian cancer were found to be ineligible (four in the experimental group and one in the control group) and did not receive treatment. Median age for all treated patients (n=119) was 62 years (IQR 54-67). Progression-free survival was longer with adavosertib plus gemcitabine (median 4·6 months [95% CI 3·6-6·4] with adavosertib plus gemcitabine vs 3·0 months [1·8-3·8] with placebo plus gemcitabine; hazard ratio 0·55 [95% CI 0·35-0·90]; log-rank p=0·015). The most frequent grade 3 or worse adverse events were haematological (neutropenia in 38 [62%] of 61 participants in the adavosertib plus gemcitabine group vs ten [30%] of 33 in the placebo plus gemcitabine group; thrombocytopenia in 19 [31%] of 61 in the adavosertib plus gemcitabine group vs two [6%] of 33 in the placebo plus gemcitabine group). There were no treatment-related deaths; two patients (one in each group in the high-grade serous ovarian cancer cohort) died while on study medication (from sepsis in the experimental group and from disease progression in the control group). INTERPRETATION: The observed clinical efficacy of a Wee1 inhibitor combined with gemcitabine supports ongoing assessment of DNA damage response drugs in high-grade serous ovarian cancer, a TP53-mutated tumour type with high replication stress. This therapeutic approach might be applicable to other tumour types with high replication stress; larger confirmatory studies are required. FUNDING: US National Cancer Institute Cancer Therapy Evaluation Program, Ontario Institute for Cancer Research, US Department of Defense, Princess Margaret Cancer Foundation, and AstraZeneca.

Lheureux, S., et al. (2022). "Translational randomized phase II trial of cabozantinib in combination with nivolumab in advanced, recurrent, or metastatic endometrial cancer." Journal for Immunotherapy of Cancer 10(3).
	Background: Combining immunotherapy and antiangiogenic agents is a promising treatment strategy in endometrial cancer. To date, no biomarkers for response have been identified and data on post-immunotherapy progression are lacking. We explored the combination of a checkpoint inhibitor (nivolumab) and an antiangiogenic agent (cabozantinib) in immunotherapy-naïve endometrial cancer and in patients whose disease progressed on previous immunotherapy with baseline biopsy for immune profiling.; Patients and Methods: In this phase II trial (ClinicalTrials.gov NCT03367741, registered December 11, 2017), women with recurrent endometrial cancer were randomized 2:1 to nivolumab with cabozantinib (Arm A) or nivolumab alone (Arm B). The primary endpoint was Response Evaluation Criteria in Solid Tumors-defined progression-free survival (PFS). Patients with carcinosarcoma or prior immune checkpoint inhibitor received combination treatment (Arm C). Baseline biopsy and serial peripheral blood mononuclear cell (PBMC) samples were analyzed and associations between patient outcome and immune data from cytometry by time of flight (CyTOF) and PBMCs were explored.; Results: Median PFS was 5.3 (90% CI 3.5 to 9.2) months in Arm A (n=36) and 1.9 (90% CI 1.6 to 3.4) months in Arm B (n=18) (HR=0.59, 90% CI 0.35 to 0.98; log-rank p=0.09, meeting the prespecified statistical significance criteria). The most common treatment-related adverse events in Arm A were diarrhea (50%) and elevated liver enzymes (aspartate aminotransferase 47%, alanine aminotransferase 42%). In-depth baseline CyTOF analysis across treatment arms (n=40) identified 35 immune-cell subsets. Among immunotherapy-pretreated patients in Arm C, non-progressors had significantly higher proportions of activated tissue-resident (CD103+CD69+) ɣδ T cells than progressors (adjusted p=0.009).; Conclusions: Adding cabozantinib to nivolumab significantly improved outcomes in heavily pretreated endometrial cancer. A subgroup of immunotherapy-pretreated patients identified by baseline immune profile and potentially benefiting from combination with antiangiogenics requires further investigation.; Competing Interests: Competing interests: SL has received honoraria from AstraZeneca, Merck, Eisai, GSK, and Roche. PAK has participated in Advisory Boards/Scientific Advisory Committees for Alkermes, AstraZeneca, Bayer, GSK, Merck, Pfizer, Tesaro, Vertex, and Repare; and has received institutional funding as Principal Investigator from AstraZeneca, Bayer, Eli Lilly, GSK, Merck, Merck KGaA, Pfizer, and Tesaro/GSK. BXW has no conflicts of interest related to this manuscript; financial disclosures that are not related: he has received honoraria from Tessa Therapeutics and AstraZeneca. MSB has no conflicts of interest related to this manuscript; financial disclosures that are not related: he has received institutional research support from Merck, Transgene, Pharmacyclics, Immune Design, Bristol Myers Squibb, Marker Therapeutics, Sorrento, Viewpoint Molecular Targeting, and Genentech; and is an Advisory Board member (unpaid) for TILT Biotherapeutics, Viewpoint Molecular Targeting, and Sorrento. SLG has received personal fees from AstraZeneca, Immunogen, Sermonix, Elvar Therapeutics, and GSK; and has received grants from AstraZeneca, AbbVie, Pfizer, Rigel, Iovance, Tesaro, Genentech/Roche, PharmaMar, and GSK; and has patents for Sermonix (US patent no. 10,905,659 and 10,258.604). FJB has participated in Advisory Boards for Merck, Eisai, and Agenus; and has received research funding from Eisai, Clovis, ImmunoGen, Merck, and Beigene (all outside the submitted work). TLW has no significant conflicts of interest related to this manuscript; financial disclosures that are not related: she has received research support to the institution for clinical trials from AbbVie, AstraZeneca, Clovis Oncology, Mersana, Mirati, Novartis, Roche Genentech, and Tesaro-GSK. LD has received personal fees from AstraZeneca, Genentech/Roche, MorphoTek, Merck, Inovio, Advance Medical, UpToDate, Cue Biopharma, British Journal of Obstetrics and Gynaecology, Parexel, State of California, Elsevier, ASCO, Expert review, ClearView Heath Care, National Cancer Institute, and JB Learning; and has received grants from Genentech/Roche, Cerulean/NextGen, AbbVie, Tesaro, Pfizer, GSK/Novartis, Morab, MorphoTek, Merck, Aduro BioTech, Syndax, Ludwig, LEAP Therapeutics, Eisai, Lycera, Inovio, and Advaxis; she reports other disclosures from Merck, GSK/Novartis and Genentech/Roche. IC has received travel grants from Tesaro; and is an advisor for AstraZeneca and GSK. PSO has no conflicts of interest related to this manuscript; financial disclosures that are not related to the current work: EMD Serono, Symphogen, Providence, and Tessa Therapeutics. GFF participates in an Advisory Board for GSK; has received honoraria from UpToDate; has received reviewer compensation from Journal of Clinical Oncology and Lancet Oncology; and has received payments to institution for clinical trial conduct from Roche, Syros, GSK, Iovance, Sermonix, Comugen, Cellex, Corcept, and Plexxikon. No disclosures were reported by the other authors. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Li, C., et al. (2019). "Probiotics for the treatment of women with bacterial vaginosis: A systematic review and meta-analysis of randomized clinical trials." European Journal of Pharmacology 864: 172660.
	This systematic review and meta-analysis systematically evaluated the efficacy of probiotic monotherapy and combination therapy for bacterial vaginosis (BV). Published randomized controlled trials were searched in the Cochrane Library, PubMed, EMBASE, OVID Database and ClinicalTrials.gov from the inception dates to 12 July 2019. The literature was screened and evaluated according to the inclusion criteria, and the data were analysed by a random effect model. A chi-square test was used to test heterogeneity between trials. This study included 13 randomized controlled trials (RCTs), which included 1258 patients, and the cure rate of BV was analysed. Three RCTs compared probiotics with a placebo (control) [risk ratios (RR) = 4.39, 95% CI (2.05, 9.41), P = 0.0001]. Two RCTs compared probiotics with antibiotics (control) [RR = 1.03, 95% CI (0.38, 2.81), P = 0.95]. Nine of 13 RCTs compared the combination of probiotics and antibiotics with antibiotics alone [RR = 1.28, 95% CI (1.05, 1.56), P = 0.02]. Despite the high heterogeneity of the pooled analysis, neither the subgroup analysis results nor the sensitivity analysis results were statistically significant. Probiotics may have a positive effect on the treatment of BV, but there is a lack of strong evidence. (Copyright © 2019. Published by Elsevier B.V.)

Li, F. G., et al. (2021). "Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal Symptoms: A Randomized Clinical Trial." JAMA 326(14): 1381-1389.
	IMPORTANCE: Postmenopausal vaginal symptoms are common and frequently detrimental to a woman's quality of life. Fractional carbon dioxide vaginal laser is increasingly offered as a treatment, but the efficacy remains unproven. OBJECTIVE: To determine the efficacy of fractional carbon dioxide laser for treatment of vaginal symptoms associated with menopause. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, randomized, sham-controlled trial with 12-month follow-up was undertaken at a single tertiary referral hospital in Sydney, Australia. Enrollment commenced on September 19, 2016, with final follow-up on June 30, 2020. Participants were postmenopausal women with vaginal symptoms substantive enough to seek medical treatment. Of 232 participants approached, 85 were randomized. INTERVENTIONS: Three treatments using a fractional microablative carbon dioxide laser system performed 4 to 8 weeks apart, with 43 women randomized to the laser group and 42 to the sham group. MAIN OUTCOMES AND MEASURES: The co-primary outcomes were symptom severity assessed using a visual analog scale (VAS; range, 0-100; 0 indicates no symptoms and 100 indicates the most severe symptoms) and the Vulvovaginal Symptom Questionnaire (VSQ; range, 0-20; 0 indicates no symptoms and 20 indicates the most severe symptoms) at 12 months. The minimal clinically important difference was specified as a 50% decrease in both VAS and VSQ severity scores. There were 5 prespecified secondary outcomes, including quality of life (range, 0-100; higher scores indicate better quality of life), the Vaginal Health Index Score (range, 5-25; higher scores indicate better health), and vaginal histology (premenopausal or postmenopausal status). RESULTS: Of 85 randomized participants (mean [SD] age, 57 [8] years), 78 (91.7%) completed the 12-month follow-up. From baseline to 12 months, there was no significant difference between the carbon dioxide laser group and the sham group in change in symptom severity (VAS score for overall vaginal symptoms: -17.2 vs -26.6; difference, 9.4 [95% CI, -28.6 to 47.5]; VAS score for the most severe symptom: -24.5 vs -20.4; difference -4.1 [95% CI, -32.5 to 24.3]; VSQ score: -3.1 vs -1.6; difference, -1.5 [95% CI, -5.9 to 3.0]). There were no significant differences between the laser and sham group in the mean quality of life score (6.3 vs 1.4; difference, 4.8 [95% CI, -3.9 to 13.5]) and Vaginal Health Index Score (0.9 vs 1.3; difference, -0.4 [95% CI, -4.3 to 3.6]) or in histological comparisons between laser and sham treatment groups. There were 16 adverse events in the laser group and 17 in the sham group, including vaginal pain/discomfort (44% vs 68%), spotting, discharge, and lower urinary tract symptoms. No severe adverse events were reported in either group. CONCLUSIONS AND RELEVANCE: Among women with postmenopausal vaginal symptoms, treatment with fractional carbon dioxide laser vs sham treatment did not significantly improve vaginal symptoms after 12 months. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry: ACTRN12616001403426.

Li, J., et al. (2020). "Meta-analysis of heparin combined with aspirin versus aspirin alone for unexplained recurrent spontaneous abortion." International Journal of Gynaecology and Obstetrics 151(1): 23-32.
	Background: Unexplained recurrent spontaneous abortion (URSA) frustrates women of childbearing age profoundly, and effective therapies are particularly important.; Objective: To compare the efficacy of heparin combined with aspirin and aspirin alone for URSA.; Search Strategy: Electronic databases (PubMed, Medline, Web of Science, Clinical key and Cochrane Library) were searched for relevant studies from database inception to August 2019.; Selection Criteria: Studies of women of childbearing age with at least two consecutive abortions were included.; Data Collection and Analysis: Relevant items were extracted, tabulated, and subjected to STATA for data analysis. Study women were divided into group A (taking heparin plus aspirin) and group B (taking aspirin alone). The primary outcome was the rate of live birth.; Main Results: Women from eight randomized controlled trials were included: 493 in group A and 501 in group B. The number of live births was significantly higher in group A (P=0.003). The result remained the same in subgroup analysis by presence of antiphospholipid antibodies. Among women who had a live birth, gestational age at delivery tended to be older in group B (P=0.054). No differences in birthweight or intrauterine growth restriction were observed. Adverse effects were sporadically reported.; Conclusion: Among women with URSA, heparin combined with aspirin increased the live birth rate as compared with aspirin alone. There was a beneficial tendency of taking aspirin-only to prolong gestation week. (© 2020 International Federation of Gynecology and Obstetrics.)

Li, J., et al. (2023). "Treatment options for recurrent platinum-resistant ovarian cancer: A systematic review and Bayesian network meta-analysis based on RCTs." Frontiers in Oncology 13: 1114484.
	Background: There are a variety of treatment options for recurrent platinum-resistant ovarian cancer, and the optimal specific treatment still remains to be determined. Therefore, this Bayesian network meta-analysis was conducted to investigate the optimal treatment options for recurrent platinum-resistant ovarian cancer.; Methods: Pubmed, Cochrane, Embase, and Web of Science were searched for articles published until 15 June 2022. The outcome measures for this meta-analysis were overall survival (OS), progression-free survival (PFS), and adverse events (AEs) of Grade 3-4. The Cochrane assessment tool for risk of bias was used to evaluate the risk of bias of the included original studies. The Bayesian network meta-analysis was conducted. This study was registered on PROSPERO (CRD42022347273).; Results: Our systematic review included 11 RCTs involving 1871 patients and 11 treatments other than chemotherapy. The results of meta-analysis showed that the overall survival (OS) was the highest in adavosertib + gemcitabine compared with conventional chemotherapy, (HR=0.56,95%CI:0.35-0.91), followed by sorafenib + topotecan (HR=0.65, 95%CI:0.45-0.93). In addition, Adavosertib + Gemcitabine regimen had the highest PFS (HR=0.55,95%CI:0.34-0.88), followed by Bevacizumab + Gemcitabine regimen (HR=0.48,95%CI:0.38-0.60) and the immunotherapy of nivolumab was the safest (HR=0.164,95%CI:0.312-0.871) with least adverse events of Grades 3-4.; Conclusions: The results of this study indicated that Adavosertib (WEE1 kinase-inhibitor) + gemcitabine regimen and Bevacizumab + Gemcitabine regimen would be significantly beneficial to patients with recurrent platinum-resistant ovarian cancer, and could be preferred for recurrent platinum-resistant ovarian cancer. The immunotherapeutic agent, Nivolumab, is of considerable safety, with a low risk for grade-III or IV adverse events. Its safety is comparable to Adavosertib + gemcitabine regimen. Pazopanib + Paclitaxel (weekly regimen), Sorafenib + Topotecan/Nivolumab could be selected if there are contraindications of the above strategies.; Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42022347273.; 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 Li, Zou, Wang, Yin, Yan and Liu.)

Li, L., et al. (2022). "Effectiveness of Internet-based psychological interventions for treating perinatal depression: A systematic review and meta-analysis." Journal of Clinical Nursing.
	BACKGROUND: Perinatal depression can result in short- and long-term adverse effects for women and their children if untreated. Psychological interventions, the preferred treatment for most women with perinatal depression, can also be provided online. AIMS: This study aimed to provide a comprehensive and systematic review of Internet-based psychological interventions and to evaluate their effectiveness in the treatment of perinatal depression. DESIGN: Systematic review and meta-analysis. METHODS: A systematic literature search was conducted of six databases, including CINAHL, PubMed, Embase, Web of Science, the Cochrane Library and PsycINFO. Depression and anxiety, which were the primary and secondary results of this search, were presented as standardised mean differences (SMD) and 95% confidence intervals (CIs). This review was conducted according to the PRISMA checklist. RESULTS: Thirteen studies involving 2158 perinatal women were included. Content, method, duration and frequency of Internet-based psychological interventions were varied. Participants indicated a high rate of satisfaction with these interventions; participants' dropout rates ranged from 2.6% to 60.8%. Meta-analysis demonstrated that Internet-based psychological interventions improved perinatal depression (SMD = -0.72, CI = [-1.02, -0.42], p < .01) and anxiety symptoms (SMD = -0.52, CI = [-0.73, -0.30], p < .01), with heterogeneity of 86% and 59%, respectively. CONCLUSIONS: Internet-based psychological interventions are considered as convenient and effective alternative treatment for perinatal depression and anxiety. In the future, additional studies are needed to investigate the long-term effects of these interventions on the mental health of perinatal women and the effects on the growth and development of infants while controlling for the dropout rate. RELEVANCE TO CLINICAL PRACTICE: Internet-based psychological interventions are innovative approaches to improving perinatal depressive symptoms that can leverage mental health resources and improve accessibility while promoting multidisciplinary integration. The approach, content, frequency and duration of intervention should be considered comprehensively to achieve the objectives of the intervention while maintaining compliance of women with perinatal depression.

Li, L., et al. (2020). "Effect of progestogen for women with threatened miscarriage: a systematic review and meta-analysis." BJOG 127(9): 1055-1063.
	Background: Threatened miscarriage is a common complication of pregnancy. Results of randomised controlled trials on the efficacy of progestogen in the treatment of threatened miscarriage remain inconsistent.; Objective: To investigate whether the use of progestogen is associated with improved event rate of live birth and other benefits in women with threatened miscarriage.; Search Strategy: Ovid MEDLINE, Ovid Embase and Cochrane CENTRAL Register of Controlled Trials from their inception until 8 July 2019.; Selection Criteria: Randomised controlled trials comparing progestogen with a placebo or no treatment for pregnancy outcomes in women with threatened miscarriage.; Data Collection and Analysis: Two authors independently conducted data extraction and assessed study quality. We calculated risk ratios (RR) and 95% confidence intervals using the Mantel-Haenszel approach for dichotomous outcomes.; Main Results: Ten trials with a total of 5056 participants were eligible for analysis. The use of progesterone increased the incidence of live birth (RR 1.07, 95% CI 1.00-1.15; P = 0.04; I 2 = 18%), with benefit only seen with the use of oral progestogen (RR 1.17, 95% CI 1.04-1.31; P = 0.008; I 2 = 0%) and not with vaginal progesterone (RR 1.04, 95% CI 1.00-1.08; P = 0.07; I 2 = 0%). Similarly, progestogen reduced the risk of miscarriage (RR 0.73, 95% CI 0.59-0.92), with benefit only seen with oral progestogen and not with vaginal progesterone.; Conclusion: Progestogens may have benefits on live birth rate and miscarriage rate for women with threatened miscarriage. These benefits appear to be confined to the use of oral progestogen, and no statistically significant improvements were seen with vaginal progesterone.; Tweetable Abstract: A meta-analysis of 10 trials found that progestogens increased live birth rates and reduced miscarriage rates for women with threatened miscarriage. (© 2020 Royal College of Obstetricians and Gynaecologists.)

Li, M., et al. (2019). "A Classic Herbal Formula Guizhi Fuling Wan for Menopausal Hot Flushes: From Experimental Findings to Clinical Applications." Biomedicines 7(3).
	A classic herbal formula Guizhi Fuling Wan (GFW) has been used for managing menopausal hot flushes (MHFs), but the evidence across different study types has not been systematically summarized. This project investigated the clinical effects, phytochemistry, pharmacodynamics, and potential mechanisms of actions of GFW on the causative target proteins potentially driving MHFs. Twenty English and Chinese databases were searched for relevant clinical and experimental studies. A total of 12,988 studies were identified, of which 46 were included. Seven clinical studies demonstrated GFW had no statistically significant changes in the frequency and severity of MHFs; however, it could improve peripheral blood flow in the fingertips, jaw, and toes. Thirty-five studies on phytochemistry identified 169 chemical compounds of GFW. Four experimental studies revealed GFW's therapeutic effects (e.g., normalize calcitonin gene-related peptide [CGRP] level) and potential target protein/cytokine (estrogen receptor beta [ESR2] with genetic variation, CGRP receptor, and interleukin-8) on MHFs. Therapeutic effects across different study types were inconsistent, possibly due to the dose difference and genotype variety of ESR2 in the human population. Further clinical and experimental studies, as well as biochemical investigation on the mechanisms of actions of GFW, are recommended.

Li, P., et al. (2022). "Effects of Acupuncture Combined with Moxibustion on Reproductive and Metabolic Outcomes in Patients with Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis." Evidence-based Complementary and Alternative Medicine 2022: 3616036.
	Objectives: In this systematic review, the effects of acupuncture combined with moxibustion on reproductive and metabolic outcomes in patients with polycystic ovary syndrome (PCOS) were evaluated.; Methods: Randomized controlled trials (RCTs) assessing acupuncture combined with moxibustion + basic treatment (experimental group) versus basic treatment alone (control group) for treating PCOS were identified from English and Chinese databases up to November 3, 2021. Outcomes related to pregnancy, ovulation, miscarriage, sex hormones, and metabolic disorders were of interest. In the meta-analysis, risk ratios (RRs) and mean differences (MDs) and their 95% confidence intervals (CIs) were used as effect measures.; Results: Twenty-five RCTs ( n = 1991) were included. The pooled results showed that the experimental group had significant increases in the pregnancy rate (RR 1.81, 95% CI 1.58 to 2.08) and ovulation rate (RR 1.31, 95% CI 1.22 to 1.40) and decreases in the miscarriage rate (RR 0.45, 95% CI 0.28 to 0.73), and ovarian volume (MD -0.75 cm 3 , 95% CI -1.30 to -0.20). In the experimental group, improvements in the luteinizing hormone (LH) level, the LH-to-follicle-stimulating hormone (FSH) ratio, total testosterone level, fasting insulin level, and body mass index, but not in FSH, oestradiol, or dehydroepiandrosterone sulfate levels, were significantly greater. All reported adverse events were mild. Based on the limitations of risk of bias, inconsistency, imprecision, and/or publication bias, the level of evidence was judged to be moderate for the pregnancy rate, ovulation rate, miscarriage rate, LH level, and LH/FSH ratio and very low for the other outcomes.; Conclusion: Among patients with PCOS, using acupuncture combined with moxibustion as a complementary therapy to basic treatments can improve pregnancy, ovulation, and miscarriage rates, the levels some sex hormones, and metabolic indicators, with good safety. Additionally, this combination therapy may have no effect on the FSH, oestradiol, or dehydroepiandrosterone sulfate level.; Competing Interests: The authors claim that they have no conflicts of interest. (Copyright © 2022 Peishuang Li et al.)

Li, R., et al. (2022). "The effect of magnesium alone or its combination with other supplements on the markers of inflammation, OS and metabolism in women with polycystic ovarian syndrome (PCOS): A systematic review." Frontiers in Endocrinology 13: 974042.
	The objective of this systematic review is to synthesize the available evidence on the effectiveness of magnesium supplements on the markers of inflammation, oxidative stress (OS), and metabolism in PCOS patients and to provide a basis for its clinical treatment. Electronic databases (PubMed, Cochrane Library databases, Embase, Web of science, CMB, CNKI, VIP, Wan Fang and ClinicalTrials.gov) were searched from their inception until January 2022. Randomized controlled trials (RCTs) for PCOS undergoing therapy with magnesium supplementation alone or in combination with other agents. The primary outcomes were the markers of blood glucose and OS.363 patients from nine RCTs were included in the current systematic review. Four of the nine studies reported the effects of magnesium supplementation alone on OS or metabolic markers in women with PCOS. Whilemagnesium supplementation alone did not show any significant improvement in the markers of inflammation, OS or metabolism in PCOS, seven of the nine articles reported the effect of magnesium co-supplementation on OS or metabolic markers in PCOS patients. Magnesium combined with vitamin E or zinc-calcium-vitamin D significantly improved glucose and lipid metabolism in PCOS patients. Magnesium intake alone did not lead to a significant improvement in the markers of OS, blood glucose, or serum lipids in PCOS. However, magnesium combined with other supplements (vitamin E, zinc, zinc-calcium-vitamin D) significantly improved serum hs-CRP, insulin, HOMA-IR, TG, TC levels, and the improvement in OS markers was inconclusive. The effect of magnesium and melatonin supplementation on the markers of metabolism needs to be further verified.; System Review Registration: PROSPERO https://www.crd.york.ac.uk/PROSPERO/#myprospero, CRD42022303410.; 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 Li, Li, Huang, Hu, Ma and Yang.)

Li, S., et al. (2021). "Efficacy and safety evaluation of acupuncture therapy for patients with salpingitis in IVF-ET: A protocol of systematic review and meta-analysis." Medicine 100(2): e24015.
	Background: As an alternative for salpingitis in IVF-ET, acupuncture has gradually attracted the attention of clinicians based on the theory of syndrome differentiation and treatment of Chinese traditional medicine. However, due to the lack of evidence-based medical evidence, the author designed the program to evaluate the effectiveness and safety of acupuncture.; Methods: From the beginning to August 2020, 7 electronic databases will be searched. Two of our researchers will independently conduct research selection, data extraction, and risk assessment of bias. We will use Review Manager 5.3 software for meta-analysis and heterogeneity assessment. In addition, we will use the grading of recommendations assessment, development, and evaluation to evaluate the evidence quality.; Results: This study will demonstrate an evidence-based review of acupuncture for salpingitis in IVF-ET.; Conclusion: The study will provide clear evidence to assess the effectiveness and side effects of acupuncture for salpingitis in IVF-ET.; Trial Registration Number: INPLASY2020110125.; Competing Interests: The authors have no conflict of interests to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Li, X., et al. (2024). "Efficacy of non-pharmacological interventions for primary dysmenorrhoea: a systematic review and Bayesian network meta-analysis." BMJ Evidence-Based Medicine: bmjebm-2023.
	Objectives To assess the relative benefits of various non-pharmacological interventions on treating primary dysmenorrhoea within a network meta-analysis. Study design Systematic review and Bayesian network meta-analysis. Inclusion criteria Randomised controlled trial involving patient with primary dysmenorrhoea and received non-pharmacological interventions. Data sources Four databases (Medline, Embase, Cochrane Library and Web of Science) were searched from inception to October first, 2022. Risk-of-bias (RoB) assessment RoB 2.0 assessment tools was used to assess the risk of bias in the included studies. Synthesis of results Conventional meta-analysis was conducted by pairwise comparison between non-pharmacological therapy and control treatment. The Bayesian network meta-analysis was conducted by the Aggregate Data Drug Information System Software based on the consistency or inconsistency model, and rank probability was used to indicate the priority of non-pharmacological therapy. Results 33 studies involving eight non-pharmacological interventions were included. With regard to conventional meta-analysis, we selected Visual Analogue Scale (VAS) as primary outcome to evaluate the pain intensity. The result showed that eight interventions (Exercise, Herb, Acupuncture, Aromatherapy, Transcutaneous Electrical Nerve Stimulation, Topical heat, Acupressure, Yoga) displayed positive effect on reduction of menstrual pain compared with placebo or no treatment. A Bayesian network meta-analysis revealed that exercise -3.20 (95% CI -4.01 to -2.34), acupuncture -2.90 (95% CI -3.97 to -2.85) and topical heat -2.97 (95% CI -4.66 to -1.29) probably resulted in a reduction in pain intensity (VAS) . Conclusions Non-pharmacological interventions may result in a reduction or slight reduction in pain intensity compared with no treatment or placebo. Specifically, exercise and acupuncture are considered as potentially effective non-pharmacological treatments in short-term treatment. Indeed, larger and better methodological quality research is needed. Trial registration number CRD42022351021.Copyright © 2024 BMJ Publishing Group. All rights reserved.

Li, X., et al. (2023). "Effects of gonadotropin-releasing hormone agonist pretreatment on frozen embryo transfer outcomes in artificial cycles: a meta-analysis." Archives of Gynecology and Obstetrics 308(3): 675-683.
	Purpose: Gonadotropin-releasing hormone agonist (GnRHa) before artificial cycle (AC) is expected to improve pregnancy outcomes in frozen-thawed embryo transfer (FET). Many studies have explored the impact of GnRHa pretreatment of AC in FET, but the results were inconsistent. This meta-analysis was performed to systematically evaluate the effect of GnRHa pretreatment on AC in FET.; Methods: The last search was January 31, 2022. Randomized controlled trials and cohort studies aiming to assess the effect of GnRHa as the pretreatment of AC for endometrial preparation in FET were included. GnRHa was used before AC in the treatment group. In the control group, no pretreatment was used before AC. The eligible studies included at least one of the following outcomes: implantation, clinical pregnancy, and live birth. We calculated the odds ratio (OR) or mean difference (MD) and 95% confidence interval (CI) for each study and used a random-effects or fixed model to estimate the results.; Results: 27 articles (10 RCTs and 17 non-RCTs) and 14152 patients were included. AC + GnRHa improved the implantation rate (OR = 1.31, 95% CI 1.03-1.66, I 2 = 79%), clinical pregnancy rate (OR = 1.27, 95% CI 1.10-1.45, I 2 = 53%), and live birth rate (OR = 1.16, 95% CI 1.05-1.29, I 2 = 39%). We also found that AC + GnRHa increased the implantation rate (OR = 1.35, 95% CI 1.07-1.69, I 2 = 53%) and clinical pregnancy rate (OR = 1.50, 95% CI 1.12-2.01, I 2 = 50%) in repeated implantation failure. In addition, AC + GnRHa was positively associated with preterm birth (OR = 1.5, 95% CI 1.15-1.94, I 2 = 0%).; Conclusions: GnRHa pretreatment in FET can improve implantation, clinical pregnancy, and live birth rates, especially in patients with repeated implantation failure. GnRHa pretreatment seems to improve FET outcomes, though with a higher preterm birth rate. (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Li, X., et al. (2023). "Pretreatment of Dienogest for Women with Endometriosis in in vitro Fertilization: A Systematic Review and Meta-Analysis." Gynecologic and Obstetric Investigation 88(3): 135-142.
	Introduction: Dienogest (DNG) was demonstrated to be comparable to gonadotropin-releasing hormone agonist (GnRH-a) in controlling symptoms of endometriosis. GnRH-a is used before in vitro fertilization (IVF) in women with endometriosis to improve pregnancy outcomes. We aimed to determine the effect of DNG pretreatment on IVF outcomes, including number of mature oocytes, rate of clinical pregnancies, and rate of live births in women with endometriosis.; Methods: All studies involving DNG, IVF, and endometriosis were searched from the PubMed; Ovid/MEDLINE, Wanfang, CQVIP, China National Knowledge Infrastructure databases; and ClinicalTrials.gov. The study population was women with endometriosis in IVF. Randomized controlled trials and cohort studies were included. All included studies comprised a DNG group and a control group. The outcomes were number of mature oocytes, rate of clinical pregnancies, and rate of live births. We calculated the odds ratio or mean difference and 95% confidence interval for each study and used a random-effects model to estimate the results.; Results: Five articles were screened by the search strategy. One article without a control group was excluded. Finally, four articles with 422 patients were included. No significant differences in number of mature oocytes (MD = -1.27, 95% CI: -3.63 to 1.09, I2 = 91%), the rate of clinical pregnancies (odds ratio = 1.07, 95% CI: 0.33-3.47, I2 = 84%), or the rate of live births (odds ratio = 1.09, 95% CI: 0.34-3.46, I2 = 84%) were found between the DNG group and the control group.; Conclusion: Pretreatment with DNG for women with endometriosis who underwent IVF could not improve the number of mature oocytes, the rate of clinical pregnancies, or the rate of live births. (© 2023 S. Karger AG, Basel.)

Li, X., et al. (2020). "Effect of sildenafil citrate on treatment of infertility in women with a thin endometrium: a systematic review and meta-analysis." The Journal of International Medical Research 48(11): 300060520969584.
	Objective: Endometrial thickness is a prognostic factor for successful pregnancy. This meta-analysis aimed to examine the role of sildenafil citrate on infertile women with a thin endometrium.; Methods: Two investigators independently searched the literature on sildenafil citrate and infertile women with a thin endometrium from PubMed, EMBASE, and the Cochrane Controlled Trials Register Database from inception to January 2019.; Results: Nine studies involving 1452 patients were included for analysis in our study. We found that endometrial thickness in patients who received sildenafil citrate was significantly higher than that in the control group (placebo or no treatment) (weighted mean difference: 1.22; 95% confidence interval [CI]: 1.07-1.38). The radial artery resistance index was significantly lower (weighted mean difference: -0.12; 95% CI: -0.17 to -0.06), and the clinical pregnancy rate (risk ratio: 1.31; 95% CI: 1.11-1.53) and biochemical pregnancy rate (risk ratio: 1.45; 95% CI: 1.11-1.89) were significantly higher in the sildenafil citrate group compared with the control group.; Conclusion: Sildenafil citrate is effective in improving endometrial thickness, the clinical pregnancy rate, and the biochemical pregnancy rate in women who have a thin endometrium. This treatment is a potential therapeutic intervention for a thin endometrium.

Li, X.-R., et al. (2021). "The impact of Pegylated liposomal doxorubicin in recurrent ovarian cancer: an updated meta-analysis of randomized clinical trials." Journal of Ovarian Research 14(1): 42.
	Background: Previous meta-analysis studies suggested that pegylated liposomal doxorubicin (PLD) may improve the survival rate of patients with recurrent ovarian cancer. The aim of the present meta-analysis, then, was to further update the role of PLD in the treatment of recurrent ovarian cancer.; Methods: We performed a literature search using the electronic databases Medicine, EMBASE, Web of Science, and the Cochrane Library to 27 July 2020. We only restricted the randomized clinical trials. Study-specific hazard ratios and 95% confidence interval (HR/95% CI) and risk ratios and 95% confidence interval (RR/95% CI) were pooled using a random-effects model.; Results: Ten studies (12 trials) were included after screening 940 articles. We categorized the eligible studies into two groups: the doublet regimens (four trials, 1767 patients) showed that PLD plus carbo provided superior progression-free survival (PFS) (HR, 0.85; 95% CI, 0.74-0.97) and similar overall survival (OS) (HR, 1.00; 95% CI, 0.88-1.14) compared to paclitaxel (PAC) plus carboplatin (carbo). PLD plus carbo was associated with significantly more anemia and thrombocytopenia, and other side effects were well tolerated. The monotherapy regimens (eight trials, 1980 patients) showed that PLD possessed a similar PFS (HR, 1.02; 95% CI, 0.90-1.16) and OS (HR, 0.88; 95% CI, 0.77-1.01) relative to other monotherapies. PLD alone was also more associated with mucositis/stomatitis and hand-foot syndrome, while other side effects were well tolerated.; Conclusions: In platinum-sensitive recurrent ovarian cancer, PLD plus carbo was more effective than PAC plus carbo, while in platinum-resistant or -refractory recurrent ovarian cancer, PLD exhibited similar survival to other monotherapies. Regarding side effects, PLD plus carbo and mono chemotherapy were both well tolerated.

Li, Y., et al. (2021). "Single blastocyst stage versus single cleavage stage embryo transfer following fresh transfer: A systematic review and meta-analysis." European Journal of Obstetrics, Gynecology, and Reproductive Biology 267: 11-17.
	Objectives: To compare the available evidence of the effectiveness of single blastocyst stage transfer against the effectiveness of single cleavage stage embryo transfer.; Study Design: A systematic research based on Pubmed, Embase and the Cochrane Library was performed until May 2, 2020 to identify all relevant studies. The Cochrane Collaboration's Review Manager (RevMan) 5.0.2 software was used for statistical analysis.; Results: Five randomized controlled trials (RCTs) were included in analysis, involving 1784 patients in total, who were divided into 2 groups, which were the single blastocyst stage transfer (SBT) group of 932, and the single cleavage stage transfer (SCT) group of 852. Our meta-analysis concluded that SBT group had a significantly higher clinical pregnancy rate (RR 1.26; 95%CI: 1.14-1.39), ongoing pregnancy rate (RR 1.19; 95%CI: 1.05-1.35) and delivery rate (RR 1.4; 95%CI: 1.13-1.75) than SCT group during the fresh transfer. While miscarriage rate (RR 0.93; 95% CI: 0.66-1.33), multiple pregnancy rate (RR, 1.12; 95% CI, 0.51-2.45) and ectopic pregnancy rate (RR, 0.5; 95% CI: 0.13-1.90) between two groups showed no significant difference. However, the SCT group contained notably more cryopreserved embryos than the SBT group. (RR -0.68, 95% CI: -0.95 to -0.41).; Conclusions: Our results indicate that single blastocyst stage transfer is associated with higher ongoing pregnancy rate and delivery rate comparing to single cleavage stage transfer in the clinical practice. Due to the low quality of the evidence of the primary outcomes, other higher-quality lager RCTs are necessary before a fully informed decision is made.; 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.)

Li, Y. and R. Qin (2022). "coenzyme Q10 related treaments in improving women fertity-a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question the aim of this meta-analysis of randomized controlled trials is to evaluate the efficacy of coenzyme Q10 and coenzyme Q10 related treament for women infertility Searches PubMed, EMBASE, Web of Science, the World Health Organization (WHO) International Clinical Trials Registry Platform, Cochrane Gynecology and Fertility Group Specialized Register of Controlled Trials, The Cochrane Librarywith no time, language restrictions. Types of study to be included Randomized controlled trials (RCTs) will be included. Condition or domain being studied Infertility is a disease refers to the absence of any contraception for more than one year intercourse without successful pregnancy.The ovulatory dysfunction like polycystic ovary syndrome(PCOS) and dismissed ovarian reserve are the indispensable factors that leads to female infertility. Participants/population female of reproductive age with data of common clinical measurement of at least one of primary outcome indicators Intervention(s), exposure(s) intervention is Coq10 or combination of Coq10 and other medication which conducted in included research Comparator(s)/control control group including placebo, no treatment Context Inclusion criteria:1. CoQ10 relevant randomized controlled trials (therapies) to improve female fertility were included. 2. RCTs providing extractable data for at least one of the primary outcomes and Secondary outcomes.3. related RCTs which were included in other meta-analysis to avoid omission would also be incorporated. Exclusion criteria: 1.non-RCTs2. clinical trials prematurely terminated without providing data on any of the primary or secondary outcomes3. experimental subject are animals. Main outcome(s) 1. clinical pregnancy rate (CPR) 2. effect on live birth (LBR) 3. miscarriage rate (MR) Measures of effect P value<0.5 and 95% confidence intervals( CrI ) will be used as the criteria for statistical differences(I²). Heterogeneity was tested with the Cochrane χ² test (χ2) and the degree of heterogeneity was quantified by the I² statistics. Random effects model was used for data synthesis when I² > 30% and fixed effects model was used when I² < 30%19. Associations were reported as odds ratio (OR) with their 95% confidence intervals (CIs). A p value of < 0.05 was considered statistically authentic. OR will be reported as effect measure. Additional outcome(s) (1) ovarian stimulation parameters: number of mature follicles,oocytes retrieved, oocytes fertilized. (2) embryological parameters : day 3 high-quality embryos, number of embryos per embryo transfer, proportion of cryopreserved embryos, frozen-thawed embryo transfers (ET) (3) ART parameters: canceled treatment cycles, total dose of gonadotropins, peak estradiol (E2) serum concentration (4). ovarian reserve indicator : serum FSH, LH, and E2 levels between day 2 to day 5 of the menstrual cycle, Anti Mullerian Hormone (AMH) levels, Antral follicle count (AFC) between day 2 to day 5 of the menstrual cycle (assessed by transvaginal ultrasound) (5) thickness of endometrium Measures of effect P value<0.5 and 95% confidence intervals( CrI ) will be used as the criteria for statistical differences(I²). Heterogeneity was tested with the Cochrane χ² test (χ2) and the degree of heterogeneity was quantified by the I² statistics. Random effects model was used for data synthesis when I² > 30% and fixed effects model was used when I² < 30%19. Associations were reported as odds ratio (OR) with their 95% confidence intervals (CIs). A p value of < 0.05 was considered statistically authentic. OR will be reported as effect measure. Data extraction (selection and coding) Two authors will independently extract data. Any disagreement will be resolved by discussion until consensus is reached or by consulting a third author.The following data will be extracted: author, year of publication, country where the study was conducted, interventions and duration, age of patients, total number of people included in the study. Risk of bias (quality) assessment Cochrane Collaboration Handbook (Cochrane Handbook for Systematic Reviews of Interventions Cochrane Collaboration, 2021, http://handbook.cochrane.org/). Briefly, the tool proposed for assessing the risk of bias addressed seven specific items, including allocation concealment, random sequence generation, blinding of participants and personnel,blinding of outcome assessment, selective reporting, incomplete outcome data and other sources of bias. Strategy for data synthesis R version 3.6.1 and STATA version 15.0 were exploited to perform data into visualized graphics. Heterogeneity sources will be determined through a subgroup analysis and sensitivity analysis would be performed. Possible variables result in heterogeneity may include: age of patient, course of the disease or interventions. Analysis of subgroups or subsets If I²>50%, heterogeneity sources will be determined through a subgroup analysis. A detailed subgroup analysis will be listed. For example : Patient characteristics: age, course of the infertility. Contact details for further information yan huangqun yanhuangqun882@sina.com Organisational affiliation of the review Center of Reproductive Medicine, Guangxi Medical University First Affiliated Hospital https://www.gxmuyfy.cn/departFck/departgxszyxyjzx.html Review team members and their organisational affiliations Miss li yanhui. guangxi medical university Miss qin rongyan. guangxi medical university Type and method of review Systematic review Anticipated or actual start date 01 June 2021 Anticipated completion date 31 August 2022 Funding sources/sponsors guangxi medical university Conflicts of interest Language English Country China Stage of review Review Ongoing

Li, Z. and F. Lina (2022). "A comparison of the effects of ethinylestradiol cyproterone versus clomiphene versus letrozole on polycystic ovary syndrome infertility: a network meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question Which effects on polycystic ovary syndrome infertility is better? Ethinylestradiol cyproterone, clomiphene or letrozole? Searches The databases of CNKI, CBM, Wanfang, PubMed, EMBASE and Cochrane were searched to screen the randomized controlled trials about ethinylestradiol cyproterone/clomiphene /letrozole on polycystic ovary syndrome infertility from database establishment time to Feb 22, 2022. The quality of the RCT was reviewed by Jadad scale, and curative effect was given a Meta-analysis by using RevMan 5.2 software from Cochrane Library. Types of study to be included We will include randomised trials to assess the beneficial effects of the treatments. Condition or domain being studied Polycystic ovary syndrome (PCOS) is one of the most common endocrine pathologies and is a frequent cause of anovulatory infertility affecting 5 to 8% of reproductive age women. The main symptoms of PCOS are chronic anovulation, hyperandrogenism, obesity, hypertension, diabetes mellitus type 2, and insulin resistance. ethinylestradiol cyproterone/clomiphene/letrozole are common drugs on polycystic ovary syndrome infertility. The purpose of the present meta-analysis was to systematically examine the literature and identify the results of RCTs to provide evidence for the effectiveness of these drugs to guide clinical use. Participants/population Inclusion: (1) Adults with polycystic ovary syndrome infertility (as diagnosed using any recognised diagnostic criteria); (2) an RCT design; (3) PCOS diagnosed as fulfilling the Rotterdam 2003 criteria; (4) CC resistance; (5) an intervention of ethinylestradiol cyproterone versus clomiphene for the induction of ovulation in women with PCOS; (6) an intervention of ethinylestradiol cyproterone versus letrozole for the induction of ovulation in women with PCOS; (7) an intervention of clomiphene versus letrozole for the induction of ovulation in women with PCOS; and (8) reporting at least one of the following outcomes: ovulation rate (calculated as the number of ovulatory cycles divided by the total number of menstrual cycles), pregnancy rate, endometrial thickness at human chorionic gonadotrophin (HCG) injection, live birth rate and miscarriage rate (calculated as the number of first-trimester spontaneous abortions divided by the number of patients). Exclusion: (1) Adults with polycystic ovary syndrome infertility (under 18 years of age) and elderly people (over 70); (2) case reports, review articles, expert opinions, letters, or observational studies; (3) non-RCTs; (4) patients without a diagnosis of PCOS or infertility of unknown cause; and (4) non-CC resistance. Intervention(s), exposure(s) Inclusion: (1) Adults with polycystic ovary syndrome infertility (as diagnosed using any recognised diagnostic criteria); (2) an RCT design; (3) PCOS diagnosed as fulfilling the Rotterdam 2003 criteria; (4) CC resistance; (5) an intervention of ethinylestradiol cyproterone versus clomiphene for the induction of ovulation in women with PCOS; (6) an intervention of ethinylestradiol cyproterone versus letrozole for the induction of ovulation in women with PCOS; (7) an intervention of clomiphene versus letrozole for the induction of ovulation in women with PCOS; and (8) reporting at least one of the following outcomes: ovulation rate (calculated as the number of ovulatory cycles divided by the total number of menstrual cycles), pregnancy rate (calculated as the number of clinical pregnancies divided by the number of patients), endometrial thickness at human chorionic gonadotrophin (HCG) injection, live birth rate (calculated as the number of live births divided by the number of patients), and miscarriage rate (calculated as the number of first-trimester spontaneous abortions divided by the number of patients). Comparator(s)/control (1) Adults with polycystic ovary syndrome infertility (under 18 years of age) and elderly people (over 70); (2) case reports, review articles, expert opinions, letters, or observational studies; (3) non-RCTs; (4) patients without a diagnosis of PCOS or infertility of unknown cause; and (4) non-CC resistance. Context Studies in hospital accidents and emergency departments. Research in all races no matter black, white, yellow and so on. Main outcome(s) reporting at least one of the following outcomes: ovulation rate (calculated as the number of ovulatory cycles divided by the total number of menstrual cycles), pregnancy rate (calculated as the number of clinical pregnancies divided by the number of patients), endometrial thickness at human chorionic gonadotrophin (HCG) injection, live birth rate (calculated as the number of live births divided by the number of patients), and miscarriage rate (calculated as the number of first-trimester spontaneous abortions divided by the number of patients). Additional outcome(s) not applicable Data extraction (selection and coding) Data were extracted independently from the included studies by two investigators and recorded in a spreadsheet as follows: first author name(s), publication year, country, intervention procedures, number of cases, and main outcome parameters. We used the Cochrane Collaboration tool to evaluate the quality of all of the selected studies. Studies with good-quality criteria addressed the following elements: random sequence generation, allocation concealment, blinding, incomplete outcome data, selective reporting, and other bias. Discrepancies were resolved through consultation and discussion with a senior reviewer when necessary. Risk of bias (quality) assessment Literature bias and literature quality were evaluated by RevMan5.2, a special software for meta analysis, and literature quality was evaluated by Jadad scale, with scores of ≥3 for high quality literature and < 3 for low quality literature. Strategy for data synthesis RevMan ver. 5.2 was used to perform the statistical analysis. Statistical heterogeneity was evaluated according to the values of P and I² using the standard χ² Q test. If I² < 50% and P < 0.05, which indicated low or moderate heterogeneity, a fixed-effects model was calculated with use of the Mantel-Haenszel test for meta-analysis. Otherwise, a random-effects model was applied. Dichotomous outcomes were calculated using the relative risk (RR) with 95% confidence interval (CI), and continuous outcomes were calculated using the standardized mean difference (SMD) with 95% CI. Funnel plots were used to evaluate publication bias. A P value of less than 0.05 was considered to be statistically significant. Analysis of subgroups or subsets None avaliable Contact details for further information Liu junbao junbao@jlu.edu.cn Organisational affiliation of the review none Review team members and their organisational affiliations Miss Li Zhuohan. Beihua university Lina Feng. Changchun university of Chinese medicine Type and method of review Meta-analysis, Systematic review Anticipated or actual start date 28 February 2022 Anticipated completion date 31 May 2022 Funding sources/sponsors none Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Clomiphene; Cyproterone; Female; Humans; Infertility; Letrozole; Network Meta-Analysis; Polycystic Ovary Syndrome Date of registration in PROSPERO 21 March 2022 Date of first submission 18 February 2022 Stage of review at time of this submission The review has not started

Li, Z., et al. (2024). "Efficacy and safety of zuranolone for the treatment of depression: A systematic review and meta-analysis." Psychiatry Research 331: 115640.
	Major depressive disorder (MDD) and postpartum depression (PPD) are common and burdensome conditions. This study aims to evaluate the efficacy and safety of zuranolone, a neuroactive steroid gamma-aminobutyric acid type A receptors-positive allosteric modulator, in treating MDD and PPD. A comprehensive literature search was conducted until September 2023, identifying seven randomized controlled trials (RCTs). The results demonstrated that zuranolone significantly decreased Hamilton Rating Scale for Depression (HAM-D) scores in patients with PPD or MDD at day 15 (concluding the 14-day course) and day 42-45 (4 weeks after treatment cessation) compared with the placebo, albeit exhibiting a diminishing trend. Moreover, a higher percentage of patients with PPD or MDD achieved HAM-D response and remission with zuranolone treatment compared with placebo at day 15. However, zuranolone did not significantly increase the proportion of MDD patients achieving HAM-D remission at 42/43 days. Adverse events (AEs) such as somnolence, dizziness, and sedation were linked to zuranolone, with a higher but not statistically significant rate of discontinuation due to AEs in the zuranolone group. Overall, our findings support the rapid antidepressant effects of zuranolone in MDD and PPD, along with a relatively favorable safety and tolerability. Large-scale longitudinal RCTs are needed to evaluate the long-term efficacy of zuranolone.Copyright © 2023 Elsevier B.V.

Liang, D., et al. (2021). "Comparison of thermal ablative methods and myomectomy for the treatment of fibroids: a systematic review and meta-analysis." International Journal of Hyperthermia 38(1): 1571-1583.
	Objective: To examine the effectiveness and safety of thermal ablative methods and myomectomy for the treatment of uterine fibroids.; Materials and Methods: We searched EMBASE, PubMed, the Cochrane Central Register of Controlled Trials, Scopus, CINAHL, ClinicalTrials.gov and Web of Science databases through April 2021. Clinical trials comparing the thermal ablative methods and myomectomy for the treatment of uterine fibroids were included.; Results: Thirteen studies including 4205 patients were eligible. The thermal ablative treatment group was associated with less major adverse events (only ultrasound guided high-intensity focused ultrasound) (RR, 0.111 [95% CI, 0.070-0.175], p =.0), shorter duration of hospital stays in observational studies (-0.1497 day, [95% CI, -1.593 to -0.321], p =.0) and in randomized controlled trials (RCTs) (-0.844 day, [95% CI, -0.1.142 to -0.546], p =.0), higher uterine fibroid symptom (UFS) score after operation (0.252 [95% CI, 0.165-0.339]; p =.0), transformed symptom severity (tSS) score after operation (0.515 [95% CI, 0.355-0.674]; p =.0) and quality of life (QoL) score after operation (0.188 [95% CI, 0.093-0.283]; p =.0) in comparison with myomectomy group. No statistically significant difference was found between the thermal ablative treatment group and myomectomy group with respect to reintervention rate and pregnancy rate.; Conclusion: The current data available demonstrate that thermal ablative methods were not inferior to myomectomy in the treatment of uterine fibroids. The findings in this study need to be further confirmed by large RCTs.

Liangyi, X. and Z. Shuangquan (2024). "Effect of acupuncture combined with pelvic floor muscle training on patients with stress urinary incontinence: a meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Liao, S.-C., et al. (2019). "Changes in Female Sexual Function After Vaginal Mesh Repair Versus Native Tissue Repair for Pelvic Organ Prolapse: A Meta-Analysis of Randomized Controlled Trials." The Journal of Sexual Medicine 16(5): 633-639.
	Aim: To evaluate changes in female sexual function after transvaginal mesh (TVM) repair versus native tissue repair for pelvic organ prolapse.; Methods: Eligible studies, published through November 2017, were retrieved through searches of ClinicalTrials.gov, MEDLINE, Embase, and Cochrane Review databases and associated bibliographies. We included randomized control trials of transvaginal prolapse surgery with either mesh repair or native tissue repair regarding the outcomes of sexual function, de novo and postoperative dyspareunia with a minimum of 3 months of follow-up.; Results: Seventeen trials including 2,976 patients (1,488 with TVM repair and 1,488 with native tissue repair) were identified. There was no significant difference in postoperative dyspareunia after TVM repair versus native tissue repair (risk ratio [RR] = 1.07; 95% confidence interval [CI] = 0.76-1.50). Likewise, there was no significant difference in de novo dyspareunia after TVM repair versus native tissue repair (RR = 0.91; 95% CI = 0.52-1.61). There was also no significant difference in the short form Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire score after TVM mesh repair versus native tissue repair (mean difference = 0.26; 95% CI = -1.34 to 1.85).; Conclusion: Sexual function and de novo and postoperative dyspareunia were similar between the patients who underwent TVM repair and those who underwent native tissue repair. Liao S-C, Huang W-C, Su T-H, et al. Changes in Female Sexual Function After Vaginal Mesh Repair Versus Native Tissue Repair for Pelvic Organ Prolapse: A Meta-Analysis of Randomized Controlled Trials. J Sex Med 2019;16:633-639. (Copyright © 2019 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Liao, T., et al. (2021). "Bevacizumab combined with chemotherapy for ovarian cancer: A protocol for systematic review and meta-analysis." Medicine 100(51): e28376.
	Background: The impact of bevacizumab (an anti-vascular endothelial growth factor therapy) remains uncertain, which has been the focus of studies on the management of ovarian cancer (OC). We performed a protocol for systematic review and meta-analysis to assess the efficacy and safety of bevacizumab combined with chemotherapy in OC.; Methods: The presentation of methods and results in this systematic review was performed according to the evaluation guidelines for health care interventions provided in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol. This study will use the Cochrane Library, Web of Science, PubMed, Embase, Allied and Complementary Medicine Database, China Biomedical Literature Database, China National Knowledge Infrastructure, China Science and Technology Journal Database, Wanfang Database, and Ongoing Clinical Trials Database. The risk of bias of included studies is estimated by taking into consideration the characteristics including random sequence generation, allocation concealment, blinding of patients, blinding of outcome assessment, completeness of outcome data, selective reporting, and other bias by Cochrane Collaboration's tool. All analyses were performed with Review Manager (RevMan) software, version 5.3.; Results: The results of this systematic review and meta-analysis will be published in a peer-reviewed journal.; Conclusion: Bevacizumab combined with chemotherapy may improve progression-free survival and overall survival in patients with OC.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Librach Clifford, L. (2021). "Automated Sperm Selection." ClinicalTrials.gov.
	No Results Available Device: Automated sperm selection software Fertilization rate|Blastocyst formation rate|Embryo morphology grade as evaluated by the SART grading system|Differences in early embryo cleavage divisions and late developmental (blastocyst) morphokinetics.|Differences in the proportion of euploid and aneuploid embryos between the two groups|Evaluation of patient demographic and stimulation cycle characteristics for confounding variables. All Not Applicable 330 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Care Provider)|Primary Purpose: Basic Science 2395 September 30, 2024

Lieshout Ryan, V. (2022). "Public Health Nurse-Delivered 1-Day CBT Workshops for PPD." ClinicalTrials.gov.
	Postpartum depression (PPD) is one of the most common complications of childbirth, affecting 1 in 5 mothers. Left untreated, it increases the risk of future depressive episodes and can have profound effects on offspring. A single case of PPD has been estimated to cost as much as $150,000 over the lifespan, or $3 billion for each annual cohort of Canadian births. Current clinical practice guidelines recommend evidence‐based psychotherapies (e.g., cognitive behavioural therapy (CBT)) as 1st‐line treatments for the vast majority of mothers with PPD. The key role that psychotherapy plays in the treatment of PPD is further emphasized by the US Preventive Services Task Force which recommends universal PPD screening, but "only when CBT or other evidence‐based counseling is available." While treating PPD can reduce its adverse effects, safe, timely, accessible interventions are essential to optimizing outcomes. However, only treatments that can be upscaled can have an impact on PPD at the population level. The delivery of psychotherapy in large groups (up to 30 participants) is a relatively new phenomenon, but may be capable of addressing mothers' needs, as well as treating PPD on the scale required to address its prevalence. Brief (i.e., 1‐Day) interventions contain the core content of more comprehensive, evidence‐based interventions, but their brevity makes them easier to disseminate beyond traditional treatment settings (e.g., in public health). 1‐Day CBT‐Based Workshops have been delivered by trained mental health professionals (psychologists, psychiatrists) to treat generalized anxiety disorder and depression in general population samples, and postpartum depression. Research Questions: Primary: Can Online 1‐Day CBT‐Based Workshops for PPD delivered by Public Health Nurses (PHNs) added to treatment as usual (TAU) improve PPD more than TAU alone at 12 weeks post‐treatment? Secondary: Can these workshops improve PPD at 6 months post‐treatment and reduce levels of anxiety, parenting stress, partner relationship discord, improve parent‐infant attachment, and reduce problems with temperament and behaviour in offspring at 3 and 6 months? Tertiary: Are the workshops cost‐effective? A parallel‐group Ontario‐wide randomized controlled trial (RCT) with experimental (workshop) and TAU (control) groups will address our objectives. Participants in both groups will complete all study questionnaires and be compared at baseline, and 3 and 6 months. The experimental group will receive the Online 1‐Day workshop (delivered by 2 PHNs) in addition to TAU, and the control group will receive TAU alone. Participants will be mothers who have an infant under 12 months, who are 18 years or older, who are experiencing elevated symptoms of postpartum depression and who are free of current bipolar, psychotic and/or substance use disorders.

Lijun, L., et al. (2024). "Comparative efficacy of adjuvant drugs in improving IVF/ICSI outcomes and reducing ovarian hyperstimulation syndrome in women with polycystic ovary syndrome: a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Lillian, S., et al. (2021). "Effect of artificial cycle-prepared frozen embryo transfer with GnRH agonist downregulation in recurrent implantation failure women: systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Lillian, S., et al. (2021). "The influence of G-CSF intrauterine perfusion on pregnancy outcome in women with thin endometrium during freeze-thaw embryo transfer cycles: systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Lim Chi Eung, D., et al. (2019). "Acupuncture for polycystic ovarian syndrome." The Cochrane Database of Systematic Reviews 7: CD007689.
	Background: Polycystic ovarian syndrome (PCOS) is characterised by the clinical signs of oligo-amenorrhoea, infertility and hirsutism. Conventional treatment of PCOS includes a range of oral pharmacological agents, lifestyle changes and surgical modalities. Beta-endorphin is present in the follicular fluid of both normal and polycystic ovaries. It was demonstrated that the beta-endorphin levels in ovarian follicular fluid of otherwise healthy women who were undergoing ovulation were much higher than the levels measured in plasma. Given that acupuncture impacts on beta-endorphin production, which may affect gonadotropin-releasing hormone (GnRH) secretion, it is postulated that acupuncture may have a role in ovulation induction via increased beta-endorphin production effecting GnRH secretion. This is an update of our previous review published in 2016.; Objectives: To assess the effectiveness and safety of acupuncture treatment for oligo/anovulatory women with polycystic ovarian syndrome (PCOS) for both fertility and symptom control.; Search Methods: We identified relevant studies from databases including the Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CNKI, CBM and VIP. We also searched trial registries and reference lists from relevant papers. CENTRAL, MEDLINE, Embase, PsycINFO, CNKI and VIP searches are current to May 2018. CBM database search is to November 2015.; Selection Criteria: We included randomised controlled trials (RCTs) that studied the efficacy of acupuncture treatment for oligo/anovulatory women with PCOS. We excluded quasi- or pseudo-RCTs.; Data Collection and Analysis: Two review authors independently selected the studies, extracted data and assessed risk of bias. We calculated risk ratios (RR), mean difference (MD), standardised mean difference (SMD) and 95% confidence intervals (CIs). Primary outcomes were live birth rate, multiple pregnancy rate and ovulation rate, and secondary outcomes were clinical pregnancy rate, restored regular menstruation period, miscarriage rate and adverse events. We assessed the quality of the evidence using GRADE methods.; Main Results: We included eight RCTs with 1546 women. Five RCTs were included in our previous review and three new RCTs were added in this update of the review. They compared true acupuncture versus sham acupuncture (three RCTs), true acupuncture versus relaxation (one RCT), true acupuncture versus clomiphene (one RCT), low-frequency electroacupuncture versus physical exercise or no intervention (one RCT) and true acupuncture versus Diane-35 (two RCTs). Studies that compared true acupuncture versus Diane-35 did not measure fertility outcomes as they were focused on symptom control.Seven of the studies were at high risk of bias in at least one domain.For true acupuncture versus sham acupuncture, we could not exclude clinically relevant differences in live birth (RR 0.97, 95% CI 0.76 to 1.24; 1 RCT, 926 women; low-quality evidence); multiple pregnancy rate (RR 0.89, 95% CI 0.33 to 2.45; 1 RCT, 926 women; low-quality evidence); ovulation rate (SMD 0.02, 95% CI -0.15 to 0.19, I 2 = 0%; 2 RCTs, 1010 women; low-quality evidence); clinical pregnancy rate (RR 1.03, 95% CI 0.82 to 1.29; I 2 = 0%; 3 RCTs, 1117 women; low-quality evidence) and miscarriage rate (RR 1.10, 95% CI 0.77 to 1.56; 1 RCT, 926 women; low-quality evidence).Number of intermenstrual days may have improved in participants receiving true acupuncture compared to sham acupuncture (MD -312.09 days, 95% CI -344.59 to -279.59; 1 RCT, 141 women; low-quality evidence).True acupuncture probably worsens adverse events compared to sham acupuncture (RR 1.16, 95% CI 1.02 to 1.31; I 2 = 0%; 3 RCTs, 1230 women; moderate-quality evidence).No studies reported data on live birth rate and multiple pregnancy rate for the other comparisons: physical exercise or no intervention, relaxation and clomiphene. Studies including Diane-35 did not measure fertility outcomes.We were uncertain whether acupuncture improved ovulation rate (measured by ultrasound three months p st treatment) compared to relaxation (MD 0.35, 95% CI 0.14 to 0.56; 1 RCT, 28 women; very low-quality evidence) or Diane-35 (RR 1.45, 95% CI 0.87 to 2.42; 1 RCT, 58 women; very low-quality evidence).Overall evidence ranged from very low quality to moderate quality. The main limitations were failure to report important clinical outcomes and very serious imprecision.; Authors' Conclusions: For true acupuncture versus sham acupuncture we cannot exclude clinically relevant differences in live birth rate, multiple pregnancy rate, ovulation rate, clinical pregnancy rate or miscarriage. Number of intermenstrual days may improve in participants receiving true acupuncture compared to sham acupuncture. True acupuncture probably worsens adverse events compared to sham acupuncture.No studies reported data on live birth rate and multiple pregnancy rate for the other comparisons: physical exercise or no intervention, relaxation and clomiphene. Studies including Diane-35 did not measure fertility outcomes as the women in these trials did not seek fertility.We are uncertain whether acupuncture improves ovulation rate (measured by ultrasound three months post treatment) compared to relaxation or Diane-35. The other comparisons did not report on this outcome.Adverse events were recorded in the acupuncture group for the comparisons physical exercise or no intervention, clomiphene and Diane-35. These included dizziness, nausea and subcutaneous haematoma. Evidence was very low quality with very wide CIs and very low event rates.There are only a limited number of RCTs in this area, limiting our ability to determine effectiveness of acupuncture for PCOS.

Lim Myong, C. (2022). "HIPEC for Platinum-Resistant Recurrent Ovarian Cancer." ClinicalTrials.gov.
	The objective of this trial (KOV‐HIPEC‐02) is to prove the survival benefit of HIPEC with doxorubicin and mitomycin (trial arm) compared to physician‐choice chemotherapy (control arm) in patients with platinum‐resistant recurrent epithelial ovarian cancer.

Lim Myong, C. (2022). "Randomized Phase III Trial of HIPEC in Platinum-Resistant Recurrent Ovarian Cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Drug, Procedure/Surgery : 1. Experimental: HIPEC Intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) followed by physician‐choice chemotherapy until disease progression. ‐ HIPEC perfusion, doxorubicin 35mg/m2 & mitomycin 15 mg/m2, 41.5'C, 90 min. 2, Control: No HIPEC Physician‐choice chemotherapy from enrollment until disease progression. CONDITION: Neoplasms PRIMARY OUTCOME: Progression free survival SECONDARY OUTCOME: cost‐effectiveness Adverse events Overall survival and cancer‐specific survival Quality of Life INCLUSION CRITERIA: INCLUSION CRITERIA: Patients =18 years old, Patients with Eastern Cooperative Oncology Group (ECOG) Performance status 0‐2, Patients diagnosed with histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, Resistant to platinum‐based chemotherapy (Platinum‐refractory or resistant disease) Resectable intraperitoneal disease based on previous clinical history and recent image finding, A life expectancy > 3 months as clinically judged, Women who are medically unable to conceive or who are of childbearing potential, agree to follow contraceptive guidelines during treatment, Patient can also consent to the provision of clinical information for secondary use such as future biomedical research. However, in the future, subjects can participate in the main trial even if they do not intend to participate in sharing clinical information and, Adequate organ function for cytoreductive surgery

Lim Myong, C. (2023). "Interval Cytoreductive Surgery With or Without HIPEC for Ovarian Cancer (KOV-HIPEC-04)." ClinicalTrials.gov.
	The goal of this phase III randomized controlled trial is to compare the clinical efficacy of HIPEC with cisplatin (trial arm) compared to no HIPEC (control arm) during interval cytoreductive surgery followed by neoadjuvant chemotherapy, in patients with stage III‐IV primary epithelial ovarian cancer.

Lim Myong, C. (2023). "Phase III randomized trial of HIPEC in Primary Stage three & Four Ovarian Cancer after Interval Cytoreductive Surgery (FOCUS)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Drug, Procedure/Surgery : 1. Experimental: HIPEC group (Arm A) For patients assigned to the HIPEC (Hyperthermic Intraperitoneal Chemotherapy) group, HIPEC is performed after Interval cytoreductive surgery. Cisplatin 75 mg/m2 is perfused for 90 minutes when the intraperitoneal fluid temperature was maintained above 41.5°C. 2, Control: No HIPEC group (Arm B) Only Interval cytoreductive surgery is performed without performing Hyperthermic Intraperitoneal Chemotherapy (HIPEC). CONDITION: Neoplasms PRIMARY OUTCOME: OS: Overall survival SECONDARY OUTCOME: CSS: Cancer‐Specific Survival Economic evaluation analysis of HIPEC PFS: Progression free survival Quality of Life TFST :Time to first subsequent therapy toxicity INCLUSION CRITERIA: 1. A person aged 19 years or older but younger than 80 years of age at the time of providing informed written consent 2. Among patients diagnosed with histologically confirmed FIGO stage 3‐4 epithelial ovarian, fallopian tube, or primary peritoneal cancer, patients who underwent Interval cytoreductive surgery after 3 cycles of neoadjuvant chemotherapy 3. Patients with residual tumor depth less than 2.5mm after Interval cytoreductive surgery 4. Persons with a life expectancy of 3 months or more at the time of clinical trial assignment 5. It has adequate organ function. (Specimens must be collected within 28 days.) 1) Adequate bone marrow function ANC (Absolute Neutrophil Count)= 1,000/? Platelet count = 80,000/? Hemoglobin= 8.5 g/dl (After correction in case of anemia) 2) Adequate renal function Creatinine or creatinine clearance (GFR can also be used instead of Cr or CrCl)= 2.0 XULN or CrCl=60m

Lim Myong, C., et al. (2022). "Survival After Hyperthermic Intraperitoneal Chemotherapy and Primary or Interval Cytoreductive Surgery in Ovarian Cancer: A Randomized Clinical Trial." JAMA Surgery 157(5): 374-383.
	Importance: Ovarian cancer has the highest mortality rate among gynecologic malignant tumors. Data are lacking on the survival benefit of hyperthermic intraperitoneal chemotherapy (HIPEC) in women with ovarian cancer who underwent primary or interval cytoreductive surgery.; Objective: To assess the clinical benefit of HIPEC after primary or interval maximal cytoreductive surgery in women with stage III or IV primary advanced ovarian cancer.; Design, Setting, and Participants: In this single-blind randomized clinical trial performed at 2 institutions in South Korea from March 2, 2010, to January 22, 2016, a total of 184 patients with stage III or IV ovarian cancer with residual tumor size less than 1 cm were randomized (1:1) to a HIPEC (41.5 °C, 75 mg/m2 of cisplatin, 90 minutes) or control group. The primary end point was progression-free survival. Overall survival and adverse events were key secondary end points. The date of the last follow-up was January 10, 2020, and the data were locked on February 17, 2020.; Exposures: Hyperthermic intraperitoneal chemotherapy after cytoreductive surgery.; Main Outcomes and Measures: Progression-free and overall survival.; Results: Of the 184 Korean women who underwent randomization, 92 were randomized to the HIPEC group (median age, 52.0 years; IQR, 46.0-59.5 years) and 92 to the control group (median age, 53.5 years; IQR, 47.5-61.0 years). After a median follow-up of 69.4 months (IQR, 54.4-86.3 months), median progression-free survival was 18.8 months (IQR, 13.0-43.2 months) in the control group and 19.8 months (IQR, 13.7-55.4 months) in the HIPEC group (P = .43), and median overall survival was 61.3 months (IQR, 34.3 months to not reported) in the control group and 69.5 months (IQR, 45.6 months to not reported) in the HIPEC group (P = .52). In the subgroup of interval cytoreductive surgery after neoadjuvant chemotherapy, the median progression-free survival was 15.4 months (IQR, 10.6-21.1 months) in the control group and 17.4 months (IQR, 13.8-31.5 months) in the HIPEC group (hazard ratio for disease progression or death, 0.60; 95% CI, 0.37-0.99; P = .04), and the median overall survival was 48.2 months (IQR, 33.8-61.3 months) in the control group and 61.8 months (IQR, 46.7 months to not reported) in the HIPEC group (hazard ratio, 0.53; 95% CI, 0.29-0.96; P = .04). In the subgroup of primary cytoreductive surgery, median progression-free survival was 29.7 (IQR, 17.2-90.1 months) in the control group and 23.9 months (IQR, 12.3-71.5 months) in the HIPEC group, and the median overall survival was not reached in the control group and 71.3 months (IQR, 45.6 months to not reported) in the HIPEC group.; Conclusions and Relevance: The addition of HIPEC to cytoreductive surgery did not improve progression-free and overall survival in patients with advanced epithelial ovarian cancer. Although the results are from a subgroup analysis, the addition of HIPEC to interval cytoreductive surgery provided an improvement of progression-free and overall survival.; Trial Registration: ClinicalTrials.gov Identifier: NCT01091636.

Lim Siew, S., et al. (2019). "Lifestyle changes in women with polycystic ovary syndrome." The Cochrane Database of Systematic Reviews 3: CD007506.
	Background: Polycystic ovary syndrome (PCOS) affects 8% to 13% of reproductive-aged women and is associated with reproductive and metabolic dysfunction. Obesity worsens the presentation of PCOS and weight management (weight loss, maintenance or prevention of excess weight gain) is proposed as an initial treatment strategy, best achieved through lifestyle changes incorporating diet, exercise and behavioural interventions.; Objectives: To assess the effectiveness of lifestyle treatment in improving reproductive, anthropometric (weight and body composition), metabolic and quality of life factors in PCOS.; Search Methods: We searched the Cochrane Gynaecology and Fertility Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, CINAHL and AMED (date of last search March 2018). We also searched controlled trials registries, conference abstracts, relevant journals, reference lists of relevant papers and reviews, and grey literature databases, with no language restrictions applied.; Selection Criteria: Randomised controlled trials (RCTs) comparing lifestyle treatment (diet, exercise, behavioural or combined treatments) to minimal or no treatment in women with PCOS.; Data Collection and Analysis: Two authors independently selected trials, assessed evidence quality and risk of bias, and extracted data. Our primary outcomes were live birth, miscarriage and pregnancy. We used inverse variance and fixed-effect models in the meta-analyses. We reported dichotomous outcomes as an odds ratio and continuous outcomes as a mean difference (MD) or standardised mean difference (SMD).; Main Results: We included 15 studies with 498 participants. Ten studies compared physical activity to minimal dietary and behavioural intervention or no intervention. Five studies compared combined dietary, exercise and behavioural intervention to minimal intervention. One study compared behavioural intervention to minimal intervention. Risk of bias varied: eight studies had adequate sequence generation, seven had adequate clinician or outcome assessor blinding, seven had adequate allocation concealment, six had complete outcome data and six were free of selective reporting. No studies assessed the fertility primary outcomes of live birth or miscarriage. No studies reported the secondary reproductive outcome of menstrual regularity, as defined in this review.Lifestyle intervention may improve a secondary (endocrine) reproductive outcome, the free androgen index (FAI) (MD -1.11, 95% confidence interval (CI) -1.96 to -0.26, 6 RCTs, N = 204, I 2 = 71%, low-quality evidence). Lifestyle intervention may reduce weight (kg) (MD -1.68 kg, 95% CI -2.66 to -0.70, 9 RCTs, N = 353, I 2 = 47%, low-quality evidence). Lifestyle intervention may reduce body mass index (BMI) (kg/m 2 ) (-0.34 kg/m 2 , 95% CI -0.68 to -0.01, 12 RCTs, N = 434, I 2 = 0%, low-quality evidence). We are uncertain of the effect of lifestyle intervention on glucose tolerance (glucose outcomes in oral glucose tolerance test) (mmol/L/minute) (SMD -0.02, 95% CI -0.38 to 0.33, 3 RCTs, N = 121, I 2 = 0%, low-quality evidence).; Authors' Conclusions: Lifestyle intervention may improve the free androgen index (FAI), weight and BMI in women with PCOS. We are uncertain of the effect of lifestyle intervention on glucose tolerance. There were no studies that looked at the effect of lifestyle intervention on live birth, miscarriage or menstrual regularity. Most studies in this review were of low quality mainly due to high or unclear risk of bias across most domains and high heterogeneity for the FAI outcome.

Lin, L., et al. (2023). "Glucocorticoid supplementation during ovulation induction for assisted reproductive technology: a systematic review and meta-analysis." The Journal of Maternal-fetal & Neonatal Medicine 36(2): 2227310.
	Background: There is ongoing interest in glucocorticoid treatment during oocyte stimulation to treat infertility in women who have undergone Assisted Reproductive Technology (ART).; Objective: This meta-analysis was performed to evaluate the efficiency and safety of adjuvant glucocorticoid therapy on pregnancy outcomes in infertile women undergoing ART cycles.; Study Design: A literature search was performed in PubMed, EMBASE, Web of Science, and the Cochrane Library up to December 2022. To assess the efficacy and safety of additional glucocorticoid treatment during ovulation induction in women who underwent IVF or ICSI treatment, only randomized controlled trials were included.; Results: Overall, glucocorticoid therapy during ovulation showed a nonsignificant effect of prednisolone improving the live birth rate (OR = 1.03, 95% CI [.75, 1.43], I 2 = .0%, p = .84), abortion rate (OR = 1.14, 95% CI [.62, 2.08], I 2 = 31%, p = .68), and implantation rate (OR = 1.1, 95% CI [.82, 1.5], I 2 = 8%, p = .52) of infertile women compared to the control group. The present meta-analysis revealed that the clinical pregnancy rate per cycle tended to increase after glucocorticoid treatment (OR = 1.29, 95% CI [1.02, 1.63], I 2 = 8%, p = .52).; Conclusions: The present meta-analysis suggested that ovarian stimulation prednisolone therapy does not significantly improve clinical outcomes in women undergoing IVF/ICSI. Although the results indicated that adjuvant glucocorticoid therapy during ovarian stimulation may increase the clinical pregnancy rate, subgroup analysis showed that it was affected by infertility factors, dose schedules, and length of treatment. Therefore, these results should be interpreted with caution.

Lin, Q., et al. (2021). "PARP inhibitors as maintenance therapy in newly diagnosed advanced ovarian cancer: a meta-analysis." BJOG 128(3): 485-493.
	Background: Up to 70% of patients with advanced ovarian cancer have a relapse after primary therapy. New agents and approaches are urgently needed to avoid or slow down this recurrence.; Objectives: To investigate the efficacy of PARP inhibitors (PARPis) as maintenance treatment in patients with newly diagnosed advanced ovarian cancer.; Search Strategy: PubMed, MEDLINE, EMBASE, Cochrane Library and Web of Science databases.; Selection Criteria: All randomised clinical trials (RCTs) that compared PARPis with placebo as first-line maintenance therapy in ovarian cancer.; Data Collection and Analysis: Two reviewers extracted data. Pooled hazard ratio (HR) and risk ratio (RR) with 95% confidence interval (CI) were calculated.; Main Results: PARPis were associated with significant improvement of progression-free survival (PFS) in advanced epithelial ovarian cancer (AeOC) (HR = 0.53, 95% CI 0.40-0.71; P < 0.0001). The benefit was not only in women with BRCA mutations (HR = 0.35, 95% CI 0.29-0.42; P < 0.00001) and homologous recombination deficiency (HRD) (HR = 0.43, 95% CI 0.32-0.60; P < 0.00001), but also in those with nonmutated BRCA (HR = 0.72, 95% CI 0.63-0.82; P < 0.00001) and even non-HRD (HR = 0.83, 95% CI 0.70-0.99; P = 0.04).; Conclusions: PARP inhibitors are effective as maintenance therapy among patients with newly diagnosed advanced ovarian cancer after platinum-based chemotherapy, regardless of BRCA mutation or HRD status.; Tweetable Abstract: PARPis provide a significant PFS benefit as first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer. (© 2020 Royal College of Obstetricians and Gynaecologists.)

Lin, T., et al. (2019). "Enoxaparin (or plus aspirin) for the prevention of recurrent miscarriage: A meta-analysis of randomized controlled studies." European Journal of Obstetrics, Gynecology, and Reproductive Biology 234: 53-57.
	Enoxaparin treatment has emerged as an important approach to prevent recurrent miscarriage, but the use of enoxaparin for the prevention of recurrent miscarriage has not been well established. We conduct a systematic review and meta-analysis to evaluate the efficacy of enoxaparin to prevent recurrent miscarriage. PubMed, Embase, and the Cochrane Central Register of Controlled Trials are searched. Randomized controlled trials (RCTs) assessing the influence of enoxaparin (or plus aspirin) treatment versus placebo on prevention of recurrent miscarriage are included. Three RCTs are included in the meta-analysis. Compared with control intervention for recurrent miscarriage, enoxaparin treatment has no substantial influence on live births (RR = 1.07; 95% CI = 0.77-1.47; P = 0.69), miscarriage rate (RR = 0.82; 95% CI = 0.31-2.17; P = 0.68), gestational age (Std. MD=-0.13; 95% CI=-0.78 to 0.52; P = 0.69), birth weight (Std. MD = 0.05; 95% CI=-0.41 to 0.51; P = 0.82), but leads to the increase in pre-eclampsia (RR = 3.42; 95% CI = 1.15-10.11; P = 0.03). Enoxaparin treatment has no additional benefits for women with recurrent miscarriage. (Copyright © 2018. Published by Elsevier B.V.)

Lin, W., et al. (2022). "Therapeutic efficacy of clomiphene citrate combined with metformin in patients with polycystic ovary syndrome." Journal of Clinical Pharmacy and Therapeutics 47(3): 321-329.
	What Is Known and Objective: Although several clinical trials have compared the clinical efficacy of clomiphene citrate (CC) combined with metformin (MET) in the treatment of women with polycystic ovary syndrome (PCOS), the results are controversial. Therefore, this study was designed to conduct a pooled analysis to evaluate the efficacy of CC combined with MET versus CC in these patients.; Methods: Computerized searches of the PubMed, Web of Science, Embase and Cochrane Library databases were conducted to identify eligible randomized controlled trials (RCTs) from the data obtained up to June 2021. The Cochrane Collaboration risk of bias tool was used to assess the risk of bias in individual RCTs, and RevMan 5.4 was used for data statistical analysis.; Results and Discussion: A total of 13 RCTs were included in the meta-analysis. These studies involved 1,353 patients, 707 of these were in the combination group and 646 in the monotherapy group. The results indicated a higher clinical pregnancy rate (risk ratio [RR] 1.28, 95% confidence interval [CI] 1.06-1.54, p = 0.01) in the combined group compared to the monotherapy group. However, no significant differences were observed in the ovulation rate (RR 1.13, 95% CI 0.98-1.30, p = 0.10), live birth rate (RR 1.13, 95% CI 0.89-1.42, p = 0.32), multiple pregnancy rate (RR 0.58, 95% CI 0.19-1.73, p = 0.33) and abortion rate (RR 1.26, 95% CI 0.86-1.84, p = 0.23) between the two groups.; What Is New and Conclusion: CC combined with MET has an advantage in improving the clinical pregnancy rate compared to CC alone; however, there is no significant difference in the rate of ovulation. For better management of PCOS, a high-quality RCT is needed to demonstrate the safety of the combination. (© 2021 John Wiley & Sons Ltd.)

Lina, A.-H. and K. Astrid (2022). "Network meta-analysis on the comparison of multiple interventions on Premenstrual Dysphoric Disorder." PROSPERO International prospective register of systematic reviews.
	
Lionett, S., et al. (2021). "Absent Exercise-Induced Improvements in Fat Oxidation in Women With Polycystic Ovary Syndrome After High-Intensity Interval Training." Frontiers in Physiology 12: 649794.
	Background: Polycystic ovary syndrome (PCOS) and metabolic inflexibility are linked to insulin resistance, and women with PCOS appear to be metabolic inflexible in the rested, insulin-stimulated state. Exercise training is a primary lifestyle intervention in PCOS. Exercise training improves whole-body fat oxidation during submaximal exercise in healthy women, yet little is known about the effect on this outcome in women with PCOS. Methods: We measured whole-body fat oxidation rates during sub maximal exercise before and after 16 weeks of high-intensity interval training (HIT) in women with PCOS randomly allocated to either: low- or high-volume HIT (n = 41; low-volume HIT, 10 × 1 min work bouts at maximal, sustainable intensity and high-volume HIT, 4 × 4 min work bouts at 90-95% of maximal heart rate) or non-exercise control (n = 23), and in women without PCOS (Non-PCOS) allocated to low- or high volume HIT (n = 15). HIT was undertaken three times weekly. In a subset of women with and without PCOS, we measured mitochondrial respiration in abdominal and gluteal subcutaneous adipose tissue using high-resolution respirometry, as well as fat cell sizes in these tissues. Results: At baseline, women with PCOS had lower whole-body fat oxidation and mitochondrial respiration rates in abdominal adipose tissue compared to Non-PCOS. Peak oxygen uptake (mL/min/kg) increased in women with PCOS (~4%, p = 0.006) and Non-PCOS (~6%, p = 0.003) after 16 weeks of HIT. Whole-body fat oxidation only improved in Non-PCOS after HIT. No changes were observed in mitochondrial respiration and cell size in abdominal and gluteal adipose tissue after HIT in either group of women. Conclusion: We observed exercise-induced improvements in whole-body fat oxidation during submaximal exercise in Non-PCOS, but not in women with PCOS, after 16 weeks of HIT, suggesting metabolic inflexibility in women with PCOS. Clinical Trial Registration: www.clinicaltrials.gov, identifier NCT02419482 and NCT02943291.

Lipetskaia, L., et al. (2022). "Thirty-six-month Prospective Study of Transvaginal Bovine Graft vs Native Tissue Repair for the Treatment of Pelvic Organ Prolapse." Urology 167: 234-240.
	Objective(s): To compare the safety and effectiveness of dermal bovine transvaginal graft, Xenform, to native tissue in the surgical treatment of anterior and/or apical pelvic organ prolapse. This study was designed in conjunction with Food and Drug Administration requirements.; Methods: This was a prospective, non-randomized, parallel cohort, multi-center trial. The primary objective was to demonstrate noninferiority between transvaginal graft and native tissue repair at 36 months compared to baseline. Treatment success was based on a composite of objective and subjective measures. The co-primary outcome was the rate of serious device- or procedure-related adverse events. A total of 228 patients at 25 sites were included in the study arm and 485 patients underwent native tissue repair. Propensity score stratification was applied to achieve balance between treatment groups. Study outcomes were compared in per protocol and intent-to-treat analysis.; Results: The primary outcome, treatment success at 36 months, was 83.6% (191/228) for transvaginal graft and 80.5% (390/485) native tissue repair (0.2%, 90% confidence interval [-5.6% to 5.9%]), demonstrating noninferiority at a preset margin of -12%. The overall rate of severe adverse events was 5.3% (12/228) in transvaginal graft vs 2.7% (13/485) in native tissue repair groups. The study group demonstrated noninferiority in serious adverse events at the preset margin of 11.6% (2.0%, 90% confidence interval [-0.8% to 4.7%]). There were no reports of graft erosion, and graft exposure rates were low (0.9% [2/228]).; Conclusions: Transvaginal repair of anterior and/or apical prolapse with a biological graft is noninferior to traditional native tissue repair in effectiveness and safety at 36 months. (Copyright © 2022. Published by Elsevier Inc.)

Lírio, J., et al. (2022). "Antifungal (oral and vaginal) therapy for recurrent vulvovaginal candidiasis: a systematic review and meta-analysis." Revista da Associacao Medica Brasileira 68(2): 261-267.
	
Lisieux, P., et al. (2021). "Efficacy and safety of laser therapy for the genitourinary syndrome of menopause: a systematic review and meta-analysis of controlled clinical trials." PROSPERO International prospective register of systematic reviews.
	
Liu, C., et al. (2023). "Live birth rate of gonadotropin-releasing hormone antagonist versus luteal phase gonadotropin-releasing hormone agonist protocol in IVF/ICSI: a systematic review and meta-analysis." Expert Reviews in Molecular Medicine 26: e2.
	In vitro fertilization (IVF) and embryo transfer and intracytoplasmic sperm injection (ICSI) have allowed millions of infertile couples to achieve pregnancy. As an essential part of IVF/ICSI enabling the retrieval of a high number of oocytes in one cycle, controlled ovarian stimulation (COS) treatment mainly composes of the standard long gonadotrophin-releasing hormone agonist (GnRH-a) protocol and the gonadotrophin-releasing hormone antagonist (GnRH-ant) protocol. However, the effectiveness of GnRH-ant protocol is still debated because of inconsistent conclusions and insufficient subgroup analyses. This systematic review and meta-analysis included a total of 52 studies, encompassing 5193 participants in the GnRH-ant group and 4757 in the GnRH-a group. The findings of this study revealed that the GnRH-ant protocol is comparable with the long GnRH-a protocol when considering live birth as the primary outcome, and it is a favourable protocol with evidence reducing the incidence of ovarian hyperstimulation syndrome in women undergoing IVF/ICSI, especially in women with polycystic ovary syndrome. Further research is needed to compare the subsequent cumulative live birth rate between the two protocols among the general and poor ovarian response patients since those patients have a lower clinical pregnancy rate, fewer oocytes retrieved or fewer high-grade embryos in the GnRH-ant protocol.

Liu, C., et al. (2022). "Effect of acupuncture on menopausal hot flushes and serum hormone levels: a systematic review and meta-analysis." Acupuncture in Medicine 40(4): 289-298.
	OBJECTIVE: To evaluate the efficacy/effectiveness and safety of acupuncture for the treatment of hot flushes and its impact on serum hormone levels in menopausal women. METHOD(S): A total of 10 databases were searched from their inception to August 2018. Reference lists of reviews and included articles were also hand-searched. Randomized controlled trials (RCTs) comparing the effect of acupuncture versus sham acupuncture, or acupuncture versus hormone therapy (HT), as treatment for menopausal hot flushes were included. Outcomes included hot flush frequency, hot flush severity and serum hormone levels of estradiol (E2), luteinizing hormone (LH) and follicle-stimulating hormone (FSH). Meta-analyses were performed using Review Manager 5.3 software. RESULT(S): Thirteen RCTs including 1784 patients were selected, seven of which were available for meta-analysis. Compared with sham acupuncture, acupuncture significantly decreased hot flush frequency (mean difference (MD) -0.84, 95% confidence interval (CI) [-1.64, -0.05], I2 = 54%) from baseline to the end of study, but did not impact end scores of hot flush frequency (MD 0.19, 95% CI [-0.61, 0.99], I2 = 0%) or severity (MD 0.02, 95% CI [-0.13, 0.17], I2 = 0%). No differences were found between acupuncture and HT in serum levels of E2 (MD 6.56, 95% CI [-3.77, 16.89], I2 = 76%), FSH (MD 1.06, 95% CI [-1.44, 3.56], I2 = 0%) or LH (MD -3.36, 95% CI [-13.37, 6.65], I2 = 89%). CONCLUSION(S): Acupuncture may not decrease hot flush frequency, but yet appears to have similar effects on serum hormone levels as HT, that is, increased E2 and decreased FSH and LH. Considering that no firm conclusions could be drawn due to the low quality and limited number of included trials included, further high-quality RCTs need to be conducted.

Liu, F.-T., et al. (2021). "Effects of Growth Hormone Supplementation on Poor Ovarian Responders in Assisted Reproductive Technology: a Systematic Review and Meta-analysis." Reproductive Sciences 28(4): 936-948.
	To investigate whether additional growth hormone (GH) treatment can improve pregnancy outcomes in poor ovarian responders (POR), this systematic review and meta-analysis is prospectively designed and has been registered in PROSPERO (Registration number: CRD42019137866). Literature search was conducted in PubMed, EMBASE, Web of Science, and Cochrane Library from January 2010 to June 2019, and studies before 2010 were included based on a Cochrane review published in 2010. Only English articles and randomized clinical trial studies were included. A total of 12 studies were included for analysis. GH treatment in poor ovarian responders significantly increased the clinical pregnancy rate (odds ratio (OR) = 1.75 (1.23, 2.50)), and the live birth rate also tended to increase after GH treatment (OR = 1.51 (0.97, 2.35)). Other outcomes including the gonadotropin requirement, oocyte retrieval number, endometrium thickness, and the number of patients with available embryos for transfer were also improved by growth hormone treatment (weighted mean differences (WMD) = - 0.78 (- 1.23, - 0.33), 1.41 (0.72, 2.09), 0.36 (0.18, 0.53), OR = 2.67 (1.47, 4.68), respectively). Based on the current study, GH treatment in POR can increase clinical pregnancy rate and show a higher but not statistically significant likelihood of live birth rate. The effect is likely to be mediated by improving ovarian response and endometrium thickness. The effect of GH treatment on live birth rate should be tested by further studies with a larger sample size.

Liu, H., et al. (2022). "Concurrent chemoradiotherapy followed by adjuvant chemotherapy versus concurrent chemoradiotherapy alone in locally advanced cervical cancer: A systematic review and meta-analysis." Frontiers in Oncology 12: 997030.
	Objective: This study aimed to assess the efficacy and safety of adjuvant chemotherapy (ACT) after concurrent chemoradiation (CCRT) in patients with locally advanced cervical cancer (LACC) via meta-analysis.; Methods: A systematic literature search of MEDLINE, PubMed, Web of Science, EMBASE, and the Cochrane Central Register of Controlled Trials was conducted from January 10, 1966 to May 20, 2022. Randomized controlled trials and observational studies comparing the CCRT alone with CCRT plus ACT were included. The literature search, quality assessment, and data extraction were conducted by two reviewers independently. The primary endpoints were 3-year rates of overall survival (OS) and progression-free survival (PFS). Complete response rate, local recurrence, distant metastasis, and adverse events were secondary outcomes. The hazard ratios (HRs) and relative risk (RR) were pooled.; Results: Nine studies with a total of 2732 patients were included in this meta-analysis, including 1411 patients in the CCRT group and 1321 in the CCRT plus ACT group. The HR for 3-year rates of OS and PFS of the CCRT group compared with the CCRT plus ACT group was 0.72 [95%confidence interval (CI) = 0.44-1.17] and 0.78 (95%CI = 0.5-1.75), respectively. No significant differences were observed between the two groups in the complete response rate (RR = 1.06, 95%CI = 0.96-1.16). However, local recurrence and distant metastasis were significantly lower in the CCRT plus ACT group than in the CCRT group (RR = 0.63, 95%CI = 0.44 -0.91 and RR = 0.64, 95%CI = 0.47-0.88). Grade 3-4 acute toxicities were more frequent in the CCRT plus ACT group (RR = 1.73, 95%CI =1.19-2.52).; Conclusion: Although associated with a decreased risk of local recurrence and distant metastasis, ACT did not significantly improve the survival rate and the complete response rate with increasing grade 3-4 acute toxicities in patients with LACC. Thus, this ACT regimen cannot be recommended for patients with LACC.; Systematic Review Registration: https://inplasy.com/inplasy-2022-9-0089/, identifier INPLASY202290089.; 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 Liu, Ma, Sun, Wu, Xu, Zhou, Yao, Liu, Qin and Han.)

Liu, J., et al. (2023). "The effects of N-acetylcysteine supplement on metabolic parameters in women with polycystic ovary syndrome: a systematic review and meta-analysis." Frontiers in Nutrition 10: 1209614.
	Objectives: Polycystic ovary syndrome (PCOS) is a common endocrine disease, often accompanied by metabolic disorders. Metformin, as an insulin sensitizer, is widely used to improve the metabolic function of PCOS, but may have gastrointestinal side effects. Emerging evidence suggests that N-acetylcysteine (NAC) improves metabolic parameters in PCOS and may be a potential alternative to metformin.; Methods: We searched four online databases, PubMed, Embase, Web of Science, and Cochrane Library, from inception to April 1, 2023. The I 2 statistic and Cochrane's Q test were employed to determine heterogeneity between studies, with an I 2 value >50% or p < 0.1 considered significant. The data were expressed as standardized mean differences and corresponding 95% confidence intervals.; Results: A total of 11 randomized controlled trials were included in the final analysis, including 869 women with PCOS. The results showed that NAC caused more changes in body mass index (SMD: -0.16, 95% CI: -0.40 to 0.08), body weight (SMD: -0.25, 95% CI: -0.50 to 0.00), fasting insulin (SMD: -0.24, 95% CI: -0.53 to 0.06), ratio of fasting blood glucose to fasting insulin (SMD: 0.38, 95% CI: -0.33 to 1.08), total cholesterol (SMD: -0.11, 95% CI: -0.39 to 0.17), triglycerides (SMD: -0.18, 95% CI: -0.63 to 0.28), and low-density lipoprotein (SMD: -0.09, 95% CI: -0.51 to 0.33) compared with metformin. Compared with metformin or placebo, NAC significantly reduced fasting blood-glucose levels (SMD: -0.23, 95% CI: -0.43 to -0.04; SMD: -0.54, 95% CI: -1.03 to -0.05, respectively). In addition, NAC significantly reduced total cholesterol (SMD: -0.74, 95% CI: -1.37 to -0.12), and this effect was observed when NAC was compared with placebo. However, NAC reduced HDL levels in women with PCOS compared with metformin (SMD: -0.14, 95% CI: -0.42 to 0.14).; Conclusion: This study suggests that NAC is effective in improving metabolic parameters in PCOS and may be a promising nutritional supplement for the treatment of PCOS. Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/display&#95;record.php?RecordID=415172, identifier CRD42022339171.; 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 Liu, Su, Jin, Wang and Huang.)

Liu Joyce, F., et al. (2022). "Olaparib With or Without Cediranib Versus Platinum-Based Chemotherapy in Recurrent Platinum-Sensitive Ovarian Cancer (NRG-GY004): A Randomized, Open-Label, Phase III Trial." Journal of Clinical Oncology 40(19): 2138-2147.
	Purpose: Platinum-based chemotherapy is the standard of care for platinum-sensitive ovarian cancer, but complications from repeated platinum therapy occur. We assessed the activity of two all-oral nonplatinum alternatives, olaparib or olaparib/cediranib, versus platinum-based chemotherapy.; Patients and Methods: NRG-GY004 is an open-label, randomized, phase III trial conducted in the United States and Canada. Eligible patients had high-grade serous or endometrioid platinum-sensitive ovarian cancer. Patients were randomly assigned 1:1:1 to platinum-based chemotherapy, olaparib, or olaparib/cediranib. The primary end point was progression-free survival (PFS) in the intention-to-treat population. Secondary end points included activity within germline BRCA -mutated or wild-type subgroups and patient-reported outcomes (PROs).; Results: Between February 04, 2016, and November 13, 2017, 565 eligible patients were randomly assigned. Median PFS was 10.3 (95% CI, 8.7 to 11.2), 8.2 (95% CI, 6.6 to 8.7), and 10.4 (95% CI, 8.5 to 12.5) months with chemotherapy, olaparib, and olaparib/cediranib, respectively. Olaparib/cediranib did not improve PFS versus chemotherapy (hazard ratio [HR] 0.86; 95% CI, 0.66 to 1.10; P = .077). In women with germline BRCA mutation, the PFS HR versus chemotherapy was 0.55 (95% CI, 0.32 to 0.94) for olaparib/cediranib and 0.63 (95% CI, 0.37 to 1.07) for olaparib. In women without a germline BRCA mutation, the PFS HR versus chemotherapy was 0.97 (95% CI, 0.73 to 1.30) for olaparib/cediranib and 1.41 (95% CI, 1.07 to 1.86) for olaparib. Hematologic adverse events occurred more commonly with chemotherapy; however, nonhematologic adverse events were higher with olaparib/cediranib. In 489 patients evaluable for PROs, patients receiving olaparib/cediranib scored on average 1.1 points worse on the NFOSI-DRS-P subscale (97.5% CI, -2.0 to -0.2, P = .0063) versus chemotherapy; no difference between olaparib and chemotherapy was observed.; Conclusion: Combination olaparib/cediranib did not improve PFS compared with chemotherapy and resulted in reduced PROs. Notably, in patients with a germline BRCA mutation, both olaparib and olaparib/cediranib had significant clinical activity.; Competing Interests: Joyce F. LiuConsulting or Advisory Role: Tesaro, Mersana, Clovis Oncology, Genentech/Roche, GlaxoSmithKline, Regeneron, AstraZenecaResearch Funding: Genentech/Roche (Inst), AstraZeneca (Inst), Boston Biomedical (Inst), Acetylon Pharmaceuticals (Inst), Bristol Myers Squibb (Inst), Agenus (Inst), CytomX Therapeutics (Inst), Regeneron (Inst), Tesaro (Inst), Clovis Oncology (Inst), Surface Oncology (Inst), 2X Oncology (Inst), Vigeo Therapeutics (Inst), Aravive (Inst), Arch Oncology (Inst)Travel, Accommodations, Expenses: AstraZeneca, MerckUncompensated Relationships: Merck Mark F. BradyConsulting or Advisory Role: Cel-Sci Ursula A. MatulonisHonoraria: Advaxis, Alkermes, SymphogenConsulting or Advisory Role: Merck, Novartis, NextCure, AstraZeneca, Blueprint Medicines, Trillium Therapeutics, GlaxoSmithKline, AgenusResearch Funding: Merck, Novartis, Tesaro, Syndax, Immunogen, Mersana, Leap Therapeutics, Fujifilm, SQZ BiotechTravel, Accommodations, Expenses: AstraZeneca Austin MillerConsulting or Advisory Role: AstraZeneca/Merck, Regeneron (Inst)Uncompensated Relationships: Genetect Elizabeth M. SwisherLeadership: IDEAYA Biosciences David CellaStock and Other Ownership Interests: FACIT.orgConsulting or Advisory Role: AbbVie, GlaxoSmithKline, Pfizer, Astellas Pharma, Novartis, Bristol Myers Squibb, Asahi Kasei, Ipsen, Mei PharmaResearch Funding: Novartis (Inst), Ipsen (Inst), Pfizer (Inst), PledPharma (Inst), Bristol Myers Squibb (Inst), AbbVie (Inst), Regeneron (Inst), Clovis Oncology (Inst) Noelle G. ClovenConsulting or Advisory Role: Toray Industries Carolyn Y. MullerResearch Funding: AstraZeneca (Inst), Genmab (Inst), VBL Therapeutics (Inst), Roche/Genentech (Inst), TapImmune Inc (Inst), Linnaeus Therapeutics (Inst), agenus (Inst), Incyte (Inst), Merck (Inst)Patents, Royalties, Other Intellectual Property: Have a pending patent on the cancer use for R-ketorolac - not yet its own new drug (Inst)Other Relationship: NCI, NCI, Department of Defense Richard G. MooreHonoraria: Fujirebio DiagnosticsConsulting or Advisory Role: Abcodia, Fujirebio DiagnosticsResearch Funding: Angle Steven E. WaggonerConsulting or Advisory Role: Regeneron Melissa A. GellerResearch Funding: Tesaro, Genentech, FATE Therapeutics, Morphotek, Bayer Keiichi FujiwaraHonoraria: Kyowa Hakko Kirin, Zeria Pharmaceutical, Nippon Kayaku, Chugai Pharma, Eisai, Taiho Pharmaceutical, Daiichi Sankyo, Ono Pharmaceutical, TakedaConsulting or Advisory Role: MSD, Taiho Pharmaceutical, Eisai, Takeda, Genmab, NanoCarrierResearch Funding: Eisai (Inst), Kaken Pharmaceutical (Inst), Chugai Pharma (Inst), Immunogen (Inst), Oncotherapeutics (Inst), AstraZeneca (Inst), Zeria Pharmaceutical (Inst), Ono Pharmaceutical (Inst), MSD (Inst), Regeneron (Inst), Merck KGaA (Inst), Ono Pharmaceutical (Inst), Genmab (Inst), Seattle Genetics (Inst)Travel, Accommodations, Expenses: MSD Angeles Alvarez SecordHonoraria: Myriad GeneticsResearch Funding: Tesaro (Inst), AstraZeneca (Inst), Genentech (Inst), Boehringer Ingelheim (Inst), AbbVie (Inst), Merck (Inst), PharmaMar (Inst), Clovis Oncology (Inst), Eisai (Inst), Seattle Genetics (Inst), Immutep (Inst), GlaxoSmithKline (Inst), VBL Therapeutics (Inst), OncoQuest Pharmaceuticals (Inst)Travel, Accommodations, Expenses: GlaxoSmithKlineUncompensated Relationships: Roche/Genentech, VBL Therapeutics, GOG Foundation, OncoQuest Pharmaceuticals, Regeneron, Aravive Katherine M. MoxleyConsulting or Advisory Role: Tessa Therapeutics (Inst), Clovis Oncology (Inst), GlaxoSmithKline Michael A. BookmanEmployment: The Permanente Medical GroupConsulting or Advisory Role: AstraZeneca, AbbVie, Immunogen, Merck Sharp & Dohme, Genentech/Roche, Seattle Genetics, AraviveNo other potential conflicts of interest were reported.

Liu, L., et al. (2021). "Efficacy and safety of moxibustion for menstrual irregularities: A protocol for systematic review and meta-analysis." Medicine 100(14): e25281.
	Background: Menstrual irregularities (MI) is 1 of the most common clinical gynaecological diseases, with abnormal menstrual cycles, abnormal bleeding, and abdominal pain before or during menstruation as the main clinical manifestations. In modern medicine, abnormalities in the function of the pituitary gland, hypothalamus, and ovaries can affect menstruation. Currently, hormone levels in the body are mostly regulated by hormonal drugs, but these drugs can lead to hormonal imbalance, which can lead to adverse reactions. Many clinical studies have reported that moxibustion has a good effect on MI treatment, but there is no relevant systematic review. So the purpose of this study is to evaluate the effectiveness and safety of moxibustion in treating MI.; Methods: The following 8 electronic databases will be searched, including PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure, Web of Science, Chinese Scientific Journal Database, Wanfang Database, and Chinese Biomedical Literatures Database from their inception to 1 December 2020 without any restrictions. Researchers retrieve the literature and extracted the data, evaluation of research methods, quality of literature. The outcomes will include total effective rate, incidence of any adverse events. We use the Cochrane Risk of a bias assessment tool to evaluate methodological qualities. Data synthesis will be completed by RevMan 5.3.0.; Results: We will show the results of this study in a peer-reviewed journal.; Conclusions: This meta-analysis will provide reliable evidence for treatment of menstrual irregularities.; Inplasy Registration Number: INPLASY2020120042.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Liu, L. and W. Xiong (2021). "Effect of molecular targeted agents in chemotherapy for treating platinum-resistant recurrent ovarian cancer: A systematic review and meta-analysis." Medicine 100(32): e26849.
	Abstract: This study aimed to investigate the effect of molecular targeted agents (MTAs) in chemo on platinum-resistant recurrent ovarian cancer (ROC). We performed this meta-analysis according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statements. Randomized controlled trials reporting data about platinum-resistant ovarian cancer treated by MTAs were included. The endpoints for the present study included overall survival and progression-free survival. We analyzed 9 randomized controlled trials including 3631 patients with ROC. The pooled analysis indicated that a combination of MTAs with chemo could markedly increase objective response rate in those patients (P = .012). Nevertheless, the survival rate of those patients was not markedly changed (P = .19). Besides, the combination of MTAs with chemo dramatically aggravated the occurrence of adverse events (P < .05). Moreover, it resulted in the termination of treatment (P = .044) in those patients, but it had no effect on fatal adverse events (P = .16). Our results indicated that the combination of MTAs with chemo notably improved objective response rate in patients with platinum-resistant ROC, but its benefit did not translate into survival benefits.; Competing Interests: The authors have no funding and conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Liu, S., et al. (2021). "Effectiveness of ultra-long protocol on in vitro fertilization/intracytoplasmic sperm injection-embryo transfer outcome in infertile women with endometriosis: A systematic review and meta-analysis of randomized controlled trials." The Journal of Obstetrics and Gynaecology Research 47(4): 1232-1242.
	Objective: To evaluate the effectiveness of ultra-long protocol on reproductive and controlled ovarian hyperstimulation outcome in in vitro fertilization/intracytoplasmic sperm injection-embryo transfer (IVF/ICSI-ET) in infertile women with endometriosis versus long protocol.; Methods: We retrieved articles without language restrictions in the Elsevier ScienceDirect, Embase, Medline, PubMed, Web of Science, China National Knowledge Infrastructure, Wan Fang Data Knowledge Service Platform and China Science and Technology Journal Database from inception to August 2020. RCTs including the comparison of reproductive outcome of infertile patients with endometriosis who underwent ultra-long protocol and long protocol were selected. Data extraction was conducted using RevMan 5.3.; Results: A total of nine RCTs in compliance with the standard literature were included. This meta-analysis suggested that ultra-long protocol with a 3-month downregulation could increase clinical pregnancy rate of infertile women with endometriosis (RR=1.31, 95% CI:1.11 ~ 1.55, P = 0.002) versus long protocol. However, subgroup analysis found the different protocol provided no significant difference in improving clinical outcomes in patients with different disease stage of endometriosis.; Conclusion: The ultra-long protocol could improve the clinical pregnancy rate of infertile women with endometriosis compared with long protocol with a 3-month downregulation. And ultra-long protocol could be effective to increase the ongoing pregnancy rate compared to long-protocol. But, the efficacy of ultra-long protocol is not different between early and advanced stage of endometriosis. (© 2021 Japan Society of Obstetrics and Gynecology.)

Liu, T., et al. (2022). "Effects of exercise on vasomotor symptoms in menopausal women: a systematic review and meta-analysis." Climacteric 25(6): 552-561.
	The frequency and severity of menopausal vasomotor symptoms negatively impact quality of life. This systematic review evaluates the potential of exercise to relieve the subjective frequency and severity of vasomotor symptoms. We searched four databases to identify randomized controlled trials (RCTs) that evaluated the effect of structured exercise (e.g. aerobic training) on the severity and/or frequency of vasomotor symptoms in menopausal women. Two reviewers independently screened records for eligibility, extracted data and assessed risks of bias and evidence certainty using the Cochrane tool and Grading of Recommendations Assessment, Development and Evaluation (GRADE). When suitable, data were pooled using random-effect meta-analyses. We appraised 21 RCTs involving 2884 participants. Compared to no-treatment control, exercise significantly improved severity of vasomotor symptoms (10 studies, standardized mean difference [SMD] = 0.25; 95% confidence interval [CI]: 0.04 to 0.47, p = 0.02, very low certainty of evidence); the effect size was attenuated when studies with a high risk of bias were excluded (SMD = 0.11, 95% CI: -0.03 to 0.26, p = 0.13). No significant changes in vasomotor frequency were found between exercise and control (SMD = 0.14, 95% CI: -0.03 to 0.31, p = 0.12, high certainty of evidence). In conclusion, exercise might improve vasomotor symptom severity. Future rigorous RCTs addressing the limitations of current review are warranted to explore the optimal exercise prescription principles to target the severity of vasomotor symptoms.

Liu, W., et al. (2024). "Comparative effectiveness of nonsurgical interventions for urinary incontinence in older women: A systematic review and network meta-analysis." Archives of Gerontology and Geriatrics 116: 105214.
	Purpose: To compare the effectiveness of existing nonsurgical interventions to improve or cure urinary incontinence in older women. Method(s): Five English databases (Medline, EMBASE, Web of Science, PsychINFO and the Cochrane Library) were searched from January 1, 2018, until August 27, 2023. Studies published before 2018 were directly extracted from a review published in 2019 on a similar research question. Three Chinese databases (China National Knowledge Infrastructure (CNKI), Wanfang and SinoMed) were searched from January 1, 2000, until August 27, 2023. Randomized controlled trials of nonsurgical interventions for women aged >= 60 years with urinary incontinence were considered eligible. The primary outcome was the rate of improvement and cure. Pairwise meta-analysis and network meta-analysis were performed, with the pooled risk ratio (RR) and 95 % confidence interval (CI) being reported. Result(s): There were 15 intervention categories among the included 32 randomized controlled trials for older women with urinary incontinence. The combination of behavioral therapy with other interventions, including Chinese herbal medicine, electrical stimulation, and acupuncture were effective for both improvement and cure rates. Behavioral therapy plus Chinese herbal medicine was the most effective intervention category for both improvement and cure rates. Conclusion(s): Behavioral therapy plus Chinese herbal medicine was currently the optimal selection for the management of older women with urinary incontinence. However, the clinicians should carefully consider the effectiveness and quality of evidence because of the limited quality and quantity of the randomized controlled trials included.Copyright © 2023 Elsevier B.V.

Liu, X., et al. (2022). "The effectiveness of telemedicine interventions on women with postpartum depression: A systematic review and meta-analysis." Worldviews on Evidence-based Nursing 19(3): 175-190.
	Background: Postpartum depression (PPD) is a public health problem that has significant adverse effects on mothers, couple's relationships, newborn neurodevelopment, and child emotional and cognitive development. This study reviewed the effectiveness of telemedicine interventions in postparturient women with postpartum depression.; Aims: To evaluate the effectiveness of telemedicine intervention in women with postpartum depression.; Methods: Cochrane Library, PubMed, EMBASE, Web of Science, CINAHL, and PsycINFO were searched for relevant articles published between 2003 and March 2021. We also manually reviewed the reference lists of the retrieved articles. The present study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The risk of bias for individual studies was evaluated according to the Cochrane Handbook. RevMan 5.4 software was used to carry out the meta-analysis.; Results: The meta-analysis included 20 randomized controlled trials with a total of 3252 patients. The results demonstrated that telemedicine was an effective intervention for treating PPD and anxiety and for improving functional impairment in women during their postpartum period.; Linking Evidence to Action: This meta-analysis provided evidence that telemedicine was an effective intervention for treating PPD in women. Telemedicine also has significant effects on anxiety and improved functional impairment in women during their postpartum period. Our findings may provide accurate evidence-based guidance for postpartum women's mental health management. In the future, more high-quality studies are required for verifying these results. (© 2022 Sigma Theta Tau International.)

Liu, X., et al. (2020). "Comparison of therapeutic interventions for recurrent pregnancy loss in association with antiphospholipid syndrome: A systematic review and network meta-analysis." American Journal of Reproductive Immunology 83(4): e13219.
	Antiphospholipid syndrome (APS) is one of the treatable causes for pregnant women with recurrent pregnancy loss (RPL). This review compares the efficacy of a few treatment interventions (low-dose aspirin (LDA), aspirin plus low molecular weight heparin (LMWH), or unfractionated heparin (UFH)) in preventing complications during pregnancy and miscarriages for women with RPL and APS, and the potential differences in therapeutic effects of UFH and LMWH when combined with aspirin. We searched randomized controlled trials (RCTs) in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials and performed a systematic review and a Bayesian network meta-analysis (NMA). Finally, we found aspirin alone had a lower live birth rate compared to LMWH plus aspirin (OR = 0.37; 95% CrI, 0.17, 0.71), and UFH plus aspirin showed a higher live birth rate than aspirin alone (OR = 2.63; 95% CrI, 1.04, 5.39) in NMA, treating with UFH plus aspirin or LMWH plus aspirin did not have difference on live birth. Furthermore, LDA alone resulted in a lower birthweight compared to heparin plus aspirin, while higher birthweight was found when compared UFH plus aspirin to LMWH plus aspirin (MD = 895.40; 95% CrI, 817.40, 988.57) in NMA. Additionally, in women with RPL and APS and without a prior thrombosis, heparin plus aspirin improved birthweight but could not promote live birth rate compared to aspirin alone. In conclusion, heparin plus aspirin is recommended for women with RPL and APS. Notably UFH plus aspirin demonstrates the most significant therapeutic efficacy among these interventions in improving birthweight. (© 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Liu, Y. (2021). "Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery." ClinicalTrials.gov.
	No Results Available Radiation: Intensity modulated radiation therapy (IMRT)|Drug: Dostarlimab Incidence of dose limiting toxicities (DLTs) (Safety Run-in only)|Progression-free (PFS) Female Phase 2 31 Other|Industry Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 20-491 February 2025

Liu, Y., et al. (2022). "A comprehensive comparison of medication strategies for platinum-sensitive recurrent ovarian cancer: A Bayesian network meta-analysis." Frontiers in Pharmacology 13: 1010626.
	Background: The Platinum-based combination has been proven to have an outstanding effect on patients with platinum-sensitive recurrent ovarian cancer (PSROC), but the best scientific combination has not been established yet. The present study is aimed to seek the best treatment plan for PSROC. Methods: We did a systematic review and Bayesian network meta-analysis, during which lite before March 2022 were retrieved on PubMed, Embase, Web of Science, and Cochrane Central Registry of Controlled databases. We included randomized controlled clinical trials comparing chemotherapy combinations with other treatments for patients with PSROC. The important outcomes concerned were progression-free survival (PFS) (the primary outcome), overall survival (OS), objective response rate (ORR), adverse events (AEs), and AEs-related discontinuation. All outcomes were ranked according to the surface under the cumulative ranking curve. Results: 26 trials involving 10441 patients were retrieved in this study. For the initial treatment of PSROC, carboplatin plus pegylated liposomal doxorubicin (PLD) plus bevacizumab had the best PFS [hazard ratio (HR) 0.59, 95% credible interval (CI) 0.51-0.68]; Carboplatin plus paclitaxel plus bevacizumab resulted in the best OS (HR 1.22, 95% CI 1.09-1.35) and ORR [odds ratio (OR) 1.22, 95% CI 1.09-1.35]. For the maintenance therapy in PSROC, poly (ADP-ribose) polymerase inhibitors (PARPi) following platinum-based chemotherapy provided the best PFS (HR 0.64, 95% CI 0.61-0.68), the highest frequency of adverse events of grade three or higher (OR 0.18, 95% CI 0.07-0.44) but the treatment discontinuation was generally low. Subgroup analysis suggested that trabectedin plus PLD was comparable to single platinum in prolonging PFS in the platinum-free interval (6-12 months). Conclusion: Both platinum-based chemotherapy plus PARPi and platinum-based chemotherapy plus bevacizumab had higher survival benefits than other treatments in PSROC. Trabectedin plus PLD might be a potential alternative treatment strategy for the partially platinum-sensitive subpopulation with intolerance to platinum. Systematic Review Registration : [https://www.crd.york.ac.uk/prospero/display&#95;record.php?], identifier [CRD42022326573].; 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 Liu, Huang, Li, Wan, Jiang, Yang, Chiampanichayakul, Tima, Anuchapreeda and Wu.)

Liu, Y., et al. (2021). "Comparison of the outcomes between laparoscopic surgery and conventional open surgery in treating patients with stage II endometrial carcinoma: A protocol for systematic review and meta-analysis." Medicine 100(38): e27148.
	Background: Endometrial carcinoma is a prevalent form of cancer. In fact, its incidence ranks fourth among European and North American females. Moreover, it is the most common gynecological malignant disease. Laparotomy, bilateral salpingo-oophorectomy, total abdominal hysterectomy, etc were common methods adopted in conventional open surgery. Recent developments in laparoscopic surgery (LPS) has made it more effective. The present study aims to compare the outcomes between LPS and a conventional open surgical procedure to treat stage II endometrial carcinoma patients.; Methods: A comprehensive search will be conducted on Cochrane library, PubMed, Web of Science, EMBASE, and China National of Knowledge Infrastructure to collect LPS and conventional open surgery in treating stage II endometrial carcinoma. The search will consider all articles published since the inception of the databases till July 2021. A pair of scholars will perform independent screening of the literature and extracted data to evaluate the bias risk in the selected studies. Afterwards, RevMan5.3 software will be used to conduct a meta-analysis.; Conclusion: This study will conduct a meta-analysis to compare the clinical efficacy of LPS and conventional open surgery in the treatment of stage II endometrial carcinoma.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Liu, Y., et al. (2021). "The efficacy of enoxaparin for recurrent abortion: a meta-analysis of randomized controlled studies." The Journal of Maternal-fetal & Neonatal Medicine 34(3): 473-478.
	Introduction: The efficacy of enoxaparin for recurrent abortion remains controversial. We conduct a systematic review and meta-analysis to explore the influence of enoxaparin versus placebo on recurrent abortion. Methods: We search PubMed, Embase, Web of Science, EBSCO, and Cochrane Library databases through February 2019 for randomized controlled trials (RCTs) assessing the effect of enoxaparin versus placebo on recurrent abortion. This meta-analysis is performed using the fixed or random-effect model when appropriate. Results: Six RCTs involving 1034 patients are included in the meta-analysis. Overall, compared with control group for patients with recurrent abortion, enoxaparin has no obvious impact on live births (RR = 1.06; 95% CI = 0.97-1.16; p = .17), abortion rate (RR = 0.71; 95% CI = 0.45-1.10; p = .13), birth weight (std. MD = 0.38; 95% CI = -0.21-0.96; p = .21), preterm delivery (RR = 0.55; 95% CI = 0.30-1.00; p = .05), preeclampsia (RR = 1.52; 95% CI = 0.42-5.51; p = .52), and postpartum hemorrhage (RR = 1.17; 95% CI = 0.69-1.99; p = .55). Conclusions: Enoxaparin may provide no significant benefits to patients with recurrent abortion.

Liu, Y., et al. (2021). "The effectiveness of acupoint application of traditional Chinese medicine in treating primary dysmenorrhea: A protocol for meta-analysis and data mining." Medicine 100(24): e26398.
	Background: Primary dysmenorrhea (PD) is a functional disease of the female reproductive system, which has adverse effects on patients' physical and mental health and quality of life. At present, acupoint application of traditional Chinese medicine (TCM) as adjuvant therapy is undergoing clinical trials in different medical centers. However, there is no systematic review or meta-analysis to evaluate the efficacy of acupoint application of TCM in the treatment of PD. There is also a lack of systematic evaluation and analysis of acupoints and herbs.; Methods: All randomized controlled trials related to acupoint catgut embedding therapy on PD will be searched in the following electronic databases: Cochrane Central Registry of controlled trials, PubMed, Wed of Science, EMBASE, Science Net, China Biomedical Literature Database, China Science Journal Database, China National Knowledge Infrastructure and Wan-Fang Database, from inception to May, 2021 were searched without language restrictions. The primary outcomes contain visual analog score, The Cox Menstrual Symptom Scale, while the secondary outcomes consist of adverse events and the recurrence rate. Two reviewers will independently perform data selection, data synthesis, and quality assessment. Data meeting the inclusion criteria will be extracted and analyzed by Revman v.5.3 software. Two reviewers will evaluate the study using the Cochrane collaborative bias risk tool. We will use the scoring method to assess the overall quality of the evidence supporting the main results. We will also use Spass software (version 19.0) for complex network analysis to explore the potential core prescription of acupoint application of traditional Chinese medicine in the treatment of PD.; Results: This study will analyze the clinical effective rate, functional outcomes, quality of life, improvement of clinical symptoms of PD, and effective prescriptions of acupoint application for patients with PD.; Conclusion: Our findings will provide evidence for the effectiveness and potential treatment prescriptions of acupoint application for patients with PD.PROSPERO registration number: CRD 42021244357.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Liu, Y., et al. (2022). "Safety and efficacy of compounded bioidentical hormone therapy (cBHT) in perimenopausal and postmenopausal women: a systematic review and meta-analysis of randomized controlled trials." Menopause 29(4): 465-482.
	Importance: More information is needed about the efficacy and safety of compounded bioidentical hormone therapy (cBHT) in the published literature. A thorough synthesis of existing data is not currently available.; Objective: To provide a systematic review and meta-analysis of the existing evidence related to the safety and efficacy of commonly prescribed cBHT preparations in perimenopausal and postmenopausal women.; Evidence Review: PubMed, ClinicalTrials.gov, and The Cochrane Central Register of Controlled Trials were searched. Randomized controlled trials (RCTs) comparing cBHT with a placebo or FDA-approved products in perimenopausal or postmenopausal women were eligible. The risk of bias was assessed by the Cochrane risk of bias tool. The primary safety outcome was changes in lipid profile and glucose metabolism, and the primary efficacy outcome was the change of vaginal atrophy symptoms. The secondary outcomes included the change of endometrial thickness, risk of adverse events, vasomotor symptoms, change of serum hormone levels, and change of bone mineral density.; Findings: A total of 29 RCTs reported in 40 articles containing 1,808 perimenopausal and postmenopausal women were included. Two risk factors of cardiovascular disease, lipid profile, and glucose metabolism, were evaluated with cBHT. The results showed that compounded androgen was not associated with change of lipid profile or glucose metabolism. There was no change in endometrial thickness or serious adverse events. There were more androgenic side effects with compounded dehydroepiandrosterone compared with placebo as expected. Other safety measures including clinical cardiovascular events, endometrial biopsy, and risk of breast cancer were not studied. cBHT in the form of compounded vaginal androgen was found to significantly improve vaginal atrophy symptoms (SMD -0.66 [95% CI, -1.28 to -0.04]; I2 = 86.70%). This finding was supported by the association between compounded vaginal androgen and improved female sexual function scores. The changes of serum hormone levels were also evaluated. Despite the variations in absorption from different types of compounded hormones, routes, and strengths, the trends were consistent with published data from FDA-approved products.; Conclusions and Relevance: This review found that cBHT used in primarily short-term RCTs is not associated with adverse changes in lipid profile or glucose metabolism. cBHT in the form of vaginal androgens appears beneficial for vaginal atrophy symptoms. There are insufficient RCTs of cBHT to assess clinical risk of breast cancer, endometrial cancer, or cardiovascular disease. Long-term studies with clinical endpoints are needed.; Competing Interests: Financial disclosures/conflicts of interest: Y.L., PharmD, PhD, A.J. D., PharmD, and D.B., MS, RPh are employees of Professional Compounding Centers of America (PCCA) which is a compounding pharmacy supplier. Y.Y., PhD, received consulting fee from PCCA for his involvement in this study. W.Z., MS, P.J., PharmD, MSc, MBA, and D.J. N., PharmD are not affiliated with PCCA and have no conflict of interest. (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The North American Menopause Society.)

Liyun, D., et al. (2021). "Effectiveness and safety of elagolix for treatment of endometriosis: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Llueca, M., et al. (2023). "Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Associated with Cytoreductive Surgery in the Treatment of Advanced Ovarian Cancer: Systematic Review and Meta-Analysis." Journal of Personalized Medicine 13(2).
	Objective: The use of hyperthermic intraperitoneal chemotherapy (HIPEC) as a treatment for epithelial ovarian cancer remains controversial. Our study aims to analyze the overall survival and disease-free survival for the use of HIPEC as a treatment for advanced epithelial ovarian cancer after neoadjuvant chemotherapy.; Methods: A systematic review and meta-analysis was carried out using PubMed, Cochrane, Web of Science, and ClinicalTrials.gov . A total of six studies were used, comprising a total of 674 patients.; Results: The results of our meta-analysis of all studies analyzed together (observational and randomized controlled trials (RCT)) did not achieve significant results. Contrary to the OS (HR = 0.56, 95% IC = 0.33-0.95, p = 0.03) and DFS (HR = 0.61, 95% IC = 0.43-0.86, p < 0.01) of the RCT analyzed separately, a clear impact on survival was suggested. The subgroup analysis showed that studies making use of higher temperatures (≥42 °C) for a shorter period of time (≤60 min) achieved better results for both OS and DFS, as well as the use of cisplatin as the form of chemotherapy in HIPEC. Moreover, the use of HIPEC did not increase high-grade complications.; Conclusions: The addition of HIPEC to cytoreductive surgery demonstrates an improvement in OS and DFS for patients with epithelial ovarian cancer in advanced stages, without an increase in the number of complications. The use of cisplatin as chemotherapy in HIPEC obtained better results.

Lo Li Pharma, s. r. l. (2022). "Myo-inositol Plus Alpha-lactalbumin in PCOS Myo-inositol-resistant Patients." ClinicalTrials.gov.
	No Results Available Dietary Supplement: Myo-inositol + folic a. + α-lactalbumin|Dietary Supplement: Myo-inositol + folic a. ovulation induction Female Not Applicable 0 Industry Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment MILA February 1, 2023

Loaiza-Betancur Andrés, F., et al. (2022). "Effects of resistance training on C-reactive protein in menopausal and postmenopausal women: a systematic review and meta-analysis of randomized controlled trials." Menopause 29(12): 1430-1440.
	Importance: Menopause is a biological stage associated with increased cardiovascular morbidity and mortality due to changes in sex hormone levels.; Objective: This systematic review aimed to investigate the benefits and harms of RT in menopausal and postmenopausal women.; Evidence Review: We searched PubMed, Embase, CENTRAL, Scopus, and Web of Science from inception to 2021, and clinical trial registries. Randomized controlled trials (RCT) in menopausal and postmenopausal women that compared women undergoing RT programs with a control group were included. The primary outcomes were C-reactive protein level and adverse events; and, the secondary outcomes were lipid profile and waist circumference. Two reviewers independently selected the studies, extracted data, and assessed the completeness of RT programs, risk of bias, and quality of evidence using the Grading of Recommendations, Assessment, Development, and Evaluation approach (GRADE). A random-effects model was used. Statistical significance was set at P < 0.05.; Findings: Twelve RCTs published from 2012 to 2020 met the inclusion criteria (n = 482). Four follow-up periods were assessed. RT caused reductions in C-reactive protein levels compared to those in the control group in postmenopausal women in the short- to long-term follow-up (mean difference, -0.47 mg/dL; 95% confidence interval, -0.66 to -0.29; P < 0.00001). Furthermore, RT may reduce C-reactive protein levels even at moderate and moderate-to-high intensity ( P < 0.0001 and P = 0.0005, respectively). Similar findings were found for lipid profiles in the short- to long-term follow-up ( P < 0.05). RT may have had little to no effect on waist circumference. The certainty of the body of evidence was assessed as very low and downgraded owing to serious study limitations, inconsistency, imprecision, and publication bias.; Conclusions and Relevance: There was very low-quality evidence supporting the benefits of RT compared with control for C-reactive protein levels and lipid profile. No benefits were found for the outcome of waist circumference in postmenopausal women with different comorbidities or risk factors. Safety data were scarce. We have little confidence in the results, and the true effect is likely to be substantially different. Further well-conducted and well-reported RCTs are warranted to strengthen the evidence.; Protocol Registration: PROSPERO CRD42020213125.; Competing Interests: Financial disclosures/conflicts of interest: None reported. (Copyright © 2022 by The North American Menopause Society.)

Lobb, H. S., et al. (2021). "Suture rectopexy versus ventral mesh rectopexy for complete full-thickness rectal prolapse and intussusception: systematic review and meta-analysis." BJS Open 5(1).
	Background: This systematic review and meta-analysis aimed to compare recurrence rates of rectal prolapse following ventral mesh rectopexy (VMR) and suture rectopexy (SR).; Methods: MEDLINE, Embase, and the Cochrane Library were searched for studies reporting on the recurrence rates of complete rectal prolapse (CRP) or intussusception (IS) after SR and VMR. Results were pooled and procedures compared; a subgroup analysis was performed comparing patients with CRP and IS who underwent VMR using biological versus synthetic meshes. A meta-analysis of studies comparing SR and VMR was undertaken. The Methodological Items for Non-Randomized Studies score, the Newcastle-Ottawa Scale, and the Cochrane Collaboration tool were used to assess the quality of studies.; Results: Twenty-two studies with 976 patients were included in the SR group and 31 studies with 1605 patients in the VMR group; among these studies, five were eligible for meta-analysis. Overall, in patients with CRP, the recurrence rate was 8.6 per cent after SR and 3.7 per cent after VMR (P < 0.001). However, in patients with IS treated using VMR, the recurrence rate was 9.7 per cent. Recurrence rates after VMR did not differ with use of biological or synthetic mesh in patients treated for CRP (4.1 versus 3.6 per cent; P = 0.789) and or IS (11.4 versus 11.0 per cent; P = 0.902). Results from the meta-analysis showed high heterogeneity, and the difference in recurrence rates between SR and VMR groups was not statistically significant (P = 0.76).; Conclusion: Although the systematic review showed a higher recurrence rate after SR than VMR for treatment of CRP, this result was not confirmed by meta-analysis. Therefore, robust RCTs comparing SR and biological VMR are required. (© The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd.)

Loes, K., et al. (2024). "Effectiveness and complication rates of high intensity focused ultrasound treatment for abdominal wall endometriosis: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Long, Y., et al. (2023). "Treatment outcomes of tubal pregnancy with tubal preservation: A meta-analysis." Medicine 102(47): E36165.
	Background: Ectopic pregnancy is a common gynecological emergency that poses a significant risk of maternal mortality during the first trimester. It also increases the incidence of infertility and repeated ectopic pregnancy. The aim of this study was to evaluate whether there is a difference in the degree of tubal patency between salpingostomy and systemic treatment with methotrexate (MTX), as well as the odds of intrauterine pregnancy and repeat ectopic pregnancy, and the degree of tubal patency in salpingectomy with or without tubal suturing. Method(s): We searched PubMed, EMBASE, and the Cochrane Library up to April 2023. Four randomized controlled trials were included in the review. We analyzed the combined data using Review Manager 5.3 software and Stata 12.0 software, utilizing a random effects model. Result(s): When comparing salpingostomy and systemic treatment with MTX, there was no significant difference in the degree of tubal patency (OR = 1.09, 95% CI (0.54-2.38), P = .83). For salpingostomy with or without tubal suturing, there were no significant differences in the rates of intrauterine pregnancy, repeat ectopic pregnancy, and tubal patency degree [(OR = 1.05, 95% CI (0.41-2.68), P = .92), (OR = 0.68, 95% CI (0.19-2.42), P = .92), (OR = 1.68, 95% CI (0.14-20.33), P = .68)]. Conclusion(s): This meta-analysis demonstrates that systemic treatment with MTX is an effective treatment for patients who wish to preserve their fallopian tubes without undergoing surgery. This form of treatment can help avoid surgical procedures that may damage the fallopian tubes and improve fertility prospects. If choosing surgery, we believe that opting for salpingostomy without tubal suturing could reduce the operation time and minimize damage.Copyright © 2023 Lippincott Williams and Wilkins. All rights reserved.

Loohuis, A. M. M., et al. (2022). "Cost-effectiveness of an app-based treatment for urinary incontinence in comparison with care-as-usual in Dutch general practice: a pragmatic randomised controlled trial over 12 months." BJOG 129(9): 1538-1545.
	Objective: To assess the cost-effectiveness of app-based treatment for female stress, urgency or mixed urinary incontinence (UI) compared with care-as-usual in Dutch primary care. Design(s): A pragmatic, randomised controlled, superiority trial. Setting(s): Primary care in the Netherlands from 2015 to 2018, follow-up at 12 months. Population: Women with >=2 UI-episodes per week, access to mobile apps, wanting treatment. Method(s): The standalone app included conservative management for UI with motivation aids (e.g. reminders). Care-as-usual delivered according to the Dutch GP guideline for UI. Main Outcome Measure(s): Costs and cost-effectiveness and -utility were assessed from a societal perspective, based on incontinence impact adjusted life years (IIALYs), quality adjusted life years (QALYs) and medical, non-medical and productivity costs. Information on costs was obtained with the iMCQ and iPCQ questionnaires (medical consumption and productivity cost questionnaires). Result(s): In all, 262 women were andomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended follow-up, respectively. Costs were lower for app-based treatment with -161 (95% confidence interval [CI -180 to -151) per year. Cost-effectiveness showed small mean differences in effect for IIALY (0.04) and QALY (-0.03) and thus larger incremental cost-effectiveness ratios (ICER: -3696) and incremental cost-utility ratios (ICUR: 6379). Conclusion(s): App-based treatment is a cost-effective alternative to care-as-usual for women with UI in Dutch primary care. Tweetable abstract: App-treatment for female urinary incontinence cost-effective compared to care-as-usual in general practice after 12 months.Copyright © 2022 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.

Loohuis, A. M. M., et al. (2021). "App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial." Annals of Family Medicine 19(2): 102-109.
	PURPOSE: Electronic application (app)-based treatment is promising for common diseases with good conservative management options, such as urinary incontinence (UI) in women, but its effectiveness compared with usual care is unclear. This study set out to determine if app-based treatment for women with stress, urgency, or mixed UI was noninferior to usual care in the primary care setting. METHODS: The URinControl trial is a pragmatic, noninferiority randomized controlled trial in Dutch primary care including adult women with 2 episodes of UI per week. From July 2015 to July 2018, we screened 350 women for eligibility. A stand-alone app-based treatment with pelvic floor muscle and bladder training (URinControl) was compared with usual care according to the Dutch general practitioner guideline for UI treatment. Outcomes measured were change in symptom severity score from baseline to 4 months (primary outcome), impact on disease-specific quality of life, patient-perceived improvement, and number of UI episodes. Noninferiority (<1.5 points) was assessed with linear regression analysis. RESULTS: A total of 262 eligible women were randomized equally; 195 of them had follow-up through 4 months. The change in symptom severity with app-based treatment (-2.16 points; 95% CI, -2.67 to -1.65) was noninferior to that with usual care (-2.56 points; 95% CI, -3.28 to -1.84), with a mean difference of 0.058 points (95% CI, -0.776 to 0.891) between groups. Neither treatment was superior to the other, and both groups showed improvements in outcome measures after treatment. CONCLUSIONS: App-based treatment for women with UI was at least as effective as usual care in the primary care setting. As such, app-based treatments, with their potential advantages of privacy, accessibility, and lower cost, may provide women with a good alternative to consultation.

López-Pérez, M. P., et al. (2023). "Pelvic Floor Muscle Exercises as a Treatment for Urinary Incontinence in Postmenopausal Women: A Systematic Review of Randomized Controlled Trials." Healthcare 11(2).
	Women frequently suffer from urinary incontinence due to atrophic changes in the urogenital tract. Recommended conservative treatment includes evaluation of pelvic-floor strength and the functional use of pelvic-floor-muscle (PFM) training. Following the PRISMA 2020 guidelines, a search was conducted in the electronic databases PubMed, Web of Science, and Scopus for articles with at least one group performing PFM exercises in post-menopausal women with urinary incontinence. Eight articles were included, and each study had at least one group of PFM exercise-based intervention alone or combined. The volume or duration, frequency, and number of sessions were heterogeneous. All the studies reported significant differences in favor of PFM exercise in strength, quality of life, and/or severity of urinary incontinence. PFM exercise is a highly recommended intervention to treat urinary incontinence in postmenopausal women. However, more research is needed to establish specific factors such as dose-response relationships and to standardize methods for measuring effects.

Lopresti, A. L. and S. J. Smith (2021). "The Effects of a Saffron Extract (affron®) on Menopausal Symptoms in Women during Perimenopause: A Randomised, Double-Blind, Placebo-Controlled Study." Journal of Menopausal Medicine 27(2): 66-78.
	OBJECTIVES: There is preliminary evidence suggesting saffron may effectively treat menopausal symptoms. The aim of this study was to examine the tolerability and efficacy of a standardised saffron extract (affron®) on menopausal complaints in perimenopausal women. METHODS: In this 12-week, parallel-group, double-blind, randomised controlled trial, 86 perimenopausal women experiencing menopausal complaints received either a placebo or 14 mg of a saffron extract (affron®), twice daily. Outcome measures included the Greene Climacteric Scale (GCS), Positive and Negative Affect Schedule (PANAS), and Short Form-36 Health Survey (SF-36). RESULTS: Based on data collected from 82 participants, saffron was associated with greater improvements in mood and psychological symptoms compared to the placebo. Results from the GCS revealed a significantly greater reduction in the GCS psychological score (P = 0.032), characterised by a 33% reduction in anxiety and a 32% reduction in depression scores from baseline to week 12. There was also a significantly greater reduction in the PANAS negative affect score (P = 0.043) compared to the placebo. However, compared to the placebo, saffron was not associated with greater improvements in vasomotor symptoms, somatic symptoms, or other quality of life measures. Saffron intake was well tolerated with no reported major adverse events. CONCLUSIONS: The saffron extract, affron®, administered for 12 weeks at a dose of 14 mg twice daily was associated with greater improvements in psychological symptoms. Further studies in perimenopausal women presenting with varying severity of menopausal symptoms, using different doses of saffron will be useful to examine in future clinical trials.

Lorusso, D. (2021). "Carboplatin-Paclitaxel-Bevacizumab vs Carbo-Pacli-Beva-Rucaparib vs Carbo-Pacli-Ruca, Selected According to HRD Status, in Patients With Advanced Ovarian, Primary Peritoneal and Fallopian Tube Cancer, Preceded by a Phase I Dose Escalation Study on Ruca-Beva Combination." ClinicalTrials.gov.
	No Results Available Drug: Carboplatin|Drug: Paclitaxel|Drug: Bevacizumab|Drug: Rucaparib Phase I Primary Objective: MTD|Phase II Primary Objective: PFS|Phase I Secondary Objectives: toxicity of the Rucaparib-Bevacizumab combination in terms of haematologic and non haematologic events|Phase I Secondary Objectives: maximum plasma concentration (Cmax at Steady State) of Rucaparib|Phase I Secondary Objectives: minimal plasma concentration (Cmin at Steady State) of Rucaparib|Phase I Secondary Objectives: Area Under Curve (AUC)|Phase I Secondary Objectives: Cmax|Phase I Secondary Objectives: Tmax|Phase I Secondary Objectives: AUC (0-24h)|Phase II Secondary Objectives: OS|Phase II Secondary Objectives: PFS2|Phase II Secondary Objectives: TFST|Phase II Secondary Objectives: TSST|Phase II Secondary Objectives: ORR|Phase II Secondary Objectives: Safety and tolerability|Phase II Secondary Objectives: PRO for PHYSICAL WELL-BEING|Phase II Secondary Objectives: PRO for SOCIAL/FAMILY WELL-BEING|Phase II Secondary Objectives: PRO for EMOTIONAL WELL-BEING|Phase II Secondary Objectives: PRO for FUNCTIONAL WELL-BEING Female Phase 1|Phase 2 290 Other|Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 3329 March 1, 2025

Lorusso, D., et al. (2024). "Single-Agent Trabectedin Versus Physician's Choice Chemotherapy in Patients With Recurrent Ovarian Cancer With BRCA-Mutated and/or BRCAness Phenotype: A Randomized Phase III Trial." Journal of Clinical Oncology: JCO2301225.
	PURPOSE: Literature evidence suggests that trabectedin monotherapy is effective in patients with recurrent ovarian cancer (OC) presenting BRCA mutation and/or BRCAness phenotype. METHODS: A prospective, open-label, randomized phase III MITO-23 trial evaluated the activity and safety of trabectedin 1.3 mg/m2 given once every 3 weeks (arm A) in BRCA 1/2 mutation carriers or patients with BRCAness phenotype (ie, patients who responded to ≥two previous platinum-based treatments) with recurrent OC, primary peritoneal carcinoma, or fallopian tube cancer in comparison with physician's choice chemotherapy in the control arm (arm B; pegylated liposomal doxorubicin, topotecan, gemcitabine, once-weekly paclitaxel, or carboplatin). The primary end point was overall survival (OS) evaluated in the intention-to-treat population. RESULTS: Overall, 244 patients from 21 MITO centers were randomly assigned (arm A = 122/arm B = 122). More than 70% of patients received ≥three previous chemotherapy lines and 35.7% had received a poly (ADP-ribose) polymerase inhibitor (PARPi) before enrollment. Median OS was not significantly different between the arms: arm A: 15.8 versus arm B: 17.9 months (P = .304). Median progression-free survival was 4.9 months in arm A versus 4.4 months in arm B (P = .897). Among 208 patients evaluable for efficacy, the objective response rate was 17.1% in arm A and 21.4% in arm B, with comparable median duration of response (5.62 v 5.66 months, respectively). No superior effect was observed for trabectedin in the prespecified subgroup analyses according to BRCA mutational status, chemotherapy type, and pretreatment with a PARPi and/or platinum-free interval. Trabectedin showed a higher frequency of grade ≥3 adverse events (AEs), serious AEs, and serious adverse drug reactions compared with control chemotherapy. CONCLUSION: Trabectedin did not improve median OS and showed a worse safety profile in comparison with physician's choice control chemotherapy.

Louise, K., et al. (2023). "The effect of intravenous immunoglobulin versus placebo, no intervention or usual care in patients with recurrent pregnancy loss: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Loukovaara, M., et al. (2023). "PErsonalized TReatment for Endometrial Carcinoma (PETREC): study design and methods of a prospective Finnish multicenter trial." International Journal of Gynecological Cancer 33(11): 1807-1811.
	Background: Endometrial carcinomas can be classified into four molecular subgroups - mismatch repair deficient (MMRd), p53 abnormal (p53abn), polymerase-ϵ ( POLE ) ultramutated, and 'no specific molecular profile' (NSMP). Retrospective data imply that the response to adjuvant therapies may depend on the molecular subgroup. These findings emphasize the need for adjuvant therapy trials where patients are randomized to treatment arms separately within each molecular subgroup.; Primary Objective: The PErsonalized TReatment for Endometrial Carcinoma (PETREC) trial clarifies the value of molecular classification in the determination of adjuvant therapies of high-intermediate risk and early-stage high-risk endometrial carcinoma.; Study Hypothesis: Compared with vaginal brachytherapy, the utilization of whole pelvic radiotherapy may result in improved outcomes for either MMRd or NSMP high-intermediate risk carcinomas. Early-stage high-risk p53abn and nonendometrioid carcinomas are postulated to gain benefits from chemoradiotherapy, as opposed to chemotherapy alone. POLE ultramutated carcinomas harboring high-intermediate or high-risk clinicopathologic features are speculated to have favorable prognosis without any adjuvant therapy.; Trial Design: This prospective, multicenter, phase 3 trial compares the efficacy of vaginal brachytherapy vs whole pelvic radiotherapy in high-intermediate risk MMRd and NSMP molecular subgroups, and chemotherapy vs chemoradiotherapy in early-stage high-risk p53abn subtype and nonendometrioid carcinomas. Eligible women who consent to participation in the trial are randomly allocated (1:1) to treatment arms.; Major Inclusion/exclusion Criteria: Women with stages I-II molecular integrated high-intermediate risk or high-risk endometrial carcinoma will be included.; Primary Endpoint: The primary endpoint is the 5 year cumulative incidence of disease recurrence.; Sample Size: A total sample size of 294 patients (49 subjects in each treatment arm of the three subgroups intended for randomization) was estimated to be sufficient.; Estimated Dates for Completing Accrual and Presenting Results: Patient recruitment will be completed in 2025, and follow-up will be completed in 2030.; Trial Registration: NCT05655260.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Lu, W., et al. (2021). "Chemoradiotherapy alone vs. chemoradiotherapy and hysterectomy for locally advanced cervical cancer: A systematic review and updated meta-analysis." Oncology Letters 21(2): 160.
	The benefit of adjuvant hysterectomy after definitive concurrent chemoradiotherapy (CCRT) for locally-advanced cervical cancer (LACC) is controversial. The purpose of the present study was to systematically search the literature and perform a meta-analysis to compare overall survival (OS) and disease-free survival (DFS) between patients subjected to CCRT with hysterectomy and those who underwent CCRT alone. The PubMed, Scopus, Embase and Google scholar databases were searched. A meta-analysis to determine hazard ratios (HRs) and odds ratios (ORs) with meta-regression was performed for the following moderators: Disease stage, histology and proportion of radical hysterectomy. Data from 14 studies were included. The results indicated that patients who received CCRT with hysterectomy had significantly better OS (HR, 0.72; 95% CI, 0.56 to 0.91; I 2 =19%; P=0.007) and DFS (HR, 0.72; 95% CI, 0.56 to 0.93; I 2 =27%; P=0.01) than those treated with CCRT alone. However, in a subgroup analysis by study type, the results were significant only for retrospective studies but not for randomized controlled trials (RCTs). However, only 2 RCTs were included with small sample size, heterogeneity and low overall quality. Subgroup analyses based on the use of brachytherapy in the CCRT with hysterectomy group demonstrated no difference in OS and DFS between the two groups. Regarding the absolute numbers of death and recurrence events, no significant difference in mortality (OR, 0.91; 95% CI, 0.62 to 1.33; I 2 =0%; P=0.64) was determined between the two groups, but a significantly reduced incidence of recurrence was observed in the CCRT with hysterectomy group (OR, 0.61; 95% CI, 0.47-0.79; I 2 =29%; P=0.0002). The meta-regression results point to a significant influence of the proportion of stage II patients on OS. Despite the overall analysis indicating improved OS and DFS with the use of adjuvant hysterectomy after CCRT, subgroup analysis based on similar treatment protocols failed to demonstrate any significant benefit of hysterectomy in LACC. However, the results indicated that the recurrence rate may be higher in patients undergoing CCRT without hysterectomy. The limited quality of the studies included and selection bias from retrospective studies restrict the possibility to draw strong conclusions. (Copyright: © Lu et al.)

Lucot, J. P., et al. (2022). "Long-term outcomes of primary cystocele repair by transvaginal mesh surgery versus laparoscopic mesh sacropexy: extended follow up of the PROSPERE multicentre randomised trial." BJOG 129(1): 127-137.
	Objective: To compare the effectiveness and safety of laparoscopic sacropexy (LS) and transvaginal mesh (TVM) at 4 years.; Design: Extended follow up of a randomised trial.; Setting: Eleven centres.; Population: Women with cystocele stage ≥2 (pelvic organ prolapse quantification [POP-Q], aged 45-75 years without previous prolapse surgery.; Methods: Synthetic non-absorbable mesh placed in the vesicovaginal space and sutured to the promontory (LS) or maintained by arms through pelvic ligaments and/or muscles (TVM).; Main Outcome Measures: Functional outcomes (pelvic floor distress inventory [PFDI-20] as primary outcome); anatomical assessment (POP-Q), composite outcome of success; re-interventions for complications.; Results: A total of 220 out of 262 randomised patients have been followed at 4 years. PFDI-20 significantly improved in both groups and was better (but below the minimal clinically important difference) after LS (mean difference -7.2 points; 95% CI -14.0 to -0.05; P = 0.029). The improvement in quality of life and the success rate (LS 70%, 61-81% versus TVM 71%, 62-81%; hazard ratio 0.92, 95% CI 0.55-1.54; P = 0.75) were similar. POP-Q measurements did not differ, except for point C (LS -57 mm versus TVM -48 mm, P = 0.0093). The grade III or higher complication rate was lower after LS (2%, 0-4.7%) than after TVM (8.7%, 3.4-13.7%; hazard ratio 4.6, 95% CI 1.007-21.0, P = 0.049)).; Conclusions: Both techniques provided improvement and similar success rates. LS had a better benefit-harm balance with fewer re-interventions due to complications. TVM remains an option when LS is not feasible.; Tweetable Abstract: At 4 years, Laparoscopic Sacropexy (LS) had a better benefit-harm balance with fewer re-interventions due to complications than Trans-Vaginal Mesh (TVM). (© 2021 John Wiley & Sons Ltd.)

Luginbuehl, H., et al. (2022). "Involuntary reflexive pelvic floor muscle training in addition to standard training versus standard training alone for women with stress urinary incontinence: a randomized controlled trial." International Urogynecology Journal 33(3): 531-540.
	Introduction and hypothesis: Although involuntary reflexive pelvic floor muscle contractions seem crucial during stress urinary incontinence-provoking situations, hitherto existing guidelines feature voluntary pelvic floor muscle training only. Two pelvic floor muscle protocols were compared regarding their effect on stress urinary incontinence in women: one focusing on standard physiotherapy with voluntary pelvic floor muscle training, the other additionally including involuntary reflexive pelvic floor muscle training. Method(s): This study was designed as a triple-blind prospective randomized controlled trial with women suffering from stress urinary incontinence with two physiotherapy intervention groups (control group: standard physiotherapy, n = 48, experimental group: standard physiotherapy plus involuntary reflexive pelvic floor muscle training triggered by whole-body movements such as jumps n = 48). Both interventions lasted 16 weeks (9 personal physiotherapy consultations and 78 home training sessions). Group differences and development over time were analyzed concerning the primary outcome International Consultation on Incontinence Modular Questionnaire Urinary Incontinence short form (ICIQ-UIsf) by mixed effect regression models. Result(s): The ICIQ-UIsf score decreased significantly over time for both groups by about 3 points from about 10 to about 7 points with no group differences at any point in time. Discussion(s): This trial did not find any additional benefit for stress urinary incontinence by adding involuntary reflexive pelvic floor muscle training to standard training. Both training protocols showed similar clinically relevant improvements; however, there was still moderate incontinence after interventions. Future studies should test and apply pelvic floor muscle function-oriented training methods for pelvic floor muscle hypertrophy, intramuscular coordination, and power, which are more in line with conventional skeletal muscle training, i.e., performed with higher intensities and workout.Copyright © 2021, The Author(s).

Luis Humberto, S., et al. (2021). "Impact of hysteroscopic resection of uterine septum on live birth rates in patients with a history of gestational loss. A Systematic Review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Luisa, P.-R. and N. Polykarpos (2023). "Is exercise therapy an effective treatment for pelvic girdle pain in pregnant women? A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Lukanović, A. (2021). "Effectiveness of Magnetic Stimulation in the Treatment of Female UUI." ClinicalTrials.gov.
	No Results Available Device: Extracorporeal magnetic stimulation|Other: Sham Change in the ICIQ-UI SF score|Change in voiding diary 1|Change in voiding diary 2|Change in voiding diary 3|Change in urodynamic studies 1|Change in urodynamic studies 2|Change in UDI-6 score|Change in IIQ-7 score|Change in PISQ-12 score|Change in King's Health questionnaire Female Not Applicable 40 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment UMCL-UUI May 2023

Luo, F., et al. (2021). "Evaluation of efficacy and safety of chemotherapy in the treatment of recurrent or resistant gestational trophoblastic neoplasia: A protocol for systematic review and meta-analysis." Medicine 100(40): e27320.
	Background:Gestational Trophoblastic Neoplasia (GTN) is a spectrum of pregnancy-associated tumours emerging from placental tissue. Generally, GTN patients are considered to have a high rate of recovery. However, almost 25 per cent of GTN tumours resist, or have a high probability of relapsing following the first line of chemo treatment. Thus, tumours that resist or relapse requires salvage chemotherapy, sometimes accompanied by surgery. Globally, clinicians utilize a range of salvage regimens. Currently, ongoing debates are centred around choosing the best regimens in terms of safety and efficacy. Therefore, the current research aims to appraise the success and level of safeness using chemotherapy to treat patients with resistant or recurrent GTN. Method(s):The authors will conduct a methodological exploration in online-based databases to find Randomized Controlled Trials related to the adoption of chemotherapy agents as treatment for resistant or recurrent GTN patients. The databases are as follows: EMBASE, PubMed, Cochrane Database Central, UpToDate, Chinese National Knowledge Infrastructure, Web of Science, and WanFang Database. The search will be limited to articles published in either English or Chinese. Moreover, the authors will also perform a search for ongoing trials on online-based clinical trial registries. Two independent authors will screen and select articles for review. A similar process will be followed by two independent authors to complete the extraction of data and evaluate the bias risk. In relevant cases, the authors will contract trial investigators to obtain related, unpublished data. The authors will use the random-effects model for pooling data in RevMan software (v5.3). Result(s):The present systematic review aims to evaluate the efficacy and level of safeness associated with using chemotherapy for resistant or recurrent GTN patients. Conclusion(s):The results of the proposed systematic analysis could summarize the most recent evidence for the use of chemotherapy agents on GTN patients.Ethics and dissemination:Since the proposed study uses pre-published data, an ethical approval is not required.Copyright © 2021 Lippincott Williams and Wilkins. All rights reserved.

Luo Fang, Y., et al. (2020). "Botulinum toxin injection for chronic pelvic pain: A systematic review." Acta Obstetricia et Gynecologica Scandinavica 99(12): 1595-1602.
	Introduction: Botulinum toxin has proven therapeutic effects in alleviating pain in several myofascial disorders, with an expanding potential in chronic pelvic pain. The objective of this systematic review is to evaluate the efficacy and safety of botulinum toxin injection as an off-label treatment for female chronic pelvic pain.; Material and Methods: Using PRISMA guidelines, MEDLINE, EBM Reviews, PubMed, CINAHL, TRIP Database, EMBASE, Web of Science and gray literature were searched. Studies assessing the efficacy of botulinum toxin for chronic pelvic pain in adult females, with 10 or more women, published in English up to 13 January 2020, were included. All eligible studies were reviewed and data were extracted by two independent reviewers using a standardized form. Quality of evidence was graded using the Cochrane Risk of Bias 2 tool for randomized controlled trials and the Ottawa-Newcastle scale for observational studies.; Results: In all, 491 records were screened. Seventeen articles were included in the final review: 5 randomized controlled trials and 12 observational studies. The quality of evidence ranged from low to high. There was a large degree of heterogeneity in study designs, and thus a meta-analysis was not feasible. All observational studies concluded that botulinum toxin was an effective treatment for chronic pelvic pain, with the greatest change in visual analog scale from 8.69 at baseline to 3.07 at 24 months post-injection. However, only one of the five randomized controlled trials found statistical significant differences favoring botulinum toxin in the reporting of the EQ-5D (botulinum 0.78 [0.69-1.00], control 0.69 [0.25-0.81], P = .03) and frequency of intercourse (botulinum 1 [1-1.75], placebo 1 [0-1], P = .025). The most common adverse effect was transient localized pain at injection site (6%-88%). No serious adverse events were reported.; Conclusions: Although observational studies were encouraging, there is insufficient high quality evidence to recommend botulinum toxin injection for chronic pelvic pain. However, it appears to be safe to use. Future studies of higher quality in its treatment efficacy are indicated. (© 2020 Nordic Federation of Societies of Obstetrics and Gynecology (NFOG). Published by John Wiley & Sons Ltd.)

Luo, J., et al. (2022). "Comparative Efficacy and Safety of Poly (ADP-Ribose) Polymerase Inhibitors in Patients With Ovarian Cancer: A Systematic Review and Network Meta-Analysis." Frontiers in Oncology 12: 815265.
	Objective: This study aims to compare the efficacy and safety of different poly (ADP-ribose) polymerase (PARP) inhibitors in patients with ovarian cancer through a network meta-analysis to support clinical treatment choices.; Methods: The Cochrane Library, PubMed, Embase, Science Citation Index, China National Knowledge Infrastructure (CNKI), Wanfang Data, Chongqing VIP (CQVIP), and Chinese BioMedical Literature Database (CBM) were searched with a cutoff date of 14 January 2021. ClinicalTrials.gov was also checked for supplementary data. Phase II or III randomized controlled trials that compared a PARP inhibitor with a placebo in patients with relapsed or newly diagnosed advanced ovarian cancer were included. The hazard ratios (HRs) for progression-free survival and overall survival and odds ratios (ORs) for grade 3 or higher adverse events were analyzed. The network meta-analysis was conducted in a Bayesian framework based on the Markov Chain Monte Carlo model in the R gemtc package (version 4.0.3).; Results: Eight eligible articles reporting six trials with a total of 2,801 patients were incorporated in this network meta-analysis. Three trials compared olaparib with placebo. Two trials compared niraparib with placebo. One trial compared rucaparib with placebo. The network meta-analysis failed to show significant differences in progression-free survival among the three PARP inhibitors: HR of 0.64, 95% confidence interval of 0.3 to 1.42 for olaparib versus niraparib, and olaparib versus rucaparib (0.86; 0.33 to 2.33). The comparison between niraparib and rucaparib also did not express a statistical difference (1.34; 0.47 to 3.72). Subgroup analysis bybreast cancer susceptibility gene (BRCA) status showed no obvious difference in progression-free survival among the three PARP inhibitors regardless of BRCA mutation status. Olaparib had fewer grade 3 or higher adverse events than niraparib (OR, 0.27; 95% confidence interval, 0.13 to 0.55) and rucaparib (0.34; 0.14 to 0.86). However, the analysis failed to show a significant difference between niraparib and rucaparib (1.27; 0.49 to 3.27).; Conclusion: Current evidence indicates that there is no significant difference observed in efficacy among olaparib, niraparib, and rucaparib. However, olaparib might have fewer grade 3 or higher adverse events.; 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 Luo, Ou, Wei, Qin and Jiang.)

Luo, J. H., et al. (2022). "The clinical outcomes between IVM and conventional IVF for treatment of PCOS patients: a meta-analysis." Acta Medica Mediterranea 38(2): 791-800.
	Introduction: Current studies on clinical outcomes of in vitro maturation (IVM) and in vitro fertilization (IVF) procedures for infertile polycystic ovary syndrome (PCOS) patients were inconsistent. Material(s) and Method(s): PubMed, the Cochrane Library, EMbase databases were searched of any design, published until July 25, 2018. In accordance with the Cochrane 5.1.0 standard, both a quality assessment and a risk assessment were conducted for including studies meeting the inclusion criteria. The extracted data were analyzed by Revman 5.3 and Stata 14.0 software. Result(s): Five studies were included the present meta-analysis. Compared to conventional IVF, IVM yielded significantly lower rate of oocyte cleavage (pooledRR=0.90, 95%CI 0.87~0.92), excellent-quality embryo (pooledRR=0.85, 95%CI 0.77~0.94), implantation (pooledRR=0.63, 95%CI 0.51~0.78), fertilization (pooledRR=0.95, 95%CI 0.93~0.98),moderate and severe OHSS (pooledRR=0.10, 95%CI 0.02~0.7) and Gn dose(pooledRR=-2.21, 95%CI -2.55~ -1.86).No significant differences in clinical pregnancy rate (pooledRR=0.88,95%CI 0.72~1.08), abortion rate (pooledRR=1.21, 95%CI 0.75~1.97), cycle cancellation rate (pooledRR=0.36, 95%CI 0.09~1.48)and birth rate (pooledRR= 1.12, 95%CI 0.85~1.47) were found between IVM with IVF. Conclusion(s): IVM was associated with a lower incidence of moderate and severe OHSS and a lower Gn dose. The implantation and pregnancy rates of IVM were significantly lower than standard IVF. Currently IVM was not an alternative to the standard IVF but may be a potential first line treatment option in some special situations. More intensive studies should be conducted to confirm results.Copyright © 2022 A. CARBONE Editore. All rights reserved.

Luo, R., et al. (2023). "Personalized versus standard frozen-thawed embryo transfer in IVF/ICSI cycles: a systematic review and meta-analysis." Journal of Assisted Reproduction and Genetics 40(4): 719-734.
	Purpose: To investigate whether personalized embryo transfer (pET) protocol guided by an endometrial receptivity array (ERA) can improve clinical outcomes of assisted reproduction.; Methods: We searched PubMed, Embase, Web of Science, and the Cochrane library for studies in which analytical comparisons of outcomes of pET and standard embryo transfer (sET) groups were undertaken. The references to the included studies were also manually searched. The primary outcome was clinical pregnancy rate (CPR), and the secondary outcomes were live birth rate (LBR), human chorionic gonadotropin (HCG) positivity, biochemical pregnancy rate (BPR), miscarriage rate (MR), implantation rate (IR), and ongoing pregnancy rate (OPR).; Results: Ten studies were included in the meta-analysis, including one randomized controlled trial (RCT) and nine cohort studies. We observed no significant difference in the primary outcome of CPR between the pET and sET groups in unselected patients (RR = 1.07; 95% confidence interval [CI], 0.87-1.30; P = 0.53; I 2 = 89%). In terms of secondary outcomes, we likewise noted no significant differences between the groups. Further subgroup analyses indicated that the pET protocol not only significantly reduced the MR for poor-prognosis patients, but it also reduced the CPR in donor cycles, elevated the BPR for good-prognosis patients, non-preimplantation genetic testing (PGT), and programmed cycles, and decreased the proportion of women showing HCG positivity in non-PGT cycles.; Conclusions: This meta-analysis revealed that ERA appears to possess limited guidance in embryo transfer. More high-quality RCTs are therefore needed to investigate the clinical validity and feasibility of ERA in the future. (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Luo, Z., et al. (2020). "Contasure-needleless single incision slings versus transobturator slings (TOT/TVT-O) for female patients with stress urinary incontinence: A systematic review and meta-analysis." BMC Urology 20(1): 51.
	Background: To assess the current evidence on the effectiveness and safety of Contasure-Needleless (C-NDL) versus transobturator slings (TOT/TVT-O) in the management of female stress urinary incontinence (SUI). Method(s): A comprehensive literature review of articles that investigated the efficacy and safety of C-NDL and TOT/TVT-O was performed based on studies published before June 2019 and retrieved from PubMed, Embase, CNKI and the Cochrane Library. Two reviewers searched the literature, independently extracted the data and evaluated the quality of the data according to the inclusion and exclusion criteria. A meta-analysis was performed by using Review Manager 5.3 software. Result(s): Seven studies with 1188 SUI female patients without intrinsic sphincter deficiency (ISD) or mixed urinary incontinence were included. Our meta-analysis showed that the clinical efficacy of C-NDL is statistically non-inferior to that of TOT / TVT-O in terms of subjective cure rate [OR = 0.77, 95% confidence interval (CI) (0.53 to 1.10), p = 0.15] and objective cure rate [OR = 0.78, 95% CI (0.53 to 1.13), p = 0.19]. In addition, operating times were statistically shorter with C-NDL compared to TOT / TVT-O [mean difference (MD) = - 7.38, 95% CI (- 10.73 to - 4.04), p < 0.0001]. In terms of the postoperative visual analogue scale (VAS) and the incidence of postoperative pain, C-NDL has a greater advantage [MD = - 1.71, 95% CI (- 2.91 to - 0.50), p = 0.005]; [OR = 0.21, 95% CI (0.05 to 0.96), p = 0.04]. Complication rates were statistically similar between the groups, except for groin pain which was higher in TOT / TVT-O. Conclusion(s): Our data suggest that C-NDL slings have similar short-term efficacy as TOT/TVT-O in curing SUI patients. Compared with TOT/TVT-O, C-NDL is associated with a shorter operative time, and the incidence of postoperative pain is decreased. Nevertheless, these findings should be further confirmed through large-volume, well-designed prospective randomized controlled trials (RCTs) with long-term follow-up.Copyright © 2020 The Author(s).

Lv, Y., et al. (2023). "Is glucocorticoid use associated with a higher clinical pregnancy rate of in vitro fertilization and embryo transfer? A meta-analysis." Heliyon 9(5): e15833.
	Background: It has been reported that the use of glucocorticoids may be able to improve clinical pregnancy rates in patients receiving in vitro fertilization and embryo transfer (IVF-ET). The purpose of this study was to investigate the association between glucocorticoid use and clinical pregnancy rate in IVF-ET patients.; Methods: This study has been registered on the International Register of Prospective Systems Evaluation (PROSPERO) (ID: CRD42022375427). A thorough and detailed search of databases including PubMed, Web of Science, Embase, and Cochrane Library was conducted to identify eligible studies up to October 2022. Quality assessment was conducted on the modified Jadad Scoring Scale and Newcastle-Ottawa Scale, and the inter-study heterogeneity was estimated by Q test and I 2 test. Combined hazard ratios with 95% CI were calculated using random effects or fixed effects models based on heterogeneity. Meanwhile, Begg's and Egger's tests were used to detect the existence of publication bias, the leave-one-out method was used for sensitivity analysis and multiple subgroup analyses were conducted.; Results: Seventeen studies involving 3056 IVF-ET cycles were included. We found that glucocorticoid use was associated with a higher IVF-ET pregnancy rate (OR = 1.86, 95% CI = 1.27-2.74, P = 0.002). In the subgroup analysis, studies of different regions and different study types all showed similar results that glucocorticoid is beneficial to improve the clinical pregnancy rate of patients with IVF-ET, and patients with positive autoantibodies and patients receiving IVF-ET multiple times also showed the same results. However, there was no significant change in clinical pregnancy rates in the seven studies with negative autoantibodies and in the seven studies with initial IVF-ET treatment. The results of the 12 medium-acting glucocorticoids and 4 long-acting glucocorticoids were also generally consistent with each other. There was no statistical difference in subgroup analysis of whether patients had endometriosis or not.; Conclusion: Appropriate use of glucocorticoids is beneficial for improving the clinical pregnancy rate in women receiving IVF-ET, but this result still needs to be verified by more high-quality and large sample size randomized controlled trials (RCTs).; 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 Authors. Published by Elsevier Ltd.)

Lv, Y., et al. (2021). "A systematic review of Tuina for women with primary dysmenorrhea: A protocol for systematic review and meta-analysis." Medicine 100(47): e27935.
	Background: Primary dysmenorrhea (PD) occurs most often in adolescent girls. Tuina, a kind of Chinese massage, can effectively relieve women's pain and is widely used in clinical practice. However, there is no relevant systematic review show its effectiveness and safety. The study aims to assess the effectiveness and safety of Tuina for PD.; Methods: The following electronic databases will be searched from the respective dates of database inception to September 1st, 2021: The Cochrane Library, Web of Science, EMBASE, Springer, MEDLINE, China National Knowledge Infrastructure, the Chinese Biomedical Literature Database, the World Health Organization International Clinical Trials Registry Platform, the Chinese Scientific Journal Database, Wanfang database, and other sources.; Results: This study will provide a high quality comprehensive and/or descriptive analysis of existing evidence on Tuina therapy for PD.; Conclusion: This study will provide the evidence of whether Tuina is an effective and safe intervention for women with PD.; Prospero Registration Number: CRD42021257392.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Lyu, X., et al. (2021). "The Antiobesity Effect of GLP-1 Receptor Agonists Alone or in Combination with Metformin in Overweight /Obese Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis." International Journal of Endocrinology 2021: 6616693.
	Objectives. Both glucagon-like peptide-1 receptor agonists (GLP-1RAs) and metformin (MET) have markedly antiobesity effects in overweight/obese polycystic ovary syndrome (PCOS) patients. However, there was no literature to compare the antiobesity effects of these two medicines. Therefore, a systematic review and meta-analysis were conducted in our present study to evaluate the antiobesity effects of GLP-1RAs either as monotherapy or combined with MET in comparison with MET alone in overweight/obese PCOS patients. Methods. All randomized controlled trials (RCTs) which reported the efficacy of GLP-1RAs and MET in overweight/obese PCOS patients in Medline (from Pubmed), Embase, Cochrane Central Register of Controlled Trials, Web of Science, and Scopus databases were independently searched by two reviewers. The random-effect model was used to pool data extracted from the included literature. The weighted mean difference (WMD) and 95% confidence interval (CI) were used to present the meta-analysis results (PROSPERO registration number: CRD42020173199). Results. A total of eight eligible RCTs were finally enrolled in our meta-analysis from the 587 retrieved literature. The results showed that GLP-1RAs alone or combined with MET was associated with a greater weight loss (N = 318, WMD = -2.61, 95% CI: -3.51 to -1.72, P<=0.001, I2 = 77.5%), more obvious reduction of waist circumference (N = 276, WMD = -3.46, 95% CI: -4.36 to -2.56, P<=0.001, I2 = 0.0%), and body mass index (BMI) (N = 318, WMD = -0.93, 95% CI: -1.60 to -0.26, P=0.007, I2 = 84.9%) in overweight/obese PCOS patients when compared with MET alone. Further sensitivity analysis demonstrated that the meta-analysis results of the efficacy differences in terms of body weight, waist circumference, and BMI were relatively stable and reliable. Conclusion. Our meta-analysis demonstrated that the antiobesity effect of GLP-1RAs alone or combined with MET was superior to MET alone in terms of weight loss, the reduction of waist circumference, and BMI. More large-scale, high-quality RCTs are needed to further confirm these results in PCOS patients.Copyright © 2021 Xiaorui Lyu et al.

Ma, J., et al. (2019). "Efficacy and safety of olaparib maintenance therapy in platinum-sensitive ovarian cancer patients with BRCA mutations: a meta-analysis on randomized controlled trials." Cancer Management and Research 11: 3061-3078.
	Background: Olaparib, a potent oral poly (ADP-ribose) polymerase inhibitor, exhibits antitumor activity and prevents the recurrence in advanced ovarian cancer. In this article, we assessed the efficacy and safety of olaparib maintenance therapy on platinum-sensitive ovarian cancer patients with BRCA mutations through a meta-analysis of available randomized controlled trials (RCTs) to provide more evidence for its clinical applications. Methods: We searched PubMed, Embase, Wanfang, CNKI, Web of Science, Cochrane Library, and VIP databases from 1 August 2018 to identify RCTs and finally included four RCTs (seven articles) with 567 eligible participants beyond the participants, interventions, comparisons, outcomes, and study design regulation. The outcomes of olaparib efficacy including progression-free survival (PFS) and overall survival (OS) were measured by HR and 95% CI, while the quality of life was evaluated by calculating the combination of P -value. Seven common adverse events were tested by risk ratio and 95% CI as the outcomes of olaparib safety. These data were analyzed, and the forest figures were produced using Review Manager 5.3. Results: Compared with other interventions (ie, placebo or chemotherapy drugs), olaparib significantly prolonged PFS (HR=0.31, 95% CI=0.15-0.62) and slightly improved OS (HR=0.75, 95% CI=0.56-0.99), but did not influence the quality of life ( P =0.058) in the patients with platinum-sensitive BRCA -mutated ovarian cancer. Additionally, the toxicity profile of olaparib involved anemia, fatigue, vomiting, diarrhea, and nausea with grade 1-2. Conclusion: This meta-analysis suggests that olaparib maintenance therapy is effective and well-tolerated for the patients with platinum-sensitive BRCA -mutated ovarian cancer. More updated RCTs and long-term follow-up should be conducted to compare and analyze the efficacy and toxicity of olaparib at different doses in ovarian cancer patients.; Competing Interests: The authors report no conflicts of interest in this work.

Ma, R.-C., et al. (2023). "Effects of Physical Exercise Interventions for Individuals With Gynecologic Cancer: A Systematic Review and Meta-Analysis." Oncology Nursing Forum 50(4): 531-543.
	Problem Identification: Data on the efficacy of physical exercise interventions for individuals with gynecologic cancer are limited and discordant. The purpose of this review was to determine the benefits of exercise interventions in this population.; Literature Search: The PubMed®, Web of Science, Embase® (Ovid), and Cochrane Central Register of Controlled Trials databases were searched for studies published from January 1, 2010, to November 9, 2022.; Data Evaluation: 12 randomized controlled trials were included. A quantitative synthesis method was used to investigate the effects of exercise interventions on individuals with gynecologic cancer.; Synthesis: The findings indicate that physical exercise interventions may have beneficial effects on the fatigue, depression, and health-related quality of life of this patient population. However, because of the small group of studies available, the evidence must be regarded as preliminary.; Implications for Practice: Clinicians and oncology nurses should recommend and refer individuals with gynecologic cancer to clinic- or community-based physical exercise programs.

Ma, S. and J. Song Sae (2023). "Oral contraceptives containing drospirenone for premenstrual syndrome." The Cochrane Database of Systematic Reviews 6: CD006586.
	Background: Premenstrual syndrome (PMS) is a common problem. Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome. Combined oral contraceptives (COC), which provide both progestin and oestrogen, have been examined for their ability to relieve premenstrual symptoms. A combined oral contraceptive containing drospirenone and a low oestrogen dose has been approved for treating PMDD in women who choose combined oral contraceptives for contraception.; Objectives: To evaluate the effectiveness and safety of COCs containing drospirenone in women with PMS.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group trial register, CENTRAL (now containing output from two trials registers and CINAHL), MEDLINE, Embase, PsycINFO, LILACS, Google Scholar, and Epistemonikos on 29 June 2022. We checked included studies' reference lists and contacted study authors and experts in the field to identify additional studies.; Selection Criteria: We included randomised controlled trials (RCT) that compared COCs containing drospirenone with placebo or with another COC for treatment of women with PMS.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. The primary review outcomes were effects on premenstrual symptoms that were prospectively recorded, and withdrawal due to adverse events. Secondary outcomes included effects on mood, adverse events, and response rate to study medications.; Main Results: We included five RCTs (858 women analysed, most diagnosed with PMDD). The evidence was very low to moderate quality; the main limitations were serious risk of bias due to poor reporting of study methods, and serious inconsistency and imprecision. COCs containing drospirenone and ethinylestradiol (EE) versus placebo COCs containing drospirenone and EE may improve overall premenstrual symptoms (standardised mean difference (SMD) -0.41, 95% confidence interval (CI) -0.59 to -0.24; 2 RCTs, N = 514; I 2 = 64%; low-quality evidence); and functional impairment due to premenstrual symptoms in terms of productivity (mean difference (MD) -0.31, 95% CI -0.55 to -0.08; 2 RCTs, N = 432; I 2 = 47%; low-quality evidence), social activities (MD -0.29, 95% CI -0.54 to -0.04; 2 RCTs, N = 432; I 2 = 53%; low-quality evidence), and relationships (MD -0.30, 95% CI -0.54 to -0.06; 2 RCTs, N = 432; I 2 = 45%; low-quality evidence). The effects from COCs containing drospirenone may be small to moderate. COCs containing drospirenone and EE may increase withdrawal from trials due to adverse effects (odds ratio (OR) 3.41, 95% CI 2.01 to 5.78; 4 RCT, N = 776; I 2 = 0%; low-quality evidence). This suggests that if you assume the risk of withdrawal due to adverse effects from placebo is 3%, the risk from drospirenone plus EE will be between 6% and 16%. We are uncertain of the effect of drospirenone plus EE on premenstrual mood symptoms, when measured by validated tools that were not developed to assess premenstrual symptoms. COCs containing drospirenone may lead to more adverse effects in total (OR 2.31, 95% CI 1.71 to 3.11; 3 RCT, N = 739; I 2 = 0%; low-quality evidence). This suggests that if you assume the risk of having adverse effects from placebo is 28%, the risk from drospirenone plus EE will be between 40% and 54%. It probably leads to more breast pain, and may lead to more nausea, intermenstrual bleeding, and menstrual disorder. Its effect on nervousness, headache, asthenia, and pain is uncertain. There was no report of any rare but serious adverse effects, such as venous thromboembolism in any of the included studies. COCs containing drospirenone may improve response rate (OR 1.65, 95% CI 1.13 to 2.40; 1 RCT, N = 449; I 2 not applicable; low-quality evidence). This suggests that if you assume the response rate from placebo is 36%, the risk from drospirenone plus EE will be between 39% and 58%. We did not identify any studies that compared COCs containing drospirenone with other COCs.; Authors' Conclusions: COCs containing drospirenone and EE may improve premenstrual symptoms at result in functional impairments in women with PMDD. The placebo also had a significant effect. COCs containing drospirenone and EE may lead to more adverse effects compared to placebo. We do not know whether it works after three cycles, helps women with less severe symptoms, or is better than other combined oral contraceptives that contain a different progestogen. (Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Ma, S., et al. (2019). "Platinum single-agent vs. platinum-based doublet agent concurrent chemoradiotherapy for locally advanced cervical cancer: A meta-analysis of randomized controlled trials." Gynecologic Oncology 154(1): 246-252.
	Objectives: This study compared treatment outcomes and adverse events in patients with locally advanced cervical cancer undergoing radiotherapy (RT) with concurrent platinum-based doublet therapy vs. RT plus platinum single-agent therapy. The main outcomes were progression-free survival (PFS), overall survival (OS), and the occurrence of adverse events.; Methods: We comprehensively searched Medline, Embase, the Cochrane Library, China National Knowledge Web, Wanfang Database, and VIP database, and performed a systematic review and cumulative meta-analysis of all randomized controlled trials (RCTs) by using the fixed-effect or random-effect models. The primary endpoints were OS and PFS, reported as hazard ratios (HRs) and 95% confidence intervals (95% CIs). The meta-analysis was performed with RevMan 5.2.; Results: Seven randomized trials including 1503 patients were identified. The meta-analysis showed that, for locally advanced cervical cancer, concurrent RT with platinum-based doublet chemotherapy significantly improved the OS (HR 0.75, 95% CI 0.60-0.94, p = 0.01) and the PFS (HR 0.78, 95% CI 0.65-0.94，p = 0.01) compared to RT with cisplatin monotherapy. Grade 3 or 4 vomiting (related ratio [RR] = 3.19, 95% CI 1.85-5.49, p < 0.0001) and thrombocytopenia (RR = 2.75, 95% CI 1.39-5.44, p = 0.004) occurred more frequently in the polychemotherapy arm. The incidence of urinary system toxicity tended to be higher in the polychemotherapy arm (RR = 4.58, 95% CI 1.00-20.89, p = 0.05).; Conclusions: Under the premise of good tolerance, RT plus platinum-based doublet therapy improves survival compared to RT plus platinum single-agent therapy in patients with locally advanced cervical cancer. (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Ma, S., et al. (2023). "Antibiotics therapy combined with probiotics administered intravaginally for the treatment of bacterial vaginosis: A systematic review and meta-analysis." Open Medicine 18(1): 20230644.
	The objective was to examine the pooled effects of antibiotic-probiotic combinations by examining the cure rate and recurrence rate for bacterial vaginosis (BV). A systematic literature search was conducted from electronic databases. All parallel randomized controlled trials (RCTs) that focused on the effects of antibiotics combined with intravaginal probiotics were included. Cure rate and recurrence rate were the primary and secondary outcomes to be analyzed. Meta-analysis was conducted following the Cochrane handbook for Systematic Reviews of Interventions. As a result, of 923 studies identified, 11 articles involving 1,493 BV patients met the inclusion criteria and nine were available for meta-analysis. A meta-analysis of two studies evaluated the recurrence rate 12-16 weeks after treatment. Results showed a statistically significant difference favoring the antibiotics plus probiotics group vs the antibiotics plus placebo group (relative risk 0.62, 95% confidence interval [CI]: 0.45-0.85). The narrative review in one study indicated that the cure rate was higher in the antibiotics plus probiotics group, giving a significant HR ratio of 0.73 (95% CI 0.54-0.98) ( p = 0.042). In conclusion, vaginal application of Lactobacillus in combination with antibiotics for the treatment of BV could be a promising method for both reducing the recurrence rate and relieving symptoms of BV.; Competing Interests: Conflict of interest: The authors report that there is no conflicts of interest in this work. (© 2023 the author(s), published by De Gruyter.)

Ma, X., et al. (2023). "Efficacy and safety of adjuvant chemotherapy for locally advanced cervical cancer: A systematic review and meta-analysis." Critical Reviews in Oncology/Hematology 184: 103953.
	Background: Locally advanced cervical cancer (LACC) is generally treated using concurrent chemo-radiotherapy (CCRT); yet, the effectiveness of adjuvant chemotherapy (ACT) following CCRT remains controversial.; Methods: The databases Embase, Web of Science, and PubMed were analyzed for relevant research. Primary endpoints included overall survival (OS) and progression-free survival (PFS).; Results: Fifteen trials with 4041 patients were included. Pooled HRs for PFS and OS were 0.81 (95 % CI: 0.67-0.96) and 0.69 (95 % CI: 0.51-0.93), respectively. However, subgroup analyses indicated that in randomized trials and trials with larger sample sizes (n > 100) as well as ACT cycles ≤ 3, ACT was not linked with improved PFS and OS. Moreover, ACT induced a greater rate of hematologic toxicities (P < 0.05).; Conclusion: Higher quality of evidence suggests that ACT could not yield additional survival benefits for LACC; however, identifying high-risk patients who may benefit from ACT is required to design further clinical trials and better inform treatment decisions. (Copyright © 2023 Elsevier B.V. All rights reserved.)

Maastricht University Medical, C. (2021). "Fluconazol Versus Medical Honey in the Treatment of Recurrent Vulvovaginal Candidiasis." ClinicalTrials.gov.
	No Results Available Drug: Fluconazole|Other: L-Mesitran Vaginal swab|Quality of life will be termined with questionnaires|Side effect of medication will be termined with questionnaires Female Phase 4 252 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NL 73794.068.20 March 1, 2025

Maastricht University Medical, C. (2022). "The Effect of Medical Grade Honey Formulation (L-Mesitran) Administration on Recurrent Vulvovaginal Candidiasis Symptoms." ClinicalTrials.gov.
	No Results Available Drug: Fluconazole|Device: L-Mesitran vaginal swab|Quality of life will be determined with questionnaires|Side effects of medication will be determined with questionnaires Female Phase 3 252 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NL73974.068.21 April 22, 2027

Machida, H., et al. (2020). "Survival outcome and perioperative complication related to neoadjuvant chemotherapy with carboplatin and paclitaxel for advanced ovarian cancer: A systematic review and meta-analysis." European Journal of Surgical Oncology 46(5): 868-875.
	Objective: To compare the effectiveness and safety of neoadjuvant chemotherapy with carboplatin/paclitaxel followed by interval debulking surgery (NACT-IDS) to primary debulking surgery plus postoperative chemotherapy (PDS) for advanced ovarian cancer.; Methods: A comprehensive systematic review and meta-analysis were conducted by an Expert Panel of the Japan Society of Gynecologic Oncology Ovarian Cancer Committee. Multiple public search engines including PubMed/MEDLINE and the Cochrane Database, were searched in March 2019 using the entry keywords "ovarian cancer [all fields]" AND "interval debulking surgery [all fields]", AND "neoadjuvant chemotherapy [all fields]". Key inclusion criteria were prospective clinical trials examining platinum-based NACT for stage II-IV epithelial ovarian cancer. The primary outcome of interest was survival, and the secondary outcome was adverse events with each intervention.; Results: After screening 333 studies, four phase III randomized clinical trials were identified that met the inclusion criteria. These trials included 1692 women (847 receiving NACT-IDS and 845 receiving PDS). It was found that NACT-IDS and PDS had similar overall survival (hazard ratio [HR]: 0.97, 95% confidence interval [CI]: 0.87-1.07, P = 0.53) and progression-free survival (HR: 0.98, 95%CI: 0.90-1.08, P = 0.74). In contrast, NACT-IDS was associated with significantly lower rates of perioperative complications (odds ratio [OR] 0.27, 95%CI: 0.20-0.36, P < 0.001) and perioperative mortality (OR: 0.17, 95%CI: 0.06-0.50, P < 0.001) compared to PDS.; Conclusion: This systematic review and meta-analysis suggests that NACT-IDS with carboplatin and paclitaxel does not negatively impact the survival of women with advanced ovarian cancer compared to PDS, while perioperative complications and mortality are significantly reduced by 70-80%.; Competing Interests: Declaration of competing interest Honorarium, Chugai, textbook editorial, Springer, and investigator meeting attendance expense, VBL therapeutics (K.M.); none for others. (Copyright © 2019 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

MacIntyre, S. (2021). "Study of Navicixizumab Plus Paclitaxel and Navicixizumab Monotherapy in Comparison to Paclitaxel Monotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Navicixizumab Product Code: OMP‐305B83 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Navicixizumab CAS Number: 1638338‐43‐8 Current Sponsor code: OMP‐305B83 Other descriptive name: Navicixizumab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ Trade Name: Paclitaxel AqVida 6 mg/ml concentrate for solution for infusion Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Paclitaxel CAS Number: 33069‐62‐4 Current Sponsor code: N/A Other descriptive name: Paclitaxel Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6‐ CONDITION: Patients With Platinum‐Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube 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] SECONDARY OUTCOME: Secondary end point(s): • OS, defined as the time from randomization to death; • Time to response (TTR), defined as the time from randomization to first documentation of response(CR or PR); • Disease control rate (DCR), defined as the proportion of patients with stable disease (SD) or a confirmed BOR of CR or PR; • DOR, defined as the time from first documentation of response (CR or PR) to documentation of objective disease progression or death due to any cause, whichever occurs first; • Changes in measures of health‐related QOL (EORTC QLC‐30 and supplemental ovarian cancer module [QLQ‐OV28]; EQ‐5D‐5L); • Concordance in Xerna™ TME Panel biomarker status between archived and core tumor samples collected during the screening period. Timepoint(s) of evaluation of this end point: As defined in the secondary end point(s) INCLUSION CRITERIA: 1. Patient provides signed informed consent to participate in the study prior to undergoing any study procedures, including screening procedures. 2. Patient is =18 years old or age of majority in the country in which they reside, whichever is higher. 3. Patient must have epithelial ovarian, fallopian tube, or primary peritoneal cancer consisting of one of the following histological subtypes: ‐ adenocarcinoma not otherwise specified ‐ clear cell adenocarcinoma ‐ endometrioid adenocarcinoma ‐ malignant Brenner's tumor ‐ mixed epithelial carcinoma ‐ malignant mixed Mullerian ‐ serous adenocarcinoma ‐ transitional cell carcinoma ‐ undifferentiated carcinoma 4. Patients must have received =2 and not more than 5 prior therapies, including at least 1 line of therapy containing bevacizumab (or biosimilar). ‐ Adjuvant/neoadjuvant therapy is counted as only 1 regimen in the absence of intervening progression. ‐ Maintenance therapy PRIMARY OUTCOME: Main Objective: • To compare the objective response rate (ORR) and evaluate the duration of response (DOR) in patients with B+ disease, as well as in all‐comers, treated with navicixizumab in combination with weekly paclitaxel to patients treated with weekly paclitaxel monotherapy; • To compare the progression‐free survival (PFS) in patients with B+ disease, as well as in all‐comers, treated with navicixizumab in combination with weekly paclitaxel to patients treated with weekly paclitaxel monotherapy; • To compare the ORR and evaluate the DOR in patients with B+ disease, as well as in all‐comers, treated with navicixizumab monotherapy to patients treated with weekly paclitaxel monotherapy Primary end point(s): • ORR, defined as the proportion of patients with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR), by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1); • PFS, defined as the time from randomization to the date of first documentation of objective disease progression or death (any cause), whichever occurs first Secondary Objective: • To evaluate overall survival ( ) in patients with B+ disease, as well as in all‐comers, treated with navicixizumab in combination with weekly paclitaxel to patients treated with weekly paclitaxel monotherapy; • To evaluate whether biomarker status on the Xerna™ TME Panel is a predictive biomarker for ORR, PFS, and OS in patients receiving treatment with navicixizumab either in combination with weekly paclitaxel or as monotherapy; ; Other Secondary Objectives:; • To evaluate the PFS and OS in patients treated with navicixizumab monotherapy vs patients treated with weekly paclitaxel monotherapy; • To further characterize the antitumor activity and clinical benefit of navicixizumab in combination with weekly paclitaxel in comparison to weekly paclitaxel monotherapy or navicixizumab monotherapy; • To characterize concordance between archived and core tumor samples in terms of Xerna™ TME Panel biomarker status Timepoint(s) of evaluation of this end point: As defined in the primary end point(s)

Mackenzie, B., et al. (2021). "Effectiveness of endometriosis interventions on symptom improvement, quality of life, health service use and related costs." PROSPERO International prospective register of systematic reviews.
	
Mackenzie Scott, C., et al. (2023). "Effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (ESPriT2): protocol for a multi-centre randomised controlled trial." Trials 24(1): 425.
	Background: Endometriosis affects 190 million women and those assigned female at birth worldwide. For some, it is associated with debilitating chronic pelvic pain. Diagnosis of endometriosis is often achieved through diagnostic laparoscopy. However, when isolated superficial peritoneal endometriosis (SPE), the most common endometriosis subtype, is identified during laparoscopy, limited evidence exists to support the common decision to surgically remove it via excision or ablation. Improved understanding of the impact of surgical removal of isolated SPE for the management of chronic pelvic pain in women is required. Here, we describe our protocol for a multi-centre trial to determine the effectiveness of surgical removal of isolated SPE for the management of endometriosis-associated pain.; Methods: We plan to undertake a multi-centre participant-blind parallel-group randomised controlled clinical and cost-effectiveness trial with internal pilot. We plan to randomise 400 participants from up to 70 National Health Service Hospitals in the UK. Participants with chronic pelvic pain awaiting diagnostic laparoscopy for suspected endometriosis will be consented by the clinical research team. If isolated SPE is identified at laparoscopy, and deep or ovarian endometriosis is not seen, participants will be randomised intraoperatively (1:1) to surgical removal (by excision or ablation or both, according to surgeons' preference) versus diagnostic laparoscopy alone. Randomisation with block-stratification will be used. Participants will be given a diagnosis but will not be informed of the procedure they received until 12 months post-randomisation, unless required. Post-operative medical treatment will be according to participants' preference. Participants will be asked to complete validated pain and quality of life questionnaires at 3, 6 and 12 months after randomisation. Our primary outcome is the pain domain of the Endometriosis Health Profile-30 (EHP-30), via a between randomised group comparison of adjusted means at 12 months. Assuming a standard deviation of 22 points around the pain score, 90% power, 5% significance and 20% missing data, 400 participants are required to be randomised to detect an 8-point pain score difference.; Discussion: This trial aims to provide high quality evidence of the clinical and cost-effectiveness of surgical removal of isolated SPE.; Trial Registration: ISRCTN registry ISRCTN27244948. Registered 6 April 2021. (© 2023. The Author(s).)

Mackova, K., et al. (2020). "Laser therapy for urinary incontinence and pelvic organ prolapse: a systematic review." BJOG 127(11): 1338-1346.
	Background: Laser therapy is now being proposed for the treatment of pelvic organ prolapse (POP) and urinary incontinence (UI).; Objectives: To systematically review the available literature on laser therapy for POP and UI.; Search Strategy: PubMed, Web Of Science and Embase were searched for relevant articles, using a three-concept (POP, UI, laser therapy) search engine composed as (concept 1 OR concept 2) AND concept 3.; Selection Criteria: Only full-text clinical studies in English.; Data Collection and Analysis: Data on patient characteristics, laser setting, treatment outcome and adverse events were independently collected by two researchers. There was a lack of methodological uniformity so meta-analysis was not possible and the results are presented narratively.; Main Results: Thirty-one studies recruiting 1530 adult women met the inclusion criteria. All studies showed significant improvement either on UI, POP or both; however the heterogeneity of laser settings, application and outcome measures was huge. Only one study was a randomised controlled trial, two studies were controlled cohort studies. All three were on UI and used standardised validated tools. The risk of bias in the randomised controlled trial was low on all seven domains; the controlled studies had a serious risk of bias. No major adverse events were reported, mild pain and burning sensation were the most commonly described adverse events.; Conclusions: All studies on vaginal and/or urethral laser application for POP and UI report improvement, but the quality of studies needs to be improved.; Tweetable Abstract: There is weak evidence that laser therapy is effective for urinary incontinence and pelvic organ prolapse #LASER#UI#POP. (© 2020 Royal College of Obstetricians and Gynaecologists.)

Madukkakuzhy, J. (2024). "Biological mesh versus synthetic mesh in interdisciplinary RRP with SCP." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group 1: Experimental intervention: Bionet for L‐SCP in the combined intervention Group 2: Control intervention: standard synthetic mesh for L‐SCP in the combined intervention Follow‐up per patient: 12 months Duration of intervention per patient: Surgery (1 day) CONDITION: ; K59.00 K59.00 PRIMARY OUTCOME: Morbidity and mortality according to the Clavien‐Dindo Classification (CDC) up to 12 months after surgery (maximum value) SECONDARY OUTCOME: Improvement in medical condition as measured by clinical scores for bowel function (Altomare, rectal toxicity, Wexner incontinence) ; Improvement of the pelvic organ prolapse (Pelvic Organ Prolapse Quantification (POP‐Q)) INCLUSION CRITERIA: Female patient with ODS and POP scheduled for surgery, clinical POP Q = 1°, age > 18 years < 80 years, ASA 1 ‐ 3, negative pregnancy test, no planned pregnancy during the study

Magdi, Y., et al. (2019). "Effect of embryo selection based morphokinetics on IVF/ICSI outcomes: evidence from a systematic review and meta-analysis of randomized controlled trials." Archives of Gynecology and Obstetrics 300(6): 1479-1490.
	Purpose: Debate exists for the optimal tool to select embryos for transfer in assisted reproductive technology (ART). Time-lapse monitoring (TLM) is a noninvasive tool suggested where each embryo can be captured every 5-20 min. Given the inconsistency in the existing studies, we conducted this meta-analysis of RCTs to summarize the evidence available concerning the predictive ability of morphokinetics compared with the routine assessment of embryo development in ART.; Methods: The primary databases MEDLINE, EMBASE, Cochrane, NHS, WHO, and Other Non-Indexed Citations were consulted for RCTs that have been published until November 2018, with no language restriction.; Results and Conclusion: Our review includes 6 RCTs (n = 2057 patients). The data showed an improvement (~ 9%) in live birth TLM (OR 1.43; 95% CI 1.10-1.85; P = 0.007), with low-quality evidence. There was no evidence of a significant difference between both groups concerning ongoing pregnancy, clinical pregnancy and implantation rates. The data further showed that morphokinetics is associated with decreased early pregnancy loss rate. These estimates must be interpreted with caution owing to the statistical and clinical heterogeneities and the consequent difficulty in drawing any meaningful conclusion.

Maged Ahmed, M., et al. (2023). "Endometrial scratch injury in infertile women undergoing in vitro fertilization cycles: a systematic review and meta-analysis." The Journal of International Medical Research 51(7): 3000605231175365.
	Objective: This study aimed to evaluate the effect of endometrial scratch injury (ESI) in infertile women undergoing in vitro fertilization (IVF).; Methods: We screened MEDLINE, CENTRAL, EMBASE, Web of Science, and the Cochrane Central Register from inception to April 2023 using keywords related to endometrial scratch, implantation, infertility, and IVF. We included 41 randomized, controlled trials of ESI in IVF cycles (9084 women). The primary outcomes were the clinical pregnancy, ongoing pregnancy, and live birth rates.; Results: The clinical pregnancy rate was reported in all 41 studies. The odds ratio (OR) for the clinical pregnancy rate had an effect estimate of 1.34 with a 95% confidence interval (CI) of 1.14 to 1.58. The live birth rate was reported in 32 studies with 8129 participants. The OR for the live birth rate had an effect estimate of 1.30 with a 95% CI of 1.06 to 1.60. The multiple pregnancy rate was reported in 21 studies with 5736 participants. The OR for the multiple pregnancy rate had an effect estimate of 1.35 with a 95% CI of 1.07 to 1.71.; Conclusion: ESI increases the clinical pregnancy, ongoing pregnancy, live birth, multiple pregnancy, and implantation rates in women undergoing IVF cycles.

Maghalian, M., et al. (2022). "The effect of oral vitamin E and omega-3 alone and in combination on menopausal hot flushes: A systematic review and meta-analysis." Post Reproductive Health 28(2): 93-106.
	This systematic review was conducted to investigate the effects of vitamin E and omega-3 used alone and in combination on the frequency and intensity of hot flushes (primary outcomes) and adverse effects (secondary outcome) in menopausal women. English and Persian databases were searched until March 18, 2021. The quality of the published papers was evaluated using Cochrane Handbook and the meta-analysis was conducted in RevMan 5.3. Heterogeneity was assessed using I 2 . In cases with substantial heterogeneity, a random effects model was used instead of a fixed effects model. A total of 387 papers were obtained from the databases. Finally, 10 papers with a sample size of 1100 participants entered the systematic review and a meta-analysis was conducted on nine of them. The results of the meta-analysis of two studies indicated that using vitamin E and omega-3 in combination significantly reduced the intensity of hot flushes compared to the placebo (mean difference (MD): -0.35; 95% CI: -0.48 to -0.21). The mean frequency (MD: -0.50; 95% CI: -1.58 to 0.58) and intensity (SMD: -0.61; 95% CI: -1.50 to 0.29) of hot flushes in the omega-3 group and the frequency of hot flushes (SMD: -0.21; 95% CI: -0.47 to 0.04) in the vitamin E group showed no significant differences with the placebo. No serious adverse effects were reported in the studies. Given the low number of RCTs, more clinical trials with larger sample size are required.

Magnusson, Å. (2021). "Progesterone as Luteal Support in Frozen IVF Natural Cycles." ClinicalTrials.gov.
	Vaginal progesterone supplementation is routine treatment after IVF with fresh embryo transfer, but it is uncertain whether vaginal progesterone after frozen embryo transfer in natural cycles is efficacious in terms of increasing the chance of a live birth. The ProFET study is a multicenter, open randomized, controlled trial planning to include 1800 women, intended to undergo a FET in a natural cycle. Primary objectives are to investigate if luteal phase support by vaginal progesterone, is superior to no luteal phase support, in terms of live birth rate per woman after a frozen embryo transfer, in a natural cycle and if 7 weeks of treatment is superior to 3 weeks duration. Secondary objectives are to compare groups regarding pregnancy outcomes including biochemical pregnancy, clinical, ongoing and term pregnancy rates, as well as rates of miscarriage, termination of pregnancy, and ectopic pregnancy. Secondary objectives are also perinatal and obstetrics outcomes, self‐reported side effects, adverse events and cost effectiveness. The investigators will also analyze the effect of S‐Progesterone level before FET on the chance of achieving live birth and secondary pregnancy outcomes.

Magzoub, R., et al. (2022). "Does metformin improve reproduction outcomes for non-obese, infertile women with polycystic ovary syndrome? Meta-analysis and systematic review." European Journal of Obstetrics, Gynecology, and Reproductive Biology 271: 38-62.
	Background: Polycystic ovary syndrome (PCOS) affects 10-12% of women of reproductive age. The prevalence of infertility in women with PCOS is high at between 70 and 80%. Treatment initially includes recommendations to follow preconception guidelines, such as lifestyle changes, folic acid therapy and halting the consumption of tobacco and alcohol. Management with pharmacological agents and surgical procedures have been incorporated into treatment regimens to improve fertility. Of these, metformin, an insulin sensitizer used as oral hypoglycemic agent, is gaining popularity.; Objectives: The aim of this study was to perform a meta-analysis of randomized controlled trials (RCTs) to evaluate the role of metformin in improving the reproduction outcomes for non-obese, infertile women with polycystic ovary syndrome.; Search Methods: In June 2019, we searched PubMed (from inception to present), Ovid Medline, Ovid EMBASE, Scopus, and the Cochrane library without date or language restrictions for relevant RCTs. Search was then updated in April 2020. Bibliographies of included studies were also searched for eligible studies.; Selection Criteria: RCTs that compared the effectiveness of metformin with other modalities in treating infertility in non-obese women with PCOS were included. The eligible outcomes for inclusion were pregnancy rate, miscarriage rate, live birth rate, ovarian hyperstimulation (OHSS) and multiple pregnancy.; Data Collection and Analysis: Data extraction and study quality assessment were performed independently by two reviewers, and any disagreements resolved by consensus or by arbitration by a third reviewer. Where two or more studies reported on the same outcome a meta-analysis was conducted using Cochrane RevMan 5.; Results: We found 21 RCTs which were eligible for inclusion in our systematic review, including 2638 patients with PCOS. Our meta-analysis showed that the use of metformin in non-obese women with PCOS is associated with slight increase in clinical pregnancy rate compared to placebo (47.7% vs. 42.9%) (Pooled risk ratio = 1.08 [0.82, 1.42], 95% CI, p = 0.60). It also showed that metformin is comparable to clomiphene citrate (CC) when the outcome is clinical pregnancy rate and the risk of multiple pregnancies tended to be lower (Pooled risk ratio = 0.36 [0.07, 1.92], 95% CI, p = 0.23, 3 studies). However, metformin had a higher risk of miscarriage rate (Pooled risk ratio = 2.41 [0.39, 14.86], 95% CI, p = 0.72). Furthermore, this analysis suggested that adding metformin to CC treatment decreases miscarriage risk by two folds compared to metformin alone (Pooled risk ratio = 2.67 [1.32, 5.39], 95% CI, p = 0.006) and showed no difference compared to CC alone. In comparison to letrozole, combination of metformin and CC is associated with lower clinical pregnancy rate (Pooled risk ratio = 0.52 [0.14, 1.91] 95% CI, p = 0.33) and multiple pregnancies (Pooled risk ratio = 0.45 [0.06, 3.19] 95% CI, p = 0.42).; Conclusion: Although this study illustrated that metformin may be better than placebo for some pregnancy outcomes, stronger, more definitive evidence from sufficiently powered trials are required before considering metformin for treating non-obese infertile women with PCOS within the current recommended guidelines. (Copyright © 2022 Elsevier B.V. All rights reserved.)

Mahdi Haider, S. (2021). "Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma." ClinicalTrials.gov.
	PRIMARY OBJECTIVE: I. To assess efficacy in terms of progression‐free survival (PFS) for immunotherapy with dual immune checkpoint blockade (nivolumab/ipilimumab) versus (vs.) monotherapy (nivolumab) in patients with recurrent mismatch repair (MMR) deficient endometrial carcinoma with measurable or non‐measurable (detectable) disease. SECONDARY OBJECTIVES: I. To evaluate the overall survival (OS) as estimated from time of enrollment to last follow‐up or death. II. To evaluate the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in those with measurable disease at start of treatment. III. To evaluate progression‐free survival at 6 months. IV. To evaluate the nature, frequency and degree of toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. V. To evaluate PFS and objective response rate in patients with prior anti‐PD1/PDL1 therapy and compare efficacy of dual immune checkpoint inhibition vs. anti‐PD1 monotherapy. OUTLINE: Patients are randomized into 1 of 2 arms. ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle and ipilimumab IV over 90 minutes on day 1 of every other cycle. Cycles repeat every three weeks. Treatment with nivolumab and ipilimumab repeats for up to 8 cycles in the absence of disease progression, unacceptable toxicity, or complete response (CR). Patients then receive nivolumab alone on day 1 of each cycle. Cycles repeat every 4 weeks in the absence of disease progression, unacceptable toxicity, or CR. ARM II: Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for up to 8 cycles, then every 4 weeks thereafter in the absence of disease progression, unacceptable toxicity, or CR. MAINTENANCE THERAPY: Patients achieving CR on Arm I or II receive nivolumab for an additional 12 months in the absence of disease progression or unacceptable toxicity. All patients also undergo collection of blood and tissue samples throughout the trial, and computed tomography (CT) scan and/or magnetic resonance imaging (MRI) at screening. Patients are followed every 3 months for 2 years, and then, every 6 months for 3 years.

Mahdi Haider, S. (2022). "Antitumor Activity of Neoadjuvant Chemotherapy With or Without BINTRAFUSP ALFA in Patients With Metastatic Advanced Stage Ovarian Cancer." ClinicalTrials.gov.
	No Results Available Drug: Carboplatin AUC 5 and paclitaxel|Drug: Bintrafusp alfa (M7824) Safety - Dose Limiting Toxicities (DLT)|Complete Pathologic Response|Duration of Response (DOR)|Time to Tumor Response (TTR)|Objective Response Rate (ORR)|Disease Control Rate (DCR)|Progression-free Survival (PFS)|Progression-free Survival (PFS) at 18 months|Progression-free Survival (PFS) at 12 months|Overall Survival (OS)|Overall Survival (OS) at 12 months|Overall Survival (OS) at 18 months Female Phase 1 33 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment HCC 21-162 January 2027

Mahdi Haider, S. (2024). "Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)." ClinicalTrials.gov.
	No Results Available Procedure: Biopsy|Procedure: Biospecimen Collection|Procedure: Computed Tomography|Procedure: Echocardiography|Procedure: Magnetic Resonance Imaging|Procedure: Multigated Acquisition Scan|Drug: Neratinib Maleate|Drug: Palbociclib Progression free survival|Overall survival All Phase 2 70 NIH Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment NCI-2023-09270|EAY191-N5|U10CA180868 April 30, 2025

Maher, C., et al. (2023). "Surgery for women with apical vaginal prolapse." The Cochrane Database of Systematic Reviews 7: CD012376.
	Background: Apical vaginal prolapse is the descent of the uterus or vaginal vault (post-hysterectomy). Various surgical treatments are available, but there are no guidelines to recommend which is the best.; Objectives: To evaluate the safety and efficacy of any surgical intervention compared to another intervention for the management of apical vaginal prolapse.; Search Methods: We searched the Cochrane Incontinence Group's Specialised Register of controlled trials, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings and ClinicalTrials.gov (searched 14 March 2022).; Selection Criteria: We included randomised controlled trials (RCTs).; Data Collection and Analysis: We used Cochrane methods. Our primary outcomes were awareness of prolapse, repeat surgery and recurrent prolapse (any site).; Main Results: We included 59 RCTs (6705 women) comparing surgical procedures for apical vaginal prolapse. Evidence certainty ranged from very low to moderate. Limitations included imprecision, poor methodology, and inconsistency. Vaginal procedures compared to sacral colpopexy for vault prolapse (seven RCTs, n=613; six months to f four-year review) Awareness of prolapse was more common after vaginal procedures (risk ratio (RR) 2.31, 95% confidence interval (CI) 1.27 to 4.21, 4 RCTs, n = 346, I 2 = 0%, moderate-certainty evidence). If 8% of women are aware of prolapse after sacral colpopexy, 18% (10% to 32%) are likely to be aware after vaginal procedures. Surgery for recurrent prolapse was more common after vaginal procedures (RR 2.33, 95% CI 1.34 to 4.04; 6 RCTs, n = 497, I 2 = 0%, moderate-certainty evidence). The confidence interval suggests that if 6% of women require repeat prolapse surgery after sacral colpopexy, 14% (8% to 25%) are likely to require it after vaginal procedures. Prolapse on examination is probably more common after vaginal procedures (RR 1.87, 95% CI 1.32 to 2.65; 5 RCTs, n = 422; I 2 = 24%, moderate-certainty evidence). If 18% of women have recurrent prolapse after sacral colpopexy, between 23% and 47% are likely to do so after vaginal procedures. Other outcomes: Stress urinary incontinence (SUI) was more common after vaginal procedures (RR 1.86, 95% CI 1.17 to 2.94; 3 RCTs, n = 263; I 2 = 0%, moderate-certainty evidence). The effect of vaginal procedures on dyspareunia was uncertain (RR 3.44, 95% CI 0.61 to 19.53; 3 RCTs, n = 106, I 2 = 65%, low-certainty evidence). Vaginal hysterectomy compared to sacral hysteropexy/cervicopexy (six RCTS, 554 women, one to seven year review) Awareness of prolapse - There may be little or no difference between the groups for this outcome (RR 1.01 95% CI 0.10 to 9.98; 2 RCTs, n = 200, very low-certainty evidence). Surgery for recurrent prolapse - There may be little or no difference between the groups for this outcome (RR 0.85, 95% CI 0.47 to 1.54; 5 RCTs, n = 403; I 2 = 9%, low-certainty evidence). Prolapse on examination- there was little or no difference between the groups for this outcome (RR 0.78, 95% CI 0.54 to 1.11; 2 RCTs n = 230; I 2 = 9%, moderate-certainty evidence). Vaginal hysteropexy compared to sacral hysteropexy/cervicopexy (two RCTs, n = 388, 1-four-year review) Awareness of prolapse - No difference between the groups for this outcome (RR 0.55 95% CI 0.21 to 1.44; 1 RCT n = 257, low-certainty evidence). Surgery for recurrent prolapse - No difference between the groups for this outcome (RR 1.34, 95% CI 0.52 to 3.44; 2 RCTs, n = 345; I 2 = 0%, moderate-certainty evidence). Prolapse on examination- There were little or no difference between the groups for this outcome (RR 0.99, 95% CI 0.83 to 1.19; 2 RCTs n =367; I 2 =9%, moderate-certainty evidence). Vaginal hysterectomy compared to vaginal hysteropexy (four RCTs, n = 620, 6 months to five-year review) Awareness of prolapse - There may be little or no difference between the groups for this outcome (RR 1.0 95% CI 0.44 to 2.24; 2 RCTs, n = 365, I 2 = 0% moderate-quality c rtainty evidence). Surgery for recurrent prolapse - There may be little or no difference between the groups for this outcome (RR 1.32, 95% CI 0.67 to 2.60; 3 RCTs, n = 443; I 2 = 0%, moderate-certainty evidence). Prolapse on examination- There were little or no difference between the groups for this outcome (RR 1.44, 95% CI 0.79 to 2.61; 2 RCTs n =361; I 2 =74%, low-certainty evidence). Other outcomes: Total vaginal length (TVL) was shorter after vaginal hysterectomy (mean difference (MD) 0.89cm 95% CI 0.49 to 1.28cm shorter; 3 RCTs, n=413, low-certainty evidence). There is probably little or no difference between the groups in terms of operating time, dyspareunia and stress urinary incontinence. Other analyses There were no differences identified for any of our primary review outcomes between different types of vaginal native tissue repair (4 RCTs), comparisons of graft materials for vaginal support (3 RCTs), pectopexy versus other apical suspensions (5 RCTs), continuous versus interrupted sutures at sacral colpopexy (2 RCTs), absorbable versus permanent sutures at apical suspensions (5 RCTs) or different routes of sacral colpopexy. Laparoscopic sacral colpopexy is associated with shorter admission time than open approach (3 RCTs) and quicker operating time than robotic approach (3 RCTs). Transvaginal mesh does not confer any advantage over native tissue repair, however is associated with a 17.5% rate of mesh exposure (7 RCTs).; Authors' Conclusions: Sacral colpopexy is associated with lower risk of awareness of prolapse, recurrent prolapse on examination, repeat surgery for prolapse, and postoperative SUI than a variety of vaginal interventions. The limited evidence does not support the use of transvaginal mesh compared to native tissue repair for apical vaginal prolapse. There were no differences in primary outcomes for different routes of sacral colpopexy. However, the laparoscopic approach is associated with a shorter operating time than robotic approach, and shorter admission than open approach. There were no significant differences between vaginal hysteropexy and vaginal hysterectomy for uterine prolapse nor between vaginal hysteropexy and abdominal hysteropexy/cervicopexy. There were no differences detected between absorbable and non absorbable sutures however, the certainty of evidence for mesh exposure and dyspareunia was low. (Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Mahmoud Marwa, Y., et al. (2022). "The impact of music therapy on anxiety and pregnancy rate among infertile women undergoing assisted reproductive technologies: a systematic review and meta-analysis." Journal of Psychosomatic Obstetrics and Gynaecology 43(2): 205-213.
	Objective : We aimed to perform a systematic review and meta-analysis to evaluate the effect of music therapy on anxiety and pregnancy rates among infertile women undergoing to perform assisted reproductive technologies (ART). Methods : Cochrane Library, PubMed, ISI web of science, and Scopus were searched from inception to May 2021. We included randomized controlled trials (RCTs) that compared music therapy (intervention group) to no music intervention (control group). Our primary outcomes were anxiety score using the State-Trait Anxiety Inventory (STAI) tool and pain score utilizing the Visual Analog Scale (VAS). Our secondary outcomes were the overall satisfaction score and clinical pregnancy rate. We extracted the available data from included studies and pooled them in a meta-analysis model using RevMan software. The overall quality of evidence was assessed through GRADEpro GDT software. Results : Seven RCTs with a total number of 793 patients were included in our study. Music therapy significantly reduced the anxiety score compared to control group (MD= -3.09, 95% CI [-5.57, -0.61], p = 0.01). Moreover, pain score was significantly improved after music treatment (MD= -2.93, 95% CI [-3.86, -2.00], p > 0.001). A significant improvement in the overall satisfaction score was found among music therapy group (MD= 1.51, 95% CI [0.40, 2.61], p = 0.008). Although more women in music therapy group experienced an increase in the clinical pregnancy rate in comparison with control group, the result was not statistically significant (RR= 1.08, 95% CI [0.94, 1.26], p = 0.28). The GRADEpro GDT tool showed a moderate quality of evidence for the evaluated outcomes. Conclusions : There is evidence of moderate quality that music therapy improves anxiety, pain, and satisfaction scores among infertile women undergoing ART. Moreover, it increases the clinical pregnancy rate but without statistical significance. More trials with a larger sample size are needed to investigate the influence of music therapy on the clinical outcomes of ART.

Maiorano Brigida, A., et al. (2022). "Efficacy and safety of PARP inhibitors in elderly patients with advanced ovarian cancer: a systematic review and meta-analysis." International Journal of Gynecological Cancer.
	Background: Poly-(ADP-ribose)-polymerase (PARP) inhibitors have shown to be effective as maintenance treatment in patients with advanced ovarian cancer. Although most ovarian cancers develop after age 65, older patients are often under-represented in clinical trials.; Objective: To assess the efficacy and safety of PARP inhibitors versus placebo as maintenance therapy in older patients with ovarian cancer.; Methods: This systematic review and meta-analysis was performed in accordance with the Preferred Reporting Items of Systematic reviews and Meta-Analysis (PRISMA) guidelines. We searched PubMed, Embase, Cochrane databases, and the American Society of Clinical Oncology (ASCO), European Society of Medical Oncology (ESMO), Society of Gynecologic Oncology (SGO) meeting abstracts, for randomized clinical trials using maintenance with PARP inhibitors in patients with advanced ovarian cancer, up to June 30, 2021. The measured outcomes were progression-free survival and safety (number and grade of adverse events), stratified by age (cut-off point: 65 years).; Results: A total of eight phase III trials were selected. Among the 4364 patients, 1435 (32.9%) were aged ≥65 (919 receiving PARP inhibitors, 516 receiving placebo). Compared with placebo, maintenance with PARP inhibitors improved progression-free survival in older patients (HR=0.54; 95% CI 0.45 to 0.65; p<0.00001). No differences were found in progression-free survival in comparison with a younger population (HR=0.47; p=0.13). Only hematologic adverse events were available for the age subgroups, and no differences emerged for all-grade hematologic adverse events (risk ratio (RR)=1.22, p=0.33 for anemia; RR=0.97, p=0.74 for neutropenia) and severe neutropenia (RR=0.97, p=0.86); old women were at lower risk of severe anemia (RR=0.79, p=0.04) but had a higher risk of severe thrombocytopenia (RR=1.27, p=0.01).; Conclusions: Maintenance with PARP inhibitors prolongs progression-free survival compared with placebo, both as monotherapy and combined with chemotherapy or bevacizumab, in older patients with advanced ovarian cancer (high-quality evidence). Hematologic safety is similar to that seen in younger patients. No overall survival data are available at this time.; Prospero Registration Number: CRD42021261039.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2022. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)

Makker, V., et al. (2023). "Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775." Journal of Clinical Oncology 41(16): 2904-2910.
	Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. We report the final prespecified analysis for overall survival (OS), along with updated progression-free survival (PFS) and objective response rate (ORR), and safety from the open-label, randomized, phase III Study 309/KEYNOTE-775. In total, 827 patients with advanced, recurrent, or metastatic endometrial cancer (EC) were randomly assigned to receive lenvatinib 20 mg orally once daily plus pembrolizumab 200 mg intravenously once every 3 weeks (n = 411) or chemotherapy of the treating physician's choice (doxorubicin 60 mg/m 2 intravenously once every 3 weeks or paclitaxel 80 mg/m 2 intravenously once weekly [3 weeks on; 1 week off] [n = 416]). Efficacy was reported for patients with mismatch repair proficient (pMMR) tumors and all-comers, and by subgroups (histology, prior therapy, MMR status). Updated safety was also reported.Lenvatinib plus pembrolizumab showed benefits in OS (pMMR HR, 0.70; 95% CI, 0.58 to 0.83; all-comer HR, 0.65; 95% CI, 0.55 to 0.77), PFS (pMMR HR, 0.60; 95% CI, 0.50 to 0.72; all-comer HR, 0.56; 95% CI, 0.48 to 0.66), and ORR (pMMR patients, 32.4% v 15.1%; all-comers, 33.8% v 14.7%) versus chemotherapy. OS, PFS, and ORR favored lenvatinib plus pembrolizumab in all subgroups of interest. No new safety signals were observed. Lenvatinib plus pembrolizumab continued to show improved efficacy versus chemotherapy and manageable safety in patients with previously treated advanced EC.

Makker, V., et al. (2022). "Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer." The New England Journal of Medicine 386(5): 437-448.
	Background: Standard therapy for advanced endometrial cancer after failure of platinum-based chemotherapy remains unclear.; Methods: In this phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with advanced endometrial cancer who had previously received at least one platinum-based chemotherapy regimen to receive either lenvatinib (20 mg, administered orally once daily) plus pembrolizumab (200 mg, administered intravenously every 3 weeks) or chemotherapy of the treating physician's choice (doxorubicin at 60 mg per square meter of body-surface area, administered intravenously every 3 weeks, or paclitaxel at 80 mg per square meter, administered intravenously weekly [with a cycle of 3 weeks on and 1 week off]). The two primary end points were progression-free survival as assessed on blinded independent central review according to the Response Evaluation Criteria in Solid Tumors, version 1.1, and overall survival. The end points were evaluated in patients with mismatch repair-proficient (pMMR) disease and in all patients. Safety was also assessed.; Results: A total of 827 patients (697 with pMMR disease and 130 with mismatch repair-deficient disease) were randomly assigned to receive lenvatinib plus pembrolizumab (411 patients) or chemotherapy (416 patients). The median progression-free survival was longer with lenvatinib plus pembrolizumab than with chemotherapy (pMMR population: 6.6 vs. 3.8 months; hazard ratio for progression or death, 0.60; 95% confidence interval [CI], 0.50 to 0.72; P<0.001; overall: 7.2 vs. 3.8 months; hazard ratio, 0.56; 95% CI, 0.47 to 0.66; P<0.001). The median overall survival was longer with lenvatinib plus pembrolizumab than with chemotherapy (pMMR population: 17.4 vs. 12.0 months; hazard ratio for death, 0.68; 95% CI, 0.56 to 0.84; P<0.001; overall: 18.3 vs. 11.4 months; hazard ratio, 0.62; 95% CI, 0.51 to 0.75; P<0.001). Adverse events of grade 3 or higher occurred in 88.9% of the patients who received lenvatinib plus pembrolizumab and in 72.7% of those who received chemotherapy.; Conclusions: Lenvatinib plus pembrolizumab led to significantly longer progression-free survival and overall survival than chemotherapy among patients with advanced endometrial cancer. (Funded by Eisai and Merck Sharp and Dohme [a subsidiary of Merck]; Study 309-KEYNOTE-775 ClinicalTrials.gov number, NCT03517449.). (Copyright © 2022 Massachusetts Medical Society.)

Maleki-Hajiagha, A., et al. (2019). "Intrauterine administration of autologous peripheral blood mononuclear cells in patients with recurrent implantation failure: A systematic review and meta-analysis." Journal of Reproductive Immunology 131: 50-56.
	Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC) has been proposed to improve implantation rates in women with recurrent implantation failure (RIF). The objective of this study was to evaluate whether intrauterine administration of PBMC improves clinical pregnancy and live birth in couples with RIF. Various databases were searched including Medline, Embase, Scopus, Web of Science and Cochrane Central Register of Controlled Trials up to April 2018. This review included all studies that compared intervention of PBMC in infertile women undergoing any form of assisted reproductive technology (ART). Two independent reviewers assessed eligibility; methodological quality; and extracted data. Meta-analysis using a random-effects model was performed to calculate the pooled estimates. Eight studies involving 886 patients were included. The probability of clinical pregnancy was significantly higher in women who received PBMC compared with control (RR: 1.92, 95% CI: 1.48-2.49; P < 0.001). No difference was observed in the studies that transmitted the embryo at blastocyst (RR: 2.44, 95% CI: 1.42-4.20; P = 0.001), or cleavage stage (RR: 2.01, 95% CI: 1.36-2.96; P < 0.001). There was no difference between studies that transmitted the embryo in fresh (RR: 2.14, 95% CI: 1.38-3.32; P < 0.001), or frozen condition (RR: 1.79, 95% CI: 1.32-2.43; P < 0.001). The probability of live birth was significantly higher in women who received PBMC compared with control (RR: 1.93, 95% CI: 1.35-2.76; P < 0.001). Administration of PBMC, irrespective of embryo stage and cycle type, increases clinical pregnancy and live birth in patients experienced RIF. However, these overall estimates should be considered with caution due to the small number, quasi-experimental design and poor quality of most included studies. (Copyright © 2019 Elsevier B.V. All rights reserved.)

Malinauskas Ana, P., et al. (2023). "Efficacy of pelvic floor physiotherapy intervention for stress urinary incontinence in postmenopausal women: systematic review." Archives of Gynecology and Obstetrics 308(1): 13-24.
	Introduction and Hypothesis: Our objective was to evaluate the effectiveness of pelvic floor physiotherapy interventions for stress urinary incontinence (SUI) in postmenopausal women.; Methods: Searches were performed in MEDLINE/PubMed, PEDro, Cochrane Library Registry and LILACS databases until October 2021. Only randomized controlled trials (RCTs) which had physiotherapy interventions as primary outcome were included. There were no restrictions on the year of publication or language. Qualitative methodology was evaluated using the PEDro scale.; Results: After applying inclusion/exclusion criteria and quality control, 6 randomized controlled trials were included in this systematic review. Methodological quality of trials varied from 5 to 8 (out of 10 possible points in PEDro scale score). Sample consisted of 715 subjects; mean age was between 51.6 and 66.3 years; SUI severity scale ranged from small to severe. Interventions were pelvic floor muscle training (PFMT); vaginal cone (VC); biofeedback (BF); electrical muscle stimulation (EMS); radiofrequency (RF) and electroacupuncture (EA). Pelvic floor physiotherapy was effective in all studies, however, meta-analysis was considered irrelevant due to the heterogeneity of the reported interventions.; Conclusion: There is not a literature consensus about the most effective pelvic floor physiotherapy intervention applied to stress urinary incontinence in postmenopausal women. It seems appropriate to state that further randomized controlled clinical trials should be done, due to the limited number of studies and heterogeneity of physiotherapeutic interventions applied to date.; Trial Registration: This systematic review is registered in PROSPERO in the trial registration CRD42021255062. (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Maltepe, U. (2022). "THE EFFECT OF COGNITIVE AWARENESS SUPPORT ON THE PSYCHOSOCIAL STATUS OF WOMEN TREATED FOR INFERTILITY." ClinicalTrials.gov.
	Infertility is a process with social, cultural and psychological interaction as well as physical condition. Infertility is a perceived loss for women, men and families. It requires adapting to a childless lifestyle and developing a coping mechanism with the difficulties encountered (Lee, Choi, Chan , Chan , & Ernest, 2009). Infertility treatments are stressful, physically painful and financially demanding life crises for most couples (Boivin, Griffiths, & Venetis, 2011). It is not enough that the nursing care that women who experience such a complex psychosocial process will receive during the same complex treatment process is only physical care. For this reason, individuals in the diagnosis and treatment process of infertility, especially women, need social support (Blevins, 2011). Providing psychosocial support to infertile patients is one of the important tasks of nursing care. There are studies in the literature showing that mindfulness‐based care is an effective method for improving psychological health (such as quality of life, stress, marital adjustment) in women in infertility clinics (Fard, Kalantarkousheh, & Faramarzi, 2018) (Lunn & Sherratt, 2013) (Shargh, et al. , 2016) (Hosseini, et al., 2020). A study of the mindfulness‐based care intervention found increases in awareness levels, self‐compassion, and coping strategies in infertile women during their first IVF treatment. Thus, it was found to improve fertility‐related quality of life and pregnancy rates (Li, Long, Liu, He, & Li, 2016). With this project, a mobile application was developed to provide mindfulness‐based psychosocial support to infertile women. The mobile application contains mindfulness‐based audio recordings developed specifically for infertility. Participants listened regularly (twice a day) to meditation appropriate to the treatment phase. Psychosocial assessments (pretest and posttest) were applied to measure the benefit of this practice on participants. The psychosocial status of women receiving infertility treatment was measured through the scales used, and the effect of mobile application and mindfulness nursing support on the participants was evaluated.

Maneuver, M. (2023). "A Randomized-Controlled Trial to Examine the Effects of a Daily Probiotic Supplement on Common Symptoms of Menopause." ClinicalTrials.gov.
	No Results Available Dietary Supplement: Provitalize Natural Menopause Probiotic|Other: Placebo Change in body weight. [Timeframe: Baseline to Day 90]|Change in waist circumference. [Timeframe: Baseline to Day 90]|Changes in scores on the Bristol Stool Chart. [Timeframe: Baseline to Day 90]|Changes in the frequency of hot flashes. [Timeframe: Baseline to Day 90]|Changes in the frequency of night sweats. [Timeframe: Baseline to Day 90]|Changes in the severity of brain fog experienced. [Timeframe: Baseline to Day 90]|Changes in the severity of mood swings. [Timeframe: Baseline to Day 90]|Changes in the severity of fatigue. [Timeframe: Baseline to Day 90]|Changes in the severity of bloating. [Timeframe: Baseline to Day 90]|Changes in the frequency of bloating. [Timeframe: Baseline to Day 90]|Changes in the severity of joint pain. [Timeframe: Baseline to Day 90]|Changes in total time asleep. [Timeframe: Baseline to Day 90]|Changes in overall sleep score provided by Fitbit wearable sleep tracker. [Timeframe: Baseline to Day 90]|Changes in total time awake at night. [Timeframe: Baseline to Day 90] Female Not Applicable 100 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Other 20379 March 1, 2024

Manon, V., et al. (2023). "Clinical efficacy of ibuprofen and naproxen in dysmenorrhea : a systematic review and meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Mansoor, M., et al. (2023). "Comparison of the Efficacy of Cisplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Improving Survival and Quality of Life in the Advanced Ovarian Cancer Patient Population: A Systematic Review and Meta-Analysis of Randomized Control Trials." Cureus 15(12): e51011.
	Ovarian cancer, being one of the prevalent gynecological cancers, warrants a therapy that's both effective and well tolerated. After extensive drug testing, combination regimens with paclitaxel plus platinum-based agents such as cisplatin/carboplatin and taxanes, have shown promising results for advanced ovarian cancer. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to compare the efficacy of two treatment regimens for advanced ovarian cancer: cisplatin/paclitaxel and carboplatin/paclitaxel. PubMed (Medline), Science Direct, and Cochrane Library were searched from inception to March 2023. The meta-analysis included patients with histologically verified International Federation of Gynaecology and Obstetrics (FIGO) stages IIB to IV ovarian carcinoma who received either carboplatin/paclitaxel or cisplatin/paclitaxel. The primary outcomes were progression-free survival (PFS), overall survival (OS), quality of life (QOL), complete response rate (CRR), and partial response rate (PRR). The revised Cochrane Risk of Bias Tool 2.0 was used to assess the quality of the RCTs The five RCTs chosen for this statistical analysis consisted of a total of 2239 participants, with 1109 receiving paclitaxel/cisplatin for treatment and the remaining 1130 receiving carboplatin/paclitaxel. Among all included outcomes, these reported significant findings: QoL (p-value=0.0002), thrombocytopenia (p=<0.00001), neurological toxicity (p-value=0.003), nausea/vomiting (p-value=<0.00001), myalgia/arthralgia (p-value=0.02), and febrile neutropenia (p-value=0.01). We concluded that the carboplatin/paclitaxel doublet endows a better quality of life (QOL) to patients along with significantly fewer gastrointestinal and neurological toxicities when compared with the cisplatin/paclitaxel combination. However, the myelosuppressive effects of carboplatin/paclitaxel remain a point of concern and may require clinical management.; Competing Interests: The authors have declared that no competing interests exist. (Copyright © 2023, Mansoor et al.)

Manuela, V. and P. Nicola (2022). "Oral GnRH antagonists with or without add-back therapy for endometriosis-associated pain: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Mao, Q., et al. (2023). "The efficacy of CO 2 laser in the treatment of genitourinary syndrome of menopause: a systematic review and meta-analysis of randomized controlled trials." Lasers in Medical Science 38(1): 152.
	CO 2 laser has been proposed as a treatment strategy for genitourinary syndrome of menopause (GSM). In order to assess its efficacy for treating GSM, we conducted a systematic review and meta-analysis. To identify the current state of randomized controlled trials on CO 2 laser therapy for GSM, a literature review was conducted. We systematically searched the following databases: PUBMED, EMBASE and the Cochrane Controlled Trials Register. In addition, a review of the references in the retrieved studies was carried out. Of 562 identified studies, 9 were eligible and were included in our analysis, involving 523 patients in total. Based on our analysis, CO 2 laser has no statistical difference compared with estrogen in VHI (p = 0.87), FSFI total score (p = 0.19), FSFI-Arousal (p = 0.11), FSFI-Desire (p = 0.72), FSFI-Orgasm (p = 0.45) and FSFI-Satisfaction (p = 0.08). The meta-analysis also showed that CO 2 laser significantly improved FSFI-Lubrication scores compared with estrogen therapy (p = 0.0004). Furthermore, compared with the sham group, CO 2 laser group had statistically improved VHI scores (p = 0.003) and FSFI scores (p < 0.00001). CO 2 laser therapy may be an effective alternative to estrogen therapy for GSM both in cases where estrogen is not applicable because of comorbidities and in cases in which women do not desire to take estrogen. (© 2023. The Author(s), under exclusive licence to Springer-Verlag London Ltd., part of Springer Nature.)

Mao, X., et al. (2019). "Effect of hysteroscopy before starting in-vitro fertilization for women with recurrent implantation failure: A meta-analysis and systematic review." Medicine 98(7): e14075.
	Objective: To study if hysteroscopy (HSC) before starting an in-vitro fertilization (IVF) cycle improves IVF outcomes in women with recurrent implantation failure (RIF).; Methods: The Medline, Cochrane, EMBASE, and Google Scholar databases were searched using the following keywords until March 31, 2017: in-vitro fertilization; infertility; hysteroscopy; recurrence; embryo implantation; and pregnancy. Randomized controlled trials (RCTs), two-arm prospective studies, and retrospective studies were included.; Results: Three RCTs, 3 nonrandomized prospective studies, and 2 retrospective cohort studies were included. The eligible studies included 3932 women with RIF: 1841 in the HSC group and 2091 in the control group. The clinical pregnancy rate and implantation rate was significantly higher in the HSC group compared with the control group (for clinical pregnancy rate, pooled odds ratio [OR] = 1.64, 95% confidence intervals [CI]: 1.30-2.07, P < 0.001; for implantation rate, pooled OR = 1.22, 95% CI: 1.02-1.45, P = 0.025). The live birth rate (pooled OR = 1.30, 95% CI: 0.90-1.88, P = 0.168) and the miscarriage rate (pooled OR = 0.94, 95% CI: 0.66-1.35, P = 0.744) of the 2 groups were not statistically significantly.; Conclusions: HSC improved the implantation rate and clinical pregnancy rates, but failed to improve live birth rate and did not affect the miscarriage rate in women with RIF undergoing IVF. Since HSC plays a significant role in pregnancy and birth outcomes of women with RIF, further studies are warranted.

Mapinduzi, J., et al. (2022). "Effectiveness of motor control exercises versus other musculoskeletal therapies in patients with pelvic girdle pain of sacroiliac joint origin: A systematic review with meta-analysis of randomized controlled trials." Journal of Back and Musculoskeletal Rehabilitation 35(4): 713-728.
	Background: Pelvic girdle pain represents a group of musculoskeletal pain disorders associated with the sacroiliac joint and/or the surrounding musculoskeletal and ligamentous structures. Its physical management is still a serious challenge as it has been considered the primary cause of low back pain.; Objective: This review sought to determine the effectiveness of motor control exercises for two clinically relevant measures; i.e., pain and disability, on patients with pelvic girdle pain of sacroiliac joint origin.; Methods: This review covered only randomized controlled studies. Online databases, such as PubMed, Embase, Scopus, and Cochrane Library, were searched from January 1, 1990, to December 31, 2019. PEDro scale was used to assess the methodological quality of included studies, while Review Manager was employed to synthesize data in view of meta-analysis. The PRISMA guidelines were applied for this review.; Results: Twelve randomized controlled trials of moderate-to-high quality were included in this review. The studies involved 1407 patients with a mean age ranging from 25.5 to 42.1 years as well as intervention and follow-up durations from 1 week to 2 years. Motor control exercises alone for pelvic girdle pain of sacroiliac joint origin were not effective in terms of pain reduction (SMD = 0.29 [-0.64,1.22]) compared to control interventions whereas they were slightly effective in terms of disability reduction (SMD =-0.07 [-0.67, 0.53]) at short-term. The combination of motor control exercises with other musculoskeletal therapies, however, revealed to be more effective than control interventions in terms of pain reduction (SMD =-1.78 [-2.49, -1.07]; 95%CI) and lessened disability (SMD =-1.80 [-3.03, -0.56]; 95%CI) at short-term.; Conclusion: Motor control exercises alone were not found to be effective in reducing pain at short-term. However, their combination with other musculoskeletal therapies revealed a significant and clinically-relevant decrease in pain and disability at short-term, especially in peripartum period.

Marchand, G., et al. (2023). "Meta-analysis of laparoscopic radical hysterectomy, excluding robotic assisted versus open radical hysterectomy for early stage cervical cancer." Scientific Reports 13(1): 273.
	Recent evidence has shown an increase in recurrence and a decrease in overall survival in patients treated with laparoscopic radical hysterectomy (LRH) and robotic assisted radical hysterectomy (RRH) open techniques (ORH). In addition, several high quality trials were recently published regarding the laparoscopic treatment of early stage cervical cancer. We sought out to reassess the recurrence rates, overall survival, complications and outcomes associated with laparoscopic radical hysterectomy (LRH) techniques against open techniques (ORH) when robotic assisted techniques were excluded. We searched PubMed, Medline, Cochrane CENTRAL, SCOPUS, ClinicalTrials.Gov and Web of Science for relevant clinical trials and observational studies. We included all studies that compared with early stage cervical cancer receiving LRH compared with ORH. We included randomized clinical trials, prospective cohort, and retrospective cohort trials. We included studies that included LRH and RRH as long as data was available to separate the two arms. We excluded studies that combined LRH and RRH without supplying data to differentiate. Of 1244 total studies, we used a manual three step screening process. Sixty studies ultimately met our criteria. We performed this review in accordance with PRISMA guidelines. We analyzed continuous data using mean difference (MD) and a 95% confidence interval (CI), while dichotomous data were analyzed using odds ratio (OR) and a 95% CI. Review Manager and Endnote software were utilized in the synthesis. We found that when excluding RRH, the was no significant difference regarding 5-year overall Survival (OR = 1.24 [0.94, 1.64], (P = 0.12), disease free survival (OR = 1.00 [0.80, 1.26], (P = 0.98), recurrence (OR = 1.01 [0.81, 1.25], (P = 0.95), or intraoperative complications (OR = 1.38 [0.94, 2.04], (P = 0.10). LRH was statistically better than ORH in terms of estimated blood loss (MD = - 325.55 [- 386.16, - 264.94] (P < 0.001), blood transfusion rate (OR = 0.28 [0.14, 0.55], (P = 0.002), postoperative complication rate (OR = 0.70 [0.55, 0.90], (P = 0.005), and length of hospital stay (MD = - 3.64[- 4.27, - 3.01], (P < 0.001). ORH was superior in terms of operating time (MD = 20.48 [8.62, 32.35], (P = 0.007) and number of resected lymph nodes (MD = - 2.80 [- 4.35, - 1.24], (P = 0.004). The previously seen increase recurrence and decrease in survival is not seen in LRH when robotic assisted techniques are included and all new high quality is considered. LRH is also associated with a significantly shorter hospital stay, less blood loss and lower complication rate.Prospero Prospective Registration Number: CRD42022267138. (© 2023. The Author(s).)

Marchand, G., et al. (2023). "Systematic Review and Meta-analysis of laparoscopic radical hysterectomy vs. Robotic assisted radical hysterectomy for early stage cervical cancer." European Journal of Obstetrics, Gynecology, and Reproductive Biology 289: 190-202.
	Objective: Following compelling evidence that open techniques may be related to better survival and disease free survival rates, many gynecologic oncologists in the US have turned away from performing laparoscopic radical hysterectomy (LRH) and robotic radical hysterectomy (RRH) for the treatment of early-stage cervical cancer. While this may be warranted as a safety concern, there is little high-quality data on the head-to-head comparison of LRH and RRH and therefore little evidence to answer the question of where this decrease in patient survival is originating from. In our systematic review, we aimed to compare the complications and outcomes of LRH against those of RRH.; Data Sources: We searched PubMed, Cochrane CENTRAL, Medline, ClinicalTrials.Gov, SCOPUS, and Web of Science from database inception until February 1st, 2022.; Methods of Study Selection: A total of 676 studies were identified and screened through a manual three-step process. Ultimately 33 studies were included in our final analysis. We included all studies that compared LRH and RRH and included at least one of our selected outcomes. We included retrospective cohorts, prospective cohorts, case-control, and randomized clinical trials.; Tabulation, Integration, and Results: Data was independently extracted manually by multiple observers and the analysis was performed using Review Manager Software. PRISMA guidelines were followed. We analyzed homogenous data using a fixed-effects model, while a random-effects model was used for heterogeneous outcomes. We found that following RRH, women had a decreased hospital stay (MD = 0.80[0.38,1.21],(P < 0.002). We found no differences in estimated blood loss (MD = 35.24[-0.40,70.89],(P = 0.05), blood transfusion rate ((OR = 1.32[0.86,2.02],(P = 0.20), rate of post-operative complications (OR = 0.84[0.60,1.17],(P = 0.30), the operative time (MD = 6.01[-4.64,16.66],(P = 0.27), number of resected lymph node (MD = -1.22[-3.28,0.84],(P = 0.25) intraoperative complications (OR = 0.78[0.51,1.19],(P = 0.25), five-year overall survival (OR = 1.37[0.51,3.69],(P = 0.53), lifetime disease free survival (OR = 0.89[0.59,1.32],(P = 0.55), intraoperative and postoperative mortality (within 30 days) (OR = 1.30[0.66,2.54],(P = 0.44), and recurrence (OR = 1.14[0.79,1.64],(P = 0.50).; Conclusions: RRH seems to result in the patient leaving the hospital sooner after surgery. We were unable to find any differences in our ten other outcomes related to complications or efficacy. These findings suggest that the decreased survival seen in minimally invasive RH in previous studies could be due to factors inherent to both LRH and RRH.; Prospero Prospective Registration Number: CRD42022273727.; 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.)

Marchand, G. J., et al. (2021). "Systematic review, meta-analysis and statistical analysis of laparoscopic supracervical hysterectomy vs endometrial ablation." Journal of the Turkish German Gynecological Association.
	OBJECTIVE: This meta-analysis aims to compare the effect of laparoscopic supracervical hysterectomy with endometrial ablation (EA) regarding the general and menstrual-related quality of life in women opting for surgical treatment for abnormal uterine bleeding. MATERIAL AND METHODS: We searched PubMed, Cochrane Library, SCOPUS, and Web of Science for relevant clinical trials. Our main outcomes of interest included quality of life assessed using medical outcomes survey short form 36 (SF-36), survey short form 12 (SF-12), operation time, time from operation to discharge, pain, fever, and hemoglobin level. Screening and data extraction were performed independently and the analysis was conducted using Review Manager Software v5.4.1. RESULTS: We included four clinical trials, results of SF-12 score showed that for both MCS and PCS, the overall mean difference revealed no significant difference between both groups (MD= - 4.15 [-16.01, 7.71], (P=0.49), and (MD= 2.67 [-0.37, 5.71], (P = 0.08) respectively. Subgroup analysis of the SF-36 score showed that only two components (general health and social function) were significantly improved in the hysteroscopy group (P<0.01), the other six components were not significant (P>0.05). The overall mean difference favored EA group significantly in terms of operation time (MD=72.65 [35.48, 109.82], (P = 0.0001), time from operation to discharge (MD=13.61 [3.21, 24.01], (P = 0.01), hemoglobin level outcome (MD=0.57 [0.40, 0.74], (P < 0.01), and pain score (SMD= 0.46 [0.32, 0.60], (P < 0.01). CONCLUSION: Laparoscopic supracervical hysterectomy has better outcomes in regards to quality of life. This includes patient indicated responses to social health, general health, and superior hemoglobin levels at all measured points postoperatively. EA, however, consistently is associated with less operative time, a shorter hospital stay and is also considered as a more minimally invasive technique which also can also result in satisfying outcomes.

Marchand Greg, J., et al. (2023). "Effect of a 20% intravenous fat emulsion therapy on pregnancy outcomes in women with RPL or RIF undergoing IVF/ICSI: a systematic review and meta-analysis." Journal of Clinical and Translational Research 9(4): 236-245.
	BACKGROUND AND AIM: The aim of this study was to evaluate the efficacy a 20% intravenous fat emulsion therapy in women suffering from recurrent pregnancy loss or recurrent implantation failure (RPL/RIF) who are undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). MATERIALS AND METHODS: We searched Cochrane Library, ISI Web of Science, MEDLINE, ClinicalTrials.gov, PubMed, and Scopus using relevant keywords during February 2020 for randomized controlled trials (RCTs) comparing the therapy versus placebo or no intervention in women suffering from RPL/RIF and undergoing IVF/ICSI. RESULTS: We included five RCTs with 840 patients. The intravenous fat emulsion therapy was significantly effective in increasing clinical pregnancy rates compared to the control group (risk ratios [RR] = 1.48, 95% confidence intervals [CI] [1.23, 1.79], P < 0.001). Furthermore, ongoing pregnancy and live birth rates were significantly higher with 20% intravenous fat emulsion therapy RR = 1.71, 95% CI [1.27, 2.32], P = 0.005 and RR = 1.85, 95% CI [1.44, 2.38], P < 0.001. Despite the statistically significant differences, the quality of evidence was only considered moderate, and this was primarily due to high risk of bias in the included RCTs. CONCLUSION: Our review provides a moderate level of evidence that intravenous fat emulsion therapy is effective in improving reproductive outcomes among women with RPL/RIF performing IVF/ICSI techniques. Further, investigation is required to ascertain optimal dosage and timing of administration. RELEVANCE FOR PATIENTS: Women suffering from RPL or RIF may wish to consider discussing with their reproductive endocrinologist the addition of a 20% fat emulsion therapy to planned IVF or ICSI cycles, which may improve outcomes.

Marchand Greg, J., et al. (2023). "Effect of the decision to perform hysteroscopy on asymptomatic patients before undergoing assisted reproduction technologies-a systematic review and meta-analysis." AJOG Global Reports 3(2): 100178.
	Objective: Routine hysteroscopic evaluation before assisted reproductive technology treatment is a novel approach with the potential to reduce assisted reproductive technology failure even in the absence of evidence of uterine pathology. Following the publication of several relatively high-quality trials on this topic, we sought to determine if this practice is beneficial.; Data Sources: We searched Web of Science, MEDLINE, PubMed, Scopus, Cochrane Library, and ClinicalTrials.gov from each database's inception until May 31, 2022 with our search strategy, attempting to locate all randomized controlled trials assessing the use of hysteroscopy in otherwise asymptomatic women undergoing assisted reproductive technology.; Study Eligibility Criteria: We included only randomized controlled trials that included at least one of our selected outcomes, and we excluded any studies with suspicion of pathology before the time of hysteroscopy, other than knowledge of the patient's infertility. We included all the aforementioned studies regardless of procedures or modifications performed as a result of hysteroscopic findings. Our initial search yielded 1802 results, which were reduced to 1421 after removal of duplicates. Ultimately, 11 studies were found to meet our criteria and were included in our quantitative synthesis.; Methods: We used ReviewManager software, version 5.4.1 to analyze the data, which we imported after manually gathering from the 11 studies. Continuous and dichotomous outcomes were imported as standard deviations. Pooled analysis was described as a mean difference, relative to 95 % confidence interval in cases of continuous data. Dichotomous outcomes were analyzed using risk ratios and 95% confidence intervals. In homogeneous outcomes, we used a fixed-effects model, and in heterogeneous outcomes we used a random-effects model.; Results: Our results showed that hysteroscopy was associated with significant improvement in the clinical pregnancy rate (risk ratio, 1.27 [1.11-1.45]; P <.001). We found no differences between the hysteroscopy group and the control group in live birth rate (risk ratio, 1.26 [0.99-1.59]; P =.06), miscarriage rate (risk ratio, 0.99 [0.81-1.19]; P =.88), fertilization rate (risk ratio, 1.01 [0.93-1.09]; P =.88), incidence of multiple gestations (risk ratio, 1.29 [0.98-1.71]; P =.07), number of embryos transferred (mean difference, 0.04 [-0.18 to 0.26]; P =.73), chemical pregnancy rate (risk ratio, 1.01 [0.86-1.17]; P =.93), and number of oocytes retrieved (mean difference, 0.44 [-0.11 to 0.98]; P =.11).; Conclusion: We observed an improvement in the clinical pregnancy rate, but no significant improvement in the live birth rate with routine hysteroscopy before assisted reproductive technology treatment. We believe this does not represent sufficient evidence to recommend routine hysteroscopy for otherwise asymptomatic patients before assisted reproductive technology treatment at this time. (© 2023 The Authors.)

Marchetti, C., et al. (2023). "Quality of life in patients with advanced ovarian cancer after primary debulking surgery versus neoadjuvant chemotherapy: Results from the randomised SCORPION trial (NCT01461850)." BJOG 130(13): 1579-1588.
	Objective: To investigate the effect of treatment with neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS), versus primary debulking surgery (PDS), on quality of life (QoL) in patients with advanced epithelial ovarian cancer (EOC).; Design: Randomised trial conducted in a single institution.; Setting: Division of Gynaecologic Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.; Sample: Patients with stage-IIIC/IV EOC and high tumour load.; Methods: Patients were randomised (1:1) to undergo either PDS (PDS group) or NACT followed by IDS (NACT/IDS group).; Main Outcome Measures: Quality-of-life (QoL) data, assessed using the European Organization for Research and Treatment of Cancer core QoL questionnaire (QLQ-C30) and ovarian cancer module (OV28); co-primary outcomes were the QLQ-C30 global health score at 12 months (cross-sectional analysis) and the difference in mean QLQ-C30 global health score over time between treatment groups (longitudinal analysis).; Results: From October 2011 to May 2016, 171 patients were enrolled (PDS = 84; NACT/IDS = 87). We observed no clinical or statistically significant difference between treatment groups in any of the QoL functioning scales at 12 months, including QLQ-C30 global health score (NACT/IDS group vs PDS group, mean difference 4.7, 95% CI -4.99 to 14.4, p = 0.340). Over time, we found lower global health scores for those undergoing PDS than for those receiving NACT (difference in mean score 6.27, 95% CI 0.440-12.11, p = 0.035), albeit this was not clinically relevant.; Conclusions: We found no difference in global QoL related to treatment approach at 12 months, even though patients in the NACT/IDS group reported better global health scores across the 12-month period compared with the PDS group; these findings further confirm that NACT/IDS might be a feasible option for patients unsuitable for PDS. (© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Mardon, A. K., et al. (2023). "The Efficacy of Self-Management Strategies for Females with Endometriosis: a Systematic Review." Reproductive Sciences 30(2): 390-407.
	Self-management is critical for the care of endometriosis. Females with endometriosis frequently use self-management strategies to manage associated symptoms; however, the efficacy of such strategies is unknown. The aim of this review was to systematically appraise the evidence concerning efficacy of self-management strategies for endometriosis symptoms. Electronic databases, including Medline, Embase, Emcare, Web of Science Core Collection, Scopus, and the Cochrane Central Register of Controlled Trials, were searched from inception to March 2021. We included peer-reviewed experimental studies published in English evaluating the efficacy of self-management strategies in human females laparoscopically diagnosed with endometriosis. Studies underwent screening, data extraction, and risk of bias appraisal (randomised studies: Risk of Bias 2 tool; non-randomised studies: Risk Of Bias In Non-randomized Studies - of Interventions tool). Of the fifteen studies included, 10 evaluated dietary supplements, three evaluated dietary modifications, one evaluated over-the-counter medication, and one evaluated exercise. Most studies had a high-critical risk of bias. Many self-management strategies were not more effective at reducing endometriosis symptoms compared to placebo or hormonal therapies. Where studies suggest efficacy for self-management strategies, no recommendations can be made due to the poor quality and heterogeneity of evidence. High-quality empirical evidence is required to investigate the efficacy of self-management strategies for females with endometriosis.Copyright © 2022, The Author(s).

Maria, C., et al. (2023). "The role of endometrial scratching prior to in vitro fertilization- An updated systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Maria, d., et al. (2021). "Systematic review and meta analysis of oral gonadotrophin-releasing hormone receptor-antagonists for treatment of fibroids in premenopausal women." PROSPERO International prospective register of systematic reviews.
	
Mariana, H., et al. (2023). "Ketogenic diet – a nutritional intervention for endometriosis control: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Ma'rifah, A. R., et al. (2022). "Effectiveness of psychoeducation intervention among women with gynecological cancer: a systematic review and meta-analysis of randomized controlled trials." Supportive Care in Cancer 30(10): 8271-8285.
	Psychoeducation interventions have been suggested to improve sexual functioning and quality of life. The aim of this study was to examine the effects of the psychoeducation intervention on quality of life, sexual function, and psychological outcomes; and to identify the critical components of psychoeducation intervention for women with gynecological cancer. This study was a systematic review and meta-analysis. Psychoeducation interventions were searched using six English databases, eligible studies were extracted, and the risk of bias was evaluated by two authors independently. A random effects model was used to examine the intervention effects. We conducted subgroup analysis and meta-regression to assess the variables underlying the heterogeneity. In total, eight trials were identified, and 1128 participants were included. Women who received the psychoeducation intervention had better quality of life (standardized mean difference (SMD) = 0.59, 95% confidence interval (CI): 0.22, 0.97), sexual functioning (SMD = 0.63, 95% CI: 0.27, 0.99), and psychological outcomes (i.e., anxiety and depression (SMD = - 0.27, 95% CI: - 0.09, - 0.44)). Interventions that combined lecture-based, skill practical, discussion, and counseling were conducted using an online format and were delivered by a team of health professionals that had higher scores of qualities of life. Additionally, involving significant others in the intervention improved sexual functioning. Psychoeducation interventions effectively improve quality of life, sexual functioning, anxiety, and depression. Incorporating lecture-based, practical skills, discussion, and counseling through an online format and involving significant others are beneficial for improving the quality of life and sexual functioning among women with gynecological cancer.Copyright © 2022, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Marin, L., et al. (2021). "Sildenafil Supplementation for Women Undergoing Infertility Treatments: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." Journal of Clinical Medicine 10(19).
	The aim of this systematic review and meta-analysis is to summarize data on the effectiveness of Sildenafil supplementation for women undergoing assisted reproduction techniques. This meta-analysis of randomized controlled trials (RCTs) evaluates the effects of Sildenafil administration during infertility treatments compared with a control group in infertile women. Outcomes evaluated were endometrial thickness (ETh) and the clinical pregnancy rate (CPR). The chemical pregnancy rate (ChPR) was also evaluated. Pooled results were expressed as the risk ratio (RR) or mean differences (MD) with a 95% confidence interval (95% CI). Women undergoing ovulation induction who received Sildenafil showed higher ETh and a higher CPR in comparison to controls. In this group, both the ETh and ChPR resulted in significantly higher values only with delayed start administration. Women undergoing fresh or frozen embryo transfer who received Sildenafil showed no significant advantages regarding ETh and CPR in comparison to controls. In this group, we found a significantly higher ChPR in women receiving Sildenafil. A subgroup analysis revealed significant advantages regarding ETh with oral administration for women undergoing fresh or frozen embryo transfer. Sildenafil therapy appears to improve endometrial thickness and pregnancy rate in women undergoing timed intercourses but it resulted not effective in IUI and IVF treatments. Further RCTs with rigorous methodology are still mandatory.

Markland, A. D., et al. (2023). "Optimizing remote access to urinary incontinence treatments for women veterans (PRACTICAL): Study protocol for a pragmatic clinical trial comparing two virtual care options." Contemporary Clinical Trials 133: 107328.
	Objectives: In this pragmatic clinical trial, the primary objective is to increase access to behavioral treatment of urinary incontinence (UI) for women Veterans by comparing the effectiveness of two virtual care delivery modalities. Method(s): Veterans Affairs (VA) clinical sites in AL, GA, NC will virtually randomize 286 women Veterans with UI (ie, stress, urge, or mixed). We will compare the effectiveness of our mHealth UI application (MyHealtheBladder) to a single VA Video Connect (VVC) session delivered by trained UI providers. Women without improvement after 8 weeks will receive an optimization VVC visit using a sequential, multiple assignment, randomized trial (SMART) design. The primary outcome is UI symptom improvement at 12-weeks with or without optimization; secondary outcomes include improvements in lower urinary tract symptoms, adherence, retention rates, perceptions of improvement, and visit-related miles saved. Sample size needed to identify a 2.5-point change (range 0-21) in the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) from baseline to 12-weeks post-randomization is 200 participants. Allowing for an attrition rate of 25%, 286 participants are required. Key results: Study team initiated remote recruitment on April 2020. Recruitment is on target with a 75% retention rate. We expect completion in fall of 2023 (clinicaltrials.gov NCT04237753). Discussion/Conclusion: Engaging women Veterans with virtual modalities for initial UI treatment may increase access to UI care while also improving symptoms. After assessing efficacy, adherence, and retention, the next step is to implement the most effective option for remote delivery of evidence-based behavioral UI treatment for women Veterans. Trial registration: ClinicalTrials.gov number NCT04237753Copyright © 2023

Marmara, U. (2021). "Effectiveness of Video Conferencing in Urinary Incontinence." ClinicalTrials.gov.
	During the COVID‐19 pandemic in the world, telerehabilitation methods are widely used in order to ensure the continuity of patients' access to health services, as well as to reduce the likelihood of both health personnel and the patient catching the disease. Telerehabilitation (TR) refers to the provision of rehabilitation services through information and communication technologies. Information and communication technologies include secure messaging services and e‐mail services, but new applications such as wearable, virtual reality and activity trackers are increasingly used in healthcare. On the other hand, real‐time applications, where information is instantly exchanged between all users by telephone and video conferencing, are the most common of information and communication technologies. Urinary incontinence is defined as the complaint of involuntary urinary incontinence. This condition, which affects both sexes, is more common in women. Urinary incontinence is caused by the disruption of the continence mechanism as a result of prostate enlargement or prostate cancer in men; In women, it is due to dysfunction in the bladder and pelvic floor muscles that occur during menopause, childbirth or pregnancy. urinary incontinence; It is classified as stress incontinence, urge incontinence, mixed type incontinence, overflow incontinence and functional incontinence. In a study conducted in our country, it was reported that stress type incontinence is the most common type of incontinence. Stress type incontinence is followed by mixed type incontinence and urge type incontinence, respectively. Urinary incontinence is a health problem that significantly affects people's social interactions, interests and psychosocial status. Studies have shown that even mild incontinence complaints cause a decrease in the quality of life in women. Conservative treatment, pharmacological treatment and surgical interventions are used in the treatment of urinary incontinence. Pelvic floor muscle training is one of the conservative treatment methods used in the treatment of urinary incontinence. Studies in the literature have reported that pelvic floor muscle training should be included in the primary care program in women with stress or any type of incontinence, and this training causes less urinary incontinence, less urine in the pad test, and patients empty their bladders less frequently during the day. It has been shown that the pelvic floor muscles work synergistically with the diaphragm and abdominal muscles to control respiration and changes in intra‐abdominal pressure. Therefore, it has been reported in the literature that adding breathing exercises and deep abdominal muscle strengthening exercises to pelvic floor muscle training in patients with urinary incontinence may be beneficial. When the studies are examined, the programs that include pelvic floor muscle training are quite variable. Different methods were used in order to increase the effectiveness of the applied muscle training program and the adherence of the patients to the program. One of these applied methods is telerehabilitation applications. It has been shown that pelvic floor muscle training can be applied safely and effectively with telehealth applications, and significant improvements are achieved in stress incontinence and mixed type incontinence types with these applications. It has been reported that these technological methods are advantageous in order to ensure continuity of treatment without leaving the house during the pandemic process. Women with regular contact with the supervisor during pelvic floor muscle training in patients with urinary incontinence are more likely to report their recovery. However, group physiotherapy has not been shown to be less effective than individual physiotherapy in reducing incontinence episodes. In the light of this information in the literature, pelvic floor muscle training, breathing exercise and core exercises performed individually with video conference monitoring, which is one of the telerehabilitation methods in p ients with urinary incontinence, on muscle strength, incontinence degree, pelvic floor muscle thickness, symptoms on quality of life, patient satisfaction, exercise. We have established our hypothesis in terms of positive effects on commitment and sexual life. Therefore, the aim of this study is; The aim of this study is to compare the effectiveness of group video conferencing method and individual video conferencing method on urinary incontinence in patients with urinary incontinence.

Marschalek, M. L., et al. (2021). "Does preoperative locally applied estrogen treatment facilitate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse? A randomised controlled double-masked, placebo-controlled, multicentre study." BJOG 128(13): 2200-2208.
	OBJECTIVE: To evaluate whether locally applied vaginal estrogen affects prolapse-associated complaints compared with placebo treatment in postmenopausal women prior to surgical prolapse repair. DESIGN: Randomised, double-masked, placebo-controlled, multicentre study. SETTING: Urogynaecology unit at the Medical University of Vienna and University Hospital of Tulln. POPULATION: Postmenopausal women with symptomatic pelvic organ prolapse and planned surgical prolapse repair. METHODS: Women were randomly assigned local estrogen cream or placebo cream 6 weeks preoperatively. MAIN OUTCOME MEASURES: The primary outcome was differences in subjective prolapse-associated complaints after 6 weeks of treatment prior to surgery, assessed with the comprehensive German pelvic floor questionnaire. Secondary outcomes included differences in other pelvic floor-associated complaints (bladder, bowel or sexual function). RESULTS: Out of 120 women randomised, 103 (86%) remained for the final analysis. After 6 weeks of treatment the prolapse domain score did not differ between the estrogen and the placebo groups (4.4 ± 0.19 versus 4.6 ± 0.19; mean difference, -0.21; 95% CI -0.74 to 0.33; P = 0.445). Multivariate analysis, including only women receiving the intervention, showed that none of the confounding factors modified the response to estradiol. CONCLUSIONS: These results demonstrate that preoperative locally applied estrogen does not ameliorate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse. TWEETABLE ABSTRACT: Preoperative local estrogen does not ameliorate prolapse-associated symptoms in postmenopausal women with pelvic organ prolapse.

Marschall, H., et al. (2022). "Is laparoscopic excision for superficial peritoneal endometriosis helpful or harmful? Protocol for a double-blinded, randomised, placebo-controlled, three-armed surgical trial." BMJ Open 12(11): e062808.
	Introduction: Placebo-controlled surgical designs are recommended to ascertain treatment effects for elective surgeries when there is genuine doubt about the effectiveness of the surgery. Some elective surgeries for pain have been unable to show an effect beyond sham surgery, suggesting contributions from contextual factors. However, the nature of contextual factors in elective surgery is largely unexplored. Further, methodological difficulties in placebo-controlled surgical trials impact the ability to estimate the effectiveness of a surgical procedure. These include an overall lack of testing the success of blinding, absence of comparison to a no-surgery control group and dearth of test for neuropathic pain.For women with peritoneal endometriosis, there is uncertainty regarding the pain-relieving effect of surgery. Surgery may put patients at risk of complications such as postsurgical neuropathic pain, without guarantees of sufficient pelvic pain relief. The planned placebo-controlled trial aims to examine the effect of surgery on pelvic pain, widespread pain and neuropathic pain symptoms in women with peritoneal endometriosis, and to test the contribution of contextual factors to pain relief.; Methods and Analysis: One hundred women with peritoneal endometriosis will be randomised to either diagnostic laparoscopy with excision of endometrial tissue (active surgery), purely diagnostic laparoscopy (sham surgery) or delayed surgery (no-surgery control group). Outcomes include pelvic pain relief, widespread pain, neuropathic pain symptoms and quality of life. Contextual factors are also assessed. Assessments will be obtained at baseline and 1, 3 and 6 months postrandomisation. Mixed linear models will be used to compare groups over time on all outcome variables.; Ethics and Dissemination: The trial is approved by the Regional Ethics Committee in the Central Denmark Region (1-10-72-152-20). The trial is funded by a PhD scholarship from Aarhus University, and supported by a grant from 'Helsefonden' (20-B-0448). Findings will be published in international peer-reviewed journals and disseminated at international conferences.; Trial Registration Number: NCT05162794.; 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.)

Marta Calero, d., et al. (2021). "Effectiveness of stabilising exercises in lumbo-pelvic pain during pregnancy and postpartum period: A systematic review." PROSPERO International prospective register of systematic reviews.
	
Marta Da Cunha Lobo Souto, M., et al. (2023). "Evaluation of the efficacy and safety of dienogest for the maintenance treatment of endometriosis: Systematic Review." PROSPERO International prospective register of systematic reviews.
	
Martinez, A., et al. (2023). "PARa-aOrtic LymphAdenectomy in locally advanced cervical cancer (PAROLA trial): a GINECO, ENGOT, and GCIG study." International Journal of Gynecological Cancer 33(2): 293-298.
	Background: Positron emission tomography/computed tomography (PET/CT) fails to detect approximately 25% of aortic lymph node metastasis in patients with PET/CT stage IIIC1 cervical cancer. Surgical staging could lead to treatment modification and to improved para-aortic and distant control.; Primary Objectives: To demonstrate if chemoradiation with tailored external beam radiation field based on surgical staging and pathologic examination of the para-aortic lymph node is associated with improved 3-year disease-free survival compared with patients staged with PET/CT staging only.; Study Hypothesis: Surgical staging followed by tailored chemoradiation will improve disease-free survival while avoiding unnecessary prophylactic extended-field chemoradiation in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIIC1 cervical cancer.; Trial Design: This is an international multicenter, randomized, phase III study. Eligible patients will be randomized 1:1 between PET/CT staging followed by chemoradiation (control arm), or surgical staging followed by tailored chemo-radiation (experimental arm). Randomization will be stratified by tumor stage according to TNM classification, center, and adjuvant treatment.; Major Inclusion/exclusion Criteria: Main inclusion criteria are histologically proven PET/CT FIGO stage IIIC1 cervical cancer. Main exclusion criteria include unequivocal positive common iliac or para-aortic lymph node at pre-therapeutic imaging PET/CT.; Primary Endpoints: The primary endpoint is disease-free survival defined as the time from randomization until first relapse (local, regional, or distant), or death from any cause.; Sample Size: 510 eligible patients ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: The estimated date for completing accrual will be Q2 2027. The estimated date for presenting results will be Q4 2030.; Trial Registration Number: NCT05581121.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Martyna, K.-J., et al. (2021). "Manual therapy for pelvic floor muscle function in women- systematic review." PROSPERO International prospective register of systematic reviews.
	
Martyna, S., et al. (2023). "The Effect of Diet on Primary and Secondary Dysmenorrhea: A Systematic Review of Randomized Controlled Trials." PROSPERO International prospective register of systematic reviews.
	
Maryam, A., et al. (2021). "Effect of Vitamin E on Intensity of Primary Dysmenorrhea: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Masoud, A., et al. (2022). "Systematic review and meta-analysis of the efficacy of acupuncture as an adjunct to IVF cycles in China and the world." Turkish Journal of Obstetrics and Gynecology 19(4): 315-326.
	Acupuncture has been introduced as an adjuvant therapy to in vitro fertilization (IVF) cycles in many randomized controlled trials (RCTs). However, there has been a debate among trials regarding the effectiveness and safety of the procedure. To determine how effective and safe acupuncture is as an adjunct to IVF cycles for primary and secondary female infertility. We conducted a literature search for relevant RCTs and ultimately included nine studies. The main selected outcomes included the rates of clinical pregnancy, ongoing pregnancy, miscarriage, live birth, and side effects. Patients receiving acupuncture were grouped together regardless of the acupuncture points used or the protocol for the insertion of needles. We performed a subgroup analysis according to whether studies originated inside and outside China to investigate the results of the different RCTs. We pooled outcomes as a risk ratio (RR) with 95% confidence interval (CI). The analysis revealed that in China, acupuncture led to lower clinical [RR=0.80, 95% CI (0.66, 0.97), p=0.02] and ongoing [RR=0.78, 95% CI (0.63, 0.97), p=0.03] pregnancy rates than placebo. Outside China, acupuncture increased clinical pregnancy rates [RR=1.38, 95% CI (1.11, 1.71), p=0.003] and ongoing [RR=1.73, 95% CI (1.29, 2.31), p<0.001] pregnancy rates. Rates of live birth and miscarriage did not significantly differ between the arms. Regarding side effects, acupuncture groups had a significantly higher rate of puncture site itching compared to control groups [RR=1.51, 95% CI (1.12, 2.04), p=0.007]. Overall analysis does not show a statistically significant increase in clinical pregnancy rates worldwide when using acupuncture as an adjunct therapy to IVF. There were no issues regarding patient safety from any included study. Subgroup results indicated that better rates for clinical pregnancy seem to be occurring more often in RCTs performed outside China than within.; Competing Interests: Conflict of Interest: No conflict of interest was declared by the authors. (©Copyright 2022 by Turkish Society of Obstetrics and Gynecology | Turkish Journal of Obstetrics and Gynecology published by Galenos Publishing House.)

Masoud, M., et al. (2022). "The effect of Flavonoids on Menorrhagia: A systematic Review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Massimo, C., et al. (2024). "Safety and efficacy of TVT-Abbrevo in the treatment of stress urinary incontinence. Comparison with other techniques and short and medium term outcomes of TVT-Abbrevo. A systematic review." PROSPERO International prospective register of systematic reviews.
	
Mateus, T., et al. (2023). "Exploring the Clinical Relevance of Maintenance Therapy after First-Line Chemotherapy in Ovarian Cancer: An Extracted Individual Patient Data and Trial-Level Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Mathew, S., et al. (2021). "The effect of preoperative pelvic floor muscle training on urinary and colorectal-anal distress in women undergoing pelvic organ prolapse surgery-a randomized controlled trial." International Urogynecology Journal 32(10): 2787-2794.
	INTRODUCTION AND HYPOTHESIS: Pelvic floor muscle training (PFMT) improves urinary incontinence and mild pelvic organ prolapse (POP). We aimed to investigate the effect of preoperative PFMT on urinary and colorectal-anal distress and related quality of life (QoL) in women with severe POP scheduled for surgery. METHODS: Randomized controlled trial of 159 women scheduled for POP surgery (intervention = 81, controls = 78). Intervention consisted of daily PFMT from inclusion to the day of surgery. Symptoms and QoL were assessed at inclusion, day of surgery and 6 months postoperatively using the Urinary Distress Inventory (UDI-6), Colorectal-Anal Distress Inventory (CRADI-8), Urinary Impact Questionnaire (UIQ) and Colorectal-Anal Impact Questionnaire (CRAIQ) (range 0-100). Mixed model statistical analyses were used. RESULTS: One hundred fifty-one (95%) women completed the study (intervention = 75, controls = 76). Mean waiting times until surgery and follow-up were 22 and 28 weeks. There was no difference in mean postoperative symptom and QoL scores (95% CI) between the intervention and control group: UDI-6 16 (12-21) vs. 17 (13-22), CRADI-8 15 (11-18) vs. 13 (10-16), UIQ 11 (7-15) vs. 10 (6-13) and CRAIQ 5 (2-7) vs. 6 (4-9), all p > 0.05. Overall mean scores were reduced from baseline to postoperative follow-up: UDI-6 37 (33-41) vs. 17 (14-20), CRADI-8 22 (19-25) vs. 14 (11-16); UIQ 28 (24-32) vs. 10 (7-13) and CRAIQ 16 (12-19) vs. 5 (3-7), all p < 0.01. CONCLUSIONS: We found no added effect of preoperative PFMT on symptoms or QoL related to urinary and colorectal-anal distress in women scheduled for POP surgery. They achieved symptomatic improvement postoperatively regardless of PFMT. CLINICAL TRIAL REGISTRATION: The study was registered in clinicaltrials.gov: NCT 03,064,750.

Mathias, N. and T. Christophe (2021). "Hormone therapy for endometrial cancer: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Mathilde, B., et al. (2021). "Does surgery for endometriosis impact reproductive outcomes in women who underwent IVF/ICSI?" PROSPERO International prospective register of systematic reviews.
	
matteo, p. and B. Alessandro (2023). "Robotic assisted versus laparoscopic surgery for deep endometriosis: a meta-analysis of current evidence." PROSPERO International prospective register of systematic reviews.
	
Matteson Kristen, A., et al. (2023). "A randomized trial comparing the 52-mg levonorgestrel system with combination oral contraceptives for treatment of heavy menstrual bleeding." American Journal of Obstetrics and Gynecology 229(5): 532.e531-532.e513.
	Background: The levonorgestrel intrauterine system and combined oral contraceptives are the 2 most commonly used nonsurgical treatments for heavy menstrual bleeding in the United States. However, there are limited data on their relative effectiveness and on their impact on bleeding-specific quality of life.; Objective: This study aimed to compare the effectiveness of the 52-mg levonorgestrel intrauterine system with that of combined oral contraceptives for improving quality of life among individuals who self-report heavy menstrual bleeding. We hypothesized that the levonorgestrel intrauterine system would be more effective than combined oral contraceptives at 6 and 12 months after treatment.; Study Design: We conducted a pragmatic randomized trial of individuals who self-reported heavy menstrual bleeding. Individuals were eligible if they did not have contraindications to either the levonorgestrel intrauterine system or combined oral contraceptives and were determined to have a nonstructural cause of heavy menstrual bleeding. Eligible and consenting participants were randomly assigned in a 1:1 ratio to receive a 52-mg levonorgestrel intrauterine system or a monophasic 30- or 35-μg ethinyl estradiol-containing combined oral contraceptive. The main outcome was mean change in bleeding-related quality of life, measured by the 20-question Menstrual Bleeding Questionnaire (score range, 0-75) at 6 and 12 months. Differences in group means and confidence intervals for the Menstrual Bleeding Questionnaire score were computed by multivariable linear mixed-effects regression; 24 participants per group were needed to detect a 10-point difference in change in mean Menstrual Bleeding Questionnaire score between individuals treated with the levonorgestrel intrauterine system and those treated with combined oral contraceptives at each follow-up time point.; Results: A total of 62 individuals were randomly assigned to treatment (n=29 allocated to levonorgestrel intrauterine system and n=33 allocated to combined oral contraceptives) and included in the intention-to-treat analyses; 19 of 29 received the levonorgestrel intrauterine system and 31 of 33 received combined oral contraceptives. Eleven percent identified as Black or African American and 44% identified as Hispanic or Latina. Participant characteristics were similar among study groups. Bleeding-related quality of life increased in both study arms, as reflected by a significant decrease in Menstrual Bleeding Questionnaire scores beginning at 6-week follow-up. In the main intention-to-treat analyses (n=62), there were no differences in mean change in Menstrual Bleeding Questionnaire scores at 6 months (difference=-2.5; 95% confidence interval, -10.0 to +5.0) or 12 months (difference=-1.1; 95% confidence interval, -8.7 to +6.5). Findings were similar in the subsets of participants with any follow-up visits (n=52) and who completed all follow-up visits (n=42). In the per-protocol analyses (n=47), a significantly greater decrease in Menstrual Bleeding Questionnaire score was observed in the levonorgestrel intrauterine system arm at 6 months after treatment (difference=-7.0; 95% confidence interval, -13.8 to -0.2) but not at 12 months (difference=-4.8; 95% confidence interval, -11.8 to 2.3) compared with the combined oral contraceptive arm.; Conclusion: No differences in change of bleeding-related quality of life were observed between the levonorgestrel intrauterine system and combined oral contraceptives at 6 or 12 months. Patients should be counseled that the levonorgestrel intrauterine system and combined oral contraceptives are both effective options for improving bleeding-related quality of life. (Copyright © 2023. Published by Elsevier Inc.)

Matthews, C. (2022). "INTIBIA Pivotal Study." ClinicalTrials.gov.
	All eligible subjects will be implanted with the INTIBIA device. Subjects will be randomized to either INTIBIA therapeutic or INTIBIA non‐therapeutic in a 2:1 ratio for the first 3 months of the study, at which point all subjects will receive therapeutic stimulation. Subjects will complete voiding diaries and questionnaires at Baseline and prior to each follow‐up visit, which will occur at Months 3, 6, 12, and 24. Subjects will be offered to keep the device or have it explanted at the end of the study.

Mauck, C., et al. (2022). "Single-Dose, Bioadhesive Clindamycin 2% Gel for Bacterial Vaginosis: A Randomized Controlled Trial." Obstetrics and Gynecology 139(6): 1092-1102.
	Objective: To assess efficacy and safety of a single-dose vaginal clindamycin gel for bacterial vaginosis treatment.; Methods: We conducted a double-blind, placebo-controlled, randomized study comparing clindamycin gel with placebo (2:1 ratio). Entry required clinical diagnosis of bacterial vaginosis, that is, all four Amsel's criteria, without other genital infections. Nugent scores of 7-10 were required for efficacy assessment, per updated 2019 U.S. Food and Drug Administration guidance. Patients were evaluated at screening, day 7-14, and day 21-30 (test of cure). Clinical cure was defined as resolution of three of four Amsel's criteria. Bacteriologic cure was defined as Nugent score lower than 4. Therapeutic cure was both clinical and bacteriologic cure. Primary outcome was clinical cure at the test-of-cure visit. Secondary endpoints were clinical cure at day 7-14, and bacteriologic and therapeutic cures at day 7-14 and test of cure. A sample size of 188 patients in the clindamycin group compared with 94 patients in the placebo group had 90% power to detect statistically significant difference (P=.05, 2-tailed).; Results: Participants were seen between July 9, 2020, and November 12, 2020. Of 307 randomized women, 56.0% were Black and 88.3% reported one or more previous bacterial vaginosis episodes. In the modified intention-to-treat population, 70.5% of patients in the clindamycin group and 35.6% in the placebo group achieved clinical cure at test of cure (primary outcome) (difference of 34.9, 95% CI 19.0-50.8), as did 77.5% of patients in the clindamycin group and 42.6% of patients in the placebo group in the per-protocol population (difference of 34.9, 95% CI 17.0-52.7). Statistically significant differences between groups were seen for all secondary endpoints. Clinical cure rate in patients in the clindamycin group with more than three bacterial vaginosis episodes in the prior year was 70.0%. Approximately 15% (15.3%) of patients in the clindamycin group experienced one or more treatment-emergent adverse events related to study treatment, as did 9.7% of patients in the placebo group. The most frequent treatment-related, treatment-emergent adverse event was vulvovaginal candidiasis.; Conclusion: A new, single-dose clindamycin vaginal gel was highly effective, with excellent safety, in women disproportionately affected by bacterial vaginosis, with Nugent scores of 7-10 at study entry.; Funding Source: The study was funded by Daré Bioscience, Inc.; Clinical Trials Registration: ClinicalTrials.gov, NCT04370548. (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Mayara, M. and H. Kathryn (2024). "Is an anti-inflammatory diet effective in improving the symptoms of women of reproductive age with polycystic ovaries syndrome?" PROSPERO International prospective register of systematic reviews.
	
McKendrick, K. (2021). "Does the removal of small submucous fibroids and endometrial polyps improve the chances of achieving a live birth in women with infertility or recurrent miscarriage?" International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Eligible participants will be randomised to one of two groups. One group will have their fibroids of polyps removed by a procedure called hysteroscopic resection. The second group will have their fibroids or polyps left alone. Patients in both groups will continue to receive planned fertility treatments (e.g. IVF, ovulation induction, IUI, Donor Sperm Insemination, ICSI or medications e.g. clomid). The Sheffield Clinical Trials Research Unit (CTRU) will oversee randomisation. Participants will be allocated on a ratio of 1:1 to either receive hysteroscopic resection of the abnormalities (intervention group) or not (control group). Stratified block randomisation will be used, stratified by recruiting centre and infertility or recurrent miscarriage. The randomisation schedule will be generated by the CTRU prior to the start of the study. The randomisation sequence will be computer‐generated. Block sizes will not be disclosed during the trial. CONDITION: Women with infertility or recurrent miscarriage and with a diagnosis of submucous fibroids and/or endometrial polyps ; Pregnancy and Childbirth ; Female infertility, polyp of endometrium, submucous leiomyoma of uterus PRIMARY OUTCOME: Live birth rate measured from participant records at 15 months post‐randomisation SECONDARY OUTCOME: ; 1. Live birth rate measured from participant records at 24 months post‐randomisation; 2. Time from randomisation to live birth measured from participant records at 15 and 24 months post‐randomisation; 3. Time from randomisation to pregnancy measured from participant records at 6, 15, and 24 months post‐randomisation; 4. Clinical pregnancy, miscarriage, and ectopic pregnancy rates measured from participant records at 6, 15, and 24 months post‐randomisation; 5. Incidence of premature labour, multiple births and still birth measured from participant records at 15 and 24 months post‐randomisation; 6. Detail of hysteroscopy received, including the number of hysteroscopic procedures received, duration of time post‐surgery abstaining from sexual intercourse, and type of resection performed, collected from participant records within two weeks post‐hysteroscopy; 7. Patient satisfaction measured using a bespoke questionnaire at 6, 15, and 24 months post‐randomisation; 7. Details of fertility treatments received, including details of medications received, collected from participant records at 6, 15, and 24 months post‐randomisation; 8. Details of correct diagnosis/absence of abnormalities at surgery are collected from participant records within two weeks post‐hysteroscopy; 9. Type of submucous fibroid (type 0, 1, or 2) collected from participant records within two weeks post‐hysteroscopy; 10. Number of participants in the control arm who undergo resection collected from participant records at 6, 15, and 24 months post‐randomisation; INCLUSION CRITERIA: 1. History of primary or secondary infertility. Defined as being: 1.1. Of reproductive age who has not conceived after 1 year of unprotected vaginal sexual intercourse, in the absence of any known cause of infertility 1.2. Of reproductive age who is using artificial insemination to conceive (with either partner or donor sperm) who has not conceived after 6 cycles of treatment, in the absence of any known cause of infertility) 1.3. Recurrent miscarriage (defined as the loss of two or more pregnancies before 24 weeks gestation). 2. Diagnosed endometrial polyp or submucosal fibroid =3 cm in size

McLean, L., et al. (2022). "Pelvic floor muscle training as an adjunct to a midurethral sling: a single-blind randomised controlled trial." International Urogynecology Journal 33(4): 809-819.
	Introduction and hypothesis: This single-blind, randomised controlled trial was aimed at determining whether peri-operative physiotherapist-supervised pelvic floor muscle (PFM) training was superior to standard care (handout) in terms of improvements in stress urinary incontinence (SUI) symptoms, cure rate, and/or post-operative filling or voiding symptoms among women undergoing surgical mid-urethral sling (MUS) insertion for SUI. Method(s): Women with SUI were recruited from surgical wait lists at four participating urogynecology clinics. Participants were assessed at baseline (V1) then randomised (1:1 allocation) to receive supervised PFM training or a handout. Immediately following the 12-week intervention period (V2) and at 12 weeks following surgery (V3) the groups were compared based on the Female Lower Urinary Tract Symptoms (FLUTS) questionnaire total score and urinary incontinence, filling, and voiding subscale scores as well as on a standardised 30-min pad test administered by a blinded assessor. Intention-to-treat analyses were performed. Result(s): A total of 52 participants were randomised to physiotherapy and 51 to the control group between December 2012 and August 2016. The groups were not different on any outcomes at V1 and all were improved at V3 compared with V1 (p < 0.001). At V3 the physiotherapy group reported significantly fewer UI symptoms (FLUTS UI subscale score) than the control group; yet, there were no group differences in FLUTS overall score or the pad test (p > 0.05). Based on a FLUTS UI subscale score <4, the cure rate at V3 was higher in the intervention group (73%) than in the control group (47%); (2.36 < OR < 3.47, p = 0.012). There were no group differences in cure rate at V3 based on a pad test (p = 0.27). No group differences were found in the filling or voiding symptoms at V3 (p > 0.05). No adverse events were reported. Conclusion(s): Physiotherapist-supervised PFM training improves SUI cure rates associated with surgical MUS insertion when considering symptoms of SUI, but does not improve post-operative continence function as measured by a pad test, nor does it lead to fewer post-operative voiding or filling symptoms.Copyright © 2021, Crown.

McLindon Lucas, A., et al. (2023). "Progesterone for women with threatened miscarriage (STOP trial): a placebo-controlled randomized clinical trial." Human Reproduction 38(4): 560-568.
	Study Question: In women with threatened miscarriage, does progesterone supplementation until the completion of the first trimester of pregnancy increase the probability of live birth?; Summary Answer: In women with threatened miscarriage, 400 mg vaginal progesterone nightly, from onset of bleeding until 12 weeks, did not increase live birth rates.; What Is Known Already: Limited evidence has indicated that vaginal micronized progesterone may make little or no difference to the live birth rate when compared with placebo in women with threatened miscarriage. Subgroup analysis of one recent randomized trial reported that in women with bleeding and at least one previous miscarriage, progesterone might be of benefit.; Study Design, Size, Duration: We performed a randomized, double-blinded, placebo-controlled trial between February 2012 and April 2019. Eligible pregnant women under 10 weeks gestation, experiencing a threatened miscarriage as apparent from vaginal bleeding were randomized into two groups in a 1:1 ratio: the intervention group received 400 mg progesterone as vaginal pessaries, the control group received placebo vaginal pessaries, both until 12 weeks gestation. The primary endpoint was live birth. We planned to randomize 386 women (193 per group). The study was stopped at a planned interim analysis for futility after randomization of 278 women.; Participants/materials, Setting, Methods: This trial was conducted at the Mater Mothers' Hospital, a tertiary centre for maternity care in South Brisbane, Queensland, Australia. We randomized 139 women to the intervention group and 139 women to the placebo group. Primary outcome data were available for 136 women in the intervention group and 133 women in the placebo group.; Main Results and the Role of Chance: The live birth rates were 82.4% (112/136) and 84.2% (112/133) in the intervention group and placebo group, respectively (risk ratio (RR) 0.98, 95% CI 0.88 to 1.09; risk difference -0.02, 95% CI -0.11 to 0.07; P = 0.683). Among women with at least one previous miscarriage, live birth rates were 80.6% (54/67) and 84.4% (65/77) (RR 0.95, 95% CI 0.82-1.11; P = 0.550). No significant effect was seen from progesterone in women with two (RR 1.28, 95% CI 0.96-1.72; P = 0.096) or more (RR 0.79, 95% CI 0.53-1.19; P = 0.267) previous miscarriages. Preterm birth rates were 12.9% and 9.3%, respectively (RR 1.38; 95% CI 0.69 to 2.78; P = 0.361). Median birth weight was 3310 vs 3300 g (P = 0.992). There were also no other significant differences in obstetric and perinatal outcomes.; Limitations, Reasons for Caution: Our study was single centre and did not reach the planned sample size because it was stopped prematurely at an interim analysis.; Wider Implications of the Findings: We did not find evidence supporting the treatment effect of vaginal progesterone in women with threatened miscarriage. Progesterone in this setting should not be routinely used for threatened miscarriage. The treatment effect in women with threatened miscarriage after previous miscarriages warrants further research.; Study Funding/competing Interest(s): Mothers' and babies Golden Casket Clinical Fellowship (L.A.M.). Progesterone and placebo pessaries were provided by Perrigo Australia.B.W.J.M. reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck KGaA, personal fees from Guerbet, personal fees from iGenomix, outside the submitted work.; Trial Registration Number: ACTRN12611000405910.; Trial Registration Date: 19 April 2011.; Date of First Patient’s Enrolment: 06 February 2012. (© 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.)

Mechsner, S., et al. (2023). "Transcranial direct current stimulation to reduce chronic pelvic pain in endometriosis: phase II randomized controlled clinical trial." Pain Medicine 24(7): 809-817.
	Background: It is known that various chronic pain conditions lead to maladaptive changes in the central nervous system. Endometriosis is frequently associated with chronic pelvic pain (CPP). Its sufficient treatment remains a clinical challenge. Transcranial direct current stimulation (tDCS) has been shown to be a powerful method to reduce chronic pain. Therefore, this study aimed to investigate pain reduction via anodal tDCS in patients with endometriosis and CPP.; Methods: This clinical phase II, placebo-controlled, randomized, parallel-design study included 36 patients with endometriosis and CPP. All patients had CPP, defined as a score of ≥3/10 on the visual analog scale for ≥3 months in the prior 6 months. Anodal or placebo tDCS (18 patients per arm) was applied over the primary motor cortex for 10 days. The primary outcome measure was the pressure pain threshold (objective pain measure), and secondary outcomes were the numerical rating scale score (subjective pain measure), Von Frey monofilaments, and disease- and pain-related questionnaires. Data were collected at baseline, after the 10-day stimulation, and at a follow-up session, which took place 1 week after the tDCS had ended. Statistical analyses were performed with analyses of variance and t tests.; Results: Significant decreased pain perception in both pain measurements (pressure pain threshold and numerical rating scale score) was found for the active tDCS group compared with the placebo group. This proof-of-concept study shows that tDCS is a helpful supporting pain therapy for patients with endometriosis and CPP. Moreover, further analyses revealed that 1 week after the stimulation had ended, pain reduction as indexed by pressure pain threshold remained significantly decreased, which indicates possible long-term analgesic effects.; Conclusion: The present study provides evidence that tDCS is an effective therapy for pain reduction in endometriosis-associated CPP. The results support the notion that CPP is developed and maintained in the central nervous system, making a multimodal pain therapy necessary.; Trial Registration: www.ClinicalTrials.gov ID: NCT05231239. (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Medeiros Lidia, R., et al. (2023). "Anti-Müllerian Hormone levels after metformin treatment in polycystic ovary syndrome: A systematic review and meta-analysis." Obesity Research & Clinical Practice 17(4): 288-297.
	This systematic review and meta-analysis aim to evaluate whether treatment with metformin would reduce Anti-Müllerian Hormone levels in patients with polycystic ovary syndrome. A search was performed in Medline, Embase, Web of Science, and Cochrane Library databases and grey literature (Google Scholar). The following keywords were used in the search strategy: "Polycystic Ovary Syndrome", "Anti-Mullerian Hormone", "Metformin". The search was limited to human studies, with no language restriction. 328 studies were found, 45 studies were selected for full-text reading and 16 of those studies, six randomized controlled trial and 10 non-randomized studies were included. The synthesis of randomized controlled trials, metformin showed a reduction in serum levels of Anti-Müllerian Hormone compared to control groups (SMD - 0.53, 95 %CI - 0.84 to - 0.22, p < 0.001, I 2 = 0 %, four studies, 171 participants, high quality of evidence). Six non-randomized studies evaluated data before and after the metformin intervention. The synthesis showed that using metformin reduced serum Anti-Müllerian Hormone values (SMD - 0.79, 95 %CI - 1.03 to - 0.56, p < 0.001, I 2 = 0 %, six studies, 299 participants, low quality of evidence). Metformin administration in women with polycystic ovary syndrome is associated significantly with reduced Anti-Müllerian Hormone serum levels.; Competing Interests: Declaration of Competing Interest No conflict of interest. (Copyright © 2023 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.)

Medical University of, G. (2022). "Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain." ClinicalTrials.gov.
	Background: Vulvodynia and chronic pelvic pain (CPP) are common and challenging gynecologic pain syndromes. A multidisciplinary approach is recommended. Study aim: To study the effectiveness of acupuncture as part of a multimodal treatment for women with vulvodynia and CPP. Design: Randomised controlled clinical study Study Population: Recruitment from a University outpatient clinic Study groups: Participants will be randomised (1:1) ‐ Acupuncture group ‐ Waiting list control group Sample size: 68 patients Study outcome ‐ Subjective Pain Perception (VAS) ‐ Health‐related quality of life (questionnaires)

Medipol, U. (2022). "Effect of Red Clover on Menopause Symptoms and Lipid Profile." ClinicalTrials.gov.
	No Results Available Dietary Supplement: red clover The primary outcome measures were to assess the differences in MRS scores (somatic, psychological, urogenital and total score) and lipid profile (total cholesterol, LDL-C, HDL-C and triglyceride levels). Female Not Applicable 82 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Supportive Care redclover* September 20, 2023

Meenakshi, M., et al. (2021). "Role of autologous platelet-rich plasma in recurrent implantation failure – protocol for systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Mehmet Akif Ersoy, U. (2021). "The Effect Of Reiki And Massage With Sage Oil On Primary Dysmenorrhea." ClinicalTrials.gov.
	No Results Available Other: Sage oil group|Behavioral: Reiki group Individual Introductory Information Form|VAS pain scores|Body Mass Index All Not Applicable 90 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment MAKU-BSYO-NB-01 July 10, 2021

Mei, J. (2023). "Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer." ClinicalTrials.gov.
	This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.

Mei, Y., et al. (2023). "Does endometrial receptivity array improve reproductive outcomes in euploid embryo transfer cycles? a systematic review." Frontiers in Endocrinology 14: 1251699.
	Besides chromosomal normality, endometrial receptivity is an important factor in determining successful pregnancies. Endometrial receptivity array (ERA), a promising endometrial receptivity test, was speculated to improve the reproductive outcomes. However, its effectiveness is controversial in clinical practice. Therefore, we conducted this review to investigate its role in in vitro fertilization (IVF) treatment. To eliminate the interference of embryo quality, we only analyzed studies that originally reported the reproductive outcomes of patients who underwent ERA-guided euploid embryo transfer (EET). Unexpectedly, it revealed that ERA could not optimize the reproductive outcomes in EET cycles, no matter in general infertile population or in patients with a history of previous failed embryo transfers.; 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 Mei, Wang, Ke, Liang, Lin and Wang.)

Meina, Y., et al. (2024). "Effects of nutrients supplementation on ovulation and pregnancy in women with polycystic ovary syndrome: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Meister Melanie, R., et al. (2021). "Effectiveness of Botulinum Toxin for Treatment of Symptomatic Pelvic Floor Myofascial Pain in Women: A Systematic Review and Meta-analysis." Female Pelvic Medicine & Reconstructive Surgery 27(1): e152-e160.
	Objectives: The aims of the study were to systematically review the literature and to synthesize the evidence for the effectiveness of botulinum toxin injection to the pelvic floor muscles for treating pelvic floor myofascial pain in female patients.; Methods: This systematic literature search was performed in February 2018 and updated in September 2019. Articles were screened based on predefined criteria: (1) adult population, (2) female patients, (3) treatment of pelvic pain by transvaginal botulinum toxin injection into the pelvic floor, (4) published in English or English translation available, (5) study design including randomized controlled trials, cohort studies, and case series with more than 10 participants, and (6) quantitative report of pain scores. Nine studies were included in the primary analysis, and an unpublished study was included in a sensitivity analysis. A random effects model with robust variance estimation was used to estimate the pooled mean difference in patient-reported pain scores after botulinum toxin injection.; Results: A statistically significant reduction in patient-reported pain scores was noted at 6 weeks after botulinum toxin injection (mean difference, 20.3; 95% confidence interval, 11.7-28.9) and continued past 12 weeks (mean difference, 19.4; 95% confidence interval, 14.6-24.2). Significant improvement was noted in secondary outcomes including dyspareunia, dyschezia, and quality of life.; Conclusions: This systematic review and meta-analysis support the conduct of future, large-scale randomized controlled trials to determine the efficacy and optimize administration of botulinum toxin injections for treatment of pelvic floor myofascial pain and associated symptoms in women.; Competing Interests: The authors have declared they have no conflicts of interest. (Copyright © 2020 American Urogynecologic Society. All rights reserved.)

Meixue, Z. and X. Wei (2023). "Efficacy and Safety of Sophora Flavescens on Bacterial Vaginosis: A Systematic Review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Mejlhede Maria Alekseevna, B., et al. (2021). "Oral melatonin supplementation during in vitro fertilization treatment: a systematic PRISMA review and meta-analysis of randomized controlled trials." Gynecological Endocrinology 37(12): 1079-1085.
	Objective: High levels of reactive oxygen species (ROS) have been suspected of reducing the success rate of assisted reproductive technology (ART). Melatonin has anti-oxidative properties and could therefore be of interest as a supplement in in vitro -fertilization (IVF) protocols. The objective of this study was to evaluate if a melatonin supplementation given in vivo to women undergoing IVF-treatment can improve the outcome.; Methods: A systematic literature search was performed on PubMed, Embase and Cochrane. The methodological quality of the included studies was assessed using the version 2 of the Cochrane risk-of-bias tool (RoB2). Primary outcome was clinical pregnancy rate (CPR). Secondary outcomes were total number of oocytes, number of mature oocytes, embryo quality, biochemical pregnancy rate, miscarriage rate and live birth rate (LBR).; Results: Seven randomized controlled trials (RCT) were included. The meta-analysis demonstrated a significantly higher mature oocyte count when melatonin was used (Mean Diff. = 1,82; 95% CI 0.37-3.27; p = .01). All seven studies showed a trend for increase in CPR, although not significant. No other measured outcomes showed a significant improvement. Two studies had 'low risk', three 'some concerns' and two studies had 'high risk' of bias.; Conclusion: This meta-analysis including RCT indicates that an oral melatonin supplement during IVF-treatment can increase the number of mature oocytes, and a trend for increase CPR, albeit not significant. Most of the included studies were small. The methodological quality in three of the seven studies was moderate and two were low. Further investigations are needed to support the positive findings.

Mekinian, A. (2023). "Certolizumab in Recurrent Implantation Failure (RIF)." ClinicalTrials.gov.
	The European Society of Human Reproduction and Embryology (ESHRE) consortium has proposed to define recurrent implantation failure (RIF) as the failure to obtain a clinical pregnancy after the transfer of three good‐quality embryos according to the Istanbul consensus 2011. Although its prevalence is difficult to estimate, RIF could concern up to 40% of couples undergoing assisted reproductive technology (ART) treatments. More than 50% of RIF cases remain unexplained after extensive exploration and clinical pregnancy rate in this population is particularly low, estimated at about 15%. Endometrial environment plays a crucial role in embryo implantation and early placental development. In normal pregnancy, the survival of the semi‐allogeneic fetus is dependent on the induction of maternal immune tolerance, with regulatory T cells and Th‐2 anti‐inflammatory profile. Several studies show a misbalance of immune cells and cytokines expression in women with implantation failure. Most studies analyze immune cells and cytokines profile in peripheral blood, with few data on cells and cytokines profiles in endometrial tissues during the periimplantation period. However, the immune endometrial balance could be disturbed in up to 80% of RIF cases. Tumor Necrosis Factor (TNF) α, together with other pro‐inflammatory cytokines, participates in the regulation of the immune balance of the endometrium. TNF‐α and TNF‐α / interleukin (IL)‐10 ratio are increased in the endometrium of RIF patients, which suggests they could be involved in physiopathology of RIF. To date there is no effective treatment to improve the low clinical pregnancy rate in unexplained RIF. The repeated failure of embryo transfers and the lack of efficient treatment are associated with psychological distress in infertile couples and raises economic problems because of the important cost of in vitro fertilisation (IVF). Some treatments with immunomodulatory effect, such as steroids, were previously evaluated. However, studies were small and included heterogeneous populations, resulting in inconclusive results. Our hypothesis is that TNF‐α antagonists may be particularly useful by blocking TNF‐α induced excessive immune‐response. In a pilot placebo controlled study, TNF‐α antagonists were associated with 56% live births versus 13% in controls, in 13 women with unexplained implantation failure. However, this treatment was not further evaluated in this indication because of the lack of tolerance data and the fear of congenital abnormalities. Concerning the safety of TNF‐α antagonists, we now have sufficient data as they are widely used since more than 15 years in several autoimmune and inflammatory diseases. More than 1200 women treated with TNF‐α antagonists for an inflammatory disease have provided evidence of their safety in early pregnancy and the French national center of drug‐related effects (www.lecrat.org) allows the use of TNF‐α antagonists during pregnancy, except during the third trimester. Among TNF‐α antagonists, certolizumab have the particularity not to cross the placental barrier and thus can be used during pregnancy, This is why we focus on this particular drug for this trial.

Melanie, M., et al. (2022). "Effectiveness of non-pharmacological, conservative therapies for persistent pelvic pain in women: a systematic review." PROSPERO International prospective register of systematic reviews.
	Review question [1 change] What is the effectiveness of conservative therapies for women with persistent (also called chronic) pelvic pain, i.e. pain in the pelvic and/or perineal region, in comparison with no treatment, placebo, active treatment (surgical, pharmacological, or ingestible compounds), or treatment as usual control? Searches The following bibliographic databases will be searched from inception: Amed, CINAHL, PsyINFO, Sportdiscuss, MEDLINE, Embase and Cochrane Central Register of Controlled Trials. We will not apply any language restrictions to the search. We will identify additional studies from the reference lists and citations searches of retrieved papers. We will also search online trial registries including ClinicalTrials.gov (www.ClinicalTrials.gov) and World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) (http://apps.who.int/trialsearch/). We will search the reference list of recovered reviews and selected papers for further additional randomised clinical trials. Types of study to be included [1 change] We will include randomised clinical trials investigating conservative therapies for persistent pelvic pain in women. We will include studies that meet the following criteria: • are available as a full publication of a randomised clinical trial; • have a design that investigated a conservative therapy as an active treatment of primary interest; • are published (or electronically pre-published) in a peer-reviewed scientific journal; and • include participants reporting persistent pelvic pain, meeting our pre-specified inclusion criteria Condition or domain being studied [1 change] Persistent pelvic pain has been defined by the European Association of Urology as chronic or persistent pain perceived in structures related to the pelvis (Engeler et al. 2022). It is often associated with negative cognitive, behavioural, sexual and emotional consequences as well as with symptoms suggestive of lower urinary tract, sexual, bowel, pelvic floor or gynaecological dysfunction (Engeler et al. 2022). For the purpose of this review, we will focus on persistent pelvic pain in the pelvic and/or perineal region in women, of at least 3 months duration (or defined as “chronic” by authors), where the pain is not related to defined pathology or known disease (e.g. endometriosis, infection, cancer). Participants/population [1 change] We will include studies in adult women with persistent pelvic pain in the pelvic and/or perineal region (e.g., including but not limited to vulvodynia and bladder pain syndrome), reporting persistent pain of at least three months’ duration (or reported as “chronic”), where the pain is not related to defined pathology or known disease (e.g., endometriosis, cancer, infection). Studies involving women with persistent pelvic pain and co-occurrence of other common overlapping pain conditions will be included as long as persistent pelvic pain described above is investigated as a primary complaint or main focus of the study. By these pre-specified inclusion criteria, our review will exclude studies investigating the following conditions as their primary inclusion criteria: • Pelvic girdle pain (as this condition is distinct from pelvic pain investigated in this review) • Endometriosis (as the pain may be related to this underlying pathology/disease) • Genitourinary syndrome of menopause (as the pain may be a symptom of underlying pathology) • Irritable bowel syndrome (as this is defined as primarily an abdominal pain condition and pelvic pain may not be present) • Hunner-type Interstitial Cystitis/Bladder Pain Syndrome (as this condition is clinically and pathologically different from other types of IC/BPS). Therefore, studies will be excluded if the authors will state that more than 25% of the group had positive cystoscopy findings (i.e., confirmed Hunner’s lesions) Intervention(s), exposure(s) [1 change] We will include studies if at least one trial arm consists of conservative intervention (excluding pharmacological or ingestible compounds) applied with the intention to affect pelvic pain. If the conservative intervention is combined with another active treatment (e.g., surgical, pharmacological, or ingestible compounds), then we will include studies if this treatment is applied equally to both arms, e.g., physiotherapy + pharmacotherapy versus pharmacotherapy; or physiotherapy + surgery versus surgery. Conservative therapies that are of interest to this review may include (but are not limited to): 1- Education, exercise, manual therapies and psychological interventions e.g., - Pain management, education, relaxation; - General exercise; - Pelvic floor muscle-specific exercise; - Manual therapies: touch de-sensitisation, visceral mobilisation, trigger point therapy, myofascial releases; - Multimodal physiotherapy; - Psychotherapy. 2- Devices and tools, e.g.: - Intra-vaginal dilator; - Wand (e.g., intra-anal or intra-vaginal); - Intra-vaginal cone. 3- Electrotherapies and other physical agents e.g.: - Electrical stimulation (e.g. TENS); - Laser; - Magnetic stimulation; - Therapeutic ultrasound; - Thermal modality (cold, heat). 4- Dry needling / acupuncture Comparator(s)/control [1 change] We will include studies that compared a conservative intervention with at least one comparator arm of a placebo condition, treatment as usual or waiting list control or other active treatment (pharmacological, surgical, ingestible compound). Context Any clinical or research settings and any geographical setting will be considered for inclusion. Main outcome(s) [1 change] Studies reporting at least one of the following outcomes of benefit or harm will be included. Pain outcomes: • Pain severity: pain intensity, pain-related distress, pain related interference (e.g., Visual Analogue Scale, Numeric Rating Scale) • Temporal characteristics of pain • Pain quality Sexual measures: • E.g., sexual function, sexual satisfaction, sexual distress, sexual function interference Physical function: • Bladder, bowel function • Specific measures related to the effects of the pain on physical/other function Health related quality of life Pelvic symptom severity and/or bother Pelvic floor muscle function (e.g., tone/tension/stiffness, contractility, relaxation ability) and morphometry Psychological function Perceived improvement (e.g., Patient global impression of change) Adverse events Additional outcome(s) None Data extraction (selection and coding) Two review authors will independently determine eligibility by reading the abstract of each study identified by the search. Two review authors will independently read these studies that meet the inclusion criteria to select relevant studies and, in the event of disagreement, a third author will adjudicate. Two review authors will independently extract data using a standard form and check for agreement before entry into a customised data extraction form. In the event of disagreement, a third author will adjudicate. The following information will be extracted: design of the study, participants’ characteristics, primary diagnosis, intervention details, outcome measures used, and detailed results of the studies. Data will be collected first by one reviewer and the accuracy of information will be checked by another reviewer. If necessary, authors of the randomised clinical trial will be contacted via email to provide further information / data. Risk of bias (quality) assessment Two authors will independently assess risk of bias following the recommended Physiotherapy Evidence Database (PEDro) scale. Strategy for data synthesis Effect sizes expressed as weighted mean difference or standardized mean difference for continuous data or odds ratio for dichotomous data and their 95% confidence intervals will be calculated for analysis (if possible). The heterogeneity or homogeneity of the studies will be analysed and discussed, and a meta-analysis will be performed (if possible) for clinically and statistically homogenous data that include similar participants, interventions and outcomes. Minimum of 5 studies will be required to attempt meta-analysis. Quality of evidence will be assessed using GRADE. Analysis of subgroups or subsets None planned. Contact details for further information Mélanie Morin Melanie.m.morin@usherbrooke.ca Organisational affiliation of the review University of Sherbrooke Centre of Postgraduate Medical Education in Warsaw Norwegian School of Sport Sciences and Akershus University Hospital The University of Melbourne, Royal Women’s Hospital and Mercy Hospital for Women www.usherbrooke.ca https://www.cmkp.edu.pl https://www.nih.no/ https://www.ahus.no/akershus-university-hospital www.unimelb.edu.au https://www.thewomens.org.au/ https://health-services.mercyhealth.com.au/our-health-services/mercy-hospital-women/ Review team members and their organisational affiliations Dr Melanie Morin. University of Sherbrooke Dr Małgorzata Starzec-Proserpio. Centre of Postgraduate Medical Education, Warsaw; University of Sherbrooke Dr Kari Bø. Norwegian School of Sport Sciences, Oslo; Akershus University Hospital, Lorenskog Dr Helena Frawley. The University of Melbourne; Allied Health Research, Royal Women’s Hospital and Mercy Hospital for Women, Melbourne Type and method of review Meta-analysis, Systematic review Anticipated or actual start date 15 December 2022 Anticipated completion date [1 change] 30 November 2023 Funding sources/sponsors Self-funded Conflicts of interest Language English Country Australia, Canada, Norway, Poland Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Chronic Pain; Conservative Treatment; Female; Humans; Manipulation, Osteopathic; Pelvic Pain; Pelvis Date of registration in PROSPERO 26 December 2022 Date of first submission 15 December 2022

Melin, J., et al. (2023). "Metformin and combined oral contraceptive pills in the management of polycystic ovary syndrome: a systematic review and meta-analysis." The Journal of Clinical Endocrinology and Metabolism.
	CONTEXT: Polycystic ovary syndrome (PCOS) is affecting more than every tenth woman. OBJECTIVE: As part of the 2023 International PCOS Guidelines update, comparisons between combined oral contraceptive pills (COCP), metformin and combination treatment were evaluated. DATA SOURCES: Ovid Medline, Embase, PsycINFO, All EBM and CINAHL were searched. STUDY SELECTION: Women with PCOS included in randomized controlled trials (RCT). DATA EXTRACTION: We calculated mean differences (MD) and 95% confidence intervals (CI) regarding anthropometrics, metabolic and hyperandrogenic outcomes. Meta-analyses and quality assessment using GRADE was performed. DATA SYNTHESIS: The search identified 1660 publications, 36 RCTs were included. For hirsutism no differences were seen when comparing metformin versus COCP, nor when comparing COCP versus combination treatment with metformin and COCP. Metformin was inferior on free androgen index (FAI) (7.08, 95% CI 4.81; 9.36), sex hormone binding globulin (SHBG) (-118.61 nmol/l, 95% CI -174.46; -62.75) and testosterone (0.48 nmol/l,95% CI 0.32; 0.64) compared with COCP. COCP was inferior for FAI (0.58, 95% CI 0.36; 0.80) and SHBG (-16.61 nmol/L, 95% CI -28.51; -4.71) compared with combination treatment, whereas testosterone did not differ. Metformin lowered insulin (-27.12 pmol/l, 95%CI -40.65; -13.59) and triglycerides (-0.15 mmol/l, 95%CI -0.29; -0.01) compared with COCP. COCP was inferior for insulin (17.03 pmol/l, 95%CI 7.79; 26.26) and insulin resistance (0.44, 95%CI 0.17; 0.70) compared with combination treatment. CONCLUSIONS: The choice of metformin or COCP treatment should be based on symptoms, noting that there are some biochemical benefits from combination treatment, targeting both major endocrine disturbances seen in PCOS; hyperinsulinemia and hyperandrogenism.

Melin, J., et al. (2023). "The impact of metformin with or without lifestyle modification versus placebo on polycystic ovary syndrome: a systematic review and meta-analysis of randomized controlled trials." European Journal of Endocrinology 189(2): S37-S63.
	Objective: Available evidence has shown that metformin improves insulin sensitivity and weight management in polycystic ovary syndrome (PCOS). Nevertheless, key knowledge gaps remain regarding its efficacy and the specific outcomes in this population. This review evaluates the effectiveness of metformin and lifestyle modification compared with placebo in the management of PCOS and will inform the forthcoming, 2023 evidence-based PCOS guidelines.; Design: Systematic review and meta-analysis of the literature.; Methods: A search was performed in MEDLINE, EMBASE, PsycINFO, All EBM, and CINAHL. The review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines and included randomized controlled trials published in English through July 2022.; Results: Moderate certainty of evidence showed a larger reduction of body mass index (BMI) (mean difference [MD] -0.53, 95% confidence interval [CI] -0.95 to -0.12 kg/m2), homeostatic model assessment for insulin resistance (MD -0.50, 95% CI -0.91 to -0.09) (critical outcomes), and fasting glucose (MD -0.13, 95% CI -0.19 to -0.07 mmol/L) with metformin compared to placebo with increased mild gastrointestinal adverse effects (odds ratio [OR] 7.67, 95% CI 2.74-21.46). Low certainty of evidence showed a larger reduction of waist-hip ratio (MD -0.02, 95% CI -0.03 to -0.00), total cholesterol (MD -0.24, 95% CI -0.43 to -0.05 mmol/L), low-density lipoprotein (MD -0.16, 95% CI -0.30 to -0.01 mmol/L), and triglycerides (MD -0.11, 95% CI -0.20 to -0.02 mmol/L) with metformin than placebo.; Conclusions: Metformin should be considered an efficacious adjunct to lifestyle interventions in adults with PCOS, especially for those with a higher BMI, to improve weight loss, insulin resistance, and lipids.; Competing Interests: Conflict of interest: J.M. reports a postdoc research grant from Orion Research Foundation. D.R. reports an honorarium from Novo Nordisk for a lecture on PCOS and obesity. T.P. is on the editorial board of the European Journal of Endocrinology but was not involved in the review or editorial process of this paper. The other authors have no conflicts to declare. (© The Author(s) 2023. Published by Oxford University Press on behalf of European Society of Endocrinology.)

Melin, J. M., et al. (2024). "Effects of different insulin sensitisers in the management of polycystic ovary syndrome: A systematic review and meta-analysis." Clinical Endocrinology 100(2): 149-163.
	Objective: Characteristic features of polycystic ovary syndrome (PCOS) include insulin resistance and an increased risk for type 2 diabetes. To promote improved insulin sensitivity, insulin sensitisers have been used in PCOS. However, direct comparisons across these agents are limited. This study compared the effects of metformin, rosiglitazone and pioglitazone in the management of PCOS to inform the 2023 International Evidence-based PCOS Guideline. Design(s): Systematic review and meta-analysis of the literature. Patient(s): Women with PCOS and treatment with insulin sensitisers. Measurements: Hormonal and clinical outcomes, as well as side effects. Result(s): Of 1660 publications identified, 13 randomised controlled trials were included. Metformin was superior in lowering weight (mean difference [MD]: -4.39, 95% confidence interval [CI]: -7.69 to -1.08 kg), body mass index (MD: -0.95, 95% CI: -1.41 to -0.49 kg/m2) and testosterone (MD: -0.10, 95% CI: -0.18 to -0.03 nmol/L) versus rosiglitazone, whereas there was no difference when comparing metformin to pioglitazone. Adding rosiglitazone or pioglitazone to metformin did not improve metabolic outcomes. However, rosiglitazone seemed superior to metformin in lowering lipid concentrations. Conclusion(s): Metformin should remain the first-line insulin sensitising treatment in adults with PCOS for the prevention and management of weight and metabolic features. The addition of thiazolidinediones appears to offer little benefit.Copyright © 2023 John Wiley & Sons Ltd.

Melo, P., et al. (2020). "Surgical treatment for tubal disease in women due to undergo in vitro fertilisation." The Cochrane Database of Systematic Reviews 10: CD002125.
	Background: Tubal disease accounts for 20% of infertility cases. Hydrosalpinx, caused by distal tubal occlusion leading to fluid accumulation in the tube(s), is a particularly severe form of tubal disease negatively affecting the outcomes of assisted reproductive technology (ART). It is thought that tubal surgery may improve the outcome of ART in women with hydrosalpinges.; Objectives: To assess the effectiveness and safety of tubal surgery in women with hydrosalpinges prior to undergoing conventional in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).; Search Methods: We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, DARE, and two trial registers on 8 January 2020, together with reference checking and contact with study authors and experts in the field to identify additional trials.; Selection Criteria: Randomised controlled trials (RCTs) comparing surgical treatment versus no surgical treatment, or comparing surgical interventions head-to-head, in women with tubal disease prior to undergoing IVF.; Data Collection and Analysis: We used Cochrane's standard methodological procedures. The primary outcomes were live birth rate (LBR) and surgical complication rate per woman randomised. Secondary outcomes included clinical, multiple and ectopic pregnancy rates, miscarriage rates and mean numbers of oocytes retrieved and of embryos obtained.; Main Results: We included 11 parallel-design RCTs, involving a total of 1386 participants. The included trials compared different types of tubal surgery (salpingectomy, tubal occlusion or transvaginal aspiration of hydrosalpingeal fluid) to no tubal surgery, or individual interventions to one another. We assessed no studies as being at low risk of bias across all domains, with the main limitations being lack of blinding, wide confidence intervals and low event and sample sizes. We used GRADE methodology to rate the quality of the evidence. Apart from one moderate-quality result in one review comparison, the evidence provided by these 11 trials ranged between very low- to low-quality. Salpingectomy versus no tubal surgery No included study reported on LBR for this comparison. We are uncertain of the effect of salpingectomy on surgical complications such as the rate of conversion to laparotomy (Peto odds ratio (OR) 5.80, 95% confidence interval (CI) 0.11 to 303.69; one RCT; n = 204; very low-quality evidence) and pelvic infection (Peto OR 5.80, 95% CI 0.11 to 303.69; one RCT; n = 204; very low-quality evidence). Salpingectomy probably increases clinical pregnancy rate (CPR) versus no surgery (risk ratio (RR) 2.02, 95% CI 1.44 to 2.82; four RCTs; n = 455; I 2 = 42.5%; moderate-quality evidence). This suggests that in women with a CPR of approximately 19% without tubal surgery, the rate with salpingectomy lies between 27% and 52%. Proximal tubal occlusion versus no surgery No study reported on LBR and surgical complication rate for this comparison. Tubal occlusion may increase CPR compared to no tubal surgery (RR 3.21, 95% CI 1.72 to 5.99; two RCTs; n = 209; I 2 = 0%; low-quality evidence). This suggests that with a CPR of approximately 12% without tubal surgery, the rate with tubal occlusion lies between 21% and 74%. Transvaginal aspiration of hydrosalpingeal fluid versus no surgery No study reported on LBR for this comparison, and there was insufficient evidence to identify a difference in surgical complication rate between groups (Peto OR not estimable; one RCT; n = 176). We are uncertain whether transvaginal aspiration of hydrosalpingeal fluid increases CPR compared to no tubal surgery (RR 1.67, 95% CI 1.10 to 2.55; three RCTs; n = 311; I 2 = 0%; very low-quality evidence). Laparoscopic proximal tubal occlusion versus laparoscopic salpingectomy We are uncertain of the effect of laparoscopic proximal tubal occlusion versus laparoscopic salpingectomy on LBR (RR 1.21, 95% CI 0.76 to 1.95; one RCT; n = 165; very low-quality evidence) and CPR (RR 0.81, 95% CI 0.62 to 1.07; three RCTs; n = 347; 2 = 77%; very low-quality evidence). No study reported on surgical complication rate for this comparison. Transvaginal aspiration of hydrosalpingeal fluid versus laparoscopic salpingectomy No study reported on LBR for this comparison, and there was insufficient evidence to identify a difference in surgical complication rate between groups (Peto OR not estimable; one RCT; n = 160). We are uncertain of the effect of transvaginal aspiration of hydrosalpingeal fluid versus laparoscopic salpingectomy on CPR (RR 0.69, 95% CI 0.44 to 1.07; one RCT; n = 160; very low-quality evidence).; A thors' Conclusions: We found moderate-quality evidence that salpingectomy prior to ART probably increases the CPR compared to no surgery in women with hydrosalpinges. When comparing tubal occlusion to no intervention, we found that tubal occlusion may increase CPR, although the evidence was of low quality. We found insufficient evidence of any effect on procedure- or pregnancy-related adverse events when comparing tubal surgery to no intervention. Importantly, none of the studies reported on long term fertility outcomes. Further high-quality trials are required to definitely determine the impact of tubal surgery on IVF and pregnancy outcomes of women with hydrosalpinges, particularly for LBR and surgical complications; and to investigate the relative efficacy and safety of the different surgical modalities in the treatment of hydrosalpinges prior to ART. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Memmi Ali, i. (2024). "Investigation of the Effectiveness of Acupuncture in Patients Diagnosed With Interstitial Cystitis." ClinicalTrials.gov.
	No Results Available Other: ACUPUNCTURE O'Leary-Saint symptom score Female Not Applicable 26 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 34043404 January 1, 2025

Mena Gabriela, P., et al. (2019). "The effect of physical activity on reproductive health outcomes in young women: a systematic review and meta-analysis." Human Reproduction Update 25(5): 541-563.
	Background: In the context of increasing rates of overweight and obesity in young adult women, and the increasing numbers of women seeking help for fertility problems, it is important to understand whether physical activity (PA) could help with management of reproductive health problems, with or without weight loss.; Objective and Rationale: The primary aim of this systematic review and meta-analysis was to assess the effects of PA on selected reproductive health outcomes in young adult women, in order to inform best practice advice for women in terms of promoting fertility and reproductive health in young adulthood.; Search Methods: An electronic search of PubMed, EMBASE, MEDLINE, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Web of Science, SportDiscus, and Cochrane was performed for studies published between January 2000 and May 2018. Keywords and Medical Subject Headings terms related to PA, reproductive health, and weight gain were used. Studies were selected if they were intervention studies, if PA was delivered as part of an intervention to pre-menopausal women, and if any reproductive health outcome was reported. Quality analysis was performed using the Tool for the assEssment of Study qualiTy and reporting in EXercise.; Outcomes: Eighteen studies, with a mix of four types of study design (4 randomized controlled trials (RCTs), 11 randomized comparison trials, 2 non-randomized comparison trials, and 1 single-arm clinical trial), were identified. Comparisons included fertility treatment (four studies) and common treatments for women with polycystic ovary syndrome (PCOS) symptoms (nine studies). Pooled analysis of data from three of the four studies with a control group showed higher pregnancy [risk ratio (RR) 2.10, 95% CI (1.32, 3.35); three studies] and live birth [RR 2.11, 95% CI (1.02, 4.39); two studies] rates in the intervention groups compared with non-therapy controls. Aggregated data from the fertility treatment comparative studies (i.e. those that compared PA with standard fertility treatment such as clomiphene, gonadotrophins, and/or IVF) showed no significant intervention differences: RR 1.46, 95% CI (0.87, 2.45) for clinical pregnancy (four studies) and RR 1.09, 95% CI (0.56, 2.12) for live births (two studies). Pooled analysis from the comparison trials that used pharmaceutical or dietary treatment for PCOS as comparison showed higher pregnancy rates [RR 1.59, 95% CI (1.06, 2.38); five studies] and live birth rates [RR 2.45, 95% CI (1.24, 4.83); two observations] in the PA intervention groups than in the comparison groups. Analysis of other outcomes, such as ovulation rates, menstrual regularity, and conception rates, showed no differences between the PA intervention and comparison groups.; Wider Implications: There is emerging evidence from RCT that PA may improve pregnancy rates in women with reproductive health problems. Comparative studies indicate that PA intervention may be as effective as other commonly used clinical intervention strategies for improving reproductive health outcomes. While the type, intensity, frequency, and duration of optimal PA intervention, and the role of PA independent of weight loss, remain unclear, these preliminary findings suggest that PA may be an affordable and feasible alternative or complementary therapy to fertility treatments. (© The Author(s) 2019. 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.)

Meneghini, C., et al. (2023). "The Impact of Nutritional Therapy in the Management of Overweight/Obese PCOS Patient Candidates for IVF." Nutrients 15(20): 4444.
	Polycystic ovary syndrome (PCOS) is the most common female endocrine disorder, and it has two main pathological aspects: reproductive and metabolic. Overweight/obesity is a risk factor in terms of adverse effects during hormone stimulation, a reduced response to ovulation induction regimens, reduced success of IVF, and an increased risk of obstetric complications. To resolve this vicious cycle of pathological events, weight loss and lifestyle modifications are promising strategies. Among these possible approaches, the consumption of a very-low-calorie ketogenic diet (VLCKD) or Mediterranean diet (MD) represents a valid option. In our study, 84 obese/overweight PCOS patients were recruited to evaluate the effects induced by the VLCKD and MD on weight, hormonal, and metabolic parameters. BMI decreased significantly among the VLKCD patients compared to the MD patients (both presenting p values < 0.0001 at 90 and 120 days), and a significant reduction in body circumference was observed. At the same time, HOMA index values statistically decreased for the VLCKD patients compared to those on the MD (p value < 0.001 at 90 days and p value < 0.05 at 120 days), and this phenomenon was also observed for AFC at 90 and 120 days (both p values < 0.001) and AMH at 90 days (p value < 0.05). Interestingly, the ovarian hyperstimulation syndrome (OHSS) incidence was statistically lower in the VLKCD patients compared to the MD patients (p < 0.001). We state that these dietary regimes may improve anthropometric parameters (such as BMI) and women's reproductive health, restore menstrual regularity, and reduce the risk of OHSS. Regarding the different nutritional therapies, the results suggest that the VLCKD is an optimal choice for entry into IVF, especially in terms of the time range in which these results are achieved.Copyright © 2023 by the authors.

Meng, J. and Y. Zhu (2021). "Efficacy of simvastatin plus metformin for polycystic ovary syndrome: A meta-analysis of randomized controlled trials." European Journal of Obstetrics, Gynecology, and Reproductive Biology 257: 19-24.
	Introduction: The efficacy of simvastatin plus metformin to treat polycystic ovary syndrome (PCOS) remained controversial. Therefore, we conducted this meta-analysis to explore the influence of simvastatin plus metformin versus metformin monotherapy on the treatment of PCOS.; Methods: We have searched PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases through June 2020 and included randomized controlled trials (RCTs) assessing simvastatin plus metformin versus metformin for PCOS. This meta-analysis was performed using the random-effect model.; Results: Five RCTs were included in the meta-analysis. Overall, compared with metformin monotherapy for PCOS, combined treatment with simvastatin plus metformin was associated with significantly reduced total testosterone (mean difference [MD] = -0.31; 95 % confidence interval [CI] = -0.50 to -0.13; P = 0.0009), leuteinizing hormone: follicle stimulating hormone (LH:FSH) ratio (MD = -0.92; 95 % CI = -1.62 to -0.23; P = 0.009) and low-density lipoprotein (LDL) cholesterol (MD = -34.90; 95 % CI = -39.33 to -30.47; P < 0.00001), but spontaneous menses per 6 months, volume of both ovaries, body mass index (BMI) and fasting glucose were found to be similar between two groups.; Conclusions: Combined treatment with simvastatin plus metformin was better to treat PCOS than metformin alone as evidenced by significantly reduced total testosterone, LH:FSH ratio and LDL cholesterol.; Competing Interests: Declaration of Competing Interest The authors report no declarations of interest. (Copyright © 2020. Published by Elsevier B.V.)

Meng, X., et al. (2023). "Influence of Vitamin D supplementation on reproductive outcomes of infertile patients: a systematic review and meta-analysis." Reproductive Biology and Endocrinology 21(1): 17.
	Background: Low vitamin D status has been associated with an increased risk for infertility. Recent evidence regarding the efficacy of vitamin D supplementation in improving reproductive outcomes is inconsistent. Therefore, this systematic review was conducted to investigate whether vitamin D supplementation could improve the reproductive outcomes of infertile patients and evaluate how the parameters of vitamin D supplementation affected the clinical pregnancy rate.; Methods: We searched seven electronic databases (CNKI, Cqvip, Wanfang, PubMed, Medline, Embase, and Cochrane Library) up to March 2022. Randomized and cohort studies were collected to assess the reproductive outcomes difference between the intervention (vitamin D) vs. the control (placebo or none). Mantel-Haenszel random effects models were used. Effects were reported as odds ratio (OR) and their 95% confidence interval (CI). PROSPERO database registration number: CRD42022304018.; Results: Twelve eligible studies (n = 2352) were included: 9 randomized controlled trials (RCTs, n = 1677) and 3 cohort studies (n = 675). Pooled results indicated that infertile women treated with vitamin D had a significantly increased clinical pregnancy rate compared with the control group (OR: 1.70, 95% CI: 1.24-2.34; I 2 = 63%, P = 0.001). However, the implantation, biochemical pregnancy, miscarriage, and multiple pregnancy rates had no significant difference (OR: 1.86, 95% CI: 1.00-3.47; I 2 = 85%, P = 0.05; OR: 1.49; 0.98-2.26; I 2 = 63%, P = 0.06; OR: 0.98, 95% CI: 0.63-1.53; I 2 = 0%, P = 0.94 and OR: 3.64, 95% CI: 0.58-11.98; I 2 = 68%, P = 0.21). The improvement of clinical pregnancy rate in the intervention group was influenced by the vitamin D level of patients, drug type, the total vitamin D dosage, the duration, administration frequency, and daily dosage of vitamin D supplementation. The infertile women (vitamin D level < 30 ng/mL) treated with the multicomponent drugs including vitamin D (10,000-50,000 IU or 50,000-500,000 IU), or got vitamin D 1000-10,000 IU daily, lasting for 30-60 days could achieve better pregnancy outcome.; Conclusion: To the best of our knowledge, this is the first meta-analysis systematically investigated that moderate daily dosing of vitamin D supplementation could improve the clinical pregnancy rate of infertile women and reported the effects of vitamin D supplementation parameters on pregnancy outcomes. A larger sample size and high-quality RCTs are necessary to optimize the parameters of vitamin D supplementation to help more infertile patients benefit from this therapy. (© 2023. The Author(s).)

Meng, Y., et al. (2020). "The effects of uterine manipulators in minimally invasive hysterectomy for endometrial cancer: A systematic review and meta-analysis." European Journal of Surgical Oncology 46(7): 1225-1232.
	Background: Minimally invasive surgery has achieved great success in the surgical treatment of many kinds of cancer. This study aimed to systematically review the available evidence evaluating the effects of the use of uterine manipulators in minimally hysterectomies for endometrial cancer patients.; Methods: We searched the CENTRAL, MEDLINE, PubMed, EMBASE and ClinicalTrials.gov databases to Sep. 12, 2019 to identify relevant prospective or retrospective studies, using the intersection of "endometrial neoplasms", "endometrial carcinoma", "endometrial cancer"; "uterine manipulator", and "intrauterine manipulator". The initial search identified 251 items in total. The main outcomes of interest were the presence of LVSI (lymphovascular space invasion), the incidence of positive peritoneal cytology, and the presence of recurrence during follow-up.; Results: After screening for eligibility, 11 studies were included in the meta-analysis finally. The timing of uterine manipulators insertion during MIS for endometrial cancer was not associated with an increased risk of positive peritoneal cytology (RR: 1.21, 95% CI, 0.68 to 2.16). Moreover, there was no significant difference for the rate of positive peritoneal cytology (RR: 1.53, 95% CI, 0.85 to 2.77), LVSI (RR: 1.18, 95% CI, 0.66 to 2.11) or the rate of recurrence (RR: 1.25, 95% CI, 0.89 to 1.74) regarding the use of uterine manipulators for laparoscopic surgery in the treatment of endometrial cancer patients.; Conclusion: We found that the use of uterine manipulators is not associated with an increased incidence of positive peritoneal cytology, LVSI, or recurrence among patients with endometrial cancer.; Systematic Review Registration: PROSPERO, CRD42020147111.; Competing Interests: Declaration of competing interest All authors declare that they have no financial or other conflicts of interest. (Copyright © 2020. Published by Elsevier Ltd.)

Meng, Y., et al. (2022). "Which vaginal douching agent is the best choice before oocyte retrieval? A systematic review and network meta-analysis." Frontiers in Reproductive Health 4: 1032062.
	OBJECTIVE: The aim of this study was to evaluate six vaginal douching agents (Iodine, Saline, Iodine followed by saline, chlorhexidine acetate followed by saline, Ozone, Potassium permanganate) on oocytes pick-up related pelvic infection (OPU-PI) and IVF outcome in patients underwent assisted reproduction technology (ART). DESIGN: Through searching PubMed, Embase, Cochrane Library, Web of Science, Ovid, CINAHL CNKI, only human clinical trials were collected to study the effects of the six vaginal douching agents on OPU-PI and IVF outcomes. The included studies were evaluated for methodological quality by the Cochrane bias risk assessment tool, and the data analysis software was used to analyze the data accordingly. RESULTS: The clinical trials were collected between the earliest available date and June 2022. Eight studies were included, the total sample size used in the study was 12,567. The results of the network meta-analysis showed that Ozone can significantly decrease OPU-PI; Iodine followed by saline can be a antiseptic protocol ranked first without affecting the quality of oocytes and Chlorhexidine acetate followed by saline can improve patients' clinical pregnancy rate. CONCLUSION: Based on Ranking Plot of the Network, this review reports the best evidence available regarding different vaginal douching agents used before OPU.

Mengxue, R., et al. (2021). "Evaluation of the effect of Cyclosporine A in recurrent pregnancy loss: a meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question The occurrence of two or more consecutive spontaneous abortions is defined as recurrent pregnancy loss (RPL). RPL morbidity is estimated to affect 5% of reproductiveaged females.Currently recognized causes include infectious diseases, chromosomal abnormalities, uterine abnormalities, endocrine factors, autoimmune diseases, alloimmune disorders, and endometrial microenvironment disorders, among Others.However, there are still 50% of recurrent miscarriages in clinical practice that the cause cannot be determined, which brings great difficulties to the treatment. It is currently believed that this type of unexplained miscarriage is related to the abnormal immune function of the patient.Pregnancy failure is mostly the mother's immune rejection of the fetus, so inducing immune tolerance is the main goal of treating unexplained recurrent miscarriage. Cyclosporine can significantly inhibit the autoimmune response. It can not only inhibit the mother's rejection of embryonic antigens, but also promote the growth of trophoblasts. It is expected to become an effective drug for the treatment of repeated pregnancy failures. However, the effectiveness of cyclosporine in recurrent miscarriage is still controversial. To explore the effect of cyclosporine in recurrent miscarriage, we conducted this meta-analysis. Searches The database for electronic retrieval includes: Cochrane Library, PubMed, EMBASE, SinoMed, WOS, CNKI, VIP Data, and Wangfang Database. The search time is from the establishment of the database to October 2021. Types of study to be included All of the random controlled trials (RCTs) examining the effect of Cyclosporine A or Cyclosporine A combined with others for the treatment of recurrent pregnancy loss with no limitations on language and publication status were included. Non-RCTs or animal experiments were excluded. Condition or domain being studied Recurrent pregnancy loss (RPL), defined as miscarriages of two or more consecutive pregnancies before the 24th week of gestation, affects up to 5% of couples during reproductive age. Risks factors for miscarriage include genetics, endocrine abnormalities, reproductive tract infections, abnormal anatomical structures, immune factors and so on. After a comprehensive examination, the etiology of RPL cannot be identified in half of such patients.The failure ofgestation results in substantial adverse clinical and psychological consequences in couples. Participants/population Patients who had been confirmed pregnant by serum human chorionic gonadotropin (HCG) or ultrasound in the first trimester of pregnancy with a diagnosis history of RPL, defined as two or more spontaneous abortions that had ruled out the following four definite etiologies: infections, abnormal parental karyotypes, endocrine disorders, and anatomic abnormality, regardless of maternal age, gestational age, ethnicity, nationality, education, or economic status.. The inclusion criteria also stipulated that participants included pregnant RPL patients and unpregnant RPL patients.Trials involving recurrent spontaneous abortion with definite etiologies were excluded. Intervention(s), exposure(s) Cyclosporine A or cyclosporin A combined with other treatments. Comparator(s)/control placebo or no use of Cyclosporine A or other treatments such as low molecular weight heparin and Chinese herbal medicine Main outcome(s) pregnancy outcome Additional outcome(s) Additional outcomes include the levels of Blood chorionic gonadotropin（HCG), progesterone (P), estradiol (E2), T lymphocyte subsets, and incidence of maternal and perinatal adverse events during treatment Data extraction (selection and coding) We made the retrieval formula according to the PICOS strategy. The search terms for literature searching were as follows:（Habitual Abortion OR Habitual Abortions OR Miscarriage, Recurrent OR Recurrent Miscarriage OR Recurrent Miscarriages OR Abortion, Recurrent OR Recurrent Abortion OR Recurrent Abortions OR Recurrent Early Pregnancy Loss OR Repeated pregnancy failures）AND (Cyclosporine A OR Cyclosporin A OR Ciclosporin OR Cyclosporin) AND(Randomized Controlled Trial OR randomized OR placebo OR RCT) .We also manually searched the reference lists of all identified articles for possible related studies to supplement the relevant literature. Risk of bias (quality) assessment The two researchers will evaluate the treatment of included literature based on the “risk of bias assessment tool”of Cochrane Handbook. The items to be evaluated include: random sequence generation, random allocation concealment, blind method implementation, outcome assessor, result data integrity, selective outcome report, and other biases. Strategy for data synthesis Review Manager 5.4 software will be used for statistical analysis. Dichotomous data will be analyzed by using the risk ratio with 95% confidence interval (CI) and continuous variables will be analyzed by using the mean difference with 95% CI. Analysis of subgroups or subsets If there is significant heterogeneity in our study, we will perform a subgroup analysis based on the type of control group. Contact details for further information Mengxue Ren 854202590@qq.com Organisational affiliation of the review Graduate School of China Academy of Chinese Medical Sciences Review team members and their organisational affiliations Miss Mengxue Ren. Graduate School of China Academy of Chinese Medical Sciences Miss Guo Li. Beijing University of Chinese Medicine Miss Chen ruixue. Guang'anmen Hospital, China Academy of Chinese Medical Sciences Type and method of review Intervention, Meta-analysis, Systematic review Anticipated or actual start date 20 October 2021 Anticipated completion date 31 December 2021 Funding sources/sponsors

Mengyi, R. and L. Suyu (2022). "Xiaozhiling injection combined with ruiyun procedure for hemorrhoids in the treatment of Rectocele: a systematic review and meta-analysis of RCTs." PROSPERO International prospective register of systematic reviews.
	Review question Is Xiaozhiling injection combined with ruiyun procedure for hemorrhoids (RPH) more effective and safe than Block (Block repair procedure) in the treatment of rectocele（RC）? Searches 7 electronic databases will be searched, including the China National Knowledge Infrastructure (CNKI), Wanfang Database, Chinese Scientific Journal Database (VIP), China Biomedical Literature Database (CBM), PubMed, the Cochrane Library and EMBASE. All the publications until 22nd February 2022 will be searched without any restriction of countries or article types. Reference list of all selected articles will be screened independently to identify additional studies left out in the initial search. Types of study to be included RCTs will be included. Condition or domain being studied

Menshawy, A., et al. (2019). "Effect of chlormadinone acetate versus drospirenone-containing oral contraceptives on the endocrinal features of women with polycystic ovary syndrome: Systematic review and meta-analysis of randomized clinical trials." Journal of Gynecology Obstetrics and Human Reproduction 48(9): 763-770.
	Background: Polycystic ovary syndrome (PCOS) is a serious endocrinal disorder in women of reproductive age. Hormonal treatment with oral contraceptives, containing estrogen (ethinyl-estradiol, EE) with progestogen (drospirenone, DRSP) or (chlormadinone acetate, CMA), has improved symptoms and biomarkers of PCOS.; Objective: The aim of the present meta-analysis is to compare the effects of EE/DRSP versus EE/CMA on the endocrinal features of women with PCOS.; Data Sources: Several electronic databases were searched for combinations of the following relevant MeSH terms were used: (ethinyl-estradiol OR EE) AND (drospirenone OR DRSP) AND (chlormadinone acetate OR CMA) AND (polycystic ovary syndrome).; Methods: Records were screened for eligible studies and data were extracted to an online data extraction form. Outcomes of Ferryman-Gallwey score (FGS), body mass index, dehydroepiandrosterone sulfate (DHEAS), free androgen index, sex hormone-binding globulin, delta-4-androstenedione (A) and total testosterone levels (T) were pooled as weighted mean difference (WMD) and 95% confidence interval (CI) in a fixed effect meta-analysis model.; Results: Three RCTs (EE/DRSP: n = 98 and EE/CMA: n = 87) were pooled in the analysis. The overall effect favoured EE/DRSP over EE/CMA in reducing (A) levels after three months (WMD -0.63; 95% CI [-0.94, -0.32], P < 0.001), FGS after six months (WMD -0.44; 95% CI [-0.99, -0.19], P = 0.0006), and total (T) after three months (WMD -0.12; 95% CI [-0.23, -0.01], P = 0.03).; Conclusions: EE/DRSP showed a more potent effect than EE/CMA in the reduction of FGS after six months, (A) levels and (T) levels after three months in patients with PCOS. (Copyright © 2019 Elsevier Masson SAS. All rights reserved.)

Merck, S. and L. L. C. Dohme (2021). "Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)." ClinicalTrials.gov.
	The primary objective is 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 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD‐L1) positive tumors (Combined Positive Score [CPS] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.

Merck, S. and L. L. C. Dohme (2021). "Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 KEYNOTE-B21 ENGOT-en11 GOG-3053)." ClinicalTrials.gov.
	No Results Available Biological: Pembrolizumab|Drug: Carboplatin|Drug: Paclitaxel|Drug: Placebo for pembrolizumab|Drug: Docetaxel|Drug: Cisplatin|Radiation: External Beam Radiotherapy (EBRT)|Drug: Cisplatin (as radiosensitizer)|Radiation: Brachytherapy Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence|Overall Survival (OS)|Disease-Free Survival (DFS) as Assessed Radiographically by Blinded Independent Central Review (BICR) or by Histopathologic Confirmation of Suspected Disease Recurrence|Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Combined Positivity Score (CPS)-Determined Programmed Cell Death 1 Ligand 1 (PD-L1) Status|Overall Survival (OS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Combined Positivity Score (CPS)-Determined Programmed Cell Death 1 Ligand 1 (PD-L1) Status|Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status|Overall Survival (OS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status|Number of Participants Who Experience One or More Adverse Events (AEs)|Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)|Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (QoL) Score|Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Function Score|Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Endometrial Cancer (EORTC QLQ-EN24) Score Female Phase 3 990 Industry|Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 3475-B21|KEYNOTE-B21|ENGOT-en11|GOG-3053|jRCT2031200399|2020-003424-17 June 18, 2025

Merck, S. and L. L. C. Dohme (2021). "Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)." ClinicalTrials.gov.
	The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK‐3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy. The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).

Merck, S. and L. L. C. Dohme (2023). "MK-2870 in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)." ClinicalTrials.gov.
	The primary objectives of this study are to compare MK‐2870 to Treatment of Physician's Choice (TPC) with respect to progression‐free survival (PFS) per RECIST 1.1, as assessed by blinded independent central review (BICR), and overall survival (OS). The primary hypotheses are that MK‐2870 is superior to TPC with respect to PFS per RECIST 1.1, as assessed by BICR, and that MK‐2870 is superior to TPC with respect to OS.

Merck Sharp Dohme Corp, a. s. o. M. and I. Co (2021). "MK-7684A With or Without Other Anticancer Therapies in Participants with Selected Solid Tumors." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: MK‐7684A Pharmaceutical Form: Solution for infusion INN or Proposed INN: Vibostolimab CAS Number: 2231305‐30‐7 Current Sponsor code: MK‐7684 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ 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: 10‐ Trade Name: KEYTRUDA (pembrolizumab, 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‐ Product Name: Lenvatinib Product Code: E7080 Pharmaceutical Form: Capsule, hard INN or Proposed INN: LENVATINIB MESILATE CAS Number: 857890‐39‐2 Current Sponsor code: MK‐7902 Other descriptive name: LENVATINIB MESILATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Product Name: Lenvatinib Product Code: E7080 Pharmaceutical Form: Capsule, hard INN or Proposed INN: LENVATINIB MESILATE CAS Number: 857890‐39‐2 Current Sponsor code: MK‐7902 Other descriptive name: LENVATINIB MESILATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4‐ CONDITION: Advanced solid tumors ; MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864 Therapeutic area: Diseases [C] ‐ Cancer [C04] SECONDARY OUTCOME: Secondary end point(s): 1. Overall Survival (OS).; 2. PFS per RECIST 1.1 as Assessed by Investigator.; 3. Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR.; 4. DOR per RECIST 1.1 as Assessed by Investigator.; 5. Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality‐of‐Life Questionnaire Core 30 [EORTC QLQ‐C30] Items 29 and 30).; 6. Change from Baseline in Physical Functioning Score (EORTC QLQ‐C30 Items 1‐5).; 7. Number of Participants Who Experienced One or More Adverse Events (AEs).; 8. Number of Participants Who Discontinued Study Intervention Due to an AE. Timepoint(s) of evaluation of this end point: 1. Up to approximately 36 months.; 2. Up to approximately 36 months.; 3. Up to approximately 36 months.; 4. Up to approximately 36 months.; 5. Baseline and up to approximately 36 months.; 6. Baseline and up to approximately 36 months.; 7. Up to approximately 36 months.; 8. Up to approximately 35 months. PRIMARY OUTCOME: Main Objective: 1. To compare MK‐7684A to pembrolizumab alone with respect to objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) in participants with cervical cancer whose tumors express programmed cell death 1 ligand 1 (PD‐L1) [combined positive score (CPS) =1)] enrolled in Cohort A1.; 2. To compare MK‐7684A to pembrolizumab alone with respect to progression‐free survival (PFS) per RECIST 1.1 as assessed by BICR in participants with cervical cancer whose tumors express PD‐L1 (CPS =1) enrolled in Cohort A1.; 3. To evaluate MK‐7684A alone or in combination with other anticancer therapies with respect to ORR per RECIST 1.1 as assessed by the investigator in participants with selected solid tumors, excluding those with cervical cancer whose tumors express PD‐L1 (CPS =1) enrolled in Cohort A1. Primary end point(s): 1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR).; 2. Progression‐Free Survival (PFS) per RECIST 1.1 as Assessed by BICR.; 3. ORR per RECIST 1.1 as Assessed by Investigator. Secondary Objective: 1. To evaluate MK‐7684A alone or with other anticancer therapies for overall survival (OS).; 2. To evaluate MK‐7684A alone or with other anticancer therapies for PFS per RECIST 1.1 as assessed by i estigator in participants with selected solid tumors except those enrolled in Cohort A1.; 3. To evaluate MK‐7684A alone for duration of response (DOR) per RECIST 1.1 as assessed by BICR in participants enrolled in Cohort A1.; 4. To evaluate MK‐7684A alone or with other anticancer therapies for DOR per RECIST 1.1 as assessed by investigator in participants with selected solid tumors, except those enrolled in Cohort A1.; 5. To evaluate change from baseline in health‐related quality‐of‐life (HRQoL) using the European Organisation for Research and Treatment of Cancer (EORTC) Quality‐of‐life questionnaire core 30 (QLQ‐C30) in participants enrolled in Cohort A1.; 6. To evaluate the safety and tolerability of MK‐7684A alone or with other anticancer therapies. Timepoint(s) of evaluation of this end point: 1. Up to approximately 36 months.; 2. Up to approximately 36 months.; 3. Up to approximately 36 months. INCLUSION CRITERIA: A participant will be eligible for inclusion in the study if the participant: Has histologically‐ or cytologically‐confirmed, advanced (locally recurrent unresectable or metastatic) solid tumor as follows: 1. Cohort A: squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has progressed on standard of care chemotherapy with or without radiation but must not have been treated with prior anti‐PD‐1/PD L1 therapy. Chemotherapy given with radiation therapy will not be considered a first‐line therapy. ‐ Cohort A1: participants whose tumors are PD‐L1 positive (CPS =1) as determined by the central laboratory ‐ Cohort A2: participants whose tumors are PD‐L1 negative (CPS <1) as determined by the central laboratory 2. Cohort B: endometrial cancer that has progressed after 1 prior systemic, platinum‐based chemotherapy regimen for endometrial cancer but must not have been treated with prior anti‐PD‐1/ PD L1 therapy. Parti

Merck Sharp Dohme Corp, a. s. o. M. and I. Co (2022). "A Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High Grade Serous Ovarian Cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: MK‐4830 Product Code: MK‐4830 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Not applicable Current Sponsor code: MK‐4830 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ Trade Name: KEYTRUDA (pembrolizumab,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‐ CONDITION: Therapeutic area: Diseases [C] ‐ Cancer [C04] First‐line treatment of advanced High Grade Serous Ovarian 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) PRIMARY OUTCOME: Secondary Objective: 1. Among patients with detectable ctDNA at baseline, to evaluate the association between neoadjuvant ?ctDNA at Cycle 3 from baseline and surgical outcomes; 2. To estimate the difference in pCR and CRS following neoadjuvant treatment between arms; 3. To evaluate the safety and tolerability of MK‐4830 administered with pembrolizumab and chemotherapy Primary end point(s): 1. Change from Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Timepoint(s) of evaluation of this end point: 1. Baseline and Week 7 Main Objective: 1. Among patients with detectable ctDNA at baseline, to evaluate whether the reduction from baseline in circulating tumor DNA at Cycle 3 (?ctDNA) is larger in participants receiving MK‐4830 + pembrolizumab in combination with standard of care (SOC) chemotherapy than in those receiving pembrolizumab + SOC. SECONDARY OUTCOME: Secondary end point(s): 1. Change from Baseline in Neoadjuvant ctDNA; 2. Pathological Complete Response (pCR) Rate; 3. Chemotherapy Response Score (CRS); 4. Number of Participants Who Experienced an Adverse Event (AE); 5. Number of Participants Who Discontinued Study Treatment Due to an AE Timepoint(s) of evaluation of this end point: 1. Baseline and Week 7; 2. Up to approximately 12 Weeks; 3. Up to approximately 12 Weeks; 4. Up to approximately 40 Weeks; 5. Up to approximately 28 Weeks INCLUSION CRITERIA: 1. Has histologically‐confirmed FIGO Stage III or Stage IV HGSOC, primary peritoneal cancer, or fallopian tube cancer 2. Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant and adjuvant setting 3. Is a candidate for interval debulking surgery 4. Has either a CA‐125 (kilounits/L):CEA (ng/mL) ratio =25 or, if the CA‐125:CEA ratio is <25, then a workup should be negative for the presence of a non‐OC tumor (eg, breast or GI cancers including CRC) 5. Is able to provide archival tissue or newly obtained core, incisional, or excisional biopsy of a tumor lesion 6. Is female and at least 18 years of age on the day of providing documented informed consent 7. Has an ECOG PS of 0 or 1, as assessed within 7 days prior to the first dose of study intervention on Day 1 of Cycle 1 8. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditio

Merck Sharp Dohme, L. L. C. (2022). "Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)." ClinicalTrials.gov.
	No Results Available Biological: Pembrolizumab|Drug: Paclitaxel|Drug: Carboplatin|Biological: Avastin|Biological: MK-4830|Drug: Docetaxel Change from Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA)|Change from Baseline in Neoadjuvant ctDNA|Pathological Complete Response (pCR) Rate|Chemotherapy Response Score (CRS)|Number of Participants Who Experienced an Adverse Event (AE)|Number of Participants Who Discontinued Study Treatment Due to an AE Female Phase 2 160 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 4830-002|MK-4830-002|2021-005458-27 December 26, 2024

Merck Sharp Dohme, L. L. C. (2023). "Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)." ClinicalTrials.gov.
	No Results Available Biological: favezelimab/pembrolizumab|Biological: pembrolizumab|Drug: lenvatinib Pathological Complete Response (pCR) - Cohort A|Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Investigator - Cohort B|Overall Survival (OS) - All Cohorts|Clinical Benefit Rate - Cohort A|Event-Free Survival (EFS) - Cohort A|Major Pathological Response (mPR) - Cohort A|ORR per RECIST 1.1 as assessed by Investigator - Cohort A|Number of participants with an adverse event (AE) - Cohorts A and B|Number of participants discontinuing from study therapy due to AE - Cohorts A and B|Number of participants experiencing perioperative complications - Cohort A|Number of participants with an AE that precludes surgery/initiation of adjuvant therapy - Cohort A|Progression Free Survival (PFS) - Cohort B|Duration of Response (DOR) - Cohort B All Phase 2 160 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 4280A-010|MK-4280A-010|2023-505022-34 March 9, 2027

Meriwether, K. (2021). "Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation." ClinicalTrials.gov.
	No Results Available Behavioral: Treatment|Other: Usual Cares Global Response Assessment|O'Leary-Sant Symptom and Problem Index Female Not Applicable 120 Other Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment 20-664 December 31, 2023

Meriwether Kate, V. (2022). "INvestigation of TENS Efficacy Versus Posterior Tibial Nerve Stimulation for Overactive Bladder." ClinicalTrials.gov.
	The investigators plan to perform an unmasked, non‐inferiority randomized controlled trial to determine if the quality of life is improved with the use of TENS compared to PTNS for urgency urinary incontinence and overactive bladder. Women will be informed of the arm of the study to which they are randomized, as the intervention is unable to be masked. All women will give written consent prior to enrollment. The investigators will recruit women with OAB and/or UUI who present to the University of New Mexico Urogynecology practice at UNM Eubank Clinic (UNM) or Sandoval Regional Medical Center (SRMC) with OAB, urgency urinary incontinence (UUI) without other types of incontinence, or mixed urinary incontinence with urge predominant‐symptoms who have failed a trial of at least one medication. To confirm diagnosis and eligibility, the investigators will conduct a standard intake history and physical, complete with cough stress test, POP‐Q pelvic examination, urinalysis and urine culture. If the potential participant predominantly complains of OAB or UUI, she will be introduced to the study and provided with written information that may help her decide if participation in the study is right for her. All potential participants will be counseled about possible treatment options for OAB and UUI including non‐surgical and surgical techniques. If a woman is withdrawn from the study either by her desire or that of the research staff, or does not desire to participate, she will be offered the same treatment options. Recruitment will take place either in private exam rooms at these clinics or over HIPAA compliant telephone or Zoom conversation. After recruitment, they will undergo the informed consent via the same means as recruitment and complete initial questionnaires in clinic or will be sent a copy (digital or mail) to complete if enrolled virtually. Patients in the TENS group will be given their TENS device in clinic and research staff will assist in educating participants on proper placement and use of the device, as well as provide a standardized treatment protocol they will complete at home. The patients randomized to PTNS will have their sessions at the UNM Eubank Women's Primary Care Clinic. The primary aim of the study is to determine if symptoms and quality of life related to overactive bladder are improved similarly with TENS use versus PTNS in women with OAB/UUI. If the patient is interested in non‐surgical management with PTNS and fulfills study inclusion criteria, the investigators will then offer her the choice of volunteering for the study. All women will give written and/or electronic consent prior to their enrollment at this time and fill out baseline questionnaires in the clinic. Research staff and clinicians will obtain consent and administer study. After enrollment, participants will fill out a baseline OAB‐q and will be given a 3‐day voiding diary to complete prior to starting their intervention. Urinalysis and urine culture will be obtained to rule out urinary tract infection. This is routinely done on all new patients in the clinic and would be performed on patients not participating in the study as well. Data collected in addition to the above outcome measures includes patient demographics, medical/surgical history, and contact information, which are attached as supporting documents. This information will be collected from the patient on the day of enrollment and the investigators will review the patient's medical record if information is missing or unclear. The randomization sequence will be generated by computer‐based randomization in a sequence that preserves 1:1 randomization and also preserves allocation concealment (likely with randomly alternating block sizes of 6‐10 in blocked randomization). Randomization assignments will be completed via REDCAP by a research coordinator. Randomization will only occur after consent has been signed and all baseline data has been obtained. This is a single‐center study at the University of New Mexico, and this site will recruit up to 130 pa ents. Outcomes collected: Outcomes will be collected at baseline, 6 weeks, and 12 weeks, and will involve patient questionnaires such a the OAB‐q (overactive bladder questionnaire), a validated tool to assess the patient's perceptions of symptom bother and impart on HRQL among patients with both continent and incontinent OAB. It is comprised of 8 symptom bother questions and 25 HRQL questions that form 4 subscales (coping, concern, sleep, and social interaction) and a total HRQL score. OAB‐q is widely utilized in OAB/UUI. It will also include a voiding trial, which is a patient completed record of micturition behavior to obtain objective data on subjective symptoms. The International Continence Society (ICS) recommends use of voiding diaries in the clinical assessment of patients with lower urinary tract symptoms2. It is a chart where patients record their urinary habits for at least 24 hours and is widely used in OAB/UUI. Lastly, the study will measure the Patient Satisfaction Question (PSQ), which is a validated tool to assess patient satisfaction of treatment. It is comprised of a single question and is widely used in OAB/UUI. Data Analysis: Between and within group differences will be evaluated using Fisher's exact test for categorical variables and t‐tests for continuous variables, as the investigators expect the data will be normally distributed. Wilcoxon rank‐sum test will be used for continuous variables that are not normally distributed. If there are any baseline differences between groups, a multivariate analysis will determine the contribution of these differences to observed differences (if any) between groups. Intention‐to‐treat analysis: The investigators plan to perform the primary analysis as "intention‐to‐treat" indicating that patients will be analyzed in the group to which they were randomized, regardless of compliance with study procedures, unless they asked to be withdrawn or were withdrawn by investigators due to safety or validity concerns. For example, PTNS patients that miss more than one session or do not make up a missed session of their office PTNS would still be analyzed in the "intention‐to‐treat" analysis as being in the PTNS group. Per protocol analysis: The investigators plan to perform a secondary analysis as "per protocol" indicating that patients will be analyzed in the group to which they were randomized only if they complete a full 12 weeks of treatment in compliance with study procedures, meaning that women assigned to the PTNS arm completed 12 weekly PTNS session in the office in 13 weeks or less, and women in the at‐home TENS arm performed TENS stimulation at least 5 days per week for 12 weeks, as averaged over 12 weeks. For example, PTNS patients that miss more than one session or do not make up a missed session of their office PTNS will not be analyzed in the "per protocol" analysis as being in the PTNS group. Sample size calculation: The primary outcome for this study is the change in the OAB‐q HRQOL score from baseline to 3 months. The study team used the means and standard deviation for this questionnaire from an unpublished pilot RCT study from Walter Reed that compares PTNS and TENS for the treatment of OAB (unpublished work). The investigators have powered the study based on a 10‐point difference as significant between groups. This 10‐point difference used for the power calculation is based on the previously established minimum important difference. To achieve power for this non‐inferiority RCT study showing that the difference between groups is less than 10 points, the study will require 40 patients per group (80 total) to detect no difference with alpha = 0.05 and 80% power. Allowing for dropout of up to 30%, the investigators aim to randomize 114 patients, and will plan to recruit up to 130 to allow for potentially higher drop‐out, as the study primary outcome is at the 12 weeks' time point. As the investigators plan to perform both per‐protocol and intention‐to‐treat analysis, the sample size must be met for both per‐protocol an ntention‐to‐treat analysis, with the per‐protocol patients (those in the PTNS group completing at 12 treatments in a total of 13 weeks) being expected to be a lower sample size. Data Management/Confidentiality: Participants will be given a de‐identified study subject number. Data collection sheets and questionnaires will contain the subject number. No other patient identifiers will be collected on study forms. PHI including patient name, date of birth, phone number, email address and medical record number will be collected to track appointments and ensure patient follow‐up. The data collection, HIPAA and consent forms will be maintained in a locked file cabinet in the locked Eubank research office or via REDCap. A separate folder will be designated for each participant. PHI will not be entered into the study database. The link between PHI and study IDs will be kept on a password protected computer on a secure UNM OBGYN department server. The study database does not include sensitive information or information requiring additional protection. Study binders will be kept in a locked cabinet in the research administrative area. In order to further ensure patient confidentiality, the identifying information will be kept separately from the numbered study files in a locked cabinet. Electronic data entry will be performed on REDCAP, using the de‐identified subject study number. The electronic data and subject link will be encrypted, password protected, and stored on the secure UNM OBGYN department server. This server's electronic security is monitored / maintained by the Health Sciences Library and Informatics Center (HSLIC). A REDCAP database will be created to collect, store and manage the data. REDCAP databases are reposed securely and all data entered is de‐identified. The REDCAP database is only accessible using an individual unique login and password and access is only provided to co‐investigators. Access is restricted to co‐investigators and research staff and will be protected using the unique REDCAP login and password provided to each co‐investigator. Access to the files and REDCAP will be restricted to research personnel and Investigators and will be locked or password‐protected using the unique REDCAP login and password provided to each co‐investigator. The data will be stored for 6 years after completion of analysis and study closure and then will be destroyed. A Certificate of Confidentiality will not be used to protect data from forced release. No identifying or study related data will be transported to outside locations. There will be no audio or video recordings or photographs taken.

Mersana Therapeutics, I. (2022). "Phase 3 Study of Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Upifitamab rilsodotin Product Code: [XMT‐1536] Pharmaceutical Form: Powder for solution for injection/infusion CAS Number: 2254119‐00‐9 Current Sponsor code: XMT‐1536 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80‐ Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the placebo: Intravenous use Product Name: Sodium Chloride 0.9% w/v Product Code: [‐] Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: SODIO CLORURO Current Sponsor code: ‐ Concentration unit: % percent Concentration type: equal Concentration number: 90‐ CONDITION: Recurrent Platinum‐Sensitive 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: Demonstrate superiority in Progression‐free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 of upifitamab rilsodotin versus placebo as maintenance therapy Primary end point(s): Progression‐free survival (PFS) assessed by Blinded Independent Central Review (BICR) Secondary Objective: ‐ Compare Overall Survival (OS) of upifitamab rilsodotin versus placebo as maintenance therapy; ‐ Compare PFS as assessed by Investigator using RECIST v1.1 of upifitamab rilsodotin versus placebo as maintenance therapy; ‐ Compare the Objective Response Rate (ORR) as assessed by Investigator using RECIST v1.1 of upifitamab rilsodotin versus placebo as maintenance therapy; ‐ Evaluate safety and tolerability in participants treated with upifitamab rilsodotin versus placebo as maintenance therapy Timepoint(s) of evaluation of this end point: Every 6 weeks and then every 12 weeks until disease progression or start of a new therapy, assessed up to an average of 12 months INCLUSION CRITERIA: 1 Participants must be at least 18 years of age, and female 2 Participants must have an ECOG performance status 0 or 1 3 Participants must have a histological diagnosis of high grade serous ovarian cancer, which includes fallopian tube and primary peritoneal cancer, that is metastatic or recurrent. 4 Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent. 5 Participant must have platinum‐sensitive recurrent disease, defined as having achieved either a partial or complete response to 4 or more cycles in their penultimate platinum‐ containing regimen and their disease progressing more than 6 months after completion of the last dose of platinum containing therapy in the penultimate regimen. 6.Participant must have had 4 to 8 cycles of platinum‐based chemotherapy in 2nd to 4th line setting in their most recent treatment regimen as defined below: a. Platinum‐based chemo

Mersin, U. (2022). "The Effect of Acupressure on Pain, Menstrual Symptoms, and General Comfort in Adolescents With Primary Dysmenorrhea." ClinicalTrials.gov.
	Methods: Adolescents aged 14‐17 years with primary dysmenorrhea will be randomly assigned to the acupressure and control groups. The study group (n=26) and placebo group (n=26) will be applied to the determined points in a certain order. The order of application is Hegu (LI4), Zusanli (ST36), Sanyinjiao (SP6). Acupressure will be applied to the adolescents in the groups individually for 18‐20 minutes, twice a day in the first three days of their menstrual periods. The primary outcome measures of the study is the effect of acupressure on adolescent pain severity and menstrual symptoms. The secondary outcome measures of the study is the effect of acupressure on general comfort. Data collection forms will be applied four times in total for the second and third cycles, before and immediately after the acupressure application.

Mersin, U. (2023). "The Effect of Acupressure on Menopausal Symptoms." ClinicalTrials.gov.
	Menopause is a physiological process during which most women have difficulties and face many problems. Acupressure can be taught and used safely as an effective method to manage the symptoms that women experience during menopause. This study aims to determine the effect of acupressure on menopausal symptoms. The study has a prospective, randomized, sham‐controlled, single‐blind design. The research was conducted with 81 women (acupressure n=40, sham acupressure n=41) attending the "Menopause School" in a public hospital in Türkiye between July 05, 2021 and August 02, 2021. Both groups received acupressure application thrice a week for four weeks, 12 sessions in total. The data was obtained using a personal information form and a Menopause Rating Scale.

Merza, D., et al. (2023). "Online peer-delivered group cognitive-behavioral therapy for postpartum depression: A randomized controlled trial." Acta Psychiatrica Scandinavica.
	Background: Postpartum depression (PPD) affects up to one in five mothers and birthing parents, yet just 10% receive evidence-based care. This randomized controlled trial aimed to determine if a synchronous online 9-week group cognitive-behavioral therapy (CBT) intervention delivered by mothers who have recovered from postpartum depression (i.e., peers) could effectively improve PPD and its comorbidities.; Methods: Participants (n = 183) in this study lived in Ontario, Canada, were ≥18 years-old, had an infant <12 months, were fluent in English, and scored ≥10 on the Edinburgh Postnatal Depression Scale (EPDS). They were randomized to experimental (received intervention plus treatment as usual (TAU)) or waitlist control (TAU plus the intervention after a 9-week wait) groups. Depression, anxiety, social support, mother-infant bonding, and infant temperament were assessed at baseline and 9 weeks later. Outcomes were assessed in the experimental group 3 months post-intervention to assess stability.; Results: Statistically significant reductions were observed in EPDS (B = 5.99; p < 0.001; d = 1.32) and Generalized Anxiety Disorder Questionnaire-7 scores (B = 5.94; p < 0.001; d = 1.22), improvements that remained stable 3 months post-intervention in the experimental group. Maternal social support (p = 0.02; d = 0.40), infant-focused anxiety (p = 0.02; d = 0.54), and infant negative emotionality (p < 0.01; d = 0.23) also improved post-intervention and remained stable 3 months later.; Conclusion: Online peer-delivered group CBT for PPD can effectively treat PPD and anxiety, and improve social support, infant-focused anxiety, and negative emotionality in infants. This intervention could provide the means to increase access to treatment for those experiencing PPD and improve outcomes for mothers, birthing parents, and families. (© 2023 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Metwally, M., et al. (2022). "Endometrial scratch to increase live birth rates in women undergoing first-time in vitro fertilisation: RCT and systematic review." Health Technology Assessment 26(10): 1-212.
	Background: In vitro fertilisation is a widely used reproductive technique that can be undertaken with or without intracytoplasmic sperm injection. The endometrial scratch procedure is an in vitro fertilisation 'add-on' that is sometimes provided prior to the first in vitro fertilisation cycle, but there is a lack of evidence to support its use.; Objectives: (1) To assess the clinical effectiveness, safety and cost-effectiveness of endometrial scratch compared with treatment as usual in women undergoing their first in vitro fertilisation cycle (the 'Endometrial Scratch Trial') and (2) to undertake a systematic review to combine the results of the Endometrial Scratch Trial with those of previous trials in which endometrial scratch was provided prior to the first in vitro fertilisation cycle.; Design: A pragmatic, multicentre, superiority, open-label, parallel-group, individually randomised controlled trial. Participants were randomised (1 : 1) via a web-based system to receive endometrial scratch or treatment as usual using stratified block randomisation. The systematic review involved searching electronic databases (undertaken in January 2020) and clinicaltrials.gov (undertaken in September 2020) for relevant trials.; Setting: Sixteen UK fertility units.; Participants: Women aged 18-37 years, inclusive, undergoing their first in vitro fertilisation cycle. The exclusion criteria included severe endometriosis, body mass index ≥ 35 kg/m 2 and previous trauma to the endometrium.; Interventions: Endometrial scratch was undertaken in the mid-luteal phase of the menstrual cycle prior to in vitro fertilisation, and involved inserting a pipelle into the cavity of the uterus and rotating and withdrawing it three or four times. The endometrial scratch group then received usual in vitro fertilisation treatment. The treatment-as-usual group received usual in vitro fertilisation only.; Main Outcome Measures: The primary outcome was live birth after completion of 24 weeks' gestation within 10.5 months of egg collection. Secondary outcomes included implantation, pregnancy, ectopic pregnancy, miscarriage, pain and tolerability of the procedure, adverse events and treatment costs.; Results: One thousand and forty-eight (30.3%) women were randomised to treatment as usual ( n = 525) or endometrial scratch ( n = 523) and were followed up between July 2016 and October 2019 and included in the intention-to-treat analysis. In the endometrial scratch group, 453 (86.6%) women received the endometrial scratch procedure. A total of 494 (94.1%) women in the treatment-as-usual group and 497 (95.0%) women in the endometrial scratch group underwent in vitro fertilisation. The live birth rate was 37.1% (195/525) in the treatment-as-usual group and 38.6% (202/523) in the endometrial scratch group: an unadjusted absolute difference of 1.5% (95% confidence interval -4.4% to 7.4%; p = 0.621). There were no statistically significant differences in secondary outcomes. Safety events were comparable across groups. No neonatal deaths were recorded. The cost per successful live birth was £11.90 per woman (95% confidence interval -£134 to £127). The pooled results of this trial and of eight similar trials found no evidence of a significant effect of endometrial scratch in increasing live birth rate (odds ratio 1.03, 95% confidence interval 0.87 to 1.22).; Limitations: A sham endometrial scratch procedure was not undertaken, but it is unlikely that doing so would have influenced the results, as objective fertility outcomes were used. A total of 9.2% of women randomised to receive endometrial scratch did not undergo the procedure, which may have slightly diluted the treatment effect.; Conclusions: We found no evidence to support the theory that performing endometrial scratch in the mid-luteal phase in women undergoing their first in vitro fertilisation cycle significantly improves live birth rate, although the procedure was well tolerated and safe. We recommend that endometrial scratch is not undertaken in this population.; Trial Re istratio : This trial is registered as ISRCTN23800982.; 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. 26, No. 10. See the NIHR Journals Library website for further project information.

Metwally, M., et al. (2022). "Endometrial scratch in women undergoing first-time IVF treatment: a systematic review and meta-analysis of randomized controlled trials." Reproductive Biomedicine Online 44(4): 617-629.
	The endometrial scratch procedure is an IVF 'add-on' sometimes provided prior to the first IVF cycle. A 2019 systematic review concluded that there was insufficient evidence to show whether endometrial scratch has a significant effect on pregnancy outcomes (including live birth rate, LBR) when undertaken prior to the first IVF cycle. Further evidence was published following this review, including the Endometrial Scratch Trial (ISRCTN23800982). The objective of the current review was to synthesize and critically appraise the evidence for the clinical effectiveness and safety of the endometrial scratch procedure in women undergoing their first IVF cycle. Databases searched include MEDLINE, Embase, CINAHL and ClinicalTrials.gov. Eligible randomized controlled trials included women undergoing IVF for the first time that reported the effectiveness and/or safety of the endometrial scratch procedure; 12 studies were included. Meta-analysis showed no evidence of a significant effect of the endometrial scratch on LBR (10 trials, odds ratio [OR] 1.17, 95% confidence interval [CI] 0.76-1.79) or other pregnancy outcomes. This review confirms that there is a lack of evidence that endometrial scratch improves pregnancy outcomes, including LBR, for women undergoing their first IVF cycle. Clinicians are recommended not to perform this procedure in individuals undergoing their first cycle of IVF. (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Metwally, M., et al. (2020). "Surgical treatment of fibroids for subfertility." The Cochrane Database of Systematic Reviews 1: CD003857.
	Background: Fibroids are the most common benign tumours of the female genital tract and are associated with numerous clinical problems including a possible negative impact on fertility. In women requesting preservation of fertility, fibroids can be surgically removed (myomectomy) by laparotomy, laparoscopically or hysteroscopically depending on the size, site and type of fibroid. Myomectomy is however a procedure that is not without risk and can result in serious complications. It is therefore essential to determine whether such a procedure can result in an improvement in fertility and, if so, to then determine the ideal surgical approach.; Objectives: To examine the effect of myomectomy on fertility outcomes and to compare different surgical approaches.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group (CGFG) Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, Epistemonikos database, World Health Organization (WHO) International Clinical Trials Registry Platform search portal, Database of Abstracts of Reviews of Effects (DARE), LILACS, conference abstracts on the ISI Web of Knowledge, OpenSigle for grey literature from Europe, and reference list of relevant papers. The final search was in February 2019.; Selection Criteria: Randomised controlled trials (RCTs) examining the effect of myomectomy compared to no intervention or where different surgical approaches are compared regarding the effect on fertility outcomes in a group of infertile women suffering from uterine fibroids.; Data Collection and Analysis: Data collection and analysis were conducted in accordance with the procedure suggested in the Cochrane Handbook for Systematic Reviews of Interventions.; Main Results: This review included four RCTs with 442 participants. The evidence was very low-quality with the main limitations being due to serious imprecision, inconsistency and indirectness. Myomectomy versus no intervention One study examined the effect of myomectomy compared to no intervention on reproductive outcomes. We are uncertain whether myomectomy improves clinical pregnancy rate for intramural (odds ratio (OR) 1.88, 95% confidence interval (CI) 0.57 to 6.14; 45 participants; one study; very low-quality evidence), submucous (OR 2.04, 95% CI 0.62 to 6.66; 52 participants; one study; very low-quality evidence), intramural/subserous (OR 2.00, 95% CI 0.40 to 10.09; 31 participants; one study; very low-quality evidence) or intramural/submucous fibroids (OR 3.24, 95% CI 0.72 to 14.57; 42 participants; one study; very low-quality evidence). Similarly, we are uncertain whether myomectomy reduces miscarriage rate for intramural fibroids (OR 1.33, 95% CI 0.26 to 6.78; 45 participants; one study; very low-quality evidence), submucous fibroids (OR 1.27, 95% CI 0.27 to 5.97; 52 participants; one study; very low-quality evidence), intramural/subserous fibroids (OR 0.80, 95% CI 0.10 to 6.54; 31 participants; one study; very low-quality evidence) or intramural/submucous fibroids (OR 2.00, 95% CI 0.32 to 12.33; 42 participants; one study; very low-quality evidence). This study did not report on live birth, preterm delivery, ongoing pregnancy or caesarean section rate. Laparoscopic myomectomy versus myomectomy by laparotomy or mini-laparotomy Two studies compared laparoscopic myomectomy to myomectomy at laparotomy or mini-laparotomy. We are uncertain whether laparoscopic myomectomy compared to laparotomy or mini-laparotomy improves live birth rate (OR 0.80, 95% CI 0.42 to 1.50; 177 participants; two studies; I 2 = 0%; very low-quality evidence), preterm delivery rate (OR 0.70, 95% CI 0.11 to 4.29; participants = 177; two studies; I 2 = 0%, very low-quality evidence), clinical pregnancy rate (OR 0.96, 95% CI 0.52 to 1.78; 177 participants; two studies; I 2 = 0%, very low-quality evidence), ongoing pregnancy rate (OR 1.61, 95% CI 0.26 to 10.04; 115 participants; one study; very low-quality evidence), miscarriage rate (OR 1.25, 95% CI 0.40 to 3.89; participants = 177; two studies; I 2 = 0%, very low-quality evidence), or caesarean s ction rate (OR 0.69, 95% CI 0.34 to 1.39; participants = 177; two studies; I 2 = 21%, very low-quality evidence). Monopolar resectoscope versus bipolar resectoscope One study evaluated the use of two electrosurgical systems during hysteroscopic myomectomy. We are uncertain whether bipolar resectoscope use compared to monopolar resectoscope use improves live birth/ongoing pregnancy rate (OR 0.86, 95% CI 0.30 to 2.50; 68 participants; one study, very low-quality evidence), clinical pregnancy rate (OR 0.88, 95% CI 0.33 to 2.36; 68 participants; one study; very low-quality evidence), or miscarriage rate (OR 1.00, 95% CI 0.19 to 5.34; participants = 68; one study; very low-quality evidence). This study did not report on preterm delivery or caesarean section rate.; Authors' Conclusions: There is limited evidence to determine the role of myomectomy for infertility in women with fibroids as only one trial compared myomectomy with no myomectomy. If the decision is made to have a myomectomy, the current evidence does not indicate a superior method (laparoscopy, laparotomy or different electrosurgical systems) to improve rates of live birth, preterm delivery, clinical pregnancy, ongoing pregnancy, miscarriage, or caesarean section. Furthermore, the existing evidence needs to be viewed with caution due to the small number of events, minimal number of studies and very low-quality evidence. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Meyer, I. (2023). "Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery." ClinicalTrials.gov.
	No Results Available Procedure: Platelet rich plasma (PRP) Injection|Procedure: Placebo Anterior wall descensus measured by the POP-Q System, Ba point|Apical wall descensus measured by the POP-Q System, C point|Posterior wall descensus|Leading edge|Safety outcomes|Subjective|Retreatment Female Not Applicable 60 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment IRB-300009943 December 31, 2028

Meziou, N., et al. (2023). "Hormone therapy for sexual function in perimenopausal and postmenopausal women: A systematic review and meta-analysis update." Menopause 30(6): 659-671.
	Importance Distressing sexual problems are a common complaint of menopausal women. In 2013, a Cochrane review assessed the effect of hormone therapy on sexual function in menopausal women; however, new evidence has since been published, which should be considered. Objective This systematic review and meta-analysis aims to update the evidence synthesis on the effect of hormone therapy, compared with control, on sexual function in perimenopausal and postmenopausal women. Evidence Review Thirteen databases and clinical trial registries (Cochrane Central Register of Controlled Trials, EMBASE, Medical Literature Analysis and Retrieval System Online, PsycINFO, Web of Science, Cumulative Index to Nursing and Allied Health Literature, Literatura Latino-Americana e do Caribe em Ciencias da Saude, Database of Abstracts of Reviews of Effects, ClinicalTrials.gov, International Clinical Trials Registry Platform, Iranian Registry of Clinical Trials, Chinese Clinical Trial Registry, ISRCTN) were searched from December 2012 to March 30, 2022. Backward reference searching on all retrieved full texts was also performed. Study quality was assessed using the Cochrane ROB.2 tool. Data were pooled in random-effect model meta-analyses, which included all studies identified in the present search and all studies previously included in the 2013 Cochrane review. Findings Forty-seven randomized controlled trials (35,912 participants) were included in the systematic review, and 34 randomized controlled trials (15,079 participants) were included in the meta-analysis. The meta-analysis revealed that, in comparison to control, estrogen therapy (standardized mean difference [SMD], 0.16; 95% confidence interval [CI], 0.02 to 0.29; I2 = 59%; 2,925 participants, 16 studies), estrogen plus progestogen therapy (SMD, 0.11; 95% CI, -0.07 to 0.29; I2 = 65%; 2,432 participants, 7 studies), tibolone (SMD, 0.15; 95% CI, 0.02 to 0.28; I2 = 0%; 916 participants, 2 studies), and selective estrogen receptor modulators (SMD, 0.18; 95% CI, 0.06 to 0.30; I2 = 0%; 1,058 participants, 4 studies) may result in no effect to small benefit on sexual function composite score. Conclusion and Relevance Hormone therapy may slightly improve sexual functioning. This potential small benefit should be considered when discussing treatment options for other menopausal symptoms.Copyright © Wolters Kluwer Health, Inc. All rights reserved.

Miao, C. Y., et al. (2020). "Effect of vitamin D supplementation on polycystic ovary syndrome: A meta-analysis." Experimental and Therapeutic Medicine 19(4): 2641-2649.
	The aim of the present meta-analysis was to evaluate the effect of vitamin D supplementation on patients with polycystic ovary syndrome (PCOS). A literature search was performed to identify all of the relevant studies comparing the effect of vitamin D supplementation with placebo in PCOS patients, in the PubMed, Embase and Web of Science databases. All statistical analyses were performed on case-control studies using Review Manager 5.3 software, provided by the Cochrane Collaboration. A total of 11 studies involving 483 participants were included in the current meta-analysis. Vitamin D supplementation appeared to lead to an improvement in the levels of total testosterone [weighted mean differences (WMD) = -0.10, 95% CI (-0.18, -0.02)], homeostasis model assessment of insulin resistance [WMD = -0.44, 95% CI (-0.86, -0.03)], homeostasis model assessment of beta-cell function [WMD = -16.65, 95% CI (-19.49, -13.80)], total cholesterol [WMD = -11.90, 95% CI (-15.67, -8.13)] and low-density lipoprotein-cholesterol [WMD = -4.54; 95% CI (-7.29, -1.80)]. The results failed to show a positive effect of vitamin D supplementation on the body mass index, dehydroepiandrosterone sulfate, triglyceride levels or high-density lipoprotein-cholesterol. In conclusion, the data from the available randomized controlled trials (RCTs) suggested vitamin D supplementation reduced insulin resistance and hyperandrogenism, as well improving the lipid metabolism of patients with PCOS to an extent. Further high-quality RCTs from a variety of regions in the world are required to determine the effectiveness of vitamin D supplementation in PCOS patients, and to determine a suitable dose and unit of vitamin D.Copyright © 2020 Spandidos Publications. All rights reserved.

Miao, J., et al. (2023). "Effects of Chinese Patent Medicine Combined with Hormone Replacement Therapy on Ovarian Function in Patients with premature ovarian insufficiency: a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question How do various Chinese patent medicine combined with hormone replacement therapy for POI compare with each other? What is the optimal treatment regimen for each indicator of ovarian function-related effects? Searches Literature search was conducted in PubMed, Embase, the Cochrane Library, Web of Science, Sino-Med, cnki, WanFang, VIP. Important keywords used for the search included:Premature ovarian failure; Menopause, Premature; Premature Menopause; Premature Ovarian Insufficiency; Diminished Ovarian Reserve; Ovarian Hypoplasia; Chinese medicine; Chinese herbal medicine; Herbal medicine; Capsule; Tablet; Bulk; Pill; Ointment; Dan; Pellet; Oral liquid Types of study to be included A randomized controlled trial of oral Chinese patent medicine combined with hormone replacement therapy for POI (or POF or DOR). Condition or domain being studied At present, hormone replacement therapy(HRT) is the first choice for clinical treatment of POI. However, HRT has the problem of failure of menstruation to come on time after stopping the drug, as well as lack of relief of perimenopausal symptoms such as hot flashes, night sweats, and insomnia. Some patients with POI also have reproductive needs and the hope of delaying or even reversing the trend of ovarian hypoplasia. Chinese medicine has unique advantages in treating POI, and clinical observation shows that it has outstanding efficacy in relieving perimenopausal symptoms and improving ovarian function. Participants/population P: Patients diagnosed with premature ovarian insufficiency (or premature ovarian failure, diminished ovarian reserve) Intervention(s), exposure(s) I: Oral Chinese patent medicine for the the treatment of POI, including different dosage forms (capsules, tablets, bulk, pills, creams, dans, drops, granules, oral liquid) + hormone replacement therapy (HRT) Comparator(s)/control C: hormone replacement therapy (HRT) Main outcome(s) Serum FSH, AFC levels before and after treatment Additional outcome(s) Serum AMH levels and Kupperman scores、clinical effect before and after treatment Data extraction (selection and coding) Two researchers were responsible for independently screening the literature based on the nerf criteria, and if there was disagreement it was discussed and resolved with a third researcher. Then an Excel sheet was created to extract basic information on the finally included studies as well as data on study outcome metrics Risk of bias (quality) assessment Two authors will independently assess the quality and risk of bias of included researches based on the ROB2 criteria and using the ROB2_IRPG_beta_v9 Excel. The funnel plot is adopted to evaluate the reporting characteristics.The GRADE system will be used for evaluation of quality of evidence. Disagreement will be resolved by discussion and consensus reached through a third individual . Strategy for data synthesis Relevant findings from the literature were ultimately included, and data that were significantly different were excluded to ensure stability of the results odds ratio for efficient，mean difference for FSH, AFC, AMH levels andKupperman scores Net meta-analysis will be conducted based on Bayesian theory Analysis of subgroups or subsets If assay heterogeneity is high then subgroup analysis will be done. Subgroup analysis will be based on FSH levels. Contact details for further information miao jing 1016944135@qq.com Organisational affiliation of the review Henan University of Chinese Medicine Review team members and their organisational affiliations Miss miao jing. Henan University of Chinese Medicine Kexin Zhang. Henan University of Chinese Medicine Gaijie Duan. Henan University of Chinese Medicine Zhiyuan Kang. The First Affiliated Hospital of Henan University of Chinese Medicine Baihan Niu. The First Affiliated Hospital of Henan University of Chinese Medicine Type and method of review Meta-analysis, Network meta-analysis, Systematic review Anticipated or actual start date 15 November 2023 Anticipated completion date 01 February 2024 Funding sources/sponsors Henan Province Chinese Medicine Scientific Research Special Project Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms MeSH headings have not been applied to this record Date of registration in PROSPERO 26 November 2023 Date of first submission 14 November 2023 Stage of review at time of this submission Stage

Miao, J., et al. (2022). "Systematic review and meta-analysis of the effect of Dangguishaoyao decoction in the treatment of pelvic inflammatory disease." PROSPERO International prospective register of systematic reviews.
	Review question How does Dangguishaoyao decoction impact on chronic pelvic inflammatory disease compared with other treatments? Searches PubMed （from the database set up to April first 2022） Web of Science（from the database set up to April first 2022） Cochrane Library（from the database set up to April first 2022） language was limited from English to Chinese Types of study to be included We will include randomized controlled trials to assess the beneficial effects of the treatments. Condition or domain being studied Pelvic Inflammatory Disease Participants/population Adults with pelvic inflammatory disease (as diagnosed using any recognised diagnostic criteria). Intervention(s), exposure(s) The experimental group was treated with Dangguishaoyao decoction, or with the treament of Dangguishaoyao decoction based on the control group. Comparator(s)/control The group of patients, with pelvic inflammatory disease, was treated with conventional antibiotics or other treatments. Main outcome(s) The primary outcome was total effective rate. Measures of effect relative risks of the total effective rate Additional outcome(s) The secondary outcomes were TCM syndrome score, CRP, abdominal pain score, CD4+/CD8+, and recurrence rate. Data extraction (selection and coding) Two reviewers will first independently apply eligibility criteria and selecting studies for inclusion in the systematic review, then cross-check the decisions, and discussion or ask for the third researcher will be needed if disagreements appear. Risk of bias (quality) assessment Characteristics be assessed:Selective reporting (reporting bias), methods of randomisation, treatment allocation, blinding, Incomplete outcome data (attrition bias), Other bias. The assessment use the Cochrane risk of bias tool. Ues Review Manager 5.3 to synthesize the data. Strategy for data synthesis The data be synthesised: the minimum number of studies, arithmetic mean，standard deviation，the number of positive events. Analysis of subgroups or subsets The analysis was be divided into four subgroup:the control group used antibiotics, the control group used Chinese patent medicine, the control group used herbal enema + microwave therapy, and danggui-shaoyao-san by acupoint application。 Contact details for further information miao jing 1016944135@qq.com Organisational affiliation of the review Henan University of Chinese Medicine Review team members and their organisational affiliations Miss miao jing. Henan University of Chinese Medicine Zhang Kexin. Henan University of Chinese Medicine Duan Gaijie. Henan University of Chinese Medicine Type and method of review Meta-analysis, Systematic review Anticipated or actual start date 01 May 2022 Anticipated completion date 31 December 2022 Funding sources/sponsors none Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Drugs, Chinese Herbal; Female; Humans; Pelvic Inflammatory Disease; Phytotherapy Date of registration in PROSPERO 10 May 2022 Date of first submission 13 April 2022

Miao, Z. and L. Minhui (2023). "Effectiveness and Safety of Acupoint Catgut Embedding for Premature Ovarian Insufficiency: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	Review question How does acupoint catgut embedding impact on patients with premature ovarian insufficiency compared to HRT alone? Searches We will electronically search the following databases from their from their inception to Septmber 2022: PubMed, Cochrane Library, Web of Science, Chinese Biomedical Literature Database, CNKI, Wanfang, and VIP databases. We will not apply any language or country restrictions. Various combinations of MeSH headings and keywords were used as follows: (“primary ovarian insufficiency” or “premature ovarian insufficiency” or “premature ovarian failure” or “premature ovarian dysfunction” or “decreased ovarian reserve function” or “diminished ovarian reserve function” or “poor ovarian response” or “premature menopause” or “early menopause” or “POI” or “POF”) and (“acupoint catgut embedding” or “acupoint thread embedding” or “acupoint catgut implantation” or “acupoint thread implantation” or “acupoint embedding” or “point embedding” or “acupoint implantation” or “point implantation” or “catgut embedding” or “thread embedding” or “catgut implantation” or “thread implantation” or “catgut” or “medicated threads” or “embedding” ) Types of study to be included The trails had to be RCTs that aimed to investigate the clinical efficacy of acupoint catgut embedding on POI. Condition or domain being studied Premature ovarian insufficiency (POI) refers to a clinical syndrome of decreased ovarian activity in women before the age of 40, characterized by menstrual disorders, with high gonadotropin and low estrogen levels. Women with POI experience a range of perimenopausal symptoms. POI increases the risk of serious health consequences. Currently, there is no definite and effective way to restore ovarian function. Western medicine treatment mainly includes Hormone replacement therapy (HRT) , ovulation induction, immunosuppression and so on. However, HRT requires long-term medication, with the risk of breast cancer, endometrial hyperplasia, neurodegenerative diseases, liver damage, vascular diseases and other long-term complications. Participants/population Inclusion: patients with diagnoses of POI according to Management Guidelines of POI patients. Intervention(s), exposure(s) I: acupoint catgut embedding Acupoint catgut embedding therapy is based on the theory of acupuncture and moxibustion in traditional Chinese medicine and uses absorbable surgical sutures to produce lasting acupoint stimulation in the human body, so as to achieve the purpose of treatment. Trials that evaluate acupoint catgut embedding combined with HRT will also be included. Comparator(s)/control C: HRT, sham catgut embedding therapy, placebo or blank control. Main outcome(s) The primary outcome measurement included the resumption of menstruation and the serum FSH levels between day 2 to day 5 of the menstrual cycle. Additional outcome(s) The secondary outcome measures included Serum E2, LH, AMH, menopausal symptoms and adverse events. Data extraction (selection and coding) Data extraction was performed independently by 2 authors. In case of inconsistency in the data, a third author was called to verify. The following data were extracted: first author, publication year, country, participant characteristics (age, disease duration); research features (assigned group, sample size, treatment periods); outcome indicators and adverse events. Risk of bias (quality) assessment The quality of the eligible studies were evaluated according to the “bias risk assessment” tool recommended by the Cochrane Handbook, which consisted of 6 areas: selection bias(random sequence generation/allocation concealment), performance bias, detection bias, attrition bias, reporting bias, and other biases. Each index was judged by “low risk,” “unclear,” and “high risk,” and the risk of bias distribution map was drawn. The assessment was conducted by two reviewers independently. Any disagreements were resolved by group discussion until a consensus was reached. Strategy for data synthesis Revman5.3 software was used to draw the distribution map of the risk of bias and for meta analysis. The counting data were expressed by odds ratio (OR). The measurement data were expressed by weighted mean difference (WMD) as all the evaluation hormone index units were different and the scales were not uniform. 95% confidence interval (CI) was used for both to represent each effect size. The heterogeneity between comparative studies was determined by I² and P values. When I² ≤ 50% and P > 0.10, the fixed-effect model was used to combine the data. When I² > 50% and P < 0.10, the random-effects model was used to combine the data. A two-sided P value of <0.05 was considered statistically significant. Publication bias was evaluated by funnel plots. Analysis of subgroups or subsets The following subgroup analyses plan will be considered: acupoint catgut embedding alone or combined with HRT. Contact details for further information Miao Zhou 873434749@qq.com Organisational affiliation of the review Taizhou Hospital of Zhejiang Province Review team members and their organisational affiliations Dr Miao Zhou. Taizhou Hospital of Zhejiang Province Dr Minhui Liu. Taizhou Hospital of Zhejiang Province Type and method of review Systematic review Anticipated or actual start date 01 September 2022 Anticipated completion date 31 May 2023 Funding sources/sponsors no Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Acupuncture Points; Catgut; Female; Humans; Menopause, Premature; Patients; Primary Ovarian Insufficiency Date of registration in PROSPERO 17 April 2023 Date of first submission 06 April 2023 Stage of review at time of this submission

Michaan, N., et al. (2023). "Cost-Utility Analysis of Open Radical Hysterectomy Compared to Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer." Cancers 15(17).
	We aimed to investigate the cost-effectiveness of open surgery, compared to minimally invasive radical hysterectomy for early-stage cervical cancer, using updated survival data. Costs and utilities of each surgical approach were compared using a Markovian decision analysis model. Survival data stratified by surgical approach and surgery costs were received from recently published data. Average costs were discounted at 3%. The value of health benefits for each strategy was calculated using quality-adjusted life years (QALYs). Incremental cost-effectiveness ratio, calculated using the formula (average cost minimal invasive surgery-average cost open surgery)/(average QALY minimal invasive surgery-average QALY open surgery), was used for cost-effectiveness analysis. One-way sensitivity analysis was conducted for all variables. Open radical hysterectomy was found to be cost-saving compared to minimally invasive surgery with an incremental cost-effectiveness ratio of USD -66 and USD -373 for laparoscopic and robotic surgery, respectively. The most influential parameters in the model were surgery costs, followed by the disutility involved with open surgery. Until further data are generated regarding the survival of patients with early-stage cervical cancer treated by minimally invasive surgery, at current pricing, open radical hysterectomy is cost-saving compared to minimally invasive radical hysterectomy, both laparoscopic and robotic.

Michail, P., et al. (2022). "Reproductive, obstetric and perinatal outcomes of vitrified vs. slow-frozen vs. fresh oocytes/embryos in ART: a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Miguel, F., et al. (2022). "Treatment of Pelvic Vein Disease for Lessening Dyspareunia Derived from Symptomatic Pelvic Congestion Syndrome: A Systematic Review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Mihaľová, M., et al. (2022). "Pelvic floor muscle training, the risk of falls and urgency urinary incontinence in older women." Zeitschrift fur Gerontologie und Geriatrie 55(1): 51-60.
	PURPOSE: The primary aim of the work was to evaluate the effect of physical training and pelvic floor muscle training combined with dual tasks (PFMT-DT) in older women on urgency urinary incontinence (UUI). The secondary aim of the work was to evaluate the impact of interventions on static and dynamic balance, risk of falls and fear of falls. SAMPLE: The research sample consisted of 88 older women with UUI, with a mean age of 75 ± 4.3 years. They were randomly divided into two groups: the experimental (n = 40) and control (n = 40) groups. METHODS: The duration of the intervention was 12 weeks. Both groups underwent physical training three times a week for 30 minutes. In addition, the experimental group received pelvic floor muscle training in different positions and with dual cognitive tasks two times a week for 30 minutes. We used The International Consultation on Incontinence Questionnaire (ICIQ-UI SF), the modified Voiding Diary, and the Overactive Bladder Questionnaire(OAB-q). The risk of falls were assessed according to Tinetti's Performance Oriented Mobility Assessment. Fear of falls was assessed by the Falls Efficacy Scale. RESULTS: After the treatment, significant differences between groups were recorded in favor of the experimental group in the daytime frequency of voiding (7.6 to 5.3), in nycturia (2.1 to 0.7), in UUI (1.8 to 1.0), OAB-q SS (40.8 to 17.6) and OAB-q HR (61.2 to 83.8) (p ≤ 0.001), with large effect size (ES), as well as in the Tinetti balance and gait and in the fall risk assessment (19.2 to 23.2) (p ≤ 0.001), also with a large ES. For fear of falls, significant differences were noted (80.0 to 71.5) (p ≤ 0.05), with a small ES in favor of the experimental group. CONCLUSION: The PFMT-DT proved to be an effective intervention in improving the symptoms of OAB and UUI. We were able to significantly reduce the risk of falls according to POMA by about 21% (19.2 ± 2.7 to 23.20 ± 3.25%) in older women with UUI.

Mikail, K., et al. (2023). "Vitamin D Levels and Outcomes After In Vitro Fertilization:A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Mikayla, S., et al. (2023). "Complementary, Integrative, Psychological &amp; Multimodal Physical Therapy Treatments for the Management of Dyspareunia, and Sexual Dysfunction in Women: A Systematic Review." PROSPERO International prospective register of systematic reviews.
	
Mikocka-Walus, A. (2023). "Co-Designing, Evaluating, and Implementing Supportive Care for Endometriosis (CoDeEndo)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: CoDeEndo is a modular telehealth‐based supportive care program for people with endometriosis. Phase 1 of the study will occur over 10 months and involve refining the structure of CoDeEndo (as a whole model) utilising workshops and interviews with consumers, their representatives, and interdisciplinary healthcare professionals. Phase 2 will follow phase 1 and will occur over 34 months. Phase 2 will evaluate the efficacy of CoDeEndo (versus education) as follows: CoDeEndo is an adaptive and flexible self‐guided intervention where the dose and the content of the intervention is individualised to each person, based on their needs and attributes. A screening algorithm built into the online platform suggests the order of the modules to be taken based on needs. However, participants will have access to all the modules and the algorithm only dictates their order. CoDeEndo includes eight modules that are evidence‐based, self‐directed and comprised of a mi Xof video, podcasts and written resources, which have been developed by our team for people with endometriosis or other chronic pelvic conditions to assist participants to master new skills through practical activities. They involve psychological, movement and dietary approaches to target poor QoL, pain, fatigue, gut symptoms, anxiety, depression and infertility, and are provided during and in addition to usual medical care. Participants will receive email notifications every week directing them to information and resources within CoDeEndo and will be able to access each module as needed. Each weekly recording will go for between 1‐2 hours, with the total weekly time commitment being no more than three hours. Participants’ adherence to the intervention will be monitored using Google analytics. Each week, partici CONDITION: Endometriosis;Pain; ; Endometriosis ; Pain Reproductive Health and Childbirth ‐ Menstruation and menopause PRIMARY OUTCOME: Endometriosis‐related quality of life measured by the 30‐item endometriosis Health Profile (EHP‐30)[Baseline, post‐treatment at 8 weeks and 6 months (primary endpoint) since baseline] Quality of life will be measured by the Euroqol (EQ)‐5D‐5L[Baseline, post‐treatment at 8 weeks and 6 months (primary endpoint) since baseline] INCLUSION CRITERIA: Participants will be adults with a diagnosis of endometriosis by a qualified physician (confirmed by histology, operation reports, and/or ultrasound scan), capacity for consent, sufficient level of English to understand the intervention and be able answer relevant questionnaires via internet (individually or with support). SECONDARY OUTCOME: Diet data on a 3‐day food diary (composite: energy, nutrient and FODMAP intake on Foodworks and the Monash FODMAP calculator)[Baseline, post‐treatment at 8 weeks and 6 months since baseline] Fatigue with the Fatigue Symptom Inventory (FSI)[Baseline, post‐treatment at 8 weeks and 6 months since baseline] Gastrointestinal symptom data will be collected using the Gastrointestinal Symptom Rating Scale (GSRS), a 7‐level Likert scale (1–7), based on the intensity and frequency of GI symptoms experienced during the previous seven days. [Baseline, post‐treatment at 8 weeks and 6 months since baseline] Health utilisation and cost data will be collected via a consumer Resource Use Questionnaire and employment questionnaire, including hospitalisation use, length of stay, diagnostic tests, hospital attendance with no admission community allied health visits related to endometriosis and any other related out‐of‐pocket expenses, e.g., transportation, child care. Medicare Australia records will be retrieved for consented participants to determine medical services and pharmaceutical use.[Baseline, post‐treatment at 8 weeks and 6 months since baseline] Menstrual symptoms with the Menstrual Symptoms Questionnaire (MSQ)[Baseline, post‐treatment at 8 weeks and 6 months since baseline] Pain and functioning with the Brief Pain Inventory (BPI)[Baseline, post‐treatment at 8 weeks and 6 months since baseline] Psycho gical symptoms with the Depression Anxiety Stress Scale ‐ 21 items (DASS‐21)[Baseline, post‐treatment at 8 weeks and 6 months since baseline] Self‐efficacy with the Pain Self‐Efficacy Questionnaire (PSEQ)[Baseline, post‐treatment at 8 weeks and 6 months since baseline]

Milgrom, J., et al. (2021). "Internet and Face-to-face Cognitive Behavioral Therapy for Postnatal Depression Compared With Treatment as Usual: Randomized Controlled Trial of MumMoodBooster." Journal of Medical Internet Research 23(12): e17185.
	BACKGROUND: Previous research has confirmed that symptoms of postnatal depression (PND) can be ameliorated through internet-delivered psychological interventions. Advantages of internet-delivered treatment include anonymity, convenience, and catering to women who are unable to access face-to-face (FTF) treatments. To date, no research has examined the efficacy of such interventions compared directly with FTF treatments in women clinically diagnosed with PND. OBJECTIVE: This study aims to compare the efficacy of one of the first web-based cognitive behavioral therapy (CBT) interventions (internet CBT+coach calls) for PND (MumMoodBooster [MMB]) with FTF-CBT in a randomized controlled trial (RCT). METHODS: In this study, 116 postnatal women with a Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition (DSM-IV) diagnosis of major or minor depression were randomized to MMB (39/116, 33.6%), FTF-CBT (39/116, 33.6%), or a treatment-as-usual (TAU) control condition (38/116, 32.8%). Diagnostic status was determined at baseline and at 21-week follow-up using the Structured Clinical Interview for the DSM-IV. Severity of anxiety and depressive symptoms was evaluated using the Depression Anxiety Stress Scales and the revised Beck Depression Inventory at baseline, 12-week follow-up (after treatment), and 21-week follow-up. RESULTS: Of the 116 participants, 107 (92.2%) had a diagnosis of major depression at baseline. Rates of remission from a major or minor depressive episode at 21 weeks in both the FTF-CBT and MMB groups were superior to that of the TAU group (56.6% and 47.7% less likely to be depressed, respectively) and they were not significantly different from each other. Although remission rates differed between TAU and FTF-CBT, growth models showed that, in terms of symptom reduction across time, the FTF-CBT treatment was not significantly better than TAU. By comparison, MMB was statistically superior to both TAU and FTF-CBT in reducing symptoms of depression, anxiety, and stress from baseline to the 21-week follow-up (large and moderate effect sizes). Thus, after 21 weeks, the average symptom scores for depression and anxiety of women receiving MMB were approximately half those of women in both the TAU and FTF-CBT groups. CONCLUSIONS: In this RCT, MMB was at least as effective as FTF-CBT in achieving remission from a diagnosed PND episode. MMB was superior to TAU and FTF-CBT in encouraging and maintaining reduction of symptom severity over the 21-week follow-up for depressed postnatal women. These findings replicate results of prior studies on MMB that showed clinically significant improvements in depressive symptoms, and they provide direct empirical support that internet-delivered treatment for depressed postnatal women is a viable alternative to FTF treatment. The generalizability of the results needs to be examined in future research, as RCTs of internet-based versus FTF treatments necessarily involve a subset of people who are willing to undertake either modality of treatment. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12613000881730; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364683&isReview=true.

Miller, J. M., et al. (2022). "Fluids affecting bladder urgency and lower urinary symptoms: results from a randomized controlled trial." International Urogynecology Journal 33(5): 1329‐1345.
	Introduction and hypothesis: Caffeinated, alcoholic, artificially sweetened, carbonated, and acidic beverages are pervasive and consumed in large quantities. Reputedly, these beverages are “irritating to the bladder” and result in heightened void frequency, but prior studies lack control for intake volume. We tested the null hypothesis that women recruited from the community who demonstrate overactive bladder symptoms will show no difference by groups in void frequency when one group is instructed to replace listed beverages by substituting non‐irritants (emphasis on water or milk) and the other group is instructed in healthy eating. Methods: This was a parallel‐group randomized controlled trial design with a three‐period fixed sequence (baseline and 2 and 6 weeks post‐baseline). We recruited 105 community women with overactive bladder symptoms. Inclusion criteria: >7 voids per day or 2 voids per night, daily intake of ≥16 oz. (473 ml) of beverages containing the ingredients listed above, and ≥ 32 oz. (946 ml) of total fluid intake. Stratified randomization was conducted. The primary outcome was average daily void frequency on a 3‐day diary. Results: Participants were 86% white, mean (SD) age was 46.6 (17.6) years, and baseline void frequency was 9.2 (2.9) voids per day. At 2 and 6 weeks, estimated average (SD) difference in void frequency between group 1 and group 2 was −0.46 (0.57) and −0.31 (0.57) voids per day (p > 0.05); the null hypothesis was not rejected. Conclusions: Women who reduce potentially irritating beverages while maintaining total fluid volume intake is not predictive of void frequency. Further research on type and volume of beverage intake is recommended.

Min, J., et al. (2023). "Efficacy and safety of GnRH receptor agonist/antagonist, Estrogen-progestin contraceptive, IUD, NSAIDs in treating endometriosis associated pelvic pain: A systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Min, X. and Y. Honge (2023). "Effectiveness of acupuncture in infertility patients due to luteal phase defect: a meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Min, X., et al. (2023). "The effects of behavioral intervention in womon on patients with polycystic ovary syndrome&#xff1a;A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Mina, M., et al. (2022). "Physiotherapy Interventions for Pregnancy-Related Lumbo-Pelvic Pain during Antepartum: a Systematic Review of Randomized Control Trials." PROSPERO International prospective register of systematic reviews.
	
Minami, H. (2023). "Patient Reported Outcomes Study Using Electronic Monitoring System for Advanced or Metastatic Solid Cancer." ClinicalTrials.gov.
	This is a multicenter, open‐label, randomized, controlled study to test the hypothesis that ePRO monitoring added to usual care helps prolong OS or maintain and improve HRQoL in patients with unresectable advanced cancers or metastatic/recurrent solid tumors receiving systemic drug therapy.

Miriello, D., et al. (2021). "Uterine fibroids treatment: do we have new valid alternative? Experiencing the combination of vitamin D plus epigallocatechin gallate in childbearing age affected women." European Review for Medical and Pharmacological Sciences 25(7): 2843-2851.
	OBJECTIVE: Uterine myomas are the most common benign tumors in females, and at least 25% of affected patients experience symptoms severe enough to need treatment, like heavy hemorrhage, pelvic pain, and infertility. Currently, a non-invasive approach is preferred in women of childbearing age who desire pregnancy. The aim of our study was to determine the effect of oral supplementation with a combination of vitamin D plus epigallocatechin gallate (EGCG) and vitamin B6 in women with myomas. PATIENTS AND METHODS: Between April and December 2020, we enrolled 95 women of childbearing age, afferent to our hospital, displaying at least one myoma with a diameter <4 cm. Patients were divided in two groups: 41 women were treated daily with two tablets of 25 μg vitamin D + 150 mg EGCG + 5 mg vitamin B6 for 4 months; 54 women, representing the control group, received no treatment. Total volume and vascularization of myomas were analyzed ultrasonographically. Bleeding and pelvic pain was also evaluated, as well as patients' quality of life and health through questionnaire Short Form Health Survey (SF-36) and Patient Global Impression of improvement (PGI-I). RESULTS: After treatment myomas' total volume and peripherical vascularization significantly decreased respectively by 37.9% (p<0.001) and 7.7%. On the other hand, we observed an increase in myomas' volume by 5.5 % and of peripherical vascularization by 5% in the control group. The treated group reported an improvement in SF-36 (p<0.001) and PGI-I (85.4%) questionnaire scores. CONCLUSIONS: We demonstrated, in young women who want to preserve fertility, that the combined supplementation of vitamin D, EGCG, and vitamin B6 reduced myomas' volume and improved patients' quality of life, without side effects.

Mirza Mansoor, R., et al. (2023). "Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer." The New England Journal of Medicine 388(23): 2145-2158.
	Background: Dostarlimab is an immune-checkpoint inhibitor that targets the programmed cell death 1 receptor. The combination of chemotherapy and immunotherapy may have synergistic effects in the treatment of endometrial cancer.; Methods: We conducted a phase 3, global, double-blind, randomized, placebo-controlled trial. Eligible patients with primary advanced stage III or IV or first recurrent endometrial cancer were randomly assigned in a 1:1 ratio to receive either dostarlimab (500 mg) or placebo, plus carboplatin (area under the concentration-time curve, 5 mg per milliliter per minute) and paclitaxel (175 mg per square meter of body-surface area), every 3 weeks (six cycles), followed by dostarlimab (1000 mg) or placebo every 6 weeks for up to 3 years. The primary end points were progression-free survival as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, and overall survival. Safety was also assessed.; Results: Of the 494 patients who underwent randomization, 118 (23.9%) had mismatch repair-deficient (dMMR), microsatellite instability-high (MSI-H) tumors. In the dMMR-MSI-H population, estimated progression-free survival at 24 months was 61.4% (95% confidence interval [CI], 46.3 to 73.4) in the dostarlimab group and 15.7% (95% CI, 7.2 to 27.0) in the placebo group (hazard ratio for progression or death, 0.28; 95% CI, 0.16 to 0.50; P<0.001). In the overall population, progression-free survival at 24 months was 36.1% (95% CI, 29.3 to 42.9) in the dostarlimab group and 18.1% (95% CI, 13.0 to 23.9) in the placebo group (hazard ratio, 0.64; 95% CI, 0.51 to 0.80; P<0.001). Overall survival at 24 months was 71.3% (95% CI, 64.5 to 77.1) with dostarlimab and 56.0% (95% CI, 48.9 to 62.5) with placebo (hazard ratio for death, 0.64; 95% CI, 0.46 to 0.87). The most common adverse events that occurred or worsened during treatment were nausea (53.9% of the patients in the dostarlimab group and 45.9% of those in the placebo group), alopecia (53.5% and 50.0%), and fatigue (51.9% and 54.5%). Severe and serious adverse events were more frequent in the dostarlimab group than in the placebo group.; Conclusions: Dostarlimab plus carboplatin-paclitaxel significantly increased progression-free survival among patients with primary advanced or recurrent endometrial cancer, with a substantial benefit in the dMMR-MSI-H population. (Funded by GSK; RUBY ClinicalTrials.gov number, NCT03981796.). (Copyright © 2023 Massachusetts Medical Society.)

Mizuno, M. (2022). "Effects and Functioning of an Online Support Program to Facilitate Female Cancer Patients Managing their Health and Illness." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: An online support program was designed to improve and maintain quality of life in female cancer patients by empowering them to manage their own health behavior. The program consisted of three kinds of applications to help patients: a) check their own understanding of cancer diagnosis and treatment; b) facilitate health monitoring, and c) address mental health issues. The program will be provided to the patients after having received a diagnosis and explanation of the disease and its treatment from their physician. The patients assigned to the experimental group will use the application to carry out health monitoring, check their understanding of their cancer diagnosis and treatment, and to address mental health issues. Meanwhile the patients who are assigned to a control group will use the application only for health monitoring. CONDITION: Neoplasms of Breast, Ovarian, Uterine Cervical, Uterine, Colon, or Thyroid D001943, D010051, D002583, D014594, D003110 ,D013964 PRIMARY OUTCOME: The total score measured by using the Japanese version of the Ferrans and Powers Quality of Life Index (QLI‐J) at 6 months after measuring baseline score. SECONDARY OUTCOME: 1) The total scores measured using the QLI‐J at baseline, at 1 month, and at 3 months.; 2) Four kinds of subscales' scores (health/functioning, social/economic, psychological/spiritual, family) measured using the QLI‐J; two kinds of subscales' scores (symptoms, symptom related interference) measured using the M.D. Anderson Symptom Inventory; and two kinds of subscales' scores (anxiety, depression) measured using the Hospital Anxiety and Depression Scale at baseline, at 1 month, at 3 months, and at 6 months.; 3) Level of satisfaction with health care needs and evaluation of the online support program measured using ordinal scales.; 4) Nominal variables will be drawn from participants' responses to questions about their own medical conditions,the treatment course, and issues related to the disease and treatment. ; 5) Descriptions written to help participants improve their mental health improve through use of the application. INCLUSION CRITERIA: Patients will be included who meet the following criteria: 1) Patients with cancer diagnosis who have been explained about medical condition and the treatment courses by their physician 2) Patients who receive treatment for cancer for the first time in the National Cancer Center Hospital East 3) Patients who are waiting to be treated in hospital or in an outpatient setting 4) Patients who are from 18 to 75 years old at the time of obtaining informed consent 5) Patients who can go through the online support‐program using tablet computers, personal computers, or smartphones at an outpatient setting or in their homes 6) Patients who are required to receive treatment at the departments of breast surgery, medical oncology, gynecology, gastrointestinal oncology, or head and neck medical oncology

Mizuno, M., et al. (2023). "Veliparib with frontline chemotherapy and as maintenance in Japanese women with ovarian cancer: a subanalysis of efficacy, safety, and antiemetic use in the phase 3 VELIA trial." International Journal of Clinical Oncology 28(1): 163-174.
	Background: The phase 3 VELIA trial evaluated veliparib with carboplatin/paclitaxel and as maintenance in patients with high-grade serous ovarian carcinoma.; Methods: Patients with previously untreated stage III-IV high-grade serous ovarian carcinoma were randomized 1:1:1 to control (placebo with carboplatin/paclitaxel and placebo maintenance), veliparib-combination-only (veliparib with carboplatin/paclitaxel and placebo maintenance), or veliparib-throughout (veliparib with carboplatin/paclitaxel and veliparib maintenance). Randomization stratification factors included geographic region (Japan versus North America or rest of the world). Primary end point was investigator-assessed median progression-free survival. Efficacy, safety, and pharmacokinetics were evaluated in a subgroup of Japanese patients.; Results: Seventy-eight Japanese patients were randomized to control (n = 23), veliparib-combination-only (n = 30), and veliparib-throughout (n = 25) arms. In the Japanese subgroup, median progression-free survival for veliparib-throughout versus control was 27.4 and 19.1 months (hazard ratio, 0.46; 95% confidence interval, 0.18-1.16; p = 0.1 [not significant]). In the veliparib-throughout arm, grade 3/4 leukopenia, neutropenia, and thrombocytopenia rates were higher for Japanese (32%/88%/32%) versus non-Japanese (17%/56%/28%) patients. Grade 3/4 anemia rates were higher in non-Japanese (65%) versus Japanese (48%) patients. Early introduction of olanzapine during veliparib monotherapy maintenance phase may help prevent premature discontinuation of veliparib, via its potent antiemetic efficacy.; Conclusions: Median progression-free survival was numerically longer in Japanese patients in the veliparib-throughout versus control arm, consistent with results in the overall study population. Pharmacokinetics were comparable between Japanese and non-Japanese patients. Data for the subgroup of Japanese patients were not powered to show statistical significance but to guide further investigation. (© 2022. The Author(s).)

Mizutani, Y. (2023). "Ovarian cancer ctDNA Nir-Bev study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Patients with ctDNA‐positive advanced ovarian cancer will be randomized to TC therapy + niraparib maintenance therapy or TC + Bev combination/maintenance therapy with niraparib maintenance therapy, both standard therapy. CONDITION: Ovarian cancer PRIMARY OUTCOME: Progression free survival: PFS SECONDARY OUTCOME: ctDNA negative conversion rate; Overall survival (OS); Time to first subsequent treatment (TFST); Adverse event rate; Treatment completion rate; Response rate (RR); Disease control rate (DCR); QOL INCLUSION CRITERIA: 1. Participated in "Genetic Alterations and clinical record in surgically debulked OVarian cancer patients by Liquid biopsy And whole eXome analYsis: GALAXY‐OV trial" with written consent. 2. Histopathologically diagnosed with primary ovarian cancer (including ovarian cancer, fallopian tube cancer, and peritoneal cancer). 3. 2014 FIGO classification stage III‐IV 4. Interval debulking surgery (IDS) has been performed for primary and metastatic lesions. 5. Ovarian cancer tumor tissue or cell block was collected before neoadjuvant chemotherapy. 6. No more than 4 cycles of neoadjuvant chemotherapy. 7. Aged 18 years or older at the time of informed consent. 8. Oral intake is possible. 9. ctDNA positive in the SignateraTM analysis using postoperative blood specimens. 10. ECOG performance status (PS) of 0 or 1 at the time of informed consent for this study. 11. At the time of informed consent and screening test for this study, there is no seve

Mletzko, S. (2023). "Open-label, controlled, randomized, multicenter study to demonstrate the effect of the INKA digital therapy companion on symptoms of overactive bladder (with or without urinary incontinence)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group 1: INKA digital therapy (Study duration is approximately 12 weeks per patient; patients in the INKA group will also receive a handout with instructions on how to download and install the INKA app) Group 2: No INKA digital therapy ( Study duration is approximately 12 weeks per patient; patients randomized to the control group will not be given the opportunity to download and activate the INKA app) CONDITION: ; N32.8 N32.8 Other specified disorders of bladder PRIMARY OUTCOME: To demonstrate the medical benefit of the INKA digital therapy companion in terms of change in symptoms associated with OAB or mixed incontinence in relation to the number of daily micturitions (3‐day bladder protocol according to ICIQ) in an integrated pooled analysis in patients receiving stable pharmacological treatment ("OAB med" cohort) and in patients not receiving pharmacological treatment ("OAB naive" cohort). SECONDARY OUTCOME: Investigation of the effect of the digital therapy companion INKA on ; • Disease‐specific symptoms, measured with the 3‐day bladder protocol according to ICIQ ; • Symptoms and the impact on quality of life, measured with the ICIQ‐OAB and ICIQ‐OABqol questionnaires. ; INCLUSION CRITERIA: 1. Diagnosis of OAB with or without UI or mixed incontinence due to overactive bladder in combination with stress incontinence, when overactive bladder is the predominant symptom 2. Averaged daily micturition frequency at randomization of = 8 micturitions/day, collected with a 3‐day bladder protocol according to ICIQ 3. Gender: male/female 4. Age: 18 years or older 5. Patients o who have been receiving stable pharmacologic treatment1 for the above indications for at least =4 weeks prior to screening or o who have not received (or have stopped receiving) pharmacological treatment1 for the named indications for = 4 weeks 6. Ability to read and write German. 7. Ownership and familiarity with a smartphone and ability to use it in daily life to respond to push messages, including regular use of mobile data away from home 8. Informed consent for study participation and data processing.

Mocking Roel, J. T., et al. (2020). "Omega-3 Fatty Acid Supplementation for Perinatal Depression: A Meta-Analysis." The Journal of Clinical Psychiatry 81(5).
	Objective: Several randomized controlled trials (RCTs) investigated omega-3 polyunsaturated fatty acids (PUFAs) (ie, fish oil) in perinatal depression, but their efficacy remains unclear. We performed a meta-analysis of RCTs on omega-3 PUFAs for perinatal depression, comparing a priori defined subgroups: pregnant women vs postpartum women and prevention vs treatment of perinatal depression.; Methods: We searched Web of Science, Embase, PsycINFO, and the Cochrane Library, combining omega-3 PUFAs and perinatal depression terms and including publications up to February 18, 2019, for RCTs on omega-3 PUFAs compared to placebo or any active comparator.; Results: Data from 18 RCTs on 4,052 participants showed an overall significant small beneficial effect of omega-3 PUFAs on depressive symptoms compared to placebo (-0.236 standardized difference in means [SDM]; 95% CI = -0.463 to -0.009; P = .042). Heterogeneity was considerable (I² = 88.58; P < .001), with significant subgroup differences explaining 55% of between-study variance (P = .001). In depressed women, omega-3 PUFAs showed a medium effect (SDM = -0.545; 95% CI = -1.182 to 0.093; P = .094) vs no effect in nondepressed women (SDM = -0.073). Moreover, the effect was medium to large in postpartum women (SDM = -0.656; 95% CI = -1.690 to 0.378; P = .214) compared to a negligible effect during pregnancy (SDM = -0.071). RCTs specifically studying postpartum depression showed the largest effect (SDM = -0.886; 95% CI = -2.088 to 0.316; P = .149).; Conclusions: Omega-3 PUFAs have an overall significant small beneficial effect on perinatal depression, with important subgroup differences. We advise against prescribing omega-3 PUFAs for the treatment or prevention of depressive symptoms during pregnancy, given a lack of effect with low heterogeneity. In contrast, omega-3 PUFA supplementation may be a promising (add-on) treatment for postpartum depression. (© Copyright 2020 Physicians Postgraduate Press, Inc.)

Moffatt, J., et al. (2023). "Lymphadenectomy or sentinel node biopsy for the management of endometrial cancer: a network meta-analysis." The Cochrane Database of Systematic Reviews 2023(9): CD015786.
	Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To evaluate the effectiveness and safety of lymphadenectomy and sentinel node biopsy for the management of women with endometrial cancer, comparing different head-to-head comparisons in a network meta-analysis, thereby allowing ranking of alternative treatment strategies.Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Moghetti, P. (2021). "Effects of Inositol Alone or Associated With Alpha-lipoic Acid in Polycystic Ovary Syndrome Treatment." ClinicalTrials.gov.
	The aim of this study is to evaluate the effects of a 6 months treatment with inositol, alone or associated with alpha‐lipoic acid, in women with PCOS. This is a double blinded, three‐armed RCT. The study population is composed of 90 women with PCOS, recruited at the Department of Endocrinology and Metabolic Disease of Azienda Ospedaliera Universitaria Integrata (AOUI), Verona. After recruitment, subjects are randomly assigned to one of the 3 arms of treatment (Inositol + alpha lipoic acid + folic acid vs inositol + folic acid vs folic acid alone). Randomisation is stratified by BMI category (3 categories 18<BMI<25, 25≥BMI<30, 30≥BMI<35 Kg/m2); randomisation list is generated by the statistical software Stata 13.1. At baseline and after 6 months of treatment, the following data are collected: ‐ clinical examination: family and personal medical history, menstrual diary, physical examination including height, weight, waist and hip circumferences, blood pressure and hirsutism score (modified Ferriman‐Gallwey score) ‐ total and free testosterone and sex hormone binding globulin (SHBG) blood levels, evaluated in the early follicular phase or after 3 months of amenorrhea ‐ metabolic profile: glycemia and insulinemia at fasting and after 2h OGTT, serum lipids (total cholesterol, HDL‐cholesterol and triglycerides). Glycemia and insulinemia values during OGTT will be used to calculate surrogate indexes of insulin resistance ‐ insulin‐sensitivity measured by the hyperinsulinemic‐euglycemic clamp technique. Data obtained with this test will be normalized for lean mass, measured by bioelectrical impedance. The hyperinsulinemic‐euglycemic clamp is repeated after 6 months of treatment only in subjects who are insulin‐resistant at baseline (M‐value < 8.6 mg/kg min). ‐ Chronic inflammation markers (CRP) ‐ Ovarian ultrasound evaluation, including measurement of the 3 diameters for ovarian volume calculation, and follicle count. The ultrasound examination will be executed by a gynaecologist at the Department of Gynaecology and Obstetrics at AOUI, Verona. Furthermore, all the study participants are subjected to: ‐ ovulation assessment by serial progesterone dosages on weekly urinary samples. Patients are given numbered urine beakers and are instructed to collect night urine weekly, starting at the 3rd month of treatment and until the end of the study (17 samples). ‐ monitoring visits after 2 and 4 months of treatment, to evaluate therapy compliance and possible adverse events. 30 ml blood samples of the study participants will be preserved for 10 years. On these samples, further examinations will be considered if new important markers of PCOS will emerge in the future.

Mohammad, A., et al. (2023). "Effects of movement-based interventions on dysmenorrhea: a systematic review and meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Mohammad, A., et al. (2023). "Effectiveness of Pilates on postural control in women ‎with menopause: a ‎‎systematic review of interventional studies." PROSPERO International prospective register of systematic reviews.
	
Mohammadi Mohammad, M., et al. (2022). "The impact of omega-3 polyunsaturated fatty acids on primary dysmenorrhea: a systematic review and meta-analysis of randomized controlled trials." European Journal of Clinical Pharmacology 78(5): 721-731.
	Background: Primary dysmenorrhea is one of the most common complaints in women. To date, no definitive results have been reported on the effect of omega-3 polyunsaturated fatty acids (n-3 PUFAs) on primary dysmenorrhea. Therefore, this study aimed to determine the effect of n-3 PUFAs on primary dysmenorrhea using a systematic review and meta-analysis.; Methods: This study is a systematic review and meta-analysis in which the electronic databases of PubMed, Scopus, Web of Science, ProQuest, Google Scholar, and SID were searched. In this regard, randomized controlled trials (RCTs) conducted to investigate the effect of n-3 PUFAs on primary dysmenorrhea were included. The quality of the studies was assessed using the Cochrane Collaboration's Risk of Bias Tool. Meta-analysis was performed based on the random-effects model using CMA software version 2.; Results: The results of the meta-analysis showed that n-3 PUFAs reduce the severity of primary dysmenorrhea in women (SMD = -1.075, 95% CI: -1.871 to -0.279); meta-regression showed that the daily intake of n-3 PUFAs (β = 0.005, 95% CI 0.003 to 0.008, p < 0.001) and age of women (β = 0.256, 95% CI -0.157 to -0.354, p < 0.001) had a significant effect on the severity of primary dysmenorrhea.; Conclusion: The present study showed that n-3 PUFAs could have a mild effect on the severity of primary dysmenorrhea in women. Furthermore, the highest effectiveness of treatment was seen at low doses of n-3 PUFAs, and with increasing daily intake, the effectiveness of treatment with n-3 PUFAs decreased. Another finding indicated that with the increasing age of women, n-3 PUFAs showed lesser effectiveness in reducing the severity of primary dysmenorrhea. The results of the present study provide valuable evidence to primary healthcare providers and health policymakers in the treatment of primary dysmenorrhea. (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Mohammed, h., et al. (2024). "The effect of chromium supplementation in women with polycystic ovarian syndrome." PROSPERO International prospective register of systematic reviews.
	
Moheboleslam, Z., et al. (2022). "A Systematic Review and Meta-analysis of Randomized Controlled Trials of Stabilizing Exercises for Lumbopelvic Region Impact in Postpartum Women With Low Back and Pelvic Pain." Biological Research for Nursing 24(3): 338-349.
	BackgroundCountless women experience lumbopelvic pain (LBPP) after pregnancy. Physical activity is revealed as a beneficial procedure to alleviate LBPP, yet it appears that individual investigations report mixed conclusions about its effectiveness. Objective: This systematic review and meta-analysis examined the impact of stabilizing exercises on pain intensity, disability, and quality of life (QoL) in postpartum women. Data sources : A systematic search was conducted in PubMed, MEDLINE, Google Scholar, Scopus, and reference lists of included studies up to September, 2021. Study selection: Eleven studies comprising 623 participants were included and analyzed using a random-effects model. Results: Data displayed that stabilizing exercises significantly reduced pain (standard mean difference; SMD: -0.76, 95% confidence interval (CI): -1.26 to -0.27, p = .002), and disability (SMD: -1.19, 95% CI: -1.7 to -0.68, p < .001). However, our study found no significant change in QoL following stabilizing exercises (MD: 4.42, 95% CI: -5.73, 14.57, p = .39). Conclusion: Our systematic review and meta-analysis demonstrated that stabilizing interventions had some benefits in postpartum women. While there is some evidence to display the efficacy of stabilizing exercises for relieving LBPP, additional longer-term and high-quality studies are required to confirm the current findings.

Mojgan, M., et al. (2022). "the effect of cognitive behavioral therapy on depression in women with polycystic ovarian syndrome." PROSPERO International prospective register of systematic reviews.
	
Mojgan, M., et al. (2023). "The effect of Foot Reflexology for Managing Menopausal Symptoms in Women: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Mollie, M., et al. (2023). "Do intraovarian platelet-rich plasma injections improve ovarian dysfunction? A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Moloud, F. and Y. Seyde Sedighe (2023). "Evaluation of the effect of ginger, cinnamon and fennel on primary dysmenorrhea based on VAS scale: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Monk Bradley, J., et al. (2022). "A Randomized, Phase III Trial to Evaluate Rucaparib Monotherapy as Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer (ATHENA-MONO/GOG-3020/ENGOT-ov45)." Journal of Clinical Oncology 40(34): 3952-3964.
	Purpose: ATHENA (ClinicalTrials.gov identifier: NCT03522246) was designed to evaluate rucaparib first-line maintenance treatment in a broad patient population, including those without BRCA1 or BRCA2 (BRCA) mutations or other evidence of homologous recombination deficiency (HRD), or high-risk clinical characteristics such as residual disease. We report the results from the ATHENA-MONO comparison of rucaparib versus placebo.; Methods: Patients with stage III-IV high-grade ovarian cancer undergoing surgical cytoreduction (R0/complete resection permitted) and responding to first-line platinum-doublet chemotherapy were randomly assigned 4:1 to oral rucaparib 600 mg twice a day or placebo. Stratification factors were HRD test status, residual disease after chemotherapy, and timing of surgery. The primary end point of investigator-assessed progression-free survival was assessed in a step-down procedure, first in the HRD population (BRCA-mutant or BRCA wild-type/loss of heterozygosity high tumor), and then in the intent-to-treat population.; Results: As of March 23, 2022 (data cutoff), 427 and 111 patients were randomly assigned to rucaparib or placebo, respectively (HRD population: 185 v 49). Median progression-free survival (95% CI) was 28.7 months (23.0 to not reached) with rucaparib versus 11.3 months (9.1 to 22.1) with placebo in the HRD population (log-rank P = .0004; hazard ratio [HR], 0.47; 95% CI, 0.31 to 0.72); 20.2 months (15.2 to 24.7) versus 9.2 months (8.3 to 12.2) in the intent-to-treat population (log-rank P < .0001; HR, 0.52; 95% CI, 0.40 to 0.68); and 12.1 months (11.1 to 17.7) versus 9.1 months (4.0 to 12.2) in the HRD-negative population (HR, 0.65; 95% CI, 0.45 to 0.95). The most common grade ≥ 3 treatment-emergent adverse events were anemia (rucaparib, 28.7% v placebo, 0%) and neutropenia (14.6% v 0.9%).; Conclusion: Rucaparib monotherapy is effective as first-line maintenance, conferring significant benefit versus placebo in patients with advanced ovarian cancer with and without HRD.

Monks David, T., et al. (2022). "Interventions to treat and prevent postpartum depression: a protocol for systematic review of the literature and parallel network meta-analyses." Systematic Reviews 11(1): 282.
	Introduction: Postpartum depression has costly consequences for the mother, baby, and society. Numerous pharmacological and non-pharmacological interventions are available for the prevention and treatment of postpartum depression. To date, no attempt has been made to synthesize the evidence from comparisons of interventions both within and across these categories.; Methods: We will perform a systematic review of the literature and perform network meta-analysis of interventions to (a) prevent and (b) treat postpartum depression. This review will include studies of primiparous or multiparous women during pregnancy or within 12 months of delivery of their baby that assess either interventions initiated during pregnancy or within 1 year of childbirth. Comparators will be other eligible interventions or control conditions. The outcome of interests will be related to the antidepressant efficacy of the interventions as well as their acceptability. The published literature will be searched in Ovid MEDLINE 1946-, Embase.com 1947-, Scopus 1823-, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov. The search will use a combination of standardized terms and keywords for postpartum depression, a sensitive search filter to limit for randomized controlled trials, and a librarian-created "humans" filter. The search results will be uploaded to the Covidence online systematic review platform (Veritas Health Information Ltd., Victoria, Australia) where two review team members will independently screen articles. We will extract data to include year of publication, language, country, participants (number, demographic data, eligibility criteria, psychiatric symptoms, and co-morbidities), characteristics of the intervention and control conditions, and reported outcomes. Risk of bias for each study will be assessed independently by two review authors using the RoB 2: A revised Cochrane risk of bias tool for randomized trials. Network meta-analysis will be performed using a Bayesian hierarchical model supplemented with a Markov chain Monte Carlo approach.; Discussion: Postpartum depression is a devastating disease with long-lasting consequences. Given the numerous available interventions to both prevent and treat postpartum depression and the great number of studies comparing them, it is imperative that clinicians and patients are provided with an assessment of their comparative efficacy and acceptability.; Systematic Review Registration: Prospero registration (CRD42022303247). (© 2022. The Author(s).)

Moore Kathleen, N. (2022). "A Study of Navicixizumab in Patients With Platinum Resistant Ovarian Cancer." ClinicalTrials.gov.
	No Results Available Drug: navicixizumab|Device: Xerna™ TME Panel ORR|PFS|OS|TTR|DCR|DOR Female Phase 3 400 Industry Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment ONCX-NAV-G301|2021-001933-38 August 15, 2024

Moore, K. N., et al. (2021). "Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-Controlled Randomized Phase III Trial (IMagyn050/GOG 3015/ENGOT-OV39)." Journal of Clinical Oncology 39(17): 1842-1855.
	PURPOSE: To evaluate the addition of the humanized monoclonal antiprogrammed death ligand-1 (PD-L1) antibody, atezolizumab, to platinum-based chemotherapy and bevacizumab in newly diagnosed stage III or IV ovarian cancer (OC). METHODS: This multicenter placebo-controlled double-blind randomized phase III trial (ClinicalTrials.gov identifier: NCT03038100) enrolled patients with newly diagnosed untreated International Federation of Gynecology and Obstetrics (FIGO) stage III or IV OC who either had undergone primary cytoreductive surgery with macroscopic residual disease or were planned to receive neoadjuvant chemotherapy and interval surgery. Patients were stratified by FIGO stage, Eastern Cooperative Oncology Group performance status, tumor immune cell PD-L1 staining, and treatment strategy and randomly assigned 1:1 to receive 3-weekly cycles of atezolizumab 1,200 mg or placebo (day 1, cycles 1-22), with paclitaxel plus carboplatin (day 1, cycles 1-6) plus bevacizumab 15 mg/kg (day 1, cycles 2-22), omitting perioperative bevacizumab in neoadjuvant patients. The co-primary end points were investigator-assessed progression-free survival and overall survival in the intention-to-treat and PD-L1-positive populations. RESULTS: Between March 8, 2017, and March 26, 2019, 1,301 patients were enrolled. The median progression-free survival was 19.5 versus 18.4 months with atezolizumab versus placebo, respectively (hazard ratio, 0.92; 95% CI, 0.79 to 1.07; stratified log-rank P = .28), in the intention-to-treat population and 20.8 versus 18.5 months, respectively (hazard ratio, 0.80; 95% CI, 0.65 to 0.99; P = .038), in the PD-L1-positive population. The interim (immature) overall survival results showed no significant benefit from atezolizumab. The most common grade 3 or 4 adverse events were neutropenia (21% with atezolizumab v 21% with placebo), hypertension (18% v 20%, respectively), and anemia (12% v 12%). CONCLUSION: Current evidence does not support the use of immune checkpoint inhibitors in newly diagnosed OC. Insight from this trial should inform further evaluation of immunotherapy in OC.

Moore, K. N., et al. (2021). "Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I." Annals of Oncology 32(6): 757-765.
	BACKGROUND: Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent. The randomized, open-label, phase III study FORWARD I compared MIRV and investigator's choice chemotherapy in patients with platinum-resistant epithelial ovarian cancer (EOC). PATIENTS AND METHODS: Eligible patients with 1-3 prior lines of therapy and whose tumors were positive for FRα expression were randomly assigned, in a 2 : 1 ratio, to receive MIRV (6 mg/kg, adjusted ideal body weight) or chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan). The primary endpoint was progression-free survival [PFS, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, blinded independent central review] in the intention-to-treat (ITT) population and in the prespecified FRα high population. RESULTS: A total of 366 patients were randomized; 243 received MIRV and 109 received chemotherapy. The primary endpoint, PFS, did not reach statistical significance in either the ITT [hazard ratio (HR), 0.98, P = 0.897] or the FRα high population (HR, 0.69, P = 0.049). Superior outcomes for MIRV over chemotherapy were observed in all secondary endpoints in the FRα high population including improved objective response rate (24% versus 10%), CA-125 responses (53% versus 25%), and patient-reported outcomes (27% versus 13%). Fewer treatment-related grade 3 or higher adverse events (25.1% versus 44.0%), and fewer events leading to dose reduction (19.8% versus 30.3%) and treatment discontinuation (4.5% versus 8.3%) were seen with MIRV compared with chemotherapy. CONCLUSIONS: In patients with platinum-resistant EOC, MIRV did not result in a significant improvement in PFS compared with chemotherapy. Secondary endpoints consistently favored MIRV, particularly in patients with high FRα expression. MIRV showed a differentiated and more manageable safety profile than chemotherapy.

Moori Mozhgan, H., et al. (2023). "The Effect of Exercise on Inflammatory Markers in PCOS Women: A Systematic Review and Meta-Analysis of Randomized Trials." International Journal of Clinical Practice 2023: 3924018.
	Background: Polycystic ovary syndrome (PCOS) is a typical female disorder that influences different aspects of women's health. There is a direct association between inflammation and PCOS status. Some evidence supports the beneficial effects of exercise on inflammation status in PCOS women, while others cannot find a significant association. This study aimed to clarify the effect of exercise on inflammatory markers in women with PCOS.; Method: Electronic searches in international databases were performed to identify eligible publications up to August 2021, which compared the effects of exercise on inflammatory markers in the intervention group compared to the control group in PCOS women. A weighted mean difference (WMD) using a random-effect model was applied for reporting results.; Results: A total of 2525 records were found via database searching, of which 10 were eligible to be included in the analysis. The results of the meta-analysis revealed that exercise could significantly lower the serum level of CRP (WMD: -0.43 mg/L; 95% CI: -0.66 to -0.21; P ≤ 0.01; I 2 : 84.9%; P < ≤0.01), while it was not considerable for adiponectin (WMD: -0.33 μ g/mL; 95% CI: -0.97 to 0.31; P =0.30; I 2 : 0%; P =0.97). In addition, subgroup analyses indicated a significant effect of exercise on CRP in individuals ≥30 years, sample size ≥15 individuals, and aerobic training.; Conclusion: Exercise training can reduce CRP levels in women with CRP, particularly in women older than 30 years of age, and in studies with more than 15 participants. The effect of exercise on adiponectin was not noticeable.; Competing Interests: The authors declare that they have no conflicts of interest. (Copyright © 2023 Mozhgan Hafizi Moori et al.)

Moossdorff-Steinhauser, H. F. A., et al. (2021). "Pelvic floor muscle group therapy for the treatment of urinary incontinence during pregnancy and post-partum: a randomized controlled trial." Pelviperineology 40(2): 67‐75.
	Objective: Pelvic Floor Muscle Group Therapy (PFMGT) is an effective treatment option in the general population. However, the effect of therapy during pregnancy and shortly thereafter is unclear. Therefore, this study investigates the effect of PFMGT in peri‐partum women with UI compared to care‐as‐usual. Materials and Methods: Two randomized controlled trials: Study 1: Pregnant women and study 2: 6 weeks post‐partum women, were performed. The primary outcome was UI severity based on the International Consultation on Incontinence Questionnaire‐Urinary Incontinence Short form (ICIQ‐UI SF). Secondary outcomes were the Global Impression of Severity (GPE) measuring patient’s self‐reported improvement and the Incontinence Impact Questionnaire‐7 (IIQ‐7), measuring UI impact. Descriptive and univariate analysis were reported and the non‐parametric Mann‐Whitney U test was used to compare differences between groups. Results: Inclusion numbers could not be met, and therefore all women received individual Pelvic floor muscles training (PFMT). Study 1 showed no significant results regarding the prevalence of UI (ICIQ‐UI SF), GPE and IIQ‐7 at any measurement moment. As compared to baseline, study 2 showed a significant improvement for prevalence of UI and impact of UI at 4 months post‐partum, however there was no significant difference between groups at other measurement moments. Significant subjective improvement was seen at 4th and 9th months post‐partum, in favor of the PFMT group (p=0.02). Conclusion: PFMT, started after childbirth, demonstrated improved UI and quality of life with a lower number of complaints at the 4 months post‐partum assessment. However, the full potential of effectiveness of PFMT could not be established due to insufficient inclusions.

Moradi, M., et al. (2023). "The Effect of Salvia Officinalis on Hot Flashes in Postmenopausal Women: A Systematic Review and Meta-Analysis." International Journal of Community Based Nursing and Midwifery 11(3): 169-178.
	Background: The experience of hot flashes during menopause has a negative effect on quality of life and can cause disturbance in the workplace and disrupt daily activities. Phytoestrogens in Salvia officinalis reduce menopause symptoms due to their anti-dopaminergic effects. This study was conducted to systematically review and summarize the results of clinical trials on the effect of Salvia officinalis on hot flashes in postmenopausal women.; Methods: In this systematic review, databases including Pubmed, Web of Science, Cochrane library, Scopus, SID, and Magiran were searched using keywords such as menopause, hot flashes, Salvia officinalis , and herbal medicines; all possible combinations of these words were used with the Boolean operators of "OR" and "AND". To evaluate the quality of articles, we used Cochrane's Risk of bias tools.; Results: After eliminating the duplicates, a total of 148 articles were found. Following the exclusion of irrelevant articles, 4 studies with number of 310 people were examined. Among them, 3 out of 4 studies examined the effect of Salvia officinalis on the frequency of hot flashes, 3 out of 4 studies examined the severity of hot flashes, and only 1 out of 4 studies examined the effect of Salvia officinalis on the duration of hot flashes. All 4 reviewed studies indicated that the use of Salvia officinalis reduced the frequency and severity of hot flashes in postmenopausal women. Meta-analysis results showed that the effect of Salvia Officinalis on the frequency [ES=-1.12 (%95 CI:-2.37; 0.14), I 2 =71%] of hot flashes in postmenopausal women was significant compared to placebo, but severity [ES=-2.05 (%95 CI:-6.53; 2.43), I 2 =70%] was not significant.; Conclusion: Salvia officinalis can be used to reduce the frequency of menopausal hot flashes. Expansive use of this plant can be suggested in case it is confirmed in further investigations.; Competing Interests: None declared. (Copyright: © International Journal of Community Based Nursing and Midwifery.)

Morch, N. F., et al. (2022). "Estradiol and progesterone levels in early pregnancy after natural, estradiol + progesterone or gonadotrophin stimulated frozen embryo transfer cycle: a randomised controlled trial protocol." BMJ Open 12(7): e058468.
	Introduction Frozen embryo transfer is being increasingly used for assisted reproductive therapy and offers similar pregnancy rates as treatment with fresh embryo transfer. In women with regular menstrual cycles, transfer of a frozen thawed blastocyst can be performed in either natural cycle or substituted cycle. Anovulatory women can only be offered a substituted or a stimulated cycle. Knowledge on fetal exposure to estradiol in early pregnancy is very limited, but studies on mice and rats have shown hormonal and metabolic disturbances in cubs born from estradiol-exposed mothers. We aim to investigate serum estradiol and progesterone levels in women who conceived after natural, estradiol and progesterone, or gonadotrophin stimulated frozen embryo transfer. Methods and analysis The study is an open-label, randomised controlled trial with normo-ovulatory women being randomised to natural cycle or estradiol and progesterone substitution and anovulatory women being randomised to estradiol and progesterone substitution or gonadotrophin stimulation. Serum estradiol and progesterone will be measured every 2 weeks from cycle days 2-3 until gestational age 9+6. Serum levels will be compared according to treatment regimens and cycle length. Furthermore, obstetric outcomes (live birth rates, birth weight, gestational age at birth, complications and malformations) and a possible association with serum estradiol and progesterone levels will be evaluated. Ethics and dissemination The three treatment regimens are all standard treatments and are comparable with regard to pregnancy rates. Patients will be following routine treatments and thus discomforts are limited to routine transvaginal ultrasound scans and additional blood testing. The study is approved by the Scientific Ethical Committee of the Capital Region of Denmark and the Danish Medicines Agency. The study will be carried out in accordance with the Declaration of Helsinki and monitored by a good clinical practice unit. Positive, negative and inconclusive findings will be published in international peer-reviewed journals.Copyright © Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

Morciano, A., et al. (2023). "Laparoscopic posterior vaginal plication plus sacral colpopexy for severe posterior vaginal prolapse: A randomized clinical trial." Neurourology and Urodynamics 42(1): 98-105.
	Aim: A randomized clinical trial proposing a new laparoscopic prosthetic and fascial approach to severe posterior vaginal prolapse. The primary endpoint was to evaluate the objective and subjective outcomes of our laparoscopic posterior plication (LPP) combined to "two-mesh" sacral colpopexy (laparoscopic sacral colpopexy [LSC]) in severe posterior vaginal prolapse, with a 1-year follow-up. The secondary endpoint was to evaluate the safety of this surgical procedure.; Methods: This is single-center prospective randomized double-blinded clinical trial. A total of 130 consecutive patients with anterior and/or apical pelvic organ prolapse (POP) (POP-Q stage ≥II) and severe posterior vaginal prolapse (posterior POP-Q stage ≥III) were prospectively assessed for inclusion into the study from November 2018 to January 2020. Patients underwent "two-meshes" LSC and were randomized in Group A (LSC plus LPP) and Group A (LSC alone). Of the 130 included subjects, 8 were excluded, not meeting inclusion criteria. Cure rate was evaluated objectively, using POP-Q study, and subjectively using PGI-I, POPDI-6, and FSDS questionnaires. Complications were assessed intra-, peri-, and postoperatively. Twelve-month follow-ups were analyzed for the study.; Results: We found in LSC plus LPP Group a significant improvement of Ap and genital hiatus POP-Q points. Our subjective study showed, at 12 months, a statistical difference in PGI-I successful outcomes rate in favor of LPP. Also the FSDS resulted significantly much more improved in Group A. We observed no statistical differences in terms of postoperative complications.; Conclusions: Our LPP approach to LSC could be considered an effective and safe technique to POP patients with severe posterior prolapse. (© 2022 Wiley Periodicals LLC.)

Morga, A., et al. (2024). "Systematic review and network meta-Analysis comparing the efficacy of fezolinetant with hormone and nonhormone therapies for treatment of vasomotor symptoms due to menopause." Menopause 31(1): 68-76.
	Importance The neurokinin 3 receptor antagonist fezolinetant 45 mg/d significantly reduced frequency/severity of moderate to severe vasomotor symptoms (VMS) of menopause compared with placebo in two phase 3 randomized controlled trials. Its efficacy relative to available therapies is unknown. Objective We conducted a systematic review and Bayesian network meta-Analysis to compare efficacy with fezolinetant 45 mg and hormone therapy (HT) and non-HT for VMS in postmenopausal women. Evidence Review Using OvidSP, we systematically searched multiple databases for phase 3 or 4 randomized controlled trials in postmenopausal women with >=7 moderate to severe VMS per day or >=50 VMS per week published/presented in English through June 25, 2021. Mean change in frequency and severity of moderate to severe VMS from baseline to week 12 and proportion of women with >=75% reduction in VMS frequency at week 12 were assessed using fixed-effect models. Findings The network meta-Analysis included data from the pooled phase 3 fezolinetant trials plus 23 comparator publications across the outcomes analyzed (frequency, 19 [34 regimens]; severity, 6 [7 regimens]; >=75% response, 9 [15 regimens]). Changes in VMS frequency did not differ significantly between fezolinetant 45 mg and any of the 27 HT regimens studied. Fezolinetant 45 mg reduced the frequency of moderate to severe VMS events per day significantly more than all non-HTs evaluated: paroxetine 7.5 mg (mean difference [95% credible interval {CrI}], 1.66 [0.63-2.71]), desvenlafaxine 50 to 200 mg (mean differences [95% CrI], 1.12 [0.10-2.13] to 2.16 [0.90-3.40]), and gabapentin ER 1800 mg (mean difference [95% CrI], 1.63 [0.48-2.81]), and significantly more than placebo (mean difference, 2.78 [95% CrI], 1.93-3.62]). Tibolone 2.5 mg (the only HT regimen evaluable for severity) significantly reduced VMS severity compared with fezolinetant 45 mg. Fezolinetant 45 mg significantly reduced VMS severity compared with desvenlafaxine 50 mg and placebo and did not differ significantly from higher desvenlafaxine doses or gabapentin ER 1800 mg. For >=75% responder rates, fezolinetant 45 mg was less effective than tibolone 2.5 mg (not available in the United States) and conjugated estrogens 0.625 mg/bazedoxifene 20 mg (available only as 0.45 mg/20 mg in the United States), did not differ significantly from other non-HT regimens studied and was superior to desvenlafaxine 50 mg and placebo. Conclusions The only HT regimens that showed significantly greater efficacy than fezolinetant 45 mg on any of the outcomes analyzed are not available in the United States. Fezolinetant 45 mg once daily was statistically significantly more effective than other non-HTs in reducing the frequency of moderate to severe VMS. Relevance These findings may inform decision making with regard to the individualized management of bothersome VMS due to menopause.Copyright © Wolters Kluwer Health, Inc. All rights reserved.

Mori, A. (2021). "Effects of pelvic floor muscle training for patients with stress urinary incontinence - a randomized controlled trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention group: Pelvic floor muscle training and lifestyle advice for 12 weeks Control group: Lifestyle advice CONDITION: Stress urinary incontinence PRIMARY OUTCOME: International Consultation on Incontinence Questionnaire‐short form at 12 weeks SECONDARY OUTCOME: 24‐hour pad test (amount of urinary leakage) ; King&#39;s Health Questionnaire; Overactive Bladder Symptoms Score; 3‐day bladder diary (incontinence frequency, number of micturition, number of pad use); Vaginal pressure; Patient Global Impression of Improvement; Questionnaire (further treatment) INCLUSION CRITERIA:

Morin, M. (2022). "Efficacy of High Intensity Laser for Provoked Vestibulodynia." ClinicalTrials.gov.
	No Results Available Radiation: High Intensity Laser Therapy (HILT)|Radiation: Sham High Intensity Laser Therapy Change in pain intensity during intercourse|Change in pain quality|Change in sexual function|Change in sexual distress|Change in pain catastrophizing|Change in fear of pain|Change in cognitions regarding vaginal penetration|Change in the life impact of pelvic pain|Change in intercourse self-efficacy|Level of satisfaction with treatment|Patient's global impression of change Female Not Applicable 142 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment MP-31-2023-4770 November 1, 2025

Morin, M., et al. (2021). "Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a multicenter, randomized trial." American Journal of Obstetrics and Gynecology 224(2): 189.e181-189.e112.
	BACKGROUND: Provoked vestibulodynia is the most common subtype of chronic vulvar pain. This highly prevalent and debilitating condition is characterized by acute recurrent pain located at the entry of the vagina in response to pressure application or attempted vaginal penetration. Although physical therapy is advocated as a first-line treatment for provoked vestibulodynia, evidence supporting its efficacy is scarce. OBJECTIVE: The purpose of this study was to establish the efficacy of multimodal physical therapy compared with topical lidocaine, a frequently used first-line treatment. STUDY DESIGN: We conducted a multicenter, parallel-group, randomized clinical trial in women diagnosed as having provoked vestibulodynia recruited from the community and 4 Canadian university hospitals. Women were randomly assigned (1:1) to receive either weekly sessions of physical therapy or overnight topical lidocaine (5% ointment) for 10 weeks. Randomization was stratified by center using random permuted blocks from a computer-generated list managed by an independent individual. Physical therapy entailed education, pelvic floor muscle exercises with biofeedback, manual therapy, and dilation. Assessments were conducted at baseline, posttreatment, and 6-month follow-up. Outcome assessors, investigators, and data analysts were masked to allocation. The primary outcome was pain intensity during intercourse evaluated with the numeric rating scale (0-10). Secondary outcomes included pain quality (McGill-Melzack Pain Questionnaire), sexual function (Female Sexual Function Index), sexual distress (Female Sexual Distress Scale), satisfaction (numeric rating scale of 0-10), and participants' impression of change (Patient Global Impression of Change). Intention-to-treat analyses were conducted using piecewise linear-growth models. RESULTS: Among 212 women who were recruited and randomized, 201 (95%) completed the posttreatment assessment and 195 (92%) completed the 6-month follow-up. Multimodal physical therapy was more effective than lidocaine for reducing pain intensity during intercourse (between-group pre-post slope difference, P<.001; mean group postdifference, 1.8; 95% confidence interval, 1.2-2.3), and results were maintained at 6-month follow-up (mean group difference, 1.8; 95% confidence interval, 1.2-2.5). The physical therapy group also performed better than the lidocaine group in all secondary outcomes (pain quality, sexual function, sexual distress, satisfaction, and participants' impression of change) at posttreatment and 6-month follow-up. Moreover, the changes observed after physical therapy were shown to be clinically meaningful. Regarding participants' impression of change, 79% of women in the physical therapy group reported being very much or much improved compared with 39% in the lidocaine group (P<.001). CONCLUSION: The findings provide strong evidence that physical therapy is effective for pain, sexual function, and sexual distress and support its recommendation as the first-line treatment of choice for provoked vestibulodynia.

Morris, E. (2023). "A study to evaluate the efficacy and safety of AMY109 in women with endometriosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Period 1: 4–12‐week washout period, required for participants receiving certain types of medication. Period 2: 21–45‐day screening period, to confirm participant eligibility for the study. Period 3: 52‐week treatment period, for participants to receive study treatment. Period 4: a post‐treatment follow‐up period, 52 weeks after the last dose of study drug to assess long‐term safety of AMY109. Participants will be randomised in a 3:3:2 ratio to one of the following treatment groups: 1. AMY109, and desogestrel‐placebo. A placebo looks like a medicine but does not contain any active ingredients 2. AMY109 and desogestrel 3. AMY109‐placebo and desogestrel 4. AMY109 or AMY109‐placebo will be administered every 4 weeks intravenously (directly into the vein) 5. Desogestrel will be administered daily orally (by mouth). CONDITION: Endometriosis ; Urological and Genital Diseases PRIMARY OUTCOME: Changes of total score and stage in the revised American Society of Reproductive Medicine (r‐ASRM) score assessed by laparoscopy from pre‐treatment to post‐treatment (Baseline and Week 53) INCLUSION CRITERIA: 1. Provide written informed consent and sign the Informed Consent Form 2. Female patients between 18 and 45 years of age inclusive at entering the screening period 3. Patient who is diagnosed as having endometriosis by laparoscopy, but have not yet received any surgical treatment at the diagnosis, within 6 months before entering the screening period and who is staged according to the revised American Society of Reproductive Medicine (r‐ASRM) score by central readers based on images obtained at the laparoscopic diagnosis 4. Not suitable for surgical treatment at laparoscopic diagnosis due to severe condition of the disease 5. Able to comply with study requirements in the Investigator’s judgment 6. Agree to use non‐hormonal, double‐barrier contraception such as a combination of male condom with either cap, diaphragm or sponge with spermicide and refrain from egg collection for preservation or donation until 32 weeks after the last administration of AMY1 SECONDARY OUTCOME: 1. Change in size of ovarian endometrioma assessed by MRI from baseline to Week 37 and 53.; 2. Change in size of endometriotic nodule assessed by MRI from baseline to Week 37 and 53.; 3. Change in adhesions assessed by MRI from baseline to Week 37 and 53. ; 4. Change of grade in the ENZIAN classification assessed by MRI from baseline to Week 37 and 53.; 5. Change in the MEDL score assessed by MRI from baseline to Week 37 and 53.; 6. Change in size of ovarian endometrioma from baseline to Week 25 and 53 assessed by transvaginal ultrasound (TVUS); 7.Change in size of endometriotic nodule from baseline to Week 25 and 53 assessed by TVUS; 8. Change in adhesions from baseline to Week 25 and 53 assessed by TVUS; 9. Change in monthly mean endometriosis associated pain scores (dysmenorrhea, dyspareunia, and NMPP) from baseline to each month as recorded by daily completion of an 11–point numerical rating scale (NRS) using an electronic diary (Baseline and then monthly up to Week 105); 10. Change in monthly mean endometriosis associated pain scores (dysmenorrhea, dyspareunia, and NMPP) from baseline to each month measured by the modified Biberoglu and Behrman Scale (mBBS) using an electronic diary on daily basis (Baseline and then monthly up to Week 105); 11. Change in monthly mean number of days of analgesics use to treat endometriosis associated pain from baseline to each month as recorded by daily completion of an electronic diary (Baseline and then monthly up to Week 105); 12. Change in monthly mean dose of analgesics use to treat endometriosis associated pain from baseline to each month as recorded by daily completion of an electronic diary (Baseline and then monthly up to Week 105); 13. Incidence and severity of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and adverse drug reactions up to Week 105; 14. Vital signs (pulse rate, blood pressure, body temperature). Scr ning until Week 105.; 15.12‐lead electrocardiograms (ECGs). Screening until Week 53.; 16. Laboratory investigations (urinalysis, hematology, blood chemistry, coagulation tests, and other investigations). Screening until Week 105; 17. Plasma concentration of AMY109 and IL‐8. Screening until Week 105; 18. Ovarian function measured by uterine bleeding and serum level of anti‐Müllerian hormone (AMH), follicle stimulating hormone (FSH), estradiol (E2), and progesterone (P4). Week 1 until Week 53; 19. Plasma CA125. Week 1 until Week 53; 20. Change in incidence of anti‐AMY109 antibodies. Week 1 until Week 105; 21. Change in plasma concentration of AMY109 and total IL‐8 by anti‐AMY109 antibody status (seropositive or seronegative) up to Week 105

Morris Joshua, M., et al. (2023). "A Systematic Review of Minimally Invasive Approaches to Uterine Fibroid Treatment for Improving Quality of Life and Fibroid-Associated Symptoms." Reproductive Sciences 30(5): 1495-1505.
	Improvement in symptom severity and quality of life (QoL) are critical concerns for women with fibroids as they evaluate treatment options. This systematic review analyzed available evidence regarding minimally invasive approaches to fibroid treatment and compared validated QoL and fibroid-associated symptom scores before and after treatment. A comprehensive search was conducted using PubMed, Embase, Cochrane Library, and Scopus from January 1990 to July 2020. English-language publications were included if they evaluated associations between minimally invasive approaches to fibroid treatment and QoL or fibroid-associated symptoms, and they used validated questionnaires before and after treatment. QoL or fibroid-associated symptom scores were compared and summarized for each minimally invasive approach. Thirty-seven studies were ultimately included in this review: 26 evaluating individual approaches and 11 which were comparative studies of minimally invasive approaches and surgical interventions. Radiofrequency ablation (RFA) and ultrasound-guided sclerotherapy (USGS) significantly improved overall QoL. Uterine artery embolization (UAE) and ultrasound-guided high-intensity frequency ultrasound (US-HIFU) improved overall QoL to a similar extent as surgical interventions. Twenty-eight studies assessed fibroid-associated symptoms with the Uterine Fibroid Symptoms Quality of Life Questionnaire (UFS-QoL). UAE, magnetic resonance imaging-guided high-intensity frequency ultrasound (MR-HIFU), US-HIFU, RFA, and percutaneous microwave ablation (PMWA) significantly decreased Symptom Severity Score by a range of 21 to 39 points (out of 100) at 6 months. Minimally invasive approaches to treat fibroids were effective alternatives to surgical interventions for improving quality of life, fibroid-associated symptoms, and pain. Outcomes among minimally invasive approaches were similar, presenting patients with numerous options for fibroid treatment. (© 2022. The Author(s), under exclusive licence to Society for Reproductive Investigation.)

Morris, N. (2024). "Hot Water Therapy for the Treatment of Menopause-related Hot Flashes." ClinicalTrials.gov.
	No Results Available Behavioral: Hot water therapy|Behavioral: Warm water immersion Greene climacteric questionnaire|Daily hot flash diary|Core temperature|Maximum skin wettedness|Blood plasma volume|Sweat rate|Skin blood flow|Reproductive hormone levels (estrogen, progesterone, luteinizing hormone, orexin) Female Not Applicable 100 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 2024-029-HYBL May 1, 2025

Moscho, M., et al. (2023). "A systematic review of the effect of weight loss on fertility treatment outcomes in women with excess weight." PROSPERO International prospective register of systematic reviews.
	
Motohashi, T., et al. (2021). "Randomized phase III trial comparing pegylated liposomal doxorubicin (PLD) at 50 mg/m² versus 40 mg/m² in patients with platinum-refractory and -resistant ovarian carcinoma: the JGOG 3018 Trial." Journal of Gynecologic Oncology 32(1): e9.
	OBJECTIVE: The standard dose for pegylated liposomal doxorubicin (PLD) is 50 mg/m² every 4 weeks. While 40 mg/m² has recently been used in clinical practice, evidence supporting this use remains lacking. METHODS: This phase III randomized, non-inferiority study compared progression-free survival (PFS) for patients with platinum-resistant ovarian carcinoma between an experimental arm (40 mg/m² PLD) and a standard arm (50 mg/m² PLD) until 10 courses, disease progression or unacceptable toxicity. Eligible patients had received ≤2 prior lines. Stratification was by performance status and PFS of prior chemotherapy (<3 months versus ≥3 months). The primary endpoint was PFS and secondary endpoints were overall survival (OS), toxicity profile, clinical response and tolerability. The total number of patients was 470. RESULTS: The trial was prematurely closed due to slow recruitment, with 272 patients randomized to the experimental arm (n=137) and standard arm (n=135). Final analysis was performed with 234 deaths and 269 events for PFS. In the experimental arm vs. standard arm, median PFS was 4.0 months vs. 4.0 months (hazard ratio [HR]=1.065; 95% confidence interval [CI]=0.830-1.366) and median OS was 14.0 months vs. 14.0 months (HR=1.078; 95% CI=0.831-1.397). Hematologic toxicity and oral cavity mucositis (≥grade 2) were more frequent in the standard arm than in the experimental arm, but no difference was seen in ≥grade 2 hand-foot skin reaction. CONCLUSION: Non-inferiority of 2 PLD dosing schedule was not confirmed because the trial was closed prematurely. However, recommendation of dose reduction of PLD should be based both on efficacy and safety. TRIAL REGISTRATION: UMIN Clinical Trials Registry Identifier: UMIN000003130.

Mou, T., et al. (2022). "Cost-effectiveness of prophylactic retropubic sling at the time of vaginal prolapse surgery." American Journal of Obstetrics and Gynecology 227(3): 471.e471-471.e477.
	Background: Prophylactic midurethral sling placement at the time of prolapse repair significantly reduces the risk for de novo stress urinary incontinence, but it is associated with some small but significant morbidities. Because there has not been a standardized approach to midurethral sling utilization, decision analysis provides a method to evaluate the cost and effectiveness associated with varying midurethral sling placement strategies in addressing the risk for de novo stress urinary incontinence. Objective(s): We aimed to compare the cost effectiveness of the 3 midurethral sling utilization strategies in treating de novo stress urinary incontinence 1 year after vaginal prolapse repair. The 3 approaches are (1) staged strategy in which prolapse repair is done without prophylactic midurethral sling placement, (2) universal sling placement in which prolapse repair is accompanied by prophylactic midurethral sling placement, and (3) selective sling placement in which prolapse repair is accompanied by prophylactic midurethral sling placement only in patients with a positive prolapse-reduced cough stress test. Study Design: We created a decision analysis model to compare staged strategy, universal sling placement, and selective sling placement. We modeled probabilities of de novo stress urinary incontinence, patients choosing subsequent midurethral sling surgery for de novo stress urinary incontinence, and outcomes related to midurethral sling placement. De novo stress urinary incontinence rates were determined for each strategy from published data. The likelihood of patients with de novo stress urinary incontinence choosing midurethral sling surgery as their first-line treatment was also determined from the literature, and this scenario was only applied to patients without prophylactic midurethral sling placement at their index prolapse repair. Finally, outcomes related to midurethral sling placement, including recurrent or persistent stress urinary incontinence, voiding dysfunction requiring sling lysis, mesh exposure requiring excision, and de novo overactive bladder requiring medications, were all derived from publicly available data. All midurethral sling placement procedures were assumed to be retropubic. The costs for each procedure were obtained from the 2020 Centers for Medicare & Medicaid Services Physician Fee Schedule or from previous literature with convertion to 2020 equivalent US dollar prices using the Consumer Price Index. The primary outcome was modeled as the incremental cost-effectiveness ratio. We performed multiple 1-way sensitivity analyses to assess model robustness. Result(s): The lowest-cost strategy was the staged strategy, which cost $1051.70 per patient, followed by $1093.75 for selective sling placement and $1125.54 for universal sling placement. The selective sling approach, however, had the highest health utility value; therefore, universal sling placement was dominated by selective sling placement because it is both less costly and more effective. When compared with the staged strategy, selective sling placement was cost effective with an incremental cost-effectiveness ratio of $2664 per quality adjusted life-years, meeting the predetermined threshold. In multiple 1-way sensitivity analyses, the variable with the largest effect was the percentage of patients electing to undergo subsequent midurethral sling surgery for de novo stress urinary incontinence after the index surgery. Only when this proportion exceeded 62% did universal sling placement become the cost-effective option because selective sling placement surpassed the predetermined incremental cost-effectiveness ratio threshold and became dominated. Conclusion(s): Selective sling placement was the preferred and cost-effective strategy in treating de novo stress urinary incontinence 1 year after vaginal prolapse repair. Surgeons should counsel their patients preoperatively regarding the possibility of de novo stress urinary incontinence after prolapse repair, as well as on the benefits and risks of prophylactic midurethral sli g placement surgery.Copyright © 2022 Elsevier Inc.

Mourad, A., et al. (2021). "Aspirin for Endometrial Preparation in Patients Undergoing IVF: A Systematic Review and Meta-analysis." Journal of Obstetrics and Gynaecology Canada 43(8): 984.
	Objective: To investigate the effect of aspirin on IVF success rates when used as an adjuvant treatment for endometrial preparation.; Data Sources: Relevant publications were comprehensively selected from PubMed, MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) up to November 15, 2020.; Study Selection: Randomized controlled trials (RCTs) and retrospective cohort studies that used aspirin as an adjuvant treatment for endometrial preparation and reported subsequent pregnancy outcomes were included. Studies were excluded if aspirin was used before and/or during ovarian stimulation.; Data Extraction and Synthesis: This systematic review and meta-analysis included a total of 7 studies. Risk of bias assessment was based on the methodology and categories listed in the Cochrane Handbook for the RCTs and the Newcastle-Ottawa scale for the retrospective studies. The primary outcome was live birth rate. Summary measures were reported as odds ratios (ORs) with 95% confidence intervals (CIs). There was significant evidence that aspirin for endometrial preparation improved live birth rates (OR 1.52; 95% CI 1.15-2.00). No effect was noted for clinical pregnancy rates (OR 1.37; 95% CI 1.00-1.87); however, aspirin was associated with improved pregnancy rates in a subgroup analysis of patients receiving oocyte donation (OR 2.53; 95% CI 1.30-4.92) and in the sensitivity analysis (OR 1.3; 95% CI 1.02-1.66). No effect of aspirin was found for implantation or miscarriage rates (OR 1.31; 95% CI 0.51-3.36 and OR 0.41; 95% CI 0.02-7.42, respectively).; Conclusion: These findings support a beneficial effect of aspirin for endometrial preparation on IVF success rates, mainly live birth rates, outside the context of ovarian stimulation. However, this evidence is based on poor quality data and needs to be confirmed with high-quality RCTs. (Copyright © 2021 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.)

Moya-Alarcón, C., et al. (2022). "Olaparib as first line in BRCA-mutated advanced ovarian carcinoma: Is it cost-effective in Spain?" Gynecologic Oncology 164(2): 406-414.
	Objective: To estimate the cost-effectiveness of olaparib after being funded by the Spanish National Health Service (SNHS) as first-line monotherapy maintenance treatment in patients with advanced high-grade serous ovarian carcinoma (HGSOC) and BRCA mutations in Spain.; Methods: A semi-Markov model with one-month cycles was adapted to the Spanish healthcare setting, using the perspective of the SNHS, and a time horizon of 50 years. Two scenarios were compared: receiving olaparib vs. no maintenance treatment. The model comprised four health states and included the clinical results of the SOLO1 study, along with the direct healthcare costs associated with the use of first-line and subsequent treatment resources (2020 €). A discount rate of 3% was applied for future cost and quality-of-life outcomes. A probabilistic sensitivity analysis (PSA) was also carried out and a cost-effectiveness threshold of €25,000 per quality adjusted life year (QALY) was considered.; Results: The introduction of olaparib as a first-line maintenance treatment for advanced HGSOC patients with BRCA mutations implied a cost of €131,614.98 compared to €102,369.54 without olaparib (difference: €29,245.44), with an improvement of 2.00 QALYs (5.56 and 3.57, respectively). Therefore, olaparib is cost-effective for advanced HGSOC patients with BRCA mutations, with an incremental cost-effectiveness ratio of €14,653.2/QALY. The results from the PSA showed that 92.1% of the simulations fell below the €25,000/QALY threshold. The model showed that olaparib could improve the overall survival by 2 years, vs. no maintenance treatment.; Conclusions: Olaparib as first-line maintenance treatment is cost-effective in advanced HGSOC patients with BRCA mutations in Spain. (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Mu, E. (2023). "Zoely vs. Zoloft in Premenstrual Dysphoric Disorder." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Arm 1 : Sertraline 100mg oral tablet daily for 2 months or Arm 2: Nomegestrol acetate (2.5mg) and 17‐beta estradiol (1.5mg) (Zoely) oral tablet daily for 2 months. CONDITION: Mental Health ‐ Depression premenstrual dysphoric disorder; ; premenstrual dysphoric disorder PRIMARY OUTCOME: Change in the Daily Record of Severity of Problems (DRSP) in the luteal phase[7‐days before menses, to 7‐days after menses, and to be completed across two menstrual cycles in months 1 and 2 therefore 2 months prior to treatment ] SECONDARY OUTCOME: Depression, anxiety and stress scale (DASS)[Change in DASS scores over time from Baseline to week 8 ] Montgomery‐Asberg Depression Rating Scale (MADRS) ; [Change in MADRS scores over time from Baseline to week8 ] INCLUSION CRITERIA: Women of reproductive age (18‐50 years) with regular menstrual cycles who: 1. Meet the DSM‐5 diagnostic criteria for PMDD 2. Confirmation of PMDD diagnosis using the Carolina Premenstrual Assessment Scoring System (C‐PASS) within the past 6 months. This scoring system confirms a PMDD diagnosis using two or more months of daily symptom ratings with the Daily Record of Severity of Problems measurement tool. 3. Report at least one‐year history of regularly experiencing PMDD symptoms, with sudden onset and sudden offset of depressive symptoms. This may or may not directly coincide with the luteal phase 4. No increase/initiation of new antidepressant(s) in the 4 weeks prior to randomisation 5. Must use appropriate barrier contraception precaution 6. Demonstrated capacity to give informed consent

Mu, F., et al. (2023). "Efficacy and safety of recombinant human granulocyte colony-stimulating factor in patients with unexplained recurrent spontaneous abortion: A systematic review and meta-analysis." Journal of Reproductive Immunology 156: 103830.
	Introduction: Published data regarding efficacy of intrauterine perfusion of recombinant human granulocyte colony-stimulating factor for patients with unexplained recurrent spontaneous abortion (URSA) is inconclusive. This study aims at evaluating the efficacy and safety of G-CSF in URSA.; Materials and Methods: Electronic databases were searched including Cochrane Library, PubMed, Embase, China Biology Medicine disc, China Science and Technology Journal Database, Wanfang Database and China National Knowledge Infrastructure Database (last search was performed on Sep 10th, 2022). A systematic review and meta-analysis was conducted with R-language software. Combined relative risk (RRs), and 95% confidence intervals (CIs) were calculated to estimate efficacy and safety.; Results: Compared with placebo, the efficacy of G-CSF in the treatment of URSA patients was significant in conception rate (RR=1.34, 95%CI: 1.03-1.74, P = 0.028), and was none of significance in live birth rate (RR=1.35, 95%CI: 0.99-1.84, P = 0.06). Subgroup analysis showed that the ovulation-period-medication was the protective factor for conception rate, while "Ethnicity Asian" and "ovulation-period medication" were the protective factors for live birth rate. When it comes to the safety of rhG-CSF on URSA, meta-analysis showed that rhG-CSF had no significant effect on the incidence of adverse events (AEs) (RR=1.13, 95% CI: 0.89-1.43, P = 0.322), and subgroup analysis showed that the incidence of AEs in each subgroup did not increase significantly (P > 0.05).; Conclusion: Based on our meta-analysis, intrauterine perfusion of rhG-CSF in ovulation period is an effective and safe way to improve conception rate in URSA.; Competing Interests: Conflict of interest The authors declare that they have no competing interests. (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Mu, F., et al. (2023). "Effect of granulocyte colony-stimulating factor on clinical pregnancy outcomes of recurrent miscarriage and recurrent implantation failure cases: A meta-analysis." Journal of Biological Regulators and Homeostatic Agents 37(4): 1933-1947.
	Objective: This meta-analysis aimed to evaluate the effect of granulocyte colony-stimulating factor (G-CSF) on the treatment of recurrent miscarriage (RM) and recurrent implantation failure (RIF). Method(s): Eligible randomized controlled trials (RCTs) and cohort studies were retrieved from the Web of Science, Cochrane, and PubMed databases and evaluated using the Jadad scale or Newcastle-Ottawa Scale. Cochran's Q test and I2 statistics were used to assess heterogeneity. The effect sizes for clinical pregnancy and abortion rates of patients were pooled as risk ratios (RRs) and 95% confidence intervals (CI) using RevMan 5.3. Publication bias was assessed using funnel plots. Result(s): Thirteen studies (nine RCTs and three cohort studies) involving 1262 participants were included. Compared to the control/placebo group, the use of G-CSF significantly improved the clinical pregnancy rate [RRs (95% CI) = 1.73 (1.41, 2.12), p <0.00001] of RIF patients; Whereas it had no significant impact on their abortion rate [RRs (95% CI) = 1.13 (0.43, 2.95), p = 0.80]. Both subcutaneous and intrauterine injections of G-CSF could improve the clinical pregnancy rate in RIF patients. However, subcutaneous injection showed a tendency to increase the abortion rate [RRs (95% CI) = 1.98 (0.40, 9.87), p = 0.40], whereas intrauterine injection showed a tendency to decrease the abortion rate for RIF patients [RRs (95% CI) = 0.93 (0.24, 3.53), p = 0.11]. In addition, G-CSF use had no significant impact on the clinical pregnancy rate of RIF patients in a South American study [RRs (95% CI) = 1.20 (0.60, 2.38), p = 0.60]. For RM patients, the use of G-CSF showed improved clinical pregnancy rates [RRs (95% CI) = 1.43 (0.76, 2.70), p = 0.27] and lower abortion rates [RRs (95% CI) = 0.80 (0.46, 1.14), p = 0.44] than control/placebo group; However, the difference was not significant. Similar results were observed in the subcutaneous, intrauterine injection, and regions subgroups of RM patients. Conclusion(s): This meta-analysis confirmed the benefits of G-CSF in improving the clinical pregnancy rate of RIF patients. No conclusive evidence supports the link between G-CSF use and increased abortion rate in RIF patients and clarifies the association of G-CSF use with clinical pregnancy and abortion rates in patients with RM.Copyright © 2023 The Author(s).

Mu, T.-Y., et al. (2021). "Internet-based interventions for postpartum depression: A systematic review and meta-analysis." Nursing Open 8(3): 1125-1134.
	Aim: To determine the efficacy of Internet-based interventions in decreasing the prevalence of postpartum depression in perinatal women.; Design: This review was conducted according to the standards outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.; Methods: We performed a systematic meta-analysis of randomized controlled trials on the efficacy of Internet-based interventions for postpartum depression. Studies (2008-2018) were identified through a search conducted on PubMed, EMBASE and the Cochrane Library. Risk ratios or weighted mean differences with 95% confidence intervals were calculated using a fixed-effects model or a random-effects model. Stata software 11.0 was used to perform the meta-analysis.; Results: Most of the seven eligible studies were randomized controlled trials. The random-effects model indicated that Internet-based interventions significantly improved postpartum depression (d = 0.642, N = 7). Attrition rates ranged from 4.5%-86.9% and from 0%-87.1% for the intervention and control groups, respectively. (© 2020 The Authors. Nursing Open published by John Wiley & Sons Ltd.)

Muhammad Irfan Bin Abdul, J., et al. (2023). "PD-1 and PDL-1 immunotherapy in advanced and recurrent cervical cancer: A Systematic Review and Bayesian Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Muhammad, J., et al. (2022). "Elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroid: a systematic review and meta-analysis." BMC Women's Health 22(1): 14.
	Background: Elagolix is effective and safe for treating menorrhagia in women with uterine fibroid. However, it is reported to be associated with hypoestrogenism that can be alleviated by adding estradiol/norethindrone acetate. This systematic review and meta-analysis aimed to determine the effectiveness of elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroid by comparing: elagolix versus placebo and elagolix versus estradiol/norethindrone acetate.; Methodology: The Cochrane Central Register of Controlled Trials (CENTRAL 2021, Issue 3 of 12), MEDLINE databases (1980 to December week 1, 2020), and trial registries for relevant randomized clinical trials were used. All randomized clinical trials were reviewed and evaluated. Random effects models were used to estimate the dichotomous outcomes and mean differences with 95% confidence intervals. Data for risk of bias, heterogeneity, sensitivity, reporting bias and quality of evidence were assessed.; Results: Four randomized controlled trials with 1949 premenopausal women from 323 locations were included. Elagolix improved menstrual blood loss of less than 80 ml (RR 4.81, 95% CI 2.45 to 9.45; four trials, 869 participants; moderate quality evidence) or more than 50% reduction from baseline (RR 4.87, 95% CI 2.55 to 9.31; four trials, 869 participants; moderate quality evidence) compared to placebo. There was no difference in menstrual blood loss of less than 80 ml (RR 1.08, 95% CI 1.00 to 1.16; five trials, 1365 participants; moderate quality evidence) or more than 50% reduction from baseline between the elagolix (RR 1.08, 95% CI 1.01 to 1.15; five trials, 1365 participants; high quality evidence) and elagolix with estradiol/norethindrone acetate. In both comparisons, elagolix has reduced the mean percentage change in uterine and fibroid volume, improved symptoms, and health-related quality of life. More patients had hot flush, and bone mineral density loss in the elagolix treatment compared to both placebo and elagolix with estradiol/norethindrone acetate.; Conclusions: Elagolix appeared to be effective in reducing heavy menstrual bleeding caused by uterine fibroid and combination with estradiol/norethindrone acetate was able to alleviate the hypoestrogenism side effects in premenopausal women. Review registration PROSPERO CDR 42021233898. (© 2022. The Author(s).)

Muhammad, M., et al. (2023). "Efficacy and safety of Clomiphene alone versus Clomiphene and Sildenafil in Women with infertility : A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Muhammad, N., et al. (2023). "Effectiveness of sequential Letrozole and Gonadotropins therapy for ovulation induction in infertile women with PCOS: A systematic review and meta-analysis of randomized controlled trials (RCTs)." PROSPERO International prospective register of systematic reviews.
	
Mural Oncology, I. (2021). "Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)." ClinicalTrials.gov.
	Patients will be centrally allocated in a randomized fashion (3:1:1:3) to receive either: Arm 1: Nemvaleukin and pembrolizumab combination therapy Arm 2: Pembrolizumab monotherapy Arm 3: Nemvaleukin monotherapy Arm 4: Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine.

Murali Mohan, R., et al. (2023). "Role of Stereotactic body radiation therapy (SBRT) in management of oligometastatic lesions among patients with cervical cancer, a systematic review." PROSPERO International prospective register of systematic reviews.
	
Murina, F. (2022). "Local delivery of cannabidiol in patients with vestibulodynia." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Randomization is determined by a computer‐generated number list (MedCalc Version 20.110). Active group: patients will receive one treatment cycle of transmucosal delivery of cannabidiol (3 ml CBD 8% gel) using vestibular electroporation for si Xtreatments total, once a week. This is followed by follow‐up visits at 4 and 8 weeks. Non‐active group: patients in the placebo group will receive one treatment cycle of transmucosal delivery of placebo gel 3 ml using vestibular electroporation once a week for up to 6 weeks. This is followed by follow‐up visits at 4 and 8 weeks CONDITION: Vulvodynia ; Urological and Genital Diseases PRIMARY OUTCOME: ; Symptoms evaluated at baseline, 4 weeks and 8 weeks after treatment using:; 1. 0‐10 point visual scale (VAS) related to vulvar burning/pain and dyspareunia; 2. Vestibular cotton swab test (small cotton‐tipped applicator lightly rolled over the surfaces of the vestibule (mean of values at the 1, 3, 5, 6, 7, 9, and 11 o’clock locations by asking the subject to report pain intensity on a discrete visual analog scale of 1 (no pain) to 10 (worst possible pain).; 3. Validated instruments: Female Sexual Function Index (FSFI), Vulvar Pain Functional Questionnaire (V‐Q); SECONDARY OUTCOME: Evaluation of current perception threshold (CPT) testing (a technique which quantifies the sensitivity of vestibular nerve fibers) and vaginal EMG measurements, collected at states of rest and during several pelvic floor exercises through an EMG device with a vaginal sensor (Myotonus plus©‐London‐UK). The CPT values will be measured using the Neurometer CPT/C electrodiagnostic neurostimulator (Neurotron, Inc., Baltimore, MD), and vulvar vestibule CPT values will be determined using a G‐trode Vaginal/ Rectal Electrode (Neurotron, Inc., Baltimore, MD). Measured at baseline, 4 weeks and 8 weeks follow‐up visits. INCLUSION CRITERIA: 1. Women at least 18 years of age and before the menopause 2. Experience moderate to severe pain (minimum of 5/10 on a numerical rating scale in at least 90 % of attempted sexual intercourse) 3. Pain limited to the vestibule during vaginal intercourse and during activities exerting pressure on the vestibule (tampon insertion, tight jeans or pants, cycling, horseback riding) 4. Presence of VBD for at least 6 months and diagnosed according to the standardized gynecological examination protocol by a staff gynecologist 5. Have a stable sexual partner (sexual activity should include some attempted vaginal penetrations to evaluate pain intensity) 6. Subject is willing to attempt sexual activity between visits 7. Read and signed informed consent

Murina, F., et al. (2023). "The role of female intimate hygiene practices in the management of vulvovaginal candidiasis: A randomized, controlled open-label trial." Health Care for Women International 44(5): 689-700.
	In this multicenter, observational, controlled open-label trial, researchers randomized 200 women with vulvovaginal candidiasis (VVC) to: Group 1, 6-days clotrimazole 2% vaginal cream once-daily plus 15-days concomitant acid pH thymol and zinc-containing cleansing wash (SaugellaActi3) twice-daily; Group 2, 6-days clotrimazole treatment alone. In both groups, pruritus and burning VAS scores improved from baseline at Days 6, 10 and 15. On Day 10 and Day 15, the pruritus score was significantly lower in Group 1 versus Group 2 ( P <0.005 at both timepoints), suggesting acid pH thymol and zinc-containing cleansing wash ameliorates VVC-associated pruritus as part of a female hygiene regimen.

Murugesu, S., et al. (2023). "Intrauterine instillation of human chorionic gonadotropin at the time of blastocyst transfer: Systematic review and meta-analysis." Journal of Gynecology Obstetrics and Human Reproduction 52(10): 102663.
	Intrauterine instillation (IU) of Human Chorionic Gonadotropin (hCG) before embryo transfer (ET) has been proposed to enhance implantation success rates. This is the first meta-analysis to evaluate the effect at the blastocyst-stage. A systematic literature search was performed using Medline, Embase, Cochrane Library and Google. Randomized clinical trials (RCTs) were included. The primary outcome combined live birth rate (LBR) and ongoing pregnancy rate (OPR). The secondary outcomes were clinical pregnancy rate (CPR), implantation rate (IR) and miscarriage rate (MR). 93 citations were identified, of which there were seven eligible RCTs. 2499 participants were included in the meta-analysis; 1331 were assigned to an experimental group and 1168 were assigned to the control group. The overall effect of IU hCG instillation on LBR and OPR was not significant: risk ratio (RR) 1.00 (95% CI, 0.90-1.12). Analysis of secondary outcomes found the effect of IU hCG instillation was not significant. Analysis of the data suggests that the studies conducted have too much heterogeneity to identify whether a specific cohort may have a significant benefit. The findings of this meta-analysis demonstrate that there is insufficient evidence at present to support the use of IU hCG instillation prior to blastocyst-stage ET.; Competing Interests: Declaration of Competing Interest The authors declare there is no conflict of interests. (Copyright © 2023. Published by Elsevier Masson SAS.)

Musacchio, L., et al. (2021). "Randomized phase III trial on niraparib-TSR-042 (dostarlimab) versus physician's choice chemotherapy in recurrent ovarian, fallopian tube, or primary peritoneal cancer patients not candidate for platinum retreatment: NItCHE trial (MITO 33)." International Journal of Gynecological Cancer 31(10): 1369-1373.
	BACKGROUND: Platinum-resistant ovarian cancer patients have a poor prognosis and few treatment options are available. Preclinical and clinical data demonstrated that the combination of poly-ADP ribose polymerase inhibitors with immune checkpoint inhibitors could have a synergistic antitumor activity in this setting of patients. PRIMARY OBJECTIVE: The primary objective is to assess the efficacy of niraparib plus dostarlimab compared with chemotherapy in recurrent ovarian cancer patients not suitable for platinum treatment. STUDY HYPOTHESIS: This trial will assess the hypothesis that niraparib plus dostarlimab therapy is effective to increase overall survival, progression-free survival, and time to first subsequent therapy respect to chemotherapy alone, with an acceptable toxicity profile. TRIAL DESIGN: This is a phase III, multicenter trial, where recurrent ovarian cancer patients not eligible for platinum re-treatment will be randomized 1:1 to receive niraparib plus dostarlimab vs physician's choice chemotherapy until disease progression, intolerable toxicity, or withdrawal of patient consent. The study will be performed according to European Network for Gynaecological Oncological Trial groups (ENGOT) model B and patients will be recruited from 40 sites across MITO, CEEGOG, GINECO, HeCOG, MANGO, and NOGGO groups. MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients must have recurrent epithelial ovarian cancer not eligible for platinum retreatment. Patients who received previous treatment with poly-ADP ribose polymerase inhibitors and/or immune checkpoint inhibitors will be eligible. No more than two prior lines of treatment are allowed. PRIMARY ENDPOINT: The primary endpoint is overall survival defined as the time from the randomization to the date of death by any cause. SAMPLE SIZE: 427 patients will be randomized. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: June 2024 TRIAL REGISTRATION NUMBER: NCT04679064.

Mustafa, M. T., et al. (2024). "Safety and efficacy of Rucaparib in the treatment of ovarian cancer and patients with BRCA mutation: a systematic review and meta-analysis of phase III randomized clinical trials." Expert Review of Anticancer Therapy 24(1-2): 71-79.
	Introduction: Our systematic review and meta-analysis aimed to evaluate the clinical efficacy and safety of Rucaparib, a PARP inhibitor (PARPi), in patients with ovarian cancer and BRCA mutation. Method(s): Online databases were comprehensively searched for all phase III Randomized trials that used Rucaparib therapy for ovarian cancer patients and patients having BRCA mutation. Efficacy results are progression-free survival and overall response rate in addition to addressing its safety concerns. Result(s): After pooling data from 4 clinical trials, the analysis showed a significant improvement in PFS among ovarian cancer patients and for the maintenance therapy with a hazard ratio (HR) of 0.49 (95% CI 0.34-0.73, p = 0.0003) and 0.42 (95% CI 0.29-0.62, p < 0.0001), respectively. For patients with BRCA mutations, the PFS showed significant improvement with a (HR) of 0.42 (95% CI 0.25-0.71, p < 0.001). A difference was observed in the risk of grade >= 3 TEAEs between the two groups (RR = 2.48; 95% CI 1.40-4.37). Conclusion(s): Rucaparib demonstrated significant efficacy in improving PFS and ORR in ovarian cancer patients, particularly those having BRCA mutations. However, they should be closely monitored due to the greater risk of various adverse effects.Copyright © 2024 Informa UK Limited, trading as Taylor & Francis Group.

Muzny, C. A., et al. (2021). "Efficacy and Safety of Single Oral Dosing of Secnidazole for Trichomoniasis in Women: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Delayed-Treatment Study." Clinical Infectious Diseases 73(6): e1282-e1289.
	BACKGROUND: Trichomonas vaginalis is the most prevalent nonviral sexually transmitted infection. We evaluated the efficacy and safety of secnidazole vs placebo in women with trichomoniasis. METHODS: Women with trichomoniasis, confirmed by a positive T. vaginalis culture, were randomized to single-dose oral secnidazole 2 g or placebo. The primary endpoint was microbiological test of cure (TOC) by culture 6-12 days after dosing. At the TOC visit, participants were given the opposite treatment. They were followed for resolution of infection afterward and offered treatment at subsequent visits, if needed. Fifty patients per group (N = 100) provided approximately 95% power to detect a statistically significant difference between treatment groups. RESULTS: Between April 2019 and March 2020, 147 women enrolled at 10 sites in the United States. The modified intention-to-treat (mITT) population included 131 randomized patients (secnidazole, n = 64; placebo, n = 67). Cure rates were significantly higher in the secnidazole vs placebo group for the mITT population (92.2% [95% confidence interval {CI}: 82.7%-97.4%] vs 1.5% [95% CI: .0%-8.0%]) and for the per-protocol population (94.9% [95% CI: 85.9%-98.9%] vs 1.7% [95% CI: .0%-8.9%]). Cure rates were 100% (4/4) in women with human immunodeficiency virus (HIV) and 95.2% (20/21) in women with bacterial vaginosis (BV). Secnidazole was generally well tolerated. The most frequently reported treatment-emergent adverse events (TEAEs) were vulvovaginal candidiasis and nausea (each 2.7%). No serious TEAEs were observed. CONCLUSIONS: A single oral 2 g dose of secnidazole was associated with significantly higher microbiological cure rates vs placebo, supporting a role for secnidazole in treating women with trichomoniasis, including those with HIV and/or BV. CLINICAL TRIALS REGISTRATION: NCT03935217.

Na, Z., et al. (2023). "Acupuncture for primary dysmenorrhea: a protocol for systematic review and meta-analysis with trial sequential analysis."
	
Nacipe, J., et al. (2022). "Exercises for vasomotor symptoms in climacteric woman. A systematic review with meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Nagendra, D., et al. (2022). "Medical management of early pregnancy loss is cost-effective compared with office uterine aspiration." American Journal of Obstetrics and Gynecology 227(5): 737.e731-737.e711.
	Background: Early pregnancy loss, also referred to as miscarriage, is common, affecting approximately 1 million people in the United States annually. Early pregnancy loss can be treated with expectant management, medications, or surgical procedures-strategies that differ in patient experience, effectiveness, and cost. One of the medications used for early pregnancy loss treatment, mifepristone, is uniquely regulated by the Food and Drug Administration.; Objective: This study aimed to compare the cost-effectiveness from the healthcare sector perspective of medical management of early pregnancy loss, using the standard of care medication regimen of mifepristone and misoprostol, with that of office uterine aspiration.; Study Design: We developed a decision analytical model to compare the cost-effectiveness of early pregnancy loss treatment with medical management with that of office uterine aspiration. Data on medical management came from the Pregnancy Failure Regimens randomized clinical trial, and data on uterine aspiration came from the published literature. The analysis was from the healthcare sector perspective with a 30-day time horizon. Costs were in 2018 US dollars. Effectiveness was measured in quality-adjust life-years gained and the rate of complete gestational sac expulsion with no additional interventions. Our primary outcome was the incremental cost per quality-adjust life-year gained. Sensitivity analysis was performed to identify the key uncertainties.; Results: Mean per-person costs were higher for uterine aspiration than for medical management ($828 [95% confidence interval, $789-$868] vs $661 [95% confidence interval, $556-$766]; P=.004). Uterine aspiration more frequently led to complete gestational sac expulsion than medical management (97.3% vs 83.8%; P=.0001); however, estimated quality-adjust life-years were higher for medical management than for uterine aspiration (0.082 [95% confidence interval, 0.8148-0.08248] vs 0.079 [95% confidence interval, 0.0789-0.0791]; P<.0001). Medical management dominated uterine aspiration, with lower costs and higher confidence interval. The probability that medical management is cost-effective relative to uterine aspiration is 97.5% for all willingness-to-pay values of ≥$5600/quality-adjust life-year. Sensitivity analysis did not identify any thresholds that would substantially change outcomes.; Conclusion: Although office-based uterine aspiration more often results in treatment completion without further intervention, medical management with mifepristone pretreatment costs less and yields similar quality-adjust life-years, making it an attractive alternative. Our findings provided evidence that increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Nahshon, C., et al. (2020). "The impact of endometrial injury on reproductive outcomes: results of an updated meta-analysis." Reproductive Medicine and Biology 19(4): 334-349.
	Background: It is still unclear whether endometrial injury (EI) has a beneficial effect on reproductive outcomes, and if so, the optimal procedure characteristics are not clear. All previous papers concluded that more research is needed, and as additional studies were recently published, the insights on EI have changed significantly.; Methods: Searches were conducted in MEDLINE, Embase, Web of Science, and Cochrane Library, to identify randomized controlled trials examining the EI effect on IVF outcomes in women at least one previous failed cycle.; Results: 2015 references were identified through database searching. Ultimately, 17 studies were included, involving 3016 patients. Clinical pregnancy rate (CPR) (RR = 1.19, [95% CI 1.06-1.32], P = .003) and live birth rate (LBR) (RR = 1.18, [95%CI 1.04-1.34], P = .009) were significantly improved after EI. Number of previous failed cycles, maternal age, and hysteroscopy were found to be relevant confounders. Higher CPR and LBR were found when EI was performed twice, while performing EI once did not significantly improve reproductive rates.; Conclusion: According to the present meta-analysis, EI may be offered to younger patients with few previous failed cycles and should be additionally studied in an RCT comparing different timing and more than one EI before treatment.; Competing Interests: Chen Nahshon, Lena Sagi‐Dain and Martha Dirnfeld declare that they have no conflict of interest. (© 2020 The Authors. Reproductive Medicine and Biology published by John Wiley & Sons Australia, Ltd on behalf of Japan Society for Reproductive Medicine.)

Najaf, N., et al. (2021). "The Effect of Aromatherapy Alone or in Combination with Massage on Dysmenorrhea: A Systematic Review and Meta-analysis." Revista Brasileira de Ginecologia e Obstetricia 43(12): 968-979.
	
Najafi, M. N., et al. (2019). "Herbal medicines against bacterial vaginosis in women of reproductive age: A systematic review." Farmacia 67(6): 931-940.
	The aim of this systematic review was to present the effect of herbal medicines on both clinical symptoms and laboratory findings of bacterial vaginosis in the reproductive age. Four major databases (PubMed, Scopus, ISI Web of Science, and Cochrane Library) were systematically searched for articles that evaluated the effect of herbal medicines on bacterial vaginosis and were published until July 31, 2019. Zataria multiflora was found to be as effective as oral or vaginal metronidazole in improvement of both clinical symptoms and laboratory parameters. However, it caused vaginal irritation and burning. The effect of garlic tablet was reported to be more marked than oral metronidazole in alleviating the clinical symptoms and comparable to that of oral metronidazole in improving laboratory findings. The effect of Nigella sativa was similar to metronidazole in treating both clinical symptoms and laboratory findings. Hypericum perforatum vaginal gel 3% has proved to be as effective as metronidazole vaginal gel 0.75% in preventing bacterial vaginosis. Cure rate (recovery) in Myrtus communis L. plus metronidazole or Berberis vulgaris plus metronidazole was higher than that of metronidazole alone. Treatment with Hypercum perforatum for a week was very well tolerated, and caused no side effect. Herbal medicines including H. perforatum, Z. multiflora, B. vulgaris and Allium sativum was found to be as effective as metronidazole with a fewer side effect. Hence, they might be considered potential candidates to combat vaginosis.Copyright © 2019, Romanian Society for Pharmaceutical Sciences. All rights reserved.

Nakib, N., et al. (2024). "Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women." Therapeutic Advances in Urology 16.
	Background: Stress urinary incontinence (SUI) presents as unintentional urine leakage associated with activities. It significantly affects quality of life (QoL) and is the most common type of incontinence in women. Current treatment options, particularly non-surgical therapies, are lacking. Objective(s): To assess the efficacy of mechanotherapy provided by the Flyte intra-vaginal device during pelvic floor muscle training (PFMT). Design(s): This was a randomized, controlled, double-blinded trial. Material(s) and Method(s): Flyte is a repeat use device for conditioning and strengthening the pelvic floor muscles (PFMs). It provides two-part mechanotherapy. Part 1 is the stretching and preloading of the PFM from the internal wand. Part 2 integrates mechanical pulses which elicit muscle cellular and tissue level responses that trigger cellular regeneration, improve neuromuscular facilitation and motor learning. Subjects used the device for 5 min/day for 12 weeks. Subjects (144) were randomized and evaluated at 6 and 12 weeks. Arm A (72) received both Part 1 and Part 2 mechanotherapy for 12 weeks, whereas Arm B (72) received Part 1 therapy for 6 weeks, then crossed over to full therapy. Mean age was 50, 49, respectively, prior pelvic/abdominal surgery 26%, 46%, and previous incontinence treatments 13%, 22%. The primary endpoint was 24-h pad weight (24-HR PW) at 6 weeks. Secondary endpoints were 24-HR PW at 12 weeks and QoL [International Consultation on Incontinence Questionnaire (ICIQ), Urinary Incontinence Quality of Life (IQOL)]. Result(s): Part 1 therapy had a greater than anticipated therapeutic effect. Thus, the study was underpowered to identify differences between study arms. Therefore, data were pooled to assess the effects of mechanotherapy. Twenty four-HR PW was significantly reduced at 6 weeks (p = <0.0001), with further reduction from 6 to 12 weeks (p = <0.0001). Data were stratified based on 24-HR PW severity. Significant reductions were noted in all severity groups (mild p = <0.0001, moderate p = <0.0001, severe p = <0.01). QoL was similarly improved at 6 weeks (ICIQ p = <0.0001, IQOL p = <0.0001), and 12 weeks (ICIQ p = <0.0001, IQOL p = <0.0001). Compliance was >80% at 6 weeks and 70% at 12 weeks. Conclusion(s): Two-part mechanotherapy significantly improved 24-HR PW and QoL across all severities of SUI. Improvements were noted in as little as 2 weeks and appeared to be sustained through 2-year follow up. Trial registration: Registered on ClinTrials.gov (NCT02954042).Copyright © The Author(s), 2024.

Namira, W., et al. (2022). "A systematic review of live birth rate following endometrial receptivity test in patients undergoing IVF cycle." PROSPERO International prospective register of systematic reviews.
	
Nandi, A., et al. (2022). "Intrauterine insemination + controlled ovarian hyperstimulation versus in vitro fertilisation in unexplained infertility: a systematic review and meta-analysis." Archives of Gynecology and Obstetrics 305(4): 805-824.
	Background: IUI + COH is widely used in cases of unexplained infertility before resorting to IVF. Debate continues about what should be the first-line treatment for couples with unexplained infertility. Objective(s): This systematic review assessed the relative efficacy of IUI + COH compared with IVF in couples with unexplained infertility. Search strategy: We searched Medline, Embase, CIHNL, Pscy Info, and Cochrane Library from 1980 to November 2019. Selection Criteria: Only RCTs published articles in full text with female patients aged 18-43 years and diagnosed with unexplained infertility were included. Data Collection and Analysis: Two authors reviewed citations from primary search independently and any disagreement was resolved by mutual discussion and consultation with a third author. Main Result(s): In total, eight RCTs were included. The quality of evidence was moderate to low due to inconsistency across the trials and imprecision. The pooled result showed that IVF was associated with a statistically significant higher live birth rate (RR 1.53, 95% CI 1.01-2.32, P < 0.00001 I2 = 86%) with no significant difference in multiple pregnancy rate or OHSS rate. Sensitivity analysis based on women's age and a history of previous IUI or IVF treatment showed no significant difference in the live birth rates (RR 1.01, 95% CI 0.88-1.15, I2 = 0%, 3 RCTs) in treatment-naive women younger than 38 years. In women over 38 years, the live birth rates were significantly higher in the IVF group (RR 2.15, 95% CI 1.16-4.0, I2 = 42%, 1 RCT). Conclusion(s): Further research using a standardised treatment protocol and taking into account important prognostic variables and cumulative live birth rates from fresh IVF and all sibling frozen embryos is required to further guide clinical practice.Copyright © 2021, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Nappi, R. E., et al. (2024). "Efficacy and safety of a device that combines multipolar radiofrequency with pulsed electromagnetic field for the treatment of vulvovaginal atrophy: a randomized, sham-controlled trial." Journal of Sexual Medicine 21(3): 203-210.
	Background: Vulvovaginal atrophy (VVA) negatively affects the sexual well-being and quality of life of postmenopausal women, yet it is underreported and undertreated. Aim(s): The study sought to investigate the efficacy and safety of a nonablative, noncoagulative multipolar radiofrequency (RF) and pulsed electromagnetic field-based device (PEMF) in treatment of symptoms related to VVA. Method(s): Seventy-six women >=19 years of age with symptoms associated with VVA were enrolled into this prospective, randomized, sham-controlled, multicenter clinical study. Subjects were randomized to receive 3 RF + PEMF treatments (active group) or sham treatments (sham group) delivered to vaginal tissue at monthly intervals. The Vaginal Health Index (VHI), along with the Female Sexual Function Index (FSFI), subject sexual satisfaction and vaginal laxity (VL) score, treatment-associated pain, and adverse events were assessed at 4 follow-up (FU) visits between 1 and 12 months after treatment. Outcome(s): Changes from baseline VHI, pH, FSFI, VL, and sexual satisfaction scores between the active and sham groups were compared before and after treatment. Result(s): Mean VHI scores in the active group were significantly better compared with the sham group after treatment at all but the last FU visit (P < .001). A greater decrease in pH (active over sham) was seen at 1 and 4 months after treatment (P < .05). FSFI improvement was shown in the active group; however, it was not significantly better than sham improvement at all FU visits. Subject sexual satisfaction in the active group showed better improvement over sham at all FU visits (P < .05), while VL evaluations saw greater improvement in the active group at 4, 6, and 12 months posttreatment (P < .05). Treatment satisfaction was greater in the active group and pain was minimal in both groups. No serious adverse effects were reported. Clinical Implications: As a noninvasive alternative to traditional surgical and topical procedures, 3 sessions of noninvasive combination RF/PEMF safely demonstrated improvement in symptoms related to VVA. Strengths and Limitations: This study was strengthened by the randomized, sham-controlled design; large sample size; and extended FU period. The study assessments were decreased at later FU visits due to the global COVID pandemic, and this was a key limitation to the study. Conclusion(s): Nonablative, noncoagulative multipolar RF/PEMF therapy was safe, improved symptoms associated with VVA, and improved female sexual function while yielding high subject satisfaction.Copyright © The Author(s) 2024.

Nappi Rossella, E., et al. (2022). "Treatment of vulvo-vaginal atrophy with hyaluronate-based gel: a randomized controlled study." Minerva Obstetrics and Gynecology 74(6): 480-488.
	Background: The study aimed to assess the performance and safety of single-use applicators prefilled with hyaluronic acid (HA)-based vaginal gel (Hyalo Gyn) for the treatment of vulvovaginal atrophy (VVA)-related signs and symptoms in postmenopausal women.; Methods: Eighty women were randomized, 46 to Hyalo Gyn gel and 34 to a standard treatment (water-based lubricant). Outcome data collected included: the proportion of subjects having a reduction ≥1 point in the Verbal Rating Scale (VRS) Dryness Score, VRS Global Score, vaginal pH, Vaginal Health Index, Female Sexual Function Index, Female Sexual Distress Scale-Revised, patients' global assessment, tolerability, and safety.; Results: Significant improvements were observed for all the assessed endpoints in both treatment groups. The perception of any improvement on the VRS Dryness Score was not statistically different between the treatment groups. A sensitivity analysis on the absolute change in VRS Dryness Score showed a statistically significant difference in favor of the Hyalo Gyn group at 3 months.; Conclusions: A 3-month treatment with Hyalo Gyn gel is effective, safe, and well tolerated for VVA-related symptoms in postmenopausal women.

Nascimento, R. P., et al. (2024). "Efficacy of Physiotherapy for Treating Vulvodynia: A Systematic Review." Journal of Lower Genital Tract Disease 28(1): 54-63.
	Objectives: We set out to assess the efficacy of physiotherapy for vulvodynia. Material(s) and Method(s): PubMed, Embase, Scopus, Web of Science, SciELO, PEDro, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched in February 2023. Two authors selected and extracted the data independently. The risk of bias was assessed using the Cochrane Risk of Bias tool (Rob 2). Because of the high heterogeneity presented between the studies, it was not possible to carry out qualitative analysis. The results were presented narratively. This systematic review was registered with the PROSPERO database. Result(s): A total of 2,274 articles were retrieved. Seven studies met the criteria and were included in a systematic review, which included a total of 477 patients. The interventions included were electromyography biofeedback (n = 2), transcutaneous electrical nerve stimulation (n = 1), transcranial direct current stimulation (n = 1), low-intensity shockwave (n = 1), physiotherapy treatment (n = 1), and pelvic floor exercise with behavioral modification (n = 1). All studies evaluated pain reduction, 5 evaluated sexual function, and 2 evaluated quality of life. All interventions were effective for the main outcomes; only the transcranial direct current stimulation intervention showed no significant difference when compared with the placebo or sham group. Three studies presented a high risk of bias due to the lack of blinding. Conclusion(s): The studied interventions (electromyography biofeedback, transcutaneous electrical nerve stimulation, shockwave, physiotherapy, and pelvic floor exercise) seem to improve pain, sexual function, and quality of life. However, the heterogeneity of the studies prevented meta-analysis. In addition, well-designed trials are needed to improve the certainty of this evidence.Copyright © 2023 Lippincott Williams & Wilkins.

Natália, O., et al. (2022). "Efficacy of hormonal treatment in the clinical management of endometriosis." PROSPERO International prospective register of systematic reviews.
	
Nathalie, S., et al. (2023). "Reproductive outcomes in letrozole stimulated vs artificial frozen-thawed embryo transfer cycles in women with PCOS and/or oligo-anovulation: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
National Institute for, H. and E. Care (2023). "Clinical and cost effectiveness of cabergoline for fertility problems associated with hyperprolactinaemic amenorrhoea or oligomenorrhea." PROSPERO International prospective register of systematic reviews.
	
National Institute for, H. and E. Care (2023). "Clinical and cost effectiveness of endometrial scratching as a treatment add-on for people undergoing fertility treatment." PROSPERO International prospective register of systematic reviews.
	
National Institute for, H. and E. Care (2023). "Clinical and cost effectiveness of hysteroscopic septum resection in people with fertility problems associated with a septate uterus." PROSPERO International prospective register of systematic reviews.
	
National Institute for, H. and E. Care (2023). "Clinical and cost effectiveness of intracytoplasmic sperm injection (ICSI) in non-male factor fertility problems." PROSPERO International prospective register of systematic reviews.
	
National Institute for, H. and E. Care (2023). "Clinical and cost effectiveness of ovulation induction strategies for people with a health-related female factor fertility problem associated with hypogonadotrophic hypogonadism." PROSPERO International prospective register of systematic reviews.
	
National Institute for, H. and E. Care (2023). "Clinical and cost effectiveness of ovulation induction strategies in people with polycystic ovary syndrome (PCOS)." PROSPERO International prospective register of systematic reviews.
	
Naveed, A. K., et al. (2022). "Methotrexate versus expectant management in ectopic pregnancy: a meta-analysis." Archives of Gynecology and Obstetrics 305(3): 547-553.
	Background: Ectopic pregnancy (EP) affects 1-2% of all pregnant females'(Barnhart et al., Expert Opin Pharmacother 2(3):409-417, 2001) that can require emergent surgical intervention. Noninvasive diagnostic tests like transvaginal ultrasound (TVUS), and serial beta-hCG levels have enabled early diagnosis and allowed medical therapy to be tried. Methotrexate (MTX) versus expectant management, both have been considered safe but superiority of one over the other is lacking. Method(s): We searched for RCT that have shown efficacy of MTX versus expectant management in hemodynamically stable patients. Our primary outcome was whether one modality is superior to the other. Result(s): Four RCT were included in the meta-analysis after review. Our pooled analysis when comparing MTX and expectant management showed us that the difference between the uneventful decline in beta-hCG levels (treatment success) was statistically insignificant (RR = 1.06, 95% CI 0.93-1.21) with no significant heterogeneity between trials (I2 = 0.0%, P = 0.578). The difference between need for surgical intervention between methotrexate and expectant management was also statistically insignificant (RR = 0.77, 95% CI 0.43-1.40) with no significant heterogeneity between trials (I2 = 0.0%, P = 0.552). Conclusion(s): We conclude that expectant management is not inferior to MTX in hemodynamically stable patients with ectopic pregnancy that have declining or low beta-hCG levels.Copyright © 2021, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Nazaryan, H., et al. (2023). "Impact of iron supplementation on patient outcomes for women with abnormal uterine bleeding: a protocol for a systematic review and meta-analysis." Systematic Reviews 12(1): 121.
	Background: Abnormal uterine bleeding (AUB), which includes heavy menstrual bleeding (HMB), is a common condition placing women at increased risk for developing iron deficiency and iron deficiency anemia (IDA). Depletion of iron stores has negative implications on physical, social, and emotional health, as well as quality of life. Iron supplements are safe, effective, and readily available, while red blood cell (RBC) transfusions have inherent risks including infectious and immune reactions. Despite high prevalence of IDA among women with AUB, there are limited studies on the impact of iron therapies on patient outcomes. This systematic review and meta-analysis will evaluate the impact of iron supplementation on patient outcomes for women with AUB, when compared to combination therapy, no intervention, placebo, or standard of care.; Methods: We will conduct a systematic review and meta-analysis of randomized controlled trials and observational studies evaluating the impact of iron interventions on patient outcomes for women with AUB. Systematic literature searches will be conducted in major databases including MEDLINE, EMBASE, CENTRAL, CINAHL, and Web of Science. Studies assessing the impact of iron interventions on patient outcomes in women experiencing AUB, in comparison to combination therapy, no intervention, placebo, or standard of care, will be included in the review. Independent reviewers will screen for eligibility, assess risk of bias, and abstract data. Overall certainty of evidence for each outcome will be assessed using the GRADE approach. We will meta-analyze outcomes which are sufficiently homogeneous to summarize intervention effects and narratively synthesize nonhomogeneous outcomes. The main outcomes of interest are hemoglobin levels immediately prior to surgery and post-operatively, number of RBC transfusions, and adverse effects. Secondary outcomes will include length of hospital stay, intraoperative blood loss, adverse and side effects, quality of life, and iron indices.; Discussion: This review will evaluate the impact of iron interventions on patient outcomes in women with IDA secondary to AUB with focus on changes in hematological and iron indices, red blood cell utilization, quality of life, cost of treatment, and adverse events. The results will inform evidence-based clinical practice for the management of iron deficiency and IDA secondary to AUB.; Systematic Review Registration: PROSPERO CRD42019137282. (© 2023. The Author(s).)

Neal, H., et al. (2022). "Efficacy and Safety of Moxibustion for Endometriosis: A Systematic Review." PROSPERO International prospective register of systematic reviews.
	
Neal-Perry, G., et al. (2023). "Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause: A Randomized Controlled Trial." Obstetrics and Gynecology 141(4): 737-747.
	Objective: To evaluate the safety, tolerability, and effect of fezolinetant on endometrial health over 52 weeks.; Methods: We conducted a phase 3, randomized, double-blind, 52-week safety study (SKYLIGHT 4 [Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause]) of placebo, fezolinetant 30 mg, and fezolinetant 45 mg once daily (1:1:1). Participants were postmenopausal and seeking treatment for vasomotor symptoms associated with menopause. Primary endpoints were treatment-emergent adverse events, percentage of participants with endometrial hyperplasia, and percentage with endometrial malignancy. Endometrial hyperplasia or malignancy was evaluated according to U.S. Food and Drug Administration guidance (point estimate of 1% or less with an upper bound of one-sided 95% CI of 4% or less). Secondary endpoints included change in bone mineral density (BMD) and trabecular bone score. A sample size of 1,740 was calculated to enable observation of one or more events (≈80% probability for events with background rate of less than 1%).; Results: A total of 1,830 participants were randomized and took one or more medication dose (July 2019-January 2022). Treatment-emergent adverse events occurred in 64.1% (391/610) of the placebo group, 67.9% (415/611) of the fezolinetant 30-mg group, and 63.9% (389/609) of the fezolinetant 45-mg group. Treatment-emergent adverse events leading to discontinuation were similar across groups (placebo, 26/610 [4.3%]; fezolinetant 30 mg, 34/611 [5.6%]; fezolinetant 45 mg, 28/609 [4.6%]). Endometrial safety was assessed in 599 participants. In the fezolinetant 45-mg group, 1 of 203 participants had endometrial hyperplasia (0.5%; upper limit of one-sided 95% CI 2.3%); there were no cases in the placebo (0/186) or fezolinetant 30 mg (0/210) group. Endometrial malignancy occurred in 1 of 210 in the fezolinetant 30-mg group (0.5%; 95% CI 2.2%) with no cases in the other groups. Liver enzyme elevations more than three times the upper limit of normal occurred in 6 of 583 placebo, 8 of 590 fezolinetant 30 mg, and 12 of 589 fezolinetant 45 mg participants; no Hy's law cases were reported (ie, no severe drug-induced liver injury with alanine aminotransferase or aspartate aminotransferase more than three times the upper limit of normal and total bilirubin more than two times the upper limit of normal, with no elevation of alkaline phosphatase and no other reason to explain the combination). Changes in BMD and trabecular bone score were similar across groups.; Conclusion: Results from SKYLIGHT 4 confirm the 52-week safety and tolerability of fezolinetant and support its continued development.; Funding Source: Astellas Pharma Inc.; Clinical Trial Registration: ClinicalTrials.gov , NCT04003389. (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Neeraj, P., et al. (2023). "Effectiveness of misoprostol as an incomplete abortion treatment when given by midwives as opposed to doctors:A systematic review with meta analysis." PROSPERO International prospective register of systematic reviews.
	
Nekkanti, S., et al. (2022). "A randomized trial comparing continence pessary to continence device (Poise Impressa) for stress incontinence." International Urogynecology Journal 33(4): 861-868.
	Introduction and hypothesis: To conduct a multi-centered randomized trial evaluating stress urinary incontinence (SUI) treatment based on the Patient Global Impression of Improvement score after 4 weeks using a continence pessary (CP) or a disposable intravaginal continence device (DICD). The null hypothesis is no difference in treatment success between cohorts. Method(s): This parallel group, active treatment comparative effectiveness trial randomized women with SUI to either CP or DICD for 4 weeks in a 1:1 allocation ratio. Exclusion criteria included pregnancy, UTI, postmenopausal bleeding, neurogenic bladder, urinary retention, prolapse, contraindication to or prior treatment with CP/DICD, and prior SUI surgery. Assuming an 80% power, an alpha of 5% and 20% dropout, we needed 138 participants to detect 50% success with CP versus 25% with DICD. Due to slow enrollment, the study was stopped after 16 months with 50 participants enrolled. Result(s): Of the 50 women enrolled, 25 (50%) were randomized to CP and 25 (50%) to DICD. Thirty-five of 50 (70%) completed a fitting, and 22/50 (44%) completed 4-week and 17/50 (34%) completed 6-month follow-up. Baseline characteristics were similar, and there was high treatment success in each cohort [80% (8/10) CP vs. 75% (9/12) DICD; p = 1.0]. DICD patients showed improvement on all questionnaires but had higher use of other therapies over 6 months. CP patients showed improvements except for lower sexual function scores at 4 weeks. No serious adverse events occurred. Conclusion(s): Most women fitted with a CP/DICD experienced treatment success after 4 weeks without serious adverse events.Copyright © 2021, The International Urogynecological Association.

Nelson, S. (2023). "Evaluating Piezo-ICSI. - The EPI Study." ClinicalTrials.gov.
	No Results Available Device: Piezo-ICSI Fertilization rate|Percentage of degenerated oocytes|Percentage of 0 PN oocytes|Percentage of 1 PN oocytes.|Percentage of >2PN oocytes.|Differences in KID scores.|Differences in iDA scores.|Blastocyst rate (number of grade 3 or higher).|Percentage of cryopreserved blastocysts on day 5 and 6.|8. Utilization rate (Number of transferred and cryopreserved blastocysts). Utilization rate All Not Applicable 265 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 4026 - EPI October 2024

Neumann, K. and G. Griesinger (2021). "Is oxytocin receptor antagonist administration around embryo transfer associated with IVF treatment success? A systematic review and meta-analysis." Reproductive Biomedicine Online 43(6): 983-994.
	
Neves Ana, R., et al. (2022). "Androgens and diminished ovarian reserve: the long road from basic science to clinical implementation. A comprehensive and systematic review with meta-analysis." American Journal of Obstetrics and Gynecology 227(3): 401.
	Objective: This study aimed to present a narrative review regarding androgen production, androgens' role in folliculogenesis, and the available therapeutic approaches for androgen supplementation, and to perform a systematic review and meta-analysis regarding the impact of androgens (dehydroepiandrosterone/testosterone) compared with placebo or no treatment on ovarian response and pregnancy outcomes in patients with diminished ovarian reserve and/or poor ovarian responders.; Data Sources: An electronic search of MEDLINE, Embase, Cochrane Library, Cochrane Central Register of Controlled Trials, Scopus, ClinicalTrials.gov, the ISRCTN registry, and the World Health Organization International Clinical Trials Registry, was conducted for studies published until September 2021.; Study Eligibility Criteria: Randomized controlled trials that compared ovarian response and/or pregnancy outcomes between the different in vitro fertilization protocols using androgens (ie, dehydroepiandrosterone and testosterone) and conventional in vitro fertilization stimulation in patients with diminished ovarian reserve and/or poor ovarian responders were included.; Methods: The quality of each study was evaluated with the revised Cochrane risk-of-bias tool for randomized trials (RoB 2). The meta-analysis used random-effects models. All results were interpreted on the basis of intention-to-treat analysis (defined as the inclusion of all randomized patients in the denominator). Risk ratios and 95% confidence intervals were used and combined for meta-analysis.; Results: No significant differences were found regarding the number of oocytes retrieved (mean difference, 0.76; 95% confidence interval, -0.35 to 1.88), mature oocytes retrieved (mean difference, 0.25; 95% confidence interval, -0.27 to 0.76), clinical pregnancy rate (risk ratio, 1.17; 95% confidence interval, 0.87-1.57), live-birth rate (risk ratio, 0.97; 95% confidence interval, 0.47-2.01), or miscarriage rate (risk ratio, 0.80; 95% confidence interval, 0.29-2.22) when dehydroepiandrosterone priming was compared with placebo or no treatment. Testosterone pretreatment yielded a higher number of oocytes retrieved (mean difference, 0.94; 95% confidence interval, 0.46-1.42), a higher clinical pregnancy rate (risk ratio, 2.07; 95% confidence interval, 1.33-3.20), and higher live-birth rate (risk ratio, 2.09; 95% confidence interval, 1.11-3.95).; Conclusion: Although dehydroepiandrosterone did not present a clear effect on outcomes of assisted reproductive techniques, we found a potentially beneficial effect of testosterone priming on ovarian response and pregnancy outcomes. However, results should be interpreted with caution, taking into account the low to moderate quality of the available evidence. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Newhouse, R., et al. (2023). "Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer." The Cochrane Database of Systematic Reviews 7: CD006910.
	Background: Cancer of ovarian, fallopian tube and peritoneal origin, referred to collectively as ovarian cancer, is the eighth most common cancer in women and is often diagnosed at an advanced stage. Women with relapsed epithelial ovarian cancer (EOC) are less well and have a limited life expectancy, therefore maintaining quality of life with effective symptom control is an important aim of treatment. However, the unwanted effects of chemotherapy agents may be severe, and optimal treatment regimens are unclear. Pegylated liposomal doxorubicin (PLD), which contains a cytotoxic drug called doxorubicin hydrochloride, is one of several treatment modalities that may be considered for treatment of relapsed EOCs. This is an update of the original Cochrane Review which was published in Issue 7, 2013.; Objectives: To evaluate the efficacy and safety of PLD, with or without other anti-cancer drugs, in women with relapsed high grade epithelial ovarian cancer (EOC).; Search Methods: We searched CENTRAL, MEDLINE (via Ovid) and Embase (via Ovid) from 1990 to January 2022. We also searched online registers of clinical trials, abstracts of scientific meetings and reference lists of included studies.; Selection Criteria: We included randomised controlled trials (RCTs) that evaluated PLD in women diagnosed with relapsed epithelial ovarian cancer.; Data Collection and Analysis: Two review authors independently extracted data to a pre-designed data collection form and assessed the risk of bias according to the Cochrane Handbook for Systematic Reviews of Interventions guidelines. Where possible, we pooled collected data in meta-analyses.; Main Results: This is an update of a previous review with 12 additional studies, so this updated review includes a total of 26 RCTs with 8277 participants that evaluated the effects of PLD alone or in combination with other drugs in recurrent EOC: seven in platinum-sensitive disease (2872 participants); 11 in platinum-resistant disease (3246 participants); and eight that recruited individuals regardless of platinum sensitivity status (2079 participants). The certainty of the evidence was assessed for the three most clinically relevant comparisons out of eight comparisons identified in the included RCTs. Recurrent platinum-sensitive EOC PLD with conventional chemotherapy agent compared to alternative combination chemotherapy likely results in little to no difference in overall survival (OS) (hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.83 to 1.04; 5 studies, 2006 participants; moderate-certainty evidence) but likely increases progression-free survival (PFS) (HR 0.81, 95% CI 0.74 to 0.89; 5 studies, 2006 participants; moderate-certainty evidence). The combination may slightly improve quality of life at three months post-randomisation, measured using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (mean difference 4.80, 95% CI 0.92 to 8.68; 1 study, 608 participants; low-certainty evidence), but this may not represent a clinically meaningful difference. PLD in combination with another chemotherapy agent compared to alternative combination chemotherapy likely results in little to no difference in the rate of overall severe adverse events (grade ≥ 3) (risk ratio (RR) 1.11, 95% CI 0.95 to 1.30; 2 studies, 834 participants; moderate-certainty evidence). PLD with chemotherapy likely increases anaemia (grade ≥ 3) (RR 1.37, 95% CI 1.02 to 1.85; 5 studies, 1961 participants; moderate-certainty evidence). The evidence is very uncertain about the effect of PLD with conventional chemotherapy on hand-foot syndrome (HFS)(grade ≥ 3) (RR 4.01, 95% CI 1.00 to 16.01; 2 studies, 1028 participants; very low-certainty evidence) and neurological events (grade ≥ 3) (RR 0.38, 95% CI 0.20 to 0.74; 4 studies, 1900 participants; very low-certainty evidence). Recurrent platinum-resistant EOC PLD alone compared to another conventional chemotherapy likely results in little to no difference in OS (HR 0.96, 95% CI 0.77 to 1.19; 6 studies, 1995 participants; moderate-certai ty evidence). The evidence is very uncertain about the effect of PLD on PFS (HR 0.94, 95% CI 0.85 to 1.04; 4 studies, 1803 participants; very low-certainty evidence), overall severe adverse events (grade ≥ 3) (RR ranged from 0.61 to 0.97; 2 studies, 964 participants; very low-certainty evidence), anaemia (grade ≥ 3) (RR ranged from 0.19 to 0.82; 5 studies, 1968 participants; very low-certainty evidence), HFS (grade ≥ 3) (RR ranged from 15.19 to 109.15; 6 studies, 2184 participants; very low-certainty evidence), and the rate of neurological events (grade ≥ 3)(RR ranged from 0.08 to 3.09; 3 studies, 1222 participants; very low-certainty evidence). PLD with conventional chemotherapy compared to PLD alone likely results in little to no difference in OS (HR 0.92, 95% CI 0.70 to 1.21; 1 study, 242 participants; moderate-certainty evidence) and it may result in little to no difference in PFS (HR 0.94, 95% CI 0.73 to 1.22; 2 studies, 353 participants; low-certainty evidence). The combination likely increases overall severe adverse events (grade ≥ 3) (RR 2.48, 95% CI 1.98 to 3.09; 1 study, 663 participants; moderate-certainty evidence) and anaemia (grade ≥ 3) (RR 2.38, 95% CI 1.46 to 3.87; 2 studies, 785 participants; moderate-certainty evidence), but likely results in a large reduction in HFS (grade ≥ 3) (RR 0.24, 95% CI 0.14 to 0.40; 2 studies, 785 participants; moderate-certainty evidence). It may result in little to no difference in neurological events (grade ≥ 3) (RR 1.40, 95% CI 0.85 to 2.31; 1 study, 663 participants; low-certainty evidence).; Authors' Conclusions: In platinum-sensitive relapsed EOC, including PLD in a combination chemotherapy regimen probably makes little to no difference in OS compared to other combinations, but likely improves PFS. Choice of chemotherapy will therefore be guided by symptoms from previous chemotherapy and other patient considerations. Single-agent PLD remains a useful agent for platinum-resistant relapsed EOC and choice of agent at relapse will depend on patient factors, e.g. degree of bone marrow suppression or neurotoxicity from previous treatments. Adding another agent to PLD likely increases overall grade ≥ 3 adverse events with little to no improvement in survival outcomes. The limited evidence relating to PLD in combination with other agents in platinum-resistant relapsed EOC does not indicate a benefit, but there is some evidence of increased side effects. (Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Ngoi Natalie, Y., et al. (2022). "Weekly versus tri-weekly paclitaxel with carboplatin for first-line treatment in women with epithelial ovarian cancer." The Cochrane Database of Systematic Reviews 2: CD012007.
	Background: Epithelial ovarian cancer is the sixth most common cancer worldwide: 295,414 new cases were diagnosed in 2018, with 184,799 deaths. The lack of an effective screening strategy has led to the majority of women being diagnosed at an advanced stage. For these women, intravenous carboplatin combined with paclitaxel for six cycles is widely accepted as the standard first-line treatment for epithelial ovarian cancer, in combination with debulking surgery. However, there is conflicting evidence regarding the optimal dosing schedule of paclitaxel when combined with carboplatin in this setting.; Objectives: To compare the efficacy and tolerability of intravenous weekly paclitaxel with that of tri-weekly paclitaxel, in combination with intravenous carboplatin, as first-line treatment for epithelial ovarian cancer (defined as epithelial ovarian, primary peritoneal and fallopian tube cancer).; Search Methods: We searched CENTRAL, MEDLINE, and Embase databases for relevant studies up to 15 November 2021, using keywords and MeSH terms. We additionally handsearched conference libraries, online clinical trial databases and screened through lists of retrieved references.; Selection Criteria: We Included randomised controlled trials (RCTs) comparing weekly paclitaxel in combination with carboplatin versus tri-weekly paclitaxel in combination with carboplatin, for treatment of newly-diagnosed epithelial ovarian cancer.; Data Collection and Analysis: We used the hazard ratio (HR) to estimate the primary efficacy outcomes progression-free (PFS) and overall survival (OS). We used the risk ratio (RR) to estimate the primary toxicity outcome of severe neutropenia and secondary outcomes of quality of life (QoL) and treatment-related adverse events. Two review authors independently selected studies, extracted data, and assessed risk of bias, using standard Cochrane methodological procedures. We included individual participant data (IPD) from one of the included studies, ICON-8, provided by the study team. We analysed data using a random-effects model in Review Manager 5.4 software. Additionally, we reconstructed IPD for PFS and OS data from published Kaplan-Meier curves from all studies and subsequently pooled these to analyse the two primary efficacy outcomes.; Main Results: From 2469 records, we identified four eligible RCTs with data for 3699 participants. All eligible studies were included in the main meta-analysis and reported on PFS and OS. There was likely a slight improvement in PFS when paclitaxel was dosed weekly compared to tri-weekly (HR 0.89, 95% confidence interval (CI) 0.81 to 0.98; 4 studies, 3699 participants; moderate-certainty evidence). We found little to no improvement in OS when paclitaxel was dosed weekly compared to tri-weekly (HR 0.92, 95% CI 0.79 to 1.06; 4 studies, 3699 participants; high-certainty evidence). There was likely little to no difference in high-grade (grade 3 or 4) neutropenia when paclitaxel was dosed weekly compared to tri-weekly (RR 1.11, 95% CI 0.86 to 1.43; 4 studies, 3639 participants; moderate-certainty evidence). However, weekly paclitaxel increased high-grade (grade 3 or 4) anaemia when compared to tri-weekly dosing (RR 1.57, 95% CI 1.12 to 2.20; 4 studies, 3639 participants; high-certainty evidence). There may be little to no difference in high-grade neuropathy when paclitaxel was dosed weekly compared to tri-weekly (RR 1.12, 95% CI 0.64 to 1.94; 4 studies, 3639 participants; low-certainty evidence). The overall risk of detection bias and performance bias was low for OS, but was unclear for other outcomes, as treatments were not blinded. The risk of bias in other domains was low or unclear. We note that OS data were immature for three of the included studies (GOG-0262, ICON-8 and MITO-7).; Authors' Conclusions: Weekly paclitaxel combined with carboplatin for first-line treatment of epithelial ovarian cancer likely improves PFS slightly (moderate-certainty evidence) but not OS (high-certainty evidence), compared to tri-weekly paclitaxel combined with carboplatin. However, this was associated with increased risk for high-grade anaemia, treatment discontinuation, dose delays and dose omissions (high- to low-certainty evidence). Our findings may not apply to women receiving bevacizumab in first-line therapy, those receiving treatment in the neo-adjuvant setting, or those with rare subtypes of clear cell or mucinous ovarian cancer. (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Nguyen, T. (2023). "A study comparing pelvic organ prolapse surgery in women with or without graft made from blood." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention group: autologous graft If a patient is randomised to "intervention group", she will undergo native tissue repair surgery [by two gynaecologists] with an autologous graft to augment the repair of the pelvic organ prolapse. Immediately before surgery, the experimental treatment involves drawing up 40mls of the patient s own blood for processing the autologous graft; this graft will be prepared in the operating theatre and produced at the time of surgery, which takes 40‐60 minutes, and then be sutured or glued to the underlying connective tissue during prolapse repair surgery. In the operating theatre room, the patient will be under a general anaesthesia during surgery. The conventional native tissue vaginal repair will be performed and then the autologous graft will be placed onto the prolapse repair site for augmentation. The vaginal skin is closed after this layer. At the completion of surgery, a vaginal pack and in‐dwelling catheter will be placed until the next morning. Adherence of intervention can be review of surgical record after the surgery and review of the patient and her records at each followup, at si Xweeks, si Xmonths, and 12 months. CONDITION: Pelvic organ prolapse; ; Pelvic organ prolapse Renal and Urogenital ‐ Other renal and urogenital disorders Surgery ‐ Other surgery PRIMARY OUTCOME: The primary outcome is the anatomical success rate of pelvic organ prolapse at one‐year post‐op, based on the change from baseline in pelvic organ prolapse quantification (POPQ) staging and at the 12‐month follow‐up visit. Success is defined as a decrease of 1 or more in POPQ stage at 12 months from baseline, with no reoperation for anterior and posterior vaginal wall prolapse. Participants with either no change in POPQ from baseline, or an increase, will be designated as failures. [ 12‐month post‐op follow‐up visit] SECONDARY OUTCOME: Minor and major complication rates, infection, severe bleeding (blood loss of 500mls), urinary tract infection, wound breakdown, graft rejection, unplanned return to theatre, urinary retention treated with catheter, visceral injury, venous thromboembolism and pulmonary embolism. These will be assessed as a composite outcome. This will be assess by clinician review, Australian Pelvic Floor Questionnaire (APFQ), review of patient medical record[ Post‐op, 6 weeks, 6 months, and 12 months postop] need for analgesia by review of medical records[ at baseline, 6 weeks, 6 months, 12 months postop] pain score by visual analogue scale by review of medical records[ at baseline, 6 weeks, 6 months, 12 months post‐op] Pain score postop by pain visual analogue scale and need for analgesia will be compared in both groups.[ Post‐op (within 24 hours post‐surgery)] Quality of Life (QOL) as assessed by total score of the Australian pelvic floor questionnaire (APFQ), which is a validated tool that integrates bladder, bowel, prolapse, and sexual function. Higher scores in each domain suggest greater QOL impairment. Patients will be asked to fill out APFQ questionnaires at baseline and each follow‐up visit. [ at 6 weeks, 6 months, and 12 months post‐op.] INCLUSION CRITERIA: Participants will be considered eligible for this study if they: 1. Are female patients over the age of 18 2. Have been formally diagnosed with pelvic organ prolapse quantification (POPQ) stage 2 of anterior and or posterior compartment with or without apical prolapse, defined as c ‐1 (cervi Xor vaginal cuff 1 cm above hymen) or less. 3. Understand the conditions of the study fully and are willing to participate for the length of the study in its entirety; 4. Are capable of giving informed consent to their participation in the study.

Nguyen Thi, M., et al. (2020). "Exercise and Quality of Life in Women with Menopausal Symptoms: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." International Journal of Environmental Research and Public Health 17(19).
	Menopausal symptoms are associated with deterioration in physical, mental, and sexual health, lowering women's quality of life (QoL). Our study objective is to examine the effect of exercise on QoL in women with menopausal symptoms. After initially identifying 1306 studies published on PubMed, Web of Science, Scopus, and Cochrane Library before June 2020, two researchers independently selected nine randomized controlled trials (RCTs) in which any type of exercise was compared with no active treatment. We assessed the risk of bias in the included studies using the Cochrane risk-of-bias 2.0 tool for RCTs and computed the converged standardized mean difference with a 95% confidence interval. We found evidences for the positive effects of exercise on physical and psychological QoL scores in women with menopausal symptoms. However, there was no evidence for the effects of exercise on general, social, and menopause-specific QoL scores. The most common interventions for women with menopausal and urinary symptoms were yoga and pelvic floor muscle training (PFMT), respectively. In our meta-analyses, while yoga significantly improved physical QoL, its effects on general, psychological, sexual, and vasomotor symptoms QoL scores as well as the effect of PFMT on general QoL were not significant. Our findings suggest that well-designed studies are needed to confirm the effect of exercise on QoL in women with menopausal symptoms.

Nguyen, T. T. B., et al. (2024). "The Effect of Pelvic Floor Muscle Training on Health-Related Quality of Life in Postmenopausal Women With Genitourinary Syndrome: A Systematic Review and Meta-Analysis." The Journal of Nursing Research 32(1): e316.
	BACKGROUND: Genitourinary syndrome is commonly reported in postmenopausal women. Kegel's exercise is a noninvasive therapy that improves pelvic floor muscle parameters. However, the effect of Kegel's exercise on health-related quality of life (HRQoL) in postmenopausal women with genitourinary syndrome has not been synthesized or shown. PURPOSE: This study was designed to systematically review and analyze the previous literature to determine whether Kegel's exercise enhances HRQoL in postmenopausal women with genitourinary syndrome of menopause. METHODS: A systematic review and meta-analysis of randomized controlled trials was conducted, and six databases were searched, including Embase, MEDLINE, Cochrane, CINAHL, Web of Science, and Scopus, from their dates of inception to November 2021. Eligible studies evaluated the effects of Kegel's exercise on HRQoL in postmenopausal women with urinary, sexual, or genital symptoms. Review Manager software was used to perform the meta-analysis using a random-effects model. Chi-square and I2 tests were used to evaluate heterogeneity among the studies. Meta-analysis was performed based on the symptoms (i.e., urinary, sexual, and genital) identified in the quality-of-life questionnaires. RESULTS: This systematic review covered five studies with 268 participants. The research appraisal found most of these studies had a low risk of bias. The intervention periods ranged from 4 to 12 weeks. Compared with non-Kegel's exercise or regular activity, Kegel's exercise was found to significantly improve HRQoL-related urinary symptoms (three studies, standardized mean difference = -0.95, 95% CI [-1.35, -0.54], I2 = 0%). However, the effect of this exercise on HRQoL-related sexual symptoms did not differ from non-Kegel's exercise or regular activity (two studies, standardized mean difference = 1.11, 95% CI [-0.25, 2.47], I2 = 94%). None of the covered studies examined the effect of Kegel's exercise on HRQoL-related genital symptoms. CONCLUSIONS/IMPLICATIONS FOR PRACTICE: Kegel's exercise is an effective intervention for improving HRQoL-related urinary symptoms in postmenopausal women. However, there remains insufficient evidence to assess the effectiveness of Kegel's exercise on HRQoL-related genital symptoms in this population. The results support using Kegel's exercise as a useful intervention to manage urinary symptoms in postmenopausal women.

Nguyen Van, T., et al. (2022). "Dose-Intense Cisplatin-Based Neoadjuvant Chemotherapy Increases Survival in Advanced Cervical Cancer: An Up-to-Date Meta-Analysis." Cancers 14(3).
	Purpose: We set out to demonstrate the benefit of using dose-intense cisplatin-based neoadjuvant chemotherapy in terms of overall survival and progression-free survival.; Methods: We searched through MEDLINE and Cochrane Library databases up to May 2021 to identify randomized clinical trials comparing the benefit of using cisplatin-based neoadjuvant chemotherapy followed by local treatment with local treatment alone for the treatment of locally advanced cervical cancer. The PRISMA statement was applied.; Results: Twenty-two randomized clinical trials were retrieved between 1991 and 2019, corresponding to 3632 women with FIGO stages IB2-IVA cervical cancer. More than 50% of the randomized clinical trials were assessed as having a low risk of bias. There was no benefit of neoadjuvant chemotherapy on overall survival, but there was significant heterogeneity across studies (I 2 = 45%, p = 0.01). In contrast, dose-intense cisplatin at over 72.5 mg/m 2 /3 weeks was significantly associated with increased overall survival (RR = 0.87, p < 0.05) with no heterogeneity across the pooled studies (I 2 = 36%, p = 0.11). The survival benefit was even greater when cisplatin was administered at a dose over 105 mg/m 2 /3 weeks (RR = 0.79, p < 0.05).; Conclusion: Even though radiotherapy combined with weekly cisplatin-based chemotherapy remains standard of care for the treatment of locally advanced cervical cancer, our meta-analysis makes it possible to consider the use of dose-intense cisplatin-based neoadjuvant chemotherapy when local treatment is suboptimal and opens perspectives for designing new clinical trials in this setting. Neoadjuvant chemotherapy could be proposed when surgery is local treatment instead of standard chemoradiotherapy for the treatment of locally advanced cervical cancer.

Ni, Y. and J. Lian (2023). "Carbon dioxide laser therapy for the management of genitourinary syndrome of menopause: A meta‑analysis of randomized controlled trials." Experimental and Therapeutic Medicine 27(1): 10.
	Genitourinary symptoms of menopause (GSM) affect ~50% of women after menopause. Recently, CO 2 laser therapy has been used for managing GSM but without high quality evidence. The present review assessed the effectiveness of CO 2 laser therapy in the management of GSM. PubMed, Embase, Web of Science, CENTRAL and Scopus databases were searched for randomized controlled trials (RCTs), published up to June 30, 2023, comparing CO 2 laser and sham laser treatments for GSM management. The outcomes of interest included Female Sexual Function Index (FSFI), Vaginal Health Index (VHI) and visual analog scale (VAS) for dyspareunia, dryness, burning, itching and dysuria. A total of seven RCTs were included in the review and meta-analysis, with 6/7 studies using three sessions of laser therapy, 4-8 weeks apart. Meta-analysis demonstrated no statistically significant difference in FSFI [mean difference (MD), -1.48; 95% CI, -5.85, 2.89; I 2 =45%] and VHI scores (MD, -0.18; 95% CI, -1.66, 1.31; I 2 =72%) between laser and control groups. Meta-analysis also demonstrated no statistically significant difference in VAS scores for dyspareunia (MD, -1.63; 95% CI; -4.06, 0.80; I 2 =91%), dryness (MD, -1.30; 95% CI, -3.14, 0.53; I 2 =75%), burning (MD, -0.76; 95% CI, -2.03; 0.51 I 2 =56%), itching (MD, -0.28; 95% CI, -0.95, 0.38; I 2 =0%) and dysuria (MD, 0.15; 95% CI, -0.37, 0.67; I 2 =23%) between the groups. The included RCTs had low risk of bias. In conclusion, meta-analyses of high-quality sham-controlled RCTs indicated that CO 2 may not have any beneficial effect on GSM. Limited data and high heterogeneity in meta-analyses in this area of research are important limitations that need to be addressed by future RCTs.; Competing Interests: The authors declare that they have no competing interests. (Copyright: © Ni and Lian.)

Niaz, R., et al. (2022). "Efficacy and Safety of Oral GnRh Antagonists in Patients With Uterine Fibroids: A Systematic Review." Journal of Obstetrics and Gynaecology Canada 44(12): 1279-1288.
	Objective: This review aimed to assess the efficacy and safety of GnRH antagonists in patients with symptomatic uterine fibroids.; Data Sources: A literature search was performed on PubMed, Web of Science, Embase, Cochrane, and ClinicalTrials.gov using the MeSH and Emtree terms "leiomyoma" and "gonadotropin-releasing hormone."; Study Selection: All clinical trials that provided efficacy and safety data in clinical terms (i.e., reduction in menstrual bleeding and discomfort, changes in the size of leiomyoma and uterine volume, etc.) were included. We excluded all preclinical studies, case reports, meta-analyses, review articles, and clinical studies irrelevant to the study question.; Data Extraction and Synthesis: Two authors extracted data from 9 clinical studies. The extracted data included the study's characteristics, participants' baseline characteristics, treatment drugs, efficacy measures, and toxicity.; Conclusion: Among oral GnRH antagonists, relugolix, elagolix, and linzagolix were safe in patients with uterine fibroids. These drugs, alone and in combination with E2/NETA (estradiol/norethindrone acetate), showed significantly better efficacy than placebo in improving bleeding, discomfort, uterine/leiomyoma sizes, and quality of life in premenopausal patients with symptomatic uterine fibroids. However, more randomized, double-blind, multicentre clinical trials are needed to confirm these results and to see long-term benefits. (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.)

Nica, A., et al. (2021). "Cost-effectiveness of maintenance hormonal therapy in patients with advanced low grade serous ovarian cancer." Gynecologic Oncology 160(1): 206-213.
	Objectives: To assess the cost-effectiveness of using maintenance hormonal therapy in patients with low grade serous ovarian cancer (LGSC). Method(s): A simulated decision analysis with a Markov decision model over a lifetime horizon was performed using the base case of a 47-year old patient with stage IIIC, LGSC following first-line treatment with primary cytoreductive surgery and adjuvant chemotherapy. Two treatment strategies were analyzed - maintenance daily letrozole until disease progression and routine observation. The analysis was from the perspective of the healthcare payer. Direct medical costs were estimated using public data sources and previous literature and were reported in adjusted 2018 Canadian dollars. The model estimated lifetime cost, quality-adjusted life years (QALY), life years (LY), median overall survival (OS), and number of recurrences with each strategy. Cost-effectiveness was compared using an incremental cost-effectiveness ratio (ICER). A strategy was considered cost-effective when the ICER was less than the willingness to pay (WTP) threshold of $50,000 CAD per QALY. Deterministic sensitivity analysis was performed to assess the impact of changing key clinical and cost variables. Result(s): Maintenance letrozole was the preferred strategy with an associated lifetime cost of $69,985 CAD ($52,620 USD) and an observed improvement of 0.91 QALYs and 1.55 LYs. The ICER for letrozole maintenance therapy was an additional $11,037 CAD ($8298 USD) per QALY. The modeled median OS was 150 months with maintenance letrozole and 126 months in the observation strategy. The maintenance letrozole strategy resulted in 34% and 17% fewer first recurrences at 5-year and 10-year follow-up, respectively. Conclusion(s): Maintenance letrozole is a cost-effective treatment strategy in patients with advanced LGSC resulting in clinically-relevant improvement in QALYs, LYs, and fewer disease recurrences.Copyright © 2020 Elsevier Inc.

Nichola, W., et al. (2022). "Non-pharmacological interventions in primary care for women experiencing the perimenopause: A systematic review." PROSPERO International prospective register of systematic reviews.
	
Nicole, K., et al. (2022). "What is the effect of dietary patterns, foods and nutrients on premenstrual syndrome symptoms in women of reproductive age?" PROSPERO International prospective register of systematic reviews.
	
Nicum, S., et al. (2024). "Results of a randomised Phase II trial of olaparib, chemotherapy or olaparib and cediranib in patients with platinum-resistant ovarian cancer." British Journal of Cancer.
	Background: OCTOVA compared the efficacy of olaparib (O) versus weekly paclitaxel (wP) or olaparib + cediranib (O + C) in recurrent ovarian cancer (OC). Aim(s): The main aim of the OCTOVA trial was to determine the progression-free survival (PFS) of olaparib (O) versus the oral combination of olaparib plus cediranib (O + C) and weekly paclitaxel (wP) in recurrent ovarian cancer (OC). Method(s): In total, 139 participants who had relapsed within 12 months of platinum therapy were randomised to O (300 mg twice daily), wP (80 mg/m2 d1,8,15, q28) or O + C (300 mg twice daily/20 mg daily, respectively). The primary endpoint was progression-free survival (PFS) of olaparib (O) versus olaparib plus cediranib (O + C) or weekly paclitaxel (wP). The sample size was calculated to observe a PFS hazard ratio (HR) 0.64 in favour of O + C compared to O (20% one-sided type I error, 80% power). Result(s): The majority had platinum-resistant disease (90%), 22% prior PARPi, 34% prior anti-angiogenic therapy, 30% germline BRCA1/2 mutations. The PFS was increased for O + C vs O (O + C 5.4 mo (2.3, 9.6): O 3.7 mo (1.8, 7.6) HR = 0.73; 60% CI: 0.59, 0.89; P = 0.1) and no different between wP and O (wP 3.9 m (1.9, 9.1); O 3.7 mo (1.8, 7.6) HR = 0.89, 60% CI: 0.72, 1.09; P = 0.69). The main treatment-related adverse events included manageable diarrhoea (4% Grade 3) and hypertension (4% Grade 3) in the O + C arm. Discussion(s): OCTOVA demonstrated the activity of O + C in women with recurrent disease, offering a potential non-chemotherapy option. Trial registration: ISRCTN14784018, registered on 19th January 2018 http://www.isrctn.com/ISRCTN14784018 .Copyright © 2024, The Author(s).

Nie, W., et al. (2020). "Efficacy and safety of over-the-counter analgesics for primary dysmenorrhea: A network meta-analysis." Medicine 99(19): e19881.
	Background: Primary dysmenorrhea is common and troublesome. The comparative efficacy of over-the-counter analgesics (OTCAs) for dysmenorrhea is unclear. This study was aimed at conducting a network meta-analysis to assess the efficacy and safety of 5 OTCAs - naproxen, ibuprofen,diclofenac, aspirin, and ketoprofen - in patients with primary dysmenorrhea.; Methods: The study was registered with PROSPERO (number: CRD42019133556). The search strategy involved a review of PubMed, Embase, Cochrane Library, Web of Science, and CINAHL for relative randomized controlled trials of the 5 analgesics from the date of database establishment to July 2019. The outputs are presented as odds ratios (ORs), their corresponding 95% confidence intervals (CIs), and the surface under the cumulative ranking area (SUCRA) probabilities.; Results: Thirty-five trials with 4383 participants were included in our study. As for efficacy outcomes, all the included analgesics except aspirin were more effective than placebo in treating dysmenorrhea [naproxen (OR 3.99, 95% CI 2.18-7.30), ibuprofen (OR 10.08, 95% CI 3.29-30.85), diclofenac (OR 11.82, 95% CI 2.66-52.48), and ketoprofen (OR 5.12, 95% CI 1.57-16.69). The OTCAs were superior to the placebo in terms of pain relief in primary dysmenorrhea. Aspirin was less effective than ibuprofen (OR 0.17, 95% CI 0.04-0.73) and diclofenac (OR 1.17, 95% CI 0.02-0.85). The SUCRA curves showed that diclofenac and ibuprofen were the most and second most effective (85.1% and 83.8%, respectively), followed by ketoprofen, naproxen, and aspirin. Regarding safety, there was no significant difference between the 5 OTCAs included and the placebo. Diclofenac versus ibuprofen (OR 4.31, 95% CI 1.18-15.67), ketoprofen versus diclofenac (OR 0.18, 95% CI 0.04-0.78), and ketoprofen versus aspirin (OR 0.41, 95% CI 0.18-0.97) presented statistically significant differences. Ketoprofen and ibuprofen were ranked the best (SUCRA 90.6% and 79.6%), followed by naproxen, aspirin, and diclofenac.; Conclusion: Considering the efficacy and safety, ibuprofen is recommended as the optimal OTCA for primary dysmenorrhea. Further well-designed studies that directly compare these analgesics are needed to support our conclusion.

Nieuwenhuyzen-de Boer, G. M., et al. (2022). "Adjuvant Use of PlasmaJet Device During Cytoreductive Surgery for Advanced-Stage Ovarian Cancer: Results of the PlaComOv-study, a Randomized Controlled Trial in The Netherlands." Annals of Surgical Oncology 29(8): 4833-4843.
	Objective: Standard surgical treatment of advanced-stage ovarian carcinoma with electrosurgery cannot always result in complete cytoreductive surgery (CRS), especially when many small metastases are found on the mesentery and intestinal surface. We investigated whether adjuvant use of a neutral argon plasma device can help increase the complete cytoreduction rate.; Patients and Methods: 327 patients with FIGO stage IIIB-IV epithelial ovarian cancer (EOC) who underwent primary or interval CRS were randomized to either surgery with neutral argon plasma (PlasmaJet) (intervention) or without PlasmaJet (control group). The primary outcome was the percentage of complete CRS. The secondary outcomes were duration of surgery, blood loss, number of bowel resections and colostomies, hospitalization, 30-day morbidity, and quality of life (QoL).; Results: Complete CRS was achieved in 119 patients (75.8%) in the intervention group and 115 patients (67.6%) in the control group (risk difference (RD) 8.2%, 95% confidence interval (CI) -0.021 to 0.181; P = 0.131). In a per-protocol analysis excluding patients with unresectable disease, complete CRS was obtained in 85.6% in the intervention group and 71.5% in the control group (RD 14.1%, 95% CI 0.042 to 0.235; P = 0.005). Patient-reported QoL at 6 months after surgery differed between groups in favor of PlasmaJet surgery (95% CI 0.455-8.350; P = 0.029). Other secondary outcomes did not differ significantly.; Conclusions: Adjuvant use of PlasmaJet during CRS for advanced-stage ovarian cancer resulted in a significantly higher proportion of complete CRS in patients with resectable disease and higher QoL at 6 months after surgery. (Funded by ZonMw, Trial Register NL62035.078.17.) TRIAL REGISTRATION: Approved by the Medical Ethics Review Board of the Erasmus University Medical Center Rotterdam, the Netherlands, NL62035.078.17 on 20-11-2017. Recruitment started on 30-1-2018. (© 2022. The Author(s).)

Nihar, B., et al. (2022). "Safety and Efficacy of oral tablet vs. transdermal estrogen (gel) for Endometrial preparation for frozen-thawed embryo transfer in a hormone replacement artificial cycle: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Nipa, S. I., et al. (2020). "Effectiveness of therapeutic interventions for women with urinary incontinence: A systematic review." Critical Reviews in Physical and Rehabilitation Medicine 32(1): 1-22.
	Background: Urinary incontinence is a common condition that reduces the quality of life of women specifically. To reduce this problem, it is necessary to identify the best possible therapeutic options. Purpose(s): To synthesize the evidence on effective therapeutic options for women with urinary incontinence. Data Sources: We extracted relevant papers from the Hinari, PubMed, Cochrane, Science Direct, Embase, PEDro, and Cinahl databases. Several studies were searched comprehensively. Study Selection: We integrated data from 17 randomized controlled trials related to therapeutic interventions for the management of urinary incontinence in women. Data Extraction: The PEDro scale was used to grade the level of evidence. The contents and outcomes of different therapeutic interventions for various types of urinary incontinence were explored. Data Synthesis: The comparative effectiveness of the interventions was analyzed based on intervention and control groups, long-term follow-up, adequate sample size, and intention to treat analyses. The primary outcomes of the studies considered reduced severity of urinary incontinence and secondary outcomes such as satisfaction, improved self-esteem, sexual function, and quality of life. Conclusion(s): Our findings suggest that pelvic-floor muscle exercise, behavioral training, electrical stimulation, vaginal cones, whole-body vibration treatment, and modified Pilates are significantly effective at reducing urinary incontinence. Nevertheless, persisting with one of these intervention procedures is difficult. Therefore, we recommend further study for long-term follow-up.Copyright © 2020 by Begell House, Inc.

Niu, C. (2021). "Adjuvant tislelizumab plus chemotherapy after post-operative pelvic chemoradiation in high risk endometrial cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: The experimental group will receive a sequential adjuvant treatment of pelvic chemoradiation, followed by 4 cycles of tislelizumab and carboplatin plus paclitaxel chemotherapy, followed by tislelizumab alone for another 8 cycles. Tislelizumab 200 mg will be administered via an intravenous infusion once every 3 weeks for up to 12 cycles, and carboplatin (AUC 5) and paclitaxel (175 mg/m^2) will also be administered via an intravenous infusion once every 3 weeks for up to 4 cycles and as per local institution guidelines). Pelvic chemoradiation should commence within 4‐6 weeks after surgery, but no later than 8 weeks of surgery, and prior to chemotherapy +/‐ immunotherapy. Pelvic chemoradiation will be at a dose of 45Gy in 25 fractions, delivered to the clinical target volume, 5 days a week for 5 weeks. CONDITION: Cancer ‐ Womb (Uterine or endometrial cancer) Endometrial Cancer; ; Endometrial Cancer PRIMARY OUTCOME: Failure free survival (FFS) at 12 months. Failure is defined by development of new lesions or progression of existing abnormalities thought to be due to cancer as determined by site investigator, and assessed using patient medical chart.[12 months post randomisation] SECONDARY OUTCOME: EORTC QLQ‐C30 to measure patients' physical, psychological and social functions. [12 months post randomisation] EQ‐5D‐5L is a scale that measures quality of life on a 5‐component scale including mobility, self‐care, usual activities, pain/discomfort, and anxiety/depression[12 months post randomisation] FACIT TS‐G to obtain an overall evaluation of current treatment in chronic illnesses[12 months post randomisation] Failure free survival time at 6 months. Failure is defined by development of new lesions or progression of existing abnormalities thought to be due to cancer as determined by site investigator, and assessed using patient medical chart. ; ; [6 months post randomisation] Failure rate at 6 months. Failure is defined by development of new lesions or progression of existing abnormalities thought to be due to cancer as determined by site investigator, and assessed using patient medical chart.[6 months post randomisation] Feasibility of delivering combined adjuvant tislelizumab and carboplatin plus paclitaxel chemotherapy after post‐operative pelvic chemoradiation for high‐risk EC. Feasibility is defined by the proportion of of participants who received at least two thirds of their prescribed number of cycles of their allocated treatment. ; ; Study database will record the number of participants who received at least two thirds of their prescribed number of cycles in their allocated treatment as all participant visits and treatment will be documented. [Two thirds or more of the prescribed number of cycles in experimental group is defined as: ; i) completed 3 or more cycles of chemotherapy and tislelizumab ; ii) completed 8 or more cycles tislelizumab (of the planned total of 12) ; ; Outcome will be assessed after all participants have completed treatment. ; ; ; ] Frequency and severity of treatment‐related adverse events as per CTCAE v5.0 assessed using patient medical chart[Duration of the trial] Overall survival time assessed using patient medical chart.[From the date of randomisation to date of death from any cause] QLQ‐CIPN to assess peripheral neuropathy ; [12 months post randomisation] QLQ‐EN24 to assess disease and treatment specific aspects of the quality of life of patients with endometrial cancer[12 months post randomisation] INCLUSION CRITERIA: Inclusion Criteria at REGISTRATION: 1) People aged 18 years and older, with a histological diagnosis of high‐risk endometrial cancer, defined as: Note: ECs with mixed histology will be accepted. a) FIGO 2018 stage III or IVA endometrial cancer with endometroid histology; or b) FIGO 2018 stage II‐IVA endometrial cancer with serous, clear cell or carcinosarcoma histology. 2) Completed prior surgical treatment with total hysterectomy and bilateral salpingo‐oophorectomy +/‐ lymph node evaluation (either lymph node sampling o ymphadenectomy) and planned for adjuvant therapy 3) Have not received any prior chemotherapy for endometrial cancer 4) Have not received any prior pelvic radiation therapy 5) Adequate bone marrow function • Haemoglobin greater or equal to 90 g/L • Absolute neutrophil count greater or equal to 1.5 x 10^9/L • Platelets greater or equal to 100 x 10^9/L 6) Adequate renal function • creatinine

Nl (2021). "Luteal Phase Support in MOH/IUI treatment (LUMO study)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Exogenous progesterone (Utrogestan) CONDITION: Unexplained Infertility/ sub fertility PRIMARY OUTCOME: Pregnancy within 6 months of treatment, leading to Live birth. SECONDARY OUTCOME: Clinical pregnancy rate (Number and rate op patients that achieve a clinical pregnancy within 6 months). Miscarriage rate (Number and rate of patients that experience a miscarriage (<16weeks gestation) within 6months). Multiple pregnancy rate (number of pregnancies with 2 or more fetuses, <6 months). Pregnancy complications (pregnancies complicated by preterm labor (<37weeks), loss of pregnancy (>16 weeks gestation), gestational diabetes, preeclampsia, HELLP syndrome or pregnancy induced hypertension, within one year). Perinatal outcomes (stillbirth, live birth, perinatal death <6 weeks, gestational age and birthweight). Side effects (e.g. nausea, stomach ache, vaginal discharge, other (self reported) side effects) within treatment cycle) and compliance to therapy (use of medication as prescribed during treatment cycles). Added Medication Costs (increase in total therapy costs due to the addition of utrogestan). Budget impact (economic assessment that estimates financial consequences of adopting a new intervention). INCLUSION CRITERIA: ‐ Couples starting IUI with Mild Ovarian HyperStimulation (MOH), with the intend to receive this treatment for at least six months. ‐ Diagnosis of unexplained (primary or secondary) infertility ‐ Hunault <30% (or >30%, after an expectant management period of at least 6 additional months). ‐ Females aged >18 years with regular menstrual cycle. ‐ Total mobile sperm count (VCM) >10 million.

Noh, Y.-H., et al. (2022). "A Complex of Cirsium japonicum var. maackii (Maxim.) Matisum. and Thymus vulgaris L. Improves Menopausal Symptoms and Supports Healthy Aging in Women." Journal of Medicinal Food 25(3): 281-292.
	We evaluated the efficacy and safety of MS-10 ® for the treatment of menopausal symptoms. A double-blind randomized placebo-controlled clinical trial was performed in 71 premenopausal women for 4 and 12 weeks. A total of 12 individual menopausal symptom scores were assessed using the Kupperman index. MS-10 treatment effectively improved the symptoms by ∼48%. In addition, the quality of life of the women improved by 36% from four perspectives: vasomotor, psychosocial, physical, and sexual symptoms as evaluated using the menopause-specific quality of life (MenQoL) questionnaire. Our results show that MS-10 improves insulin-like growth factor-1 (IGF-1) and estrogen utilization through receptor activation, which are thought to have causative therapeutic effects on menopause and aging inhibition in women. Improvement of Enthotheline-1 (ET-1) in the blood after MS-10 intake led to an improvement in menopausal vascular symptoms. Improvements in bone formation and absorption markers such as osteocalcin, bone-specific alkaline phosphatase (BSALP), C-telopeptides of type I collagen (CTx), deoxypyridinoline (deoxyPYD), and N-telopeptides of type I collagen (NTx) in blood or urine indicate that MS-10 fundamentally improves bone health in women. By confirming the improvement of the psychological well-being index based on the improvement of stress hormone cortisol, MS-10 can solve causative psychological and physical stress-related symptoms. Moreover, various safety tests, such as those for female hormones, were confirmed. Therefore, it can be confirmed that MS-10 is a natural pharmaconutraceutical that causatively and safely improves health of women and aids in antiaging processes.

Norah, A., et al. (2024). "Effectiveness of combining gefitinib and methotrexate in treating tubal ectopic pregnancy compared to methotrexate alone: systematic review and metanalysis." PROSPERO International prospective register of systematic reviews.
	
Nørgaard-Pedersen, C., et al. (2022). "Intravenous immunoglobulin and prednisolone to women with unexplained recurrent pregnancy loss after assisted reproductive technology treatment: a protocol for a randomised, double-blind, placebo-controlled trial." BMJ Open 12(9): e064780.
	Introduction: Recurrent pregnancy loss (RPL), defined as two or more consecutive pregnancy losses in the first trimester, affects around 5% of fertile women. The underlying causes remain unknown in up to 60% of patients; however, most studies point at an immunological pathology in unexplained RPL, and therefore, an effective treatment may be immunomodulatory. This study aims to evaluate the effect of intravenous immunoglobulin (IVIg) and prednisolone on reproductive outcome and the immune system in women with unexplained RPL undergoing assisted reproductive technology treatment.; Methods and Analysis: This randomised, placebo-controlled trial with double-blinded randomisation to two parallel arms evaluate if immunomodulatory (active) treatment is superior to placebo in increasing the chance of ongoing pregnancy assessed at nuchal translucency scan in gestational weeks (GW) 11-13 after embryo transfer (ET) in 74 RPL patients with ≥2 pregnancy losses as its primary objective. The active treatment consists of IVIg (one infusion preferably 1-5 days before ET and in GW 5, 6 and 7) and prednisolone (5 mg/day from first day of menstrual bleeding until ET and 10 mg/day from ET to GW 8+0) while the comparator consists of intravenous human albumin (5%) and placebo tablets. Allocation is concealed for participants, caregivers, and investigators until trial termination and is performed in a 1:1 ratio. The secondary objective is to evaluate treatment safety, and the tertiary objective is exploration of the association between treatment, reproductive outcome after ET, and the lymphocyte subset distribution in peripheral blood collected before and after intravenous infusion(s). Excess biological material is stored in a biobank for future research.; Ethics and Dissemination: The North Denmark Region Committee on Health Research Ethics (N-20200066) approved this trial. The results will be published in peer-reviewed scientific journals and presented to relevant patient associations, at relevant academic conferences and to key stakeholders.; Trial Registration Number: NCT04701034.; Competing Interests: Competing interests: USK received consulting fees from Merck for Update of patient information leaflet and from IBSA Nordic for Clinical instruction and support for attending meeting/congress from Merck. (© 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.)

NorthShore University, H. (2021). "IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone." ClinicalTrials.gov.
	No Results Available Drug: low-dose naltrexone|Drug: Placebo oral tablet Interstitial Cystitis Symptom Index|Visual analog scale|Interstitial Cystitis Problem Index|Urinary frequency|Nocturia|pelvic pain and urgency/frequency symptoms|pelvic pain and urgency/frequency bother|Patient perceived changes in quality of life: SF-36|Adverse effects|Medication tolerability|Change in pain medications Female Phase 4 2 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment EH20-127 February 23, 2023

Novartis Pharma, A. G. (2021). "Study to assess the efficacy and safety of alpelisib in combination with olaparib in patients with high-grade serous ovarian cancer without hereditary BRCA mutation that did not respond to prior platinum-based chemotherapy or recurred within six months after such therapy." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: Piqray Product Name: alpelisib Product Code: BYL719 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: ALPELISIB CAS Number: 1217486‐61‐7 Current Sponsor code: BYL719 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Trade Name: Piqray Product Name: alpelisib Product Code: BYL719 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: ALPELISIB CAS Number: 1217486‐61‐7 Current Sponsor code: BYL719 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Trade Name: Lynparza Product Name: olaparib Product Code: AZD2281 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: OLAPARIB CAS Number: 763113‐22‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: Lynparza Product Name: olaparib Product Code: AZD2281 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: OLAPARIB CAS Number: 763113‐22‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Paclitaxel CAS Number: 33069‐62‐4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6‐ Trade Name: Caelyx pegylated liposomal Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Doxorubicin Hydrochloride Other descriptive name: doxorubicin hydrochloride in a pegylated liposomal formulation Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2‐ CONDITION: Platinum‐resistant or refractory, high‐grade serous ovarian cancer with no germline BRCA mutation Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: Primary objective: To determine whether treatment with alpelisib in combination with olaparib prolongs PFS compared to single agent cytotoxic chemotherapy Primary end point(s): Progression‐free survival based on blinded independent review committe assessment using RECIST 1.1 criteria Secondary Objective: Key secondary objective: To determine whether treatment with alpelisib in combination with olaparib prolongs OS compared to single agent cytotoxic chemotherapy; ; Secondary objectives: ; 1. To assess safety and tolerability of alpelisib in combination with olaparib; ; 2. To evaluate alpelisib in combination with olaparib compared to single agent cytotoxic chemotherapy with respect to time to deterioration of ECOG (Eastern Cooperative Oncology Group) performance status; ; 3. To assess additional efficacy parameters; ; 4. To characterize alpelisib when administered in combination with olaparib; ; 5. To evaluate patient reported‐outcomes of alpelisib in combination with olaparib compared to single agent cytotoxic chemotherapy Timepoint(s) of evaluation of this end point: Futility analysis based on progression‐free survival: approximately after 90 progression‐free survival events (first documented progression or death due to any cause), approximately 14 months after randomization of the first subject; ; Final analysis for progression‐free survival: approximately after 224 progression‐free survival events, approximately 22 months after randomization of the first subject ; ; ; INCLUSION CRITERIA: Participant has histologically confirmed diagnosis of high‐grade serous or high‐grade endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. If no measurable disease is present, the disease should be assessable by Gynecologic Cancer Intergroup criteria (GCIC) for CA‐125. Participant has no germline BRCA1/2 mutation as determined by an FDA‐approved assay. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. SECONDARY OUTCOME: Secondary end point(s): Key secondary endpoint: To determine whether treatment with alpelisib in combination with olaparib prolongs OS compared to single agent cytotoxic chemotherapy in participants with platin ‐resistant or refractory, gBRCAnm HGSOC ; Secondary endpoints: To assess safety and tolerability of alpelisib in combination with olaparib with administered to participants with platinum‐resistant or refractory gBRCAnm HGSOC. To Evaluate alpelisib in combination with olaparib compared to single agent cytotoxic chemotherapy in participants with platinum‐resistant or refractory, gBRCAnm HGSOC with respect to time to deterioration of ECOG performance status. To assess additional efficacy parameter, such as ORR, CBR, DOR and TTR based on BIRC assessment using RECIST 1.1. To characterize alpelisib when administered in combination with olaparib in participants with platinum‐ resistant or refractory gBRCAnm HGSOC. To evaluate patient report outcomes of alpelisib in combination with olaparib compared to single agent cytotoxic chemotherapy in participants with platinum‐resistant or refractory, gBRCAnm HGSOC. Timepoint(s) of evaluation of this end point: Key secondary endpoint: OS will only be tested if final analysis of PFS is statistically significant. ; • The time point for the first OS interim analysis will be at the time of final PFS analysis after approximately 50% of deaths (126 deaths) are expected to have been recorded in the clinical database. ; • If OS is not statistically significant at the first interim analysis, the second OS analysis will be planned after approximately 75% of deaths (189 deaths) have been recorded in the clinical database (approximately 31 months after randomization of the first subject). If OS is not statistically significant at this stage, a final analysis is planned at the time approximately 252 deaths have been recorded (approximately 44 months after randomization of the first subject). Measurable disease, i.e., at least one measurable lesion per RECIST 1.1 criteria (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation). Participant has platinum‐resistant (progression within one to six months after completing platinum‐based therapy) or platinum refractory disease (progression during treatment or within 4 weeks after the last dose), where platinum‐b

Noventa, M., et al. (2019). "Testosterone therapy for women with poor ovarian response undergoing IVF: a meta-analysis of randomized controlled trials." Journal of Assisted Reproduction and Genetics 36(4): 673-683.
	Purpose: The aim of the present systematic review and meta-analysis was to summarize evidence on the effectiveness of testosterone supplementation for poor ovarian responders (POR) on IVF outcomes. The primary outcome was live birth rate (LBR); secondary outcomes were clinical pregnancy rate (CPR), miscarriage rate (MR), total and MII oocytes, and total embryos.; Methods: This meta-analysis of randomized controlled trials (RCTs) evaluates the effects of testosterone administration before/during COS compared with a control group in patients defined as POR. The primary outcome was live birth rate (LBR); secondary outcomes were clinical pregnancy rate (CPR), miscarriage rate (MR), total and MII oocytes, and total embryos. Pooled results were expressed as risk ratio (RR) or mean differences (MD) with 95% confidence interval (95% CI). Sources of heterogeneity were investigated through sensitivity and subgroup analysis. All analyses were performed by using the random-effects model.; Results: Women receiving testosterone showed higher LBR (RR 2.29, 95% CI 1.31-4.01, p = 0.004), CPR (RR 2.32, 95% CI 1.47-3.64, p = 0.0003), total oocytes (MD = 1.28 [95% CI 0.83, 1.73], p < 0.00001), MII oocytes (MD = 0.96 [95% CI 0.28, 1.65], p = 0.006), and total embryos (MD = 1.17 [95% CI 0.67, 1.67], p < 0.00001) in comparison to controls, with no difference in MR (p = ns). Sensitivity and subgroup analysis did not provide statistical changes to the pooled results.; Conclusions: Testosterone therapy seems promising to improve the success at IVF in POR patients. Further RCTs with rigorous methodology and inclusion criteria are still mandatory.

Nugent, K., et al. (2023). "Prospective randomised phase II trial evaluating adjuvant pelvic radiotherapy using either IMRT or 3-Dimensional planning for endometrial cancer." Acta Oncologica 62(8): 907-914.
	Objective: To compare the incidence of grade ≥2 gastrointestinal (GI) or genitourinary (GU) toxicity for patients undergoing 3DRT versus IMRT in the postoperative setting for endometrial cancer.; Methods: Eligible patients were post-operatively randomly assigned to one of two parallel groups in a 1:1 ratio, to have their RT delivered using either a 3DRT technique or using IMRT. The prescription dose was 45 Gy in 25 fractions over 5 weeks followed by vaginal vault brachytherapy. Toxicity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 3.0. Fisher's exact tests were used to test for associations between toxicity and arm. Differences in dosimetric parameters for patients with or without toxicity were tested using Mann-Whitney U -tests.; Results: 84 patients with a median age of 62 were evaluable for primary outcome. The median follow-up was 52 months. 14 (35%) participants from the 3DRT arm and 15 (34%) from the IMRT arm experienced acute grade ≥2 GI toxicity with older patients having a statistically higher risk of grade ≥2 acute GI toxicity. 20 (50%) participants from the 3DRT arm and 25 (57%) from the IMRT arm experienced acute grade ≥2 GI or GU toxicity ( p = .662). 12 (30%) patients from the 3DRT arm and 17 (39%) from the IMRT arm experienced acute grade ≥2 GU toxicity ( p = .493).; Conclusion: Although IMRT can reduce dose to normal tissue, in this study no benefit in acute GI or GU toxicity outcome was seen.

Nunes, E. F. C., et al. (2019). "Biofeedback for pelvic floor muscle training in women with stress urinary incontinence: a systematic review with meta-analysis." Physiotherapy 105(1): 10-23.
	Background: Several clinical effects have been attributed to the use of biofeedback (BF) as an adjuvant in the treatment of women with stress urinary incontinence (SUI). Objective(s): To determine whether BF is more effective than other interventions for women with SUI in terms of quantification of urine leakage, episodes of urinary loss, quality of life and muscle strength. Data sources: Science Direct, Embase, MEDLINE, Pedro, SciELO, CINAHL and LILACS from January 2000 to February 2017. Study selection: Randomised controlled trials (RCTs) addressing the effects of pelvic muscle floor training (PFMT) with BF for the conservative treatment of women with SUI. Data extraction and data synthesis: Two independent assessors extracted data from articles. The risk of bias for individual studies was assessed using the Jadad scale and Physiotherapy Evidence Database (PEDro) scale. Mean differences (MD) and 95% confidence intervals were calculated and combined in meta-analyses. Result(s): In total, 1194 studies were retrieved and 11 were included in this review. Only two RCTs demonstrated a low risk of bias according to the PEDro scale. The results demonstrated that PFMT with BF was no better than alternative interventions in terms of muscle strength measured using a perineometer. Limitation(s): Low methodological quality of studies, heterogeneity of outcomes, and differences in implementation of intervention protocols and BF modalities. Conclusion(s): PFMT with BF does not offer therapeutic benefits over alternative interventions (no training, PFMT alone and vaginal electrical stimulation) for the treatment of female SUI. Systematic review registration number PROSPERO: CRD42017060780.Copyright © 2018 Chartered Society of Physiotherapy

Nuo, X., et al. (2022). "Comparative effectiveness of different dietary supplements in patients with polycystic ovary syndrome. A systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Nurainiwati Sri, A., et al. (2022). "Effectivity and efficacy probiotics for Bacterial Vaginosis treatments: Meta-analysis." Infectious Disease Modelling 7(4): 597-604.
	Introduction: Bacterial Vaginosis (BV) is the most common cause of vaginal discharge. However, in some cases, side effects and resistance rates have been reported when antibiotics are administered. This problem has prompted several investigations on the administration of probiotics as an adjunct therapy to treat this infection.; Objection: This study aims to conduct a meta-analysis based on evidence to determine the efficacy and safety of probiotic and antibiotic treatments.; Methods: The meta-analysis was performed using PRISMA guidelines. The literature review was conducted in December 2020 using PubMed, Science Direct, Cochrane Library, and RevMan V.5.3.; Result: The results showed a high and significant cure rate from the analysis of 1006 and 528 samples of probiotics and non-probiotics or control in 16 studies. The recurrence rate was statistically significant with probiotic treatment. Furthermore, neither procedures nor therapy failure showed a significantly lower adverse event rate than the control group.; Conclusion: Probiotic shows better results compared to the control group. However, both have the same occurrence of adverse event.; Competing Interests: The authors declare no conflict. (© 2022 The Authors.)

Nyachieo, A., et al. (2019). "Nonsteroidal anti-inflammatory drugs for assisted reproductive technology." The Cochrane Database of Systematic Reviews 10: CD007618.
	Background: Despite substantial improvements in the success of treatments through assisted reproduction technologies (ART), live birth rates remain constantly low, and practitioners are seeking aetiologic treatments to improve the outcomes.Local inflammatory response is believed to contribute to implantation failure, where prostaglandins may increase uterine contractions and decrease uterine receptivity, decreasing the possibility of an IVF cycle leading to successful embryo transfer. In this context, nonsteroidal anti-inflammatory drugs (NSAIDs) have been employed to inhibit the negative prostaglandin effect. They are often offered in clinical practice to improve ART outcomes, but current robust evidence on their efficacy is lacking.; Objectives: To evaluate the effectiveness and safety of nonsteroidal anti-inflammatory drugs as co-treatments in infertile women undergoing assisted reproduction, in terms of improving live birth and miscarriage rates.; Search Methods: We designed the search using standard Cochrane methods and performed it on databases from their inception to 20 February 2019.We searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL via the Cochrane Central Register of Studies Online, MEDLINE, Embase, CINAHL, and the trial registers for ongoing and registered trials, grey literature and treatment guidelines. We handsearched reference lists of relevant systematic reviews and RCTs, and PubMed and Google for any recent trials. There were no restrictions by language or country of origin.; Selection Criteria: All RCTs on the use of NSAIDs as co-treatment during an ART cycle compared with no use or the use of placebo or any other similar drug, along with the comparison of any NSAID to another.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. Our primary outcomes were live birth/ongoing pregnancy and miscarriage. We performed statistical analysis using Review Manager 5. We assessed evidence quality using GRADE methods.; Main Results: We found 11 RCTs (1884 women) suitable for inclusion in the review. Most studies were at unclear or high risk of bias. The main limitations in the overall quality of the evidence were high risk of bias, unexplained heterogeneity and serious imprecision and indirectness.There were no data on our primary outcome - live birth per woman randomised - in any review comparisons.NSAIDs vs. placebo/no treatmentWe are uncertain of an effect on ongoing pregnancy when NSAIDs were compared to placebo/no treatment (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.71 to 1.59; 4 studies, 1159 participants; I² = 53%; very low quality evidence). Results suggest that if the chance of ongoing pregnancy following placebo or no treatment is assumed to be 15%, the chance following the use of NSAIDs is estimated to be between 12% and 24%. Subgroup analysis according to the type of NSAID yielded similar results.We are also uncertain of an effect on miscarriage rates when NSAIDs were compared to placebo/no treatment (RR 0.62, 95% CI 0.33 to 1.16; 4 studies, 525 participants; I² = 43%; very low quality evidence). Results suggest that if the chance of miscarriage following placebo or no treatment is assumed to be 21%, the chance following the use of NSAIDs is estimated to be between 7% and 27%. The results were similar when two studies were excluded due to high risk of bias.Concerning the secondary outcomes, we are uncertain of an effect on clinical pregnancy rates (RR 1.23, 95% CI 1.00 to 1.52; 6 studies, 1570 participants; I² = 49%; low-quality evidence); on ectopic pregnancy (RR 0.56, 95% CI 0.05 to 5.89; 1 study, 72 participants); on multiple pregnancy (RR 2.00, 95% CI 0.18 to 21.67; 1 study, 180 participants); and on side effects (RR 1.39, 95% CI 0.02 to 119.35; 3 studies, 418 participants; I² = 79%). The evidence suggests that if the chance of clinical pregnancy following placebo or no treatment is assumed to be 30%, the chance following the use of NSAIDs is estimated to be between 31% and 45% If the chance of ectopic pregnancy following placebo or no treatment is assumed to be 5%, the chance following the use of NSAIDs is estimated to be between 0.3% and 31%. If the chance of multiple pregnancy following placebo or no treatment is assumed to be 1%, the chance following the use of NSAIDs is estimated to be between 0.2 % and 24%.There were no cases of congenital anomalies during antenatal ultrasound screening of the women in one study.NSAID vs. another NSAIDOnly one study compared piroxicam with indomethacin: we are uncertain of an effect on ongoing pregnancy (RR 1.12, 95% CI 0.63 to 2.00; 1 study, 170 participants; very low quality evidence); and on miscarriage (RR 1.00, 95% CI 0.44 to 2.28; 1 study, 170 participants; very low quality evidence). The evidence suggests that if the chance of ongoing pregnancy following indomethacin is assumed to be 20%, the chance following the use of piroxicam is estimated to be between 13% and 40%; while for miscarriage, the evidence suggests that if the chance following indomethacin is assumed to be 12%, the chance following the use of piroxicam is estimated to be between 5% and 27%.Similar results were reported for clinical pregnancy (RR 1.07, 95% CI 0.71 to 1.63; 1 study, 170 participants; very low quality evidence).There were no data for the other outcomes specified in this review.NSAID vs. aspirinNo study reported this comparison.; Authors' Conclusions: Currently we are uncertain of an effect of the routine use of NSAIDs as co-treatments in infertile women undergoing assisted reproduction in order to improve ongoing pregnancy and miscarriage rates. This is based on available data from RCTs, where very low quality evidence showed that there is no single outcome measure demonstrating a benefit with their use. Further large, well-designed randomised placebo-controlled trials reporting on live births are required to clarify the exact role of NSAIDs.

Oaknin, A., et al. (2023). "Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial." Lancet 403(10421): 31‐43.
	BACKGROUND: The GOG240 trial established bevacizumab with chemotherapy as standard first-line therapy for metastatic or recurrent cervical cancer. In the BEATcc trial (ENGOT-Cx10-GEICO 68-C-JGOG1084-GOG-3030), we aimed to evaluate the addition of an immune checkpoint inhibitor to this standard backbone. METHODS: In this investigator-initiated, randomised, open-label, phase 3 trial, patients from 92 sites in Europe, Japan, and the USA with metastatic (stage IVB), persistent, or recurrent cervical cancer that was measurable, previously untreated, and not amenable to curative surgery or radiation were randomly assigned 1:1 to receive standard therapy (cisplatin 50 mg/m2 or carboplatin area under the curve of 5, paclitaxel 175 mg/m2, and bevacizumab 15 mg/kg, all on day 1 of every 3-week cycle) with or without atezolizumab 1200 mg. Treatment was continued until disease progression, unacceptable toxicity, patient withdrawal, or death. Stratification factors were previous concomitant chemoradiation (yes vs no), histology (squamous cell carcinoma vs adenocarcinoma including adenosquamous carcinoma), and platinum backbone (cisplatin vs carboplatin). Dual primary endpoints were investigator-assessed progression-free survival according to Response Evaluation Criteria in Solid Tumours version 1.1 and overall survival analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT03556839, and is ongoing. FINDINGS: Between Oct 8, 2018, and Aug 20, 2021, 410 of 519 patients assessed for eligibility were enrolled. Median progression-free survival was 13·7 months (95% CI 12·3-16·6) with atezolizumab and 10·4 months (9·7-11·7) with standard therapy (hazard ratio [HR]=0·62 [95% CI 0·49-0·78]; p<0·0001); at the interim overall survival analysis, median overall survival was 32·1 months (95% CI 25·3-36·8) versus 22·8 months (20·3-28·0), respectively (HR 0·68 [95% CI 0·52-0·88]; p=0·0046). Grade 3 or worse adverse events occurred in 79% of patients in the experimental group and in 75% of patients in the standard group. Grade 1-2 diarrhoea, arthralgia, pyrexia, and rash were increased with atezolizumab. INTERPRETATION: Adding atezolizumab to a standard bevacizumab plus platinum regimen for metastatic, persistent, or recurrent cervical cancer significantly improves progression-free and overall survival and should be considered as a new first-line therapy option. FUNDING: F Hoffmann-La Roche.

Oaknin, A., et al. (2021). "Maintenance treatment with rucaparib for recurrent ovarian carcinoma in ARIEL3, a randomized phase 3 trial: The effects of best response to last platinum-based regimen and disease at baseline on efficacy and safety." Cancer Medicine 10(20): 7162-7173.
	BACKGROUND: The efficacy and safety of rucaparib maintenance treatment in ARIEL3 were evaluated in subgroups based on best response to most recent platinum-based chemotherapy and baseline disease. METHODS: Patients were randomized 2:1 to receive either oral rucaparib at a dosage of 600 mg twice daily or placebo. Investigator-assessed PFS was assessed in prespecified, nested cohorts: BRCA-mutated, homologous recombination deficient (HRD; BRCA mutated or wild-type BRCA/high loss of heterozygosity), and the intent-to-treat (ITT) population. RESULTS: Median PFS for patients in the ITT population with a complete response to most recent platinum-based chemotherapy was 11.1 months in the rucaparib arm (126 patients) versus 5.6 months in the placebo arm (64 patients) (HR, 0.33 [95% CI, 0.23-0.48]), and in patients with a partial response (249 vs. 125), it was 9.0 versus 5.3 months (HR, 0.38 [0.30-0.49]). In subgroups of the ITT population based on baseline disease, median PFS was 8.2 versus 5.3 months (HR, 0.40 [0.28-0.57]) in patients with measurable disease (141 rucaparib vs. 66 placebo), 10.4 versus 4.5 months (HR, 0.31 [0.20-0.48]) in those with nonmeasurable but evaluable disease (104 vs. 56), and 14.1 versus 7.3 months (HR, 0.35 [0.24-0.51]) in those with no residual disease (130 vs. 67). Across subgroups, significantly longer median PFS was observed with rucaparib versus placebo in the BRCA-mutated and HRD cohorts. Objective responses were reported in patients with measurable disease and in patients with nonmeasurable but evaluable baseline disease. Safety was consistent across subgroups. CONCLUSION: Rucaparib maintenance treatment provided clinically meaningful efficacy benefits across subgroups based on response to last platinum-based chemotherapy or baseline disease.

Obaid, U., et al. (2024). "Bevacizumab Combination Therapy versus Standard Chemotherapy for Ovarian Cancer in Shorter and Longer Followup Duration: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." PROSPERO International prospective register of systematic reviews.
	
Obaid, U., et al. (2023). "Comparative Survival Outcomes of Ovarian Cancer Treated with Bevacizumab Combination Therapy or Standard Chemotherapy: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Obut, M., et al. (2021). "Comparison of the Quality of Life and Female Sexual Function Following Laparoscopic Pectopexy and Laparoscopic Sacrohysteropexy in Apical Prolapse Patients." Gynecology and Minimally Invasive Therapy 10(2): 96-103.
	OBJECTIVES: We sought to compare the surgical outcomes, safety, effectiveness, and mid-term outcomes in patients who had undergone laparoscopic hysterosacropexy and laparoscopic pectopexy due to apical prolapse. MATERIALS AND METHODS: This prospective randomized study was conducted on a total of 62 women who underwent apical prolapse surgery (32 undergoing a pectopexy and 30 undergoing a sacrohysteropexy) between June 2015 and June 2017. Patients with symptomatic uterine or vaginal vault prolapse with stage 2 or worse were included in the sudy. Before and after the operation, we used the Pelvic Organ Prolapse Quantification System (POP-Q) and questionnaires, which are the Prolapse Quality of Life Questionnaire (P-QOL) and Female Sexual Function Index (FSFI), to evaluated cases. Baseline characteristics, perioperative and postoperative complications, and follow-up results at 12 months were also evaluated. RESULTS: All domains of POP-Q, P-QOL, and FSFI scores improved significantly after surgery both in pectopexy and sacrohysteropexy group. The postoperative complications of both procedures were similar except for constipation after surgery (3.2% in the pectopexy group and 20% in the hysterosacropexy group [P = 0.036]). CONCLUSION: Both sacrohysteropexy and pectopexy are effective surgical options for apical prolapse patients. The pectopexy is an acceptable alternative to laparoscopic sacrohysteropexy because of its less complexity and not reducing pelvic space for the rectum to exist. We suggest that the laparoscopic pectopexy may be widely used in clinical routine.

Ocampo-Godinez Juan, M. (2021). "Vaginal Biorevitalization With Polydeoxyribonucleotides for the Improvement of the Genitourinary Syndrome of Menopause." ClinicalTrials.gov.
	No Results Available Drug: 3 g Polynucleotide vaginal suppositories|Drug: Conjugated estrogens cream 1g Tube Change from baseline urogenital domain score in the Menopause Rating Scale (MRS) at 3 months|Change from baseline Item 9 Menopause Rating Scale (MRS) total score at 3 months|Change from baseline Item 10 Menopause Rating Scale (MRS) total score at 3 months|Change from baseline Item 11 Menopause Rating Scale (MRS) total score at 3 months|Change from baseline Vaginal Maturity Index (VMI) at 3 months|Change from baseline Estrogenic Effect at 3 months|Change from baseline Oxford grading scale at 3 months|Change from baseline vaginal pH at 3 months|Change from baseline colposcopic findings at 3 months Female Not Applicable 136 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment 012-20170421 December 31, 2022

Odendaal, J., et al. (2023). "Preconceptual administration of doxycycline in women with recurrent miscarriage and chronic endometritis: protocol for the Chronic Endometritis and Recurrent Miscarriage (CERM) trial, a multicentre, double-blind, placebo-controlled, adaptive randomised trial with an embedded translational substudy." BMJ Open 13(12): e081470.
	Introduction: Recurrent miscarriage is a common condition with a substantial associated morbidity. A hypothesised cause of recurrent miscarriage is chronic endometritis (CE). The aetiology of CE remains uncertain. An association between CE and recurrent miscarriage has been shown. This study will aim to determine if preconceptual administration of doxycycline, in women with recurrent miscarriages, and CE, reduces first trimester miscarriages, increasing live births.; Methods and Analysis: Chronic Endometritis and Recurrent Miscarriage is a multicentre, double-blind adaptive trial with an embedded translational substudy. Women with a history of two or more consecutive first trimester losses with evidence of CE on endometrial biopsy (defined as ≥5 CD138 positive cells per 10 mm 2 ) will be randomised to oral doxycycline or placebo for 14 days. A subset will be recruited to a mechanistic substudy in which microbial swabs and preintervention/postintervention endometrial samples will be collected. Up to 3062 women recruited from 29 National Health Service (NHS) hospital sites across the UK are expected to be screened with up to 1500 women randomised in a 1:1 ratio. Women with a negative endometrial biopsy (defined as <5 CD138 positive cells per 10 mm 2 ) will also be followed up to test validity of the tool. The primary outcome is live births plus pregnancies ≥24 + 0 weeks gestation at the end of the trial, in the first or subsequent pregnancy. Secondary clinical outcomes will also be assessed. Exploratory outcomes will assess the effect of doxycycline treatment on the endometrial microbiota, the differentiation capacity of the endometrium and the senescent profile of the endometrium with CE.; Ethics and Dissemination: Ethical approval has been obtained from the NHS Research Ethics Committee Northwest-Haydock (19/NW/0462). Written informed consent will be gained from all participants. The results will be published in an open-access peer-reviewed journal and reported in the National Institute for Health and Care Research journals library.; Trial Registration Number: ISRCTN23947730.; Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Ofir, E., et al. (2021). "Long-term effects of a placebo-controlled trial of enoxaparin for treatment of severe provoked vulvodynia." Pelviperineology 40(2): 89‐95.
	Objective: Provoked vulvodynia (PV) is the main cause of dyspareunia, affecting millions of women worldwide. Its cause is yet unknown, and treatment is empirical in most cases. Our purpose was to assess the long‐term beneficial effects of enoxaparin on PV. Materials and Methods: Women who previously participated in a three‐month trial comparing enoxaparin to placebo for the treatment of severe PV were evaluated regarding their current pain levels using Numeric Rating Scale with various activities, whether they sought additional treatment for their condition and their satisfaction with their treatment. For pain levels, we compared time‐time points within groups using a paired‐sample t‐test or Wilcoxon signed rank test, and we compared groups at any given time point using an independentsamples t‐test or a Wilcoxon rank‐sum test. Results: Thirty‐one of the 39 original participants completed the follow‐up survey, 17 had been treated with enoxaparin, and 14 had received saline. Compared to their pain at the end of the prior trial, at the time of the present study, those treated with enoxaparin experienced greater decreases in pain during intercourse (34% decrease, p=0.012) than those who received placebo (22.5% decrease, p=0.064), this was also true for other activities. Conclusion: Enoxaparin exhibited continuing benefits three years after daily treatment for 90 days for severe PV and may have an implication for women suffering from PV.

Oh, M.-R. (2023). "Clinical trial of red clover and hop extract for menopausal symptoms." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Dietary Supplement : Subject were randomly assigned to either RHE (n=50) or placebo groups (n=50), and were administered 500 mg of the RHE or placebo, respectively, daily for 12 weeks. CONDITION: Diseases of the genitourinary system PRIMARY OUTCOME: 100 mm hot flashes VAS Total score of KI SECONDARY OUTCOME: Cardiovascular risk factors (triglyceride, total cholesterol, HDL‐C, LDL‐C Endotheline‐1, Apolipoprotein B, Apolipoprotein A1, Apoliproprotein B/A1 ratio, hs‐CRP Individual item score of modified KI Mean duration of perceived hot flashes (min) Osteocalcin, Type 1 collagen cross‐linked telopeptide, Alkaline phosphatas Score of MRS INCLUSION CRITERIA: 1) Women aged 45‐65 years 2) Postmenopausal women (at least 12 months of amenorrhea) or at least 6 weeks after bilateral oophorectomy 3) Estradiol < 30 pg/ml and FSH = 40 mIU/ml 4) Kupperman's inde Xscore = 20 5) Subjects who agree to participated in the study and sign the informed consent form

Oh, M. R., et al. (2024). "Efficacy of plant-derived dietary supplements in improving overall menopausal symptoms in women: An updated systematic review and meta-analysis." Phytotherapy Research.
	This updated systematic review and meta-analysis aims to confirm the effectiveness of plant-based supplements in improving overall menopausal symptoms and vasomotor symptoms. A systematic review of the literature was conducted by searching the PubMed/MEDLINE, Web of Science, EMBASE, and CENTRAL databases up to June 2022. Randomized placebo-controlled clinical trials that evaluated the effects of dietary supplements on menopausal symptoms were included. Outcome measures included daily hot flash frequency, Kupperman's index, Menopause Rating Scale, and Greene Climacteric Scale. Pooled data were analyzed using a fixed-effects model and expressed as a weighted mean difference with a 95% confidence interval for continuous outcomes. For qualitative assessment, 67 studies were selected. For quantitative assessment, 54 reports were obtained from 61 studies. The study participants were peri- or postmenopausal women aged 38-85, most of whom experienced hot flashes as a menopausal symptom. The investigational products included 28 soy-derived, 6 red clover-derived, and 28 other plant-derived supplements. Qualitative assessment revealed that approximately 76% of the studies were generally of fair or good quality, whereas 24% were of low quality. Meta-analysis results indicated significant improvements in all questionnaire scores, including hot flash frequency, in the dietary supplement group compared with the placebo group. Comprehensive evaluation using different questionnaire tools showed that the various plant-derived dietary supplements can significantly alleviate menopausal symptoms. However, further rigorous studies are needed to determine the association of plant-derived dietary supplements with menopausal health because of the general suboptimal quality and heterogeneous nature of current evidence.Copyright © 2024 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd.

Ojo-Carons, M. (2022). "Effects of Flourish HEC on Localized Provoked Vulvodynia." ClinicalTrials.gov.
	No Results Available Device: BioNourish, a component of the Flourish HEC kit|Other: Control - no intervention Vaginal microbiome in women with localized provoked vulvodynia (LPV)|Changes in the vaginal microbiome in women with localized provoked vulvodynia (LPV) with and without Flourish HEC|Pain intensity by cotton swab test|Vulvovaginal symptoms questionnaire (VSQ) and addendum|Treatment escalation Female Not Applicable 7 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment LPV0522 January 15, 2024

Okeke, O., et al. (2021). "Cost-effectiveness of mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage: an economic evaluation based on the MifeMiso Trial." BJOG 128(9): 1534‐1545.
	OBJECTIVE: To assess the cost‐effectiveness of mifepristone and misoprostol (MifeMiso) compared with misoprostol only for the medical management of a missed miscarriage. DESIGN: Within‐trial economic evaluation and model‐based analysis to set the findings in the context of the wider economic evidence for a range of comparators. Incremental costs and outcomes were calculated using nonparametric bootstrapping and reported using cost‐effectiveness acceptability curves. Analyses were performed from the perspective of the UK's National Health Service (NHS). SETTING: Twenty‐eight UK NHS early pregnancy units. SAMPLE: A cohort of 711 women aged 16‐39 years with ultrasound evidence of a missed miscarriage. METHODS: Treatment with mifepristone and misoprostol or with matched placebo and misoprostol tablets. MAIN OUTCOME MEASURES: Cost per additional successfully managed miscarriage and quality‐adjusted life years (QALYs). RESULTS: For the within‐trial analysis, MifeMiso intervention resulted in an absolute effect difference of 6.6% (95% CI 0.7‐12.5%) per successfully managed miscarriage and a QALYs difference of 0.04% (95% CI ‐0.01 to 0.1%). The average cost per successfully managed miscarriage was lower in the MifeMiso arm than in the placebo and misoprostol arm, with a cost saving of £182 (95% CI £26‐£338). Hence, the MifeMiso intervention dominated the use of misoprostol alone. The model‐based analysis showed that the MifeMiso intervention is preferable, compared with expectant management, and this is the current medical management strategy. However, the model‐based evidence suggests that the intervention is a less effective but less costly strategy than surgical management. CONCLUSIONS: The within‐trial analysis found that based on cost‐effectiveness grounds, the MifeMiso intervention is likely to be recommended by decision makers for the medical management of women presenting with a missed miscarriage. TWEETABLE ABSTRACT: The combination of mifepristone and misoprostol is more effective and less costly than misoprostol alone for the management of missed miscarriages.

Okpo, E., et al. (2022). "Interventions to improve psychosexual function in women treated for gynaecological cancers." The Cochrane Database of Systematic Reviews 2022(8): CD014674.
	Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To determine the effectiveness and safety of interventions to improve psychosexual function in women treated for gynaecological cancers.Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Olaparib Maintenance Monotherapy in Participants with, B. W. T. O. (2021). "Olaparib Maintenance Monotherapy in Participants with BRCA Wild Type Ovarian Cancer Following Response to First-line Platinum-based Chemotherapy." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: Lynparza Tablet 100 mg Product Name: Olaparib 100 mg Product Code: AZD2281 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: olaparib CAS Number: 763113‐22‐0 Current Sponsor code: AZD2281 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Lynparza Tablet 150 mg Product Name: Olaparib 150 mg Product Code: AZD2281 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: olaparib CAS Number: 763113‐22‐0 Current Sponsor code: AZD2281 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Olaparib Maintenance Monotherapy in Participants with BRCAWild Type Ovarian Cancer Following Response toFirst‐line Platinum‐based Chemotherapy Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: To demonstrate superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS in participants with Stage III or IV ovarian cancer (including fallopian tube and peritoneal cancers) with a BRCAwt HRD positive tumour and a CR or PR following standard first line platinum based chemotherapy treatment.; To demonstrate superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS in participants with Stage III or IV ovarian cancer (including fallopian and peritoneal cancers) with a BRCAwt tumour and a CR or PR following standard first‐line platinum‐based chemotherapy treatment. Primary end point(s): PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by the investigator at the local site, or death due to any cause. Secondary Objective: To demonstrate superiority of olaparib as maintenance treatment relative to placebo in participants with Stage III or IV ovarian cancer (including fallopian tube and peritoneal cancers) and a CR or PR following standard first line platinum based chemotherapy treatment with a BRCAwt HRD positive/BRCAwt tumour, by assessment of:; a) Overall survival ; b) TFST; c) second progression free survival (PFS2); d) TSST; e) time to study intervention discontinuation or death (TDT); f) time to earliest progression by RECIST 1.1 or CA‐125 or death; To assess disease‐related symptoms, functioning, and HRQoL in participants treated with olaparib compared with placebo using the EORTC QLQ C30 questionnaire and its ovarian specific module, EORTC QLQ OV28 in participants with a BRCAwt HRD positive/BRCAwt tumour and a CR or PR following standard first‐line platinum based chemotherapy treatment. Timepoint(s) of evaluation of this end point: randomisation until progression or death due to any cause. SECONDARY OUTCOME: Secondary end point(s): OS is defined as time?from randomisation until the date of death due to any cause. ; TFST is defined as time?randomisation until the start date of the first subsequent anti‐cancer therapy after discontinuation of randomised treatment, or death due to any cause.; PFS2 is defined as time from the randomisation to the earliest of the progression event, subsequent to first subsequent therapy or death.?; TSST is defined as time from randomisation until the start date of the second subsequent anti‐cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.; TDT is defined as time from randomisation until discontinuation of treatment for any reason, including disease progression, toxicity and death.; Time to earliest progression by RECIST 1.1 or CA 125 or death will be measured from time of randomisation to the earlier date of RECIST 1.1 or CA‐125 progression or death by any cause.; Change from baseline in EORTC QLQ C30 and EORTC QLQ OV28 selected scores. Timepoint(s) of evaluation of this end point: OS: date of death. ; TFST: the first subsequent anti‐cancer therapy after discont uation of randomised treatment, or death due to any cause.; PFS2: the earliest of the progression event, subsequent to first subsequent therapy or death.?; TSST: the start date of the second subsequent anti‐cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.; TDT: discontinuation of treatment for any reason, including disease progression, toxicity and death.; Time to earliest progression by RECIST 1.1 or CA 125 or death: the earlier date of RECIST 1.1 or CA‐125 progression or death by any cause.; Change from baseline in EORTC QLQ C30 and EORTC QLQ OV28 selected scores. INCLUSION CRITERIA: 1,Participants must be =18 years at the time of (pre‐)screening 2,Histological and staging criteria:Female participants who must have histologically newly diagnosed high‐grade serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to the International FIGO 2009. 3, Participants are eligible if they fulfil any of the following surgical criteria: ? ‐Stage III: primary debulking surgery with macroscopic residual disease post‐surgery, neoadjuvant chemotherapy, or inoperable. ? ‐Stage IV: primary debulking surgery regardless of residual disease, neoadjuvant chemotherapy, or inoperable. 4, Chemotherapy criteria: ‐Participants must have received platinum‐based chemotherapy consisting of a minimum of 6 treatment cycles and a maximum of 9, however, if platinum‐based therapy must be discontinued early as a result of toxicities specifically related to the platinum regimen, participants

Oldham, J., et al. (2021). "Effects of a disposable home electro-stimulation device (Pelviva) for the treatment of female urinary incontinence: a randomised controlled trial." Archives of Gynecology and Obstetrics 304(5): 1243‐1251.
	Aims: To compare current General Medical Practitioner treatment as usual (TAU) for the treatment of female urinary incontinence with a novel disposable home electro‐stimulation device (Pelviva). Methods: Open label, Primary Care post‐market evaluation. 86 women with urinary incontinence were randomly assigned to one of two 12‐week treatments: TAU or Pelviva for 30 min every other day plus TAU. Outcome measures included ICIQ‐UI (primary), PISQ‐IR, PGI‐S / PGI‐I and FSFI (secondary) at recruitment and immediately after intervention, 1‐h pad test at recruitment and usage diaries throughout. Results: Pelviva plus TAU produced significantly better outcome than TAU alone: 3 versus 1 point for ICIQ‐UI (Difference − 1.8 95% CI: − 3.5 to − 0.1, P = 0.033). Significant differences were also observed for PGI‐I at both 6 weeks (P = 0.001) and 12 weeks (P < 0.001). In the Pelviva group, 17% of women described themselves as feeling very much better and 54% a little or much better compared to 0% and 15% in the TAU. Overall PISQ‐IR score reached statistical significance (P = 0.032) seemingly related to impact (P = 0.027). No other outcome measures reached statistical significance. Premature termination due to COVID‐19 meant only 86 women were recruited from a sample size of 264. TAU did not reflect NICE guidelines. Conclusions: This study suggests Pelviva is more successful than TAU in treating urinary incontinence in Primary Care. The study had reduced power due to early termination due to COVID‐19 and suggests TAU does not follow NICE guidelines.

Olshnika Keren, R. (2023). "Two Different Types of Luteal Phase Support in Natural Cycle Frozen Embryo Transfer and Its Effect on Pregnancy Rates." ClinicalTrials.gov.
	The rate of frozen embryos transfer (FET) has increased in recent years due to a higher tendency of single embryo transfer, use of preimplantation genetic testing, and prevention of ovarian hyperstimulation. There are different methods to prepare the endometrium for FET: 1. Natural cycle (NC) ‐ natural preparation of the body for implantation without the need for medicinal intervention. 2. Modified natural cycle (mNC) ‐ Inducing ovulation by administration of Human Chorionic Gonadotropin (HCG) trigger. 3. Medical ‐ preparation of endometrium with hormones (estrogen and progesterone). Following embryo transfer, luteal phase support should be considered. Administration of treatment depends on the type of cycle chosen (either natural or medicated). Treatment options include progesterone, HCG and Gonadotropin Releasing Hormone (GnRH) analog ‐ either one of them or combined. Different protocols (dosages and duration of use) with different pregnancy outcomes were explore before with inconclusive results. We wish to investigate administration of GnRH agonist+HCG vs. progesterone. Patients included in the study will be women undergoing natural cycle FET at the IVF center in Shaare Zedek, Jerusalem, Israel. All patients will be randomly divided into two groups, each will receive a different luteal treatment support as will be detailed later. Patients demographic data and pregnancy outcomes will be collected. Based on the clinical pregnancy rate in the prospective study by Bjuresten, et al [Fertil Steril, 2011], where a clinical pregnancy rate of 32% was found among women treated with progesterone for luteal support, and given an alpha of 5% and a power of 80%, 144 women (72 women in each group) are required in order to demonstrate a clinical pregnancy rate of 55% in the study group. Comparison of categorical variables will be carried out using the the chi‐squared test. Comparison of continuous variables will be performed using the Students t‐Test or Mann‐Whitney U method depending on the variable distribution (normal vs. non‐normal distribution, respectively). A multivariate regression will also be conducted in order to determine which variables are significantly and independently related. Statistical significance will be defined when P values are less than 0.05

Ong, J. W., et al. (2023). "The Effectiveness of Mind-Body Therapies for Women With Gynecological Cancer: A Systematic Review and Meta-analysis." Cancer Nursing.
	BACKGROUND: Mind-body therapies (MBTs) have gained popularity among patients with cancer as a supportive therapy. To date, no systematic reviews have assessed the effect of MBTs on the health outcomes in women with gynecological cancer. OBJECTIVE(S): This systematic review and meta-analysis aimed to synthesize the effectiveness of MBTs on quality of life, anxiety, depression, cancer-related pain, and fatigue among women with gynecological cancer. METHOD(S): We searched and screened randomized controlled trials in 7 databases, trial registries, and gray literature from the databases' inception to December 2021. Data were extracted from eligible studies, with each study's quality assessed using the Cochrane risk-of-bias tool. Meta-analyses were conducted using RevMan 5.4. Sensitivity and subgroup analyses were performed. The quality of evidence across the studies was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. RESULT(S): Nine trials were included. Statistically significant effects of MBTs on depression (standardized mean difference, -0.56; 95% confidence interval, -1.01 to -0.11; P = .01), pain (standardized mean difference, -1.60; 95% confidence interval, -3.14 to -0.07; P = .04), and fatigue (standardized mean difference, -1.17; 95% confidence interval, -2.16 to -0.18; P = .02) were observed, but not on quality of life and anxiety. The quality of evidence was low due to the high risks of bias and high heterogeneity among the studies. CONCLUSION(S): Mind-body therapies were effective in reducing depression, pain, and fatigue of women with gynecological cancer. However, the low quality of the evidence implies the need for more future studies with better methodologies. IMPLICATIONS FOR PRACTICE: Mind-body therapies may be used as an additional strategy to help manage depressive mood, pain, and fatigue among women with gynecological cancer.Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.

Ontario Health, Q. (2021). "Vaginal Pessaries for Pelvic Organ Prolapse or Stress Urinary Incontinence: A Health Technology Assessment." Ontario Health Technology Assessment Series 21(3): 1-155.
	Background: Pelvic organ prolapse (POP) is the downward descent of the female pelvic organs into or through the vagina. The symptom that most strongly correlates with and is most specific for POP is a feeling of vaginal bulging. Stress urinary incontinence (SUI) is an involuntary loss of urine upon physical exertion or sneezing or coughing. Conservative (non-surgical) treatment options for both conditions include vaginal pessaries. We conducted a health technology assessment of vaginal pessaries for the treatment of POP and SUI, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding vaginal pessaries, and patient preferences and values.; Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using ROBIS, the Cochrane Risk of Bias tool, and the Newcastle-Ottawa Scale and 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 and conducted a cost-utility analysis with a 10-year horizon from a public payer perspective. We also analyzed the budget impact of publicly funding vaginal pessaries for individuals with pelvic organ prolapse and/or stress urinary incontinence in Ontario. We explored the underlying values, needs, and priorities of those who have lived experience with POP and/or SUI, as well as the preferences and perceptions of both patients and providers of vaginal pessaries.; Results: We included 15 studies in the clinical evidence review. Compared with no treatment for people with SUI, pessaries were associated with a significant improvement in some symptoms at 14 days follow-up (SUI subscore of Urinary Symptom Profile, mean difference -2.20; 95% CI -3.47 to -0.93; GRADE: Very low). Compared with pelvic floor muscle training (PFMT), pessaries were associated with no difference in improvement at 12 months follow-up for some symptoms (Urinary Distress Inventory subscale of the Pelvic Floor Distress Inventory, risk ratio = 0.86; 95% CI 0.64 to 1.16; GRADE: Low). For people with POP, pessaries were associated with a significant improvement in the Pelvic Organ Prolapse Distress Inventory score and in sexual function compared with PFMT plus feedback/electrical stimulation/lifestyle advice at 12- and 24-month follow ups (GRADE: Low). Pessary continuation rate at 12 months follow up was reported to be 60% (44/74 patients) (GRADE: Very low).When evaluating various POP and SUI treatments in sequential order, pessaries were within the most cost-effective treatment sequence; therefore, it is likely to be a cost-effective intervention for treating POP and SUI. There was a high degree of certainty that pessaries were cost-effective in a population with POP, and a moderate degree of certainty in a population with SUI. When the treatment sequence of pessaries and surgery was compared with surgery alone, the pessaries treatment sequence dominates surgery in the cohort with POP, and in the cohort with SUI pessaries had an incremental cost-effectiveness ratio (ICER) of $1,033 per QALY gained. The annual budget impact of publicly funding vaginal pessaries in Ontario over the next 5 years ranges from $0.3 million in year 1 to $0.5 million in year 5 for POP, and $0.2 million in year 1 to $0.3 million in year 5 for SUI.We included one study in our quantitative evidence review and spoke to 29 people in our direct patient engagement. The evidence indicated that patient preferences vary and that patients accept the risks of their chosen treatment option. The 24 people we spoke with who had direct experience with vaginal pessaries reported that their POP and/or SUI limited their social activities and restricted their activity levels, taking a huge emotional toll. Many were hesitant or even fearful of surgery due to side effects and perceived failure rate of the surgery. Most people reported that pessaries relieved most or all of their symptoms, allowing th m to return to their normal daily activities. However, wait times for pessary fittings could be as long as 2 years, and out-of-pocket expenses could be a barrier for people without extended insurance.; Conclusions: For people with SUI, vaginal pessaries may improve symptoms compared with no treatment, but the evidence is very uncertain. Pessaries may result in little to no difference in longer-term improvement of SUI symptoms compared with PFMT. For people with POP, pessaries may improve some longer-term symptoms, as well as sexual function compared with PFMT. For people with symptomatic POP and SUI, vaginal pessaries may be a cost-effective intervention to be used within a stepped care model (a sequence of interventions followed after the current treatment proves ineffective). We estimate that publicly funding vaginal pessaries in Ontario would result in a total 5-year budget impact of $2.0 million for POP and $1.3 million for SUI. People with POP and/or SUI reported pessary use as being an effective treatment option to manage their symptoms. (Copyright © Queen's Printer for Ontario, 2021.)

Ontario Health, Q. (2023). "Homologous Recombination Deficiency Testing to Inform Patient Decisions About Niraparib Maintenance Therapy for High-Grade Serous or Endometrioid Epithelial Ovarian Cancer: A Health Technology Assessment." Ontario Health Technology Assessment Series 23(5): 1-188.
	Background: Ovarian cancer affects the cells of the ovaries, and epithelial cancer is the most common type of malignant ovarian cancer. The homologous recombination repair pathway enables error-free repair of DNA double-strand breaks. Damage of key genes associated with this pathway leads to homologous recombination deficiency (HRD), which results in unrepaired DNA and can lead to cancer. Tumours with HRD are believed to be sensitive to treatment with poly-adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors, such as niraparib. We conducted a health technology assessment to evaluate the clinical utility and cost-effectiveness of HRD testing to inform patient decisions about the use of niraparib maintenance therapy for patients with high-grade serous or endometrioid epithelial ovarian cancer. We also evaluated the efficacy and safety of niraparib maintenance therapy in patients with HRD or homologous recombination proficiency (HRP), the cost-effectiveness of HRD testing, the budget impact of publicly funding HRD testing, and patient preferences and values.; Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane risk-of-bias tool for randomized trials version 2, and 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 and conducted a cost-utility analysis with a 5-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding HRD testing in people with ovarian cancer in Ontario. We performed a literature search for quantitative evidence of patient and provider preferences with respect to HRD testing and maintenance therapy with PARP inhibitors. To contextualize the potential value of HRD testing, we spoke with people with ovarian cancer.; Results: The clinical evidence review included two studies in high-grade epithelial ovarian cancer (one in patients with newly diagnosed advanced cases and one in patients with recurrent cancer). The studies evaluated niraparib maintenance therapy compared with no maintenance therapy and used HRD testing to group patients according to HRD status. Compared to placebo, niraparib maintenance therapy improved progression-free survival in patients with newly diagnosed and recurrent ovarian cancer, and in tumours with HRD or HRP (GRADE: High), but the studies did not compare the results between the HRD and HRP groups. The frequency of adverse events was higher in the niraparib group. We identified no studies that evaluated the clinical utility of HRD testing.We conducted a primary economic evaluation to evaluate the cost-effectiveness of HRD testing for people with newly diagnosed ovarian cancer in an Ontario setting. Our analysis used a 5-year time horizon. HRD testing (for all eligible people or only for people with BRCA wild type) resulted in a lower proportion of patients receiving niraparib maintenance therapy, leading to lower costs and fewer quality-adjusted life-years (QALYs). The average total cost per patient was $131,375 for no HRD testing, $126,867 for HRD testing only in people with BRCA wild type, and $127,746 for HRD testing in all eligible people. The average total QALYs per patient were 2.087 for no HRD testing, 1.971 for HRD testing only in people with BRCA wild type, and 1.971 for HRD testing in all eligible people. Our budget impact analysis suggested that assuming a high uptake rate, publicly funding HRD testing for people with newly diagnosed ovarian cancer would lead to a total saving of $9.00 million (if HRD testing were funded for all) to $12.67 million (if HRD testing were funded for people with BRCA wild type) over the next 5 years. Publicly funding HRD testing for people with recurrent cancer would lead to a total saving of $16.31 million (if HRD testing were funded for all) to $21.67 million (if HRD testing were funded for people with BRCA wild type) over the next ears.We identified no studies that evaluated quantitative preferences for HRD testing. Based on two studies that evaluated patients and oncologists' preferences for maintenance therapy with a PARP inhibitor in the recurrent setting, a decrease in moderate to severe adverse events was more important for patients than an improvement in progression-free survival; however, improvement in progression-free survival was more important for oncologists. Both patients and oncologists accepted some trade-offs between efficacy and safety. The people with ovarian cancer we spoke with demonstrated a shared value for access to information, prevention of cancer recurrence, and overall survival with minimal adverse effects. This was consistent with findings from another survey in patients with ovarian cancer and at least one episode of recurrence, which suggest that patients prioritize treatment benefit over some treatment adverse events in the context of niraparib maintenance therapy. Interviewees also emphasized the importance of the patient-doctor partnership, access to local health care services, and patient education.; Conclusions: In patients with newly diagnosed (advanced) or recurrent high-grade serous or endometrioid ovarian cancer, niraparib maintenance therapy improved progression-free survival compared with no maintenance therapy in tumours with HRD or HRP (GRADE: High). Because we identified no studies on the clinical utility of HRD testing, we cannot comment on how it would affect patient decisions and clinical outcomes.Over a 5-year time horizon, HRD testing for people with BRCA wild type could save $4,509 per person and lead to a loss of 0.116 QALY. The findings of our economic analyses are dependent on assumptions about the use of niraparib following HRD testing. We estimate that publicly funding HRD testing would lead to a total saving of $9 million to $12.67 million for newly diagnosed cancer, and a total saving of $16.31 million to $21.67 million for recurrent cancer over 5 years, assuming the use of niraparib maintenance therapy would be reduced following HRD testing.Patients prioritized decreasing the risk of moderate to severe adverse events of maintenance therapy with PARP inhibitors over improving progression-free survival, and oncologists prioritized improving progression-free survival over decreasing the risk of moderate to severe adverse events. However, both patients and oncologists were open to accepting certain trade-offs between treatment efficacy and toxicity. The people we interviewed, who had lived experience with ovarian cancer and genetic testing, valued the potential clinical benefits of HRD testing for themselves and their family members. They emphasized patient education as an important consideration for public funding in Ontario. (Copyright © King's Printer for Ontario, 2023.)

Oregon, H. and U. Science (2023). "Postoperative Active Recovery." ClinicalTrials.gov.
	No Results Available Other: Standard of Care|Other: Active Recovery Change in the Pelvic Floor Distress Inventory-20 (PFDI-20)|Change in the Short Form Health Survey (SF-36)|Change in the Patient Health Questionnaire (PHQ-9)|Change in the Patient Global Impression of Improvement (PGI-I) Female Not Applicable 80 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment OHSU IRB 25625 December 30, 2024

O'Reilly, B. A., et al. (2024). "Vaginal erbium laser treatment for stress urinary incontinence: A multicenter randomized sham-controlled clinical trial." International Journal of Gynecology and Obstetrics 164(3): 1184-1194.
	Objective: To evaluate the efficacy and safety of non-ablative vaginal Er:YAG laser device in stress urinary incontinence (SUI) treatment. Method(s): We conducted a multicenter blinded randomized sham-controlled trial in which women with urodynamic SUI were randomization to active arm using Er:YAG laser therapy, and sham arm using sham handpiece. Patients received two treatments 1 month apart. The primary outcomes measure was 1 h pad weight test measured at 6 months. Secondary outcomes were durability of treatment success at 12 months, and questionnaires for assessment of SUI severity (ICIQ-UI SF), sexual function (PISQ-12) and HRQoL (KHQ), and incidence and severity of device related adverse events and pain (VAS). Result(s): A total of 110 participants with SUI were recruited; 73 in the active arm and 37 in the sham arm. Two participants were excluded; one was assigned the wrong treatment and one withdrew their consent. Treatment success was observed in 36% of the sham arm and 59% of the active arm; in the latter, odds of achieving treatment success were more than three-fold higher (OR 3.63, 95% CI: 1.3-11.2, P = 0.02). HRQoL by KHQ showed significant improvement in the active versus the sham arm (OR 0.36, 95% CI: 0.15-0.87, P = 0.003). Similarly, subjective patient assessment of general and sexual function improvement with PISQ-12 and PGI-I showed superior effect over sham (OR 2.8, 95% CI: 1.2-7.0, P = 0.02 and OR 0.13, 95% CI: 0.05-0.36, P < 0.001, respectively). Conclusion(s): Non-ablative vaginal Er:YAG laser therapy significantly improves SUI symptoms versus sham treatment. Er:YAG laser therapy should be considered as a non-surgical treatment option for SUI patients.Copyright © 2023 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.

Orestis, T., et al. (2021). "Optimum protocol for frozen-thawed embryo transfer (FET) cycles - Network Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Organon and Co (2022). "A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 to 49 With Moderate to Severe Endometriosis-related Pain." ClinicalTrials.gov.
	This is a global multicenter, Phase 2a/b, randomized, double‐blind, Placebo‐controlled study to assess the efficacy, safety, and tolerability of 3 dose levels of OG‐6219, in pre‐menopausal women 18 to 49 years of age (inclusive), who have been surgically diagnosed with endometriosis with moderate to severe endometriosis‐related pain. This study includes treatment lasting approximately 16 weeks in total and is followed by a Safety Follow‐up. Pre‐menopausal females aged 18 to 49 years old (inclusive), who have been surgically diagnosed with endometriosis will be screened to randomly assign to study treatment. A minimum subset of 10 participants per treatment group (including Placebo group) will be voluntarily enrolled for optional intensive PK sampling for the entire duration of the study.

Ortiz-Flores, A. E., et al. (2021). "Iron Overload in Functional Hyperandrogenism: In a Randomized Trial, Bloodletting Does Not Improve Metabolic Outcomes." The Journal of Clinical Endocrinology and Metabolism 106(4): e1559-e1573.
	CONTEXT: Functional hyperandrogenism may be associated with a mild increase in body iron stores. Iron depletion exerts a beneficial effect on metabolic endpoints in other iron overload states. OBJECTIVES: (i) To determine the effect of iron depletion on the insulin sensitivity and frequency of abnormal glucose tolerance in patients with functional hyperandrogenism submitted to standard therapy with combined oral contraceptives (COC). ii) To assess the overall safety of this intervention. DESIGN: Randomized, parallel, open-label, clinical trial. SETTING: Academic hospital. PATIENTS: Adult women with polycystic ovary syndrome or idiopathic hyperandrogenism. INTERVENTION: After a 3-month run-in period of treatment with 35 μg ethinylestradiol plus 2 mg cyproterone acetate, participants were randomized (1:1) to 3 scheduled bloodlettings or observation for another 9 months. MAIN OUTCOME MEASURES: Changes in insulin sensitivity index and frequency of prediabetes/diabetes, and percentage of women in whom bloodletting resulted in plasma hemoglobin <120 g/L and/or hematocrit <0.36. RESULTS: From 2015 to 2019, 33 women were included by intention-to-treat. During the follow-up, insulin sensitivity did not change in the whole group of women or between study arms [mean of the differences (MD): 0.0 (95%CI: -1.6 to 1.6)]. Women in the experimental arm showed a similar odds of having prediabetes/diabetes than women submitted to observation [odds ratio: 0.981 (95%CI: 0.712 to 1.351)]. After bloodletting, 4 (21.1%) and 2 women (10.5%) in the experimental arm had hemoglobin (Hb) levels <120 g/L and hematocrit (Hct) values <0.36, respectively, but none showed Hb <110 g/L or Hct <0.34. CONCLUSIONS: Scheduled bloodletting does not improve insulin sensitivity in women with functional hyperandrogenism on COC.

O'Shea Laura, E., et al. (2020). "Cervical priming before surgical abortion up to 13 +6 weeks' gestation: a systematic review and metaanalyses for the National Institute for Health and Care Excellence-new clinical guidelines for England." American Journal of Obstetrics & Gynecology MFM 2(4): 100220.
	Objective: This study aimed to determine the optimal cervical priming regimen before surgical abortion up to and including 13 +6 weeks' gestation.; Data Sources: Embase, MEDLINE, and the Cochrane Library were searched for publications up to February 2020. Experts were consulted for any ongoing or missed trials.; Study Eligibility Criteria: This study included randomized controlled trials published in English after 2000 that compared the following: (1) mifepristone and misoprostol against each other, placebo, or no priming; (2) different doses of mifepristone or misoprostol; (3) different intervals between priming and abortion; or (4) different routes of misoprostol administration.; Study Appraisal and Synthesis Methods: Risk of bias was assessed using the Cochrane Collaboration checklist for randomized controlled trials, and data were metaanalyzed in Review Manager 5.3. Dichotomous outcomes were analyzed as risk ratios using the Mantel-Haenszel method, and continuous outcomes were analyzed as mean differences using the inverse variance method. Fixed effects models were used when there was no substantial heterogeneity (I 2 <50%), random effects models were used for moderate heterogeneity (I 2 ≤50% and <80%), and evidence was not pooled when there was high heterogeneity (I 2 ≥80%). Subgroup analyses were undertaken based on parity where available. The overall quality of the evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation.; Results: A total of 18 randomized controlled trials (n=8538) were included and showed the following: decreased incomplete abortion rate (risk ratio=0.44; 95% confidence interval, 0.21-0.9) and force required to dilate the cervix (mean difference= -7.08 N; 95% confidence interval, -11.67 to -2.49) and increased preoperative bleeding (risk ratio=5.90; 95% confidence interval, 5.08-6.86) with misoprostol compared with no priming; decreased preoperative bleeding when sublingual misoprostol was given 1 hour before abortion compared with 3 hours before (risk ratio=0.14; 95% confidence interval, 0.03-0.56); and increased force required to dilate the cervix (mean difference=14.3 N; 95% confidence interval, 2.13-26.47) when mifepristone was given 24 hours before abortion compared with 48 hours before. The quality of the evidence base was limited by low event rates and risk of bias in included studies.; Conclusion: Cervical priming with misoprostol decreases the force needed to dilate the cervix for first trimester surgical abortion and reduces the risk of incomplete abortion. Considered alongside clinical expertise, this evidence supports the use of routine cervical priming before first trimester surgical abortion with 400 µg misoprostol or, if misoprostol cannot be used, 200 mg oral mifepristone. (Copyright © 2020 Elsevier Inc. All rights reserved.)

Ospedale San, R. (2021). "Reduction of progesterone elevation at trigger in poor responder Bologna’ criteria patients after controlled ovarian stimulation with long acting standard stimulation protocol compared with conventional daily protocol: a single center prospective randomized Fase IV trial." 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 Product Code: [Elonva] Pharmaceutical Form: Solution for injection INN or Proposed INN: corifollitropina alfa Current Sponsor code: Elonva ‐ Corifollitropina alfa Other descriptive name: CFA Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 150‐ Trade Name: PUREGON ‐ 300 UI/0.362 ML SOLUZIONE INIETTABILE 1 CARTUCCIA USO SOTTOCUTANEO Product Name: Puregon Product Code: [Puregon] Pharmaceutical Form: Solution for injection INN or Proposed INN: FOLLITROPINA BETA Current Sponsor code: Puregon ‐ Ormone follicolo‐stimolante ricombinante Other descriptive name: rFSH Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 833‐ CONDITION: Patient with poor ovarian response ; MedDRA version: 20.0 Level: LLT Classification code 10021935 Term: Infertility, female, associated with anovulation System Organ Class: 100000004872 Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] PRIMARY OUTCOME: Main Objective: The overarching objective of this research is to generate clinical evidence to argue the bene‐fits of long acting stimulation protocol compared to the daily stimulation protocol in poor ovarian responders. Primary end point(s): Reduction in the proportion of subjects with progesterone > 1.1 ng/ml on the day of triggering (day + 13) in the experimental group (Expected 5%) compared to the control group (Expected 25%) Secondary Objective: To reduce the freeze‐all IVF cycles due to prema‐ture PE; To increase the n° of oocytes collected at ovum re‐trieval; To increase the fertilization rate; To increase the n° of embryo available; To increase the pregnancy rate; To increase the ongoing pregnancy rate (vital fetus at 20 weeks of gestation) Timepoint(s) of evaluation of this end point: on the day of triggering (day + 13) SECONDARY OUTCOME: Secondary end point(s): Comparison of the n° of oocytes collected between the two Arms at day + 14; Percentage of fertilized oocytes at day +15 of ex‐perimental group compared to the control group; Total n° of embryos obtained at day +17 of experi‐mental group compared to the control group; Percentage of positive pregnancy test at day +31 of experimental group compared to the control group; Percentage of abortion at week 20th of experimental group compared to the control group; Total n° of embryos cryopreserved at day +21 of ex‐perimental group compared to the control group Timepoint(s) of evaluation of this end point: day + 14; day +15; day +17; day +31; week 20th; day +21 INCLUSION CRITERIA: Women undergoing IVF cycle, aged between 25 and 42 years, normal BMI (18.5‐24.9 kg/m2), AMH level < 1.1 ng/ml and/or AFC < 5 follicles and/or < 3 oo‐cytes retrieved in previous cycle, regular menstrual cycles, FSH on cycle day 3 < 20 IU/L, who have signed informed consent 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

Osuga, Y., et al. (2021). "Ulipristal acetate compared with leuprorelin acetate for Japanese women with symptomatic uterine fibroids: a phase III randomized controlled trial." Fertility and Sterility 116(1): 189‐197.
	Objective: To evaluate the efficacy and safety of ulipristal acetate (UPA) for uterine fibroids (UFs), a phase III study was conducted with leuprorelin (LEU) as a comparator. This is the first confirmatory trial of UPA for UFs among Asians. Design: Multicenter, randomized, double‐blind, double‐dummy, parallel‐group study. Setting: Thirty‐two sites in Japan. Patient(s): Patients were assigned to 2 arms, with 82 patients in the UPA group and 79 patients in the LEU group. Intervention(s): In the UPA group, 10 mg of UPA was orally administered once a day for 12 weeks. In the LEU group, 1.88 mg or 3.75 mg of LEU was subcutaneously administered at weeks 0, 4, and 8. Main Outcome Measure(s): The primary endpoint was the percentage of patients with amenorrhea for 35 days. For safety evaluation, adverse events (AEs) were recorded. Result(s): The percentage of patients with amenorrhea for 35 days was 87.0% in the UPA group and 81.8% in the LEU group, and the efficacy of UPA for causing amenorrhea for 35 days was confirmed to be noninferior to that of LEU. AEs occurred in 78.0% of the patients in the UPA group and 88.8% of the patients in the LEU group. Conclusion(s): The effect of UPA on heavy menstrual bleeding was shown to be comparable with that of LEU in Japanese patients with symptomatic UFs. No notable AEs occurred because of the UPA treatment, and the incidence of AEs in the UPA group was comparable with that of AEs in the LEU group. This result demonstrates the clinical utility of UPA for Asians.

Osuga, Y., et al. (2021). "Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain in a dose-response manner: a randomized, double-blind, placebo-controlled study." Fertility and Sterility 115(2): 397-405.
	OBJECTIVE: To evaluate the efficacy and safety of three dose levels of relugolix, a gonadotropin-releasing hormone receptor antagonist, compared with placebo and leuprorelin in women with endometriosis-associated pain. DESIGN: Phase 2, multicenter, randomized, double-blind, placebo-controlled study. SETTING: Hospitals and clinics. PATIENT(S): Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain. INTERVENTION(S): During a 12-week treatment period, patients received relugolix 10 mg (n = 103), 20 mg (n = 100), or 40 mg (n = 103) as a daily oral dose; placebo (n = 97) as a daily oral dose; or leuprorelin 3.75 mg (n = 80) as a monthly subcutaneous injection. MAIN OUTCOME MEASURE(S): Primary endpoint was the change from baseline in mean visual analog scale score for pelvic pain during 28 days before the end of treatment. RESULT(S): The mean changes in mean visual analog scale score for pelvic pain were -3.8 mm in the placebo group; -6.2, -8.1, and -10.4 mm in the relugolix 10-mg, 20-mg, and 40-mg groups; respectively; and -10.6 mm in the leuprorelin group. The major adverse events with relugolix were hot flush, metrorrhagia, menorrhagia, and irregular menstruation, and bone mineral density decrease in a dose-response manner, which were also observed in the leuprorelin group with a frequency comparable with that in the relugolix 40-mg group. CONCLUSION(S): Oral administration of relugolix alleviated endometriosis-associated pain in a dose-response manner and was generally well tolerated. Relugolix 40 mg demonstrated efficacy and safety comparable with those of leuprorelin. CLINICAL TRIAL REGISTRATION NUMBER: NCT01458301.

Ottolina, J., et al. (2022). "Surgery versus IVF for the treatment of infertility associated to ovarian and deep endometriosis (SVIDOE: Surgery Versus IVF for Deep and Ovarian Endometriosis). Clinical protocol for a multicenter randomized controlled trial." PloS One 17(8): e0271173.
	The management of endometriosis-related infertility is still a challenging issue. Women can be managed with either surgery or in vitro fertilization (IVF). The decision is tailored to the patients considering pros and cons of both approaches. Surgery might increase the chances of natural conception and relieve symptoms. IVF may be more effective, but costs are higher and unoperated women face some peculiar additional risks during the procedure and pregnancy. The unavailability of randomized trials comparing the two strategies hampers the possibility to provide precise estimates. This Randomized Controlled Trial (RCT) aims at filling this gap. This is a multicenter, non-blinded, randomized controlled trial with parallel groups and allocation 1:1. Three Italian Academic Infertility Units will be involved. Main inclusion criteria are infertility for more than one year, age less than 40 years and a sonographic diagnosis of endometriosis (ovarian endometriomas or deep peritoneal lesions). Previous IVF and previous surgery for endometriosis are exclusion criteria. Women will be randomized to either surgery and then natural pregnancy seeking or a standard program of three IVF cycles. The primary aim is the comparison of live birth rate between the two groups (IVF versus surgery) within one year of randomization. The secondary aim is the evaluation of cost-effective profile of the two interventions. The present study can influence the clinical practice of infertility treatment in women with endometriosis. From a public health perspective, information on the more cost-effective clinical management strategy would consent a wiser allocation of resources. Trial registration: NCT04743167, registered on 8 February 2021.; Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: - Dr. Somigliana reports grants from Ferring, grants and personal fees from Merck-Serono, grants and personal fees from Theramex, OUTSIDE the submitted work.

Ouyang, C. (2021). "Photobiomodulation for Myofascial Pelvic Pain." ClinicalTrials.gov.
	No Results Available Device: SoLá therapy|Other: Pelvic floor physical therapy Pelvic Pain Intensity|Intensity of Dyspareunia|Intensity of pain with sitting|Pain interference Female Not Applicable 28 U.S. Fed Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 1591638 August 1, 2024

Ouyang, C., et al. (2022). "Efficacy of excision versus ablation for improving endometriosis related pain: A systematic review and meta-analysis." Journal of Endometriosis and Pelvic Pain Disorders 14(1): 52-62.
	Background: Surgical treatment of superficial peritoneal endometriosis includes excision or ablation. Controversy exists about which method is better for providing pain relief. We performed a meta-analysis of randomized control trials (RCTs) comparing the efficacy of excision versus ablation for improving the most frequently encountered endometriosis pain symptoms: dysmenorrhea, dyspareunia, non-cyclic pelvic pain, and dyschezia. Method(s): A search from inception to May 2020 was conducted in PubMed, MEDLINE, Clinicaltrials.gov, Cochrane Central Register of Controlled Trials, and Web of Science. RCTs comparing excision versus ablation for peritoneal endometriosis were included if they assessed dysmenorrhea, dyspareunia, dyschezia, and pelvic pain/non-menstrual pain. Exclusion criteria included extra-peritoneal endometriosis or endometriomas, and non-English publications. Publications were assessed for risk of bias and quality of evidence using Cochrane risk of bias tool (RoB 2) and GradePro. Result(s): Of the 2025 records identified initially, four met inclusion criteria. The sample sizes of the included studies ranged from 24 to 133 participants. The excision and ablation groups included 204 participants each. There was no difference after excision or ablation for dysmenorrhea when comparing the mean change in pain scores from baseline to 12 months after surgery (-0.31, 95% CI -1.66, 1.04, p = 0.65), dyspareunia (-0.24, 95% CI -1.78, 1.30, p = 0.76), dyschezia (-0.72, 95% CI -1.94, 0.50, p = 0.25), or non-cyclic pain (-0.78, 95% CI -2.47, 0.91, p = 0.37). Conclusion(s): We found low to moderate quality evidence suggesting that neither excision nor ablation is superior in reduction of endometriosis-related pain up to 12 months after surgery.Copyright © The Author(s) 2022.

Oxolife, S. L. (2021). "A clinical study assess the ongoing pregnancy rate with an Investigational Medicinal Product in woman undergoing a donor oocyte IVF/ICSI." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Sodium tungstate Product Code: OXO‐001 (100 mg) Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Sodium Tungstate CAS Number: 13472‐45‐2 Current Sponsor code: OXO‐001 Other descriptive name: Sodium tungstate(VI); Sodium tungstate(VI) Dihydrate ; Sodium tungstate(VI), 181W‐labeled Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Sodium Tungstate Product Code: OXO‐001 (150 mg) Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Sodium Tungstate CAS Number: 13472‐45‐2 Current Sponsor code: OXO‐001 Other descriptive name: Sodium tungstate(VI); Sodium tungstate(VI) Dihydrate ; Sodium tungstate(VI), 181W‐labeled Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Infertility treatment and fertility enhancer in women undergoing assisted reproductive techniques or natural reproduction Therapeutic area: Body processes [G] ‐ Reproductive physiologi cal processes [G08] PRIMARY OUTCOME: Main Objective: The primary objective of this trial is to assess the efficacy of oral OXO‐001 (200 mg and 300 mg) versus placebo taken once‐daily to increase the ongoing pregnancy rate (defined as the rate of intrauterine pregnancy with foetal heartbeat) at 10 weeks post embryo transfer (ET) Primary end point(s): Efficacy will be assessed using the ongoing pregnancy rate, defined as the rate of subjects with uterine pregnancy and a foetal heartbeat, confirmed by ultrasound (US) at 10 weeks post embryo transfer. Secondary Objective: The secondary objective of this trial is to assess the efficacy of OXO‐001 (200 mg and 300 mg) versus placebo in terms of biochemical pregnancy rate and pregnancy loss rate until 10 weeks post ET and to assess the safety and tolerability of OXO‐001 (200 mg and 300 mg) from the first administration until 10 weeks post ET. Timepoint(s) of evaluation of this end point: At the end of the main part of the trial. SECONDARY OUTCOME: Secondary end point(s): 1. Percentage of women with positive blood pregnancy test 10 to 15 days post ET.; 2. Percentage of women with vital pregnancy (defined as intra‐uterine pregnancy with foetal heartbeat) at 6 weeks post ET.; 3. Early pregnancy loss rate within 10 weeks of gestation (i.e. after positive blood pregnancy test 10 ‐ 15 days post ET).; 4. Incidence and severity of AEs/ SAEs, reported during the period from the first intake of the IP until 10 weeks post ET.; 5. Changes from baseline in haematology and biochemistry values 6 weeks post ET.; 6. Changes from baseline in vital signs (heart rate, blood pressure). ; 7. Changes in endometrial thickness.; 8. Proportion of subjects achieving the endometrial criteria to undergo ET. Timepoint(s) of evaluation of this end point: At the end of the main part of the trial. INCLUSION CRITERIA: 1. Voluntary written informed consent before initiation of any trial‐related procedures, including the agreement to participate in the pregnancy and infant follow‐up if becoming pregnant. 2. Infertile female subjects indicated for egg donor programme in the context of ART. Infertility is defined as the failure to achieve a clinical pregnancy after: a. at least 12 months of regular unprotected sexual intercourse, if < 35 years of age, b. at least 6 months of regular unprotected sexual intercourse, if = 35 years of age. 3. Subjects aged = 18 to = 45 years at screening. 4. Body mass index (BMI) = 18.0 and < 30.0 kg/m2. 5. Normal results of a 2‐dimensional (2D) or 3‐dimensional (3D) transvaginal US (TVUS) at screening (no presence of gynaecological abnormality suspected to affect the ART procedure and outcome). The TVUS should have been performed in the mid of the second part of a menstrual cycle. . 6. Planned transfer of a fresh single blas

Ozcan, M. C. H., et al. (2021). "A Systematic Review and Meta-analysis of Surgical Treatment of Ectopic Pregnancy with Salpingectomy versus Salpingostomy." Journal of Minimally Invasive Gynecology 28(3): 656-667.
	Objective: To evaluate the fertility outcomes of salpingectomy compared with those of salpingostomy among patients treated for tubal ectopic pregnancies, including a separate analysis of women with risk factors along with a review of the surgical technique. Data Sources: Systematic review and meta-analysis from 1990 to the present through PubMed, Embase, CINAHL, and Ovid MEDLINE. The search string included "tubal pregnancy" or "ectopic" as well as "salpingectomy" and various terms describing salpingotomy. Methods of Study Selection: Articles studying women who underwent surgical management of an ectopic pregnancy and the contrasted outcomes of salpingectomy vs salpingostomy were reviewed. The primary outcomes included subsequent intrauterine pregnancy (IUP) and repeat ectopic pregnancy (REP). Tabulation, Integration, and Results: Two randomized controlled trials (RCTs), which consisted mostly of patients classified as low risk, and patients from 16 cohort studies were included. In the RCTs, there was no significant difference in the odds of subsequent IUP in patients who underwent a salpingectomy compared with those who were treated with salpingotomy (odds ratio [OR] 0.97; 95% confidence interval [CI], 0.71-1.33). However, a significant and clinically meaningful difference was noted in the cohort studies, with the patients having a lower chance of IUP after salpingectomy (OR 0.45; 95% CI, 0.39-0.52). No significant difference was noted in the OR for a REP in the randomized trials (OR 0.77; 95% CI, 0.41-1.47), but the patients followed in the cohort studies had a cumulatively higher risk of REP after a salpingostomy (OR 0.73; 95% CI, 0.60-0.90). The subgroup analysis examining women within the studies with risk factors for tubal pathology found an even more impressive lowering in the odds of a subsequent IUP in patients classified as at-risk who were treated with salpingectomy (OR 0.30; 95% CI, 0.17-0.54), with a change in the direction of the odds for an REP rate favoring those who were treated with salpingostomy (OR 1.96; 95% CI, 0.88-4.35). Conclusion(s): Salpingectomy has clear advantages over salpingostomy, and RCTs consisting mainly of patients classified as low risk show no difference in outcomes between salpingectomy and salpingostomy. However, in cohort studies inclusive of all patients, the likelihood of a subsequent spontaneous IUP is decreased in patients treated with salpingectomy, and salpingostomies may be especially underused in women with risk factors for tubal disease.Copyright © 2020 AAGL

Ozcan, P. (2023). "Comparison of Human Menopausal Gonadotropins and the Combination of Human Menopausal Gonadotropins With Clomiphene Citrate in Stimulated Intrauterine Insemination Cycles." ClinicalTrials.gov.
	Approximately %10‐15 of couples of reproductive age, have infertility issues. %30‐40 male factor, %40‐50 female factor, and %20‐25 both play a role in infertility etiology. Contributory factors of cases are %30‐40 male factors, %40‐50 female factors, and %20‐25 mixed type. Ovulation induction and intrauterine insemination (IUI) are the main treatments for infertility. IUI is accepted as the most used treatment procedure according to other assisted reproductive techniques because it has lower costs, can be easily applied, and is less invasive. Clomiphene citrate is the most commonly used for ovulation induction, which is cheaper and has a lower incidence of multiple pregnancies. Controlled ovarian hyperstimulation with human menopausal gonadotropins and IUI has a higher incidence of pregnancy rates in an ovulation, unexplained and mild male factor infertility cases. Data including age, BMI, smoking, the duration of infertility, the type of infertility, total motile sperm count (TMSS) of inseminated material and sperm morphology, antral follicle count, number of developed follicles and endometrial thickness on HCG day will be recorded. On the 2nd or 3rd day of the cycle, the patient will be randomized into two groups. Group 1 (HMG: n=127, 75 IU hMG/day), and Group 2 (clomiphene citrate 100 mg/day for 5 days following by 75 IU hMG/day; n=127). Human chorionic gonadotropin (hCG) will be used for trigger when the dominant follicle's diameter reaches 17‐18mm for ovulation. Thirty‐six hours after the hCG injection, single IUI will be performed by using the fresh sperm obtained by the density gradient method with a soft catheter in the dorsolithotomy position under ultrasound guidance. The patient will be kept supine position after the procedure for 15 minutes. After IUI, sexual intercourse will be recommended for three days. Intravaginal progesterone (LUTINUS® 100 mg vaginal tablet, Ferring GmbH Wittland/Kiel/Germany) to both groups will be used once a day after insemination for luteal phase support. Clinical pregnancy rates will be recorded by performing a blood test for on the 15th day after the procedure. The aim of study is to evaluate the results of two different protocols for ovulation induction during IUI cycles. All patients undergo IUI cycles are randomly divided in to two groups. the first group is human menopausal gonadotropins and the second group is the combination of human menopausal gonadotropins with clomiphene citrate

Ozcan, P. (2023). "Comparison of Recombinant Follicle Stimulating Hormone and the Combination of Recombinant Follicle Stimulating Hormone With Clomiphene Citrate in Stimulated Intrauterine Insemination Cycles." ClinicalTrials.gov.
	Approximately %10‐15 of couples of reproductive age, have infertility issues. %30‐40 male factor, %40‐50 female factor, and %20‐25 both play a role in infertility etiology. Contributory factors of cases are %30‐40 male factors, %40‐50 female factors, and %20‐25 mixed type. Ovulation induction and intrauterine insemination (IUI) are the main treatments for infertility. IUI is accepted as the most used treatment procedure according to other assisted reproductive techniques because it has lower costs, can be easily applied, and is less invasive. Clomiphene citrate is the most commonly used for ovulation induction, which is cheaper and has a lower incidence of multiple pregnancies. Controlled ovarian hyperstimulation with recombinant follicle stimulating hormone and IUI has a higher incidence of pregnancy rates in an ovulation, unexplained and mild male factor infertility cases. Data including age, BMI, smoking, the duration of infertility, the type of infertility, total motile sperm count (TMSS) of inseminated material and sperm morphology, antral follicle count, number of developed follicles and endometrial thickness on HCG day will be recorded. On the 2nd or 3rd day of the cycle, the patient will be randomized into two groups. Group 1 (rFSH: n=127, 75 IU FSH/day), and Group 2 (clomiphene citrate 100 mg/day for 5 days following by 75 IU FSH/day; n=127). Human chorionic gonadotropin (hCG) will be used for trigger when the dominant follicle's diameter reaches 17‐18mm for ovulation. Thirty‐six hours after the hCG injection, single IUI will be performed by using the fresh sperm obtained by the density gradient method with a soft catheter in the dorsolithotomy position under ultrasound guidance. The patient will be kept supine position after the procedure for 15 minutes. After IUI, sexual intercourse will be recommended for three days. Intravaginal progesterone (LUTINUS® 100 mg vaginal tablet, Ferring GmbH Wittland/Kiel/Germany) to both groups will be used once a day after insemination for luteal phase support. Clinical pregnancy rates will be recorded by performing a blood test for on the 15th day after the procedure. The aim of study is to evaluate the results of two different protocols for ovulation induction during IUI cycles. All patients undergo IUI cycles are randomly divided in to two groups. the first group is recombinant follicle stimulating hormone and the second group is the combination of recombinant follicle stimulating hormone with clomiphene citrate

özcan, p. (2022). "The Importance of Embryo Transfer Day Progesterone Value in Natural Cycle Frozen Embryo Transfers and the Evaluation of the Effect of Rescue Therapy on Pregnancy Outcomes in Patients With Low Progesterone Levels." ClinicalTrials.gov.
	No Results Available Other: Normal Progesterone group|Other: Low Progesterone group Clinical pregnancy rates|Ongoing pregnancy rate|Miscarriage Female Not Applicable 126 Other Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 26.07.2022-E.71262 December 1, 2023

özdemir, m. (2021). "Advanced Glycation End Products and Dietary Intervention in Polycystic Ovary Patients." ClinicalTrials.gov.
	No Results Available Behavioral: Low AGE diet with reduced energy and fat|Behavioral: Energy and fat-reduced normal diet Serum advanced glycation end products levels|Total antioxidant/oxidant capacity|İnflammation|Cardio metabolic profile|Hormonal Profile|Body composition|Body weight|Body Mass İndex|Circumference measurements Female Not Applicable 24 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care HACETTEPE UNIVERSITY-OZDEMIR-1 November 2023

Özgül, S. (2022). "Comparison of Two Different Pelvic Floor Muscle Training Programs in Stress Urinary Incontinence." ClinicalTrials.gov.
	Our study is designed as a parallel group, randomized clinical trial. Participants who meet the inclusion criteria will be assigned randomly to one of the study groups. The participants in the 1st group will be given classical PFMT, and the participants in the 2nd group will be given functional PFMT. The study period is 8 weeks for each individual participating in the study. All participants will be called for control every 2 weeks and progress will be made in exercise programs in accordance with the protocol. At the beginning of the study, demographic information, physical characteristics, smoking habit, primary and secondary urinary symptoms and their duration, obstetric history, menstrual and menopausal status, comorbidities, drugs used and, if any, the effects of these drugs on the urinary system, previous UI treatments and their duration will be recorded. For individuals over 65 years of age, Mini Mental Test will be applied in terms of cooperation suitability for the research. The objective severity of incontinence will be assessed with the 1‐hour pad test. The subjective severity of incontinence and its impact on life will be evaluated with the International Incontinence Consultation Questionnaire‐Short Form (ICIQ‐UI SF). The King's Health Questionnaire (KHQ) will be used to investigate the effects of interventions on the sub‐dimensions of quality of life. With the Patient Global Impression of Severity Scale and the Patient Global Impression of Change Scale, the individual's perception of severity and recovery of UI will be evaluated. Vaginal palpation will be performed to determine whether individuals can voluntarily contract their pelvic floor muscles and to teach correct contraction before pelvic floor muscle training. Outcome measurements will be recorded at the beginning of the study, at the end of the 4th week and at the end of the 8th week. Participants will be given an exercise diary to increase motivation and exercise adherence.

Özgül, S. (2022). "Effects of Connective Tissue Manipulation on Menopausal Symptoms." ClinicalTrials.gov.
	Menopause is defined as the permanent cessation of menstruation as a result of the loss of ovarian follicular function. It is part of the natural aging process and occurs by declining the estrogen secretion from the ovaries. This process involves some bothersome physical and psychological climacteric symptoms that negatively influence the women's well‐being and quality of life. The most common symptoms are vasomotor symptoms (hot flashes, sweating, night sweats), psychological symptoms (anxiety, depression, stress) and insomnia. Although hormonal and non‐hormonal pharmacological methods are widely used effective approaches to control these symptoms, they have some risks or adverse side effects. For this reason, women tend to alternative therapies and complementary medicine methods to improve climacteric symptoms and their quality of life. Connective tissue manipulation (CTM) is a manual reflex therapy method which aims to restore the balance between the sympathetic and parasympathetic components of the autonomic nervous system. It is characterised by special type of manual stroke which is applied to the connective tissue. These stretching maneuvers are applied to areas called "reflex zones", and create local, segmental and general therapeutic effects in the body. The aim of this study is to investigate the effects of CTM on vasomotor symptoms, psychological symptoms, sleep quality and quality of life in the postmenopausal period in a randomized placebo controlled study design. For this purpose, 58 postmenopausal women ages between 45 to 65 who meet the inclusion criteria and volunteer to participate in the study will be randomly assigned to one of the two research arms, CTM or placebo control. The women in the experimental group will receive CTM for 5‐20 minutes, 3 times a week for 4 weeks. On the other hand, the women in the placebo control group will receive superficial massage with the head of the therapeutic ultrasound device for 15 minutes at the same frequency for 4 weeks. In this study, primary outcomes are frequency of vasomotor symptoms and vasomotor symptom score and they will be evaluated by daily diaries. Secondary outcomes are general severity of menopausal symptoms, psychological status, severity and effect of insomnia and quality of life associated with menopause. These outcomes will be assessed by questionnaires; "Menopausal Symptoms Rating Scale", "Depression‐Anxiety‐Stress 21 Scale", "Insomnia Severity Index", and "Menopause‐Specific Quality of Life Scale". State anxiety, mobility and flexibility of connective tissue, autonomic functions and treatment satisfaction will also be evaluated in the study. The diaries will be filled out for one week (7 days each); at the baseline and just after the completion of the study. All other outcome measurements will be performed before and immediately after the study is completed. The results will be compared within groups and between two study groups.

Özgül, S. (2022). "Yoga and Aerobic Exercise Training in Primary Dysmenorrhea." ClinicalTrials.gov.
	The aim of this study is to compare the effects of aerobic exercise and yoga exercises on menstrual pain parameters (pain severity and duration, analgesic usage), uterine artery blood flow, menstrual stress level, physical fitness, anxiety/depressive symptom level, quality of life and sleep quality in individuals with primary dysmenorrhea. This study is a prospective, parallel group, randomized study. It was planned to enroll 44 individuals with Primary Dysmenorrhea in this randomized study. A physical therapist is responsible for all assessments. Participants were included in one of two treatment groups (G1: Aerobic exercise; G2: Yoga exercise). In the literature, there are no studies comparing the effectiveness of aerobic exercise and yoga in the management of PD, which is a public health problem that seriously affects women's lives. Especially when aerobic exercise and yoga exercises are considered, there is no study on how much the features such as uterine artery blood flow and physical fitness sub‐parameters have changed with these two commonly used exercise types separately in the management of PD. The results of our study show that norm values can be established by evaluating uterine arterial blood flow and physical fitness, instead of focusing on pharmacological treatment and classical nonpharmacological approaches (warm application, transcutaneous electrical nerve stimulation (TENS), acupuncture, etc.) in individuals with PD. It is aimed to develop new exercise protocols that can be done easily. It is expected that our results, which we will obtain in the light of the original values of our research, will contribute to the literature and guide future studies.

Özgül, S., et al. (2023). "The Effects of Connective Tissue Manipulation in Primary Dysmenorrhea: a Randomized Placebo-Controlled Study." Reproductive Sciences 30(1): 181-191.
	The aim of this study was to identify the effects of connective tissue manipulation (CTM) in primary dysmenorrhea (PD) in a randomized, placebo-controlled design. Thirty-eight nulliparous women with PD were randomly allocated into 3 groups: CTM (n = 13), placebo therapeutic ultrasound (US) (n = 13), and control (n = 12). The primary outcome measure was the maximum and mean menstrual pain intensity at the last menstrual period on the visual analogue scale (VAS). Secondary outcome measures were menstrual symptom frequency and distress score, the number of analgesic/anti-inflammatory drugs used during the last menstrual period, and perception of improvement in dysmenorrhea severity via interventions. The chi-square test and analysis of variance were used to determine within-group and between-group differences. Statistical significance level was determined as p < 0.05. Compared with the placebo US and control groups, it was observed that menstrual pain (VAS mean and VAS maximum), menstrual symptom frequency, and distress level decreased more after treatment (T2) and the 3-month follow-up (T3) in de CTM group (p < 0.001, p = 0.001, p = 0.014, p = 0.015, respectively). There was no difference between the groups in terms of analgesic/anti-inflammatory drugs use (p > 0.05). The rate of individuals reporting perceived improvement at the end of intervention period was higher in the CTM group than in the placebo-US and control groups (p < 0.001). In the 3rd month follow-up, there was no difference between groups in the perception of improvement (p > 0.05). CTM is superior to placebo intervention and control in improving menstrual pain and other menstrual symptoms in PD in the short-term. On the other hand, when the application is terminated, this superiority seems to disappear during the follow-up period. (© 2022. Society for Reproductive Investigation.)

Ozols Robert, F., et al. (2023). "Phase III Trial of Carboplatin and Paclitaxel Compared With Cisplatin and Paclitaxel in Patients With Optimally Resected Stage III Ovarian Cancer: A Gynecologic Oncology Group Study." Journal of Clinical Oncology 41(25): 4077-4083.
	Purpose: In randomized trials the combination of cisplatin and paclitaxel was superior to cisplatin and cyclophosphamide in advanced-stage epithelial ovarian cancer. Although in nonrandomized trials, carboplatin and paclitaxel was a less toxic and highly active combination regimen, there remained concern regarding its efficacy in patients with small-volume, resected, stage III disease. Thus, we conducted a noninferiority trial of cisplatin and paclitaxel versus carboplatin and paclitaxel in this population. Patients and Methods: Patients with advanced ovarian cancer and no residual mass greater than 1.0 cm after surgery were randomly assigned to receive cisplatin 75 mg/m 2 plus a 24-hour infusion of paclitaxel 135 mg/m 2 (arm I), or carboplatin area under the curve 7.5 intravenously plus paclitaxel 175 mg/m 2 over 3 hours (arm II). Results: Seven hundred ninety-two eligible patients were enrolled onto the study. Prognostic factors were similar in the two treatment groups. Gastrointestinal, renal, and metabolic toxicity, as well as grade 4 leukopenia, were significantly more frequent in arm I. Grade 2 or greater thrombocytopenia was more common in arm II. Neurologic toxicity was similar in both regimens. Median progression-free survival and overall survival were 19.4 and 48.7 months, respectively, for arm I compared with 20.7 and 57.4 months, respectively, for arm II. The relative risk (RR) of progression for the carboplatin plus paclitaxel group was 0.88 (95% confidence interval [CI], 0.75 to 1.03) and the RR of death was 0.84 (95% CI, 0.70 to 1.02). Conclusion: In patients with advanced ovarian cancer, a chemotherapy regimen consisting of carboplatin plus paclitaxel results in less toxicity, is easier to administer, and is not inferior, when compared with cisplatin plus paclitaxel.

Paasch, C. (2022). "Prospective, multicenter, randomized, controlled, single-blind other clinical trial. "What is the efficacy of pelvic floor biofeedback training with ACTICORE1® for stress incontinence?"." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention 1: Use of ACTICORE1® according to training program 6 minutes daily for 16 weeks. Intervention 2: Recommendation to perform physiotherapist‐guided pelvic floor training. CONDITION: N39.4 ‐ Other specified urinary incontinence PRIMARY OUTCOME: ICIQ‐Score after 16 weeks SECONDARY OUTCOME: Secondary endpoints ; 8 weeks after study inclusion; Quality of life according to Kings ´s Health questionnaire. ; Oxford grading (by same therapist as at study inclusion) ; ACTICORE1 performance data (All available data from the AC1 app: ; Compliance, level, exercise types, quality of ; Exercise performance, pain on use, etc.). ; ; 16 weeks after study inclusion ; ICIQ score ; Quality of life according to King ´s Health questionnaire. ; Oxford grading (by same therapist as at study inclusion). ; ACTICORE1 performance data (All available data from the AC1 app: ; Compliance, level, exercise types, quality of ; Exercise performance, pain on use, etc.). ; ; Translated with www.DeepL.com/Translator (free version) INCLUSION CRITERIA: Stress incontinence with subjective impairment and an ICIQ score of 5 or greater. ‐ Women and men who can contract their BB at will with an Oxford grading "standing" of of at least 2. ‐ Women and men over the age of 65 are also included as vulnerable individuals. Availability of a smartphone/tablet, ability to operate same e.g. download app, Pairing smartphone sensor ‐ Internet access available on a daily basis ‐ Creation of a user profile in the ACTICORE1 app.

Page, A.-S., et al. (2022). "Cervicosacropexy or vaginosacropexy for urinary incontinence and apical prolapse: A systematic review." European Journal of Obstetrics, Gynecology, and Reproductive Biology 279: 60-71.
	Several anatomic theories suggest that lax uterosacral ligaments may result in apical prolapse and urinary incontinence. Therefore, prolapse repair such as cervicosacropexy or vaginosacropexy, may resolve urinary incontinence. Shortcomings in current treatment options endorse further exploration of the potential benefit of a surgical alternative. This systematically review of the literature aimed to summarize the evidence on the efficacy and safety of cervicosacropexy and vaginosacropexy as alternative surgical treatment options for urge and/or mixed urinary incontinence and apical prolapse. The PRISMA 2020 statement was followed and the review protocol was registered with PROSPERO (CRD42021267941). Studies from inception to 9/2021 were systematically reviewed and included. Data collection, risk of bias, and certainty of evidence were assessed using the standard Cochrane methods. The primary outcome measures were improvements in prolapse and urinary symptoms. Secondary outcomes included surgical safety and reintervention rates for complications and recurrence. The included studies showed a moderate-to-high risk of bias and low certainty of evidence. Owing to their heterogeneity, no meta-analysis was performed. Cure rates for mixed and urge urinary incontinence and apical prolapse were 47.5 % (CI95%:42.4-52.6), 73.8 % (CI95%:61.9-85.7) and 97-100 % respectively, at a mean follow-up of 9.7 ± 7.3 months. Additional incontinence surgery in 38.9 % (216/555) of women with initial urinary incontinence, and concomitant or subsequent surgery for prolapse was performed in 4.4 % (13/299). Cervicosacropexy or vaginosacropexy may remedy symptoms of urge and mixed urinary incontinence and seem to correct apical prolapse in the short term. Nevertheless, the overall level of evidence is low. Therefore, further clinical trials, integrated in the IDEAL framework, targeting better-identified patient selection, and using validated outcome measures are needed.; 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.)

Page, A.-S., et al. (2023). "Laser versus sham for genitourinary syndrome of menopause: A randomised controlled trial." BJOG 130(3): 312-319.
	Objective: To assess whether CO 2 laser treatment is more effective than sham application in relieving the most bothersome symptom (MBS) in women with genitourinary syndrome of menopause (GSM).; Design: Single-centre, sham-controlled, double-blind, randomised trial.; Setting: A tertiary centre in Belgium.; Population: Sixty women with moderate to severe GSM symptoms.; Methods: All participants eventually received three consecutive laser and three consecutive sham applications, either first laser followed by sham, or conversely.; Main Outcome Measures: The primary outcome was the participant-reported change in severity of the MBS at 12 weeks. Secondary outcomes included subjective (patient satisfaction, sexual function, urinary function) and objective (pH, Vaginal Health Index Score, in vivo microscopy) measurements assessing the short-term effect and the longevity of treatment effects at 18 months after start of the therapy. Adverse events were reported at every visit.; Results: The MBS severity score decreased from 2.86 ± 0.35 to 2.17 ± 0.93 (-23.60%; 95% CI -36.10% to -11.10%) in women treated with laser compared with 2.90 ± 0.31 to 2.52 ± 0.78 (-13.20%; 95% CI -22.70% to -3.73%) in those receiving sham applications (p = 0.13). There were no serious adverse events reported up to 18 months.; Conclusions: In women with GSM, the treatment response 12 weeks after laser application was comparable to that of sham applications. There were no obvious differences for secondary outcomes and no serious adverse events were reported. (© 2022 John Wiley & Sons Ltd.)

Pagkali, A., et al. (2022). "Safety Profile of Niraparib as Maintenance Therapy for Ovarian Cancer: A Systematic Review and Meta-Analysis." Current Oncology 29(1): 321-336.
	Background: Patients with epithelial ovarian cancer (EOC), treated with niraparib maintenance, present with haematological and gastrointestinal toxicities. Limited data exist on niraparib safety assessment.; Objective: To evaluate niraparib safety profile, as maintenance therapy, in women with platinum-sensitive EOC.; Methods: PubMed and Cochrane searches were carried out up to April 2021 for randomised controlled trials (RCTs) evaluating niraparib versus placebo in EOC patients with a response to platinum-based chemotherapy. Regarding the meta-analysis, for dichotomous data, the pooled risk ratio (RR) was calculated.; Results: A total of 1539 patients from three RCTs revealed that niraparib-treated patients are associated with a significantly higher risk of any grade of nausea (RR, 2.15; 95% CI, 1.86 to 2.48), fatigue (RR, 1.26; 95% CI, 1.05 to 1.52, p < 0.00001), anemia (RR, 6.86; 95% CI, 2.54 to 18.52, p = 0.0001), thrombocytopenia (RR, 7.02; 95% CI, 1.68 to 29.38, p < 0.00001), vomiting (RR, 2.51; 95% CI, 1.50 to 4.19, p = 0.0005), neutropenia (RR, 2.96; 95% CI, 1.13 to 7.73, p < 0.00001), headache (RR, 2.08; 95% CI, 1.57 to 2.74, p < 0.00001), constipation (RR, 2.10; 95% CI, 1.72 to 2.57, p < 0.00001) and insomnia (RR, 2.48; 95% CI, 1.52 to 2.89, p = 0.0003) when compared with placebo. For grade 3 or 4 adverse effects, significantly higher risk was only noted for fatigue (RR,6.25; 95% CI, 1.70 to 23.05, p = 0.006), anemia (RR, 16.23; 95% CI, 4.86 to 54.17, p < 0.00001), thrombocytopenia (RR, 35.12; 95% CI, 12.23 to 100.82, p < 0.00001) and neutropenia episodes (RR, 6.35; 95% CI, 2.08 to 19.39, p = 0.001) for those taking niraparib. Notably, incidents of adverse effects and discontinuation rates were substantially lower among patients treated with an individualised niraparib dose than those treated with the standard one. Efficacy was not reduced, and no treatment-related deaths occurred during the included trials.; Conclusion: Niraparib is considered an effective and well-tolerated choice, with an improved safety profile, for the maintenance treatment of EOC patients.

Pan, Z., et al. (2022). "Different regimens of menopausal hormone therapy for improving sleep quality: a systematic review and meta-analysis." Menopause 29(5): 627-635.
	Importance: Long-term sleep disturbances in menopausal women are closely related to cardiovascular disorders, metabolic disorders, and cognitive impairment. At present, hormone therapy (HT) is a standard treatment for menopausal symptoms. However, it remains unclear whether HT can improve sleep quality.; Objective: We did a systematic review and meta-analysis to assess the effects of different HT regimens on menopausal sleep quality.; Evidence Review: We systematically searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, PsycINFO, CINAHL, and Web of Science for randomized controlled trials of menopausal HT on sleep disturbances up to June 14,2021. Information about ongoing and unpublished trials was collected by searching WHOICTRP and ClinicalTrials.gov. Our primary outcome was sleep quality with objective measurements. We estimated the standardized mean difference (SMD) using random-effects models.; Findings: We identified a total of 3,059 studies and finally included 15 studies in the meta-analysis. Compared with placebo, HT improved self-reported sleep outcomes (SMD = -0.13; 95% CI, -0.18 to -0.08, P < 0.00001 and I2 = 41%), but not sleep parameters measured by polysomnography. Subgroup analyses according to the regimen of HT showed that 17β-estradiol (17β-E2) (SMD = -0.34; 95% CI, -0.51 to -0.17, P < 0.0001, and I2 = 0%) and conjugated equine estrogens (SMD = -0.10; 95% CI, -0.12 to -0.07, P < 0.00001, and I2 = 0%) improved sleep quality. Moreover, transdermal administration (SMD = -0.35; 95% CI, -0.64 to -0.06, and P = 0.02) was more beneficial than oral (SMD = -0.10; 95% CI, -0.14 to -0.07, and P < 0.00001). In addition, the combination of estrogen and progesterone had a positive effect on sleep disturbance (SMD = -0.10; 95% CI, -0.13 to -0.07, P < 0.00001, and I2 = 0%), while estrogen monotherapy did not. The results showed that estrogen/micronized progesterone (SMD = -0.22; 95% CI, -0.37 to -0.06, P = 0.007, and I2 = 0%) and estrogen/medroxyprogesterone acetate (SMD = -0.10; 95% CI, -0.13 to -0.07, P < 0.00001, and I2 = 0%) could alleviate sleep disturbance.; Conclusions and Relevance: HT has a beneficial effect on sleep disturbance to some extent, and the formulations and routes of administration of hormonal agents influence the effect size.; Competing Interests: Financial disclosure/conflicts of interest: None reported. (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The North American Menopause Society.)

Pao-Yen, L., et al. (2022). "Chinese herbal medicine for dysmenorrhea: a meta-analysis of randomized controlled studies." PROSPERO International prospective register of systematic reviews.
	
Papaleo, E. (2021). "Reduction of Progesterone Elevation at Trigger in POR After Long Acting COS Compared With Daily COS: a Prospective Randomized Trial." ClinicalTrials.gov.
	No Results Available Drug: Corifollitropin alfa|Drug: Follitropin Beta Premature progesterone elevation|Percentage of freeze-all cycles due to premature progesterone elevation|Number of oocytes collected at ovum retrieval|Fertilization rate|Number of embryos available|Pregnancy rate|Ongoing pregnancy Female Phase 4 110 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention PE-PMA|2020-004329-21 February 28, 2023

Parijot, K., et al. (2024). "Effects of Intravenous Immunoglobulin in Recurrent Implantation Failure: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Park, J.-S., et al. (2022). "Efficacy of Rubus coreanus Miq. and Astragalus membranaceus Bunge Extract for Postmenopausal Syndrome: A Randomised, Double-Blind, Placebo Comparative Clinical Trial." Evidence-based Complementary and Alternative Medicine 2022: 4066054.
	Objectives: The most effective way to improve menopausal symptoms is to supplement deficient oestrogen; however, long-term administration of synthetic oestrogen increases the risk for breast and uterine cancers. Here, we report results from a clinical trial of Rubus coreanus Miq. and Astragalus membranaceus Bunge as agents for improving the menopause syndrome.; Methods: This study was a single-centre, double-blinded, parallel-group, placebo-controlled study. The efficacy of an extract of R. coreanus Miq. and A. membranaceus Bunge was investigated. Participants were females with postmenopausal syndrome in the menopausal or menopausal transition period. The primary endpoint of validation was improvement in the Kupperman index (KI) score of women. The secondary end point was change in the Menopause Rating Scale (MRS) and lipid profile. The participants were randomly allocated at a 1 : 1 ratio into R. coreanus Miq. and A. membranaceus Bunge extract (RCAM) or placebo groups and were administered 2000 mg of the extract or placebo, respectively, daily for 12 weeks. Outcomes were measured at visits 2 (day 0) and 5 (week 12).; Results: The RCAM group demonstrated decreased KI score and MRS compared with the placebo group after 12 weeks. In the safety evaluation, laboratory tests and vital signs demonstrated no clinically significant changes in subjects, and there was no difference in adverse reactions between the groups. The R. coreanus Miq. and A. membranaceus Bunge extract was effective in reducing postmenopausal symptoms in women. Moreover, the extract was found to be safe.; Conclusions: For females with menopausal symptoms in the menopausal transitional and postmenopausal periods, ingestion of the R. coreanus Miq. and A. membranaceus Bunge extract for 12 weeks was effective, as demonstrated by a decrease in KI score and MRS relative to that in the placebo group, and significantly improved the menopausal symptoms.; Competing Interests: The authors declare that they have no conflicts of interest. (Copyright © 2022 Jeong-Su Park et al.)

Park, S., et al. (2022). "Effects of High-Frequency Treatment using Radiofrequency on Autonomic Nervous System and Pain in Women with Dysmenorrhea." Physical Therapy Rehabilitation Science 11(4): 493-501.
	Sungeon Park, Seungwon Lee and Inok Kim. PTRS 2022;11:493-501. https://doi.org/10.14474/ptrs.2022.11.4.493

Parvaneh, G., et al. (2022). "The effects of Vitex agnus-castus on menopausal hot flashes." PROSPERO International prospective register of systematic reviews.
	
Parvaneh, M., et al. (2023). "The effect of Valeriana Officinalis on primary dysmenorrhea: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Patel, A., et al. (2022). "Taxane monotherapy regimens for the treatment of recurrent epithelial ovarian cancer." The Cochrane Database of Systematic Reviews 7: CD008766.
	Background: Ovarian cancer is the seventh most frequent cancer diagnosis worldwide, and the eighth leading cause of cancer mortality. Epithelial ovarian cancer is the most common kind, accounting for 90% of cases. First-line therapy for women with epithelial ovarian cancer consists of a combination of cytoreductive surgery and platinum and taxane-based chemotherapy. However, more than 50% of women with epithelial ovarian cancer will experience a relapse and require further chemotherapy and at some point develop resistance to platinum-based drugs. Currently, guidance on the use of most chemotherapy drugs, including taxanes, is unclear for women whose epithelial ovarian cancer has recurred. Paclitaxel, topotecan, pegylated liposomal doxorubicin hydrochloride, trabectedin and gemcitabine are all licensed for use in the UK at the discretion of clinicians, following discussion with the women as to potential adverse effects. Taxanes can be given in once-weekly regimens (at a lower dose) or three-weekly regimens (at a higher dose), which may have differences in the severity of side effects and effectiveness. As relapsed disease suggests incurable disease, it is all the more important to consider side effects and the impact of treatment schedules, as well as quality of life, and not only the life-prolonging effects of treatment.; Objectives: To assess the efficacy and toxicity of different taxane monotherapy regimens for women with recurrent epithelial ovarian, tubal or primary peritoneal cancer.; Search Methods: We searched CENTRAL, MEDLINE and Embase, up to 22 March 2022. Other related databases and trial registries were searched as well as grey literature and no additional studies were identified. A total of 1500 records were identified.; Selection Criteria: We included randomised controlled trials of taxane monotherapy for adult women diagnosed with recurrent epithelial ovarian, tubal or primary peritoneal cancer, previously treated with platinum-based chemotherapy. We included trials comparing two or more taxane monotherapy regimens. Participants could be experiencing their first recurrence of disease or any line of recurrence.; Data Collection and Analysis: Two review authors screened, independently assessed studies, and extracted data from the included studies. The clinical outcomes we examined were overall survival, response rate, progression-free survival, neurotoxicity, neutropenia, alopecia, and quality of life. We performed statistical analyses using fixed-effect and random-effects models following standard Cochrane methodology. We rated the certainty of evidence according to the GRADE approach.; Main Results: Our literature search yielded 1500 records of 1466 studies; no additional studies were identified by searching grey literature or handsearching. We uploaded the search results into Covidence. After the exclusion of 92 duplicates, we screened titles and abstracts of 1374 records. Of these, we identified 24 studies for full-text screening. We included four parallel-group randomised controlled trials (RCTs). All trials were multicentred and conducted in a hospital setting. The studies included 981 eligible participants with recurrent epithelial ovarian cancer, tubal or primary peritoneal cancer with a median age ranging between 56 to 62 years of age. All participants had a WHO (World Health Organization) performance status of between 0 to 2. The proportion of participants with serous histology ranged between 56% to 85%. Participants included women who had platinum-sensitive (71%) and platinum-resistant (29%) relapse. Some participants were taxane pre-treated (5.6%), whilst the majority were taxane-naive (94.4%). No studies were classified as having a high risk of bias for any of the domains in the Cochrane risk of bias tool. We found that there may be little or no difference in overall survival (OS) between weekly paclitaxel and three-weekly paclitaxel, but the evidence is very uncertain (risk ratio (RR) of 0.94, 95% confidence interval (CI) 0.66 to 1.33, two studies, 263 participants, very low-certainty evi ence). Similarly, there may be little or no difference in response rate (RR of 1.07, 95% CI 0.78 to 1.48, two studies, 263 participants, very low-certainty evidence) and progression-free survival (PFS) (RR of 0.83, 95% CI 0.46 to 1.52, two studies, 263 participants, very low-certainty evidence) between weekly and three-weekly paclitaxel, but the evidence is very uncertain. We found differences in the chemotherapy-associated adverse events between the weekly and three-weekly paclitaxel regimens. The weekly paclitaxel regimen may result in a reduction in neutropenia (RR 0.51, 95% 0.27 to 0.95, two studies, 260 participants, low-certainty evidence) and alopecia (RR 0.58, 95% CI 0.46 to 0.73, one study, 205 participants, low-certainty evidence). There may be little or no difference in neurotoxicity, but the evidence was very low-certainty and we cannot exclude an effect (RR 0.53, 95% CI 0.19 to 1.45, two studies, 260 participants). When examining the effect of paclitaxel dosage in the three-weekly regimen, the 250 mg/m 2 paclitaxel regimen probably causes more neurotoxicity compared to the 175 mg/m 2 regimen (RR 0.41, 95% CI 0.21 to 0.80, one study, 330 participants, moderate-certainty evidence). Quality-of-life data were not extractable from any of the included studies.; Authors' Conclusions: Fewer people may experience neutropenia when given weekly rather than three-weekly paclitaxel (low-certainty evidence), although it may make little or no difference to the risk of developing neurotoxicity (very low-certainty evidence). This is based on the participants receiving lower doses of drug more often. However, our confidence in this result is low and the true effect may be substantially different from the estimate of the effect. Weekly paclitaxel probably reduces the risk of alopecia, although the rates in both arms were high (46% versus 79%) (low-certainty evidence). A change to weekly from three-weekly chemotherapy could be considered to reduce the likelihood of toxicity, as it may have little or no negative impact on response rate (very low-certainty evidence), PFS (very low-certainty evidence) or OS (very low-certainty evidence). Three-weekly paclitaxel, given at a dose of 175 mg/m 2 compared to a higher dose,probably reduces the risk of neurotoxicity.We are moderately confident in this result; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. A change to 175 mg/m 2 paclitaxel (from a higher dose), if a three-weekly regimen is used, probably has little or no negative impact on PFS or OS (very low-certainty evidence). (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Pathak, B. G., et al. (2023). "Effects of kangaroo mother care on maternal and paternal health: systematic review and meta-analysis." Bulletin of the World Health Organization 101(6): 391-402.
	Objective To investigate the effect of kangaroo mother care for low-birth-weight and preterm infants on parents' mental and physical health. Methods The Cochrane Central Register of Controlled Trials, Cochrane Register of Studies Online, PubMed, Web of Science, Scopus and EMBASE databases were searched on 16 January 2023 for randomized and quasi-randomized trials on kangaroo mother care. Records identified were screened independently by two reviewers. Pooled relative risks (RRs) are reported for categorical variables, and standardized mean differences (SMDs) or mean differences are reported for continuous variables. Evidence quality was assessed using the GRADE approach. Findings The search identified 30 studies involving 7719 preterm or low-birth-weight infants. There was high-certainty evidence that kangaroo mother care substantially reduced the risk of moderate-to-severe postpartum maternal depressive symptoms compared with no kangaroo mother care (RR: 0.76; 95% confidence interval, CI: 0.59 to 0.96). In addition, there was low-certainty evidence that kangaroo mother care reduced scores for maternal stress (SMD: -0.82; 95% CI: -1.32 to -0.32) and anxiety (SMD: -0.62; 95% CI: -1.01 to -0.23) and increased mother-infant attachment and bonding scores (SMD: 1.19; 95% CI: 0.27 to 2.10). Limited evidence indicated father-infant interactions may be improved, though no marked effect on paternal depression or stress was observed. No trial reported parental physical health outcomes. Conclusion Kangaroo mother care for preterm and low-birth-weight infants was associated with less postpartum maternal depression, stress and anxiety and better mother-infant attachment and bonding. More research is required to evaluate effects on paternal health.Copyright © 2023, World Health Organization. All rights reserved.

Patricia, A., et al. (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." PROSPERO International prospective register of systematic reviews.
	
Patten Rhiannon, K., et al. (2022). "High-intensity training elicits greater improvements in cardio-metabolic and reproductive outcomes than moderate-intensity training in women with polycystic ovary syndrome: a randomized clinical trial." Human Reproduction 37(5): 1018-1029.
	Study Question: Does 12 weeks of high-intensity interval training (HIIT) result in greater improvements in cardio-metabolic and reproductive outcomes compared to standard moderate-intensity continuous training (MICT) in women with polycystic ovary syndrome (PCOS)?; Summary Answer: HIIT offers greater improvements in aerobic capacity, insulin sensitivity and menstrual cyclicity, and larger reductions in hyperandrogenism compared to MICT.; What Is Known Already: Exercise training is recognized to improve clinical outcomes in women with PCOS, but little is known about whether HIIT results in greater health outcomes compared to standard MICT.; Study Design, Size, Duration: This was a two-armed randomized clinical trial enrolling a total of 29 overweight women with PCOS between May 2016 and November 2019.; Participants/materials, Setting, Methods: Women with PCOS aged 18-45 years were randomly assigned to 12 weeks of either MICT (60-75% peak heart rate, N = 14) or HIIT (>90% peak heart rate, N = 15), each completed three times per week. The primary clinical outcomes were aerobic capacity (VO2peak) and insulin sensitivity (euglycaemic-hyperinsulinaemic clamp). Secondary outcomes included hormonal profiles, menstrual cyclicity and body composition.; Main Results and the Role of Chance: Both HIIT and MICT improved VO2peak (HIIT; Δ 5.8 ± 2.6 ml/kg/min, P < 0.001 and MICT; Δ 3.2 ± 2 ml/kg/min, P < 0.001), however, the HIIT group had a greater improvement in aerobic capacity compared to MICT (β = 2.73 ml/kg/min, P = 0.015). HIIT increased the insulin sensitivity index compared to baseline (Δ 2.3 ± 4.4 AU, P = 0.007) and MICT (β = 0.36 AU, P = 0.030), and caused higher increases in sex hormone-binding globulin compared to MICT (β = 0.25 nmol/l, P = 0.002). HIIT participants were 7.8 times more likely to report improved menstrual cyclicity than those in the MICT group (odds ratio 7.8, P = 0.04).; Limitations, Reasons for Caution: This study has a small sample size and the findings of the effect of the exercise interventions are limited to overweight reproductive-aged women, who do not have any co-existing co-morbidities that require medication.; Wider Implications of the Findings: Exercise, regardless of intensity, has clear health benefits for women with PCOS. HIIT appears to be a more beneficial strategy and should be considered for promoting health and reducing cardio-metabolic risk in overweight women with PCOS.; Study Funding/competing Interest(s): This work was supported by a Project Support Grant from the Australian National Health and Medical Research Council (NHMRC) Centre for Research Excellence in PCOS. The authors have no conflicts of interest to disclose.; Trial Registration Number: ACTRN12615000242527.; Trial Registration Date: 19 February 2015.; Date of First Patient’s Enrolment: 27 May 2016. (© 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.)

Pavarini, N., et al. (2023). "Sexual function after energy-based treatments of women with urinary incontinence. A systematic review and meta-analysis." International Urogynecology Journal 34(6): 1139-1152.
	Introduction and Hypothesis: Urinary incontinence (UI) affects approximately 50% of adult women worldwide and is associated with declining sexual function (SF). Energy-based devices emerged as a minimally invasive alternative treatment. Nevertheless, their effect on sexuality is uncertain. We hypothesize that the UI energy treatment can lead to sexual function improvement.; Methods: A search was performed in PubMed, Cochrane Library, Web of Science, Embase, and Scopus for randomized clinical trials (RCTs) and nonrandomized studies of intervention, which treated incontinent women using energy, with UI and sexual function (SF) as outcomes. Severe comorbidities, pelvic organ prolapse (POP)> grade 2, and use of medication to treat UI or that affects SF were excluded. Quality assessment and meta-analysis were performed.; Results: From 322 articles, 11 RCTs were included for qualitative analysis. UI symptoms improved in all studies. Regarding SF, RCT with premenopausal women showed improvement in SF in the Er:Yag group (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 and Female Sexual Function Index). A prospective study showed improvement in SF independent of the grade of SUI. RF showed benefits for SF but was not superior to pelvic floor muscle training. One nonrandomized study of intervention with a High-Intensity Focused Electromagnetic Field showed significant improvement of SF in the Golombok Rust Inventory of Sexual Satisfaction total score, a decline in pain and dissatisfaction domains. Meta-analysis with 4 RCTs and 2 nonrandomized studies found no difference between groups (0.26 (95% CI -0.67 to 1.20, and -0.74 (95% CI -3.78 to 2.30) respectively).; Conclusions: This meta-analysis did not confirm that energy equipment improved the SF of women with UI. (© 2023. The International Urogynecological Association.)

Payne, L. (2023). "Non-Steroidal Anti-Inflammatory Drug (NSAID) Response and Central Sensitization of Pain in Women With Dysmenorrhea." ClinicalTrials.gov.
	Menstrual pain is the most common gynecological complaint and the leading cause of school and work absences in reproductive‐age girls and women. One of the primary treatments for menstrual pain is use of nonsteroidal anti‐inflammatory drugs (NSAIDs; over‐the‐counter medications such as naproxen, ibuprofen, or aspirin), although up to 18% of women do not get pain relief from these medications. One reason for this may be due to central sensitization of pain, which is when alterations in the central nervous system change how pain is processed in the brain and experienced. Determining the role of central sensitization in menstrual pain is important because central sensitization is associated with the development of chronic pain. Understanding the relationship between NSAID response and central sensitization is important because it could indicate women who may go on to develop chronic pain later in life. This study would directly address this question. Identifying women at risk for chronic pain would help target new treatments to this vulnerable group to ideally prevent pain from becoming chronic. This is particularly important for women in the military because the severity of menstrual pain is associated with missed work, such that in active‐duty military women, less than 4.4% with mild menstrual pain missed work, whereas 20.7% of women with moderate to severe menstrual pain missed work. Addressing the significant impact of menstrual pain for military women will help reducing suffering and potentially decrease the risk of developing future chronic pain problems in this population.

Pedro Lopez, d., et al. (2023). "Exercise effects on psychological distress in women living with polycystic ovary syndrome." PROSPERO International prospective register of systematic reviews.
	
Pedro, O., et al. (2023). "Evaluating the Efficacy of Non-Surgical Interventions for Dysmenorrhea in Adenomyosis: A Systematic Review and Network Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Peigné, M. (2023). "Ovulation induction and luteal phase support with GnRH agonists in in vitro fertilization." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: FOLLITROPIN BETA,Product Code: SUB12503MIG,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: 150I.U. / 0.18mL,Product Name: CORIFOLLITROPIN ALFA,Product Code: SUB01455MIG,Pharmaceutical Form: SOLUTION FOR INJECTION IN PRE‐FILLED SYRINGE,Other descriptive name: ,Strength: 150µg / 0.5mL,Product Name: CETRORELIX,Product Code: SUB07459MIG,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: 0.25mg,Product Name: FOLLITROPIN ALFA,Product Code: SUB12426MIG,Pharmaceutical Form: POWDER AND SOLVENT FOR SOLUTION FOR INJECTION,Other descriptive name: ,Strength: 75I.U.,Product Name: GANIRELIX,Product Code: SUB07883MIG,Pharmaceutical Form: SOLUTION FOR INJECTION IN PRE‐FILLED SYRINGE,Other descriptive name: ,Strength: 0.25mg / 0.5mL,Product Name: CHORIOGONADOTROPIN ALFA,Product Code: SUB12481MIG,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: 250µg,Product Name: FOLLITROPIN DELTA,Product Code: SUB178607,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: 72µg / 2.16mL,Product Name: SYNAREL 0,2 mg/dose, solution pour pulvérisation nasale,Product Code: PRD422901,Pharmaceutical Form: NASAL SPRAY, SOLUTION,Other descriptive name: ,Strength: Nafarelin 0.2mg,Product Name: PROGESTERONE,Product Code: SUB10076MIG,Pharmaceutical Form: VAGINAL CAPSULE, SOFT,Other descriptive name: ,Strength: 200mg,Product Name: DECAPEPTYL 0,1 mg, poudre et solvant pour solution injectable (S.C.),Product Code: PRD390681,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Triptorelin 100µg CONDITION: IVF (In vitro fertilization) or ICSI (intracytoplasmic sperm injection) protocol with embryo transfer planned on the same cycle. ; MedDRA version: 21.0Level: PTClassification code: 10080951Term: Assisted reproductive technologySystem Organ Class: 100000004865 MedDRA version: 21.0Level: PTClassification code: 10080951Term: Assisted reproductive technologySystem Organ Class: 100000004865 Therapeutic area: Phenomena and Processes [G] ‐ Biological Phenomena [G16] INCLUSION CRITERIA: Patients requiring conventional IVF or IVF with sperm injection (ICSI) from a partner or donor under the conditions defined by French law, after agreement by a multidisciplinary consultation meeting,Signed informed consent,Social security affiliation (excluding AME),Patients aged 18 to 39 included,First or second attempt at IVF or ICSI,BMI < 35 kg/m2,AMH > 1 ng/ml (= 7 pmol/L) and/or antral follicle count = 8,AMH <5 ng/ml and/or antral follicle count <40,Antagonist protocol (programmed or not),Treatment with recombinant FSH,Initial dose of recombinant FSH between 75 and 450 IU PRIMARY OUTCOME: Main Objective:Demonstrate an increase in the rate of live births after 22 weeks' amenorrhea (SA) per cycle with GnRH agonist induction and support compared with the reference protocol combining hCG induction and luteal support with exogenous vaginal progesterone. Primary end point(s):Live birth, defined as the presence of a live birth after 22 weeks. Twin pregnancies will be counted as one birth. Secondary Objective:Demonstrate improved embryo implantation rate with GnRH agonist induction and support versus hCG induction and luteal support with exogenous vaginal progesterone,Demonstrate an improvement in the rate of early pregnancy between induction and GnRH agonist support versus induction with hCG and luteal support with vaginal exogenous progesterone,Demonstrate improvement in clinical pregnancy rate between induction and GnRH agonist support versus hCG induction and luteal support with exogenous vaginal progesterone,Demonstrate a decrease in the rate of miscarriage per incipient pregnancy between induction and GnRH agonist support versus induction with hCG and luteal support with vaginal exogenous progesterone,Demonstrate an increase in the rate of progressive pregnancy at 12 weeks' amenorrhea (12 SA) per cycle with GnRH agonist induction and support compared with the reference protocol combining hCG induction and lu al support with exogenous vaginal progesterone,Compare the impact on obstetrical data of induction and support with GnRH agonist versus induction with hCG and luteal support with exogenous vaginal progesterone,Demonstrate a decrease in the rate of moderate to severe ovarian hyperstimulation syndrome, both early and late, with GnRH agonist induction and support versus hCG induction and luteal support with vaginal exogenous progesterone,To compare the evolution of corpora lutea in the luteal phase between initiation and support by GnRH agonist versus initiation by hCG and luteal support by exogenous vaginal progesterone,Evaluate the association of progesterone, estradiol, LH and hCG levels with pregnancies and miscarriages throughout follow‐up between induction and GnRH agonist support, and induction by hCG and luteal support by vaginal exogenous progesterone,Evaluate side effects between induction and GnRH agonist support versus induction with hCG and luteal support with vaginal exogenous progesterone,Compare embryonic development between triggering and support by GnRH agonist versus triggering by hCG and luteal support by exogenous vaginal progesterone. SECONDARY OUTCOME: Secondary end point(s):1. Embryo implantation defined by the presence of a gestational sac visible on the first ultrasound (5‐8 weeks) Secondary end point(s):10. All adverse events up to delivery Secondary end point(s):2. Early pregnancy defined by the presence of an hCG level > 10 IU/ml 14 days after oocyte retrieval. Secondary end point(s):3. Clinical pregnancy, defined by the presence of an intrauterine gestational sac with embryo showing cardiac activity on ultrasound for 5‐10 SA Secondary end point(s):4. Miscarriage before 12 weeks, defined by the cessation of development of an early pregnancy before 12 weeks. An early pregnancy is defined as having an hCG level > 10 IU/ml 14 days after oocyte retrieval. Secondary end point(s):5. Ongoing pregnancy, defined as the presence of an intrauterine sac with an embryo with cardiac activity visible on ultrasound between 11 WA and 13 WA + 6 days (first trimester ultrasound of pregnancy). Secondary end point(s):6. Pregnancy hypertension and its term of onset, pre‐eclampsia and its term of onset, gestational diabetes and its term of onset, term and mode of delivery, medical termination of pregnancy, late miscarriage (between 12 and 22 SA), fetal death in utero Secondary end point(s):7. Ovarian hyperstimulation syndrome defined as the presence of a moderate to severe syndrome, early and late. Early defined as the period before D10 post puncture and late defined as OHSS linked to pregnancy, according to the ABM reference system. Secondary end point(s):8. Level of progesterone, estradiol, LH and hCG on the day of the puncture and on D7 post puncture Secondary end point(s):9. Progesterone, estradiol, LH and hCG levels during follow‐up, presence of pregnancy and presence of miscarriage Secondary end point(s):Number of oocytes collected, number of mature oocytes, number of fertilized oocytes, number of embryos on the second day of development, number of blastocysts obtained, number of blastocysts transferred, number of blastocysts frozen

Peiru, L. and h. xia (2023). "The effectiveness of different acupuncture treatments in patients with polycystic ovarian syndrome: A network meta-analysis of randomized clinical trials." PROSPERO International prospective register of systematic reviews.
	
Pelit, A., et al. (2022). "Effects of health education and progressive muscle relaxation on vasomotor symptoms and insomnia in perimenopausal women: A randomized controlled trial." Patient Education and Counseling 105(11): 3279-3286.
	Objectives: This study aims to determine the effects of health education (HE) and progressive muscle relaxation (PMR), individually or combined, on vasomotor symptoms and insomnia in perimenopausal women.; Methods: This study is a single-center, pretest-posttest, randomized controlled trial with a factorial design. The research sample consists of 108 women who were randomly divided into three groups: HE + PMR group (n = 36), PMR group (n = 36) and control group (n = 36). 90 women completed the study. The data were collected in three steps by using instruments of Personal Information Form, Visual Analog Scale and a diary for vasomotor symptoms, Women's Health Initiative Insomnia Rating Scale.; Results: Hot flash and night sweats frequency and severity scores/24 h, the VAS scores for hot flashes and night sweats, and the WHIIRS scores significantly improved more in the intervention groups compared to the control group (p &lt; 0,05). Compared to the group PMR, the group PMR + HE had a greater improvement with larger effect size in all measurements.; Conclusions: PMR and HE counseling by nurses benefit perimenopausal women who suffer from insomnia and vasomotor symptoms.; Practice Implications: PMR combined with HE or PMR alone is effective in managing vasomotor symptoms and insomnia; therefore, they can easily be integrated into clinical practice.; Competing Interests: Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. (Copyright © 2022 Elsevier B.V. All rights reserved.)

Peng, J., et al. (2023). "Whether exercise or cognitive behavioral therapy is more effective in improving postpartum depression and its optimal dose: a meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Peng, J., et al. (2021). "Effect assessment of laparoscopy in combination with traditional Chinese medicine decoction in the treatment of endometriosis: A protocol for systematic review and meta-analysis." Medicine 100(29): e26699.
	Background: Endometriosis (EMs) affects about 10% of women of childbearing age. It is defined as functional endometrial tissue appearing in other parts of the uterine cavity, manifested by varying degrees of pelvic pain and pelvic mass, etc. Therefore, to improve the therapeutic effect of endometriosis, we must constantly explore new ways to treat the disease. The purpose of this study is to evaluate the effectiveness and safety of the combined use of laparoscopy and traditional Chinese medicine in the treatment of patients with EMs.; Methods: A systematic literature search will be conducted at China National Knowledge Infrastructure, WanFang databases, VIP, SinoMed, PubMed, Embase, Web of Science, and the Cochrane library. The search period limit is from the time the date of database establishment to June 21, 2021. To ensure the comprehensiveness of the search, relevant references and conference literature are also included. The risk of bias in the final included studies will be evaluated based on the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions. The RevMan software will be employed to perform data synthesis and statistical analysis.; Results: The effectiveness and safety of laparoscopic surgery combined with traditional Chinese medicine decoction in the treatment of patients with EMs will be systematically evaluated.; Conclusion: The results of this study will provide strong evidence for judging whether laparoscopy combined with traditional Chinese medicine decoction is an effective strategy for the treatment of patients with EMs.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Peng, L., et al. (2019). "Magnetic stimulation for female patients with stress urinary incontinence, a meta-analysis of studies with short-term follow-up." Medicine 98(19): e15572.
	Background: To determine the efficacy of magnetic stimulation (MS) in female patients with stress urinary incontinence (SUI) by performing a meta-analysis on peer-reviewed randomized controlled trails (RCTs). Method(s): PubMed, Embase, and Cochrane library were retrieved for any peer-reviewed original articles in English. Databases were searched up to July 2018. Included studies investigated effects of MS on SUI. The data were analyzed by review manager 5.3 software (Cochrane Collaboration, Oxford, UK). Result(s): A total of 4 studies involving 232 patients were identified and included in present meta-analysis. Compared with the sham stimulation, the MS group had statistically significantly fewer leaks/3 days (MD=-1.42; 95%CI: -2.42 to -0.59; P=.007), less urine loss on pad test (g.)/24h (MD=-4.99; 95%CI: -8.46 to -1.53; P=.005), higher QoL scores (MD=0.42; 95%CI: 0.02-0.82; P=.009), and lower ICIQ scores (MD=-4.60; 95%CI: -5.02 to -4.19; P<.001). MS presented higher cure or improvement rate, with a statistically significant improvement in UDI and IIQ-SF scores compared to sham stimulation. No MS-related adverse effects were reported in study. Conclusion(s): MS leads to an improvement in SUI without any reported safety concerns and an improvement in patient quality of life. The long-term outcome of this technique remains unclear and is the subject of ongoing research.Copyright © 2019 the Author(s).

Peng, Y., et al. (2022). "Effectiveness and Safety of Two Consecutive Cycles of Single Embryo Transfer Compared With One Cycle of Double Embryo Transfer: A Systematic Review and Meta-Analysis." Frontiers in Endocrinology 13: 920973.
	OBJECTIVE: To date, evidence regarding the effectiveness and safety of two consecutive cycles of single embryo transfer (2SETs) compared with one cycle of double embryo transfer (DET) has been inadequate, particularly considering infertile women with different prognostic factors. This study aimed to comprehensively summarize the evidence by comparing 2SETs with DET. METHODS: PubMed, Embase, Cochrane Library databases, ClinicalTrails.gov, and the WHO International Clinical Trials Registry Platform were searched up to March 22, 2022. Peer-reviewed, English-language randomized controlled trials (RCTs) and observational studies (OS) comparing the outcomes of 2SETs with DET in infertile women with their own oocytes and embryos were included. Two authors independently conducted study selection, data extraction, and bias assessment. The Mantel-Haenszel random-effects model was used for pooling RCTs, and a Bayesian design-adjusted model was conducted to synthesize the results from both RCTs and OS. MAIN RESULTS: Twelve studies were finally included. Compared with the DET, 2SETs were associated with a similar cumulative live birth rate (LBR; 48.24% vs. 48.91%; OR, 0.97; 95% credible interval (CrI), 0.89-1.13, τ2 = 0.1796; four RCTs and six observational studies; 197,968 women) and a notable lower cumulative multiple birth rate (MBR; 0.87% vs. 17.72%; OR, 0.05; 95% CrI, 0.02-0.10, τ2 = 0.1036; four RCTs and five observational studies; 197,804 women). Subgroup analyses revealed a significant increase in cumulative LBR (OR, 1.33; 95% CrI, 1.29-1.38, τ2 = 0) after two consecutive cycles of single blastocyst transfer compared with one cycle of double blastocyst transfer. Moreover, a lower risk of cesarean section, antepartum hemorrhage, preterm birth, low birth weight, and neonatal intensive care unit admission but a higher gestational age at birth and birth weight were found in the 2SETs group. CONCLUSION: Compared to the DET strategy, 2SETs result in a similar LBR while simultaneously reducing the MBR and improving maternal and neonatal adverse outcomes. The 2SETs strategy appears to be especially beneficial for women aged ≤35 years and for blastocyst transfers.

Peng, Y., et al. (2022). "Meta analysis of the effect of phloroglucinol combined with progesterone in the treatment of threatened miscarriage before 20 weeks of gestation: A protocol for a systematic review." Medicine 101(47): e31885.
	Background: Threatened miscarriage (TM) is an important factor endangering the health of pregnant women. It not only affects women's physical and mental health, but also destroys family happiness. To treat this disease, it is necessary to find a treatment with better clinical efficacy and fewer side effects. The purpose of this systematic study was to evaluate the efficacy and safety of phloroglucinol (PHL) combined with progesterone in the treatment of TM before 20 weeks of pregnancy.; Methods: Electronic databases (EMBASE, PubMed, Cochrane Central Register of Controlled Trials, Web of Science, Elsevier, China National Knowledge Infrastructure, Chongqing VIP, and WanFang Data) were searched from inception until September. 2022. Randomized controlled trials of PHL combined with progesterone in the treatment of TM before 20 weeks of gestation will be included, and all articles will be independently screened and collected by 2 reviewers. Revman 5.3.5 software will be used for meta-analysis. The specific process is described in the Cochrane Handbook for Systematic Reviews.; Results: The efficacy and safety of PHL combined with progesterone for the treatment of threatened abortion were comprehensively evaluated in terms of efficacy, efficiency, time of symptom relief, length of hospital stay, and incidence of adverse events.; Conclusion: This study provides reliable evidence for the clinical application of PHL combined with progesterone for the treatment of TM.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Pereira, R., et al. (2023). "Multicomponent recreational team handball training improves global health status in postmenopausal women at the long term - A randomised controlled trial." European Journal of Sport Science 23(8): 1789-1799.
	We studied the long-term effects of a multicomponent exercise training protocol (recreational team handball training, RTH) on global health status in inactive postmenopausal women. Participants ( n = 45; age 65 ± 6 years, stature 157 ± 6 cm, body mass 66.2 ± 9.4 kg, fat mass 41.4 ± 5.5%, VO 2peak 25.7 ± 3.6 mL/min/kg) were randomised into a control group (CG; n = 14) and a multicomponent exercise training group (EXG; n = 31, performing two to three weekly 60-min RTH sessions). Attendance was 2.0 ± 0.4 sessions/week (first 16 weeks) and 1.4 ± 0.5 (following 20 weeks) and mean heart rate (HR) loading was 77 and 79% of maximal HR ( p = .002) for the first 16 and the following 20 weeks, respectively. Cardiovascular, bone, metabolic health, body composition and physical fitness markers were evaluated at baseline, and after 16 and 36 weeks . An interaction ( p ≤ .046) was shown for the 2-h oral glucose tolerance test, HDL, Yo-Yo intermittent endurance level 1 test (YYIE1) and knee strength, in favour of EXG. At 36 weeks, YYIE1 and knee strength were higher ( p ≤ .038) for EXG vs CG. Also, within-group improvements ( p ≤ .043) were observed after 36 weeks for EXG in VO 2peak , lumbar spine bone mineral density, lumbar spine bone mineral content, P1NP, osteocalcin, total cholesterol, HDL, LDL, body mass, android fat mass, YYIE1, knee strength, handgrip strength and postural balance. At 36 comparatively to 16 weeks, EXG showed an increase ( p ≤ .036) in fasting blood glucose, HDL, knee strength and handgrip strength, and a decrease ( p ≤ .025) in LDL. Collectively, this multicomponent exercise training (RTH) induces beneficial changes in global health status in postmenopausal women. Highlights We evaluated the long-term effects of a recreational team handball-based multicomponent training on broad-spectrum health and physical fitness markers of inactive postmenopausal women.Improvements in VO 2peak and aerobic performance achieved after 16 weeks of training were maintained at 36 weeks.The 20-week extension of the training intervention resulted in further improvements in lipid profile markers and physical fitness variables.Recreational team handball could be suggested as an effective and safe strategy to counteract postmenopausal health-related constrains.

Pérez-López Faustino, R., et al. (2019). "Systematic review and meta-analysis of the effects of treatment modalities for vestibulodynia in women." The European Journal of Contraception & Reproductive Health Care 24(5): 337-346.
	Objective: To quantify the effects of available treatments of vestibulodynia. Methods: Systematic review of randomised controlled trials (RCTs) in six search engines until December 2018, comparing any intervention vs. placebo or sham in women with vestibulodynia. Primary outcome was dyspareunia assessed with visual analogue (VAS) or numeric rating (NRS) scales. Secondary outcomes were daily vestibular symptoms (DVS), McGill Pain Questionnaire (MPQ) and Index of Sexual Satisfaction (ISS). Effects were described as mean differences (MDs) with their 95% confidence intervals (CIs). Traditional and frequentist network meta-analyses (NMA) were performed using random effect models. Results: Four RCTs ( n = 275) were included evaluating vaginal cream of conjugated oestrogens, oral desipramine with or without topical lidocaine, topical lidocaine, laser therapy and transcranial direct current. In traditional MA, interventions did not reduce dyspareunia (MD = 0.08; 95%CI = -0.49 to 0.64), DVS (MD = -0.04; 95%CI = -0.31 to 0.24; 4 interventions), or MPQ (MD = -0.17; 95%CI = -2.16 to 1.81; 4 interventions). ISS was significantly improved (MD = -5.14; 95%CI = -9.52 to -0.75). In NMA, oral desipramine with or without lidocaine significantly improved ISS vs. other treatments. Conclusions: Several existing interventions were not associated with improvements in vestibulodynia. There only was improvement of sexual function with oral desipramine with or without lidocaine.

Pergialiotis, V., et al. (2023). "Survival Outcomes of Epithelial Ovarian Cancer Patients Following Dose-dense Versus 3-Weekly Platinum-Paclitaxel Chemotherapy: A Meta-Analysis." Clinical Oncology 35(2): e189-e198.
	Aims: Dose-dense chemotherapy has proven its value in several cancer fields. The purpose of the present systematic review is to evaluate the impact of dose-dense chemotherapy on survival outcomes of epithelial ovarian cancer patients.; Materials and Methods: Medline, Scopus, the Cochrane Central Register of Controlled Trials CENTRAL, Google Scholar and Clinicaltrials.gov databases were searched for relevant articles. Effect sizes were calculated in Rstudio using the meta and metafor functions. A sensitivity analysis was carried out to evaluate the possibility of small study effects and P-hacking. The methodological quality of the included studies was assessed using Risk of Bias 2 (RoB2) and Risk of Bias in non-Randomized Trials (RoBINS) tools.; Results: Overall, 12 studies were included in the present systematic review, involving 4979 epithelial ovarian cancer patients. The risk of recurrence was substantially improved in patients receiving dose-dense chemotherapy (hazard ratio 0.82, 95% confidence interval 0.70, 0.96); however, the result of the meta-analysis may be attributed to the effect size of smaller studies as following adjustment for small study effects the outcome becomes non-significant (hazard ratio 0.91, 95% confidence interval 0.81, 1.02, P = 0.123). Overall survival rates were not improved by dose-dense chemotherapy (hazard ratio 0.79, 95% confidence interval 0.60, 1.04). Thirty-five types of adverse effect were identified following retrieval of data from the original studies. Dose-dense chemotherapy did not increase significantly the rates of severe adverse effects, although thrombosis, severe diarrhoea and severe nausea were more prevalent in this group of patients.; Conclusion: Dose-dense chemotherapy is associated with comparable side-effects to those of standard chemotherapy; however, data related to survival outcomes are not positive; hence, its use outside the setting of clinical trials should be discouraged. (Copyright © 2022 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.)

Perkins, R., et al. (2023). "Online songwriting reduces loneliness and postnatal depression and enhances social connectedness in women with young babies: randomised controlled trial." Public Health 220: 72-79.
	Objective: Loneliness is a public health challenge associated with postnatal depression (PND). This study developed and tested an online songwriting intervention, with the aim of reducing loneliness and symptoms of PND and enhancing social connectedness among women with young babies.; Study Design: This was a two-armed non-blinded randomised controlled trial (RCT, ISRCTN17647261).; Methods: Randomisation was conducted in Excel using a 1:1 allocation, with participants (N = 89) allocated to an online 6-week songwriting intervention (Songs from Home) or to waitlist control. Inclusion criteria were women aged ≥18 years, with a baby ≤9 months old, reporting loneliness (4+ on UCLA 3-Item Loneliness Scale) and symptoms of PND (10+ on Edinburgh Postnatal Depression Scale [EPDS]). Loneliness (UCLA-3) was measured at baseline, after each intervention session and at 4-week follow-up. The secondary measures of PND (EPDS) and social connectedness (Social Connectedness Revised 15-item Scale [SC-15]) were measured at baseline, postintervention and at 4-week follow-up (Week 10). Factorial mixed analyses of variance with planned custom contrasts were conducted for each outcome variable comparing the intervention and control groups over time and across baseline, Weeks 1-6 and the follow-up at Week 10 for each outcome variable.; Results: Compared with waitlist control, the intervention group reported significantly lower scores postintervention and at follow-up for loneliness (P < 0.001, η 2 P = 0.098) and PND (P < 0.001, η 2 P = 0.174) and significantly higher scores at follow-up for social connectedness (P < 0.001, η 2 P = 0.173).; Conclusions: A 6-week online songwriting intervention for women with young babies can reduce loneliness and symptoms of PND and increase social connectedness. (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Perrone Anna, M. (2022). "Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer." ClinicalTrials.gov.
	Patients with vulvar cancer who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy), or patients not eligible for standard therapies. The study aims to: ‐ Evaluate the oncology response to electroporation after administration of Bleomycin (BLM) + carboplatinum (CBP )to BLM alone in terms of local progression‐free survival (LPFS) in women with relapsed vulvar cancer after multimodal treatments. ‐ Compare quality of life (HR‐QoL) in the two groups of patients with questionnaires (FACT‐V, FACT‐PAL, E5‐5L‐D5). ‐ To compare Overall Survival in the two study arms. ‐ To compare local and systemic toxicity, morbidity and mortality, intraoperative and post‐operative complications among the two study arms. ‐ To compare costs and cost‐effectiveness between the two study arms.

Pessoa Lisieux de Lourdes Martins, N., et al. (2021). "Efficacy and Safety of Laser Therapy for the Treatment of Genitourinary Syndrome of Menopause: A Protocol for Systematic Review and Meta-Analysis of Clinical Trials." Frontiers in Reproductive Health 3: 772690.
	Laser therapy has been proposed to improve the symptoms of genitourinary syndrome of menopause (GSM), especially in women who do not accept hormonal therapy or are at a high risk of complications if they undergo hormonal therapy. However, studies evaluating the effectiveness and safety of laser treatment for GSM have shown controversial results. Thus, we aimed to determine the efficacy and safety of laser therapy in post-menopausal women with GSM. We have developed a protocol according to the Preferred Reporting Items for Systematic Review and Meta-analysis Protocol using the population, intervention, comparison, outcome, and study design (PICOS) framework for post-menopausal women who have received no treatment, laser therapy, placebo, or vaginal estrogen for GSM. As per our protocol, randomized controlled trials and quasi-randomized trials, regardless of language of publication, will be searched in PubMed, Embase, Scopus, Web of Science, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, and clinicaltrials.gov. Gray literature will be searched in Open Gray and Google Scholar. The reference lists will be scanned for additional trials, and the authors will be contacted if necessary. Outcome data reported in a trial registry, even when no published results were available, will be analyzed. The search will be performed using key terms, such as "post-menopausal women," "menopausal genitourinary syndrome," "vulvovaginal atrophy," and "laser therapy." Two review authors will independently screen the titles and abstracts, while three others will independently evaluate the full text of each study to determine its eligibility for this systematic review (SR). Any disagreement will be resolved through discussion and consensus. Data extraction will be performed independently using a standardized data collection form. Clinical outcomes, including vaginal atrophy, vaginal pH, dryness, dyspareunia, itching, burning, dysuria, urinary frequency, urinary urgency, and urinary incontinence, will be systematically evaluated. We will not perform a separate search for adverse effects; instead, we will consider the adverse effects described in the included studies. Furthermore, we will summarize the effects of dichotomous outcomes as risk ratios with 95% confidence intervals. On the other hand, continuous outcomes will be summarized by expressing treatment effects as a mean difference with standard deviation or as a standardized mean difference when different scales were used to measure the same outcome. We will use the Cochrane Risk of Bias 2 tool for bias assessment and the Grading of Recommendations Assessment, Development and Evaluation approach to rate the overall certainty of evidence. Review Manager 5.3.5 will be used for quantitative data synthesis, subgroup analysis, sensitivity analysis, meta-regression, and risk of bias assessment. The SR findings will provide highly relevant evidence through the synthesis of well-designed and robust clinical trials on the effectiveness and safety of laser therapy in GSM. The Prospective Register of Systematic Reviews (PROSPERO) registration number (2021) of the SR is CRD42021253605.; 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 Pessoa, Sarmento, Medeiros, Costa, Gonçalves and Cobucci.)

Peter, O. and O. Oluwatobi (2023). "Efficacy and safety of Ibrexafungerp in the treatment of vulvovaginal candidiasis: a systematic review and meta – analysis." PROSPERO International prospective register of systematic reviews.
	
Peters Inge, T. A., et al. (2023). "Cytoreductive surgery for advanced epithelial ovarian cancer in the poly(ADP-ribose) polymerase inhibitors era-Is it time for a new paradigm shift? A systematic review and meta-analysis." European Journal of Cancer 187: 77-86.
	Introduction: In patients with newly diagnosed advanced high-grade serous and endometrioid epithelial ovarian cancer (EOC) first-line maintenance therapy with poly(ADP-ribose) polymerase inhibitors (PARPi) tremendously improved progression-free survival (PFS). Yet, data on the effect of PARPi in proportion to postoperative residual disease status were lacking.; Material and Methods: A systematic review and meta-analysis was conducted in accordance with the Preferred Reporting Items of Systematic reviews and Meta-Analysis (PRISMA) guidelines. We searched Medline/Pubmed, Embase and Cochrane databases as well as meeting abstracts until 18th March 2023. Hazard ratios (HRs) alongside their 95% confidence intervals (CIs) for PFS were extracted from the studies. A subgroup analysis was conducted to examine the effect of PARPi according to postoperative residual disease.; Results: A total of six phase III randomised controlled trials were included and comprised SOLO 1, PAOLA 1, PRIMA, PRIME, ATHENA-MONO and VELIA. Patients who received PARPi following complete gross resection showed greatest PFS benefit. Compared with placebo, maintenance with PARPi significantly improved PFS in patients with macroscopic residual disease (pooled HR 0.55; 95% CI 0.44-0.68). This magnitude was comparable to that found in patients with complete gross resection (pooled HR 0.53; 95% CI 0.41-0.67).; Conclusions: Patients with macroscopic residual disease benefit from PARPi at the same extent as cases with complete gross resection. However, patients with complete gross resection who were treated with PARPi show the most favourable PFS rates. Hence, the pursuit of achieving complete cytoreduction remains valid in the PARPi era.; 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 Ltd. All rights reserved.)

Peters, K. (2021). "BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder." ClinicalTrials.gov.
	Overactive bladder (OAB) is a common and often debilitating condition in both men and women. OAB symptoms including urinary frequency, urgency, and/or urge incontinence (UI), have been found to negatively impact quality of life. Due to side effects and the lack of patient compliance to pharmacologic treatments for OAB, non‐pharmacologic treatments are in high demand for this condition. Neuromodulation therapies have become increasingly popular for the treatment of overactive bladder in men and women. These neuromodulation therapies work in treating OAB by stimulating the pudendal nerve. The BTL EmsellaTM (Emsella Chair) is a conservative neuromodulation therapy that may have a role for patients who are not surgical candidates or who desire a noninvasive treatment option. The ideal treatment for OAB is still lacking. Many patients are interested in pursuing conservative treatment options. The Emsella chair may have a role for patient who do not desire surgery found with SNM or desire a noninvasive treatment option. The Emsella chair is approved as a treatment for stress urinary incontinence (SUI). Overactive bladder patients may benefit from treatment. The Emsella chair generates electromagnetic stimulation which is able to penetrate deep into the pelvic floor muscles inducing stimulation and providing rehabilitation for weak pelvic floor muscles. The Emsella chair is a novel high‐intensity focused electromagnetic (HIFEM) technology for the treatment of SUI, in addition to other pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes.

Peters Pamela, N., et al. (2022). "Cost-effectiveness of management strategies for patients with recurrent ovarian cancer and inoperable malignant bowel obstruction." Gynecologic Oncology 167(3): 523-531.
	Objectives: Patients with recurrent platinum-resistant ovarian cancer often present with inoperable malignant bowel obstruction (MBO) from a large burden of abdominal disease. Interventions such as total parenteral nutrition (TPN) and chemotherapy may be used in this setting. We aim to describe the relative cost-effectiveness of these interventions to inform clinical decision making.; Methods: Four strategies for management of platinum-resistant recurrent ovarian cancer with inoperable MBO were compared from a societal perspective using a Monte Carlo simulation: (1) hospice, (2) TPN, (3) chemotherapy, and (4) TPN + chemotherapy. Survival, hospitalization rates, end-of-life (EOL) setting, and MBO-related utilities were obtained from literature review: hospice (survival 38 days, 6% hospitalization), chemotherapy (42 days, 29%), TPN (55 days, 25%), TPN + chemotherapy (74 days, 47%). Outcomes were the average cost per strategy and incremental cost-effectiveness ratios (ICERs) in US dollars per quality-adjusted life year (QALY) gained.; Results: In the base case scenario, TPN + chemotherapy was the most costly strategy (mean; 95% CI) ($49,741; $49,329-$50,162) and provided the highest QALYs (0.089; 0.089-0.090). The lowest cost strategy was hospice ($14,591; $14,527-$14,654). The TPN alone and chemotherapy alone strategies were dominated by a combination of hospice and TPN + chemotherapy. The ICER of TPN + chemotherapy was $918,538/QALY compared to hospice. With a societal willingness to pay threshold of $150,000/QALY, hospice was the strategy of choice in 71.6% of cases, chemotherapy alone in 28.4%, and TPN-containing strategies in 0%.; Conclusions: TPN with or without chemotherapy is not cost-effective in management of inoperable malignant bowel obstruction and platinum-resistant ovarian cancer.; Competing Interests: Declaration of Competing Interest S.E.B. serves in an unpaid position as President of the Mid-Atlantic Society for Parenteral and Enteral Nutrition (MASPEN). S.B. participates as a study team member in a clinical trial sponsored by Baxter Nutrition, which includes provision of a parenteral nutrition product. B.A.D. serves in a paid position on the advisory board of GlaxoSmithKline (GSK). All other authors declare that they have no relevant conflicts of interest to disclose. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Peters William, A., et al. (2023). "Concurrent Chemotherapy and Pelvic Radiation Therapy Compared With Pelvic Radiation Therapy Alone as Adjuvant Therapy After Radical Surgery in High-Risk Early-Stage Cancer of the Cervix." Journal of Clinical Oncology 41(29): 4605-4612.
	Purpose: To determine whether the addition of cisplatin-based chemotherapy (CT) to pelvic radiation therapy (RT) will improve the survival of early-stage, high-risk patients with cervical carcinoma.; Patients and Methods: Patients with clinical stage IA 2 , IB, and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes and/or positive margins and/or microscopic involvement of the parametrium were eligible for this study. Patients were randomized to receive RT or RT + CT. Patients in each group received 49.3 GY RT in 29 fractions to a standard pelvic field. Chemotherapy consisted of bolus cisplatin 70 mg/m 2 and a 96-hour infusion of fluorouracil 1,000 mg/m 2 /d every 3 weeks for four cycles, with the first and second cycles given concurrent to RT.; Results: Between 1991 and 1996, 268 patients were entered onto the study. Two hundred forty-three patients were assessable (127 RT + CT patients and 116 RT patients). Progression-free and overall survival are significantly improved in the patients receiving CT. The hazard ratios for progression-free survival and overall survival in the RT only arm versus the RT + CT arm are 2.01 ( P = .003) and 1.96 ( P = .007), respectively. The projected progression-free survivals at 4 years is 63% with RT and 80% with RT + CT. The projected overall survival rate at 4 years is 71% with RT and 81% with RT + CT. Grades 3 and 4 hematologic and gastrointestinal toxicity were more frequent in the RT + CT group.; Conclusion: The addition of concurrent cisplatin-based CT to RT significantly improves progression-free and overall survival for high-risk, early-stage patients who undergo radical hysterectomy and pelvic lymphadenectomy for carcinoma of the cervix.

Petrelli, F., et al. (2023). "Treatments for relapsed, BRCA-wild type, platinum-sensitive ovarian cancer: A systematic review and network meta-analysis." Cancer Treatment Reviews 118: 102571.
	Introduction: Although platinum-based chemotherapy (CT) is considered the standard treatment for relapsed platinum-sensitive ovarian cancer, there is currently no standard treatment for these patients. We compared the effectiveness of modern and older therapies in relapsed platinum-sensitive, BRCA-wild type, and ovarian cancers using a network meta-analysis (NMA).; Methods: A systematic search of PubMed, EMBASE, and Cochrane Library was performed up to October 31, 2022. Randomized controlled trials (RCT) that compared different second-line approaches were included. The primary endpoint was overall survival (OS) and the secondary endpoint was progression-free survival (PFS).; Results: In total, 17 RCTs (n = 9405) comparing various strategies were included. The risk of death was significantly decreased with carboplatin + pegylated liposomal doxorubicin + bevacizumab compared to platinum-based doublet CT (hazard ratio [HR] = 0.59, 95%CI 0.35, 1). Various strategies, including secondary cytoreduction followed by platinum-based CT, carboplatin + pegylated liposomal doxorubicin + bevacizumab, and platinum-based CT with bevacizumab or cediranib, were better than platinum-based doublets alone for PFS.; Conclusions: This NMA showed that carboplatin + pegylated liposomal doxorubicin + bevacizumab seems to increase the efficacy of standard second-line CT. These strategies can be considered when treating patients with relapsed platinum-sensitive ovarian cancer without BRCA mutations. This study provides systematic comparative evidence for the efficacy of different second-line therapies for relapsed ovarian cancer.; 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 Ltd. All rights reserved.)

Pfisterer, J., et al. (2023). "Optimal Treatment Duration of Bevacizumab as Front-Line Therapy for Advanced Ovarian Cancer: AGO-OVAR 17 BOOST/GINECO OV118/ENGOT Ov-15 Open-Label Randomized Phase III Trial." Journal of Clinical Oncology 41(4): 893-902.
	Purpose: To compare standard versus extended duration of bevacizumab treatment in combination with front-line chemotherapy in women with newly diagnosed stage IIB-IV ovarian cancer.; Methods: In this multicenter, open-label, randomized phase III trial (ClinicalTrials.gov identifier: NCT01462890), patients with newly diagnosed International Federation of Gynecology and Obstetrics stage IIB-IV epithelial ovarian, fallopian tube, or peritoneal cancer underwent primary cytoreductive surgery followed by six cycles of chemotherapy (paclitaxel 175 mg/m 2 plus carboplatin area under the curve 5 once every 3 weeks) and bevacizumab (15 mg/kg once every 3 weeks). Patients were randomly assigned 1:1 to receive bevacizumab for either 15 or 30 months, stratified by International Federation of Gynecology and Obstetrics stage/residual tumor. The primary end point was investigator-assessed progression-free survival (PFS) according to RECIST version 1.1. Secondary end points included overall survival (OS), safety, and tolerability.; Results: Between November 11, 2011, and August 6, 2013, 927 women were randomly assigned. There was no difference in PFS between treatment arms (hazard ratio, 0.99; 95% CI, 0.85 to 1.15; unstratified log-rank P = .90). Median PFS was 24.2 versus 26.0 months with standard versus extended duration of bevacizumab, respectively; restricted mean PFS was 39.5 versus 39.3 months, respectively. There was no OS difference between treatment arms (hazard ratio, 1.04; 95% CI, 0.87 to 1.23; P = .68). Serious/nonserious adverse events of special interest occurred in 29% versus 34% of patients in the standard versus experimental arms, respectively, and were consistent with the known safety profile of standard bevacizumab.; Conclusion: Longer treatment duration with bevacizumab for up to 30 months did not improve PFS or OS in patients with primary epithelial ovarian, fallopian tube, or peritoneal cancer. A bevacizumab treatment duration of 15 months remains the standard of care.

Pham, C., et al. (2023). "Cost-effectiveness modelling of three different hysterosalpingography diagnostic strategies in addition to standard fertility management for couples with unexplained infertility in the United Kingdom." Human Fertility 26(1): 97-106.
	Previous studies have demonstrated hysterosalpingography (HSG) in general, and specifically with an oil-soluble contrast medium, directly increases pregnancy rates. Decision modelling was performed to compare fertility management using three HSG diagnostic strategies: (i) water-soluble contrast medium (WSCM)-HSG; (ii) Lipiodol Ultra Fluid (LUF)-HSG; and (iii) No HSG, for women aged <=39 years with unexplained infertility. Four reimbursement scenarios were modelled to reflect the various funding arrangements across the regions of the United Kingdom. Compared with WSCM-HSG, the live birth rates after 24 months increased by 3.4% with LUF-HSG and decreased by 2.7% with no HSG. From a patient perspective, fertility management with LUF-HSG is the most cost-effective strategy with cost-savings ranging from 299 to 857 per patient depending on the funding arrangement for IVF. From an NHS perspective, fertility management with LUF-HSG is cost-effective when 2 or more IVF cycles are NHS-funded. If none of the IVF cycles are NHS-funded, fertility management with LUF-HSG can be considered cost-effective if society is willing to pay 8,353 for an additional live birth. The findings from this analysis suggest that fertility management with WSCM-HSG is cost-effective compared to no HSG and LUF-HSG is the most cost-effective with increased live birth rates after 24 months.Copyright © 2021 The British Fertility Society.

Phan, Z., et al. (2023). "DNA repair biomarkers to guide usage of combined PARP inhibitors and chemotherapy: a meta-analysis and systematic review." MedRxiv.
	Purpose The addition of PARP inhibitors to chemotherapy has been assessed in ~80 clinical trials across multiple malignancies, on the premise that PARP inhibitors will increase chemotherapy effectiveness regardless of whether cancers have underlying disruption of DNA repair pathways. Consequently, the majority of combination therapy trials have been performed on patients without biomarker selection, despite the use of homologous recombination deficiency to dictate use of PARP inhibitors in the maintenance setting. An unresolved question is whether biomarkers are needed to identify patients who respond to combination PARP inhibitors and chemotherapy. Methods A systematic literature review identified studies using PARP inhibitors in combination with chemotherapy versus chemotherapy alone, where the study included a biomarker of DNA repair function (BRCA1, BRCA2, BRCAPRO, ATM, ERCC1, SFLN11). Hazard ratios (HR) were pooled in a meta-analysis using generic inverse-variance and fixed or random effects modelling. Subgroup analyses were conducted on biomarker selection and type of malignancy. Results Nine studies comprising 2,084 patients met the inclusion criteria. Progression-free survival (PFS) was significantly better in patients with a DNA repair biomarker (HR 0.52, 95% confidence interval (CI) 0.43-0.63; p < 0.00001), but there was no benefit in patients who lacked a biomarker (HR 0.94, 95% CI 0.82-1.08; p = 0.38). Subgroup analysis showed that BRCA mutation and SFLN11 biomarkers could predict benefit, and biomarker-driven benefit occurred in ovarian, breast and small cell lung cancers. The addition of PARP inhibitors was associated with increased grade 3/4 side effects, and particularly neutropenia. Conclusions Combination therapy only increases PFS in patients with identifiable DNA repair biomarkers. This indicates that PARP inhibitors do not sensitise patients to chemotherapy treatment, except where their cancer has a homologous recombination defect, or an alternative biomarker of altered DNA repair. While effective in patients with DNA repair biomarkers, there is a risk of high-grade haematological side-effects with the use of combination therapy. Thus, the benefit in PFS from combination therapy must be weighed against potential adverse effects, as individual arms of treatment can also confer benefit (Image Presented).Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.

Pharmiva, A. B. (2021). "Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis." ClinicalTrials.gov.
	No Results Available Device: D005 Vaginal Mousse|Other: Placebo Clinical cure rate|Modified Hay/Ison <grade III at Visit 2|Modified Hay/Ison <grade III at Visit 3|Clinical cure + Modified Hay/Ison <grade III at Visit 2|Clinical cure + Modified Hay/Ison <grade III at Visit 3|Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 2|Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 3|pH of the vaginal fluid during treatment|pH of the vaginal fluid at Visit 2|pH of the vaginal fluid at Visit 3|Absence of clue cells greater than 20 % of the total epithelial cells on microscopic examination at Visit 2 and Visit 3.|Total absence of clue cells (0%) of the total epithelial cells on microscopic examination at Visit 2 and Visit 3. Female Not Applicable 83 Industry|Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment Piva01 February 28, 2024

Pickett, C. M., et al. (2023). "Surgical approach to hysterectomy for benign gynaecological disease." The Cochrane Database of Systematic Reviews 8(8): CD003677.
	BACKGROUND: Currently, there are five major approaches to hysterectomy for benign gynaecological disease: abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparoscopic hysterectomy (LH), robotic-assisted hysterectomy (RH) and vaginal natural orifice hysterectomy (V-NOTES). Within the LH category we further differentiate the laparoscopic-assisted vaginal hysterectomy (LAVH) from the total laparoscopic hysterectomy (TLH) and single-port laparoscopic hysterectomy (SP-LH). OBJECTIVES: To assess the effectiveness and safety of different surgical approaches to hysterectomy for women with benign gynaecological conditions. SEARCH METHODS: We searched the following databases (from their inception to December 2022): the Cochrane Gynaecology and Fertility Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO. We also searched the trial registries and relevant reference lists, and communicated with experts in the field for any additional trials. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in which clinical outcomes were compared between one surgical approach to hysterectomy and another. DATA COLLECTION AND ANALYSIS: At least two review authors independently selected trials, assessed risk of bias and performed data extraction. Our primary outcomes were return to normal activities, satisfaction and quality of life, intraoperative visceral injury and major long-term complications (i.e. fistula, pelvic-abdominal pain, urinary dysfunction, bowel dysfunction, pelvic floor condition and sexual dysfunction). MAIN RESULTS: We included 63 studies with 6811 women. The evidence for most comparisons was of low or moderate certainty. The main limitations were poor reporting and imprecision. Vaginal hysterectomy (VH) versus abdominal hysterectomy (AH) (12 RCTs, 1046 women) Return to normal activities was probably faster in the VH group (mean difference (MD) -10.91 days, 95% confidence interval (CI) -17.95 to -3.87; 4 RCTs, 274 women; I2 = 67%; moderate-certainty evidence). This suggests that if the return to normal activities after AH is assumed to be 42 days, then after VH it would be between 24 and 38 days. We are uncertain whether there is a difference between the groups for the other primary outcomes. Laparoscopic hysterectomy (LH) versus AH (28 RCTs, 3431 women) Return to normal activities may be sooner in the LH group (MD -13.01 days, 95% CI -16.47 to -9.56; 7 RCTs, 618 women; I2 = 68%, low-certainty evidence), but there may be more urinary tract injuries in the LH group (odds ratio (OR) 2.16, 95% CI 1.19 to 3.93; 18 RCTs, 2594 women; I2 = 0%; moderate-certainty evidence). This suggests that if the return to normal activities after abdominal hysterectomy is assumed to be 37 days, then after laparoscopic hysterectomy it would be between 22 and 25 days. It also suggests that if the rate of ureter injury during abdominal hysterectomy is assumed to be 0.2%, then during laparoscopic hysterectomy it would be between 0.2% and 2%. We are uncertain whether there is a difference between the groups for the other primary outcomes. LH versus VH (22 RCTs, 2135 women) We are uncertain whether there is a difference between the groups for any of our primary outcomes. Both short- and long-term complications were rare in both groups. Robotic-assisted hysterectomy (RH) versus LH (three RCTs, 296 women) None of the studies reported satisfaction rates or quality of life. We are uncertain whether there is a difference between the groups for our other primary outcomes. Single-port laparoscopic hysterectomy (SP-LH) versus LH (seven RCTs, 621 women) None of the studies reported satisfaction rates, quality of life or major long-term complications. We are uncertain whether there is a difference between the groups for rates of intraoperative visceral injury. Total laparoscopic hysterectomy (TLH) versus laparoscopic-assisted vaginal hysterectomy (LAVH) (three RCTs, 233 women) None of the studies reported satisfaction rates or quality of life. We are uncertain whether there is a difference between the groups for rates of intraoperative visceral injury or major long-term complications. Transvaginal natural orifice transluminal endoscopic surgery (V-NOTES) versus LH (two RCTs, 96 women) We are uncertain whether there is a difference between the groups for rates of bladder injury. Our other primary outcomes were not reported. Overall, adverse events were rare in the included studies. AUTHORS' CONCLUSIONS: Among women undergoing hysterectomy for benign disease, VH appears to be superior to AH. When technically feasible, VH should be performed in preference to AH because it is associated with faster return to normal activities, fewer wound/abdominal wall infections and shorter hospital stay. Where VH is not possible, LH has advantages over AH including faster return to normal activities, shorter hospital stay, and decreased risk of wound/abdominal wall infection, febrile episodes or unspecified infection, and transfusion. These advantages must be balanced against the increased risk of ureteric injury and longer operative time. When compared to LH, VH was associated with no difference in time to return to normal activities but shorter operative time and shorter hospital stay. RH and V-NOTES require further evaluation since there is a lack of evidence of any patient benefit over conventional LH. Overall, the evidence in this review has to be interpreted with caution as adverse event rates were low, resulting in low power for these comparisons. The surgical approach to hysterectomy should be discussed with the patient and decided in the light of the relative benefits and hazards. Surgical expertise is difficult to quantify and poorly reported in the available studies and this may influence outcomes in ways that cannot be accounted for in this review. In conclusion, when VH is not feasible, LH has multiple advantages over AH, but at the cost of more ureteric injuries. Evidence is limited for RH and V-NOTES.

Piero Luis, E., et al. (2021). "Effectiveness of laparoscopic ablation versus laparoscopic excision for pain and infertility in endometriosis: a protocol for a systematic review." PROSPERO International prospective register of systematic reviews.
	
Pierpaolo, N. and V. Amerigo (2023). "Oocyte cryopreservation (OC) for patients with endometriosis: where are we now? A systematic review." PROSPERO International prospective register of systematic reviews.
	
Pignata, S., et al. (2023). "Overall survival and patient-reported outcome results from the placebo-controlled randomized phase III IMagyn050/GOG 3015/ENGOT-OV39 trial of atezolizumab for newly diagnosed stage III/IV ovarian cancer." Gynecologic Oncology 177: 20-31.
	Objective: To determine the impact on overall survival (OS) and patient-reported outcomes (PROs) of combining atezolizumab with standard therapy for newly diagnosed stage III/IV ovarian cancer.; Methods: The placebo-controlled double-blind randomized phase III IMagyn050/GOG 3015/ENGOT-OV39 trial (NCT03038100) assigned eligible patients to 3-weekly atezolizumab 1200 mg or placebo for 22 cycles with platinum-based chemotherapy and bevacizumab. Coprimary endpoints were progression-free survival (already reported) and OS in the PD-L1-positive and intent-to-treat (ITT) populations, tested hierarchically. Prespecified PRO analyses focused on disease-related abdominal pain and bloating symptoms (European Organisation for Research and Treatment of Cancer QLQ-OV28), functioning, and health-related quality of life (HRQoL) (QLQ-C30).; Results: After 38 months' median follow-up, the OS hazard ratio in the PD-L1-positive population was 0.83 (95% CI, 0.66-1.06; p = 0.13); median OS was not estimable with atezolizumab versus 49.2 months with placebo. The hazard ratio for OS in the ITT population was 0.92 (95% CI, 0.78-1.09; median 50.5 versus 46.6 months, respectively). At week 9, similar proportions of patients in both arms of the neoadjuvant cohort showed ≥10-point improvement from baseline in abdominal pain and bloating, functioning, and HRQoL. In the primary surgery cohort, similar proportions of patients in each arm had improved, stable, or worsened physical and role function and HRQoL from baseline over time. Neither cohort showed differences between arms in treatment-related symptoms or overall side-effect bother.; Conclusions: Incorporation of atezolizumab into standard therapy for newly diagnosed ovarian cancer does not significantly improve efficacy or impose additional treatment burden for patients.; Clinicaltrials: gov registration: NCT03038100.; Competing Interests: Declaration of Competing Interest Sandro Pignata: Personal fees (Roche, AstraZeneca, MSD, PharmaMar, GSK, Clovis, Incyte); Research funding to institution (Roche, MSD, AstraZeneca, Clovis, GSK). Michael Bookman: Administrative and per-capita funding for conduct of the clinical trial paid to institution; Consultation fees paid to institution for ad hoc advisory boards (Merck Sharp & Dohme, AstraZeneca, Genentech/Roche, Clovis Oncology, Seattle Genetics, Aravive, AbbVie) and Data Monitoring Committee (Immunogen). Jalid Sehouli: Research funding (Roche Pharma, AstraZeneca, Bayer, Clovis Oncology, GSK, Lilly, Tesaro); Honoraria (Tesaro, GSK, PharmaMar, AstraZeneca, Clovis Oncology, Bayer, Roche, PharmaMar, Vifor Pharma, Hexal AG, Novartis Pharma); Consulting (Tesaro, Merck/Pfizer, PharmaMar, Clovis Oncology, AstraZeneca, Roche Pharma, GSK, MSD, Eisai, Novocure, Oncoinvent). Richard T. Penson: Institutional research funding as principal investigator (Array BioPharma Inc., AstraZeneca., Eisai Inc., Genentech, Inc., Regeneron, Sanofi-Aventis US LLC, Vascular Biogenics Ltd); Royalties (BMJ Publishing, UptoDate, Elsevier Ltd., Wolters Kluwer Health, Wiley Blackwell); Consulting fees for advisory boards (AstraZeneca, Eisai, GSK Inc., ImmunoGen Inc., Merck & Co., Mersana, Novacure, Roche Pharma, Sutro Biopharma, Vascular Biogenics Ltd); serves on Data and Safety Monitoring Boards (AstraZeneca, EQRx, Roche Pharma). Sakari Hietanen: Consultancy fees (AstraZeneca, Eisai, MSD, GSK); Speaker bureau (AstraZeneca, GSK). Radoslaw Madry: Licences/payments (AstraZeneca); Consulting fees (Roche, MSD, AstraZeneca); Honoraria (GSK, AstraZeneca, Roche); Support for attending meetings and/or travel (AstraZeneca, Roche); Participation on Data Safety Monitoring or Advisory Boards (GlaxoSmithKline, AstraZeneca); Receipt of equipment, materials, drugs, medical writing, gifts, or other services (AstraZeneca). Lyndsay Willmott: Honoraria for speaker bureau (AstraZeneca, Clovis, Eisai, Immunogen, GSK, Merck, Seagen); Honoraria for advisory bureau (Genentech); Participation on advisory boards (AstraZeneca, Clovis, Eisai, Genentech, GSK, Immunogen, Seagen). Tashanna Myers: Persona honorarium for lecture (Immunogen); Honorarium to institution for advisory board (Immunogen). Alain Lortholary: Personal honoraria (AstraZeneca, Clovis Oncology, Tesaro/GSK, Roche, MSD, Novartis). Jessica Thomes-Pepin: Consulting fees for advisory board (Immunogen). Carol Aghajanian: Clinical trial funding to institution (AbbVie, AstraZeneca, Clovis, Genentech/Roche); Consulting fees for advisory boards (AbbVie, Roche/Genentech, Eisai/Merck, AstraZeneca/Merck, Repare Therapeutics); Participation on an advisory board (Blueprint medicine [unrecompensed]); Membership of the Board of Directors (GOG-F [travel cost reimbursement for attending meetings], NRG Oncology [unpaid]). Carolyn McCourt: Royalties (UpToDate). Ashley Stuckey: Royalties (UpToDate). Xiaohua Wu: Honorarium for advisory board (Roche). Larry J. Copeland: DMC membership (Corcept Therapeutics, Inc.); Personal fees for advisory boards (Celsion Corporation, Corcept Therapeutics, Inc., Elevar Therapeutics, GSK Inc., Immunogen, Myriad Genetics, Inc., Rubius Therapeutics, Sorrento Therapeutics, Toray Industries, Inc., VBL Therapeutics, Inc., OncoNova, Inc., Inx Med); Research funding to institution (AbbVie, Advaxis, Agenus, Ajinomoto, Array BioPharm, AstraZeneca, Bristol Myers Squibb, Clovis Oncology, Deciphera Pharma, Eisai, EMD Serono Inc., ERGOMED Clinical Research, Exelixis, Genentech/Roche, Genmab, GSK, Inc., Hoffmann-La Roche, Immunogen, Incyte Corporation, Iovance Biotherapeutics, InVentive Health Clinical, Jansen R&D, Leap Therapetuics, Ludwig Institute for Pharmaceuticals, Merck, Mersana Therapeutics, Inc., Novocure, Novartis Pharmaceuticals, OncoQuest, PRA International, Regeneron Pharmaceuticals, Seattle Genetics, Serono, Sutro Biopharm, Tesaro (GSK), Arcus Biosciences, Inc., Sumitomo Dainippon Pharma Oncology, Cerulean Pharma, Karyopharm, BeiGene USA, Inc., Ovagene, Pfizer Inc., PharmaMar USA Inc.,Precision Therapeutics, Inc., Sanofi, Stemcentrx, Inc., TRACON Pharm, Verastem, Inc.). Yvette He: Employee contracted to provide statistical support to Roche (Parexel). Luciana Molinero, Sheetal Patel, and Victor K. Khor: Employees (Roche/Genentech); Share holders (Roche). Yvonne G. Lin: Employee (Roche/Genentech); Participation on Advisory Board (Intervenn Biosciences, unpaid); Leadership position/committee member (SGO Membership Committee); Share holder (Roche). Kathleen N. Moore: Research funding to institution (PTC Therapeutics, Lilly, Clovis, Genentech, GSK, Verastem), Personal royalties (UptoDate), Personal consulting fees for advisory boards (Aadi, Alkemeres, Aravive, AstraZeneca, Blueprint pharma, Caris, Clovis, Eisai, Genentech/Roche, GSK, Hengrui, Immunogen, Inxmed, IMab, Iovance, Lilly, Merck, Mereo, Mersana, Myriad, Novartis, Novocure, Onconova, OncXerna, Pannavance, Tarveda, VBL Therapeutics, Verastem); Personal honoraria for lectures/presentations/speaker bureau (AstraZeneca, GSK, Immunogen, PRIME, RTP, Medscape, Great Debates and Updates); Support for attending meetings and/or travel (AstraZeneca); Leadership role (GOG Partners Associate director). All authors: Medical writing and article processing charges (F. Hoffmann-La Roche). (Copyright © 2023. Published by Elsevier Inc.)

Pignata, S., et al. (2021). "Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial." The Lancet Oncology 22(2): 267‐276.
	BACKGROUND: Bevacizumab is approved in combination with chemotherapy for the treatment of ovarian cancer, either in first‐line therapy or for patients with recurrent disease not previously treated with the same drug. We aimed to test the value of continuing bevacizumab beyond progression after first‐line treatment with the same drug. METHODS: In our open‐label, randomised, phase 3 trial done at 82 sites in four countries, we enrolled women (aged ≥18 years) who had previously received first‐line platinum‐based therapy including bevacizumab, and had recurrent (≥6 months since last platinum dose), International Federation of Gynaecology and Obstetrics stage IIIB‐IV ovarian cancer with an Eastern Cooperative Oncology Group performance status 0‐2. Patients were randomly assigned (1:1) to receive a carboplatin‐based doublet intravenously (carboplatin area under the concentration curve [AUC] 5 on day 1 plus paclitaxel 175 mg/m2 on day 1, every 21 days; carboplatin AUC 4 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8, every 21 days; or carboplatin AUC 5 on day 1 plus pegylated liposomal doxorubicin 30 mg/m2 on day 1, every 28 days), or a carboplatin‐based doublet plus bevacizumab (10 mg/kg intravenous every 14 days combined with pegylated liposomal doxorubicin‐carboplatin, or 15 mg/kg every 21 days combined with gemcitabine‐carboplatin or paclitaxel‐carboplatin). Evaluable disease according to RECIST 1.1 guidelines was required before randomisation. Randomisation was done through the trial website with a minimisation procedure, stratified by centre, time of recurrence, performance status, and type of second‐line chemotherapy. The primary endpoint was investigator‐assessed progression‐free survival, analysed on an intention‐to‐treat basis. Safety was assessed in all participants who received at least one dose. This trial is registered with ClinicalTrials.gov, NCT01802749 and EudraCT 2012‐004362‐17. FINDINGS: Between Dec 6, 2013, and Nov 11, 2016, 406 patients were recruited (203 [50%] assigned to the bevacizumab group and 203 [50%] to the standard chemotherapy group). 130 patients (64%) in the bevacizumab group and 131 (65%) in the standard chemotherapy group had progressed after receiving a last dose of platinum more than 12 months before, and 146 patients (72%) in the bevacizumab group and 147 (72%) in the standard chemotherapy group had progressed after completion of first‐line bevacizumab maintenance. 161 participants (79%) progressed in the standard chemotherapy group, as did 143 (70%) in the bevacizumab group. Median progression‐free survival was 8·8 months (95% CI 8·4‐9·3) in the standard chemotherapy group and 11·8 months (10·8‐12·9) in the bevacizumab group (hazard ratio 0·51, 95% CI 0·41‐0·65; log‐rank p<0·0001). Most common grade 3‐4 adverse events were hypertension (20 [10%] in the standard chemotherapy group vs 58 (29%) in the bevacizumab group), neutrophil count decrease (81 [41%] vs 80 [40%]), and platelet count decrease (43 [22%] vs 61 [30%]). 68 patients (33%) died in the standard chemotherapy group and 79 (39%) died in the bevacizumab group; two deaths (1%) in the standard chemotherapy group and one death (<1%) in the bevacizumab group were deemed to be treatment‐related. FUNDING: Hoffmann‐La Roche and Associazione Italiana per la Ricerca sul Cancro. INTERPRETATION: Continuing bevacizumab beyond progression combined with chemotherapy in patients with platinum‐sensitive recurrent ovarian cancer improves progression‐free survival compared with standard chemotherapy alone and might be considered in clinical practice.

Pignata, S., et al. (2023). "Carboplatin and paclitaxel plus avelumab compared with carboplatin and paclitaxel in advanced or recurrent endometrial cancer (MITO END-3): a multicentre, open-label, randomised, controlled, phase 2 trial." The Lancet Oncology 24(3): 286-296.
	Background: Adding immunotherapy to first-line chemotherapy might improve outcomes for patients with advanced or recurrent endometrial cancer. We aimed to compare carboplatin and paclitaxel versus avelumab plus carboplatin and paclitaxel as first-line treatment with avelumab given concurrent to chemotherapy and as maintenance after the end of chemotherapy.; Methods: MITO END-3 is an open-label, randomised, controlled, phase 2 trial conducted at 31 cancer institutes, hospitals, and universities in Italy. Eligible patients were aged 18 years or older with histologically confirmed advanced (FIGO stage III-IV) or recurrent endometrial cancer, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no previous systemic anticancer therapy as primary treatment for advanced or metastatic disease. Participants were randomly assigned (1:1) using a computerised minimisation procedure stratified by centre, histology, and stage at study entry, to either receive carboplatin (area under the curve [AUC] 5 mg/mL × min) and paclitaxel (175 mg/m 2 ; standard group) intravenously every 3 weeks for six to eight cycles or avelumab (10 mg/kg intravenously) added to carboplatin and paclitaxel (experimental group) every 3 weeks and then every 2 weeks as a single maintenance treatment after the end of chemotherapy until disease progression or unacceptable toxicity. Patients, treating clinicians, and those assessing radiological examinations were not masked to study treatment. The primary endpoint was investigator-assessed progression-free survival, measured in the intention-to-treat (ITT) population. Patients who received at least one dose of study drug were included in the safety analysis. Experimental group superiority was tested with 80% power and one-tailed α 0·20. This trial is registered with ClinicalTrials.gov (NCT03503786) and EudraCT (2016-004403-31).; Findings: From April 9, 2018, to May 13, 2021, 166 women were assessed for eligibility and 39 were excluded. 125 eligible patients were randomly assigned to receive carboplatin and paclitaxel (n=62) or avelumab plus carboplatin and paclitaxel (n=63) and included in the ITT population. The median follow-up was 23·3 months (IQR 13·2-29·6) and was similar between the two groups. 91 progression-free survival events were reported, with 49 events in 62 patients in the standard group and 42 events in 63 patients in the experimental group. The median progression-free survival was 9·9 months (95% CI 6·7-12·1) in the standard group and 9·6 months (7·2-17·7) in the experimental group (HR of progression or death 0·78 [60% CI 0·65-0·93]; one-tailed p=0·085). Serious adverse events were reported more frequently in the experimental group (24 vs seven events in the standard group); neutrophil count decrease was the most frequent grade 3-4 adverse event (19 [31%] of 61 patients in the experimental group vs 26 [43%] of 61 patients in the standard group). Two deaths occurred in the experimental group during treatment (one respiratory failure following severe myositis [possibly related to treatment] and one cardiac arrest [not related to treatment]).; Interpretation: Adding avelumab to first-line chemotherapy deserves further testing in patients with advanced or recurrent endometrial cancer, although consideration of mismatch repair status is warranted.; Funding: Pfizer.; Competing Interests: Declaration of interests SP received grants or contracts from Pfizer and personal honoraria from AstraZeneca, MSD, Roche, GSK, and Clovis. GS received grants or contracts from MSD; consulting fees from TESARO Bio and Johnson and Johnson; and personal honoraria from Clovis Oncology. UDG received personal honoraria from Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Clovis Oncology, Eisai, Janssen, MSD, Pfizer, Ipsen, and Roche; and support for attending meetings or travel support (or both) from Janssen, Bristol Myers Squibb, and Ipse. CDA received consulting fees from Novartis, GSK, and Eli-Lilly; personal honoraria from Novartis, Pfizer, GSK, Eli-Lilly, and Seagen; and s pport for attending meetings or travel support (or both) from Seagen, Gilead, Pfizer, and Ipsen. DP received personal honoraria from Clovis and GSK; and support for attending meetings or travel support (or both) from Pierre Fabre Pharma. VS received consulting fees from Novocure, MSD, AstraZeneca, and GSK; personal honoraria from Novocure, MSD, AstraZeneca, and GSK; support for attending meetings or travel support (or both) from GSK and PharmaMar; and personal payment for an advisory board from MSD, Novocure, AstraZeneca, and GSK. AF received personal honoraria from AstraZeneca, GSK (Tesaro), and Clovis; travel grants from Astellas, MSD, and Bayer; and personal payment for an advisory board from Janssen, GSK (Tesaro), and AstraZeneca. DL received consulting fees from AstraZeneca, Clovis Oncology, GSK, MSD, Immunogen, Genmab, Amgen, Seagen, and PharmaMar; personal honoraria from AstraZeneca, Clovis Oncology, GSK, MSD, and PharmaMar; payment for expert testimony from Clovis; travel grants from Roche, PharmaMar, AstraZeneca, Clovis Oncology, and GSK; personal payment for an advisory board from Merck Serono, Seagen, Immunogen, Genmab, Oncoinvest, Corcept, Sutro, AstraZeneca, Clovis Oncology, GSK, MSD, PharmaMar, and Gynecologic Cancer InterGroup for being a member of the board of directors; and institutional grants for research activities from AstraZeneca, Clovis Oncology, GSK, MSD, Genmab, PharmaMar, Seagen, Immunogen, Novartis, Roche, and Incyte. FP received institutional financial support for clinical trials promoted by the National Cancer Institute of Naples from Roche, Bayer, AstraZeneca, Pfizer, Incyte, GSK (Tesaro), and Merck; and personal honoraria from Bayer, Pierre Fabre, AstraZeneca, Incyte, Ipsen, Clovis, Astellas, Sanofi, Roche, and Pfizer. All other authors declare no competing interests. (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Pinborg Anja, B. (2021). "Immediate Versus Postponed Single Blastocyst Transfer in mNC-FET." ClinicalTrials.gov.
	No Results Available Procedure: Immediate mNC-FET Live birth rate per randomized patient|Live birth rate per protocol|Live birth rate per blastocyst transfer|Positive hCG rate per randomized patient and per blastocyst transfer|Ongoing pregnancy rate per randomized patient and per blastocyst transfer|Biochemical pregnancy loss|Clinical pregnancy loss|Cycle cancellation|Reason for cycle cancellation|Number of ovarian follicular structures >10 mm|Day of ovulation|Endocrinology of the luteal phase|Time-to-pregnancy|Time-to-live-birth|Pregnancy related complications|Neonatal outcome|Quality of life assessment Female Not Applicable 464 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment H-19086300 June 2026

Piotr, Z., et al. (2021). "Value of diagnostic hysteroscopy for the outcome of the first and repeated in-vitro fertilizations - a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Pivazyan, L., et al. (2022). "Effectiveness and safety of bulking agents versus surgical methods in women with stress urinary incontinence: a systematic review and meta-analysis." International Urogynecology Journal 33(4): 777-787.
	Introduction and hypothesis: The objective was to evaluate the efficacy and safety of bulking agents compared with surgical methods for female stress urinary incontinence. Method(s): Inclusion and exclusion criteria: women with stress urinary incontinence. Bulking agents versus any surgical treatment as a comparison. Patients with other types of incontinence and treatment were excluded. Electronic databases (PubMed, MEDLINE, and the Cochrane Library) were searched from 2000 until 2021 to identify articles evaluating the effectiveness and safety of urethral bulking agents versus surgical methods. Risk-of-bias assessment tools recommended by the Cochrane Society were used to evaluate the risk of bias in the studies included. Result(s): Six studies were included in the quantitative synthesis for a total of 710 patients. Our systematic review and meta-analysis showed that bulking agents are less effective than surgical procedures according to subjective improvement after treatment (RR = 0.70, 95% CI: 0.53 to 0.92, p = 0.01). There was no statistically significant difference between these two methods with regard to complications after the intervention (RR = 1.30, 95% CI: 0.30 to 5.66, p = 0.73). Conclusion(s): The main limitation of this systematic review and meta-analysis was the absence of a common objective outcome measure to evaluate effectiveness. However, it shows that bulking agents are less effective than surgical procedures in subjective improvement. Safety analysis showed no significant difference between these methods. Hence, we believe that the first and final surgery is considered to be the best.Copyright © 2021, The International Urogynecological Association.

Ploesser, M. and D. Martin (2023). "The Effects of Anthroposophic Medicine in Chronic Pain Conditions: A Systematic Review." Journal of Integrative and Complementary Medicine 29(11): 705-717.
	Background: The currently available evidence is unclear in regard to pain-related outcomes of patients with chronic pain conditions who undergo treatment with anthroposophic medicine (AM). Aim: To identify and synthesize the evidence in patients with chronic pain before and after AM therapy. Methods: The following databases and search interfaces were searched on October 21, 2021: Embase (via Embase.com), Medline (via PubMed), and the Cochrane Library. Additional references were identified via bibliographies of included studies. In at least one experimental arm that used anthroposophic therapy to treat chronic pain, AM treatments were required to be documented. Included studies reported on pain severity and physical and emotional functioning. Two authors independently assessed the studies for inclusion criteria, extracted the data, and conducted the quality evaluation of the included studies based on the critical appraisal tools provided by the Joanna Briggs Institute. Results: Seven studies (eight publications) were included in the review, of which were three randomized controlled trials (RCTs), two non-RCTs, and two pretest-post-test studies. A total number of 600 patients participated in the identified experimental studies, of whom all were adults. Three studies included patients with low back pain, one study each assessed patients with fibromyalgia, migraine, dysmenorrhea, and postpolio syndrome, respectively. The identified clinical studies reported considerable reductions in symptoms and effect sizes of pain outcomes after AM therapies being predominantly large, with no notable adverse effects. Conclusion: The findings of this systematic review of studies assessing AM therapies in patients with chronic pain problems revealed that there is a scarcity of evidence currently available, with unclear effects of AM treatments in reducing pain intensity and improving quality of life in the evaluated health conditions. Although most of the studies revealed a favorable benefit on one or more pain-related outcomes, the variability of the research did not allow for generalization across different studies, health conditions, and populations.

Polat, F. and R. Aylaz (2022). "The effect of exercise training based on the health promotion model on menopausal symptoms." Perspectives in Psychiatric Care 58(3): 1160-1169.
	Purpose: This study was conducted to determine the effect of exercise training provided based on the health promotion model on menopausal symptoms.; Design and Methods: The sample size was identified as 156 women. The women who were given exercise training applied a 30-min daily exercise program for 12 weeks, while those in the control group were not trained and did not exercise.; Findings: The difference between the mean scores of the groups was statistically significant (p = 0.000).; Practice Implications: Exercise training given to women in the experimental group based on a health promotion model reduced menopausal symptoms. (© 2021 Wiley Periodicals LLC.)

Polyzos Nikolaos, P. (2021). "INTEnsity of ovariaN Stimulation and Embryo Quality." ClinicalTrials.gov.
	No Results Available Drug: Ovarian Stimulation with CC+rFSH|Drug: Ovarian Stimulation with rFSH Number of good quality blastocysts|Change in Progesterone values|Change in Estradiol values|Change in FSH Values|Change in LH values|Length of ovarian stimulation|Number of oocytes retrieved|Number of mature oocytes (MIIs) retrieved|Follicle to Oocyte Index (FOI)|Total dose of rFSH|Follicular Output Rate (FORT)|Cycle cancelation rate|Reason for cycle cancelation|Fertilization rate|Time of appearance of the 2nd polar body (tPB2)|Time of pronuclei appearance (tPNa)|Evaluation of both pronuclei (PN)|Time of pronuclei disappearance (tPNf)|Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8)|Time of compactation (tSC)|Time of morula (tM)|Time of cavitation (tSB)|Time of full blastulation (tB)|Time of expanded blastocyst (tEB)|Time of hatched blastocyst (tHB)|Time of embryo discarding (tDead)|Total number of embryos|Blastocyst formation rate|Number of embryos cryopreserved|Embryo stage (D5, D6, D7)|Clinical pregnancy rate|Ongoing pregnancy rate Female Phase 4 110 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment FSD-IEQ-2021-03|2021-000941-42 June 2024

Popovic, M. (2024). "FSH Doser for Controlled Ovarian Stimulation." ClinicalTrials.gov.
	No Results Available Device: Machine learning model called IDoser|Procedure: Standard clinical practice Number of MII oocytes|Cycle cancellation rate|OHSS risk|Clinical pregnancy rate|Live birth rate Female Not Applicable 0 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Treatment ALGO3 December 2025

Pouhin, C. (2023). "Efficacy of Korean Manupuncture on Pain in Women With Endometriosis: a Parallel-group Randomized Controlled Trial." ClinicalTrials.gov.
	No Results Available Other: Korean manupuncture|Other: Placebo session Variation in the Visual Analog Scale (VAS) All Not Applicable 60 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Supportive Care POUHIN AOIparaM 2021 January 2026

Pourmoghadam, Z., et al. (2020). "Efficacy of intrauterine administration of autologous peripheral blood mononuclear cells on the pregnancy outcomes in patients with recurrent implantation failure: A systematic review and meta-analysis." Journal of Reproductive Immunology 137: 103077.
	One in every nine couples suffers from implantation defects and pregnancy failures. In spite of many contributions that ART has given to infertility treatment, there are many reports of the failure of ART. Therefore, scientists suggested many complementary therapies for use besides ART to improve the quality of infertility treatments. Intrauterine PBMC-therapy is one of these complementary therapies that were used before IVF. Studies that examined PBMC treatment in women with at least three IVF/ET failure were included in this review. These studies involved RCT and quasi-experimental (non-randomized experimental) studies. A three-step search strategy was used for published and unpublished clinical trials written in English and Persian. No time limitation was set for studies. Study selection according to the inclusion criteria and methodological quality assessment and data extraction were done by two independent reviewers, which result in five studies being included (two RCTs and three quasi-experimental studies). Finally, all of these article extracted data were pooled in a statistical meta-analysis. Findings demonstrated that implantation, pregnancy and live birth rate were statistically increased and the miscarriage rate was significantly decreased in the PBMC-treated group than that non-treated group. In conclusion, based on the evidence, PBMCs can be an effective therapeutic approach in women with at least three IVF/ET failure and lacking initial inflammation that is essential for implantation.; Competing Interests: Declaration of Competing Interest The authors declare no conflict of interest. (Copyright © 2019 Elsevier B.V. All rights reserved.)

Poveda, A., et al. (2021). "Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial." The Lancet Oncology 22(5): 620-631.
	BACKGROUND: Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, has previously been shown to extend progression-free survival versus placebo when given to patients with relapsed high-grade serous or endometrioid ovarian cancer who were platinum sensitive and who had a BRCA1 or BRCA2 (BRCA1/2) mutation, as part of the SOLO2/ENGOT-Ov21 trial. The aim of this final analysis is to investigate the effect of olaparib on overall survival. METHODS: This double-blind, randomised, placebo-controlled, phase 3 trial was done across 123 medical centres in 16 countries. Eligible patients were aged 18 years or older, had an Eastern Cooperative Oncology Group performance status at baseline of 0-1, had histologically confirmed, relapsed, high-grade serous or high-grade endometrioid ovarian cancer, including primary peritoneal or fallopian tube cancer, and had received two or more previous platinum regimens. Patients were randomly assigned (2:1) to receive olaparib tablets (300 mg in two 150 mg tablets twice daily) or matching placebo tablets using an interactive web or voice-response system. Stratification was by response to previous chemotherapy and length of platinum-free interval. Treatment assignment was masked to patients, treatment providers, and data assessors. The primary endpoint of progression-free survival has been reported previously. Overall survival was a key secondary endpoint and was analysed in all patients as randomly allocated. Safety was assessed in all patients who received at least one treatment dose. This trial is registered with ClinicalTrials.gov, NCT01874353, and is no longer recruiting patients. FINDINGS: Between Sept 3, 2013 and Nov 21, 2014, 295 patients were enrolled. Patients were randomly assigned to receive either olaparib (n=196 [66%]) or placebo (n=99 [34%]). One patient, randomised in error, did not receive olaparib. Median follow-up was 65·7 months (IQR 63·6-69·3) with olaparib and 64·5 months (63·4-68·7) with placebo. Median overall survival was 51·7 months (95% CI 41·5-59·1) with olaparib and 38·8 months (31·4-48·6) with placebo (hazard ratio 0·74 [95% CI 0·54-1·00]; p=0·054), unadjusted for the 38% of patients in the placebo group who received subsequent PARP inhibitor therapy. The most common grade 3 or worse treatment-emergent adverse event was anaemia (which occurred in 41 [21%] of 195 patients in the olaparib group and two [2%] of 99 patients in the placebo group). Serious treatment-emergent adverse events were reported in 50 (26%) of 195 patients receiving olaparib and eight (8%) of 99 patients receiving placebo. Treatment-emergent adverse events with a fatal outcome occurred in eight (4%) of the 195 patients receiving olaparib, six of which were judged to be treatment-related (attributed to myelodysplastic syndrome [n=3] and acute myeloid leukaemia [n=3]). INTERPRETATION: Olaparib provided a median overall survival benefit of 12·9 months compared with placebo in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation. Although statistical significance was not reached, these findings are arguably clinically meaningful and support the use of maintenance olaparib in these patients. FUNDING: AstraZeneca and Merck.

Powell Matthew, A., et al. (2022). "Randomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial." Journal of Clinical Oncology 40(9): 968-977.
	Purpose: This phase III randomized trial (NCT00954174) tested the null hypothesis that paclitaxel and carboplatin (PC) is inferior to paclitaxel and ifosfamide (PI) for treating uterine carcinosarcoma (UCS).; Patients and Methods: Adults with chemotherapy-naïve UCS or ovarian carcinosarcoma (OCS) were randomly assigned to PC or PI with 3-week cycles for 6-10 cycles. With 264 events in patients with UCS, the power for an overall survival (OS) hybrid noninferiority design was 80% for a null hazard ratio (HR) of 1.2 against a 13% greater death rate on PI with a type I error of 5% for a one-tailed test.; Results: The study enrolled 536 patients with UCS and 101 patients with OCS, with 449 and 90 eligible, respectively. Primary analysis was on patients with UCS, distributed as follows: 40% stage I, 6% stage II, 31% stage III, 15% stage IV, and 8% recurrent. Among eligible patients with UCS, PC was assigned to 228 and PI to 221. PC was not inferior to PI. The median OS was 37 versus 29 months (HR = 0.87; 90% CI, 0.70 to 1.075; P < .01 for noninferiority, P > .1 for superiority). The median progression-free survival was 16 versus 12 months (HR = 0.73; P = < 0.01 for noninferiority, P < .01 for superiority). Toxicities were similar, except that more patients in the PC arm had hematologic toxicity and more patients in the PI arm had confusion and genitourinary hemorrhage. Among 90 eligible patients with OCS, those in the PC arm had longer OS (30 v 25 months) and progression-free survival (15 v 10 months) than those in the PI arm, but with limited precision, these differences were not statistically significant.; Conclusion: PC was not inferior to the active regimen PI and should be standard treatment for UCS.; Competing Interests: Matthew A. Powell Consulting or Advisory Role: Roche/Genentech, AstraZeneca, Tesaro, Clovis Oncology, Eisai, GOG partners, Seattle Genetics, GlaxoSmithKline/Tesaro Research Funding: GlaxoSmithKline/Tesaro (Inst) Virginia L. Filiaci Other Relationship: GOG Foundation Martee L. Hensley Employment: Sanofi (I) Stock and Other Ownership Interests: Sanofi (I) Consulting or Advisory Role: Lilly, Tesaro, GlaxoSmithKline, Thrive, An Exact Sciences Company Patents, Royalties, Other Intellectual Property: author, UpToDate Kathleen N. Moore Honoraria: Research To Practice, Prime Oncology, Physicans' Education Resource, Great Debates and Updates Consulting or Advisory Role: Genentech/Roche, Immunogen, AstraZeneca, TESARO (Inst), VBL Therapeutics, Merck, Aravive, Eisai, Vavotar Life Sciences, Mersana (Inst), Myriad Genetics, Alkermes (Inst), Blueprint Pharmaceuticals (Inst), GlaxoSmithKline/Tesaro (Inst), I-Mab (Inst), InxMed (Inst), Mereo BioPharma (Inst) Research Funding: PTC Therapeutics (Inst), Lilly (Inst), Merck (Inst), Tesaro (Inst), Genentech (Inst), Clovis Oncology (Inst), Lilly Foundation (Inst), Regeneron (Inst), Advaxis (Inst), Bristol Myers Squibb (Inst), Verastem (Inst), Novartis Pharmaceuticals UK Ltd (Inst), AstraZeneca (Inst), Agenus (Inst), Takeda (Inst), Forty Seven (Inst), Stemcentrx (Inst), Immunogen (Inst), Bayer (Inst), Novogen (Inst), AbbVie/Stemcentrx (Inst) Other Relationship: GOG Partners (Inst) Krishnansu S. Tewari Honoraria: Tesaro, Clovis Oncology, Merck, Eisai, AstraZeneca, Genmab Consulting or Advisory Role: Roche/Genentech, Tesaro, Clovis Oncology, AstraZeneca Speakers' Bureau: Roche/Genentech, AstraZeneca, Merck, Tesaro, Clovis Oncology, Eisai, Genmab Research Funding: AbbVie (Inst), Genentech/Roche (Inst), Morphotek (Inst), Merck (Inst), Regeneron (Inst) Travel, Accommodations, Expenses: Roche/Genentech Larry J. Copeland Consulting or Advisory Role: Tarveda Therapeutics, Tarveda Therapeutics, Myriad Genetics, GlaxoSmithKline, Elevar Therapeutics, Toray Industries, Rubius Therapeutics, Sorrento Therapeutics, Celsion, Corcept Therapeutics Angeles Secord Honoraria: Myriad Genetics Research Funding: Tesaro (Inst), AstraZeneca (Inst), Genentech (Inst), Boehringer Ingelheim (Inst), AbbVie (Inst), Merck (Inst), PharmaMar (Inst), Clovis Oncology (Inst), Eisai (Inst), Seattle Genetics nst), Immutep (Inst), GlaxoSmithKline (Inst), VBL Therapeutics (Inst), OncoQuest Pharmaceuticals (Inst) Travel, Accommodations, Expenses: GlaxoSmithKline Uncompensated Relationships: Roche/Genentech, VBL Therapeutics, GOG Foundation, OncoQuest Pharmaceuticals, Regeneron, Aravive David G. Mutch Consulting or Advisory Role: Lilly Alessandro Santin Consulting or Advisory Role: Merck, Tesaro Research Funding: Tesaro (Inst), Merck (Inst), Boehringer Ingelheim (Inst), Gilead Sciences (Inst), Puma Biotechnology (Inst), Genentech/Roche (Inst), Genentech/Roche (Inst), R-Pharm (Inst), Immunomedics (Inst) Nick M. Spirtos Research Funding: AbbVie (Inst), AstraZeneca (Inst), Genentech/Roche (Inst), Clovis Oncology (Inst), Seattle Genetics (Inst) Patents, Royalties, Other Intellectual Property: Application No. PCT/US 2019/19465, Cannabis Based Therapeutic and Method of Use; Application No.: US Patent 0024098766, Compounds Cannabidiol and Flavanones, 63/047550 (July 1, 2020) 63/055458 (July 23, 2020), Title Country Status Filed Date Application No. Patent Ref. No. 199236-701611/EP, Title: Cannabis Based Therapeutic and Method of Use Country, European Patent Status: Published February 25, 2019, 19710540.6; Patent Ref. No. 199236-701691/PCT-BR, Title: Cannabis Based Therapeutic and Method of Use Country Brazil Status: Application February 25, 2019, 1120200170232; Patent Ref. No. 199236-701831/PCT-US, Title: Cannabis Based Therapeutic and Method of Use Country United States of America Status: Published February 25, 2019, 16/971,781; Patent Ref. No. 199236-701891/HK, Title: Cannabis Based Therapeutic and Method of Use Country Hong Kong Status: Published June 25, 2021, 62021033676.9; Patent Ref. No. Title Country Status Filed Date; Application No. Patent Ref. No. 199237-701601/PCT, Title: Compositions Comprising Cannabidiol and Flavanones Country: Patent Cooperation Treaty Status: Application July 1, 2021, PCT/US21/40115; Patent Ref. No. 199237-701691/BR, Title: Compositions Comprising Cannabidiol and Flavanones Country: Brazil Status: Application November 19, 2020, 1020200236644; Patent Ref. No. 199237-7019761/UY, Title: Compositions Comprising and Flavanones Country: Uruguay Status: Application November 20, 2020, 38965, John Wiley and Sons Editor 12th Edition Bonney's Gynaecological Surgery Open Payments Link: https://openpaymentsdata.cms.gov/physician/8054, https://openpaymentsdata.cms.gov/physician/8054 Paul A. DiSilvestro Consulting or Advisory Role: AstraZeneca, Agenus Research Funding: Janssen Oncology (Inst), Tesaro (Inst), AstraZeneca (Inst), Genentech (Inst), AbbVie (Inst) David S. Miller Consulting or Advisory Role: Genentech, Tesaro, Eisai, AstraZeneca, Guardant Health, Janssen Oncology, Alexion Pharmaceuticals, Karyopharm Therapeutics, Incyte, Guardant Health, Janssen, Alexion Pharmaceuticals, Clovis Oncology, Merck Sharp & Dohme (Inst), Asymmetric Therapeutics, Boston Biomedical Research Institute, Tarveda Therapeutics, Myriad Genetic Laboratories, GlaxoSmithKline, AbbVie, Incyte, EMD Serono, Seattle Genetics, Clinical Education Alliance, LLC, Eisai, GlaxoSmithKline, iTeos Belgium SA, Novocure, Novartis, Immunogen, Agenus Speakers' Bureau: Clovis Oncology, Genentech Research Funding: US Biotest (Inst), Advenchen Laboratories (Inst), Tesaro (Inst), Xenetic Biosciences (Inst), Advaxis (Inst), Janssen (Inst), Aeterna Zentaris (Inst), TRACON Pharma (Inst), Pfizer (Inst), Immunogen (Inst), Mateon Therapeutics (Inst), Merck Sharp & Dohme (Inst), AstraZeneca (Inst), Millennium Pharmaceuticals (Inst), Aprea AB (Inst), Regeneron (Inst), NVision (Inst), Leap Therapeutics (Inst), Novartis (Inst), Syros Pharmaceuticals (Inst), Karyopharm Therapeutics (Inst), Agenus (Inst), Akesobio (Inst), EMD Serono Research & Development Institute, Incyte (Inst)No other potential conflicts of interest were reported.

Preeyanuch, K., et al. (2024). "Effectiveness of Dane Fukang decoction for Endometriosis treatment: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Prior Jerilynn, C., et al. (2023). "Oral micronized progesterone for perimenopausal night sweats and hot flushes a Phase III Canada-wide randomized placebo-controlled 4 month trial." Scientific Reports 13(1): 9082.
	This study tested progesterone for perimenopausal hot flush ± night sweat (vasomotor symptom, VMS) treatment. It was a double-blind, randomized trial of 300 mg oral micronized progesterone@bedtime versus placebo for 3-months (m) after a 1-m untreated baseline during 2012/1-2017/4. We randomized untreated, non-depressed, screen- and baseline-eligible by VMS, perimenopausal women (with flow within 1-year), ages 35-58 (n = 189). Participants aged 50 (± SD = 4.6) were mostly White, educated, minimally overweight with 63% in late perimenopause; 93% participated remotely. The 1° outcome was 3rd-m VMS Score difference. Participants recorded VMS number and intensity (0-4 scale)/24 h on a VMS Calendar. Randomization required VMS (intensity 2-4/4) of sufficient frequency and/or ≥ 2/week night sweat awakenings. Baseline total VMS Score (SD) was 12.2 (11.3) without assignment difference. Third-m VMS Score did not differ by therapy (Rate Difference - 1.51). However, the 95% CI [- 3.97, 0.95] P = 0.222, did not exclude 3, a minimal clinically important difference. Women perceived progesterone caused decreased night sweats (P = 0.023) and improved sleep quality (P = 0.005); it decreased perimenopause-related life interference (P = 0.017) without increased depression. No serious adverse events occurred. Perimenopausal night sweats ± hot flushes are variable; this RCT was underpowered but could not exclude a minimal clinically important VMS benefit. Perceived night sweats and sleep quality significantly improved. (© 2023. The Author(s).)

Priya, K. and G. Qingwen (2021). "Efficacy of conservative rehabilitation approaches for the treatment of urinary incontinence in women: a systematic review and meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Priyatini, T., et al. (2024). "Is Vaginal Laser Promising for Stress Urinary Incontinence Treatment? A Systematic Review." Journal of South Asian Federation of Obstetrics and Gynaecology 16(2): 121-125.
	Introduction: The treatment for stress urinary incontinence (SUI) includes conservative and surgical management. Apart from advantages and disadvantages, vaginal laser is considered as an alternative therapy for SUI. This study aims to review the effectiveness of laser therapy either erbium-doped yttrium-aluminum-garnet (Er:YAG) or carbon dioxide (CO2) laser for female SUI. Method(s): We used preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines for the appraisal. Eligibility criteria was SUI women undergoing Er:YAG or CO2 lasers compared with conservative or surgical management concerning the outcome such as improvement of SUI severity, sexual function, and quality of life. Result(s): Three studies consisting of one randomized controlled trial (RCT) and two prospective studies were included and assessed for risk of bias using the revised Cochrane risk-of-bias tool (RoB 2) and the risk of bias in nonrandomized studies - of interventions (ROBINS-I) assessment tool. All studies showed improvement of SUI in Er:YAG laser therapy, subjectively; however, they were still inconsistent objectively. Meanwhile, based on data on sexual function, both lasers showed little improvement and were not statistically significant (p = 0.066). Conclusion(s): Current evidence shows Er:YAG laser has a superior effect to sham laser in SUI patients subjectively. On the contrary, there is only a little evidence comparing Er:YAG laser with both conservative and surgical management of SUI.Copyright © The Author(s). 2024 Open Access.

Prodromidou, A., et al. (2023). "CO2 Laser versus Sham Control for the Management of Genitourinary Syndrome of Menopause: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." Journal of Personalized Medicine 13(12): 1694.
	In the context of the menopausal transition, genitourinary syndrome of menopause (GSM) refers to a range of genitourinary symptoms, from vaginal dryness to dysuria and urinary urgency. While hormonal treatments are standard, their associated side effects have driven the exploration of alternatives like vaginal CO2 laser. We aimed to evaluate the randomized controlled trials (RCTs) comparing vaginal CO2 laser treatment for GSM to sham controls. This systematic review sourced four electronic databases until June 2023. The analysis incorporated seven RCTs with 407 women. The CO2 laser and sham control were comparable for most parameters, including the female sexual function index (FSFI) and visual analogue scale (VAS) for dyspareunia, vaginal health index, pH, and patient satisfaction. However, the CO2 laser group showed significant improvement in the vaginal assessment scale for GSM symptoms. Sensitivity analyses revealed that parameters like FSFI showed significant differences in favor of CO2 laser group upon the exclusion of specific studies. In conclusion, vaginal CO2 laser therapy emerges as a promising alternative for GSM management, especially for most bothersome GSM symptoms; however, the need for further well-designed RCTs remains to validate its broad safety and efficacy.Copyright © 2023 by the authors.

Pujade-Lauraine, E., et al. (2021). "Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study." The Lancet Oncology 22(7): 1034-1046.
	BACKGROUND: Most patients with ovarian cancer will relapse after receiving frontline platinum-based chemotherapy and eventually develop platinum-resistant or platinum-refractory disease. We report results of avelumab alone or avelumab plus pegylated liposomal doxorubicin (PLD) compared with PLD alone in patients with platinum-resistant or platinum-refractory ovarian cancer. METHODS: JAVELIN Ovarian 200 was an open-label, parallel-group, three-arm, randomised, phase 3 trial, done at 149 hospitals and cancer treatment centres in 24 countries. Eligible patients were aged 18 years or older with epithelial ovarian, fallopian tube, or peritoneal cancer (maximum of three previous lines for platinum-sensitive disease, none for platinum-resistant disease) and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned (1:1:1) via interactive response technology to avelumab (10 mg/kg intravenously every 2 weeks), avelumab plus PLD (40 mg/m2 intravenously every 4 weeks), or PLD and stratified by disease platinum status, number of previous anticancer regimens, and bulky disease. Primary endpoints were progression-free survival by blinded independent central review and overall survival in all randomly assigned patients, with the objective to show whether avelumab alone or avelumab plus PLD is superior to PLD. Safety was assessed in all patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, NCT02580058. The trial is no longer enrolling patients and this is the final analysis of both primary endpoints. FINDINGS: Between Jan 5, 2016, and May 16, 2017, 566 patients were enrolled and randomly assigned (combination n=188; PLD n=190, avelumab n=188). At data cutoff (Sept 19, 2018), median duration of follow-up for overall survival was 18·4 months (IQR 15·6-21·9) for the combination group, 17·4 months (15·2-21·3) for the PLD group, and 18·2 months (15·8-21·2) for the avelumab group. Median progression-free survival by blinded independent central review was 3·7 months (95% CI 3·3-5·1) in the combination group, 3·5 months (2·1-4·0) in the PLD group, and 1·9 months (1·8-1·9) in the avelumab group (combination vs PLD: stratified HR 0·78 [repeated 93·1% CI 0·59-1·24], one-sided p=0·030; avelumab vs PLD: 1·68 [1·32-2·60], one-sided p>0·99). Median overall survival was 15·7 months (95% CI 12·7-18·7) in the combination group, 13·1 months (11·8-15·5) in the PLD group, and 11·8 months (8·9-14·1) in the avelumab group (combination vs PLD: stratified HR 0·89 [repeated 88·85% CI 0·74-1·24], one-sided p=0·21; avelumab vs PLD: 1·14 [0·95-1·58], one-sided p=0·83]). The most common grade 3 or worse treatment-related adverse events were palmar-plantar erythrodysesthesia syndrome (18 [10%] in the combination group vs nine [5%] in the PLD group vs none in the avelumab group), rash (11 [6%] vs three [2%] vs none), fatigue (ten [5%] vs three [2%] vs none), stomatitis (ten [5%] vs five [3%] vs none), anaemia (six [3%] vs nine [5%] vs three [2%]), neutropenia (nine [5%] vs nine [5%] vs none), and neutrophil count decreased (eight [5%] vs seven [4%] vs none). Serious treatment-related adverse events occurred in 32 (18%) patients in the combination group, 19 (11%) in the PLD group, and 14 (7%) in the avelumab group. Treatment-related adverse events resulted in death in one patient each in the PLD group (sepsis) and avelumab group (intestinal obstruction). INTERPRETATION: Neither avelumab plus PLD nor avelumab alone significantly improved progression-free survival or overall survival versus PLD. These results provide insights for patient selection in future studies of immune checkpoint inhibitors in platinum-resistant or platinum-refractory ovarian cancer. FUNDING: Pfizer and Merck KGaA, Darmstadt, Germany.

Pujade-Lauraine, E., et al. (2023). "Maintenance olaparib rechallenge in patients with platinum-sensitive relapsed ovarian cancer previously treated with a PARP inhibitor (OReO/ENGOT-ov38): a phase IIIb trial." Annals of Oncology 34(12): 1152-1164.
	Background: Poly(ADP-ribose) polymerase (PARP) inhibitor maintenance therapy is the standard of care for some patients with advanced ovarian cancer. We evaluated the efficacy and safety of PARP inhibitor rechallenge.; Patients and Methods: This randomized, double-blind, multicenter trial (NCT03106987) enrolled patients with platinum-sensitive relapsed ovarian cancer who had received one prior PARP inhibitor therapy for ≥18 and ≥12 months in the BRCA-mutated and non-BRCA-mutated cohorts, respectively, following first-line chemotherapy or for ≥12 and ≥6 months, respectively, following a second or subsequent line of chemotherapy. Patients were in response following their last platinum-based chemotherapy regimen and were randomized 2 : 1 to maintenance olaparib tablets 300 mg twice daily or placebo. Investigator-assessed progression-free survival (PFS) was the primary endpoint.; Results: Seventy four patients in the BRCA-mutated cohort were randomized to olaparib and 38 to placebo, and 72 patients in the non-BRCA-mutated cohort were randomized to olaparib and 36 to placebo; >85% of patients in both cohorts had received ≥3 prior lines of chemotherapy. In the BRCA-mutated cohort, the median PFS was 4.3 months with olaparib versus 2.8 months with placebo [hazard ratio (HR) 0.57; 95% confidence interval (CI) 0.37-0.87; P = 0.022]; 1-year PFS rates were 19% versus 0% (Kaplan-Meier estimates). In the non-BRCA-mutated cohort, median PFS was 5.3 months for olaparib versus 2.8 months for placebo (HR 0.43; 95% CI 0.26-0.71; P = 0.0023); 1-year PFS rates were 14% versus 0% (Kaplan-Meier estimates). No new safety signals were identified with olaparib rechallenge.; Conclusions: In ovarian cancer patients previously treated with one prior PARP inhibitor and at least two lines of platinum-based chemotherapy, maintenance olaparib rechallenge provided a statistically significant, albeit modest, PFS improvement over placebo in both the BRCA-mutated and non-BRCA-mutated cohorts, with a proportion of patients in the maintenance olaparib rechallenge arm of both cohorts remaining progression free at 1 year.; Competing Interests: Disclosure EPL reports lecture fees, fees for serving on a speakers bureau, and travel support from AstraZeneca, GSK, Roche, and Tesaro; lecture fees from Clovis Oncology and Pfizer; expert testimony fees from AstraZeneca; support for attending meetings and/or travel from AstraZeneca and GSK; fees from AstraZeneca, Incyte, and Roche for participating on a data safety monitoring board or advisory board; and employment by ARCAGY Research. FS reports institutional research funding from AstraZeneca, Agenus, GSK/Tesaro, Immunogen, Incyte, MSD, and Roche; and honoraria from AstraZeneca, Clovis Oncology, GSK/Tesaro, MSD, and Sandoz (Novartis). GS reports grant/research support from MSD Italia S.r.l.; consulting fees from Johnson & Johnson and Tesaro Bio Italy S.r.l.; and speakers bureau fees/honoraria from Clovis Oncology Italy S.r.l. and MSD Italia Srl. BA reports honoraria from BMS, AstraZeneca, Roche, Daiichi, Servier, and Pierre Fabre. FM reports support for the present manuscript from AstraZeneca; grants or contracts to their institution from AstraZeneca, Clovis, Gilead Sciences, GSK/Tesaro, MSD, Novartis, Roche, and Vaccibody; personal consulting fees from AstraZeneca, Eisai, Genomic Health, GSK/Tesaro, and Pfizer; consulting fees to their institution from Vaccibody; personal/institutional consulting fees from Gilead; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Agendia, AstraZeneca, Clovis, Eli Lilly, Eisai, Genomic Health, GSK/Tesaro, Immunomedics/Gilead, MSD, Myriad Genetics, Novartis, Pfizer, PharmaMar, Pierre Fabre, Roche, and Seattle Genetic; support for attending meetings and/or travel from AstraZeneca, Pfizer, and Roche; and participation on a data safety monitoring board or advisory board for Palleos. KL reports support for the present manuscript from AstraZeneca and Merck; grants to their institution from GSK; consulting fees their institution from AstraZeneca; fees paid to their institution for participation on a data safety monitoring board or advisory board from AstraZeneca, MSD, and Eisai; and being the deputy director of the Nordic Society of Gynecologic Oncology (NSGO) and on the advisory group to the Cancer Registry of Norway cervical cancer reference group. NC reports grants from AstraZeneca, PharmaMar, and Roche; honoraria for lectures from AstraZeneca, Clovis Oncology, Eisai, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, and Tesaro; honoraria for advisory boards from AstraZeneca, BioCad, Clovis Oncology, Eisai, GlaxoSmithKline, Immunogen, Merck Sharp & Dohme, Mersana, Nuvation Bio, OncXerna, Pfizer, PharmaMar, Roche, and Tesaro; and being a steering committee member on European Society for Medical Oncology (ESMO) clinical guidelines and a scientific committee chair for Acto Onlus. RM reports serving on advisory boards with AstraZeneca, Roche, and GSK; and personal fees from AstraZeneca, Roche, and GSK. RG reports support for the present manuscript from AstraZeneca/MSD, including institutional funding for the conduct of the trial; funding for an investigator-initiated study from Clovis Oncology, Boehringer Ingelheim, and Lilly/Ignyta; personal consultancy/advisory board fees from GSK and Clovis Oncology and institutional fees for a trial steering committee from Novartis; honoraria for lectures and educational reports from GSK, honoraria for lectures from Clovis Oncology, and honorarium for educational events from AstraZeneca; virtual meeting registration fees from GSK; participation on an independent data monitoring committee for the MATAO trial; being an International Gynecologic Cancer Society (IGCS) council member and advocacy committee chair elect, and Past Chair of the Gynecologic Cancer InterGroup (GCIG) meta-analysis committee; being Chair of the Scottish Gynaecological Cancer Trials Group (SGCTG) and ovarian cancer workstream committee member of the National Cancer Research Institute (NCRI); and that their institution received niraparib on a drug donation scheme from GSK. IV reports grants or contracts (corporate-sponsored research) from Amgen and Roche; grants or contracts (contracted research via KULeuven) from Oncoinvent AS and Genmab; consulting fees from Aksebio, Amgen (Europe) GmbH, AstraZeneca, Bristol Myers Squibb, Carrick Therapeutics, Clovis Oncology, Deciphera Pharmaceuticals, Eisai, Elevar Therapeutics, F. Hoffman-La Roche Ltd., Genmab, GSK, Immunogen Inc., Jazz Pharma, Karyopharm, Mersana, Millennium Pharmaceuticals, MSD, Novocure, Novartis, Octimet Oncology NV, Oncoinvent AZ, Seagen, Sotio a.s., Verastem Oncology, and Zentalis; and support for attending meetings and/or travel from Amgen, AstraZeneca, MSD, Roche, and Tesaro. SL reports support for the present manuscript from AstraZeneca; grants or contracts to their institution from Merck, AstraZeneca, Regeneron, Roche, Repare, GSK, and Seagen; consulting fees from Novocure, Merck, AstraZeneca, GSK, Eisai, and Shattuck Labs; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from AstraZeneca, GSK, and Eisai; and participation on a data safety monitoring board or advisory board from AstraZeneca. CD reports participation on a data safety monitoring board or advisory board for MSD, Eisai, and AstraZeneca. AO reports grants to their institution from AbbVie Deutschland GmbH & Co. Hg, Ability Pharmaceuticals, Advaxis, Agenus, Aprea Therapeutics AB, Beigene USA, Inc., Belgian Gynaecological Oncology Group (BGOG), Bristol Myers Squibb International Corporation, Clovis Oncology, Corcept Therapeutics, Eisai, F. Hoffmann-La Roche Ltd., Grupo Español de Investigación en Cáncer de Ovario (GEICO), Immunogen, Iovance Biotherapeutics, Lilly, Medimmune, Merck Sharp & Dohme, Millennium Pharmaceuticals, Mundipharma Research, Novartis Farmacéutica, Regeneron Pharmaceuticals, Seagen, Seattle Genetics, Sutro Biopharma, Tesaro, University Health Network, and Werastem; payment or honoraria for lectures, presentations, peakers bureaus, manuscript writing, or educational events from AstraZeneca, Clovis Oncology, Deciphera Pharmarceuticals, Genmab, GSK, Immunogen, Mersana Therapeutic, PharmaMar, Roche, Sutro, and Tesaro; support for attending meetings and/or travel from AstraZeneca, PharmaMar, and Roche; and participation on a data safety monitoring board or advisory board for Agenus, AstraZeneca, Clovis Oncology, Inc., Corcept Therapeutics, Deciphera Pharmaceuticals, Eisai Europe Limited, EMD Serono, Inc., F. Hoffmann-La Roche, GlaxoSmithKline, Immunogen, KL Logistics, Medison Pharma, Merck Sharp & Dohme de España, Mersana Therapeutics, Novocure GmbH, Pharma Mar, prIME Oncology, Roche Farma, Sattucklabs, and Sutro Biopharma, Inc. CZ reports grants or contract to self from Amgen, Celgene, Daiichi, Eisai, Eli Lilly, GSK, MSD, and PharmaMar; grants or contract to self and institution from AstraZeneca, Instituto Gentili, Novartis, Pfizer, Pierre Fabre, Roche, Seagen, Tesaro, and Teva; support for attending meetings and/or travel from Celgene, Instituto Gentili, Novartis, Pfizer, PharmaMar, Pierre Fabre, Roche, and Tesaro; participation on a data safety monitoring board or advisory board for Amgen, AstraZeneca, Celgene, Daiichi, Eisai, Eli Lilly, GSK, MSD, Novartis, Pfizer, PharmaMar, QuintilesIMS, Roche, and Tesaro; and other financial or non-interests for Amgen, AstraZeneca, Daiichi, GSK, MSD, Novartis, Pfizer, PharmaMar, QuintilesIMS, Roche, and Tesaro. FH reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Amedes, AstraZeneca, Clovis, GSK, Novocure, PharmaMar, Roche, and Tesaro; participation on a data safety monitoring board or advisory board for Amedes, AstraZeneca, Clovis, GSK, Roche, and Tesaro; and leadership or fiduciary role in the AGO study group. LG reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AstraZeneca, Clovis, Eisai, GSK, and MSD; and participation on an advisory board for AstraZeneca, GSK, and MSD. PS reports honoraria from GSK. CB reports full-time employment with AstraZeneca during the conduct of the study and AstraZeneca stock ownership. BS reports full-time employment with AstraZeneca during the conduct of the study and AstraZeneca stock ownership. IR-C reports grants to self from BMS, MSD, and Roche; grants to their institution from AstraZeneca, BMS, Merck Serono, MSD, Novartis, and Roche; consulting fees from AstraZeneca, Agenus, Advaxis, Amgen, BMS, Clovis, Deciphera, Genmab, GSK, Mersana, Merck Serono, MSD, Novartis, Pfizer, PharmaMar, Roche/Genentech, and Tesaro; payment or honoraria to self for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie, Agenus, Advaxis, Amgen, AstraZeneca, BMS, Clovis, Deciphera, Genmab, GSK, Mersana, Merck Serono, MSD, Novartis, Pfizer, PharmaMar, Roche, and Tesaro; payment or honoraria to institution for lectures, presentations, speakers bureaus, manuscript writing, or educational events from BMS, GSK, MSD, and Roche; and support for attending meetings and/or travel from AstraZeneca, GSK, and Roche. AR reports consulting fees from AstraZeneca, Clovis, GSK, MSD, and PharmaMar; payment or honoraria to self for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AstraZeneca, Clovis, GSK, MSD, and PharmaMar; and support for attending meetings and/or travel from AstraZeneca, Clovis, and PharmaMar. All other authors have declared no conflicts of interest. (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Pulatova, A., et al. (2023). "Pelvic floor muscle exercises plus biofeedback versus pelvic floor muscle exercises for patients with stress urinary incontinence: A systematic review and meta-analysis of randomized controlled trials." Electronic Journal of General Medicine 20(5): em520.
	Background: Stress urinary incontinence (SUI) is a widespread illness that mostly affects women, particularly those who have recently given birth or gone through menopause. The purpose of this meta-analysis is to compare the effectiveness of pelvic floor muscle exercises (PFME) plus biofeedback to PFME alone in treating SUI in female patients. Method(s): We systemically searched six electronic databases (PubMed, Scopus, and Web of Science) from inception until February 7, 2022. We included randomized controlled trials (RTCs) comparing patients who had undergone PFME plus biofeedback to PFME alone. For risk of bias-2 (RoB2) assessment, we used cochrane risk of bias assessment tool. Continuous data were pooled as standardized mean difference (SMD), and dichotomous data were pooled as odds ratio with the corresponding 95% confidence intervals (CI). Result(s): 15 RCTs were included, with a total of 788 patients with SUI. The overall effect estimate between PFME+BF and PFME alone groups favored the PFME+BF group in improving PFME strength (SMD=0.33, 95% CI [0.14 to 0.52], p=.0009) and did not favor either of the two groups for quality of life (SMD=-0.22, 95% CI [-0.44 to 0.00], p=0.05), leakage (SMD=-0.10, 95% CI [-0.37 to 0.17], p=0.47), pad weight test (SMD=-0.22, 95% CI [-0.44 to 0.00], p=0.05), cure rate (odd ratio [OR]=2.44, 95% CI [0.52 to 11.42, p=0.26), and social activity (SMD=0.66, 95% CI [-0.04 to 1.36], p=0.07). Conclusion(s): BF addition to PRME improves cure rate and PFME strength without affecting leakage or quality of life. Healthcare providers must consider patient safety and comfort while choosing BF devices with PFME. SUI management strategies should include BF to improve results.Copyright © 2023 by Author/s and Licensed by Modestum.

Purwar, R., et al. (2023). "Role of PARP inhibitors beyond BRCA mutation and platinum sensitivity in epithelial ovarian cancer: a meta-analysis of hazard ratios from randomized clinical trials." World Journal of Surgical Oncology 21(1): 157.
	Background: PARP inhibitors (PARPi) have a well-established role in platinum-sensitive ovarian cancer (PSOC), in BRCA mutant (BRCAm), and homologous recombination deficiency (HRD) population. However, their role in wild type and homologous recombination proficient population is still not clear.; Methods: A meta-analysis of hazard ratios (HR) of randomized control trials (RCTs) was conducted to study the role of PARPi. The published RCTs comparing the efficacy of PARP inhibitors alone or in combination with chemotherapy and/or target therapies versus placebo/chemotherapy alone/target therapy alone in primary or recurrent ovarian cancer settings were selected. Progression-free survival (PFS) and overall survival (OS) were the primary endpoints.; Results: A total of 14 primary studies and 5 updated studies are considered, consisting of 5363 patients. Overall, HR for PFS was 0.50 [95% CI 0.40-0.62]. HR of PFS was 0.94 [95% CI 0.76-1.15] in the PROC group, 0.41 [95% CI 0.29-0.60] was in HRD with BRCA unknown (BRCAuk), 0.38 [95% CI 0.26-0.57] in HRD with BRCAm, and 0.52 [95% CI 0.38-0.71] in HRD with BRCAwt. In the HRP group, overall HR for PFS was 0.67 [95% CI 0.56-0.80], 0.61 [95% CI 0.38-0.99] in HRD unknown with BRCA wt, and 0.40 [95% CI 0.29-0.55] in BRCAm HR for PFS. Overall, HR for OS was 0.86 [95% CI 0.73-1.031].; Conclusions: The results suggest that PARPi have a meaningful clinical benefit in PSOC, HRD, BRACm, and also in HRP and PROC; however, the evidence is not sufficient to recommend their routine use and further studies are needed to expand their role in the HRP and PROC groups. (© 2023. The Author(s).)

Putri, I. (2022). "pRophylactic utErosacral suspension AT Total lAparoscopiC Hysterectomy and the risk of prolapse occurrence – a randomised controlled trial (REATTACH)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Consistent with our standard technique of hysterectomy, gynaecological surgeons commence the exposure of the uterosacrals by developing the medial pararectal space of Okabayashi. By this stage the lateral pararectal space of Latzko already has already been developed, ureters identified and lysed if necessary, and uterine vessels secured at the origin of the internal iliacs. The ureter is identified separating these two potential spaces, with the medial dissection carried to expose the uterosacral through its entire extent, especially the junction of the upper and middle thirds. The inferior hypogastric nerve is identified and preserved whenever possible. If excision of deep infiltrating endometriotic deposits make the preservation of parts of the uterosacrals untenable, a proximal anchor towards the upper third of the ligament is chosen. A marking stitch may be appropriate in such cases for easy identification. The hysterectomy will then proceed per usual methods, including possible removal of associated adnexae. Uniformity of surgery will be ensured by a single surgical team performing all surgeries. For patients that are randomised to the high uterosacral suspension arm, following the hysterectomy ensuring adequate “pedicalisation” of the uterine vessels, the assistant places the uterosacral ligament ligament under stretch by lifting the vaginal angle. A 0 Prolene D7580 on a 26 mm CT2 needle is cut to 30 cm length (shorter if 2 separate suture packs used). The uterosacral ligament is plicated in an inside‐out, outside‐in fashion, always commencing within the medial rectal space with the ureter coursing laterally in view. This suture is then driven through the bulky attachment of the uterosacral to the peri‐cervical ring. The next bite is taken lateral to the va CONDITION: Reproductive Health and Childbirth ‐ Other reproductive health and childbirth disorders Surgery ‐ Other surgery Uterovaginal prolapse; ; Uterovaginal prolapse PRIMARY OUTCOME: ‐ Change in sexual function assessed using the PISQ‐12 questionnaire;; ; [Baseline (pre‐surgery) and 3 months post surgery] ‐ Change in symptom distress from pelvic floor dysfunction assessed using the PFDI ‐ 20;; ; [Baseline (pre‐surgery) and 3 months post surgery] ‐ Quantitative C point; ; (C point is part of POP Q (pelvic organ prolapse quantification) assessment, which is the distance the cervix (or vault in a post hysterectomy setting) from the hymenal remnant). Data collected at different time points will be stored on a data collection spreadsheet stored on REDCap at Townsville University Hospital. REDCap (Research Electronic Data capture) is a secure, web‐based software platform about the study.; [post surgery, 6 and 12 months (primary endpoint)] SECONDARY OUTCOME: length of operative time through an audit of operative notes by obtaining surgery start and end times ; ; [immediately post‐surgery] presence of complications such as rates of urinary retention, urinary tract infection, bladder injury, paraesthesia. This data will be obtained through an audit of operative notes and will be asked to patients in the phonemail for their routine 3 months followup in going through their questionnaire[3 months post surgery] INCLUSION CRITERIA: • Patients must be 18 years of age or older • Patients must be able to provide informed consent • Preoperative inclusion criteria include: C point not past the hymenal remnant, i.e. C point at point 0 at Valsalva • Patients with no prolapse symptoms • A Pelvic ultrasound scan (USS) in the last 6 months from booking of procedure to show that size of uterus is less than or equal to 300cc

Qi, J. and Z. Na (2021). "The effecacy of administering GnRH agonist or Estradiol versus standard regimen during luteal phase in women undergoing ART with GnRH antagonist protocol: A meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Qi, J., et al. (2023). "Non-pharmacological interventions for polycystic ovary syndrome (PCOS) with hyperandrogenism: a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Qian, J., et al. (2023). "The effect of exercise intervention on improving sleep in menopausal women: a systematic review and meta-analysis." Frontiers in Medicine 10: 1092294.
	BACKGROUND: Sleep disturbance is common in menopausal women and negatively affects their quality of life and could cause increased risks of other menopause-related diseases. OBJECTIVE: This systematic review aims to synthesize evidence regarding the effects of exercise interventions on improving sleep in menopausal women. METHODS: A comprehensive search in seven electronic databases for randomized controlled trials (RCTs) was performed on June 3, 2022. The systematic review included seventeen trials, ten of which provided data for the meta-analysis. The effects on outcomes were presented as mean differences (MDs) or standard mean differences (SMDs) and their 95% confidence intervals (CI). Cochrane risk-of-bias tool was used in quality assessment. RESULTS: The results suggest that exercise intervention significantly reduces insomnia severity (SMD = -0.91, 95% CI = -1.45 to -0.36, Z = 3.27, P = 0.001) and alleviates sleep problems (MD = -0.09, 95% CI = -0.17 to -0.01, Z = 2.20, P = 0.03). For sleep quality, the results showed that insignificant differences were found between the exercise intervention and the control groups (MD = -0.93, 95% CI = -2.73 to 0.87, Z = 1.01, P = 0.31). The results of the subgroup analysis indicated that more apparent effects of exercise intervention were found among women with sleep disorders than among women without sleep disorders. Which exercise intervention duration was more beneficial to sleep outcomes could not be judged. Overall, there was a moderate risk of bias in the primary studies. CONCLUSION: According to this meta-analysis, exercise interventions can be recommended for menopausal women to improve their sleep. High-quality RCTs applying different types of exercise (e.g., walking, yoga, meditative exercise and so on) with different intervention durations as well as subjective and objective sleep assessment are warranted. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022342277, identifier: CRD42022342277.

Qiaorui, Y. and F. Zhenliang (2022). "Efficacy of vitamin D, inositol, berberine and metformin in improving the endocrine and metabolic profiles in women with polycystic ovary syndrome: a network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Qiaosong, H., et al. (2023). "The effect of traditional Chinese medicine on in vitro fertilization/intracytoplasmic sperm injection-embryo transfer clinical outcomes: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Qiliang, J., et al. (2024). "The efficacy of sequential frozen-thawed embryo transfer on clinical pregnancy outcomes in patients with repeated implantation failure: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Qin, F., et al. (2020). "Comparison of clomiphene and letrozole for superovulation in patients with unexplained infertility undergoing intrauterine insemination: A systematic review and meta-analysis." Medicine 99(31): e21006.
	Background: With the medical advancement some studies put forward that letrozole (LE), a specific aromatase inhibitor with the function of reducing oestrogen synthesis, has recently been applied as a potentially better alternative compared with clomiphene citrate (CC), owing to that it has a superior efficacy as compared with CC in patients of unexplained infertility undergoing intrauterine insemination (IUI). However, there is no one study can clear and definite whether LE can replace the CC as first line drug.; Objective: Our objective is to compare the LE with CC in the induction of ovulation in patients with unexplained infertility IUI.; Method: Searching databases consist of all kinds of searching tools, such as Medline, The Cochrane Library, Embase, PubMed, etc. All the include studies should meet our demand of this meta-analysis: RESULT:: Based on the current meta-analysis, we rigorously consider that LE has a likelihood to improve dominant follicles (MD= -0.56, I= 100%, P= .04; MD= -0.39, I= 73%, P = .0003, respectively) and reduces the miscarriage rate (RR= 0.61, I= 0%, P = .03). There is no significant differences between the 2 groups in The total rate of pregnancy, pregnancy rate per cycle, multiple pregnancy and endometrial thickness. (RR= 1.06, I= 11%, P = .38; RR= 1.09, I= 7%, P = .32; RR= 0.79, I= 0%, P = .46; respectively) CONCLUSION:: Combined with the results of current systematic review and meta-analysis through subgroup analysis and sensitivity analysis, we can be cautious: in general, compared with CC, LE is an effective treatment in the IUI cycle, has a likelihood to improve dominant follicles and reduces the miscarriage rate.

Qin, X., et al. (2023). "The efficiency of uterine infusion strategies on pregnant outcomes in patients with recurrent implantation failure: A pairwise and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Qingzhi, W., et al. (2023). "A meta-analysis of Kuntai capsule improving ovarian function and IVF outcome in patients with DOR/POR." PROSPERO International prospective register of systematic reviews.
	Review question Does Kuntai capsule supplementation for patients with DOR/POR can improve ovarian function and IVF outcome? Searches [1 change] PubMed，Cochrane Library，EMBASE，CNKI，Wanfang Data，VIP Database. The publication time is from the start to each database up to 1 May , 2024 Types of study to be included Randomized controlled clinical trials(RCTs) Condition or domain being studied Poor ovarian response，Diminished ovarian reserve，Kuntai capsule，IVF-ET Participants/population Patients who were diagnosed as POR, DOR during IVF-ET. There was no limit to the patient’s age, region, occupation, race, nationality, course of disease and so on. Intervention(s), exposure(s) Kuntai capsule will be used only or in combination before or during superovulation. Comparator(s)/control The control group was treated with western medicine, placebo or no adjuvant therapy before or during superovulation. Main outcome(s) 1. the number of oocytes retrieved 2. the number of MII oocytes 3. clinical preganancy rate(CPR) Additional outcome(s) 1. AMH—anti-mullerian hormone 2. AFC—antral follicle count 3. The dosage of Gonadotropin(Gn) 4. The E2 level on the day og HCG injection 5. Total embryos 6. Miscarriage rate(MR) 7. Live birth rate(LBR) Data extraction (selection and coding) Study selection: The number of researchers meets the standard. Two researchers indepently review the literature and cross check it. In case of any divergence, they will discuss it or submit it to a third party for decision. Data extraction: The number of researchers meets the standard. Two researchers indepently extract the literature data and cross check them. In case of any divergence of literature, they will discuss it or submit it to a third party for decision. Risk of bias (quality) assessment According to 5.1.0 of Cochorane manual, the risk of bias was assessed for each RCT study including randomized method, assignment concealment, blind method application, lost visit and drop off analysis, selective report and other deviation. Strategy for data synthesis Two author will use the Review Manager(RevMan)version 5.3(Copenhagen, The Nordic Cochrane Centre, the Cochrane Collaboration, 2012)software programme provided by Cochrane Collaboration to conduct Meta analysis. Using χ² test for heterogeneity test. If P>0.10, it is considered that many similar studies are homogeneous, and the fixed-effects model is used to calculate the combined statistics. If P ≤ 0.10, it represents the heterogeneity of multiple research results, and the random-effects model is used to calculate the combined statistics. When the analysis index is a binary variable, the combined statistics of ratio (odds ratio, OR) and relative risk (relative risk, RR) are selected. If the analysis index is a numerical variable, choose mean difference (MD, WMD) or standardized mean difference (SMD) to merge statistics. Both of them judge whether there is statistical significance according to 95% confidence interval (CI). Analysis of subgroups or subsets Subgroup analysis and sensitivity analysis will also be performed if necessary to identify the source of heterogeneity. Contact details for further information wan qingzhi wanqingzhi2022@163.com Organisational affiliation of the review [1 change] Lianyungang maternal and Child Health Hospital http://www.njucm.edu.cn/ Review team members and their organisational affiliations [1 change] Dr Qingzhi Wan. Lianyungang maternal and Child Health Hospital Dr Yaru Zhu. Lianyungang maternal and Child Health Hospital Dr Bo Wang. Lianyungang maternal and Child Health Hospital Dr Yinghuan Li. Lianyungang maternal and Child Health Hospital Dr Xinwen Zhang. Lianyungang maternal and Child Health Hospital Type and method of review Meta-analysis, Systematic review Anticipated or actual start date [1 change] 01 May 2024 Anticipated completion date [1 change] 30 May 2024 Funding sources/sponsors none Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Dietary Supplements; Female; Fertilization in Vitro; Humans; Ovarian Reserve; Pregnancy; Pregnancy Rate Date of registration in PROSPERO 20 January 2023 Date of first submission 09 January 2023 Stage of review at time of this submission The review has not started

Qiongnan, B., et al. (2023). "Comparative effectiveness of non-pharmacological interventions for primary dysmenorrhea: a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question Whether different non-pharmacological interventions can alleviate pain in primary dysmenorrhea and which one should be preferred? Searches The literature search will be performed using PubMed, Embase, Web of Science, and the Cochrane Library. The year of publication will be limited to January, 2000 - November 2023. Only full-text published in English will be included. In addition, the references of relevant reviews will be also searched to identify further potential studies for inclusion. Types of study to be included Randomized controlled trials Condition or domain being studied Non-pharmacological interventions for primary dysmenorrhea Participants/population Inclusion criteria: (1) women who had menstrual pain without underlying cause, regardless of severity or duration of disease; (2) had a regular menstrual period and cycles; (3) being older than 18 years. Exclusion criteria: (1) postmenopausal women; (2) women with secondary dysmenorrhea caused by ovarian cysts, endometriosis, uterine myomas, or pelvic inflammatory disease; (3) taking analgesics, contraceptives or any other drugs; (4) presence of psychiatric disorders. Intervention(s), exposure(s) Any structured non-pharmacological interventions, including manual acupuncture, electro-acupuncture, acupressure, auriculotherapy, transcutaneous electrical nerve stimulation, massage, aromatherapy, moxibustion, exercise, et al, used as intervention, will be included. Studies used drugs as intervention will be excluded. Comparator(s)/control Another type of non-pharmacological interventions, usual care, no treatment, waitlist, or sham controlled studies will be included. Those compared with medication or different type of the same non-drug intervention will be excluded. Main outcome(s) Short-term and long-term efficacy of non-pharmacological treatment. Short-term efficacy is defined as changes in pain intensity from baseline to the end of treatment. Long-term efficacy is defined as pain intensity changes from baseline to the end of follow-up (1-12 months). Pain intensity was evaluated by validated scales, including visual analogue scale (VAS), numeric rating scale (NRS), retrospective symptom scale-severity rating score (RSS-COX2), Cox menstrual symptom scale severity rating score (CMSS), McGill Questionnaire Short-form. Additional outcome(s) None Data extraction (selection and coding) We will extract data on study characteristics (e.g., year of publication, sample size, intervention and comparator), participant characteristics (e.g. number of patients, mean age and standard deviation), outcomes results (changes in pain intensity from baseline to the end of treatment and follow-up) from the included RCTs. Study authors will be contacted if important data appear to be missing or are unclear. Data abstraction will be completed by pair of independent reviewers, conflicts will be resolved by a third reviewer. Risk of bias (quality) assessment The revised Cochrane risk of bias tool for randomized trials (RoB 2) will be used to assess the risk of bias of included trials. Strategy for data synthesis Firstly, pairwise meta-analyses will be performed to directly compare the treatment effects of any two nonpharmacological interventions. All data will be continuous variables, the standardized mean difference (SMD) will be presented with 95% CI. The I² test will be used to assess heterogeneity between studies, with 25%, 50%, and 75% indicating mild, moderate, and high heterogeneity severally. A fixed-effects model will be applied if I² ＜ 50%; otherwise, the random effects model will be used. Then, the Bayesian random-effects network meta-analysis model will be used to compare multiple regimens simultaneously. The node splitting methods will be used to investigate the inconsistency between direct and indirect comparisons from the network. A consistency model will be adopted if the p-value exceeds 0.05, indicating no significant inconsistency. Comparisons between interventions will be presented as a network plot. Finally, the rankings will then be generated for each non-pharmacological interventions. The pairwise meta-analyses will be conducted using RevMan V.5.4. The network meta-analysis will be performed using ADDIS V.1.16.8. The networkplot command of Stata V.17 will be used to draw the network plots. Analysis of subgroups or subsets If the necessary data are available, subgroup analysis will be conducted based on different treatment timing and courses. Contact details for further information Qiongnan Bao baoqn1111@163.com Organisational affiliation of the review School of Acu-Mox and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China Review team members and their organisational affiliations Dr Qiongnan Bao. School of Acu-Mox and Tuina, Chengdu University of Traditional Chinese Medicine Miss Jin Yao. School of Acu-Mox and Tuina, Chengdu University of Traditional Chinese Medicine Dr Zihan Yin. School of Acu-Mox and Tuina, Chengdu University of Traditional Chinese Medicine Professor Fanrong Liang. School of Acu-Mox and Tuina, Chengdu University of Traditional Chinese Medicine Type and method of review Network meta-analysis, Systematic review Anticipated or actual start date 15 October 2023 Anticipated completion date 01 March 2024 Funding sources/sponsors This review will be funded by the State Administration of Traditional Chinese Medicine, National key research and development program of China (No. 2019YFC1709700), the National Natural Science Foundation of China (Nos. 81973961, 82004486), and the Project of Science and Technology Department of Sichuan Province (No. 2021YFS0087). Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms MeSH headings have not been applied to this record Date of registration in PROSPERO 13 October 2023 Date of first submission 02 October 2023 Stage of review at time of this submission The review has not started

Qiu, P., et al. (2023). "Curative effect of oral Chinese medicine on recurrent ovarian endometriosis cyst;A systematic review and meta-analysis of radomized controllded trials." PROSPERO International prospective register of systematic reviews.
	Review question Assess the effectiveness and safety of oral Chinese medicine on recurrent ovarian endometriosis cyst. Searches PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure(CNKI), Chinese Scientifific Journal Database(VIP), Wanfang Database, and Sinomed were systematically searched from the inception dates to October 30, 2023 Types of study to be included Only RCT studies were included.The included studies met diagnostic criteria for recurrent ovarian endometriosis cysts, and the intervention measures were the use of oral Chinese medicine alone or the addition of oral Chinese medicine to the control group. The control group was treated with conventional western medicine. The outcomes included total effective rate, ovarian endometriosis cyst size, TCM syndrome score, serum ca125 level, serum IL-2, IL-6 levels, recurrence rate, and adverse reactions. Exclusion criteria include the following: (1) ovarian endometriosis cyst diameter greater than 7cm; (2) interventions combined with acupuncture, TCM enema or other TCM external treatment; (3) Duplicate literature; (4) Animal experiments Condition or domain being studied Endometriosis is a chronic recurrent disease with an annual recurrence rate of about 10%. Recurrent ovarian endometriosis cysts are the most common recurrent type of endometriosis and the main cause of reoperation. Histologically, although the lesion is benign, it has a variety of malignant biological behaviors, such as recurrence, metastasis, invasion, proliferation, etc., which poses a serious threat to female reproduction and life safety, so it has received clinical attention. How to prevent and treat the recurrence of cysts after operation is a difficult problem in clinical research. In recent years, traditional Chinese medicine has gradually become one of the important means to treat recurrent ectopic endometrial cysts because of its unique treatment system and good clinical effect, but there is a lack of evidence-based evidence. Therefore, it is necessary to comprehensively evaluate the effectiveness and safety of Chinese medicine for patients with recurrent ovarian endometrial cysts by evidence-based medicine, so as to guide the current practice and the treatment of recurrent endometrial cysts in the future. Participants/population The included studies met diagnostic criteria for recurrent ovarian endometriosis cysts, and the intervention measures were the use of oral Chinese medicine alone or the addition of oral Chinese medicine to the control group. The control group was treated with conventional western medicine. The outcomes included total effective rate, ovarian endometriosis cyst size, TCM syndrome score, serum ca125 level, serum IL-2, IL-6 levels, recurrence rate, and adverse reactions. Exclusion criteria include the following: (1) ovarian endometriosis cyst diameter greater than 7cm; (2) interventions combined with acupuncture, TCM enema or other TCM external treatment; (3) Duplicate literature; (4) Animal experiments Intervention(s), exposure(s) The intervention measures were using oral Chinese medicine treatment alone or adding oral Chinese medicine treatment on the basis of control group Comparator(s)/control The control group was treated with conventional western medicine. Main outcome(s) The main outcomes included total effective rate, ovarian endometriosis cyst size, TCM syndrome score, serum ca125 level Additional outcome(s) Additional outcomes included serum IL-2, IL-6 levels, recurrence rate, adverse reactions Data extraction (selection and coding) Two independent reviewers search and screen the literature according to the research protocol. Any discrepancies will be resolved through consensus and arbitrated by a third author if necessary. Data extracted from the selected studies included author names, year of publication, subject characteristics, sample size, grouping, intervention method, course of treatment, follow-up duration, and outcome measures. Risk of bias (quality) assessment The quality assessment of individual trial was performed using Cochrane Risk of Bias tool, which considers the following: (1) Random sequence generation; (2) Allocation concealment; (3) Blinding of participants and personnel; (4) Binding of outcome assessment; (5) Incomplete outcome data; (6)Selective outcome reporting; (7)Other sources of bias. The evaluation criteria of each item were judged as "low risk of bias","unclearrisk of bias”and“high risk of bias". Strategy for data synthesis We analyse data using Review Manager 5.3.Risk ratio(RR) and meandifference(MD) with their 95% confidence intervals(CI) were used for dichotomous outcomes and continuous outcomes, separately.I² statisticswere used to measure heterogeneity.A fixed-effect(FE) model was used if I²＜50%;otherwise, the random-effect(RE) model was used. Analysis of subgroups or subsets If data are available, subgroup analyses by different interventions will be planned Contact details for further information Qiu Ping Lin zam1814@163.com Organisational affiliation of the review Fujian Maternity and Child Health Hospital Review team members and their organisational affiliations Qiu Ping Lin. Fujian Maternity and Child Health Hospital Jin Bang Xu. Fujian Maternity and Child Health Hospital Juan Yang. Fujian Maternity and Child Health Hospital Li Hua Lin. Fujian Maternity and Child Health Hospital Hui Bin Zhang. Fujian Maternity and Child Health Hospital Type and method of review Meta-analysis, Systematic review Anticipated or actual start date 14 November 2023 Anticipated completion date 31 December 2023 Funding sources/sponsors none Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms MeSH headings have not been applied to this record Date of registration in PROSPERO 24 November 2023 Date of first submission 13 November 2023 Stage of review at time of this submission The review has not started

Quan, K. and M. Wu (2022). "A Systematic review and meta-analysis of the effects of intervention on PCOS complicated with fatty liver." PROSPERO International prospective register of systematic reviews.
	Review question Whether intervention can effectively reduce the incidence and grade of PCOS fatty liver disease. Searches We will search, with no time restrictions, the following databases for relevant English language literature: PubMed (MEDLINE), the Cochrane Central Register of Controlled Trials (CENTRAL) and Web of Science.The search string will be built as follows:(Polycystic ovary syndrome OR PCOS) AND (Intervention ) AND (Non-alcoholic Fatty Liver Disease OR NAFLD OR Nonalcoholic Fatty Liver Disease OR Fatty Liver, Nonalcoholic OR Nonalcoholic Fatty Liver OR Nonalcoholic Fatty Livers OR Nonalcoholic Steatohepatitis). The electronic database search will be supplemented by a manual search of the reference lists of included articles. We will search articles in three electronic database including PubMed, EMBASE and Cochrane Library. All the English publications until 30 May 2022 will be searched without any restriction of countries or article type. Reference list of all selected articles will independently screened to identify additional studies left out in the initial search. Types of study to be included RCT Condition or domain being studied Polycystic ovary syndrome (PCOS) is a multifactorial endocrine and metabolic syndrome with clinical manifestations of chronic persistent ovulation disorder, infertility, insulin resistance and polycystic ovary changes. It affects menstruation, fertility, and can lead to diabetes, coronary heart disease, hypertension, fatty liver and a series of complications. Studies have reported that women with PCOS are at increased risk of NAFLD. This article reviews the research progress of lifestyle intervention in PCOS fatty liver patients, including drug intervention, increasing exercise, weight control, improving mood, ensuring sleep, improving diet and so on. Participants/population the patients of nonalcoholic fatty liver disease in PCOS Intervention(s), exposure(s) drug intervention, increasing exercise, weight control, improving mood, ensuring sleep and improving diet in PCOS patients with fatty liver. Comparator(s)/control Non-pharmacological or non-lifestyle interventions Context Polycystic ovary syndrome with nonalcoholic fatty liver disease Main outcome(s) BMI or liver function indicators(ALT /AST) and liver morphology under B-mode ultrasound were used as observational indicators. Measures of effect For studies that published their findings as mean values with ranges, standard deviations were calculated using statistical algorithms. Heterogeneity among cases was evaluated by the χ² test with significance set at P-values of <0.10; if heterogeneity among studies was high, we used the random-effects model; otherwise, we used the fixed-effects model. Additional outcome(s) Sex hormone or insulin resistance index was used as secondary observation Measures of effect For studies that published their findings as mean values with ranges, standard deviations were calculated using statistical algorithms. Heterogeneity among cases was evaluated by the χ² test with significance set at P-values of <0.10; if heterogeneity among studies was high, we used the random-effects model; otherwise, we used the fixed-effects model. Data extraction (selection and coding) ll analyses were performed using Review Manager 5.6 (Cochrane Collaboration, Oxford, UK) and STATA 12.0 (StataCorp, College Station, TX, USA). Risk of bias (quality) assessment Review Manager 5.6 (Cochrane Collaboration, Oxford, UK) Strategy for data synthesis All analyses were performed using STATA 12.0 (StataCorp, College Station, TX, USA). We used the weighted mean difference to analyze continuous variables, and the OR was used as the summary statistic for dichotomous variables. For studies that published their findings as mean values with ranges, standard deviations were calculated using statistical algorithms. Heterogeneity among cases was evaluated by the χ² test with significance set at P-values of <0.10; if heterogeneity among studies was high, we used the random-effects model; otherwise, we used the fixed-effects model. Analysis of subgroups or subsets Not applicable Contact details for further information quan kewei 279271961@qq.com Organisational affiliation of the review Dongguan Hospital of Traditional Chinese Medicine http://www.dg-tcm.com Review team members and their organisational affiliations Ms quan kewei. Dongguan Hospital of Traditional Chinese Medicine Ms Wu mulian. The First Affiliated Hospital of Guangzhou Medical University, Type and method of review Intervention, Living systematic review, Meta-analysis, Systematic review Anticipated or actual start date 31 March 2022 Anticipated completion date 31 July 2022 Funding sources/sponsors NO Grant number(s) State the funder, grant or award number and the date of award NO Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Female; Humans; Non-alcoholic Fatty Liver Disease; Polycystic Ovary Syndrome; Risk Factors Date of registration in PROSPERO 16 June 2022 Date of first submission 05 June 2022

Quan, K., et al. (2022). "Acupuncture as Treatment for Female Infertility: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." Evidence-based Complementary and Alternative Medicine 2022: 3595033.
	Background: The effects of acupuncture on female infertility remain controversial. Also, the variation in the participant, interventions, outcomes studied, and trial design may relate to the efficacy of adjuvant acupuncture. The aim of the study is to systematically evaluate the efficacy and safety of acupuncture for female with infertility and hopefully provide reliable guidance for clinicians and patients.; Methods: We searched digital databases for relevant studies, including EMBASE, PubMed, Cochrane Library, and Web of Science, and the Cochrane Library up to April 2021, for randomized controlled trials (RCTs) evaluating the effects of acupuncture on women undergoing IVF and other treatment. We included studies with intervention groups using acupuncture and control groups consisting of no acupuncture or sham (placebo) acupuncture. Primary outcomes were clinical pregnancy rate (CPR) and live birth rate (LBR). Meta-regression and subgroup analysis were conducted on the basis of ten prespecified covariates to investigate the variances of the effects of adjuvant acupuncture on pregnancy rates and the sources of heterogeneity. Results: Twenty-seven studies with 7676 participants were included. The results showed that the intervention group contributes more in outcomes including live birth rate (RR = 1.34; 95% CI (1.07, 1.67); P < 0.05), clinical pregnancy rate (RR = 1.43; 95% CI (1.21, 1.69); P < 0.05), biochemical pregnancy rate (RR = 1.42; 95% CI (1.05, 1.91); P < 0.05), ongoing pregnancy rate (RR = 1.25; 95% CI (0.88, 1.79); P < 0.05), adverse events (RR = 1.65; 95% CI (1.15, 2.36); P < 0.05), and implantation rate (MD = 1.19; 95% CI (1.07, 1.33); P < 0.05) when compared with the control group, and the difference is statistically significant. In terms of the number of oocytes retrieved, good-quality embryo rate, miscarriages, and ectopic pregnancy rate, the difference between the acupuncture group and the control group was not statistically significant. Conclusions: Our analysis finds a benefit of acupuncture for outcomes in women with infertility, and the number of acupuncture treatments is a potential influential factor. Given the poor reporting and methodological flaws of existing studies, studies with larger scales and better methodologies are needed to verify these findings. More double-blind RCTs equipped with high quality and large samples are expected for the improvement of the level of evidence.; Competing Interests: All authors declare that there are no conflicts of interest. (Copyright © 2022 Kewei Quan et al.)

Queißert, F. (2021). "Prospective, randomized, placebo controlled trial to evaluate the efficacy of transcutaneous stimulation of n. tibialis posterior in treatment of idiopathic overactive bladder." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention 1: Stimulation of the tibial posterior nerve 5 x 15 min a week with the device contic+ and 20 Hz Intervention 2: Stimulation of the fibular superficial nerve 5 x 15 min a week with the device contic+ and 20 Hz. After unblinding on week 6, verum stimulation at tibial posterior nerve will be performed in same setting CONDITION: N31.82 ‐ [generalization N31.8: Other neuromuscular dysfunction of bladder] N39.42 ‐ [generalization N39.4: Other specified urinary incontinence] PRIMARY OUTCOME: Change in Patient Global Impression of Improvement (PGI‐I) SECONDARY OUTCOME: Kings Health Questionnaire; OAB‐SS; Quality of life (QoL); ICIQ‐SF; Reduction of the average frequency of micturition / day; Reduction of average urine loss / day:; ‐ padweight 24h; ‐ Incontinence episodes 24h INCLUSION CRITERIA: Idiopathic overactive bladder Age 18 to 70 years Ability to give consent Oral drug treatment of OAB should be discontinued 4 weeks before the start of treatment or continued for the duration of the study

Quynh, P. N. N., et al. (2023). "PARP inhibitors in newly diagnosed or recurrent ovarian cancer maintenance therapy: evidence of efficacy and safety from randomized controlled trials." Biomedical Research and Therapy 10(12): 6090-6102.
	Objective: This review aimed to systematically synthesize and report the clinical outcomes of poly-ADP ribose polymerase inhibitors (PARPis) for maintenance therapy among ovarian cancer (OC) patients. Method(s): This review was based on the updated PRISMA statement 2020. Eligible studies were identified from PubMed and the Cochrane Library from the database inception to October 7, 2021. Randomized controlled trials reporting the clinical outcomes of PARPis as maintenance therapy for OC were included in this review. The Risk of Bias 2 tool was used for the quality assessment of studies. Result(s): Out of 26 studies, 10 were eligible. For patients with newly diagnosed disease, compared with placebo, either olaparib or niraparib considerably prolonged progression-free survival (PFS), with hazard ratios (HRs) of 0.59 (95% confidence interval [CI]: 0.49-0.72) and 0.62 (95% CI: 0.50-0.76), respectively. Among recurrent patients, olaparib, niraparib, and rucaparib also achieved higher PFS than placebo, with HRs of 0.39 (95% CI: 0.27-0.55), 0.32 (95% CI: 0.23-0.45), and 0.35 (95% CI: 0.28-0.45), respectively. Regarding adverse events, patients taking PARPis experienced a higher risk of hematologic events than the placebo group. Conclusion(s): PARPis as maintenance therapy were beneficial in PFS improvement for OC patients. However, the considerable risk of hematologic events must be considered when using this treatment class.Copyright © Biomedpress. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license.

Rachael, M., et al. (2023). "Update of a systematic review of clinical effects, safety and patient-reported outcomes of treatment for previously treated, recurrent or metastatic cervical cancer." PROSPERO International prospective register of systematic reviews.
	Review question What are the efficacy and patient-reported outcomes of second-line or later (second-line+) treatments for previously treated, persistent/recurrent or metastatic cervical cancer? What is the safety data of second-line or later (second-line+) treatments for previously treated, persistent/recurrent or metastatic cervical cancer? Searches We will search the following databases and information sources: MEDLINE ALL (OvidSP) Embase (OvidSP) Cochrane Database of Systematic Reviews (CDSR) (Cochrane Library / Wiley) Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library / Wiley) HTA Database (https://www.inahta.org/hta-database/) Database of Abstracts of Reviews of Effects (DARE) (https://www.crd.york.ac.uk/CRDWeb/) Search results will be deduplicated against the results of the previous search. The following will be searched for ongoing trials: ClinicalTrials.gov (https://ClinicalTrials.gov./) WHO International Clinical Trials Registry Portal (ICTRP) (https://trialsearch.who.int/Default.aspx) Targeted searches of the following websites will be conducted (from the previous 2022 search to current): Guidelines International Network (GIN) International Guidelines Library (https://www.g-i-n.net/home) ECRI Guidelines Trust (https://guidelines.ecri.org/) Canadian Agency for Drugs and Technologies in Health (CADTH) website (https://www.cadth.ca/) Drugs@FDA (https://www.accessdata.fda.gov/scripts/cder/daf/) If the following conferences have been held since the 2022 search and are not found in Embase, we will undertake a search via conference webpages or journal supplements (if available online free of charge): American Society of Clinical Oncology (ASCO) Annual Meeting. European Society for Medical Oncology (ESMO) Congress. Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer. World Meeting on Sexual Medicine (WMSM). International Society for the Study of Women's Sexual Health (ISSWSH) Annual Meeting. Congress of the European Society for Sexual Medicine (ESSM). European Society of Gynaecological Oncology (ESGO) Congress. American Association for Cancer Research (AACR) Annual Meeting. There will be no language restrictions. Additional search strategy information can be found in the attached PDF document (link provided below). Types of study to be included RCTs (any duration, cross-over RCTs if data presented at time of cross-over), prospective and retrospective non-RCTs (e.g. observational studies) and conference abstracts from 2014 onwards (if reporting sufficient data to determine eligibility or if they support other eligible publications) are eligible. Systematic reviews published from 2014 onwards will be checked to ensure that all relevant primary studies had been identified and assessed for relevance to this review. Systematic reviews will not be data extracted. Open-label extension studies, non-systematic reviews, news items, editorials and case reports are not eligible for inclusion. Condition or domain being studied This review focuses on the safety, efficacy and patient-reported outcomes of second line or later treatments for previously treated, persistent/recurrent or metastatic cervical cancer. Participants/population Participants aged ≥18 years undergoing treatment for cervical cancer. Patients must have persistent/recurrent or (extra-pelvic) metastatic cervical cancer for squamous cell, adenocarcinoma or adenosquamous histologies. Patients with neuroendocrine or sarcomatoid tumours are not eligible. Studies with a mixture of eligible and ineligible histologies will be included if eligible histologies make up 80% of the patients in each arm in the study. Studies with fewer than 10 patients are not eligible. Patients must have been previously treated. Patients receiving first-line treatment for recurrent or metastatic disease are not eligible. In studies where patients have a mix of eligible and ineligible prior treatments, studies are only eligible if second-line+ treatments make up >80% of the patients in each arm of the study or data are reported separately for the eligible subpopulation. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiotherapy was not counted as a prior systemic treatment regimen. Candidates for curative therapy, including but not limited to, radiotherapy or exenterative surgery are not eligible. The following subgroups are eligible: All populations Biomarker-selected populations Patients who had received second-line monotherapy regimens Patients who had received second-line combination regimens Patients who had received investigational agents used in a second-line setting Intervention(s), exposure(s) Systemic interventions at 2L or more that have been recommended in NCCN, ESMO, JSCO and S-1 clinical guidelines are eligible for inclusion alone or in combination. These include: Albumin-bound paclitaxel Bevacizumab Cemiplimab Docetaxel Fluorouracil Gemcitabine Irinotecan Paclitaxel Pemetrexed Tisotumab vedotin Topotecan Vinorelbine Paclitaxel–ifosfamide–cisplatin Gemcitabine-cisplatin Paclitaxel–cisplatin Topotecan-cisplatin Paclitaxel-cisplatin-bevacizumab Paclitaxel-carboplatin Nedaplatin Nedaplatin-irinotecan Nedaplatin-paclitaxel The following interventions will be included in targeted populations: Atezolizumab (PD-L1). Entrectinib (NTRK+). Larotrectinib (NTRK+). Nivolumab (PD-L1). Pembrolizumab (PD-L1). Selpercatinib (RET+). Studies of systemic therapies combined with other interventions (radiotherapy, surgery) or used as neoadjuvant or adjuvant treatment will not be eligible for inclusion. In studies where patients have a mix of eligible and ineligible interventions, studies are only eligible if the data are reported separately for the eligible subpopulation. Comparator(s)/control For this review, studies with any interventions as outlined in 'Intervention(s), exposure (s)', any other systemic therapy or no comparator are eligible. Main outcome(s) Overall survival Progression-free survival Response outcomes: • (Confirmed) objective response rate • Duration of response • Complete response • Partial response • Stable disease • Time to response • Unconfirmed response Health-related quality of life/patient reported outcomes: • EORTC-QLQ-C30. • EORTC-QLQ-CX24. • EQ-5D. • SF-36 • SF-12 • Brief Pain Inventory. • FACT/GOG-NTX • FACT-Cx. • FCT-CX TOI Adverse events (AEs): • Overall rates for any stage 3 or greater AEs • Overall rates for serious AEs • All ocular adverse events independent of grading • Peripheral neuropathy grade 3 and above • Bleeding events greater than grade 3 • Treatment discontinuation due to adverse events • AE’s that affect 5% or more of the population Measures of effect For dichotomous outcomes; absolute and relative risks (or odds ratios) and risks (or rate) differences (where reported / applicable). For continuous outcomes; the mean change and measure of variance from baseline (or at both baseline and final visit), or mean difference between treatments. For time-to-event analysis; the number of events in each arm, median time to event and a hazard ratio and p-value. Where possible, absolute and relative data will be extracted. A measure of precision for each estimate of effect (95% confidence intervals, standard error or standard deviation). Additional outcome(s) None Measures of effect Not applicable Data extraction (selection and coding) Record assessment will be undertaken as follows: • A single researcher will assess the search results according to their relevance in providing information on the review and will remove the obviously irrelevant records such as those about ineligible diseases or in children. • Two reviewers will independently assess the titles and abstracts of remaining records for relevance against the eligibility criteria, with disagreements adjudicated by a third reviewer. • We will obtain the full text of potentially relevant studies. Two reviewers will independently assess the full texts for relevance against the eligibility criteria. A third reviewer will adjudicate any disagreements. One reviewer will extract data from the eligible studies with all extracted data checked by a second reviewer and disagreements adjudicated by a third reviewer. When selecting publications for inclusion, we will check the included studies list of any newly identified relevant systematic reviews from the update search meeting the eligibility criteria for additional references only. We will not data extract the systematic reviews. Any relevant non-duplicate publications included in any of these reviews will be counted as ‘records from other sources’ and we will assess their eligibility for inclusion in the review. Data will be extracted into the same data extraction sheet as for the previous systematic review. The current version of the sheet has been amended to reflect the current protocol. The main fields for data extraction will be study details, study characteristics, patient baseline characteristics, details of prior treatments, details of intervention (details will be captured separately for induction, maintenance and combined therapy as far as possible), details of the statistical analysis and outcome related data (outcome definition, the unit of measurement, the number of patients included in the analysis, the size of the effect for each outcome and a measure of precision for each estimate of effect). Risk of bias (quality) assessment One reviewer will assess the risk of bias in each included study and all assessments will be checked by a second reviewer. Any disagreements will be resolved through discussion or by consulting a third reviewer. For RCTs we will use the Cochrane Risk of Bias Tool v1.0 with the additional question specified by NICE. For case control studies we will use the CRD Case Control Checklist and for cohort studies we will use the CRD Cohort Study Checklist. For cross-sectional studies we will use the Adapted Newcastle-Ottawa for Cross-Sectional studies, adapted by Herzog et al. (2013). Strategy for data synthesis We will update the text and tables from the original systematic review report with data from the new studies identified. This update review report will also include the narrative synthesis of all safety data extracted but not previously reported by the original review and any new safety data identified at this update. We will assess the similarity of studies and availability of data, and where studies are similar enough and data are available we can undertake statistical pooling, in the form of a meta-analysis. Analysis of subgroups or subsets None planned. Contact details for further information Rachael McCool rachael.mccool@york.ac.uk Organisational affiliation of the review York Health Economics Consortium (YHEC) https://yhec.co.uk/ Review team members and their organisational affiliations Ms Rachael McCool. YHEC Ms Anita Fitzgerald. YHEC Miss Alice Sanderson. YHEC Mr Mick Arber. YHEC Miss Emma Bishop. YHEC Mr Chris Bartlett. YHEC Collaborators Dr Jie Ting. Seagen Type and method of review Intervention, Narrative synthesis, Systematic review Anticipated or actual start date 17 July 2023 Anticipated completion date 06 October 2023 Funding sources/sponsors Seattle Genetics (Seagen) Conflicts of interest This review is commissioned and funded by Seagen Yes Language English Country England Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Bevacizumab; Female; Genital Neoplasms, Male; Humans; Male; Patient Reported Outcome Measures; Uterine Cervical Neoplasms Date of registration in PROSPERO 08 August 2023 Date of first submission 07 August 2023 Details of any existing review of the same topic by the same authors This is an update of: Katy Wilson, Jacoby Patterson, Mick Arber, Anita Fitzgerald, Alice Sanderson, Maria Cikalo, Deborah Watkins. Update of a systematic literature review of clinical effects, safety and patient-reported outcomes of treatment for previously treated, recurrent or metastatic cervical cancer. PROSPERO 2022 CRD42022310979 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022310979

Rachael, M., et al. (2023). "Update of systematic reviews of economic evaluations, utilities and costs and healthcare resource use data for previously treated, recurrent or metastatic cervical cancer." PROSPERO International prospective register of systematic reviews.
	Review question What are the costs and healthcare resource use associated with previously treated, recurrent or metastatic cervical cancer? Searches We will search the following databases and information sources: MEDLINE ALL (OvidSP) Embase (OvidSP) Cochrane Database of Systematic Reviews (CDSR) (Cochrane Library / Wiley) Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library / Wiley) HTA Database (https://www.inahta.org/hta-database/) Database of Abstracts of Reviews of Effects (DARE) (https://www.crd.york.ac.uk/CRDWeb/) NHS Economic Evaluation Database (NHS EED) (https://www.crd.york.ac.uk/CRDWeb/) Cost-Effectiveness Analysis (CEA) Registry (https://cevr.tuftsmedicalcenter.org/databases/cea-registry) EconLit (OvidSP) ScHARRHud (http://www.scharrhud.org/) National Institute for Health and Care Excellence (NICE) website (https://www.nice.org.uk/) Institute for Clinical & Economic Review (ICER) website (https://icer-review.org/) Canadian Agency for Drugs and Technologies in Health (CADTH) website (https://www.cadth.ca/) Pharmaceutical Benefits Advisory Committee (PBAC) public summary documents (http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd) Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) (https://www.sbu.se/en/publications/) Institute for Quality and Efficiency in Health Care (IQWiG) (https://www.iqwig.de/) Search results will be deduplicated against the results of the previous search. There will be no date limits, aside from for searches of the following, which will be restricted to publications published since the date of the previous 2019 search: NICE website, ICER website, CADTH website, PBAC public summary documents, SBU website, IQWiG website. There will be no language restrictions. Additional search strategy information can be found in the attached PDF document (link provided below). Types of study to be included Economic evaluations: Cost-effectiveness analyses (including cost-utility analyses). Cost-benefit analyses. Cost consequence analyses. Cost-minimisation analyses. HTA reports investigating the cost-effectiveness of treatments. Studies published as abstracts or conference presentations, published since 2015, will be eligible for inclusion providing that adequate information is provided. The utilities and costs and healthcare resource use SRs will not be restricted by study design with the exception of case reports, narrative reviews, SRs and non-SRs Condition or domain being studied This review focuses on the costs and healthcare resource use associated with previously treated, recurrent or metastatic cervical cancer. Although the primary population of interest has been previously treated, due to the paucity of data for this population, the review eligibility criteria was expanded to also include patients who were chemotherapy naïve. Participants/population Patients aged ≥18 years old with recurrent or metastatic cervical cancer of any histology, including both previously treated or chemotherapy naïve patients are eligible. Patients who are candidates for curative therapy are not eligible. Studies must have been conducted in North America, Western Europe, Australia, Japan, China and Taiwan. Intervention(s), exposure(s) For economic evaluations, any chemotherapy regimens will be eligible. Any dose will be eligible. Any drug combinations will be eligible. For utilities and monetary costs and non-monetary healthcare resource use, studies assessing any intervention or no intervention will be eligible. Comparator(s)/control For this review, studies with any interventions as outlined in 'Intervention(s), exposure(s)' are eligible. Main outcome(s) Economic Evaluations: Total costs. Summary health outcomes (e.g. QALYs). Incremental analyses outcomes (e.g. ICERs). Other economic evaluations outcomes, e.g. for cost consequence studies. Utilities: EuroQol five dimensions (EQ-5D) data (both EQ-5D 3L and EQ-5D 5L). Short-Form (SF)-6D. 15D. Health Utilities Index (HUI). Discrete choice experiments, time trade off or standard gamble. Any other preference-based utility data Utilities that have been mapped from other tools. Monetary costs and non-monetary healthcare resource use: Direct medical monetary costs (overall and specific costs). Indirect medical monetary costs (overall and specific costs). Non-monetary healthcare resource utilisation data. Additional outcome(s) None Measures of effect Not applicable Data extraction (selection and coding) Record assessment will be undertaken as follows: • A single researcher will assess the search results according to their relevance in providing information on the review and remove the obviously irrelevant records such as those about ineligible diseases or in children. • Two reviewers will independently assess the titles and abstracts of remaining records for relevance against the eligibility criteria, with disagreements adjudicated by a third reviewer. • We will obtain the full text of potentially relevant studies. Two reviewers will independently assess the full texts for relevance against the eligibility criteria. A third reviewer will adjudicate any disagreements. One reviewer will extract data from the eligible studies with all extracted data checked by a second reviewer and disagreements adjudicated by a third reviewer. When selecting publications for inclusion, we will check the included studies list of any newly identified relevant systematic reviews from the update search meeting the eligibility criteria for additional references. We will not data extract the systematic reviews. Any relevant non-duplicate publications included from these reviews will be counted as ‘records from other sources’ and we will assess their eligibility for inclusion. Study details and characteristics will be extracted for all studies. For economic evaluations, a summary of the model, patient population QALYs, costs, ICERs (per QALY gained) and relevant comments from experts will be extracted. For utilities, the population in which health effects were measured, information on recruitment, interventions/comparators, sample sizes, response rates, health state descriptions, adverse reactions, appropriateness of health states, methods of elicitation and valuation, mapping, uncertainty around values, consistency with reference case, source of value perspectives, high anchor of utility, mean and median utility values with SEs and CIs of utilities will be extracted. For resource use, applicability to clinical practice in England, cost valuations, costs for use in the economic analysis, technology costs and outcomes will be extracted. Risk of bias (quality) assessment One reviewer will assess the risk of bias in each included study using the relevant tool for each study design and all assessments will be checked by a second reviewer. Any disagreements will be resolved through discussion or by consulting a third reviewer. Economic evaluations will be assessed using the 36-point Drummond and Jefferson (1996) criteria. For utility and resource use studies, there are no widely accepted published or validated quality assessment checklists or tools for assessment. We will assess the assess the quality and relevance of utility studies by considering issues such as: • Selection of participants – was there clear inclusion and exclusion criteria? • How representative of the target population were the participants in the study, considering age, disease severity, co-morbidities? • Was a reasonable pilot testing approach used? • Were the utility elicitation methods reasonable/valid? • Have the researchers tried to reduce potentials for bias, for example, interviewer bias? • Have the researchers offered assessments of the limitations of the study approach? As NICE does not require a quality assessment of studies which report resource use for NICE submissions, we will not quality assess the studies of resource use. Strategy for data synthesis We will provide a narrative summary exploring the quality of the studies, the relationship between studies and patterns that we have discerned in the data. We will provide an overall assessment of the strength of the research evidence in relation to the research question. We will update the text and tables from the original systematic review report with data from the new studies identified. Analysis of subgroups or subsets None planned. Contact details for further information Rachael McCool rachael.mccool@york.ac.uk Organisational affiliation of the review York Health Economics Consortium (YHEC) https://yhec.co.uk/ Review team members and their organisational affiliations Ms Rachael McCool. YHEC Ms Anita Fitzgerald. YHEC Mr Chris Bartlett. YHEC Miss Alice Sanderson. YHEC Mr Mick Arber. YHEC Miss Emma Bishop. YHEC Collaborators Dr Jie Ting. Seagen Type and method of review Intervention, Narrative synthesis, Systematic review Anticipated or actual start date 17 July 2023 Anticipated completion date 06 October 2023 Funding sources/sponsors Seattle Genetics (Seagen) Conflicts of interest This review is commissioned and funded by Seagen Yes Language English Country England

Rachel, C., et al. (2021). "Effectiveness of Heat Therapy in Pain Relief among Women with Dysmenorrhea: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	Review question 1) Is heat therapy effective as a sole therapeutic approach in pain control for primary dysmenorrhea? 2) Is heat therapy more effective than other pharmacological or CAM therapies in dysmenorrheal pain management? 3) Can heat therapy demonstrate similar effectiveness when used with other approaches to reduce dysmenorrheal pain? Searches 21/1) PubMed (26/10/21-27/10/21), Filters: Articles from 2011-2021 2) Excerpta Medica DataBASE (EMBASE) (11/10/21-26/10/21), Filters: Articles from 2011-2021 3) Cumulative Index to Nursing and Allied Health Literature (CINAHL) (10/10/21), Filters: Articles from 2011-2021 4) Web of Science (7/10/21-27/10/21), Filters: Articles from 2011-2021 5) Scopus (10/10/21-26/10/21), Filters: Articles from 2011-2021 6) Cochrane Central Register of Controlled Trials (Cochrane) (11/10/21-26/10/21), Filters: Articles from 2011-2021 7) Google Scholars (21/10/21-27/10/21), Filters: Articles from 2011-2021 Types of study to be included Inclusion: RCTs and Quasi-Experimental Studies (QES) Exclusion: Editorials, clinical guidelines, conference papers, letters, qualitative studies, non-experimental studies, incomplete trial studies, case reports and discussion papers Condition or domain being studied Primary dysmenorrhea. Pain levels among women with dysmenorrhea. Participants/population Inclusion: young, nulliparous female adolescents or adult female individuals before menopausal age with PD or painful menstruation Exclusion: women with SD or other menstrual disorders Intervention(s), exposure(s) Studies involving heat application as pain reduction interventions for PD before or during menstruation will be the main focus of the review. Interventions involving comparisons between heat therapy application with control groups, where participants are exposed to either usual routine care or without any heat intervention administration; analgesic medications and other complementary therapies, such as physical exercises, will be included. However, studies that explore heat intervention used in adjunct with other therapies will also be considered in reference to the review questions. Comparator(s)/control Heat Therapy vs Control groups; heat therapy vs analgesia groups; heat therapy vs exercise interventions; heat therapy with FRI belts Context This review focuses on pain relief efforts among both young, nulliparous adolescents and pre-menopausal adult women. Main outcome(s) Pain levels are the primary outcomes for this review, evaluation tools for pain levels include the Visual Scale Analogue (VAS) and Numeric Rating Scale (NRS) Measures of effect Standardized mean differences (SMD) will be used Additional outcome(s) Other evaluation tools that measure the indirect impacts of the intervention administered for dysmenorrhea, such as Moos Menstrual Distress Questionnaire (MMDQ) and frequency of analgesic medication consumption during the intervention Measures of effect Standardized mean differences (SMD) will be used Data extraction (selection and coding) Study Selection: 2 reviewers (RC and AJ) will independently review the articles by screening via title and abstract, followed by screening and filtering articles via full text relevance to the eligibility criteria and review questions. The EndNote X9 software will be used to document the screening process. After independently screening the articles, both reviewers will come together during discussions to establish mutual consensus on the included articles for the review. Any disagreements will be documented and a third reviewer (SK) will be introduced for consultation to resolved any conflicting opinions Data Extraction: Details to be extracted will include publication years of the studies, the participants involved, settings, interventions, comparators, outcomes, measures, study design, statistical analysis and their results, with other relevant data, such as funding granted for the study or conflict of interests. Adverse events, ITT analysis, attrition rates, time frame of intervention, intervention aims and resources will also be extracted. All details extracted will be recorded into an Excel spreadsheet. Study authors will be contacted for any missing data. Both reviewers (RC and AJ) will independently extract data using the data extraction form created by the main reviewer (RC) before coming together during discussions to establish mutual consensus on the included articles for the review. Any disagreements will be documented and a third reviewer (SK) will be introduced for consultation to resolved any conflicting opinions. Risk of bias (quality) assessment The respective critical appraisal checklist for both RCTs and QES papers from the JBI Manual will be used for the quality assessment of the included articles. Characteristics to be assessed for RCT includes: True randomization; Concealed allocation to intervention groups; Similarity in participants’ demographics at baseline; Blinding performed to participants, facilitators and outcome assessors; Presence of external factors in influencing intervention; Completion of any follow-up activity; Intention-to-treat (ITT) analysis; Reliability and validity of findings; Relevance of statistical analysis and Appropriateness of study design used. Characteristics to be assessed for QES include: Clarity in causal relationship; Similarity in participants’ demographics; Presence of external factors in influencing intervention; Inclusion of a control group; Multiple measurement points at pre- and post-intervention; Completion of any follow-up activity; Reliability and validity of findings and Appropriateness of statistical analysis used. Both reviewers (RC and AJ) will appraise the articles before coming together during discussions to establish mutual consensus on the included articles for the review. Any disagreements will be documented and a third reviewer (SK) will be introduced for consultation to resolved any conflicting opinions. Articles that satisfy at least 60% of the appraisal checklist will be included into the review Strategy for data synthesis Narrative synthesis will be used to describe the methodological qualities and features of the included studies. If possible, meta-analysis will be performed for result analysis in both RCTs and QES, using the RevMan software to determine the homogeneity of the included studies. Narrative synthesis will also be used to summarize the analytical findings in the meta-analysis. Since most studies in the review will be employing various pain evaluation tools with continuous outcome findings, standardized mean differences (SMD) will be used with a confidence interval (CI) of 95% for clarity in the interpretation of effect size. If any mean differences or standard deviation is not observed in any paper, differences between the post-intervention outcomes will be accounted instead. As the random effects model will be used for the meta-analysis of the SMD, the DerSimonian and Laird method will be used as the statistical methods for the meta-analysis. Overall effect of heat therapy will be calculated via the Z statistics, with p<0.05 indicating significant differences present, favoring either the heat intervention group or other comparison groups. Effect size will be estimated with the Cohen’s d as recommended by the JBI. Heterogeneity is assessed by the χ² test and I² statistics. Statistical heterogeneity is observed if p<0.10. Analysis of subgroups or subsets Subgroup analysis will be conducted if heterogeneity are beyond moderate levels, where I²> 40%. Each subgroup will have minimally 3 articles with the subgroups being categorized based on the intervention used. Subgroups will include the following: heat therapy vs NSAIDs, heat therapy vs control groups, heat therapy vs exercise groups and heat therapy with FRI belts. Contact details for further information Rachel Ching rachelching1206@gmail.com Organisational affiliation of the review None Review team members and their organisational affiliations Miss Rachel Ching. Alice Lee Centre for Nursing Studies. National University of Singapore (NUS). Miss Avani Jain. Alice Lee Centre for Nursing Studies. National University of Singapore (NUS). Dr Serena Koh Siew Lin. Alice Lee Centre for Nursing Studies. National University of Singapore (NUS). Type and method of review Intervention, Meta-analysis, Narrative synthesis, Systematic review Anticipated or actual start date 10 December 2021 Anticipated completion date 04 March 2022 Funding sources/sponsors Nil Grant number(s) State the funder, grant or award number and the date of award Nil Conflicts of interest Language English Country Singapore Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Dysmenorrhea; Female; Hot Temperature; Humans; Pain Management; Quality of Life Date of registration in PROSPERO 09 December 2021 Date of first submission 09 December 2021 Details of any existing review of the same topic by the same authors Nil

Rahman Ummi, A., et al. (2023). "Efficacy and safety of fezolinetant, a neurokinin-3 antagonist, in treating vasomotor symptoms in postmenopausal women: A systematic review and meta-analysis." Medicine 102(50): e36592.
	Background: Menopause causes a variety of symptoms such as hot flashes and night sweats. While menopausal hormonal therapy has been used for managing postmenopausal vasomotor symptoms (VMS) for quite a while, it has a considerably poor safety profile.; Objective: To review and analyze existing data to evaluate the efficacy of the neurokinin-3 antagonist, fezolinetant, in treating postmenopausal VMS and to assess its safety profile.; Methods: A thorough literature search was performed on PubMed, Cochrane Library, and Google Scholar in compliance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis 2020, to find publications on the efficacy of fezolinetant for postmenopausal VMS. Changes in the frequency and severity scores of moderate/severe VMS and changes in the Hot Flash-Related Daily Interference Scale (HFRDIS), Greene Climacteric Scale (GCS), and Menopause-Specific Quality of Life (MENQoL) were the efficacy outcomes. Adverse events, drug-related treatment-emergent adverse effects (TEAEs), drug-related dropouts, hepatotoxicity, endometrial hyperplasia or tumor, and uterine bleeding were all safety outcomes. We used Review Manager 5.4 for pooling risk ratios (RRs) and mean differences (MDs) for dichotomous and continuous outcomes, respectively. A P value of < .05 was considered significant.; Results: There was a significant reduction in mean daily VMS frequency at weeks 4 and 12 (MD, -2.36; 95% confidence interval [CI], -2.85 to -1.87; P < .00001, for week 12) and also a significant decrease in VMS severity scores in the treatment group. Furthermore, improvements in MENQoL, HFRDIS, and GCS scores were observed. There was no significant difference in adverse events while drug-related TEAEs (RR, 1.21; 95% CI, 0.90-1.63; P = .21) showed a slight increase with fezolinetant. Drug-related dropouts were again similar across the 2 groups. Uterine bleeding had a lower incidence while endometrial events and hepatotoxicity showed a statistically insignificant, increasing trend in the fezolinetant group.; Discussion and Implications: Fezolinetant can be a treatment option for postmenopausal VMS but warns of a risk increase in endometrial hyperplasia or tumors. The heterogeneity in the data being analyzed, short follow-up period, and small sample size in most of the included randomized controlled trials were the greatest limitations, which must be considered in further research and safety profile exploration.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.)

Rahn David, D., et al. (2023). "Perioperative Vaginal Estrogen as Adjunct to Native Tissue Vaginal Apical Prolapse Repair: A Randomized Clinical Trial." JAMA 330(7): 615-625.
	Importance: Surgical repairs of apical/uterovaginal prolapse are commonly performed using native tissue pelvic ligaments as the point of attachment for the vaginal cuff after a hysterectomy. Clinicians may recommend vaginal estrogen in an effort to reduce prolapse recurrence, but the effects of intravaginal estrogen on surgical prolapse management are uncertain.; Objective: To compare the efficacy of perioperative vaginal estrogen vs placebo cream on prolapse recurrence following native tissue surgical prolapse repair.; Design, Setting, and Participants: This randomized superiority clinical trial was conducted at 3 tertiary US clinical sites (Texas, Alabama, Rhode Island). Postmenopausal women (N = 206) with bothersome anterior and apical vaginal prolapse interested in surgical repair were enrolled in urogynecology clinics between December 2016 and February 2020.; Interventions: The intervention was 1 g of conjugated estrogen cream (0.625 mg/g) or placebo, inserted vaginally nightly for 2 weeks and then twice weekly to complete at least 5 weeks of application preoperatively; this continued twice weekly for 12 months postoperatively. Participants underwent a vaginal hysterectomy (if uterus present) and standardized apical fixation (either uterosacral or sacrospinous ligament fixation).; Main Outcomes and Measures: The primary outcome was time to failure of prolapse repair by 12 months after surgery defined by at least 1 of the following 3 outcomes: anatomical/objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment. Secondary outcomes included measures of urinary and sexual function, symptoms and signs of urogenital atrophy, and adverse events.; Results: Of 206 postmenopausal women, 199 were randomized and 186 underwent surgery. The mean (SD) age of participants was 65 (6.7) years. The primary outcome was not significantly different for women receiving vaginal estrogen vs placebo through 12 months: 12-month failure incidence of 19% (n = 20) for vaginal estrogen vs 9% (n = 10) for placebo (adjusted hazard ratio, 1.97 [95% CI, 0.92-4.22]), with the anatomic recurrence component being most common, rather than vaginal bulge symptoms or prolapse repeated treatment. Masked surgeon assessment of vaginal tissue quality and estrogenization was significantly better in the vaginal estrogen group at the time of the operation. In the subset of participants with at least moderately bothersome vaginal atrophy symptoms at baseline (n = 109), the vaginal atrophy score for most bothersome symptom was significantly better at 12 months with vaginal estrogen.; Conclusions and Relevance: Adjunctive perioperative vaginal estrogen application did not improve surgical success rates after native tissue transvaginal prolapse repair.; Trial Registration: ClinicalTrials.gov Identifier: NCT02431897.

Rakic, L., et al. (2021). "Double versus single intrauterine insemination (IUI) in stimulated cycles for subfertile couples." The Cochrane Database of Systematic Reviews 7: CD003854.
	Background: In subfertile couples, couples who have tried to conceive for at least one year, intrauterine insemination (IUI) with ovarian hyperstimulation (OH) is one of the treatment modalities that can be offered. When IUI is performed a second IUI in the same cycle might add to the chances of conceiving. In a previous update of this review in 2010 it was shown that double IUI increases pregnancy rates when compared to single IUI. Since 2010, different clinical trials have been published with differing conclusions about whether double IUI increases pregnancy rates compared to single IUI.; Objectives: To determine the effectiveness and safety of double intrauterine insemination (IUI) compared to single IUI in stimulated cycles for subfertile couples.; Search Methods: We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase and CINAHL in July 2020 and LILACS, Google scholar and Epistemonikos in February 2021, together with reference checking and contact with study authors and experts in the field to identify additional studies.; Selection Criteria: We included randomised controlled, parallel trials of double versus single IUIs in stimulated cycles in subfertile couples.; Data Collection and Analysis: Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information.; Main Results: We identified in nine studies involving subfertile women. The evidence was of low quality; the main limitations were unclear risk of bias, inconsistent results for some outcomes and imprecision, due to small trials with imprecise results. We are uncertain whether double IUI improves live birth rate compared to single IUI (odds ratio (OR) 1.15, 95% confidence interval (CI) 0.71 to 1.88; I 2 = 29%; studies = 3, participants = 468; low quality evidence). The evidence suggests that if the chance of live birth following single IUI is 16%, the chance of live birth following double IUI would be between 12% and 27%. Performing a sensitivity analysis restricted to only randomised controlled trials (RCTs) with low risk of selection bias showed similar results. We are uncertain whether double IUI reduces miscarriage rate compared to single IUI (OR 1.78, 95% CI 0.98 to 3.24; I 2 = 0%; studies = 6, participants = 2363; low quality evidence). The evidence suggests that chance of miscarriage following single IUI is 1.5% and the chance following double IUI would be between 1.5% and 5%. The reported clinical pregnancy rate per woman randomised may increase with double IUI group (OR 1.51, 95% CI 1.23 to 1.86; I 2 = 34%; studies = 9, participants = 2716; low quality evidence). This result should be interpreted with caution due to the low quality of the evidence and the moderate inconsistency. The evidence suggests that the chance of a pregnancy following single IUI is 14% and the chance following double IUI would be between 16% and 23%. We are uncertain whether double IUI affects multiple pregnancy rate compared to single IUI (OR 2.04, 95% CI 0.91 to 4.56; I 2 = 8%; studies = 5; participants = 2203; low quality evidence). The evidence suggests that chance of multiple pregnancy following single IUI is 0.7% and the chance following double IUI would be between 0.85% and 3.7%. We are uncertain whether double IUI has an effect on ectopic pregnancy rate compared to single IUI (OR 1.22, 95% CI 0.35 to 4.28; I 2 = 0%; studies = 4, participants = 1048; low quality evidence). The evidence suggests that the chance of an ectopic pregnancy following single IUI is 0.8% and the chance following double IUI would be between 0.3% and 3.2%.; Authors' Conclusions: Our main analysis, of which the evidence is low quality, shows that we are uncertain if double IUI improves live birth and reduces miscarriage compared to single IUI. Our sensitivity analysis restricted to studies of low risk of selection bias for both outcomes is consistent with the main analysis. Clinical pregnancy rate may increase in the double IUI group, but this should be interpreted with caution due to the low quality evidence. We are uncertain whether double IUI has an effect on multiple pregnancy rate and ectopic pregnancy rate compared to single IUI. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Ramasahitya, K., et al. (2021). "Exploring the use of low carbohydrate diets in obese and overweight females with Polycystic Ovary Syndrome: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Rana, D., et al. (2021). "Uterine artery embolisation or myomectomy for women with uterine fibroids wishing to avoid hysterectomy: a cost-utility analysis of the FEMME trial." BJOG 128(11): 1793-1802.
	Objectives: To assess the cost-effectiveness of uterine artery embolisation (UAE) and myomectomy for women with symptomatic uterine fibroids wishing to avoid hysterectomy. Design(s): Economic evaluation alongside the FEMME randomised controlled trial. Setting(s): 29 UK hospitals. Population: Premenopausal women who had symptomatic uterine fibroids amenable to UAE or myomectomy wishing to avoid hysterectomy. 254 women were randomised to UAE (127) and myomectomy (127). Method(s): A within-trial cost-utility analysis was conducted from the perspective of the UK NHS. Main Outcome Measure(s): Quality-adjusted life years (QALYs) measured using the EuroQoL EQ-5D-3L, combined with costs to estimate cost-effectiveness over 2 and 4 years of follow-up. Result(s): Over a 2-year time horizon, UAE was associated with higher mean costs (difference 645; 95% CI -1381 to 2580) and lower QALYs (difference -0.09; 95% CI -0.11 to -0.04) when compared with myomectomy. Similar results were observed over the 4-year time horizon. Thus, UAE was dominated by myomectomy. Results of the sensitivity analyses were consistent with the base case results for both years. Over 2 years, UAE was associated with higher costs (difference 456; 95% CI -1823 to 3164) and lower QALYs (difference -0.06; 95% CI -0.11 to -0.02). Conclusion(s): Myomectomy is a cost-effective option for the treatment of uterine fibroids. The differences in costs and QALYs are small. Women should be fully informed and have the option to choose between the two procedures. Tweetable abstract: Fully informed women with uterine fibroids should have a choice between uterine artery embolisation or myomectomy.Copyright © 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.

Rane, A. (2022). "Post-operative pessary in prolapse surgery and its impact on recurrent prolapse." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: A vaginal pessary device is a removable device made of silicone. It is normally inserted into the vagina by a gynaecologist to support the prolapsed walls of the vagina and/or uterus. However, the indication in this instance is to take tension away from the native tissue and suture lines post operatively (if randomised to treatment group) which may improve tissue regeneration and healing which could lead to better surgical results and patient satisfaction. There are various sorts of pessaries available. However for this study, we have opted to use a Shaatz type pessary as it is the most applicable for keeping tension off the native tissue while providing extra support to the vagina as it heals from the surgery. Participants if enrolled into the study, would need to fill in a pre‐operative questionnaire and post‐operative questionnaire. All participants would receive their surgery which would be routine surgery with or without the study. The patients enrolled into the treatment arm would at the end of surgery have the vaginal pessary inserted by the surgeon (which would take an additional 2 minutes) while still under general anaesthesia to minimise discomfort. The total duration of device use is 4 weeks post‐surgery and will be removed by Prof Rane at the time for the 4 week post operative review. The associate investigator (urogynaecology fellow) will be doing the pre and post surgery vaginal assessment without being aware of which treatment arm the patient is in so as to have an objective vaginal assessment. Further follow up in the outpatient clinic would be at 3 and 6 months post operative as well. CONDITION: Renal and Urogenital ‐ Other renal and urogenital disorders Surgery ‐ Other surgery vaginal prolapse; ; vaginal prolapse PRIMARY OUTCOME: Success in anterior compartment at 6 months post operation; ; Success is defined as a composite of objective findings and subjective patient report. ; ; Objective anatomic success is defined as anterior prolapse no greater than Stage 1 (reference point Ba < ‐1cm on Pelvic Organ Prolapse Quantifications System (POP Q) examination. ; ; Subjective success as defined as absence of “bulge” symptom based on the PDFI‐20 validated questionnaire. ; ; Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba >= ‐1cm) or presence of “vaginal bulge” symptom on validated questionnaire.; [6 months post operative] INCLUSION CRITERIA: ‐ Women (18 years and over) with symptomatic pelvic organ prolapse requiring an anterior vaginal repair (level 1 or level 2) at our facility ‐ Medically fit for surgery ‐ Able to complete the questionnaire independently with reasonable level of English and English is their first language ‐ Patients that have not been recommended surgery that involves colpocleisis, mesh or other surgical approach (such as laparoscopy or laparotomy) SECONDARY OUTCOME: Anatomic success of any associated apical repair procedure at 6 months post operation. Objective anatomic success as apical prolapse no greater than Stage 1 (reference point C < ‐1cm) on POPQ examination[6 months post operative] Anatomic success of any associated posterior repair procedure. Objective anatomic success as posterior prolapse no greater than Stage 1 (reference point Bp < ‐1cm) on Pelvic Organ Prolapse Quantifications System (POP Q) examination[6 months post operative] Any change in Ten point Patient Global Assessment of Change (PGA‐C) visual analogue scale 3 months post operation[3 months post operative] Any change in Ten point Patient Global Assessment of Change (PGA‐C) visual analogue scale 4 weeks post operation [4 weeks post operative] Any change in Ten point Patient Global Assessment of Change (PGA‐C) visual analogue scale 6 months post operation[6 months post operative] Change in POPQ quantitative measurements from baseline at 6 months post operation ; [6 months post operative] Complications of surgery as per Clavien‐Dindo Classification (Appendi XA) ‐ as referenced in attached protocol do ment. ; Complications data will be sourced from patient operation reports, hospital progress notes discharge summaries and note of re‐admission to hospital.[6 months post operative]

Ranisavljevic, N. (2021). "Benefit of Amlodipine in HRT Cycle for Frozen Embryo Transfer in the Correction of Uterine Pulsatility Index." ClinicalTrials.gov.
	Embryo implantation is a key stage that depends on two main factors: embryo grading quality and endometrial receptivity. Numerous tools have been suggested to evaluate these two factors, without making it possible to predict with certainty the outcome of an embryo transfer in terms of pregnancy. However, some diagnostic tests have shown a good negative predictive value: it is the case of the measurement of the pulsatility index (PI) of the uterine arteries which is associated with extremely low chances of pregnancy when it is high, especially higher than 3 (Cacciatore et al., 1996; Steer et al., 1992). The Pulsatility Index PI is calculated by the ratio between the maximum amplitude of the tracing and the mean velocity. It evolves according to downstream resistance. Uterine hypoperfusion would readily be associated with subfertility (Goswamy et al., 1988). The uterine arterial pulsatility index is easily accessible during pelvic ultrasound, with satisfactory intra‐ and inter‐observer reproducibility (Steer et al., 1995). There is no significant difference between the measurement of the right and left uterine PI (Favre et al., 1993). Uterine PIs vary during the menstrual cycle (Goswamy and Steptoe, 1988) and depending on hormonal effects (de Ziegler et al., 1991; Strigini et al., 1995) or ovarian micropolycystic status (PCOS, syndrome of polycystic ovaries) of the patient (Resende et al., 2001). The impact of tobacco (Battaglia et al., 2011) and parity (Guedes‐Martins et al., 2015) on uterine PIs is described in the literature. Age, although controversial, does not seem to have an impact on uterine PIs, at least in premenopausal women case (Check et al., 2000). Likewise, body mass index (BMI) could have an impact on PIs, as in increased PIs in obese women (Battaglia et al., 1996; Zeng et al., 2013) If high uterine PIs are associated with reduced chances of pregnancy, how can they be improved? A pilot study of women with premature ovarian failure with uterine PIs greater than 3 showed the efficiency of nifedipine in uterine vascularization. This calcium channel blocker, used sublingually in this study, significantly lowered uterine PI in nearly half an hour (Huissoud et al., 2004). This medication could therefore be promising in the treatment of patients in assisted medical reproduction (ART) for whom the measurements of the uterine PIs would be greater than 3 and therefore have lower chances of pregnancy. This study aims to investigate weither the use of a calcium channel blocker (amlodipine) improves the value of uterine PIs in patients with at least one of the uterine PIs greater than 3, during a cycle for frozen embryo transfer (FET).

Ranjbar, A., et al. (2022). "Vaginal Laser Therapy for Stress Urinary Incontinence: A Systematic Review of Prospective Randomized Clinical Trials." Journal of Menopausal Medicine 28(3): 103-111.
	The most common type of urinary incontinence in women is stress urinary incontinence (SUI) which negatively impacts several aspects of life. The newly introduced vaginal laser therapy is being considered for treating SUI. This systematic review aimed to evaluate the efficacy of vaginal laser therapy for stress urinary incontinence in menopausal women. We searched the following databases: MEDLINE (via PubMed), EMBASE, Cochrane Library databases, Web of Science, clinical trial registry platforms, and Google Scholar, using the MeSH terms and keywords [Urinary Incontinence, Stress] and [(lasers) OR laser]. In our systematic review, prospective randomized clinical studies on women diagnosed with SUI as per the International Continence Society's diagnostic criteria were included. The Cochrane Risk-of-Bias assessment tool for randomized clinical trials was used to evaluate the quality of studies. A total of 256 relevant records in literature databases and registers and 25 in additional searches were found. Following a review of the titles, abstracts, and full texts, four studies involving 431 patients were included. Three studies used CO2-lasers, and one used Erbium: YAG-laser. The results of all four studies revealed the short-term improvement of SUI following both the Erbium: YAG-laser and CO2-laser therapy. SUI treatment with CO2-laser and Erbium: YAG-laser therapy is a quick, intuitive, well-tolerated procedure that successfully improves incontinence-related symptoms. The long-term impact of such interventions has not been well established as most trials focused on the short-term effects.

Raos, M., et al. (2022). "EFFORT study: Comparing impact of operation and assisted reproductive technologies on fertility for women with deep infiltrating endometriosis - study protocol for a multicentre randomised trial." BMJ Open 12(4): e052877.
	Introduction: Deep infiltrating endometriosis (DIE) affecting the rectum or sigmoid colon is associated with infertility, severe pain and decreased quality of life. As most women with DIE are young, many have a pregnancy intention. Treatment possibilities of endometriosis-associated infertility are surgery or assisted reproductive technologies (ART). However, no studies have compared the two interventions directly. Therefore, this study aims to determine the cumulative pregnancy rate (CPR) and the live birth rate (LBR) after first-line surgery compared with first-line ART for women with rectosigmoid DIE and a pregnancy intention.; Methods and Analysis: Multicentre, parallel-group, randomised trial of women with rectosigmoid DIE and a pregnancy intention for at least 6 months in Aarhus, Denmark and Bordeaux, France. 352 women aged 18-38 years are randomised 1:1 to either surgical management (shaving, disc excision or segmental resection) or ART management (at least two in vitro fertilisation or intracytoplasmic sperm injection procedures if not pregnant after the first cycle). Women in the surgical intervention group will attempt to get pregnant by either spontaneous conception or ART, depending on the endometriosis fertility index score. Primary outcome measures are CPR and LBR at 18 months' follow-up. Secondary outcomes are: Non-viable pregnancies, time to pregnancy, pain score, quality of life, complication rate, bowel and bladder function, endocrine and inflammatory profile, number of oocytes, blastocysts, frozen embryos and blastocyst morphology score within 18 months after either intervention.; Ethics and Dissemination: Conduct of this study is approved by the Danish National Committee on Health Research Ethics and Comité de Protection des Personnes Ile de France VIII. Study participants must sign an informed consent form. The results will be presented at national and international conferences and published in international peer-reviewed journals.; Trial Registration Number: This trial is registered at ClinicalTrials.gov (no. NCT04610710).; Protocol Version: The Danish National Committee on Health Research Ethics: Fifth protocol version approved 7 September 2020 (no. 1-10-72-96-20). Comité de Protection des Personnes Ile de France VIII: Version 1.1 22JAN2021 the 9 March 2021.; Competing Interests: Competing interests: UBK has received institutional funding targeted for this study by IBSA Nordic, and institutional funding by Ferring Pharmaceuticals and Merck A/S for departmental research activity. HR has received consultant fees for training involvement by Olympus, Karl Storz, PlasmaSurgical and Ethicon. (© 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.)

Rapbarcelona (2023). "Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women." ClinicalTrials.gov.
	The intervention group will perform the pelvic floor muscle trainning (PFMT) plus the use of vaginal spheres, while the control group will perform the PFMT treatment only, daily at home. The study will be conducted on women with stress urinary incontinence. The intervention will last four months and will consist of a monthly session with the physiotherapist, doing a total of 4 sessions and the final assessment.

Raquel, L.-R. and M.-G. Alba (2023). "Effectiveness of physiotherapy in the treatment of endometriosis symptoms." PROSPERO International prospective register of systematic reviews.
	
Raquel, L.-R. and G.-Á. Alicia (2023). "Effectiveness of pessaries for the treatment of vaginal pelvic organ prolapse." PROSPERO International prospective register of systematic reviews.
	
Rathinam Kiran, K., et al. (2022). "Evaluation of pharmacological interventions in the management of adenomyosis: a systematic review." European Journal of Clinical Pharmacology 78(4): 531-545.
	Purpose: Medical management of adenomyosis largely revolves around symptom management, with very few drugs having received regulatory approval for the disease. However, the level of evidence supporting the use of pharmacological interventions is low, making it difficult to establish their efficacy in the treatment of adenomyosis. Hence, the aim of our systematic review is to identify the strength of evidence currently available and evaluate the effectiveness of different medical interventions in the management of adenomyosis.; Methods: The search was performed in MEDLINE, Embase, Cochrane Library, CENTRAL and ClinicalTrials.gov. Articles published between 1 January 2010 and 30 November 2020 were considered. Randomized controlled trials and observational studies that assessed the efficacy of medical interventions in patients with adenomyosis were included. The quality of the data was analyzed using RevMan 5.3 software.; Results: LNG-IUS (levonorgestrel intrauterine system), dienogest and gonadotropin-releasing hormone (GnRH) analogues were effective in reducing pain, uterine volume and menstrual bleeding. However, these data were largely obtained in the non-trial setting and were fraught with issues that included patient selection, short duration of therapy, small sample size, and limited long-term safety and effectiveness data.; Conclusions: Although LNG-IUS, dienogest and GnRH analogues have better evidence for effectiveness in adenomyosis, the need of the hour is to thoroughly evaluate other novel molecules for adenomyosis using well-designed randomized controlled trials. (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Ravn, P., et al. (2022). "Myoinositol vs. Metformin in Women with Polycystic Ovary Syndrome: A Randomized Controlled Clinical Trial." Metabolites 12(12).
	Polycystic ovary syndrome (PCOS) is associated with insulin resistance. Few randomized controlled trials (RCT) compared myoinositol (MI) with metformin (MET) regarding insulin resistance in PCOS. This was an open-label six-month RCT in women with PCOS (n = 45) with interventions MI 4 g/day or MET 2 g/day. Primary outcome was the homeostasis model assessment of insulin resistance (HOMA-IR). Secondary outcomes were fasting glucose, weight, cycle length, lipids, testosterone, adverse effects, quality of life, and depression scores. Median age was 26 years. Body mass was index was 34.4 kg/m2. HOMA-IR was unchanged during MI (p = 0.31) and MET (p = 0.11) (MI vs. MET, p = 0.09). Median fasting glucose changed +0.2 mmol/L during MI (p < 0.001) and −0.1 mmol/L during MET (p = 0.04) (MI vs. MET p < 0.001). Median weight changed −2.3 kg during MI (p = 0.98) and −6.1 kg during MET (p < 0.001) (MI vs. MET, p = 0.02). Median cycle length decreased nine days during MI (p = 0.03) and 13 days during MET (p = 0.03) (MI vs. MET, p = 0.93). High-density lipoprotein (HDL) changed +0.1 mmol/L during MET (p = 0.04) (MI vs. MET, p = 0.07). All other blood parameters and scores of quality of life and depression remained unchanged during MI and MET (all p > 0.06) (MI vs. MET, all p > 0.27). Adverse effects appeared in four women during MI and 16 women during MET (MI vs. MET, p = 0.001). In conclusion, there was no effect on the metabolic outcomes during MI, but positive effects on fasting blood glucose, weight, and HDL during MET. The effect on cycle length was comparable during MI and MET. Adverse effects were less frequent during MI.

Rayce Signe, B., et al. (2020). "Effects of parenting interventions for mothers with depressive symptoms and an infant: systematic review and meta-analysis." BJPsych Open 6(1): e9.
	Background: Postpartum depression is common in the perinatal period and poses a risk for the development of the infant and the mother-infant relationship. Infancy is a critical developmental period of life and supportive parenting is crucial for healthy development, however, the effects of interventions aimed at improving parenting among mothers with depression are uncertain.; Aims: To assess the effects of parenting interventions on parent-child relationship and child development among mothers with depressive symptoms with 0-12-month-old infants.; Method: We conducted a systematic review with the inclusion criteria: (a) randomised controlled trials of structured psychosocial parenting interventions for women with depressive symptoms and a child aged 0-12 months in Western Organisation for Economic Co-operation and Development countries, (b) minimum three sessions with at least half of these delivered postnatally and (c) outcomes relating to the parent-child-relationship and/or child development. Publications were extracted from 10 databases in September 2018 and supplemented with grey search and hand search. We assessed risk of bias, calculated effect sizes and conducted meta-analysis.; Results: Eight papers representing seven trials were included. We conducted meta-analysis on the post-intervention parent-child relationship. The analysis included six studies and showed no significant effect. For individual study outcomes, no significant effects on the majority of both the parent-child relationship and child development outcomes were reported.; Conclusions: No evidence of the effect of parenting interventions for mothers with depressive symptoms was found on the parent-child relationship and child development. Larger studies with follow-up assessments are needed, and future reviews should examine the effects in non-Western countries.

Rebekah, R., et al. (2023). "Is multidisciplinary management of female chronic pelvic pain superior to single discipline intervention?: A Systematic Review." PROSPERO International prospective register of systematic reviews.
	
Reema, A., et al. (2024). "Comparative Analysis of Robotic-Assisted Laparoscopic Myomectomy Versus Traditional Abdominal and Laparoscopic Myomectomy: A Meta-Analysis and Systematic Review." PROSPERO International prospective register of systematic reviews.
	
Reid Fiona, M., et al. (2023). "PROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse." International Urogynecology Journal 34(1): 67-78.
	Introduction and Hypothesis: Our aim was to compare the mid-term results of native tissue, biological xenograft and polypropylene mesh surgery for women with vaginal wall prolapse.; Methods: A total of 1348 women undergoing primary transvaginal repair of an anterior and/or posterior prolapse were recruited between January 2010 and August 2013 from 35 UK centres. They were randomised by remote allocation to native tissue surgery, biological xenograft or polypropylene mesh. We performed both 4- and 6-year follow-up using validated patient-reported outcome measures.; Results: At 4 and 6 years post-operation, there was no clinically important difference in Pelvic Organ Prolapse Symptom Score for any of the treatments. Using a strict composite outcome to assess functional cure at 6 years, we found no difference in cure among the three types of surgery. Half the women were cured at 6 years but only 10.3 to 12% of women had undergone further surgery for prolapse. However, 8.4% of women in the mesh group had undergone further surgery for mesh complications. There was no difference in the incidence of chronic pain or dyspareunia between groups.; Conclusions: At the mid-term outcome of 6 years, there is no benefit from augmenting primary prolapse repairs with polypropylene mesh inlays or biological xenografts. There was no evidence that polypropylene mesh inlays caused greater pain or dyspareunia than native tissue repairs. (© 2022. The Author(s).)

Reilly Thomas, J., et al. (2023). "Intermittent selective serotonin reuptake inhibitors for premenstrual syndromes: A systematic review and meta-analysis of randomised trials." Journal of Psychopharmacology 37(3): 261-267.
	Background: Intermittent (luteal phase) dosing of selective serotonin reuptake inhibitors is one treatment strategy for premenstrual syndromes such as premenstrual dysphoric disorder. This avoids the risk of the antidepressant withdrawal syndrome associated with long-term continuous dosing.; Aims: To compare intermittent dosing to continuous dosing in terms of efficacy and acceptability.; Methods: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycINFO, PubMed and CINAHL for randomised trials of intermittent compared with continuous dosing of selective serotonin reuptake inhibitors in premenstrual syndromes. We extracted response rates, dropout rates and changes in symptom scores. We used random effects meta-analyses to pool study-level data and calculated odds ratio for dichotomous data and standardised mean difference for continuous data. Risk of bias was assessed using the Cochrane risk-of-bias tool. The study was registered with PROSPERO (CRD42020224176).; Results: A total of 1841 references were identified, with eight studies being eligible for analysis, consisting of a total of 460 participants. All included studies provided response rates, six provided dropout rates and five provided symptom scores. There was no statistically significant differences between intermittent and continuous dosing in terms of response rate (odds ratio: 1.0, 95% confidence interval (CI): 0.23-4.31, I 2 = 71%), dropout rate (odds ratio 1.26, 95% CI: 0.39-4.09, I 2 = 33%) or symptom change (standardised mean difference: 0.04, 95% CI: -0.27 to 0.35, I 2 = 39%). All studies had a moderate or high risk of bias.; Conclusion: Since intermittent dosing avoids the potential for withdrawal symptoms, it should be considered more commonly in this patient population.

Reisenauer, C., et al. (2022). "Absorbable versus non-absorbable sutures for vaginal mesh attachment during sacrocolpopexy: a randomized controlled trial." International Urogynecology Journal 33(2): 411-419.
	Introduction and Hypothesis: The purpose of the study was to analyze anatomical and functional outcomes after sacrocolpopexy (SCP) for vaginal vault prolapse pelvic organ prolapse quantification (POPQ) II-III by random use of absorbable (Vicryl) and non-absorbable sutures (Ethibond) for vaginal mesh fixation.; Methods: This study was designed as a two-center randomized controlled study (RCT). The primary objective was to evaluate the anatomical outcome. Success was defined when the vaginal apex (point C; POPQ) did not descend more than 50% of the total vaginal length (tvl) during Valsalva. Patients completed a pelvic examination incorporating the POPQ and questionnaires (the German pelvic floor questionnaire and the PISQ-12 questionnaire) at baseline and 6 months postsurgery. Perioperative adverse events (AE) were recorded. Sample size calculations, based on a 10% non-inferiority limit required 100 participants per group, with power = 90%.; Results: In 190 out of 195 women (ETH group n = 96; VIC group n = 94) anatomical success was achieved. The relative risk of anatomical success failure in the VIC group versus the ETH group was 0.69, with a 95% confidence interval 0.12-4.02. The change in the symptom scores did not differ significantly between the ETH and the VIC group. In the ETH group, three suture penetrations into the vagina were observed, and none in the VIC group 6 months postoperatively.; Conclusions: Anatomical success after SCP for vaginal vault prolapse POPQ II-III is not affected by suture type for vaginal monofilament mesh attachment. Moreover, we did not see any differences in functional outcomes between the two groups. Three suture penetrations into the vagina were observed in the ETH group, and none in the VIC group 6 months postoperatively. (© 2021. The International Urogynecological Association.)

Ren, h., et al. (2023). "Efficacy of Nutritional Supplementation on Endometriosis patients: A Systematic Review and Meta-Analysis of Randomized Clinical Trials." PROSPERO International prospective register of systematic reviews.
	
Ren, N., et al. (2021). "Efficacy and Safety of PARP Inhibitor Combination Therapy in Recurrent Ovarian Cancer: A Systematic Review and Meta-Analysis." Frontiers in Oncology 11: 638295.
	Objectives: Though it is known to all that PARP inhibitors (PARPis) are effective when used as maintenance alone for women with recurrent ovarian cancer (ROC), little is known about whether using them in combination with other drugs would contribute to a better efficacy. We performed a systematic review and meta-analysis to explore the efficacy and safety of PARPi combination therapy compared with monotherapy.; Materials and Methods: We searched for randomized controlled trials (RCTs) that offered the date we needed in PubMed, Embase, Cochrane, and major conference. Data extraction and processing were completed by three investigators to compare OS, PFS, and ORR both in intervention and in control subset. Then, we calculated the pooled RR and 95% CI of all-grade and high-grade adverse effects to study its safety. And we evaluated the within-study heterogeneity by using subgroup and sensitivity analysis.; Results and Conclusion: A total of three eligible RCTs covering 343 women were included. In PFS analysis, PARP inhibitor (PARPi) combination therapy can significantly improve PFS for women with ROC when compared with the controls (HR: 0.46, 95% CI: 0.35 to 0.59), especially for those with mutated BRCA (HR: 0.29, 95% CI: 0.19 to 0.45). And in OS analysis, combination therapy is not inferior to monotherapy (HR: 0.90, 95% CI: 0.50 to 1.61). As for ORR, the effectiveness of combination therapy and monotherapy was almost the same (RR: 1.04, 95% CI: 0.82 to 1.31). Additionally, combination therapy seldom causes more adverse events, both in all-grade and in high grade.; Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/, International Prospective Register of Systematic Reviews (PROSPERO) (identifier, CRD42018109933).; 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 Ren, Zhang, Yu, Guan, Dai, Sun and Ying.)

Ren-ting, Z., et al. (2022). "Effectiveness and safety of cupping therapy for primary dysmenorrhea: a protocol for a systematic reviews and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
RenXian, X. I. E., et al. (2023). "Neoadjuvant chemotherapy followed by radical surgery versus chemoradiotherapy in patients with locally advanced cervical cancer: a meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Reproductive Medicine Associates of New, J. (2021). "Prospective Assessment of Impact of Personalized Dosing of Low-dose Human Chorionic Gonadotropin (hCG) on in Vitro Fertilization (IVF) Outcomes." ClinicalTrials.gov.
	The objective of this study is to conduct a double‐blind prospective randomized control trial to determine if individualized hCG titration based on a patient's serum hCG level above or below the predetermined serum hCG level improves IVF outcomes, primarily sustained implantation rates. Patients who fall below the desired serum hCG threshold will be randomized to either maintaining their current dose of low dose hCG or being increased.

Restaino, S., et al. (2020). "Robotic surgery vs laparoscopic surgery in patients with diagnosis of endometriosis: a systematic review and meta-analysis." Journal of Robotic Surgery 14(5): 687-694.
	Endometriosis is one of the most common medical conditions affecting the women. The study aimed to evaluate the safety and efficacy of robotic-assisted laparoscopic surgery (RAS) versus conventional laparoscopic surgery (LPS) in the treatment of endometriosis. PubMed, Embase, Cochrane and CINAHL databases were searched from January 1995 to March 2019. According to meta-analysis criteria, five comparative studies were selected. A total of 1527 patients were identified. In the meta-analysis, there were no significant differences in blood loss, complication, and hospital stay between RAS and LPS surgeries in the treatment of patients with endometriosis. However, RAS surgery required a higher weighted mean operating time than LPS surgery, 0.54 (95% confidence interval; 0.37 to 0.70; p < 0.00001) min. This meta-analysis confirmed that the robotic surgery is safe and feasible in patients affected by endometriosis. We could suggest that RAS is a valid option and might be considered an alternative to LPS especially in advanced cases.

Reviewer, N. G. A. S. S. and N. G. A. S. Reviewer (2022). "Effects of hormone replacement therapy for menopausal symptoms on all-cause mortality." PROSPERO International prospective register of systematic reviews.
	
Reviewer, N. G. A. S. S. and N. G. A. S. Reviewer (2022). "What is the effectiveness of cognitive behavioural therapy for managing symptoms associated with the menopause?" PROSPERO International prospective register of systematic reviews.
	
Reynolds-Wright John, J., et al. (2023). "Using telemedicine to improve early medical abortion at home (UTAH): a randomised controlled trial to compare telemedicine with in-person consultation for early medical abortion." BMJ Open 13(9): e073630.
	Objectives: To compare telephone consultations with in-person consultations for the provision of medical abortion (using mifepristone 200 mg and misoprostol 800 µg). We hypothesised that telemedicine consultations would be non-inferior to in-person consultations with a non-inferiority limit of 3%.; Design: Randomised controlled trial with 1:1 allocation.; Setting: Community abortion service housed within an integrated sexual and reproductive health service in Edinburgh, UK.; Participants: The trial began on 13 January 2020, but was stopped early due to COVID-19; recruitment was suspended on 31 March 2020, and was formally closed on 31 August 2021. A total of 125 participants were randomised, approximately 10% of the total planned, with 63 assigned to telemedicine and 62 to in-person consultation.; Primary and Secondary Outcome Measures: Primary outcome: efficacy of medical abortion, defined as complete abortion without surgical intervention.; Secondary Outcomes: satisfaction with consultation type, preparedness, unscheduled contact with care, complication rate, time spent in clinical contact and uptake of long-acting contraception.; Results: Primary outcome was available for 115 participants (lost-to-follow-up telemedicine=2, in-person=8), secondary outcomes were available for 110 participants (n=5 and n=10 in telemedicine and in-person groups did not complete questionnaires). There were no significant differences between groups in treatment efficacy (telemedicine 57/63 (90.5%), in-person 48/62 (77.4%)). However, non-inferiority was not demonstrated (+3.3% in favour of telemedicine, CI -6.6% to +13.3%, lower than non-inferiority margin). There were no significant differences in most secondary outcomes, however, there was more unscheduled contact with care in the telemedicine group (12 (19%) vs 3 (5%), p=0.01). The overall time spent in clinical contact was statistically significantly lower in the telemedicine group (mean 94 (SD 24) vs 111 (24) min, p=0.0005).; Conclusions: Telemedicine for medical abortion appeared to be effective, safe and acceptable to women, with less time spent in the clinic. However, due to the small sample size resulting from early cessation, the study was underpowered to confirm this conclusion. These findings warrant further investigation in larger scale studies.; Trial Registration Number: NCT04139382.; Competing Interests: Competing interests: JRW has received an educational grant from Gedeon Richter. STC and JN have no competing interests to declare. (© 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.)

Riazi, H., et al. (2019). "Effect of Vitamin D on the Vaginal Health of Menopausal Women: A Systematic Review." Journal of Menopausal Medicine 25(3): 109-116.
	Menopause is associated with the onset of climacteric symptoms due to low estradiol levels, which may cause insufficient maturation of the vaginal mucosa. Vitamin D may regulate the growth and differentiation of cells that are adversely affected due to low estradiol levels, thereby restoring vaginal health. The objective of this systematic review, the first on this subject, was to investigate the effect of vitamin D on the vaginal health of menopausal women. PubMed, Embase, Scopus, Web of Science, and Google Scholar databases and reference lists of hand-searched articles were searched for published studies from February 2000 to November 2018. The selection criteria were as follows: randomized or quasi-randomized trials that compared the effects of vitamin D or related compounds, alone or with calcium, on vaginal health (growth and differentiation of epithelial cells, dryness, acidity [pH]) outcomes in menopausal women. The methodological quality of these studies was examined using the Cochrane tool checklist by two independent investigators, following which the data were extracted. Of six examined studies, two showed that vitamin D administration improved the growth and differentiation of vaginal epithelial cells, improved vaginal pH, and decreased vaginal dryness in menopausal women. Although the level of evidence for the effects of vitamin D on vaginal health is low in our study, we concluded that vitamin D may improve the vaginal health of women, especially during menopause.

Richard, E., et al. (2022). "Effect of Postoperative Hormonal Suppression on Fertility in Patients With Endometriosis After Conservative Surgery: A Systematic Review and Meta-analysis." Obstetrics and Gynecology 139(6): 1169-1179.
	Objective: To evaluate the effect of hormonal suppression on fertility when administered to infertile patients or patient wishing to conceive after surgery for endometriosis.; Data Sources: A systematic search of MEDLINE, EMBASE, CENTRAL and ClinicalTrials.gov was performed by two independent reviewers from the databases' inception until December 2020.; Methods of Study Selection: We included randomized controlled trials comparing any suppressive hormonal therapy to an inactive control (placebo or absence of treatment) after conservative surgery for endometriosis. Studies that did not report fertility outcomes after surgery were excluded.; Tabulation, Integration and Results: This systematic review and meta-analysis was registered in PROSPERO. Two reviewers extracted data and assessed the risk of bias as well as the strength of evidence using GRADE (Grading of Recommendations, Assessment, Development and Evaluation) methodology. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines were followed. Relative risks (RRs) were pooled by quantitative random effect meta-analysis. From 3,138 citations, 19 trials (2,028 patients) were included. Overall, no difference was observed between the treatment and the control group for pregnancy (RR 1.15; 95% CI 1.00-1.32) and live births (RR 1.05; 95% CI 0.84-1.32). When pooling all hormonal therapies, the duration of administration of postoperative therapy was identified as a substantial source of heterogeneity between studies (I2 difference=74%) with increased chances of pregnancy compared with control when administered for at least 3 months (RR 1.22; 95% CI 1.04-1.43). Gonadotropin-releasing hormone (GnRH) agonists (14 trials, 1,721 patients) were associated with increased chances of pregnancy compared with placebo or no treatment (RR 1.20; 95% CI 1.03-1.41; I2=25%). Data were limited for other hormonal treatments with no significant difference between groups. Subgroup analyses taking into account the use of fertility treatments (insemination or in vitro fertilization), stages of the disease and risk of bias of included trials did not modify the results.; Conclusion: Postoperative hormonal suppression should be considered on a case-by-case basis to enhance fertility while balancing this benefit with the risks of delaying conception. If chosen, GnRH agonists would be the treatment of choice, and a duration of at least 3 months should be favored.; Systematic Review Registration: PROSPERO, CRD42021224424.; 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.)

Richardson, M. T., et al. (2023). "Sequential Targeted Therapy for Advanced, Metastatic, and Recurrent Cervical Cancer: A Cost-Effectiveness Analysis of the Patient Journey." Cancer Control 30.
	Objectives: To evaluate outcomes and cost-effectiveness of targeted therapy sequencing for metastatic and recurrent cervical cancer. Method(s): Models were simulated based on phase II and III trials on bevacizumab (bev) from GOG-240, cemiplimab (cemi) from GOG 3016, pembrolizumab (pembro) from KEYNOTE-826, and tisotumab vedotin (tiso) from GOG 3023. Costs were based on IBM Micromedex RED BOOKTM and company listed costs. Result(s): For [chemo + bev -> chemo], total cost was $125,918.04, with median overall survival (mOS) of 21.8 months, and cost-effectiveness ratio (CER) of $119,835.79. For [chemo + bev -> cemi], total cost was $187,562.99 with mOS of 28.5 months and CER of $162,039.16. For [chemo + bev + pembro -> chemo], total cost was $319,963.78 with mOS 32.9 months and CER of $249,930.10. For [chemo + bev + pembro -> tiso], total cost was $455,204.45, with mOS 36.5 months and CER of $320,072.99. Conclusion(s): The combination of immunotherapies and biologics have significantly increased overall survival, but with associated higher costs, primarily related to drug costs.Copyright © The Author(s) 2023.

Riemma, G., et al. (2023). "Impact of Hemostatic Approach after Laparoscopic Endometrioma Excision on Ovarian Reserve: Systematic Review and Network Meta-Analysis of Randomized Controlled Trials." International Journal of Gynaecology and Obstetrics 162(1): 222-232.
	BACKGROUND: Laparoscopic excision of endometrioma and subsequent hemostasis have detrimental effects on ovarian reserve. OBJECTIVES: To evaluate which hemostatic approach after stripping cystectomy shows less damage on ovarian reserve. SEARCH STRATEGY: EMBASE, MEDLINE, Scopus, Scielo.br, LILACS, Cochrane at Central, Clinicaltrials.gov, CINAHL, conference abstracts and international controlled trials registry were searched from inception until April 2022. SELECTION CRITERIA: Randomized controlled trials (RCTs) of women undergoing laparoscopic endometrioma excision that compared at least two hemostatic approaches. DATA COLLECTION AND ANALYSIS: Relevant data were extracted and tabulated. Network meta-analysis based on random effects model for mixed multiple treatment to rank hemostatic strategies using the surface under the cumulative ranking curve area (SUCRA) was performed. Quality assessment was performed using Cochrane criteria. Primary outcome was serum Antimullerian hormone (AMH) levels 3 months after surgery. MAIN RESULTS: Ten studies, including 748 women, were selected. Suturing the ovary with barbed suture (SUCRA=82.80%) seem the most effective strategy to avoid AMH reduction. Similarly, for ultrasonographic antral follicular count, barbed (SUCRA=30.70%) and simple suture (SUCRA=30.70%) were ranked best choices. Ovarian suturing with simple suture demonstrated lower FSH levels (SUCRA=88.70%). CONCLUSIONS: Suturing the ovary, with simple or barbed suture, seems the most effective approach to keep ovarian reserve higher.

Riemma, G., et al. (2019). "Efficacy of Low-Dose Paroxetine for the Treatment of Hot Flushes in Surgical and Physiological Postmenopausal Women: Systematic Review and Meta-Analysis of Randomized Trials." Medicina 55(9).
	Background and Objectives: Hot flushes and sleep disturbances are the most common vasomotor symptoms (VMS) reported by postmenopausal women. Hormonal treatment is to date referred to as the gold standard approach but not suitable for all the patients. Alternative treatments are needed in case of a contraindication to menopausal hormone therapy (MHT), adverse side effects, and poor compliance. Paroxetine salt is the only nonhormonal medication approved by the US Food and Drug Administration for the management of VMS. Nonetheless, few trials with low consensus are available about this topic. In this review, we aimed to evaluate the efficacy of low-dose paroxetine therapy in the treatment of vasomotor hot flushes and night sleep disturbances in postmenopausal women. Materials and Methods: We performed an electronic search from the beginning of all databases to July 2019. All results were then limited to a randomized trial. Restrictions for language or geographic location were not utilized. Inclusion criteria were randomized clinical trials of physiological or surgical postmenopausal women experiencing hot flushes and sleep disturbances who were randomized to either low-dose paroxetine or placebo (i.e., formulations without active ingredients). The primary outcome evaluated was the mean weekly reduction of hot flushes. Results: Five randomized clinical trials, including 1482 postmenopausal women, were analyzed. Significant heterogeneity (I 2 = 90%) between studies was noted. Hot flushes episodes were significantly reduced in the treatment arm compared to placebo (mean difference (MD) -7.97 [-10.51, -5.92] episodes/week). Results on the improvement on sleep were limited by being reported in only two studies; however, no significant reduction of night-time awakenings was observed (MD, -0.40 awakenings/night [-1.38, 0.58 CI]). Conclusions: Low-dose paroxetine is an effective treatment for vasomotor menopause symptoms, including hot flushes.

Riley Kristin, W. (2022). "Use of TENS Unit in the Management of Endometriosis Pain." ClinicalTrials.gov.
	No Results Available Device: Ovira Transcutaneous Electrical Nerve Stimulation Unit Change in Average Daily VAS Pain Score|Change in Quality of Life Score from baseline to end of study using the EHP30 questionnaire|Change in Female Sexual Function Index Total Score using the FSFI questionnaire Female Not Applicable 40 Other Allocation: Non-Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care STUDY00019024 January 1, 2025

Rimel Bobbie, J., et al. (2023). "NRG-GY012: Randomized phase 2 study comparing olaparib, cediranib, and the combination of cediranib/olaparib in women with recurrent, persistent, or metastatic endometrial cancer." Cancer.
	Purpose: This paper reports the efficacy of the poly (ADP-ribose) polymerase inhibitor olaparib alone and in combination with the antiangiogenesis agent cediranib compared with cediranib alone in patients with advanced endometrial cancer.; Methods: This was open-label, randomized, phase 2 trial (NCT03660826). Eligible patients had recurrent endometrial cancer, received at least one (<3) prior lines of chemotherapy, and were Eastern Cooperative Oncology Group performance status 0 to 2. Patients were randomly assigned (1:1:1), stratified by histology (serous vs. other) to receive cediranib alone (reference arm), olaparib, or olaparib and cediranib for 28-day cycles until progression or unacceptable toxicity. The primary end point was progression-free survival in the intention-to-treat population. Homologous repair deficiency was explored using the BROCA-GO sequencing panel.; Results: A total of 120 patients were enrolled and all were included in the intention-to-treat analysis. Median age was 66 (range, 41-86) years and 47 (39.2%) had serous histology. Median progression-free survival for cediranib was 3.8 months compared with 2.0 months for olaparib (hazard ratio, 1.45 [95% CI, 0.91-2.3] p = .935) and 5.5 months for olaparib/cediranib (hazard ratio, 0.7 [95% CI, 0.43-1.14] p = .064). Four patients receiving the combination had a durable response lasting more than 20 months. The most common grade 3/4 toxicities were hypertension in the cediranib (36%) and olaparib/cediranib (33%) arms, fatigue (20.5% olaparib/cediranib), and diarrhea (17.9% cediranib). The BROCA-GO panel results were not associated with response.; Conclusion: The combination of cediranib and olaparib demonstrated modest clinical efficacy; however, the primary end point of the study was not met. The combination was safe without unexpected toxicity. (© 2023 American Cancer Society.)

Rimmer Michael, P., et al. (2021). "Intralipid infusion at time of embryo transfer in women with history of recurrent implantation failure: A systematic review and meta-analysis." The Journal of Obstetrics and Gynaecology Research 47(6): 2149-2156.
	Aim: Recurrent implantation failure (RIF) affects 10% of couples undergoing assisted conception, often due to poor endometrial receptivity. We conducted a systematic review and meta-analysis to evaluate the effectiveness of Intra-venous intralipid (IVI) in improving pregnancy rates in women with history of RIF using.; Methods: We searched MEDLINE, EMBASE, and CENTRAL for any randomized trials evaluating the use of IVI at the time of embryo transfer in women undergoing assisted conception until September 2020. We extracted data in duplicate and assessed risk of bias using the Cochrane Risk of Bias tools. We meta-analyzed data using a random effect model.; Results: We included five randomized trials reporting on 843 women with an overall moderate risk of bias. All trials used 20% IVI solution at the time of embryo transfer compared to normal saline infusion or no intervention (routine care). The IVI group had a higher chance of clinical pregnancy (172 vs 119, risk ratio [RR] 1.55, 95% confidence interval [CI] 1.16-2.07, I 2 44.2%) and live birth (132 vs 73, RR 1.83, 95% CI 1.42-2.35, I 2 0%) post treatment compared to no intervention. Our findings are limited by the small sample size and the variations in treatment protocols and population characteristics.; Conclusion: There is limited evidence to support the use of IVI at the time of embryo transfer in women with the history of RIF. More research is needed before adopting it in clinical practice. (© 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.)

Rinaldi, L. (2023). "Different routes of progesterone administration for sustaining implantation in in vitro fertilisation patients: impact on pregnancy and live birth rates." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: All the patients are going to have a mild ovarian stimulation protocol: rFSH will be started at a dose of 75‐150 IU on the base of AMH level. GnRH antagonist (0.25 mg/day) will be administered when the leading follicle measures 14 mm. The FSH dose will be adjusted when necessary according to the follicular size and estradiol level. Final oocyte maturation will be induced by a dose of 10,000 IU of hCG. Recovered oocytes will be inseminated by standard IVF or intracytoplasmic sperm injection (ICSI). Up to three embryos will be transferred on day 3 after oocyte insemination. Randomization will be performed using a computer‐generated random assignment schedule for each patient. Sealed and numbered envelopes will be used to conceal the treatment allocation until randomization. On the day of oocyte recovery, the patients will be randomized into two groups: Group A will receive vaginal administration of capsules of micronized progesterone (800 mg/day) for luteal phase support; Group B will receive a combination of vaginal administration of a gel of micronized progesterone (90 mg/day) and oral dydrogesterone 10 mg twice a day for luteal phase support. The duration of the treatment is 14 ‐ 21 days; follow‐up will be around 9 months for each patient, from the established pregnancy to the delivery. CONDITION: Luteal phase supplementation in assisted reproduction ; Pregnancy and Childbirth PRIMARY OUTCOME: Clinical pregnancy measured using a blood test to evaluate the level of human chorionic gonadotropin (hCG), which indicates the eventual embryo implantation and pregnancy, 14 days after embryo replacement in the patient's uterus; SECONDARY OUTCOME: Embryo implantation rate measured using ultrasonography at 4 weeks following a positive hCG test to confirm the clinical pregnancy INCLUSION CRITERIA: 1. Infertility attributable to tubal factors, moderate endometriosis, male factor, or idiopathic infertility 2. Serum hormonal profile within the normal range (AMH >1 ng/ml) 3. Regular menstrual cycles 4. The presence of a normal uterine cavity 5. Body mass inde X(BMI) of 20–26 kg/m²

Rinninella, E., et al. (2019). "Nutritional Interventions to Improve Clinical Outcomes in Ovarian Cancer: A Systematic Review of Randomized Controlled Trials." Nutrients 11(6).
	Among all gynaecological neoplasms, ovarian cancer has the highest rate of disease-related malnutrition, representing an important risk factor of postoperative mortality and morbidity. Hence, the importance of finding effective nutritional interventions is crucial to improve ovarian cancer patient's well-being and survival. This systematic review of randomized controlled trials (RCTs) aims at assessing the effects of nutritional interventions on clinical outcomes such as overall survival, progression-free survival, length of hospital stay (LOS), complications following surgery and/or chemotherapy in ovarian cancer patients. Three electronic bibliographic databases (MEDLINE, Web of Science, and Cochrane Central Register of Controlled Trials) were used to conduct a systematic literature search based on fixed inclusion and exclusion criteria, until December 2018. A total of 14 studies were identified. Several early postoperative feeding interventions studies ( n = 8) were retrieved mainly demonstrating a reduction in LOS and an ameliorated intestinal recovery after surgery. Moreover, innovative nutritional approaches such as chewing gum intervention ( n = 1), coffee consumption ( n = 1), ketogenic diet intervention ( n = 2) or fruit and vegetable juice concentrate supplementation diet ( n = 1) and short-term fasting ( n = 1) have been shown as valid and well-tolerated nutritional strategies improving clinical outcomes. However, despite an acceptable number of prospective trials, there is still a lack of homogeneous and robust endpoints. In particular, there is an urgent need of RCTs evaluating overall survival and progression-free survival during ovarian oncology treatments. Further high-quality studies are warranted, especially prospective studies and large RCTs, with more homogeneous types of intervention and clinical outcomes, including a more specific sampling of ovarian cancer women, to identify appropriate and effective nutritional strategies for this cancer, which is at high risk of malnutrition.

Rita, Z., et al. (2022). "Investigating the effect of Letrozole on fertility in women with PCOS." PROSPERO International prospective register of systematic reviews.
	
Ritesh, W., et al. (2022). "Intravaginal electrical stimulation for pelvic organ prolapse and urinary incontinence: a systematic review and meta-analysis of randomised trials." PROSPERO International prospective register of systematic reviews.
	
Rittig, N. (2023). "Exogenous Ketone Ester in Women With Polycystic Ovary Syndrome." ClinicalTrials.gov.
	No Results Available Dietary Supplement: 3-OHB (KE4)|Dietary Supplement: water Plasma concentration of testosterone|plasma SHBG|plasma 3-OHB|plasma glucose|serum insulin|plasma C-peptide|plasma free fatty acids|plasma triglycerides|plasma cholesterol|C reactive protein|plasma cytokines (such as Tumor Necrotic Factor alpha, Interleukin 6, Lipopolysaccharide -binding protein, soluble CD163)|plasma prolactin|Plasma FSH|Plasma LH|plasma free testosterone|plasma estradiol|plasma keto-testosterone|Homeostatic Model Assessment for Insulin Resistance Female Not Applicable 20 Other Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment 1-10-72-217-22 December 1, 2024

Rizzo, A., et al. (2020). "Impact of chemotherapy in the adjuvant setting of early stage uterine leiomyosarcoma: A systematic review and updated meta-analysis." Cancers 12(7): 1-12.
	Background: Although the use of adjuvant chemotherapy (AC) appears to be increasing over the past few years, several clinical trials and previous meta-analyses failed to determine whether AC could improve clinical outcomes in uterine leiomyosarcoma (uLMS). The aim of this systematic review and meta-analysis was to compare AC (with or without radiotherapy) versus observation (obs) after primary surgery in early stage uLMS. Material(s) and Method(s): Randomized controlled (RCTs) and non-randomized studies (NRSs) were retrieved. Outcomes of interest were as follows: distant recurrence rate, locoregional recurrence rate and overall recurrence rate. Results about distant recurrence rate, locoregional recurrence rate and overall recurrence rate were compared by calculating odds ratios (ORs) with 95% confidence intervals (CIs); ORs were combined with Mantel-Haenszel method. Result(s): Nine studies were included in the analysis, involving 545 patients (AC: 252, obs: 293). Compared with obs, AC did not reduce locoregional and distant recurrence rate, with a pooled OR of 1.36 and 0.63, respectively. Similarly, administration of AC did not decrease overall recurrence rate in comparison to obs. Conclusion(s): According to our results, AC (with or without radiotherapy) did not decrease recurrence rate in early stage uLMS; thus, the role of AC in this setting remains unclear.Copyright © 2020 by the authors. Licensee MDPI, Basel, Switzerland.

Roberts, S. (2023). "A Study of Participants Ages 21-65 Diagnosed With Dyspareunia and the Effects of Low Intensity Shockwave Treatment." ClinicalTrials.gov.
	No Results Available Device: Low intensity shockwave treatment to pelvic floor region plus typical physical therapy|Device: Sham shockwave treatment plus typical physical therapy Tampon Test|Numerical pain rating scale for tampon test|Female Sexual Function Index, (FSFI)|Numeric pain score for deep penetration.|Beck Depression Scale Female Not Applicable 60 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 2018453-1 April 30, 2024

Robin, G. (2022). "Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome." ClinicalTrials.gov.
	No Results Available Dietary Supplement: Myo-Inositol + Levomefolic acid|Drug: Clomiphene Citrate|Dietary Supplement: placebo Total resistance rate under CC for ovulation induction in patients with PCOS.|Rate of responders (i.e., 100% cycles with ovulation and/or occurrence of a pregnancy) at doses of 50 and 100mg of CC|Rate of drop out|Cumulative incidence of clinical pregnancy (cardiac activity on ultrasound at 6 weeks of amenorrhea)|Rate of patients switched to a 2nd line treatment with exogenous gonadotropins over the whole period of the study Female Phase 3 276 Other|Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment 2015_68|2016-A01246-45|PHRC_N_15-0116 March 2024

Robinson, J. (2022). "Transvaginal Low-level Laser Therapy to Improve Pelvic Pain and Sexual Function in Patients With Endometriosis." ClinicalTrials.gov.
	Active intervention: Transvaginal photobiomodulation (TV‐PBM) Control intervention: Sham transvaginal probe All subjects will complete 9 treatments over 3‐4 weeks and all treatments will be performed with a sheet over the patient's pelvic area to prevent the subject from seeing the probe light, as well as a screen blocking the patient's view of the machine. Subjects randomized to active therapy will undergo TV‐PBM treatment during each session per standard TV‐PBM treatment protocol. Subjects randomized to sham will undergo blinded sham therapy using an identical probe but without photobiomodulation. Sham therapy will involve the same regimen as the active arm but with the machine turned off. Instead, there will be a recording of the usual noise of the machine to mimic the activation that occurs when stepping on the pedal with the machine on for TV‐PBM treatment.

Rodrigo Chithramali, H., et al. (2023). "Effectiveness of workplace-based interventions to promote wellbeing among menopausal women: A systematic review." Post Reproductive Health 29(2): 99-108.
	Menopausal symptoms are known to affect quality of life and work productivity. This systematic review aimed to describe the range and effectiveness of workplace-based interventions for menopause. MEDLINE, PubMed, Embase, CINAHL, Cochrane Library, Web of Science, PsycINFO, EconLit, and SCOPUS were searched from the inception until April 2022. Quantitative interventional studies evaluating physical/virtual workplace-based interventions aiming to improve well-being, work, and other outcomes, that involved women in menopausal transition, or their line managers/supervisors were eligible for inclusion. Two randomized controlled trials and three uncontrolled trials, comprising 293 women aged 40-60 years and 61, line managers/supervisors, were included in the review. Results were narratively synthesized due to the heterogeneity of interventions and outcomes and we found that only a limited range of interventions have been evaluated for their ability to support women going through menopausal transition in the workplace. Self-help cognitive behavioural therapy (CBT); Raja yoga; and health promotion (involving menopause consultations, work-life coaching and physical training) improved menopausal symptoms significantly. Self-help CBT was associated with a significant improvement in mental resources for work, presenteeism, and work and social adjustment. Awareness programs significantly improved knowledge and attitudes of both employees and line managers/supervisors about menopause. The interventions have mostly been evaluated in small studies with selected populations but have improved menopausal symptoms and work outcomes. A customizable menopause wellbeing intervention package incorporating these evidence-supported interventions should be developed and implemented on a wider scale within organizations alongside robust evaluation of its effectiveness.

Rodriguez Magdalena, B., et al. (2019). "Endometrial resection and ablation techniques for heavy menstrual bleeding." The Cochrane Database of Systematic Reviews 1: CD001501.
	Background: Heavy menstrual bleeding (HMB) is a significant health problem in premenopausal women; it can reduce their quality of life and can cause social disruption and physical problems such as iron deficiency anaemia. First-line treatment has traditionally consisted of medical therapy (hormonal and non-hormonal), but this is not always successful in reducing menstrual bleeding to acceptable levels. Hysterectomy is a definitive treatment, but it is more costly and carries some risk. Endometrial ablation may be an alternative to hysterectomy that preserves the uterus. Many techniques have been developed to 'ablate' (remove) the lining of the endometrium. First-generation techniques require visualisation of the uterus with a hysteroscope during the procedure; although it is safe, this procedure requires specific technical skills. Newer techniques for endometrial ablation (second- and third-generation techniques) have been developed that are quicker than previous approaches because they do not require hysteroscopic visualisation during the procedure.; Objectives: To compare the efficacy, safety, and acceptability of endometrial destruction techniques to reduce heavy menstrual bleeding (HMB) in premenopausal women.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE, Embase, CINAHL, and PsycInfo (from inception to May 2018). We also searched trials registers, other sources of unpublished or grey literature, and reference lists of retrieved studies, and we made contact with experts in the field and with pharmaceutical companies that manufacture ablation devices.; Selection Criteria: Randomised controlled trials (RCTs) comparing different endometrial ablation or resection techniques for women reporting HMB without known uterine pathology, other than fibroids outside the uterine cavity and smaller than 3 centimetres, were eligible. Outcomes included improvement in HMB and in quality of life, patient satisfaction, operative outcomes, complications, and the need for further surgery, including hysterectomy.; Data Collection and Analysis: Two review authors independently selected trials for inclusion, assessed trials for risk of bias, and extracted data. We contacted study authors for clarification of methods or for additional data. We assessed adverse events only if they were separately measured in the included trials. We undertook comparisons with individual techniques as well as an overall comparison of first- and second-generation ablation methods.; Main Results: We included in this update 28 studies (4287 women) with sample sizes ranging from 20 to 372. Most studies had low risk of bias for randomisation, attrition, and selective reporting. Less than half of these studies had adequate allocation concealment, and most were unblinded. Using GRADE, we determined that the quality of evidence ranged from moderate to very low. We downgraded evidence for risk of bias, imprecision, and inconsistency.Overall comparison of second-generation versus first-generation (i.e. gold standard hysteroscopic ablative) techniques revealed no evidence of differences in amenorrhoea at 1 year and 2 to 5 years' follow-up (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.78 to 1.27; 12 studies; 2145 women; I² = 77%; and RR 1.16, 95% CI 0.78 to 1.72; 672 women; 4 studies; I² = 80%; very low-quality evidence) and showed subjective improvement at 1 year follow-up based on a Pictorial Blood Assessment Chart (PBAC) (< 75 or acceptable improvement) (RR 1.03, 95% CI 0.98 to 1.09; 5 studies; 1282 women; I² = 0%; and RR 1.12, 95% CI 0.97 to 1.28; 236 women; 1 study; low-quality evidence). Study results showed no difference in patient satisfaction between second- and first-generation techniques at 1 year follow-up (RR 1.01, 95% CI 0.98 to 1.04; 11 studies; 1750 women; I² = 36%; low-quality evidence) nor at 2 to 5 years' follow-up (RR 1.02, 95% CI 0.93 to 1.13; 672 women; 4 studies; I² = 81 ).Compared with first-generation techniques, second-generation endometrial ablation techniques were associated with shorter operating times (mean difference (MD) -13.52 minutes, 95% CI -16.90 to -10.13; 9 studies; 1822 women; low-quality evidence) and more often were performed under local rather than general anaesthesia (RR 2.8, 95% CI 1.8 to 4.4; 6 studies; 1434 women; low-quality evidence).We are uncertain whether perforation rates differed between second- and first-generation techniques (RR 0.32, 95% CI 0.10 to 1.01; 1885 women; 8 studies; I² = 0%).Trials reported little or no difference between second- and first-generation techniques in requirement for additional surgery (ablation or hysterectomy) at 1 year follow-up (RR 0.72, 95% CI 0.41 to 1.26; 6 studies: 935 women; low-quality evidence). At 5 years, results showed probably little or no difference between groups in the requirement for hysterectomy (RR 0.85, 95% CI 0.59 to 1.22; 4 studies; 758 women; moderate-quality evidence).; Authors' Conclusions: Approaches to endometrial ablation have evolved from first-generation techniques to newer second- and third-generation approaches. Current evidence suggests that compared to first-generation techniques (endometrial laser ablation, transcervical resection of the endometrium, rollerball endometrial ablation), second-generation approaches (thermal balloon endometrial ablation, microwave endometrial ablation, hydrothermal ablation, bipolar radiofrequency endometrial ablation, endometrial cryotherapy) are of equivalent efficacy for heavy menstrual bleeding, with comparable rates of amenorrhoea and improvement on the PBAC. Second-generation techniques are associated with shorter operating times and are performed more often under local rather than general anaesthesia. It is uncertain whether perforation rates differed between second- and first-generation techniques. Evidence was insufficient to show which second-generation approaches were superior to others and to reveal the efficacy and safety of third-generation approaches versus first- and second-generation techniques.

Rodriguez, M. B., et al. (2021). "Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding." The Cochrane Database of Systematic Reviews 2(2): CD000329.
	BACKGROUND: Heavy menstrual bleeding (HMB) is common in otherwise healthy women of reproductive age, and can affect physical health and quality of life. Surgery is usually a second-line treatment of HMB. Endometrial resection/ablation (EA/ER) to remove or ablate the endometrium is less invasive than hysterectomy. Hysterectomy is the definitive treatment and can be via open (laparotomy) approach, or via minimally invasive approaches (vaginally or laparoscopically). Each approach has its own advantages and risk profile. OBJECTIVES: To compare the effectiveness, acceptability and safety of endometrial resection or ablation versus different routes of hysterectomy (open, minimally invasive hysterectomy, or unspecified route) for the treatment of HMB. SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility specialised register, CENTRAL, MEDLINE, Embase and PsycINFO (July 2020), and reference lists, grey literature and trial registers. SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared techniques of endometrial resection/ablation with hysterectomy (by any technique) for the treatment of HMB in premenopausal women. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 10 RCTs (1966 participants) comparing EA/ER to hysterectomy (open (abdominal), minimally invasive (laparoscopic or vaginal), or unspecified (or at surgeon's discretion) route of hysterectomy). The results were rated as moderate-, low- and very low-certainty evidence. Endometrial resection/ablation versus open hysterectomy We found two trials. Women having EA/ER are probably less likely to perceive an improvement in HMB compared to women having open hysterectomy (risk ratio (RR) 0.90, 95% confidence interval (CI) 0.84 to 0.95; 2 studies, 247 women; moderate-certainty evidence) and probably have a 13% risk of requiring further surgery for treatment failure (compared to 0 on the open hysterectomy group; 2 studies, 247 women; moderate-certainty evidence). Both treatments probably lead to similar quality of life at two years (mean difference (MD) -5.30, 95% CI -11.90 to 1.30; 1 study, 155 women; moderate-certainty evidence) and satisfaction rate at one year (RR 0.91, 95% CI 0.82 to 1.00; 1 study, 194 women; moderate-certainty evidence). There may be no difference in serious adverse events (RR 1.29, 95% CI 0.32 to 5.20; 2 studies, 247 women; low-certainty evidence). EA/ER probably reduces time to return to normal activity compared to open hysterectomy (MD -21.00 days, 95% CI -24.78 to -17.22; 1 study, 197 women; moderate-certainty evidence). Endometrial resection/ablation versus minimally invasive hysterectomy We found five trials. The proportion of women with perception of improvement in HMB at two years may be similar between groups (RR 0.97, 95% CI 0.90 to 1.04; 1 study, 79 women; low-certainty evidence). Blood loss may be higher in the EA/ER group when assessed using the Pictorial Blood Assessment Chart (MD 44.00, 95% CI 36.09 to 51.91; 1 study, 68 women; low-certainty evidence). Quality of life is probably lower in the EA/ER group compared to the minimally invasive hysterectomy group at two years according to the 36-item Short Form (SF-36) (MD -10.71, 95% CI -15.11 to -6.30; 2 studies, 145 women; moderate-certainty evidence) and Menorrhagia Multi-Attribute Scale (RR 0.82, 95% CI 0.70 to 0.95; 1 study, 616 women; moderate-certainty evidence). EA/ER probably increases the risk of further surgery for HMB compared to minimally invasive hysterectomy (RR 7.70, 95% CI 2.54 to 23.32; 4 studies, 922 women; moderate-certainty evidence) and treatments probably have similar rates of any serious adverse events (RR 0.75, 95% CI 0.35 to 1.59; 4 studies, 809 women; moderate-certainty evidence). Women with EA/ER are probably less likely to be satisfied with treatment at one year (RR 0.90, 95% CI 0.85 to 0.94; 1 study, 558 women; moderate-certainty evidence). We were unable to pool data for time to return to work or normal life because of extreme heterogeneity (99%); however, the t ree studies reporting this all had the same direction of effect favouring EA/ER. Endometrial resection/ablation versus unspecified route of hysterectomy We found three trials. EA/ER may lead to a lower perception of improvement in HMB compared to unspecified route of hysterectomy (RR 0.89, 95% CI 0.83 to 0.95; 2 studies, 403 women; low-certainty evidence). Although EA/ER may lead to similar quality of life using the SF-36 General Health Perception at two years' follow-up (MD -1.90, 95% CI -8.67 to 4.87; 1 study, 209 women; low-certainty evidence), the proportion of women with improvement in general health at one year may be lower (RR 0.85, 95% CI 0.77 to 0.95; 1 study, 185 women; low-certainty evidence). EA/ER probably has a risk of 5.4% of requiring further surgery for treatment failure (compared to 0 with total hysterectomy; 2 studies, 374 women; moderate-certainty evidence) and reduces the proportion of women with any serious adverse event (RR 0.21, 95% CI 0.06 to 0.80; 2 studies, 374 women; moderate-certainty evidence). Both treatments probably lead to a similar satisfaction rate at one year' follow-up (RR 0.96, 95% CI 0.88 to 1.04; 3 studies, 545 women; moderate-certainty evidence). EA/ER may lead to shorter time to return to normal activity (MD -18.90 days, 95% CI -24.63 to -13.17; 1 study, 172 women; low-certainty evidence). AUTHORS' CONCLUSIONS: Endometrial resection/ablation (EA/ER) offers an alternative to hysterectomy as a surgical treatment for HMB. Effectiveness varies with EA/ER compared to different hysterectomy approaches. The perception of improvement in HMB with EA/ER is probably lower compared to open and unspecified route of hysterectomy, but may be similar compared to minimally invasive. Quality of life with EA/ER is probably similar to open and unspecified route of hysterectomy, but lower compared to minimally invasive hysterectomy. Further surgery for treatment failure is probably more likely with EA/ER compared to all routes of hysterectomy. Satisfaction rates also vary. EA/ER probably has a similar rate of satisfaction compared to open and unspecified route of hysterectomy, but a lower rate of satisfaction compared to minimally invasive hysterectomy. The proportion having any serious adverse event appears similar in all groups, but specific adverse events did reported difference between EA/ER and different routes. We were unable to draw conclusions about the time to return to normal activity, but the direction of effect suggests it is likely to be shorter with EA/ER.

Roghayeh, A., et al. (2021). "Impact of probiotics, prebiotics, and synbiotic consumption on the treatment of bacterial vaginosis: a systematic review of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Roh, J.-W. (2022). "Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr." ClinicalTrials.gov.
	Bulky or multiple lymph nodes metastasis in cervical cancer shows poor prognosis and can also diminish the effect of radiotherapy or concurrent chemoradiation therapy (CCRT). However, it is difficult to increase the dose of radiation and chemotherapy considering their side effects. Therefore, the objective of this study is to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (CCRT) compared to CCRT only, in cervical cancer stage IIICr. This study is a phase III, multicenter and randomized clinical trial (DEBULK trial). ‐ Concurrent chemoradiation therapy (CCRT) ‐ Surgical debulking of bulky or multiple lymph node followed by CCRT

Rolland Anne, C. (2024). "New Cognitive Treatment for Peripartum Depression." ClinicalTrials.gov.
	No Results Available Behavioral: Metacognitive training|Behavioral: control EPDS score Female Not Applicable 96 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment PO23063* December 2028

Roncolato, F., et al. (2019). "PI3K/AKT/mTOR inhibitors for advanced or recurrent endometrial cancer." The Cochrane Database of Systematic Reviews(10).
	- Background Endometrial cancer is one of the most common gynaecological cancers in developed countries. Treatment of advanced endometrial cancer usually involves radiotherapy, chemotherapy, endocrine therapy or a combination of these. However, survival outcomes are poor in advanced or metastatic disease. Better systemic treatment options are needed to improve survival and safety outcomes for these women. The PI3K/AKT/mTOR pathway is a frequently altered signalling pathway in endometrial cancer. Single‐arm studies have reported some encouraging results of the PI3K/AKT/mTOR inhibition in advanced or recurrent endometrial cancer. Objectives To assess the efficacy and safety of PI3K/AKT/mTOR inhibitor‐containing regimens in women with locally‐advanced, metastatic or recurrent endometrial cancer. Search methods We searched the Cochrane Central Register of Controlled Trials, MEDLINE and Embase to 16 January 2019; and the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov in July 2018. We also reviewed reference lists from included studies and endometrial cancer guidelines. Selection criteria We included randomised controlled trials (RCTs) comparing a regimen with a PI3K/AKT/mTOR inhibitor (either alone or in combination with other treatments, such as chemotherapy or hormonal therapy) versus a comparator regimen without a PI3K/AKT/mTOR inhibitor. There were no restrictions on which comparator(s) were included. Data collection and analysis We extracted data independently, and assessed risks of bias and the certainty of the evidence. The primary outcome measures were progression‐free survival and toxicity (grade 3/4 where available). We derived hazard ratios (HRs) for time‐to‐event outcomes and risk ratios (RRs) for dichotomous outcomes. Secondary outcomes included overall survival, objective tumour response rate, quality of life and treatment‐related death. We used GRADEproGDT to assess the certainty of the evidence for the most important outcomes (by first‐line and second/third‐line therapy for progression‐free survival and overall survival). Main results We included two RCTs involving 361 women. One study assessed the effects of the mTOR inhibitor temsirolimus, in combination with carboplatin/paclitaxel versus carboplatin/paclitaxel and bevacizumab in treatment‐naïve women with advanced or recurrent endometrial cancer. The second study compared the mTOR inhibitor ridaforolimus alone versus progestin or investigator choice of chemotherapy in women who had received prior treatment for metastatic or recurrent endometrial cancer. We identified five ongoing studies on the effects of PI3K and AKT inhibitors, metformin and dual mTOR inhibitors. For first‐line therapy, an mTOR inhibitor‐containing regimen may worsen progression‐free survival (HR 1.43, 95% CI 1.06 to 1.93; 1 study, 231 participants; low‐certainty evidence), while for second/third‐line therapy, an mTOR inhibitor probably improves progression‐free survival compared to chemotherapy or endocrine therapy (HR 0.53, 95% CI 0.31 to 0.91; 1 study, 95 participants; moderate‐certainty evidence). Data on toxicity were available from both studies: administering an mTOR inhibitor regimen may increase the risk of grade 3/4 mucositis (RR 10.42, 95% CI 1.34 to 80.74; 2 studies, 357 participants; low‐certainty evidence), but may result in little to no difference in risk of anaemia or interstitial pneumonitis (low‐certainty evidence for both toxicities). Overall, event rates were low. For first‐line therapy, an mTOR inhibitor‐containing regimen may result in little to no difference in overall survival compared to chemotherapy (HR 1.32, 95% CI 0.98 to 1.781 study, 231 participants; low‐certainty evidence). The finding was similar for second/third‐line therapy (HR 1.06, 95% CI 0.70 to 1.61; 1 study, 130 participants; low‐certainty evidence). Administering mTOR inhibitor‐containing regimens may result in little to no difference in tumour response compared to chem therapy o hormonal therapy in first‐line or second/third‐line therapy (first line: RR 0.93, 95% CI 0.75 to 1.17; 1 study, 231 participants; second/third line: RR 0.22, 95% CI 0.01 to 4.40; 1 study, 61 participants; low‐certainty evidence). Neither study collected or reported quality‐of‐life data. Authors' conclusions Two RCTs have been reported to date, with low certainty of evidence. In a recurrent disease setting, mTOR inhibitors may result in improved progression‐free survival, but we found no clear benefit in overall survival or tumour response rate. We await the publication of at least five ongoing studies investigating the role of PI3K/AKT/mTOR inhibitors in advanced or recurrent endometrial cancer before any conclusions can be drawn on their use. Plain language summary Drugs targeting PI3K/AKT/mTOR pathway for locally‐advanced, metastatic or recurrent endometrial cancer What is the aim of this review? To find out whether drugs that inhibit the PI3K/AKT/mTOR pathway (known as PI3K, AKT and mTOR inhibitors) can improve survival of women diagnosed with locally‐advanced (cancer that has spread beyond the uterus/womb), metastatic or recurrent endometrial cancer. Key messages There is a low certainty of evidence from two clinical trials about the use of drugs targeting PI3K/AKT/mTOR pathway in women with locally‐advanced, metastatic or recurrent endometrial cancer. Based on the small number of completed studies, women who have received prior treatment for advanced or recurrent endometrial cancer and received an mTOR inhibitor may have a lower risk of their cancer progressing compared to those who received chemotherapy/hormonal therapy alone. However, in women who received mTOR inhibitor‐containing chemotherapy as part of their treatment when first diagnosed with advanced disease, mTOR inhibitor‐containing treatment may result in their disease progressing more quickly and probably with increased complications compared to chemotherapy or hormonal therapy alone. Although mTOR inhibitors may change how long it takes for their cancer to progress, there may be little or no difference in how long women lived after treatment (known as overall survival). We await the publication of at least five studies examining the role of PI3K, AKT and mTOR inhibitors in advanced or recurrent endometrial cancer. What was studied in the review? Treatment for women with metastatic or recurrent endometrial cancer usually involves radiotherapy, chemotherapy, endocrine therapy or a combination of these to try to shrink or slow the growth of the cancer. The response of the cancer to these treatments is variable, but mostly modest. New treatments are needed to improve outcomes. The PI3K/AKT/mTOR pathway within an endometrial cancer cell is involved in the growth of endometrial cancer, and various drugs have been developed to target this pathway with the aim of reducing the growth of endometrial cancer cells. These are known as PI3K, AKT and mTOR inhibitors. We found relevant studies looking at mTOR inhibitors. mTOR inhibitors can be given alone or in combination with other cancer treatment drugs. They may be given along with chemotherapy or endocrine therapy. mTOR inhibitors act by blocking cancer cells from dividing and reproducing. Their adverse events can include ulcers along the digestive tract (known as mucositis), inflammation of lung tissues (known as pneumonitis) and low red blood cell counts (anaemia). We include two studies that randomised 361 women. In one study, women received either an mTOR inhibitor (temsirolimus) in combination with other chemotherapy drugs, or the same chemotherapy drugs without the mTOR inhibitor and with a different targeted therapy (bevacizumab). This was given as part of their 'first‐line' treatment after their initial diagnosis of advanced endometrial cancer. In the second study, women with recurrent disease or who had been treated with chemotherapy at least once before received an mTOR inhibitor (ridaforolimus) on its own, compared with a chemotherapy or hormonal therapy and no mTOR inhibitor. Wh t are the main results of the review? For women who received mTOR inhibitor drugs as part of their first treatment, there may be a higher risk of disease worsening with an mTOR inhibitor than with conventional treatment and bevacizumab. However, for women with recurrent disease who had received chemotherapy previously, receiving an mTOR inhibitor drug may reduce the risk of the disease worsening compared to further chemotherapy or hormonal treatments. These results are based on one study only in each treatment setting. There were side effects from mTOR inhibitors. Women may be more likely to experience ulcers within the digestive tract with mTOR inhibitors than women who received treatments without these drugs. There was probably little or no difference in the rates of inflammation of the lungs or anaemia between those who received mTOR inhibitors and those who did not, although we have only low certainty evidence about the result. None of the studies reported quality‐of‐life information. There are five clinical trials currently recruiting women. We hope to have a clearer answer in the next update of this review, once data from these studies are available. How up‐to‐date is this review? We searched for studies that had been published up to January 2019.

Roque Dana, M., et al. (2022). "Randomised phase II trial of weekly ixabepilone ± biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer." British Journal of Cancer 126(12): 1695-1703.
	Background: This multi-center RP2 study assessed activity/safety of ixabepilone + bevacizumab compared to ixabepilone in platinum-resistant/refractory ovarian/fallopian tube/primary peritoneal cancer. Additional objectives were to examine the role of prior bevacizumab and taxanes, and explore class III-ß-tubulin (TUBB3) as a predictive biomarker.; Methods: Participants were randomised to receive ixabepilone 20 mg/m 2 days 1, 8, 15 with (IXA + BEV) or without (IXA) bevacizumab 10 mg/kg days 1, 15 every 28 days. Patients were stratified by prior BEV. The primary endpoint was PFS. OS, safety, and ORR served as secondary endpoints.; Results: Among 76 evaluable patients who received IXA + BEV (n = 39) compared to IXA (n = 37), the ORR was 33% (n = 13) versus 8% (n = 3)(P = 0.004), durable at 6 months in 37% (n = 14) and 3% (n = 1) (P < 0.001). BEV significantly improved PFS (median:5.5 vs 2.2 months, HR = 0.33, 95%CI 0.19-0.55, P < 0.001) and OS (median:10.0 vs 6.0 months, HR = 0.52, 95%CI 0.31-0.87, P = 0.006). Both regimens were well-tolerated. TUBB3 expression did not predict response. Subgroup analyses revealed minimal effect of prior BEV or taxane resistant/refractory status on response to IXA + BEV.; Conclusions: IXA + BEV is a well-tolerated, effective combination for platinum/taxane-resistant ovarian cancer that extends PFS and likely OS relative to IXA monotherapy. Prior receipt of BEV should not preclude the use of IXA + BEV. TUBB3 is not a predictive biomarker.; Clinical Trial Registration: NCT3093155. (© 2022. The Author(s), under exclusive licence to Springer Nature Limited.)

Rosamilia, A. (2021). "Comparing Vaginal And Laparoscopic Uterosacral Suspension For Pelvic Organ Prolapse." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Laparoscopic uterosacral ligament suspension (L‐USLS). This is an operation already performed by the unit but we are comparing it to another routine suspension of the uterosacral ligament but perfromed vaginally (V‐USLS) Surgical approach in the laparoscopic group will conform to the following approach: • Abdominal entry as per surgeon preference • Laparoscopic hysterectomy with use of bipolar and monopolar instruments or vessel sealant device (eg. Ligasure, Harmonic etc) • Use of McCartney tube or other device for colpotomy • Vault suspension using 0 PDS or V‐loc bilaterally with at least two bites of uterosacral ligament with attachment to vaginal vault • Closure of vault • Anterior vaginal repair with 2/0 PDS and 2/0 vicryl if residual defect after suspension • Posterior repair if required with 2/0 PDS, 1 vicryl and 2/0 vicryl using site specific repair or midline plication • Cystoscopy Approximate duration 2.5 hours. Will be performed by gynaecologist or urogynaecologist. Practitioners performing this operation have agreed to perform operation in this manner and feedback from the group has been sought to determine the most appropriate techniques. CONDITION: pelvic organ prolapse; ; pelvic organ prolapse Renal and Urogenital ‐ Other renal and urogenital disorders Reproductive Health and Childbirth ‐ Other reproductive health and childbirth disorders Surgery ‐ Surgical techniques PRIMARY OUTCOME: ; To assess the success of L‐USLS and V‐USLS defined as combined:; • No symptomatic recurrence, No anatomical recurrence beyond the hymen for anterior and posterior repair and ‐1 for the vault and No pelvic organ prolapse (POP) retreatment (multiple components assessed as one primary outcome); [6 months, 2 years (primary endpoint) and 5 years post procdure] SECONDARY OUTCOME: 1. Anatomical: ; a. All Pelvic Organ Prolapse Quantification (POP‐Q) points‐ will assess POP recurrence ; [6 months, 2 years and 5 years post‐procedure] 2. Subjective success ; a. Presence or absence of vaginal bulge according to participant assessed by asking the participant during follow up appointments: "do you feel a bulge, heaviness or dragging sensation in your vaginal area?" ; [6 months, 2 years and 5 years post‐procedure] 3. Reoperation ; a Repeat surgery assessed by patient interview and/or accessing patient medical record ; ; [6 months, 2 years and 5 years post‐procedure] Bowel dysfunction‐ colorectal‐anal distress inventory (CRADI‐6) ; [6 months, 2 years and 5 years post‐procedure] Completion of planned adnexal surgery accessed by medical record or noted after surgery[At time of surgery] Complications‐Clavien‐Dindo classification accessed by accessing medical record ; ; [6 months post‐procedure] Hospital stay length measured by accessing medical record ; [At completion of inpatient stay] Inpatient outcomes ; a. Post‐operative pain‐ VAS scores and Analgaesia requirements by accessing medical record ; [Monitored for during of inpatient stay] Lower urinary tract symptoms‐ Urinary distress inventory (UDI‐6)[6 months, 2 years and 5 years post‐procedure] Patient satisfaction‐ PGII ; ; ; [6 months, 2 years and 5 years post‐procedure] Peri‐operative outcomes ; ‐Bloods loss assessed by accessing patient medical record ; ; [At time of surgery] Quality of life‐ POP distress inventory (POPDI) ; [6 months, 2 years and 5 years post‐procedure] Sexual function‐ pelvic organ prolapse/ urinary incontinence sexual questionnaire (PISQ‐12) INCLUSION CRITERIA: All participants between the ages of 18‐80 with symptomatic stage II‐III POP requesting surgery including hysterectomy Capable of providing informed consent and able to return for follow up. ; [6 months, 2 years and 5 years post‐procedure] Surgery for complications Accessed by patient interview and/or medical record[6 months, 2 years and 5 years post‐procedure] Surgery for stress urinary incontinence (SUI) Accessed by patient interview and/or medical record[6 months, 2 years and 5 years post‐pro dure] Ureteric kinking assessed by the presence or absence of ureteric jets intra‐operatively during cystoscopy[6 months post procedure]

Rosana, R., et al. (2022). "Efficacy and safety of selenium supplementation in polycystic ovary syndrome: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Rosen, M. (2023). "Sperm Preparation Prior to Intrauterine Insemination Study." ClinicalTrials.gov.
	No Results Available Device: Zymot Multi sperm separation device|Other: Density gradient centrifugation Cumulative clinical pregnancy rate All Not Applicable 270 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment 22-36913 December 31, 2025

Ross, B., et al. (2021). "Systematic review of clinical studies assessing the efficacy and safety of use of ultrasound guided laparoscopic radiofrequency ablation for the treatment of uterine fibroids." PROSPERO International prospective register of systematic reviews.
	
Rothenberger Rodger, W. (2023). "Vaginal Baclofen Suppositories in Chronic Pelvic Pain." ClinicalTrials.gov.
	Study Design/Methodology This is a single center, double‐blinded, placebo‐controlled, randomized trial. Women will be recruited from a subspecialty clinic at the University of Louisville and be eligible for participation if they meet the diagnosis of Chronic Pelvic Pain and are between the ages of 18‐65 years old. Eligible, consenting participants will undergo randomization with equal probability of assignment to one of the two groups: 1. Baclofen 20mg vaginal suppository daily per vagina and 2. placebo. Participants will be blinded to study allocation. Baclofen or placebo suppositories will be continued to 8 weeks, at which time all participants will be offered a baclofen suppository prescription. Patients will then follow up at the 12 week mark and whether they continued baclofen suppositories and pill count will be recorded in addition to the below questionnaires. Clinical outcomes and questionnaires will be assessed at baseline and after 4, 8, and 12 weeks of treatment. Participants will be randomized with a stratified block randomization scheme (with a random block size of 4, 6, and 8 participants). Participants will be required to come in for at least 1 visit at 8 weeks to assess pelvic muscle dysfunction and perform pill count. We hypothesize a significant change in PROMIS Pain Interference score, patient satisfaction, PROMIS global health scores, and PROMIS sexual function scores for patients assigned to the baclofen treatment arm. Inclusion Criteria: ‐ Women ages 18‐65 years old ‐ Women are not sexually active, sexually active with same sex partners or are on effective contraception ‐ Diagnosed with Chronic Pelvic Pain Exclusion Criteria: ‐ Gross hematuria ‐ Currently pregnant or breastfeeding ‐ Unable to speak and read English ‐ History of allergic reaction to baclofen tablet ‐ History of allergic reaction to components of placebo (coconut oil) ‐ History of gastrointestinal, genitourinary, or pelvic cancer in the last 5 years

Rougier, N. (2023). "Benefit of Early Intrauterine Transfer of "Blank" Culture Medium Prior to Transfer of a Thawed Embryo From 1st in Vitro Fertilization." ClinicalTrials.gov.
	Despite technical advances in Medically Assisted Reproduction (AMP), the success of fertility treatments is sometimes limited by embryo implantation failure. The coordinated development of the embryo and the uterine endometrium requires close communication between the maternal tissue and the embryo. In in vitro fertilization (IVF), embryo transfer generally takes place between the 2nd (D2) and the 6th (D6) day following oocyte fertilization. Recent studies have shown the advantages of sequential transfer (transfer of an embryo on D2/D3 followed by the transfer of another embryo on D5/D6), with higher implantation and clinical pregnancy rate, fewer miscarriages, more live births, and yet no increase in multiple pregnancies. However, the American Society for Reproductive Medicine recommendations continue to prioritize the transfer of a single embryo for all patients aged under 38. To improve pregnancy rates for patients having a single embryo transferred, the study investigators wish to carry out on "blank" transfer, based on the principle of sequential transfer. The study investigators hypothesize that a culture medium, placed in the uterus before the time of embryo transfer, will modify immune tolerance. The study will test whether transferring the same culture medium in an equivalent quantity as during the real transfer into the uterus 2/3 days before the embryo transfer will improve tolerance to this foreign medium and, therefore, embryo implantation. The aim of this study is thus to evaluate the impact of a "blank" transfer with culture medium alone, on the results of frozen embryo transfers (FET) from IVF.

Rovner Eric, S. (2021). "Prospective US Radiofrequency SUI Trial." ClinicalTrials.gov.
	PURSUIT: Prospective US Radiofrequency SUI Trial (VI‐17‐06) is a prospective, randomized, sham controlled, double blind study in premenopausal women with stress urinary incontinence. The study will be conducted in 390 subjects, randomized 2:1 with active or sham treatment. Study duration is 12 months post treatment. The primary objective is to evaluate the efficacy of the Viveve treatment, SUI protocol, in improving mild to moderate stress urinary incontinence (SUI), assessed using the 1‐hour Pad Weight Test for up to 12 months post‐treatment. Secondary endpoints include: ‐ Percent of subjects who are responders in the 1‐hour Pad Weight Test at 3‐ and 6‐months post‐treatment. ‐ Change from Baseline (CFB) to 3, 6‐ and 12‐months post‐treatment in the number of incontinence episodes as assessed by the 3‐day bladder voiding diary. ‐ Percent of subjects with no incontinence episodes at 3, 6‐ and 12‐months post‐treatment as assessed by the 3‐day bladder voiding diary. ‐ CFB to 3, 6, 9‐ and 12‐months post‐treatment in the I‐QOL, ICIQ‐UI‐SF, PGI‐I and MESA questionnaires. ‐ Percent CFB to 3, 6‐ and 12‐months post‐treatment in the 1‐hour Pad Weight Test.

Ruan, F. A. N. and B. Beilei (2022). "Bazedoxifene conjugated estrogens improve menopausal symptoms in postmenopausal women: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Ruan Wen, P., et al. (2023). "The impact of yoga on postpartum depression." PROSPERO International prospective register of systematic reviews.
	
Rui, L., et al. (2021). "The efficacy and safety of pazopanib in the treatment of ovarian cancer: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Rui, W., et al. (2021). "INdividual participant data meta-analysis of trials comparing FrOzen versus fResh eMbryo transfer strategy (INFORM)." PROSPERO International prospective register of systematic reviews.
	
Ruiz-López Ketty, K. (2021). "Radiofrequency and Pelvic Organ Prolapse." ClinicalTrials.gov.
	Effectiveness and safety of non‐ablative radiofrequency in the treatment of pelvic organ prolapse and its associated symptoms OBJECTIVES Primary To compare the effectiveness of application of non‐ablative radiofrequency applied in combination with the usual treatment versus usual treatment for the treatment of pelvic organ prolapse (POP) ‐ specifically in the reduction of vaginal prolapses. Secondary To compare the effectiveness of both interventions in the symptoms most commonly associated with vaginal prolapse (pelvic heaviness, bulging, and POP‐related low back pain). Specific ‐ To analyze the prevalence of symptoms associated with vaginal prolapse depending on the stage of POP. ‐ Compare the effectiveness depending on the location of prolapse: anterior vaginal wall, posterior vaginal wall or vaginal vault. ‐ Compare the effectiveness according to the degree of prolapse (stages extracted from the simplified POP‐Q: I, IIA, IIB and III). ‐ Compare the effectiveness based on age. ‐ Evaluate the relationship of vaginal prolapse symptoms with the location and severity of vaginal prolapse, respectively in the anterior, posterior and apex wall (Ba, Bp and C). ‐ Evaluate the immediate effect of RF application on the stage of prolapse. ‐ Estimate the effect of both interventions (usual treatment vs usual treatment with active RF), at the end of the 1st treatment session and after finishing the treatment: short (1 week after the last session), medium (at 3 and 6 months post‐intervention) and long‐term (at 12 months post‐intervention) on the quantitative assessment of POP and the most commonly associated symptoms. ‐ Evaluate the safety of the RF technique (presence of adverse events) METHODOLOGY DESIGN Double‐blind clinical trial with two interventions: usual treatment for POP versus the usual treatment including application of RF. These interventions are randomly assigned. The full follow‐up period is 12 months. The study design conforms to the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) for Statement to Randomized Trials of Nonpharmacological Treatment. SAMPLE SELECTION CRITERIA 1. Subject inclusion criteria ‐ Women between 18 and 75 years old. ‐ Women who state symptoms of vaginal prolapse, defined as "sensation of mass or lump" and / or "sensation of dragging in the vagina" and who also have the presence of POP; i.e. descent of one of the anterior, posterior or uterus vaginal walls (cervix) diagnosed under clinical criteria and quantified using the simplified POP‐Q assessment system. 2. Criteria for exclusion of subjects ‐ Prolapse vaginal GIV (according to clinical stage evaluated by POP‐Q ‐Pelvic Organ Prolapse Quantification‐). ‐ Presence of more than one POP ‐ Asymptomatic vaginal prolapse grade IV or less than GI of the cervix or less than or equal to GI of the anterior and / or posterior vaginal Wall ‐ Women with chronic connective tissue diseases ‐ Women who present contraindication to the application of RF therapy such as: pregnancy, metallic prostheses within the electric field, decompensated arteriopathies, malignant neoplasms, active infectious processes, pacemakers, loss of thermal sensitivity,…. 3. Study withdrawal criteria ‐ Revocation of informed consent ‐ Presence of severe adverse effects derived from RF treatment RECRUITMENT The study will be carried out by the University of the Balearic Islands. The women will be recruited from the patients who attend the Ketty Ruiz Pelviperineal Physiotherapy Clinic, which it´s specialized in treating pelvic floor dysfunction. The control group (CG) will receive the usual intervention (described later) plus the "sham RF" application, that is, not active; while the intervention group (IG) will receive the same usual intervention that is provided to the CG subjects plus the application of active RF in the parameters that are considered most appropriate for the approach of this kind of dysfunction (described later) The application of sham‐RF will allow, on the one hand, o blind women who have never received RF treatment and will also allow the assessment of placebo effect of the RF application itself. The interventions will be carried out by members of the work team, made up of 3 physiotherapists specialized in pelvic floor physiotherapy (KRL, ELlF, MAQ). The homogeneity of the so‐called "usual intervention" will be ensured because all the physiotherapists who work in the clinic where the intervention is carried out (KRL, ELlF, MAQ) use the same work protocol for the treatment of POPs. In addition, for the application of RF (sham or active) a standardized protocol will be followed, to remove differences in RF application that may influence the results obtained. INTERVENTIONS USUAL INTERVENTION The usual intervention begins with a physical examination that includes the assessment of the strength of pelvic floor muscles (PFM) using the PERFECT method, assessment of tone of PFM to rule out hypertonia, ultrasound evaluation of the abdominal‐perineal synergies and electromyographic assessment (by surface EMG) of pelvic floor and internal oblique muscles. The intervention will consist of supervised individualized sessions (up to a maximum of 8 sessions) by physiotherapists who are part of the research team. They will include the application of exercises to balance the pelvis and the muscles related to it, treatment of the trigger points detected through the application of manual and / or instrumental techniques, teaching of the activation of the transverse abdominis with ultrasound biofeedback and teaching of reflex activation exercises of the transverse abdominis and pelvic floor muscles in different body positions. If PFM strength is less than 3 on modified Oxford scale, intravaginal electrotherapy (muscle electrostimulation) will be applied. All treatment techniques will be adapted individually based on the results obtained in the previous physical examination process. In addition to the supervised sessions, the patient is given an exercise sheet that includes reflex postural activation of transversus abdominis muscle and PFM by means of slowed exhalation to be carried out daily (even after the supervised treatment sessions have ended). In addition, within the "usual intervention", standards of water, urination, food, defecation, postural hygiene and physical activity for their generalization at home are given to all women. They are provided with information on voiding and defecation physiology and the importance of maintainance proper habits in each of these fields. It is recommended the reduction or even avoidance of tobacco consumption, limit caffeine intake, eat a balanced diet according to the Harvard dish to avoid constipation, avoid weight gain or recommend to lose weight in case of overweight and avoid lifting weight, as well as playing high‐impact sports. Patients who also present constipation (according to Rome IV criteria) are instructed in proper habits to go to the bathroom, avoiding the push / tension of the pelvic floor. Finally, patients with loss of abdominoperineal anticipation synergies (through ultrasound evaluation) are taught the knack maneuver before and during any task that involves an increase in intra‐abdominal pressure. RADIO FREQUENCY IG: active RF The active RF will be administered during the exercises of reflex activation of transversus abdominis and pelvic floor muscles on a stretcher (supine position). It will be applied intracavitary, in monopolar application, reaching a temperature between 42‐45ºC in the tissues (according to the patient's tolerance), and with a power of 50% until the desired temperature is reached. It will be applied with a frequency that will be individualized according to the maximum level of energy absorption by the patient's tissues (between 0.8‐1.2MHz) and with a dose of approximately between 3‐4 KJ depending on the application time (20 minutes / session). In addition, they will be applied 1 session per week. The treatment will last 8 weeks. CG: sham RF The application of RF in the control group will follow the same ap l cation procedure as in the intervention group i. e. it will be applied during the exercises of reflex activation of transversus abdominis and pelvic floor muscles on a stretcher (supine position) and with the same technical execution (including technical application and duration of session, weekly frequency and total number of sessions). The only difference will be that in the CG subjects, no parameter is applied to the RF device (in terms of temperature, power, frequency and dose); that is, it remains off for the entire duration of the session. FOLLOW‐UP The immediate and the short, medium and long term effects will be assessed ‐ Inmediate effect: the immediate effect of both treatments will be compared ("usual intervention" plus " sham RF " vs "usual intervention" plus "active RF") in the quantitative assessment of prolapse (through simplified POP‐Q). ‐ Short term: the effect of both treatments at the end of the RF sessions (1 week after the last session) will be compared both in the quantitative assessment of prolapse (through simplified POP‐Q) and in the symptoms most commonly associated with vaginal prolapses: pelvic heaviness, bulging and low pelvic‐lumbar pain related to POP (through the measurement instruments described in the section "Outcomes and measurement instruments"). The potential adverse events of RF in both groups (CG and IG) will also be assessed. ‐ Medium term: three and six months after the end of the treatment, the effect of both treatments will be compared on the previously mentioned variables. ‐ Long‐term: twelve months after the end of the treatment, the effect of both treatments will be compared on the variables mentioned above. OUTCOMES AND MEASUREMENT INSTRUMENTS Main variable Degree of prolapse through the simplified POP‐Q (Parekh et al. 2011; Swift et al. 2006). This standardized prolapse assessment method has excellent inter and intra observer reliability, as well as a significant association between assessments using the POP‐Q and the simplified POP‐Q itself (Manonai et al., 2011). This instrument is internationally recognized, being considered the "gold standard" for prolapse classification (Hall et al., 1996). For this, measurements that allow the quantitative description of the position of the pelvic organs (i.e. the numerical values in cm of the various vaginal segments) will be used (Bump 2014; Bump et al, 1996), specifically: ‐ Anterior vaginal segment: called point Ba (estimated around 3 cm proximal to the hymenal caruncles) ‐ Posterior vaginal segment: called point Bp (estimated around 3 cm proximal to the hymenal caruncles) ‐ Cervix: called point C ‐ Posterior apex / fornix: called point D To measure these points, the subject is placed in a standardized dorsal lithotomy position (90º hip and knee flexion and with leg support on the gynecological stretcher), From there, the subject is asked to push hard, performing a standardized maximum Valsalva maneuver with a minimum of 5 s in duration (Orejuela et al., 2012), closing the mouth while pressing out as if the individual is straining to defecate (in order to demonstrate the maximum descent of the pelvic organs). A mirror is used to confirm the correlation of physical findings with the study participant's medical history (Manonai et al. 2016). Measurements will be made using a calliper, an hysterometer and a half leaflet of a Collin‐type speculum following the procedure described by Busquets et al. (Busquets et al., 2009). In addition, it will also be included the measurement of: ‐ Degree of prolapse (according to the simplified POP‐Q classification): I, IIa, IIb, III and IV. ‐ Prolapse location: anterior wall, posterior wall, cervix ("diagnosed" by ultrasound and physical examination) (Dietz & Mann, 2014; Dietz, 2019). Measurement standardization procedure To ensure that all measurements are carried out equally by the members of the work team, made up of 3 physiotherapists specialized in pelvic floor physiotherapy (KRL, ELlF, MAQ), a training activity will be carried out by the principal in e tigator. Furthermore, a pilot test to verify the intra‐ and inter‐examiner reliability of the measurements with the POP‐Q will be carried out. Secondary variables A. Related to the effectiveness of the intervention Symptoms of POP (vaginal prolapse) Measurement of the most frequent symptoms derived from vaginal prolapse: ‐Bulging It is defined as the sensation of bulging or that something is descending through the vaginal introitus. The woman claims that she notices a lump by direct palpation or that she sees it with the help of a mirror (Haylen et al., 2016). This symptom is considered prolapse‐specific and correlates with the severity of the prolapse (Jelovsek et al., 2007, Ghetti et al., 2005). ‐Pelvic heaviness It is defined as the feeling of heaviness, pressure or a dragging sensation (pain or discomfort) in the suprapubic or pelvic area (Haylen et al., 2016). To measure prolapse symptoms, the Pelvic Organ Prolapse Symptom Score (POP‐SS) questionnaire will be used in its Spanish version. It presents an adequate internal consistency with a Cronbach's alpha coefficient> 0.7. It has adequate validity to measure the symptoms of prolapse and correct sensitivity to change. It is especially important in scales that measure the effectiveness of interventions for the treatment of prolapse (Hagen et al., 2009). ‐Low back pain ‐ related to POP‐ It is defined as a complaint of low back or sacrum pain (or quite similar to menstruation pain) temporarily associated with vaginal prolapse and that is relieved when the prolapse is reduced. It will be assessed using a visual analog scale (VAS). This scale allows one‐dimensional assessment of pain intensity to be measured in a horizontal line of 100 mm, in which participants are asked to indicate the mean intensity of pain they feel, ranging from 0 mm (no pain) to 100 mm (the greatest pain imaginable). It is a simple, valid, reliable and reproducible method (Thong et al., 2018; Eizaga & García, 2015). Quality of life To measure quality of life related to prolapse symptoms, the Spanish validated version (Flores‐Espinoza et al., 2015) of the Prolapse Quality of Life (P‐QOL) questionnaire (Digesu et al., 2005) will be used. It shows an excellent content validity (CVI = 0.9), adequate construct validity concerned to its association with the severity of urogenital and intestinal symptoms (discriminative validity), and with respect to its correlation with the POP stages assessed by the POP‐ Q in the domains of "impact of prolapse", "personal relationships", "emotions" and "measures of severity". It also presents adequate internal consistency, with Cronbach's alpha values higher than 0.70 in all dimensions except for "severity measures". Satisfaction with treatment (Sodré et al. 2019) For the subjective evaluation of satisfaction with the treatment technique used, a 5‐point Likert scale will be used: 1‐ very dissatisfactory, 2‐ dissatisfactory, 3‐ neutral, 4‐ satisfied, 5‐very satisfied B. Basal ‐ Age ‐ Weight ‐ Height ‐ Waist circumference ‐ Menopause (yes / no / presence of perimenopausal symptoms) ‐ Use of hormone replacement therapy (in menopausal women) ‐ Hysterectomy: total or subtotal ‐ Women who have had previous surgeries for POP: type of intervention ‐ Women who have had previous surgeries for incontinence: type of intervention ‐ Consumption of hormonal contraceptive drugs (oral, contraceptive adhesive, vaginal ring, injectable contraceptive, contraceptive implant, other: to be specified) Obstetric history ‐ Date of last delivery ‐ Number of deliveries ‐ Type of delivery (of each delivery): vaginal, instrumental, caesarean section ‐ Episiotomy If the woman is in immediate postpartum (<6 months): ‐ Current breastfeeding (yes / no / mixed) ‐ Presence of POP diagnosed prior to the current pregnancy (yes / no) C. Related to the safety of the intervention Information about the safety of the intervention will be collected through interviews with the study subjects. All adverse events (AE) that occur from the begin i g of the treatment procedure until the end of the study will be recorded by each of the intervening physiotherapists. For each AE, the description, start date, severity, duration and relationship with the treatment will be recorded. All AEs will be followed until they decline or, in the case of permanent damage, until the AEs stabilize and the overall clinical outcome is determined. It is also collected if the subjects had to discontinue the treatment, if they had to discontinue any session or if they had to stop the application of RF at some point during the course of treatment and their reason / s (Sodré et al. 2019). The relationship of the EA with the treatment will be determined by the IP of the project (JCFD) using the following classifications: related, possibly related, unknown and unrelated. Tamaño muestral: Sample size: The sample size for independent means with respect to both the CG and IG measurements has been obtained. Considering a bilateral contrast accepting an alpha risk of 0.05 and a beta risk of 0.20 and assuming a change in the main variable of the study, i.e. in the position of the pelvic organs of at least 15 mm, regardless of the vaginal segment (point Ba, Bp, C or D), a minimum total of 20 subjects in each group will be required for a total of 40 subjects, estimating a loss to follow‐up rate of 20%. Randomization: The women will be assigned to each of the study groups in an individualized random way, based on the table of random numbers generated prior to the start of the study through the EPIDAT v.4 software (Galicia, Spain). The randomization sequence will be kept hidden, through the use of sealed and opaque envelopes previously prepared by the main investigator of the project (JCFD) and which will be placed in a box available to the physiotherapists who perform each of the interventions. Blinding It is not possible to blind the physiotherapist professionals who perform the intervention (neither in the IG nor in the CG). However, the allocation of women to the treatment groups will be blinded and also the blinding will be maintained in the analysis (evaluation of results), in such a way that in the data analysis only the groups will be identified. Statistical analysis A descriptive analysis of all variables, both categorical and quantitative, will be carried out, with frequency and percentage for categorial, and Exploratory Data Analysis (AED) for the latter; as well as the Shapiro‐Wilk normality tests to establish compliance or not with the statistical assumptions of the parametric analysis. Shapiro‐Wilk normality tests will be performed to establish compliance with the statistical assumptions for the parametric analysis. The differences in the baseline values between both study groups will be performed using parametric (Student's t‐test for independent samples) or non‐parametric (U‐Mann Whitney) tests depending on the results of the goodness‐of‐fit tests. In case of statistically significant differences between the groups in the baseline measurements, the pre‐intervention values will be included as a potential covariate (analysis of covariance) to adjust the effect. For the comparison between the pre and post intervention phases (at the end of the intervention, 3 months, 6 months and 12 months) in each study group with respect to the main and secondary variables related to both the effectiveness of the intervention and the quality of life, Student's t test for independent samples or the U‐Mann Whitney test will be used. The effect size will be estimated using Cohen's d and the 95% confidence interval of the difference of the pre‐post means in the study variables mentioned above. An analysis of the variance of repeated measures of two factors will be carried out using time (pre and post‐1 ‐ at the end of the intervention and post 2‐ at 3 months, post 3‐ at 6 months and post 4 ‐ at 12 months) and the treatment group (control group vs. intervention). To check the immediate effect (after the 1st session) of the application of RF in the IG, an analysis for withi ⠐subject measurements using the Student's t test for paired means or the Wilcoxon test was performed. The effect size will also be estimated using Cohen's d and the 95% confidence interval to check the magnitude of the differences, if required. Data will be analyzed and processed using the SPSS v.25 statistical package. Ethical aspects The study will have the approval of the Committee of Ethics and Clinical Research (CEI) of the Balearic Islands (in process). All subjects in the study must be informed, and if they agree to participate, sign the informed consent. In the event that as a result of the treatment in the IG, significant results are obtained in relation to the variables studied, the research team undertakes to offer the same treatment and under the same conditions to the subjects randomly assigned to the GC, once the study period is over. Boutron I., Moher D., Altman DG., Schulz KF., Ravaud P.,& CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148(4):295‐309. doi: 10.7326/0003‐4819‐148‐4‐200802190‐00008. Bump RC. The POP‐Q system: two decades of progress and debate. Int Urogynecol J. 2014;25(4):441‐3. doi: 10.1007/s00192‐013‐2262‐0 Bump RC, Mattiasson A, Bø K, Brubaker LP, DeLancey JO, Klarskov P, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996;175(1):10‐7. doi: 10.1016/s0002‐9378(96)70243‐0. Busquets M., Castillo F., Bravo S., & Contreras D. Uso del sistema POPQ para la clasificación de los prolapsos: hospital parroquial de San Bernardo. Rev. Chil. Obstet. Ginecol. 2009;74(1):4‐10. doi: 10.4067/S0717‐75262009000100002 Dietz HP. Ultrasound in the assessment of pelvic organ prolapse. Best Pract Res Clin Obstet Gynaecol. 2019 Jan;54:12‐30. doi: 10.1016/j.bpobgyn.2018.06.006. Epub 2018 Jun 28. Dietz HP., & Mann KP. What is clinically relevant prolapse? An attempt at defining cutoffs for the clinical assessment of pelvic organ descent. Int Urogynecol J. 2014;25:451‐455. doi:10.1007/s00192‐013‐2307‐4 Dietz HP., & Mann KP. What is clinically relevant prolapse? An attempt at defining cutoffs for the clinical assessment of pelvic organ descent. Int Urogynecol J. 2014;25:451‐455. doi:10.1007/s00192‐013‐2307‐4 Digesu GA., Khullar V., Cardozo L., Robinson D., & Salvatore S. P‐QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2005;16(3):176‐81; discussion 181. doi: 10.1007/s00192‐004‐1225‐x. Eizaga R., & García M. Escalas de Valoración de Dolor. 2015. Available from: https://www.researchgate.net/publication/321462394_Escalas_de_Valoracion_de_Dolor Flores‐Espinoza C., Araya AX., Pizarro‐Berdichevsky J., Santos V., Ferrer M., Garin O., et al. Validation of the Spanish‐language version of the Prolapse Quality of Life questionnaire in Chilean women. Int Urogynecol J. 2015;26(1):123‐30. doi: 10.1007/s00192‐014‐2484‐9 Ghetti C., Gregory WT., Edwards SR., Otto LN., & Clark AL. Pelvic organ descent and symptoms of pelvic floor disorders. Am J Obstet Gynecol. 2005;193(1):53‐7. doi:10.1016/j.ajog.2004.12.004 Hagen S., Glazener C., Sinclair L., Stark D., & Bugge C. (2009). Psychometric properties of the pelvic organ prolapse symptom score. BJOG. 2009;116(1):25‐31. doi:10.1111/j.1471‐0528.2008.01903.x Haylen BT, Maher CF, Barber MD, Camargo S, Dandolu V, Digesu A, et al. 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Manonai J., Mouritsen L., Palma P., Contreras‐Ortiz O., Korte JE., & Swift S. The inter‐system association between the simplified pelvic organ prolapse quantification system (S‐POP) and the standard pelvic organ prolapse quantification system (POPQ) in describing pelvic organ prolapse. Int Urogynecol J. 2011;22(3):347‐52. doi: 10.1007/s00192‐010‐1286‐y. Epub 2010 Oct 9. Orejuela FJ., Shek KL., Dietz HP. The time factor in the assessment of prolapse and levator ballooning. Int Urogynecol J. 2012 Feb;23(2):175‐8. doi: 10.1007/s00192‐011‐1533‐x. Parekh M., Swift S., Lemos N., Iskander M., Freeman B., Arunkalaivanan AS., et al. Multicenter inter‐examiner agreement trial for the validation of simplified POPQ system. Int Urogynecol J. 2011;22(6):645‐50. doi: 10.1007/s00192‐011‐1395‐2. Sodré DSM., Sodré PRS., Brasil C., Teles A., Dória M., Café LE., et al. New concept for treating urinary incontinence after radical prostatectomy with radiofrequency: phase 1 clinical trial. 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Ruiz-Schutz Viviane, C., et al. (2019). "Risk of fatigue and anemia in patients with advanced cancer treated with olaparib: A meta-analysis of randomized controlled trials." Critical Reviews in Oncology/Hematology 141: 163-173.
	Introduction: PARP inhibitors are a new class of drugs that are currently being studied in several malignancies. Olaparib is FDA-approved for advanced breast cancer and advanced ovarian cancer patients. Fatigue and anemia are among the most common cancer and treatment-related symptoms. Therefore, we conducted a meta-analysis of randomized controlled trials (RCT) to characterize the incidence and relative risks (RRs) of fatigue and anemia associated with olaparib.; Methods: PubMed, Cohrane, Embase and abstracts presented at the annual meeting of the American Society of Clinical Oncology (ASCO) were searched for articles published from 2000 to June 2018. The eligible studies were phase II and III RCT of olaparib. Safety profile from each selected study was evaluated for all-grade and high-grade fatigue and anemia adverse events. Summary incidences and the RR, with 95% confidence intervals, of all-grade and high-grade events were calculated using random-effects or fixed-effects model based on the heterogeneity of selected studies.; Results: A total of 9 trials were selected, and included 2074 patients with advanced ovarian, gastric, prostate, lung or breast cancer. 908 patients received placebo/control treatments and 1166 received olaparib alone or combination with other active cancer treatments. The RR of all-grade and high fatigue was 1.24 (95% CI, 1.10-1.39) and 1.71 (95% CI, 1.06-2.77), respectively. The RR of all-grade and high-grade anemia was 2.10 (95% CI, 1.48-2.98) and 3.15 (95% CI, 1.73-5.71), respectively.; Conclusion: Our findings suggest that the olaparib treatment is associated with an increased risk of fatigue and anemia. Since fatigue and anemia are very common treatment related adverse events, and both can impair the quality of life of patients, it is important to identify them early and manage it accordingly in order to optimize the overall treatment. (Copyright © 2019 Elsevier B.V. All rights reserved.)

Rukayya, I., et al. (2023). "Effect of aerobic exercise on ovulatory function and quality of life among women with anovulatory infertility: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Ruotong, M., et al. (2023). "Recombinant human luteinizing hormone (r-hLH) increases endometrial thickness in women undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI): a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Ruscito, I., et al. (2020). "Incorporating Parp-inhibitors in Primary and Recurrent Ovarian Cancer: A Meta-analysis of 12 phase II/III randomized controlled trials." Cancer Treatment Reviews 87: 102040.
	Background: The second decade of 2000s is witnessing a new ovarian cancer (OC) paradigm shift thanks to the results recently obtained by a new class of targeted agents: the Poly(ADP-ribose)polymerase (PARP)-Inhibitors (PARPi). Aim of this meta-analysis is to analyze available results obtained with PARPi, administered alone or in combination with chemo- and/or target-therapies in terms of efficacy and safety for the treatment of recurrent and primary advanced OC.; Methods: On December 2019, all published phase II/III randomized clinical studies were systematically searched using the terms "[Parp-Inhibitor] AND [ovar*]". Twelve phase II/III randomized controlled trials were identified, with a total number of 5171 patients included.; Results: Results demonstrated that PARPi account for a significant improvement of PFS in both recurrent and primary OC setting, independently from their administration schedule and independently from patients' BRCA mutational status. Moreover, patients harboring a Homologous Recombination Deficiency (HRD) positive testing primary or recurrent OC progress significantly later after PARPi administration/association. Results also reported that PARPi increase the occurrence of severe (G3-G4) anemia. Furthermore, severe fatigue occurred more frequently among patients subjected to PARPi combined with chemotherapy and to PARPi plus Bevacizumab. Finally, a significant increase in severe high blood pressure occurrence was observed when PARPi was added to antiangiogenetics, compared to PARPi alone but a significant decrease in G3-G4 hypertension occurrence was found in PARPi plus bevacizumab users compared to Bevacizumab alone.; Conclusions: PARPi are a valid option for the treatment of both primary and relapsed OC patients, with a relative low incidence of severe side effects. (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Ruye, W., et al. (2022). "The Dietary Antioxidants for improving the metabolic profiles in Women with Polycystic Ovary Syndrome: A Network Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Sá Kamilla Mayr, M., et al. (2023). "Resistance training for postmenopausal women: systematic review and meta-analysis." Menopause 30(1): 108-116.
	Importance: Numerous studies have been published assessing the effects of resistance muscle training to mitigate menopausal symptoms, given the endocrine muscle function and its metabolic regulation. Therefore, mapping and synthesizing high-quality studies are necessary to help clinical decisions.; Objective: The aim of this study was to assess the effects (benefits and harms) of resistance muscle training for postmenopausal women.; Evidence Review: Electronic searches were conducted in MEDLINE (via PubMed), EMBASE, CENTRAL, PEDro, LILACS, and SPORTDiscus up to December 2021. Two independent reviewers selected the retrieved references and extracted relevant data from included studies. The methodological quality (risk of bias) using the Cochrane Risk of Bias table and the certainty of the evidence (GRADE approach) were assessed.; Findings: Twelve randomized clinical trials (n = 452) with unclear to high risk of bias were identified. Compared with no exercise, resistance training (up to 16 weeks) seems to promote an improvement in functional capacity (mean difference [MD], 2.90 points; 95% CI, 0.60-5.20) and bone mineral density (MD, 0.10; 95% CI, 0.10-0.10) and a reduction in the hot flash frequency (13/29 vs 1/29; risk ratio, 13.0; 95% CI, 1.82-93.01) and fat mass (MD, -3.15; 95% CI, -6.68 to 0.38), and no differences were observed between groups regarding abdominal circumference and body mass index. When compared with aerobic exercises, resistance training may result in a reduction of hot flash frequency (7/18 vs 14/18; risk ratio, 0.50; 95% CI, 0.27-0.94) and fat mass (MD, -7.80; 95% CI, -14.02 to -1.58) and no difference in the quality of life and body mass index. Regarding safety, no serious adverse events were reported. Based on the GRADE approach, the certainty of this evidence was graded as very low to low, leading to imprecisely estimated effects.; Conclusions and Relevance: Resistance muscle training seems to improve postmenopausal symptoms and functional capacity. Given the low to very low certainty of the evidence, further randomized clinical trials with higher methodological quality and better reports are still needed. As an implication for clinical practice, health professionals should consider individualized aspects such as the previous history of exercise practice, physical capacity, and adaptation period.; Competing Interests: Financial disclosure/conflicts of interest: None reported. (Copyright © 2022 by The North American Menopause Society.)

Sabadell, J., et al. (2021). "Polypropylene and polyvinylidene fluoride transobturator slings for the treatment of female stress urinary incontinence: 1-Year outcomes from a multicentre randomized trial." Neurourology and Urodynamics 40(1): 475‐482.
	Aims: To compare the effectiveness and safety of polypropylene (PP) and polyvinylidene fluoride (PVDF) transobturator tapes (TOT) for the treatment of female stress urinary incontinence (SUI). Methods: This is a multicentre randomized trial. Women with SUI or stress‐predominant mixed urinary incontinence and scheduled for a TOT procedure were randomized to PP or PVDF slings. The primary outcome was 1‐year cure or improvement rate using composite criteria. Complications were also compared. Relationships with outcomes were analyzed using multivariable logistic regressions models. Results: From April 2016 to January 2018 285 participants were randomized. PP and PVDF slings showed similar high cure or improvement rate (91.0% vs. 95.6%, p =.138). Improvement in validated questionnaires was also similar. PVDF slings were associated with a lower rate of de novo urgency incontinence (adjusted odds ratio = 0.35; 95% confidence interval = 0.15–0.80). We found no statistical differences in complications rates, although a higher incidence of long‐term pain events were observed in the PP group. The study is underpowered to find differences in specific complications owing to the low number of events. Conclusion: PP and PVDF TOTs are equally effective, although PVDF is associated with fewer cases of de novo urgency incontinence. Further studies are needed to give robust conclusions on safety profiles.

Saccone, G., et al. (2019). "Effectiveness of seminal plasma in in vitro fertilisation treatment: a systematic review and meta-analysis." BJOG 126(2): 220-225.
	Background: With in vitro fertilization (IVF) techniques, only 20-25% of the transferred embryos lead to a pregnancy.; Objective: To evaluate the beneficial effects of seminal plasma (SP) or semen applied at the time of oocyte aspiration or embryo transfer.; Search Strategy: Electronic databases were searched from their inception up to August 2017.; Selection Criteria: We included all randomized controlled trials (RCTs) evaluating the effects of SP or semen in IVF treatment. Trials were considered if women were exposed to any kind of SP or semen (either SP/semen injection or sexual intercourse) around the time of oocyte pickup and embryo transfer.; Data Collection and Analysis: The primary outcome was clinical pregnancy rate (CPR).; Main Results: Eight RCTs on women undergoing IVF (2128 in total) were included in the meta-analysis. Women randomized in the intervention group had a significantly higher CPR compared with controls (30.0 versus 25.1%; RR 1.20; 95% CI, 1.04-1.39). No significant differences were found in the secondary outcomes, including livebirth rate, biochemical pregnancy, miscarriage, multiple pregnancies, and birth weight. The subgroup analyses (four RCTs, 780 participants), including only those RCTs in which prepared undiluted SP was injected just after oocyte pickup, conformed with the overall analysis for the primary outcome (46.3 versus 37.2%; RR 1.23; 95% CI, 1.05-1.45).; Conclusion: Because intravaginal or intracervical SP application around the time of oocyte pickup is associated with higher CPR, local application SP may be considered as a potential treatment to improve implantation.; Tweetable Abstract: SP at the time of oocyte pickup is associated with higher CPR. (© 2017 Royal College of Obstetricians and Gynaecologists.)

Sadahiro, R., et al. (2023). "Black cohosh extracts in women with menopausal symptoms: an updated pairwise meta-analysis." Menopause 30(7): 766-773.
	Objective: Menopausal symptoms are common in midlife women and have broad impacts on their daily functioning and quality of life. Black cohosh extracts have been widely used to relieve menopausal symptoms. However, the comparative benefits of different combined black cohosh regimens remain inconclusive. The aim of the current updated meta-analysis is to address the comparative efficacies of different black cohosh regimens in improving menopausal symptoms.; Methods: Random-effect model pairwise meta-analysis of randomized controlled trials was conducted to investigate the treatment effect on menopausal symptoms by the black cohosh extract both alone or combined with other related active ingredients. The outcomes studied were changes in menopausal symptoms after treatment with black cohosh extracts in menopausal women.; Results: Twenty-two articles including information on 2,310 menopausal women were included in the analyses. Black cohosh extracts were associated with significant improvements in overall menopausal symptoms (Hedges' g = 0.575, 95% CI = 0.283 to 0.867, P < 0.001), as well as in hot flashes (Hedges' g = 0.315, 95% CIs = 0.107 to 0.524, P = 0.003), and somatic symptoms (Hedges' g = 0.418, 95% CI = 0.165 to 0.670, P = 0.001), compared with placebo. However, black cohosh did not significantly improve anxiety (Hedges' g = 0.194, 95% CI = -0.296 to 0.684, P = 0.438) or depressive symptoms (Hedges' g = 0.406, 95% CI = -0.121 to 0.932, P = 0.131). The dropout rate for black cohosh products was similar to that for placebo (odds ratio = 0.911, 95% CI = 0.660 to 1.256, P = 0.568).; Conclusions: This study provides updated evidence regarding the potentially beneficial effects of black cohosh extracts for relieving menopausal symptoms in menopausal women.; Competing Interests: Financial disclosure/conflicts of interest: Y.J.M. has received speaker fees from Suntory Wellness, Pfizer, Mochida, Eli Lilly, Morinaga Milk, and Cimic. The other authors have nothing to disclose. (Copyright © 2023 by The North American Menopause Society.)

Saei Ghare, N., et al. (2020). "The Effect of Micronutrients on Pain Management of Primary Dysmenorrhea: a Systematic Review and Meta-Analysis." Journal of Caring Sciences 9(1): 47-56.
	Introduction: Primary dysmenorrhea is considered as one of the main problems in women. This review study aimed to characterize the effect of micronutrients on primary dysmenorrhea. Methods: In this systematic and meta-analysis study, the articles were searched at Cochrane library, PubMed, Scopus, Web of Science databases. The searching process was conducted with the key terms related to dysmenorrhea and micronutrients. Risk of bias assessment was performed, using Rev Man 5.3 software. In view of the heterogeneity of some of the studies, they were analyzed, using a qualitative method (n=10), and only 6 studies were included in Meta analyze. STATA statistical software version 11 was used for the analysis. Results: In this study, finally 16 clinical trials were investigated. Most micronutrients studied in the relevant articles had anti-inflammatory and analgesic properties with a desirable effect on dysmenorrhea pain relief. Vitamins (K, D, B1, and E) and calcium, magnesium, zinc sulfate and boron contributed effectively to dysmenorrhea pain management. Two months after the intervention, there was a significant mean decrease in the pain score for the vitamin D intervention group (SMD: -1.02, 95% CI: -1.9 to - 0.14, P =0.024) , as well as in the vitamin E intervention group compared to placebo group (SMD: -0.47,95% CI:-0.74 to - 0.2, P = 0.001). Conclusion: Despite the paucity of related research, the studies indicated the potential effects of micronutrients on reducing the pain severity in primary dysmenorrhea. But more studies are needed to confirm the safety and effectiveness of various types of micronutrients on primary dysmenorrhea. (© 2020 The Author(s).)

Sagi-Dain, L., et al. (2019). "Cervical Cancer with Intermediate Risk Factors: Is there a Role for Adjuvant Radiotherapy? A Systematic Review and a Meta-Analysis." Gynecologic and Obstetric Investigation 84(6): 606-615.
	Background: The yield of adjuvant radiotherapy in cervical cancer patients with intermediate risk factors is controversial. The objective of our meta-analysis was to shed light on this important issue.; Material and Methods: Search was conducted in several databases. By independent screening of titles and abstracts, 2 investigators selected original researches examining the effect of adjuvant radiation treatment on overall survival and progression-free survival in cervical cancer patients with intermediate risk factors.; Results: Of the 5 articles included, a total of 591 patients with intermediate risk factors were encompassed. Statistical significance was noted in favor of radiation therapy in a subgroup of patients with 2 or more intermediate factors in terms of recurrence (OR 0.46 [95% CI 0.28-0.74, p = 0.001]) and overall survival (OR 1.86 [95% CI 1.03-3.36, p = 0.04]). After adding patients with one risk factor, radiation exerted a non-significant effect on recurrence rate, overall survival, disease-free survival, and 5-year cancer-specific survival, while increasing the rate of gastrointestinal side effects (2.4 vs. 0%, p = 0.0156).; Conclusions: Adjuvant radiation therapy decreases the risk for recurrence and increases the overall survival in patients with 2 intermediate risk factors. These benefits were not shown after adding patients with one risk factor. (© 2019 S. Karger AG, Basel.)

Saglik Bilimleri, U. (2023). "Effects of Breathing Exercises in Women With Chronic Pelvic Pain." ClinicalTrials.gov.
	No Results Available Other: Breathing Exercises|Other: Pelvic Floor Exercises Change from Baseline Pelvic Floor Muscle Activity (PFMA) at 8 weeks|Change from Baseline Visual Analogue Scale (VAS) at 8 weeks|Change from Baseline McGill Pain Scale- Short Form at 8 weeks|Global Pelvic Floor Disorder Questionnaire|Corbin Postural Rating Scale|Pelvic Pain Impact Questionnaire|Short Form-36|Depression, Anxiety and Stress Scale Female Not Applicable 38 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 109 (19.10.2022) April 1, 2024

Saha, S. and S. Saha (2023). "Comparison of the effect of dietary and herbal supplements on anthropometric, metabolic and androgenic profiles of women with polycystic ovary syndrome: a systematic review and network meta-analysis protocol." Journal of the Turkish German Gynecological Association 24(4): 277-283.
	Polycystic ovarian syndrome (PCOS) is characterized by obesity, glucose intolerance, dyslipidemia, and hyperandrogenemia. Although several, placebo-controlled 2x2 factorial design, randomized controlled trials have tested the efficacy of dietary and herbal supplements in controlling these parameters in PCOS patients, these studies are not suitable for a comparative efficacy assessment across these supplements. Herein, a protocol for systematic review and network meta-analysis (NMA) is presented to make such a comparison. PubMed, Embase, and Scopus, were interrogated to identify relevant trials, published in English, factors to be investigated will include dietary factors, micronutrients, choline, essential fatty acids, and herbal extracts. Other factors to be considered include trial design, population characteristics, interventions compared, and outcomes of interest. The revised Cochrane tool was used for the appraisal of eligible trials. NMA (frequentist method) will be used for respective outcomes to compare effect sizes (weighted or standardized mean difference) among the interventions. Both logical and statistical (inconsistency assessment) approaches will be used to minimize intransitivity risk. The surface under the cumulative ranking curve values will be used to gauge the best intervention for outcomes with a statistically significant effect size suggesting a favorable outcome. Additionally, the exploration of interrelation among interventions and the small study effect in respective NMA models will be investigated using network maps and comparison-adjusted funnel plots, respectively. Statistical significance is assumed at p<0.05 with 95% confidence interval. Stata statistical software (v16) was used for analysis. The study was registered with PROSPERO, registration number: CRD42022301530.; 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.)

Sahin, U. K., et al. (2022). "Effects of external electrical stimulation added to pelvic floor muscle training in women with stress urinary incontinence: A randomized controlled study." Neurourology and Urodynamics 41(8): 1781-1792.
	Objective: In this study, the combination of external electrical stimulation (EES) with pelvic floor muscle training (PFMT) was assessed to determine if it yielded better results than PFMT or EES alone for treatment of stress urinary incontinence (SUI). Study Design: Fifty-one women with SUI were randomly allocated to EES + PFMT (n = 17), PFMT (n = 17), or EES groups (n = 17) for 8 weeks of treatment. Personal, demographic, and clinical characteristics of the patients were recorded. Outcome measures included self-reported improvement, severity of incontinence, symptom distress, quality of life (QOL), urinary incontinence episodes, pelvic floor muscle strength (PFMS) and endurance (PFME) and dysfunction. All evaluations were made pre- and posttreatment. Data were analyzed using the Chi-square, marginal homogeneity, Kruskal-Wallis, Wilcoxon signed-rank or paired t test and Dunn-Bonferroni post hoc tests. Result(s): In the 8th week, there were significant changes in self-reported improvement, severity of incontinence, symptom distress score, urinary incontinence episodes, PFMS, PFME, pelvic floor dysfunction and all areas of QoL in all groups (p < 0.05). Combined therapy was not superior to PFMT and EES for overall outcome measures, except for the incontinence impact subdomain of the QoL score (p < 0.05). Conclusion(s): Our study supports the idea that PFMT should be preferred as the first line therapy for women with SUI. However, the acceptable EES method can be recommended in addition to PFMT to increase motivation and treatment compliance in patients with insufficient or inaccurate pelvic floor muscle contractions.Copyright © 2022 Wiley Periodicals LLC.

Salame, Y. (2021). "Evaluation of a Nutraceutical for Endometriosis Pain Relief." ClinicalTrials.gov.
	No Results Available Dietary Supplement: Meta19.01 Pain relief|Inflammation marker C-reactive protein (CRP)|General well-being|The need for analgesics Female Not Applicable 5 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Supportive Care Meta19.01 December 16, 2022

Salang, L., et al. (2022). "Luteal phase support for women trying to conceive by intrauterine insemination or sexual intercourse." The Cochrane Database of Systematic Reviews 8: CD012396.
	Background: Ovulation induction may impact endometrial receptivity due to insufficient progesterone secretion. Low progesterone is associated with poor pregnancy outcomes.; Objectives: To assess the effectiveness and safety of luteal phase support (LPS) in infertile women trying to conceive by intrauterine insemination or by sexual intercourse.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, LILACS, trial registries for ongoing trials, and reference lists of articles (from inception to 25 August 2021).; Selection Criteria: Randomised controlled trials (RCTs) of LPS using progestogen, human chorionic gonadotropin (hCG), or gonadotropin-releasing hormone (GnRH) agonist supplementation in IUI or natural cycle.; Data Collection and Analysis: We used standard methodological procedures expected by Cochrane. Our primary outcomes were live birth rate/ongoing pregnancy rate (LBR/OPR) and miscarriage. MAIN RESULTS: We included 25 RCTs (5111 participants). Most studies were at unclear or high risk of bias. We graded the certainty of evidence as very low to low. The main limitations of the evidence were poor reporting and imprecision. 1. Progesterone supplement versus placebo or no treatment We are uncertain if vaginal progesterone increases LBR/OPR (risk ratio (RR) 1.10, 95% confidence interval (CI) 0.81 to 1.48; 7 RCTs; 1792 participants; low-certainty evidence) or decreases miscarriage per pregnancy compared to placebo or no treatment (RR 0.70, 95% CI 0.40 to 1.25; 5 RCTs; 261 participants). There were no data on LBR or miscarriage with oral stimulation. We are uncertain if progesterone increases LBR/OPR in women with gonadotropin stimulation (RR 1.24, 95% CI 0.80 to 1.92; 4 RCTs; 1054 participants; low-certainty evidence) and oral stimulation (clomiphene citrate or letrozole) (RR 0.97, 95% CI 0.58 to 1.64; 2 RCTs; 485 participants; low-certainty evidence). One study reported on OPR in women with gonadotropin plus oral stimulation; the evidence from this study was uncertain (RR 0.73, 95% CI 0.37 to 1.42; 1 RCT; 253 participants; low-certainty evidence). Given the low certainty of the evidence, it is unclear if progesterone reduces miscarriage per clinical pregnancy in any stimulation protocol (RR 0.68, 95% CI 0.24 to 1.91; 2 RCTs; 102 participants, with gonadotropin; RR 0.67, 95% CI 0.30 to 1.50; 2 RCTs; 123 participants, with gonadotropin plus oral stimulation; and RR 0.53, 95% CI 0.25 to 1.14; 2 RCTs; 119 participants, with oral stimulation). Low-certainty evidence suggests that progesterone in all types of ovarian stimulation may increase clinical pregnancy compared to placebo (RR 1.38, 95% CI 1.10 to 1.74; 7 RCTs; 1437 participants, with gonadotropin; RR 1.40, 95% CI 1.03 to 1.90; 4 RCTs; 733 participants, with gonadotropin plus oral stimulation (clomiphene citrate or letrozole); and RR 1.44, 95% CI 1.04 to 1.98; 6 RCTs; 1073 participants, with oral stimulation). 2. Progesterone supplementation regimen We are uncertain if there is any difference between 300 mg and 600 mg of vaginal progesterone for OPR and multiple pregnancy (RR 1.58, 95% CI 0.81 to 3.09; 1 RCT; 200 participants; very low-certainty evidence; and RR 0.50, 95% CI 0.05 to 5.43; 1 RCT; 200 participants, very low-certainty evidence, respectively). No other outcomes were reported for this comparison. There were three different comparisons between progesterone regimens. For OPR, the evidence is very uncertain for intramuscular (IM) versus vaginal progesterone (RR 0.59, 95% CI 0.34 to 1.02; 1 RCT; 225 participants; very low-certainty evidence); we are uncertain if there is any difference between oral and vaginal progesterone (RR 1.25, 95% CI 0.70 to 2.22; 1 RCT; 150 participants; very low-certainty evidence) or between subcutaneous and vaginal progesterone (RR 1.05, 95% CI 0.54 to 2.05; 1 RCT; 246 participants; very low-certainty evidence). We are uncertain if IM or oral progesterone reduces miscarriage per clinical pregnancy compared to vaginal progesterone (RR 0.75, 95% I 0.43 to 1.32; 1 RCT; 81 participants and RR 0.58, 95% CI 0.11 to 3.09; 1 RCT; 41 participants, respectively). Clinical pregnancy and multiple pregnancy were reported for all comparisons; the evidence for these outcomes was very uncertain. Only one RCT reported adverse effects. We are uncertain if IM route increases the risk of adverse effects when compared with the vaginal route (RR 9.25, 95% CI 2.21 to 38.78; 1 RCT; 225 participants; very low-certainty evidence). 3. GnRH agonist versus placebo or no treatment No trials reported live birth. The evidence is very uncertain about the effect of GnRH agonist in ongoing pregnancy (RR 1.10, 95% CI 0.70 to 1.74; 1 RCT; 291 participants, very low-certainty evidence), miscarriage per clinical pregnancy (RR 0.73, 95% CI 0.26 to 2.10; 2 RCTs; 79 participants, very low-certainty evidence) and clinical pregnancy (RR 1.00, 95% CI 0.68 to 1.47; 2 RCTs; 340 participants; very low-certainty evidence), and multiple pregnancy (RR 0.28, 95% CI 0.11 to 0.70; 2 RCTs; 126 participants). 4. GnRH agonist versus vaginal progesterone The evidence for the effect of GnRH agonist injection on clinical pregnancy is very uncertain (RR 1.00, 95% CI 0.51 to 1.95; 1 RCT; 242 participants). 5. HCG injection versus no treatment The evidence for the effect of hCG injection on clinical pregnancy (RR 0.93, 95% CI 0.40 to 2.13; 1 RCT; 130 participants) and multiple pregnancy rates (RR 1.03, 95% CI 0.22 to 4.92; 1 RCT; 130 participants) is very uncertain. 6. Luteal support in natural cycle No study evaluated the effect of LPS in natural cycle. We could not perform sensitivity analyses, as there were no studies at low risk of selection bias and not at high risk in other domains.; Authors' Conclusions: We are uncertain if vaginal progesterone supplementation during luteal phase is associated with a higher live birth/ongoing pregnancy rate. Vaginal progesterone may increase clinical pregnancy rate; however, its effect on miscarriage rate and multiple pregnancy rate is uncertain. We are uncertain if IM progesterone improves ongoing pregnancy rates or decreases miscarriage rate when compared to vaginal progesterone. Regarding the other reported comparisons, neither oral progesterone nor any other medication appears to be associated with an improvement in pregnancy outcomes (very low-certainty evidence). (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Sally, K., et al. (2021). "Early GnRH antagonist protocols VS agonist protocols in Polycystic ovary syndrome patients undergo IVF/ICSI: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Salvatore, S., et al. (2021). "CO2 laser and the genitourinary syndrome of menopause: a randomized sham-controlled trial." Climacteric 24(2): 187-193.
	PURPOSE: This study aimed to clarify the efficacy of intravaginal CO2-laser treatment in postmenopausal women with genitourinary syndrome of menopause (GSM). MATERIALS AND METHODS: This double-blind, randomized, sham-controlled trial included postmenopausal women diagnosed with GSM and bothersome dryness and dyspareunia. Treatment consisted of three sessions. Active CO2-laser treatments (active group) were compared to sham treatments (sham group) with the primary endpoints being changes in dryness and dyspareunia intensity, as assessed by the 10-cm visual analog scale. Secondary endpoints were as follows: changes in Female Sexual Function Index (FSFI; total score and all domains), itching, burning, dysuria, and Urogenital Distress Inventory (UDI-6); incidence of symptoms; and presence of adverse events. All outcomes were evaluated at baseline and 4 months post baseline. RESULTS: Fifty-eight women (28 in the active group and 30 in the sham group) were eligible for inclusion. In the active group, dryness, dyspareunia, FSFI (total score), itching, burning, dysuria, and UDI-6 were significantly improved (mean [standard deviation] -5.6 [2.8], -6 [2.6], 12.3 [8.9], -2.9 [2.8], -2.3 [2.8], -0.9 [2.1], and -8.0 [15.3], respectively). In the sham group, dryness, itching, and burning were significantly improved (-1.9 [2], -1.4 [1.9], and -1 [1.9], respectively). All changes were in favor of the active group. After completion of the protocol, the proportion of participants with dryness, dyspareunia, and sexual dysfunction was significantly lower in the active group compared to those in the sham group (all p < 0.005). CONCLUSIONS: CO2 laser could be proposed as an effective alternative treatment for the management of GSM as it is superior to sham treatments.

Samami, E., et al. (2022). "The effects of psychological interventions on menopausal hot flashes: A systematic review." International Journal of Reproductive Biomedicine 20(4): 255-272.
	Background: Menopause is a normal physiological phenomenon, closely identified with a great deal of physical-psychological symptoms, including hot flashes (HFs) with a prevalence rate of 20-80%. Various pharmacological and non-pharmacological interventions have been thus far practiced to reduce this common symptom of the menopausal transition.; Objective: This systematic review was conducted to evaluate the effects of psychological interventions on menopausal HFs.; Materials and Methods: In this review, the databases of Google Scholar, Scopus, PubMed, Web of Science, Science Direct, the Cochrane Library, and Scientific Information Database were searched applying the Boolean searching operators as well as the keywords of `hot flashes', `menopause', `psychological intervention', and `vasomotor symptoms'. Accordingly, a total number of 20,847 articles published from January 2000 to June 2019 were retrieved. After excluding the duplicate and irrelevant ones, the risk of bias of 19 clinical or quasi-experimental clinical trials was assessed using the Cochrane collaboration tool.; Results: The interventions implemented in the studies on menopausal HFs included cognitive behavioral therapy, mindfulness-based stress reduction, hypnotherapy, and relaxation techniques. All of the articles reported improvements in HFs in postmenopausal women, except for 4 studies.; Conclusion: Based on the findings of this systematic review, psychological interventions, especially cognitive behavioral therapy and relaxation techniques, are potentially effective for vasomotor symptoms and HFs in healthy postmenopausal women, although the quality of published research on this topic is sometimes questionable.; Competing Interests: The authors declare that there is no conflict of interest. (Copyright © 2022 Samami et al.)

Samy, A., et al. (2021). "Medical therapy options for endometriosis related pain, which is better? A systematic review and network meta-analysis of randomized controlled trials." Journal of Gynecology Obstetrics and Human Reproduction 50(1): 101798.
	Our objective was to assess and rank different pharmacological interventions for relieving endometriosis-related pain. We conducted an online bibliographic search in different databases from their inception until March 2019. We included randomized controlled trials (RCTs) that assessed different medical therapies in the management of endometriosis-related pain. We applied this network meta-analysis (NMA) based on the frequentist approach using statistical package "netmeta" (version 1.0-1) in R software. Our main outcomes were the change in severity of pelvic pain, dysmenorrhea score, non-menstrual pelvic pain score, and dyspareunia score. Overall, 36 RCTs were included in this study (patients no. = 7942). Dienogest (0.94), combined hormonal contraceptives (CHCs) (0.782), and elagolix (0.38) were the highest-ranked interventions for reducing the severity of pelvic pain at three months, while at six months, gonadotropin-releasing hormone (GnRH) analogues (0.75), levonorgestrel-releasing intrauterine system (LNG-IUS) (0.73), and dienogest (0.65) were linked to more reduction in pelvic pain. The ranking p-score showed that GnRH analogues was the highest-ranked treatment for reducing dysmenorrhea at 3 months (1.00), while CHCs were the highest-ranked treatment at 6 months (0.97), followed by GnRH analogues (0.89). GnRH analogues (0.63) and elagolix (0.54) at three months while desogestrel (0.94) and CHCs (0.91) at six months were the highest-ranked treatment to reduce non-menstrual pelvic pain. GnRH analogues and elagolix were the highest-ranked pharmacologic therapies for reducing dyspareunia. In conclusion, CHCs, GnRH analogues, progesterone, and elagolix were the best approaches in reducing the pain of endometriosis. (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Sanders Ari, P., et al. (2019). "Surgical outcomes after uterine artery occlusion at the time of myomectomy: systematic review and meta-analysis." Fertility and Sterility 111(4): 816.
	Objective: To systematically review and meta-analyze evidence on surgical outcomes after uterine artery occlusion (UAO) at myomectomy.; Design: Systematic review and meta-analysis.; Setting: Not applicable.; Patient(s): Twenty-six studies involving 2,871 patients located via database searches of MEDLINE, Embase, Web of Science, PubMed, clinicaltrials.gov, and cited references.; Intervention(s): Intervention groups undergoing UAO at laparoscopic or abdominal myomectomy (UAO+M) (1,569 patients), and control groups undergoing myomectomy alone (1,302 patients).; Main Outcome Measure(s): Primary outcome of surgical blood loss (estimated blood loss, transfusion rate, and change in hemoglobin values), and secondary outcomes including operative time, length of stay, conversion and complications rates, fibroid recurrence, and changes in fibroid-related symptoms.; Result(s): The patients undergoing UAO+M had a statistically significant reduction in estimated blood loss (mean difference [MD] -103.7 mL; 95% confidence interval [CI], -126.5 to -80.8), blood transfusion (relative risk [RR] 0.24; 95% CI, 0.15-0.39), and change in hemoglobin values (MD -0.60 g/dL; 95% CI, -0.79 to -0.40) compared with controls. Using UAO+M prolonged operative times (MD 10.9 minutes; 95% CI, 3.5-18.2) but shortened the length of stay (MD -0.37 days; 95% CI, -0.62-0.11). Using UAO+M lowered the complication rates (RR 0.73; 95% CI, 0.52-1.00) to the threshold of statistical significance and reduced the risk of fibroid recurrence (RR 0.36; 95% CI, 0.16-0.83) compared with controls.; Conclusion(s): Uterine artery occlusion at myomectomy is associated with decreased surgical blood loss and transfusion rate compared with control patients. However, further research is required on reproductive outcomes and the effect on ovarian reserve before routine use can be recommended in women desiring future fertility. (Copyright © 2018 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Sangkomkamhang Ussanee, S., et al. (2020). "Progestogens or progestogen-releasing intrauterine systems for uterine fibroids (other than preoperative medical therapy)." The Cochrane Database of Systematic Reviews 11: CD008994.
	Background: Uterine fibroids can cause heavy menstrual bleeding. Medical treatments are considered to preserve fertility. It is unclear whether progestogens or progestogen-releasing intrauterine systems can reduce fibroid-related symptoms. This is the first update of a Cochrane Review published in 2013.; Objectives: To determine the effectiveness of progestogens or progestogen-releasing intrauterine systems in treating premenopausal women with uterine fibroids.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, and PsycINFO databases to July 2020. We also searched trials registers for ongoing and registered trials, and checked references of relevant trials.; Selection Criteria: All identified published or unpublished randomised controlled trials (RCTs) assessing the effect of progestogens or progestogen-releasing intrauterine systems in treating premenopausal women with uterine fibroids.; Data Collection and Analysis: Two authors independently extracted data, assessed risk of bias, and assessed the quality of the evidence using the GRADE approach.; Main Results: This updated review included four studies with 221 women with uterine fibroids. The evidence was very low quality, downgraded for serious risk of bias, due to poor reporting of study methods, and serious imprecision. Levonorgestrel-releasing intrauterine device (LNG-IUS) versus hysterectomy There was no information on the outcomes of interest, including adverse events. LNG-IUS versus low dose combined oral contraceptive (COC) At 12 months, we are uncertain whether LNG-IUS reduced the percentage of abnormal uterine bleeding, measured with the alkaline hematin test (mean difference (MD) 77.50%, 95% confidence interval (CI) 70.44 to 84.56; 1 RCT, 44 women; very low-quality evidence), or the pictorial blood assessment chart (PBAC; MD 34.50%, 95% CI 11.59 to 57.41; 1 RCT, 44 women; very low-quality evidence); increased haemoglobin levels (MD 1.50 g/dL, 95% CI 0.85 to 2.15; 1 RCT, 44 women; very low-quality evidence), or reduced fibroid size more than COC (MD 1.90%, 95% CI -12.24 to 16.04; 1 RCT, 44 women; very low-quality evidence). The study did not measure adverse events. LNG-IUS versus oral progestogen (norethisterone acetate (NETA)) Compared to NETA, we are uncertain whether LNG-IUS reduced abnormal uterine bleeding more from baseline to six months (visual bleeding score; MD 23.75 points, 95% CI 1.26 to 46.24; 1 RCT, 45 women; very low-quality evidence); increased the percentage of change in haemoglobin from baseline to three months (MD 4.53%, 95% CI 1.46 to 7.60; 1 RCT, 48 women; very low-quality evidence), or from baseline to six months (MD 10.14%, 95% CI 5.57 to 14.71; 1 RCT, 45 women; very low-quality evidence). The study did not measure fibroid size. Spotting (adverse event) was more likely to be reported by women with the LNG-IUS (64.3%) than by those taking NETA (30%; 1 RCT, 45 women; very low-quality evidence). Oral progestogen (dienogest, desogestrel) versus goserelin acetate Compared to goserelin acetate, we are uncertain whether abnormal uterine bleeding was reduced at 12 weeks with dienogest (PBAC; MD 216.00 points, 95% CI 149.35 to 282.65; 1 RCT, 14 women; very low-quality evidence) or desogestrel (PBAC; MD 78.00 points, 95% CI 28.94 to 127.06; 1 RCT, 16 women; very low-quality evidence). Vasomotor symptoms (adverse events, e.g. hot flashes) are only associated with goserelin acetate (55%), not with dienogest (1 RCT, 14 women; very low-quality evidence) or with desogestrel (1 RCT, 16 women; very low-quality evidence). The study did not report fibroid size.; Authors' Conclusions: Because of very low-quality evidence, we are uncertain whether the LNG-IUS reduces abnormal uterine bleeding or increases haemoglobin levels in premenopausal women with uterine fibroids, compared to COC or norethisterone acetate. There was insufficient evidence to determine whether the LNG-IUS reduces the size of uterine fibroids compared to COC. We are uncertain whether oral progestogens reduce abnor al uterine bleeding as effectively as goserelin acetate, but women reported fewer adverse events, such as hot flashes. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Sania, L., et al. (2021). "The effectiveness of prolonged downregulation in women with adenomyosis of the uterus undergoing assisted conception: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Santiago Dexeus Font Fundacio, P. (2023). "INtensity of OVarian stimualtion and Euploid Embryos (INOVEE Study)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: Seidigestan 200 mg cápsulas blandas,Product Code: PRD308331,Pharmaceutical Form: CAPSULE, SOFT,Other descriptive name: ,Strength: Progesterone 200mg,Product Name: REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre‐filled pen,Product Code: PRD6680136,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Follitropin Delta 72µg / 2.16mL,Product Name: Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable,Product Code: PRD390680,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Triptorelin 0.1mg CONDITION: Infertility ; MedDRA version: 20.1Level: LLTClassification code: 10016398Term: Female infertilitySystem Organ Class: 10038604 MedDRA version: 20.1Level: LLTClassification code: 10016398Term: Female infertilitySystem Organ Class: 10038604 Therapeutic area: Diseases [C] ‐ Female Urogenital Diseases and Pregnancy Complications [C13] PRIMARY OUTCOME: Main Objective:To compare the two stimulation groups of 15 vs 20 mcg of follitropin‐delta (equivalent to 225IU vs 300IU of rFSH) regarding the number of euploid embryos in advanced age women undergoing PGT‐A with a PPOS protocol. Primary end point(s):To compare the two stimulation groups of 15 vs 20 mcg of follitropin‐delta (equivalent to 225IU vs 300IU of rFSH) regarding the number of euploid embryos in advanced age women undergoing PGT‐A with a PPOS protocol Secondary Objective:Total gonadotropin dose and length of stimulation,Number of oocytes and mature oocytes (MIIs) retrieved,Endocrine profile at specific intervals (estradiol, progesterone, FSH and LH),Follicle to Oocyte Index (FOI) (ratio between the total number of oocytes collected at the end of ovarian stimulation and the number of antral follicles available at the start of stimulation).,Follicular Output RaTe (FORT) (ratio of the number of preovulatory follicles and the number of antral follicles available at the start of stimulation).,Cycle cancelation rate,Reason for cycle cancelation,Fertilization rate,Time of appearance of the 2nd polar body (tPB2),Time of pronuclei appearance (tPNa),Evaluation of both pronuclei (PN),Time of pronuclei disappearance (tPNf),Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8),Time of compactation (tSC),Time of morula (tM),Time of cavitation (tSB),Time of full blastulation (tB),Total number of day 5 blastocysts,Total number of good quality blastocysts,Total number of embryos,Blastocyst formation rate, defined as the proportion of 2PN zygotes that reach the blastocyst stage,Number of embryos cryopreserved,Embryo stage (D5, D6, D7),Clinical pregnancy rate, defined as the visualization of one or more gestational sacs,Ongoing pregnancy rate, defined as a viable intrauterine pregnancy of at least 8‐10 weeks duration confirmed on an ultrasound scan INCLUSION CRITERIA: Infertile patients with indication for IVF,Undergoing preimplantation genetic screening cycles,Age >= 38 and < 42 years old,AMH > 1.5 ng/ml and < 3.5 ng/ml (AMH result of up to one year will be valid),BMI 18.5 – 30 Kg/m2 SECONDARY OUTCOME: Secondary end point(s):Blastocyst formation rate, defined as the proportion of 2PN zygotes that reach the blastocyst stage Secondary end point(s):Clinical pregnancy rate, defined as the visualization of one or more gestational sacs Secondary end point(s):Cycle cancelation rate Secondary end point(s):Embryo stage (D5, D6, D7) Secondary end point(s):Endocrine profile at specific intervals (estradiol, progesterone, FSH and LH) Secondary end point(s):Evaluation of both pronuclei (PN) Secondary end point(s):Fertilization rate Secondary end point(s):Follicle to Oocyte Inde X(FOI) (ratio between the total number of oocytes collected at the end of ovarian stimulation and the number of antral follicles available at the start of stimulation). Secondary end point(s):Follicular Output RaTe (FORT) (ratio of the number of preovulatory follicles and the number of antral follicles available at the start of stimulation). Secondary end point(s):Number of embryos cryo eserved Secondary end point(s):Number of oocytes and mature oocytes (MIIs) retrieved Secondary end point(s):Ongoing pregnancy rate, defined as a viable intrauterine pregnancy of at least 8‐10 weeks duration confirmed on an ultrasound scan Secondary end point(s):Reason for cycle cancelation Secondary end point(s):Time of appearance of the 2nd polar body (tPB2) Secondary end point(s):Time of cavitation (tSB) Secondary end point(s):Time of compactation (tSC) Secondary end point(s):Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8) Secondary end point(s):Time of full blastulation (tB) Secondary end point(s):Time of morula (tM) Secondary end point(s):Time of pronuclei appearance (tPNa) Secondary end point(s):Time of pronuclei disappearance (tPNf) Secondary end point(s):Total gonadotropin dose and length of stimulation Secondary end point(s):Total number of day 5 blastocysts Secondary end point(s):Total number of embryos Secondary end point(s):Total number of good quality blastocysts

Santiago, M., et al. (2023). "A Hybrid-Telerehabilitation Versus a Conventional Program for Urinary Incontinence: a Randomized Trial during COVID-19 Pandemic." International Urogynecology Journal 34(3): 717-727.
	Introduction and hypothesis: This study aimed to compare the effectiveness of a hybrid telerehabilitation program with a traditional face to face model in women with stress urinary incontinence (SUI) and mixed incontinence (MUI) with a predominance of SUI. The authors hypothesized that home pelvic floor muscle training (PFMT) would have a similar benefit to outpatient PFMT. Method(s): Parallel randomized controlled trial including 58 patients consecutively admitted to a tertiary academic hospital for pelvic floor rehabilitation consultation from 1 January to 30 April 2021 for conservative treatment of UI. Participants randomized to the intervention were submitted to a 12-week PFMT program: (1) a hybrid telerehabilitation program of two individual face-to-face sessions followed by 2-weekly sessions of video-telerehabilitation with a follow-up by a specialized physiotherapist, including one individual face-to-face session at 8 weeks; (2) a re-evaluation teleconsultation at 6 and 16 weeks; (3) a face-to-face consultation at 12 weeks. The control group had two initial individual sessions followed by twice-weekly group classes, and consultations were face to face. The primary outcome measure (at baseline and 12 weeks) was UI-related quality of life using the Portuguese Version of the King's Health Questionnaire. Result(s): At baseline the intervention (n = 18) and control (n = 17) groups were similar. UI-related quality of life significantly improved in both the intervention and control groups betweenbaseline (T0) and the end of the 12-week PFMT program (T12) (p = 0.002, p < 0.001, respectively), although the magnitude of the improvement was not significantly different between groups (-10.0 vs. -9.5 points, p = 0.918, respectively). Conclusion(s): This hybrid telerehabilitation protocol showed effectiveness comparable to the traditional model in improving UI-related quality of life. Trial registration at www.ClinicalTrials.gov, no. NCT05114395.Copyright © 2022, The International Urogynecological Association.

Sapiyat, I. and P. Laura (2023). "The effectiveness, safety and harms of combined fertility-sparing therapy in women with early endometrial cancer or atypical endometrial hyperplasia." PROSPERO International prospective register of systematic reviews.
	
Sapiyat, I., et al. (2023). "The effectiveness of antioxidant therapy in women with endometriosis." PROSPERO International prospective register of systematic reviews.
	
Sarah, P., et al. (2023). "Complementary and Alternative Interventions for Chronic Pelvic Pain in Adult Women: A Systematic Review." PROSPERO International prospective register of systematic reviews.
	
Saraswat, L. (2021). "Comparing gonadotrophin-releasing hormone analogues with repeat laparoscopic surgery for the treatment of recurrent pain following surgery for endometriosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Women who experience recurrence of pain following previous laparoscopic treatment for endometriosis will be invited to take part. Women will be referred by their GP to specialist endometriosis centres and will be invited to take part by the endometriosis team. Potentially eligible women will be given information about the study. Those who are interested in taking part will be asked to sign a consent form. Baseline data will be collected, and women will be asked to complete a questionnaire about their condition and their quality of life. After consent, women will be randomised to either GnRHa (with HRT) or for further laparoscopic surgery. For women randomised to GnRHa (with HRT), the GnRHa can be administered through various routes including intramuscular injections or subcutaneously monthly or every 12 weeks. The HRT can be given orally, transdermally or via the intrauterine system. GnRHa and HRA will not be specifically manufactured or labelled for use within the REGAL trial. The trial will use routine stocks prescribed by the endometriosis team or their GP and dispensed by the hospital or local pharmacy. For women randomised to GnRHa (with HRT), bone mineral density will be monitored by DEXA scans at baseline, 12 and 24 months. Women who are randomised to laparoscopic surgery will be added to the waiting list for surgery. The researchers will ask women to complete questionnaires every 6 months to collect information on pain, quality of life, compliance with treatment and any side effects. There is a qualitative sub‐study. The first involves audio‐recording consultations ‐ women will receive information about this in CONDITION: Endometriosis ; Urological and Genital Diseases ; Endometriosis PRIMARY OUTCOME: ; Clinical:; Endometriosis‐associated pain measured using the pain domain of the condition‐specific Endometriosis Health Profile‐30 (EHP‐30) at 24 months; ; Economic:; Incremental cost per QALY gained from a health service perspective, measured using self‐completed questionnaires and case note reviews at 24 months post‐randomisation; SECONDARY OUTCOME: ; Clinical:; 1. Bone mineral density (BMD) measured using Dual Energy X‐ray absorptiometry (DEXA) scan for a subgroup of patients (90 women in each arm across a minimum of 5 centres ideally recruited over 18 months). For the GnRHa group BMD will be measured at baseline, 12 and 24 months post‐randomisation, for the laparoscopic surgery group at baseline and 24 months post‐randomisation; 2. Surgical and anaesthetic complications and adverse events assessed using self‐completed questionnaires and case note reviews at 24 months post‐randomisation; ; Patient‐reported (measured using self‐completed questionnaires at 6, 12, 18 and 24‐months post‐randomisation unless stated otherwise):; 1. Adverse events that are a result of treatment for endometriosis; 2. Endometriosis treatment received; 3. Generic and condition‐specific quality of life, measured using EQ‐5D and EHP‐30 at baseline, 6, 12, 18 and 24 months post‐randomisation; 4. Endometriosis‐associated pain measured using the pain domain of EHP‐30 at 6, 12, and 18 months; 5. Patient satisfaction measured on a six‐point scale from ‘totally satisfied’ to ‘totally dissatisfied’; 6. Further pharmacological treatment (change of hormonal treatment, increased use of analgesics, start of neuromodulators such as pregabalin, gabapentin, amitryptiline) or surgery for endometriosis or other treatments (e.g. acupuncture, CBT) for endometriosis‐associated pain; 7. Pregnancy; INCLUSION CRITERIA: 1. Women aged 21–49 years with recurrent pain following laparoscopic surgery for endometriosis (excision or ablation) who wish to avoid removal of ovaries and hysterectomy, irrespective of site and stage of endometriosis, number of previous surgeries or use of post‐operative hormonal treatment. 2. Women who are considered suitable for both treatment arms 3. Able and willing to give informed consent to participate and to participate in study procedures, including D

Saraswat, L., et al. (2020). "Traditional suburethral sling operations for urinary incontinence in women." The Cochrane Database of Systematic Reviews(1).
	- Background Stress urinary incontinence constitutes a significant health and economic burden to society. Traditional suburethral slings are surgical operations used to treat women with symptoms of stress urinary incontinence. Objectives To assess the effectiveness of traditional suburethral sling procedures for treating stress urinary incontinence in women; and summarise the principal findings of relevant economic evaluations. Search methods We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), as well as MEDLINE, MEDLINE In‐Process, MEDLINE Epub Ahead of Print, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP); we handsearched journals and conference proceedings (searched 27 February 2017) and the reference lists of relevant articles. On 23 January 2019, we updated this search; as a result, several additional reports of studies are awaiting classification. Selection criteria Randomised or quasi‐randomised trials that assessed traditional suburethral slings for treating stress or mixed urinary incontinence. Data collection and analysis At least two review authors independently extracted data from included trials and assessed risk of bias. When appropriate, a summary statistic was calculated: risk ratio (RR) for dichotomous data, odds ratio (OR) for continence and cure rates that were expected to be high, and mean difference (MD) for continuous data. We adopted the GRADE approach to assess the quality of evidence. Main results A total of 34 trials involving 3244 women were included. Traditional slings were compared with 10 other treatments and with each other. We did not identify any trials comparing suburethral slings with no treatment or sham treatment, conservative management, anterior repair, or laparoscopic retropubic colposuspension. Most trials did not distinguish between women having surgery for primary or recurrent incontinence. One trial compared traditional slings with bladder neck needle suspension, and another trial compared traditional slings with single‐incision slings. Both trials were too small to be informative. Traditional suburethral sling operation versus drugs One small trial compared traditional suburethral sling operations with oxybutynin to treat women with mixed urinary incontinence. This trial did not report any of our GRADE‐specific outcomes. It is uncertain whether surgery compared with oxybutynin leads to more women being dry (83% vs 0%; OR 195.89, 95% confidence interval (CI) 9.91 to 3871.03) or having less urgency urinary incontinence (13% vs 43%; RR 0.29, 95% CI 0.09 to 0.94) because the quality of this evidence is very low. Traditional suburethral sling versus injectables One small trial compared traditional slings with suburethral injectable treatment. The impact of surgery versus injectables is uncertain in terms of the number of continent women (100% were dry with a traditional sling versus 71% with the injectable after the first year; OR 11.57, 95% CI 0.56 to 239.74), the need for repeat surgery for urinary incontinence (RR 0.52, 95% CI 0.05 to 5.36) or the occurrence of perioperative complications (RR 1.57, 95% CI 0.29 to 8.49), as the quality of evidence is very low. Traditional suburethral sling versus open abdominal retropubic colposuspension Eight trials compared slings with open abdominal retropubic colposuspension. Moderate‐quality evidence shows that the traditional suburethral sling probably leads to more continent women in the medium term (one to five years) (69% vs 59% after colposuspension: OR 1.70, 95% CI 1.22 to 2.37). High‐quality evidence shows that women were less likely to need repeat continence surgery after a traditional sling operation than after colposuspension (RR 0.15, 95% CI 0.05 to 0.42). We found no evidence of a difference in perioperative complications between the two groups, but the CI was ery wide a d the quality of evidence was very low (RR 1.24, 95% CI 0.83 to 1.86). Traditional suburethral sling operation versus mid‐urethral slings Fourteen trials compared traditional sling operations and mid‐urethral sling operations. Depending on judgements about what constitutes a clinically important difference between interventions with regard to continence, traditional suburethral slings are probably no better, and may be less effective, than mid‐urethral slings in terms of number of women continent in the medium term (one to five years) (67% vs 74%; OR 0.67, 95% CI 0.44 to 1.02; n = 458; moderate‐quality evidence). One trial reported more continent women with the traditional sling after 10 years (51% vs 32%: OR 2.22, 95% CI 1.07 to 4.61). Mid‐urethral slings may be associated with fewer perioperative complications (RR 1.74, 95% CI 1.16 to 2.60; low‐quality evidence). One type of traditional sling operation versus another type of traditional sling operation Nine trials compared one type of traditional sling operation with another. The different types of traditional slings, along with the number of different materials used, mean that trial results could not be pooled due to clinical heterogeneity. Complications were reported by two trials ‐ one comparing non‐absorbable Goretex with a rectus fascia sling, and the second comparing Pelvicol with a rectus fascial sling. The impact was uncertain due to the very low quality of evidence. Authors' conclusions Low‐quality evidence suggests that women may be more likely to be continent in the medium term (one to five years) after a traditional suburethral sling operation than after colposuspension. It is very uncertain whether there is a difference in urinary incontinence after a traditional suburethral sling compared with a mid‐urethral sling in the medium term. However, these findings should be interpreted with caution, as long‐term follow‐up data were not available from most trials. Long‐term follow‐up of randomised controlled trials (RCTs) comparing traditional slings with colposuspension and mid‐urethral slings is essential. Evidence is insufficient to suggest whether traditional suburethral slings may be better or worse than other management techniques. This review is confined to RCTs and therefore may not identify all of the adverse effects that may be associated with these procedures. A brief economic commentary (BEC) identified three eligible economic evaluations, which are not directly comparable due to differences in methods, time horizons, and settings. End users of this review will need to assess the extent to which methods and results of identified economic evaluations may be applicable (or transferable) to their own setting. Plain language summary Traditional suburethral sling operations for urinary incontinence in women Review question How do traditional slings compare with other surgical or conservative treatments for women with stress urinary incontinence (SUI)? Background A traditional suburethral sling operation is one of the surgical options for treating women with SUI. Stress urinary incontinence is loss (leakage) of urine when coughing, laughing, sneezing, or exercising. It may be due to damage to the muscles that hold up the bladder neck or damage to their nerves, which often occurs during childbirth. When stress urinary incontinence occurs together with an urge to empty the bladder that is difficult to defer (urgency urinary incontinence (UUI)), this is known as mixed urinary incontinence (MUI). The traditional suburethral sling operation aims to hold up the bladder neck with a strip of material that may be biological (made from human or animal tissue) or made of non‐absorbable synthetic plastic (mesh/tape). How up‐to‐date is this review? The evidence is current to 27 February 2017. A further search on 23 January 2019 was not fully incorporated into the review. Study characteristics We found 34 randomised controlled trials (RCTs) involving 3244 women that compared traditional slings with drugs or other types of su gery (colp suspension, mid‐urethral slings, bladder neck needle suspension, single‐incision slings (mini‐slings); one type of traditional sling with another; and traditional slings with injectables. All trials included women with SUI, but some also involved women with UUI, who are said to have MUI. We did not find any studies comparing suburethral slings with no treatment or sham treatment, conservative management such as pelvic floor exercises, anterior repair, or laparoscopic colposuspension. Study funding sources Few trialists reported who had funded their work. Key results Surgery appears to work better than drugs for treating urinary incontinence. Some evidence suggests that women had less leakage with traditional slings in the medium term (one to five years) compared with those undergoing colposuspension (a major abdominal operation), and fewer needed repeat surgery in one trial. However, information about adverse effects is lacking. It is not clear whether traditional slings were better or worse than mid‐urethral slings (synthetic tape) in the medium term, but one small trial showed that women who had a traditional sling might have less leakage 10 years later. It is not clear whether traditional slings were better or worse than injectable treatment, bladder neck needle suspension, or mini‐slings. We found insufficient information about different types of slings compared with each other, except that slings made of porcine dermis (Pelvicol) were more likely to fail than other materials. Slings made of non‐absorbable synthetic Goretex involved more complications. Quality of the evidence Many trials were small and used different ways of measuring success, which made combining information difficult. The quality of evidence for most outcomes was judged to be low or very low. This means that most of our conclusions about traditional slings are uncertain. Authors' conclusions Some evidence suggests that women had less leakage with traditional slings in the medium term (one to five years) compared with those undergoing colposuspension (a major abdominal operation), and fewer needed repeat surgery in one trial. Evidence on comparison of traditional suburethral slings with other treatments is insufficient. Three eligible economic evaluations reported similar results, but they are not directly comparable because of differences in their methods. This review is confined to randomised controlled trials (RCTs) and therefore may not identify all of the adverse effects that may be associated with these procedures.

Sar-Shalom, N., et al. (2019). "The impact of intentional endometrial injury on reproductive outcomes: a systematic review and meta-analysis." Human Reproduction Update 25(1): 95-113.
	Background: Endometrial injury is an intentional damage made to the endometrium, usually produced by a Pipelle catheter. Over the last two decades, endometrial injury has been studied to improve implantation rates and decrease the incidence of implantation failure in invitro fertilization (IVF) cycles. Recently, additional studies of endometrial injury, performed not only in patients with implantation failure but also in intrauterine insemination cycles, have been conducted, and the endometrial injury made by hysteroscopy has been researched. The evidence describing the impact of endometrial injury is controversial; therefore, we conducted a systematic review and meta-analysis to examine the issue.; Objective and Rationale: Our objective is to review the research that has been done until now and perform a meta-analysis regarding endometrial injury and its influence on implantation success and pregnancy rates in patients with at least one failed IVF cycle. In particular, we aim to study the efficacy of the procedure and look for confounding factors, such as maternal age, in assessing the efficacy of endometrial injury.; Search Methods: The systematic review of the literature was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement. Study protocol can be assessed at PROSPERO International prospective register of systematic reviews (registration number CRD42018092773). Searches were conducted by an experienced research librarian in the following databases: MEDLINE(R) using the OvidSP interface and PUBMED, Embase, Web of Science and Cochrane Library. This review considered for inclusion randomized-controlled trials examining the success of performing local endometrial injury on IVF outcomes in women with previous failed IVF cycles.; Outcomes: Ten studies, comprising a total of 1260 patients, were selected. Overall, when studying the effect of endometrial injury on clinical pregnancy rates (CPRs) and live birth rates (LBRs), higher rates were shown in the endometrial injury group. However, endometrial injury did not significantly improve CPRs and LBRs, when considering sub-group analyses of studies including patients with two or more failed IVF cycles, studies examining older patients or studies which did not include hysteroscopy. There was no significant difference found regarding multiple pregnancy rates, while a handful of studies showed an improvement in miscarriage rates.; Wider Implications: Endometrial injury should be used restrictively and not routinely in clinics. Maternal age and number of previous failed treatment cycles may be contributing factors which can influence the results when studying the effect of endometrial local injury. It is possible that the relative contribution of endometrial receptivity to the chances of implantation decreases with any additional failed cycle. The optimal study to prove the efficacy of local endometrial injury on implantation and pregnancy rates, should be a random-controlled trial studying the effect of local endometrial injury in oocyte donation cycles, in recipients with repeated implantation failure. This kind of study will conclude whether local endometrial injury is an efficient procedure with minimum confounding factors, and may assist in defining the population, even outside of donation cycles, that will benefit from the procedure.

Sassani, J. (2021). "Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary Incontinence." ClinicalTrials.gov.
	The objective of this proposal is to determine if home biofeedback devices are noninferior to pelvic floor physical therapy for the treatment of postpartum urinary incontinence through a randomized noninferiority clinical trial. The hypothesis is that both interventions will improve incontinence‐related quality of life and that home biofeedback will be noninferior to PFPT. Two specific aims will be investigated: 1) Determine the impact of both interventions on urinary incontinence‐related quality of life measured by the change in score at 3‐months on the International Consultation on Incontinence Questionnaire Short Form (ICIQ‐SF); 2) Determine patient impression of symptoms improvement (measured by the change in score at 3‐months and 1‐year on the Patient Global Impression of Improvement scale or PGI‐I), overall pelvic floor symptoms (measured by the change in score at 3‐months and 1‐year on the Pelvic Floor Distress Inventory of PFDI) and changes in sexual function (measured by a change in score at 3‐months and 1‐year in the Female Sexual Function Index or FSFI). An additional exploratory aim will be to observe the change in pelvic floor symptoms in the postpartum period at 3‐months and 1‐year among a cohort of women who elect for the standard of care without PFPT or biofeedback.

Sassani Jessica, C., et al. (2024). "Cost-Utility Analysis of Midurethral Sling Timing Among Women Undergoing Prolapse Surgery." Urogynecology 30(1): 65-72.
	Importance: There are no guidelines regarding the ideal timing of midurethral sling (MUS) placement following prolapse repair.; Objective: The objective of this study was to estimate the cost-utility of concomitant MUS versus staged MUS among women undergoing apical suspension surgery for pelvic organ prolapse.; Study Design: Cost-utility modeling using a decision analysis tree compared concomitant MUS with staged MUS over a 1-year time horizon. The primary outcome was the incremental cost-effectiveness ratio (ICER). Six scenarios were modeled to estimate cost-utilities for women with preoperative overt, occult, or no stress urinary incontinence (SUI) who underwent either minimally invasive sacrocolpopexy or vaginal native tissue apical suspension. Possible complications of de novo overactive bladder, urinary retention requiring sling lysis, mesh exposure, and persistent SUI were included. Costs from a third-party payer perspective were derived from Medicare 2022 reimbursements. One-way sensitivity analyses were performed.; Results: Among women without preoperative SUI, staged MUS was the dominant strategy for both surgical routes with higher utility and lower costs. For women with either occult or overt SUI undergoing sacrocolpopexy or vaginal repair, concomitant MUS was cost-effective (ICER = $21,114-$96,536 per quality-adjusted life-year). Therefore, concomitant MUS is preferred for patients with preoperative SUI as higher costs were offset by higher effectiveness. One-way sensitivity analyses demonstrated that ICERs were most affected by probability of cure following MUS.; Conclusions: A staged MUS procedure is the dominant strategy for women undergoing apical prolapse repair without preoperative SUI. In women with either overt or occult SUI, the ICER was below the willingness-to-pay threshold of $100,000 per quality-adjusted life-year, suggesting that concomitant MUS surgery is cost-effective.; Competing Interests: The authors have declared they have no conflicts of interest. (Copyright © 2023 American Urogynecologic Society. All rights reserved.)

Satar, D. A., et al. (2024). "Dexketoprofen versus Tenoxicam in Acute Severe Pain Due to Primary Dysmenorrhea." Journal of the College of Physicians and Surgeons Pakistan 34(2): 160-165.
	OBJECTIVE: To evaluate the analgaesic efficacy of tenoxicam and dexketoprofen in patients admitted to the Emergency Medicine (EM) Clinic with severe acute pain due to primary dysmenorrhea (PD). STUDY DESIGN: Randomised-controlled trial. Place and Duration of the Study: Emergency Medicine Clinic, Health Sciences University, Adana City Training and Research Hospital, Adana, Turkiye, from January to December 2022. METHODOLOGY: Patients presenting with PD, were divided into two groups of 60 each, administered 50 mg dexketoprofen and 20 mg tenoxicam intravenously. Visual analogue scale (VAS) scores were recorded at the 15th, 30th, 60th, and 120th minutes. VAS scores and ΔVAS scores were compared with the effectiveness of drugs, the need for rescue drugs and its side-effects. RESULTS: Intravenous (IV) dexketoprofen was administered to 60 of the patients and IV tenoxicam was administered to another 60. At the time of admission, mean VAS scores of the patients were 8.8 ± 0.9 for the dexketoprofen group and 8.6 ± 0.8 for the tenoxicam group. The VAS scores of the dexketoprofen group were found to be statistically significantly lower after 30 minutes with lower need for rescue analgaesics. ΔVAS scores of the dexketoprofen group were statistically significantly higher from the 30th minute. CONCLUSION: According to the VAS scoring, IV dexketoprofen was a more effective drug than IV tenoxicam in patients who were admitted to the EM clinic with severe pain due to PD. KEY WORDS: Dexketoprofen, Primary dysmenorrhea, VAS score.

Sathyapalan, T. (2022). "A clinical trial to see if LPRI-424 is safe and works for Polycystic Ovary Syndrome compared to a placebo for 9 months." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Duration of treatment: 9 sequential cycles of 28 days (252 days in total) Dose and mode of administration: a) Test product: LPRI‐424 tablets (dienogest [DNG] 2 mg / ethinyl estradiol [EE] 0.02 mg), film‐coated tablets, oral administration. Each blister contains 28 tablets. One treatment cycle consists of 24 active white tablets followed by 4 green placebo tablets. The tablets will be taken once daily at approximately the same time each day. b) Reference therapy: LPRI‐424 tablets matching placebo tablets, film‐coated tablets, oral administration. Each blister contains 28 tablets. One treatment cycle consists of 24 white placebo tablets followed by 4 green placebo tablets. The tablets will be taken once daily at approximately the same time each day. Follow‐up activity for both arms: • Document concomitant medication • Vital signs (blood pressure, heart rate, respiration rate, body temperature), height only in adolescent subjects, body weight, waist circumference • Gynaecological examination • Urine pregnancy test • Check for Adverse events Randomisation process: Online tool CONDITION: Excess of body hair in women with polycystic ovarian syndrome (PCOS) ; Nutritional, Metabolic, Endocrine ; Hirsutism related to Polycystic Ovarian Syndrome PRIMARY OUTCOME: Hirsutism is measured using a modified Ferriman‐Gallwey score (mFG) based on the investigator's decision at baseline, treatment cycle 6 (day 20+/‐ 7 of medication cycle) and at the end of treatment. SECONDARY OUTCOME: ; Changes in laboratory parameters from baseline to trial termination; 1. Adverse events (AEs); 2. Vital signs; 3. Clinical laboratory parameters; 4. Physical examination; 5. Electrocardiogram (ECG); 6. Gynaecological examination; 7. Cervical cytology; 8. Changes in weight and waist; 9. Change in bleeding pattern from baseline; 10. Number of subjects with prolonged bleeding/spotting >10 days; 11. IP acceptability based on IP satisfaction and wellbeing; 12. Changes in quality of life based on the Polycystic Ovarian Syndrome Questionnaire (PCOSQ) from baseline; INCLUSION CRITERIA: At Visit 1a (Screening) and at Visit 1b (IP Dispensation), subjects must meet ALL of the following criteria: 1. Two years postmenarcheal women of any ethnic origin between 14 and 40 years (inclusive at the time of enrolment), not seeking pregnancy. Female subjects at risk of pregnancy aged between 14 and 17 years (inclusive) provided that: a. Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services, b. All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed. 2. Diagnosed with PCOS according to the following criteria: a. Presence of hirsutism measured using an adapted mFG with a cut‐off value of =7 (at V1a only based on patient’s history or interview; to be determined only at Visit 1b) and b. Presence of one of the following criteria: 1. Oligomenorr

Sathyapalan, T. (2022). "Semaglutide vs Metformin in Polycystic Ovary Syndrome (PCOS)." ClinicalTrials.gov.
	Background: Polycystic ovary syndrome (PCOS) is one of the most common metabolic disorders that affects 6‐20% of reproductive‐aged women and has an increased risk for type 2 diabetes mellitus (T2DM) and cardiovascular disease. Obesity affects more than 50% of women with PCOS and has been demonstrated to play a vital role in the establishment of symptoms in these patients. Bariatric surgery has been shown to improve metabolic parameters but reports of dietary intervention studies have been variable. PCOS is associated with an increased risk of depressive symptoms and a low quality of life (QOL) with weight being a major contributor. Even modest weight loss of 5% of initial body weight has been shown to improve menstrual disturbance, testosterone levels, hyperlipidaemia, and insulin resistance in women with PCOS. Metformin, most commonly used medication for PCOS works by improving insulin sensitivity in peripheral tissues, inhibit hepatic glucose production and increase glucose disposal by the peripheral tissues. It has been used for decades in treatment of PCOS with improvement in menstrual irregularities and possible reduction of androgen levels. However, the effect of metformin on body weight (a major contributor of pathophysiology and symptoms in PCOS) remained highly variable between these patients. The first observational study of metformin in PCOS reported weight loss during metformin therapy. In a randomised controlled trial (RCT) designed to investigate the effect of metformin in body weight reported a significant decrease in BMI in obese women independent of their lifestyle. The recent meta‐analysis assessed the effectiveness of metformin in PCOS reported a significant effect on body mass index (BMI) in women with PCOS. It is clear, however, that metformin does not increase body weight and might help to limit weight gain. Along with wide variation in response metformin is not tolerated by 10‐20% of women with PCOS mainly due to its gastrointestinal side effects. Therefore, it is imperative that investigators look beyond metformin in obese women with PCOS, as this has shown to improve metabolic and hormonal parameters. In a pilot study, another glucagon like peptide ‐ 1 receptor agonist (GLP‐1RA), liraglutide 1.8mg daily for 6 months reduced weight in obese women with PCOS and age and body mass index matched control women. They also demonstrated that liraglutide 1.8mg daily for 6 months in young obese women with PCOS showed significant improvement in physical health, social health, psychological and hence quality of life in this group. Semaglutide a new GLP‐1RA approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes and is associated with significant weight loss. In patients with type 2 diabetes, there was ≥5% weight loss in 63% of patients treated with Semaglutide. On the other hand, liraglutide has shown around 5‐7 kg of weight reduction from the baseline in patient with T2DM. However, it has been previously reported in the SUSTAIN trials, Semaglutide‐treated subjects have achieved a significant weight loss of >10% compared to placebo. The effect of Semaglutide on weight loss and resultant improvement in the metabolic parameters and QOL in women with PCOS is unknown. In a recent double‐blind randomized trial, compared Semaglutide to liraglutide in obese patients with no diabetes has shown a significant weight loss compared to placebo. Liraglutide is administered as a daily subcutaneous injection whereas Semaglutide is administered as a weekly subcutaneous injection. Therefore, investigators are conducting this trial to assess the feasibility and trying to replicate the greater weight loss with Semaglutide that has already been shown in other trial, in obese women with PCOS. Overall hypothesis: Treatment with Semaglutide will result in significant weight loss compared to metformin and that will be associated with significant improvements in hormonal and metabolic parameters, quality of life and cardiovascular risk factors as secondary end ints in obese women with PCOS. This is a randomized controlled trial The trial consists of 7 visits and 3 telephone calls. Patients will be randomized on a 1:1 ratio to receive either: Semaglutide 0.25mg subcutaneous weekly for 4 weeks followed by semaglutide 0.5 mg weekly for 4 weeks, then escalating to semaglutide 1 mg/ week for 4 weeks, followed by semaglutide 1.7 mg/week for 4 weeks before titrated up to maximum dose of 2.4 mg a week for 12 weeks if tolerated. Or Metformin 500 mg/ day for 1 week followed by 500mg/twice a day for 1 week titrated up to 500 mg / day with breakfast and 1000 mg/ day with evening meals for 26 weeks if tolerated.

Saus-Ortega, C., et al. (2023). "Effect of pelvic floor muscle training on female sexual function: A systematic review protocol and meta-analysis." Nursing Open.
	AIM: To recognize, appraise and summarize the research evidence that has explored the results of pelvic floor muscle training on female sexual function. DESIGN: Systematic review and possible meta-analysis. METHODOLOGY: Between September and October 2022, the Cochrane Library, CINAHL, MEDLINE, EMBASE, PsycINFO and Scopus electronic databases will be searched. We will include RCT's in English, Spanish and Portuguese that investigate the results of pelvic floor muscle training on female sexual function. The data will be extracted by two researchers independently. Risk of bias will be measured from the Cochrane Risk of Bias Tool. The meta-analysis of the results will be performed using Comprehensive Meta-Analysis Version 2. RESULTS: This systematic review and possible meta-analysis will contribute significantly to the promotion of pelvic floor health and women's sexual function and to strengthen clinical practice and define other areas of study.

Savaris Ricardo, F., et al. (2020). "Antibiotic therapy for pelvic inflammatory disease." The Cochrane Database of Systematic Reviews 8: CD010285.
	Background: Pelvic inflammatory disease (PID) affects 4% to 12% of women of reproductive age. The main intervention for acute PID is broad-spectrum antibiotics administered intravenously, intramuscularly or orally. We assessed the optimal treatment regimen for PID. OBJECTIVES: To assess the effectiveness and safety of antibiotic regimens to treat PID.; Search Methods: In January 2020, we searched the Cochrane Sexually Transmitted Infections Review Group's Specialized Register, which included randomized controlled trials (RCTs) from 1944 to 2020, located through hand and electronic searching; CENTRAL; MEDLINE; Embase; four other databases; and abstracts in selected publications.; Selection Criteria: We included RCTs comparing antibiotics with placebo or other antibiotics for the treatment of PID in women of reproductive age, either as inpatient or outpatient treatment. We limited our review to a comparison of drugs in current use that are recommended by the 2015 US Centers for Disease Control and Prevention guidelines for treatment of PID.; Data Collection and Analysis: We used standard methodological procedures expected by Cochrane. Two authors independently extracted data, assessed risk of bias and conducted GRADE assessments of the quality of evidence.; Main Results: We included 39 RCTs (6894 women) in this review, adding two new RCTs at this update. The quality of the evidence ranged from very low to high, the main limitations being serious risk of bias (due to poor reporting of study methods and lack of blinding), serious inconsistency, and serious imprecision. None of the studies reported quinolones and cephalosporins, or the outcomes laparoscopic evidence of resolution of PID based on physician opinion or fertility outcomes. Length of stay results were insufficiently reported for analysis. Regimens containing azithromycin versus regimens containing doxycycline We are uncertain whether there was a clinically relevant difference between azithromycin and doxycycline in rates of cure for mild-moderate PID (RR 1.18, 95% CI 0.89 to 1.55; 2 RCTs, 243 women; I 2 = 72%; very low-quality evidence). The analyses may result in little or no difference between azithromycin and doxycycline in rates of severe PID (RR 1.00, 95% CI 0.96 to 1.05; 1 RCT, 309 women; low-quality evidence), or adverse effects leading to discontinuation of treatment (RR 0.71, 95% CI 0.38 to 1.34; 3 RCTs, 552 women; I 2 = 0%; low-quality evidence). In a sensitivity analysis limited to a single study at low risk of bias, azithromycin probably improves the rates of cure in mild-moderate PID (RR 1.35, 95% CI 1.10 to 1.67; 133 women; moderate-quality evidence), compared to doxycycline. Regimens containing quinolone versus regimens containing cephalosporin The analysis shows there may be little or no clinically relevant difference between quinolones and cephalosporins in rates of cure for mild-moderate PID (RR 1.05, 95% CI 0.98 to 1.14; 4 RCTs, 772 women; I 2 = 15%; low-quality evidence), or severe PID (RR 1.06, 95% CI 0.91 to 1.23; 2 RCTs, 313 women; I 2 = 7%; low-quality evidence). We are uncertain whether there was a difference between quinolones and cephalosporins in adverse effects leading to discontinuation of treatment (RR 2.24, 95% CI 0.52 to 9.72; 6 RCTs, 1085 women; I 2 = 0%; very low-quality evidence). Regimens with nitroimidazole versus regimens without nitroimidazole There was probably little or no difference between regimens with or without nitroimidazoles (metronidazole) in rates of cure for mild-moderate PID (RR 1.02, 95% CI 0.95 to 1.09; 6 RCTs, 2660 women; I 2 = 50%; moderate-quality evidence), or severe PID (RR 0.96, 95% CI 0.92 to 1.01; 11 RCTs, 1383 women; I 2 = 0%; moderate-quality evidence). The evidence suggests that there was little to no difference in in adverse effects leading to discontinuation of treatment (RR 1.05, 95% CI 0.69 to 1.61; 17 studies, 4021 women; I 2 = 0%; low-quality evidence). . In a sensitivity analysis limited to studies at low risk of bias, there was little or no difference for rates of cur in mi d-moderate PID (RR 1.05, 95% CI 1.00 to 1.12; 3 RCTs, 1434 women; I 2 = 0%; high-quality evidence). Regimens containing clindamycin plus aminoglycoside versus quinolone We are uncertain whether quinolone have little to no effect in rates of cure for mild-moderate PID compared to clindamycin plus aminoglycoside (RR 0.88, 95% CI 0.69 to 1.13; 1 RCT, 25 women; very low-quality evidence). The analysis may result in little or no difference between quinolone vs. clindamycin plus aminoglycoside in severe PID (RR 1.02, 95% CI 0.87 to 1.19; 2 studies, 151 women; I 2 = 0%; low-quality evidence). We are uncertain whether quinolone reduces adverse effects leading to discontinuation of treatment (RR 0.21, 95% CI 0.02 to 1.72; 3 RCTs, 163 women; I 2 = 0%; very low-quality evidence). Regimens containing clindamycin plus aminoglycoside versus regimens containing cephalosporin We are uncertain whether clindamycin plus aminoglycoside improves the rates of cure for mild-moderate PID compared to cephalosporin (RR 1.02, 95% CI 0.95 to 1.09; 2 RCTs, 150 women; I 2 = 0%; low-quality evidence). There was probably little or no difference in rates of cure in severe PID with clindamycin plus aminoglycoside compared to cephalosporin (RR 1.00, 95% CI 0.95 to 1.06; 10 RCTs, 959 women; I 2 = 21%; moderate-quality evidence). We are uncertain whether clindamycin plus aminoglycoside reduces adverse effects leading to discontinuation of treatment compared to cephalosporin (RR 0.78, 95% CI 0.18 to 3.42; 10 RCTs, 1172 women; I 2 = 0%; very low-quality evidence).; Authors' Conclusions: We are uncertain whether one treatment was safer or more effective than any other for the cure of mild-moderate or severe PID Based on a single study at a low risk of bias, a macrolide (azithromycin) probably improves the rates of cure of mild-moderate PID, compared to tetracycline (doxycycline). (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Saveria, C., et al. (2022). "A Systematic Review of the effect of Ethanol Sclerotherapy for Ovarian Endometrioma on ART Outcomes." PROSPERO International prospective register of systematic reviews.
	
Sawada, D., et al. (2022). "Effects of Lactobacillus gasseri CP2305 on Mild Menopausal Symptoms in Middle-Aged Women." Nutrients 14(9): 1695.
	Lactobacillus gasseri CP2305 (CP2305) is a paraprobiotic that exhibits beneficial effects on the intestinal function and microbiota, and increases resistance to psychological stress. The stress response mechanism mainly involves the hypothalamic-pituitary-adrenal axis, which is influenced by the gut-brain axis. Furthermore, the gut-brain axis also communicates bidirectionally with the intestinal microbiota. Additionally, the hypothalamic-pituitary-adrenal and hypothalamic-pituitary- gonadal axes share a common route that affects both mental and health aspects in women. This double-blind, placebo-controlled, parallel-group clinical trial aimed to analyze the influence of the intake of CP2305 on mild symptoms associated with menopause. Eighty women aged 40-60 years ingested CP2305 or placebo tablets for six consecutive menstrual cycles. Assessment was based on the observation of climacteric symptoms with two validated questionnaires-the Simplified Menopausal Index (SMI) and the Greene Climacteric Scale (GCS). The results showed that CP2305 provided significant relief in the SMI total score, SMI vasomotor score, SMI psychological score, GCS total score, GCS somatic score, and GCS vasomotor score compared to the placebo. The percentage of women with symptom relief for the SMI total score was 75.0%, with 30 of 40 women in the CP2305 group, and 55.0%, with 22 of 40 women in the placebo group (p = 0.0594). These findings provide new insights into the function of paraprobiotic CP2305 in relieving mild climacteric symptoms in women.Copyright © 2022 by the authors. Licensee MDPI, Basel, Switzerland.

Scannell, N., et al. (2022). "Efficacy, Feasibility and Acceptability of a Mediterranean Diet Intervention on Hormonal, Metabolic and Anthropometric Measures in Overweight and Obese Women with Polycystic Ovary Syndrome: Study Protocol." Metabolites 12(4).
	Polycystic ovary syndrome (PCOS) is a common endocrine condition in reproductive-aged women associated with metabolic, reproductive and psychological features. Lifestyle modification (diet/physical activity) is considered first-line treatment for PCOS. However, there is limited high-quality evidence to support therapeutic dietary interventions for PCOS beyond general population-based healthy eating guidelines. Adherence to a Mediterranean diet (MedDiet), with or without energy restriction, improves cardiometabolic health in populations including persons with or at high risk of cardiovascular disease and type 2 diabetes. However, there is limited research examining the MedDiet in PCOS. Therefore, this 12 week randomized controlled trial will investigate the efficacy of a MedDiet on cardiometabolic and hormonal parameters and explore its acceptability and feasibility in PCOS. Forty-two overweight and obese women with PCOS (aged 18-45 years) will be randomized to receive dietary advice consistent with Australian Dietary Guidelines or an ad libitum MedDiet intervention. All participants will receive fortnightly counselling to facilitate behaviour change. The primary outcomes will be changes in insulin resistance, glucose, total testosterone and sex hormone-binding globulin. Secondary outcomes include changes in body weight and feasibility and acceptability of the MedDiet intervention. The results of this study will provide further evidence on specific dietary approaches for management of PCOS.

Schäfer Sebastian, D. (2021). "Impact on Quality of Life of "Endo-App" (ELEA)." ClinicalTrials.gov.
	randomized controlled trial enrolment of patients with diagnosed endometriosis 300 patients in total, 150 patients per group, randomization to control group (no Endo App use) vs intervention group (12 weeks Endo App use). The Endo App is a german language certified medical device which can be used to monitor the disease and gives support by providing complementary, multimodal interventions to standard therapy and is commercially available. Purpose of this study is the evaluation of quality of life at onset and then at 4, 8 and 12 weeks by using endometriosis health profile (EHP) 5 as a global index. The secondary endpoints of this study to evaluate are Fatigue symptoms (FSSsurvey), pain‐ specific self‐efficacy (FESS), difficulty in everyday life due to pain (PDI) and emotional wellbeing (DASS‐ 21)

Schettino, C. (2022). "MITO 35B: olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients." ClinicalTrials.gov.
	MITO 35b is designed as randomized, open label, phase III trial that aims to assess the efficacy of olaparib maintenance beyond progression compered to standard platinum‐based chemotherapy after secondary cytoreductive surgery. The target population of this study are ovarian cancer patients who experience a disease recurrence or progression to a first line maintenance therapy with PARPi; at progression patients must have received a secondary cytoreduction according to clinical practice.

Schettino, C., et al. (2022). "Olaparib beyond progression compared with platinum chemotherapy after secondary cytoreductive surgery in patients with recurrent ovarian cancer: phase III randomized, open-label MITO 35b study, a project of the MITO-MANGO groups." International Journal of Gynecological Cancer 32(6): 799-803.
	Background: Poly (ADP-ribose) polymerase inhibitors have transformed the management landscape for patients with ovarian cancer, demonstrating remarkable improvements in progression-free survival and overall survival. Unfortunately, most relapses are due to an acquired mechanism of resistance to these agents. We hypothesize that secondary cytoreductive surgery, removing resistant clones, might help to overcome the development of resistance to poly (ADP-ribose) polymerase inhibitors, prolonging their therapeutic effect.; Primary Objective: To determine the efficacy of olaparib beyond progression compared with standard platinum-based chemotherapy in patients with recurrent ovarian cancer progressed during or after poly (ADP-ribose) polymerase inhibitor maintenance therapy after secondary cytoreductive surgery.; Study Hypothesis: Olaparib administered beyond progression is more effective in increasing progression-free survival and progression-free survival 2 compared with second-line platinum-based chemotherapy in patients after secondary cytoreductive surgery.; Trial Design: Phase III, randomized, open-label, multicenter trial. Eligible patients will be randomized in a 1:1 ratio to receive olaparib or platinum-based chemotherapy of the investigator's choice.; Major Eligibility Criteria: Eligible patients must have high-grade serous or endometrioid ovarian cancer progressed during or after first-line poly (ADP-ribose) polymerase inhibitor maintenance therapy and must have undergone secondary cytoreductive surgery.; Primary Endpoint: The dual primary endpoints will include progression-free survival and progression-free survival 2. Progression-free survival is defined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as the time between randomization and progression or death from any cause. Progression-free survival 2 is defined by the investigator using RECIST version 1.1 as the time frame from randomization to the second progression or death from any cause after subsequent treatment.; Sample Size: Approximately 200 patients will be enrolled in this study.; Estimated Dates for Completing Accrual and Presenting Results: Enrollment will be completed in 2024. Results will be presented in 2026.; Trial Registration: EudraCT 2021-000245-41 NCT05255471.; Competing Interests: Competing interests: FP reports honoraria for educational and advisory activity from Incyte, GSK, Eli Lilly, Ipsen, Astellas, AstraZeneca, Roche, BMS, Bayer, Clovis, Pierre Fabre and grants for clinical trials to his institution from Roche, AstraZeneca, Pfizer, MSD, Bayer, Incyte Taiho, Janssen, Exelixis, Ailenor, Daiichi Sankyo. SP reports honoraria from AstraZeneca, MSD, Roche, Pfizer, Clovis, GSK, Pharmamar and research funding from MSD, Roche, AstraZeneca and Pfizer. NN reports personal financial interests (speaker’s fee and/or advisory boards): MSD, Qiagen, Bayer, Biocartis, Illumina, Incyte, Roche, BMS, MERCK, Thermofisher, AstraZeneca, Sanofi, Eli Lilly, Novartis and institutional financial interests (financial support to research projects) from MERCK, Thermofisher, QIAGEN, Roche, AstraZeneca, Biocartis, Illumina, Blueprint. (© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Schloss, J. (2021). "A Phase II Randomised Double-Blind, placebo-controlled clinical trial evaluating the efficacy of Happy Hormones in menopausal women." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: The intervention is Happy hormones: Dose: 4 capsules daily (equivalent to 5grams) ‐ 2 capsules with breakfast, and 2 capsules with dinner Duration: 12 weeks. The herbal formulation of Happy Hormones consists of whey protein, liquorice root powder, maca, psyllium husks, natural vanilla flavour, red clover powder, passion flora powder, sage powder, guar gum, natural berry flavour, wild yam powder, raspberry leaf powder, gymnema sylvestre extract, dandelion root extract, black cohosh extract, chaste berry extract and stevia extract. Each 5g of powder contains: Salvia officinalis (Garden Sage) ext equiv to dry leaf 3g. Vitex agnus‐castus (Chaste Berry) ext equiv to dry fruit 2g Actaea racemose (Black Cohosh) ext equkiv to dry rhizome 280mg standardized to triterpene glycosides 1mg. Passiflora incarnata (Passion Flower), et equiv to dry herb flowering and fruiting 416mg, Trifolium pratense (Red Clover) ext equiv to dry leaf 337.2mg Lepidium meyenii (Maca) tuber powder 333mg Dioscorea oppositifolia (Chinese yam) ext equiv to dry root and rhizome 266.5mg Rubus idaues (Raspberry) ext equiv to dry root 150mg Taraxacum officinale (Dandelion) ext equiv to dry leaf 150mg Gymnema sylvesytre (Gymnema) ext equiv to dry leaf 111mg Glycyrrhiza Glabra (Liquorice) powder equiv to dry root and stolon 14.85mg Free from artificial sweeteners, flavours, colours and preservatives. Contains lactose and sugars. This powder will be put into maroon capsules whereby 4 capsules will equal 1 teaspoon of powder per day. The compliance strategy is via capsule return. At each follow up, the capsules remaining will be countered and checked with the participant diary. As this trial is via telehealth, the participants will be CONDITION: Alternative and Complementary Medicine ‐ Herbal remedies Menopause; ; Menopause PRIMARY OUTCOME: To evaluate the efficacy of Happy Hormones compared to placebo in healthy menopausal women by the change in scores in menopause‐related health symptoms as measured by the Menopausal Rating Scale (MRS) scores from baseline to 12 weeks. [Week 0, 4, 8, 12 weeks (primary endpoint)] SECONDARY OUTCOME: To assess the safety of Happy Hormones from baseline to 12 weeks via adverse events and side effects using the CTCAE v5 and a self reported participant diary. [0 week, 4 weeks, 8 weeks and 12 weeks] To evaluate the number of vasomotor episodes daily from baseline to 12 weeks via a self reported participant diary where they write the number of vasomotor episodes each morning (this accounts for the following day and night)[0 week, 4 weeks, 8 weeks and 12 weeks] To evaluate the quality of life of healthy menopausal women taking Happy Hormones compared to placebo in healthy menopausal women by the menopausal rating scale from baseline to 12 weeks.[Week 0. week 4, week 8 and 12 weeks] INCLUSION CRITERIA: Females between 40 to 66 years of age More than 3 vasomotor symptoms (hot flushes) within a 24‐hour period. BMI between 18‐30 kg/m2 Normal liver and kidney function (within range of the pathology lab used) Ability to speak and understand English sufficiently to comprehend the purpose and risks of the study and to provide consent

Schmidt, M. (2023). "Effects of intermittent fasting on quality of life and toleance of chemotherapy in patients with gynaecological cancers: a randomized-controlled multi-center study." International Clinical Trials Registry Platform (ICTRP).
	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

Schmidt Mona, W., et al. (2022). "Efficacy and Safety of Immunotherapy for Cervical Cancer-A Systematic Review of Clinical Trials." Cancers 14(2).
	Purpose: To systematically review the current body of evidence on the efficacy and safety of immunotherapy for cervical cancer (CC).; Material and Methods: Medline, the Cochrane Central Register of Controlled Trials and Web of Science were searched for prospective trials assessing immunotherapy in CC patients in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Full-text articles in English and German reporting outcomes of survival, response rates or safety were eligible.; Results: Of 4655 screened studies, 51 were included (immune checkpoint inhibitors (ICI) n =20; therapeutic vaccines n = 25; adoptive cell transfer therapy n =9). Of these, one qualified as a phase III randomized controlled trial and demonstrated increased overall survival following treatment with pembrolizumab, chemotherapy and bevacizumab. A minority of studies included a control group ( n = 7) or more than 50 patients ( n = 15). Overall, response rates were low to moderate. No response to ICIs was seen in PD-L1 negative patients. However, few remarkable results were achieved in heavily pretreated patients. There were no safety concerns in any of the included studies.; Conclusion: Strong evidence on the efficacy of strategies to treat recurrent or metastatic cervical cancer is currently limited to pembrolizumab in combination with chemotherapy and bevacizumab, which substantiates an urgent need for large confirmatory trials on alternative immunotherapies. Overall, there is sound evidence on the safety of immunotherapy in CC.

Schmidt-Hansen, M., et al. (2020). "Surgical or medical abortion of pregnancies between 13 +0 and 23 +6 weeks' gestation? A systematic review and new NICE national guidelines." BMJ Sexual & Reproductive Health.
	Background: Abortion in the second trimester may be performed surgically or medically. The objective of this systematic review was to examine the effectiveness, safety and acceptability/satisfaction of surgical compared with medical abortion of pregnancy between 13 +0 and 23 +6 weeks' gestation for a new national guideline.; Methods: We searched Embase, Medline and the Cochrane Library on 4 March 2019. We included randomised controlled trials (RCTs; any size) and non-randomised comparative studies with n≥100 in each arm, published in English from 1985. Risk-of-bias was assessed using the Cochrane Collaboration checklist for RCTs. Meta-analysis of risk ratios (RRs)used the Mantel-Haenszel method. The quality of the evidence was assessed using GRADE.; Results: Two RCTs (n=140) were included. 'Incomplete abortion requiring surgical intervention' was clinically significantly higher with medical than surgical methods (RR=4.58, 95% CI 1.07 to 19.64). 'Abortion completed by the intended method' was statistically, but not clinically, significantly lower after medical than surgical methods, but was marked by high between-study heterogeneity (RR=0.88, 95% CI 0.79 to 0.98). To the extent that 'haemorrhage requiring transfusion/≥500 mL blood loss', 'uterine injury', 'cervical injury requiring repair' and 'infection reported within 1 month of abortion' were reported, they did not differ significantly between methods. Depending on measurement method, 'patient satisfaction/acceptability' was either clinically significantly higher or comparable after surgical than medical methods. The quality of this evidence was limited by low event rates and attrition bias.; Conclusion: Based on this evidence and consensus, women should be offered the choice of medical or surgical methods of abortion between 13 +0 and 23 +6 weeks' gestation, unless not clinically appropriate.; Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Schmidt-Hansen, M., et al. (2020). "Simultaneous compared to interval administration of mifepristone and misoprostol for medical abortion up to 10 +0 weeks' gestation: a systematic review with meta-analyses." BMJ Sexual & Reproductive Health 46(4): 270-278.
	Background: Medical abortion with mifepristone and misoprostol usually involves an interval of 36-48 hours between administering these drugs; however, it is possible that the clinical efficacy at early gestations may be maintained when the drugs are taken simultaneously. The objective of this systematic review was to determine the safety and effectiveness of simultaneous compared with interval administration of mifepristone and misoprostol for abortion up to 10 +0 weeks' gestation.; Methods: We searched Embase Classic, Embase; Ovid MEDLINE(R) including Daily, and Epub Ahead-of-Print, In-Process & Other Non-Indexed Citations; and Cochrane Library on 11 December 2019. We included randomised controlled trials (RCTs), published in English from 1985, comparing simultaneous to interval administration of mifepristone and misoprostol for early abortion. Risk of bias was assessed using the Cochrane Collaboration checklist for RCTs. Meta-analysis of risk ratios (RRs) using the Mantel-Haenszel method were performed. The quality of the evidence was assessed using GRADE.; Results: Meta-analyses of three RCTs (n=1280) showed no differences in 'ongoing pregnancy' (RR 1.78, 95% CI 0.38 to 8.36), 'haemorrhage requiring transfusion or ≥500 mL blood loss' (RR 0.11, 95% CI 0.01 to 2.03) and 'incomplete abortion with the need for surgical intervention' (RR 1.30, 95% CI 0.76 to 2.25) between the interventions. Individual study results showed no difference in patient satisfaction, or 'need for repeat misoprostol', although 'time to onset of bleeding or cramping' was longer after simultaneous than interval administration. The quality of evidence was very low to moderate.; Conclusion: The published data support the use of simultaneous mifepristone and misoprostol for medical abortion up to 9 +0 weeks in women who prefer this method of administration.; Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Schnack Tine, H. (2021). "FRAGINOC Study: screening and Geriatric Assessment and Intervention in Older Patients With Epithelial Ovarian Cancer." PROSPERO International prospective register of systematic reviews.
	Introduction Several studies have shown that a high percentage of patients with epithelial ovarian cancer (EOC) are undertreated due to their age, even in the absence of comorbidity. On the other hand, there seems to exist a group of frail patients unfit for extensive treatment that are over‐treated. Therefore, it is of great interest to identify the group of older patients with EOC, who are frail and would benefit of a comprehensive geriatric assessment and optimisation, including individualised physical training. Unfortunately, no specific screening tool can be recommended or discouraged, and none of these tests are validated in patients with EOC. Immunodeficiency and biomarkers regarding nutritional status, strength, and general health are not part of the standard evaluation, although several studies have shown a correlation between these factors and the functional independence of older patients, comorbidity, postoperative complications, tolerance to chemotherapy and quality of life. In oncologic geriatrics a Comprehensive Geriatric Assessment (CGA ‐ an examination performed by an interdisciplinary geriatric team) can be performed before start of treatment. Unfortunately, a complete CGA is both time and resource consuming, and the impact of interventions in older patients with EOC has never been examined. Hypothesis and purpose Our hypothesis is that frail patients with advanced ovarian cancer can benefit from a geriatric assessment and optimization, including physical training, increasing their chances of referral to surgery and to get full oncological treatment. The investigators believe that it is possible to develop a frailty screening tool with highly improved accuracy by combining known frailty screening tests, functional tests, and relevant biomarkers, which can help us select those patients who will benefit from a geriatric assessment and intervention. The clinical study is parceled out in two working projects, WP1 and WP2, which are anchored at the departments of gynecology, geriatric medicine, and oncology at several centers in Denmark. ‐ WP1: Geriatric assessment and intervention and its impact on treatment outcomes examined in a cohort of older patients with EOC referred to NACT Primary endpoint: To determine whether a CGA and tailored intervention vs. standard of care can increase the proportion of patients referred to IDS. Secondary endpoints are a)to evaluate whether a CGA and tailored intervention can improve completion of chemotherapy, b) to investigate if CGA and a tailored intervention with physical training vs. standard of care improves treatment outcome and quality of life. ‐ WP2: Impact of biomarkers, functional tests and immunological profile in assessing frailty and as predictors of adverse treatment outcomes in a national cohort of older EOC patients. Primary endpoint: to examine the performance of three validated frailty screening tests (G8, mG8, and Clinical Frailty Index (CFI)) in EOC patients in predicting impairments in CGA. Secondary endpoints are a)to examine whether adding functional tests, biomarkers, and the immunological profile can improve the accuracy of the frailty screening tests b) to examine whether the screening tool is predictive of patients achieving radical surgery and completing oncological treatment, as well as predict adverse treatment outcomes Method description The FRAGINOC project is a multicenter study, where WP1 is a clinical randomized trial of screening and intervention in older patients (≥70 years) with a diagnose of advanced EOC (FIGO stage III‐IV). WP2 is a prospective observational study, where patients from WP1 will be asked to participate. Furthermore, older patients (≥70 years) referred to PDS or palliation will also be included. Patients will be evaluated at MDT conference, where they will be referred to either PDS and chemotherapy or NACT or palliation. Those referred to NACT will be re‐evaluated at a second MDT conference after three cycles of chemotherapy to decide whether they can be referred to IDS. Screening All included patie s will be screened for frailty after the MDT conference using a combination of the following tools: ‐ Questionnaires (Geriatric‐8, modified Geriatric‐8 and clinical frailty scale). ‐ Functional tests (hand grip test, 30 second chair test and 6 minutes walk test) ‐ Blood samples, which have all been validated previously although in other cancer types. These tests will be repeated after the second MDT conference (after 3rd cycle of chemotherapy or before interval surgery) Randomization and Intervention After the initial frailty screening, patients eligible for primary chemotherapy will be randomized 1:1 to CGA and tailored intervention or standard of care. The intervention group will be evaluated by a geriatric specialist team examining different domains of their health status with the help of different validated questionnaires and tests, and tailored interventions will be made according to identified needs in the assessed health domains following the geriatric evaluation. The intervention will specifically include a tailored‐made physiotherapy training program of around 9‐12 weeks duration, available in both physical and virtual versions. The program consists on supervised resistance training two days a week, either at hospital appointments or virtually from the patients' own home. Those patients who are not able to make the virtual training will be followed up by phone twice a week by the physiotherapist. Additionally, the training will be supported by a progressive walking program measured with a Garmin Vivofit 4 activity tracker. Patients will be thoroughly assessed by a physiotherapist during the training process. Nutritional supplements and advice on sufficient nutrition will be provided according to current clinical guidelines. Patient‐reported outcomes Measures (PROMs) All patients will be asked to complete the European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire ‐ Ovarian Cancer Module (EORTC QLQ C‐30, QLQ‐OV28) and the supplemental Elderly Cancer Patients Module questionnaire (ELD‐14), as well as European Quality of Life‐ 5 dimensions‐ 5 levels questionnaire (EQ‐5D‐5L for cost‐utility analysis, at inclusion, after three cycles of chemotherapy, and at the end of treatment. When assessing the quality of recovery, the QoR‐15 questionnaire will be used and evaluated before surgery and 72 hours after PDS or IDS. Statistical plan/recruitment consideration According to the literature and clinical experience, increasing the number of patients who receive surgery from the present 57 % to 77 % is clinically relevant and possible. To detect a difference of 20 % and obtain a type I error rate of 5% and a power of 80%, a sample size of 86 patients per study arm will be needed. To account for an expected dropout rate of 20%, it was decided to increase this number to a group size of 100. Thus, a total of 206 patients referred to NACT will be included in the study (WP1 only). Patients referred to PDS will be followed in an observational design. For the last three years, 130 patients fulfilling the inclusion criteria have been treated at RH, OUH, HUH, and SUH each year. Thus, inclusion is expected to run over 2‐3 years. Data will be collected prospectively (demographic, clinical, pathologic, and results from frailty screening, functional tests, blood tests, and intervention effects), and recorded in predesigned RedCap. PRO will be completed by the patients either electronically and registered directly in RedCap, by phone calls or delivered in hand to the Ph.D. student or research nurses. Life‐long follow‐up data on overall survival will be obtained from the Danish Hospital Registry through linkage with a personal identification number. Logistic regression will be used to evaluate change over time in ordinal categorical values. Independent T‐tests will be used to evaluate in‐group and between‐groups differences. Kaplan‐Meier method and Cox regression analyses will be used to analyze Progression Free Survival.

Schoenmakers, S. (2023). "Innovation for Small-scale Experiments: receptIVFity Test." ClinicalTrials.gov.
	The ReceptIVFity acts as a timing‐tool for prediction of optimal pregnancy chances and provides insight into the patient's current (two months after sampling) success rate of an IVF/IVF‐ICSI treatment. Benefits of physician decision treatment in case of an unfavorable vaginal profile and a low chance of achieving a pregnancy include reducing unnecessary morbidity and treatment cycles, stress and disappointment, while increasing efficacy of the treatment and lowering the costs needed to achieve a pregnancy. The goal of this prospective, clinical non‐invasive randomized controlled study, with an additional observational study arm (for women of non‐European origin) in naïve IVF or IVF/ICSI patients is to evaluate the efficiency of Shared Decision Making compared to Physician Decision in terms of 1. the success probability of an IVF cycle, 2. the proportion of women with a successful pregnancy 3. the number of unsuccessful IVF cycles. Randomization component Women of European origin will be randomized 1:1 to either the shared decision group or the physician decision group. All women of European origin may undergo one to three cycles of IVF/IVF‐ICSI reimbursed by the health insurance. The follow‐up ends after the outcome of the last of these cycles has been determined. The desired outcome of the IVF or IVF/ICSI treatment is a successful pregnancy, i.e., a pregnancy with a heart‐beat at 12 weeks of gestation. Observational component Women of non‐European origin are invited to take part in an observational component of this study. Without further evaluation of the results of their vaginal microbiome, they will continue with the IVF/IVF‐ICSI cycle. Women eligible for participation are naïve patients and the follow‐up ends after the outcome of the first IVF/IVF‐ICSI cycle has been determined.

Schöttker, B. (2023). "Optimization of polypharmacy in geriatric oncology." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group 1: Comprehensive medication review with the 4th edition of the FORTA list of 2021 Group 2: Usual care CONDITION: ; C15‐C26 ; C50 ; C51‐C58 ; C81‐C96 ; C33 ; C34 ; C43 ; C61 ; C64 ; C67 C15‐C26 C51‐C58 C81‐C96 Malignant melanoma of skin Malignant neoplasm of bladder Malignant neoplasm of breast Malignant neoplasm of bronchus and lung Malignant neoplasm of kidney, except renal pelvis Malignant neoplasm of prostate Malignant neoplasm of trachea Malignant neoplasms of digestive organs Malignant neoplasms of female genital organs Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue PRIMARY OUTCOME: Change in global quality of life (assessed by the European Organisation for Research and Treatment of Cancer’s Quality of Life Questionnaire’s Core 30 items (EORTC QLQ‐C30) global health status (GHS)/quality of life score) from start of in‐patient rehabilitation to 8‐month follow‐up SECONDARY OUTCOME: • Medication quality (Total FORTA score and sub‐scores for medication underuse, medication overuse and potentially inappropriate medication use) ; • Global, domain‐specific and symptom‐related quality of life (All EORTC QLQ‐C30 scores) ; • Fatigue (Physical, emotional and cognitive fatigue as well as interference of fatigue with daily life (assessed with the EORTC Fatigue Questionnaire with 12 items (EORTC‐FA12)) ; • Frailty (assessed by FRAIL‐Scale) ; • Dizziness (self‐developed question) ; • Falls (self‐developed question) ; • Hospitalizations (self‐developed question) ; • Cancer mortality (ICD‐10 code C00‐C97), non‐cancer mortality and all‐cause mortality (assessed by register matching for up to 10 years) INCLUSION CRITERIA: • Diagnosis or recurrence requiring treatment of one of 22 frequent cancers (see chapter „Health condition“ for complete list) in last 5 years • Exposure to polypharmacy, defined as = 5 chronically, concurrently used active substances • At least 3 weeks of in‐patient rehabilitation in a cooperating clinic are planned • Sufficient capabilities for informed consent

Schroeder, T. (2022). "The Role of Transcutaneous Electrical Nerve Stimulation (TENS) for Menstrual Pain Relief." ClinicalTrials.gov.
	No Results Available Device: One Unit TENS|Device: Two Unit TENS Analgesic effects of TENS on primary dysmenorrhea.|Change in analgesic pill consumption during menstruation Female Not Applicable 44 Other Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment HS-21-00629 May 1, 2023

Schroll Jeppe, B., et al. (2023). "Combined oral contraceptive pill for primary dysmenorrhoea." The Cochrane Database of Systematic Reviews 7: CD002120.
	Background: Dysmenorrhoea (painful menstrual cramps) is common and a major cause of pain in women. Combined oral contraceptives (OCPs) are often used in the management of primary dysmenorrhoea, but there is a need for reporting the benefits and harms. Primary dysmenorrhoea is defined as painful menstrual cramps without pelvic pathology.; Objectives: To evaluate the benefits and harms of combined oral contraceptive pills for the management of primary dysmenorrhoea.; Search Methods: We used standard, extensive Cochrane search methods. The latest search date 28 March 2023.; Selection Criteria: We included randomised controlled trials (RCTs) comparing all combined OCPs with other combined OCPs, placebo, or management with non-steroidal anti-inflammatory drugs (NSAIDs). Participants had to have primary dysmenorrhoea, diagnosed by ruling out pelvic pathology through pelvic examination or ultrasound.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. The primary outcomes were pain score after treatment, improvement in pain, and adverse events.; Main Results: We included 21 RCTs (3723 women). Eleven RCTs compared combined OCP with placebo, eight compared different dosages of combined OCP, one compared two OCP regimens with placebo, and one compared OCP with NSAIDs. OCP versus placebo or no treatment OCPs reduce pain in women with dysmenorrhoea more effectively than placebo. Six studies reported treatment effects on different scales; the result can be interpreted as a moderate reduction in pain (standardised mean difference (SMD) -0.58, 95% confidence interval (CI) -0.74 to -0.41; I² = 28%; 6 RCTs, 588 women; high-quality evidence). Six studies also reported pain improvement as a dichotomous outcome (risk ratio (RR) 1.65, 95% CI 1.29 to 2.10; I² = 69%; 6 RCTs, 717 women; low-quality evidence). The data suggest that in women with a 28% chance of improvement in pain with placebo or no treatment, the improvement in women using combined OCP will be between 37% and 60%. Compared to placebo or no treatment, OCPs probably increase the risk of any adverse events (RR 1.31, 95% CI 1.20 to 1.43; I² = 79%; 7 RCTs, 1025 women; moderate-quality evidence), and may also increase the risk of serious adverse events (RR 1.77, 95% CI 0.49 to 6.43; I² = 22%; 4 RCTs, 512 women; low-quality evidence). Women who received OCPs had an increased risk of irregular bleeding compared to women who received placebo or no treatment (RR 2.63, 95% CI 2.11 to 3.28; I² = 29%; 7 RCTs, 1025 women; high-quality evidence). In women with a risk of irregular bleeding of 18% if using placebo or no treatment, the risk would be between 39% and 60% if using combined OCP. OCPs probably increase the risk of headaches (RR 1.51, 95% CI 1.11 to 2.04; I² = 44%; 5 RCTs, 656 women; moderate-quality evidence), and nausea (RR 1.64, 95% CI 1.17 to 2.30; I² = 39%; 8 RCTs, 948 women; moderate-quality evidence). We are uncertain of the effect of OCP on weight gain (RR 1.83, 95% CI 0.75 to 4.45; 1 RCT, 76 women; low-quality evidence). OCPs may slightly reduce requirements for additional medication (RR 0.63, 95% CI 0.40 to 0.98; I² = 0%; 2 RCTs, 163 women; low-quality evidence), and absence from work (RR 0.63, 95% CI 0.41 to 0.97; I² = 0%; 2 RCTs, 148 women; low-quality evidence). One OCP versus another OCP Continuous use of OCPs (no pause or inactive tablets after the usual 21 days of hormone pills) may reduce pain in women with dysmenorrhoea more effectively than the standard regimen (SMD -0.73, 95% CI -1.13 to 0.34; 2 RCTs, 106 women; low-quality evidence). There was insufficient evidence to determine if there was a difference in pain improvement between ethinylestradiol 20 μg and ethinylestradiol 30 μg OCPs (RR 1.06, 95% CI 0.65 to 1.74; 1 RCT, 326 women; moderate-quality evidence). There is probably little or no difference between third- and fourth-generation and first- and second-generation OCPs (RR 0.99, 95% CI 0.93 to 1.05; 1 RCT, 178 women; moderate-quality evidence). The standard regimen of OCPs may slightly increase e risk of any adverse events over the continuous regimen (RR 1.11, 95% CI 1.01 to 1.22; I² = 76%; 3 RCTs, 602 women; low-quality evidence), and probably increases the risk of irregular bleeding (RR 1.38, 95% CI 1.14 to 1.69; 2 RCTs, 379 women; moderate-quality evidence). Due to lack of studies, it is uncertain if there is a difference between continuous and standard regimen OCPs in serious adverse events (RR 0.34, 95% CI 0.01 to 8.24; 1 RCT, 212 women), headaches (RR 0.94, 95% CI 0.50 to 1.76; I² = 0%; 2 RCTs, 435 women), or nausea (RR 1.08, 95% CI 0.51 to 2.30; I² = 23%; 2 RCTs, 435 women) (all very low-quality evidence). We are uncertain if one type of OCP reduces absence from work more than the other (RR 1.12, 95% CI 0.64 to 1.99; 1 RCT, 445 women; very low-quality evidence). OCPs versus NSAIDs There were insufficient data to determine whether OCPs were more effective than NSAIDs for pain (mean difference -0.30, 95% CI -5.43 to 4.83; 1 RCT, 91 women; low-quality evidence). The study did not report on adverse events.; Authors' Conclusions: OCPs are effective for treating dysmenorrhoea, but they cause irregular bleeding, and probably headache and nausea. Long-term effects were not covered in this review. Continuous use of OCPs was probably more effective than the standard regimen but safety should be ensured with long-term data. Due to lack of data, we are uncertain whether NSAIDs are better than OCPs for treating dysmenorrhoea. (Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Schubert, K., et al. (2022). "Internet-based cognitive behavioral therapy for improving health-related quality of life in patients with endometriosis: study protocol for a randomized controlled trial." Trials 23(1): 300.
	Background: The trial investigates the efficacy of internet-based cognitive behavioral therapy (iCBT) in improving health-related QoL in patients with endometriosis, which is a chronic gynecological condition affecting up to 15% of people with female-assigned reproductive organs. Endometriosis is stress-related and comes with various physical symptoms such as pelvic pain and infertility. It has a substantial impact on health-related quality of life (QoL), and mind-body interventions seem promising in reducing the psychological burden.; Methods: This is a monocentric randomized-controlled trial recruiting 120 patients with endometriosis. The intervention consists of eight iCBT modules focusing on psychoeducation, cognitive restructuring, pacing, and emotion regulation. Participants will receive written feedback from a trained therapist weekly. The comparator is a waitlist control group. All participants will be followed up 3 months after the intervention, and the intervention group will additionally be followed up 12 months after the intervention. Trial participants will not be blinded to the allocated trial arm. Primary outcome measures are endometriosis-related QoL, pain, and pain-related disability. Secondary outcomes include coping, illness representations, and psychological flexibility. Statistical analyses will be performed following intention-to-treat principles.; Discussion: This randomized-controlled trial is the first trial to test the efficacy of iCBT for improving endometriosis-related QoL. Potential predictor variables and key mechanisms in treatment will be investigated to enable further progression in medical and psychological care for patients with endometriosis.; Trial Registration: ClinicalTrials.gov , NCT05098444 Registered on October 28, 2021. (© 2022. The Author(s).)

Schulz, H. (2024). "Exercise and Nutrition Intervention in Ovarian Cancer." ClinicalTrials.gov.
	No Results Available Behavioral: combined exercise and nutrition intervention 6 Minute Walk Test (distance in metre)|Global physical activity questionnaire (GPAQ)|Assessment of body composition using bioelectrical impedance analysis (BIA)|Grip force dynamometer|Polyneuropathy; item derived from EORTC CIPN20 (Item 9)|Patient Health Questionnaire-9 (PHQ-9)|Generalized Anxiety Disorder using GAD-2|Adherence to a Mediterranean diet (MEDAS)|EORTC QLQ-C30|EORTC OV-28|EORT FA-12|Nutritional Risk Screening (NRS 2002)|Brief Social Support Scale (BS6)|Patient Activation Measure (PAM-13) Female Not Applicable 185 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Investigator, Outcomes Assessor)|Primary Purpose: Supportive Care BENITA December 31, 2025

Schutte, T., et al. (2023). "Clinical development of WEE1 inhibitors in gynecological cancers: A systematic review." Cancer Treatment Reviews 115: 102531.
	Introduction: The anti-tumor activity of WEE1 inhibitors (WEE1i) in gynecological malignancies has recently been demonstrated in clinical trials and its rationale is based on biological/molecular features of gynecological cancers. With this systematic review, we aim to outline the clinical development and current evidence regarding the efficacy and safety of these targeted agents in in this patient group.; Methods: Systematic literature review of trials including patients with gynecological cancers treated with a WEE1i. The primary objective was to summarize the efficacy of WEE1i in gynecological malignancies regarding objective response rate (ORR), clinical benefit rate (CBR), overall survival (OS) and progression-free survival (PFS). Secondary objectives included toxicity profile, Maximum Tolerated Dose (MTD), pharmacokinetics, drug-drug interactions and exploratory objectives such as biomarkers for response.; Results: 26 records were included for data extraction. Almost all trials used the first-in-class WEE1i adavosertib; one conference abstract reported about Zn-c3. The majority of the trials included diverse solid tumors (n = 16). Six records reported efficacy results of WEE1i in gynecological malignancies (n = 6). Objective response rates of adavosertib monotherapy or in combination with chemotherapy ranged between 23% and 43% in these trials. Median PFS ranged from 3.0 to 9.9 months. The most common adverse events were bone marrow suppression, gastrointestinal toxicities and fatigue. Mainly alterations in cell cycle regulator genes TP53 and CCNE1 were potential predictors of response.; Conclusion: This report summarizes encouraging clinical development of WEE1i in gynecological cancers and considers its application in future studies. Biomarker-driven patient selection might be essential to increase the response rates.; Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be seen as a potential conflict of interest to the presented work. Each author provided a detailed conflict of interest statement according to the Journals policy. N Steeghs received research grants (All outside the submitted work, all payment to the Netherlands Cancer Institute) from: Abbvie, Actuate Therapeutics, Amgen, Array, Ascendis Pharma, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim, BridgeBio, Bristol-Myers Squibb, Cantargia, CellCentric, Cogent Biosciences, Cresecendo Biologics, Cytovation, Deciphera, Dragonfly, Eli Lilly, Exelixis, Genentech, GlaxoSmithKline, IDRx, Immunocore, Incyte, InteRNA, Janssen, Kinnate Biopharma, Kling Biotherapeutics, Luszana, Merck, Merck Sharp & Dohme, Merus, Molecular Partners, Navire Pharma, Novartis, Numab Therapeutics, Pfizer, Relay Pharmaceuticals, Revolution Medicin, Roche, Sanofi, Seattle Genetics, Taiho, Takeda. N. Steeghs received consulting fees (All outside the submitted work, all payment to the Netherlands Cancer Institute) from Boehringer Ingelheim, Cogent Biosciences, Ellipses Pharma, Luszana. (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Schwarz Julie, K. (2022). "Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer." ClinicalTrials.gov.
	Advanced cervical cancer patients treated with standard of care (SOC) chemoradiation plus glutaminase inhibition with telaglenastat (CB‐839) will have increased progression‐free survival (PFS) compared to historical rates for patients receiving SOC chemoradiation alone.

Schwarze, J. E., et al. (2020). "Atosiban improves the outcome of embryo transfer. A systematic review and meta-analysis of randomized and non-randomized trials." Jornal Brasileiro de Reproducao Assistida 24(4): 421-427.
	Objective: To estimate the effectiveness of Atosiban in improving the outcome after embryo transfer. The effectiveness of embryo transfer per cycle is still relatively low. One possible explanation might be uterine contractility that expels the transferred embryos. Atosiban improved the outcome of embryo transfer by reducing uterine con-tractility. Method(s): Data sources: A systematic review of papers in English using MEDLINE and EMBASE (1990-2019). Search terms included Atosiban, embryo transfer. Study selection: We included studies that compared the outcomes of embryo transfer with Atosiban and a control group. Data Extracting: Independent extraction of papers by two au-thors, using predefined data fields, including study quality indicators. Result(s): All pooled analyses were based on a fixed-ef-fect model. Four randomised controlled trials, including 1,025 women, and two non-randomised trials, including 686 patients, met our inclusion criteria. In both studies, the heterogeneity was moderate. Atosiban increased clinical pregnancy rates regardless of the indication for ART or type of embryo transferred. Pooled OR in randomized controlled trials reached 1.47 (1.18-1.82), and in non-ran-domised controlled trials it reached 1.50 (95% CI 1.10-2.05) Conclusion(s): Atosiban appears to increase the clinical pregnancy rates in women undergoing embryo transfer.Copyright © 2020, Sociedade Brasileira de Reproducao Assistida. All rights reserved.

Schwarze, J. E., et al. (2022). "Originator recombinant human follitropin alfa versus recombinant human follitropin alfa biosimilars in Spain: A cost-effectiveness analysis of assisted reproductive technology related to fresh embryo transfers." Best Practice and Research: Clinical Obstetrics and Gynaecology 85: 203-216.
	This study compared the cost per live birth and cost-effectiveness of the originator recombinant human follicle-stimulating hormone follitropin alfa (r-hFSH-alfa) and r-hFSH-alfa biosimilars for ovarian stimulation prior to assisted reproductive technology treatment in Spain. A decision tree model was developed, comprising pregnancy and live birth for one treatment cycle with fresh embryo transfer. Clinical inputs were based on a recent meta-analysis by Chua et al. [4]. Cost inputs were extracted from publicly available Spanish sources. The costs per live birth were lower with originator r-hFSH-alfa (18,138) versus r-hFSH-alfa biosimilars (20,377). The incremental cost-effectiveness ratio was 7208 for originator r-hFSH-alfa versus biosimilars. Drug acquisition costs for originator r-hFSH-alfa represented 10.5% of total costs in the base case analysis, and 6.2% in a treatment cycle resulting in live birth with one fresh embryo transfer. Results from the sensitivity analyses confirmed the robustness of the findings.Copyright © 2022 The Authors

Schwebke Jane, R., et al. (2022). "Ibrexafungerp Versus Placebo for Vulvovaginal Candidiasis Treatment: A Phase 3, Randomized, Controlled Superiority Trial (VANISH 303)." Clinical Infectious Diseases 74(11): 1979-1985.
	Background: Current treatment of vulvovaginal candidiasis (VVC) is largely limited to azole therapy. Ibrexafungerp is a first-in-class triterpenoid antifungal with broad-spectrum anti-Candida fungicidal activity. The objective of this study was to evaluate the efficacy and safety of ibrexafungerp compared with placebo in patients with acute VVC.; Methods: Patients were randomly assigned 2:1 to receive ibrexafungerp (300 mg twice for 1 day) or placebo. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms [VSS] = 0) at test-of-cure (day 11 ± 3). Secondary endpoints included the percentage of patients with mycological eradication, overall success (clinical cure and mycological eradication), clinical improvement (VSS ≤ 1) at test-of-cure, and symptom resolution at follow-up (day 25 ± 4).; Results: Patients receiving ibrexafungerp had significantly higher rates of clinical cure (50.5% [95/188] vs 28.6% [28/98]; P = .001), mycological eradication (49.5% [93/188] vs 19.4% [19/98]; P < .001), and overall success (36.0% [64/178] vs 12.6% [12/95]; P < .001) compared with placebo. Symptom resolution was sustained and further increased with ibrexafungerp compared with placebo (59.6% [112/188] vs 44.9% [44/98]; P = .009) at follow-up. Post hoc analysis showed similar rates of clinical cure and clinical improvement at test-of-cure for Black patients (54.8% [40/73] and 63.4% [47/73], respectively) and patients with a body mass index >35 (54.5% [24/44] and 68.2% [30/44], respectively) compared with overall rates. Ibrexafungerp was well tolerated. Adverse events were primarily gastrointestinal and mild in severity.; Conclusions: Ibrexafungerp provides a promising safe and efficacious oral treatment that mechanistically differs from current azole treatment options for acute VVC. (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America.)

Schwebke, J. R., et al. (2021). "A phase 3, randomized, controlled trial of Astodrimer 1% Gel for preventing recurrent bacterial vaginosis." European Journal of Obstetrics & Gynecology and Reproductive Biology: X 10: 100121.
	OBJECTIVE: The objective of the study was to confirm the efficacy and safety of Astodrimer 1% Gel to prevent recurrence of bacterial vaginosis. STUDY DESIGN: 864 women with a diagnosis of bacterial vaginosis and a history of recurrent bacterial vaginosis were enrolled in North America and first received oral metronidazole (500 mg twice daily for 7 days). Women successfully treated with metronidazole were randomly assigned 1:1 to Astodrimer 1% Gel (N = 295) or placebo (N = 291) at a dose of 5 g vaginally every second day for 16 weeks, and followed for a further 12 weeks off-treatment. The primary endpoint was recurrence of bacterial vaginosis (presence of ≥3 Amsel criteria) at or by Week 16. Secondary endpoints included time to recurrence, and recurrence of subject-reported symptoms. Adverse events were monitored throughout the study. RESULTS: Astodrimer 1% Gel was superior to placebo for the primary and many secondary efficacy measures. At or by Week 16, bacterial vaginosis recurred in 44.2 % (130/294) of women receiving astodrimer and 54.3 % (158/291) receiving placebo (P = .015). Time to recurrence of bacterial vaginosis was significantly longer for women receiving astodrimer compared with placebo (Kaplan-Meier survival curves, P = .007). Recurrence of subject-reported symptoms at or by Week 16 was also significantly lower in the astodrimer arm compared with placebo (vaginal odor and/or discharge, 27.9 % [75/269] vs 40.6 % [108/266], P = .002). A significantly lower proportion of patients receiving astodrimer compared with placebo had recurrence of bacterial vaginosis at or by Week 16 by other secondary measures, including individual Amsel criteria (vaginal discharge and clue cells) and Nugent score 7-10. Recurrence of subject-reported vaginal odor and/or discharge was significantly lower in the astodrimer arm compared with placebo up to 8 weeks after cessation of therapy (36.1 % [97/269] vs 45.5 % [121/266], P = .027).Adverse events were infrequent, and rates were generally similar between placebo and astodrimer groups. Vulvovaginal candidiasis and urinary tract infection occurred more often in women receiving astodrimer. CONCLUSIONS: Astodrimer 1% Gel, administered every second day for 16 weeks, was effective and superior to placebo for prevention of recurrent bacterial vaginosis in women with a history of recurrent BV, and was well-tolerated.

Schwerla, F. (2023). "Effectiveness of osteopathic treatment complementary to current therapy (usual care) on the impairment of quality of life in women with primary dysmenorrhea." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Group 1: 5 osteopathic treatments at intervals of 2 weeks + usual care Group 2: Usual care Patients receive the usual conventional medical therapy for this clinical picture, which is usually referred to as "usual care". It is not usually prescribed exactly which therapy this is. The patients in the control group remain untreated until the 4th cycle (waiting period). Only then do they also receive 5 osteopathic treatments. CONDITION: ; N94.4 N94.4 Primary dysmenorrhoea PRIMARY OUTCOME: Impairment of quality of life due to primary dysmenorrhea measured with the Numerical Rating Scale (NRS; e.g., 0 = no impairment to 10 = maximum impairment), retrospectively for menstruation from cycle 1 ‐ 10. (End of study cycle 4, 1st follow‐up cycle 7, 2nd follow‐up cycle 10). SECONDARY OUTCOME: The intensity of pain and the intensity of menstruation will also be asked in the menstrual diary, which is to be kept throughout the study, using a numerical rating scale NRS, as well as the use of medication. The general quality of life is assessed using the generic SF‐36 questionnaire. Side effects and osteopathic dysfunctions are recorded ; INCLUSION CRITERIA: a) Menstruation present b) Regular cycle (between 21 and 35 days). c) There must be a gynecological specialist diagnosis of primary dysmenorrhea. This must be evidenced by a written certificate. (d) Pain intensity =5 days (NRS) on at least one day of menstruation of the baseline cycle. (e) A written informed consent form must be signed. In the case of minors, the signature of a legal guardian is also required f) Sufficient knowledge of the German language

Seagen, I. (2021). "Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer." ClinicalTrials.gov.
	This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.

Seino, H. (2021). "A randomized controlled trial of brief interpersonal psychotherapy for Japanese women with perinatal depression." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Brief Interpersonal Psychotherapy Treatment as usual CONDITION: Depression PRIMARY OUTCOME: Edinburgh Postnatal Depression Scale SECONDARY OUTCOME: Patient Health Questionnaire‐9,Hospital Anxiety and Depression Scale, Self‐rating Depression Scale, Rate of Depression diagnosis INCLUSION CRITERIA:

Selda, K. (2023). "MOPEXE and RE in Treating Dysmenorrhea." ClinicalTrials.gov.
	No Results Available Other: MOPEX Exercise|Other: Relaxation Exercise|Other: Combine Exercise Visual Analogue Scale|McGill pain questionnaire- short form|Menstruation attitude scale (MBI)|Functional and emotional dysmenorrhea scale (FEDS) Female Not Applicable 60 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment UskudarU65 November 1, 2023

Seli Emre, U. (2023). "PRogrammed Versus Modified Natural Cycle After Euploid Failed Embryo Transfer." ClinicalTrials.gov.
	No Results Available Other: FET Protocol Sustained implantation rate|Biochemical Pregnancy Rate|Biochemical pregnancy loss rate|Clinical Pregnancy Rate|Clinical Pregnancy Loss Rate|Live Birth Rate|Rate of pregnancies of undetermined location and ectopic pregnancies|Rate of maternal obstetrical outcomes and complications|Rate of neonatal outcomes and complications|Elastography Data Female Not Applicable 780 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 2302-BRG-024-ES August 2026

Selina, D., et al. (2022). "Biopsychosocial approaches for the management of female chronic pelvic pain- a systematic review." PROSPERO International prospective register of systematic reviews.
	
Seo, J., et al. (2020). "Dangguijagyag-san for primary dysmenorrhea: A PRISMA-compliant systematic review and meta-analysis of randomized-controlled trials." Medicine 99(42): e22761.
	Background: This systematic review and meta-analysis aim to assess the effectiveness of Dangguijagyag-san (DJS) for primary dysmenorrhea (PD) and to update the previous reviews.; Methods: We searched for randomized controlled trials (RCTs) of DJS for PD from inception to April 2019. The search databases were the PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Oriental Medicine Advanced Searching Integrated System, Korean Traditional Knowledge Portal, Korean Medical Database, National Digital Science Library, and the China National Knowledge Infrastructure. The selection of studies, the extraction of data, and the quality assessment with risk of bias tool were performed by 2 authors independently. To analyze the data, the meta-analysis was conducted and qualitative analysis was also performed.; Results: Total 2766 studies were identified, and 14 RCTs were enrolled in this review. According to the type of interventions, the analysis was performed in 4 groups. In comparison to western medication, DJS showed a higher total effective rate (TER) (RR 1.16, 95% CI 1.08-1.24) and a higher effect in reducing the pain (MD = -0.86, 95% CI -1.56--0.16). Compared with placebo, DJS was superior to placebo in reducing pain (MD = -1.1, 95% CI -2.04 --0.16) and also in reducing the consumption of the rescue medication during menstrual period (MD = -2.3, 95% CI -3.58--1.02). Compared with other herbal medicines, the subgroup analysis showed that DJS applied with PD of differentiated patterns had a higher total effective rate (TER) (RR 1.21, 95% CI 1.03-1.43, P=.02). DJS with moxibustion as an adjuvant therapy was also more effective than western medication (RR 1.47, 95% CI 1.23-1.76).; Conclusion: DJS may be effective for the treatment of PD. However, the quality of the evidence is relatively low, so larger-scale and well-designed RCTs are needed to confirm the effects of DJS.; Systematic Review Registration: PROSPERO registration number is CRD42019130768.

Seol, A., et al. (2020). "Effect of luteal phase support with vaginal progesterone on pregnancy outcomes in natural frozen embryo transfer cycles: A meta-analysis." Clinical and Experimental Reproductive Medicine 47(2): 147-152.
	Objective: The purpose of this study was to determine the effect of vaginal progesterone for luteal phase support (LPS) on the clinical pregnancy rate (CPR) in natural frozen embryo transfer (FET) cycles via a meta-analysis.; Methods: We performed a meta-analysis of randomized controlled trials (RCTs) and retrospective studies that met our selection criteria. Four online databases (PubMed, Embase, Medline, and the Cochrane Library) were searched between January 2017 and May 2017. Studies were selected according to predefined inclusion criteria and meta-analyzed using R software version 2.14.2. The main outcome measure was CPR.; Results: A total of 18 studies were reviewed and assessed for eligibility. One RCT (n=435) and three retrospective studies (n=3,033) met the selection criteria. In a meta-analysis of the selected studies, we found no significant difference in the CPR (odds ratio [OR], 0.96; 95% confidence interval [CI], 0.60-1.55) between the vaginal progesterone and control groups. An analysis of the two retrospective cohort studies that reported the live birth rate (LBR) following FET showed a significantly higher LBR in the vaginal progesterone group (OR, 1.72; 95% CI, 1.21-2.46). A subgroup meta-analysis of FET conducted 5 days after injection of human chorionic gonadotropin showed no significant differences between the two groups with regard to the CPR (OR, 1.18; 95% CI, 0.90-1.55) or miscarriage rate (OR, 0.73; 95% CI, 0.36-1.47).; Conclusion: The results of this meta-analysis of the currently available literature suggest that LPS with vaginal progesterone in natural FET cycles does not improve the CPR.

Sevgi, P. Ç. (2021). "Effect of Hegu Point Ice Massage and Music in Dysmenorrhea." ClinicalTrials.gov.
	No Results Available Behavioral: ice massage|Behavioral: music medicine Questions about the menstrual characteristics of the students were asked using the Dysmenorrhea identification form|The intensity of pain experienced during the last menstrual period was asked using the Visual Analogue Scale (VAS|To evaluate dysmenorrhea severity using Functional and Emotional Dysmenorrhea Scale.|The Student Information Form|Description of the students' comfort level.|To evaluate assessing menstrual pain characteristics.|To evaluate the severity of pain secondary to dysmenorrhea with the Visual Analogue Scale (VAS)|To evaluate the effect of Hegu point ice massage in reducing the pain severity secondary to dysmenorrhea through a Visual Analogue Scale (VAS).|To evaluate the effect of music medicine in reducing the pain severity secondary to dysmenorrhea through a Visual Analogue Scale (VAS).|To evaluate the effect of Hegu point ice massage in increasing comfort level.|To evaluate the effect of music medicine in increasing comfort level.|To determine the level of students being affected by dysmenorrhea. Female Not Applicable 129 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention CBU-PAKİSCETİN-1 June 30, 2022

Sfakianoudis, K. (2021). "Εffectiveness of Intrauterine Antibiotic Administration for Treatment of Chronic Endometritis." ClinicalTrials.gov.
	Primary Purpose : Treatment Allocation : Non-Randomized Interventional Model : Parallel Assignment Masking : None (Open Label) Brief Summary Chronic Endometritis (CE) is related to infertility and entails a challenging management. This study investigates the treatment of off-label intrauterine antibiotic infusion either separately or combined with oral antibiotic administration, and it assesses respective performance against the gold standard treatment of oral antibiotic adminstration. Data sourced herein reports on treatment efficiency, defined as a negative diagnosis for chronic endometritis. Detailed Description An infectious endometrial environment caused by certain pathologies could compromise establishment of the initial interaction between the embryo and the endometrium. Chronic endometritis (CE) is a case of a persistent endometrial inflammation caused by infectious agents namely Escherichia Coli, Enterococcus faecalis, Streptococcus agalactiae, Mycoplasma, Ureaplasma, and Chlamydia. The perplexity of managing CE is attributed to its asymptomatic nature rendering a definitive diagnosis rather challenging. The list of potential symptoms is limited and vague while manifestation of the disease may be mild and may not correspond to severity. Symptoms include pain in the pelvic cavity, dispareunia, uterine bleeding, vaginal infections and cystitis, and mild gastro-intestinal discomfort. CE is described as a chronic disorder due to its long duration and persistent nature, with potentially slow progression and complex causality, severely compromising reproductive potential of patients. The antibiotic treatments are primarily administered orally and endometrial re-examination is performed following treatment. It should be emphasized that apart from the differences in the types of antibiotics included, there are also significant discrepancies regarding the dosage of each antibiotic and the different schemes suggested by each practice. Following the antibiotic regime, endometrial receptivity is anticipated to improve. However, a significant correlation between the antibiotic therapeutic approach and a positive results in IVF has failed to be established in literature, indicating that oral antibiotic administration is unseccessful in improving IVF outcome. A pilot study published by the investigators indicated that combination of intrauterine infusion of antibiotics and oral administration can be more effective in treating CE than solely oral administration. However, it has not been evaluated if sole intrauterine infusion of antibiotics can be of similar effectiveness when compared to the combined regime including intrauterine infusion and oral andministration, or when compared to the gold standard treatment including only oral administration of antibiotics.

Shabani, F., et al. (2022). "The effect of mindfulness training on stress and sleep quality of postmenopausal women: A systematic review and meta-analysis." Post Reproductive Health 28(4): 223-236.
	Introduction: Mindfulness is an effective method for empowering women to cope with menopausal changes. This study aimed to determine the effect of mindfulness training on stress and sleep quality in postmenopausal women.; Materials and Methods: English (PubMed, Cochrane Library, Google Scholar, Scopus, Web of Science, and CINHAL) and Persian (SID, Magiran) databases were searched until 25 June 2022, using the free and MeSH keywords included Mindfulness and Menopause. The quality of the published papers was evaluated using Cochrane Handbook for Systematic Reviews of Interventions version 5.2.0. The meta-analysis was conducted in RevMan 5.3 and the results were reported with mean difference (95% confidence interval). The quality of evidence was assessed using the GRADE approach.; Results: A total of 1206 records were obtained. After removing duplicate and non-eligible records, finally five articles were included in the systematic review and meta-analysis. The results indicated that sleep quality score (SMD = -1.44; 95% CI = -2.44 to -0.46; p = 0.004) and perceived stress score (MD = -4.21; 95% CI = -6.41 to -2.00; p = 0.0002) were significantly reduced in the mindfulness training group compared to control group.; Conclusion: Mindfulness training is associated with improving sleep quality and perceived stress (with a low quality of evidence) in postmenopausal women. Mental health and quality of life in postmenopausal women impressively affect the community health. Given the low quality of evidence of the studies in this field, randomized controlled trials with better methodologies are suggested.

Shafikka, R. and K. Maheshkumar (2023). "The efficacy of yoga in menopause: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Shah Nemi, M. (2021). "Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence." ClinicalTrials.gov.
	This is a single‐center, double‐blinded, randomized controlled trial evaluating the efficacy of TTNS versus a sham intervention. Both interventions will be performed by participants in their homes after standardized instruction. The primary outcome is a comparison of the mean change in OAB‐q scores before and after treatment between the intervention and control groups. Changes in the number of urgency incontinence episodes and an estimation of cost effectiveness will additionally be measured. Intention to treat analysis will be performed.

Shalini, C., et al. (2022). "Effect of Yoga on Anti-mullerian hormone AMH level and androgen level in female with polycystic ovarian syndrome – A Systematic Review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Shan, D., et al. (2020). "Efficacy and safety of gabapentin and pregabalin in patients with vasomotor symptoms: a systematic review and meta-analysis." American Journal of Obstetrics and Gynecology 222(6): 564.
	Objective: Vasomotor symptoms are common among postmenopausal women and patients receiving hormone deprivation therapies, and emerging studies are exploring gabapentin's and pregabalin's effects as nonhormonal treatment options. We aimed to assess the efficacy and safety of these 2 drugs.; Data Sources: Based on a preregistered protocol (Prospective Register of Systematic Reviews -CRD42019133650), we searched 10 databases (PubMed, Embase, Web of Science, PsycINFO, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, Chinese Biological Medical Literature, Chinese National Knowledge Infrastructure, Chinese Journals Full-text Database [VIP], and Wanfang) as well as the World Health Organization international clinical trials registry platform and reference lists of related literatures.; Study Eligibility Criteria: Randomized controlled trials and randomized crossover studies exploring gabapentin and pregabalin among women patients with vasomotor symptoms were included.; Study Appraisal and Synthesis Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement was followed. Two reviewers independently selected studies, assessed bias, and extracted data. Mean difference and standardized mean difference with 95% confidence intervals were assessed by random-effects models. Heterogeneities were assessed by I 2 statistics, and the quality of evidence was evaluated by the Grading of Recommendations Assessment, Development and Evaluation approach.; Results: Nineteen randomized controlled trials and 2 randomized crossover trials reporting results from 3519 participants were included. Gabapentin could reduce hot flash frequency (mean difference, -1.62, 95% confidence interval, -1.98 to -1.26 after 4 weeks; mean difference, -2.77, 95% confidence interval, -4.29 to -1.24 after 12 weeks) and composite score (standardized mean difference, -0.47, 95% confidence interval, -0.71 to -0.23 after 4 weeks; standardized mean difference, -0.77, 95% confidence interval, -1.15 to -0.40 after 12 weeks) compared with placebo. Both menopausal participants and patients with breast cancer benefited from treatment. Higher risks of dizziness and somnolence were found in the gabapentin group than in the control group (risk ratio, 4.45, 95% confidence interval, 2.50-7.94; risk ratio, 3.29, 95% confidence interval, 1.97-5.48, respectively). Estrogen was more effective in reducing hot flash frequency than gabapentin. No statistically significant difference in reduction of hot flash severity score was found between gabapentin and antidepressants. The trials comparing gabapentin or pregabalin with the other interventions were too limited to make a conclusion.; Conclusion: Favorable effects of gabapentin in relieving vasomotor symptoms were observed, compared with controls, but were less effective than those of estrogen. Evidence supporting the therapeutic effect of pregabalin is still lacking. (Copyright © 2019 Elsevier Inc. All rights reserved.)

Shan, Y., et al. (2023). "Efficacy of Probiotics in the Treatment of Adult Female Bacterial Vaginosis: A Meta-Analysis." Clinical and Experimental Obstetrics and Gynecology 50(3): A42.
	Background: The purpose of this meta-analysis was to assess the value of probiotics in the treatment of adult female bacterial vaginosis (BV). Method(s): We looked for published randomized controlled trials in PubMed, Embase and The Cochrane Library from the inception dates of the database to January 3rd, 2022. We conducted the search focusing on the treatment of adult female BV with probiotics. Two independent researchers screened the literature, evaluated the trial quality and extracted the data according to the inclusion and exclusion criteria. The primary outcome was the ratio of patients with BV with recurrence according to Nugent score 7-10 for recurrence after treatment. After heterogeneity was assessed using Review Manager 5.4 software, meta-analysis and bias assessment were performed using Stata 17.0 software. Result(s): A total of 5 articles representing 425 patients were included in this meta-analysis. Compared with antibiotics alone or antibiotics combined with a placebo, probiotics or probiotics combined with antibiotics significantly reduced the rate of recurrence at around the 30th day (risk ratio (RR) 0.11; 95 % confidence interval (CI) 0.03-0.33). However, in the analysis of heterogeneity, we found that after 30 days, the therapeutic effect of probiotics decreased with the extension of follow-up time (RR 0.50; 95% CI 0.24-1.03), (RR 1.24; 95% CI 0.88-1.76). Conclusion(s): The short-term efficacy of probiotics in the treatment of BV in adult female patients may be satisfactory, but the long-term efficacy of probiotic therapy may be suboptimal and still requires validation by further clinical trials.Copyright © 2023 The Author(s).

Shang, Y., et al. (2022). "Administration of growth hormone improves endometrial function in women undergoing in vitro fertilization: a systematic review and meta-analysis." Human Reproduction Update 28(6): 838-857.
	Background: The positive effects of growth hormone (GH) on IVF are often attributed to improvements in oocyte and embryo quality. While emerging evidence emphasizes GH-induced improvements in the endometrium, these results are controversial.; Objective and Rationale: This meta-analysis aimed to evaluate whether GH administration improved endometrial function and reproductive outcomes during IVF cycles and to thus guide clinical practice.; Search Methods: A literature search in the Cochrane Central Register of Controlled Trials, PubMed and Embase was performed through to 30 November 2021, without language restrictions. Randomized controlled trials (RCTs) evaluating the effects of GH on IVF outcomes were included. Risk of bias and quality of evidence (QoE) were assessed according to the Cochrane Collaboration's tool and the Grading of Recommendations Assessment, Development and Evaluation system. Odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CIs) were assessed by random-effects models.; Outcomes: A total of 25 trials with 2424 women were included. Seventeen RCTs with poor responders (n = 1723) showed that GH administration significantly increased endometrial thickness (EMT) (MD = 0.38, 95% CI: 0.18-0.59; moderate QoE), which contributed to an improved live birth rate (OR = 1.67, 95% CI: 1.13-2.49; very low QoE) and clinical pregnancy rate (CPR) (OR = 1.97, 95% CI: 1.43-2.72; low QoE). Subgroup analyses showed a dose- and time-dependent relationship between GH cotreatment and IVF outcomes; the optimal recommendation for improving CPR was consistent with that for EMT, rather than for oocytes and embryos. Hence, GH might improve fertility via effects on the endometrium. Administration of GH daily from the follicular phase of previous cycle until the hCG trigger with &lt; 5 IU/day led to a thicker endometrium and a greater chance of becoming pregnant, while 5-10 IU/day or administration from the luteal phase of the previous cycle until the hCG trigger resulted in higher oocyte and embryo quality. Poor responders might benefit from cotreatment with the GnRH agonist long protocol more than other stimulation protocols. Pooled data from four trials (n = 354) on women with a thin endometrium indicated that improved endometrial function might be critical for improving reproductive outcomes during GH treatment, as no improvements in embryo quality were found. GH administration not only increased EMT (MD = 1.48, 95% CI: 1.21-1.75; moderate QoE) but also promoted endometrial morphology (OR = 2.67, 95% CI: 1.36-5.23; low QoE) and perfusion (OR = 5.84, 95% CI: 1.30-26.17; low QoE), thereby improving the CPR (OR = 2.71, 95% CI: 1.69-4.34; P &lt; 0.0001; low QoE). There was insufficient evidence to reach a conclusion regarding the effects of GH in normal responders (n = 80). Due to obvious improvements in the CPR, women with a thin endometrium might be the most appropriate population to benefit from GH administration.; Wider Implications: Improving endometrial function might be another vital mechanism by which GH improves IVF outcomes. Optimal treatment should be offered to the target population according to their personal conditions and needs. The QoE was moderate to very low, due to limited sample sizes and methodological problems; thus, the results should be interpreted with caution. More rigorous RCTs with large sample sizes are needed to confirm the effects and determine optimal GH protocols. (© 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.)

Shang, Y., et al. (2021). "Dietary Modification for Reproductive Health in Women With Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis." Frontiers in Endocrinology 12: 735954.
	Objective: Diet has been reported as the first-line management of polycystic ovary syndrome (PCOS). However, the relationship between diet and fertility in PCOS is still controversial. This meta-analysis aimed to evaluate whether diet could promote reproductive health in women with PCOS while providing evidence-based nutrition advice for clinical practice.; Methods: Seven databases, including Cochrane Central Register of Controlled Trials, PubMed, Embase, Web of Science, and some Chinese database, were searched up to January 31, 2021. Randomized controlled trials evaluating the effects of diet in women with PCOS were included. Based on a preregistered protocol (PROSPERO CRD42019140454), the systematic review was performed following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Two reviewers made study selection, data extraction and bias assessment independently. Risk ratios and mean difference with 95% confidence intervals were assessed by a random-effects model. Statistical heterogeneity within comparisons was evaluated by Cochran's Q test and quantified by the I-squared ( I 2 ) statistic.; Results: Twenty RCTs with 1113 participants were included. Results showed diet significantly related to improved fertility outcomes (increasing clinical pregnancy, ovulation and menstrual regularity rate; reducing miscarriage rate), reproductive endocrine [increasing sex hormone-binding globulin (SHBG); decreasing Anti-Müllerian Hormone (AMH), free androgen index (FAI), total testosterone (T)] and clinical hyperandrogenism (hirsutism assessed by Ferriman-Gallwey score) in PCOS. Specifically, subgroup analyses indicated low-carbohydrate diets were superior in optimizing reproductive outcomes and calorie restriction was critical in ameliorating hyperandrogenism. Additionally, the positive effects were associated with the treatment duration. The longer the duration, the greater the improvement was.; Conclusion: Overall, diet is an effective intervention for improving fertility health, thus professional and dynamic dietary advice should be offered to all PCOS patients, based on the changeable circumstances, personal needs and expectations of the individuals.; 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 Shang, Zhou, He and Lu.)

Shang, Y., et al. (2020). "Effect of Diet on Insulin Resistance in Polycystic Ovary Syndrome." The Journal of Clinical Endocrinology and Metabolism 105(10).
	Objective: The effect of diet on insulin resistance (IR) in polycystic ovary syndrome (PCOS) is controversial. Thus, we conducted this systematic review and meta-analysis to evaluate whether diet could reduce IR in women with PCOS while providing optimal and precise nutrition advice for clinical practice.; Design: The search was conducted in 8 databases through June 30, 2019. The systematic review was performed following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. A random-effects model was adopted to calculate the overall effects.; Results: A total of 19 trials (1193 participants) were included. The analysis showed that diet was significantly related to improvements in IR and body composition (eg, homeostasis model assessment of insulin resistance, fasting insulin, fasting plasma glucose, body mass index [BMI], weight, and waist circumference) in PCOS patients. The Dietary Approaches to Stop Hypertension diet and calorie-restricted diets might be the optimal choices for reducing IR and improving body composition, respectively, in the PCOS population. Additionally, the effects were associated with the course of treatment. The longer the duration, the greater the improvement was. Compared with metformin, diet was also advantageous for weight loss (including BMI and weight) and had the same effects on insulin regulation.; Conclusion: Overall, our findings suggest that diet is an effective, acceptable and safe intervention for relieving IR, and professional dietary advice should be offered to all PCOS patients. (© Endocrine Society 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Shannon, K., et al. (2023). "Additive toxicity arising from the combined use of immune checkpoint inhibitors and tyrosine kinase inhibitors in patients with renal or endometrial carcinoma: Protocol for a rapid systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Shanshan, L., et al. (2023). "Adverse events and complications after high-intensity focused ultrasound ablation for gynecological diseases: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Shantanu, J., et al. (2022). "Study of comparative effectiveness and safety of metformin, myoinositol, life style changes and herbal medicines in improving endocrine and clinical variables in management PCOS patients a systematic review and a network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Shao, F., et al. (2021). "PARP inhibitors in breast and ovarian cancer with BRCA mutations: a meta-analysis of survival." Aging 13(6): 8975-8988.
	Objective: To evaluate the efficacy of poly ADP ribose polymerase (PARP) inhibitors (PARPis) in breast and ovarian cancer with BRCA (BReast CAncer susceptibility gene) mutation (BRCAm).; Methods: We conducted a meta-analysis of randomized controlled, phase II or III trials by searching of electronic databases from inception to September 1, 2020. The efficacy of PARPis measured by hazard ratios (HRs) and 95% confidence intervals (95% CIs) for progression free survival (PFS) and overall survival (OS) of patients.; Results: By addition of PARPis to conventional therapy, breast or ovarian cancer patients carrying BRCAm significantly benefited PFS (breast cancer: HR 0.64, 95% CI=0.55-0.75, P<0.001; ovarian cancer: HR 0.33, 95% CI=0.27-0.42, P<0.001), but OS of patients did not increase significantly in these two cancer types (breast cancer: HR 0.87, 95% CI=0.76-1.01, P=0.065; ovarian cancer: HR 0.78, 95% CI=0.61-1.01, P=0.058). For ovarian cancer patients carrying BRCAm, the use of therapy with PARPis yielded longer PFS at the stage of newly diagnosed than the stage of recurrence (22.5 months vs 9.6 months).; Conclusion: PARPis were beneficial to all with BRCAm, but they were "most" beneficial to the ovarian cancer subset when administered early after diagnosis, rather than after recurrence.

Shao, W., et al. (2023). "Impact of dienogest pretreatment on IVF-ET outcomes in patients with endometriosis: a systematic review and meta-analysis." Journal of Ovarian Research 16(1): 166.
	Background: To comprehensively evaluate the influence of dienogest (DNG) versus non-DNG pretreatment on in vitro fertilization and embryo transfer (IVF-ET) outcomes for patients with endometriosis.; Methods: PubMed, Embase, Cochrane Library, Web of Science, CNKI, WanFang, and VIP were comprehensively searched for relevant publications until September 14, 2022. Primary outcomes included clinical pregnancy rate and live birth rate. Secondary outcomes included retrieved oocytes, mature oocytes, blastocysts, growing follicles, transferrable embryos, fertilization rate, implantation rate, and miscarriage rate. Subgroup analysis was performed according to different grouping methods and embryo types.; Results: Five studies of 568 females with endometriosis were involved in this systematic review and meta-analysis. DNG treatment exhibited similar effects to non-DNG treatment on either the primary or the secondary outcomes (all P > 0.05). The DNG group had a significantly greater clinical pregnancy rate than the non-hormonal treatment group (pooled relative risk [RR]: 2.055, 95% confidence interval [CI]: 1.275, 3.312, P = 0.003), and exhibited a significantly lower clinical pregnancy rate than the long gonadotropin-releasing hormone agonist (GnRH-a) group (RR: 0.542, 95%CI: 0.321, 0.916, P = 0.022). For patients undergoing fresh embryo transfer, the DNG group displayed a significantly greater clinical pregnancy rate versus the non-DNG group (pooled RR: 1.848, 95%CI: 1.234, 2.767, P = 0.003). Patients receiving DNG had a significantly greater live birth rate than those with non-hormonal treatment (pooled RR: 2.136, 95%CI: 1.223, 3.734, P = 0.008), while having a significantly lower live birth rate than the long GnRH-a group (RR: 0.441, 95%CI: 0.214, 0.907, P = 0.026). While using fresh embryos, patients with DNG treatment had an increased live birth rate, compared with those without DNG treatment (pooled RR: 2.132, 95%CI: 1.090, 4.169, P = 0.027).; Conclusion: DNG treatment may have similar effects to non-DNG treatment on IVF-ET outcomes. The clinical pregnancy rate and live birth rate after DNG treatment may be significantly higher than those after non-hormonal treatment. More evidence is warranted to corroborate these findings. (© 2023. BioMed Central Ltd., part of Springer Nature.)

Shaoyu, W., et al. (2022). "Effect of intrauterine injection of HCG before embryo transfer:a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Shapiro, B. (2023). "Lovenox With Aspirin in Thawed Blastocyst Transfer." ClinicalTrials.gov.
	This prospective randomized trial will compare outcomes in patients receiving aspirin (81mg daily) in combination with a low‐molecular weight heparin (LMWH) (enoxaparin (Lovenox®), 40mg daily subcutaneous injection) and those under this center's standard protocol receiving neither medication, in order to determine if these medications may improve success rates.

Sharangini, R. and B. Rebecca (2023). "Hormonal medical treatments, surgery, combination treatments (hormonal treatment and surgery) and non-pharmacological treatments for improving pregnancy rates in endometriosis, including recurrent and asymptomatic endometriosis." PROSPERO International prospective register of systematic reviews.
	
Shareef Mohammad, A., et al. (2022). "Effect of metformin on proliferative markers in women with endometrial carcinoma: Systematic review and meta-analysis." Turkish Journal of Obstetrics and Gynecology 19(1): 35-44.
	Objective: Endometrial carcinoma (EC) is the most common gynecologic malignancy in the USA and Western Europe. Surgery is the mainstay of both staging and treatment of EC. Fertility sparing medical therapies are often offered to young women who desire fertility. Metformin has been suggested to be an anti-cancer agent as evidenced by previous studies. It decreases Antigen Ki-67 (Ki-67) proliferation and expression which is associated with proliferative activity of malignant tumors. In this systematic review and meta-analysis, we assessed the efficacy of metformin on patients with EC.; Materials and Methods: We searched PubMed, Cochrane CENTRAL, Web of Science, and SCOPUS for relevant clinical trials and excluded observational studies. The quality appraisal was evaluated according to GRADE, and we assessed the risk of bias using Cochrane's risk of bias tool. We conducted the analysis of continuous data using mean difference (MD). We included the following outcomes: Ki-67 index, glucose, insulin, P-S6, body mass index (BMI), C-peptide, Insulin-like growth factor (IGF-1), leptin, and hemoglobin.; Results: Nine studies were eligible for our meta-analysis. We found that compared to the control group, metformin is highly effective in reducing Ki-67 proliferation and expression [MD=-10.14 (-19.10, -1.17)], (p=0.03), P-S6 [MD=-1.82 (-3.17, -0.46)], (p=0.009), plasma glucose level [MD=-1.76 (-4.88, 1.37), p=0.27], and BMI [MD=-1.07 (-1.49, -0.65)], (p<0.001).; Conclusion: We conclude that metformin administration is effective in patients with EC. It decreases Ki-67 proliferation and expression, serum glucose, and p-S6 significantly.; Competing Interests: Conflict of Interest: No conflict of interest was declared by the authors. (©Copyright 2022 by Turkish Society of Obstetrics and Gynecology Turkish Journal of Obstetrics and Gynecology published by Galenos Publishing House.)

Sharma, S., et al. (2023). "Exercise Therapy and Electrotherapy as an Intervention for Primary Dysmenorrhea: A Systematic Review and Meta-Analysis." Journal of Lifestyle Medicine 13(1): 16-26.
	Primary Dysmenorrhea (PD) is characterized by painful cramps before or during menstruation. It is generally treated with nonpharmacological methods. However, with the advancement of research and the passage of time, physiotherapy plays an increasingly important role in treating patients with PD. Electrotherapy and exercise therapy are conservative methods to treat PD. Alternative methods to minimize reliance on medicinal-based treatments are the need of the hour. This review aims to determine the efficacy of exercise-based therapies and electrotherapy modalities in treating PD. Preferred Reporting Items for Systematic Reviews and Meta-Analyses standards have been used in the present systematic review and meta-analysis. Cochrane, PubMed, and Google Scholar were searched to facilitate the same. The articles from 2011 to 2021 were included in this review. The quality of the review was assessed using the Cochrane risk of bias tool. The visual analog scale was taken as a measure of pain intensity in the meta-analysis, and other outcomes have been included in the systematic review discussed. A total of 15 publications have been included, with a meta-analysis of 7. All included studies were of high quality (PEDro ≥ 5), and demonstrated the efficacy of exercise-based therapies and electrotherapy modalities in treating pain in females with PD. This review aims to check the impact of exercise and electrotherapy in females suffering from PD.; Competing Interests: • Conflicts of Interest No conflict of interest. (© 2023 2020 Journal of Lifestyle Medicine.)

Sharpe, A., et al. (2019). "Metformin for ovulation induction (excluding gonadotrophins) in women with polycystic ovary syndrome." The Cochrane Database of Systematic Reviews 12: CD013505.
	Background: Polycystic ovary syndrome (PCOS) is characterised by infrequent or absent ovulation, and high levels of androgens and insulin (hyperinsulinaemia). Hyperinsulinaemia occurs secondary to insulin resistance and is associated with an increased biochemical risk profile for cardiovascular disease and an increased prevalence of diabetes mellitus. Insulin-sensitising agents such as metformin may be effective in treating PCOS-related anovulation. This is an update of Morley 2017 and only includes studies on metformin.; Objectives: To evaluate the effectiveness and safety of metformin in combination with or in comparison to clomiphene citrate (CC), letrozole and laparoscopic ovarian drilling (LOD) in improving reproductive outcomes and associated gastrointestinal side effects for women with PCOS undergoing ovulation induction.; Search Methods: We searched the following databases from inception to December 2018: Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL. We searched registers of ongoing trials and reference lists from relevant studies.; Selection Criteria: We included randomised controlled trials of metformin compared with placebo, no treatment, or in combination with or compared with CC, letrozole and LOD for women with PCOS subfertility.; Data Collection and Analysis: Two review authors independently assessed studies for eligibility and bias. Primary outcomes were live birth rate and gastrointestinal adverse effects. Secondary outcomes included other pregnancy outcomes and ovulation. We combined data to calculate pooled odds ratios (ORs) and 95% confidence intervals (CIs). We assessed statistical heterogeneity using the I 2 statistic and reported quality of the evidence for primary outcomes and reproductive outcomes using GRADE methodology.; Main Results: We included 41 studies (4552 women). Evidence quality ranged from very low to moderate based on GRADE assessment. Limitations were risk of bias (poor reporting of methodology and incomplete outcome data), imprecision and inconsistency. Metformin versus placebo or no treatment The evidence suggests that metformin may improve live birth rates compared with placebo (OR 1.59, 95% CI 1.00 to 2.51; I 2 = 0%; 4 studies, 435 women; low-quality evidence). For a live birth rate of 19% following placebo, the live birth rate following metformin would be between 19% and 37%. The metformin group probably experiences more gastrointestinal side effects (OR 4.00, 95% CI 2.63 to 6.09; I 2 = 39%; 7 studies, 713 women; moderate-quality evidence). With placebo, the risk of gastrointestinal side effects is 10% whereas with metformin this risk is between 22% and 40%. There are probably higher rates of clinical pregnancy (OR 1.98, 95% CI 1.47 to 2.65; I 2 = 30%; 11 studies, 1213 women; moderate-quality evidence). There may be higher rates of ovulation with metformin (OR 2.64, 95% CI 1.85 to 3.75; I 2 = 61%; 13 studies, 684 women; low-quality evidence). We are uncertain about the effect on miscarriage rates (OR 1.08, 95% CI 0.50 to 2.35; I 2 = 0%; 4 studies, 748 women; low-quality evidence). Metformin plus CC versus CC alone We are uncertain if metformin plus CC improves live birth rates compared to CC alone (OR 1.27, 95% CI 0.98 to 1.65; I 2 = 28%; 10 studies, 1219 women; low-quality evidence), but gastrointestinal side effects are probably more common with combined therapy (OR 4.26, 95% CI 2.83 to 6.40; I 2 = 8%; 6 studies, 852 women; moderate quality evidence). The live birth rate with CC alone is 24%, which may change to between 23% to 34% with combined therapy. With CC alone, the risk of gastrointestinal side effects is 9%, which increases to between 21% to 37% with combined therapy. The combined therapy group probably has higher rates of clinical pregnancy (OR 1.62, 95% CI 1.32 to 1.99; I 2 = 31%; 19 studies, 1790 women; moderate-quality evidence). The combined group may have higher rates of ovulation (OR 1.65, 95% CI 1.35 to 2.03; I 2 = 63%;21 studies, 1568 women; low-quality evidence). There was no clear evidenc of an effect on miscarriage (OR 1.35, 95% CI 0.91 to 2.00; I 2 = 0%; 10 studies, 1206 women; low-quality evidence). Metformin versus CC When all studies were combined, findings for live birth were inconclusive and inconsistent (OR 0.71, 95% CI 0.49 to 1.01; I 2 = 86%; 5 studies, 741 women; very low-quality evidence). In subgroup analysis by obesity status, obese women had a lower birth rate in the metformin group (OR 0.30, 95% CI 0.17 to 0.52; 2 studies, 500 women), while the non-obese group showed a possible benefit from metformin, with high heterogeneity (OR 1.71, 95% CI 1.00 to 2.94; I 2 = 78%, 3 studies, 241 women; very low-quality evidence). However, due to the very low quality of the evidence we cannot draw any conclusions. Among obese women taking metformin there may be lower rates of clinical pregnancy (OR 0.34, 95% CI 0.21 to 0.55; I 2 = 0%; 2 studies, 500 women; low-quality evidence) and ovulation (OR 0.29, 95% CI 0.20 to 0.43; I 2 = 0%; 2 studies, 500 women; low-quality evidence) while among non-obese women, the metformin group may have more pregnancies (OR 1.56, 95% CI 1.06 to 2.29; I 2 = 26%; 6 studies, 530 women; low-quality evidence) and no clear difference in ovulation rates (OR 0.80, 95% CI 0.52 to 1.25; I 2 = 0%; 5 studies, 352 women; low-quality evidence). We are uncertain whether there is a difference in miscarriage rates between the groups (overall: OR 0.92, 95% CI 0.51 to 1.66; I 2 = 36%; 6 studies, 781 women; low-quality evidence) and no studies reported gastrointestinal side effects.; Authors' Conclusions: Our updated review suggests that metformin may be beneficial over placebo for live birth however, more women probably experience gastrointestinal side effects. We are uncertain if metformin plus CC improves live birth rates compared to CC alone, but gastrointestinal side effects are probably increased with combined therapy. When metformin was compared with CC, data for live birth were inconclusive, and the findings were limited by lack of evidence. Results differed by body mass index (BMI), emphasising the importance of stratifying results by BMI. No studies reported gastrointestinal side effects in this comparison. Due to the low quality of the evidence, we are uncertain of the effect of metformin on miscarriage in all three comparisons. (Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Sharpe, L. (2021). "Cognitive bias modification for fear of cancer recurrence/progression." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: For this study, we will adopt a double‐blind randomized controlled trial methodology, whereby the cancer survivors would be randomly allocated in one of two groups: (1) Cognitive Bias Modification intervention (2) A placebo control. Cognitive Bias Modification for Interpretation (CBM‐I): The Word Sentence Association Paradigm (WSAP) will be used to modify interpretation bias with word‐sentence pairings training participants to make a benign interpretation of these pairings. In a typical WSAP task (Beard & Amir, 2009), each trial begins with a fixation cross for 500 ms and participants are presented with a single word (benign or threatening) followed by an ambiguous sentence, and indicate whether the two are related or not. That is, participants decide whether or not a word (e.g., embarrassing) is related to an ambiguous sentence (e.g., people laugh after something you said). Each CBM‐I session would last approximately for 10‐15 minutes. Some participants may be asked to rate each situation based on how worrying each situation is for them. This may take an additional 15 minutes. The intervention will be delivered entirely online by an institutional software program (Qualtrics) that will randomly allocate participants in one of two groups. CBM‐I will be delivered four times to each participant during the entire study. Time frame: CBM‐I training session 1: day 1 of the study CBM‐I training session 2: day 4 of the study CBM‐I training session 3: day 7 of the study CBM‐I training session 4 (FOLLOW‐UP 1): day 14 of the study The number of training sessions completed is recorded for each participant. CONDITION: Breast cancer ;Ovarian cancer; ; Breast cancer ; Ovarian cancer Cancer ‐ Breast Cancer ‐ Ovarian and primary peritoneal PRIMARY OUTCOME: Fear of cancer recurrence: Fear of cancer recurrence inventory (FCRI), severity subscale. ; The Fear of Cancer Recurrence Inventory severity subscale (Simard & Savard, 2009) will be used to measure concerns about cancer recurrence which consists of 9 items. Each item is rated on a Likert scale ranging from ‘0’ (never) to ‘4’ (all the time). A higher score indicates higher levels of FCR. [Primary outcome fear of cancer recurrence (FCR) will be administered at following time points:; • Baseline (pre‐training): before intervention/training; • Follow‐up 1 (14 days post‐intervention commencement, primary endpoint) and,; • Follow‐up 2 (28 days post‐intervention commencement); ; ] Fear of progression Questionnaire ‐ Short Form (FoP‐Q‐SF).; It consists of 12 items, with response options of never (1), rarely (2), sometimes (3), often (4), and very often (5) (Herschbach et. al, 2005). [Primary outcome fear of progression (FoP) will be administered at following time points:; • Baseline (pre‐training): before intervention/training; • Follow‐up 1 (14 days post‐intervention commencement, primary endpoint) and,; • Follow‐up 2 (28 days post‐intervention commencement); ; ] SECONDARY OUTCOME: Anxiety will be measured using the Hospital Anxiety and Depression Scales. ; The questionnaire comprises of 7 items for anxiety.[ ; Secondary outcome anxiety will be administered at following time points: ; • Baseline (pre‐training): before intervention/training ; • Follow‐up 1 (14 days post‐intervention commencement) and, ; • Follow‐up 2 (28 days post‐intervention commencement) ; ] Depression will be measured using the Hospital Anxiety and Depression Scales. ; The questionnaire comprises of 7 items for depression.[Secondary outcome depression will be administered at following time points: ; • Baseline (pre‐training): before intervention/training ; • Follow‐up 1 (14 days post‐intervention commencement) and, ; • Follow‐up 2 (28 days post‐intervention commencement) ; ] Interpretation bias: We are measuring interpretation bias using the WSAP (which is the same task that is adapted for training, described above). Different items are used in the test and training phases. The test phase uses general hreat stimuli to determine whether interpretation bias has been changed by the training. ; ; Illness‐related interpretive bias will be assessed through WSAP (Beard & Amir, 2009), with 118 trials of word‐sentence pairings. However, no feedback will be presented here as we will measure the interpretation bias instead of providing a training. This will be done through measuring endorsement rates and reaction times for threat and benign interpretations of ambiguous sentences. For example, “Your co‐workers stop talking when you enter”, if participant chooses the word “greeting”, this will be a ‘benign endorsement’ whereas, choosing word “gossip” is considered as ‘threat endorsement’. The rate of threat endorsement (percentage of threat responses) and rate of benign endorsement will be calculated to measure interpretation bias.[ ; Secondary outcome interpretation bias will be administered at following time points: ; • Baseline (pre‐training): before intervention/training ; • Follow‐up 1 (14 days post‐intervention commencement) and, ; • Follow‐up 2 (28 days post‐intervention commencement) ; ] Physical Symptoms ; The physical symptoms inventory (Spector & Jex, 1998) is an 18‐item questionnaire where participants indicate whether or not they experience each symptom (during the past 30 days) and if they did, whether they had sought medical attention for it. Symptoms are scored as absent (0), present (1) and/or needed to seek medical attention (2) and summed.[Secondary outcome physical symptoms will be administered at following time points: ; • Baseline (pre‐training): before intervention/training ; • Follow‐up 1 (14 days post‐intervention commencement) and, ; • Follow‐up 2 (28 days post‐intervention commencement) ; ] Severity of pain (intensity) and its impact on daily functioning (interference). ; We are using the Brief Pain Inventory. It is a self report measure and participant is instructed to report pain as an intensity and interference. The intensity scale contains 4 items measuring worst, least, and average pain intensity (usually during the past 24 h or week) and intensity now. The interference scale includes 7 items that assess pain’s interference with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life. The response alternatives are all numerical rating scales running from 0 to 10[Secondary outcome severity and intensity of pain will be administered at following time points: ; • Baseline (pre‐training): before intervention/training ; • Follow‐up 1 (14 days post‐intervention commencement) and, ; • Follow‐up 2 (28 days post‐intervention commencement)] The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ‐C30) will be used to measure QoL. It has 30 items comprising distinct scales, each representing a different aspect of QoL. [Secondary outcome Quality of Life will be administered at following time points: ; • Baseline (pre‐training): before intervention/training ; • Follow‐up 1 (14 days post‐intervention commencement) and, ; • Follow‐up 2 (28 days post‐intervention commencement) ; ] INCLUSION CRITERIA: INCLUSION CRITERIA: To be included patients must: • Have a breast or ovarian cancer diagnosis • Participants who have high levels of FCR (cut‐off score of 13 or higher) or FoP (cut‐off score of 34 and higher) • 18 years and older • Fluent in English • Have access to internet and computer competency • NOT receiving palliative care

Shawish Muhammad, I., et al. (2021). "Effect of atorvastatin on testosterone levels." The Cochrane Database of Systematic Reviews 1: CD013211.
	Background: Statins are one of the most prescribed classes of drugs worldwide. Atorvastatin, the most prescribed statin, is currently used to treat conditions such as hypercholesterolaemia and dyslipidaemia. By reducing the level of cholesterol, which is the precursor of the steroidogenesis pathway, atorvastatin may cause a reduction in levels of testosterone and other androgens. Testosterone and other androgens play important roles in biological functions. A potential reduction in androgen levels, caused by atorvastatin might cause negative effects in most settings. In contrast, in the setting of polycystic ovary syndrome (PCOS), reducing excessive levels of androgens with atorvastatin could be beneficial.; Objectives: Primary objective To quantify the magnitude of the effect of atorvastatin on total testosterone in both males and females, compared to placebo or no treatment. Secondary objectives To quantify the magnitude of the effects of atorvastatin on free testosterone, sex hormone binding globin (SHBG), androstenedione, dehydroepiandrosterone sulphate (DHEAS) concentrations, free androgen index (FAI), and withdrawal due to adverse effects (WDAEs) in both males and females, compared to placebo or no treatment.; Search Methods: The Cochrane Hypertension Information Specialist searched the following databases for randomized controlled trials (RCTs) up to 9 November 2020: the Cochrane Hypertension Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; Embase; ;two international trials registries, and the websites of the US Food and Drug Administration, the European Patent Office and the Pfizer pharmaceutical corporation. These searches had no language restrictions. We also contacted authors of relevant articles regarding further published and unpublished work.; Selection Criteria: RCTs of daily atorvastatin for at least three weeks, compared with placebo or no treatment, and assessing change in testosterone levels in males or females.; Data Collection and Analysis: Two review authors independently screened the citations, extracted the data and assessed the risk of bias of the included studies. We used the mean difference (MD) with associated 95% confidence intervals (CI) to report the effect size of continuous outcomes,and the risk ratio (RR) to report effect sizes of the sole dichotomous outcome (WDAEs). We used a fixed-effect meta-analytic model to combine effect estimates across studies, and risk ratio to report effect size of the dichotomous outcomes. We used GRADE to assess the certainty of the evidence.; Main Results: We included six RCTs involving 265 participants who completed the study and their data was reported. Participants in two of the studies were male with normal lipid profile or mild dyslipidaemia (N = 140); the mean age of participants was 68 years. Participants in four of the studies were female with PCOS (N = 125); the mean age of participants was 32 years. We found no significant difference in testosterone levels in males between atorvastatin and placebo, MD -0.20 nmol/L (95% CI -0.77 to 0.37). In females, atorvastatin may reduce total testosterone by -0.27 nmol/L (95% CI -0.50 to -0.04), FAI by -2.59 nmol/L (95% CI -3.62 to -1.57), androstenedione by -1.37 nmol/L (95% CI -2.26 to -0.49), and DHEAS by -0.63 μmol/l (95% CI -1.12 to -0.15). Furthermore, compared to placebo, atorvastatin increased SHBG concentrations in females by 3.11 nmol/L (95% CI 0.23 to 5.99). We identified no studies in healthy females (i.e. females with normal testosterone levels) or children (under age 18). Importantly, no study reported on free testosterone levels.; Authors' Conclusions: We found no significant difference between atorvastatin and placebo on the levels of total testosterone in males. In females with PCOS, atorvastatin lowered the total testosterone, FAI, androstenedione, and DHEAS. The certainty of evidence ranged from low to very low for both comparisons. More RCTs studying the effect of atorvastatin on testosterone are needed. (Copyright © 2021 The Coc rane Collaboration. Published by John Wiley & Sons, Ltd.)

Shen, C., et al. (2023). "Adjuvant therapies in women with polycystic ovary syndrome undergoing controlled ovarian stimulation for assisted conception: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Shen, W., et al. (2021). "Effects of Tea Consumption on Anthropometric Parameters, Metabolic Indexes and Hormone Levels of Women with Polycystic Ovarian Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." Frontiers in Endocrinology 12: 736867.
	Objective: Our aim was to conduct a systematic review and meta-analysis to assess the effectiveness and safety of tea supplements for patients with polycystic ovary syndrome (PCOS).; Methods: We conducted searches of the published literature in PubMed, EMBASE, Cochrane Library, Web of Science, Chinese Biomedical Literature Database, Chinese National Knowledge Infrastructure (CNKI), VIP database, and Wanfang Database in 1985 to September 2021. Data from randomized controlled trials (RCTs) were obtained to assess the effects of tea versus placebo in women with PCOS. Weighted mean differences (WMDs) were pooled using a random-effects model or risks ratios (RRs) using a random-effects model.; Results: Six RCTs (235 participants) were included in our systematic review. Tea supplements as adjuvant therapy led to greater improvement in body weight (WMD -2.71, 95% CI -4.95 to -0.46, P = 0.02, I 2 = 0%), fasting blood glucose (FBG: WMD -0.40, 95% CI -0.59 to -0.20, P < 0.0001, I 2 = 0%) and fasting insulin (FINS: WMD -3.40, 95% CI -4.76 to -2.03, P < 0.00001, I 2 = 0%) when compared with placebo. There were no significant differences of body mass index, waist circumference, hip circumference, waist-to-hip ratio (WHR), body fat rate, total testosterone, free testosterone (FT), dehydroepiandrosterone, luteinizing hormone or follicular-stimulating hormone (FSH) between the two groups. In addition, subgroup analysis suggested that green tea was effective on body weight, FINS, FBG, FT, and FSH, and herbal tea can also reduce FT levels, tea supplements had a significant impact on FBG and FSH in trials with intervention duration ≥ 3 months, and intervention lasting less than 3 months can improve FINS. Tea had significant effect on reducing WHR, FBG and FSH in Asian PCOS patients, but not in Caucasians. And there was no statistically significant effect of tea on weight and FINS in Asians, but it was effective for Caucasian participants. Compared with placebo, tea supplements did not cause significant adverse reactions (RR 1.45, 95% CI 0.30 to 6.90, P = 0.65, I 2 = 0%).; Conclusion: This meta-analysis suggests that consumption of tea supplementation in women with PCOS could significantly decrease the levels of FBG and FINS as well as reduce body weight. Especially green tea, not only has the above effects, but also has a significant effect on improving a variety of reproductive hormone indexes. Furthermore, tea supplementation is a relatively safe therapy for PCOS patients.; Systematic Review Registration: PROSPERO https://www.crd.york.ac.uk/PROSPERO/display&#95;record.php?RecordID=212755, identifier CRD42021249196.; 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 Shen, Pan, Jin, Zhang, You, Qu, Han, Yuan and Zhang.)

Shen, W., et al. (2022). "Therapeutic effect and safety of curcumin in women with PCOS: A systematic review and meta-analysis." Frontiers in Endocrinology 13: 1051111.
	Background: Polycystic ovary syndrome (PCOS) is a multi-factorial heterogeneous syndrome that has both adverse reproductive and metabolic implications for affected women and its management is a challenging clinical problem. Curcumin, as a phenolic compound with potent anti-inflammatory and antioxidant properties exerting positive effects on the lipid profile and insulin resistance, appears to be a valuable treatment regimen for patients with PCOS.; Objective: This study aimed to evaluate the efficacy and safety of curcumin in the treatment of PCOS.; Methods: Chinese databases (Chinese National Knowledge Infrastructure, China Biology Medicine Databases, VIP database, Wanfang Database, and Chinese Clinical Trial Registry) and English databases (PubMed, Web of Science, Embase, Cochrane Library, Scopus and Clinical trials) were thoroughly investigated through screening randomized controlled trials on curcumin in PCOS published from the date of inception to May 2022. Standardized data search and abstraction were conducted following the preferred reporting items for systematic reviews and meta-analysis (PRISMA) statement. Quantitative and qualitative analyses were performed. Heterogeneity was assessed using I 2 statistics.; Results: A total of 447 patients from seven randomized controlled trials were included in the meta-analysis. Results showed that the ingestion of curcumin decreased body mass index (WMD -0.267, 95% CI -0.450 to -0.084, P = 0.004, I 2 = 0.0%), fasting plasma glucose (WMD -3.618, 95% CI -5.165 to -2.071, P < 0.001, I 2 = 20.4%), insulin (WMD -1.834, 95% CI -2.701 to -0.968, P < 0.001, I 2 = 8.4%), homeostatic model assessment for insulin resistance (WMD -0.565, 95% CI -0.779 to -0.351, P < 0.001, I 2 = 0.0%), total cholesterol (WMD -15.591, 95% CI -27.908 to -3.273, P = 0.013, I 2 = 68.9%), C-reactive protein (WMD -0.785, 95% CI -1.553 to -0.017, P = 0.045, I 2 = 23.9%), and increased the quantitative insulin sensitivity check index (WMD 0.011, 95% CI 0.005 to 0.017, P = 0.001, I 2 = 39.6%). As for safety, the treatment group did not cause significant adverse reactions than that in the control group.; Conclusion: In light of presented findings, curcumin has beneficial effects on serum markers of inflammation, weight loss and glucose and lipid metabolism in patients with PCOS. The incidence of adverse reactions does not increase with the application of curcumin. However, a larger, more definitive study is needed to further investigate these results.; Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42022332394.; 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 Shen, Qu, Jiang, Wang, Pan, Zhang, Wu, Han and Zhang.)

Sheyn, D. (2023). "Cyclic Versus Continuous Sacral Neuromodulation for LUTS." ClinicalTrials.gov.
	Overactive bladder (OAB) is characterized by urinary frequency, urgency, incontinence, and nocturia in the absence of other pathology. AUA guidelines recommend trial of sacral neuromodulation (SNM) for patients with refractory OAB who have failed treatment with behavioral modification and medication. SNM settings are typically selected based on discussion between the patient and device representative. There is a paucity of rigorous data assessing optimal SNM stimulation programming for symptomatic improvement. This will be a prospective, randomized‐controlled multi‐site trial comparing cyclic versus continuous sacral neuromodulation (SNM) in patients undergoing SNM for OAB. Patients > age 18 with a diagnosis of refractory OAB being scheduled for a trial of SNM (either stage I lead/temporary battery placement or office peripheral nerve evaluation) will be approached by study personnel during their clinic visit or by a phone call to determine if they are interested in participating in the programming study. Patients interested in participating will provide written informed consent. After informed consent is obtained, a baseline evaluation will be performed. This includes history, 3‐day voiding diary (# voiding episodes, # nocturia episodes, # urge incontinence episodes/24h), urinalysis, urine culture (if indicated), post void residuals, and symptom assessments using questionnaires. Only those with successful trial and eligible/ interested in permanent SNM placement will participate in this trial. Randomization will occur after stage 2/ full permanent implantation when the neuromodulator is being programmed in the recovery room. Patients will be randomly assigned to either continuous stimulation or cyclic stimulation. Patients will then be followed with clinical evaluation and questionnaires repeated at 1 month, 6 months, and 12 months post‐op.

Shi, J. and J. Leng (2022). "Effect and safety of drospirenone and ethinylestradiol tablets (II) for dysmenorrhea: A systematic review and meta-analysis." Frontiers in Medicine 9: 938606.
	Aim: This systematic review aimed to assess the efficacy and safety of Drospirenone and Ethinylestradiol Tablets (II) in the treatment of dysmenorrhea.; Methods: Electronic databases, namely PubMed, Embase, Cochrane Controlled Register of Trials (CENTRAL), Scopus, Science, CBM, CNKI, Wanfang, and VIP, were searched before September 2022. Randomized controlled trials (RCTs), non-randomized controlled trials, cohort studies, case-control studies, and single-arm studies were included. Furthermore, the Cochrane Risk of Bias Tool for Systematic Reviews version 1 was used for the risk of bias assessment on RCTs. The Risk of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool was used for risk of bias assessment on non-randomized studies. The risk ratio (RR) was calculated for dichotomous data. Mean difference (MD) or standardized MD (SMD) were used as the effect size for continuous data.; Results: A total of 11 studies involving 2,251 participants with dysmenorrhea were included. When Drospirenone and Ethinylestradiol Tablets (II) conventional 24/4-day regimen was compared with placebo, the total efficiency rate (defined as pain symptom disappearing or being relieved) in Drospirenone and Ethinylestradiol Tablets (II) 24/4-day regimen group was higher than in placebo group (RR = 5.55, 95%CI: 2.48-12.39, P < 0.0001). No clear differences were found on risk of overall adverse events or specific adverse events. When Drospirenone and Ethinylestradiol Tablets (II) was compared with active control drugs, no clear differences were found on the total efficiency rate or visual analog scale (VAS) scores for dysmenorrhea and other related pain. The risk of overall adverse events decreased in Drospirenone and Ethinylestradiol Tablets (II) conventional 24/4-day regimen (13/53 vs. 66/148, RR = 0.55, 95%CI: 0.33-0.91) when compared with active control drugs group. When Drospirenone and Ethinylestradiol Tablets (II) flexible extended regimen was compared with conventional 24/4-day regimen, the number of days of dysmenorrhea (MD=-3.98, 95%CI: -5.69 to -2.27), and dysmenorrhea associated with unscheduled bleedings (MD = -1.6, 95%CI: -2.8 to -0.5), were fewer in flexible extended regimen. In addition, there were no differences found on risk of adverse events (including mood changes, spotting, headache, breast pain, nausea, and vomiting) between compared groups ( P > 0.05).; Conclusion: Drospirenone and Ethinylestradiol Tablets (II) could improve symptoms of dysmenorrhea and decrease other related pain symptoms. More high-quality evidence is needed to confirm the advantages.; Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/display&#95;record.php?ID=CRD42021271605], identifier [CRD42021271605].; 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 Shi and Leng.)

Shi, Y., et al. (2022). "Cost-effectiveness analysis of pembrolizumab for treatment of US patients with persistent, recurrent, or metastatic cervical cancer." Gynecologic Oncology 164(2): 379-385.
	Objective: The effectiveness of pembrolizumab for persistent, recurrent, or metastatic cervical cancer has been demonstrated. We aimed to evaluate its cost-effectiveness from the United States (US) healthcare payers perspective.; Methods: A partitioned survival model over a 30-year lifetime horizon was developed to compare the cost and effectiveness of pembrolizumab versus placebo based on clinical data from the KEYNOTE-826 phase 3 randomized trial. Costs and health state utilities were obtained from literature and publicly available databases. The incremental cost-effectiveness ratio (ICER) was measured. One-way and probabilistic sensitivity analyses were conducted.; Results: For the Intention-to-Treat patients, pembrolizumab was associated with an additional 0.74 quality-adjusted life-year (QALY) at an additional cost of $182,271 when compared with placebo. The ICER was $247,663/QALY. For patients with a programmed death-ligand 1 combined positive score ≥ 1 and 10, the ICER was $253,322/QALY and $214,212/QALY, respectively. One-way sensitivity analyses showed that pembrolizumab had the greatest impact on the ICER. Probabilistic sensitivity analyses showed that the probability of pembrolizumab being cost-effective was zero at the current willingness-to-pay threshold of $150,000/QALY. The price of pembrolizumab had to reduce at least to $28.336 (55.8% of the current price) for it to be cost-effective in a 50% of chance.; Conclusion: The addition of pembrolizumab to chemotherapy is costly and might not be cost-effective for persistent, recurrent, or metastatic cervical cancer at the current price in the US.; Competing Interests: Declaration of Competing Interest None. (Copyright © 2021 Elsevier Inc. All rights reserved.)

Shi, Y., et al. (2022). "Efficacy of intravenous immunoglobulin in the treatment of recurrent spontaneous abortion: A systematic review and meta-analysis." American Journal of Reproductive Immunology 88(5): e13615.
	Objective: We aimed to evaluate the efficacy of IVIG in the treatment with patients with recurrent spontaneous abortion (RSA).; Methods: PubMed, Embase, Web of science, Cochrane library were searched for randomized controlled (RCTs) about effect of IVIG on RSA from inception to August 20, 2021. Values of standardized mean differences (SMD) were determined for continuous outcomes.; Results: A total of 15 articles involving 902 patients were included in meta-analysis. Compared with the control group, IVIG can increase the live birth rate of recurrent spontaneous abortion patients [OR = 3.06, 95%CI (1.23, 7.64, P = .02]. However, recurrent abortion was divided into primary and secondary abortion for subgroup analysis, and there was no statistical difference. Besides, IVIG can also increase the expression in peripheral blood CD3+[OR = .4, 95%CI(-2.47, 3.15, P = .81],CD4+[OR = 1.16, 95%CI(-4.60, 6.93, P = .69], and a decrease in the expression of CD8+[OR = -1.78, 95%CI(-5.30, 1.75, P = .32], but there is no statistical significance.; Conclusions: IVIG can significantly increase the live birth rate of recurrent spontaneous abortion. However, the evidence needs further verification and the curative effect is uncertain. It is necessary to further explore the pathogenesis of recurrent abortion and the mechanism of IVIG in the treatment of recurrent spontaneous abortion. Besides, more high-quality randomized controlled trials suitable for population, race, dosage and timing of IVIG in the treatment of recurrent abortion are needed to confirm its effectiveness, and effective systematic evaluation is also needed to evaluate its use benefit. (© 2022 The Authors. American Journal of Reproductive Immunology published by John Wiley & Sons Ltd.)

Shi-guang, S. U. N. and W. Qun (2023). "Comparative efficacy and safety of Chinese patent medicines combined with Western medicine for uterine fibroid: systematic review, meta-analysis and network meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Shim, S.-H. (2022). "Adjuvant Chemotherapy Versus Radiotherapy For Postoperative Cervical Cancer (AFTER): a Phase 3 Trial." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Drug, Radiation : 1. Experimental group: chemotherapy [1] TC therapy Paclitaxel (PTX): 175 mg/m2; intravenous infusion for 3 hours; Day 1 Carboplatin (CBDCA): AUC = 6.0; intravenous infusion for 1 hour; Day 1 6 times every 3 weeks (21 days) [2] TP therapy Paclitaxel (PTX): 175 mg/m2; intravenous infusion for 3 hours; Day 1 Cisplatin (CDDP): 50 mg/m2; intravenous infusion for 2 hours; Day 1 6 times every 3 weeks (21 days) 2. Control group: CCRT Total pelvic dose: 50.4 Gy Cisplatin (CDDP): 40 mg/m2; intravenous infusion for 2 hours; Day 1 Dosing weekly and repeat 5‐6 times CONDITION: Neoplasms PRIMARY OUTCOME: overall survival (OS) SECONDARY OUTCOME: Incidence rate of adverse events Quality of Life (QOL) Relapse‐free Survival INCLUSION CRITERIA: 1) Preoperative clinical stage IB1, IB2, IIA1, IIA2, or IIB cervical cancer 2) In case of histological diagnosis as follows from the tumor tissue after surgery ‐ Squamous cell carcinoma (keratinizing type, nonkeratinizing type) ‐ Adenocarcinoma (usual type of endocervical adenocarcinoma, intestinal type of mucinous carcinoma, endometrioid carcinoma) ‐ Adenosquamous cell carcinoma 3) Pathologically confirmed pelvic lymph node metastasis or uterine chamber invasion from surgically resected tissue 4) In contrast‐enhanced CT performed within 56 days before surgery, there should be no metastases other than pelvic lymph nodes (short diameter =10 mm) or distant metastases to the chest, upper abdomen, or pelvis, even when PET/CT was performed instead of contrast‐enhanced CT Recognition. Simple CT is also permitted if it is difficult to use a contrast medium due to complications such as allergies or bronchial asthma. 5) There should be no lymph no

Shimels, T., et al. (2023). "Comparison of mifepristone plus misoprostol with misoprostol alone for first trimester medical abortion: A systematic review and meta-analysis." Frontiers in Global Women's Health 4: 1112392.
	Objective: To compare mifepristone plus a misoprostol-combined regimen with misoprostol alone in the medical abortion of first trimester pregnancy.; Methods: An internet-based search of available literature was performed using text words contained in titles and abstracts. PubMed/Medline, Cochrane CENTRAL, EMBASE, and Google scholar were used to locate English-based articles published until December 2021. Studies fulfilling the inclusion criteria were selected, appraised, and assessed for methodological quality. The included studies were pooled for meta-analysis, and the results were presented in risk ratio at a 95% confidence interval.; Findings: Nine studies comprising 2,052 participants (1,035 intervention and 1,017 controls) were considered. Primary endpoints were complete expulsion, incomplete expulsion, missed abortion, and ongoing pregnancy. The intervention was found to more likely induce complete expulsion irrespective of gestational age (RR: 1.19; 95% CI: 1.14-1.25). The administration of misoprostol 800 mcg after 24 h of mifepristone pre-treatment in the intervention group more likely induced complete expulsion (RR: 1.23; 95% CI: 1.17-1.30) than after 48 h. The intervention group was also more likely to experience complete expulsion when misoprostol was used either vaginally (RR: 1.16; 95% CI: 1.09-1.17) or buccally (RR: 1.23; 95% CI: 1.16-1.30). The intervention was more effective in the subgroup with a negative foetal heartbeat at reducing incomplete abortion (RR: 0.45; 95% CI: 0.26-0.78) compared with the control group. The intervention more likely reduced both missed abortion (RR: 0.21; 95% CI: 0.08-0.91) and ongoing pregnancy (RR: 0.12; 95% CI: 0.05-0.26). Fever was less likely to be reported (RR: 0.78; 95% CI: 0.12-0.89), whereas the subjective experience of bleeding was more likely to be encountered (RR: 1.31; 95% CI: 1.13-1.53) by the intervention group.; Conclusion: The review strengthened the theory that a combined mifepristone and misoprostol regimen can be an effective medical management for inducing abortions during first trimester pregnancy in all contexts. Specifically, there is a high-level certainty of evidence on complete expulsion during the early stage and its ability to reduce both missed and ongoing pregnancies.; Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display&#95;record.php?ID=CRD42019134213, identifier CRD42019134213.; 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. (© 2023 Shimels, Getnet, Shafie and Belay.)

Shimizu, Y. (2022). "A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain." ClinicalTrials.gov.
	No Results Available Drug: KLH-2109|Drug: Placebo Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration|Proportion of women with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration|Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration|Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration|Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days|Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end of study drug administration|Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days|Average NRS score every 28 days for pain symptoms|Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) during 28 days before end of study drug administration|Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) every 28 days|Incidence of adverse events and adverse drug reactions Female Phase 3 78 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment KLH2302 September 2024

Shimpuku, Y. (2023). "Effect of Telenursing (SMART MAMA) on Postpartum Depression, Anxiety and Maternal Infant Bonding among Women during Postnatal Period." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention 1: The intervention provides information via a smartphone application named SMART MAMA for 12 weeks. The women download the application at the time of the baseline survey, and they can access it anytime. The intervention will be composed of physical, psychological, and informational support. Physical support intervention will teach women to apply stretching and Kegel exercises. At the same time, the psychological support will include mindfulness and muscle relaxation techniques. Besides, informational support provides the women with information about postpartum depression signs and symptoms and infant maternal bonding for 12 weeks. The application has two components. First, it provides videos, photos, and written information for learning. Second, it provides notification messages to increase the women&#39;s attention, encouragement, and motivation. Intervention 2: The control provides standard routine postnatal care provided clinic, which generally includes nursing care during the hospitalization, such as observation of postpartum physical recovery, breastfeeding support, and support for childcare techniques like changing diapers and bathing. Also, it includes 2‐week and 1‐month checkups after discharge. CONDITION: Postpartum Depression PRIMARY OUTCOME: Postpartum depressive symptoms measured by the Edinburgh Postnatal Depression Scale score at the baseline and 12 months after the intervention. SECONDARY OUTCOME: The level of anxiety measured by the State‐Trait Anxiety Inventory, and maternal���infant bonding measured by the Mother‐to‐Infant Bonding Scale. INCLUSION CRITERIA:

Shin, H. (2023). "Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer." ClinicalTrials.gov.
	The study will comprise a screening period of ‐28 Days prior to initiation of study treatment (Day 1); an enrollment period of 24 months; the treatment duration will be approximately of 5 months. The study will evaluate whether the addition of AST‐201/rhuGM‐CSF to the standard adjuvant chemotherapy will extend the Progression Free Survival(PFS) rate. Survival follow‐up will be performed every 3 months (±14 days) after the End of treatment (EOT) visit for 2 years after randomization and every 6 months (±28 days) thereafter until disease progression or death from any cause or withdrawal of consent whichever comes first. Survival follow‐up visits will be conducted by telephone, in‐person visit, or chart review. The end of study (EOS) is defined as 2 years after the date of last patient enrollment.

Shiqin, Z., et al. (2022). "Meta-analysis of Zhibaidihuang decoctionin in the treatment of senile vaginitis." PROSPERO International prospective register of systematic reviews.
	
Shiying, H., et al. (2023). "Network meta-analysis on the safety and efficacy of moxibustion related therapy in the treatment of polycystic ovary syndrome." PROSPERO International prospective register of systematic reviews.
	
Shojaei-Zarghani, S., et al. (2022). "Curcumin and Polycystic Ovary Syndrome: a Systematic Review." Reproductive Sciences 29(8): 2105-2118.
	Polycystic ovary syndrome (PCOS) is a gynecological endocrine disorder and the leading cause of anovulatory female infertility. This study aimed to systematically review the effects of curcumin or turmeric on PCOS-related parameters. PubMed, Scopus, Embase, and Web of Knowledge databases and Google Scholar were searched up to August 2021 using relevant keywords. All original articles evaluating the effects of turmeric/curcumin on PCOS were eligible. Out of 107 documents, eight animal studies and five randomized placebo-controlled clinical trials (RCTs) assessing the impact of curcumin on PCOS met our inclusion criteria. The reviewed animal studies indicated the beneficial effects of curcumin on the management of hormonal and metabolic disturbances in the PCOS condition. These effects also were confirmed in some, but not all, included RCTs. Therefore, despite promising animal results, the present literature is limited to conclude the beneficial effects of curcumin on the clinical management of PSCO symptoms. The impact of bioavailability-improved formulations of curcumin on PCOS should be assessed in further well-designed RCTs with longer duration and higher doses of curcumin. Besides, mechanistic investigations on the effects of curcumin on PCOS are also recommended.Copyright © 2022, Society for Reproductive Investigation.

Shoji, T., et al. (2022). "Efficacy and safety of standard of care with/without bevacizumab for platinum-resistant ovarian/fallopian tube/peritoneal cancer previously treated with bevacizumab: The Japanese Gynecologic Oncology Group study JGOG3023." Cancer Science 113(1): 240-250.
	We investigated the efficacy and safety of further bevacizumab therapy in patients with platinum-resistant ovarian cancer whose disease had progressed after bevacizumab plus chemotherapy. In this multicenter, open-label, phase II trial (JGOG3023), patients were randomized 1:1 to a single-agent chemotherapy alone (either pegylated liposomal doxorubicin [40 or 50 mg/m 2 administered intravenously], topotecan [1.25 mg/m 2 intravenously], paclitaxel [80 mg/m 2 intravenously], or gemcitabine [1000 mg/m 2 intravenously]) or single-agent chemotherapy + bevacizumab (15 mg/m 2 intravenously). The primary endpoint was investigator-assessed progression-free survival (PFS) according to RECIST version 1.1. Secondary endpoints were overall survival (OS), objective response rate (ORR), and response rate according to Gynecological Cancer Intergroup cancer antigen 125 criteria. In total, 103 patients were allocated to chemotherapy (n = 51) or chemotherapy + bevacizumab (n = 52). Median investigator-assessed PFS was 3.1 and 4.0 mo in each group, respectively (hazard ratio [HR] = 0.54, 95% confidence interval [CI]: 0.32-0.90, P = .0082). Median OS was 11.3 and 15.3 mo in each group, respectively (HR = 0.67, 95% CI: 0.38-1.17, P = .1556). Respective ORRs were 13.7% and 25.0% (P = .0599) and response rates were 16.7% and 21.4% (P = .8273). The incidence of grade ≥3 treatment-related AEs was 42.0% in the chemotherapy group and 54.9% in the chemotherapy + bevacizumab group; AEs were well tolerated, with only 2 and 12 events leading to discontinuation of therapy, respectively. Bevacizumab was effective beyond progressive disease and AEs were manageable. The observed improvement in PFS requires further verification. (© 2021 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.)

Shorey, S., et al. (2023). "Effectiveness of Psychological Interventions to Improve the Mental Well-Being of Parents Who Have Experienced Traumatic Childbirth: A Systematic Review and Meta-Analysis." Trauma, Violence & Abuse 24(3): 1238-1253.
	Considering the adverse impact that traumatic childbirth experiences can have on parental mental well-being, studies that have investigated the potential of providing postnatal psychological support for this group of parents require evaluation. This systematic review aimed to examine the effectiveness of psychological interventions at improving the mental well-being of parents who have experienced traumatic childbirth in terms of anxiety, depression, fear of childbirth, and post-traumatic stress disorder (PTSD) symptoms. Seven electronic databases were searched from their respective inception dates up to January 2021. Only quantitative studies that reported the effects of psychological interventions on anxiety, depression, fear of childbirth, and/or PTSD symptoms in selective (at risk of traumatic childbirth experience) or indicated (self-defined childbirth experience as traumatic for any reason) populations of parents (mothers and/or fathers) were included. Eight studies were included and meta-analyses were conducted using a random-effect model. All studies were conducted on mothers only, and one study had minimal father involvement. Results showed that psychological interventions were more effective in reducing fear of childbirth and improving PTSD symptoms compared to anxiety and depression. Greater improvement in depression was reported at 3-8 weeks' follow-up than at immediate post-intervention. Subgroup analyses showed that technology-based interventions were feasible, and indicated interventions were more effective than selective interventions. Conducting future interventions in more geographical regions, engaging and including fathers more actively, incorporating both personalized professional therapy and informal peer support, striving for flexibility and convenience, as well as addressing topics on self-doubt and coping skills can improve current interventions.

Showell, M. G., et al. (2020). "Antioxidants for female subfertility." The Cochrane Database of Systematic Reviews 2020(8): CD007807.
	Background: A couple may be considered to have fertility problems if they have been trying to conceive for over a year with no success. This may affect up to a quarter of all couples planning a child. It is estimated that for 40% to 50% of couples, subfertility may result from factors affecting women. Antioxidants are thought to reduce the oxidative stress brought on by these conditions. Currently, limited evidence suggests that antioxidants improve fertility, and trials have explored this area with varied results. This review assesses the evidence for the effectiveness of different antioxidants in female subfertility. Objective(s): To determine whether supplementary oral antioxidants compared with placebo, no treatment/standard treatment or another antioxidant improve fertility outcomes for subfertile women. Search Method(s): We searched the following databases (from their inception to September 2019), with no language or date restriction: Cochrane Gynaecology and Fertility Group (CGFG) specialised register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and AMED. We checked reference lists of relevant studies and searched the trial registers. Selection Criteria: We included randomised controlled trials (RCTs) that compared any type, dose or combination of oral antioxidant supplement with placebo, no treatment or treatment with another antioxidant, among women attending a reproductive clinic. We excluded trials comparing antioxidants with fertility drugs alone and trials that only included fertile women attending a fertility clinic because of male partner infertility. Data Collection and Analysis: We used standard methodological procedures expected by Cochrane. The primary review outcome was live birth; secondary outcomes included clinical pregnancy rates and adverse events. Main Result(s): We included 63 trials involving 7760 women. Investigators compared oral antioxidants, including: combinations of antioxidants, N-acetylcysteine, melatonin, L-arginine, myo-inositol, carnitine, selenium, vitamin E, vitamin B complex, vitamin C, vitamin D+calcium, CoQ10, and omega-3-polyunsaturated fatty acids versus placebo, no treatment/standard treatment or another antioxidant. Only 27 of the 63 included trials reported funding sources. Due to the very low-quality of the evidence we are uncertain whether antioxidants improve live birth rate compared with placebo or no treatment/standard treatment (odds ratio (OR) 1.81, 95% confidence interval (CI) 1.36 to 2.43; P < 0.001, I2 = 29%; 13 RCTs, 1227 women). This suggests that among subfertile women with an expected live birth rate of 19%, the rate among women using antioxidants would be between 24% and 36%. Low-quality evidence suggests that antioxidants may improve clinical pregnancy rate compared with placebo or no treatment/standard treatment (OR 1.65, 95% CI 1.43 to 1.89; P < 0.001, I2 = 63%; 35 RCTs, 5165 women). This suggests that among subfertile women with an expected clinical pregnancy rate of 19%, the rate among women using antioxidants would be between 25% and 30%. Heterogeneity was moderately high. Overall 28 trials reported on various adverse events in the meta-analysis. The evidence suggests that the use of antioxidants makes no difference between the groups in rates of miscarriage (OR 1.13, 95% CI 0.82 to 1.55; P = 0.46, I2 = 0%; 24 RCTs, 3229 women; low-quality evidence). There was also no evidence of a difference between the groups in rates of multiple pregnancy (OR 1.00, 95% CI 0.63 to 1.56; P = 0.99, I2 = 0%; 9 RCTs, 1886 women; low-quality evidence). There was also no evidence of a difference between the groups in rates of gastrointestinal disturbances (OR 1.55, 95% CI 0.47 to 5.10; P = 0.47, I2 = 0%; 3 RCTs, 343 women; low-quality evidence). Low-quality evidence showed that there was also no difference between the groups in rates of ectopic pregnancy (OR 1.40, 95% CI 0.27 to 7.20; P = 0.69, I2 = 0%; 4 RCTs, 404 women). In the antioxidant versus antioxidant comparison, low-quality evidence shows no difference in a lower dose of melatonin being associated with an in reased live-birth rate compared with higher-dose melatonin (OR 0.94, 95% CI 0.41 to 2.15; P = 0.89, I2 = 0%; 2 RCTs, 140 women). This suggests that among subfertile women with an expected live-birth rate of 24%, the rate among women using a lower dose of melatonin compared to a higher dose would be between 12% and 40%. Similarly with clinical pregnancy, there was no evidence of a difference between the groups in rates between a lower and a higher dose of melatonin (OR 0.94, 95% CI 0.41 to 2.15; P = 0.89, I2 = 0%; 2 RCTs, 140 women). Three trials reported on miscarriage in the antioxidant versus antioxidant comparison (two used doses of melatonin and one compared N-acetylcysteine versus L-carnitine). There were no miscarriages in either melatonin trial. Multiple pregnancy and gastrointestinal disturbances were not reported, and ectopic pregnancy was reported by only one trial, with no events. The study comparing N-acetylcysteine with L-carnitine did not report live birth rate. Very low-quality evidence shows no evidence of a difference in clinical pregnancy (OR 0.81, 95% CI 0.33 to 2.00; 1 RCT, 164 women; low-quality evidence). Low quality evidence shows no difference in miscarriage (OR 1.54, 95% CI 0.42 to 5.67; 1 RCT, 164 women; low-quality evidence). The study did not report multiple pregnancy, gastrointestinal disturbances or ectopic pregnancy. The overall quality of evidence was limited by serious risk of bias associated with poor reporting of methods, imprecision and inconsistency. Authors' conclusions: In this review, there was low- to very low-quality evidence to show that taking an antioxidant may benefit subfertile women. Overall, there is no evidence of increased risk of miscarriage, multiple births, gastrointestinal effects or ectopic pregnancies, but evidence was of very low quality. At this time, there is limited evidence in support of supplemental oral antioxidants for subfertile women.Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Shuai, W., et al. (2020). "Impact of metformin on low-grade chronic inflammatory mediators in women with polycystic ovary syndrome: A meta-analysis." Latin American Journal of Pharmacy 39(7): 1388-1399.
	Polycystic ovary syndrome (PCOS) is associated with low-grade chronic inflammatory. We conducted a meta-analysis to assess the effects of metformin on chronic inflammation mediators in women with PCOS.As of December 2018, systematic search have been conducted electronically using specific eligibility criteria. Standardized mean difference (SMD) and 95% confidence intervals (95%CI) were used as measures of effect size. A total of 19 trials were included in this meta-analysis. Metformin treatment decreased the levels of C-reactive protein (SMD =-0.761, 95%CI:-1.122 to-0.401, P = 0.000), How-ever, the therapy failed to reduce interleukin-6 (SMD =-0.135, 95%CI:-0.599 to 0.33, P = 0.57). In two studies, PAI-1 levels after metformin treatment were lower than before treatment, one of which were statistically significant. Three studies reported the impact of metformin on homocysteine in PCOS patients, the results were statistically significant. Two studies reported the impact of metformin on tumor necrosis factor-alpha (TNF-alpha) in PCOS patients, and one of the results was statistically significant. It was demonstrat-ed that metformin treatment may ameliorate the chronic inflammation status in women with PCOS. However, considering the low quality of the analysis, the effect of metformin on the levels of chronic inflammatory markers is uncertain. Large-scale randomized controlled trials with longer follow-up period are needed to ascertain this outcome and the clinical implications of practice need extensive investigation. RESUMEN. El sindrome de ovario poliquistico (PCOS) se asocia con inflamacion cronica de bajo grado. Lleva-mos a cabo un metanalisis para evaluar los efectos de la metformina en los mediadores de inflamacion cronica en mujeres con PCOS. A diciembre de 2018, la busqueda sistematica se realizo electronicamente utilizando cri-terios de elegibilidad especificos. La diferencia de medias estandarizada (DME) y los intervalos de confianza del 95% (95%CI) se utilizaron como medidas del tamano del efecto. Se incluyeron un total de 19 ensayos en este metanalisis. El tratamiento con metformina disminuyo los niveles de proteina C reactiva (DME =-0.761, IC 95%:-1.122 a-0.401, P = 0.000). Sin embargo, la terapia no logro reducir la interleucina-6 (DME =-0.135, IC 95%:-0.599 a 0.33, P = 0.57). En dos estudios los niveles de PAI-1 despues del tratamiento con metformina fueron mas bajos que antes del tratamiento, uno de los cuales fue estadisticamente significativo. Tres estudios informaron el impacto de la metformina en la homocisteina en pacientes con PCOS, con resultados estadistica-mente significativos. Dos estudios informaron el impacto de la metformina en el factor de necrosis tumoral alpha (TNF-alpha) en pacientes con PCOS y uno de los resultados fue estadisticamente significativo. Se demostro que el tratamiento con metformina puede mejorar el estado de inflamacion cronica en mujeres con PCOS. Sin embar-go, considerando la baja calidad del analisis, el efecto de la metformina en los niveles de marcadores inflamato-rios cronicos es incierto. Se necesitan ensayos controlados aleatorios a gran escala con un periodo de segui-miento mas largo para determinar este resultado y las implicaciones clinicas de la practica requieren una inves-tigacion exhaustiva.Copyright © 2020, Colegio de Farmaceuticos de la Provincia de Buenos Aires. All rights reserved.

Shuang, C. and C. Lu (2021). "Effectiveness of mindfulness therapy on negative emotions in infertile women: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Shucheng, C. and L. I. Zeng (2023). "Chinese herb decoctions for primary dysmenorrhea: A systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Shuhuan, L. and Z. Dan (2022). "Liraglutide versus placebo or metformin in obese and overweight women with polycystic ovary syndrome: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Shulin, J. and Y. Ye (2023). "The efficacy of relugelix in the treatment of patients with uterine fibroids-related menstrual bleeding :a Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Shuo, L., et al. (2023). "Long-term follow-up outcomes of transvaginal mesh surgery in patients with pelvic organ prolapse: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Sidan, H., et al. (2023). "Acupuncture and related therapies for anxiety and depression in patients with premature ovarian insufficiency and diminished ovarian reserve: a protocol for systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Siddaway, A. P., et al. (2022). "Trauma-focused guided self-help interventions for posttraumatic stress disorder: A meta-analysis of randomized controlled trials." Depression and Anxiety 39(10-11): 675-685.
	Trauma-focused guided self-help (TF-GSH) is an important alternative to psychological therapy delivered by a therapist. This meta-analysis evaluates the efficacy of TF-GSH in reducing posttraumatic stress disorder (PTSD) symptoms and comorbid depressive and anxiety symptoms. A total of 17 trials were included that compared a TF-GSH intervention (N = 610) to various control comparators (N = 570). Control conditions included treatment as usual (k = 2), waiting list (k = 11), phone monitoring (k = 1), nontrauma writing (k = 1), general support (k = 1), and supportive counseling (k = 1). A moderate- to large-sized effect favouring TF-GSH was observed for PTSD (k = 17, g = -0.81, 95% confidence interval [CI]: -1.24, -0.39) and a moderate-sized effect was observed for depressive (k = 13, g = -0.73, 95% CI: -1.16, -0.31) and anxiety (k = 11, g = -0.72, 95% CI: -1.18, -0.27) symptoms, with considerable heterogeneity. Moderator analyses were all not statistically significant. Results indicate that TF-GSH is a promising treatment for PTSD and comorbid depressive and anxiety symptoms. We discuss the nature, extent, and quality of the literature to provide a point of departure for future research. TF-GSH (and unguided self-help) may not be appropriate for certain individuals at certain times. Exploring a broad range of treatment delivery modalities will move the field closer towards a model of evidence-based care in which the likely appropriate dose and type of intervention can be matched to individuals based on presenting problems and other variables.

Siddiqui, T., et al. (2023). ""Efficacy and safety of oteseconazole in recurrent vulvovaginal candidiasis (RVVC) - A systematic review and meta-analysis"." Heliyon 9(11): e20495.
	Background: Recurrent Vulvovaginal Candidiasis (RVVC) is defined as 3 or more episodes of symptomatic Vulvovaginal Candidiasis (VVC) within a year. Out of 75 % of women with VVC, this debilitating infection is experienced by 9 % of women. Although standard guidelines recommend oral and topical fluconazole as its treatment regimen, approval of another drug Oteseconazole has drawn the attention because of its better safety profile and lower recurrence rate by its use.; Aim: The purpose of our Meta-analysis is to evaluate the safety and efficacy of Oteseconazole (Vivjoa) (VT-1161) in the treatment of Recurrent Vulvovaginal Candidiasis (RVVC).; Methodology: Four databases namely PubMed, Google Scholar, Cochrane CENTRAL and Clinical Trial.gov were used from inception till June 2023. Studies that met the predefined inclusion criteria were statistically analyzed on RevMan (Version 5.4). A random effect model was used to pool the studies. A p value of less than 0.05 was considered significant and results were presented as Odds ratio with 95 % Confidence Intervals (CIs).; Result: The pooled analysis of our selected studies showed that Oteseconazole was associated with significantly reduced incidence of Recurrent Vulvovaginal Candidiasis (OR = 0.07; 95 % CI = 0.05-0.11; p < 0.00001, I 2 = 0 %) through week 48. Additionally, Vivjoa has also been shown by our analysis to reduce incidence of RVVC through week 24. (OR = 0.05; 95 % CI = 0.03-0.09; p < 0.00001, I 2 = 0 %) Furthermore, Oteseconazole was non-significantly associated with developing serious adverse effects during the treatment for Recurrent Vulvovaginal Candidiasis in comparison to the placebo (OR = 0.79; 95 % CI = 0.33-1.89; p = 0.60, I2 = 0 %).; Conclusion: The available evidence suggests Oteseconazole to be safer and more efficacious. However, limited patient population points towards the need of further large and dedicated trials for definitive conclusion.; 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 Authors.)

Sıdıka, P. A. (2022). "Effect of Progressive Muscle Relaxation Exercise on Primary Dysmenorrhea Menstrual Symptoms and Quality of Life." ClinicalTrials.gov.
	Non‐pharmacological methods include body therapies, mind‐body based therapies, Chinese herbal medicine and vitamin mineral supplements. In particular, physical exercises, acupuncture, aromatherapy, Chinese herbal medicine and yoga are non‐pharmacological methods frequently used in the management of dysmenorrhea. Progressive muscle relaxation exercise (PMRE), one of the mind‐body based therapies, is frequently used in pain management, but there are limited studies on its effect on primary dysmenorrhea. Progressive muscle relaxation exercise focuses on recognizing muscle tension and then reducing this tension. Studies conducted in different populations have found that progressive muscle relaxation exercise reduces pain and improves quality of life. There is insufficient evidence for the effect of progressive muscle relaxation exercises in the management of primary dysmenorrhea. Therefore, in this study, it was aimed to evaluate the effect of progressive muscle relaxation exercise on dysmenorrhea, menstrual symptoms and quality of life in university students with common primary dysmenorrhea. METHOD Type of Research The research is a single center, parallel group block randomized controlled experimental study. Location and Characteristics of the Research This study will be conducted in the Department of Nursing, Faculty of Health Sciences, of a state university in Turkey. Population and Sample of the Research The universe of the research will be Gazi University Faculty of Health Sciences, third year and last year nursing students (N: 451). In order to determine the sample size in the research, power analysis was performed using the G Power 3.1.0 program. For this purpose, the study results of Sis Çelik and Ejder Apay (2021), which were similar to our study, were taken as reference. According to the power analysis made by calculating the effect size; It was determined that the sample of the study should consist of a total of 24 participants, 12 in the intervention group and 12 in the control group (α=0.05, 1‐β =0.99, Effect size d= 1.9111974, tail(s)=two). Considering the drop out rate of the study as 36%, a total of 42 people, 21 in each group, will be randomized. Inclusion criteria for the study; ‐ Having primary dysmenorrhea, ‐ Being Nulligravida, ‐ Having a history of regular menstrual cycles in the last six months (cycle duration 21‐35 days), ‐ Not using hormonal contraceptives, ‐ A score of 5 or more on the visual analog scale (VAS). ‐ Not to have metabolic disease, cancer, heart disease and diabetes, diagnosed psychiatric disease, and not using antidepressant medication that would prevent him from performing PCGE. ‐ Not doing any other body‐mind based practice ‐ Using a smartphone ‐ Not having any communication problems (mental, auditory, visual, etc.) ‐ To be willing to participate in the study. Exclusion criteria, ‐ Use of complementary therapies, anti‐inflammatory therapy, antidepressants or anxiolytics during the study ‐ Occurrence of menstrual cycle irregularity ‐ Performing PKGE 3 times a week or less in a row Validity‐Reliability Selection criteria have been determined to prevent selection bias. Inclusion criteria for the study; Having primary dysmonaea, being nulligravida, having a history of regular menstrual cycles in the last six months (cycle duration 21‐35 days), not using hormonal contraceptives, having a score of 5 or more on the visual analog scale (VAS) Metabolic disease that will prevent performing PCI, Not having cancer, heart disease and diabetes, not having a diagnosed psychiatric disease and not using antidepressant drugs, not using anti‐inflammatory drugs, not using any other body‐mind based application, using a smart phone, having any communication problems (mental, auditory, visual, etc.) .) and volunteering to participate in the study. Block randomization will be used for randomization. Permutation series and assignment list to be used for group assignments will be created in computer environment (www.randomizer.org). In this study on pplication bias, researcher and participant blinding will not be done. Because the researcher will make the application himself and placebo cannot be used in the intervention. Blinding will not be done in this study. Pre‐tests to prevent detection bias and randomization assignment of women will be done by an independent nurse. The data obtained from the research aimed at preventing reporting bias will be coded as A and B by an independent researcher and transferred to the SPSS program. Analysis of the data will also be done by an independent statistician. In order to prevent attrition bias, Intention to Treat Test will be used in case of decrease/reduction in the sample group or if post‐tests are not filled. Application Data Collection Tools The data of the research; Personal information form will be collected using Visual Analogue Scale (VAS), SF‐12 Quality of Life Scale Short Form, Menstrual Symptom Scale, Dysmenorrhea Monitoring Form. Personal Information Form: The personal information form consists of 27 questions. It was prepared by researchers in line with literature information in order to identify students with primary and secondary dysmenorrhea (Ferries‐Rowe et al., 2020; ACOG, 2018). In addition, the sociodemographic characteristics of the students and their methods of coping with dysmenorrhea, if any, were also questioned in the prepared form. Students who do not meet the eligibility criteria of the study will be excluded. Visual Analog Scale (VAS): In the 10 cm Visual Analog Scale (VAS), "0" indicates no pain and "10" indicates the most severe level of pain. As the score on the scale increases, the severity of the pain increases. Short Form of Quality of Life Scale SF‐12 It was created as a short form of SF‐36, which was developed by Ware et al. in 1995 to evaluate quality of life. It contains the same sub‐dimensions as the SF‐36. The Turkish validity and reliability study of the SF‐12 scale was conducted by Soylu and Kütük (2021). The scale is used in the evaluation of physical (FIM‐12) and mental health (MBI‐12), which are the two main components of general health status. The scale includes physical functionality (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functionality (1 item), emotional role (2 items), and mental health. It consists of 8 sub‐dimensions, including health (2 items) and 12 items. The higher the score obtained from the scale, the higher the quality of life. The Cronbach's alpha value of the FIM‐12 sub‐dimension of the scale was 0.73, and the Cronbach's alpha value of the MDS‐12 sub‐dimension was 0.72. Menstruation Symptom Scale The Menstruation Symptom Scale (MSI) was developed by Chesney and Tasto in 1975 to assess menstrual pain and symptoms. Turkish validity and reliability study Güvenç et al. (2014) by It consists of 3 sub‐dimensions including Negative Effects/Somatic Complaints, Pain Symptoms and Coping Methods. The scale has a 5‐point likert structure. The scale score is calculated by calculating the MSÖ score, the total score average of the items in the scale. An increase in the mean score indicates an increase in the severity of menstrual symptoms. The score obtained from the sub‐dimensions is calculated by taking the total score average of the items in the sub‐dimensions. An increase in the score indicates that the severity of the symptoms in that sub‐dimension increases. The total Cronbach's alpha value of the scale was found to be 0.92. The Cronbach's alpha value for the sub‐dimensions was 0.90 for "Negative Effects/Somatic Complaints", 0.81 for "Pain Symptoms" and 0.74 for "Coping Methods". Dysmenorrhea Monitoring Form: This form was prepared by the authors in accordance with the literature (Coşkuner and Kömürcü, 2014; Çelik and Apay 2021). The form provides a prospective measurement of pain intensity. Students in the experimental and control groups will be asked to record their initial (first three days of the first cycle) pain severity level on the VAS form. Progr sive relaxation exercises will be used for two menstrual cycles in the experimental group. The students in the experimental group will be asked to record on the VAS the dysmenorrhea felt before and after PBGE in the first three days of the menstrual cycle. The control group would not receive any intervention for dysmenorrhea pain in the second and third cycles when they marked their pain level. Progressive Muscle Relaxation Exercise Tracking Chart It was prepared by the researcher in order to facilitate the follow‐up of female students' PCGE application status. At the top of the chart are the student's name‐surname and the start date of the application. On the other hand, the table includes the application weeks and whether the PCG is applied or not. The duration of the schedule application will vary according to the length of the menstrual cycle. For each week, boxes have been created to mark the days of the week and whether the application has been made or not. In the first menstrual cycle after being included in the study, no marking will be made on the chart. From the end of the first cycle, progressive muscle relaxation exercise should be performed 4 times a week for two menstrual cycles and recorded in the chart. Analysis of Data The data will be stored in the computer environment using the Statistical Package for Social Sciences 20 (SPSS 20) statistical program. Kolmogorov‐Smirnov test will be performed in order to determine the conformity of the scale scores to the normal distribution. Non‐parametric tests (Mann‐Whitney U test, Wilcoxon Test) will be used in statistical analysis since it was determined that the scores were not suitable for normal distribution. Mean and standard deviation will be used in the evaluation of quantitative variables, and frequency and percentage values will be used in the evaluation of qualitative variables. The p=0.05 value will be accepted as statistical significance in all statistical analyses. The effect size was determined by calculating Cohen's d (small‐0.2, medium‐0.5 and large effect‐0.8). The Cronbach‐α coefficient will be used to evaluate the reliability of the scales used in the study. Ethical Dimension of Research Before the application, written permission from the institution where the research was conducted, approval from the Ethics Committee and written informed consent from the students will be obtained. After the implementation of the research is over, it will be planned to teach and practice progressive muscle relaxation exercises to the students in the control group.

Sijia, X., et al. (2022). "Conventional surgery Combined with traditional Chinese medicinal retention enema for tubal obstructive infertility: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Silverberg, K. (2022). "Prospective, Randomized Trial Comparing ICSI to Insemination for Non-Male Factor Patients Undergoing PGT-A." ClinicalTrials.gov.
	Intracytoplasmic sperm injection (ICSI) is a procedure performed during in vitro fertilization (IVF) in which a single sperm is injected directly into an oocyte. This procedure was developed for male factor infertility due to its requirement for a very small number of viable sperm. Fertilization rates have been noted to be approximately 60‐70%, comparable to traditional insemination. Its use has expanded and is now recommended for IVF cycles in which preimplantation genetic testing for aneuploidies (PGT‐A) is performed on blastocysts. With PGT‐A, euploid embryos can be selected to transfer, ultimately increasing implantation rates, raising ongoing pregnancy rates, and reducing the incidence of miscarriage. The recommendation to utilize ICSI for all PGT‐A cycles was initially based on ensuring monospermic fertilization and minimizing contamination from additional sperm attached to the oocyte's zona pellucida during the use of polymerase chain reaction (PCR) for genetic testing. However, this is of less concern with newer next generation sequencing molecular techniques that are now used and enable much higher resolution analysis. It has been suggested that ICSI may slightly increase the risk of imprinting disorders and birth defects, and significantly increases the cost of IVF. Meiosis II occurs during oocyte fertilization, and as such, any disruption of the meiosis apparatus could potentially lead to errors in chromosomal division. We hypothesize that the ICSI procedure may interfere with the normal meiosis process and lead to a higher rate of aneuploid blastocysts. Our study will randomly assign patients with non‐male factor infertility undergoing IVF with PGT‐A at Texas Fertility Center to either conventional insemination or ICSI. Women aged 18‐39 years old with at least 10 oocytes following retrieval will be included. Initial semen analysis must have greater than or equal to 16 million sperm/mL, 42% motile sperm, 16.4 million total motile sperm, 30% progressive motility, and 4% normal morphology (as defined by WHO 6th edition). Patients will be excluded for any of the following: any fertilization failure or more than one implantation failure from previous IVF cycles; male factor infertility as defined by sperm concentration less than 16 million sperm/mL, motility less than 42%, total motile count less than 16.4 million, progressive motility less than 30%, and normal morphology less than 4%; female partner over age 39 years old; 9 or fewer oocytes following retrieval; couples requiring single gene analysis by preimplantation genetic testing for monogenic disorders (PGT‐M); ICSI for any reason other than PGT‐A. The female partner will undergo controlled ovarian stimulation with a protocol chosen by each patient's physician based on patient age, history, and ovarian reserve. Recombinant follicle stimulating hormone (FSH) (Gonal F or Follistim) and human menopausal gonadotropin (Menopur) will be used for stimulation. Gonadotropin‐releasing hormone (GnRH) agonist (Lupron) or antagonist (Cetrotide or Ganirelix) with or without oral contraceptive pills (OCPs) or with estradiol priming will be used for suppression of ovulation. The patient will be monitored every 1‐3 days utilizing ultrasound to measure follicular growth as well as blood estradiol levels, with medication and dosing adjusted accordingly. Oocyte maturation will be triggered with gonadotropin‐releasing hormone (GnRH) agonist (Lupron) and/or human chorionic gonadotropin (Novarel or Pregnyl). Oocyte retrieval will occur 36 hours after trigger according to standard protocols at our center. Oocytes will be washed with multipurpose handling medium (MHM) plus 0.5% human serum albumin (HSA). Excess cumulus cells and blood will be trimmed. Oocytes will be transferred to a dish containing Irvine Scientific Continuous Cell Culture Complete Medium with two oocytes per dish. The dish will then be transferred to the incubator. Oocytes designated for ICSI will be immediately exposed to hyaluronidase to strip the cumulus and coronal cells. Embryol ists will assess the maturation status under inverted microscopy. ICSI will be performed on all mature metaphase II oocytes 4 hours after retrieval. Injected oocytes will then be placed in a fresh culture dish and returned to the incubator. For oocytes designated for conventional insemination, insemination will occur 4‐6 hours post‐retrieval. Sperm will be collected as a fresh specimen and washed with Irvine Scientific Continuous Single Culture‐NX. Sperm concentration and motility will be assessed before and after washing according to WHO 6th edition criteria. Sperm will be prepared to achieve a concentration of 200,000 sperm per 100 microliter drop. 6 drops of prepared sperm will be added to each dish. The following morning after ICSI or conventional insemination (Day 1), oocytes will be examined for fertilization. Zygotes with two pronuclei (2PN) will be kept in group culture to be assessed again on Days 5, 6, and 7. Embryos that reach the blastocyst stage will be morphologically graded by our embryologists. The Inner Cell Mass (ICM) and trophectoderm will each be given a grade of Good (G), Fair (F), or Poor (P). Blastocysts with grades G or F will undergo trophectoderm biopsy and subsequent vitrification. Trophectoderm biopsy will be performed using a standard protocol: Hatching trophoblast cells opposite the inner cell mass will be gently aspirated into the biopsy pipet. The SaturnActive laser will be used to separate 3‐5 cells. Biopsied cells will be prepared and loaded in PCR tubes according to the PGT‐A center protocols and stored at ‐20 degrees Celsius until transportation to the testing center. Next Generation Sequencing will be used to analyze samples at a PGT testing center (Ovation Genetics, Cooper Genomics, Natera, RGI, or Genomic Prediction). Copy number variations will be used to diagnose ploidy status. Euploidy will be defined as a normal number of chromosomes. Aneuploidy will be defined as an abnormal number of chromosomes. Mosaicism will be defined as 30‐70% mosaicism, whereas less than 30% mosaicism will be considered euploidy, and greater than 70% mosaicism will be considered aneuploidy. PGT‐A outcomes will be analyzed for percentage of euploid, aneuploid, mosaic, and no result embryos.

Simental-Mendía Luis, E., et al. (2022). "Effect of Curcumin on Glycaemic and Lipid Parameters in Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." Reproductive Sciences 29(11): 3124-3133.
	Polycystic ovary syndrome (PCOS) is a heterogeneous condition that affects women of reproductive age. It is associated with menstrual disturbances, hyperandrogenism, and polycystic ovaries. In addition to this, it results in altered anthropometric parameters, insulin resistance, and subsequently untoward cardio-metabolic sequelae. Therapeutic approaches that target weight loss and improve insulin sensitivity are used to address the metabolic complications in PCOS. Curcumin is a phytochemical which exhibits anti-inflammatory and anti-oxidant properties, and therefore, its use in PCOS has been a subject of substantial interest and research. The aim of this study was to synthesize the existing evidence on the effects of curcumin on glycaemic and lipid parameters in PCOS. We searched PubMed, Embase, Web of Science, Scopus, and ClinicalTrials databases from inception to June 07, 2021. Only randomized controlled trials (RCT) presenting sufficient data on glycemic and lipid parameters in patients with PCOS at baseline and the end of the follow-up period in each group were included. Meta-analysis of five RCTs showed a significant reduction on fasting glucose (WMD: - 3.68 mg/dL, 95% CI: - 5.11, - 2.25, p < 0.00001, I 2 = 18%), insulin levels (WMD: - 1.72 µUI/mL, 95% CI: - 2.53, -0.92, p < 0001, I 2 = 41%), and HOMA-IR index (WMD: - 0.94, 95% CI: - 1.73, - 0.16, p = 0.02, I 2 = 90%) after curcumin therapy. None of the lipid indices were significantly altered by curcumin. Curcumin administration in PCOS resulted in significant improvement in glycaemic parameters; however, no significant changes were seen in lipid parameters with its use. (© 2021. Society for Reproductive Investigation.)

Simion, L., et al. (2023). "Analysis of Efficacy-To-Safety Ratio of Angiogenesis-Inhibitors Based Therapies in Ovarian Cancer: A Systematic Review and Meta-Analysis." Diagnostics 13(6).
	(1) Background: Among new anti-angiogenesis agents being developed and ever-changing guidelines indications, the question of the benefits/safety ratio remains unclear. (2) Methods: We performed a systematic review combined with a meta-analysis of 23 randomized controlled trials (12,081 patients), evaluating overall survival (OS), progression free survival (PFS) and toxicity (grade ≥ 3 toxic effects, type, and number of all adverse effects. (3) Results: The analysis showed improvement of pooled-PFS (HR, 0.71; 95% CI, 0.64-0.78; I 2 = 77%; p < 0.00001) in first-line (HR, 0.85; 95% CI, 0.78-0.93; p = 0.0003) or recurrent cancer (HR, 0.62; 95% CI, 0.56-0.70; p < 0.00001) and regardless of the type of anti-angiogenesis drug used (Vascular endothelial growth factor (VEGF) inhibitors, VEGF-receptors (VEGF-R) inhibitors or angiopoietin inhibitors). Improved OS was also observed (HR, 0.95; 95% CI, 0.90-0.99; p = 0.03). OS benefits were only observed in recurrent neoplasms, both platinum-sensitive and platinum-resistant neoplasms. Grade ≥ 3 adverse effects were increased across all trials. Anti-angiogenetic therapy increased the risk of hypertension, infection, thromboembolic/hemorrhagic events, and gastro-intestinal perforations but not the risk of wound-related issues, anemia or posterior leukoencephalopathy syndrome. (4) Conclusions: Although angiogenesis inhibitors improve PFS, there are little-to-no OS benefits. Given the high risk of severe adverse reactions, a careful selection of patients is required for obtaining the best results possible.

Simon James, A., et al. (2023). "Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1)." Menopause 30(3): 239-246.
	Objective: Neurokinin (NK)-3 and NK-1 receptors have been implicated in the etiology of vasomotor symptoms (VMS) and sleep disturbances associated with menopause. This phase 2b, adaptive, dose-range finding study aimed to assess the efficacy and safety of multiple doses of elinzanetant (NT-814), a selective NK-1,3 receptor antagonist, in women experiencing VMS associated with menopause, and investigate the impact of elinzanetant on sleep and quality of life.; Methods: Postmenopausal women aged 40 to 65 years who experienced seven or more moderate-to-severe VMS per day were randomized to receive elinzanetant 40, 80, 120, or 160 mg or placebo once daily using an adaptive design algorithm. Coprimary endpoints were reduction in mean frequency and severity of moderate-to-severe VMS at weeks 4 and 12. Secondary endpoints included patient-reported assessments of sleep and quality of life.; Results: Elinzanetant 120 mg and 160 mg achieved reductions in VMS frequency versus placebo from week 1 throughout 12 weeks of treatment. Least square mean reductions were statistically significant versus placebo at both primary endpoint time points for elinzanetant 120 mg (week 4: -3.93 [SE, 1.02], P < 0.001; week 12: -2.95 [1.15], P = 0.01) and at week 4 for elinzanetant 160 mg (-2.63 [1.03]; P = 0.01). Both doses also led to clinically meaningful improvements in measures of sleep and quality of life. All doses of elinzanetant were well tolerated.; Conclusions: Elinzanetant is an effective and well-tolerated nonhormone treatment option for postmenopausal women with VMS and associated sleep disturbance. Elinzanetant also improves quality of life in women with VMS.; Competing Interests: Financial disclosure/conflicts of interest: C.C. and L.Z. are employees of Bayer CC AG. C.S. is an employee of Bayer AG. M.K., S.P., E.B., S.S., and M.T. are employees of NeRRe Therapeutics. J.B., as an employee of Cytel Inc, was a paid statistical consultant on this trial. R.A.A. has undertaken consultancy work for NeRRe Therapeutics and Sojournix Inc. J.A.S. has grant/research support from AbbVie, Inc, Bayer Healthcare LLC, Daré Bioscience, Ipsen, Mylan/Viatris Inc, Myovant Sciences, ObsEva SA, Sebela Pharmaceuticals Inc, and Viveve Medical; has been a consultant/advisory boards of Bayer HealthCare Pharmaceuticals Inc, Besins Healthcare, California Institute of Integral Studies, Camargo Pharmaceutical Services, LLC, Covance Inc, Daré Bioscience, DEKA M.E.L.A. S.r.l., Femasys Inc, KaNDy/NeRRe Therapeutics Ltd, Khyria, Madorra Pty Ltd, Mitsubishi Tanabe Pharma Development America, Inc, QUE Oncology Pty, Limited, Scynexis Inc, Sebela Pharmaceuticals, Inc, Sprout Pharmaceuticals, Inc, and Vella Bioscience Inc; has served on the Speaker's bureaus of Mayne Pharma, Inc, Myovant Sciences, Inc, Pfizer Inc, Pharmavite LLC, Scynexis Inc, and TherapeuticsMD; and is a stockholder (direct purchase) in Sermonix Pharmaceuticals. N.P. has undertaken consultancy and speaker's bureau work for a number of pharmaceutical companies including Bayer AG. H.J. has received grant funding from National Institutes of Health, Merck, Pfizer, and Hello Therapeutics; has undertaken consultancy work for Bayer, Jazz, and Eisai; and her spouse is an employee at Arsenal Biosciences and has equity at Merck. (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The North American Menopause Society.)

Simon James, A., et al. (2023). "Efficacy, tolerability, and endometrial safety of ospemifene compared with current therapies for the treatment of vulvovaginal atrophy: a systematic literature review and network meta-analysis." Menopause 30(8): 855-866.
	Importance: Ospemifene is a novel selective estrogen receptor modulator developed for the treatment of moderate to severe postmenopausal vulvovaginal atrophy (VVA).; Objective: The aim of the study is to perform a systematic literature review (SLR) and network meta-analysis (NMA) to assess the efficacy and safety of ospemifene compared with other therapies used in the treatment of VVA in North America and Europe.; Evidence Review: Electronic database searches were conducted in November 2021 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized or nonrandomized controlled trials targeting postmenopausal women with moderate to severe dyspareunia and/or vaginal dryness and involving ospemifene or at least one VVA local treatment were considered. Efficacy data included changes from baseline in superficial and parabasal cells, vaginal pH, and the most bothersome symptom of vaginal dryness or dyspareunia, as required for regulatory approval. Endometrial outcomes were endometrial thickness and histologic classifications, including endometrial polyp, hyperplasia, and cancer. For efficacy and safety outcomes, a Bayesian NMA was performed. Endometrial outcomes were compared in descriptive analyses.; Findings: A total of 44 controlled trials met the eligibility criteria ( N = 12,637 participants). Network meta-analysis results showed that ospemifene was not statistically different from other active therapies in most efficacy and safety results. For all treatments, including ospemifene, the posttreatment endometrial thickness values (up to 52 wk of treatment) were under the recognized clinical threshold value of 4 mm for significant risk of endometrial pathology. Specifically, for women treated with ospemifene, endometrial thickness ranged between 2.1 and 2.3 mm at baseline and 2.5 and 3.2 mm after treatment. No cases of endometrial carcinoma or hyperplasia were observed in ospemifene trials, nor polyps with atypical hyperplasia or cancer after up to 52 weeks of treatment.; Conclusions and Relevance: Ospemifene is an efficacious, well-tolerated, and safe therapeutic option for postmenopausal women with moderate to severe symptoms of VVA. Efficacy and safety outcomes with ospemifene are similar to other VVA therapies in North America and Europe.; Competing Interests: Financial disclosure/conflicts of interest: C.B. is a partner at PeriPharm, Inc, and A.C. and C.R. are employees at PeriPharm, Inc, a company that has served as a consultant to Duchesnay, Inc, and has received funding from Duchesnay, Inc. A.F. and D.B. have served as consultants for Duchesnay, Inc. D.B. currently receives funding from AbbVie, Bayer, BioSyent, Duchesnay, Merck, Organon, Pfizer, and Searchlight. R.M. is an employee at Duchesnay, Inc. J.A.S. receives grant/research support from the following: AbbVie, Bayer Healthcare, Dare Bioscience, Enteris BioPharma, Mylan/Viatris, Myovant Sciences, ObsEva, and Viveve Medical; is on consulting/advisory boards of the following: Bayer Healthcare, Besins Healthcare, California Institute of Integral Studies (CIIS), Dare Bioscience, DEKA M.E.L.A S.r.l., Duchesnay, Inc, Femasys, KaNDy/NeRRe Therapeutics, Khyria, Madorra, Mitsubishi Tanabe Pharma Development America, QUE Oncology, Scynexis, Inc, Sprout Pharmaceuticals, Vella Bioscience; serves on the speaker's bureaus of the following: Mayne Pharma, Myovant Sciences, Pfizer, Pharmavite, Scynexis, and TherapeuticsMD; and is a stockholder (direct purchase) in Sermonix Pharmaceuticals. (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The North American Menopause Society.)

Simone, R., et al. (2021). "Effectiveness of injection therapy for chronic pelvic pain in female patients: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Simopoulou, M., et al. (2019). "Investigating the Optimal Time for Intrauterine Human Chorionic Gonadotropin Infusion in Order to Improve IVF Outcome: A Systematic Review and Meta-Analysis." In Vivo 33(6): 1737-1749.
	Background/aim: Studies on the impact of intrauterine human Chorionic Gonadotropin (hCG) administration in order to improve the In Vitro Fertilization (IVF) outcome have yielded conflicting results. The aim of the present systematic review and meta-analysis is to investigate whether timing of intrauterine hCG administration prior to embryo transfer affects its efficiency.; Materials and Methods: A systematic search of the literature on Pubmed/Medline, Embase and Cochrane databases was performed. Only Randomized Control Trials were included in this meta-analysis.; Results: Live birth rates were not improved following hCG administration (RR=1.13, 95%CI=0.88-1.46, p=0.34) in the pooled results. Combined live birth and ongoing pregnancy rates were borderline statistically significant following hCG administration (RR=1.27, 95%CI=1.00-1.62, p=0.05). Following subgroup analysis regarding live birth and ongoing pregnancy rates, only the 5-12 minutes prior to the embryo transfer group reported a statistically significant improvement.; Conclusion: Intrauterine infusion of hCG within an IVF-Intracytoplasmic Sperm Injection (ICSI) cycle improves outcome only when administered 5-12 min prior to embryo transfer. (Copyright© 2019, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Singla, D. R., et al. (2023). "Protocol for an economic evaluation of scalable strategies to improve mental health among perinatal women: non-specialist care delivered via telemedicine vs. specialist care delivered in-person." BMC Psychiatry 23(1): 817.
	BACKGROUND: Perinatal depression affects an estimated 1 in 5 women in North America during the perinatal period, with annualized lifetime costs estimated at $20.6 billion CAD in Canada and over $45.9 billion USD in the US. Access to psychological treatments remains limited for most perinatal women suffering from depression and anxiety. Some barriers to effective care can be addressed through task-sharing to non-specialist providers and through telemedicine platforms. The cost-effectiveness of these strategies compared to traditional specialist and in-person models remains unknown. This protocol describes an economic evaluation of non-specialist providers and telemedicine, in comparison to specialist providers and in-person sessions within the ongoing Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) trial. METHODS: The economic evaluation will be undertaken alongside the SUMMIT trial. SUMMIT is a pragmatic, randomized, non-inferiority trial across five North American study sites (N = 1,226) of the comparable effectiveness of two types of providers (specialist vs. non-specialist) and delivery modes (telemedicine vs. in-person) of a behavioural activation treatment for perinatal depressive and anxiety symptoms. The primary economic evaluation will be a cost-utility analysis. The outcome will be the incremental cost-effectiveness ratio, which will be expressed as the additional cost required to achieve an additional quality-adjusted life-year, as assessed by the EuroQol 5-Dimension 5-Level instrument. A secondary cost-effectiveness analysis will use participants' depressive symptom scores. A micro-costing analysis will be conducted to estimate the resources/costs required to implement and sustain the interventions; healthcare resource utilization will be captured via self-report. Data will be pooled and analysed using uniform price and utility weights to determine cost-utility across all trial sites. Secondary country-specific cost-utility and cost-effectiveness analyses will also be completed. Sensitivity analyses will be conducted, and cost-effectiveness acceptability-curves will be generated, in all instances. DISCUSSION: Results of this study are expected to inform key decisions related to dissemination and scale up of evidence-based psychological interventions in Canada, the US, and possibly worldwide. There is potential impact on real-world practice by informing decision makers of the long-term savings to the larger healthcare setting in services to support perinatal women with common mental health conditions.

Siristatidis Charalampos, S., et al. (2020). "Endometrial injection of embryo culture supernatant for subfertile women in assisted reproduction." The Cochrane Database of Systematic Reviews 8: CD013063.
	Background: Despite substantial improvements in the success of assisted reproduction techniques (ART), live birth rates may remain consistently low, and practitioners may look for innovative treatments to improve the outcomes. The injection of embryo culture supernatant in the endometrial cavity can be undertaken at various time intervals before embryo transfer. It provides an altered endometrial environment through the secretion of factors considered to facilitate implantation. It is proposed that injection of the supernatant into the endometrial cavity prior to embryo transfer will stimulate the endometrium and provide better conditions for implantation to take place. An increased implantation rate would subsequently increase rates of clinical pregnancy and live birth, but current robust evidence on the efficacy of injected embryo culture supernatant is lacking.; Objectives: To evaluate the effectiveness and safety of endometrial injection of embryo culture supernatant before embryo transfer in women undergoing ART.; Search Methods: Our search strategies were designed with the help of the Cochrane Gynaecology and Fertility Group Information Specialist. We sought to identify all published and unpublished randomised controlled trials (RCTs) meeting inclusion criteria. Searches were performed on 2 December 2019. We searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL, MEDLINE, Embase, CINAHL, trials registries and grey literature. We made further searches in the UK National Institute for Health and Care Excellence (NICE) fertility assessment and treatment guidelines. We handsearched reference lists of relevant systematic reviews and RCTs, together with searches of PubMed and Google for any recent trials that have not yet been indexed in the major databases. We had no language or location restrictions.; Selection Criteria: We included RCTs testing the use of endometrial injection of embryo culture supernatant before embryo transfer during an ART cycle, compared with the non-use of this intervention, the use of placebo or the use of any other similar drug.; Data Collection and Analysis: Two review authors independently selected studies, assessed risk of bias, extracted data from studies and attempted to contact the authors where data were missing. We pooled studies using a fixed-effect model. Our primary outcomes were live birth/ongoing pregnancy and miscarriage. We performed statistical analysis using Review Manager 5. We assessed evidence quality using GRADE methods.; Main Results: We found five RCTs suitable for inclusion in the review (526 women analysed). We made two comparisons: embryo culture supernatant use versus standard care or no intervention; and embryo culture supernatant use versus culture medium. All studies were published as full-text articles. Data derived from the reports or through direct communication with investigators were available for the final meta-analysis performed. The GRADE evidence quality of studies ranged from very low-quality to moderate-quality. Factors reducing evidence quality included high risk of bias due to lack of blinding, unclear risk of publication bias and selective outcome reporting, serious inconsistency among study outcomes, and serious imprecision due to wide confidence intervals (CIs) and low numbers of events. Comparison 1. Endometrial injection of embryo culture supernatant before embryo transfer versus standard care or no intervention: One study reported live birth only and two reported the composite outcome live birth and ongoing pregnancy. We are uncertain whether endometrial injection of embryo culture supernatant before embryo transfer during an ART cycle improves live birth/ongoing pregnancy rates compared to no intervention (odds ratio (OR) 1.11, 95% CI 0.73 to 1.70; 3 RCTs; n = 340, I 2 = 84%; very low-quality evidence). Results suggest that if the chance of live birth/ongoing pregnancy following placebo or no treatment is assumed to be 42%, the chance following the endometrial injection of embryo culture su ernatant before embryo transfer would vary between 22% and 81%. We are also uncertain whether the endometrial injection of embryo culture supernatant could decrease miscarriage rates, compared to no intervention (OR 0.89, 95% CI 0.44 to 1.78, 4 RCTs, n = 430, I 2 = 58%, very low-quality evidence). Results suggest that if the chance of miscarriage following placebo or no treatment is assumed to be 9%, the chance following injection of embryo culture supernatant would vary between 3% and 30%. Concerning the secondary outcomes, we are uncertain whether the injection of embryo culture supernatant prior to embryo transfer could increase clinical pregnancy rates (OR 1.13, 95% CI 0.80 to 1.61; 5 RCTs; n = 526, I 2 = 0%; very low-quality evidence), decrease ectopic pregnancy rates (OR 0.32, 95% CI 0.01 to 8.24; n = 250; 2 RCTs; I 2 = 41%; very low-quality evidence), decrease multiple pregnancy rates (OR 0.70, 95% CI 0.26 to 1.83; 2 RCTs; n = 150; I 2 = 63%; very low-quality evidence), or decrease preterm delivery rates (OR 0.63, 95% CI 0.17 to 2.42; 1 RCT; n = 90; I 2 = 0%; very low-quality evidence), compared to no intervention. Finally, there may have been little or no difference in foetal abnormality rates between the two groups (OR 3.10, 95% CI 0.12 to 79.23; 1 RCT; n = 60; I 2 = 0%; low-quality evidence). Comparison 2. Endometrial injection of embryo culture supernatant versus endometrial injection of culture medium before embryo transfer We are uncertain whether the use of embryo culture supernatant improves clinical pregnancy rates, compared to the use of culture medium (OR 1.09, 95% CI 0.48 to 2.46; n = 96; 1 RCT; very low-quality evidence). No study reported live birth/ongoing pregnancy, miscarriage, ectopic or multiple pregnancy, preterm delivery or foetal abnormalities.; Authors' Conclusions: We are uncertain whether the addition of endometrial injection of embryo culture supernatant before embryo transfer as a routine method for the treatment of women undergoing ART can improve pregnancy outcomes. This conclusion is based on current available data from five RCTs, with evidence quality ranging from very low to moderate across studies. Further large well-designed RCTs reporting on live births and adverse clinical outcomes are still required to clarify the exact role of endometrial injection of embryo culture supernatant before embryo transfer. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Sirkeci, F., et al. (2023). "Effects on heavy menstrual bleeding and pregnancy of uterine artery embolization (UAE) or myomectomy for women with uterine fibroids wishing to avoid hysterectomy: The FEMME randomized controlled trial." International Journal of Gynaecology and Obstetrics 160(2): 492-501.
	Objective: To determine treatment options (myomectomy vs. uterine artery embolization (UAE)) for women wishing to avoid hysterectomy.; Methods: A multicenter randomized controlled trial was conducted on 254 women and data were collected on fibroid-specific quality of life (UFS-QOL), loss of menstrual blood, and pregnancy.; Results: At 4 years, the mean difference in the UFS-QOL was 5.0 points (95% confidence interval (CI) -1.4 to 11.5; P = 0.13) in favor of myomectomy. This was not statistically significant as it was at 2 years. There were no differences in bleeding scores, rates of amenorrhea, or heavy bleeding. Of those who were still menstruating, the majority reported regular or fairly regular periods: 36 of 48 (75%) in the UAE group and 30 of 39 (77%) in the myomectomy group. Twelve women after UAE and six women after myomectomy became pregnant (4 years) with seven and five live births, respectively (hazard ratio 0.48, 95% CI 0.18-1.28). There was no difference between the levels of hormones associated with the uterine reserve in each group.; Conclusion: Leiomyoma are common in reproductive-aged women, causing heavy menses and subfertility. Among women with uterine fibroids, myomectomy resulted in better fibroid-related quality of life at 4 years, compared with UAE but the treatments decreased menstrual bleeding equally. There was also no significant difference in the impact of treatment on ovarian reserve. (© 2022 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Sisi, H., et al. (2023). "Different doses of Vitamin D Supplementation for the treatment of PCOS: A meta-analysis of randomized trials." PROSPERO International prospective register of systematic reviews.
	
Sisu, S. and P. Karam (2022). "The effectiveness of a mobile health intervention for postpartum depression to develop digital therapeutics: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Skaug, K. L., et al. (2024). "Pelvic floor muscle training in female functional fitness exercisers: an assessor-blinded randomised controlled trial." British Journal of Sports Medicine.
	OBJECTIVE: Stress urinary incontinence (SUI) is common among females during functional fitness training, such as CrossFit. The aim of this study was to assess the effect of pelvic floor muscle training (PFMT) on SUI in female functional fitness exercisers. METHOD(S): This was an assessor-blinded randomised controlled trial with a PFMT group (n=22) and a control group (n=25). The PFMT group followed a 16-week home-training programme with 3 sets of 8-12 maximum pelvic floor muscle (PFM) contractions daily and weekly follow-up/reminders by phone. The primary outcome was change in a total score of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF). The secondary outcomes were perceived change of symptoms of SUI, change of PFM strength measured by vaginal manometry and symptoms of anal incontinence (AI) and pelvic organ prolapse (POP). RESULT(S): 47 women, mean age of 33.5 years (SD: 8.1), participated. At 16 weeks, there was a mean difference between groups of -1.4 (95% CI: -2.6 to -0.2) in the change of the ICIQ-UI-SF score in favour of the PFMT group. The PFMT group completed a mean of 70% (SD: 23) of the prescribed protocol. 64% in the PFMT group versus 8% in the control group reported improved symptoms of SUI (p<0.001, relative risk: 7.96, 95%CI, 2.03 to 31.19). There were no group differences in the change of PFM strength or AI/POP symptoms. CONCLUSION(S): A 16-week home-training programme of the PFM led to improvements in SUI in female functional fitness exercisers. However, PFM strength and AI and POP symptoms did not improve significantly in the PFMT group compared with the control group.Copyright © 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.

Skelin, M., et al. (2023). "The effect of PARP inhibitors in homologous recombination proficient ovarian cancer: meta-analysis." Journal of Chemotherapy 35(2): 150-157.
	BRCA1/2 mutations and homologous recombination deficiency (HRD) predispose to increased sensitivity to poly(ADP-ribose)polymerase (PARP) inhibitor treatment. Our aim was to evaluate the PARP inhibitors effect on progression free survival (PFS) in a subpopulation with homologous recombination proficient status (HRD-BRCA-). A systematic literature search was performed for all studies reporting on the effect of PARP inhibitors regarding PFS in the HRD-BRCA- subpopulation, in patients with epithelial ovarian, tubal or primary peritoneal cancers (EOC). Five studies were included, enrolling a population of 3413 patients, with 1070 of them being HRD-BRCA-. PARP inhibitors were effective in the treatment of EOC, regardless of HRD and BRCA status or line of therapy. The estimated pooled effect hazard ratio (HR), assessing PFS for PARP inhibitors compared with control, was 0.76 (95% CI: 0.65-0.88, I 2 = 46%) in the HRD-BRCA- subpopulation. Comparing both subpopulations with HRD positive status (HRD+ BRCA+, HRD+ BRCA-) versus the HRD-BRCA-subpopulation, we have found statistically significant differences in the effect on PFS (P < 0.05 for every interaction test) favouring HRD positive subpopulations (HRD+ BRCA+, HRD+ BRCA-). In the HRD-BRCA- subpopulation of patients, PARP inhibitors used as the second- or later-line of therapy showed more pronounced effect then when given as first line treatment (P = 0.04). Treatment of EOC with PARP inhibitors showed a significant effect regarding PFS in the HRD-BRCA- subpopulation, although a much higher benefit was evident for patients with HRD+ status (HRD+ BRCA+ and HRD+ BRCA-). In the HRD- subpopulation second line PARP inhibitor treatment showed greater benefit compared to first line PARP inhibitor treatment.

Slade, P. P., et al. (2021). "A systematic review of clinical effectiveness of psychological interventions to reduce post traumatic stress symptoms following childbirth and a meta-synthesis of facilitators and barriers to uptake of psychological care." Journal of Affective Disorders 281: 678-694.
	Aim: To review the literature on psychological interventions for post-traumatic stress following childbirth (PTSDFC) and determine clinical effectiveness. To synthesise the qualitative literature on the facilitators and barriers to uptake of care for PTSDFC. Background(s): The context of childbirth trauma differs from that of other events perceived as traumatic. Current guidance on treatment for PTSDFC requires further clarification. Method(s): Web of Knowledge, CINAHL, MEDLINE, PSYCINFO, the Cochrane Central Register of Controlled Trials (CENTRAL), Open Grey, UKCTG, and the ISRCTN were consulted to include journal articles published in English. Articles were segregated according to methodology and appraised using the Mixed Methods Appraisal Tool. Result(s): A total of 5355 papers were identified with five quantitative and 13 qualitative included in the review. Four types of interventions were identified: eye movement desensitisation and reprocessing, trauma focussed CBT, debriefing and expressive writing. All showed some effectiveness in treating PTSDFC. Themes emerging from the meta-synthesis included women finding it difficult to recognise having a problem, needing validation and only seeking help 'at breaking point'. Women wanted health professionals actively asking in a non-judgemental way at different time points and providing support and listening, ideally with continuity of carer to make sense of their experiences. Limitation(s): Quantitative studies were not disaggregated by intervention timing or follow-up duration. A single independent reviewer with team discussion was utilised. Conclusion(s): There is little definitive evidence assessing the effectiveness of psychological interventions for PTSDFC. There are psychological barriers for women accessing help for traumatic childbirth which services can mitigate.Copyright © 2020

Sloth, A., et al. (2022). "Effect of dual trigger on reproductive outcome in low responders: a systematic PRISMA review and meta-analysis." Gynecological Endocrinology 38(3): 213-221.
	Objective: Poor ovarian responders (PORs) pose a great challenge for fertility clinics worldwide. The aim of this study was to examine whether 'dual trigger' consisting of human chorionic gonadotropin (hCG) plus gonadotropin-releasing hormone agonist (GnRHa) is beneficial or not regarding implantation rate, pregnancy rate, and live birth rate for POR. Method(s): This systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. Risk of bias was evaluated by the Newcastle-Ottawa scale or version 2 (NOS) of the Cochrane risk-of-bias tool for randomized trials (ROB2) independently by two authors. Furthermore, RevMan version 5.4 was used to analyze the extracted data and to create an inverse-weighted summary-odds ratio (OR). Result(s): A total of 1390 studies were screened. Seven studies containing a total of 2474 POR were included. The pooled meta-analysis revealed a 1.62-fold increase in clinical pregnancy rate (OR = 1.62 [1.00, 2.62], p =.05) and a 2.65-fold increase in live birth rate (OR = 2.65 [1.66, 4.24], p <.0001) in the dual trigger group compared to hCG trigger. The pooled analysis showed no significant difference between the two groups regarding implantation rate (OR = 1.14 [0.93, 1.39], p =.21). Conclusion(s): The meta-analysis of this study indicates that dual trigger as finale oocyte maturation is advantageous compared to hCG trigger among POR. However, large-scale, high-quality, randomized controlled trials (RCT) are required to confirm this conclusion and fully address the magnitude of this effect.Copyright © 2021 Informa UK Limited, trading as Taylor & Francis Group.

Smith Caroline, A., et al. (2019). "Acupuncture performed around the time of embryo transfer: a systematic review and meta-analysis." Reproductive Biomedicine Online 38(3): 364-379.
	This was a systematic review and meta-analysis to examine the efficacy, effectiveness and safety of acupuncture as an adjunct to embryo transfer compared with controls to improve reproductive outcomes. The primary outcome was clinical pregnancy. Twenty trials and 5130 women were included in the review. The meta-analysis found increased pregnancies (risk ratio [RR] 1.32, 95% confidence interval [CI] 1.07-1.62, 12 trials, 2230 women), live births (RR 1.30, 95% CI 1.00-1.68, 9 trials, 1980 women) and reduced miscarriage (RR 1.43, 95% CI 1.03-1.98, 10 trials, 2042 women) when acupuncture was compared with no adjunctive control. There was significant heterogeneity, but no significant differences between acupuncture and sham controls. Acupuncture may have a significant effect on clinical pregnancy rates, independent of comparator group, when used in women who have had multiple previous IVF cycles, or where there was a low baseline pregnancy rate. The findings suggest acupuncture may be effective when compared with no adjunctive treatment with increased clinical pregnancies, but is not an efficacious treatment when compared with sham controls, although non-specific effects may be active in both acupuncture and sham controls. Future research examining the effects of acupuncture for women with poorer IVF outcomes is warranted. (Copyright © 2018. Published by Elsevier Ltd.)

Sobel Jack, D., et al. (2022). "Efficacy and Safety of Oteseconazole in Recurrent Vulvovaginal Candidiasis." NEJM Evidence 1(8): EVIDoa2100055.
	Oteseconazole for Recurrent Vulvovaginal CandidiasisThese two phase 3, multicenter RCTs evaluated the efficacy of oral oteseconazole in treating recurrent vulvovaginal candidiasis (RVVC). Among women with a history of RVVC, oteseconazole treatment through week 48 led to acute VVC recurrence in about 5% of patients compared to about 40% of patients receiving placebo, P<0.001. Oteseconazole showed potent activity against fluconazole-resistant C. albicans and C. glabrata species; adverse events were similar in both treatment groups.

Sobel, R., et al. (2022). "Efficacy and safety of oral ibrexafungerp for the treatment of acute vulvovaginal candidiasis: a global phase 3, randomised, placebo-controlled superiority study (VANISH 306)." BJOG 129(3): 412-420.
	Objective: To evaluate the efficacy and safety of ibrexafungerp versus placebo for acute vulvovaginal candidiasis (VVC) treatment.; Design: Global phase 3, randomised, placebo-controlled superiority study.; Setting: Study sites in the USA (n = 19) and Bulgaria (n = 18).; Population: Female patients aged ≥12 years with acute VVC and a vulvovaginal signs and symptoms (VSS) score ≥4 at baseline.; Methods: Patients were randomly assigned 2:1 to ibrexafungerp (300 mg twice for 1 day) or placebo.; Main Outcome Measures: The primary endpoint was the percentage of patients with a clinical cure (VSS = 0) at the test-of-cure visit (day 11 ± 3). Secondary endpoints included percentages of patients with mycological eradication, clinical cure and mycological eradication (overall success), clinical improvement (VSS ≤1) at test-of-cure visit, and complete resolution of symptoms at follow-up visit (day 25 ± 4).; Results: At the test-of-cure visit, patients receiving ibrexafungerp had significantly higher rates of clinical cure (63.3% [119/188] versus 44.0% [37/84]; P = 0.007), mycological eradication (58.5% [110/188] versus 29.8% [25/84]; P < 0.001), overall success (46.1% [82/188] versus 28.4% [23/84]; P = 0.022) and clinical improvement (72.3% [136/188] versus 54.8% [46/84]; P = 0.01) versus those receiving placebo. Symptom resolution was sustained and further increased with ibrexafungerp (73.9%) versus placebo (52.4%) at follow-up (P = 0.001). Ibrexafungerp was generally well tolerated. Adverse events were primarily gastrointestinal and were mild to moderate in severity.; Conclusions: Ibrexafungerp demonstrated statistical superiority over placebo for the primary and secondary endpoints. Ibrexafungerp is a promising novel, well-tolerated and effective oral 1-day treatment for acute VVC.; Tweetable Abstract: Ibrexafungerp is statistically superior to placebo for the treatment of vulvovaginal candidiasis. (© 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Söderman, L., et al. (2022). "Adjuvant use of melatonin for pain management in dysmenorrhea - a randomized double-blinded, placebo-controlled trial." European Journal of Clinical Pharmacology 78(2): 191-196.
	Purpose: Dysmenorrhea is a common, recurring, painful condition with a global prevalence of 71%. The treatment regime for dysmenorrhea includes hormonal therapies and NSAID, both of which are associated with side effects. A dose of 10 mg melatonin daily has previously been shown to reduce the level of pelvic pain in women with endometriosis. We chose to investigate how this regime, administered during the week of menstruation, would affect women with dysmenorrhea but without any signs of endometriosis, as adjuvant analgesic treatment.; Methods: Forty participants with severe dysmenorrhea were randomized to either melatonin or placebo, 20 in each group. Our primary outcome was pain measured with numeric rating scale (NRS); a difference of at least 1.3 units between the groups was considered clinically significant. Secondary outcomes were use of analgesics, as well as absenteeism and amount of bleeding. Mixed model was used for statistical analysis.; Results: Eighteen participants completed the study in the placebo group and 19 in the melatonin group. Mean NRS in the placebo group was 2.45 and 3.18 in the melatonin group, which proved to be statistically, although not clinically significant.; Conclusion: This randomized, double-blinded, placebo-controlled trial could not show that 10 mg of melatonin given orally at bedtime during the menstrual week had better analgesic effect on dysmenorrhea as compared with placebo. However, no adverse effects were observed.; Clinical Trials: NCT03782740 registered on 17 December 2018. (© 2021. The Author(s).)

Solangon, S. A., et al. (2023). "Methotrexate vs expectant management for treatment of tubal ectopic pregnancy: An individual participant data meta-analysis." Acta Obstetricia et Gynecologica Scandinavica 102(9): 1159-1175.
	Introduction: Ectopic pregnancy is an important health condition which affects up to 1 in 100 women. Women who present with mild symptoms and low serum human chorionic gonadotrophin (hCG) are often treated with methotrexate (MTX), but expectant management with close monitoring is a feasible alternative. Studies comparing the two treatments have not shown a statistically significant difference in uneventful resolution of ectopic pregnancy, but these studies were too small to define whether certain subgroups could benefit more from either treatment. Material(s) and Method(s): We performed a systematic review and individual participant data meta-analysis (IPD-MA) of randomized controlled trials comparing systemic MTX and expectant management in women with tubal ectopic pregnancy and low hCG (<2000 IU/L). A one-stage IPD-MA was performed to assess overall treatment effects of MTX and expectant management to generate a pooled intervention effect. Subgroup analyses and exploratory multivariable analyses were undertaken according to baseline serum hCG and progesterone levels. Primary outcome was treatment success, defined as resolution of clinical symptoms and decline in level of serum hCG to <20 IU/L, or a negative urine pregnancy test by the initial intervention strategy, without any additional treatment. Secondary outcomes were need for blood transfusion, surgical intervention, additional MTX side-effects and hCG resolution times. Trial registration number: PROSPERO: CRD42021214093. Result(s): 1547 studies reviewed and 821 remained after duplicates removed. Five studies screened for eligibility and three IPD requested. Two randomized controlled trials supplied IPD, leading to 153 participants for analysis. Treatment success rate was 65/82 (79.3%) after MTX and 48/70 (68.6%) after expectant management (IPD risk ratio [RR] 1.16, 95% confidence interval [CI] 0.95-1.40). Surgical intervention rates were not significantly different: 8/82 (9.8%) vs 13/70 (18.6%) (RR 0.65, 95% CI 0.23-1.14). Mean time to success was 19.7 days (95% CI 17.4-22.3) after MTX and 21.2 days (95% CI 17.8-25.2) after expectant management (P = 0.25). MTX specific side-effects were reported in 33 MTX compared to four in the expectant group. Conclusion(s): Our IPD-MA showed no statistically significant difference in treatment efficacy between MTX and expectant management in women with tubal ectopic pregnancy with low hCG. Initial expectant management could be the preferred strategy due to fewer side-effects. Copyright © 2023 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).

Soliman, S. (2024). "The Role of Granulocyte Colony Stimulating Factor in Embryo Transfer Outcomes." ClinicalTrials.gov.
	No Results Available Drug: Granulocyte Colony-Stimulating Factor (Filgrastim)|Other: Standard Embryo Transfer Media Implantation Rate|Clinical Pregnancy Rate|Pregnancy Rate|Live Birth Rate|Spontaneous Abortion Rate|Biochemical Pregnancy Rate Female Phase 4 300 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment NFC-2023-001 January 10, 2025

ŞOLT, K. A. (2022). "Effects of Mandala Coloring on Anxiety and Quality of Life of Women in the Climacteric Period." ClinicalTrials.gov.
	No Results Available Other: Mandala coloring Introductory Information Form|the Spielberger State-Trait Anxiety Inventory (STAI) Scale Female Not Applicable 80 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Supportive Care KırklareliED-1 June 30, 2023

Song, B., et al. (2020). "TVT-O versus TVT-S for female stress urinary incontinence: a systematic review and meta-analysis." International Journal of Clinical Practice 74(9): e13506.
	BACKGROUND: Tension-free Vaginal Tape Obturator (TVT-O) and Tension-free Vaginal tape Secur (TVT-S) are common surgeries for the treatment of stress urinary incontinence (SUI), several randomized controlled trials (RCTs) have compared the effects of TVT-O and TVT-S, yet the results remained inconsistent. Therefore, we attempted to conduct this systematic review and meta-analysis to analyze the role of TVT-O and TVT-S in patients with SUI. METHODS: We searched PubMed et al databases from inception date to Jan 15, 2020 for RCTs that compared TVT-O and TVT-S in SUI patients. Two authors independently screened and extracted data from the published articles. Summary odd ratios (OR) or mean differences (MD) with 95% confidence intervals (95%CI) were calculated for each outcome by fixed- or random-effects model. RESULTS: Seven RCTs with a total of 755 patients were identified, with 373 patients for TVT-O and 382 patients for TVT-S. TVT-O preceded TVT-S in the objective cure at 12 months (OR =1.72, 95% CI 1.21- 2.45), subjective cure (OR =1.98, 95% CI 1.08- 3.62); but TVT-S have more advantage in the incidence of post-operative thigh pain(OR =18.94, 95% CI 7.01- 51.15); no significant differences on the duration of operative procedure(OR =-1.09, 95% CI -2.37- 0.18,), urinary retention (OR =0.77, 95% CI 0.36- 1.62) and urinary infection(OR =1.80, 95% CI 0.63- 5.13) were found. CONCLUSIONS: TVT-O should be preferred for patients with SUI even though with higher risks of post-operative thigh pain when compared with TVT-S, more related studies are needed to identify the role of TVT-O and TVT-S for the treatment of SUI.

Song, C., et al. (2023). "Shoutai pills for threatened abortion: A protocol for systematic review and meta-analysis." Medicine 102(11): e33173.
	Background: Threatened abortions are a serious health risk for women. Deferiprone tablets are commonly used in the treatment of clinical delivery. Traditional Chinese medicine, a characteristic medical system inherited for thousands of years, often applies Shoutai pills in the treatment of Threatened abortion and has achieved good results. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of Shoutai pills combined with dedrogesterone tablets for the treatment of early preterm abortion.; Methods: Electronic searches of clinical randomized controlled trials in PubMed, Web of Science, MEDLINE, EMBASE, China National Knowledge Infrastructure, Wanfang database, and China Scientific Journal Database (VIP) were conducted. References to the included literature, gray literature in Open Grey, and other relevant literature such as clinical studies registered in ClinicalTrials.gov, were also manually searched. Relevant data were extracted, and a meta-analysis was performed using Reviewer Manager 5.4.; Results: The results of this study will be submitted to peer-reviewed journals.; Conclusion: This study provides high-quality evidence on the efficacy and safety of Shoutai pills in combination with dedrogesterone tablets for the treatment of preterm abortion.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.)

Song Soo, Y., et al. (2019). "Effect of pretreatment with combined oral contraceptives on outcomes of assisted reproductive technology for women with polycystic ovary syndrome: a meta-analysis." Archives of Gynecology and Obstetrics 300(3): 737-750.
	Objective: To evaluate the effect of pretreatment with combined oral contraceptives (COC) on outcomes in women with polycystic ovary syndrome (PCOS) who underwent assisted reproductive technology for subfertility.; Methods: Two authors independently searched MEDLINE, EMBASE, and the Cochran Library to identify and review articles published from October 1995 until December 2018 according to selection criteria. Outcomes are expressed as mean difference and odds ratio (OR) in a meta-analysis model.; Results: A total of seven studies were included in this meta-analysis: one randomized controlled study and two prospective and four retrospective cohort studies. Meta-analysis showed that the COC pretreatment did not affect rate of clinical pregnancy (OR = 0.93, 95% confidence interval CI 0.65-1.34, I 2 = 76%) or ovarian hyperstimulation syndrome (OR = 0.90, 95% CI 0.57-1.44, I 2 = 0%). However, the rate of miscarriage in the COC group was significantly higher (OR = 1.33, 95% CI 1.02-1.72, I 2 = 9%) and the rate of cumulative live birth was significantly lower compared with the control group (OR = 0.72, 95% CI 0.54-0.98, I 2 = 55%). Subgroup analysis showed higher rates of miscarriage and lower rates of cumulative live birth in studies with a gonadotropin-releasing hormone (GnRH) antagonist protocol (OR = 1.69, 95% CI 1.17-2.44, I 2 = 0% and OR = 0.38, 95% CI 0.29-0.50, respectively).; Conclusion: Pretreatment with COC in women with PCOS before assisted reproductive technology may have an adverse effect on clinical outcomes, especially with a GnRH antagonist protocol.

Song, T. and D. Y. Kang (2021). "Three-dimensional versus two-dimensional laparoscopic myomectomy: a randomized controlled trial." European Journal of Obstetrics, Gynecology, and Reproductive Biology 264: 271‐275.
	Objective: This study aimed to compare the surgical outcomes of three‐dimensional (3D) and two‐dimensional (2D) laparoscopic myomectomy. Study design. A total of 64 patients with symptomatic uterine fibroids were randomly assigned to either the 3D (n = 32) group or the 2D group (n = 32). The primary outcomes were the operative blood loss and change in hemoglobin levels. The secondary outcome was operative time. Results: There were no differences in the baseline demographics between the two groups. The 3D and 2D groups were not significantly different in terms of operative blood loss (129.5 ± 86.5 mL vs. 140.9 ± 89.8 mL, P = 0.412), change in serum hemoglobin levels (1.4 ± 1.6 g/dL vs. 1.6 ± 1.6 g/dL, P = 0.553), and operative time (77.4 ± 37.8 min vs. 82.4 ± 35.4 min, P = 0.344). Furthermore, no differences were observed between the groups with regard to other surgical outcomes. Conclusion: The 3D imaging system had no additional surgical benefit in laparoscopic myomectomy compared with to the conventional 2D imaging system.

Song, Y., et al. (2020). "Comparison of the efficacy between NAC and metformin in treating PCOS patients: a meta-analysis." Gynecological Endocrinology 36(3): 204-210.
	Our aim is to evaluate the clinical effectiveness and safety by comparing N-acetyl-cysteine (NAC) with metformin administrated by polycystic ovary syndrome (PCOS) patients. Systematic review and meta-analysis of randomized clinical trials (RCTs). MEDLINE, EMBASE, Web of Science and China National Knowledge Infrastructure were searched for studies. 10 studies were considered eligible for inclusion. NAC significantly reduced BMI and total testosterone, there was no significant difference in pregnancy rate, serum LH level, fasting insulin, and LH/FSH ratio. In conclusions, NAC may be considered as an alternative supplement to metformin, but large-scale randomized controlled trials are needed to assess the efficacy and safety of NAC in PCOS patients.

Sonmez, R., et al. (2022). "Efficacy of percutaneous and transcutaneous tibial nerve stimulation in women with idiopathic overactive bladder: a prospective randomised controlled trial." Annals of Physical and Rehabilitation Medicine 65(1): 101486.
	BACKGROUND: Different studies have reported the efficacy of percutaneous tibial nerve stimulation (PTNS) and transcutaneous tibial nerve stimulation (TTNS) in treating idiopathic overactive bladder (OAB). However, no study has compared the effectiveness of PTNS and TTNS added to bladder training (BT) in idiopathic OAB. OBJECTIVE: To compare the efficacy of PTNS and TTNS added to BT in women with idiopathic OAB. METHODS: We randomised 60 women with idiopathic OAB into 3 groups. Group 1 (n=19) received BT, Group 2 (n=19) received PTNS in addition to BT, and Group 3 (n=20) received TTNS in addition to BT. PTNS and TTNS were performed 2 days a week, for 30 min a day, for a total of 12 sessions for 6 weeks. Patients were evaluated by incontinence severity (pad test), a 3‐day voiding diary (frequency of voiding, incontinence episodes, nocturia and number of pads used), symptom severity, quality of life, treatment success (positive response rate), treatment satisfaction (Likert scale), discomfort level and preparation time for stimulation (sec). RESULTS: At the end of treatment; severity of incontinence, frequency of voiding, incontinence episodes, nocturia, number of pads used, symptom severity and quality of life were significantly improved in Groups 2 and 3 versus Group 1 (p<0.0167). Treatment success and treatment satisfaction were higher in Groups 2 and 3 than Group 1 (p<0.001 and p<0.0167, respectively). Level of discomfort was lower, treatment satisfaction was higher and preparation time for stimulation was shorter in Group 3 than Group 2 (p<0.05). CONCLUSION: Both the PTNS plus BT and TTNS plus BT were more effective than BT alone in women with idiopathic OAB. These 2 tibial nerve stimulation methods had similar clinical efficacy but with slight differences: TTNS had shorter preparation time, less discomfort level and higher patient satisfaction than PTNS.

Sood, A., et al. (2021). "Growth hormone for in vitro fertilisation (IVF)." The Cochrane Database of Systematic Reviews 11: CD000099.
	Background: In an effort to improve outcomes of in vitro fertilisation (IVF) cycles, the use of growth hormone (GH) has been considered as adjuvant treatment in ovarian stimulation. Improving the outcomes of IVF is especially important for women with infertility who are considered 'poor responders'. We have compared the outcomes of IVF with adjuvant GH versus no adjuvant treatment in routine use, and specifically in poor responders.; Objectives: To assess the effectiveness and safety of growth hormone as an adjunct to IVF compared to standard IVF for women with infertility SEARCH METHODS: We searched the following databases (to November 2020): Cochrane Gynaecology and Fertility (CGF) Group specialised register, CENTRAL, MEDLINE, Embase, CINAHL, Epistemonikos database and trial registers together with reference checking and contact with study authors and experts in the field to identify additional trials.; Selection Criteria: We included all randomised controlled trials (RCTs) of adjuvant GH treatment in IVF compared with no adjuvant treatment for women with infertility. We excluded trials where additional adjuvant treatments were used with GH. We also excluded trials comparing different IVF protocols.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. Two review authors independently performed assessment of trial risk of bias and extraction of relevant data. The primary review outcome was live birth rate. The secondary outcomes were clinical pregnancy rate, oocytes retrieved, embryo transfer, units of gonadotropin used and adverse events, i.e. ectopic pregnancy, multiple pregnancy, ovarian hyperstimulation syndrome (OHSS), congenital anomalies, oedema.; Main Results: We included 16 RCTs (1352 women). Two RCTs (80 women) studied GH in routine use, and 14 RCTs (1272 women) studied GH in poor responders. The evidence was low to very low certainty, the main limitations being risk of bias, imprecision and heterogeneity. Adjuvant growth hormone compared to no adjuvant: routine use for in vitro fertilisation (IVF) The evidence is very uncertain about the effect of GH on live birth rate per woman randomised for routine use in IVF (odds ratio (OR) 1.32, 95% confidence interval (CI) 0.40 to 4.43; I 2 = 0%; 2 trials, 80 participants; very low-certainty evidence). If the chance of live birth without adjuvant GH is assumed to be 15%, the chance of live birth with GH would be between 6% and 43%. There was insufficient evidence to reach a conclusion regarding clinical pregnancy rates per woman randomised, number of women with at least one oocyte retrieved per woman randomised and embryo transfer achieved per woman randomised; reported data were unsuitable for analysis. The evidence is very uncertain about the effect of GH on mean number of oocytes retrieved in normal responders (mean difference (MD) -0.02, 95% CI -0.79 to 0.74; I 2 = 0%; 2 trials, 80 participants; very low-certainty evidence). The evidence is very uncertain about the effect of GH on mean units of gonadotropin used in normal responders (MD 13.57, 95% CI -112.88 to 140.01; I 2 = 0%; 2 trials, 80 participants; very low-certainty evidence). We are uncertain of the effect of GH on adverse events in normal responders. Adjuvant growth hormone compared to no adjuvant: use in poor responders for in vitro fertilisation (IVF) The evidence is very uncertain about the effect of GH on live birth rate per woman randomised for poor responders (OR 1.77, 95% CI 1.17 to 2.70; I 2 = 0%; 8 trials, 737 participants; very low-certainty evidence). If the chance of live birth without adjuvant GH is assumed to be 11%, the chance of live birth with GH would be between 13% and 25%. Adjuvant GH results in a slight increase in pregnancy rates in poor responders (OR 1.85, 95% CI 1.35 to 2.53; I 2 = 15%; 11 trials, 1033 participants; low-certainty evidence). The results suggest, if the pregnancy rate without adjuvant GH is assumed to be 15%, with GH the pregnancy rate in poor responders would be between 19% and 31%. The evidence suggests that GH r sults in little to no difference in number of women with at least one oocyte retrieved (OR 5.67, 95% CI 1.54 to 20.83; I 2 = 0%; 2 trials, 148 participants; low-certainty evidence). If the chance of retrieving at least one oocyte in poor responders was 81%, with GH the chance is between 87% and 99%. There is a slight increase in mean number of oocytes retrieved with the use of GH for poor responders (MD 1.40, 95% CI 1.16 to 1.64; I 2 = 87%; 12 trials, 1153 participants; low-certainty evidence). The evidence is very uncertain about the effect of GH on embryo transfer achieved (OR 2.32, 95% CI 1.08 to 4.96; I 2 = 25%; 4 trials, 214 participants; very low-certainty evidence). If the chance of achieving embryo transfer is assumed to be 77%, the chance with GH will be 78% to 94%. Use of GH results in reduction of mean units of gonadotropins used for stimulation in poor responders (MD -1088.19, 95% CI -1203.20 to -973.18; I 2 = 91%; 8 trials, 685 participants; low-certainty evidence). High heterogeneity in the analyses for mean number of oocytes retrieved and units of GH used suggests quite different effects according to differences including in trial protocols (populations, GH dose and schedule), so these results should be interpreted with caution. We are uncertain of the effect of GH on adverse events in poor responders as six of the 14 included trials failed to report this outcome.; Authors' Conclusions: The use of adjuvant GH in IVF treatment protocols has uncertain effect on live birth rates and mean number of oocytes retrieved in normal responders. However, it slightly increases the number of oocytes retrieved and pregnancy rates in poor responders, while there is an uncertain effect on live birth rates in this group. The results however, need to be interpreted with caution, as the included trials were small and few in number, with significant bias and imprecision. Also, the dose and regimen of GH used in trials was variable. Therefore, further research is necessary to fully define the role of GH as adjuvant therapy in IVF. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Sordia-Hernandez Luis, H., et al. (2021). "The Effect of Post warming Culture Period Between Thawing and Transfer of Cryopreserved Embryos on Reproductive Outcomes After In Vitro Fertilization (IVF): A Systematic Review and Meta-analysis." Journal of Reproduction & Infertility 22(2): 77-84.
	Background: The purpose of this study was to evaluate the effect of post warming culture period between thawing and transfer of cryopreserved embryos on reproductive outcomes after in vitro fertilization (IVF).; Methods: An extensive literature search was performed using PubMed, EmBase, and the Cochrane library from January 2000 to August 2019. A systematic review and meta-analysis of clinical trials was performed in this manuscript. The trials represented patients with embryo transfers of at least one previously cryopreserved good quality embryo. Main outcome measures of the study included clinical pregnancy rate, live birth rate, miscarriage rate, and ectopic pregnancy rate.; Results: A total of 5338 trial/abstracts were identified through a literature search. Totally, five studies were included in the systematic review, and three in the final meta-analysis. The studies included 1717 embryo transfers, 605 after short culture, and 1112 after long culture. The clinical pregnancy rate (CPR) was the most consistent outcome reported. The CPR was slightly better after short time culture with a RR of 1.09 (0.95-1.26, 95%CI) but this difference was not statistically significant. The great heterogenicity in the results reported in the included studies made it impossible to compare all planned outcomes.; Conclusion: There are no differences in reproductive outcomes if cryopreserved embryos are transferred after overnight culture or after two hours of culture following thawing. Due to small number and the poor quality of trials reported on this topic, the results of this review should be treated with caution.; Competing Interests: Conflict of Interest The authors declare that they have no conflict of interest. (Copyright© 2021, Avicenna Research Institute.)

Spector, A., et al. (2024). "The effectiveness of psychosocial interventions on non-physiological symptoms of menopause: A systematic review and meta-analysis." Journal of Affective Disorders 352: 460-472.
	Background: Menopause, a crucial transitioning stage for women, can significantly impact mood and wellbeing. We aimed to evaluate the effectiveness of psychosocial interventions on non-physiological symptoms of menopause (depression, anxiety, cognition, and quality of life) through systematic review and meta-analysis. Method(s): Five databases were searched from inception to August 2023 for randomized controlled trials. Pre- and post-test means and standard deviations for groups were extracted and used to calculate effect sizes. The effectiveness of Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Interventions (MBI) on depression and anxiety were examined by subgroup analysis. Result(s): Thirty studies comprising 3501 women were included. From meta-analysis, mood symptoms significantly benefited from CBT (anxiety: d = -0.22, 95 % CI = -0.35, -0.10; depression: d = -0.33, 95 % CI = -0.45, -0.21) and MBI (anxiety: d = -0.56, 95 % CI = -0.74, -0.39; depression: d = -0.27, 95 % CI = -0.45, -0.09). Psychosocial interventions were also found to significantly improve cognition (d = -0.23, 95 % CI = -0.40, -0.06) and quality of life (d = -0.78, 95 % CI = -0.93, -0.63). Mean total therapy hours ('dose') was lower for CBT (11.3) than MBI (18.6), indicating reduced costs and burden for women. Limitation(s): Data regarding menopausal status were not collected, limiting our ability to identify the optimal timing of interventions. Potential longer-term, effects of interventions were not investigated. Conclusion(s): Our review highlighted the value of psychosocial interventions in improving non-physiological symptoms (particularly depression and anxiety) during menopause, noting the heterogeneity of findings and importance of implementing effective interventions.Copyright © 2024 University College London (UCL)

Spruijt, M., et al. (2023). "Efficacy of botulinum toxin A injection in pelvic floor muscles in chronic pelvic pain patients: a study protocol for a multicentre randomised controlled trial." BMJ Open 13(7): e070705.
	Introduction: Chronic pelvic pain (CPP) is a common multifactorial condition affecting 6%-27% of women aged 18-50 years worldwide. The aim of this randomised controlled trial (RCT) is to investigate the efficacy and safety of botulinum toxin A (BTA) injection compared with placebo injections in the pelvic floor muscles in women with CPP to improve pain, function and quality of life.; Methods and Analysis: This is a study protocol for a multicentre, double-blinded placebo controlled RCT conducted in five gynaecology departments across the Netherlands. A total of 94 women over 16 years, with at least 6 months of CPP without anatomical cause and pelvic floor hypertonicity refractory to first-line pelvic floor physical therapy will be included. Participants will be randomised equally to BTA or placebo, both following physical therapy and (re-)education on the pelvic floor at 4, 8, 12 and 26 weeks after intervention. Multiple validated questionnaires focusing on pain, quality of life and sexual function will be collected at baseline and during all follow-up visits. Statistical analysis includes mixed models for repeated measurements.; Ethics and Dissemination: Ethical approval (NL61409.091.17) was obtained from Radboud University Medical Research Ethics Committee (MREC) and Central Committee on Research involving human Subjects (CCMO). The findings will be presented through international conferences and peer-reviewed scientific journals.; Trial Registration Number: EudraCT number (2017-001296-23), CCMO/METC number: NL61409.091.17.; 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.)

Stania, M., et al. (2022). "Intravaginal electrical stimulation as a monotherapy for female stress urinary incontinence: A systematic review and meta-analysis." Complementary Therapies in Clinical Practice 49: 101624.
	BACKGROUND AND PURPOSE: Since patients, physiotherapists and gynaecologists continue to seek effective conservative treatments for stress urinary incontinence (SUI), the aim of this systematic review and meta-analysis was to determine the therapeutic efficacy of intravaginal electrical stimulation (ES) in women with SUI. METHOD(S): We searched PubMed, Embase, EBSCOHost and Ovid for randomized controlled trials. For dichotomous data, we calculated the risk ratio (RR) and 95% confidence interval (CI). For continuous data, we calculated the mean difference (MD) and 95% CI. Heterogeneity was assessed with I2 statistics. RESULT(S): Of the 686 records identified, a total of 10 articles met the inclusion criteria. A meta-analysis revealed significant differences between the ES and no active treatment groups in the pooled objective cure rates (RR: 4.20; 95% CI: 1.70 to 10.40; p = 0.001; I2 = 0%) and subjective cure or improvement rates (RR: 4.96; 95%: 1.01 to 24.37; p = 0.04; I2 = 0%). No significant differences were found in the pooled number of incontinence episodes per 24 h (MD: 0.16; 95% CI: 0.68 to 0.37; p = 0.56; I2 = 0%), the pooled Incontinence Quality of Life Questionnaire scores (MD: 1.84; 95% CI: 2.11 to 5.80; p = 0.36; I2 = 0%) or the pooled number of adverse effects (RR: 0.69; 95% CI: 0.38 to 1.27; p = 0.23; I2 = 0%) between the ES and other conservative treatment groups. CONCLUSION(S): There was insufficient evidence for or against the use of intravaginal ES therapy for women with SUI, partly due to the variability in the interventions of the included trials and the small number of trials included.Copyright © 2022 Elsevier Ltd. All rights reserved.

Stanley Russell, F. (2021). "Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M Study)." ClinicalTrials.gov.
	Specific Aims: Introduction/Background: Urgency Urinary Incontinence (UUI) remains a challenging clinical problem for urogynecologists as they treat women and seek to find better therapies. There is a wealth of literature addressing individual therapies for first, second, and third line treatments for UUI. There are three main third line treatment options for UUI including percutaneous tibial nerve stimulation (PTNS), sacral neuromodulation, and intradetrusor botox. At the current time, there are limited studies that have looked at a combination of second and third‐line therapy therapies for UUI. While some anticholinergic medications have been studied in combination with percutaneous tibial nerve stimulation (PTNS) such as solifenacin, tolterodine, and trospium, there is limited data on the combination of mirabegron, a beta‐3 agonist, and PTNS for treatment of refractory UUI. The studies that looked at anticholinergic medications in combination with PTNS revealed improvement in UUI compared to PTNS plus placebo. However, there are patients who do not tolerate anticholinergic medications well because of side effects. A relatively new finding as reported by the American Urogynecologic Society (AUGS) about avoiding anticholinergic medications in women greater than age 70 secondary to increased risk for cognitive impairment, dementia, and Alzheimer's disease is further impetus to conduct this trial [1]. The rationale for studying mirabegron in combination with PTNS versus PTNS plus placebo is important as mirabegron does not have the significant side effect profile that anticholinergic medications have and better tolerated in the older population. Therefore, more research should be performed to evaluate the effect of the combination of mirabegron and PTNS for refractory UUI. The purpose of this study is to evaluate the combination of PTNS and mirabegron and compare that to PTNS plus placebo in the treatment of refractory UUI. Hypothesis: Combination therapy of PTNS and mirabegron, a beta‐3 agonist, will contribute to greater improvement in the number of urgency urinary incontinence episodes as measured by a 3‐day bladder diary compared to PTNS plus placebo in women. Method: This is a randomized clinical trial comparing the efficacy of combination therapy with PTNS plus mirabegron to PTNS plus placebo in women with refractory urgency urinary incontinence. Primary Aim: The primary aim of this study is to compare the efficacy of combined treatment of PTNS and mirabegron versus PTNS plus placebo on change in the number of UUI episodes at 12 weeks. Secondary Aims: ‐ Comparing urinary symptom specific distress and quality of life over a 12‐week course of PTNS. ‐ Comparing the side effect/adverse event profile of combined treatment of PTNS and mirabegron versus PTNS plus placebo over a 12‐week course of PTNS ‐ Comparing the treatment efficacy and adverse events of combined treatment of PTNS and mirabegron versus PTNS plus placebo in women > 70 years of age as a sub analysis within the study

Staropoli, N., et al. (2024). "The impact of PARP inhibitors in the whole scenario of ovarian cancer management: A systematic review and network meta-analysis." Critical Reviews in Oncology/Hematology 193: 104229.
	Background: Carboplatin is still the cornerstone of the first-line treatment in advanced Epithelial Ovarian Cancer (aEOC) management and the clinical response to platinum-derived agents remains the major predictor of long-term outcomes. Patient and methods: We aimed to identify the best treatment of the aEOC in terms of efficacy and safety, considering all treatment phases. A systematic literature search has been done to compare all treatments in aEOC population. Randomized trials with available survival and safety data published in the 2011-2022 timeframe were enclosed. Only trials reporting the BRCA or HRD (Homologous Recombination Deficiency) status were considered. Data extraction and synthesis: A ranking of treatment schedules on the progression-free survival (PFS) endpoint was performed. The random-effect model was used to elaborate and extract data. The Network Meta-Analysis (NMA) by Bayesian model was performed by STATA v17. Data on PFS were extracted in terms of Hazard ratio with relative confidence intervals. Result(s): This NMA involved 18 trials for a total of 9105 patients. Within 12 treatment groups, we performed 3 different sensitivity analyses including "all comers" Intention to Treat (ITT) population, BRCA-mutated (BRCAm), and HRD subgroups, respectively. Considering the SUCRA-reported cumulative PFS probabilities, we showed that in the ITT population, the inferred best treatment was niraparib plus bevacizumab with a SUCRA of 96.7. In the BRCAm subgroup, the best SUCRA was for olaparib plus chemotherapy (96,9). The HRD population showed an inferred best treatment for niraparib plus bevacizumab (SUCRA 98,4). Moreover, we reported a cumulative summary of PARPi toxicity, in which different 3-4 grade toxicity profiles were observed, despite the PARPi "class effect" in terms of efficacy. Conclusion(s): Considering all aEOC subgroups, the best therapeutical option was identified as PARPi plus chemotherapy and/or antiangiogenetic agents, suggesting the relevance of combinatory approaches based on molecular profile. This work underlines the potential value of "chemo-free" regimens to prolong the platinum-free interval (PFI).Copyright © 2023 The Authors

Steenstrup, B. (2022). "Effectiveness of a Hip Abductor Training in Women With Stress Urinary Incontinence." ClinicalTrials.gov.
	Urinary incontinence (UI) is estimated to affect 25% à 45 % women all over the world. UI is associated with a poor Quality of life, with a strong level of certainty. Stress urinary incontinence (SUI) is the second more prevalent type of UI . First‐line treatment for SUI is conservative, non‐drug and non‐surgical treatment. Among these techniques, physiotherapist‐supervised pelvic floor muscle (PFM) training (PFMT) as a first‐line treatment; however, only half of women with SUI are cured with PFMT. Brain imaging shows that PFMs (involved in continence mechanisms) and gluteal muscles can activate the same cortical region. This synergy is found if the gluteal muscles are voluntarily activated, but not if the PFMs are volontary activated alone . In women, hip abductor physiotherapy is a common practice which has already been the subject of a very extensive literature and has largely shown its effectiveness in the quality of lumbo‐pelvic control, balance, quality of life and risk of fall prevention. This rehabilitation is based on exercises that induce solicitation of the hip abductors by synergistic reflex activation during a range of well‐known exercises. Recent work has shown the effect of hip abductors on the activation of the PFMs . Until today, there is no literature evaluating the effectiveness of a hip abductors training program without associated voluntary contraction of the PFMs (PPM) on UI. The hypothesis of this work will be to demonstrate that a complementary training focused on the hip abductor, complementary to concomitant PFMT, would benefit from a more significant improvement in continence, and also in physical abilities and quality of life. Because balance seems involved in UI, we therefore propose to to observe the effects on the frontal balance of the pelvis. As the investigators have already done in previous studies, to identifying factors that predict the success of our interventions, investiagtors have planned to evaluate the observance and adherence of our patients .Complementary, the investigators planned to evaluate the effect of both intervention on pelvic floor muscles and hip abductors strength and endurance, pelvic organ prolapse symptoms and quality of life. For this objective, the investigators intend to compare two randomized parallel groups: Group A follow a 12 sessions supervised PFMT + home based PFMs exercices. Group B follow a 12 sessions supervised PFMT + home based hip abductor exercices.

Steenstrup, B., et al. (2022). "Cognitive-behavioral therapy and urge urinary incontinence in women. A systematic review." International Urogynecology Journal 33(5): 1091-1101.
	Introduction and hypothesis: UUI co-exists with numerous health conditions, having a substantial negative impact on health-related quality of life and mental health. Cognitive-behavioral therapy (CBT) could help patients manage these problems by changing the way they think and behave. Method(s): We carried out a systematic review of the literature assessing the modalities and effects of CBT as a stand-alone strategy, without adding PFMT, on symptoms and clinical signs, in women with UUI. Our secondary objective was to report modalities and effects of CBT on health-related quality of life, psychological symptoms and patient-reported satisfaction. The PRISMA methodology was used to carry out this systematic review. A literature search was conducted in PubMed, PEDro, Web of Science and Cochrane Library databases from inception to December 2020. The PICO approach was used to determine the eligibility criteria. Result(s): Twelve papers were included in the present review which showed beneficial effects on both symptom severity (p < 0.05) and more subjective areas such as quality of life, psychological symptoms or patient satisfaction level (p < 0.05), respectively). However, results on the effectiveness of CBT on clinical signs remains conflicting. Conclusion(s): Based on the available literature, this review suggested a high level of evidence for the effectiveness of CBT on symptom severity and a moderate level of evidence for the effectiveness of CBT on quality of life, psychological symptoms and patient satisfaction. However, we highlighted no evidence for the effects of CBT on clinical signs.Copyright © 2021, The International Urogynecological Association.

Stemmer, A., et al. (2020). "Comparison of Poly (ADP-ribose) Polymerase Inhibitors (PARPis) as Maintenance Therapy for Platinum-Sensitive Ovarian Cancer: Systematic Review and Network Meta-Analysis." Cancers 12(10).
	Background: Three PARPis (olaparib, niraparib and rucaparib) are currently FDA-approved as maintenance therapy in newly diagnosed and recurrent ovarian cancer. However, thus far, no trial has compared the three approved PARPis in the overall population, in patients with BRCA mutations, or in those with wild-type BRCA .; Methods: A frequentist network meta-analysis was used for indirect comparisons between the different PARPis with respect to progression free survival (PFS), overall survival (OS), and adverse events.; Results: Overall, six randomized clinical trials involving 2,770 patients, were included in the analysis. Results from the indirect comparisons revealed no statistically significant differences between the three PARPis with respect to PFS or OS in the entire population and in patients with mutated and wild-type BRCA, separately. Niraparib showed a statistically significant increased risk for grade 3 and 4 thrombocytopenia (risk-difference [RD] from placebo: 0.3; 95% confidence interval [CI], 0.27‒0.34) and any grade neutropenia (RD from placebo: 0.22; 95% CI, 0.18‒0.25) as compared with the other PARPis.; Conclusion: No statistically significant difference was found between the three PARPis with respect to PFS or OS (overall and in subpopulations by BRCA status). There is, however, a statistical difference in toxicity as niraparib is associated with a greater risk for thrombocytopenia and neutropenia.

Stentzel, U., et al. (2023). "Mental health-related telemedicine interventions for pregnant women and new mothers: a systematic literature review." BMC Psychiatry 23(1): 292.
	Background: Pregnancy and the postpartum period are times when women are at increased risk for depression and mental problems. This may also negatively affect the foetus. Thus, there is a need for interventions with low-threshold access and care. Telemedicine interventions are a promising approach to address these issues. This systematic literature review examined the efficacy of telemedicine interventions for pregnant women and/or new mothers to address mental health-related outcomes. The primary objective was to analyse whether telemedicine interventions can reduce mental health problems in pregnant women and new mothers. The secondary aim was to clarify the impact of type of interventions, their frequency and their targets.; Methods: Inclusion criteria: randomized controlled trials, with participants being pregnant women and/or new mothers (with infants up to twelve months), involving telemedicine interventions of any kind (e.g. websites, apps, chats, telephone), and addressing any mental health-related outcomes like depression, postnatal depression, anxiety, stress and others. Search terms were pregnant women, new mothers, telemedicine, RCT (randomised controlled trials), mental stress as well as numerous synonyms including medical subject headings. The literature search was conducted within the databases PubMed, Cochrane Library, Web of Science and PsycINFO. Screening, inclusion of records and data extraction were performed by two researchers according to the PRISMA guidelines, using the online tool CADIMA.; Results: Forty four articles were included. A majority (62%) reported significantly improved mental health-related outcomes for participants receiving telemedicine interventions compared to control. In particular (internet-delivered) Cognitive Behavioural Therapy was successful for depression and stress, and peer support improved outcomes for postnatal depression and anxiety. Interventions with preventive approaches and interventions aimed at symptom reduction were largely successful. For the most part there was no significant improvement in the symptoms of anxiety.; Conclusion: Telemedicine interventions evaluated within RCTs were mostly successful. However, they need to be designed to specifically target a certain mental health issue because there is no one-size-fits-all approach. Further research should focus on which specific interventions are appropriate for which mental health outcomes in terms of intervention delivery modes, content, target approaches, etc. Further investigation is needed, in particular with regard to anxiety. (© 2023. The Author(s).)

Stewart, L. E., et al. (2022). "Oral phenazopyridine vs intravesical lidocaine for bladder onabotulinumtoxinA analgesia: a randomized controlled trial." American Journal of Obstetrics and Gynecology 227(2): 308.e301‐308.e308.
	BACKGROUND: The efficacy of intradetrusor onabotulinumtoxinA injections for the management of idiopathic overactive bladder has been well‐established. The injections are typically performed in the office setting using local analgesia, most commonly a 20 to 30‐minute intravesical instillation of lidocaine. There are limited data evaluating alternative bladder analgesics. OBJECTIVE: To compare pain scores with preprocedure oral phenazopyridine vs intravesical lidocaine in women undergoing intradetrusor onabotulinumtoxinA injections for idiopathic overactive bladder. STUDY DESIGN: Nonpregnant adult females with idiopathic overactive bladder, scheduled for office injection of 100 units of intradetrusor onabotulinumtoxinA were randomized to either 200 mg of oral phenazopyridine taken 1 to 2 hours preprocedure or a 20‐minute preprocedure intravesical instillation of 50 mL of 2% lidocaine. We excluded participants with neurogenic bladders, and those who had received intradetrusor onabotulinumtoxinA injections in the previous 12 months. The primary outcome was pain measured by a 100‐mm visual analog scale. Demographic characteristics and overall satisfaction with the procedure were also recorded. Providers answered questions about cystoscopic visualization, ease of procedure, and perception of participant comfort. Prespecified noninferiority margin was set to equal the anticipated minimum clinically important difference of 14 mm. A planned sample of 100 participants, 50 in each treatment arm, provided 80% power to detect noninferiority at a significance level of.05. We performed a modified intention‐to‐treat analysis and compared variables with the t test or the Fisher exact test. RESULTS: A total of 111 participants were enrolled, and complete data were obtained for 100 participants; 47 participants were randomized to phenazopyridine and 53 to lidocaine. Baseline characteristics did not differ between groups. There were 19.6% and 20.8% of participants in the phenazopyridine and lidocaine groups, respectively, who previously underwent intradetrusor onabotulinumtoxinA injections. The mean postprocedure pain was 2.7 mm lower in the phenazopyridine group than in the lidocaine group (95% confidence interval, ‐11.3 to 10.7), demonstrating noninferiority. More than 90% of participants in both groups stated that the pain was tolerable. Slightly more participants reported being "very satisfied" in the lidocaine group, although this was not statistically significant (50.0% vs 40.4%; P=.34). Providers reported clear visualization in 89.4% of participants in the phenazopyridine group and in 100% of participants in the lidocaine group (P=.02). Provider perception of participant comfort and overall ease of procedure were not different between groups. Length of time in the exam room was significantly shorter in the phenazopyridine than in the lidocaine group (44.4 vs 57.5 minutes; P=.0003). CONCLUSION: In women receiving intradetrusor onabotulinumtoxinA injections for idiopathic overactive bladder, oral phenazopyridine was noninferior to intravesical lidocaine for procedural pain control. Phenazopyridine is well‐tolerated by participants, allows for the procedure to be performed with similar ease, and is associated with shorter appointment times.

Stomati, M. (2022). "Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid." ClinicalTrials.gov.
	The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D‐chiro‐inositol and Vitamin B6. The patients will be evaluated at baseline and after three months of treatment with placebo or product.

Stratpharma, A. G. (2023). "Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause." ClinicalTrials.gov.
	The goal of this randomized controlled trial is to test the efficacy of StrataMGT in the management of Genitourinary Syndrome of Menopause (GSM) compared to estrogen therapy. The main question it aims to answer is: ‐ Will StrataMGT be non‐inferior regarding patient quality of life compared to standard of care? Participants will use either StrataMGT or estrogen vaginal cream to treat GSM for 3 consecutive months. After the baseline assessment, participants will be assessed monthly for quality of life, clinical signs, symptoms, pathology and adverse reactions.

Stute, P. (2023). "Efficacy of Vitex Agnus-castus BNO 1095 (20 mg) in Women With Primary Dysmenorrhea." ClinicalTrials.gov.
	No Results Available Drug: Vitex agnus-castus BNO 1095 (20 mg)|Drug: Placebo Proportion of patients who respond to treatment defined as: a) a ≥3-point reduction in the peak pelvic pain score and b) no increase in the number of standard pain relief medication|Proportion of patients who respond to treatment defined as: a) a ≥3-point reduction in the peak pelvic pain score and b) no increase in the number of standard pain relief medication in the cramping window of Cycles 3, 4, and 6 compared to Baseline|Proportion of patients with a ≥3-point reduction in the peak pelvic pain score and a decrease in the number of standard pain relief medication|Proportion of patients with a peak pelvic pain score of "0" or "1" and no use of standard pain relief medication|Assessment of change of peak pelvic pain score|Assessment of the sum of the pelvic pain scores|Assessment of the change of the sum of the pelvic pain scores|Assessment of the change in the number of days with pelvic pain|Assessment of change in the number of standard pain relief medication taken|Assessment of change in the number of days with use of standard pain relief medication|Proportion of patients with no use of standard pain relief medication|Assessment of change in the impact on the patient's daily life|Investigator's and patient's overall assessment of efficacy using a 5-point verbal rating scale|Assessment of change in the intensity of menstrual bleeding|Assessment of change in the number of pieces of sanitary protection used|Assessment of change in the severity of nausea, vomiting, diarrhea, fatigue, weakness, fainting, and headache on a numeric rating scale (NRS)|Proportion of patients with migraine|Assessment of change in the peak pelvic pain score|Assessment of relative change in the peak pelvic pain score|Assessment of relative change in the number of standard pain relief medication taken Female Phase 3 300 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment AgnoMed|2023-503688-41-00|U1111-1288-9484 March 31, 2025

Su, X. and H. Peng (2022). "ZishenYutai pill accompany plus ovulation induction agents for women with infertility associated with anovulation——a meta analysis." PROSPERO International prospective register of systematic reviews.
	
Suárez Ónica, A. (2023). "Insemination in patients with polycystic ovary syndrome: gestation rates using two stimulation patterns: letrozole vs gonadotropins." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Code: SCP236273,Pharmaceutical Form: ,Other descriptive name: ,Product Name: GONAL‐f 450 IU/0.75 mL powder and solvent for solution for injection,Product Code: PRD3311566,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Follitropin Alfa 600I.U.,Product Name: Ovaleap 450 IU/0.75 mL solution for injection,Product Code: PRD6962009,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Follitropin Alfa (Genetical Recombination) 450I.U. / 0.75mL,Product Name: Bemfola 75 IU/0.125 mL solution for injection in pre‐filled pen,Product Code: PRD4622468,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Follitropin Alfa 75I.U. / 0.125mL,Product Name: Puregon 600 IU/0.72 mL solution for injection,Product Code: PRD9022786,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Follitropin Beta 600I.U. / 0.72mL CONDITION: Insemination in patients with polycystic ovary syndrome Therapeutic area: Diseases [C] ‐ Female Urogenital Diseases and Pregnancy Complications [C13] PRIMARY OUTCOME: Main Objective:The main objective of the research study is to know if letrozole is a therapeutic alternative to gonadotropins in artificial inseminations in patients with polycystic ovary in terms of gestation rate and live birth rate. Primary end point(s):The gestation rate is calculated as the number of gestations (determined as positive urine pregnancy test between the 15th‐17th day of insemination) per insemination performed.,The rate of new borns is calculated as the number of newborns per insemination performed. Secondary Objective:To examine the results of the cycles in terms of clinical miscarriage rate.,To examine the results of the cycles in terms of bioquimical miscarriage rate.,To examine the results of the cycles in terms of cycle cancellation due to non‐response.,To examine the results of the cycles in terms of cycle cancellation due to hyper‐response.,To analyze if there is a different duration of treatment and a greater number of dominant follicles recruited comparing both patterns.,To analyze if these differences are observed in both conjugal and donor inseminations. INCLUSION CRITERIA: Age: women between 18‐40 years old.,Body mass inde X(BMI): =18 and =30.,Primary or secondary infertility.,Diagnosis of PCOS according to Rotterdam criteria (The Rotterdam ESHRE/ASRM‐ sponsored PCOS Consensus Workshop Group Revised 2003 consensus on diagnostic criteria and long‐term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod 2004; 19: 41‐47).,Insemination indication.,Women giving informed consent to participate in the study. SECONDARY OUTCOME: Secondary end point(s):Abortion rate: defined as the loss of pregnancy before 20 weeks of gestational age per gestation achieved. Secondary end point(s):Antimullerian hormone: the determination of AMH (ECLIA Roche Diagnostics) Secondary end point(s):Biochemical pregnancy rate defined as the termination of a pregnancy before the gestational sac is detected by ultrasound. Secondary end point(s):BMI: is calculated by dividing the kilograms of weight by the square of the height in meters (BMI = weight (kg)/ [height (m)]2 Secondary end point(s):Cancellation due to hyperresponse (defined as the presence of 3 or more follicles larger than 14mm on the day of ultrasound control). Secondary end point(s):Cancellation due to non‐response (defined as no response to stimulation treatment after 28 days of stimulation, defined as the non‐observation of dominant follicles (larger than 14 mm) on vaginal ultrasound. Secondary end point(s):Days of stimulation: stimulation days defined as the number of days until ovulatory discharge. Secondary end point(s):Incidence of gestational diabetes Secondary end point(s):Insulin resistance: Peripheral insulin resistance is calculated using the formula HOMA IR= IB*GB/22.5. Its cut‐off point is 3.8. or a glucose overload of 75 gr positive. A test is performed with 75 gr. of glucose administered on an empty stomach a controlled blood glucose levels at two hours. If the value is between 140 and 199 mg/dl then it is called Glucose Intolerance. Secondary end point(s):Newborn weight Secondary end point(s):Number of dominant follicles recruited, defined as the number of follicles larger than 14 mm visualized on the last day of ultrasound control performed on the patient prior to insemination. Secondary end point(s):Perinatal data Secondary end point(s):Route of delivery: eutocic, instrumental o cesarean

Subirá, J., et al. (2021). "Testosterone does not improve ovarian response in Bologna poor responders: a randomized controlled trial (TESTOPRIM)." Reproductive Biomedicine Online 43(3): 466‐474.
	Research question: Does testosterone, either in a long or short course, before IVF increase the number of mature oocytes retrieved in poor ovarian response? Design: Single‐centre, single‐blinded, randomized controlled trial. Poor ovarian response is defined according to Bologna criteria. Sixty‐three participants were included and assigned to three arms: group 1 (long testosterone [n = 17]) 12.5 mg/day testosterone gel for 56 days before ovarian stimulation; group 2 (short testosterone [n = 16]) 12.5 mg/day testosterone gel for 10 days before ovarian stimulation; and group 3 (control, no intervention). Primary outcome was number of mature oocytes retrieved. Secondary outcomes included other cycle parameters (duration of stimulation, antral follicle count, number of follicles >16 mm, total oocytes retrieved and testosterone levels). Results: The number of mature oocytes retrieved did not differ between the three groups (2.16, 2.71 and 2.91, P = 0.719, groups 1, 2 and 3, respectively). No other significant differences were found in the remaining cycle parameters, except for testosterone levels at the beginning of ovarian stimulation, which were higher in both testosterone groups and relatively higher in group 2 (1.67 and 3.03, respectively versus 0.14 control group, P = 0.01). A Poisson regression model showed no significant differences for the primary outcome (group 3 versus group 2: 0.925, 95% CI 0.572 to 1.508, P = 0.753; group 3 versus group 1: 0.873, 95% CI 0.534 to 1.426, P = 0.587). Conclusions: The use of testosterone, even when applied for a prolonged period, does not improve the number of mature oocytes in poor ovarian response.

Sufredini, F., et al. (2022). "The effects of social support on depression and anxiety in the perinatal period: A mixed-methods systematic review." Journal of Affective Disorders.
	BACKGROUND: The social support offered to women in the perinatal period can buffer against depression and anxiety. The sources and types of support that reduce maternal levels of depression and anxiety are not well understood. AIMS: To investigate the effects of structural and functional support on depression and anxiety in women in the perinatal period, and to explore the experiences of women around support during the perinatal period. METHOD: A comprehensive search of six electronic databases was undertaken. Relevant studies published from January 2010 to April 2020 were included (PROSPERO reference number: CRD42020194228). Quantitative and qualitative studies were eligible if they reported the effects of, or had themes related to receiving functional or structural support in the perinatal period on women's levels of depression or anxiety. Qualitative data was synthesised using a thematic synthesis method. Quantitative data could not be pooled due to the lack of comparable RCTs or cohort studies and was thus presented in a narrative form. RESULTS: Fifty-one articles (41 quantitative and 10 qualitative studies) were included. Analysis of quantitative studies demonstrated that insufficient support from partner, friends and family was associated with greater risk of symptoms of depression and anxiety. Distance-delivered interventions (via internet or telephone) diminished levels of depression and anxiety. Qualitative data revealed three overarching themes: appreciating all forms of support in the perinatal period, recognising appropriate and inappropriate support from health professionals and services, and having barriers to mobilising functional and structural support. LIMITATIONS: Grey literature was not explored and search strategies only included English, Spanish and Portuguese language articles. The reviewed studies were heterogeneous and for this reason, quantitative assessments were not feasible. CONCLUSION: Support from specific sources such as family members, friends who are also mothers, health professionals, neighbours, supervisors, co-workers and online communities still need to be further investigated. Implications for health professionals involved in the care of women in the perinatal period are discussed.

Suharwardy, S., et al. (2023). "Feasibility and impact of a mental health chatbot on postpartum mental health: a randomized controlled trial." AJOG Global Reports 3(3): 100165.
	Background: Perinatal mood disorders are common yet underdiagnosed and un- or undertreated. Barriers exist to accessing perinatal mental health services, including limited availability, time, and cost. Automated conversational agents (chatbots) can deliver evidence-based cognitive behavioral therapy content through text message-based conversations and reduce depression and anxiety symptoms in select populations. Such digital mental health technologies are poised to overcome barriers to mental health care access but need to be evaluated for efficacy, as well as for preliminary feasibility and acceptability among perinatal populations.; Objective: To evaluate the acceptability and preliminary efficacy of a mental health chatbot for mood management in a general postpartum population.; Study Design: An unblinded randomized controlled trial was conducted at a tertiary academic center. English-speaking postpartum women aged 18 years or above with a live birth and access to a smartphone were eligible for enrollment prior to discharge from delivery hospitalization. Baseline surveys were administered to all participants prior to randomization to a mental health chatbot intervention or to usual care only. The intervention group downloaded the mental health chatbot smartphone application with perinatal-specific content, in addition to continuing usual care. Usual care consisted of routine postpartum follow up and mental health care as dictated by the patient's obstetric provider. Surveys were administered during delivery hospitalization (baseline) and at 2-, 4-, and 6-weeks postpartum to assess depression and anxiety symptoms. The primary outcome was a change in depression symptoms at 6-weeks as measured using two depression screening tools: Patient Health Questionnaire-9 and Edinburgh Postnatal Depression Scale. Secondary outcomes included anxiety symptoms measured using Generalized Anxiety Disorder-7, and satisfaction and acceptability using validated scales. Based on a prior study, we estimated a sample size of 130 would have sufficient (80%) power to detect a moderate effect size (d=.4) in between group difference on the Patient Health Questionnaire-9.; Results: A total of 192 women were randomized equally 1:1 to the chatbot or usual care; of these, 152 women completed the 6-week survey (n=68 chatbot, n=84 usual care) and were included in the final analysis. Mean baseline mental health assessment scores were below positive screening thresholds. At 6-weeks, there was a greater decrease in Patient Health Questionnaire-9 scores among the chatbot group compared to the usual care group (mean decrease=1.32, standard deviation=3.4 vs mean decrease=0.13, standard deviation=3.01, respectively). 6-week mean Edinburgh Postnatal Depression Scale and Generalized Anxiety Disorder-7 scores did not differ between groups and were similar to baseline. 91% (n=62) of the chatbot users were satisfied or highly satisfied with the chatbot, and 74% (n=50) of the intervention group reported use of the chatbot at least once in 2 weeks prior to the 6-week survey. 80% of study participants reported being comfortable with the use of a mobile smartphone application for mood management.; Conclusion: Use of a chatbot was acceptable to women in the early postpartum period. The sample did not screen positive for depression at baseline and thus the potential of the chatbot to reduce depressive symptoms in this population was limited. This study was conducted in a general obstetric population. Future studies of longer duration in high-risk postpartum populations who screen positive for depression are needed to further understand the utility and efficacy of such digital therapeutics for that population. (© 2023 Published by Elsevier Inc.)

Sun, K., et al. (2021). "Efficacy of magnetic stimulation for female stress urinary incontinence: a meta-analysis." Therapeutic Advances in Urology 13.
	Aim: This meta-analysis aimed to evaluate the efficacy of magnetic stimulation (MS) in treating female stress urinary incontinence (SUI) and providing an alternative treatment for patients who are unwilling to undergo surgery. Method(s): Randomized controlled trials (RCTs) that evaluated MS as a remedy for female SUI were retrieved from various electronic databases, including MEDLINE, EMBASE, and the Cochrane Controlled Trial Registry system. Moreover, reference lists for related papers were carefully screened for relevant studies. Result(s): A total of six RCTs evaluating the effect of MS in treating female SUI were included in this study. Compared with the placebo group, the MS group exhibited higher quality-of-life scores [mean difference (MD) 0.59, 95% credibility interval (CI) 0.23-0.95; p = 0.001] and lower International Consultation on Incontinence Questionnaire scores (MD -3.93, 95% CI -5.85 to -2.01; p < 0.0001). Moreover, they exhibited a higher objective cure rate (odds ratio 8.49, 95% CI 3.08-23.37). In addition, MS treatment reduced the number of episodes of urinary incontinence (MD -1.42, 95% CI -2.24 to -0.59; p = 0.0007) and urine loss on pad test (MD -4.67, 95% CI -8.05 to -1.28; p = 0.007). There were no significant treatment-related adverse reactions. Conclusion(s): This study evaluated the efficacy and safety of MS in the treatment of female SUI. The results have important implications for patients who do not wish to undergo surgical therapy. We found that MS treatment for SUI has positive outcomes, however, future studies should aim at establishing the best protocol for optimizing the therapeutic effect.Copyright © The Author(s), 2021.

Sun, M.-L., et al. (2022). "Metformin With or Without Clomiphene Citrate Versus Laparoscopic Ovarian Drilling With or Without Clomiphene Citrate to Treat Patients With Clomiphene Citrate-Resistant Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis." Frontiers in Pharmacology 13: 576458.
	Introduction: Which is optimal to treat clomiphene citrate-resistant polycystic ovary syndrome (CCR-PCOS) with LOD or metformin remains a problem. There are three inconsistent or even contradictory views. Objectives: The present meta-analysis aimed to evaluate the effectiveness and safety of Metformin with or without CC and to compare them with LOD with or without CC (Met/Met-CC vs. LOD/LOD-CC) in women with CCR-PCOS who also have anovulation. Data source: The PubMed, Cochrane, and Embase databases were searched to identify relevant studies reported between 1 Jan 1966 and 31 Aug 2019; the search was updated on 17 May 2022. Study eligibility criteria: We included randomized controlled trials (RCTs) of CCR-PCOS that had considered Met/Met-CC and LOD/LOD-CC as the exposure variables and fertility as the main outcome variable. Study appraisal and synthesis methods: We assessed study quality using the Cochrane risk-of-bias tool. The primary effectiveness outcome was live birth/ongoing pregnancy rate and the primary safety outcome was miscarriage rate. A fixed-effect meta-analysis was performed. The robustness of the results was assessed using sensitivity analyses. Meta-regression and subgroup analysis were performed to examine the reasons for heterogeneity. Publication bias was examined using the funnel plot, Egger linear regression, and Begg rank correlation tests. The quality of this meta-analysis was estimated according to the GRADE approach. This meta-analysis has been registered in PROSPERO (CRD42021240156). Results: Among 71 potentially relevant studies, we included five RCTs in our meta-analysis. We found no difference in effectiveness between Met-CC and LOD in terms of live birth/ongoing pregnancy (RR = 1.02, 95% CI: 0.87-1.21, z = 0.28; p = 0.780), and miscarriage rates (RR = 0.79, 95% CI: 0.46-1.36, z = 0.86; p = 0.390). I2 tests results revealed moderate or no heterogeneity (I2 = 51.4%, p = 0.083; I2= 0.0%; p = 0.952). Sensitivity analysis confirmed the robustness of the results. Funnel plot, Egger linear regression, and Begg rank correlation tests implied no publication bias ( p > 0.05). LOD was more expensive than Met (€1050 vs. €50.16). The evidence quality was moderate. Conclusion: There is no evidence on the difference in the outcomes between the two interventions regarding ovulation, pregnancy, and live birth. As LOD is an invasive procedure and carries inherent risks, the use of Met/Met-CC should be the second-line treatment for women with CCR-PCOS. Systematic Review Registration: identifier CRD42021240156.; 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 Sun, Bai, Song, Wang, Gao, Zheng and Wang.)

Sun, P., et al. (2022). "Efficacy and safety of Yunkang oral liquid combined with conventional therapy for threatened miscarriage of first-trimester pregnancy a protocol for systematic review and meta-analysis." PloS One 17(2): e0263581.
	Introduction: Threatened miscarriages is a common complication of first-trimester pregnancy. Due to the beneficial effects, there are increasing clinical studies on Yunkang oral liquid(YKOL). However, the efficacy and safety of YKOL are still unknown. The aim of this systematic review was to assess the efficacy and safety of YKOL in the treatment of threatened miscarriage during the first-trimester pregnancy (TMFP).; Methods: This protocol will be prepared according to the preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) statement. The systematic review will include all randomized controlled trials (RCTs) studies published until April 2021. Electronic sources including CNKI, WF, VIP, CBM, MEDLINE(PubMed), Embase, Cochrane Library, and Web of Science will be searched for potentially eligible studies. The international clinical trial registration platform and the Chinese clinical trial registration platform of controlled trials will be searched from their inception until April 1st, 2021. According to the inclusion and exclusion criteria, screening literature, extraction data will be conducted by two researchers independently. Statistical analysis will use RevMan 5.3.5 software. The strength of evidence from the studies will be evaluated with the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) methods.; Results: This study will provide evidence for YKOL combined with conventional therapy for TMFP.; Conclusion: The efficacy and safety of YKOL combined with conventional therapy for TMFP will be assessed.; Systematic Review Registration: INPLASY202140105 (https://www.doi.org/10.37766/inplasy2021.4.0105).; Competing Interests: The authors have declaredthat no competing interests exist.

Sun, X., et al. (2023). "Effect of psychological interventions on mental health, personal relationships and quality of life of women who have subjectively experienced traumatic childbirth." Journal of Affective Disorders 339: 706-716.
	Background: No targeted review has assessed the effect of psychological interventions on the mental health, personal relationships, and the quality of life of women who have subjectively experienced traumatic childbirth. Method(s): Eight databases were searched from inception to January 2023. Study selection, data extraction, quality appraisal, and data analysis were conducted by two researchers independently. Result(s): In total, eight studies were included. The results indicated that psychological interventions could effectively alleviate post-traumatic stress disorder (PTSD) symptoms, depression, and anxiety in women who have subjectively experienced traumatic childbirth. The interventions were more effective in alleviating PTSD symptoms than depression or anxiety. The subgroup analysis results showed that the effect of multiple sessions might be better than that of a single session. There was insufficient evidence supporting the effect of psychological interventions to improve personal relationships and the quality of life. Limitation(s): Study limitations included the small number of studies included for meta-analysis, substantial heterogeneity, and the retrieval of only studies written in English or Chinese. Conclusion(s): Psychological intervention is a promising method for the mental health of women who have subjectively experienced traumatic childbirth, but more studies are needed to confirm the effects. More studies are also required to explore the impact of psychological interventions on personal relationships and the quality of life. Future studies should focus on comparing which specific type of psychological intervention is most effective. Additional investigations should include the potential adverse effects and long-term effects of psychological interventions and details, such as content, process, and timing.Copyright © 2023 Elsevier B.V.

Sun, Y., et al. (2022). "Acupuncture combined with metformin for polycystic ovary syndrome: A protocol for systematic review and meta-analysis." Medicine 101(49): e32234.
	Background: Polycystic ovary syndrome is an endocrine disorder that occurs mostly in women of reproductive age and has lifelong effects on their health.; Methods: Randomized controlled clinical trials that met the inclusion criteria were screened by searching multiple databases. Relevant data were extracted, and meta-analysis was performed using Reviewer Manager 5.4.; Results: The results of this study will be submitted to peer-reviewed journals.; Conclusion: This study provides evidence for the efficacy and safety of the clinical application of acupuncture combined with metformin in the treatment of polycystic ovary syndrome.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Sung, V. (2022). "Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence." ClinicalTrials.gov.
	The purpose of this study is to directly compare 2 primary outcomes (Treatment satisfaction and urinary symptom severity) between beta agonist oral medication versus onabotulinumtoxinA intradetrusor bladder injection for the treatment of UUI. The study will also compare secondary outcomes identified as important by patients. At the end of the study, the investigators will have patient and stakeholder‐derived comparative outcomes between these 2 commonly available treatment categories. A stakeholder and community engagement (CE) plan will be developed and implemented. The investigators will also develop a model to help guide patients and providers through this decision process. SPECIFIC AIMS Specific Aim 1: Compare the efficacy of beta agonist versus onabotulinumtoxinA on patient‐important treatment outcomes at 3 months in women with UUI. This multi‐center, randomized clinical trial (RCT) includes 5 sites across the U.S. Two co‐primary outcomes will be measured using validated patient‐reported outcomes (PROs), selected by patients: Co‐primary outcome 1: Symptom severity, measured by change in Overactive Bladder Questionnaire‐Symptom Bother Scale (OAB‐q‐SS) score. Co‐primary outcome 2: Treatment satisfaction, measured by the Functional Assessment of Chronic Illness Therapy‐Treatment Satisfaction‐General (FACIT‐TS‐G), powered based on a single item. Specific Aim 2: Compare secondary patient‐important outcomes. Direct comparisons between intervention effects on secondary outcomes chosen by patients and stakeholders, including adverse events, UUI quality of life, global improvement, and sexual function. Specific Aim 3: Use predictive modeling to help stakeholders better determine expected outcomes after treatment with beta agonist versus onabotulinumtoxinA. Comparators: Beta agonist oral medication (mirabegron or vibegron) versus intradetrusor onabotulinumtoxinA. Both beta‐agonists and onabotulinumtoxinA are US Food and Drug Administration (FDA) approved for the treatment of UUI, and widely available options with established efficacy. 432 women will be randomly assigned to each treatment option: 216 to beta agonist oral medication and 216 to intradetrusor onabotulintoxinA. Women will be undergo outcomes assessments at 3, 6, 9, and 12 months. The primary outcome measure will be at 3 months.

Sunkara, S. K., et al. (2023). "In vitro fertilisation for unexplained subfertility." The Cochrane Database of Systematic Reviews(9).
	- Background In vitro fertilisation (IVF) is a treatment for unexplained subfertility but is invasive, expensive, and associated with risks. Objectives To evaluate the effectiveness and safety of IVF versus expectant management, unstimulated intrauterine insemination (IUI), and IUI with ovarian stimulation using gonadotropins, clomiphene citrate (CC), or letrozole in improving pregnancy outcomes. Search methods We searched following databases from inception to November 2021, with no language restriction: Cochrane Gynaecology and Fertility Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL. We searched reference lists of articles and conference abstracts. Selection criteria Randomised controlled trials (RCTs) comparing effectiveness of IVF for unexplained subfertility with expectant management, unstimulated IUI, and stimulated IUI. Data collection and analysis We followed standard Cochrane methods. Main results IVF versus expectant management (two RCTs) We are uncertain whether IVF improves live birth rate (LBR) and clinical pregnancy rate (CPR) compared to expectant management (odds ratio (OR) 22.0, 95% confidence interval (CI) 2.56 to 189.37; 1 RCT; 51 women; very low‐quality evidence; OR 3.24, 95% CI 1.07 to 9.8; 2 RCTs; 86 women; I 2 = 80%; very low‐quality evidence). Adverse effects were not reported. Assuming 4% LBR and 12% CPR with expectant management, these would be 8.8% to 9% and 13% to 58% with IVF. IVF versus unstimulated IUI (two RCTs) IVF may improve LBR compared to unstimulated IUI (OR 2.47, 95% CI 1.19 to 5.12; 2 RCTs; 156 women; I 2 = 60%; low‐quality evidence). We are uncertain whether there is a difference between IVF and IUI for multiple pregnancy rate (MPR) (OR 1.03, 95% CI 0.04 to 27.29; 1 RCT; 43 women; very low‐quality evidence) and miscarriage rate (OR 1.72, 95% CI 0.14 to 21.25; 1 RCT; 43 women; very low‐quality evidence). No study reported ovarian hyperstimulation syndrome (OHSS). Assuming 16% LBR, 3% MPR, and 6% miscarriage rate with unstimulated IUI, these outcomes would be 18.5% to 49%, 0.1% to 46%, and 0.9% to 58% with IVF. IVF versus IUI + ovarian stimulation with gonadotropins (6 RCTs), CC (1 RCT), or letrozole (no RCTs) Stratified analysis was based on pretreatment status. Treatment‐naive women There may be little or no difference in LBR between IVF and IUI + gonadotropins (1 IVF to 2 to 3 IUI cycles: OR 1.19, 95% CI 0.87 to 1.61; 3 RCTs; 731 women; I 2 = 0%; low‐quality evidence; 1 IVF to 1 IUI cycle: OR 1.63, 95% CI 0.91 to 2.92; 2 RCTs; 221 women; I 2 = 54%; low‐quality evidence); or between IVF and IUI + CC (OR 2.51, 95% CI 0.96 to 6.55; 1 RCT; 103 women; low‐quality evidence). Assuming 42% LBR with IUI + gonadotropins (1 IVF to 2 to 3 IUI cycles) and 26% LBR with IUI + gonadotropins (1 IVF to 1 IUI cycle), LBR would be 39% to 54% and 24% to 51% with IVF. Assuming 15% LBR with IUI + CC, LBR would be 15% to 54% with IVF. There may be little or no difference in CPR between IVF and IUI + gonadotropins (1 IVF to 2 to 3 IUI cycles: OR 1.17, 95% CI 0.85 to 1.59; 3 RCTs; 731 women; I 2 = 0%; low‐quality evidence; 1 IVF to 1 IUI cycle: OR 4.59, 95% CI 1.86 to 11.35; 1 RCT; 103 women; low‐quality evidence); or between IVF and IUI + CC (OR 3.58, 95% CI 1.51 to 8.49; 1 RCT; 103 women; low‐quality evidence). Assuming 48% CPR with IUI + gonadotropins (1 IVF to 2 to 3 IUI cycles) and 17% with IUI + gonadotropins (1 IVF to 1 IUI cycle), CPR would be 44% to 60% and 28% to 70% with IVF. Assuming 21% CPR with IUI + CC, CPR would be 29% to 69% with IVF. There may be little or no difference in multiple pregnancy rate (MPR) between IVF and IUI + gonadotropins (1 IVF to 2 to 3 IUI cycles: OR 0.82, 95% CI 0.38 to 1.77; 3 RCTs; 731 women; I 2 = 0%; low‐quality evidence; 1 IVF to 1 IUI cycle: OR 0.76, 95% CI 0.36 to 1.58; 2 RCTs; 221 women; I 2 = 0%; low‐quality evidence); or between IVF and IUI + CC (OR 0.64, 95% CI 0.17 to 2.41; 1 RCT; 102 women; low‐quality evidence). We are uncertain if there is a difference in OHSS between IVF and IUI + gonadotropins with 1 IVF to 2 o 3 IUI cycles (OR 6.86, 95% CI 0.35 to 134.59; 1 RCT; 207 women; very low‐quality evidence); and there may be little or no difference in OHSS with 1 IVF to 1 IUI cycle (OR 1.22, 95% CI 0.36 to 4.16; 2 RCTs; 221 women; I 2 = 0%; low‐quality evidence). There may be little or no difference between IVF and IUI + CC (OR 1.53, 95% CI 0.24 to 9.57; 1 RCT; 102 women; low‐quality evidence). We are uncertain if there is a difference in miscarriage rate between IVF and IUI + gonadotropins with 1 IVF to 2 to 3 IUI cycles (OR 0.31, 95% CI 0.03 to 3.04; 1 RCT; 207 women; very low‐quality evidence); and there may be little or no difference with 1 IVF to 1 IUI cycle (OR 1.16, 95% CI 0.44 to 3.02; 1 RCT; 103 women; low‐quality evidence). There may be little or no difference between IVF and IUI + CC (OR 1.48, 95% CI 0.54 to 4.05; 1 RCT; 102 women; low‐quality evidence). In women pretreated with IUI + CC IVF may improve LBR compared with IUI + gonadotropins (OR 3.90, 95% CI 2.32 to 6.57; 1 RCT; 280 women; low‐quality evidence). Assuming 22% LBR with IUI + gonadotropins, LBR would be 39% to 65% with IVF. IVF may improve CPR compared with IUI + gonadotropins (OR 14.13, 95% CI 7.57 to 26.38; 1 RCT; 280 women; low‐quality evidence). Assuming 30% CPR with IUI + gonadotropins, CPR would be 76% to 92% with IVF. Authors' conclusions IVF may improve LBR over unstimulated IUI. Data should be interpreted with caution as overall evidence quality was low. Plain language summary In vitro fertilisation compared to other options for unexplained subfertility Key messages In vitro fertilisation (IVF) treatment may be associated with a higher chance of a live birth compared to unstimulated intrauterine insemination (IUI) treatment. IVF may also result in higher live birth rates when compared to ovarian stimulation plus IUI in women previously treated with IUI plus clomiphene citrate (CC). However, in treatment‐naive women, live birth following IVF may be no better than IUI plus gonadotropins or IUI plus CC. Background IVF is frequently used for couples with unexplained subfertility, as it may bypass a variety of undiagnosed biological problems. However, it is expensive and invasive and can lead to complications. Other management options for unexplained subfertility include trying naturally for a pregnancy, introducing washed sperm within the womb (known as intrauterine insemination, or IUI), and performing IUI after the use of fertility drugs clomiphene citrate (CC) and gonadotropins to stimulate the ovaries. What did we want to find out? We investigated whether IVF treatment leads to more live births than other treatments for unexplained subfertility. What did we do? We included nine randomised controlled trials (a type of study where participants are randomly assigned to one of two or more treatment groups) in the review. Some trials involved several comparisons. Two trials compared IVF with expectant management; two with IUI alone; and six with IUI plus stimulation of the ovaries. What did we find? Scanty evidence meant that we were unable to draw any firm conclusions as to whether IVF may be associated with higher live birth rate (LBR) than trying naturally (expectant management). If we assume 4% LBR with expectant management, LBR with IVF would be between 8.8% and 9%. IVF may lead to improved LBR compared to unstimulated IUI. If we assume LBR 16% with unstimulated IUI, LBR with IVF would be between 18.5% and 49%. In women pretreated with IUI plus CC, IVF may lead to improved LBR compared with IUI plus gonadotropins. In women pretreated with IUI plus CC, if we assume 22% LBR with IUI plus gonadotropins, LBR with IVF would be between 39% and 65%. In women never previously treated with IUI plus CC, LBR may be no better after one IVF cycle compared to two to three cycles of IUI plus gonadotropins; one IVF cycle compared to one IUI cycle plus gonadotropins; or IVF compared to IUI plus CC. If we assume 42% LBR with IUI plus gonadotropins (in one IVF to two to three IUI cycles), LBR would be between 39% and 54% with IVF; as uming 26% LBR wit IUI plus gonadotropins (in one IVF to one IUI cycle), LBR would be between 24% and 51% with IVF. Assuming 15% LBR with IUI plus CC, LBR would be between 15% and 54% with IVF. We were unable to examine complications associated with these treatments owing to lack of evidence. What are the limitations of the evidence? We have low confidence in the evidence because there were relatively few studies, with low numbers of participants. How up‐to‐date is this evidence? The evidence is current to November 2021.

Surjit, S., et al. (2021). "Uterine Artery Embolization versus Myomectomy for Uterine Fibroids: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Suzuki, Y., et al. (2023). "Toxicity profiles of antibody-drug conjugates for anticancer treatment: a systematic review and meta-analysis." JNCI Cancer Spectrum 7(5): pkad069.
	Background: Antibody-drug conjugates are attractive targeted agents in anticancer treatment because of their unique mechanism of action and reduced toxicity. Little is known about the spectrum of adverse events associated with antibody-drug conjugates, despite tens of clinical trials. Method(s): A systematic review of randomized controlled trials evaluating antibody-drug conjugate efficacy in anticancer treatment was conducted. PubMed, EMBASE, and ClinicalTrial.gov were searched for relevant studies. Meta-analyses assessed the odds ratios (ORs) of 12 treatment-related symptoms and toxicities in patients treated with antibody-drug conjugates compared with those receiving other anticancer agents without antibody-drug conjugates. All-grade and high-grade (grade >=3) toxicities were examined. Result(s): Twenty studies involving 10075 patients were included. Compared with control groups, antibody-drug conjugates were associated with a higher risk of all-grade fatigue (OR = 1.25, 95% confidence interval [CI] = 1.08 to 1.45), anorexia (OR = 1.36, 95% CI = 1.09 to 1.69), nausea (OR = 1.46, 95% CI = 1.09 to 1.97), and sensory neuropathy (OR = 2.18, 95% CI = 1.27 to 3.76) as treatment-related symptoms. Patients treated with antibody-drug conjugates had a statistically significantly lower risk of all-grade febrile neutropenia (OR = 0.46, 95% CI = 0.22 to 0.96). Conversely, they had a higher risk of thrombocytopenia (OR = 2.07, 95% CI = 1.00 to 4.31), increased alanine aminotransferase (OR = 2.51, 95% CI = 1.84 to 3.40), and increased aspartate aminotransferase (OR = 2.83, 95% CI = 2.04 to 3.93). Subgroup analysis showed a similar toxicity profile when comparing the solid tumors with hematologic malignancy groups and the antibody-drug conjugate vs antibody-drug conjugate plus chemotherapy groups, except for some neurologic and hematologic adverse events. Conclusion(s): This comprehensive profile of adverse events associated with antibody-drug conjugate-based treatment shows an increase in various types of all-grade treatment-related symptoms and adverse events, although no increase in high-grade adverse events was seen.Copyright © 2023 The Author(s).

Svenstrup, L., et al. (2022). "Does the HCG trigger dose used for IVF impact luteal progesterone concentrations? a randomized controlled trial." Reproductive Biomedicine Online 45(4): 793-804.
	Research question: Is there an association between the ovulation trigger dose of human chorionic gonadotrophin (HCG) and endogenous progesterone production during the luteal phase? Design: This randomized controlled four-arm study, at the Fertility Clinic, Odense University Hospital, Denmark, included women undergoing gonadotrophin-releasing hormone (GnRH) antagonist IVF treatment with <=11 follicles >=12 mm. Group 1-3 were triggered with 5000 IU, 6500 IU or 10,000 IU HCG, respectively, receiving 17alpha-hydroxyprogesterone caproate intramuscularly for luteal-phase support (LPS) to measure endogenous progesterone production. Group 4 received 6500 IU HCG trigger and vaginal progesterone. During the study, the 5000 IU and 10,000 IU HCG groups were switched from urinary to recombinant HCG, as urinary HCG was removed from market. Eight blood samples were drawn during the luteal phase. Result(s): Ninety-four participants completed the study. There was a significant positive association between the HCG trigger dose and the progesterone at 8 days (P < 0.001), 10 days (P < 0.001) and 14 days (P < 0.001) post-oocyte retrieval. Comparing the groups individually revealed a significant difference in progesterone concentration between low and high trigger doses at 4 days (P = 0.037) and 8 days (P = 0.007) post-oocyte retrieval and between all intervention groups at oocyte retrieval + 6 days: group 1 and 2 (P = 0.011), group 2 and 3 (P = 0.042) and group 1 and 3 (P < 0.001). Higher HCG trigger dose increased the progesterone from the individual follicle. Conclusion(s): Increasing HCG trigger doses significantly increased endogenous progesterone concentration during the mid-late luteal phase.Copyright © 2022

Sverrisdóttir Una, Á., et al. (2022). "Impact of diet on pain perception in women with endometriosis: A systematic review." European Journal of Obstetrics, Gynecology, and Reproductive Biology 271: 245-249.
	Introduction: Endometriosis is a painful, chronic inflammatory disorder that is difficult to treat. Studies have suggested that diet may have a therapeutic effect on chronic inflammation. However, only limited information is available regarding the impact of diet on pain perception in relation to endometriosis. As such, the aim of this review was to evaluate if diet has any impact on pain perception in women suffering from endometriosis.; Materials and Methods: A systematic review was conducted by searching Medline and Embase to identify randomized controlled trials and observational studies adhering to the PRISMA and SWiM guidelines. A table summarizing the findings was developed using the GRADE approach. Inclusion criteria were: women of reproductive age; laparoscopically confirmed diagnosis of endometriosis; and intervention including any type of dietary change. This review was registered with PROSPERO on 14 November 2020 (CRD42020212314).; Results: In total, the database search identified 2185 studies; of these, six studies fulfilled the inclusion criteria. The Newcastle-Ottawa scale and the Cochrane tool were used to assess the studies, which were concluded to be of high quality and to have low risk of bias. All studies had a positive impact on pain perception, with all except one study reporting a significant reduction in pain perception, indicating that high intake of polyunsaturated fatty acids, a gluten-free diet and a low nickel diet may improve painful endometriosis. It was not possible to conduct a meta-analysis due to considerable heterogeneity amongst the included studies due to differences in dietary adherence, dietary therapies, outcome measurements, populations, durations and study designs.; Conclusion: All studies found that diet had a positive impact on pain perception among women with endometriosis. However, the majority of available evidence on dietary interventions in relation to endometriosis-associated pain was derived from non-randomized controlled trials, which have multiple sources of bias. Therefore, further studies are needed to investigate diet and its effect on pain perception in women with endometriosis. (Copyright © 2022 Elsevier B.V. All rights reserved.)

Swanson, L. (2021). "A Wearable Morning Light Treatment for Postpartum Depression." ClinicalTrials.gov.
	This study will test a consumer health light therapy device (Re‐Timer) for women with postpartum depression to better understand how it affects mood and the body clock (also called the circadian clock). Eligible participants will be enrolled and randomized after baseline assessments. In addition to using the Re‐Timer light for 5 weeks participants will complete questionnaires at various timepoints, record sleep information, wear an actigraph watch, and provide saliva samples. Additionally, the sleep of the participants' infants will also be monitored using an ankle‐worn device (actigraph) and sleep diary at certain time‐points as this may influence the mother's mood/sleep, and in turn affect the results. The hypotheses regarding the bright light versus the placebo dim light of the study are: ‐ morning bright light therapy will produce greater improvement from pre‐ to post‐treatment on the Hamilton Rating Scale for Depression ‐ morning bright light therapy will lengthen the Phase angle difference (PAD) and this will mediate change in depression symptoms. ‐ morning bright light therapy will produce greater improvements on self‐reported depression symptoms, excessive daytime sleepiness, maternal‐infant bonding, social functioning, and sleep‐related impairment from pre‐ to post‐treatment.

Tabrizi, R., et al. (2022). "The Effects of Probiotic Supplementation on Clinical Symptom, Weight Loss, Glycemic Control, Lipid and Hormonal Profiles, Biomarkers of Inflammation, and Oxidative Stress in Women with Polycystic Ovary Syndrome: a Systematic Review and Meta-analysis of Randomized Controlled Trials." Probiotics and Antimicrobial Proteins 14(1): 1-14.
	The purpose of this systematic review and meta-analysis of randomized controlled trials (RCTs) is to determine the effectiveness of probiotic supplementation on clinical symptoms, weight loss, glycemic control, lipid and hormonal profiles, and biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome (PCOS). Eligible studies were systematically searched from Cochrane Library, Embase, Medline, and Web of Science databases until January 2019. Cochran (Q) and I-square statistics were used to measure heterogeneity among included studies. Data were pooled by using random-effect model and expressed as standardized mean difference (SMD) with 95% confidence interval (CI). Eleven articles were included in this meta-analysis. Probiotic supplementation significantly decreased weight (SMD - 0.30; 95% CI, - 0.53, - 0.07; P = 0.01), body mass index (BMI) (SMD - 0.29; 95% CI, - 0.54, - 0.03; P = 0.02), fasting plasma glucose (FPG) (SMD - 0.26; 95% CI, - 0.45, - 0.07; P < 0.001), insulin (SMD - 0.52; 95% CI, - 0.81, - 0.24; P < 0.001), homeostatic model assessment for insulin resistance (HOMA-IR) (SMD - 0.53; 95% CI, - 0.79, - 0.26; P < 0.001), triglycerides (SMD - 0.69; 95% CI, - 0.99, - 0.39; P < 0.001), VLDL-cholesterol (SMD - 0.69; 95% CI, - 0.99, - 0.39; P < 0.001), C-reactive protein (CRP) (SMD - 1.26; 95% CI, - 2.14, - 0.37; P < 0.001), malondialdehyde (MDA) (SMD - 0.90; 95% CI, - 1.16, - 0.63; P < 0.001), hirsutism (SMD - 0.58; 95% CI, - 1.01, - 0.16; P < 0.001), and total testosterone levels (SMD - 0.58; 95% CI, - 0.82, - 0.34; P < 0.001), and also increased the quantitative insulin sensitivity check index (QUICKI) (SMD 0.41; 95% CI, 0.11, 0.70; P < 0.01), nitric oxide (NO) (SMD 0.33; 95% CI 0.08, 0.59; P = 0.01), total antioxidant capacity (TAC) (SMD 0.64; 95% CI, 0.38, 0.90; P < 0.001), glutathione (GSH) (SMD 0.26; 95% CI, 0.01, 0.52; P = 0.04), and sex hormone binding globulin (SHBG) levels (SMD 0.46; 95% CI, 0.08, 0.85; P = 0.01). Probiotic supplementation may result in an improvement in weight, BMI, FPG, insulin, HOMA-IR, triglycerides, VLDL-cholesterol, CRP, MDA, hirsutism, total testosterone, QUICKI, NO, TAC, GSH, and SHBG but did not affect dehydroepiandrosterone sulfate levels, and total, LDL, and HDL cholesterol levels in patients with PCOS. (© 2019. Springer Science+Business Media, LLC, part of Springer Nature.)

Taghavi Seyed, A., et al. (2021). "Pharmacological and non-pharmacological strategies for obese women with subfertility." The Cochrane Database of Systematic Reviews 3: CD012650.
	Background: Clinicians primarily recommend weight loss for obese women seeking pregnancy. The effectiveness of interventions aimed at weight loss in obese women with subfertility is unclear.; Objectives: To assess the effectiveness and safety of pharmacological and non-pharmacological strategies compared with each other, placebo, or no treatment for achieving weight loss in obese women with subfertility.; Search Methods: We searched the CGF Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, and AMED from inception to 18 August 2020. We also checked reference lists and contacted experts in the field for additional relevant papers.; Selection Criteria: We included published and unpublished randomised controlled trials in which weight loss was the main goal of the intervention. Our primary effectiveness outcomes were live birth or ongoing pregnancy and primary safety outcomes were miscarriage and adverse events. Secondary outcomes included clinical pregnancy, weight change, quality of life, and mental health outcome.; Data Collection and Analysis: Review authors followed standard Cochrane methodology.; Main Results: This review includes 10 trials. Evidence was of very low to low quality: the main limitations were due to lack of studies and poor reporting of study methods. The main reasons for downgrading evidence were lack of details by which to judge risk of bias (randomisation and allocation concealment), lack of blinding, and imprecision. Non-pharmacological intervention versus no intervention or placebo Evidence is insufficient to determine whether a diet or lifestyle intervention compared to no intervention affects live birth (odds ratio (OR) 0.85, 95% confidence interval (CI) 0.65 to 1.11; 918 women, 3 studies; I² = 78%; low-quality evidence). This suggests that if the chance of live birth following no intervention is assumed to be 43%, the chance following diet or lifestyle changes would be 33% to 46%. We are uncertain if lifestyle change compared with no intervention affects miscarriage rate (OR 1.54, 95% CI 0.99 to 2.39; 917 women, 3 studies; I² = 0%; very low-quality evidence). Evidence is insufficient to determine whether lifestyle change compared with no intervention affects clinical pregnancy (OR 1.06, 95% CI 0.81 to 1.40; 917 women, 3 studies; I² = 73%; low-quality evidence). Lifestyle intervention resulted in a decrease in body mass index (BMI), but data were not pooled due to heterogeneity in effect (mean difference (MD) -3.70, 95% CI -4.10 to -3.30; 305 women, 1 study; low-quality evidence; and MD -1.80, 95% CI -2.67 to -0.93; 43 women, 1 study; very low-quality evidence). Non-pharmacological versus non-pharmacological intervention We are uncertain whether intensive weight loss interventions compared to standard care nutrition counselling affects live birth (OR 11.00, 95% CI 0.43 to 284; 11 women, 1 study; very low-quality evidence), clinical pregnancy (OR 11.00, 95% CI 0.43 to 284; 11 women, 1 study; very low-quality evidence), BMI (MD -3.00, 95% CI -5.37 to -0.63; 11 women, 1 study; very low-quality evidence), weight change (MD -9.00, 95% CI -15.50 to -2.50; 11 women, 1 study; very low-quality evidence), quality of life (MD 0.06, 95% CI -0.03 to 0.15; 11 women, 1 study; very low-quality evidence), or mental health (MD -7.00, 95% CI -13.92 to -0.08; 11 women, 1 study; very low-quality evidence). No study reported on adverse events . Pharmacological versus pharmacological intervention For metformin plus liraglutide compared to metformin we are uncertain of an effect on the adverse events nausea (OR 7.22, 95% CI 0.72 to 72.7; 28 women, 1 study; very low-quality evidence), diarrhoea (OR 0.31, 95% CI 0.01 to 8.3; 28 women, 1 study; very low-quality evidence), and headache (OR 5.80, 95% CI 0.25 to 133; 28 women, 1 study; very low-quality evidence). We are uncertain if a combination of metformin plus liraglutide vs metformin affects BMI (MD 2.1, 95% CI -0.42 to 2.62; 28 women, 1 study; very low-quality evidence) and total body fat (MD -0.50, 95% CI -4.65 to 3.65; 28 women, 1 study; very low-quali y evidence). For metformin, clomiphene, and L-carnitine versus metformin, clomiphene, and placebo, we are uncertain of an effect on miscarriage (OR 3.58, 95% CI 0.73 to 17.55; 274 women, 1 study; very low-quality evidence), clinical pregnancy (OR 5.56, 95% CI 2.57 to 12.02; 274 women, 1 study; very low-quality evidence) or BMI (MD -0.3, 95% CI 1.17 to 0.57, 274 women, 1 study, very low-quality evidence). We are uncertain if dexfenfluramine versus placebo affects weight loss in kilograms (MD -0.10, 95% CI -2.77 to 2.57; 21 women, 1 study; very low-quality evidence). No study reported on live birth, quality of life, or mental health outcomes. Pharmacological intervention versus no intervention or placebo We are uncertain if metformin compared with placebo affects live birth (OR 1.57, 95% CI 0.44 to 5.57; 65 women, 1 study; very low-quality evidence). This suggests that if the chance of live birth following placebo is assumed to be 15%, the chance following metformin would be 7% to 50%. We are uncertain if metformin compared with placebo affects gastrointestinal adverse events (OR 0.91, 95% CI 0.32 to 2.57; 65 women, 1 study; very low-quality evidence) or miscarriage (OR 0.50, 95% CI 0.04 to 5.80; 65 women, 1 study; very low-quality evidence) or clinical pregnancy (OR 2.67, 95% CI 0.90 to 7.93; 96 women, 2 studies; I² = 48%; very low-quality evidence). We are also uncertain if diet combined with metformin versus diet and placebo affects BMI (MD -0.30, 95% CI -2.16 to 1.56; 143 women, 1 study; very low-quality evidence) or waist-to-hip ratio (WHR) (MD 2.00, 95% CI -2.21 to 6.21; 143 women, 1 study; very low-quality evidence). Pharmacological versus non-pharmacological intervention No study undertook this comparison.; Authors' Conclusions: Evidence is insufficient to support the use of pharmacological and non-pharmacological strategies for obese women with subfertility. No data are available for the comparison of pharmacological versus non-pharmacological strategies. We are uncertain whether pharmacological or non-pharmacological strategies effect live birth, ongoing pregnancy, adverse events, clinical pregnancy, quality of life, or mental heath outcomes. However, for obese women with subfertility, a lifestyle intervention may reduce BMI. Future studies should compare a combination of pharmacological and lifestyle interventions for obese women with subfertility. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Tagliaferri, V., et al. (2021). "Comparison of absorbable and permanent sutures for laparoscopic sacrocervicopexy: A randomized controlled trial." Acta Obstetricia et Gynecologica Scandinavica 100(2): 347-352.
	INTRODUCTION: Pelvic organ prolapse is a common cause of morbidity and decreased quality of life among women and is treatable by laparoscopic sacrocolpopexy. Recent data suggest that absorbable sutures are a feasible and appealing option for mesh attachment given a potential decreased risk of complications related to mesh erosion. The aim of the present study was to demonstrate the non-inferiority of absorbable sutures to permanent sutures for laparoscopic sacrocervicopexy. MATERIAL AND METHODS: We performed a randomized, single-blinded, non-inferiority trial comparing late-absorbable sutures (group A) to non-absorbable sutures (group B) for anterior and posterior vaginal mesh fixation during laparoscopic sacrocervicopexy at a single center in Italy. The primary outcome was prolapse correction at 12 months after surgery, defined as the absence of a pelvic organ prolapse leading edge reaching or extending below the level of the hymen and the absence of bulge symptoms. Secondary outcomes included intraoperative parameters, postoperative characteristics, and long-term morbidity. Statistical analyses were performed using STATA version 16. RESULTS: A total of 150 patients with pelvic organ prolapse were prospectively randomized 1:1 into two groups (A or B). Baseline characteristics and intraoperative parameters including blood loss, operation time, and intraoperative complications were comparable between groups. The success rate was 100% in both groups and no differences in prolapse correction were observed. The rates of de novo urinary incontinence and persistent urinary incontinence were also similar between groups. The rate of mesh erosion at 12 months was 0% in group A and 4% in group B (P = .24). CONCLUSIONS: Late absorbable sutures are non-inferior to non-absorbable sutures for laparoscopic sacrocervicopexy in terms of procedural success. Moreover we did not see any differences in terms of operative parameters, or intraoperative and postoperative characteristics, although the study was not powered to these outcomes.

Tairy, D. (2024). "Speculum Insertion During Embryo Transfer." ClinicalTrials.gov.
	No Results Available Other: Sterile water-based gel Ongoing pregnancy or live birth rate.|Positive serum BHCG|Clinical pregnancy|Questionnaire Female Not Applicable 416 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 0147-23-WOMC December 31, 2026

Taithongchai, A., et al. (2023). "Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women." The Cochrane Database of Systematic Reviews 2023(7): CD014592.
	Background: Pelvic organ prolapse (POP) is the descent of a woman's uterus, bladder, or rectum into the vagina. It affects 50% of women over 50 years old who have given birth to at least one child, and recognised risk factors are older age, higher number of births, and higher body mass index. This review assesses the effects of oestrogen therapy, alone or in combination with other treatments, on POP in postmenopausal women. Objective(s): To assess the benefits and harms of local and systemic oestrogen therapy in the management of pelvic organ prolapse symptoms in postmenopausal women, and to summarise the principal findings of relevant economic evaluations. Search Method(s): We searched the Cochrane Incontinence Specialised Register (up to 20 June 2022), which includes CENTRAL, MEDLINE, two trials registers, and handsearching of journals and conference proceedings. We also checked the reference lists of relevant articles for additional studies. Selection Criteria: We included randomised controlled trials (RCTs), quasi-RCTs, multi-arm RCTs, and cross-over RCTs that evaluated the effects of oestrogen therapy (alone or in combination with other treatments) versus placebo, no treatment, or other interventions in postmenopausal women with any grade of POP. Data Collection and Analysis: Two review authors independently extracted data from the included trials using prespecified outcome measures and a piloted extraction form. The same review authors independently assessed the risk of bias of eligible trials using Cochrane's risk of bias tool. Had data allowed, we would have created summary of findings tables for our main outcome measures and assessed the certainty of the evidence using GRADE. Main Result(s): We identified 14 studies including a total of 1002 women. In general, studies were at high risk of bias in terms of blinding of participants and personnel, and there were also some concerns about selective reporting. Owing to insufficient data for the outcomes of interest, we were unable to perform our planned subgroup analyses (systemic versus topical oestrogen, parous versus nulliparous women, women with versus without a uterus). No studies assessed the effects of oestrogen therapy alone versus no treatment, placebo, pelvic floor muscle training, devices such as vaginal pessaries, or surgery. However, we did identify three studies that assessed oestrogen therapy in conjunction with vaginal pessaries versus vaginal pessaries alone and 11 studies that assessed oestrogen therapy in conjunction with surgery versus surgery alone. Authors' conclusions: There was insufficient evidence from RCTs to draw any solid conclusions on the benefits or harms of oestrogen therapy for managing POP symptoms in postmenopausal women. Topical oestrogen in conjunction with pessaries was associated with fewer adverse vaginal events compared with pessaries alone, and topical oestrogen in conjunction with surgery was associated with reduced postoperative urinary tract infections compared with surgery alone; however, these findings should be interpreted with caution, as the studies that contributed data varied substantially in their design. There is a need for larger studies on the effectiveness and cost-effectiveness of oestrogen therapy, used alone or in conjunction with pelvic floor muscle training, vaginal pessaries, or surgery, for the management of POP. These studies should measure outcomes in the medium and long term.Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Takahashi, S., et al. (2021). "Efficacy and safety of the noradrenaline reuptake inhibitor, TAS-303, in women with stress urinary incontinence: results of a double-blind, randomized, placebo-controlled, early phase II trial." International Journal of Urology 28(1): 82‐90.
	Objective: To carry out an exploratory assessment of the efficacy and safety of TAS‐303, a noradrenaline reuptake inhibitor, in women with stress urinary incontinence. Methods: In a double‐blind, placebo‐controlled, early phase II study, women with stress urinary incontinence and stress urinary incontinence‐predominant mixed urinary incontinence were randomized to a placebo or TAS‐303 (3 or 6 mg) once daily for 8 weeks. The main efficacy end‐points were mean percentage change in incontinence episode frequency per 24 h from baseline to week 8 (the primary end‐point) and week 4. Results: At week 8, the mean percentage change in incontinence episode frequency per 24 h was −34.73% in the TAS‐303 3 mg group, −35.41% in the TAS‐303 6 mg group and −28.07% in the placebo group (differences vs placebo, not significant). In patients with stress urinary incontinence, or incontinence episode frequency less than two episodes per 24 h at baseline, TAS‐303 significantly reduced incontinence episode frequency versus placebo after 4 weeks; some secondary end‐points also showed a tendency to improve in the same subgroups. No serious adverse events (e.g. central nervous system or cardiovascular effects) were observed; TAS‐303 was well tolerated and had a favorable safety profile. Conclusion: These findings suggest that TAS‐303 is effective for improving stress urinary incontinence symptoms in some subgroups of patients with stress urinary incontinence. Therefore, further research is warranted.

Takamatsu, K., et al. (2021). "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Effects of Kamishoyosan, a Traditional Japanese Medicine, on Menopausal Symptoms: The KOSMOS Study." Evidence-based Complementary and Alternative Medicine 2021: 8856149.
	OBJECTIVE: The KOSMOS study, a multicenter, randomized, double-blind, placebo-controlled trial, investigated the effects and safety of kamishoyosan (TJ-24), a traditional Japanese medicine, in the treatment of climacteric disorder. METHODS: Japanese women with climacteric disorder were administered a placebo during a 4-week run-in period, after which they were classified as placebo responders (R group) if their score on the modified Questionnaire for the Assessment of Climacteric Symptoms in Japanese Women (m-QACS) with excitability and irritability as the primary outcome improved by ≥ 3 points and as placebo nonresponders (NR group) otherwise. Members of the NR group were randomly allocated to receive either TJ-24 or placebo. After 12 weeks, their m-QACS scores, anxiety and depression, sleep, and overall quality of life (QOL) were compared. RESULTS: The TJ-24 and placebo arms in the NR group included 20 patients each. The change in the m-QACS scores of members of the NR group for excitability and irritability at 12 weeks versus baseline was -3.1 ± 1.7 in the TJ-24 arm, a significant decrease, but compared with -2.7 ± 2.2 in the placebo arm, no significant difference was between two arms. However, the proportion of participants whose score improved by ≥3 points was significantly higher in the TJ-24 arm. In the subgroup analysis of premenopausal women, the changes in the score for excitability and irritability were significantly larger in the TJ-24 arm. The incidence of adverse drug reactions or adverse events did not differ between the two arms, and no serious events were reported. CONCLUSION: Although no significant difference was identified for the primary outcome, a significantly higher proportion of patients who received TJ-24 displayed improvement. Its high level of safety and effects on excitability and irritability in premenopausal women suggest that TJ-24 may be a useful treatment.

Takayanagi, T. (2021). "A study of FSN-013 in Japanese patients with dysmenorrhea." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: FSN‐013 or Placebo administered orally CONDITION: dysmenorrhea PRIMARY OUTCOME: The amount of change in the total dysmenorrhea score INCLUSION CRITERIA: 1.Secondary dysmenorrhea ‐Diagnosed as Endometriosis or Adenomyosis by laparotomy or laparoscopy ‐Diagnosed as Endometriosis with ovarian chocolate cysts or Adenomyosis or Uterine fibroids by TVUS or MRI 2.Functional dysmenorrhea ‐Patients whose secondary dysmenorrhea was ruled out by history taking, vaginal examination, and TVUS, etc. 3.Aged >= 20 years at the time of informed consent 4.BMI < 30 kg/m2

Takayanagi, T. (2021). "A study of FSN-013 in Japanese patients with endometriosis." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Each subject will receive one tablet of FSN‐013(Estetrol Hydrate/Drospirenone) or Placebo orally once a day. CONDITION: endometriosis PRIMARY OUTCOME: The amount of change in the most severe pelvic pain (lower abdominal pain / back pain) INCLUSION CRITERIA: 1.Diagnosed as endometriosis by laparotomy or laparoscopy 2.Diagnosed as endometriosis (having ovarian chocolate cysts) by TVUS or MRI 3.Patients clinically diagnosed as endometriosis with any of Douglas fossa induration or limited uterine mobility or pelvic tenderness by vaginal or rectal examination 4.Aged >= 20 years at the time of informed consent 5.BMI < 30 kg/m2

Tam, T. and L. Juarez (2023). "Effectiveness of a hysteroscopic tissue removal system device for hysteroscopic myomectomy on patients' quality of life: a randomized clinical trial." BMC Women's Health 23(1): 541.
	Purpose: To evaluate the quality of life in patients treated for submucosal leiomyomas after hysteroscopic myomectomy compared to medical therapy. This is the first prospective randomized analysis comparing outcomes of medical therapy versus hysteroscopic myomectomy using the TruClear™ hysteroscopic tissue removal system to treat heavy menstrual bleeding from submucosal leiomyoma(s).; Methods: Setting: private practice and community-based hospital; subjects: female patients with symptomatic submucosal leiomyomas from 2014 to 2017. A total of 69 patients enrolled, with 47 completed.; Statistical Analysis Used: randomization, linear mixed-effects modeling, hypothesis testing, and intent-to-treat analysis. Each patient was randomized to oral contraceptive pills/progesterone releasing intrauterine device or hysteroscopic myomectomy. Each patient was to complete the Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) questionnaire at baseline, one month, three months, and greater than or equal to six months after treatment.; Main Outcome Measured: Primary outcome was the health-related quality of life (HR-QOL), as reflected from UFS-QOL scores. Contrasts were constructed from a linear mixed-effects model to compare the two treatment groups for changes from baseline in UFS-QOL scores.; Results: UFS-QOL scores were similar at baseline between the two treatment groups. There was an overall improvement in all UFS-QOL scores within each group. Higher improvement scores were noted in the surgical group compared to the medical group for almost all UFS-QOL scores. At ≥ 6 months, in comparison to the medically managed patients, the most considerable score improvements for the surgical group were reported in HR-QOL concern, activities, self-consciousness and symptom severity scores having mean change scores (95% CIs) of 35.3, 28.9, 28.6, and 32.2, respectively.; Conclusion: Although there was no statistical difference in the change degree of improvement of overall quality of life among patients with symptomatic submucosal leiomyomas who received medical or surgical treatments in the study, there were greater differences in improvements in health-related quality of life scores over time after surgical treatment. (© 2023. BioMed Central Ltd., part of Springer Nature.)

Tamaki, A. (2022). "Verification of the effect of electrical stimulation on pelvic floor muscles." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: A combined program of standard pelvic floor muscle training and electrical stimulation at least three times per week. Standard pelvic floor muscle training at least 3 times per week. CONDITION: Women with urinary incontinence symptoms PRIMARY OUTCOME: Pelvic floor muscle function SECONDARY OUTCOME: Number of urinary incontinence,; Number of urination,; Subjective symptoms, ; Quality of life INCLUSION CRITERIA:

Tamy, C., et al. (2021). "Royal jelly on menopausal symtoms: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Tandon, D. (2023). "Preventing Postpartum Depression in Immigrant Latinas." ClinicalTrials.gov.
	No Results Available Behavioral: Mothers and Babies Virtual Group Intervention Depressive symptoms|Depressive episodes|Parenting self-efficacy|Parenting responsiveness|Behavioral activation|Decentering|Social support|Mood management|Anxiety symptoms|Perceived stress Female Not Applicable 300 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention STU00217105 April 30, 2027

Tang, S., et al. (2019). "A systematic review and meta-analysis of the safety and efficacy of uterine artery embolization vs. surgery for symptomatic uterine fibroids." Journal of Interventional Medicine 1(2): 112-120.
	Purpose: The aim of this study was to systematically review the safety and efficacy of uterine artery embolization (UAE) versus surgery for symptomatic uterine fibroids. Materials and Methods: An electronic search of the Cochrane Library, PubMed, Embase and Web of Science databases was conducted from their inception to May 2017 for randomized controlled trials (RCTs) that assessed UAE versus surgery for the treatment of symptomatic uterine fibroids. The references of the included studies were also retrieved. Two reviewers independently screened the studies based on the inclusion and exclusion criteria, extracted the data, and assessed the methodological quality. The meta-analysis was conducted using RevMan 5.3 software. Results: A total of seven RCTs involving 859 patients were included. The results of the meta-analysis showed a shorter hospital stay and recovery time for UAE as compared to surgery. Surgery was not reported to be better for improving health-related quality of life in any of the included studies. There were no significant differences in patient satisfaction (1-2 and 5 years), and intra-procedural complications or major complications (1 year). However, the rates of minor complications (1 year) and further interventions (2 and 5 years) were significantly higher in patients who underwent UAE rather than surgery. The rates of pregnancy and live births were significantly lower among patients who underwent UAE than surgery. Conclusion: UAE is safe and effective, and has the advantages of shorter hospital stay and recovery time as compared to surgery. However, UAE has the risk of re-intervention, and lower pregnancy and live birth rates. (© 2018 Shanghai Journal of Interventional Medicine Press. Production and hosting by Elsevier B.V. on behalf of KeAi.)

Taniguchi, F. (2023). "Relugolix and Dienogest for Endometriosis: randomized Controlled Study." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Subject is assigned in 1:1 ratio to either the Relugoli Xgroup or the Dienogest group. Relugoli Xgroup: Relugoli Xtablet 40 mg is orally administered once a day before meals for 16 weeks. Starting the day after the last dose of Relugolix, Dienogest tablet 1 mg is orally administered twice a day for 24 weeks. Dienogest group: Dienogest tablet 1 mg orally administered twice a day for 24 weeks. CONDITION: endometriosis PRIMARY OUTCOME: The amount of change from baseline in maximum VAS score for endometriotic pelvic pain during the primary evaluation period SECONDARY OUTCOME: 1) The amount of change from baseline in the mean of VAS score of endometriotic pelvic pain during the primary evaluation period.; 2) The maximum VAS score for endometriotic pelvic pain every 28 days after administration and each amount of change from baseline.; 3) The mean of VAS score for endometriotic pelvic pain every 28 days after administration and each amount of change from baseline.; 4) The maximum VAS score for menstrual pain every 28 days after administration and each amount of change from baseline.; 5) The mean of VAS score for menstrual pain every 28 days after administration and each amount of change from baseline.; 6) The maximum VAS score for endometriotic pelvic pain of out of the menstrual period every 28 days after administration and each amount of change from baseline.; 7) The mean of VAS score for endometriotic pelvic pain of out of the menstrual period every 28 days after administration and each amount of change from baseline.; 8) The VAS score of dyspareunia and each amount of change from baseline.; 9) The B&B score for dysmenorrhea, B&B score for pelvic pain (out of the menstrual period), B&B score for dyspareunia and each amount of change from baseline.; 10) Severity of Douglas cavity induration, restricted uterine mobility, and pelvic tenderness and the amount of change from baseline.; 11) Disease‐specific QOL (the 30‐item Endometriosis Health Profile: EHP‐30) score; 12) Health‐related QOL (EQ‐5D) score; 13) Work Productivity (WHO‐HPQ) score; 14) Number of days and rate of analgesic medications taken every 28 days after administration, and the amount of change from baseline.; 15) Ovarian endometrioma diameter and the amount of change from baseline. INCLUSION CRITERIA: 1)Premenopausal Japanese women aged 18 years or older at the time of informed consent. 2)Patients with endometriosis. However, the diagnosis must be made by one of the following methods. In the case of recurrence after surgical treatment of endometriosis, those diagnosed again with one of the following. ‐Those diagnosed with endometriosis by laparotomy or laparoscopy performed within 5 years prior to VISIT1 ‐Those are shown an ovarian endometrioma by performed that MRI within 1 year prior to VISIT 1 or ultrasound (transvaginal, transabdominal or ransrectal) from VISIT 1 to VISIT 2 ‐Those who have been diagnosed with clinical endometriosis and have either Douglas cavity induration, restricted uterine mobility, or pelvic tenderness by internal or rectal examination performed from VISIT 1 to VISIT 2 3)Those with a maximum VAS score of >30 for endometriotic pelvic pain during the screening period, including more than one menstrual period. 4)Those who h

Tao, Y., et al. (2023). "The efficacy of traditional chinese medicine combined with hyperthermic intraperitoneal chemotherapy for malignant ascites in ovarian cancer: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Tapanainen, J. (2021). "COaching Lifestyle Intervention for FErtility." ClinicalTrials.gov.
	No Results Available Behavioral: Life Style Behavior change|Live birth rate|Weight change|Infertility treatments, number|Infertility treatments, mode|Miscarriage rate|Height|Weight|Body mass index|Body composition|Waist circumference|Self-reported physical activity|Physical activity|Maximal oxygen uptake|Dietary content|Dietary patterns|Folate|Vitamin-D|Zinc|Carbohydrates|Protein|Alcohol|n-3 fatty acids|n-6 fatty acids|Saturated fatty acids|Monounsaturated fatty acids|Polyunsaturated fatty acids|Sleep|Sleep, measured|Stress recovery|Anxiety and depression|Fertility quality of life|Depression|Self-determined motivation for physical activity|Intention and action planning for physical activity; Intention to increase physical activity|Self-efficacy for physical activity|Pregnancy complications|Delivery complications|Neonatal outcome|Body composition of the newborn|Growth of the child|Sperm epigenetic profile|Transcriptome|Sperm oxidative stress|A cost-utility of the intervention|QALY baseline|QALY end point|Cost-effectiveness|Static postural balance|Perception of stress|Personality dimensions All Not Applicable 1560 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment TYH2020338 September 2025

Tatiana, F., et al. (2023). "The impact of conservative interventions for pain reduction in women who experience endometriosis-associated pain: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Tattersall, A., et al. (2022). "Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer." The Cochrane Database of Systematic Reviews 2: CD007929.
	Background: Ovarian cancer is the sixth most common cancer in women world-wide. Epithelial ovarian cancer (EOC) is the most common; three-quarters of women present when disease has spread outside the pelvis (stage III or IV). Treatment consists of a combination of surgery and platinum-based chemotherapy. Although initial responses to chemotherapy are good, most women with advanced disease will relapse. PARP (poly (ADP-ribose) polymerase) inhibitors (PARPi), are a type of anticancer treatment that works by preventing cancer cells from repairing DNA damage, especially in those with breast cancer susceptibility gene (BRCA) variants. PARPi offer a different mechanism of anticancer treatment from conventional chemotherapy.; Objectives: To determine the benefits and risks of poly (ADP-ribose) polymerase) inhibitors (PARPi) for the treatment of epithelial ovarian cancer (EOC).; Search Methods: We identified randomised controlled trials (RCTs) by searching the Cochrane Central Register of Controlled Trials (Central 2020, Issue 10), Cochrane Gynaecological Cancer Group Trial Register, MEDLINE (1990 to October 2020), Embase (1990 to October 2020), ongoing trials on www.controlled-trials.com/rct, www.clinicaltrials.gov, www.cancer.gov/clinicaltrials, the National Research Register (NRR), FDA database and pharmaceutical industry biomedical literature.; Selection Criteria: We included trials that randomised women with EOC to PARPi with no treatment, or PARPi versus conventional chemotherapy, or PARPi together with conventional chemotherapy versus conventional chemotherapy alone.; Data Collection and Analysis: We used standard Cochrane methodology. Two review authors independently assessed whether studies met the inclusion criteria. We contacted investigators for additional data. Outcomes included overall survival (OS), objective response rate (ORR), quality of life (QoL) and rate of adverse events.; Main Results: We included 15 studies (6109 participants); four (3070 participants) with newly-diagnosed, advanced EOC and 11 (3039 participants) with recurrent EOC. The studies varied in types of comparisons and evaluated PARPi. Eight studies were judged as at low risk of bias in most of the domains. Quality of life data were generally poorly reported. Below we present six key comparisons. The majority of participants had BRCA mutations, either in their tumour (sBRCAmut) and/or germline (gBRCAmut), or homologous recombination deficiencies (HRD) in their tumours. Newly diagnosed EOC Overall, four studies evaluated the effect of PARPi in newly-diagnosed, advanced EOC. Two compared PARPi with chemotherapy and chemotherapy alone. OS data were not reported. The combination of PARPi with chemotherapy may have little to no difference in progression-free survival (PFS) (two studies, 1564 participants; hazard ratio (HR) 0.82, 95% confidence interval (CI 0).49 to 1.38; very low-certainty evidence)(no evidence of disease progression at 12 months' 63% with PARPi versus 69% for placebo). PARPi with chemotherapy likely increases any severe adverse event (SevAE) (grade 3 or higher) slightly (45%) compared with chemotherapy alone (51%) (two studies, 1549 participants, risk ratio (RR) 1.13, 95% CI 1.07 to 1.20; high-certainty evidence). PARPi combined with chemotherapy compared with chemotherapy alone likely results in little to no difference in the QoL (one study; 744 participants, MD 1.56 95% CI -0.42 to 3.54; moderate-certainty evidence). Two studies compared PARPi monotherapy with placebo as maintenance after first-line chemotherapy in newly diagnosed EOC. PARPi probably results in little to no difference in OS (two studies, 1124 participants; HR 0.81, 95%CI 0.59 to 1.13; moderate-certainty evidence) (alive at 12 months 68% with PARPi versus 62% for placebo). However, PARPi may increase PFS (two studies, 1124 participants; HR 0.42, 95% CI 0.19 to 0.92; low-certainty evidence) (no evidence of disease progression at 12 months' 55% with PARPi versus 24% for placebo). There may be an increase in the risk of experiencing any SevAE (grad 3 or hi her) with PARPi (54%) compared with placebo (19%)(two studies, 1118 participants, RR 2.87, 95% CI 1.65 to 4.99; very low-certainty evidence), but the evidence is very uncertain. There is probably a slight reduction in QoL with PARPi, although this may not be clinically significant (one study, 362 participants; MD -3.00, 95%CI -4.48 to -1.52; moderate-certainty evidence). Recurrent, platinum-sensitive EOC Overall, 10 studies evaluated the effect of PARPi in recurrent platinum-sensitive EOC. Three studies compared PARPi monotherapy with chemotherapy alone. PARPi may result in little to no difference in OS (two studies, 331 participants; HR 0.95, 95%CI 0.62 to 1.47; low-certainty evidence) (percentage alive at 36 months 18% with PARPi versus 17% for placebo). Evidence is very uncertain about the effect of PARPi on PFS (three studies, 739 participants; HR 0.88, 95%CI 0.56 to 1.38; very low-certainty evidence)(no evidence of disease progression at 12 months 26% with PARPi versus 22% for placebo). There may be little to no difference in rates of any SevAE (grade 3 or higher) with PARPi (50%) than chemotherapy alone (47%) (one study, 254 participants; RR 1.06, 95%CI 0.80 to 1.39; low-certainty evidence). Four studies compared PARPi monotherapy as maintenance with placebo. PARPi may result in little to no difference in OS (two studies, 560 participants; HR 0.88, 95%CI 0.65 to 1.20; moderate-certainty evidence)(percentage alive at 36 months 21% with PARPi versus 17% for placebo). However, evidence suggests that PARPi as maintenance therapy results in a large PFS (four studies, 1677 participants; HR 0.34, 95% CI 0.28 to 0.42; high-certainty evidence)(no evidence of disease progression at 12 months 37% with PARPi versus 5.5% for placebo). PARPi maintenance therapy may result in a large increase in any SevAE (51%) (grade 3 or higher) than placebo (19%)(four studies, 1665 participants, RR 2.62, 95%CI 1.85 to 3.72; low-certainty evidence). PARPi compared with chemotherapy may result in little or no change in QoL (one study, 229 participants, MD 1.20, 95%CI -1.75 to 4.16; low-certainty evidence). Recurrent, platinum-resistant EOC Two studies compared PARPi with chemotherapy. The certainty of evidence in both studies was graded as very low. Overall, there was minimal information on the QoL and adverse events.; Authors' Conclusions: PARPi maintenance treatment after chemotherapy may improve PFS in women with newly-diagnosed and recurrent platinum-sensitive EOC; there may be little to no effect on OS, although OS data are immature. Overall, this is likely at the expense of an increase in SevAE. It is disappointing that data on quality of life outcomes are relatively sparse. More research is needed to determine whether PARPi have a role to play in platinum-resistant disease. (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Taylor, F. C., et al. (2021). "Interrupting Prolonged Sitting and Endothelial Function in Polycystic Ovary Syndrome." Medicine and Science in Sports and Exercise 53(3): 479-486.
	PURPOSE: In healthy adults, the impairment of vascular function associated with prolonged sitting can be mitigated with intermittent brief bouts of activity. It is unknown whether these benefits extend to women with polycystic ovary syndrome (PCOS), in whom vascular function is typically impaired and sitting time is high. We examined the acute effect of regularly interrupting sitting time with brief simple resistance activities (SRA) on vascular function in PCOS. METHODS: In a randomized crossover trial, 13 physically inactive women with PCOS (18-45 yr) completed two 3.5-h conditions: 1) uninterrupted sitting (SIT) and 2) sitting interrupted by 3-min bouts of SRA every 30 min. Femoral artery flow-mediated dilation (FMD), resting shear rate, and resting blood flow were measured at 0, 1, and 3.5 h. RESULTS: Mean resting femoral shear rate, averaged across the 3.5 h, significantly increased in the SRA condition relative to the SIT condition (40.1 ± 6.1 vs 62.8 ± 6.1 s-1, P < 0.0001). In addition, mean resting blood flow also significantly increased across the 3.5 h for SRA relative to SIT (45.0 ± 9.8 vs 72.8 ± 9.9 mL·min-1, P < 0.0001). There were no differences between conditions in the temporal change in femoral artery FMD across 3.5 h (Ptime-condition > 0.05 for all). CONCLUSION: Frequently interrupting sitting with SRA acutely increased resting shear rate and blood flow in women with PCOS but did not alter FMD. With sedentary behavior increasing in prevalence, longer-term studies of similar interventions to reduce and break up sitting time are warranted.

Taylor, H., et al. (2022). "Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial." BMJ Open 12(6): e052043.
	Introduction: Infertility is a common complication of endometriosis. While in vitro fertilisation-embryo transfer (IVF) successfully treats endometriosis-associated infertility, there is some evidence that pregnancy rates may be diminished in women seeing fertility treatment for endometriosis-associated infertility compared with other etiologies of infertility. The use of gonadotropin releasing hormone (GnRH) agonist prior to IVF has been suggested to improve success, however studies have been small and rarely reported live birth rates. Recent approval of an oral GnRH antagonist for endometriosis provides a novel option for women with endometriosis who are undergoing IVF. There have been no studies on the efficacy of GnRH antagonists for the treatment of endometriosis-related infertility.; Methods and Analysis: This study is a multicentre, prospective, randomised, double-blind, placebo-controlled trial to study the efficacy of GnRH antagonist pretreatment for women with endometriosis who are undergoing IVF. A total of 814 patients with endometriosis undergoing fertility treatment will be enrolled and randomised 1:1 into two groups: elagolix 200 mg two times per day or placebo for 8 weeks, prior to undergoing IVF. All participants will then undergo IVF treatment per local protocols. The primary outcome is live birth. Secondary outcomes include oocyte number, fertilisation rate, embryo morphology and implantation rates, as well as rates of known endometriosis-related obstetrical outcomes (pregnancy-induced hypertension, antepartum haemorrhage, caesarean delivery and preterm birth).; Ethics and Dissemination: The PREGnant trial was approved by the Institutional Review Board at Johns Hopkins University. Results will be published in a peer-reviewed journal.; Trial Registration Number: NCT04173169.; 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.)

Taylor, M., et al. (2021). "Early psychological interventions for prevention and treatment of post-traumatic stress disorder (PTSD) and post-traumatic stress symptoms in post-partum women: A systematic review and meta-analysis." PloS One 16(11): e0258170.
	Background: Pre-term or full-term childbirth can be experienced as physically or psychologically traumatic. Cumulative and trans-generational effects of traumatic stress on both psychological and physical health indicate the ethical requirement to investigate appropriate preventative treatment for stress symptoms in women following a routine traumatic experience such as childbirth.; Objective: The objective of this review was to investigate the effectiveness of early psychological interventions in reducing or preventing post-traumatic stress symptoms and post-traumatic stress disorder in post-partum women within twelve weeks of a traumatic birth.; Methods: Randomised controlled trials and pilot studies of psychological interventions preventing or reducing post-traumatic stress symptoms or PTSD, that included women who had experienced a traumatic birth, were identified in a search of Cochrane Central Register of Randomised Controlled Trials, MEDLINE, Embase, Psychinfo, PILOTS, CINAHL and Proquest Dissertations databases. One author performed database searches, verified results with a subject librarian, extracted study details and data. Five authors appraised extracted data and agreed upon risk of bias. Analysis was completed with Rev Man 5 software and quality of findings were rated according to Grading of Recommendation, Assessment, Development, and Evaluation.; Results: Eleven studies were identified that evaluated the effectiveness of a range of early psychological interventions. There was firm evidence to suggest that midwifery or clinician led early psychological interventions administered within 72 hours following traumatic childbirth are more effective than usual care in reducing traumatic stress symptoms in women at 4-6 weeks. Further studies of high methodological quality that include longer follow up of 6-12 months are required in order to substantiate the evidence of the effectiveness of specific face to face and online early psychological intervention modalities in preventing the effects of stress symptoms and PTSD in women following a traumatic birth before introduction to routine care and practice.; Prospero Registration: CRD42020202576, https://www.crd.york.ac.uk/prospero/display&#95;record.php?RecordID=202576.; Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: PWM is clinical lead for Mirabilis health a private trauma-focused mental health service, which provides pro bono psychotherapy to participants for research projects. PWM provides EMDR training as a part of Mirabilis Health Academy. PWM is a member by invitation of the Council of Scholars; part of the Future of EMDR Therapy Project. The Project works on developing global EMDR standards for training and competency benchmarking guidelines in EMDR therapy. ES is the developer of the EMDR G-TEP protocol and provides training workshops for EMDR clinicians and is also a member of the Council of Scholars.

Tefagh, G., et al. (2022). "Effect of vitamin E supplementation on cardiometabolic risk factors, inflammatory and oxidative markers and hormonal functions in PCOS (polycystic ovary syndrome): a systematic review and meta-analysis." Scientific Reports 12(1): 5770.
	Polycystic ovary syndrome (PCOS) is a common endocrinopathy among reproductive-age women. Various therapeutical approaches are currently used to manage or control symptoms associated with PCOS. This systematic review intended to assess the effects of Vit E supplementation on cardiometabolic risk factors, inflammatory and oxidative markers, and hormonal functions in PCOS women based on the clinical trial's results. The databases including PubMed, Scopus, Cochrane, Web of Science, and Embase were used to find all relevant studies. The authors reviewed all relevant clinical trials via systematic evaluation of abstracts and titles. Searches were conducted on August 1, 2020. After the initial search and reading of the article's title and abstract, 353 articles were reviewed; finally, 12 articles met the inclusion criteria. Vitamin E supplementation improves lipid profile, decreases insulin and HOMA-IR levels. Furthermore, while Vitamin E supplementation decreases LH and testosterone concentrations, it increases FSH and progestrone concentrations. The following meta-analysis showed that vitamin E supplementation made statistically significant improvements in triglyceride (TG) and low-density lipoproteins (LDL) levels, meanwhile, pooled mean difference for waist circumference (WC) and HOMA-IR were also statistically significant. Supplementary regimens containing vitamin E can positively affect metabolic and hormonal parameters in women with PCOS.Copyright © 2022. The Author(s).

Tennfjord Merete, K. (2022). "Effect of Physical Activity and Pain Education on Endometriosis-associated Pain." ClinicalTrials.gov.
	No Results Available Behavioral: Exercise Endometriosis associated pain|Level of physical activity|Pelvic floor muscle maximal contraction and resting tension|Sexual function and sexual pain|Depression and anxiety|Pain with urination|Bowel function|Health economy and related quality of life|Fear of movement Female Not Applicable 83 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 2019/28494(REK) March 1, 2024

Tewari Krishnansu, S., et al. (2022). "Survival with Cemiplimab in Recurrent Cervical Cancer." The New England Journal of Medicine 386(6): 544-555.
	Background: Patients with recurrent cervical cancer have a poor prognosis. Cemiplimab, the fully human programmed cell death 1 (PD-1)-blocking antibody approved to treat lung and skin cancers, has been shown to have preliminary clinical activity in this population.; Methods: In this phase 3 trial, we enrolled patients who had disease progression after first-line platinum-containing chemotherapy, regardless of their programmed cell death ligand 1 (PD-L1) status. Women were randomly assigned (1:1) to receive cemiplimab (350 mg every 3 weeks) or the investigator's choice of single-agent chemotherapy. The primary end point was overall survival. Progression-free survival and safety were also assessed.; Results: A total of 608 women were enrolled (304 in each group). In the overall trial population, median overall survival was longer in the cemiplimab group than in the chemotherapy group (12.0 months vs. 8.5 months; hazard ratio for death, 0.69; 95% confidence interval [CI], 0.56 to 0.84; two-sided P<0.001). The overall survival benefit was consistent in both histologic subgroups (squamous-cell carcinoma and adenocarcinoma [including adenosquamous carcinoma]). Progression-free survival was also longer in the cemiplimab group than in the chemotherapy group in the overall population (hazard ratio for disease progression or death, 0.75; 95% CI, 0.63 to 0.89; two-sided P<0.001). In the overall population, an objective response occurred in 16.4% (95% CI, 12.5 to 21.1) of the patients in the cemiplimab group, as compared with 6.3% (95% CI, 3.8 to 9.6) in the chemotherapy group. An objective response occurred in 18% (95% CI, 11 to 28) of the cemiplimab-treated patients with PD-L1 expression greater than or equal to 1% and in 11% (95% CI, 4 to 25) of those with PD-L1 expression of less than 1%. Overall, grade 3 or higher adverse events occurred in 45.0% of the patients who received cemiplimab and in 53.4% of those who received chemotherapy.; Conclusions: Survival was significantly longer with cemiplimab than with single-agent chemotherapy among patients with recurrent cervical cancer after first-line platinum-containing chemotherapy. (Funded by Regeneron Pharmaceuticals and Sanofi; EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 ClinicalTrials.gov number, NCT03257267.). (Copyright © 2022 Massachusetts Medical Society.)

Tewari Krishnansu, S., et al. (2023). "Final survival analysis of topotecan and paclitaxel for first-line treatment of advanced cervical cancer: An NRG oncology randomized study." Gynecologic Oncology 171: 141-150.
	Objective: To determine whether a non‑platinum chemotherapy doublet improves overall survival (OS) among patients with recurrent/metastatic cervical carcinoma.; Methods: Gynecologic Oncology Group protocol 240 is a phase 3, randomized, open-label, clinical trial that studied the efficacy of paclitaxel 175 mg/m 2 plus topotecan 0.75 mg/m 2 days 1-3 (n = 223) vs cisplatin 50 mg/m 2 plus paclitaxel 135 or 175 mg/m 2 (n = 229), in 452 patients with recurrent/metastatic cervical cancer. Each chemotherapy doublet was also studied with and without bevacizumab (15 mg/kg). Cycles were repeated every 21 days until progression, unacceptable toxicity, or complete response. The primary endpoints were OS and the frequency and severity of adverse effects. We report the final analysis of OS.; Results: At the protocol-specified final analysis, median OS was 16.3 (cisplatin-paclitaxel backbone) and 13.8 months (topotecan-paclitaxel backbone) (HR 1.12; 95% CI, 0.91-1.38; p = 0.28). Median OS for cisplatin-paclitaxel and topotecan-paclitaxel was 15 vs 12 months, respectively (HR 1.10; 95% CI,0.82-1.48; p = 0.52), and for cisplatin-paclitaxel-bevacizumab and topotecan-paclitaxel-bevacizumab was 17.5 vs 16.2 months, respectively (HR 1.16; 95% CI, 0.86-1.56; p = 0.34). Among the 75% of patients in the study population previously exposed to platinum, median OS was 14.6 (cisplatin-paclitaxel backbone) vs 12.9 months (topotecan-paclitaxel backbone), respectively (HR 1.09; 95% CI, 0.86-1.38;p = 0.48). Post-progression survival was 7.9 (cisplatin-paclitaxel backbone) vs 8.1 months (topotecan-paclitaxel backbone) (HR 0.95; 95% CI, 0.75-1.19). Grade 4 hematologic toxicity was similar between chemotherapy backbones.; Conclusions: Topotecan plus paclitaxel does not confer a survival benefit to women with recurrent/metastatic cervical cancer, even among platinum-exposed patients. Topotecan-paclitaxel should not be routinely recommended in this population. NCT00803062.; Competing Interests: Declaration of Competing Interest Dr. Tewari reports receiving honoraria for lectures, presentations, speakers' bureaus for Merck, Astra Zeneca, Eisai, Seagen, Tesaro and Clovis. He also reports serving on Data Safety Monitoring Board/Advisory Board for Iovance. Dr. Penson reports grants received from Array BioPharma Inc., AstraZeneca, Eisai Inc., Genentech, Inc., Regeneron, Sanofi-Aventis US LLC, Tesaro Inc. and Vascular Biogenics Ltd. Dr. Penson also reports receiving consulting fees from AstraZeneca, Eisai, GSK Inc., ImmunoGen Inc., Merck & Co, Mersana, Novacure, Roche Pharma, Sutro Biopharma, and Vascular Biogenics Ltd. and reports participating on Advisory Boards for AstraZeneca and Roche Pharma. Dr. Oaknin reports grants to her institution from the following: Abbvie Deutschland Gmbh & Co Hg, Ability Pharmaceuticals, Advaxis, Agenus, Aprea Therapeutics AB, AstraZeneca AB, BeiGene USA, Inc., Belgian Gynecological Oncology Group (BGOG), Bristol-Myers Squibb International Corporation (BMSM Clovis Oncology, Corcept Therapeutics, Eisai, F. Hoffmann-La Roche, Grupo Española de Investigación en Cáncer de Ovario (GEICO)), Immunogen, Iovance Biotherapeutics, Lilly, Medimmune, Merck Healthcare, Merck Sharp & Dohme, Millennium Pharmaceuticals, Unipharm Research, Novartis Farmacéutica, Regeneron Pharmaceuticals, Seagen, Seattle Genetics, Sutro Biopharma, Tesaro, University Health Network, and Werastem, Regeneron Pharmaceuticals, Seagen, Seattle Genetics, Sutro Biopharma, Tesaro, University Health Network, and Werastem. Dr. Oaknin also reports receiving consulting fees from: Agenus, AstraZeneca Clovis Oncology, Inc., Corcept Therapeutics, Deciphera Pharmaceutical, Eisai Europe Limited, EMD Serono, Inc., F. Hoffmann-La Roche, GlaxoSmithKline, Immunogen, KL Logistics, Medison Pharma, Merck Sharp & Dohme de España, Mersana Therapeutics, Novocure GmbH, Pharma Mar, prIME Oncology, ROCHE FARMA, Sattucklabs, and Sutro Biopharma, Inc., and GEICO. Dr. Oaknin reports personally receiving honoraria for lectures, presentations and Speakers bureaus from ESMO, Edizioni Minerva Medica SpA, Doctaforum Servicios S.L and received support for travel from Roche, AstraZeneca, PharmaMar as well as Clovis. Dr. Oaknin participated on Data Safety Monitoring Board/Advisory Board for Agenus, AstraZeneca Clovis Oncology, Inc., Corcept Therapeutics, Deciphera Pharmaceutical, Eisai Europe Limited, EMD Serono, Inc., F. Hoffmann-La Roche, GlaxoSmithKline, GOG, Immunogen, KL Logistics, Medison Pharma, Merck Sharp & Dohme de España, Mersana Therapeutics, Novocure GmbH, Pharma Mar, prIME Oncology, ROCHE FARMA, Sattucklabs and Sutro Biopharma. Dr. Leitao reports receiving consulting fees from Medtronic, honoraria for lectures from Intuitive Surgical, Inc. as an Ad-hoc Speaker and participating on an Advisory Board for JnJ/Ethicon. Dr. Monk reports receiving consulting fees from the following: Acrivon, Adaptimune, Agenus, Akeso Bio, Amgen, Aravive, AstraZeneca, Bayer, Clovis, Easai, Elevar, EMD Merck, Genmab/Seagen, GOG Foundation, Gradalis, Heng Rui, UmmunoGen, Karyopharm, Iovance, Laekna, Macrogenics, Merck, Mersana, Myriad, Novartis, Novocure, OncoC4, Panavance, Pleris, Pfizer, Puma, Regeneron, Roche/Genentech, Sorrento, Tesaro/GSK, US Oncology Research, VBL, Verastem and Zentalis. He also reports receiving honoraria from: AstraZeneca, Merck, Myriad, Tesaro/GSK, Roche/Genentech, Clovis and Easai. All other authors had no conflicts of interest to disclose with regard to this Study. (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Teychenne, M. (2022). "Food, Move and Sleep (FOMOS) for postnatal mental health." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: FOMOS is an evidence‐based, multi‐component, home‐based health behaviour program, which involves provision of home exercise equipment (free hire), information/motivational material (e.g. goal setting and self‐monitoring) and social support delivered via e‐health (website and text messaging) and a popular social media platform (e.g., Instagram). For the first 3‐months, women will receive: ‐ Home‐exercise equipment: Free‐hire (e.g. exercise bike/treadmill/cross‐trainer/yoga bands and/or resistance bands per preference) to overcome barriers of leaving home and enhance initial engagement. For the first 6‐months, women will receive: ‐ Website: Access to a purposely built website, targeting knowledge (diet quality, physical activity, sleep), self‐efficacy, overcoming barriers, goal‐setting and self‐monitoring. The website includes written informative and educational materials, short videos, as well as links to other resources (e.g., Government or not‐for‐profit health information websites). ‐ Social media: Access to a private Instagram page providing “bite‐sized” information related to website content. ‐ Text messaging: One‐ and two‐way support, educational, and encouraging text messages delivered approximately twice weekly. The aim of these text messages is to enhance social‐support, goal‐setting, monitoring, and feedback, as well as to encourage participants to engage with different components of the website and Instagram. *No recommendation or limitation regarding timing or usage of website, social media and text messages will be given to participants, and they can read the materials and engage with the website in a time‐frame suitable and convenient to them. *The FOMOS Instagram account will post approximately 6 ‐ 10 posts per week ( CONDITION: Mental Health ‐ Depression Postnatal depression (PND) ; ; Postnatal depression (PND) Reproductive Health and Childbirth ‐ Childbirth and postnatal care PRIMARY OUTCOME: Mean group difference in EPDS total score immediately post‐program (6 months post‐baseline) assessed by questionnaire using the Edinburgh Postnatal Depression Scale (EPDS) (Cox, Holden, and Sagovsky, 1987).; ; Cox, Holden, and Sagovsky (1987). Detection of postnatal depression: Development of the 10‐item Edinburgh Postnatal Depression scale. Brit J Psychiatry, 150(June):782‐786.; [‐ Pre‐intervention (Baseline); ‐ 6 months post‐intervention commencement] SECONDARY OUTCOME: Fruit consumption assessed using a modified version of the Australian Short Dietary Screener (Aus_SDS) (Gadowski et al. 2020) ; ; Gadowski AM, McCaffrey TA, Heritier S, Curtis AJ, Nanayakkara N, Zoungas S, et al. Development, relative validity and reproducibility of the Aus‐SDS (Australian short dietary screener) in adults aged 70 years and above. Nutrients. 2020;12(5):1436 ; [‐ Pre‐intervention (Baseline) ; ‐ 6 months post‐intervention commencement ; ‐ 18 months post‐intervention commencement ; ] Physical activity assessed using wrist‐worn ActiGraph GT9 XLink (device‐measured) (Sasaki, John & Freedson 2011; Troiano et al. 2014) ; ; Sasaki, JE, John, D & Freedson, PS 2011, 'Validation and comparison of ActiGraph activity monitors', Journal of Science and Medicine in Sport, vol. 14, no. 5, pp. 411‐6. ; Troiano, RP, McClain, JJ, Brychta, RJ & Chen, KY 2014, 'Evolution of accelerometer methods for physical activity research', British Journal of Sports Medicine, vol. 48, no. 13, p. 1019.[‐ Pre‐intervention (Baseline) ; ‐ 6 months post‐intervention commencement ; ‐ 18 months post‐intervention commencement] Sedentary time assessed using ActiGraph GT9 XLink [‐ Pre‐intervention (Baseline) ; ‐ 6 months post‐intervention commencement ; ‐ 18 months post‐intervention commencement ; ] Sleep quality assessed using sleep quality (PSQI) questionnaire (Saxbe et al. 2016) ; ; Saxbe, DE, Schetter, CD, Guardino, CM, Ramey, SL, Shalowitz, MU, Thorp, J, Vance, M, Eunice Kennedy Shriver National Institute for Child, H & Human Develop nt Community Child Health, N 2016, 'Sleep Quality Predicts Persistence of Parental Postpartum Depressive Symptoms and Transmission of Depressive Symptoms from Mothers to Fathers', Annals of Behavioral Medicine, vol. 50, no. 6, pp. 862‐75.[‐ Pre‐intervention (Baseline) ; ‐ 6 months post‐intervention commencement ; ‐ 18 months post‐intervention commencement ; ] Sustained intervention effects on postnatal depressive symptoms assessed by questionnaire using the Edinburgh Postnatal Depression Scale (EPDS) (Cox, Holden, and Sagovsky, 1987) between baseline and 18 months post‐intervention commencement. ; ; Cox, Holden, and Sagovsky (1987). Detection of postnatal depression: Development of the 10‐item Edinburgh Postnatal Depression scale. Brit J Psychiatry, 150(June):782‐786.[‐ Pre‐intervention (Baseline) ; ‐ 18 months post‐intervention commencement ; ] Vegetable consumption assessed using a modified version of the Australian Short Dietary Screener (Aus_SDS) (Gadowski et al. 2020) ; ; Gadowski AM, McCaffrey TA, Heritier S, Curtis AJ, Nanayakkara N, Zoungas S, et al. Development, relative validity and reproducibility of the Aus‐SDS (Australian short dietary screener) in adults aged 70 years and above. Nutrients. 2020;12(5):1436 ; [‐ Pre‐intervention (Baseline) ; ‐ 6 months post‐intervention commencement ; ‐ 18 months post‐intervention commencement ; ] INCLUSION CRITERIA: Participants will be eligible for inclusion if they: • Are mothers 2‐12 months postpartum; • Living in selected metropolitan, rural, regional areas in VIC, NSW, SA. Remote areas are excluded as the equipment hire companies utilised for the purpose of this study may not deliver to remote areas; • Experiencing heightened PND symptoms (score 10 or greater than 10 on Edinburgh PND Scale); • Are insufficiently active (<150 mins/week of moderate physical activity or 75 mins of vigorous physical activity per week – or equivalent combination); • Not meeting dietary guidelines (not consuming the recommended serves per day for fruit and vegetables); • Not meeting sleep guidelines (shorter than recommended sleep (less than 7hrs) and/or poor quality sleep (“Fairly Bad” or “Very Bad” sleep)) assessed using two items from the PSQI; • Are able to communicate fluently in English; • Have or are willing to create an Instagram account for use during the

Tezer, T., et al. (2022). "Short-term effect of magnetic stimulation added to bladder training in women with idiopathic overactive bladder: a prospective randomized controlled trial." Neurourology and Urodynamics 41(6): 1380‐1389.
	Objective: To evaluate the efficacy of magnetic stimulation (MStim) added to bladder training (BT) on incontinence‐related quality of life (QoL) and clinical parameters in women with idiopathic overactive bladder (OAB). Material and Methods: Seventy‐six women with idiopathic OAB were randomized into two groups using the random numbers generator as follows: Group 1 received BT alone (n: 38), and Group 2 received BT + MStim (n: 38). MStim was performed with MStim therapy armchair (Novamag NT60), 2 days a week, 20 min a day, a total of 12 sessions for 6 weeks. Women were evaluated in terms of incontinence severity (24‐h pad test), 3‐day voiding diary (frequency of voiding, incontinence episodes, nocturia, and number of pads), symptom severity (OAB‐V8), QoL (IIQ‐7), positive response and cure–improvement rates, and treatment satisfaction (Likert scale) at the baseline and the end of treatment (sixth week). Results: A statistically significant improvement was found in incontinence severity, frequency of voiding, incontinence episodes, nocturia, number of pads, symptom severity, and QoL parameters for two groups at the end of the treatment compared to the baseline values (p < 0.05). At the end of treatment; incontinence severity, incontinence episodes, nocturia, number of pads, symptom severity, and QoL were significantly improved in Group 2 compared to Group 1 (p < 0.05). No difference was found between the two groups in terms of frequency of voiding (p > 0.05). The positive response and cure–improvement rates, and treatment satisfaction were significantly higher in Group 2 than in Group 1 (p < 0.05). Conclusion: MStim added to BT is more effective than BT alone in women with idiopathic OAB.

Thales Antonio, T., et al. (2022). "Efficacy of oteseconazole for the treatment of recurrent vulvovaginal candidiasis: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Thao, V., et al. (2023). "Cost-effectiveness of Myomectomy versus Hysterectomy in Women with Uterine Fibroids." Journal of Minimally Invasive Gynecology 30(10): 813-819.
	Study Objective: Increasing evidence suggests that hysterectomy to treat uterine fibroids (UFs), even with ovarian conservation (OC), is associated with a 33% increased risk of coronary artery disease (CAD). We sought to compare the cost-effectiveness of various treatment approaches for UFs to understand the trade-offs among development of CAD vs new fibroids. Design(s): We developed a Markov model to include women with UFs who no longer desired pregnancy. The outcomes of interest were quality-adjusted life-years (QALYs) and total treatment costs. We conducted sensitivity analyses to test the effect of uncertain model inputs. Setting(s): Health system perspective. Patient(s): A hypothetical cohort of 10 000 40-year-old women. Intervention(s): Myomectomy, hysterectomy with OC, and hysterectomy without OC. Measurements and Main Results: Myomectomy was the best-value strategy, costing US$528 217 and providing 19.38 QALYs. Neither hysterectomy with OC nor hysterectomy without OC was found to be cost-effective, assuming a willingness-to-pay threshold of $100 000 per QALY gain as hysterectomy with OC provided more benefit than myomectomy at an average cost of $613 144 to gain one additional QALY. The sensitivity analyses showed that if the risk of new symptomatic UFs that required treatment after myomectomy was more than 13%, annually (base case, 3.6%), or the quality of life after myomectomy was less than 0.815 (base case, 0.834), then myomectomy would no longer be cost-effective, under a willingness-to-pay amount of US$100 000. Conclusion(s): Myomectomy is an optimal treatment of UFs compared with hysterectomy among women aged 40 years. The increased risk of CAD after hysterectomy and its associated costs and the effects on morbidity and quality of life made hysterectomy a costlier and less effective long-term strategy.Copyright © 2023 AAGL

Thaung, Z., et al. (2021). "Long-term effects of resveratrol on cognition, cerebrovascular function and cardio-metabolic markers in postmenopausal women: a 24-month randomised, double-blind, placebo-controlled, crossover study." Clinical Nutrition 40(3): 820‐829.
	Ageing and menopause contribute to endothelial dysfunction, causing impaired cerebral perfusion, which is in turn associated with accelerated cognitive decline. In a 14‐week pilot study, we showed that supplementation with low‐dose resveratrol, a phytoestrogen that can enhance endothelial function, improved cerebrovascular and cognitive functions in postmenopausal women. We sought to confirm these benefits in a larger, longer‐term trial. A 24‐month randomized, placebo‐controlled crossover trial was undertaken in 125 postmenopausal women, aged 45–85 years, who took 75 mg trans‐resveratrol or placebo twice‐daily for 12 months and then crossover to the alternative treatment for another 12 months. We evaluated within individual differences between each treatment period in measures of cognition (primary outcome), cerebrovascular function in the middle cerebral artery (cerebral blood flow velocity: CBFV, cerebrovascular responsiveness: CVR) and cardio‐metabolic markers as secondary outcomes. Subgroup analyses examined effects of resveratrol by life stages. Compared to placebo, resveratrol supplementation resulted a significant 33% improvement in overall cognitive performance (Cohen's d = 0.170, P = 0.005). Women ≥65 years of age showed a relative improvement in verbal memory with resveratrol compared to those younger than 65 years. Furthermore, resveratrol improved secondary outcomes including resting mean CBFV (d = 0.275, P = 0.001), CVR to hypercapnia (d = 0.307, P = 0.027), CVR to cognitive stimuli (d = 0.259, P = 0.032), fasting insulin (d = 0.174, P = 0.025) and insulin resistance index (d = 0.102, P = 0.034). Regular supplementation with low‐dose resveratrol can enhance cognition, cerebrovascular function and insulin sensitivity in postmenopausal women. This may translate into a slowing of the accelerated cognitive decline due to ageing and menopause, especially in late‐life women. Further studies are warranted to observe whether these cognitive benefits of resveratrol can reduce the risk of dementia.

Thayná¡, C., et al. (2021). "Effects of linseed oil (Linum usitatissimum) supplementation on metabolic changes associated with polycystic ovary syndrome: A systematic review." PROSPERO International prospective register of systematic reviews.
	
The Pharmaceutical Company, L. E. K. A. M. S. Z. o. (2023). "A randomized, double-blind, placebo-controlled, multicentre study to evaluate the effect of a 12-week dose of 35 mg DHEA on quality of life in menopausal women." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: Biosteron 10 mg, Biosteron 25 mg Product Name: DHEA Product Code: PR1‐888‐2022; PR2‐888‐2022 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Menopause Therapeutic area: Health Care [N] ‐ Population Characteristics [N01] PRIMARY OUTCOME: Main Objective: Demonstration that 12‐week supplementation with 35 mg DHEA improves quality ; of life and reduces symptoms of vaginal atrophy.; Demonstration that DHEA supplementation at a dose of 35 mg improves mood and reduces the ; severity of vasomotor symptoms associated with menopause. Primary end point(s): Demonstration that 12 weeks of supplementation with 35 mg DHEA improves quality of sexual ; life and reduces symptoms of vaginal atrophy.; Demonstration that DHEA supplementation at a dose of 35 mg improves mood and reduces the ; severity of vasomotor symptoms associated with menopause. Secondary Objective: Demonstration that DHEA supplementation in a dose of 35 mg affects the ; concentration of DHEA and estradiol. Timepoint(s) of evaluation of this end point: N/A SECONDARY OUTCOME: Secondary end point(s): Demonstration that 35 mg DHEA supplementation ; affects serum levels of LH, DHEAS and estradiol Timepoint(s) of evaluation of this end point: N/A INCLUSION CRITERIA: ‐ woman, ‐BMI 20.0‐29.9 kg / m2, ‐ time from the last menstruation at least 12 months, ‐stable body weight during the last 6 months, ‐ FSH concentration 35‐135 mIU / ml and estradiol 5‐55 pg / ml, ‐ concentration of total testosterone 0.084 ‐ 0.481 ng / ml, ‐ Beck Depression Score 11–27 points, ‐ result in the Kupperman Scale 17‐30 points, ‐ declared sexual activity, ‐ FSFI scale ‐ not using menopausal replacement therapy for at least 6 months, ‐ The ability to understand audit procedures and provide written informed consent 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

Theranova, L. L. C. (2021). "Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms." ClinicalTrials.gov.
	To evaluate the safety and effectiveness of the TheraNova Neuromodulation System in overactive bladder (OAB) patients. The primary safety endpoint will be device‐related adverse events. The primary effectiveness endpoint will be urinary urge incontinence (UUI) responder rate at 12 weeks (a responder is defined as a subject who experiences at least a 50% reduction in the mean frequency of UUI events per day from baseline to 12 weeks as measured in the 3‐day voiding diaries). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment.

Thiel, P. S., et al. (2024). "The Effect of Hormonal Treatment on Ovarian Endometriomas: A Systematic Review and Meta-analysis." Journal of Minimally Invasive Gynecology.
	Objective: To evaluate the effect of hormonal suppression of endometriosis on the size of endometriotic ovarian cysts. Data Sources: The authors searched MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, Embase, and ClinicalTrials.gov from January 2012 to December 2022. Methods of Study Selection: We included studies of premenopausal women undergoing hormonal treatment of endometriosis for >=3 months. The authors excluded studies involving surgical intervention in the follow-up period and those using hormones to prevent endometrioma recurrence after endometriosis surgery. Risk of bias was assessed with the Newcastle-Ottawa Scale and Cochrane Risk of Bias Tool. The protocol was registered in PROSPERO (CRD42022385612). Tabulation, Integration, and Results: The primary outcome was the mean change in endometrioma volume, expressed as a percentage, from baseline to at least 6 months. Secondary outcomes were the change in volume at 3 months and analyses by class of hormonal therapy. The authors included 16 studies (15 cohort studies, 1 randomized controlled trial) of 888 patients treated with dienogest (7 studies), other progestins (4), combined hormonal contraceptives (2), and other suppressive therapy (3). Globally, the decrease in endometrioma volume became statistically significant at 6 months with a mean reduction of 55% (95% confidence interval, -40 to -71; 18 treatment groups; 730 patients; p <.001; I2 = 96%). The reduction was the greatest with dienogest and norethindrone acetate plus letrozole, followed by relugolix and leuprolide acetate. The volume reduction was not statistically significant with combined hormonal contraceptives or other progestins. There was high heterogeneity, and studies were at risk of selection bias. Conclusion(s): Hormonal suppression can substantially reduce endometrioma size, but there is uncertainty in the exact reduction patients may experience.Copyright © 2024 AAGL

Thomas, S. (2023). "CCT-102 vs. Expectant Management in Delayed Pregnancy Loss." ClinicalTrials.gov.
	This is a Phase 3, open‐label, multi‐center study to assess the efficacy of a CCT‐102 regimen compared to expectant management for uterine evacuation in first trimester delayed pregnancy loss (DPL). Eligible study participants will have ultrasound documented DPL with estimated gestational age 10 weeks or less. DPL is defined as arrest of embryonic or fetal development, in first trimester, where the cervix is closed and there is no or only slight bleeding. This includes: 1) anembryonic pregnancy, and 2) embryonic demise. Expectant management, which is an accepted treatment protocol recognized in 2018 ACOG Practice Bulletin on Early Pregnancy Loss (ACOG, 2018), consists of patient monitoring with no additional treatment. Eligible participants will be randomized 1:1 to investigational product or expectant management on Day 1. They will be evaluated for the primary endpoint (resolution of DPL) on Study Day 7. All participants will be followed to Day 28.

Thurgar, E., et al. (2021). "Cost-effectiveness of pembrolizumab compared with chemotherapy in the US for women with previously treated deficient mismatch repair or high microsatellite instability unresectable or metastatic endometrial cancer." Journal of Medical Economics 24(1): 675-688.
	Aims: There is limited published evidence for the cost-effectiveness of treatments for unresectable or metastatic endometrial cancer (mEC). The objective of this analysis was to assess the cost-effectiveness of pembrolizumab versus chemotherapy for previously treated unresectable or mEC, in women whose tumors have deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H). The analysis was carried out from a US healthcare payer perspective. Material(s) and Method(s): A lifetime partitioned survival model comprising three health states (progression-free, progressed disease and death) was constructed. Chemotherapy was represented by single-agent paclitaxel or doxorubicin. Overall survival, progression-free survival and time on treatment data for pembrolizumab were obtained from a Phase II clinical study that included women with previously treated dMMR/MSI-H unresectable or mEC (KEYNOTE-158, NCT02628067). Survival data for chemotherapy were obtained from a published Phase III study for previously treated advanced endometrial cancer. Costs included were drug acquisition and administration, health-state, end-of-life, and adverse event management. Costs were presented in 2019 US$. Outcomes were calculated as quality-adjusted life-years (QALYs), using EQ-5D data from KEYNOTE-158. Model results were tested extensively in deterministic and probabilistic sensitivity analyses. Result(s): Results demonstrated that pembrolizumab is a highly cost-effective treatment option when compared with chemotherapy, with estimated deterministic and probabilistic incremental cost-effectiveness ratios (ICERs) of $58,165 and $57,668 per QALY gained, respectively. Pembrolizumab was associated with a large QALY and life-year gain per person versus chemotherapy over the model time horizon (deterministic 4.68 life year gain, 3.80 QALYs), with the majority of QALYs accrued in the progression-free health state. Limitation(s): The key limitation of the analysis was the lack of comparative effectiveness data for pembrolizumab versus chemotherapy. Conclusion(s): Pembrolizumab is a highly cost-effective treatment option when compared with chemotherapy for women with previously treated dMMR/MSI-H unresectable or mEC. Results were robust to the changes in parameters and assumptions explored.Copyright © 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

Tian, D., et al. (2022). "Liraglutide monotherapy and add on therapy on obese women with polycystic ovarian syndromes: a systematic review and meta-analysis." Minerva Medica 113(3): 542-550.
	Introduction: A meta-analysis was carried out to systematically evaluate the effects of liraglutide on waist circumference, BMI, weight, insulin resistance (IR), Follicle-Stimulating Hormone (FSH), and Luteinizing hormone (LH) levels in obese women with polycystic ovarian syndromes (PCOS).; Evidence Acquisition: Randomized and non-randomized control trials of liraglutide monotherapy and add-on therapy were searched through PUBMED, Web of Science, Cochrane Library, EBSCO, CNKI (China National Knowledge Infrastructure), the Wanfang database, and Google Scholar databases up to May 30 th , 2020. Information about the impact of liraglutide on polycystic ovarian syndromes (PCOS) related to obese patients was extracted by two reviewers independently, and Revman 5.3 was used for meta-analysis.; Evidence Synthesis: A total of six studies with 401 women were included in this research. Waist circumference, BMI, weight was significantly reduced by -6.28 cm (95% CI: -7.89, -4.67; P<0.00001), -2.53 kg/m 2 (95% CI: -2.79, -2.27; P<0.00001) and -4.33 kg (95% CI: -6.05, -2.61; P<0.00001) after treatment with liraglutide monotherapy or add on therapy. There was a moderate declination in HOMA-IR scores following liraglutide treatment with -0.81 (95% CI: -0.97, -0.64; P<0.00001). FSH and LH show a decline in the liraglutide group with high heterogeneity (I 2 >95%).; Conclusions: For women with PCOS, BMI, weight, and waist circumference were significantly decreased after 12~24 weeks of treatment with liraglutide monotherapy and add-on therapy. Insulin resistance might be improved with the use of liraglutide. Nevertheless, large scale randomized control trials should be carried out to elucidate the long-term outcome in improving the insulin sensitivity of liraglutide treatment.

Tian, H., et al. (2021). "The effectiveness of Tai Chi for postpartum depression: A protocol for systematic review and meta-analysis." Medicine 100(49): e28176.
	Background: As a specific type of depression, postpartum depression (PPD) causes an adverse hazard to the mother's physical and mental health. Considering the safety requirements for lactation and the expectation of the rapid response to treatment, the search for safe and effective alternative therapies has attracted wide attention. Tai Chi, a traditional Chinese exercise therapy, has been widely used to relieve the symptoms and complications of patients with PPD, which the clinical efficacy is questioned. We conduct a comprehensive systematic review and meta-analysis to find clinical medical evidence of Tai Chi in the treatment of PPD.; Methods: PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, China Science, and Technology Journal Database and Chinese Biomedical Literature Database will be searched from their inception of databases to September 30, 2021. Two reviewers will select articles, extract data, and assess the risk of bias independently. Any disagreement will be resolved by discussion with the third reviewer. Review Manager 5.3 software will be used for data synthesis. The Cochrane risk of bias assessment tool will be used to assess the risk of bias.; Results: This study will conduct a comprehensive literature search and provide a systematic synthesis of current published data to explore the effectiveness of Tai Chi for PPD.; Conclusions: The findings of our study will provide updated evidence to determine whether Tai Chi is an effective intervention for patients with PPD, which will help clinicians make a better alternative treatment schedule of PPD patients and provide a reliable basis for health-related policymakers.; Study Registration Number: CRD42021276676.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Tian, H. A. O. and l. fanrong (2023). "Effect of acupuncture on dysmenorrhea: A dose-response systematic review and meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Tian, M., et al. (2022). "Meta-analysis of Efficacy and Safety of Activating Blood Circulation Herbs Combined with Dienogest in the Treatment of Endometriosis." PROSPERO International prospective register of systematic reviews.
	
Tian, X., et al. (2021). "Clinical efficacy and safety of traditional Chinese medicine in treatment of endometriosis: a systematic review and meta analysis." PROSPERO International prospective register of systematic reviews.
	
Tian, Y., et al. (2023). "Efficacy of long-term pituitary down-regulation pretreatment prior to in vitro fertilization in infertile patients with endometriosis: A meta-analysis." Journal of Gynecology Obstetrics and Human Reproduction 52(3): 102541.
	Controversial conclusions have been made in previous studies regarding the influence of ultra-long gonadotropin-releasing hormone agonist (GnRH-a) in the reproductive outcomes of women with endometriosis who are undergoing in vitro fertilization/ intracytoplasmic sperm injection embryo transfer (IVF/ICSI-ET). An electronic search was conducted through PubMed, Embase, Cochrane Library, Web of Science, Elsevier ScienceDirect and Medline from inception until 10 September 2022. Only randomized studies were included. After the selection process, seven articles were eventually included in the meta-analysis. The pooling of the results showed the adverse effect of ultra-long protocol in terms of live birth rate (risk ratio (RR) = 0.53, 95% confidence intervals (CI): 0.31-0.9, P=0.02) and fertilization rate (RR = 1.18, 95% CI: 1.02-1.36, P=0.02). There was no statistical significance between the ultra-long protocol and long protocol of the rest outcome Indicators. The findings of this meta-analysis suggest that ultra-long GnRH-a does not appear to improve the results of IVF/ICSI treatment outcomes in patients with endometriosis.; Competing Interests: Declaration of Competing Interest There is not any conflict of interest. (Copyright © 2023. Published by Elsevier Masson SAS.)

Tianjing, W., et al. (2022). "What is the impact of personalized embryo transfer guided by endometrial receptivity array on IVF outcomes: a system review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Timotius, I., et al. (2023). "Vitamin C and E antioxidant supplementation for mitigating pain symptoms in endometriosis: A systematic review and meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Ting, H., et al. (2023). "A network meta-analysis of acupuncture-assisted treatment of diminished ovarian reserve." PROSPERO International prospective register of systematic reviews.
	
Ting, L., et al. (2022). "Efficacy of Thumb-tack Needling for primary dysmenorrhea: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." PROSPERO International prospective register of systematic reviews.
	
Ting, Z., et al. (2023). "Optimal selection of ovarian stimulation protocol for infertile women with diminished ovarian reserve according to Poseidon's stratification: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Tingting, D. U. and R. Ning (2024). "Can laser assisted hatching improve clinical outcomes in recurrent implantation failure patients: A meta-analysis of random controlled trials." PROSPERO International prospective register of systematic reviews.
	
Tingting, S., et al. (2023). "The impact of personalized embryo transfer (pET) guided by the endometrial receptivity assessment (ERA) on repeated implantation failure(IRF) outcomes: a meta-analysis." PROSPERO International prospective register of systematic reviews.
	
TiumBio Co, L. (2021). "An international Multicenter study to evaluate the efficacy and safety of orally administered TU2670 against placebo in subject with moderate to severe endometriosis -associated Pain." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Product Name: TU2670 Product Code: [TU2670] Pharmaceutical Form: Capsule, hard INN or Proposed INN: TU2670 Current Sponsor code: TU2670 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: TU2670 Product Code: [TU2670] Pharmaceutical Form: Capsule, hard INN or Proposed INN: TU2670 Current Sponsor code: TU2670 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ CONDITION: Moderate to Severe Endometriosis‐Associated Pain ; MedDRA version: 21.1 Level: LLT Classification code 10014788 Term: Endometriosis related pain 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 evaluate the efficacy and safety of orally administered TU2670 in the reduction of endometriosis‐associated pain compared with placebo after 12 weeks of treatment. Primary end point(s): Change from baseline to 12 weeks of treatment of the mean dysmenorrhea score (defined as mean overall pelvic pain [OPP] pain score on menstrual bleeding days) as measured by the Numeric Rating Scale (NRS) over the past month. Secondary Objective: To assess the pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered TU2670 in subjects with endometriosis after 12 weeks of treatment. Timepoint(s) of evaluation of this end point: NRS will be self‐assessed through entry into an e‐diary. Subjects will complete e‐diary entries on a daily basis. At last Visit during the follow up period, NRS will be assessed in the clinic. SECONDARY OUTCOME: Secondary end point(s): •Change from baseline to 12 weeks of treatment of the mean NRS pain score for non‐menstrual pelvic pain (NMPP) (mean NRS pain score on; non‐menstrual bleeding days); • Change from baseline to 12 weeks of treatment of signs and symptoms scores; • Plasma concentration of TU2670 at scheduled assessments during the treatment period; • In a subset of approximately 10 subjects/arm calculation of TU2670 PK parameters Timepoint(s) of evaluation of this end point: 12 weeks INCLUSION CRITERIA: For the screening phase: 1. Independent Ethics Committee (IEC)‐approved written informed consent/assent and privacy language as per national regulations must be voluntarily obtained from the subject. 2. Premenopausal female subject, 18 to 45 years, inclusive 3. Subject has moderate to severe endometriosis‐related pain likely to meet inclusion criteria 13 and 14 in the opinion of the Investigator. 4. Subject has documented surgically (laparoscopy, laparotomy) diagnosed endometriosis within the last 10 years before signing informed consent and has recurrent or persistent endometriosis symptoms 5. Subject reports regular menstrual cycles of 24 to 38 days inclusive for at least the last 2 years. 6. Subject must agree not to breastfeed starting at screening and throughout the study period, and for 28 days after the final study drug administration. 7. Subject must agree to use adequate non‐hormonal contraceptive method(s) to prevent pregnanc

TiumBio Co, L. (2021). "TUC3PII-01_TU2670 Phase IIa Clinical Study." ClinicalTrials.gov.
	No Results Available Drug: Placebo Comparator: Placebo|Drug: Active Comparator: TU2670 320mg|Drug: Active Comparator: TU2670 240mg|Drug: Active Comparator: TU2670 120mg overall pelvic pain|mean Numeric Rating Scale pain score|mean overall pelvic pain Numeric Rating Scale pain score|mean Numeric Rating Scale dyspareunia score|rescue medication|Time to increase of dose of rescue medication|Time to decrease of dose of rescue medication|Modified Biberoglu and Behrman sign and symptom scores|Patient Global Impression of Change|Endometriosis Health Profile-5|36-Item Short Form Health Survey|Work Productivity and Activity Impairment Questionnaire: General Health Female Phase 2 80 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment TUC3PII-01 December 31, 2023

Tokgöz Vehbi, Y. (2021). "Pre-washing the Catheter With a Culture Medium Before Intrauterine Insemination." ClinicalTrials.gov.
	No Results Available Procedure: Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination Clinical pregnancy rate Female Not Applicable 100 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Other 2222392979 June 1, 2021

Tomao, F., et al. (2019). "Parp inhibitors as maintenance treatment in platinum sensitive recurrent ovarian cancer: An updated meta-analysis of randomized clinical trials according to BRCA mutational status." Cancer Treatment Reviews 80: 101909.
	Objective: This meta-analysis investigated the effectiveness of PARP inhibitors (PARPis) as maintenance treatment in platinum sensitive recurrent ovarian cancer (ROC), stratifying results based on BRCA mutational status into five different categories: whole population, germ-line BRCA mutated patients, somatic BRCA mutated patients, HRD patients and wild type population.; Methods: PubMed, Medline, Scopus, EMBASE and clinicaltrials.gov, as well as meeting proceedings were searched for eligible studies that described RCTs testing the efficacy of PARPis as maintenance treatment in platinum sensitive ROC. Data were extracted independently and analysed using RevMan statistical software version 5.3. Primary end-point was progression free survival (PFS).; Results: The analysis confirmed the positive effect of PARPis in patients with platinum sensitive ROC in case of germinal or somatic BRCA mutations. Specifically, HR for PFS was 0.26, 95% CI 0.21-0.31, p < 0.00001 for the mutation of BRCA gene and 0.24, 95%, CI 0.12-0.48, p < 0.0001 for the somatic alteration. In addition, in the HRD population, studies that analysed the efficacy of PARPis reported a PFS improvement with HR 0.34, 95% CI 0.26-0.43, p < 0.00001. Finally, our analysis confirms the role of these drugs in prolonging PFS in the whole population with HR 0.36, 95% CI 0.32-0.42, p < 0.00001, although to a lesser extent, with a significant improvement even in wild type cancers with HR 0.49, 95%, CI 0.41-0.59, p < 0.00001).; Conclusions: PARPis are effective regardless of BRCA mutational status. Future investigations are necessary to explore the use of different PARPis as monotherapy, comparing them among each other in terms of efficacy and toxicity, and exploring their potential re-use. (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Tong, X. and X. Song (2023). "The efficacy and safety of glucagon-like peptide-1 receptor agonists in the treatment of polycystic ovary syndrome-A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Topatan, S. (2022). "The Effect of Reiki on Pain, Stress and Comfort Level in Students Experiencing Dysmenorrhea." ClinicalTrials.gov.
	No Results Available Other: reiki Change in pain|Change in stress|Change in Comfort Level Female Not Applicable 60 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Supportive Care 2022/9 June 1, 2022

Toprak, C., et al. (2022). "The effects of pelvic floor muscle training combined with Kinesio taping on bladder symptoms, pelvic floor muscle strength, and quality of life in women with overactive bladder syndrome: A randomized sham-controlled trial." Physiotherapy Theory and Practice 38(2): 266-275.
	Background: There is insufficient study using Kinesio taping (KT) in bladder problems. Objectives: To investigate the effects of pelvic floor muscle training (PFMT) combined with KT on bladder symptoms, pelvic floor muscle strength, and quality of life in women with overactive bladder (OAB) syndrome and compare this combination with PFMT plus sham tape (ST). Methods: Women with OAB were randomly allocated into PFMT+KT and PFMT+ST groups. All patients were given PFMT for 6 weeks and applied taping according to groups. Before and after treatment, the OAB symptoms with the Overactive Bladder Assessment Form (OAB-V8) and Patients' Perception of Intensity of Urgency Scale (PPIUS), bladder function with a 3-day voiding diary, pelvic floor muscle strength with the Modified Oxford Scale, and quality of life with the King's Health Questionnaire (KHQ) were assessed. Results: OAB-V8, PPIUS, and KHQ scores decreased and the MOS improved in both groups (P < .05) after treatment. The intergroup comparisons revealed a further decrease in voids/day, voids/night, incontinence episodes/day, and personal limitation scores of the KHQ in the PFMT+KT group compared to the PFMT+ST group (P < .05). Conclusion: PFMT+KT was more effective in reducing the OAB symptoms compared to PFMT+ST. KT could be a complementary application for reducing symptoms in OAB.

Tosatti, J. A. G., et al. (2021). "Influence of omega-3 fatty acid supplementation on inflammatory and oxidative stress markers in patients with Polycystic Ovary Syndrome: A systematic review and meta-analysis." The British Journal of Nutrition 125(6): 1-31.
	Polycystic ovary syndrome (PCOS) is defined as a reproductive endocrine disease that results in a low-grade inflammatory and prooxidant state. Dietary factors, including omega-3 fatty acids, may have a key role in improving metabolic disorders in PCOS patients. The present study aimed to investigate the influence of omega-3 fatty acid supplementation on inflammatory and oxidative stress markers in patients with PCOS. A systematic literature search of Medline/PubMed, Cochrane Central Register of Controlled Trials, Scopus and Lilacs, until November 2019, was conducted. Randomized clinical trials that reported inflammatory and oxidative stress markers as endpoints in women with PCOS receiving omega-3 fatty acid supplementation were included. The pooled estimates of the weighted mean differences (WMD) and the standard mean differences (SMD) were calculated. Random effect models were adopted to measure the pooled outcomes. Among the 323 studies retrieved, 10 fulfilled the inclusion criteria for a meta-analysis. We founded a significant decrease in high-sensitivity C-reactive protein (hs-CRP) [SMD: -0.29 (95%CI: -0.56 to -0.02) mg/L] and an increase of adiponectin [WMD: 1.42 (95%CI 1.09 to 1.76) ng/ml] concentrations in the intervention group when compared with the placebo group. No statistically significant results were found in the meta-analysis for visfatin, nitric oxide (NO), glutathione (GSH) or malondialdehyde (MDA) levels or total antioxidant capacity (TAC). The data suggest that supplementation of omega-3 fatty acids could reduce the inflammatory state in women with PCOS, through a decrease in hs-CRP and an increase in adiponectin levels.

Tosun, O. C., et al. (2023). "Does multiple-component intensive pelvic floor muscle training decrease muscle fatigue and symptoms in women with urinary incontinence?" International Urogynecology Journal 34(9): 2067-2080.
	Introduction and hypothesis: A multiple-component intensive pelvic floor muscle training (MCI-PFMT) protocol was developed as a neurophysiological-based rehabilitation model to improve neuroplasticity. This study aimed to investigate the effects of the MCI-PFMT protocol on muscle fatigue and symptoms in women with urinary incontinence. Method(s): This randomized controlled trial included 49 female patients with mixed urinary incontinence. Participants were divided into the MCI-PFMT group and the control group. The MCI-PFMT group performed supervised intensive pelvic floor muscle training, while the control group received bladder training and standard pelvic floor muscle training as a home program. Both training sessions were conducted 5 days a week for a single week. Participants' symptoms were evaluated with questionnaires, bladder diary, and pad tests. Superficial electromyography, ultrasonography, and the PERFECT scale were used to evaluate pelvic floor and abdominal muscle functions. Result(s): In the post-treatment evaluation, symptoms were decreased in both groups, with a significant decrease in the MCI-PFMT group (p < 0.05). While average and peak work values of pelvic floor muscles, transversus abdominus, and internal oblique muscles increased in both groups, maximum voluntary contraction values of these muscles decreased (p < 0.05). A 12.7% decrease was observed in the maximum voluntary contraction values of pelvic floor muscles in the control group, while a 9.6% decrease was observed in the MCI-PFMT group. Conclusion(s): The MCI-PFMT protocol can lead to pelvic floor and abdominal muscle fatigue. However, it may be effective at decreasing symptoms in women with urinary incontinence. Additional studies on this issue are needed.Copyright © 2023, The International Urogynecological Association.

Tozzi, R., et al. (2024). "Peritonectomy and resection of mesentery during Visceral-Peritoneal Debulking (VPD) in patients with stage IIIC-IV ovarian cancer: A phase I-II trial." European Journal of Surgical Oncology 50(2): 107957.
	Objective: To describe the surgical technique, assess feasibility, efficacy, and safety of peritonectomy and/or resection of mesentery (P-Rme) during Visceral-Peritoneal Debulking (VPD) in patients with stage IIIC-IV ovarian cancer (OC). Method(s): In April 2009 we registered a protocol study on the safety and feasibility of P-Rme. In the period April 2009-December 2022, 687 patients with FIGO stage IIIC-IV ovarian cancer underwent VPD. One hundred and twenty-nine patients (18.7%) had extensive disease on the mesentery and underwent P-Rme. Feasibility was assessed as the number of procedures completed. Efficacy was measured as the rate of Complete Resection (CR). Safety was defined by the intra- and post-operative morbidity rate specifically associated with these procedures. Result(s): In all patients P-Rme was successfully completed. P-me was performed in 82 patients and R-me in 47, both procedures in 23 patients. CR was achieved in all 129 patients with an efficacy of 100%. Intra-operatively 5 patients out of 129 experienced small bowel loop surgical devascularization. They required small bowel resection and anastomosis. The procedure specific morbidity was 3.8%. No post-operative complication was related to P-Rme. At 64 months median follow-up, survival outcomes in the study group were similar to patients in the control group. Conclusion(s): Overall, almost 20% of the VPD patients needed P-Rme to obtain a CR. P-Rme was a safe and effective step during VPD. The rate of CR in the study group was 100% achieved thanks to the addition of the P-Rme. No procedure specific post-operative complications occurred but 3.8% of the patients had unplanned additional surgery related to these procedures.Copyright © 2024 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology

Trakya, U. (2023). "Listening Music, Drawing on Coping With Dysmenorrhea Complaints of Nursing Students." ClinicalTrials.gov.
	No Results Available Behavioral: Music|Behavioral: Drawing Group Pain evaluated using the Visual Analog Scale.|Mensruation symptom evaluated using the Menstruation Symptom Scale (MSS).|Perceive stress evaluated using the Perceived Stress Scale (PSS). Female Not Applicable 96 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Supportive Care 2023/SBB/0415 December 9, 2023

Tranoulis, A., et al. (2019). "Combined Laparoscopic Uterine Artery Occlusion and Myomectomy versus Laparoscopic Myomectomy: A Direct-Comparison Meta-Analysis of Short- and Long-Term Outcomes in Women with Symptomatic Leiomyomas." Journal of Minimally Invasive Gynecology 26(5): 826-837.
	Objective: To ascertain the efficacy and safety of laparoscopic uterine artery occlusion (LUAO) during laparoscopic myomectomy (LM) on intra- and postoperative morbidity and to assess its impact on leiomyoma recurrence rates.; Data Sources: MEDLINE, Scopus, Web of Science, and Cochrane Database were searched for relevant references from inception until December 2018, in line with PRISMA guidelines.; Methods of Study Selection: Two authors screened for study eligibility and extracted data. Randomized controlled trials (RCTs) and observational studies (OSs) comparing short- and long-term morbidity of LM with or without LUAO were included. The modified Jadad score and the methodologic index for nonrandomized studies were used to evaluate the quality of RCTs and OSs, respectively.; Tabulation, Integration, and Results: Twelve studies encompassing 750 LM and 873 LUAO-LM cases were included in the meta-analysis. The studies were of moderate quality. LUAO-LM appears to significantly decrease intraoperative blood loss, postoperative hemoglobin drop, and blood transfusion rate. A trend toward shorter hospital length of stay was demonstrated, whereas no significant difference in operation duration was observed. The combined procedure seemingly contributes to lower recurrence rate. No LUAO-related complications were reported. Moderate to high heterogeneity was observed for few outcomes.; Conclusion: This is the first meta-analysis to date to provide a convincing overview of efficacy and safety of LUAO-LM. Although a medium risk of bias warrants some caution with interpretation of the results, LUAO-LM seemingly improves intra- and postoperative outcomes in women with symptomatic leiomyomas. (Copyright © 2019. Published by Elsevier Inc.)

Trédan, O., et al. (2022). "Regorafenib or Tamoxifen for platinum-sensitive recurrent ovarian cancer with rising CA125 and no evidence of clinical or RECIST progression: A GINECO randomized phase II trial (REGOVAR)." Gynecologic Oncology 164(1): 18-26.
	Objective: To evaluate the efficacy and safety of regorafenib versus tamoxifen in platinum-sensitive ovarian cancer biological recurrence, defined by CA-125 increase without radiological (RECIST criteria) or symptomatic evidence of progression.; Patients and Methods: 116 patients with platinum-sensitive ovarian cancer presenting an isolated increase of CA-125 were planned to be randomized. Regorafenib was administered orally at 160 or 120 mg daily, 3 weeks on/1 week off or tamoxifen at 40 mg daily, until disease progression or development of unacceptable toxicity. The primary endpoint was Progression-Free Survival, assessed by progression according to RECIST 1.1 or death (by any cause). Secondary endpoints included Overall Survival, Best Response and CA-125 response rate.; Results: 68 patients were randomized. Median age was 67 years (range: 30-87). Primary site of cancer was ovarian for most patients (92.6%). Tumors were predominantly serous / (89.7%), high grade (83.6%) and initial FIGO staging was III for 69.6% of the patients. Most (79.4%) patients were included after the first line of platinum-based treatment. After a median follow-up of 32 months, there was no difference of progression-free survival (PFS) between regorafenib and tamoxifen groups (p = 0.72), with median PFS of 5.6 months (CI 90%: 3.84-7.52) for the tamoxifen arm and 4.6 months (CI 90%: 3.65-7.33) for the regorafenib arm. There was also no difference in term of overall survival, best response or CA-125 response, delay to next therapy. Regorafenib presented a less favorable safety profile than tamoxifen, with grade 3/4 events occurring for 90.9% of the patients compared to 54.3% for tamoxifen. The most frequent were cutaneous, digestive, and biological events. Notably, hand-foot syndrome occurred in 36.4% of these patients.; Conclusion: Regorafenib presented an unfavorable toxicity profile compared to tamoxifen, with no superior efficacy in this population of patients.; Competing Interests: Declaration of Competing Interest Dr. Trédan reports supports from the present manuscripts to ARCAGY GINECO from Bayer HealthCare, grants or contracts from Roche, BMS and MSD-Merck (payments to his institution), consulting fees from Roche, Pfizer, Astra-Zeneca, Lilly, Novartis-Sandoz, Daiichi-Sankyo, Seagen Pierre Fabre, MSD-Merck, Eisai (payments to him), payments/honoraria from Roche, Pfizer, Astra-Zeneca, Lilly, Novartis-Sandoz, Daiichi-Sankyo, Seagen, Pierre Fabre, MSD-Merck, Eisai, support for attending meeting and/or travel from Roche, Astra-Zeneca, Pfizer (payments to him). Dr. Hardy-Bessard reports payment/honoraria from MSD, Astra-Zeneca, GSK and participation on data safety monitoring board/advisory board with Clovis, MSD, Astra-Zeneca, GSK, Novartis, Pfizer. Dr. Lortholary reports payment/honoraria from Astra-Zeneca, Roche, MSD, Clovis, Novartis, support for attending meetings/travel from Roche and Astra-Zeneca and participation in a Data Safety Monitoring Board/Advisory board with Astra-Zeneca, Roche, MSD, Clovis and Novartis. Dr. Frenel reports payments/honoraria from Astra Zeneca, Lilly, Daiichi, Pfizer, Amgen, support for attending meetings/travel from Pfizer and Astra Zeneca, and participation on a Data Safety Monitoring Board/advisory board from Pfizer, Lilly, Novartis, GSK, Astra-Zeneca, MSD, Roche and Clovis. Dr. Louvet reports payments/honoraria from Merck, Roche, Servier and Amgen and support for attending meetings/travels from Roche and Merck. Dr. You reports consulting fees from MSD, Astra-Zeneca, GSK, Bayer, Roche, ECS Progastrine, Novartis, LEK, Amgen, Clovis, Merck Serono, BMS, Seagen. Amélie Anota reports consulting fees from Roche, Astra-Zeneca, Sandoz, Pfizer/Hospira, payment or honoraria for lectures from Astra-Zeneca and BMS and support for attending meetings/travels from Roche, Astra-Zeneca and Novartis. Pr Ray-Coquard reports consulting fees from Amgen, Astra-Zeneca, Clovis Oncology, Genmab, GSK, ImmunoGen, Merck Sharp & Dohme, Pfizer/Merck-Sereno, PharmaMar, and Roche, grants/contracts with Roche, BMS, MSD, GSK Co pany and support for attending meetings/travels from Astra-Zeneca, Roche, GSK and Clovis. The remaining authors declare no conflict of interest. (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Treff, N. (2023). "GEnetic Testing in Elective Single Embryo Transfer (GETSET): a Randomized Clinical Trial." ClinicalTrials.gov.
	In this randomized controlled trial, a total of 240 patients divided evenly across the two participating IVF center will be recruited. Patients will be randomized to a control and to a treatment group, each containing 120 participants. Only patients with at least one evaluable blastocyst will be randomized. Patients will undergo ovarian hyper‐stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by IVF center. In the control arm, patients will undergo a single frozen embryo transferof the untested, best quality blastocyst. All other blastocysts with lower morphology will undergo trophectoderm biopsy on day 5, 6 or 7 and will be frozen. PGT‐A results of the untransferred embryos will be revealed to the patient AFTER the outcome of the initial ET is known. In the experimental arm, all embryos will be cultured to blastocyst and all viable blastocysts will undergo trophectoderm biopsy and PGT‐A. PGT‐A will be performed regardless of the number of blastocysts available. Patients will undergo frozen transfer of the single, best quality euploid blastocyst. If the initial transfer results in a non‐conception cycle and additional embryos are available for transfer.

Treff Nathan, R. (2021). "Preimplantation Genetic Testing in Women of Advanced Maternal Age." ClinicalTrials.gov.
	No Results Available Procedure: Preimplantation genetic testing for aneuploidy (PGT-A) Ongoing pregnancy rate|Miscarriage rate Female Not Applicable 240 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment Genomic Prediction Inc 624 December 2024

Trikhacheva Anna, S. (2023). "Xeomin vs Botox for Treatment of Overactive Bladder Syndrome." ClinicalTrials.gov.
	The study will be registered on clinicaltrials.gov after IRB approval. Institutional Review Board (IRB) approval will be received. All women 18 years of age and older with bothersome overactive bladder symptoms who are receiving care at Walter Reed National Military Medical Center (WRNMMC) in the urogynecology clinic will be eligible for the study. All study participants will undergo a complete intake assessment to include a history, physical exam, post‐void bladder residual volume assessment via straight catheterization or ultrasound, and counseling on treatment modalities for OAB using the AUGS handout to include behavioral and dietary modifications, physical therapy, oral medications, onabotulinumtoxinA and neuromodulation. Patients desiring treatment with onabotulinumtoxinA will be scheduled for the procedure. Patients do not have to fail prior treatment options in order to qualify for bladder BOTOX. This is all standard of care in our practice. All patients meeting the inclusion and exclusion criteria will be offered enrollment in this study. Enrollment will be done by the research team, who typically are also the clinicians. No patients will be pressured or coerced into participating in the study. Prior to the procedure appointment, participants will be consented for participation in the study and asked to complete demographics data sheet, 24 hours bladder diary, OAB‐q SF, PGI‐S, PISQ‐IR. OAB‐q SF is a standard of are in our practice, all other questionnaires patient will fill out for the purpose of this study. The procedure will be performed at Walter Reed National Military Medical Center either in clinic setting or in the operating room. All patients who plan to undergo the procedure in clinic will be offered a pre‐treatment anxiolytic with a single dose of 5‐10mg of oral diazepam, which is standard practice at this institution. Patients undergoing the procedure in the operating room, will be given sedation medications as per standard of care. As standard of treatment, patients will also be given a prescription for an antibiotic ‐ either nitrofurantoin 100mg to take orally twice daily for 3 days starting the day of the procedure, or trimethoprim‐sulfamethoxazole 800mg‐160mg to take orally twice daily for 3 days starting the day of the procedure depending on patient's allergy profile. The principal investigator will make randomized assignments using the RAND function in excel. The first 32 random numbers will be assigned to BOTOX arm and the second 32 numbers will be assigned to XEOMIN arm. Each assignment number will be placed in a sealed envelop by the PI. The sealed envelops will be opened by the treatment provider the day of the scheduled procedure. The envelop will reveal the medication assignment to the provider. After the provider reveals the medication only to him/herself (not the patient), the appropriate medication will be obtained from the pharmacy and administered to the patient. The patient will be blinded to the treatment allocation. The drug will be obtained from the pharmacy on the day of the procedure by the treatment team. Either onabotulinumtoxinA or incobotulinumtoxinA (as determined by the allocated assignment), will be reconstituted in 10 milliliters of injectable saline by the treatment team prior to entering the patient's room, to keep the patient blinded. The bladder will be filled with 20ml of 2% viscous lidocaine through the urethra 15 to 20 minutes prior to the procedure per the Urogynecology department standard operating procedure for intradetrusor onabotulinumtoxinA injections. Operative cystoscopy will be performed, and an adjustable‐depth injection cystoscopy needle will be used to inject the blinded study drug (either 100 units of onabotulinumtoxinA (Botox®, Allergan) or 100 units of incobotulinumtoxinA (Xeomin®, Merz Pharmaceutical)) with the needle depth set to 3mm. Injections will be performed by either a board‐certified staff Urogynecologist, or fellows or residents working under their direct supervision of the board‐certified staff urogynecol ist. An injection cystoscopy needle will be set to 3mm and used to inject 0.5mL reconstituted study medication at each injection site, approximately 1cm apart along the posterior bladder wall making sure to avoid the trigone, for a total or 20 injection sites (4 rows of 5 injection sites). After the completion of the procedure, patients will be asked to start taking their prescribed antibiotics and to continue them for 3 days. If a known UTI was inadequately treated prior to procedure appointment, or if there is evidence of an active infection at the time of cystoscopy, the intravesical injection will not be completed and patient will be rescheduled. Participants will have a follow‐up appointment in 2‐6 weeks following the procedure in person, via phone or email. At the follow‐up visit patients will be asked to complete a 24‐hour bladder diary, OAB‐q SF, PGI‐I, PGI‐S, PISQ‐IR surveys. The surveys will either be read or emailed to the patient based on patient's preference. Patients will be asked regarding urinary tract infection (UTI) symptoms and whether they needed clean intermittent catheterization (CIC). The electronic health record (EHR) will also be reviewed to confirm whether UTI has occurred or if CIC needed to be done. Patients will be asked whether they are experiencing painful urination, urinary frequency, urinary urgency, or blood in their urine. If patients answer yes to any of those questions, they will be asked to provide a urine sample. If this follow up is being done in person, then a urine sample will be obtained via straight catheterization during the appointment. If the follow up visit is being done virtually, patient will be asked to come into clinic or laboratory and provide a urine sample via straight catheterization or clean catch for urinalysis and urine culture to assess for UTI. If infection is present, patients will receive appropriate antibiotics based on culture sensitivities. Patients found to have an active infection at the time of postprocedural follow‐up will be asked to complete the study questionnaires 2‐4 weeks following treatment of infection. Patients will also be asked if they experienced any other symptoms following the procedure that concerned them and any symptoms reported will be recorded. Participants who experience initial relief in their symptoms following injection of the study medication but then experience recurrence of symptoms will be eligible for repeat injection provided it has been at least 12 weeks from prior injection and the total dose of onabotulinumtoxinA/incobotulinumtoxinA does not exceed 400 units in a three‐month time frame, as is standard of care. Six to nine months following the treatment, patients will be contacted via phone or email and asked to complete a 24‐hour voiding diary, OAB‐q SF, PGI‐I, PGI‐S, and PISQ‐IR surveys for final assessment of symptoms following treatment. They will again be asked regarding adverse events. The questionnaires again will either be read to the patient via phone or emailed based on patient's preference. This research study is a single‐blind study. Unblinding of subjects will be performed at the conclusion of the study after enrollment is closed and data collection is complete. Participants will not be notified of their group assignment unless it is requested after the completion of the final follow up encounter. If the participant would like to know their group assignment, they will contact the PI who will release that information to them after the conclusion of the study. Study participants who request to be un‐blinded as to their randomized assigned group early will need to be withdrawn from the study. The participant will supply a request in writing to the PI. Any data regarding that participant will be removed from the records and that assignment number will be noted as withdrawn. A memorandum for record will be created outlining the subject's request and both the MFR and subject's written request will be maintained with the data collection for reference. In the event of an emergency here is a way to find out which one the participant is receiving. If there is a medical emergency that may require unblinding prior to the conclusion of the study, the research team will work in coordination with the subject's primary care or emergency provider to determine if unblinding is necessary and make that information available to them as needed.

Troost, F. (2023). "The Effect of 12-week Supplementation With Olive Leaf Extract in Postmenopausal Women (FEMMED)." ClinicalTrials.gov.
	No Results Available Dietary Supplement: Olive Leaf Extract|Dietary Supplement: Cellulose Changes in body composition (total and regional fat mass and fat free mass) measured using Dual-energy X-ray absorptiometry (DXA)|Evaluate changes in muscle strength between study product and placebo groups|Evaluate changes in skin health between study product and placebo groups|Evaluate changes in menopause-related symptoms between study product and placebo groups Female Not Applicable 54 Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Supportive Care NL81363.068.22 July 2024; The current study wants to investigate the effect of 12-week olive leaf extract supplementation on body composition and muscle strength, skin-aging and menopause-related quality of life in postmenopausal women.

Trutnovsky, G. (2021). "Lasertherapy for Vulvodynia." ClinicalTrials.gov.
	No Results Available Device: Erbium:Yag laser|Device: Sham Erbium:Yag laser Change of Vestibular pain index|Change of pelvic floor muscle (PFM) function- PFM contraction strength|Change of pelvic floor muscle (PFM) function- PFM tone|Change of levator hiatal dimensions at rest|Change of levator hiatal dimensions at maximal voluntary contraction|Change of levator hiatal dimensions at maximal Valsalva maneuver|Change of Vaginal health score index (VHSI)|Change of Sexual activity|Change of Sexual Function|Change in Endometriosis Health Profile (EHP-30)|Change in German Pain Assessment (assessed by Deutscher Schmerzfragebogen/DSF)|Change in Patient Health Questionnaire (PHQ-D)|Change in Pain sensitivity questionnaire (PSQ)|Change in Patient Global Impression of Improvement (PGI-I)|Change in Patient treatment satisfaction|Change in Treatment discomfort|Change in Treatment pain Female Not Applicable 92 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 32-187 ex 19/20 December 30, 2024

Tsai, M. Z., et al. (2021). "Evaluating the effectiveness and quality of mobile applications for perinatal depression and anxiety: a systematic review and meta-analysis." Journal of Affective Disorders 296: 443-453.
	BACKGROUND: Our objectives were to assess: 1) the effectiveness of existing mHealth apps for reducing symptoms of maternal depression and/or anxiety during the prenatal period and/or the first year postpartum, and 2) the app quality of commercially available apps targeting perinatal depression and/or anxiety. METHODS: To address Objective 1, we searched five electronic databases (MEDLINE, CINAHL, PsycINFO, Web of Science, and Embase) from their inception until May 3rd, 2021. For the second objective, we searched Google Play and Apple App Stores in the United States, United Kingdom, Canada, and Australia until May 3rd, 2021. RESULTS: Our search identified 3,897 articles, seven of which were meta-analyzed. mHealth apps did not improve perinatal depression (SMD, -0.39; 95% CI, -0.80 to 0.03) or anxiety (SMD, 0.01; 95% CI, -0.13 to 0.16) within the first 3 months post-intervention or at 6 months post-intervention. Our search of app stores identified 74 commercially available apps, 37 of which were evaluated via MARS tool. Current apps for perinatal anxiety and/or depression were rated to be of moderate quality on the MARS (mean, 3.6/5). LIMITATIONS: There is a small number of overall studies in this field and the individual studies have methodological limitations. Furthermore, few apps identified in our app store search have been clinically tested. CONCLUSION: Despite their widespread availability, mHealth apps do not appear to effectively reduce perinatal depression or anxiety, and few were subjectively rated to be of high quality. There is a need to develop higher quality mHealth apps and assess their potential to improve perinatal maternal mental health.

Tsai, Z., et al. (2023). "Dietary interventions for perinatal depression and anxiety: a systematic review and meta-analysis of randomized controlled trials." The American Journal of Clinical Nutrition 117(6): 1130-1142.
	Background: Dietary interventions are a widely available mediation for depression and anxiety among pregnant and/or postpartum (i.e., perinatal) persons, but their effectiveness is not well known.; Objectives: We performed a systematic review and meta-analysis to assess the effectiveness of dietary interventions for the treatment of perinatal depression and/or anxiety.; Methods: We searched MEDLINE, EMBASE, PsycINFO, CINAHL, and Web of Science from their inception to 2 November, 2022. Studies were included if they were available in English and examined the effectiveness of a dietary intervention for perinatal depression and/or anxiety in a randomized controlled trial.; Results: Our search identified 4246 articles, of which 36 were included and 28 were eligible for meta-analysis. Random-effects meta-analyses were performed. Polyunsaturated fatty acids (PUFAs) were not found to improve symptoms of perinatal depression compared to control conditions [standardized mean differences (SMD): -0.11; 95% CI: -0.26 to 0.04]. These results neither changed when examined during pregnancy or the postpartum period separately nor varied according to the fatty acid (FA) ratio. Elemental metals (iron, zinc, and magnesium) were also not found to be superior to placebo (SMD: -0.42; 95% CI: -1.05 to 0.21), although vitamin D yielded a small to medium effect size improvement (SMD: -0.52; 95% CI: -0.84 to -0.20) in postpartum depression. Iron may help in those with confirmed iron deficiency. Narrative synthesis was performed for studies ineligible for meta-analyses.; Conclusions: Despite their widespread popularity, PUFAs and elemental metals do not appear to effectively reduce perinatal depression. Vitamin D taken in doses of 1800-3500 International Units per day may be, to some extent, promising. Additional high-quality, large-scale randomized controlled trials are needed to determine the true effectiveness of dietary interventions on perinatal depression and/or anxiety. This study was registered at PROSPERO (registration date: 5 July, 2020; CRD42020208830). (Copyright © 2023 American Society for Nutrition. Published by Elsevier Inc. All rights reserved.)

Tsiami Alexandra, P., et al. (2021). "Higher ovulation rate with letrozole as compared with clomiphene citrate in infertile women with polycystic ovary syndrome: a systematic review and meta-analysis." Hormones 20(3): 449-461.
	Background: Polycystic ovary syndrome (PCOS) is a common cause of anovulatory infertility. According to the latest guidelines, letrozole should be considered as the first-line pharmacological treatment for women with WHO Group II anovulation or PCOS. However, the use of letrozole as an ovulation induction agent is not FDA or EMA approved, and its use is "off-label." The main concern with respect to letrozole regards its potential teratogenic effect on the fetus.; Purpose: To determine whether the probability of ovulation is higher with letrozole as compared to clomiphene citrate (CC) in anovulatory women with PCOS.; Methods: Randomized controlled trials (RCTs) comparing letrozole versus CC used for ovulation induction in infertile women with PCOS followed by timed intercourse (TI) or intrauterine insemination (IUI) were included in this meta-analysis. Primary outcome was ovulation. Secondary outcomes were live birth, clinical pregnancy, miscarriage, multiple pregnancy, and congenital anomalies. Subgroup analysis included patients who received letrozole or CC as first-line treatment, and patients with PCOS diagnosed according to the Rotterdam criteria.; Results: Twenty-six RCTs published between 2006 and 2019, involving 4168 patients who underwent 8310 cycles of ovulation induction, were included. The probability of ovulation was significantly higher in letrozole as compared to CC cycles (RR: 1.148, 95% CI: 1.077 to 1.223, 3017 women, 19 trials, I 2 : 47.7%, low-quality evidence).; Conclusion: A higher probability of ovulation is expected in infertile patients with PCOS treated with letrozole as compared to CC. The higher ovulation rate might have contributed to the higher clinical pregnancy and live birth rate. This finding is also true for patients who were administered letrozole as first-line treatment.; Trial Registration: CRD42019125166. (© 2021. Hellenic Endocrine Society.)

Tso Leopoldo, O., et al. (2020). "Metformin treatment before and during IVF or ICSI in women with polycystic ovary syndrome." The Cochrane Database of Systematic Reviews 12: CD006105.
	Background: The use of insulin-sensitising agents, such as metformin, in women with polycystic ovary syndrome (PCOS) who are undergoing ovulation induction or in vitro fertilisation (IVF) cycles has been widely studied. Metformin reduces hyperinsulinaemia and suppresses the excessive ovarian production of androgens. It is suggested that as a consequence metformin could improve assisted reproductive techniques (ART) outcomes, such as ovarian hyperstimulation syndrome (OHSS), pregnancy, and live birth rates.; Objectives: To determine the effectiveness and safety of metformin as a co-treatment during IVF or intracytoplasmic sperm injection (ICSI) in achieving pregnancy or live birth in women with PCOS.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL via the Cochrane Register of Studies Online (CRSO), MEDLINE, Embase, PsycINFO, LILACS, the trial registries for ongoing trials, and reference lists of articles (from inception to 13 February 2020).; Selection Criteria: Types of studies: randomised controlled trials (RCTs) comparing metformin treatment with placebo or no treatment in women with PCOS who underwent IVF or ICSI treatment.; Types of Participants: women of reproductive age with anovulation due to PCOS with or without co-existing infertility factors. Types of interventions: metformin administered before and during IVF or ICSI treatment.; Primary Outcome Measures: live birth rate, incidence of ovarian hyperstimulation syndrome.; Data Collection and Analysis: Two review authors independently selected the studies, extracted the data according to the protocol, and assessed study quality. We assessed the overall quality of the evidence using the GRADE approach.; Main Results: This updated review includes 13 RCTs involving a total of 1132 women with PCOS undergoing IVF/ICSI treatments. We stratified the analysis by type of ovarian stimulation protocol used (long gonadotrophin-releasing hormone agonist (GnRH-agonist) or short gonadotrophin-releasing hormone antagonist (GnRH-antagonist)) to determine whether the type of stimulation used influenced the outcomes. We did not perform meta-analysis on the overall (both ovarian stimulation protocols combined) data for the outcomes of live birth and clinical pregnancy rates per woman because of substantial heterogeneity. In the long protocol GnRH-agonist subgroup, the pooled evidence showed that we are uncertain of the effect of metformin on live birth rate per woman when compared with placebo/no treatment (risk ratio (RR) 1.30, 95% confidence interval (CI) 0.94 to 1.79; 6 RCTs; 651 women; I 2 = 47%; low-quality evidence). This suggests that if the chance for live birth following placebo/no treatment is 28%, the chance following metformin would be between 27% and 51%. Only one study used short protocol GnRH-antagonist and reported live birth rate. Metformin may reduce live birth rate compared with placebo/no treatment (RR 0.48, 95% CI 0.29 to 0.79; 1 RCT; 153 women; low-quality evidence). This suggests that if the chance for live birth following placebo/no treatment is 43%, the chance following metformin would be between 13% and 34% (short GnRH-antagonist protocol). We found that metformin may reduce the incidence of OHSS (RR 0.46, 95% CI 0.29 to 0.72; 11 RCTs; 1091 women; I 2 = 38%; low-quality evidence). This suggests that for a woman with a 20% risk of OHSS without metformin, the corresponding risk using metformin would be between 6% and 14%. Using long protocol GnRH-agonist stimulation, metformin may increase clinical pregnancy rate per woman compared with placebo/no treatment (RR 1.32, 95% CI 1.08 to 1.63; 10 RCTs; 915 women; I 2 = 13%; low-quality evidence). Using short protocol GnRH-antagonist, we are uncertain of the effect of metformin on clinical pregnancy rate per woman compared with placebo/no treatment (RR 1.38, 95% CI 0.21 to 9.14; 2 RCTs; 177 women; I 2 = 87%; very low-quality evidence). We are uncertain of the effect of metformin on miscarriage rate per woman when compared with placebo/no treatment (RR 0.8 , 95% CI 0.56 to 1.32; 8 RCTs; 821 women; I 2 = 0%; low-quality evidence). Metformin may result in an increase in side effects compared with placebo/no treatment (RR 3.35, 95% CI 2.34 to 4.79; 8 RCTs; 748 women; I 2 = 0%; low-quality evidence). The overall quality of evidence ranged from very low to low. The main limitations were inconsistency, risk of bias, and imprecision.; Authors' Conclusions: This updated review on metformin versus placebo/no treatment before or during IVF/ICSI treatment in women with PCOS found no conclusive evidence that metformin improves live birth rates. In a long GnRH-agonist protocol, we are uncertain whether metformin improves live birth rates, but metformin may increase the clinical pregnancy rate. In a short GnRH-antagonist protocol, metformin may reduce live birth rates, although we are uncertain about the effect of metformin on clinical pregnancy rate. Metformin may reduce the incidence of OHSS but may result in a higher incidence of side effects. We are uncertain of the effect of metformin on miscarriage rate per woman. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Tsui, S. and A. Sofy Ahmed (2023). "A meta-analysis of fertility and adverse outcomes in oil- and water-based contrast for hysterosalpingography." Turkish Journal of Obstetrics and Gynecology 20(1): 64-73.
	Infertility is the inability to conceive after one year of regular unprotected intercourse. There is a debate about the therapeutic effect of hysterosalpingography (HSG) and whether the selection of contrast materials makes a difference in the chance of subsequent conception. In this study, we aimed to compare the fertility-enhancing outcomes and adverse effects of oil and water-based contrasts in patients who underwent HSG. This systematic review and meta-analysis was conducted following the PRISMA guidelines. We searched the Web of Science, PubMed, and Scopus until September 2022. We included all primary randomized controlled trials evaluating the fertility-enhancing benefits of HSG in oil-based versus water-based contrast media in women of childbearing age with infertility. Eleven studies with 4,739 patients were selected. The pregnancy rate in the oil group was significantly higher than that in the water group [odds ratio (OR)=1.51 (1.23, 1.86), p<0.0001]. Our meta-analysis favored the oil group in abdominal pain and vaginal bleeding with the odd ratios of 0.73 (0.58, 0.91), (p=0.006) and 0.91 (0.46, 1.81), (p=0.79), respectively. Water-based contrast was associated with less intravasation [OR=2.09 (1.09-4.02), p=0.03]. There were no differences between the contrasts for miscarriage [OR=1.02 (0.71, 1.46), p=0.92], and ectopic pregnancy [OR=0.84 (0.27, 2.63), p=0.77]. HSG with oil-based contrast was related to a higher pregnancy rate, live birth rate, and intravasation rate. While HSG using a water-based contrast medium was associated with increased abdominal discomfort, vaginal bleeding, and the visual-analogue scale pain score.; Competing Interests: Conflict of Interest: No conflict of interest was declared by the authors. (©Copyright 2023 by Turkish Society of Obstetrics and Gynecology | Turkish Journal of Obstetrics and Gynecology published by Galenos Publishing House.)

Tuncer, A. (2022). "Comparison of Pelvic Floor Therapy and Yoga on Stres Urinary Incontinence Incontinence." ClinicalTrials.gov.
	32 subjects with postnatal stress urinary incontinence will be included in the study after a voluntary consent form will be filled out. Subjects will randomly be divided into two groups according to the order. Pelvic floor physical therapy (PFT) (n=16) will be Group 1, and therapeutic yoga training (TYT) (n=16) will be the Group 2. PFT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm‐up exercises, pelvic floor muscle contractions in different positions, and abdominal breathing techniques. Each session is planned for 45 minutes. TYT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm‐up exercises, different asanas, and yogi breathing exercises. each session is planned for 45 minutes.

Tuoheti, Z., et al. (2021). "Laparo-endoscopic single-site surgery vs conventional laparoscopic surgery for endometrial cancer: A systematic review and meta-analysis." Medicine 100(12): e24908.
	Objective: To systematically review and evaluate the safety, advantages and clinical application value of laparo-endoscopic single-site surgery (LESS) for endometrial cancer by comparing it with conventional laparoscopic surgery (CLS).; Methods: We conducted a systematic review of the published literature comparing LESS with CLS in the treatment of endometrial cancer. English databases including PubMed, Embase, Ovid, and the Cochrane Library and Chinese databases including Chinese National Knowledge Infrastructure, Wanfang and China Biology Medicine were searched for eligible observational studies up to July 10, 2019. We then evaluated the quality of the selected comparative studies before performing a meta-analysis using the RevMan 5.3 software. The complications, surgical time, blood loss during surgery, postoperative length of hospital stay and number of lymph nodes removed during surgery were compared between the 2 surgical approaches.; Results: Four studies with 234 patients were finally included in this meta-analysis. We found that there was no statistically significant difference in complications between the 2 surgical approaches [odds ratio (OR): 0.63, 95% confidence interval (CI): 0.18-2.21, P = .47, I2 = 0%]. There was no statistically significant difference in blood loss between the 2 surgical approaches [mean difference (MD): -61.81, 95% CI: -130.87 to -7.25, P = .08, I2 = 74%]. There was no statistically significant difference in surgical time between the 2 surgical approaches (MD: -11.51, 95% CI: -40.19 to 17.16, P = .43, I2 = 81%). There was also no statistically significant difference in postoperative length of hospital stay between the 2 surgical approaches (MD: -0.56, 95% CI: -1.25 to -0.13, P = .11, I2 = 72%). Both pelvic and paraaortic lymph nodes can be removed with either of the 2 procedures. There were no statistically significant differences in the number of paraaortic lymph nodes and total lymph nodes removed during surgery between the 2 surgical approaches [(MD: -0.11, 95% CI: -3.12 to 2.91, P = .29, I2 = 11%) and (MD: -0.53, 95% CI (-3.22 to 2.16), P = .70, I2 = 83%)]. However, patients treated with LESS had more pelvic lymph nodes removed during surgery than those treated with CLS (MD: 3.33, 95% CI: 1.05-5.62, P = .004, I2 = 32%).; Conclusion: Compared with CLS, LESS did not reduce the incidence of complications or shorten postoperative hospital stay. Nor did it increase surgical time or the amount of bleeding during surgery. LESS can remove lymph nodes and ease postoperative pain in the same way as CLS. However, LESS improves cosmesis by leaving a single small scar.; Competing Interests: The authors have no conflicts of interests to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Tuong, N., et al. (2022). "Effect of adding gonadotropin-releasing hormone agonist pretreatment to artificial endometrial preparation protocol on frozen-thawed embryo transfer cycles: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Turktekin, N., et al. (2022). "Comparing the effects of endometrial injury with hysteroscopy or Pipelle cannula on fertility outcome." European Review for Medical and Pharmacological Sciences 26(13): 4693-4697.
	Objective: To compare the effects of mechanical endometrial injury performed with hysteroscopy or Pipelle cannula on fertility outcome in patients with implantation failure.; Patients and Methods: Sixty patients with a history of two or more failed ICSI despite the transfer of high-quality embryos were equally divided into three groups: Group A - injury with hysteroscopy (n=20), Group B - injury with Pipelle cannula (n=20), Group C - no injury (n=20). Patients in group A underwent endometrial injury with monopolar needle forceps between days 10-12 of the proliferative phase in the preceding cycle before ovarian stimulation. Patients in group B underwent endometrial injury with Pipelle cannula between days 22-24 of the mid-luteal phase in the preceding cycle. Patients in group C had no injuries. Beta-hCG, clinical pregnancy, live birth and miscarriage rates were analyzed among the groups.; Results: There were no significant differences in terms of positive pregnancy test, clinical pregnancy and live birth rates between hysteroscopy and Pipelle groups. Compared to the control group, both clinical pregnancy and live birth rates were found to be significantly higher in patients who underwent endometrial injury with hysteroscopy or Pipelle cannula. Miscarriage rates in the control group were significantly higher than those in the Pipella or hysteroscopic injury.; Conclusions: Endometrial injuries performed in the follicular phase with hysteroscopic monopolar forceps or in the secretory phase with Pipelle cannula increase pregnancy and live birth.

Tyagi, S. (2022). "Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women." ClinicalTrials.gov.
	Urgency urinary incontinence (UUI), a form of overactive bladder (OAB), is prevalent (36% of women over age 65), morbid and costly ($83 billion/year), and treatment is problematic. Current treatment is largely bladder centric has limited efficacy,and adherence rates fade to 21% at 12 months. The researchers believe that a complimentary approach, one that also addresses etiology beyond the bladder may enhance treatment success. Up to 50% of older adults complain of poor sleep and nighttime bladder symptoms (nocturia) are considered the major cause. However, the relationship between sleep and the bladder is complex and bidirectional. Poor sleep not only exacerbates daytime lower urinary tract symptoms (LUTS), but can also cause these, increasing the risk of LUTS by up to 55% over 5 years. Sleep disruption increases anxiety and impairs daytime attention, both of which affect bladder control. Consistent with findings in anxiety disorders and attention control, poor sleep is linked to media prefrontal cortex (mPFC) hypoactivity, a region the investigators have identified as key to executive control of voiding and to therapeutic response to biofeedback‐assisted pelvic floor muscle therapy. Hence, the investigators posit that enhanced mPFC function through improved sleep might ameliorate bladder control. Despite evidence of a bidirectional relationship, the impact of sleep treatment on UUI has never been assessed. The researchers prior study demonstrated that improving sleep using Brief Behavioral Treatment of Insomnia (BBTI), a simple intervention for insomnia, improved both sleep and nocturia in older adults, yet its impact on UUI and mechanism of action is not known. Our exploratory analysis of sleep and voiding data from 20 older adults with UUI and nocturia showed that with behavioral sleep intervention alone, 24‐hour UUI episodes decreased with prolongation of uninterrupted sleep before the first awakening to void (r=‐0.50, p=0.02), and increased proportion of deep sleep (r=‐0.56, p=0.01). Hence, the researchers postulate that addressing sleep in patients with UUI and nocturia may further potentiate bladder‐focused UUI treatment. The efficacy of mirabegron, a β3‐ adrenoceptor agonist is comparable to first‐line antimuscarinic pharmacotherapy for UUI, with fewer side effects, but it has only a modest effect on nocturia. Although these drugs show statistically significant improvement in LUTS, drug compliance remains poor secondary to modest perceived clinical benefit. The researchers central hypothesis is that comorbid insomnia contributes to poor therapeutic response for UUI and concurrent insomnia treatment will improve outcomes. Specifically, addition of BBTI to drug therapy will improve sleep, nocturia, and daytime LUTS, likely mediated by improvement of mPFC function. The researchers propose an 8‐week randomized controlled trial of mirabegron+BBTI vs. mirabegron alone for UUI in 100 women (aged ≥60), assessing both clinical and neural effects of treatment. The researchers will also assess durability of the combination therapy at 6 months. This design encompasses the role of sleep in OAB treatment, insight into the central and peripheral effects of mirabegron and BBTI, and response durability.

Tyler, B., et al. (2022). "Interventions to optimize embryo transfer in women undergoing assisted conception: a comprehensive systematic review and meta-analyses." Human Reproduction Update 28(4): 480-500.
	Background: Several interventions and techniques are suggested to improve the outcome of embryo transfer (ET) in assisted conception. However, there remains no consensus on the optimal practice, with high variations among fertility specialists.; Objective and Rationale: We conducted a comprehensive systematic review and meta-analyses of randomized controlled trials (RCTs) aiming to identify effective interventions that could be introduced around the time of ET to improve reproductive outcomes.; Search Methods: We searched the electronic databases (MEDLINE, EMBASE and Cochrane CENTRAL) from inception until March 2021 using a multi-stage search strategy of MeSH terms and keywords, and included all RCTs that evaluated an intervention in the 24-h period before/after ET in women undergoing IVF/ICSI. Our primary outcome was clinical pregnancy rate post-ET confirmed as viable pregnancy on ultrasound scan. We assessed the risk of bias in included trials and extracted data in duplicate. We pooled data using a random-effect meta-analysis and reported using risk ratio (RR) with 95% CI. We explored publication bias and effect modifiers using subgroup analyses.; Outcomes: Our search yielded 3685 citations of which we included 188 RCTs (38 interventions, 59 530 participants) with a median sample size of 200 (range 26-1761). The quality of included RCTs was moderate with most showing a low risk of bias for randomization (118/188, 62.8%) and attrition (105/188, 55.8%) but there was a significant risk of publication bias (Egger's test P = 0.001). Performing ET with ultrasound guidance versus clinical touch (n = 24, RR 1.265, 95% CI 1.151-1.391, I2 = 38.53%), hyaluronic acid versus routine care (n = 9, RR 1.457, 95% CI 1.197-1.261, I2 = 46.48%) and the use of a soft versus hard catheter (n = 27, RR 1.122, 95% CI 1.028-1.224, I2 = 57.66%) led to higher clinical pregnancy rates. Other pharmacological add-ons also showed a beneficial effect including granulocyte colony-stimulating factor (G-CSF: n = 4, RR 1.774, 95% CI 1.252-2.512, I2 = 0), Atosiban (n = 7, RR 1.493, 95% CI 1.184-1.882, I2 = 68.27%) and hCG (n = 17, RR 1.232, 95% CI 1.099-1.382, I2 = 57.76%). Bed rest following ET was associated with a reduction in clinical pregnancy (n = 6, RR 0.857, 95% CI 0.741-0.991, I2 = 0.01%). Other commonly used interventions, such as non-steroidal anti-inflammatory drugs, prophylactic antibiotics, acupuncture and cervical mucus removal, did not show a significant benefit on reproductive outcomes. Our effect estimates for other important outcomes, including miscarriage and live birth, were limited by the varied reporting across included RCTs.; Wider Implications: Using ultrasound guidance, soft catheters and hyaluronic acid at the time of ET appears to increase clinical pregnancy rates. The use of Atosiban, G-CSF and hCG showed a trend towards increased clinical pregnancy rate, but larger trials are required before adopting these interventions in clinical practice. Bed rest post-ET was associated with a reduction in clinical pregnancy and should not be recommended. (© 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.)

Tzur, Y., et al. (2022). "Expectant vs medical management for retained products of conception after medical termination of pregnancy: a randomized controlled study." American Journal of Obstetrics and Gynecology 227(4): 599.e591-599.e599.
	Background: Despite the rise of medical treatments for the termination of pregnancy, to date, no prospective trial has evaluated the efficacy of misoprostol in treating retained products of conception after induced termination of pregnancy.; Objective: This study aimed to compare medical management with misoprostol with expectant management for retained products of conception after first-trimester medical termination of pregnancy.; Study Design: This was an open-label randomized controlled trial conducted at a university-affiliated tertiary medical center. Consenting consecutive women who underwent a routine 3-week follow-up evaluation after medical termination of pregnancy and had a sonographic suspicion of retained products of conception, defined as sonographic evidence of intrauterine remnant (>12 mm) with a positive Doppler flow, were recruited. The participants were randomized into a medical treatment group (800 μg of sublingually administered misoprostol) or expectant management. They all underwent repeat ultrasound scans every 2 weeks until a maximum of 6 weeks, and those suspected of persistent retained products of conception were referred to operative hysteroscopy. The primary endpoint was successful treatment defined as no need for surgical intervention because of persistent retained products of conception within 8 weeks from pregnancy termination.; Results: There was no marked difference in demographic characteristics between the study groups. The median sonographically demonstrated retained product length was 20 mm (interquartile range, 17-25) in the medically managed group compared with 20 mm (interquartile range, 17-26) in the expectantly managed group (P=.733). Treatment succeeded in 42 of 68 women (61.8%) in the medically managed group compared with 36 of 63 women (57.1%) in the expectantly managed group (relative risk, 1.12; 95% confidence interval, 0.74-1.70; P=.590). There was no difference in adverse outcomes between the 2 groups.; Conclusion: There was no clinically meaningful advantage for medical treatment with misoprostol compared with expectant management after first-trimester medical termination of pregnancy in women with suspected retained products of conception. Surgical intervention can be avoided in up to 60% of women who are managed expectantly for 8 weeks of follow-up. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Uccella, S. (2022). "Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids." ClinicalTrials.gov.
	A randomized controlled trial aimed to evaluate the efficacy of a combination of Epigallocatechin gallate, vitamin D3, D‐Chiro‐inositol, and vitamin B6 as a treatment for uterine fibroids. The clinical study is double‐blind, neither patients nor investigators know whether the subject receives the combination of Epigallocatechin gallate, vitamin D, D‐Chiro‐inositol, and vitamin B6 or the placebo. After 3 months of treatment, changes in symptoms associated with uterine fibroids, quality of life, and ultrasounds characteristics are compared between the two treatment arms.

Uccella, S. (2022). "Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial." ClinicalTrials.gov.
	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.

Uchiyama, S. (2021). "A double-blind, placebo-controlled study with A-2 on symptoms of vaginal atrophy in postmenopausal women." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: 1 time or 2 times/day, for 12 weeks 1 time or 2 times/day, for 12 weeks CONDITION: Healthy postmenopausal women PRIMARY OUTCOME: The symptoms of vaginal atrophy after ingestion for 12 weeks INCLUSION CRITERIA:

Unanyan, A., et al. (2022). "Effectiveness of inositol, metformin and their combination in women with PCOS undergoing assisted reproduction: systematic review and meta-analysis." Gynecological Endocrinology 38(12): 1035-1046.
	Objective: Our study aims to compare the effect of metformin, inositol and their combinations on the efficiency in improving outcomes of assisted reproductive technologies in women with PCOS.; Data Sources: PubMed, The Cochrane Library, ClinicalTrials.gov, Embase, MEDLINE. The search was performed on studies published before November 14, 2021, to identify articles evaluating the effectiveness of treatment metformin and inositol on ART outcomes.; Study Selection: The systematic review was conducted according to the PRISMA 2020 checklist and registered in the PROSPERO 2021 CRD42021287887. Randomized controlled trials (RCTs) in English that compared metformin or inositol or metformin + inositol treatment with placebo or no treatment in women with PCOS undergoing assisted reproduction were included. In addition, RCTs with comparison combination and single metformin or inositol treatment were also included.; Data Extraction and Synthesis: 35 RCTs were included for qualitative analysis reporting on 4668 participants. In group of Metformin treatment were included 1891 patients, in Myo-inositol group - 281, in inositol + metformin group were included 110 participants and in control group (placebo or absence of treatment) - 1865 women with PCOS. 5 meta-analyses were performed. CPR in comparison of metformin and placebo in 1312 patients were higher in metformin group (RR = 1.30, 95% CI: 1.12 to 1.50, p = 0.0004). OHSS was less in metformin (RR = 0.34, 95% CI: 0.17 to 0.69, p = 0.003). However, LBR were not statistically significant (RR = 1.12, 95% CI: 0.93 to 1.36, p = 0.24). In comparison of inositol and no treatment there was also no difference in CPR (RR = 1.37, 95% CI: 0.79 to 2.38, p = 0.26). As for metformin and inositol meta-analysis in 220 patients with PCOS, CPR were higher in inositol group (RR = 1.52, 95% CI: 1.05 to 2.18, p = 0.03). Combination treatment included only two RCTs and was illegible for meta-analysis.; Conclusion: To our knowledge, it is the first meta-analysis that estimates inositol treatment compared to metformin. Based on our systematic review and meta-analysis, metformin seems to be a good option for improving ART outcomes in women with PCOS. However, it is not clear whether inositol usage is adequate. Nevertheless, we need more clinical trials of good quality to answer all questions thoroughly.

University College, L. (2021). "Adaptive ChemoTherapy for Ovarian Cancer in Patients With Replased Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer." ClinicalTrials.gov.
	ACTOv will compare standard 3‐weekly carboplatin (AUC5), to carboplatin delivered according to an AT regimen. The AT regimen will modify carboplatin dose according to changes in the clinical‐standard serum biomarker CA125 as a proxy measure of total tumour burden and an individual patient's response to the most recent chemotherapy treatment. AT could prolong sensitivity to carboplatin and extend tumour control, while simultaneously reducing chemotherapy dose and drug‐induced toxicity. Carboplatin is a low cost and low toxicity drug that has an enduring and central role in ovarian cancer treatment.

University Hospital, G. (2021). "Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone." ClinicalTrials.gov.
	The study aims to evaluate the effect of an increased dose of vaginal progesterone supplementation on the incidence of ongoing pregnancy for patients with a suboptimal serum progesterone level (defined as < 10 mcg/l) on the day of blastocyst transfer.

University of, A. (2021). "Lumbar Spine Manipulation Versus Pharmacological Therapy in Young Women With Primary Dysmenorrhea." ClinicalTrials.gov.
	Many treatments like acupuncture, manipulative therapy and pharmacological therapy have been proposed to alleviate symptoms associated with dysmenorrhea. However, no study has previously compared lumbar spine manipulation to pharmacological therapy in the treatment of primary dysmenorrhea.

University of British, C. (2022). "The SUPPORT Study: effectiveness and Usability of a Web-Enabled Resource for Postpartum Mental Health." ClinicalTrials.gov.
	This is Phase 3 of a multi‐phase project that will be completed under the supervision of Dr. Lori Brotto, the University of British Columbia Sexual Health Lab and the Women's Health Research Institute at BC Women's Hospital. The present study phase uses a randomized controlled trial design and will evaluate the effectiveness and usability of postpartumcare.ca using three outcomes: (1) depression and anxiety; (2) system usability and satisfaction; and (3) website metrics. Parents aged 19 or older experiencing postpartum depression and/or anxiety living in BC who gave birth in the past 12 months will be eligible. Fifty will be randomized to the intervention group, receiving immediate access to postpartumcare.ca for 4 weeks, and 50 will be assigned waitlist control, receiving treatment as usual. Depression and anxiety symptoms will be measured at baseline, after the 4‐week intervention period, and again 2 weeks later using the Edinburgh Postnatal Depression Scale (EPDS) and Perinatal Anxiety Screening Scale (PASS). After 4 weeks, system usability and satisfaction will be measured using the System Usability Scale (SUS), and website metrics will be collected for the intervention group only. Multivariate analyses will be conducted to compare the anxiety and depression total scores and subscale scores between the two groups (intervention and treatment as usual). Descriptive analyses will be conducted on the satisfaction and usability questionnaires and website metrics. The investigators hypothesize that following the use of postpartumcare.ca, the intervention group will see a greater reduction in depression and/or anxiety symptoms compared to the control group and that the website will be rated as usable. The findings from this trial will add to the existing body of literature investigating the use of eHealth interventions for PPD and PPA treatment. Moreover, postpartumcare.ca will serve as a practical tool for birthing persons in BC in need of accessible and effective support.

University of California, L. A. (2021). "New Moms Mood Tracking & Wellbeing." ClinicalTrials.gov.
	No Results Available Behavioral: Online therapy with coaching|Behavioral: Clinical care Change From Baseline in Computerized Adaptive Testing - Mental Health (CAT-MH) Scores At Post-Treatment and Week 26|Edinburgh Postnatal Depression Scale (EPDS-9) Female Not Applicable 167 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment 20-001924 June 30, 2024

University of, J. (2023). "Effects of Hypopressive Abdominal Gymnastics in Urinary Incontinence." ClinicalTrials.gov.
	No Results Available Other: Hypopressive intervention International Consulation on Incontinence Short Quality of Life Questionnaire|PSQI (Pittsburgh Sleep Quality Index)|Pelvic organ prolapse/urinary incontinence sexual function questionnaire-12|Prolapse quality of life questionnaire|Handgrip Strength|TUG test (Timed Up and Go test)|Chair sit and reach test.|Back scratch test.|BMI (Body Mass Index)|Waist circumference.|Hip circumference|Waist-to-hip ratio. Female Not Applicable 112 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment - University of Jaén. June 13, 2023 Spain Zaragoza, Spain Center for the Elderly "Gallur"

University of, O. (2022). "Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation." ClinicalTrials.gov.
	Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will be randomized into one of two groups and receive treatment as follows: If patients are in the first group,they will receive niraparib alone, once daily taken by mouth. If patients are in the second group, they will receive niraparib once daily taken by mouth and infusion of bevacizumab once every 3 weeks. Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable, bad side effects. Patients will be monitored during treatment with tests and exams and after treatment completion for up to 3 years.

University of, S. (2021). "Hyperthermic and Normothermic intraperitoneal chemotherapy following interval cytoreductive surgery for stage III epithelial OVArian, fallopian tube and primary peritoneal cancer." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Participants in the experimental arm of normothermic intraperitoneal chemotherapy will receive cisplatin 100mg/m^2 chemotherapy given to the abdominal cavity through a catheter for 90 minutes during surgery heated at normal body temperature (37°C). CONDITION: Cancer ‐ Ovarian and primary peritoneal Ovarian cancer;Fallopian tube cancer;Primary peritoneal cancer; ; Ovarian cancer ; Fallopian tube cancer ; Primary peritoneal cancer PRIMARY OUTCOME: Proportion of patients experiencing any adverse events greater than or equal to grade 3 (CTCAE v5.0 and Clavien‐Dindo classification) e.g. nausea and vomiting.[Within 90 days post‐surgery ] SECONDARY OUTCOME: Feasibility of NIPEC. The proportion of patients that correctly received their randomised treatment and the proportion of patients that received all 6 cycles of chemotherapy will be collected in study database. [After patients receive their randomised treatment and the proportion of patients that received all 6 cycles of chemotherapy. ] Frequency of adverse events of interest using CTCAE v5.0 and Clavien‐Dindo classification for surgical adverse events[Duration of trial] Health Related Quality of Life[At 24 months post randomisation ] Overall survival[From the date of randomisation to date of death from any cause.] Progression free survival. Progression free survival will be determined by GCIG criteria in combination with clinical and/or radiological assessments.[From randomisation until the date of first evidence of progression of disease. Progression free survival is defined as the time from randomisation until the date of first evidence of progression of disease or death due to any cause, whichever comes first.] Resource utilisation. Hospitalisation information will be collected for all patients. Major components include days in intensive care units and days in hospital, returns to operating theatre, emergency room visits, and the number of days of total parenteral nutrition (TPN).[Duration of the trial] Surgical morbidity by collecting data from hospital and surgical records (eg length of intensive care unit (ICU) stay, readmission to ICU, duration of vasopressor use, intra‐operative and post‐operative blood transfusion, length of hospital stay)[Within 90 days post‐surgery ] INCLUSION CRITERIA: 1. Age 18 ‐75 years 2. Participants diagnosed with primary FIGO stage III epithelial ovarian, fallopian tube or peritoneal cancer with disease that is limited to the abdominal cavity. 3. Histopathology must be high grade serous, endometroid (grade 2 and 3), clear cell adenocarcinoma or mixed high grade histologies. 4. Have 3‐4 cycles of pre‐operative platinum‐based chemotherapy 5. No progression of disease on radiological imaging and/or Ca125 during neoadjuvant chemotherapy 6. ECOG performance status 0 or 1 7. Fit for surgery as determined by study surgical team 9. Adequate bone marrow function. 10. Adequate liver function 11. Adequate renal function 12. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments. 13. Signed, written informed consent.

University of, V. (2022). "GMI in Women Suffering GPPPD." ClinicalTrials.gov.
	Graded Motor Imagery has been extensively used in several populations suffering pain‐related disorders. It triggers cortical stimulation gradually in order to have an effect on the alterations that might have occured due to pain Women suffering from Genito‐Pelvic Pain Penetration Disorder deal with persistent pelvic pain that is no longer responding to a noxious stimulus, therefore this clinical presentation could have several cortical alterations implicated. The main goal of this study is to assess if a Graded Motor Imagery programme is able to reduce pain intensity in women suffering from Genito‐Pelvic Pain Penetration Disorder. Secondary objectives will include if this programme also improves pain‐related outcomes such as pain catastrophizing or pain‐related fear of movement, known as kinesiophobia

University, Y. (2022). "Salvage Systemic Therapy With or Without Stereotactic Ablative Radiotherapy for Recurrent Ovarian Cancer." ClinicalTrials.gov.
	No Results Available Other: Standard salvage therapy|Radiation: Standard salvage therapy + SABR overall survival (OS) Female Not Applicable 270 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment 4-2022-0286 December 2026

Usselman, C. (2024). "Exogenous Ketone Supplementation in Females With Polycystic Ovary Syndrome." ClinicalTrials.gov.
	No Results Available Dietary Supplement: Ketone|Dietary Supplement: Water Glycemic responses to a 2-hr oral glucose tolerance test|Flow mediated dilation (FMD)|Systolic Blood Pressure (SBP)|Diastolic Blood Pressure (DBP)|Insulin area under the curve|C-peptide|Glucagon-like peptide-1 (GLP-1)|Glucose-dependent insulinotropic polypeptide (GIP)|Triglycerides|Insulinogenic index|Arterial artery blood flow|Shear rate and low-flow mediated vasoconstriction to the FMD|Muscle sympathetic nerve activity (MSNA)|Neurovascular transduction|Vascular resistance|Capillary blood Beta-OHB concentrations|Serum testosterone|Serum sex hormone binding globulin|Serum estradiol|Serum Progesterone All Not Applicable 60 Other Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment 2024-9710 December 2027

Utsunomiya, T., et al. (2022). "Creation, effects on embryo quality, and clinical outcomes of a new embryo culture medium with 31 optimized components derived from human oviduct fluid: A prospective multicenter randomized trial." Reproductive Medicine and Biology 21(1): e12459.
	Purpose: Our aim is to make an ideal embryo culture medium close to human oviduct fluid (HOF) components, and to evaluate the quality of this medium with embryo quality and clinical outcomes in assisted reproductive technology (ART) by a prospective randomized controlled trial (RCT).; Methods: Study I: HOF was collected laparoscopically from patients ( n = 28) with normal pelvic findings. According to HOF analysis results, the new medium "HiGROW OVIT ® " (OVIT) was designed. Study II: Embryos (2 pronuclei (2PN) = 9633) were assigned from 1435 patients. The blastulation rate (BR), good BR (gBR), utilized (transferred/cryo-preserved) BR (uBR), pregnancy rate (PR), and miscarriage rate (MR) were compared between the OVIT and control groups by RCT.; Results: The novel medium 'OVIT' was produced according to 31 HOF components. The concentrations of essential amino acids (e-AAs) were lower in OVIT than in current media, yet the opposite was true for ne-AA concentrations. gBR and uBR were higher in the OVIT group than in the control group. In the older female group, gBT and uBR were significantly higher in the OVIT group.; Conclusions: The novel medium 'OVIT' was produced according to HOF data. The OVIT had significantly better embryo quality and clinical outcomes than the current media.; Competing Interests: Takafumi Utsunomiya has nothing to disclose. The remaining authors have nothing to disclose. (© 2022 The Authors. Reproductive Medicine and Biology published by John Wiley & Sons Australia, Ltd on behalf of Japan Society for Reproductive Medicine.)

Uwins, C., et al. (2021). "Minimally invasive surgery (robotic or laparoscopic) versus laparotomy for advanced ovarian cancer." The Cochrane Database of Systematic Reviews 2021(2): CD013872.
	Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To compare the effectiveness and safety of minimally invasive surgery (either robotic or laparoscopic) with laparotomy (open surgery) for women with FIGO 2014 stage III-IV epithelial ovarian cancer, fallopian-tube or primary peritoneal carcinoma.Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Vajna, R. Z., et al. (2023). "Strong early impact of letrozole on ovulation induction outperforms clomiphene citrate in polycystic ovary syndrome: a systematic review with meta-analysis." MedRxiv.
	Background: Polycystic ovary syndrome is one of the most frequent endocrinological problems causing infertility in women worldwide. The main problem in these women is hyperandrogenism and/or chronic oligo/anovulation, which leads to infertility. In this systematic review and meta-analysis, we aimed to investigate the efficacy of a relatively new drug for ovulation induction, letrozole, by comparing it to the first line of treatment for ovulation induction, clomiphene citrate. Method(s): A literary search was conducted in three databases and included randomized clinical trials comparing letrozole and clomiphene citrate for ovulation induction for women with polycystic ovary syndrome. The diagnosis of polycystic ovary syndrome was determined according to the Rotterdam criteria. We pooled data using a random-effects model. Result(s): Our search provided a total of 1,994 articles, of which we included 25 studies. In the letrozole group, endometrial thickness was significantly higher (Mean Difference=1.70, Confidence Interval: 0.55-2.86; Heterogeinity: I2=97%, p-value=0.008); odds for ovulation (Odds Ratio=1.8, Confidence Interval: 1.21-2.69; Heterogeinity: I2=51%, p-value=0.010) and pregnancy (Odds Ratio=1.96, Confidence Interval: 1.37-2.81; Heterogeinity: I2=32%, p-value=0.002) were significantly higher; the resistance index of subendometrial arteries was significantly lower (Mean Difference=-0.15, Confidence Interval: -0.27- -0.04; Heterogeneity: I2=92%, p-value=0.030). Conclusion(s): Women with polycystic ovary syndrome treated with letrozole for ovulation induction had higher ovulation and pregnancy rates, their endometrium became thicker, the resistance index of subendometrial arteries was lower. The lower resistance index of the subendometrial arteries can improve intrauterine circulation, which may provide better circumstances for embryo implantation and development.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 4.0 International license.

Valverde, N., et al. (2023). "Psychodynamic Psychotherapy for Postpartum Depression: A Systematic Review." Maternal and Child Health Journal 27(7): 1156-1164.
	Objectives: Postpartum depression estimated prevalence in women is between 5 and 26% and it has adverse effects both on the mother, infant and her partner. Psychological treatments have proved to be effective for women with mild-to-moderate symptoms. Whereas several systematic reviews have assessed the effects of different psychological interventions for postpartum depression, such as cognitive-behavioural therapy or interpersonal therapy, no review assessing psychodynamic therapy has been carried out. A systematic review was conducted to evaluate the efficacy of psychodynamic therapy for postpartum depression.; Methods: Studies were identified using the following databases: PsycINFO, Psycarticles and Pubmed over January 2023. The requirements for the studies were the following: they had to be quantitative, available in English, including a psychodynamic intervention targeting treatment or prevention of postpartum depression which starts during pregnancy or within the first 12 months after giving birth. Case studies, qualitative studies or studies focused on improving parent-infant relationship or infant outcome were excluded from this research.; Results: Seven trials including 521 women met the inclusion criteria. In summary, three randomized controlled trials and four longitudinal studies were found. The most frequently used assessment tool was EPDS, five were individual interventions and the other two were group interventions.; Discussion: All studies reported the efficacy of psychodynamic interventions for postpartum depression, both in home and clinical settings and both in group and individual format. The limited number of trials, small sample sizes and lack of appropriate control groups were the main limitations.; Conclusions for Practice: Psychodynamic therapy is probably efficient intervention for postpartum depression. Future research with strong methodological designs is needed to confirm these findings.; Significance: What is already known on this subject? Several systematic reviews have assessed the effects of different psychological interventions for postpartum depression, but no review assessing psychodynamic therapy has been carried out. What this study adds? A systematic review was conducted to evaluate the efficacy of psychodynamic therapy for postpartumdepression. This makes the systematic review a unique contribution to the literature. (© 2023. The Author(s).)

van de Wijgert, J. and M. C. Verwijs (2020). "Lactobacilli-containing vaginal probiotics to cure or prevent bacterial or fungal vaginal dysbiosis: a systematic review and recommendations for future trial designs." BJOG 127(2): 287-299.
	Background: Vaginal probiotics claiming to cure and/or prevent bacterial and/or fungal vaginal dysbiosis are available on the market but, until recently, did not have to be approved as drugs for human use.; Objectives: We evaluated the impact of vaginal probiotics on bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) cure and/or recurrence, as well as vaginal microbiota (VMB) composition and vaginal detection of probiotic strains.; Search Strategy: We performed a systematic literature search in MEDLINE and Embase up to 15 January 2019.; Selection Criteria: There were no restrictions in probiotic strains/formulations, study populations, and designs. BV had to be diagnosed by Nugent or Ison-Hay Gram stain scoring, VVC by culture, wet mount or PCR, and VMB composition/detection by molecular techniques.; Data Collection and Analysis: The authors independently extracted data.; Main Results: All 22 vaginal probiotics evaluated in the 34 eligible studies contained Lactobacillus strains, and some contained additional active ingredients. The probiotics hold promise for BV cure and prevention, but much less so for VVC cure and prevention. No major safety concerns were reported in any of the studies. Vaginal detection of probiotic strains never lasted long beyond the dosing period, suggesting that they did not colonise the vagina. However, findings are not definitive because heterogeneity was high and the quality of most studies suboptimal.; Conclusions: Availability of vaginal probiotics for vaginal health indications will likely decline in 2020 because of regulatory changes. We urge the field to invest in clinical evidence-based product development and to conduct future trials more rigorously.; Tweetable Abstract: Lactobacilli-containing vaginal probiotics hold promise for bacterial vaginosis cure and prevention, but not for vulvovaginal candidiasis. (© 2019 Royal College of Obstetricians and Gynaecologists.)

van den Brink, M. J., et al. (2021). "The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis." BJOG 128(12): 2003-2011.
	Objective: To evaluate the costs and non-inferiority of a strategy starting with the levonorgestrel intrauterine system (LNG-IUS) compared with endometrial ablation (EA) in the treatment of heavy menstrual bleeding (HMB). Design(s): Cost-effectiveness analysis from a societal perspective alongside a multicentre randomised non-inferiority trial. Setting(s): General practices and gynaecology departments in the Netherlands. Population: In all, 270 women with HMB, aged >=34 years old, without intracavitary pathology or wish for a future child. Method(s): Randomisation to a strategy starting with the LNG-IUS (n = 132) or EA (n = 138). The incremental cost-effectiveness ratio was estimated. Main Outcome Measure(s): Direct medical costs and (in)direct non-medical costs were calculated. The primary outcome was menstrual blood loss after 24 months, measured with the mean Pictorial Blood Assessment Chart (PBAC)-score (non-inferiority margin 25 points). A secondary outcome was successful blood loss reduction (PBAC-score <=75 points). Result(s): Total costs per patient were 2,285 in the LNG-IUS strategy and 3,465 in the EA strategy (difference: 1,180). At 24 months, mean PBAC-scores were 64.8 in the LNG-IUS group (n = 115) and 14.2 in the EA group (n = 132); difference 50.5 points (95% CI 4.3-96.7). In the LNG-IUS group, 87% of women had a PBAC-score <=75 points versus 94% in the EA group (relative risk [RR] 0.93, 95% CI 0.85-1.01). The ICER was 23 (95% CI 5-111) per PBAC-point. Conclusion(s): A strategy starting with the LNG-IUS was cheaper than starting with EA, but non-inferiority could not be demonstrated. The LNG-IUS is reversible and less invasive and can be a cost-effective treatment option, depending on the success rate women are willing to accept. Tweetable abstract: Treatment of heavy menstrual bleeding starting with LNG-IUS is cheaper but slightly less effective than endometrial ablation.Copyright © 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.

van der Meulen Julia, F., et al. (2023). "Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy (PROSECCO trial): A multicenter randomized controlled trial." PLoS Medicine 20(12): e1004323.
	Background: Hysteroscopic resection is the first-choice treatment for symptomatic type 0 and 1 fibroids. Traditionally, this was performed under general anesthesia. Over the last decade, surgical procedures are increasingly being performed in an outpatient setting under procedural sedation and analgesia. However, studies evaluating safety and effectiveness of hysteroscopic myomectomy under procedural sedation are lacking. This study aims to investigate whether hysteroscopic myomectomy under procedural sedation and analgesia with propofol is noninferior to hysteroscopic myomectomy under general anesthesia.; Methods and Findings: This was a multicenter, randomized controlled noninferiority trial conducted in 14 university and teaching hospitals in the Netherlands between 2016 and 2021. Inclusion criteria were age ≥18 years, maximum number of 3 type 0 or 1 fibroids, maximum fibroid diameter 3.5 cm, American Society of Anesthesiologists class 1 or 2, and having sufficient knowledge of the Dutch or English language. Women with clotting disorders or with severe anemia (Hb < 5.0 mmol/L) were excluded. Women were randomized using block randomization with variable block sizes of 2, 4, and 6, between hysteroscopic myomectomy under procedural sedation and analgesia (PSA) with propofol or under general anesthesia (GA). Primary outcome was the percentage of complete resections, assessed on transvaginal ultrasonography 6 weeks postoperatively by a sonographer blinded for the treatment arm and surgical outcome. Secondary outcomes were the surgeon's judgment of completeness of procedure, menstrual blood loss, uterine fibroid related and general quality of life, pain, recovery, hospitalization, complications, and surgical reinterventions. Follow-up period was 1 year. The risk difference between both treatment arms was estimated, and a Farrington-Manning test was used to determine the p-value for noninferiority (noninferiority margin 7.5% of incomplete resections). Data were analyzed according to the intention-to-treat principle, including a per-protocol analysis for the primary outcome. A total of 209 women participated in the study and underwent hysteroscopic myomectomy with PSA (n = 106) or GA (n = 103). Mean age was 45.1 [SD 6.4] years in the PSA group versus 45.0 [7.7] years in the GA group. For 98/106 women in the PSA group and 89/103 women in the GA group, data were available for analysis of the primary outcome. Hysteroscopic resection was complete in 86/98 women (87.8%) in the PSA group and 79/89 women (88.8%) in the GA group (risk difference -1.01%; 95% confidence interval (CI) -10.36 to 8.34; noninferiority, P = 0.09). No serious anesthesiologic complications occurred, and conversion from PSA to GA was not required. During the follow-up period, 15 serious adverse events occurred (overnight admissions). All were unrelated to the intervention studied. Main limitations were the choice of primary outcome and the fact that our study proved to be underpowered.; Conclusions: Noninferiority of PSA for completeness of resection was not shown, though there were no significant differences in clinical outcomes and quality of life. In this study, hysteroscopic myomectomy for type 0 and 1 fibroids with PSA compared to GA was safe and led to shorter hospitalization. These results can be used for counseling patients by gynecologists and anesthesiologists. Based on these findings, we suggest that hysteroscopic myomectomies can be performed under PSA in an outpatient setting.; Trial Registration: The study was registered prospectively in the Dutch Trial Register (NTR 5357; registration date: 11 August 2015; Date of initial participant enrollment: 18 February 2016).; Competing Interests: No support from any organization for the submitted work was received, apart from the grant that was received from The Dutch organisation for Health Research and Development (ZonMW), as described in our funding statement; HvV received fees from Medtronic on an hourly basis for consultancy and lecturing on hysteroscopic morcellation. All the fees were donate to a foundation which promotes research in obstetrics and gynecology. NS received fees from Applied Medical for vNOTES courses and proctorship. These industries were not involved in the design, performance, analysis of this study nor the content or approval of this manuscript. All other authors report no financial relationships with any organizations that might have an interest in the submitted work in the previous three years; SC is a board member of the Dutch gynaecologic endoscopy working party ‘Werkgroep gynaecologische endoscopie’. All other authors report no other relationships or activities that could appear to have influenced the submitted work. (Copyright: © 2023 van der Meulen 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.)

van der Schans, E. M., et al. (2022). "Mesh-related complications and recurrence after ventral mesh rectopexy with synthetic versus biologic mesh: a systematic review and meta-analysis." Techniques in Coloproctology 26(2): 85-98.
	Background: Ventral mesh rectopexy (VMR) is a widely accepted surgical treatment for rectal prolapse. Both synthetic and biologic mesh are used. No consensus exists on the preferred type of mesh material. The aim of this systematic review and meta-analysis was to establish an overview of the current literature on mesh-related complications and recurrence after VMR with synthetic or biologic mesh to aid evidence-based decision making in preferred mesh material.; Methods: A systematic search of the electronic databases of PubMed, Embase and Cochrane was performed (from inception until September 2020). Studies evaluating patients who underwent VMR with synthetic or biologic mesh were eligible. The MINORS score was used for quality assessment.; Results: Thirty-two studies were eligible after qualitative assessment. Eleven studies reported on mesh-related complications including 4001 patients treated with synthetic mesh and 762 treated with biologic mesh. The incidence of mesh-related complications ranged between 0 and 2.4% after synthetic versus 0-0.7% after biologic VMR. Synthetic mesh studies showed a pooled incidence of mesh-related complications of 1.0% (95% CI 0.5-1.7). Data of biologic mesh studies could not be pooled. Twenty-nine studies reported on the risk of recurrence in 2371 synthetic mesh patients and 602 biologic mesh patients. The risk of recurrence varied between 1.1 and 18.8% for synthetic VMR versus 0-15.4% for biologic VMR. Cumulative incidence of recurrence was found to be 6.1% (95% CI 4.3-8.1) and 5.8% (95% CI 2.9-9.6), respectively. The clinical and statistical heterogeneity was high.; Conclusions: No definitive conclusions on preferred mesh type can be made due to the quality of the included studies with high heterogeneity amongst them. (© 2021. The Author(s).)

van der Vaart Lisa, R., et al. (2022). "Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse: A Randomized Clinical Trial." JAMA 328(23): 2312-2323.
	Importance: Pelvic organ prolapse is a prevalent condition among women that negatively affects their quality of life. With increasing life expectancy, the global need for cost-effective care for women with pelvic organ prolapse will continue to increase.; Objective: To investigate whether treatment with a pessary is noninferior to surgery among patients with symptomatic pelvic organ prolapse.; Design, Setting, and Participants: The PEOPLE project was a noninferiority randomized clinical trial conducted in 21 participating hospitals in the Netherlands. A total of 1605 women with symptomatic stage 2 or greater pelvic organ prolapse were requested to participate between March 2015 through November 2019; 440 gave informed consent. Final 24-month follow-up ended at June 30, 2022.; Interventions: Two hundred eighteen participants were randomized to receive pessary treatment and 222 to surgery.; Main Outcomes and Measures: The primary outcome was subjective patient-reported improvement at 24 months, measured with the Patient Global Impression of Improvement scale, a 7-point Likert scale ranging from very much better to very much worse. This scale was dichotomized as successful, defined as much better or very much better, vs nonsuccessful treatment. The noninferiority margin was set at 10 percentage points risk difference. Data of crossover between therapies and adverse events were captured.; Results: Among 440 patients who were randomized (mean [SD] age, 64.7 [9.29] years), 173 (79.3%) in the pessary group and 162 (73.3%) in the surgery group completed the trial at 24 months. In the population, analyzed as randomized, subjective improvement was reported by 132 of 173 (76.3%) in the pessary group vs 132 of 162 (81.5%) in the surgery group (risk difference, -6.1% [1-sided 95% CI, -12.7 to ∞]; P value for noninferiority, .16). The per-protocol analysis showed a similar result for subjective improvement with 52 of 74 (70.3%) in the pessary group vs 125 of 150 (83.3%) in the surgery group (risk difference, -13.1% [1-sided 95% CI, -23.0 to ∞]; P value for noninferiority, .69). Crossover from pessary to surgery occurred among 118 of 218 (54.1%) participants. The most common adverse event among pessary users was discomfort (42.7%) vs urinary tract infection (9%) following surgery.; Conclusions and Relevance: Among patients with symptomatic pelvic organ prolapse, an initial strategy of pessary therapy, compared with surgery, did not meet criteria for noninferiority with regard to patient-reported improvement at 24 months. Interpretation is limited by loss to follow-up and the large amount of participant crossover from pessary therapy to surgery.; Trial Registration: Netherlands Trial Register Identifier: NTR4883.

van Driel, C. M., et al. (2019). "Mindfulness, cognitive behavioural and behaviour-based therapy for natural and treatment-induced menopausal symptoms: a systematic review and meta-analysis." BJOG 126(3): 330-339.
	Background: During menopause women experience vasomotor and psychosexual symptoms that cannot entirely be alleviated with hormone replacement therapy (HRT). Besides, HRT is contraindicated after breast cancer.; Objectives: To review the evidence on the effectiveness of psychological interventions in reducing symptoms associated with menopause in natural or treatment-induced menopausal women.; Search Strategy: Medline/Pubmed, PsycINFO, EMBASE and AMED were searched until June 2017.; Selection Criteria: Randomised controlled trials (RCTs) concerning natural or treatment-induced menopause, investigating mindfulness or (cognitive-)behaviour-based therapy were selected. Main outcomes were frequency of hot flushes, hot flush bother experienced, other menopausal symptoms and sexual functioning.; Data Collection and Analysis: Study selection and data extraction were performed by two independent researchers. A meta-analysis was performed to calculate the standardised mean difference (SMD).; Main Results: Twelve RCTs were included. Short-term (<20 weeks) effects of psychological interventions in comparison to no treatment or control were observed for hot flush bother (SMD -0.54, 95% CI -0.74 to -0.35, P < 0.001, I 2 = 18%) and menopausal symptoms (SMD -0.34, 95% CI -0.52 to -0.15, P < 0.001, I 2 = 0%). Medium-term (≥20 weeks) effects were observed for hot flush bother (SMD -0.38, 95% CI -0.58 to -0.18, P < 0.001, I 2 = 16%). [Correction added on 9 July 2018, after first online publication: there were miscalculations of the mean end point scores for hot flush bother and these have been corrected in the preceding two sentences.] In the subgroup treatment-induced menopause, consisting of exclusively breast cancer populations, as well as in the subgroup natural menopause, hot flush bother was reduced by psychological interventions. Too few studies reported on sexual functioning to perform a meta-analysis.; Conclusions: Psychological interventions reduced hot flush bother in the short and medium-term and menopausal symptoms in the short-term. These results are especially relevant for breast cancer survivors in whom HRT is contraindicated. There was a lack of studies reporting on the influence on sexual functioning.; Tweetable Abstract: Systematic review: psychological interventions reduce bother by hot flushes in the short- and medium-term. (© 2018 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.)

van Eekelen, R., et al. (2020). "Cost-effectiveness of medically assisted reproduction or expectant management for unexplained subfertility: When to start treatment?" Human Reproduction 35(9): 2037-2046.
	STUDY QUESTION: Over a time period of 3 years, which order of expectant management (EM), IUI with ovarian stimulation (IUI-OS) and IVF is the most cost-effective for couples with unexplained subfertility with the female age below 38 years? SUMMARY ANSWER: If a live birth is considered worth e32 000 or less, 2 years of EM followed by IVF was the most cost-effective, whereas above e32 000 this was 1 year of EM, 1 year of IUI-OS and then 1 year of IVF. WHAT IS KNOWN ALREADY: IUI-OS and IVF are commonly used fertility treatments for unexplained subfertility although many couples can conceive naturally, as no identifiable barrier to conception could be found by definition. Few countries have guidelines on when to proceed with medically assisted reproduction (MAR), mostly based on the expected probability of live birth after treatment, but there is a lack of evidence to support the strategies proposed by these guidelines. The increased uptake of IUI-OS and IVF over the past decades and costs related to reimbursement of these treatments are pressing concerns to health service providers. For MAR to remain affordable, sustainable and a responsible use of public funds, guidance is needed on the cost-effectiveness of treatment strategies for unexplained subfertility, including EM. STUDY DESIGN, SIZE, DURATION: We developed a decision analytic Markov model that follows couples with unexplained subfertility of which the woman is under 38 years of age for a time period of 3 years from completion of the fertility workup onwards. We divided the time axis of 3 years into three separate periods, each comprising 1 year. The model was based on contemporary evidence, most notably the dynamic prediction model for natural conception, which was combined with MAR treatment effects from a network meta-analysis on randomized controlled trials. We changed the order of options for managing unexplained subfertility for the 1 year periods to yield five different treatment policies in total: IVF-EM-EM (immediate IVF), EM-IVF-EM (delayed IVF), EM-EM-IVF (postponed IVF), IUIOS-IVF-EM (immediate IUI-OS) and EM-IUIOS-IVF (delayed IUI-OS). PARTICIPANTS/MATERIALS, SETTING, METHODS: The main outcomes per policy over the 3-year period were the probability of live birth, the average treatment and delivery costs, the probability of multiple pregnancy, the incremental cost-effectiveness ratio (ICER) and finally, which policy yields the highest net benefit in which costs for a policy were deducted from the health effects, i.e. live births gained. We chose the Dutch societal perspective, but the model can be easily modified for other locations or other perspectives. The probability of live birth after EM was taken from the dynamic prediction model for natural conception and updated for Years 2 and 3. The relative effects of IUI-OS and IVF in terms of odds ratios, taken from the network meta-analysis, were applied to the probability of live birth after EM. We applied standard discounting procedures for economic analyses for Years 2 and 3. The uncertainty around effectiveness, costs and other parameters was assessed by probabilistic sensitivity analysis in which we drew values from distributions and repeated this procedure 20 000 times. In addition, we changed model assumptions to assess their influence on our results. MAIN RESULTS AND THE ROLE OF CHANCE: From IVF-EM-EM to EM-IUIOS-IVF, the probability of live birth varied from approximately 54-64% and the average costs from approximately e4000 to e9000. The policies IVF-EM-EM and EM-IVF-EM were dominated by EM-EM-IVF as the latter yielded a higher cumulative probability of live birth at a lower cost. The policy IUIOS-IVF-EM was dominated by EM-IUIOS-IVF as the latter yielded a higher cumulative probability of live birth at a lower cost. After removal of policies that were dominated, the ICER for EM-IUIOS-IVF was approximately e31 000 compared to EM-EM-IVF. The range of ICER values between the lowest 25% and highest 75% of simulation replications was broad. The net benefit curve showed that when we assume a liv birth to be worth approximately e20 000 or less, the policy EM-EM-IVF had the highest probability to achieve the highest net benefit. Between e20 000 and e50 000 monetary value per live birth, it was uncertain whether EM-EM-IVF was better than EM-IUIOS-IVF, with the turning point of e32 000. When we assume a monetary value per live birth over e50 000, the policy with the highest probability to achieve the highest net benefit was EM-IUIOS-IVF. Results for subgroups with different baseline prognoses showed the same policies dominated and the same two policies that were the most likely to achieve the highest net benefit but at different threshold values for the assumed monetary value per live birth. LIMITATIONS, REASONS FOR CAUTION: Our model focused on population level and was thus based on average costs for the average number of cycles conducted. We also based the model on a number of key assumptions. We changed model assumptions to assess the influence of these assumptions on our results. The change in relative effectiveness of IVF over time was found to be highly influential on results and their interpretation. WIDER IMPLICATIONS OF THE FINDINGS: EM-EM-IVF and EM-IUIOS-IVF followed by IVF were the most cost-effective policies. The choice depends on the monetary value assigned to a live birth. The results of our study can be used in discussions between clinicians, couples and policy makers to decide on a sustainable treatment protocol based on the probability of live birth, the costs and the limitations of MAR treatment.Copyright © The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

van Eekelen, R., et al. (2021). "Cost-effectiveness of ovarian stimulation agents for IUI in couples with unexplained subfertility." Human Reproduction 36(5): 1288-1295.
	STUDY QUESTION: Which agent for ovarian stimulation (OS) is the most cost-effective option in terms of net benefit for couples with unexplained subfertility undergoing IUI? SUMMARY ANSWER: In settings where a live birth is valued at e3000 or less, between e3000 and e55 000 and above e55 000, clomiphene citrate (CC), Letrozole and gonadotrophins were the most cost-effective option in terms of net benefit, respectively. WHAT IS KNOWN ALREADY: IUI-OS is a common first-line treatment for couples with unexplained subfertility and its increased uptake over the past decades and related personal or reimbursed costs are pressing concerns to patients and health service providers. However, there is no consensus on a protocol for conducting IUI-OS, with differences between countries, clinics and settings in the number of cycles, success rates, the agent for OS and the maximum number of dominant follicles in order to minimise the risk of a multiple pregnancy. In view of this uncertainty and the association with costs, guidance is needed on the cost-effectiveness of OS agents for IUI-OS. STUDY DESIGN, SIZE, DURATION: We developed a decision-analytic model based on a decision tree that follows couples with unexplained subfertility from the start of IUI-OS to a protocoled maximum of six cycles, assuming couples receive four cycles on average within one year. We chose the societal perspective, which coincides with other perspectives such as that from health care providers, as the treatments are identical except for the stimulation agent. We based our model on parameters from a network meta-analysis of randomised controlled trials for IUI-OS. We compared the following three agents: CC (oral medication), Letrozole (oral medication) and gonadotrophins (subcutaneous injection). PARTICIPANTS/MATERIALS, SETTING, METHODS: The main health outcomes were cumulative live birth and multiple pregnancy. As the procedures are identical except for the agent used, we only considered direct medical costs of the agent during four cycles. The main cost-effectiveness measures were the differences in costs divided by the differences in cumulative live birth (incremental cost-effectiveness ratio, ICER) and the probability of the highest net monetary benefit in which costs for an agent were deducted from the live births gained. The live birth rate for IUI using CC was taken from trials adhering to strict cancellation criteria included in a network meta-analysis and extrapolated to four cycles. We took the relative risks for the live birth rate after Letrozole and gonadotrophins versus CC from that same network meta-analysis to estimate the remaining absolute live birth rates. The uncertainty around live birth rates, relative effectiveness and costs was assessed by probabilistic sensitivity analysis in which we drew values from distributions and repeated this procedure 20 000 times. In addition, we changed model assumptions to assess their influence on our results. MAIN RESULTS AND THE ROLE OF CHANCE: The agent with the lowest cumulative live birth rate over 4 IUI-OS cycles conducted within one year was CC (29.4%), followed by Letrozole (32.0%) and gonadotrophins (34.5%). The average costs per four cycles were e362, e434 and e1809, respectively. The ICER of Letrozole versus CC was e2809 per additional live birth, whereas the ICER of gonadotrophins versus Letrozole was e53 831 per additional live birth. When we assume a live birth is valued at e3000 or less, CC had the highest probability of maximally 65% to achieve the highest net benefit. Between e3000 and e55 000, Letrozole had the highest probability of maximally 62% to achieve the highest net benefit. Assuming a monetary value of e55 000 or more, gonadotrophins had the highest probability of maximally 56% to achieve the highest net benefit.Copyright © The Author(s) 2021. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.

van Erp, N. (2021). "A lower dose olaparib (Lynparza®), combined with a drug which inhibits olaparib degradation, to increase tolerability and decrease the price of the treatment with olaparib." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Trade Name: Tybost Pharmaceutical Form: Tablet INN or Proposed INN: Cobicistat CAS Number: 1004316‐88‐4 Current Sponsor code: cobicistat Other descriptive name: COBICISTAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Trade Name: Lynparza Pharmaceutical Form: Tablet INN or Proposed INN: Olaparib CAS Number: 763113‐22‐0 Current Sponsor code: olaparib Other descriptive name: OLAPARIB Concentration unit: mg milligram(s) Concentration type: range Concentration number: 100‐150 Trade Name: Lynparza Pharmaceutical Form: Tablet INN or Proposed INN: Olaparib CAS Number: 763113‐22‐0 Current Sponsor code: olaparib Other descriptive name: OLAPARIB Concentration unit: mg milligram(s) Concentration type: range Concentration number: 100‐150 CONDITION: Ovarian 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] SECONDARY OUTCOME: Secondary end point(s): Part A – proof of concept; 1. Inter‐ and intrapatient variability in olaparib pharmacokinetics with and without cobicistat is calculated using non‐compartmental analysis of PK data;; 2. Adverse events and laboratory safety will be monitored and scored according to the CTCAEv5.0 to describe the safety of boosted olaparib treatment.; ; Part B – clinical evaluation; 1. Health status and satisfaction of patients will be monitored with the CTSQ and EQ‐5D‐5L questionnaires;; 2. ctDNA will be determined from plasma samples;; 3. Adverse events and laboratory safety will be monitored and scored according to the CTCAEv5.0 to describe the safety of boosted olaparib treatment;; 4. Costs for the cost‐effectiveness analysis will be assessed by the iMTA Productivity Cost Quetstionnaire (iPCQ) and iMTA Medical Consumption Questionnaires (iMCQ). Health status will be monitored with the EQ‐5D‐5L questionnaire. ; Timepoint(s) of evaluation of this end point: Part A ‐ proof of concept:; 1. Analysis of olaparib in plasma will be analyzed after data collection.; 2. Safety assessment on every study visit; ; Part B ‐ clinical evaluation; 1. Will be measured at baseline and after 4, 8, 12 weeks of therapy and every 6 months untill progression. ; 2. Plasma samples will be taken at baseline and after 4, 8 and 12 weeks of therapy. ; 3. Safety assessment on every study visit. ; 4. Cost questionnaires on baseline, after 4, 8, 12 weeks of therapy and every 6 months untill progression. PRIMARY OUTCOME: Main Objective: Part A – proof‐of‐concept:; 1. To determine the equivalence of the Area‐Under‐the‐Curve (AUC) of the reduced, boosted dose of olaparib and the regular dose.; Part B – clinical evaluation:; 1. To determine if efficacy by progression‐free survival (PFS) in patients with high grade ovarian cancer receiving olaparib maintenance therapy who are in response following completion of first‐line platinum‐based chemotherapy, treated with the lower equivalent boosted dose of olaparib is non‐inferior to patients treated with the regular dose of olaparib; ; 2. To determine if tolerance by dose reductions due to toxicity in patients treated with the lower equivalent boosted dose of olaparib is non‐inferior to patients treated with the regular dose of olaparib.; Primary end point(s): Part A – proof of concept; 1. AUC0‐12h for the regular and boosted olaparib will be determined using non‐compartmental analysis for the primary objective. Hereto, multiple PK samples will be collected after one week of each treatment regimen at the following times: pre‐dose, ½, 1, 1½, 2, 3, 4, 6, 8 hours after olaparib intake. If possible, additional PK samples will be taken after 10 and 12 hours. ; ; Part B – clinical evaluation; 1. Progression‐free survival (PFS) is defined as the time from randomization until the date of either objective radiological disease progression or biochemical progression combined with clini l progression or death;; o Objective radiological disease progression will be assessed according to RECIST version 1.1;; o Biochemical disease progression will be assessed with serum CA‐125 according to the GCIG criteria;; o Clinical progression will be assessed by treating physician;; 2. The number of patients who require a dose reduction due to toxicity will be registered. ; Secondary Objective: Part A ‐ proof‐of‐concept:; 1. To determine whether boosting reduces the inter‐ and intrapatient PK variability of olaparib;; 2. To describe the safety of boosted olaparib.; Part B ‐ clinical evaluation: ; 1. To investigate whether health status, tolerance and satisfaction of patients treated with the boosted low dose olaparib is comparable to patients treated with the regular dose of olaparib;; 2. To evaluate whether treatment response of boosted versus regular olaparib can be determined with cell‐free tumor nucleic acids (ctDNA) as pharmacodynamic biomarker;; 3. To describe toxicity of the lower equivalent boosted dose of olaparib compared to the regular dose of olaparib;; 4. To compare cost‐effectiveness of the lower equivalent boosted dose of olaparib compared to the regular dose of olaparib. ; Timepoint(s) of evaluation of this end point: Part A – proof of concept; PK assessment will be performed after one week of treatment.; ; Part B ‐ clinical evaluation; PFS and dose reductions will be followed up untill progression on every visit. Hereto, visits will be at baseline, after 4, 8, 12 weeks of therapy and every 3 months thereafter. ; ; ; INCLUSION CRITERIA: Part A – proof of concept • Subjects who start or are on treatment with olaparib tablets 300mg BID, according to the drug label and physician’s discretion; • Subjects who are able and willing to provide written informed consent prior to screening; • Age of 18 years or older; • Able to measure the outcome of the study in this subject (e.g. patient availability; willing and being able to undergo repeated plasma sample collection); • Eastern Cooperative Oncology Group (ECOG) performance status of 0‐1. Part B – clinical evaluation • Subjects who start on treatment with olaparib tablets 300mg BID, according to the drug label and physician’s discretion; • Subjects who are able and willing to provide written informed consent prior to screening; • Age of 18 years or older; • Able to measure the outcome of the study in this subject (e.g. patient availability; willing and being able to undergo sample collection for PK and PD purposes);<br

van Hoesel Maaike, H., et al. (2021). "Selective oestrogen receptor modulators (SERMs) for endometriosis." The Cochrane Database of Systematic Reviews 5: CD011169.
	Background: Endometriosis is defined as the presence of endometrial tissue outside the uterine cavity. This chronic and recurring condition occurs in women of reproductive age. It is a common cause of pain or infertility and can cause non-specific symptoms such as lower back pain, dyspareunia (pain during or after intercourse), and dysmenorrhoea (menstrual pain). Endometriosis is an oestrogen-dependent disease. Medical treatment aims to relieve symptoms and shrink lesions by suppressing the normal menstrual cycle. In this review, we consider medication specifically aiming to modulate oestrogen receptors as an alternative method of treatment.; Objectives: To evaluate the effectiveness and safety of selective oestrogen receptor modulators (SERMs) in the management of endometriosis.; Search Methods: We searched for trials in the following databases (from their inception to 28 May 2020): Cochrane Gynaecology and Fertility Group Specialised Register, Cochrane Central Register of Studies (CRS Online), MEDLINE, Embase, CINAHL, PsycINFO, and registers of ongoing trials. In addition, we searched all reference lists of included trials, and we contacted experts in the field, in an attempt to locate trials.; Selection Criteria: We included randomised controlled trials (RCTs) comparing selective oestrogen receptor modulators (SERMs) with placebo, no treatment, other medical treatment, or surgery for endometriosis.; Data Collection and Analysis: We used standard methodological procedures recommended by Cochrane. Two review authors independently selected trials for inclusion, assessed risk of bias, and extracted data using data extraction forms. We used risk ratios (RRs) with 95% confidence intervals (CIs) for reporting dichotomous data. Primary review outcomes were relief of pelvic pain and adverse events. Secondary outcomes included quality of life, recurrence rate, and economic and fertility outcomes.; Main Results: We included only one RCT, which included 93 women, comparing the SERM raloxifene with placebo in biopsy-proven endometriosis. All women first underwent complete surgical excision of all lesions. Evidence was of very low quality: the main limitation was imprecision - with very sparse data from only one small study, which included only women after surgical treatment. Relief of pelvic pain The included study did not specifically measure the primary outcome of pain relief. Study authors reported that time to return of pelvic pain (defined as two months of pain equal to or more severe than pain at study entry) was more rapid in the raloxifene group (P = 0.03). Adverse events The included study reported adverse events such as pelvic pain, ovarian cyst, headache, migraine, and depression. We are uncertain whether raloxifene improves the incidence of pelvic pain (RR 1.25, 95% CI 0.63 to 2.45), ovarian cysts (RR 1.57, 95% CI 0.55 to 4.43), headache (RR 1.09, 95% CI 0.49 to 2.43), migraine (RR 0.73, 95% CI 0.28 to 1.95), depression (RR 1.96, 95% CI 0.63 to 6.06), or other adverse events (RR 0.08, 95% CI 0.00 to 1.30) (all: 1 study, n = 93; very low-quality evidence). Quality of life The study described a statistically significant difference in mental health quality of life (QoL) by 12 months, in favour of placebo treatment (mean difference 11.1, 95% CI 0.01 to 21.19). Other QoL data did not differ between groups but were not reported in detail. Recurrence rate, fertility, and economic outcomes We are uncertain whether raloxifene improves the recurrence rate of endometriosis, proven by biopsy, when compared to placebo (RR 1.20, 95% CI 0.66 to 2.21; 1 study, n = 93; very low-quality evidence). This suggests that if 28% of women taking placebo have biopsy-proven recurrence of endometriosis, between 19% and 62% of those taking raloxifene will do so. These outcomes are prone to bias, as not all women had an actual second laparoscopy. Recurrence based on symptoms (non-menstrual pain, dysmenorrhoea, or dyspareunia) was described; in these cases, symptoms improved after use of raloxifene as well as after use of placebo. The i cluded study did not report data on economic outcomes. No comparative data were available on pregnancy, as the study included only women who agreed to postpone pregnancy until after the study endpoint; the few pregnancies that did occur were uneventful but were regarded as an adverse event. AUTHORS' CONCLUSIONS: Based on a single, small RCT and incomplete data, we are uncertain of the effects of SERMs on pain relief in surgically treated patients with endometriosis. The included study was stopped prematurely because of higher pain scores among women who took SERMs when compared to scores among those receiving placebo. Further research is needed to fully evaluate the role of SERMs in endometriosis. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

van Hoogenhuijze, N. E., et al. (2019). "Endometrial scratching prior to IVF; does it help and for whom? A systematic review and meta-analysis." Human Reproduction Open 2019(1): hoy025.
	Study Question: What is the effect of endometrial scratching in patients with or without prior failed ART cycles on live birth (LBR) and clinical pregnancy rates (CPR)?; Summary Answer: It remains unclear if endometrial scratching improves the chance of pregnancy and, if so, for whom.; What Is Known Already: Endometrial scratching is hypothesized to improve embryo implantation in ART. Multiple studies have been published, but it remains unclear if endometrial scratching actually improves pregnancy rates and, if so, for which patients.; Study Design Size Duration: For this review, a systematic search for published articles on endometrial scratching and ART was performed on 12 February 2018, in Pubmed, Embase and the Cochrane Library.; Participants/materials Setting Methods: Randomized controlled trials (RCTs) that evaluated endometrial scratching in the cycle prior to the stimulation cycle and reported CPR or LBR were included. RCTs investigating the effect of scratching during the stimulation cycle, or prior to cryo-thaw cycles were excluded. Studies were assessed using the Cochrane Risk of Bias tool. The effect of scratching was assessed for three different patient groups: patients with no prior IVF/ICSI treatment (Group 0), patients with one failed full IVF/ICSI cycle, including cryo-thaw cycles (Group 1) and patients with two or more failed full IVF/ICSI cycles (Group 2). A meta-analysis was performed when statistical heterogeneity was low; otherwise, a descriptive analysis was performed.; Main Results and the Role of Chance: Fourteen RCTs involving 2537 participants were included. Most RCTs contained a high or unclear risk of bias on one or more items. Substantial clinical and statistical heterogeneity was present; therefore meta-analysis for LBR and CPR could only be performed on Group 1. For this group, no differences between scratch and control were found for both LBR (risk ratio (RR) 1.01 [95%CI 0.68-1.51]) and CPR (RR 1.04 [95%CI 0.74-1.45]). For Groups 0 and 2, pooled analysis could not be performed, and for both groups the results of the individual RCTs were negative, neutral and positive. Miscarriage and multiple pregnancy rates were evaluated for the three groups (0, 1 and 2) together. Both outcomes were not significantly different between scratch and control (miscarriage rate RR 0.82 [95%CI 0.57-1.17] and multiple pregnancy rate RR 1.06 [95%CI 0.84-1.35]). Subgroup analysis, excluding trials with a risk of unintentional endometrial injury in the control group, was performed for Group 0 and 2 for LBR and CPR, and for the overall groups for miscarriage rate and multiple pregnancy rate. This reduced the heterogeneity and allowed for pooled analysis in these subgroups. Results of pooled analysis for the subgroups of Group 0 and 2 showed no significant difference for LBR, but CPR was significantly improved after endometrial scratching (Group 0 RR 1.28 [95%CI 1.02-1.62] and Group 2 RR 2.03 [95%CI 1.20-3.43]). Subgroup analysis of the overall groups showed no significant difference for miscarriage and multiple pregnancy rate.; Limitations Reasons for Caution: The main limitations were that many RCTs had a high or unclear risk of bias on one or several items, clinical heterogeneity was still present despite categorizing into three populations, and that not all RCTs could be included in the analyses because separate data for our three groups could not be provided.; Wider Implications of the Findings: It remains unclear if endometrial scratching improves the chance of pregnancy for women undergoing ART and, if so, for whom. This means endometrial scratching should not be offered in daily practice until results from large and well-designed RCTs and an individual patient data analysis become available.; Study Funding/competing Interests: No specific funding was sought for the study. The Department of Reproductive Medicine and Gynaecology funds of the University Medical Center of Utrecht were used to support the authors throughout the study period and preparation of the manuscript. None of the authors has a confli t of interest to declare.; Registration Number: Not applicable.

Van Horne Bethanie, S., et al. (2022). "A promising new model of care for postpartum depression: A randomised controlled trial of a brief home visitation program conducted in Houston, Texas, USA." Health & Social Care in the Community 30(5): e2203-e2213.
	Postpartum depression (PPD), a perinatal mood and anxiety disorder (PMAD), is a leading cause of complications of pregnancy and childbirth. In the United States, approximately 20 percent of women suffer from PMADs. In Houston, Texas, an estimation of 12,000 - 15,000 women experience PPD each year. Within the Texas Children's Paediatrics network, a large paediatric network located in Houston, Texas, mothers are screened during paediatric well-child visits and those screening positive receive a referral to a psychiatrist with the network. However, there are not enough psychiatrists to meet the demand of services and Black, Latina, and women on Medicaid during pregnancy are less likely to attend a psychiatric visit compared to White, non-Hispanic women. This study used a randomised control trial design to measure the effectiveness of an alternative treatment option for a racially diverse population of postpartum women with mild to moderate symptoms of PPD, a five-session home visitation program using the Problem-Solving Tools for PPD (PST4PPD) model delivered by master's level social workers. The control group was allocated to standard treatment with a psychiatrist. A total of 118 women gave consent and were randomised, 72 to home visiting and 46 to psychiatry. Results demonstrated that all participating mothers had significant decreases in PPD symptoms. The change in PPD symptoms among those in the home visitation program was not significantly different from the change in the control condition, indicating that the home visitation program was as effective as psychiatric treatment in significantly reducing PPD symptoms. Additionally, a high proportion of women in the home visitation program completed visits and demonstrated increased maternal self-efficacy. Based on these results, a short-term home visitation program by a social worker (PST4PPD) appears to be a promising treatment option for postpartum women with mild to moderate PPD symptoms. (© 2021 John Wiley & Sons Ltd.)

Van Lieshout, R. (2022). "CBT for Postpartum Depression and Infant Emotion Regulation." ClinicalTrials.gov.
	No Results Available Behavioral: Group Cognitive Behavioural Therapy (CBT) Infant Temperament|Infant emotion regulation|Maternal Depression|Maternal Anxiety|Brain-to-brain Synchrony (fNIRS)|The Face-to-Face Stillage Paradigm (FFSP)|Parent-Child Early Relational Assessment (PCERA)|Epigenetic Analyses Female Not Applicable 172 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Investigator)|Primary Purpose: Treatment PIER CBT December 31, 2025

Van Lieshout, R. J., et al. (2021). "Effect of Online 1-Day Cognitive Behavioral Therapy-Based Workshops Plus Usual Care vs Usual Care Alone for Postpartum Depression: A Randomized Clinical Trial." JAMA Psychiatry 78(11): 1200-1207.
	IMPORTANCE: Postpartum depression (PPD) affects as many as 20% of mothers, yet just 1 in 10 of these women receives evidence-based treatment. The COVID-19 pandemic has increased PPD risk, reduced treatment access, and shifted preferences toward virtual care. OBJECTIVE: To determine whether an online 1-day cognitive behavioral therapy (CBT)-based workshop added to treatment as usual improves PPD, anxiety, social support, mother-infant relationship quality, and infant temperament more than treatment as usual alone. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial included 403 women with PPD who were recruited across Ontario, Canada, during the COVID-19 pandemic (April 20 to October 4, 2020). Women with Edinburgh Postnatal Depression Scale (EPDS) scores of at least 10 who were 18 years or older and had an infant younger than 12 months were eligible. INTERVENTIONS: Women were randomly assigned to receive a live, interactive online 1-day CBT-based workshop delivered by a registered psychotherapist, psychiatrist, or clinical psychology graduate student in addition to treatment as usual (n = 202) or to receive treatment as usual and wait-listed to receive the workshop 12 weeks later (n = 201). MAIN OUTCOMES AND MEASURES: The primary outcome was change in PPD (EPDS scores) in experimental and wait list control groups 12 weeks after baseline. Secondary outcomes included maternal anxiety (7-item Generalized Anxiety Disorder Questionnaire [GAD-7]), social support (Social Provisions Scale), quality of the mother-infant relationship (Postpartum Bonding Questionnaire), and infant temperament (Infant Behavior Questionnaire-Revised Very Short Form). RESULTS: Participants all identified as women with a mean (SD) age of 31.8 (4.4) years. The workshop led to significant mean (SD) reductions in EPDS scores (from 16.47 [4.41] to 11.65 [4.83]; B = -4.82; P < .001) and was associated with a higher odds of exhibiting a clinically significant decrease in EPDS scores (odds ratio, 4.15; 95% CI, 2.66-6.46). The mean (SD) GAD-7 scores decreased from 12.41 (5.12) to 7.97 (5.54) after the workshop (B = -4.44; 95% CI, -5.47 to -3.38; P < .001) and participants were more likely to experience a clinically significant change (odds ratio, 3.09; 95% CI, 1.99-4.81). Mothers also reported improvements in bonding (B = -3.22; 95% CI, -4.72 to -1.71; P < .001), infant-focused anxiety (B = -1.64; 95% CI, -2.25 to 1.00; P < .001), social support (B = 3.31; 95% CI, 1.04 to 5.57; P < .001), and positive affectivity/surgency in infants (B = 0.31; 95% CI, 0.05 to 0.56; P < .001). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, an online 1-day CBT-based workshop for PPD provides an effective, brief option for mothers, reducing PPD and anxiety as well as improving social support, the mother-infant relationship, and positive affectivity/surgency in offspring. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04485000.

Van Lieshout Ryan, J., et al. (2022). "Public Health Nurse-delivered Group Cognitive Behavioural Therapy for Postpartum Depression: A Randomized Controlled Trial." Canadian Journal of Psychiatry 67(6): 432-440.
	Objectives: To examine the effectiveness of group cognitive behavioural therapy (CBT) for postpartum depression (PPD) delivered by public health nurses with little to no previous psychiatric training at improving depression, worry, social support and the mother-infant relationship.; Methods: Mothers (n = 141) living in Ontario, Canada with Edinburgh Postnatal Depression Scale Scores ≥10 and an infant <12 months of age were randomized to receive nine weekly 2-h sessions of in-person group CBT for PPD delivered by two public health nurses plus treatment as usual (TAU; experimental group) or TAU alone (control group). Primary outcomes were change in EPDS score and current major depressive disorder (Mini International Neuropsychiatric Interview) assessed immediately post-treatment (T2). Secondary outcomes included maternal worry, social support, and quality of the mother-infant relationship. All outcomes were assessed again six months post-treatment (T3).; Results: Participants in the experimental group had statistically significantly greater reductions in PPD symptoms immediately post-treatment (T2) (B = -5.35, p < 0.01), were more likely to manifest a clinically significant improvement in EPDS scores (≥4 points; OR = 3.44, 95%CI: 1.49-7.94), and no longer have symptoms consistent with current MDD (OR = 5.31, 95% CI: 1.78-15.83). Six months post-treatment (T3), experimental group participants had higher odds of clinically significant PPD improvement (OR = 5.10, 95%CI: 1.89-13.78), while 25% of the experimental group and 70% of remaining control group participants reported current MDD ( p < 0.01). Statistically significant improvements in worry and the mother-infant relationship were also observed, decreases maintained at six months post-treatment.; Conclusions: Public health nurses with little to no previous psychiatric training can be trained to deliver effective group CBT for PPD to improve depression, worry, and the mother-infant relationship. Task shifting PPD treatment with group CBT to public health nurses could improve treatment uptake and lead to better outcomes for mothers, families, and the healthcare system.(Trial Registration NCT03039530).

Van Lieshout Ryan, J., et al. (2023). "In-person 1-day cognitive behavioral therapy-based workshops for postpartum depression: a randomized controlled trial." Psychological Medicine: 1-11.
	Background: Postpartum depression (PPD) affects up to one in five mothers and birthing parents, yet as few as 10% access evidence-based treatment. One-day cognitive behavioral therapy (CBT)-based workshops for PPD have the potential to reach large numbers of sufferers and be integrated into stepped models of care.; Methods: This randomized controlled trial of 461 mothers and birthing parents in Ontario, Canada with Edinburgh Postnatal Depression Scale (EPDS) scores ⩾10, age ⩾18 years, and an infant <12 months of age compared the effects of a 1-day CBT-based workshop plus treatment as usual (TAU; i.e. care from any provider(s) they wished) to TAU alone at 12-weeks post-intervention on PPD, anxiety, the mother-infant relationship, offspring behavior, health-related quality of life, and cost-effectiveness. Data were collected via REDCap.; Results: Workshops led to meaningful reductions in EPDS scores ( m = 15.77 to 11.22; b = -4.6, p < 0.01) and were associated with three times higher odds of a clinically significant decrease in PPD [odds ratio (OR) 3.00, 95% confidence interval (CI) 1.93-4.67]. Anxiety also decreased and participants had three times the odds of clinically significant improvement (OR 3.20, 95% CI 2.03-5.04). Participants reported improvements in mother-infant bonding, infant-focused rejection and anger, and effortful control in their toddlers. The workshop plus TAU achieved similar quality-adjusted life-years at lower costs than TAU alone.; Conclusions: One-day CBT-based workshops for PPD can lead to improvements in depression, anxiety, and the mother-infant relationship and are cost-saving. This intervention could represent a perinatal-specific option that can treat larger numbers of individuals and be integrated into stepped care approaches at reasonable cost.

van Oudheusden Anique, M. J., et al. (2023). "Laparoscopic sacrocolpopexy versus abdominal sacrocolpopexy for vaginal vault prolapse: long-term follow-up of a randomized controlled trial." International Urogynecology Journal 34(1): 93-104.
	Introduction and Hypothesis: The objective of this study was to evaluate long-term outcomes of laparoscopic sacrocolpopexy (LSC) versus abdominal sacrocolpopexy (ASC) for vaginal vault prolapse (VVP).; Methods: Long-term follow-up of a multicenter randomized controlled trial (SALTO trial). A total of 74 women were randomly assigned to LSC (n=37) or ASC (n=37). Primary outcome was disease-specific quality of life, measured with validated questionnaires. Secondary outcomes included anatomical outcome, composite outcome of success, complications, and retreatment.; Results: We analyzed 22 patients in the LSC group and 19 patients in the ASC group for long-term follow-up, with a median follow-up of 109 months (9.1 years). Disease-specific quality of life did not differ after long-term follow-up with median scores of 0.0 (LSC: IQR 0-17; ASC: IQR 0-0) on the "genital prolapse" domain of the Urogenital Distress Inventory in both groups (p = 0.175). Anatomical outcomes were the same for both groups on all points of the POP-Q. The composite outcome of success for the apical compartment is 78.6% (n = 11) in the LSC group and 84.6% (n = 11) in the ASC group (p = 0.686). Mesh exposures occurred in 2 patients (12.5%) in the LSC group and 1 patient (7.7%) in the ASC group. There were 5 surgical reinterventions in both groups (LSC: 22.7%; ASC: 26.3%, p = 0.729).; Conclusions: At long-term follow-up no substantial differences in quality of life, anatomical results, complications, or reinterventions between LSC and ASC were observed. Therefore, the laparoscopic approach is preferable, considering the short-term advantages.; Trial Registration: Dutch Trial Register NTR6330, 18 January 2017, https://www.trialregister.nl/trial/5964. (© 2022. The Author(s).)

van Oudheusden Anique, M. J., et al. (2023). "Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse: a randomised controlled trial and prospective cohort (SALTO-2 trial)." BJOG 130(12): 1542-1551.
	Objective: To determine whether laparoscopic sacrocolpopexy (LSC) or vaginal sacrospinous fixation (VSF) is the most optimal surgical treatment in patients with POP-Q stage ≥2 vaginal vault prolapse (VVP).; Design: Multicentre randomised controlled trial (RCT) and prospective cohort study alongside.; Setting: Seven non-university teaching hospitals and two university hospitals in the Netherlands.; Population: Patients with symptomatic post-hysterectomy vaginal vault prolapse, requiring surgical treatment.; Methods: Randomisation in a 1:1 ratio to LSC or VSF. Evaluation of prolapse was done using the pelvic organ prolapse quantification (POP-Q). All participants were asked to fill in various Dutch validated questionnaires 12 months postoperatively.; Main Outcome Measures: Primary outcome was disease-specific quality of life. Secondary outcomes included composite outcome of success and anatomical failure. Furthermore, we examined peri-operative data, complications and sexual function.; Results: A total of 179 women, 64 women randomised and 115 women, participated in a prospective cohort. Disease-specific quality of life did not differ after 12 months between the LSC and VSF group in the RCT and the cohort (RCT: P = 0.887; cohort: P = 0.704). The composite outcomes of success for the apical compartment, in the RCT and cohort, were 89.3% and 90.3% in the LSC group and 86.2% and 87.8% in the VSF group, respectively (RCT: P = 0.810; cohort: P = 0.905). There were no differences in number of reinterventions and complications between both groups (reinterventions RCT: P = 0.934; cohort: P = 0.120; complications RCT: P = 0.395; cohort: P = 0.129).; Conclusions: LSC and VSF are both effective treatments for vaginal vault prolapse, after a follow-up period of 12 months. (© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

van Riel Senna, J. J. M., et al. (2023). "Efficacy of a medical grade honey formulation (L-Mesitran) in comparison with fluconazole in the treatment of women with recurrent vulvovaginal candidiasis: protocol for a randomised controlled trial (HONEY STUDY)." BMJ Open 13(8): e070466.
	Introduction: Recurrent vulvovaginal candidiasis (RVVC) affects up to 9% of women worldwide. This amount is expected to increase due to lifestyle changes, increased fungal resistance and biofilm formation. Treatment options are limited and in 57% of the cases, relapses occur within 12 months after starting fluconazole therapy (golden standard). The pathogenesis of RVVC is multifactorial and includes fungal biology, the vaginal microenvironment and the immune system. Fluconazole is antimicrobial and effective in inducing short-term remission but a long-term cure is hard to achieve. Medical grade honey (MGH) has antimicrobial, protective, antioxidative and immunomodulatory activity and may therefore be a good alternative treatment. This study aims to investigate the clinical cure rate and long-term efficacy of MGH compared with fluconazole in patients with RVVC.; Methods and Analysis: This study is a multicentre, randomised controlled trial (Maastricht University Medical Centre+ and Zuyderland Medical Centre). A total of 252 eligible women will be randomly assigned to the fluconazole group (control) or the MGH group (L-Mesitran, treatment). The primary objective is to investigate the mycological cure rate after 1 month assessed through a vaginal culture. Secondary objectives are the clinical cure rate regarding symptoms, the prophylactic activity after 6 months of maintenance therapy and the number of relapses within 12 months. Moreover, information about side effects, discomfort and quality of life will be collected with the use of questionnaires.; Ethics and Dissemination: Ethical approval from the Medical Ethics Review Committee of the academic hospital Maastricht/University Maastricht has been obtained (NL 73974.068.21, V.7 on 8 February 2022). Additional approval was obtained from the Ethics Committee of the Zuyderland Medical Centre Heerlen (Z2021141 on 4 March 2022). The first patient was randomised on 22 August 2022. Results will be made available to researchers and healthcare professionals via conferences, meetings and peer-reviewed international publications.; Trial Registration Number: NCT05367089.; Competing Interests: Competing interests: The principal and coordinating investigators have no competing interests. NC is employed by Triticum Exploitatie BV. Triticum Exploitatie BV is the manufacturer of the medical grade honey (MGH)-based product that will be used in the study and is a co-funder of the study. As an expert on MGH, NC helped with the concept and development of the study, but he did not have any ultimate authorisation over the study design, collection management, analysis and interpretation of the data; writing of the report; or the decision to submit the report for publication. (© 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.)

Van Tine, B. (2022). "Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working." ClinicalTrials.gov.
	PRIMARY OBJECTIVES: I. To compare the progression free survival (PFS) of olaparib plus temozolomide (Arm 1) as compared to investigator's choice (trabectedin or pazopanib hydrochloride [pazopanib]) (Arm 2) for the treatment of patients with advanced uterine leiomyosarcoma (uLMS) who have received two or more prior lines of therapy as determined by investigator (local site) assessment. (Phase 2) II. To compare the overall survival (OS) of olaparib plus temozolomide (Arm 1) as compared to investigator's choice (trabectedin or pazopanib) (Arm 2) for the treatment of patients with advanced uLMS who have received two or more prior lines of therapy. (Phase 3) SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of each treatment by determining adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 5 and patient‐reported toxicity using Patient‐Reported Outcome (PRO)‐CTCAE version 1 in and across each treatment arm. (Phase 2/3) II. To evaluate the objective response rate (ORR), duration of response (DOR) and disease control rate (DCR) in and across each treatment arm as determined by investigator assessment. (Phase 2/3) EXPLORATORY OBJECTIVE: I. To collect results of tumor genomic testing previously conducted as part of clinical care (when available) and (a) to determine the proportion of patients with a genomic alteration in a homologous recombination (HR) pathway gene and (b) to evaluate for any relationship between the presence of such an alteration and clinical benefit from olaparib and temozolomide. (Phase 2/3) OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients receive temozolomide orally (PO) once daily (QD) on days 1‐7 of each cycle and olaparib PO twice daily (BID) on days 1‐7 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan and may undergo magnetic resonance imaging (MRI), bone scans, and collection of blood samples throughout the study. ARM 2: Patients receive trabectedin intravenously (IV) continuously over 24 hours on day 1 of each cycle or pazopanib PO QD on days 1‐21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and may undergo MRI, bone scans, and collection of blood samples throughout the study. After completion of study treatment, patients without disease progression are followed every 6 weeks until disease progression. After disease progression, patients are followed every 3 months for the first 2 years, then every 6 months thereafter until 5 years post‐randomization or death, whichever comes first.

van Welie, N., et al. (2021). "The long-term costs and effects of tubal flushing with oil-based versus water-based contrast during hysterosalpingography." Reproductive Biomedicine Online 42(1): 150-157.
	Research question: What are the long-term costs and effects of oil- versus water-based contrast in infertile women undergoing hysterosalpingography (HSG)? Design: This economic evaluation of a long-term follow-up of a multicentre randomized controlled trial involved 1119 infertile women randomized to HSG with oil- (n = 557) or water-based contrast (n = 562) in the Netherlands. Result(s): In the oil-based contrast group, 39.8% of women needed no other treatment, 34.6% underwent intrauterine insemination (IUI) and 25.6% had IVF/intracytoplasmic sperm injection (ICSI) in the 5 years following HSG. In the water-based contrast group, 35.0% of women had no other treatment, 34.2% had IUI and 30.8% had IVF/ICSI in the 5 years following HSG (P = 0.113). After 5 years of follow-up, HSG using oil-based contrast resulted in equivalent costs (mean cost difference -144; 95% confidence interval [CI] -579 to +290; P = 0.515) for a 5% increase in the cumulative ongoing pregnancy rate compared with HSG using water-based contrast (80% compared with 75%, Relative Risk (RR) 1.07; 95% CI 1.00-1.14). Similarly, HSG with oil-based contrast resulted in equivalent costs (mean cost difference -50; 95% CI -576 to +475; P = 0.850) for a 7.5% increase in the cumulative live birth rate compared with HSG with water-based contrast (74.8% compared with 67.3%, RR 1.11; 95% CI 1.03-1.20), making it the dominant strategy. Scenario analyses suggest that the oil-based contrast medium is the dominant strategy up to a price difference of 300. Conclusion(s): Over a 5-year follow-up, HSG with an oil-based contrast was associated with a 5% increase in ongoing pregnancy rate, a 7.5% increase in live birth rate and similar costs to HSG with water-based contrast.Copyright © 2020 The Author(s)

van Wessel, S., et al. (2021). "Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol." Human Reproduction Open 2021(1): hoab001.
	Study Questions: Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth?; What Is Known Already: Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality.; Study Design Size Duration: This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%.; Participants/materials Setting Methods: Women of reproductive age (18-47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2-6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester.; Study Funding/competing Interests: This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest. (© The Author(s) 2021. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Vanderstichele, A., et al. (2022). "Randomized CLIO/BGOG-ov10 trial of olaparib monotherapy versus physician's choice chemotherapy in relapsed ovarian cancer." Gynecologic Oncology 165(1): 14-22.
	Objective: Comparison of olaparib (OLA) monotherapy versus chemotherapy in patients with platinum-sensitive (PSOC) or platinum-resistant ovarian cancer (PROC).; Methods: Patients with measurable disease and ≥ 1 prior line of chemotherapy (CT) were randomized 2:1 to OLA (300 mg tablets, BID) or physician's choice CT.: for PSOC: Carboplatin-Pegylated-Liposomal-Doxorubicin (PLD) or Carboplatin-Gemcitabine; for PROC: PLD, Topotecan, Paclitaxel or Gemcitabine.; Results: 160 patients (60 with PSOC and 100 with PROC) were randomized 2:1 to OLA (n = 107) or CT (n = 53). Baseline characteristics were similar between both arms. Overall objective response rate (ORR) for OLA and CT were similar (24.3% (26/107) and 28.3% (15/53), respectively). Clinical benefit rate (≥ 12 weeks) was similar with 54.2% (58/107) and 56.6% (30/53), respectively. In PSOC, ORR was 35.0% (14/40) and 65.0% (13/20) for OLA and CT (p = 0.053); in PROC, ORR was 17.9% (12/67) and 6.1% (2/33) for OLA and CT (p = 0.134). ORR in heavily pretreated PROC (>4 prior lines) was 22.9% (8/35) with OLA versus 0% (0/14) for CT. ORR of 35.7% (5/14) and 13.2% (7/53) was observed in BRCA-mutated and -wildtype PROC cases, respectively. Median PFS in PROC was not significantly different with 2.9 months (95% CI 2.8-5.1 in the OLA group versus 3.8 months (95% CI 3.0-6.4) in the CT group (hazard ratio [HR] 1.11 [95% CI 0.72-1.78]; log-rank p = 0.600).; Conclusion: OLA monotherapy showed overall an equal response rate in relapsed ovarian cancer compared with CT. In PROC, ORR and TFST tended to be higher with OLA than with CT. In heavily pretreated patients (four lines or more) with PROC disease, OLA treatment seemed to be more effective than CT.; Competing Interests: Declaration of Competing Interest Dr. Lambrechts reports personal fees from Astra Zeneca (Advisory boards and speaker's fee), personal fees from MSD (Advisory boards), grants from Agilent Technologies (industry-sponsored grant), outside the submitted work. In addition, Dr. Lambrechts has a patent application pending. I. Vergote reports grants and other from Amgen (Europe) GmbH (2019), personal fees and other from AstraZeneca (2019–2022), other from Clovis Oncology Inc. (2019–2019), other from Carrick Therapeutics (2019), other from Deciphera Pharmaceuticals (2020−2021), personal fees from Elevar Therapeutics (2020), personal fees and other from F. Hoffmann-La Roche Ltd. (2019–2021), other from Genmab (2019–2021), personal fees and other from GSK (2019–2021), personal fees and other from Immunogen Inc. (2019–2022), personal fees from Jazzpharma (2021−2022), personal fees from Mersana (2020), other from Millennium Pharmaceuticals (2019), personal fees and other from MSD (2019–2022), personal fees and other from Novocure (2020−2022), personal fees from Octimet Oncology NV (2019), personal fees and other from Oncoinvent AS (2019–2022), personal fees and other from Sotio a.s. (2019–2022), personal fees from Verastem Oncology (2020), personal fees from Zentalis (2020), grants and other from Roche, other from Tesaro, personal fees from Agenus (2021), personal fees from Aksebio (2021), personal fees from Eisai (2021), personal fees from Karyopharm (2021), personal fees from Novartis (2021), personal fees from Seagen (2021), outside the submitted work. All other authors declared no conflicts of interest. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Vanessa, O., et al. (2023). "Use of immunotherapy or radiotherapy in the treatment of cervical cancer - systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question What is the best method of treatment for cervical cancer between radiotherapy and immunotherapy? Searches Articles will be searched from July to August 2023 in PubMed, BVS, SciELO, Cochrane Library and clinical trials databases. The filters and inclusion criteria for the articles are: studies from the last 10 years, in English, Portuguese and Spanish, randomized studies and with full text available. Exclusion criteria are: duplicate studies, review articles and case reports, articles with unavailable texts and articles that do not address the topic. The descriptors searched in MeSH and DeCS for this review are: cervical cancer, radiotherapy and immunotherapy. Types of study to be included RCTs and clinical trials Condition or domain being studied Cervical carcinoma is the most common neoplasm of the female apparatus in developing countries and treatment strategies for this condition are constantly changing, so that there is a lack of data in the literature on the role of radiotherapy and immunotherapy alone in the treatment of this pathology. Participants/population Participants in this research will be patients with a confirmed diagnosis of cervical cancer who are able to receive radiotherapy and/or immunotherapy. Intervention(s), exposure(s) not applicable Comparator(s)/control not applicable Main outcome(s) the analyzed outcomes will be mortality, quality of life and cancer remission. Additional outcome(s) none Data extraction (selection and coding) The selection of articles will be carried out by two independent reviewers in a double-blind manner by titles and abstracts in the databases with a subsequent analysis by a third reviewer for all discrepant articles. Subsequently, the kappa coefficient will be calculated to obtain the reliability of the selection between the two reviewers in the bases. Risk of bias (quality) assessment The risk of bias will be analyzed by two reviewers for all articles through ROB2 for RCTs Strategy for data synthesis The synthesis of the data will be carried out through tables built in google documents, graphs built through google spreadsheets and forest plots built in the review manager 5.4 software for the meta analysis stage. Analysis of subgroups or subsets not applicable Contact details for further information Vanessa Oliveira van.oliveira.284@gmail.com Organisational affiliation of the review UFCG Review team members and their organisational affiliations Mrs Vanessa Oliveira. UFCG Marcela Montenegro. UPE Maria Luiza Montenegro. UPE Type and method of review Epidemiologic, Intervention, Systematic review Anticipated or actual start date 17 July 2023 Anticipated completion date 21 November 2023 Funding sources/sponsors This review is not being funded Conflicts of interest Language English, Portuguese-Brazil Country Brazil Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Female; Humans; Immunotherapy; Radiation Oncology; Uterine Cervical Neoplasms Date of registration in PROSPERO 28 July 2023 Date of first submission 17 July 2023 Stage of review at time of this submission The review has not started

Varady, K. (2022). "Time Restricted Eating for the Treatment of PCOS." ClinicalTrials.gov.
	Background: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility among young women. This syndrome is a reproductive and endocrinological disorder that affects up to 18% of reproductive‐aged women. To date, the only strategy shown to reverse PCOS is sustained weight loss of 5‐10%. At present, daily calorie restriction (CR) is the main diet prescribed to patients with PCOS for weight loss. However, some women find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day. Considering these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6‐8 h per day. TRE allows individuals to self‐select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. Recent findings show that TRE significantly reduces body weight, insulin resistance, and inflammation in adults with obesity. However, no randomized controlled trials have studied the role of TRE in treating PCOS. Accordingly, this study will compare the effects of TRE vs CR in females with PCOS over 6 months on body weight, androgen markers, inflammatory markers and insulin sensitivity. Methods: A 6‐month randomized, controlled, parallel‐arm trial will be implemented. Females with obesity and PCOS will be randomized to 1 of 3 groups: (1) 6‐h TRE (ad libitum food intake from 1‐7 pm, fasting from 7pm‐1pm); (2) CR (25% energy restriction daily); or (3) control group (ad libitum intake with no meal timing restrictions).

Varikasuvu, S., et al. (2022). "The effect of metformin intervention on leptin levels in polycystic ovary syndrome: a systematic review and meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	Review question The objective of our systematic review and meta-analysis is to synthesize all the available evidence on the use of metformin treatment on circulatory (serum, plasma) leptin levels in polycystic ovary syndrome (PCOS). Searches The following databases will be searched from inception to till-date for relevant randomized controlled trials addressing metformin intervention on leptin levels in PCOS patients. NCBI PubMed/MEDLINE database The Cochrane Library Clinical trial registry Web of Science EMBASE ScienceDirect Springer (Author mapper) Google Scholar Literature search will be conducted independently by two reviewers using both MESH terms and general keywords, as well. Links to the similar articles will also be followed to further identify more studies in search databases. The reference lists of retrieved literature will also be hand searched to indentify relevant studies. The corresponding authors will also be contacted on their e-mails to obtain any unpublished data and/or for more information. Studies published in English will be considered for inclusion in this review and meta-analysis. Types of study to be included RCTs Condition or domain being studied PCOS Participants/population PCOS Intervention(s), exposure(s) metformin Comparator(s)/control The leptin levels will be compared between PCOS patients treated with metformin and placebo (as a comparator group). Main outcome(s) Circulatory leptin levels Measures of effect Primary outcomes The effect of metformin intervention (serum/plasma) leptin levels in PCOS as compared to placebo-treated comparator group. Additional outcome(s) Secondary outcomes The associations of pre-and post metformin treatment leptin level with hormonal and metabolic variables in PCOS patients. Measures of effect SMD Data extraction (selection and coding) All the relevant articles retrieved will be thoroughly read and evaluated by two authors, independently. Data extraction will include; author’s names, year of publication, country, age, BMI, diagnostic criteria for PCOS, leptin measurement method, means and SD of leptin in metformin treated and comparator groups, randomization and blinding details, and other hormonal and metabolic characteristics of included studies. Any discrepancies will be discussed among authors for a consensus. Risk of bias (quality) assessment The Cochrane risk-of-bias tool for randomized trials (RoB 2) will be used to assess the risk of bias in the included randomizedtrials for judgements on the trial design, conduct, and reporting. The risk of bias will be reported as 'low' or 'high' risk of bias, or studies to have 'some concerns'. We will check included studies for randomization and blinding methods. We will also check inclusion and exclusion criteria applied in each study. We will also check matching for confounders. Risk of publication bias will be studied by funnel plot asymmetry and Egger’s test. This assessment will be done independently by at least two investigators. Any discrepancies will be resolved upon discussionwith the third reviewer. Strategy for data synthesis The between study heterogeneity will be examined by the Cochrane’s Q statistic and expressed as the percentages of I². Heterogeneity will also be assessed using the χ² test. A p-value of <0.10 or I² statistic of >50% will indicate a significant heterogeneity and a random-effects model will be used to compute the effect sizes. We will quantify the effect size as standardized mean difference (SMD) and its 95% confidence interval (CI) as a summary statistic for the difference of leptin levels between metformin-treated and placebo/comparator groups. The overall effect size for SMD will be presented as a Z-score. The Z-score with a p-value of <0.05 will be considered statistically significant. To assess the influence of individual study result on the pooled estimate and to explain heterogeneity, a one-study removed sensitivity analysis will be performed. Possible sources of heterogeneity will also be tested using meta-regression. All statistical analyses will be conducted using Review Manager 5.3 version and MEDCALC 16.2.0 version. Analysis of subgroups or subsets If applicable and the necessary data are available, we will attempt to analyze the effect in subgroups based on age, metformin dose and treatment duration, obese & non-obese PCOS, and leptin measurement methods and samples (serum or plasma) used. Contact details for further information Varikasuvu Seshadri Reddy lifeschemistry@live.com Organisational affiliation of the review AIIMS Deoghar www.aiimsdeoghar.edu.in Review team members and their organisational affiliations [1 change] Dr Varikasuvu Seshadri Reddy. Maheshwara Medical College Dr Vineeta Singh. Dr Subodh Kumar. AIIMS Deoghar Professor Faustino R. Perez-Lopez. University of Zaragoza Type and method of review Intervention, Meta-analysis, Systematic review Anticipated or actual start date 20 April 2022 Anticipated completion date [1 change] 25 December 2024 Funding sources/sponsors none Conflicts of interest Language English Country India Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Female; Humans; Hypoglycemic Agents; Leptin; Metformin; Polycystic Ovary Syndrome; Randomized Controlled Trials as Topic Date of registration in PROSPERO 10 May 2022 Date of first submission 20 April 2022

Vash-Margita, A. (2024). "Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)." ClinicalTrials.gov.
	No Results Available Drug: Vitamin D 4000IU daily|Drug: Placebo Change in oligomenorrhea|Changes Vitamin D (25-hydroxyvitamin D) level|Change in DHEAS level|Changes in Androstenedione level|Change in Anti-Mullerian hormone (AMH) level|Change in testosterone level|Change in Hirsutism|Change Body Acne|Change in Facial Female Not Applicable 60 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment 2000028054 December 2024

Vasillios, P., et al. (2022). "Survival outcomes following neo-adjuvant chemotherapy in advanced vulvar cancer." PROSPERO International prospective register of systematic reviews.
	Review question Studies have shown that advanced vulvar cancer is sensitive to chemotherapy and that neoadjuvant chemotherapy (NACT) can minimize the size of the tumor and the scope of surgery, thus improving the resection rate and quality of life. The purpose of the present systematic review is to evaluate survival outcomes and tumor characteristics following neoadjuvant chemotherapy for advanced vulvar cancer. Searches We will search MEDLINE (1966–2021), Scopus (2004–2021), ClinicalTrials.gov (2008–2021), Cochrane Central Register of Controlled Trials CENTRAL (1999-2021) and Google Scholar (2004-2021) from inception until January 10 2022 for relevant articles published in languages of Latin alphabet. Keywords: vulvar cancer; advanced disease; neoadjuvant; chemotherapy; survival Types of study to be included Randomized controlled trials, prospective and retrospective cohort studies, retrospective case control studies, case-series. Condition or domain being studied Locally advanced tumors of the vulva represent approximately one third of all vulvar cancers. Clinical management of vulvar cancer patients is defined upon several factors, including histology and stage, but also age, comorbidities and performance status at diagnosis. In locally advanced vulvar cancer, upfront surgery lacks appropriate indication. In these patients, the combination of chemoradiation may be the preferred choice. Overall, the administration of neoadjuvant chemotherapy remains a not negligible option. To date; however, most of the evidence is retrieved from small cohorts, as existing randomized trials are very few. Participants/population Patients presenting with advanced stage vulvar cancer (Stage III-IV) that undergo initial therapy with neo-adjuvant chemotherapy. Pathology characteristics including stage, grade of differentiation, presence of lymphovascular space involvement and perineural invasion will be recorded as well. Intervention(s), exposure(s) Women undergoing neo-adjuvant chemotherapy for advanced vulvar cancer (Stages III and IV), irrespective of the scheme that is used. Comparator(s)/control Women that undergo primary treatment with surgery or radical chemoradiotherapy Main outcome(s) Rates of disease remission, stable disease and disease progression in each group (neo-adjuvant chemotherapy and control) Measures of effect Absolute rates of disease remission and progression as well differences in mean tumor diameter Additional outcome(s) Overall and disease free survival rates Measures of effect Risk ratio of recurrences and deaths, intervals to recurrence and death Data extraction (selection and coding) Titles and abstracts of studies retrieved using the search strategy and those from additional sources will be screened independently by two review authors to identify studies that potentially meet the inclusion criteria outlined above. The full text of these potentially eligible studies will be retrieved and independently assessed for eligibility by two review team members. Any disagreement between them concerning eligibility of particular studies will be resolved following consensus of all authors. Risk of bias (quality) assessment Quality assessment will be carried out by two reviewers independently and will be checked by a third reviewer if disagreements should occur. Individual studies will be assessed using 1) the Cochrane Risk of Bias in Non-Randomized Studies of Interventions tool (ROBINS-I tool) for non-randomized trials 2) the Cochrane risk of bias tool for randomized trials Strategy for data synthesis Quantitative analysis will be performed, provided that published data in the field will provide the relevant information and that outcome reporting measures will be sufficiently homogenous. Otherwise descriptive synthesis will be performed and analysis of factors that contribute to the significant heterogeneity among included studies will be provided to guide future research in this field. Analysis of subgroups or subsets Subgroup analysis will be performed (if possible) after stratifying patients assigned to the intervention group (neoadjuvant chemotherapy) according to: chemotherapeutic regimens and patients assigned to the control group according to the use of: primary surgery primary radical chemoradiotherapy Contact details for further information Vasillios Pergialiotis pergialiotis@yahoo.com Organisational affiliation of the review National and Kapodistrian University of Athens Review team members and their organisational affiliations Dr Vasillios Pergialiotis. National and Kapodistrian University of Athens Dr Ioannis Rodolakis. National and Kapodistrian University of Athens Assistant/Associate Professor Nikolaos Thomakos. National and Kapodistrian University of Athens Type and method of review Meta-analysis, Systematic review Anticipated or actual start date 01 August 2022 Anticipated completion date 15 September 2022 Funding sources/sponsors No funding Conflicts of interest No conflicts of interest None known Language English Country Greece Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Antineoplastic Combined Chemotherapy Protocols; Chemotherapy, Adjuvant; Female; Humans; Neoadjuvant Therapy; Vulvar Neoplasms Date of registration in PROSPERO 27 August 2022 Date of first submission 16 August 2022 Stage of review at time of this submission

VEFIKULUCAY, Y. D. (2023). "Effects of Kinesio Tape in Primary Dysmenorrhea." ClinicalTrials.gov.
	No Results Available Other: Intervention (Kinesio Taping) group Mcgill Pain Scale|VAS pain scale|Menstrual Symptom Questionnaire|Adaptation of the Perceived Stress Scale|Pittsburgh Sleep Quality Index|World Health Organization Quality of Life Scale Short Form Female Not Applicable 56 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Supportive Care E-41901325-200-57905 2023/016 January 31, 2024

Venturella, R., et al. (2023). "Relugolix combination therapy in European women with symptomatic uterine fibroids: a subgroup analysis from the randomized phase 3 LIBERTY pivotal trials." Gynecological Endocrinology 39(1): 2249107.
	Objective: In the 24-week, phase 3 LIBERTY 1 (L1) and LIBERTY 2 (L2) trials, relugolix combination therapy (relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethisterone acetate 0.5 mg)) reduced uterine fibroid (UF)-associated symptoms. This post hoc analysis assessed safety and efficacy of relugolix-CT in European women from L1/L2.; Methods: Premenopausal women (aged 18-50 years) with UF-associated heavy menstrual bleeding (HMB) were randomized 1:1:1 in L1 ( N = 388) and L2 ( N = 382) to relugolix-CT or placebo for 24 weeks, or delayed relugolix-CT (relugolix 40 mg then relugolix-CT; 12 weeks each). Primary endpoint: proportion of responders (menstrual blood loss (MBL) <80 mL and reduction of ≥50% from baseline MBL volume) over the last 35 days of treatment. Secondary endpoints: MBL volume, amenorrhea, UF-associated pain, symptom severity, distress related to bleeding and pelvic discomfort, health-related quality of life (HRQoL). Safety endpoints included adverse event (AE) reporting and bone mineral density (BMD) assessment.; Results: In European women from L1/L2 ( N = 124, 16%), a significantly greater proportion of treatment responders was observed with relugolix-CT vs. placebo (85.4% vs. 19.1%, respectively; nominal p < .0001). There were statistically significant improvements with relugolix-CT vs. placebo for several secondary endpoints: reduction in MBL volume, amenorrhea rate, proportion achieving mild-to-no pain, reduction in symptom severity and distress from bleeding and pelvic discomfort, and improvement in HRQoL. Incidence of AEs and percentage changes in BMD from baseline to week 24 were similar for relugolix-CT and placebo.; Conclusions: In European women with UF and HMB, once-daily relugolix-CT vs. placebo improved UF-associated symptoms and preserved BMD.

Vera-Montoya, M., et al. (2023). "Growth Hormone Administration to Improve Reproductive Outcomes in Women with Recurrent Implantation Failure (RIF): a Systematic Review." Reproductive Sciences 30(6): 1712-1723.
	Recurrent implantation failure (RIF) has been used to describe embryos' failure to implant following IVF, arising concerns about the importance of its treatment. Growth hormone (GH) has been studied as one of the possible co-interventions. Our updated review evaluated GH intervention vs. no intervention from randomized controlled trials (RCTs) in RIF patients. Electronic searches on The Menstrual Disorders and Subfertility Group (MDSG), The Cochrane Central Register for Clinical Trials, PubMed MEDLINE, EMBASE, PsycINFO, CINAHL, LILACS, and Google Scholar up to August 2021 identified 2 RCTs and compiled with the above inclusion criteria. The risk of bias (ROB) and the quality of evidence were assessed according to the Cochrane Collaboration tool and GRADE group guidelines. Meta-analysis found higher rates of clinical pregnancy (OR: 4.97 CI 95% 2.05 to 12.05), live birth (OR: 5.13 CI 95% 2.03 to 12.91), and implantation (OR: 3.88 CI 95% 1.91 to 7.88) when compared GH to no intervention; as well as an increased endometrial thickness (mean difference: 1.14 CI 95% -0.0 to 2.28). However, this review cannot provide a strong recommendation due to the quality of evidence rated as "very low quality of evidence" in all the outcomes for reasons such as methodology issues, heterogeneity, intervention regimen, and limited sample sizes with large confidence intervals and a low number of events. We emphasize the importance of upcoming high-quality research and the need for consensus concepts in RIF patients, which may be a minority; it is still one of the highest impacts on life quality. (© 2022. The Author(s), under exclusive licence to Society for Reproductive Investigation.)

Vergote, I., et al. (2023). "Oral Selinexor as Maintenance Therapy After First-Line Chemotherapy for Advanced or Recurrent Endometrial Cancer." Journal of Clinical Oncology 41(35): 5400-5410.
	Purpose: Selinexor inhibits exportin-1 (XPO1) resulting in nuclear accumulation of tumor suppressor proteins including p53 and has clinical activity in endometrial cancer (EC). The primary end point was to assess progression-free survival (PFS) with once-weekly oral selinexor in patients with advanced or recurrent EC.; Patients and Methods: ENGOT-EN5/GOG-3055/SIENDO was a randomized, prospective, multicenter, double-blind, placebo-controlled, phase III study at 107 sites in 10 countries. Patients 18 years or older with histologically confirmed EC were enrolled. All had completed a single line of at least 12 weeks of taxane-platinum combination chemotherapy and achieved partial or complete response. Patients were assigned to receive 80 mg oral selinexor once weekly or placebo with 2:1 random assignment (ClinicalTrials.gov identifier: NCT03555422).; Results: Between January 2018 and December 2021, 263 patients were randomly assigned, with 174 allocated to selinexor and 89 to placebo. The median PFS was 5.7 months (95% CI, 3.81 to 9.20) with selinexor versus 3.8 months (95% CI, 3.68 to 7.39) with placebo (hazard ratio [HR], 0.76 [95% CI, 0.54 to 1.08]; two-sided P = .126), which did not meet the criteria for statistical significance in the intent-to-treat population. Incorrect chemotherapy response stratification data for 7 (2.7%) patients were identified. In a prespecified exploratory analysis of PFS in audited stratification data, PFS for selinexor met the threshold for statistical significance (HR, 0.71; 95% CI, 0.499 to 0.996; two-sided P = .049). Furthermore, patients with the TP53 wild-type (wt) EC had a median PFS of 13.7 and 3.7 months with selinexor and placebo. The most common grade 3 treatment-related adverse events were nausea (9%), neutropenia (9%), and thrombocytopenia (7%).; Conclusion: The significance level for PFS was only met in the audited analysis. However, a preliminary analysis of a prespecified exploratory subgroup of patients with TP53 wt EC showed promising results with selinexor maintenance therapy.

Vergote, I., et al. (2023). "Randomized phase II BGOG/ENGOT-cx1 study of paclitaxel-carboplatin with or without nintedanib in first-line recurrent or advanced cervical cancer." Gynecologic Oncology 174: 80-88.
	Objective: Nintedanib is an oral tyrosine kinase inhibitor targeting, among others, vascular endothelial growth factor receptor. The aim was to establish the role of nintedanib in addition to paclitaxel and carboplatin in first-line recurrent/metastatic cervical cancer.; Methods: Double-blind phase II randomized study in patients with first-line recurrent or primary advanced (FIGO stage IVB) cervical cancer. Patients received carboplatin-paclitaxel with oral nintedanib 200 mg BID/placebo. The primary endpoint was progression-free survival (PFS) at 1.5 years and α = 0.15, β = 80%, one sided.; Results: 120 patients (62 N, 58C) were randomized. Median follow-up was 35 months. Baseline characteristics were similar in both groups (total population: squamous cell carcinoma 62%, prior radiotherapy 64%, primary advanced 25%, recurrent 75%). The primary endpoint was met with a PFS at 1.5 years of 15.1% versus 12.8% in favor of the nintedanib arm (p = 0.057). Median overall survival (OS) was 21.7 and 16.4 months for N and C, respectively. Confirmed RECIST response rate was 48% for N and 39% for C. No new adverse events were noted for N. However, N was associated with numerically more serious adverse events for anemia and febrile neutropenia. Global health status during and at the end of the study was similar in both arms.; Conclusion: The study met its primary endpoint with a prolonged PFS in the N arm. No new safety signals were observed.; Competing Interests: Declaration of Competing Interest Vergote I. as corresponding author declares consulting fees from 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, OncXerna, Regeneron, Sanofi, Seagen, Sotio, Verastem Oncology, Zentalis; Contracted research (via KULeuven) from Oncoinvent AS; Corporate sponsored research from Amgen and Roche and accommodations and travel expenses from Karyopharm, Genmab and Novocure. Van Nieuwenhuysen E. declares consulting/advisory board fees from AstraZeneca, Regeneron; research support from Eli Lilly and travel expenses from Roche and PharmaMar. Casado A. declares consulting or advisory role from Roche Spain, PharmaMar, Eisai, Merck Sharp & Dohme, Eisai (all personal); research funding from PharmaMar (institutional); travel and accommodation support from PharmaMar, Roche, Lilly Spain (all personal); other relationship with Lilly (institutional). Laenen A. declares no conflicts. Lorusso D. declares consultant honoraria from AstraZeneca, Clovis Oncology, GSK, MSD, Immunogen, Genmab, Seagen, Novartis and PharmaMar; invited member of advisory board from Oncoinvest, Corcept, Sutro; invited speaker and member of advisory boards from AstraZeneca, Immunogen, GSK, Seagen, Genmab; research institutional funding from Clovis Oncology, GSK, MSD and PharmaMar; grants for traveling: AstraZeneca, Clovis Oncology, GSK. Braicu E.I. received research funding from Bayer, Roche Diagnostics, Tesaro, GSK, and AstraZeneca and received personal fees from AstraZeneca, Clovis, GSK, Tesaro, EISAI, RochePharma, and Roche Diagnostics. Guerra-Alia E. has received advisory/consultancy honorarium from AstraZeneca-MSD, Clovis Oncology, GSK-Tesaro, PharmaMar, Roche; she has received speaker bureau/expert testimony honorarium from AstraZeneca-MSD, PharmaMar, Roche, GSK-Tesaro, Clovis and she received travel/accommodation/expenses from Roche, GSK-Tesaro and Baxter. Zola P. declares consulting fees from Astrazeneca. Wimberger P. has received research funding from Amgen, AstraZeneca, MSD, GlaxoSmithKline, Novartis, Pfizer, Roche Pharma, Clovis, Lilly, honoraria from Amgen, AstraZeneca, MSD, GlaxoSmithKline, Novartis, Pfizer, Roche Pharma, Clovis, TEVA, Eisai, Lilly, Gilead, Daichii Sankyo. He participates at advisory boards from Amgen, AstraZeneca, MSD, GlaxoSmithKline, Novartis, Pfizer, Roche Pharma, Clovis, TEVA, Eisai, Lilly, Gilead and Daichii Sankyo. Debruyne P.R. received grants from Pf zer (institutional); consulting fees for Advisory Boards from BMS, Merck Pfizer, Ipsen; honoraria for lectures from Bayer; travel support from Janssen; (Substitute) Board Member, Clinical Trials College, Federal Public Service, Kingdom of Belgium; stock or stock options from Alkermes and Biocartis Group NV. Ferrero A declares honoraria from GlaxoSmithKline, Clovis, Astra Zeneca-MSD; invited member of advisory boards from Astra Zeneca-MSD. Muallem MZ received consulting fees from Styker, Intuitive and BD. Garcia-Martinez E. received accommodations and travel expenses from GSK, Roche, MSD and consulting or educational fees from GSK, AstraZeneca, Pharmamar, MSD. Pignata S. has no COI related to this paper. Sehouli J. received consulting fees from Tesaro, Merck/Pfizer, PharmaMar, Clovis Oncology, Eisai, Oncoinvent, AstraZeneca, Roche Pharma, GlaxoSmith, MSD, Novocure; honoraria for lectures from Tesaro, PharmaMar, Clovis, Roche, Vifor Pharma, Novartis Pharma, GlaxoSmith, AstraZeneca, Bayer, PharmaMar, Hexal AG; patents from Roche Pharma, Bayer, GlaxoSmith, Tesaro, AstraZeneca, Clovis and Lilly. Van Gorp T. received grants from Amgen, Roche and AstraZeneca (institutional); consulting fees from AstraZeneca, Eisai Europe, OncXerna Therapeutics, MSD/Merck, GSK, ImmunoGen and Seagen (all institutional); he received travel support from Amgen, Pfizer, Roche, Sanofi-Aventis, Novartis, Roche, Immunogen, MSD, AstraZeneca, PharmaMar and GSK. Gennigens Ch. declares no disclosures for the present manuscript; grants/contracts from AstraZeneca, consulting fees from Ipsen, GSK and MSD; honoraria for lectures etc. from MSD, BMS, Ipsen, Pfizer, Pharmamar, AstraZeneca, GSK; support for meetings and/or travel: Ipsen, Pharmamar, Pfizer, MSD, GSK; participation on data safety monitoring board or Advisory Board: MSD, BMS, Ipsen, AstraZeneca, GSK, Eisai. Rubio MJ. has served on advisory boards for MSD, AstraZeneca, Roche, GSK, Clovis, PharmaMar and received support for travel or accommodation from Roche, AstraZeneca, PharmaMar, MSD and GSK. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Vergote, I. B., et al. (2021). "Innovatv 301/ENGOT-CX12/GOG-3057: tisotumab vedotin vs investigator's choice chemo in second-or third-line recurrent or metastatic cervical cancer." International Journal of Gynecological Cancer 31(SUPPL 1): A1.
	Introduction/Background Doublet chemotherapy (paclitaxel plus either platinum or topotecan) with bevacizumab (if eligible) is recommended for first‐line treatment of recurrent or metastatic cervical cancer (r/mCC; Tewari 2014). In the second‐line setting, there are limited data for available treatment options. Tisotumab vedotin (TV) is an investigational antibody‐drug conjugate directed to tissue factor. In the phase 2 pivotal trial (innovaTV 204/ENGOT‐cx6/GOG‐3023) in r/mCC patients with disease progression on or after chemotherapy, TV demonstrated clinically meaningful and durable activity (objective response rate [ORR]: 24%; median duration of response [DOR]: 8.3 months) with a manageable and tolerable safety profile. Most adverse events associated with TV were mild to moderate. These findings support further investigation of TV in patients with r/mCC who progress on first‐line treatment options. Methodology innovaTV 301/ENGOT‐cx12/GOG‐3057 (NCT04697628) is a global, randomized, open‐label, phase 3 trial evaluating efficacy and safety of TV in patients with previously treated r/mCC. Eligible patients must be ≥18 years, have r/mCC, and have progressed after receiving 1‐2 prior lines of therapy (either standard of care systemic chemotherapy doublet or platinum‐based therapy with bevacizumab, if eligible). Approximately 482 patients will be randomized 1:1 to receive 21‐day cycles of TV (2.0 mg/kg IV once every 3 weeks) or investigator's choice of chemotherapy: topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed. The primary endpoint is overall survival. Key secondary endpoints are progression‐free survival, ORR, time to response, DOR, safety, and quality of life outcomes. The study is enrolling and will have sites in the USA, Europe, Japan, Latin America, Taiwan, Singapore, and South Korea. Result(s) Not applicable for trial in progress Conclusion Not applicable for trial in progress.

Vergote, I. B., et al. (2021). "Randomised phase ii bgog/engot-cx1 study of paclitaxel-carboplatin with or without nintedanib in first-line recurrent or advanced cervical cancer." International Journal of Gynecological Cancer 31(SUPPL 1): A12.
	Introduction/Background Platinum in combination with paclitaxel (P) and bevacizumab is the standard of care in first‐line recurrent/advanced cervical cancer (Tewari, NEJM 2020). Nintedanib is an oral tyrosine kinase inhibitor targeting, among others, vascular endothelial growth factor receptor. Methodology Double‐blind phase II randomised study in patients with first‐line recurrent or primary advanced (FIGO stage IVB) cervical cancer. Patients received carboplatin AUC 5‐6 and paclitaxel 175mg/m2 q 3 weeks with oral nintedanib 200 mg BID/placebo. Stratification factor was primary advanced versus recurrent disease. The primary endpoint was progression‐free survival (PFS) at 1,5 years with at least 87 events and a=0.15, b=80%, one sided, in favor of the nintedanib (N) versus control (C) arm. The study (NCT02009579) was performed according to the ENGOT model A. Result(s) 120 patients (62 N, 58 C) were randomised between March 2014 and October 2018. Median follow‐up was 35 months. Baseline characteristics were similar in both groups (total population: squamous cell carcinoma 62%, prior radiotherapy 64%, primary advanced 25%, recurrent 75%). The primary endpoint was met with a PFS at 1.5 years of 15.1% versus 12.8% in favour of the nintedanib arm (p = 0.057). Median overall survival (OS) was 21.7 and 16.4 months for N and C, respectively. Subgroup analysis did not demonstrate a difference in PFS in the primary advanced setting, but in the recurrent setting the 1 year PFS was 22.8% and 14.9% for N and C, respectively. Confirmed RECIST response rate was 48% for N and 39% for C. No new adverse events were noted for N. However N was associated with numerically more serious adverse events for anemia and febrile neutropenia. Discontinuation of chemotherapy was similar in both groups. N was discontinued in 3% versus placebo in 1.6% of the patients. Dose reduction of N was necessary in 53% of the patients. Conclusion The study met its primary endpoint with a prolonged PFS in the N arm. No new safety signals were observed.

Verma, A., et al. (2021). "Effect of Yoga Therapy on Health Outcomes in Women With Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis." American Journal of Lifestyle Medicine 17(1): 73-92.
	The purpose of this study was to assess the effect of yoga therapy (YT) on health outcomes of women suffering from polycystic ovary syndrome (PCOS). Interventional studies, with postmenarchal and premenopausal females with PCOS who received YT, with any health outcome reported, were included. Scopus, Cochrane, PubMed, Embase, and Medline databases were electronically searched. Systematic review included 11 experimental studies, representing 515 participants with PCOS, out of which 2 randomized controlled trials (RCTs) were included for meta-analysis. Random effects model was applied using Review Manager Software version 5.4.1 and strength of evidence was assessed using GRADEpro Guideline Development Tool, 2020. Meta-analysis showed that YT may significantly decrease menstrual irregularity (MD -.41, 95% CI -.74 to -.08), clinical hyperandrogenism (MD -.70, 95% CI -1.15 to -.26), fasting blood glucose (MD -.22 mmol/L, 95% CI -.44 to -.01), fasting insulin (MD -28.21 pmol/L, 95% CI -43.79 to -12.63), and homeostatic model assessment-insulin resistance value (MD -.86, 95% CI -1.29 to -.43). Strength of evidence was "low." In conclusion, YT may have beneficial effects on health outcomes in women suffering from PCOS. However, low strength of evidence suggests need of conducting well-designed RCTs to assess the efficacy of YT for PCOS.; Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. (Copyright © 2021 The Author(s).)

Vesentini, G., et al. (2022). "Interventions for treating urinary incontinence in older women: a network meta-analysis." The Cochrane Database of Systematic Reviews 2022(8): CD015376.
	Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To compare the different treatments (conservative, pharmacological, and surgical) in terms of cure or cure and improvement of urinary incontinence, and adverse events, in women aged 60 and over through a network meta-analysis, and ranking the numerous interventions within one treatment network.Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Vesentini, G., et al. (2020). "Pelvic floor muscle training for women with lumbopelvic pain: a systematic review and meta-analysis." European Journal of Pain 24(10): 1865-1879.
	BACKGROUND AND OBJECTIVE: It has been suggested that pelvic floor dysfunction may contribute to the development of lumbopelvic pain as a result of changes in trunk muscle control. However, there is limited evidence that pelvic floor muscle training (PFMT) can improve clinical outcomes in women with lumbopelvic pain. DATABASES AND DATA TREATMENT: Six databases were searched for randomised controlled trials (RCTs) comparing the effectiveness of PFMT to other conservative interventions (usual physiotherapy care or minimal intervention), no treatment, or placebo interventions on pain and disability in women with lumbopelvic pain. RESULTS: We included eight RCTs totalling 469 participants. PFMT were more effective than minimal intervention for lumbopelvic pain [Mean Difference (MD) 15.9/100 (95% Confidential Interval (CI), 8.2 to 23.6; p=0.00; I2 =3.92%)] and disability [Standardized Mean Difference (SMD) 0.5 (95% CI, 0.1 to 0.9; p=0.00; I2 =0%)] during pregnancy. PFMT were more effective than usual physiotherapy care for pain [MD 11.7/100 (95% CI, 7.5 to 15.9; p=0.00; I2 =94.14%)] and disability [SMD 0.3 (95% CI, 0.0 to 0.6; p=0.01; I2 =82.54%)] in non-pregnant women. Effect sizes were in general of arguable clinical relevance. CONCLUSIONS: Overall, the certainty of the evidence was very low-to low. There is no conclusive evidence that the addition of PFMT to usual physiotherapy care or minimal intervention is superior to minimal intervention and usual care alone given the small number of studies and high levels of heterogeneity of included studies. Further well-design trials are needed to establish the effectiveness of PFMT for lumbopelvic pain in women.

Veth Veerle, B., et al. (2023). "Gonadotropin-releasing hormone analogues for endometriosis." The Cochrane Database of Systematic Reviews 6: CD014788.
	Background: Endometriosis is a common gynaecological condition affecting 6 to 11% of reproductive-age women and may cause dyspareunia, dysmenorrhoea, and infertility. One treatment strategy is medical therapy with gonadotrophin-releasing hormone analogues (GnRHas) to reduce pain due to endometriosis. One of the adverse effects of GnRHas is a decreased bone mineral density. In addition to assessing the effect on pain, quality of life, most troublesome symptom and patients' satisfaction, the current review also evaluated the effect on bone mineral density and risk of adverse effects in women with endometriosis who use GnRHas versus other treatment options.; Objectives: To assess the effectiveness and safety of GnRH analogues (GnRHas) in the treatment of painful symptoms associated with endometriosis and to determine the effects of GnRHas on bone mineral density of women with endometriosis.; Search Methods: We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO and the trial registries in May 2022 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) which compared GnRHas with other hormonal treatment options, including analgesics, danazol, intra-uterine progestogens, oral or injectable progestogens, gestrinone and also GnRHas compared with no treatment or placebo. Trials comparing GnRHas versus GnRHas in conjunction with add-back therapy (hormonal or non-hormonal) or calcium-regulation agents were also included in this review. DATA COLLECTION AND ANALYSIS: We used standard methodology as recommended by Cochrane. Primary outcomes are relief of overall pain and the objective measurement of bone mineral density. Secondary outcomes include adverse effects, quality of life, improvement in the most troublesome symptoms and patient satisfaction. Due to high risk of bias associated with some of the studies, primary analyses of all review outcomes were restricted to studies at low risk of selection bias. Sensitivity analysis including all studies was then performed.; Main Results: Seventy-two studies involving 7355 patients were included. The evidence was very low to low quality: the main limitations of all studies were serious risk of bias due to poor reporting of study methods, and serious imprecision. Trials comparing GnRHas versus no treatment We did not identify any studies. Trials comparing GnRHas versus placebo There may be a decrease in overall pain, reported as pelvic pain scores (RR 2.14; 95% CI 1.41 to 3.24, 1 RCT, n = 87, low-certainty evidence), dysmenorrhoea scores (RR 2.25; 95% CI 1.59 to 3.16, 1 RCT, n = 85, low-certainty evidence), dyspareunia scores (RR 2.21; 95% CI 1.39 to 3.54, 1 RCT, n = 59, low-certainty evidence), and pelvic tenderness scores (RR 2.28; 95% CI 1.48 to 3.50, 1 RCT, n = 85, low-certainty evidence) after three months of treatment. We are uncertain of the effect for pelvic induration, based on the results found after three months of treatment (RR 1.07; 95% CI 0.64 to 1.79, 1 RCT, n = 81, low-certainty evidence). Besides, treatment with GnRHas may be associated with a greater incidence of hot flushes at three months of treatment (RR 3.08; 95% CI 1.89 to 5.01, 1 RCT, n = 100, low-certainty evidence). Trials comparing GnRHas versus danazol For overall pain, for women treated with either GnRHas or danazol, a subdivision was made between pelvic tenderness, partly resolved and completely resolved. We are uncertain about the effect on relief of overall pain, when a subdivision was made for overall pain (MD -0.30; 95% CI -1.66 to 1.06, 1 RCT, n = 41, very low-certainty evidence), pelvic pain (MD 0.20; 95% CI -0.26 to 0.66, 1 RCT, n = 41, very low-certainty evidence), dysmenorrhoea (MD 0.10; 95% CI -0.49 to 0.69, 1 RCT, n = 41, very low-certainty evidence), dyspareunia (MD -0.20; 95% CI -0.77 to 0.37, 1 RCT, n = 41, very low-certainty evidence), pelvic induration (MD -0.10; 95% CI -0.59 to 0.39, 1 RC , n = 4 , very low-certainty evidence), and pelvic tenderness (MD -0.20; 95% CI -0.78 to 0.38, 1 RCT, n = 41, very low-certainty evidence) after three months of treatment. For pelvic pain (MD 0.50; 95% CI 0.10 to 0.90, 1 RCT, n = 41, very low-certainty evidence) and pelvic induration (MD 0.70; 95% CI 0.21 to 1.19, 1 RCT, n = 41, very low-certainty evidence), the complaints may decrease slightly after treatment with GnRHas, compared to danazol, for six months of treatment. Trials comparing GnRHas versus analgesics We did not identify any studies. Trials comparing GnRHas versus intra-uterine progestogens We did not identify any low risk of bias studies. Trials comparing GnRHas versus GnRHas in conjunction with calcium-regulating agents There may be a slight decrease in bone mineral density (BMD) after 12 months treatment with GnRHas, compared to GnRHas in conjunction with calcium-regulating agents for anterior-posterior spine (MD -7.00; 95% CI -7.53 to -6.47, 1 RCT, n = 41, very low-certainty evidence) and lateral spine (MD -12.40; 95% CI -13.31 to -11.49, 1 RCT, n = 41, very low-certainty evidence). AUTHORS' CONCLUSIONS: For relief of overall pain, there may be a slight decrease in favour of treatment with GnRHas compared to placebo or oral or injectable progestogens. We are uncertain about the effect when comparing GnRHas with danazol, intra-uterine progestogens or gestrinone. For BMD, there may be a slight decrease when women are treated with GnRHas, compared to gestrinone. There was a bigger decrease of BMD in favour of GnRHas, compared to GnRHas in conjunction with calcium-regulating agents. However, there may be a slight increase in adverse effects when women are treated with GnRHas, compared to placebo or gestrinone. Due to a very low to low certainty of the evidence, a wide range of outcome measures and a wide range of outcome measurement instruments, the results should be interpreted with caution. (Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Vidal, F. (2022). "Impact of Ultra-long Versus Long Down-regulation Protocol on IVF/ICSI in Adenomyosis." ClinicalTrials.gov.
	No Results Available Drug: 11.25mg GnRH agonist|Drug: 0.1 mg GnRH agonist|Drug: 25 µg transdermal oestradiol Number of live birth after first or second in vitro fertilization (IVF)/intra cytoplasmic sperm injection (ICSI) attempt.|Uterine volume change|Occurrence of poor responders|Concentration of serum Human Chorionic Gonadotropin (HCG or ßhCG) ≥ 100 IU/l|Implantation rate|Number of Participants with clinical pregnancy|Number of Participants with clinical pregnancy with fetal heart beat|Number of Participants with ongoing pregnancy|First trimester miscarriage occurrence|Occurrence of menopause-like symptoms symptoms at the end of the GnRH agonist treatment|Occurrence of neonatal complications|Occurrence of any other Adverse Event|Occurrence of pregnancy and post-partum complications Female Phase 3 0 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment RC31/17/0448 January 2025

Vieira-Serna, S., et al. (2023). "Preoperative brachytherapy for early-stage cervical cancer: Systematic review and meta-analysis." Gynecologic Oncology 169: 4-11.
	Objective: To assess the rate of pathological response rate, and the oncological outcomes of preoperative brachytherapy (PBT) in early-stage cervical cancer.; Methods: A systematic literature review was conducted according to the Preferred Reporting Items for Systematic Reviews and meta-analyses (PRISMA) statement. MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Scopus databases were searched from inception until April 2022. Only English and French articles were included. Studies containing data about pathology response or oncological outcomes among patients who received PBT as compared to those who underwent up-front surgery in early-stage cervical cancer were included. This study was registered in PROSPERO (CRD42022319036).; Results: Thirteen studies met the inclusion criteria, 3 randomized controlled trials (RCT), and 10 non-randomized studies (NRS). The 5-year survival was significantly higher in the PBT group compared with the up-front surgery group (OR 1.78, 95% CI 1.11-2.84, I 2 = 0%) in the NRS. Recurrence rate was significantly lower in the PBT group compared with in up-front surgery group in the analysis of the RCT but not in NRS, (OR 0.34, 95% CI 0.13-0.91, I 2 not applicable) and (OR 0.72, 95% CI 0.26-1.95, I 2 = 51%) respectively. PBT was associated with a statistically significant lower rate of positive margins (OR 0.28, 95% CI 0.09-0.89; I 2 = 42%) in the RCT and with a significantly higher rate of complete pathology response (CPR) in the RCT analysis (OR 2.55, 95% CI 1.11-5.85, I 2 = 0%) and in the NRS (OR 9.64, 95% CI 1.88-49.48, I 2 = 76%) compared with the up-front surgery group.; Conclusion: Preoperative brachytherapy in patients with early-stage cervical cancer could improve pathologic and oncologic outcomes, but it should be assessed in high-quality randomized controlled trials before its implementation in clinical practice. (Copyright © 2022 Elsevier Inc. All rights reserved.)

Vignali, M., et al. (2021). "Hormonal therapy potentiates the effect of surgery on gene expression profile of peripheral blood mononuclear cells in patients affected by endometriosis." Minerva Endocrinology 46(1): 90-98.
	BACKGROUND: Combined oral contraceptives (COCs) represent a common pharmacological approach for endometriosis. They have been demonstrated to mitigate painful symptoms in patients and are considered the first line therapy for symptomatic disease. The goal of this study was to evaluate whether the presence of pelvic endometriotic lesions can exert a systemic effect on PBMC gene expression and to investigate whether hormonal treatment may restore a normal gene expression profile. METHODS: Forty women, with endometriosis at stage III-IV, were enrolled in the study. After surgery, 20, randomly chosen, were treated with COC for six months and 20 did not receive hormonal therapy. Blood samples were obtained few days before surgery and six months after surgery. Gene expression profile of PBMC was studied by microarray. Gene expression levels before surgery and post-surgery, in presence and absence of COC, were compared. RESULTS: Nine genes previously reported to be overexpressed by endometriosis, were confirmed to be significantly downregulated after surgery. COC treatment lead to a greater down-regulation of these genes and to a significant down-regulation of 3 additional genes. 145 genes resulted downregulated and 28 upregulated by comparing gene expression before surgery with that 6 months after surgery in the presence of COC therapy. CONCLUSIONS: Results support the concept that a systemic chronic inflammatory status is among the mechanisms underlying endometriosis. Moreover, they shed light into the mechanisms of action of COCs and strength the rationale for their use to improve quality of life of women affected by the disease.

Vikneswaran, R., et al. (2021). "Physical exercise as an effective mode of intervention to combating infertility/subfertility." PROSPERO International prospective register of systematic reviews.
	
Villadsen Annemarie, B., et al. (2023). "Use of Fermented Red Clover Isoflavones in the Treatment of Overactive Bladder in Postmenopausal Women: A Randomized, Double-Blinded, Placebo-Controlled Trial." Nutrients 15(19).
	Postmenopausal women are at risk of developing an overactive bladder (OAB). Conventional vaginal estrogen has shown promise for symptom relief. Isoflavones have proven effective as an alternative to estrogen treatment against menopause-related symptoms. However, its effect on OAB symptoms has not been studied. This study investigates if fermented red clover isoflavones reduce OAB symptoms in postmenopausal women. In this randomized, double-blinded, placebo-controlled trial, women were administered red clover extract (RCE) or a placebo twice daily for three months. Women filled out the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) and Urinary Incontinence Short Form (ICIQ-UI-SF), together with a fluid intake and voiding diary. A total of 33 women (16 in the RCE group and 17 in the placebo group) were included in the analysis. Baseline demographics and OAB characteristics were comparable across groups. Intake of RCE did not lead to significant relief in most urinary bladder symptom measures, although a significant reduction in the bother of urinary urgency ( p = 0.033) and a tendency towards a decreased ICIQ-OAB score were observed ( p = 0.056). In contrast, the placebo exhibited a significant decrease in the ICIQ-OAB score ( p = 0.021) and in some diary outcomes. We found that an intake of isoflavones did not relieve OAB symptoms in postmenopausal women.

Villarejo, C., et al. (2024). "Paclitaxel as HIPEC-Drug after Surgical Cytoreduction for Ovarian Peritoneal Metastases: A Randomized Phase III Clinical Trial (HIPECOVA)." Current Oncology 31(2): 660-671.
	Multidisciplinary strategies have transformed the management of advanced ovarian cancer. We aimed to evaluate the effectiveness of paclitaxel in hyperthermic intraperitoneal chemotherapy (HIPEC) following surgical cytoreduction for ovarian peritoneal metastases in a randomized phase III trial conducted between August 2012 and December 2019. Seventy-six patients were randomized to either the HIPEC or no HIPEC group. Although median values for the primary endpoints (recurrence-free survival (RFS) and overall survival (OS)) revealed superior outcomes for the HIPEC (RFS: 23 months, OS: 48 months) over the control group (RFS: 19 months, OS: 46 months), these differences were not statistically significant (p = 0.22 and p = 0.579). Notably, the HIPEC group demonstrated significantly higher 5-year OS and 3-year RFS rates (47.2% and 47.5%) compared to patients without HIPEC (34.5% and 21.3%). Stratification according to Peritoneal Surface Disease Severity Score (PSDSS) showed improved OS and RFS for patients with lower PSDSS (I-II) in the HIPEC-treated group (p = 0.033 and p = 0.042, respectively). The Clavien-Dindo classification of adverse event grades revealed no significant differences between HIPEC and controls (p = 0.482). While overall results were not statistically significant, our long-term follow-up emphasized the potential benefit of HIPEC-associated cytoreduction with paclitaxel, particularly in selected ovarian cancer patients with lower PSDSS indices.Copyright © 2024 by the authors.

Viswanathan, M., et al. (2021). "Maternal, Fetal, and Child Outcomes of Mental Health Treatments in Women: A Systematic Review of Perinatal Pharmacologic Interventions." AHRQ Comparative Effectiveness Reviews.
	Background: Untreated maternal mental health disorders can have devastating sequelae for the mother and child. For women who are currently or planning to become pregnant or are breastfeeding, a critical question is whether the benefits of treating psychiatric illness with pharmacologic interventions outweigh the harms for mother and child.; Methods: We conducted a systematic review to assess the benefits and harms of pharmacologic interventions compared with placebo, no treatment, or other pharmacologic interventions for pregnant and postpartum women with mental health disorders. We searched four databases and other sources for evidence available from inception through June 5, 2020 and surveilled the literature through March 2, 2021; dually screened the results; and analyzed eligible studies. We included studies of pregnant, postpartum, or reproductive-age women with a new or preexisting diagnosis of a mental health disorder treated with pharmacotherapy; we excluded psychotherapy. Eligible comparators included women with the disorder but no pharmacotherapy or women who discontinued the pharmacotherapy before pregnancy.; Results: A total of 164 studies (168 articles) met eligibility criteria. Brexanolone for depression onset in the third trimester or in the postpartum period probably improves depressive symptoms at 30 days (least square mean difference in the Hamilton Rating Scale for Depression, −2.6; p=0.02; N=209) when compared with placebo. Sertraline for postpartum depression may improve response (calculated relative risk [RR], 2.24; 95% confidence interval [CI], 0.95 to 5.24; N=36), remission (calculated RR, 2.51; 95% CI, 0.94 to 6.70; N=36), and depressive symptoms (p-values ranging from 0.01 to 0.05) when compared with placebo. Discontinuing use of mood stabilizers during pregnancy may increase recurrence (adjusted hazard ratio [AHR], 2.2; 95% CI, 1.2 to 4.2; N=89) and reduce time to recurrence of mood disorders (2 vs. 28 weeks, AHR, 12.1; 95% CI, 1.6 to 91; N=26) for bipolar disorder when compared with continued use. Brexanolone for depression onset in the third trimester or in the postpartum period may increase the risk of sedation or somnolence, leading to dose interruption or reduction when compared with placebo (5% vs. 0%). More than 95 percent of studies reporting on harms were observational in design and unable to fully account for confounding. These studies suggested some associations between benzodiazepine exposure before conception and ectopic pregnancy; between specific antidepressants during pregnancy and adverse maternal outcomes such as postpartum hemorrhage, preeclampsia, and spontaneous abortion, and child outcomes such as respiratory issues, low Apgar scores, persistent pulmonary hypertension of the newborn, depression in children, and autism spectrum disorder; between quetiapine or olanzapine and gestational diabetes; and between benzodiazepine and neonatal intensive care admissions. Causality cannot be inferred from these studies. We found insufficient evidence on benefits and harms from comparative effectiveness studies, with one exception: one study suggested a higher risk of overall congenital anomalies (adjusted RR [ARR], 1.85; 95% CI, 1.23 to 2.78; N=2,608) and cardiac anomalies (ARR, 2.25; 95% CI, 1.17 to 4.34; N=2,608) for lithium compared with lamotrigine during first-trimester exposure.; Conclusions: Few studies have been conducted in pregnant and postpartum women on the benefits of pharmacotherapy; many studies report on harms but are of low quality. The limited evidence available is consistent with some benefit, and some studies suggested increased adverse events. However, because these studies could not rule out underlying disease severity as the cause of the association, the causal link between the exposure and adverse events is unclear. Patients and clinicians need to make an informed, collaborative decision on treatment choices.

Vitagliano, A., et al. (2019). "Endometrial scratching for infertile women undergoing a first embryo transfer: a systematic review and meta-analysis of published and unpublished data from randomized controlled trials." Fertility and Sterility 111(4): 734.
	Objective: To investigate endometrial scratch injury (ESI) as an intervention to improve IVF outcome in women undergoing a first ET.; Design: Systematic review and meta-analysis.; Setting: Not applicable.; Patient(s): Infertile women undergoing a first fresh/frozen embryo transfer.; Intervention(s): We included published and unpublished data from randomized controlled trials in which the intervention group received ESI and controls received placebo or no intervention. Pooled results were expressed as relative risk (RR) with 95% confidence interval (CI). The review protocol was registered in PROSPERO to start the data extraction (CRD42018087786).; Main Outcome Measure(s): Ongoing pregnancy/live birth rate (OPR/LBR), clinical pregnancy rate (CPR), multiple pregnancy rate (MPR), miscarriage rate (MR), and ectopic pregnancy rate (EPR).; Result(s): Seven studies were included (1,354 participants). We found a nonsignificant difference between groups in terms of OPR/LBR, CPR, MR, MPR, and EPR. Subgroup analysis found that ESI on the day of oocyte retrieval (achieved by a Novak curette) reduced OPR/LBR (RR 0.31, 95% CI 0.14-0.69) and CPR (RR 0.36, 95% CI 0.18-0.71), whereas ESI during the cycle preceding ET (performed through soft devices) had no effect on OPR/LBR and CPR. No difference in the impact of ESI was observed between fresh and frozen embryo transfer.; Conclusion(s): Current evidence does not support performing ESI with the purpose of improving the success of a first ET attempt. (Copyright © 2018 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Vitagliano, A., et al. (2019). "Pituitary block with gonadotrophin-releasing hormone antagonist during intrauterine insemination cycles: a systematic review and meta-analysis of randomised controlled trials." BJOG 126(2): 167-175.
	Background: Several randomised controlled trials (RCTs) have investigated the usefulness of pituitary block with gonadotrophin-releasing hormone (GnRH) antagonists during intrauterine insemination (IUI) cycles, with conflicting results.; Objective: The aim of the present systematic review and meta-analysis of RCTs was to evaluate the effectiveness of GnRH antagonist administration as an intervention to improve the success of IUI cycles.; Search Strategy: Electronic databases (MEDLINE, Scopus, EMBASE, Sciencedirect) and clinical registers were searched from their inception until October 2017.; Selection Criteria: Randomised controlled trials of infertile women undergoing one or more IUI stimulated cycles with GnRH antagonists compared with a control group.; Data Collection and Analysis: The primary outcomes were ongoing pregnancy/live birth rate (OPR/LBR) and clinical pregnancy rate (CPR). Pooled results were expressed as odds ratio (OR) or mean differences with 95% confidence interval (95% CI). Sources of heterogeneity were investigated through sensitivity and subgroups analysis. The body of evidence was rated using GRADE methodology. Publication bias was assessed with funnel plot, Begg's and Egger's tests.; Main Results: Fifteen RCTs were included (3253 IUI cycles, 2345 participants). No differences in OPR/LBR (OR 1.14, 95% CI 0.82-1.57, P = 0.44) and CPR (OR 1.28, 95% CI 0.97-1.69, P = 0.08) were found. Sensitivity and subgroup analyses did not provide statistical changes in pooled results. The body of evidence was rated as low (GRADE 2/4). No publication bias was detected.; Conclusion: Pituitary block with GnRH antagonists does not improve OPR/LBR and CPR in women undergoing IUI cycles.; Tweetable Abstract: Pituitary block with GnRH antagonists does not improve the success of IUI cycles. (© 2018 Royal College of Obstetricians and Gynaecologists.)

Vitale Salvatore, G., et al. (2023). "Efficacy of Hysteroscopy in Improving Fertility Outcomes in Women Undergoing Assisted Reproductive Technique: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." Gynecologic and Obstetric Investigation 88(6): 336-348.
	Introduction: Usefulness of hysteroscopy before assisted reproductive technique (ART) was considered debatable. However, over the last decade, several new trials have been added to available literature. We aimed to assess the impact of diagnostic and operative hysteroscopy on reproductive outcomes of infertile women with and without intrauterine abnormalities.; Materials and Methods: MEDLINE, Scopus, SciELO, Embase, Cochrane Library at CENTRAL, PROSPERO, CINAHL, grey literature, conference proceedings, and international controlled trials registries were searched without temporal, geographical, or language restrictions. Randomized controlled trials (RCTs) of infertile women comparing hysteroscopy versus no hysteroscopy prior to the first ART or after at least one failed attempt were included. RCTs of infertile women with intrauterine pathology comparing diagnostic versus operative hysteroscopy were included in separate analysis. Random-effect meta-analysis was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Grading of Recommendations, Assessment, Development and Evaluation and Cochrane criteria were used for quality of evidence and risk of bias assessment. Primary outcome was live birth rate (LBR). Secondary outcomes were clinical pregnancy (CPR) and pregnancy loss rate.; Results: Fifteen studies (5,038 women) were included. Compared to no hysteroscopy before first or after failed ART attempts, moderate-quality evidence showed that hysteroscopy increased the LBR (relative risk [RR] 1.24, 95% confidence interval [CI] 1.09-1.43, I2 = 21%), confirmed by subgroup analysis for women with failure after one or more ART cycles (RR 1.43, 95% CI: 1.19-1.72, I2 = 0%) but not before the first ART. Moderate-quality evidence showed that it increased the CPR (RR 1.36, 95% CI: 1.18-1.57; I2 = 51%), confirmed in subgroup analysis for both implantation failure (RR 1.40, 95% CI: 1.12-1.74, I2 = 52%) and before first ART (RR 1.32, 95% CI: 1.11-1.57, I2 = 42%). Low-quality data suggest that operative hysteroscopy increases CPR when used to treat intrauterine pathologies (RR 2.13, 95% CI: 1.56-2.92, I2 = 0%).; Conclusions: Although moderate-quality evidence supports performing hysteroscopy before ART in women with history of implantation failure, hysteroscopic evaluation of uterine cavity should be considered a first-line technique in all infertile women undergoing ART. Additional high-quality RCTs are still needed, particularly to assess yield during couple's initial evaluation even before ART is considered. (© 2023 The Author(s). Published by S. Karger AG, Basel.)

Vitale Salvatore, G., et al. (2021). "Surgical and Reproductive Outcomes after Hysteroscopic Removal of Retained Products of Conception: A Systematic Review and Meta-analysis." Journal of Minimally Invasive Gynecology 28(2): 204-217.
	Objective: To evaluate the impact of hysteroscopy for retained products of conception (RPOC) removal on surgical and reproductive outcomes.; Data Sources: Electronic databases (MEDLINE, Scopus, ClinicalTrials.gov, SciELO, EMBASE, and the Cochrane Central Register of Controlled Trials at the Cochrane Library) were searched from inception to March 2020.; Methods of Study Selection: Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Meta-analysis of Observational Studies in Epidemiology guidelines were followed. Medical Subject Headings terms and text words such as "retained products of conception," "placental remnants," "placenta," and "hysteroscopy" were used for the identification of relevant studies. We included observational and randomized studies that analyzed surgical and/or reproductive outcomes of women who underwent hysteroscopic removal of RPOC. The primary outcome was the complete resection rate after 1 procedure.; Tabulation, Integration, and Results: Twenty out of 245 studies were applicable, with data provided for 2112 women. The pooled complete resection rate was 91% (95% confidence interval [CI], 0.83-0.96). The incomplete resection rate evaluated was 7% (95% CI, 0.03-0.14), with a complication rate of 2% (95% CI, 0.00-0.04). Out of 1478 procedures, only 12 cases (0.8%) of postsurgical intrauterine adhesions were reported. Regarding post-therapy fecundity, women attempting postoperative conception had a clinical pregnancy rate of 87% (95% CI, 0.75-0.95), with a live birth rate of 71% (95% CI, 0.60-0.81) and a pregnancy loss rate of 9% (95% CI, 0.06-0.12).; Conclusion: Hysteroscopy has a high rate of completely removing RPOC in a single surgical step, with low complication rates. Subsequent fecundity seems reassuring, with appropriate clinical pregnancy and live birth rates. However, standardization of approach and comparative trials of different hysteroscopic approaches are needed. (Copyright © 2020. Published by Elsevier Inc.)

Vitale Salvatore, G., et al. (2022). "Quality of Life, Anxiety and Depression in Women Treated with Hysteroscopic Endometrial Resection or Ablation for Heavy Menstrual Bleeding: Systematic Review and Meta-Analysis of Randomized Controlled Trials." Medicina 58(11).
	Background and Objectives : Hysteroscopic endometrial resection (ER) or global endometrial ablation (GEA) are feasible methods to treat heavy menstrual bleeding (HMB). The aim of this systematic review and meta-analysis of randomized controlled trials (RCTs) was to assess patient's quality of life (QoL) in women treated with ER/GEA compared to hysterectomy. Materials and Methods : Electronic searches in MEDLINE Scopus, ClinicalTrials.gov, EMBASE, PROSPERO and Cochrane CENTRAL were conducted from their inception to July 2022. Inclusion criteria were RCTs of premenopausal women with HMB randomized to conservative surgical treatment (ER/GEA) or hysterectomy. The primary outcome was the evaluation of QoL using the SF-36 score. Results : Twelve RCTs (2773 women) were included in the analysis. Women treated with hysteroscopic ER/GEA showed significantly lower scores for the SF-36 general health perception (mean difference (MD) -8.56 [95% CI -11.75 to -5.36]; I 2 = 0%), social function (MD -12.90 [95% CI -23.90 to -1.68]; I 2 = 91%), emotional role limitation (MD -4.64 [95% CI -8.43 to -0.85]; I 2 = 0%) and vitality (MD -8.01 [95% CI -14.73 to -1.30]; I 2 = 74%) domains relative to hysterectomy. Anxiety, depression scores and complication rates were similar between treatments. Relative to uterine balloon therapy, amenorrhea was more common with EA/GER (relative risk 1.51 [95% CI 1.03 to 1.20] I 2 = 28 %), but posttreatment satisfaction was similar. Conclusions : Women's perception of QoL might be seen to be less improved after hysteroscopic ER/GEA rather than hysterectomy. However, such findings need to be confirmed by additional trials due to the high number of outdated studies and recent improvements in hysteroscopic instrumentation and techniques.

Viveros-Carreño, D., et al. (2024). "De-escalation of surgical radicality for non-fertility preserving management in patients with early-stage cervical cancer: a systematic review." International Journal of Gynecological Cancer 34(3): 386-392.
	Objective: We sought to evaluate the oncologic outcomes of simple hysterectomy in patients with low-risk early-stage cervical cancer (tumors ≤2 cm with limited stromal invasion).; Methods: This study was registered in PROSPERO (registration number CRD42023433840) following the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) checklist. MEDLINE (through Ovid), EmMBASEbase, and Cochrane Central Register of Controlled Trials were searched from inception until June 2023. Randomized controlled trials and observational studies with two arms of comparison (simple hysterectomy with lymph node assessment vs radical hysterectomy with lymph node assessment) in patients with low-risk early-stage cervical cancer were considered.; Results: The search identified 1270 articles; eighteen studies were considered potentially eligible after removing duplicates, and four met the selection criteria. Three studies were randomized controlled trials, and the other was a retrospective cohort study. In total, 981 patients were included. There were 485 (49.4%) and 496 (50.6%) patients in the simple hysterectomy and radical hysterectomy groups, respectively. Simple hysterectomy with lymph node assessment was not associated with a higher risk of death at 5 years (RR 0.98, 95% CI: 0.31 to 3.10; I 2 =0%, two randomized controlled trials, 141 patients, for an absolute risk reduction of zero percentage points [95% CI -9.0 to 9.0]), pelvic recurrence at 3 years (97.5% and 97.8% for simple hysterectomy and radical hysterectomy, respectively, p=0.79), and overall recurrence at 3 years (95 %% and 100% for simple hysterectomy and radical hysterectomy, respectively, p=0.30).; Conclusion: Simple hysterectomy with lymph node evaluation for low-risk early-stage cervical cancer is not associated with a detrimental effect on oncologic outcomes and has a better morbidity profile.; Competing Interests: Competing interests: None declared. (© IGCS and ESGO 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Vogel Mary, T. J. (2023). "Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer." ClinicalTrials.gov.
	No Results Available Dietary Supplement: Fasting Mimicking Diet (Xentigen by L'Nutra)|Drug: Carboplatin|Drug: Paclitaxel|Dietary Supplement: Standard diet To determine whether the combination of standard of care platinum-taxane chemotherapy with a FMD compared to a regular diet is associated with decreased gastrointestinal (GI) toxicity in advanced and recurrent ovarian cancer patients.|To determine whether the combination of standard of care platinum-taxane chemotherapy with a FMD compared to a regular diet is associated with decreased neurotoxicity in advanced and recurrent ovarian cancer patients.|To determine whether the combination of standard of care platinum-taxane chemotherapy with a FMD compared to a regular diet is associated with decreased hematologic toxicity in advanced and recurrent ovarian cancer patients.|To determine whether the combination of standard of care platinum-taxane chemotherapy with a FMD compared to a regular diet is associated with improved quality of life (QOL) in advanced and recurrent ovarian cancer patients|To determine whether the combination of standard of care platinum-taxane chemotherapy with a FMD compared to a regular diet is associated with improved QOL specifically with regards to less neuropathy in advanced and recurrent ovarian cancer patients|To determine whether the combination of standard of care platinum-taxane chemotherapy with a FMD compared to a regular diet is associated with improved QOL specifically with regards to less fatigue in advanced and recurrent ovarian cancer patients|To describe the safety and tolerability of a concurrent FMD, including patient compliance to diet, with platinum-taxane chemotherapy in advanced and recurrent ovarian cancer patients.|To compare radiographic tumor response to therapy in advanced and recurrent ovarian cancer patients treated with the combination of platinum-taxane chemotherapy and a FMD versus a regular diet.|To compare tumor response to therapy using a serum biomarker in advanced and recurrent ovarian cancer patients treated with the combination of platinum-taxane chemotherapy and a FMD versus a regular diet.|To compare tumor pathologic response to therapy in advanced ovarian cancer patients treated with the combination of platinum-taxane chemotherapy and a FMD versus a regular diet.|To measure the progression free survival (PFS) at 2 and 5 years in each group.|To measure the overall survival (OS) in each group. Female Not Applicable 170 Other|Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment EH22-383 June 1, 2031

Volodarsky-Perel, A., et al. (2019). "Treatment of hydrosalpinx in relation to IVF outcome: a systematic review and meta-analysis." Reproductive Biomedicine Online 39(3): 413-432.
	Salpingectomy is the most widely used treatment for hydrosalpinx. The effect of salpingectomy on the stimulation response during subsequent IVF treatment, however, remains unclear. The aim of this systematic review was to evaluate the ovarian response and pregnancy outcome of IVF treatment carried out after salpingectomy compared with other pre-IVF treatment options for hydrosalpinx. We conducted a literature search using PubMed, Ovid MEDLINE, Google Scholar, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials. Five randomized studies and nine observational studies were included in the systematic review and evaluated using Cochrane Collaboration's tool for randomized, Newcastle-Ottawa scale for observational studies and GRADE guidelines for certainty of evidence assessment. The mean number of retrieved oocytes was similar between the groups in randomized (mean difference [MD] = -0.03, 95% CI -0.75 to 0.70) and observational studies (MD = -0.15, 95% CI -2.32 to 2.02). Live birth (RR 1.59, 95% CI 1.17 to 2.16), clinical pregnancy (RR 1.27, 95% CI 1.02 to 1.57) and implantation rates (RR 1.55, 95% CI 1.16 to 2.08) were higher in the salpingectomy group in randomized studies. The present systematic review and meta-analysis showed that salpingectomy does not impair the ovarian response during subsequent IVF treatment. (Copyright © 2019 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Vuong Lan, N., et al. (2023). "Outcomes of clinical in vitro maturation programs for treating infertility in hyper responders: a systematic review." Fertility and Sterility 119(4): 540-549.
	Oocyte in vitro maturation (IVM) has been proposed as an alternative to conventional ovarian stimulation (COS) in subfertile women with polycystic ovary syndrome. To evaluate the effectiveness and safety of IVM compared with COS in women with predicted hyperresponse to gonadotropins, we searched the published literature for relevant studies comparing any IVM protocol with any COS protocol followed by in vitro fertilization or intracytoplasmic sperm injection. A systematic review was undertaken on 3 eligible prospective studies. Live birth rate was not significantly lower after IVM vs. COS (odds ratio [95% confidence interval] of 0.56 [0.32-1.01] overall, 0.83 [0.63-1.10] for human chorionic gonadotropin (hCG)-triggered IVM [hCG-IVM] and 0.45 [0.18-1.13] for non-hCG-triggered IVM [non-hCG-IVM]), irrespective of the stage of transferred embryos. Data from nonrandomized studies generally showed either significantly low or statistically comparable rates of live birth with IVM vs. COS. Most studies have not identified any significant difference between IVM and COS with respect to the rates of obstetric or perinatal complications, apart from a potentially higher rate of hypertensive disorders during pregnancy. The development of offspring from IVM and COS with in vitro fertilization or intracytoplasmic sperm injection appears to be similar. Additional research is needed to identify which patient populations will benefit most from IVM, to define the appropriate clinical protocol, and to develop the optimal culture system. (Copyright © 2023 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Wagenaar, L. P., et al. (2023). "Hysteroscopic morcellation vs. curettage for removal of retained products of conception: a multicenter randomized controlled trial." Fertility and Sterility 120(6): 1243‐1251.
	Objective: To study the comparison between hysteroscopic morcellation (HM) of retained products of conception (RPOC) with ultrasound (US)‐guided electric vacuum aspiration in terms of intrauterine adhesion (IUA) formation, efficacy, and complications. Design: A randomized controlled, nonblinded trial. Setting: Three teaching hospitals and one university hospital from April 2015 to June 2022. Patients: A total of 133 women with RPOC on US, ranging from 1–4 cm, were randomized to receive either HM or electric vacuum aspiration. Intervention: Hysteroscopic morcellation was performed with the TruClear System (Medtronic, Minneapolis, MN, USA). Electric vacuum aspiration was performed using an 8‐ or 10‐mm flexible plastic Karman cannula under US guidance. Women allocated to vacuum aspiration underwent the procedure as soon as possible. Main Outcome Measures: In the HM group, an office diagnostic hysteroscopy was planned a minimum of 6 weeks after the end of pregnancy, followed by retained product of conception removal at least 8 weeks after the end of the pregnancy. Postoperatively, an office second‐look hysteroscopy was scheduled to assess the primary outcome of IUAs. Results: Postoperative IUAs were seen in 14.3% (9/63) of patients in the HM group and 20.6% (13/64) of patients in the vacuum aspiration group (−6% [−19.1% to 7.1%]). Significantly more RPOC were removed completely by HM compared with vacuum aspiration (95.2% vs. 82.5% (−14% [−24.9% to −3.1%]), and additional operative hysteroscopy was less frequently necessary in the HM group (12.5%) compared with the vacuum aspiration group (31.3%) (−20.1% [−34.3% to −6%]). The median operating time was shorter for vacuum aspiration compared with HM (5.80 minutes vs. 7.15 minutes). No differences were observed between HM and vacuum aspiration for the occurrence of intraoperative or postoperative complications (5.5% vs. 5.0% and 2.7% vs. 1.3%, respectively). Conclusion: In our randomized controlled trial, no significant differences were found in the occurrence of IUAs and complications. However, the RPOC were more often completely removed by HM than vacuum aspiration, and the HM group required fewer additional hysteroscopic treatments. Clinical Trial Registration Number: NTR4923 (https://trialsearch.who.int/Trial2.aspx?TrialID=NTR4923). Date of registration: November 23, 2014, date of initial participant enrollment: January 1, 2015

Wahyuningtyas, R. and A. Sa'adi (2020). Cinnamon Extract Effects on Insulin Resistance, Metabolic Factors, and Menstrual Cyclicity for Women with Polycystic Ovary Syndrome: A Systematic review and Meta-Analysis.
	A document by Riska Wahyuningtyas. Click on the document to view its contents.

Wake Forest University Health, S. (2022). "HOPE Trial hCG or Progesterone Effect on Recurrent Pregnancy Loss." ClinicalTrials.gov.
	Fifty (50) patients with unexplained recurrent pregnancy loss, defined as 2 or more losses. Workup will exclude structural, genetic, hormonal, and anti‐phospholipid syndrome‐related causes of RPL. Women with unexplained RPL will be randomized to receive a mid‐luteal injection of ovidril (250 ug) 1 week after ovulation vs prometrium (200 mg qhs) starting 4 days after ovulation. If pregnant, prometrium will be continued until 8 weeks of pregnancy. If pregnancy does not occur, subjects will be allowed to repeat this protocol for up to 3 cycles. Outcomes will be listed as "not pregnant", "biochemical pregnancy", "miscarriage" or "ongoing pregnancy" for each cycle. Endpoints of pregnant cycles will be compared for pregnancy rate, miscarriage rate, ongoing pregnancy rate and live birth rate.

Walker Stephen, J. (2021). "Investigation of PEMF Therapy for Female Patients With IC/BPS." ClinicalTrials.gov.
	Interstitial cystitis/bladder pain syndrome (IC/BPS) is a clinical diagnosis based primarily on chronic symptoms of pain perceived by the patient to emanate from the bladder and/or pelvis associated with urinary urgency or frequency in the absence of another identifiable cause of the symptoms. Although it is not a life‐threatening disease, the chronicity and severity of pain, along with other urinary symptoms, causes great impairment in a patient's quality of life. In addition, IC/BPS poses a significant clinical challenge for many reasons. For one, the pathophysiology described in the literature is incompletely determined and likely multi‐factorial, including factors such as inflammation, neurovascular dysfunction, ion imbalance, and impaired urothelial cell integrity. Consequently, there are many options for IC/BPS therapy, many of which are driven primarily by patient‐reported symptoms. In this regard, IC/BPS patients with moderate to severe pain typically require multi‐modal therapy, often resulting in incomplete or no resolution of symptoms. Another clinical challenge is the heterogeneity of the symptoms. While pelvic pain is the distinguishing characteristic, patients with IC/BPS also routinely present with additional urological and non‐urological medical symptoms and syndromes. This has led to the description of two specific sub‐phenotypes in IC/BPS based on anesthetized bladder capacity (BC), in which patients with BC < 400 cc are more likely to experience severe pain, urgency and frequency (bladder centric sub‐phenotype), and patients with BC > 400 cc (non‐bladder centric sub‐phenotype) have a higher prevalence of non‐urological associated syndromes (NUAS) such as fibromyalgia, chronic fatigue symptoms, irritable bowel syndrome, endometriosis and sicca syndrome. Pulsed Electromagnetic Field (PEMF) therapy may present a promising alternative therapy for patients with IC/BPS. PEMF is a safe, non‐invasive, and effective therapy currently used for wound healing, bone‐related diseases (osteoarthritis, rheumatoid arthritis), and chronic pain states (chronic lower back pain, fibromyalgia), the latter of which are frequently associated with IC/BPS as NUAS. Based on Faraday's law, electromagnetic interactions (e.g. PEMF) with biological processes and conditions (e.g. IC/BPS) will theoretically address many of the proposed pathophysiological causes of the condition. While the mechanism(s) of action are not fully understood, PEMF therapy has been shown in several studies (randomized, double‐blinded, placebo‐controlled trials) to decrease the output of pro‐inflammatory proteins, improve oxygenation of blood and tissue, stabilize transmembrane action potential and ion channels, and stimulate tissue regeneration. Thus, PEMF may provide a safe, non‐invasive therapeutic option that would be complementary to, or serve as an alternative for, the treatments that are currently being administered in IC/BPS for pain reduction. Of note, PEMF has demonstrated an excellent safety profile with no associated systemic risks reported to date. Additionally, the application of exogenous PEMF to stimulate the pelvic floor muscle has recently been introduced for treating urge and/or stress urinary incontinence and overactive bladder. Furthermore, if patient safety and efficacy for pain reduction are demonstrated, these feasibility studies will provide the foundation for larger multi‐site trials to determine additional parameters regarding the appropriate number of treatments as well as the duration of benefit (pain relief) following treatments. The purpose of this study is to determine the safety and efficacy of PEMF therapy to significantly reduce pain among female patients with IC/BPS (Aim 1) and to evaluate the duration of benefit from PEMF therapy with and without maintenance treatments over a 4‐month period (Aim 2).

Walker Stephen, J. (2023). "Efficacy of Pulsed Electromagnetic Field and Heparin/Bupivacaine Instillations." ClinicalTrials.gov.
	IC/BPS is a chronic condition affecting the urinary bladder, causing generalized pelvic pain and urinary symptoms such as urgency, frequency, and nocturia. Although it is not a life‐threatening condition, the chronicity and severity of pain, along with urinary symptoms, can negatively impact a patient's quality of life. IC/BPS poses as a significant clinical challenge for many reasons. Importantly, the pathophysiology is incompletely understood and likely multi‐factorial, including factors such as inflammation, neurovascular dysfunction, ion imbalance, and impaired urothelial cell integrity. Consequently, there are many therapeutic options for IC/BPS, many of which are driven primarily by patient‐reported symptoms. In this regard, IC/BPS patients with moderate to severe pain typically require multi‐modal therapy, often resulting in incomplete or no resolution of symptoms. Another clinical challenge is the heterogeneity of the symptoms. While pelvic pain is the distinguishing characteristic, patients with IC/BPS routinely present with additional urological and non‐urological medical symptoms and syndromes. This has led to the description of two specific sub‐phenotypes in IC/BPS based on anesthetic bladder capacity (BC), in which patients with BC ≤ 500 cc are more likely to experience severe pain, urgency and frequency (bladder centric sub‐phenotype), and patients with BC > 500 cc (non‐bladder centric sub‐phenotype) have a higher prevalence of non‐urological associated syndromes (NUAS) such as fibromyalgia, migraines, chronic fatigue symptoms, irritable bowel syndrome, endometriosis and sicca syndrome. Intravesical bladder instillations have been listed as a treatment option for IC/BPS by the American Urologic Association (AUA). Current evidence supports the use of single or multi‐dose regimens of Dimethyl sulfoxide (DMSO), heparin and/or lidocaine. Heparin is a sulfated polysaccharide that is theorized to help restore the bladder's glycosaminoglycan (GAG) layer upon instillation, and multiple studies have demonstrated its effectiveness as an intravesical agent for symptom control. The combination of heparin with local anesthetics such as lidocaine/bupivacaine has been shown to provide even greater symptom relief than heparin alone. Pulsed Electromagnetic Field (PEMF) therapy is a safe, non‐invasive, and effective treatment option currently used for enhanced wound healing, bone‐related diseases (osteoarthritis, Rheumatoid arthritis (RA)), and chronic pain states (chronic lower back pain, fibromyalgia), the latter of which is frequently associated with IC/BPS. The proposed mechanism(s) of action of PEMF therapy have been shown in several studies (randomized, double‐blinded, placebo‐controlled trials) to decrease the output of pro‐inflammatory proteins, improve oxygenation of blood and tissue, stabilize transmembrane action potential and ion channels, and stimulate tissue regeneration PEMF therapy in conjunction with intravesical instillations of heparin and lidocaine/bupivacaine may be more effective in reducing pain levels and symptomatology of IC/BPS than instillations alone. Due to PEMF's proposed mechanism of action of improving microcirculation and tissue regenerative capacity, it may be able to augment pain reduction by improving both the protective effect of heparin on the GAG layer and bupivacaine's anesthetic efficacy. Using a randomized, sham‐controlled trial design, this study will investigate the potential added therapeutic benefit of simultaneous PEMF therapy in patients who self‐administer bladder instillations of heparin‐bupivacaine multiple times per week, compared to instillations administered without PEMF.

Wallace Shannon, L., et al. (2024). "Vaginal hysteropexy compared with vaginal hysterectomy with apical suspension for the treatment of pelvic organ prolapse: A 5-year cost-effectiveness Markov model." BJOG 131(3): 362-371.
	Objective: Our objective was to perform a 5-year cost-effectiveness analysis of transvaginal hysteropexy (HP) via sacrospinous ligament fixation (SS) or uterosacral ligament suspension (US) versus vaginal hysterectomy (VH) with apical suspension via sacrospinous ligament fixation (SS) or uterosacral ligament suspension (US) for the treatment of uterine prolapse.; Design: A decision analytic model assessed the cost-effectiveness of the surgical intervention over a 5-year horizon.; Setting: This model was constructed using TreeAge® software.; Population or Sample: Healthy women undergoing surgery for uterine prolapse were modeled.; Methods: A Markov model was constructed to simulate the possible recurrence of prolapse. Recurrence rates, repeat surgery for surgical failures and complication rates were modeled. Base case, sensitivity analyses and probabilistic modeling were performed.; Main Outcome Measures: The primary outcome was the incremental cost-effectiveness ratio (ICER) of <$100 000 per quality-adjusted life year (QALY).; Results: Using the available prolapse recurrence rates and repeat surgery rates in the literature, both HP-SS and HP-US are cost-effective at a willingness-to-pay (WTP) threshold of <$100 000 per QALY. The incremental cost-effectiveness ratio (ICER) for HP-US compared to HP-SS is $90 738.14, while VH-US and VH-SS are both dominated strategies. HP-US is the optimal cost-effective strategy but decays exponentially with increasing probability of prolapse recurrence and need for repeat surgery after failed hysteropexy. The cost-effectiveness acceptability curve (CEAC) favors sacrospinous hysteropexy until reaching a WTP threshold between $90 000 and $100 000.; Conclusion: Hysteropexy surgical strategies are cost-effective transvaginal surgical approaches for uterine prolapse. Vaginal hysterectomy with apical suspension becomes more cost-effective with increasing probability of prolapse recurrence and need for repeat surgery after failed hysteropexy. Given the variability of prolapse recurrence rates in the literature, more comparative studies are needed to understand the cost-effectiveness relationship between these different surgical approaches. (© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Wanchen, S., et al. (2022). "Systematic review of OnabotulinumtoxinA for the management of overactive bladder in women." PROSPERO International prospective register of systematic reviews.
	
Wang, A., et al. (2019). "The effectiveness of metformin, oral contraceptives, and lifestyle modification in improving the metabolism of overweight women with polycystic ovary syndrome: a network meta-analysis." Endocrine 64(2): 220-232.
	Purpose: We designed a network meta-analysis that investigated relatively different interventions that included the effects of metformin, oral contraceptives, and lifestyle modification on the metabolic parameters of patients with polycystic ovary syndrome. In addition, we searched for eligible interventions that improved the metabolism of glucose and lipids.; Methods: We searched the PubMed, EMBASE, and Cochrane Central databases from inception to May 2018. Publication types that were categorized as randomized controlled trials met our inclusion criteria. The main outcome included the homeostasis model assessment of insulin resistance, total cholesterol, low-density lipoprotein cholesterol, and total triglycerides. We performed both a pairwise meta-analysis and a network meta-analysis to evaluate the mean difference value and 95% credibility intervals, and we calculated the surface cumulative rank curve.; Results: There were a total of 12 kinds of interventions: metformin, 2 mg cyproterone acetate plus 0.05 mg ethinylestradiol (EE/CA), 0.15 mg desogestrel plus 0.03 mg ethinylestradiol (EE/DSG), and 3 mg drospirenone plus 0.03 mg ethinylestradiol (EE/DRSP), lifestyle, exercise, diet, metformin + lifestyle, metformin + diet, EE/CA + lifestyle, metformin + EE/CA, and EE/DRSP + lifestyle from the 20 eligible RCTs that were included in this study. Our meta-analysis results showed that metformin + lifestyle (MD = -2.04, 95% CrI = -3.64 to -0.41), EE/CA + lifestyle (MD = -2.23, 95% CrI = -4.11 to -0.35), and EE/DRSP + lifestyle (MD = -2.59, 95% CrI = -4.66 to -0.50) resulted in lower in the levels of total cholesterol. Women treated with metformin + lifestyle (MD = -1.82, 95% CrI = -2.88 to -0.79), EE/CA + lifestyle (MD = -2.25, 95% CrI = -3.58 to -1.08), or EE/DRSP + lifestyle (MD = -2.29, 95% CrI = -3.69 to -1.07) exhibited significantly lower low-density lipoprotein cholesterol when compared with the placebo group. There was no significant difference between any of the interventions compared with a placebo in the levels of homeostasis model assessment of insulin resistance and total triglycerides. The surface cumulative rank curve revealed that metformin + lifestyle might be the best intervention with respect to the improvement of the homeostasis model of assessment insulin resistance and EE/DRSP + lifestyle appeared to be the best intervention for the reduction of total cholesterol and low-density lipoprotein cholesterol. Moreover, the metformin + diet intervention was more effective in reducing the level of total triglycerides.; Conclusions: For overweight polycystic ovary syndrome patients, our evidence revealed that EE/CA and EE/SRSP combined with metformin or lifestyle changes can reduce the adverse effects on glucose and lipid metabolism of the use of oral contraceptive agents alone. Conventional PCOS treatments, such as metformin, EE/CA, and EE/DRSP, combined with lifestyle control can be particularly effective in improving the homeostasis model assessment of insulin resistance and lipid metabolism.

Wang, B., et al. (2022). "The efficacy and safety of platinum-based chemotherapy for ovarian cancer in pregnancy: A protocol for systematic review and meta-analysis." Medicine 101(47): e31954.
	Background: Ovarian cancer during pregnancy is a rare event. Little is known about the treatment of this condition due to lack of high level evidence. Therefore, we performed a protocol for systematic review and meta-analysis to evaluate the efficacy and safety of platinum-based chemotherapy for the treatment of ovarian cancer during pregnancy.; Methods: This systematic review has been registered in PROSPERO (CRD42022370709), which will be conducted in accordance with preferred reporting items for systematic review and meta-analysis protocols 2015 statement. We will search 7 electronic databases to identify relevant studies from inception to October, 2022, which includes PubMed, MEDLINE, Embase, Cochrane Clinical Trials Database, Web of Science, China National Knowledge Infrastructure, and Chinese Biomedical Literature Database. The Cochrane Handbook for systematic reviews of interventions will be performed to assess a broad category of biases in the included studies. The Grading of Recommendations Assessment, Development and Evaluation system will be used to judge the overall quality of evidence supporting outcomes in this work. Data are analyzed with the Review Manager Version 5.3 software.; Results: The results of this meta-analysis would be submitted to peer-reviewed journals for publication.; Conclusion: This paper will provide high-quality synthesis to assess the efficacy and safety of platinum-based chemotherapy for ovarian cancer in pregnancy.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Wang, B., et al. (2021). "Survival outcomes of neoadjuvant chemotherapy-related strategies compared with concurrent chemoradiotherapy for locally advanced cervical cancer: a meta-analysis of randomized controlled trials." Archives of Gynecology and Obstetrics 304(2): 485-493.
	Purpose: The survival benefits of neoadjuvant chemotherapy (NAC) compared with those of concurrent chemoradiotherapy (CRT) for locally advanced cervical cancer (LACC) patients remain uncertain. Meta-analysis was used to compare NAC and CRT.; Methods: A systematic search was performed up to 9 September 2020. Survival outcomes were analyzed based on event frequency or hazard ratios (HRs). Multilevel mixed-effects logistic regression was applied to analyze the effect of regimen variables on survival outcomes.; Results: Analysis based on Cox regression showed that CRT was better than NAC + radical hysterectomy (RT) (HR 1.25; 95% confidence interval (CI)) 1.02-1.54; p = 0.034) in terms of overall survival (OS). According to multilevel mixed-effects model analysis comparing NAC + RT and CRT, LACC patients who used cisplatin instead of carboplatin had a better Progression-free survival (PFS) (odds ratio (OR) 1.54; 95% CI 1.08-2.20; p = 0.016). When NAC + CRT and CRT were compared, gemcitabine administration was associated with a decrease in PFS (OR 0.47; 95% CI 0.22-0.99; p = 0.047). Increased doses of cisplatin and paclitaxel were associated with survival improvement.; Conclusion: Based on traditional meta-analysis, CRT was better than NAC + RT in terms of OS. Carboplatin instead of cisplatin as part of the NAC + RT strategy or gemcitabine use in NAC + CRT may not be a good choice. An increased total dosage of paclitaxel and/or cisplatin as part of NAC + CRT and CRT strategies may improve the survival outcome of LACC patients. (© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.)

Wang, C., et al. (2021). "Comparative efficacies of different immunotherapy regimens in recurrent implantation failure: A systematic review and network meta-analysis." Journal of Reproductive Immunology 148: 103429.
	For patients with recurrent implantation failure (RIF), immune system imbalances have become the focus of research. The effects of different classes of immunotherapies on improving pregnancy outcomes have not been fully established. This network meta-analysis was performed to assess the impact of popular immunotherapies in women with RIF. We systematically searched the Cochrane Central Register of Controlled Trials, PubMed, Embase, and Web of Science databases as well as clinical trial registration websites. Randomized controlled trials comparing immunotherapeutic outcomes were included. We performed the random-effects network meta-analysis to compare efficacy measures. A total of 21 trials involving 2277 participants and 8 immunotherapies were eligible for this study. Patients that had been administered with PBMCs, G-CSF, PRP, and sirolimus exhibited higher CPR than those administered with the placebo (2.63, 1.71-4.06; 2.03, 1.35-3.05; 1.98, 1.02-3.84; 2.55, 1.36-4.79; and 3.95, 1.33-11.72, respectively). For IR, only PBMCs and G-CSF were significantly more effective than the placebo (2.92, 1.39-6.12; 2.66, 1.16-6.06, respectively). In terms of LBR, PBMCs (2.96, 1.67-5.27) and sirolimus (3.55, 1.18-10.64) were effective. However, r-hLIF (0.25, 0.10-0.62) had a reduced risk of LBR. No therapeutic regimen was found to have significantly decreased MR, but PBMCs exhibited the lowest rank among all interventions (0.28, 0.06-1.44). To improve clinical pregnancy while reducing miscarriage outcomes, PBMCs might be a beneficent therapeutic option for RIF in the future. (Copyright © 2021 Elsevier B.V. All rights reserved.)

Wang, F., et al. (2024). "Effects of high-protein diets on the cardiometabolic factors and reproductive hormones of women with polycystic ovary syndrome: a systematic review and meta-analysis." Nutrition and Diabetes 14(1): 6.
	The optimal dietary regimen for polycystic ovary syndrome (PCOS) has not been identified. High-protein diets (HPDs) are effective for weight control in individuals with metabolic abnormalities, but no systematic meta-analyses have yet summarised the effects of HPDs on PCOS. Seven electronic databases were searched from inception to 30 April 2023, and studies comparing the effects of HPDs and other diets on the anthropometrics, metabolic factors, and hormonal profiles for PCOS were identified. Data were pooled using random-effects models and expressed as weighted mean differences and 95% confidence intervals. The risk of bias was assessed by Cochrane Collaboration tool. Eight trials involving 300 women with PCOS were included. Compared with isocaloric balanced diets (BDs), HPDs significantly reduced fasting insulin (-2.69 muIU/mL, 95% CI [-3.81, -1.57], P < 0.0001, I2 = 46%) and homoeostatic model assessment for insulin resistance (HOMA-IR-0.41, 95% CI [-0.80, -0.02], P = 0.04, I2 = 94%) in women with PCOS. However, HPDs and BDs had comparable effects on weight loss, abdominal adiposity, lipid profiles, and reproductive hormones (all P >= 0.05). HPDs may benefit women with PCOS in terms of improving insulin resistance, supporting for their use as one of the dietary management options for PCOS, however further RCTs in larger and broader settings are required to confirm these observations and investigate the mechanism behind it.Copyright © The Author(s) 2024.

Wang, F., et al. (2022). "Effects of internet-based cognitive behavioral therapy on postpartum depression: A protocol for systematic review and meta-analysis." Medicine 101(9): e28964.
	Background: Postpartum depression is one of the most common complications during the postpartum period. In recent years, internet-based psychological interventions have made significant progress and provided a new psychotherapy model. Internet-based cognitive behavioral therapy (ICBT) for postpartum depression has achieved good results. However, the effectiveness of ICBT for postpartum depression reported by different studies still remains inconsistent. Therefore, a meta-analysis was used to further evaluate the efficacy of ICBT for postpartum depression, aiming to provide evidence to support nonpharmacological intervention strategies in the clinic.; Methods: The databases of PubMed, Web of Science, Scopus, Cochrane Library, Embase, China Scientific Journal Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and Wanfang Data will be searched. The randomized controlled trials of ICBT will be included for postpartum depression published before February 2022. Two independent researchers will independently complete literature selection, risk of bias assessment and data extraction. The disagreements will be discussed with a third party for the final decision. Cochrane Risk of Bias Assessment Tool will be used for literature quality assessment. Data processing will be conducted by RevMan 5.4 software.; Results: The results of this meta-analysis will be submitted to a peer-reviewed journal for publication.; Conclusions: For the question whether ICBT for postpartum depression is efficacy, this study can provide more comprehensive and strong evidence.; Ethics and Dissemination: The ethical approval was not required for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences, and shared on social media platforms.; Osf Registration Number: DOI 10.17605/OSF.IO/EQJDH.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Wang, G., et al. (2023). "Cognitive-behavioral therapy for women with infertility: a systematic review and meta-analysis." Clinical Psychology & Psychotherapy 30(1): 38-53.
	Cognitive-behavioral therapy (CBT) has been used for women with infertility. However, the efficacy of CBT among the infertile female population remains inconclusive. We performed a systematic literature search using the Cochrane Library, MEDLINE (OVID), EMBASE (OVID), CINAHL, PsycINFO (OVID), Web of Science, and ProQuest databases from the inception to May 2022. The Cochrane risk of bias tool for randomized trials was used to assess the methodological quality of the included studies. Revman 5.4 was conducted for statistical analysis, and meta-analyses were performed to calculate the pooled effects of CBT. 16 articles were finally included in the meta-analysis. The results of the meta-analysis revealed large, significant effects of cognitive-behavioral interventions that can effectively reduce depression, anxiety symptoms, psychological distress, perceived stress, infertility-specific stress, and improve the quality of life in women with infertility. However, the pooled MD using a fixed-effects model was 0.25,95% CI [-0.33, 0.84], P = 0.40, and no significant differences in BMI were observed among those who received CBT therapy compared with those who did not. Cognitive-behavioral therapy effectively alleviates depression, anxiety, psychological distress, and infertility-specific stress levels and improves the quality of life among women with infertility. Future studies should explore the sustainability and long-term effect of cognitive-behavioral interventions in women with infertility.

Wang, G., et al. (2023). "Effects of mindfulness-based intervention for women with infertility: a systematic review and meta-analysis." Archives of Women's Mental Health 26(2): 245-258.
	This review aimed to examine the effects of mindfulness-based interventions on physical and psychological outcomes in women with infertility. Studies were included if participants were women diagnosed with infertility, were over the age of 18, and the design was a randomized controlled trial of a mindfulness-based intervention program. Two independent reviewers undertook eligibility screening, data extraction, and methodological quality assessment. We used RevMan software version 5.4 (The Cochrane Collaboration) to conduct the meta-analyses. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) was followed. Ten articles were finally included in the current meta-analysis. The results of the meta-analysis revealed large, significant effects of mindfulness-based interventions that can effectively reduce depression[SMD = -1.28, 95% CI (-1.95, -0.60), P < 0.0001], anxiety [SMD = -0.89, 95% CI (-1.26, -0.51), P < 0.00001] symptoms, and improve five domains of health-related quality of life (physical function [MD = 9.47, 95% CI (4.33, 14.61), P = 0.0003], general health [MD = 15.77, 95% CI (7.62, 23.92), P = 0.0002], vitality [MD = 14.85, 95% CI (4.95, 24.74), P = 0.003], role-physical [MD = 22.44, 95% CI (14.97, 29.91), P < 0.00001] and social function [MD = 8.27, 95% CI (3.56, 12.97), P = 0.0006)] in women with infertility. The current meta-analysis results revealed that mindfulness-based interventions could effectively reduce depression and anxiety symptoms and improve health-related quality of life in women with infertility. Future rigorously designed, high-quality research is required to demonstrate whether mindfulness-based intervention programs can effectively reduce perceived stress and BMI.

Wang, G., et al. (2022). "Evaluation of the effect of low molecular weight heparin in unexplained recurrent pregnancy loss: a meta-analysis of randomized controlled trials." The Journal of Maternal-fetal & Neonatal Medicine 35(25): 7601-7608.
	Introduction: The effectiveness of low molecular weight heparin (LMWH) in preventing miscarriage of unexplained recurrent pregnancy loss remains controversial. In order to explore the effect of LMWH therapy in unexplained recurrent pregnancy loss, we conducted this meta-analysis.; Methods: We searched four databases PubMed, Cochrane Library, EMBASE, and Clinical Trials.gov (up to February 2020) for the randomized control trials (RCTs) evaluating the effectiveness of LMWH on the treatment of recurrent miscarriage. We used Stata software to perform a meta-analysis. Moreover, we performed analyses of sensitivity and predefined subgroups based on the definition of recurrent miscarriage (e.g. 2 or more miscarriages or 3 or more miscarriages) to search the source of heterogeneity.; Results: 5 studies met the selection criteria, involving 1452 participants. LMWH reduce the risk of miscarriage of women suffering ≥3 miscarriages (RR = 0.46; 95% CI = 0.35-0.61, p = .00), but the risk of miscarriage of women suffering ≥2 miscarriages was not decreased by LMWH (RR = 0.70; 95% CI = 0.57-0.86, p = .26). No substantial influence was found on Live birth rate (RR = 1.19; 95% CI = 0.99-1.43), Preterm birth (RR = 0.95; 95% CI = 0.65-1.38), Preeclampsia (RR = 0.89, 95% CI = 0.45-1.76), Small for gestational age (RR = 0.89; 95% CI = 0.64-1.51).; Conclusion: LMWH treatment may decrease the miscarriage rate in women suffering a history of 3 or more miscarriages, but not reduce the incidence of miscarriage in women suffering a history of 2 or more miscarriages. We need more RCTs to provide robust and reliable results.

Wang, H., et al. (2022). "Transobturator tape, tension-free vaginal tape, and transvaginal tension-free vaginal tape-obturator for the treatment of female stress urinary incontinence: A systematic review and network meta-analysis." International Journal of Gynecology and Obstetrics 157(3): 527-535.
	Objective: To systematically review the safety and effectiveness of tension-free vaginal tape (TVT), transobturator tape (TOT), and transvaginal tension-free vaginal tape-obturator (TVT-O) in the treatment of stress urinary incontinence (SUI). Method(s): The PubMed, Embase, The Cochrane Library, Web of Science, WanFang Data, and CNKI were electronically searched. A total of 22 trials involving 3709 patients were included. Result(s): The objective cure rate was better with TVT than with TOT and TVT-O. The incidence of postoperative thigh/groin pain was lower with TVT than with TOT and TVT-O, but the incidence of dysuria was higher with TVT than with TVT-O. The incidence of lower urinary tract infection was higher with TVT than with TOT. Conclusion(s): Tension-free vaginal tape may have a better outcome compared to TOT and TVT-O, but the risk of dysuria and lower urinary tract infection is higher with SUI.Copyright © 2021 International Federation of Gynecology and Obstetrics.

Wang, H., et al. (2021). "Comparison of Radical Surgery and Radiotherapy for the Treatment of Early-Stage Cervical Carcinoma: A Meta-Analysis." Oncology Research and Treatment 44(4): 176-183.
	Objective: To compare the efficacy and safety of radical surgery with radiotherapy in patients with early-stage cervical carcinoma.; Methods: PubMed, Web of Science, and Embase were systematically reviewed, and studies comparing radical surgery with radiotherapy were included. The main efficacy outcomes included overall survival (OS), and disease-free survival (DFS). Safety endpoints were adverse events. Hazard ratios (HR) or risk ratios (RR) with 95% CI were used to pool the estimates.; Results: A total of 6 studies were included in this meta-analysis. Radical surgery was associated with comparable survival effects in OS (HR = 0.73; 95% CI 0.46-1.17; p = 0.196) and DFS (HR = 0.84; 95% CI 0.64-1.10; p = 0.207) as compared with radiotherapy. Moreover, positive lymphangiography (HR = 3.67; 95% CI 2.86-4.70; p < 0.001), adeno-carcinomatous histotype (HR = 2.53; 95% CI 1.80-3.56; p < 0.001), adenosquamous histotype (HR = 1.55; 95% CI 1.27-1.89; p < 0.001), tumor size ≥4 cm (HR = 1.60; 95% CI 1.14-2.23; p < 0.001), stage IB2 (HR = 1.71; 95% CI 1.43-2.04; p < 0.001), and stage IIA (HR = 1.85; 95% CI 1.54-2.22; p < 0.001) were all independent predictors of decreased survival. Patients treated with radical surgery had a rate of adverse events similar to that of those treated with radiotherapy (RR = 1.23; 95% CI 0.61-2.48; p = 0.557).; Conclusion: The present study suggested that radical surgery and radiotherapy offered similarly effective treatment in terms of OS and DFS in early-stage cervical carcinoma. Moreover, the complication rate between the 2 treatments was not significantly different. Considering the potential limitations of this study, more large-scale well-designed randomized controlled trials are needed to verify our findings. (© 2021 S. Karger AG, Basel.)

Wang, H., et al. (2021). "Comparison of the Efficacy and Safety of PARP Inhibitors as a Monotherapy for Platinum-Sensitive Recurrent Ovarian Cancer: A Network Meta-Analysis." Frontiers in Oncology 11: 785102.
	Background: The present COVID-19 pandemic has tended toward normality. To provide convenient, safe, and effective home treatment programs for patients with recurrent ovarian cancer (ROC), the clinical efficacy and safety of poly (ADP-ribose) polymerase inhibitor (PARPi) (including olaparib, niraparib, and rucaparib) monotherapy as a maintenance treatment for platinum-sensitive ROC were systematically evaluated.; Methods: Numerous electronic databases were systematically searched for randomized controlled trials (RCTs) of PARPi maintenance treatment for ROC that were published before June 2021. The primary endpoints were overall survival (OS) and progression-free survival (PFS), and the secondary endpoint was grade 3-4 adverse effects (AEs). After data extraction and the quality evaluation of the included studies, Bayesian network meta-analysis (NMA) was performed using R software. The ability of each treatment was ranked using the surface under the cumulative ranking (SUCRA) curve.; Results: The analysis included five studies and 1390 patients. The NMA results demonstrated that compared with the placebo, olaparib and niraparib exhibited significant benefits in the gBRCA-mutated population, and respectively reduced the risk of death by 31% (HR = 0.69, 95% CI: 0.53-0.90) and 34% (HR = 0.66, 95% CI: 0.44-0.99). Olaparib, niraparib, and rucaparib were all found to be very effective in prolonging PFS in patients with ROC. All three PARPi treatments increased the number of grade 3-4 AEs in patients with ROC as compared with the placebo.; Conclusions: Overall, olaparib and niraparib maintenance treatment can significantly prolong the OS of patients with gBRCA mutations. Furthermore, the three investigated PARPi monotherapy maintenance treatments can prolong PFS regardless of BRCA mutation status. Although the incidence of AEs in the treatment groups was found to be significantly higher than that in the placebo group, the patients in the treatment group tolerated the treatment. Home oral PARPi treatment can balance tumor treatment and pandemic prevention and control, and is the most convenient, safe, and effective home treatment method available against the background of the current COVID-19 pandemic.; Systematic Review Registration: https://inplasy.com/inplasy-2021-6-0033/.; 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 Wang, Wu, Liu, Zhou, Zhao, Geng, Jiang, Zhang, Zhang, Han and Du.)

Wang, J., et al. (2023). "Comparative impact of exercise-based interventions for postpartum depression: A Bayesian network meta-analysis." International Journal of Gynaecology and Obstetrics.
	Objective: The current study aimed to address and rank which exercise-based interventions are preferable to standard care/no therapy or another exercise intervention for postpartum depression (PPD) management and provide estimates for future definitive evidence.; Methods: The authors systematically searched PubMed, Embase, the Web of Science, PsycInfo, and ClinicalTrails.gov for randomized controlled trials (RCTs) on exercise-based interventions for PPD from their inception to May 9, 2023. Included were RCTs of exercise-based interventions for PPD with at least 4 weeks' duration. The pooled effects of intervention comparisons were generated by the Bayesian random-effects model, and the quality of evidence was evaluated by the Grading of Recommendations, Assessment, Development, and Evaluations framework.; Results: Twelve RCTs (1260 women; mean age, 20-35 years) comparing exercise-based interventions with usual care/no therapy were included. Exercise effectively treats depressive symptoms (standard mean difference [SMD], -0.81 [95% confidence interval (CI), -1.20 to -0.42], P < 0.001). Pram walking was significantly associated with a reduction of depressive symptoms during the postpartum period (SMD, -1.00 [95% CI, -2.60 to -0.10], P = 0.020), as well as yoga (SMD, -0.73 [95% CI, -1.84 to -0.43], P < 0.001) and supervised mixed exercise (SMD, -0.77 [95% CI, -1.67 to -0.01], P = 0.041) compared with usual care/no therapy. In indirect comparisons, pram walking (surface under the cumulative ranking curve, 58.9%) was better than yoga (SMD, -0.28 [95% CI, -1.86 to 1.22], P = 0.322) and supervised mixed exercise (SMD, -0.23 [95% CI, -1.59 to 1.12], P = 0.358). However, the difference was not statistically significant. The confidence in evidence was very low to moderate.; Conclusion: In women with PPD, all commonly prescribed physical exercises were effective alternative or complementary treatments. However, pram walking may perform better in improving the symptoms of PPD. (© 2023 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Wang, J. and W. Chen (2022). "Reticular meta-analysis of oral Chinese patent medicine in the treatment of decreased ovarian reserve function." PROSPERO International prospective register of systematic reviews.
	
Wang, J., et al. (2021). "Efficacy and safety of acupuncture for adenomyosis: A protocol for systematic review and meta-analysis." Medicine 100(49): e28080.
	Background: Adenomyosis (AM) is a disease in which the endometrium (including glands and stroma) invades the myometrium and grows. The main clinical symptoms include menorrhagia, dysmenorrhea, chronic pelvic pain, metrorrhagia, and dyspareunia, which will seriously affect the physical and mental health of patients, and most of which occur in women of childbearing age. Acupuncture, as a special external treatment of Traditional Chinese medicine, has shown good effects in the treatment of adenomyosis. At present, there is a lack of systematic review on acupuncture in the treatment of adenomyosis. We conduct this study to evaluate the efficacy and safety of acupuncture in the treatment of adenomyosis.; Methods: We will search Chinese and English databases: Medline, Pubmed, EMBASE, Cochrane library, China National Knowledge Infrastructure (CNKI), Chinese Scientific and Journal Database, Wan Fang database (Wanfang), Chinese Biomedical Literature Database (CBM) to identify articles of randomized clinical trials of acupuncture for adenomyosis. All above electronic databases will be searched from inception to September 30, 2021. RevMan 5.3 software will be used to conduct this systematic review. No language and publication status restrictions will be applied.; Results: The study will prove the efficacy and safety of acupuncture for adenomyosis.; Conclusion: We plan to submit this systematic review to a peer-reviewed journal.; Trial Registration Number: CRD42021277136.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Wang, L., et al. (2021). "Effects of vitamin D supplementation on metabolic parameters of women with polycystic ovary syndrome: a meta-analysis of randomized controlled trials." Gynecological Endocrinology 37(5): 446-455.
	Objective: The purpose of this meta-analysis was to evaluate the effects of vitamin D supplementation on metabolic parameters of women with polycystic ovary syndrome (PCOS).; Methods: We performed a literature search of databases and identified randomized controlled trials (RCTs) published prior to December 2019. A meta-analysis was conducted using RevMan 5.3 and Stata 12.0 software. We compared the effects of vitamin D supplementation alone to the administration of placebos on metabolic parameters of PCOS women with vitamin D deficiency.; Results: Ten articles of RCTs were included and analyzed in this meta-analysis, which included a total of 520 PCOS women. Our meta-analysis results showed no significant effects of vitamin D supplementation on BMI ( p = .43), systolic blood pressure ( p = .05), diastolic blood pressure ( p = .87), fasting insulin concentration ( p = .86), HOMA-IR ( p = .47), HDL-C ( p = .76), LDL-C ( p = .23) and triglyceride ( p = .77). Both low dose vitamin D supplementation (<4000 IU/day) and high dose vitamin D supplementation (≥4000 IU/day) were found to significantly decreased the fasting glucose concentration ( p = .01, p = .001, respectively). Vitamin D supplementation significantly decreased total cholesterol concentration ( p = .03).; Conclusions: The results of this meta-analysis suggested that vitamin D supplementation decreases fasting glucose concentration and total cholesterol concentration in PCOS women with vitamin D deficiency.

Wang, R., et al. (2019). "Interventions for unexplained infertility: a systematic review and network meta-analysis." The Cochrane Database of Systematic Reviews 9: CD012692.
	Background: Clinical management for unexplained infertility includes expectant management as well as active treatments, including ovarian stimulation (OS), intrauterine insemination (IUI), OS-IUI, and in vitro fertilisation (IVF) with or without intracytoplasmic sperm injection (ICSI).Existing systematic reviews have conducted head-to-head comparisons of these interventions using pairwise meta-analyses. As this approach allows only the comparison of two interventions at a time and is contingent on the availability of appropriate primary evaluative studies, it is difficult to identify the best intervention in terms of effectiveness and safety. Network meta-analysis compares multiple treatments simultaneously by using both direct and indirect evidence and provides a hierarchy of these treatments, which can potentially better inform clinical decision-making.; Objectives: To evaluate the effectiveness and safety of different approaches to clinical management (expectant management, OS, IUI, OS-IUI, and IVF/ICSI) in couples with unexplained infertility.; Search Methods: We performed a systematic review and network meta-analysis of relevant randomised controlled trials (RCTs). We searched electronic databases including the Cochrane Gynaecology and Fertility Group Specialised Register of Controlled Trials, the Cochrane Central Register of Studies Online, MEDLINE, Embase, PsycINFO and CINAHL, up to 6 September 2018, as well as reference lists, to identify eligible studies. We also searched trial registers for ongoing trials.; Selection Criteria: We included RCTs comparing at least two of the following clinical management options in couples with unexplained infertility: expectant management, OS, IUI, OS-IUI, and IVF (or combined with ICSI).; Data Collection and Analysis: Two review authors independently screened titles and abstracts identified by the search strategy. We obtained the full texts of potentially eligible studies to assess eligibility and extracted data using standardised forms. The primary effectiveness outcome was a composite of cumulative live birth or ongoing pregnancy, and the primary safety outcome was multiple pregnancy. We performed a network meta-analysis within a random-effects multi-variate meta-analysis model. We presented treatment effects by using odds ratios (ORs) and 95% confidence intervals (CIs). For the network meta-analysis, we used Confidence in Network Meta-analysis (CINeMA) to evaluate the overall certainty of evidence.; Main Results: We included 27 RCTs (4349 couples) in this systematic review and 24 RCTs (3983 couples) in a subsequent network meta-analysis. Overall, the certainty of evidence was low to moderate: the main limitations were imprecision and/or heterogeneity.Ten RCTs including 2725 couples reported on live birth. Evidence of differences between OS, IUI, OS-IUI, or IVF/ICSI versus expectant management was insufficient (OR 1.01, 95% CI 0.51 to 1.98; low-certainty evidence; OR 1.21, 95% CI 0.61 to 2.43; low-certainty evidence; OR 1.61, 95% CI 0.88 to 2.94; low-certainty evidence; OR 1.88, 95 CI 0.81 to 4.38; low-certainty evidence). This suggests that if the chance of live birth following expectant management is assumed to be 17%, the chance following OS, IUI, OS-IUI, and IVF would be 9% to 28%, 11% to 33%, 15% to 37%, and 14% to 47%, respectively. When only including couples with poor prognosis of natural conception (3 trials, 725 couples) we found OS-IUI and IVF/ICSI increased live birth rate compared to expectant management (OR 4.48, 95% CI 2.00 to 10.1; moderate-certainty evidence; OR 4.99, 95 CI 2.07 to 12.04; moderate-certainty evidence), while there was insufficient evidence of a difference between IVF/ICSI and OS-IUI (OR 1.11, 95% CI 0.78 to 1.60; low-certainty evidence).Eleven RCTs including 2564 couples reported on multiple pregnancy. Compared to expectant management/IUI, OS (OR 3.07, 95% CI 1.00 to 9.41; low-certainty evidence) and OS-IUI (OR 3.34 95% CI 1.09 to 10.29; moderate-certainty evidence) increased the odds of multiple pregnancy, and there was insufficient vi ence of a difference between IVF/ICSI and expectant management/IUI (OR 2.66, 95% CI 0.68 to 10.43; low-certainty evidence). These findings suggest that if the chance of multiple pregnancy following expectant management or IUI is assumed to be 0.6%, the chance following OS, OS-IUI, and IVF/ICSI would be 0.6% to 5.0%, 0.6% to 5.4%, and 0.4% to 5.5%, respectively.Trial results show insufficient evidence of a difference between IVF/ICSI and OS-IUI for moderate/severe ovarian hyperstimulation syndrome (OHSS) (OR 2.50, 95% CI 0.92 to 6.76; 5 studies; 985 women; moderate-certainty evidence). This suggests that if the chance of moderate/severe OHSS following OS-IUI is assumed to be 1.1%, the chance following IVF/ICSI would be between 1.0% and 7.2%.; Authors' Conclusions: There is insufficient evidence of differences in live birth between expectant management and the other four interventions (OS, IUI, OS-IUI, and IVF/ICSI). Compared to expectant management/IUI, OS may increase the odds of multiple pregnancy, and OS-IUI probably increases the odds of multiple pregnancy. Evidence on differences between IVF/ICSI and expectant management for multiple pregnancy is insufficient, as is evidence of a difference for moderate or severe OHSS between IVF/ICSI and OS-IUI.

Wang, R., et al. (2021). "Cost-effectiveness of Surgical Treatment Pathways for Prolapse." Female Pelvic Medicine & Reconstructive Surgery 27(2): e408-e413.
	Objective: To evaluate the cost-effectiveness of surgical treatment pathways for apical prolapse.; Study Design: We constructed a stochastic Markov model to assess the cost-effectiveness of vaginal apical suspension, laparoscopic sacrocolpopexy, and robotic sacrocolpopexy. We modeled over 5 and 10 years, with 9 pathways accounting for up to 2 separate surgical repairs, recurrence of symptomatic apical prolapse, reoperation, and complications, including mesh excision. We calculated costs from the health care system's perspective.; Results: Over 5 years, compared with expectant management, all surgical treatment pathways cost less than the willingness-to-pay threshold of US $50,000 per quality adjusted life-years. However, among surgical treatments, all but 2 pathways were dominated. Of the remaining 2, laparoscopic sacrocolpopexy followed by vaginal repair for apical recurrence was not cost-effective compared with the vaginal-only approach (incremental cost-effectiveness ratio [ICER], >$500,000). Over 10 years, all but the same 2 pathways were dominated. However, starting with the laparoscopic approach in this case was more cost-effective with an ICER of US $6,176. If the laparoscopic approach was not available, starting with the robotic approach similarly became more cost-effective at 10 years (ICER, US $35,479).; Conclusions: All minimally invasive surgical approaches for apical prolapse repair are cost-effective when compared with expectant management. Among surgical treatments, the vaginal-only approach is the only cost-effective option over 5 years. However, over a longer period, starting with a laparoscopic (or robotic) approach becomes cost-effective. These results help inform discussions regarding the surgical approach for prolapse.; Competing Interests: The authors have declared they have no conflicts of interest. (Copyright © 2020 American Urogynecologic Society. All rights reserved.)

Wang, R., et al. (2022). "Antioxidant supplements relieve insulin resistance but do not improve lipid metabolism in women with polycystic ovary syndrome: a meta-analysis of randomized clinical trials." Gynecological Endocrinology 38(12): 1047-1059.
	Objective: The effect of antioxidant supplements on glucose metabolism and lipid profiles in polycystic ovary syndrome (PCOS) remains controversial. This systematic review and meta-analysis aimed to evaluate whether antioxidant supplements improve glucose metabolism and lipid profiles in women with PCOS to provide optimal nutritional supplement advice in clinical practice. Methods: The search was conducted across multiple medical databases from inception to January 1, 2022 and performed following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. A random effects model was used to calculate the overall effects. Results: Eighteen trials (1113 participants) were included. Antioxidant supplements significantly improved insulin resistance (95% CI, -0.62, -0.30; p < 0.00001; I 2 =48%), fasting insulin (95% CI, -0.80, -0.44; p < 0.00001; I 2 = 48%), and fasting plasma glucose (95% CI, -0.54, -0.21; p < 0.00001; I 2 = 38%) in patients with PCOS. However, antioxidant supplements were found to not improve most indices of lipid profiles in PCOS except triglyceride. Conclusions: Antioxidant supplements are an effective intervention for relieving insulin resistance but do not significantly improve lipid metabolism in women with PCOS.

Wang, R. R., et al. (2023). "Systematic review of acupuncture to improve ovarian function in women with poor ovarian response." Frontiers in Endocrinology 14: 1028853.
	OBJECTIVE: To determine the effect of acupuncture in treating poor ovarian response (POR). METHODS: We searched MEDLINE (via PubMed), EMBASE, Allied and Complementary Medicine Database, CNKI, CBM, VIP database, Wanfang Database, and relevant registration databases from inception to January 30, 2023. In this review, both Chinese and English peer-reviewed literature were included. Only randomized controlled trials (RCTs) using acupuncture as an intervention for POR patients undergoing in vitro fertilization were considered. RESULTS: Seven clinical randomized controlled trials (RCTs) were eventually included for comparison (516 women). The quality of included studies was generally low or very low. For the meta-analysis, seven studies showed that compared with controlled ovarian hyperstimulation (COH) therapy, acupuncture combined with COH therapy could significantly increase the implantation rate (RR=2.13, 95%CI [1.08, 4.21], p=0.03), the number of oocytes retrieved (MD=1.02, 95%CI [0.72, 1.32], p<0.00001), the thickness of endometrium (MD=0.54, 95%CI [0.13, 0.96], p=0.01), and the antral follicle count (MD=1.52, 95%CI [1.08, 1.95], p<0.00001), reduce follicle-stimulating hormone (FSH) levels (MD=-1.52, 95%CI [-2.41, -0.62], p=0.0009) and improve estradiol (E2) levels (MD=1667.80, 95%CI [1578.29, 1757.31], p<0.00001). Besides, there were significant differences in the duration of Gn (MD=0.47, 95%CI [-0.00, 0.94], p=0.05) between the two groups. However, no statistical variation was observed in improving clinical pregnancy rate (CPR), fertilization rate, high-quality embryo rate, luteinizing hormone (LH) value, anti-mullerian hormone (AMH) value, or reducing the dose of gonadotropin (Gn) values between the acupuncture plus COH therapy group and the COH therapy group. CONCLUSION: Acupuncture combined with COH therapy is doubtful in improving the pregnancy outcome of POR patients. Secondly, acupuncture can also improve the sex hormone level of POR women, and improve ovarian function. Furthermore, more RCTs of acupuncture in POR are needed to be incorporated into future meta-analyses. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, identifier CRD42020169560.

Wang, T., et al. (2022). "The effect of pelvic floor muscle training for women with pelvic organ prolapse: a meta-analysis." International Urogynecology Journal 33(7): 1789-1801.
	Introduction and Hypothesis: This study was aimed at evaluating the effect of pelvic floor muscle training (PFMT) as a conservative treatment for patients with pelvic organ prolapse (POP).; Methods: A comprehensive search to identify eligible randomized controlled trial (RCT) studies was conducted using electronic databases including PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and Embase up to 10 June 2021. Results were presented as risk ratio (RR), the weighted mean difference (WMD), with 95% confidence interval (95% CI) using the random effects model. Outcome variables were pooled using Review Manager version 5.3.; Results: Thirteen studies were included. Our results demonstrated that women who received PFMT intervention had a greater improvement than controls in prolapse symptom score (POP-SS; mean difference [MD] -1.66, 95% CI -2.36 to -0.97, p < 0.00001] and POP stages (risk ration [RR] 1.51, 95% CI 1.14-2.01, p = 0.004). The number of participants who felt better after PFMT was higher (RR 1.98, 95% CI 1.21-3.24, p = 0.006). Subgroup analysis showed that the symptoms of prolapse and the degree of prolapse were improved significantly in the short term, but there was no significant difference in the long-term effect. In addition, there was no significant difference in the impact of PFMT on the elderly and the quality of life. More RCTs are needed to evaluate the effect of PFMT on the elderly and whether the quality of life can be improved.; Conclusions: We found that PFMT can improve subjective symptoms and objective POP severity. More research is needed on the long-term effect. (© 2022. The International Urogynecological Association.)

Wang, X., et al. (2023). "A systematic review of interpersonal psychotherapy for postpartum depression." Journal of Affective Disorders 339: 823-831.
	Background: The current study endeavored to systematically integrate and quantitatively evaluate the effectiveness of interpersonal psychological interventions for postpartum depression patients.; Methods: Four electronic databases Pubmed, Embase, Cochrane and Web of Science were employed for literature retrieval, and the search time was from the inception of the database to May 30, 2022. Literature screening and data extraction were performed independently by two researchers.; Results: A total of 528 studies were screened, and 9 of them were finally included. There were 1012 subjects, 518 of them were assigned in experimental group and 494 in control. Evidence from interpersonal psychological interventions indicated that the data on postpartum depression, satisfaction with family, and social support in both groups after intervention included: depression score [MD = -2.80, 95%CI (-3.86 to -1.74), P < 0.05], satisfaction score [MD = 8.41, 95%CI (1.49 to -15.33), P < 0.05], and social support score [MD = 1.83, 95%CI (-2.10 to -5.76)] of postpartum depression patients. P values < 0.05 indicated substantial improvement as compared to control.; Limitations: During the research process, it is impossible for the experimental group and the researchers to use double-blind trials simultaneously, which may present a Hawthorne effect, but this can be avoided by general psychological intervention for the control.; Conclusions: Interpersonal psychotherapy could improve depression in patients with postpartum depression, but the appropriate intervention time was between 4 and 8 weeks, and it also improved satisfaction with family of patients, and the longer the intervention, the higher the satisfaction with the family.; Competing Interests: Declaration of competing interest The authors declare that they have no competing interests. (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Wang, X.-X., et al. (2019). "Efficacy of progesterone on threatened miscarriage: Difference in drug types." The Journal of Obstetrics and Gynaecology Research 45(4): 794-802.
	Aim: To investigate whether treatment with progesterone would decrease the incidence of miscarriage in women who faced threatened miscarriage.; Methods: Randomized controlled trials (RCT) were identified by searching PubMed, Embase, Cochrane Library and Web of Science. Trials were included if they compared progesterone with placebo, no treatment or any other treatment given in an effort to treat threatened miscarriage. Pregnant prophylaxis drugs were not included without strict progesterone type, language and progesterone management. The primary outcome was the incidence of miscarriage. The summary measures were reported as relative risk (RR) with 95% confidence interval (CI).; Results: Eight RCT including 845 women who faced threatened miscarriage were analyzed. Pooled data from the eight trials showed that women with threatened miscarriage who were randomized to the progesterone group had a lower risk of threatened miscarriage (RR = 0.64, 95% CI 0.48-0.85). Dydrogesterone was shown to have a lower risk of miscarriage (RR = 0.49, 95% CI 0.33-0.75) than natural progesterone (RR = 0.69, 95% CI 0.40-1.19). Oral management was demonstrated to have a lower risk of miscarriage (RR = 0.55, 95% CI 0.38-0.79) compared with vaginal administration (RR = 0.58, 95% CI 0.28-1.21).; Conclusion: Our findings show that progesterone agents are effective in reducing the incidence of miscarriage in threatened miscarriage. Dydrogesterone, but not natural progesterone, was associated with a lower risk of miscarriage. Given the limitations of the studies included in our meta-analysis, it is difficult to recommend route and dose of progesterone therapy. Further head-to-head trials of gestational weeks and long-time follow-up are required. (© 2019 Japan Society of Obstetrics and Gynecology.)

Wang, Y., et al. (2022). "Efficacy and safety of olaparib in the treatment of platinum-sensitive recurrent ovarian cancer: a systematic review and meta-analysis." European Journal of Gynaecological Oncology 43(3): 46-52.
	Background: Olaparib, an orally active inhibitor, has undergone comprehensive clinical evaluation as either single or combination therapy in several solid tumors. To explore the efficacy and safety of Olaparib versus placebo in the treatment of platinum-sensitive recurrent ovarian cancer, we conducted a systematic review and meta-analysis. Method(s): We systemically searched through April 30, 2021 PubMed, Cochrane Library, Embase and Web of Science for randomized control trials (RCTs) that compared Olaparib and placebo therapies for platinum-sensitive recurrent ovarian cancer. The primary outcomes were progression-free survival (PFS) and overall survival (OS) evaluated by Hazard ratio (HR) with 95% CI and the secondary outcome was adverse events calculated by the risk ratio (RR) with 95% CI. Result(s): A total of 3 RCTs, involving 592 patients in the Olaparib group and 359 patients in the placebo therapy, were included. The analysis results of RCTs showed that Olaparib had a significantly better PFS than placebo (HR 0.31 95% CI 0.26-0.37 p <= 0.001), and the pooled OS of the Olaparib group was significantly higher than that of the placebo group (RR 0.73 95% CI 0.60-0.90 p = 0.003). Regarding safety, the main adverse events included nausea, fatigue, vomiting, anemia, diarrhea, abdominal pain, constipation, headache, dysgeusia and decreased appetite. Conclusion(s): Olaparib has a positive effect on platinum-sensitive recurrent ovarian cancer as related to progression and overall survival with an increase in adverse events being noted. This meta-analysis demonstrated that Olaparib maintenance therapy is generally well tolerated by the patients.Copyright ©2022 The Author(s). Published by MRE Press.

Wang, Y., et al. (2023). "Acupuncture and moxibustion for endometriosis: A systematic review and analysis." Complementary Therapies in Medicine 76: 102963.
	Objectives: This study aimed to examine the effect of acupuncture on symptoms and health-related quality of life in patients with endometriosis.; Methods: Nine biomedical databases were searched to April 2022 to identify randomized controlled trials of acupuncture and/or moxibustion used alone or as adjunct to guideline-recommended pharmacotherapy for the treatment of endometriosis. One reviewer extracted data and another verified the data. A random effects model was used to calculate mean differences.; Results: Fifteen trials involving 1018 patients met the inclusion criteria, but diversity in comparisons and outcome measures prevented meta-analysis. Compared to sham acupuncture, manual acupuncture was more effective at reducing dysmenorrhea VAS pain score (mean difference [MD] - 2.40, 95 % CI [- 2.80, - 2.00]; moderate certainty evidence), pelvic pain VAS score (MD - 2.65, 95 % CI [- 3.40, - 1.90]; high certainty evidence) and dyspareunia VAS scores (MD - 2.88, [- 3.83, - 1.93]), lessened the size of ovarian cyst (MD - 3.88, 95 % CI [- 7.06, - 0.70]), and improved quality of life. Compared to conventional therapy, manual acupuncture plus conventional therapy and warm needle alone resulted in greater improvements in quality of life than conventional therapy. Among the six studies that reported safety, fewer adverse events were reported in participants who received acupuncture or moxibustion.; Conclusions: Low to moderate certainty evidence from single studies showed that manual acupuncture may improve pain-related symptoms and quality of life; however, there is insufficient evidence on the overall effectiveness of acupuncture and moxibustion for endometriosis.; Competing Interests: Declaration of Competing Interest The authors declare that they have no conflicts of interest. (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Wang, Y., et al. (2021). "Comparative Effectiveness and Safety of High-Intensity Focused Ultrasound for Uterine Fibroids: A Systematic Review and Meta-Analysis." Frontiers in Oncology 11: 600800.
	Background: Uterine fibroids are common benign tumors among premenopausal women. High- intensity focused ultrasound (HIFU) is an emerging non-invasive intervention which uses the high-intensity ultrasound waves from ultrasound probes to focus on the targeted fibroids. However, the efficacy of HIFU in comparison with that of other common treatment types in clinical procedure remains unclear. Objective: To investigate the comparative effectiveness and safety of HIFU with other techniques which have been widely used in clinical settings. Methods: We searched the Cochrane Central Register of Controlled Trials, PubMed, EMBASE, Cumulative Index to Nursing & Allied Health Literature, Web of Science, ProQuest Nursing & Allied Health Database, and three Chinese academic databases, including randomized controlled trials (RCTs), non-RCTs, and cohort studies. The primary outcome was the rate of re-intervention, and the GRADE approach was used to interpret the findings. Results: About 18 studies met the inclusion criteria. HIFU was associated with an increased risk of re-intervention rate in comparison with myomectomy (MYO) [pooled odds ratio (OR): 4.05, 95% confidence interval (CI): 1.82-8.9]. The results favored HIFU in comparison with hysterectomy (HYS) on the change of follicle-stimulating hormone [pooled mean difference (MD): -7.95, 95% CI: -8.92-6.98), luteinizing hormone (MD: -4.38, 95% CI: -5.17-3.59), and estradiol (pooled MD: 43.82, 95% CI: 36.92-50.72)]. HIFU had a shorter duration of hospital stay in comparison with MYO (pooled MD: -4.70, 95% CI: -7.46-1.94, p < 0.01). It had a lower incidence of fever (pooled OR: 0.15, 95% CI: 0.06-0.39, p < 0.01) and a lower incidence of major adverse events (pooled OR: 0.04, 95% CI: 0.00-0.30, p < 0.01) in comparison with HYS. Conclusions: High-intensity focused ultrasound may help maintain feminity and shorten the duration of hospital stay. High-quality clinical studies with a large sample size, a long-term follow-up, and the newest HIFU treatment protocol for evaluating the re-intervention rate are suggested to be carried out. Clinical decision should be based on the specific situation of the patients and individual values.; 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 Wang, Geng, Bao, Dong, Shi and Xi.)

Wang, Y., et al. (2021). "Meta analysis of single hole laparoscopy in the treatment of hysteromyoma." PROSPERO International prospective register of systematic reviews.
	
Wang, Y., et al. (2020). "Survival After Minimally Invasive vs. Open Radical Hysterectomy for Cervical Cancer: A Meta-Analysis." Frontiers in Oncology 10: 1236.
	Background: The comparison of survival outcomes between minimally invasive surgery and open surgery for cervical cancer patients remains controversial. We evaluated the survival outcomes of cervical cancer patients who underwent different surgical approaches. Methods: A literature search was performed in PubMed, Embase, and Cochrane databases up to February 2020, using the MESH terms "minimally invasive surgical procedures" and "Uterine Cervical Neoplasms." Included were all original comparative studies and trials both published and unpublished in English that were related to minimally invasive surgery and open surgery for cervical cancer patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage < IIB. Begg's and Egger's regressions were used to evaluate publication bias. Results: This meta-analysis included 28 studies enrolling 18,961 patients with cervical cancer. The overall analyses indicated that cervical cancer patients with FIGO 2009 stage < IIB who underwent minimally invasive surgery had a lower rate of OS (HR = 1.43, 95% CI = 1.06-1.92, P = 0.019) and DFS (HR = 1.50, 95% CI = 1.21-1.85, P < 0.001) than those who underwent open surgery. Moreover, minimally invasive surgery could lower OS (HR = 2.30, 95% CI = 1.50-3.52, P < 0.001) and DFS (HR = 1.94, 95% CI = 1.36-2.76, P < 0.001) of cervical cancer patients with FIGO 2009 stage ≤ IB1 compared to open surgery. However, there were no significant differences in OS (HR = 1.07, 95% CI = 0.65-1.76, P = 0.801) and DFS (HR = 1.20, 95% CI = 0.65-2.19, P = 0.559) in patients with tumors < 2 cm between the two groups. Conclusions: Minimally invasive radical hysterectomy was associated with poor survival outcomes compared to open surgery. Patients with FIGO 2009 stage ≤ IB1 cervical cancer who underwent minimally invasive surgery have lower OS and DFS rates than those who underwent open surgery. Therefore, open surgery should be performed for cervical cancer patients. However, patients with tumors < 2 cm might take the most advantage of minimally invasive surgery without increasing poor prognosis. There are some limitations in the meta-analysis, which needs further high-quality multicenter studies to confirm and update our findings. (Copyright © 2020 Wang, Li, Ren, Song, Ouyang and Liu.)

Wang, Y., et al. (2020). "Comparison of the combination of recombinant follicle-stimulating hormone and recombinant luteinizing hormone protocol versus human menopausal gonadotropin protocol in controlled ovarian stimulation: A systematic review and meta-analysis." Journal of Evidence-based Medicine 13(3): 215-226.
	Objective: To systematically review the efficacy of a combination of recombinant follicle-stimulating hormone (rFSH) and recombinant luteinizing hormone (rLH) protocol versus human menopausal gonadotropin (hMG) protocol in controlled ovarian stimulation (COS).; Methods: PubMed, EMbase, The Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, and WanFang Data were searched to collect studies published prior to January 2019 on the efficacy of rFSH combined with rLH versus hMG alone in COS. Two reviewers independently screened the literature, conducted the data extraction, and assessed the risk of bias for all selected studies. Then, Review Manager 5.3 software was used for the meta-analysis.; Results: There were 2767 patients from 9 studies. The results showed that among patients aged >30 years for IUI, the combination of rFSH and rLH was superior to hMG alone in clinical pregnancy rate per patient (relative risk [RR] = 1.47, 95% confidence interval [CI] 1.02 to 2.12) and endometrial thickness (mean difference [MD] = 0.34, 95% CI 0.04 to 0.64). In patients over 30 years old who received IVF, the results tended to favor the combination of rFSH and rLH in clinical pregnancy rate per patient (RR = 4.48, 95% CI 1.15 to 17.46) and live birth rate per started cycle (RR = 1.69, 95% CI 1.96 to 2.71). In patients less than 30 years old who received IVF, the combination of rFSH and rLH was superior to hMG in the number of retrieved oocytes (MD = 3.70, 95% CI 3.27 to 4.13) and inferior to hMG in number of high-quality embryos (MD = -0.60, 95% CI -0.91 to -0.29).; Conclusion: The combination of rFSH and rLH may have better efficacy than hMG alone in COS. However, considering the limited sample size of the included studies, the current evidence is not definitive. (© 2020 Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.)

Wang, Y., et al. (2019). "Effects of CytoReductive surgery plus hyperthermic IntraPEritoneal chemotherapy (HIPEC) versus CytoReductive surgery for ovarian cancer patients: A systematic review and meta-analysis." European Journal of Surgical Oncology 45(3): 301-309.
	Background: The effects of Hyperthermic IntraPEritoneal Chemotherapy (HIPEC) and CytoReductive Surgery (CRS) for ovarian cancer patients remain controversial.; Methods: A systematic review and meta-analysis was conducted using PubMed, Embase and Web of Science databases to investigate Overall Survival (OS), Disease Free Survival (DFS) and adverse effects between HIPEC and CRS group.; Results: In our overall analysis (13 studies), patients in the HIPEC group exhibited a significantly improved OS (HR = 0.56, 95% CI = 0.41-0.76, P < 0.01) and DFS (HR = 0.61, 95% CI = 0.48-0.77, P < 0.01). Subgroup analysis revealed improved OS (HR = 0.57, 95% CI = 0.40-0.83, P = 0.04) and DFS (HR = 0.61, 95% CI = 0.47-0.80, P < 0.01) for primary ovarian cancer in favour of HIPEC group. However, recurrent ovarian cancer patients who received HIPEC exhibited only significantly improved OS (HR = 0.48, 95% CI = 0.24-0.96, P < 0.01) but not DFS (HR = 0.59, 95% CI = 0.33-1.08, P = 0.09). In addition, both significantly improved OS and DFS were also observed in patients who received HIPEC in the subgroups based on the following factors: studies published before 2015, studies with ≥100 total patients, a single drug used for HIPEC, 90-min HIPEC duration and a regimen of CRS plus HIPEC followed by chemotherapy. Moreover systematically reviewed toxicity, morbidity, mortality and long-term outcomes were tolerable after HIPEC.; Conclusions: The addition of HIPEC to CRS could significantly improve OS of ovarian cancer patients, albeit optimal drug regimen is not clear. (Copyright © 2018 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

Wang, Y., et al. (2020). "PARP Inhibitors in Patients With Newly Diagnosed Advanced Ovarian Cancer: A Meta-Analysis of Randomized Clinical Trials." Frontiers in Oncology 10: 1204.
	Background: The efficacy of poly(adenosine diphosphate-ribose) polymerase inhibitors (PARPi) as a maintenance therapy in patients with newly diagnosed advanced ovarian cancer remains unclear. We conducted a meta-analysis to assess the benefits and safety of PARPi maintenance therapy in patients with newly diagnosed advanced ovarian cancer. Methods: We searched the PubMed, EMBASE, and Cochrane databases for randomized controlled trials (RCTs), which assessed the efficacy of PARPi as a maintenance therapy for newly diagnosed advanced ovarian cancer. Progression-free survival (PFS) was the primary endpoint, which was assessed using hazard ratios (HRs) with 95% confidence intervals (95% CI). Progression-free survival was extracted independently, and the pooled results were used to compare the prognoses of patients who received PARPi maintenance therapy and those who received a placebo. Results: Three RCTs, SOLO1, VELIA/GOG-3005, and PRIMA, which included 1,881 patients with newly diagnosed advanced ovarian cancer, were included in the meta-analysis. The overall analysis showed that PARPi maintenance therapy significantly increased PFS (HR, 0.51; 95% CI, 0.33-0.80; P = 0.004) compared to placebo. Subgroup analyses confirmed this result. We also observed an improved PFS in patients with homologous recombination deficiency (HR, 0.50; 95% CI, 0.38-0.66; P < 0.001) and in patients with BRCA mutations (HR, 0.42; 95% CI, 0.31-0.57; P < 0.001). Moreover, there were no significant differences in health-related quality of life between the PARPi and placebo groups. Conclusions: Patients with newly diagnosed advanced ovarian cancer who received PARPi maintenance therapy had a better prognosis than did those who received a placebo. Moreover, no significant changes in health-related quality of life were seen in PARPi-treated individuals. (Copyright © 2020 Wang, Ren, Song, Wang, Zhang and Ouyang.)

Wang, Y., et al. (2020). "Prognostic Significance of Systematic Lymphadenectomy in Patients With Optimally Debulked Advanced Ovarian Cancer: A Meta-Analysis." Frontiers in Oncology 10: 86.
	Background: The effect of systematic lymphadenectomy (SL) on survival in patients with optimally debulked advanced ovarian cancer remains unclear. We evaluated the therapeutic value of SL in advanced ovarian cancer patients who underwent primary optimal debulking surgery. Methods: A meta-analysis was carried out using articles retrieved from the PubMed, Embase, and Cochrane databases. Overall survival (OS) and progression-free survival (PFS) were compared between patients who underwent SL and those who underwent unsystematic lymphadenectomy (USL). Results: Seven studies that included 2,425 patients with advanced ovarian cancer were included in the meta-analysis. The overall analyses indicated significantly improved OS [hazard ratio (HR) = 0.64, 95% confidence interval (CI): 0.49-0.84, P < 0.01] but not PFS (HR = 0.89, 95% CI: 0.69-1.15, P = 0.38) in patients who underwent SL compared to those who underwent USL. Subgroup analyses based on study type, study quality, total numbers of patients, and International Federation of Gynecology and Obstetrics (FIGO) stage provided similar results. However, subgroup analysis of patients with no residual tumor revealed that SL was not associated with improved OS (HR = 0.81, 95% CI: 0.66-1.00, P = 0.05) or PFS (HR = 1.09, 95% CI: 0.91-1.30, P = 0.33). Conclusions: In patients with optimally debulked advanced ovarian cancer, SL may improve OS but not PFS. However, SL does not provide a survival advantage when macroscopically complete resection of all visible tumors is achieved. (Copyright © 2020 Wang, Ren, Song, Wang, Zhang and Ouyang.)

Wang, Y., et al. (2021). "Anti-Angiogenesis Maintenance Therapy in Newly Diagnosed and Relapsed Ovarian Cancer: A Meta-analysis of Phase III Randomized Controlled Trials." Frontiers in Pharmacology 12: 726278.
	Aim: Anti-angiogenesis agents have been added as maintenance therapy in ovarian cancer over the past decade. The aim of this meta-analysis was to analyze the efficacy of anti-angiogenesis therapy in newly diagnosed and relapsed ovarian cancer. Methods: PubMed, Embase, and Cochrane databases were searched for all phase III randomized controlled trials (RCTs) that assessed the efficacy and toxicity of anti-angiogenesis agents in ovarian cancer. Overall survival (OS) and progression-free survival (PFS) were used to evaluate the effectiveness of anti-angiogenesis therapy in ovarian cancer. Results: A total of 6097 patients with newly diagnosed ovarian cancer from 5 phase III RCTs and 2943 patients with relapsed ovarian cancer from 6 phase III RCTs were included in this meta-analysis. The pooled results showed that anti-angiogenesis maintenance therapy significantly improved PFS (hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.76-0.93; p = 0.001), but not OS (HR, 0.98; 95% CI, 0.91-1.05; p = 0.49) compared with placebo in patients with newly diagnosed ovarian cancer. In patients with relapsed ovarian cancer, the pooled results showed a significant improvement on OS (HR, 0.89; 95% CI, 0.82-0.98; p = 0.02) and PFS (HR, 0.61; 95% CI, 0.52-0.72; p < 0.001). The pooled results also showed that the anti-angiogenesis agents were associated with an increase in the occurrence of severe hypertension, neutropenia, diarrhea, thrombocytopenia, headache, and bleeding in ovarian cancer. However, infrequent fatal adverse events occurred in the anti-angiogenesis groups. Conclusions: Study results suggest that anti-angiogenesis agents were an effective therapy for newly diagnosed and relapsed ovarian cancer, especially for relapsed ovarian cancer. Anti-angiogenesis agents may be associated with some severe but not fatal adverse events. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42021283647.; 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 Wang, Zhang, Song, Ouyang and Li.)

Wang, Y. Z., et al. (2024). "Clinical benefit analysis of PD-1 inhibitors in patients with advanced, recurrent or metastatic cervical cancer: a meta-analysis and systematic review." Frontiers in Immunology 15: 1305810.
	PURPOSE: This study aims to comprehensively evaluate the efficacy and safety of programmed cell death protein-1 (PD-1) in patients with advanced, recurrent, or metastatic cervical cancer (ARMCC) and identify the population that may benefit the most. METHODS: We conducted a search of PubMed, EMBASE, and the Cochrane Collaboration Library from their inception to September 2023. We extracted and analyzed the results related to the efficacy and safety of PD-1 in patients with ARMCC. The primary endpoints included the overall objective response rate (ORR) and adverse events (AEs), while the secondary endpoints encompassed the 1-year overall survival (OS) rate, 1-year progression-free survival (PFS) rate, as well as OS and PFS. We used a random effects model to conduct a meta-analysis on single-group rates, and the Mantel-Haenszel method was utilized to compare the ORR and the incidence of AEs. RESULTS: Our study included a total of 21 trials involving 2,097 patients. The ORR of the combination of PD-1 inhibitors with chemotherapy was 56.36%, the combination of PD-1 inhibitors with anti-angiogenic agents was 38.72%, the combination of PD-1 inhibitors with Cytotoxic T-lymphocyte antigen 4 inhibitors was 25.60%, and PD-1 inhibitor monotherapy was 15.99%. The subgroup analysis showed that the group of patients with squamous cell carcinoma (SCC) exhibited a significantly higher ORR compared to the non-SCC group in patients who received PD-1 inhibitors combined with other anti-tumor drugs (Odds Ratio =2.43, P=0.002). Additionally, the group of patients with a programmed death-ligand 1 combined positive score (PD-L1 CPS) ≥1 exhibited a significantly higher ORR compared to the PD-L1 CPS <1 group in patients who received PD-1 inhibitor monotherapy (OR=4.14, P=0.02). PD-1 inhibitor monotherapy or PD-1 inhibitors combined with chemotherapy did not significantly increase the incidence of all grades of adverse events (Relative Risk=0.99, p=0.788) or the incidence of serious adverse events (RR=0.99, p=0.788) compared to chemotherapy alone. CONCLUSION: PD-1 inhibitors demonstrate outstanding efficacy in the treatment of patients with ARMCC. Patients with SCC may benefit more from treatments including PD-1 inhibitors in combination with other anti-tumor drugs, and PD-L1 CPS ≥1 can be considered a favorable indicator of immune therapy response. Importantly, the use of PD-1 inhibitor monotherapy or PD-1 inhibitors in combination with chemotherapy did not lead to an increased incidence of AEs compared with chemotherapy alone, indicting safety during treatment. SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD42023457945).

Wang, Z., et al. (2019). "Probiotics for the treatment of bacterial vaginosis: A meta-analysis." International Journal of Environmental Research and Public Health 16(20): 3859.
	Background: The effect of probiotic therapy on bacterial vaginosis (BV) is controversial. We conducted a meta-analysis of the efficacy and safety associated with probiotic treatment for BV. Method(s): We searched multiple databases covering up to 1 March 2018. Studies published as blinded randomized controlled trials (RCTs), comparing treatment using probiotic versus active or placebo control in BV patients were included, with at least one-month follow-up. Random effects model and trial sequential analysis (TSA) were applied. Result(s): Ten studies (n = 2321) were included. Compared with placebo, the probiotics-only therapy resulted in a beneficial outcome both in clinical cure rate at the 30th day (risk ratio, RR = 2.57; 95% confidential interval, 95% CI: 1.96 to 3.37), and Nugent score (mean difference, MD = -2.71; 95% CI: 3.41 to -2.00). This effect decreased but remained significant after eight weeks. Probiotics-post-antibiotics therapy had a decreased effect only for a short term and possibly among studies with a mostly black study population. No extra adverse events were observed. The TSA suggested a larger sample size for effective evaluation of the probiotics as a supplementary remedy. Conclusion(s): Probiotic regimes are safe and may exhibit a short-term and long-term beneficial effect for BV treatment. The ethnic-specific result for the probiotic used after antibiotics is worthy of further study.Copyright © 2019 by the authors. Licensee MDPI, Basel, Switzerland.

Wanjing, L. I., et al. (2023). "Effect of dual trigger on the live birth rate of advanced-age infertility women undergoing IVF/ICSI: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Warner, P., et al. (2021). "Low dose dexamethasone as treatment for women with heavy menstrual bleeding: A response-adaptive randomised placebo-controlled dose-finding parallel group trial (DexFEM)." EBioMedicine 69: 103434.
	BACKGROUND: The symptom of heavy menstrual bleeding (HMB) diminishes quality-of-life for many mid-age women and imposes substantial societal burden. We investigated our hypothesis that HMB reflects impaired endometrial vasoconstriction due to endometrial glucocorticoid deficiency. Does reversing this deficiency, by short-term luteal-phase treatment with exogenous glucocorticoid (dexamethasone), ameliorate HMB? METHODS: In our Bayesian response-adaptive parallel-group placebo-controlled randomised trial, five pre-planned interim analyses used primary outcome data to adjust randomisation probabilities to favour doses providing most dose-response information. Participants with HMB, recruited from Lothian (Scotland) NHS clinics and via community invitations/advertisements, were aged over 18 years; reported regular 21-42 day menstrual cycles; and had measured menstrual blood loss (MBL) averaging ≥ 50 mL over two screening periods. Identically encapsulated placebo, or one of six Dexamethasone doses (0·2 mg, 0·4 mg, 0·5 mg, 0·6 mg, 0·75 mg, 0·9 mg), were taken orally twice-daily over five days in the mid-luteal phase of three menstrual cycles. Participants, investigators, and those measuring outcomes were masked to group assignment. Primary outcome, change in average MBL from screening to 'treatment', was analysed by allocated treatment, for all with data. TRIAL REGISTRATION: ClinicalTrials.gov NCT01769820; EudractCT 2012-003,405-98 FINDINGS: Recruitment lasted 29/01/2014 to 25/09/2017; 176 were screened, 107 randomised and 97 provided primary outcome data (n = 24,5,9,21,8,14,16 in the seven arms, placebo to 1·8 mg total daily active dose). In Bayesian normal dynamic linear modelling, 1·8 mg dexamethasone daily showed a 25 mL greater reduction in MBL from screening, than placebo (95% credible interval 1 to 49 mL), and probability 0·98 of benefit over placebo. Adverse events were reported by 75% (58/77) receiving dexamethasone, 58% (15/26) taking placebo. Three serious adverse events occurred, two during screening, one in a placebo participant. No woman withdrew due to adverse effects. INTERPRETATION: Our adaptive trial in HMB showed that dexamethasone 1·8 mg daily reduced menstrual blood loss. The role of dexamethasone in HMB management deserves further investigation. FUNDING: UK MRC DCS/DPFS grant MR/J003611/1.

Watters, M., et al. (2020). "Short versus extended progesterone supplementation for luteal phase support in fresh IVF cycles: a systematic review and meta-analysis." Reproductive Biomedicine Online 40(1): 143-150.
	This review and meta-analysis aim to assess the effect of prolonged progesterone support on pregnancy outcomes in women undergoing fresh embryo transfer after IVF/intracytoplasmic sperm injection (ICSI). Two independent authors searched Embase, MEDLINE and grey literature from inception to January 2019 for randomized controlled trials (RCT) of prolonged progesterone support versus early cessation. Risk of bias was assessed. Outcome measures were live birth, miscarriage and ongoing pregnancy rate. The study was registered with PROSPERO (CRD42018088605). Seven trials involving 1627 participants were included: three reported live birth rate (672/830), seven the miscarriage rate (178/1627) and seven the ongoing pregnancy rate (1351/1627). Clinical outcomes were similar between early progesterone cessation versus progesterone continuation: live birth rate (risk ratio [RR] 0.94, 95% confidence interval [CI] 0.88-1.00), miscarriage rate (RR 0.91, 95% CI 0.69-1.20) and ongoing pregnancy rate (RR 0.98, 95% CI 0.91-1.05). Ongoing pregnancy rates were similar when analyses were restricted to those with cessation of progesterone on the day of a positive human chorionic gonadotrophin (RR 0.93, 95% CI 0.83-1.06). This meta-analysis suggests that prolonged progesterone support may be unnecessary after fresh embryo transfer. Further larger RCT would be useful to corroborate and lead to standardized duration of progesterone luteal phase support across IVF/ICSI centres. (Copyright © 2019 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Wei, Z., et al. (2023). "To systematically investigate whether prednisone treatment would improve pregnancy outcomes among patients with recurrent implantation failure or recurrent pregnancy loss." PROSPERO International prospective register of systematic reviews.
	
Weinberg, D. (2022). "FRIEND: fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea." ClinicalTrials.gov.
	The objective of this study is to conduct a randomized double‐blinded clinical trial to determine the effect of low caffeine green tea extract on fibroids and subsequent pregnancy in women seeking fertility treatment. The investigators hypothesize that EGCG in low caffeine green tea extract will reduce the fibroid size, improve the quality of endometrium, and increase the likelihood of pregnancy. To test this hypothesis, the investigators propose a randomized placebo‐controlled clinical trial to evaluate live birth outcomes for women with unexplained infertility who have uterine fibroids. Participants will be randomized to either oral low caffeine green tea extract (1650mg/day) vs. placebo along ovarian stimulation with clomiphene citrate and timed intrauterine insemination for up to 4 cycles. Endpoints Primary Endpoint: ‐ Our primary endpoint is cumulative live birth rate. Secondary Endpoints: ‐ The conception rate. ‐ The miscarriage rate. ‐ The change of fibroid volume, symptom severity score, and health‐related quality‐of‐life score, from baseline to completion of treatment, and endometrial receptivity biomarkers. ‐ Time to pregnancy This will be a randomized, multi‐center, prospective, and double‐blind clinical trial of low caffeine green tea extract versus placebo. Two hundred (200) participants will be randomized via computer‐generated randomization schedule to receive either: 1. low caffeine green tea extract (1650mg in 6 capsules) taken orally on a daily basis along with Clomiphene citrate‐intrauterine insemination (CC‐IUI) cycle, up to 4 cycles if no pregnancy is achieved. Participant will stop green tea if she becomes pregnant. or 2. matched (smell, taste, color, texture) placebo capsules taken orally on a daily basis along with CC‐IUI cycle, up to 4 cycles if no pregnancy is achieved. Participant will stop placebo if she becomes pregnant. The randomization scheme will be on a 3:1 basis in favor of green tea extract, thus 150 participants will be assigned to the first arm (green tea extract) and 50 participants to the second arm (placebo). Clomiphene citrate will be taken for 5 days on Day 3 +/‐ 2 days of the participant's cycle.

Weinstein, M. M., et al. (2022). "Multicenter Randomized Controlled Trial of Pelvic Floor Muscle Training with a Motion-based Digital Therapeutic Device versus Pelvic Floor Muscle Training Alone for Treatment of Stress-predominant Urinary Incontinence." Female Pelvic Medicine and Reconstructive Surgery 28(1): 1-6.
	Objective: To determine whether use of an intravaginal motion-based digital therapeutic device for pelvic floor muscle training (PFMT) was superior to PFMT alone in women with stress-predominant urinary incontinence (SUI). Method(s): A multicenter, randomized-controlled trial was conducted where women with SUI or SUI-predominant mixed urinary incontinence were treated with either PFMT using the device (intervention group) or PFMT alone (control group). Primary outcomes, measured at 8 weeks, included change in Urinary Distress Inventory, short-version and improvement in the Patient Global Impression of Improvement, defined as "much better" or "very much better." Participants also completed Pelvic Organ Prolapse and Colorectal-anal Distress Inventories, Pelvic-Floor-Impact Questionnaire and a 3-day bladder diary. Primary analysis used a modified intention-to-treat approach. Statistical analysis used Student t test and chi2 test. The trial was prematurely halted due to device technical considerations. Result(s): Seventy-seven women were randomized, and final analysis included 61 participants: 29 in intervention and 32 in control group. There was no statistical difference in Urinary Distress Inventory, short-version scores between the intervention (-13.7 +/- 18.7) and the control group (-8.7 +/- 21.8; P = 0.85), or in Patient Global Impression of Improvement (intervention 51.7% and control group 40.6%; P = 0.47). Pelvic Organ Prolapse and Colorectal-anal Distress Inventories and Pelvic-Floor-Impact Questionnaire scores improved significantly more in the intervention group than the control group (all P < 0.05). Median number of SUI episodes decreased from baseline to 8 weeks by -1.7 per-day [(-3)-0] in the intervention group and -0.7[(-1)-0] in the control group, (P = 0.047). Conclusion(s): In this prematurely terminated trial, there were no statistically significant differences in primary outcomes; however, PFMTwith this digital therapeutic device resulted in significantly fewer SUI episodes and greater improvement in symptom-specific quality of life outcomes. A larger powered trial is underway.Copyright © 2021 American Urogynecologic Society. All rights reserved.

Weinstein, M. M., et al. (2024). "A Motion-based Device Urinary Incontinence Treatment: A Longitudinal Analysis at 18 and 24 Months." International Urogynecology Journal.
	Introduction and hypothesis: There are sparse data regarding the long-term efficacy of pelvic floor muscle training (PFMT) for the treatment of urinary incontinence (UI). The objective of this study was to evaluate the impact of an 8-week PFMT program guided by a motion-based intravaginal device versus a standard home program over 24 months. Method(s): Between October 2020 and March 2021, a total of 363 women with stress or stress-predominant mixed UI were randomized and completed an 8-week PFMT program using a motion-based intravaginal device (intervention group) or a home program following written/video instructions (control group). Participants were not asked to continue training after the 8-week program. At 18 and 24 months' follow-up, the Urogenital Distress Inventory, short-form (UDI-6) and Patient Global Impression of Improvement (PGI-I) were collected. In the original trial, a total of 139 participants in each arm were needed to detect a 0.3 effect size (alpha = 0.05, power 0.8, one-tailed t test) in the difference in UDI-6 scores. Result(s): A total of 231 participants returned 24-month data. Mean age at 24 months was 51.7 +/- 14.5 years, and mean BMI was 31.8 +/- 7.4 kg/m2. Mean change in UDI-6 scores from baseline to 24 months was greater in the intervention group than the control group (-21.1 +/- 24.5 vs -14.8 +/- 19.4, p = 0.04). Reported improvement using PGI-I was greater in the intervention group than in the control group at 24 months (35% vs 22%, p = 0.03, OR 1.95(95% CI 1.08, 3.57). Conclusion(s): Pelvic floor muscle training guided by a motion-based prescription intravaginal device yielded durable and significantly greater UI symptom improvement than a standard home program, even in the absence of continued therapy.Copyright © 2024, The Author(s).

Weise, C. (2022). "Efficacy of Internet-based Cognitive Behavioral Therapy for Endometriosis." ClinicalTrials.gov.
	No Results Available Behavioral: Cognitive behavioral psychotherapy|Other: Waiting list Change in Endometriosis Health Profile 30 + 23 (EHP-30 + 23; Jones, Kennedy, Barnard, Wong & Jenkinson, 2001)|Change in Endometriosis Health Profile 5 (EHP-5; Jones, Jenkinson & Kennedy, 2004)|Change in Pain Disability Index (PDI; Tait, Pollard & Margolis, 1987)|Change in Visual analog pain scale (VAS)|Change in Brief Patient Health Questionnaire (PHQ-9; Zipfel, Herzog & Löwe, 2004)|Change in Perceived Stress Scale (PSS; Klein et al., 2016)|Change in Brief Cope (Carver, 1997)|Change in Illness Perception Questionnaire (IPQ-R; Glattacker, Bengel & Jäckel, 2009)|Change in The Acceptance and Action Questionnaire - II (FAH-II; Hoyer & Gloster, 2013) Female Not Applicable 120 Other Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment CBT for endometriosis_2021 December 31, 2024

Weiss Nienke, S., et al. (2019). "Gonadotrophins for ovulation induction in women with polycystic ovary syndrome." The Cochrane Database of Systematic Reviews 1: CD010290.
	Background: Ovulation induction with follicle stimulating hormone (FSH) is a second-line treatment in women with polycystic ovary syndrome (PCOS) who do not ovulate or conceive on clomiphene citrate.; Objectives: To compare the effectiveness and safety of gonadotrophins as a second-line treatment for ovulation induction in women with clomiphene citrate-resistant polycystic ovary syndrome (PCOS), and women who do not ovulate or conceive after clomiphene citrate.; Search Methods: In January 2018, we searched the Cochrane Gynaecology and Fertility Group Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, the World Health Organisation clinical trials register, Clinicaltrials.gov, LILACs, and PubMed databases, and Google Scholar. We checked references of in all obtained studies. We had no language restrictions.; Selection Criteria: All randomised controlled trials reporting data on clinical outcomes in women with PCOS who did not ovulate or conceive on clomiphene citrate, and undergoing ovulation induction with urinary-derived gonadotrophins, including urofollitropin (uFSH) in purified FSH (FSH-P) or highly purified FSH (FSH-HP) form, human menopausal gonadotropin (HMG) and highly purified human menopausal gonadotrophin (HP-HMG), or recombinant FSH (rFSH), or continuing clomiphene citrate. We included trials reporting on ovulation induction followed by intercourse or intrauterine insemination. We excluded studies that described co-treatment with clomiphene citrate, metformin, luteinizing hormone, or letrozole.; Data Collection and Analysis: Three review authors (NW, EK, and MvW) independently selected studies for inclusion, assessed risk of bias, and extracted study data. Primary outcomes were live birth rate per woman and multiple pregnancy per woman. Secondary outcomes were clinical pregnancy, miscarriage, incidence of ovarian hyperstimulation syndrome (OHSS) per woman, total gonadotrophin dose, and total duration of stimulation per woman. We combined data using a fixed-effect model to calculate the risk ratio (RR). We summarised the overall quality of evidence for the main outcomes using GRADE criteria.; Main Results: The review included 15 trials with 2387 women. Ten trials compared rFSH with urinary-derived gonadotrophins (three compared rFSH with human menopausal gonadotrophin, and seven compared rFSH with FSH-HP), four trials compared FSH-P with HMG. We found no trials that compared FSH-HP with FSH-P. One trial compared FSH with continued clomiphene citrate.Recombinant FSH (rFSH) versus urinary-derived gonadotrophinsThere may be little or no difference in the birth rate between rFSH and urinary-derived gonadotrophins (RR 1.21, 95% confidence interval (CI) 0.83 to 1.78; five trials, N = 505; I² = 9%; low-quality evidence). This suggests that for the observed average live birth per woman who used urinary-derived FSH of 16%, the chance of live birth with rFSH is between 13% and 28%. There may also be little or no difference between groups in incidence of multiple pregnancy (RR 0.86, 95% CI 0.46 to 1.61; eight trials, N = 1368; I² = 0%; low-quality evidence), clinical pregnancy rate (RR 1.05, 95% CI 0.88 to 1.27; eight trials, N = 1330; I² = 0; low-quality evidence), or miscarriage rate (RR 1.20, 95% CI 0.71 to 2.04; seven trials, N = 970; I² = 0; low-quality evidence). We are uncertain whether rFSH reduces the incidence of OHSS (RR 1.48, 95% CI 0.82 to 2.65, ten trials, n=1565, I² = 0%, very low-quality evidence).Human menopausal gonadotrophin (HMG) or HP-HMG versus uFSHWhen compared to uFSH, we are uncertain whether HMG or HP-HMG improves live birth rate (RR 1.28, 95% CI 0.65 to 2.52; three trials, N = 138; I² = 0%; very low quality evidence), or reduces multiple pregnancy rate (RR 2.13, 95% CI 0.51 to 8.91; four trials, N = 161; I² = 0%; very low quality evidence). We are also uncertain whether HMG or HP-HMG improves clinical pregnancy rate (RR 1.31, 95% CI 0.66 to 2.59; three trials, N = 102; I² = 0; very low quality evidence), reduces miscarriage rate (RR 0.33, 95% CI 0 06 to 1.97; two trials, N = 98; I² = 0%; very low quality evidence), or reduces the incidence of OHSS (RR 7.07, 95% CI 0.42 to 117.81; two trials, N = 53; very low quality evidence) when compared to uFSH.Gonadotrophins versus continued clomiphene citrateGonadotrophins resulted in more live births than continued clomiphene citrate (RR 1.24, 95% CI 1.05 to 1.46; one trial, N = 661; I² = 0%; moderate-quality evidence). This suggests that for a woman with a live birth rate of 41% with continued clomiphene citrate, the live birth rate with FSH was between 43% and 60%. There is probably little or no difference in the incidence of multiple pregnancy between treatments (RR 0.89, 95% CI 0.33 to 2.44; one trial, N = 661; I² = 0%; moderate-quality evidence). Gonadotrophins resulted in more clinical pregnancies than continued clomiphene citrate (RR 1.31, 95% CI 1.13 to 1.52; one trial, N = 661; I² = 0%; moderate-quality evidence), and more miscarriages (RR 2.23, 95% CI 1.11 to 4.47; one trial, N = 661; I² = 0%; moderate-quality evidence). None of the women developed OHSS.; Authors' Conclusions: There may be little or no difference in live birth, incidence of multiple pregnancy, clinical pregnancy rate, or miscarriage rate between urinary-derived gonadotrophins and recombinant follicle stimulating hormone in women with polycystic ovary syndrome. For human menopausal gonadotropin or highly purified human menopausal gonadotrophin versus urinary follicle stimulating hormone we are uncertain whether one or the other improves or lowers live birth, incidence of multiple pregnancy, clinical pregnancy rate, or miscarriage rate. We are uncertain whether any of the interventions reduce the incidence of ovarian hyperstimulation syndrome. We suggest weighing costs and convenience in the decision to use one or the other gonadotrophin. In women with clomiphene citrate failure, gonadotrophins resulted in more live births than continued clomiphene citrate without increasing multiple pregnancies.

Wen, G., et al. (2022). "Vascular endothelial growth factor receptor-associated tyrosine kinase inhibitors versus cytotoxic chemotherapy for platinum-resistant or refractory ovarian cancer: a meta-analysis of efficacy and safety profiles." PROSPERO International prospective register of systematic reviews.
	
Wen, J., et al. (2022). "Efficacy of metformin therapy in patients with cancer: a meta-analysis of 22 randomised controlled trials." BMC Medicine 20(1): 402.
	Background: To investigate whether metformin monotherapy or adjunctive therapy improves the prognosis in patients with any type of cancer compared to non-metformin users (age >=18). Method(s): Databases (Medline, Embase, and the Cochrane Central Register of Controlled Trials) and clinical trial registries (ClinicalTrials.gov; the World Health Organization International Clinical Trials Registry Platform) were screened for randomized, controlled trials (RCT) reporting at least progression-free survival (PFS) and/or overall survival (OS). Main outcome measures included hazard ratios (HR), and combined HRs and 95% confidence intervals (CI) were calculated using random-effects models. Result(s): Of the 8419 records screened, 22 RCTs comprising 5943 participants were included. Pooled HRs were not statistically significant in both PFS (HR 0.97, 95% CI 0.82-1.15, I2 = 50%) and OS (HR 0.98, 95% CI 0.86-1.13, I2 = 33%) for patients with cancer between the metformin and control groups. Subgroup analyses demonstrated that metformin treatment was associated with a marginally significant improvement in PFS in reproductive system cancers (HR 0.86, 95% CI 0.74-1.00) and a significantly worse PFS in digestive system cancers (HR 1.45, 95% CI 1.03-2.04). The PFS or OS was observed consistently across maintenance dose, diabetes exclusion, median follow-up, risk of bias, and combined antitumoral therapies. Conclusion(s): Metformin treatment was not associated with cancer-related mortality in adults compared with placebo or no treatment. However, metformin implied beneficial effects in the PFS of the patients with reproductive system cancers but was related to a worse PFS in digestive system cancers. Systematic review registration: PROSPERO registration number CRD42022324672.Copyright © 2022, The Author(s).

Wenli, Y., et al. (2022). "Comparative efficacy of acupuncture with oral metformin in improving the endocrine and metabolism profiles in insulin resistant PCOS women: a network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Wenming, C., et al. (2023). "Acupuncture combined with pelvic floor rehabilitation training for postpartum stress urinary incontinence: protocol for a systematic review and meta-analysis." Frontiers in Medicine 10: 1296751.
	Introduction: The purpose of this study is to systematically evaluate the efficacy and safety of acupuncture combined with pelvic floor rehabilitation training in the treatment of postpartum stress urinary incontinence, and to promote the further promotion and application of acupuncture in the field of rehabilitation. Methods and analysis: Randomized controlled trials (RCTs) of acupuncture combined with pelvic floor rehabilitation in the treatment of postpartum stress urinary incontinence will be searched in PubMed, Web of Science (WOS), Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), Wanfang (WF), and VIP databases. The clinical trial Registry (ClinicalTrials.gov and Chinese clinical trial Registry) will also be searched. The search period is limited to July 1, 2023, and the language limit of this systematic review is Chinese and English. The primary outcome is clinical effective rate. International Consultation on Incontinence Questionnaire-Short Form (ICI-Q-SF), 1-h pad test, pelvic floor muscle potential value, incidence of adverse events are secondary outcomes. A meta-analysis will be performed using RevMan 5.4 statistical software. If feasible, subgroup analysis and sensitivity analysis will be performed to address potential causes of inconsistency and heterogeneity. The risk of bias will be assessed using the approach recommended by Cochrane Handbook for Systematic Reviews of Interventions, and the quality of evidence will be assessed using GRADE. This Protocol has been developed in accordance with the guideline of Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) 2015. Discussion(s): Acupuncture combined with pelvic floor rehabilitation training can effectively promote the rehabilitation of postpartum stress urinary incontinence patients, and provide a reference for the clinical application of integrated Chinese and Western medicine treatment in the field of rehabilitation. Systematic review registration: PROSPERO CRD42023455801.Copyright © 2023 Wenming, Xiaoman, Ling, Yun and Xiyan.

Wenqian, S., et al. (2022). "Effective dietary patterns in polycystic ovary syndrome patients." PROSPERO International prospective register of systematic reviews.
	
Wenqing, W., et al. (2022). "The effects of lifestyle intervention on obese women with polycystic ovary syndrome:a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Wenrui, H. and L. Jing (2023). "Comparative efficacy of ten Chinese patent medicines for Endometriosis: A Bayesian network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Wenrui, H. and D. Xuelian (2023). "Comparative efficacy of Acupuncture-related interventions for Endometriosis: a systematic review and Bayesian meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Wenxi, J., et al. (2022). "Effectiveness and safety of acupuncture combined with medication for postpartum depression: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Wenzl, R. (2022). "Evaluating Ovarian Reserve After Conventional Laparoscopy Versus Robotic Surgery for Bilateral Endometrioma." ClinicalTrials.gov.
	Experimental Plan Study design This trial is a prospective, randomized‐controlled study investigating postoperative differences in ovarian reserve differing between robot‐assisted laparoscopy compared to conventional laparoscopy in patients with bilaterial ovarian endometrioma by comparing serum AMH (sAMH) level recovery. Postoperative follow‐up will take place after 6 months. All women referred to our department for endometrioma will undergo clinical examination by a senior surgeon experienced in endometriosis as well as ultrasound. All patients with bilateral endometrioma will be included. Complementary examinations, such as cystoscopy or renal sonography will be performed in women with suspected involvement of urinary tract. In women with pregnancy intention and endometrioma, an exhaustive assessment of the disease will systematically be performed before deciding between primary surgery and primary assisted reproductive techniques. Gynecological examination will be performed at each visit. Ovarian reserve will be evaluated using antral follicle count (AFC) via transvaginal sonography, anti‐Mullerian hormone (AMH), follicle‐stimulating hormone (FSH) and luteinizing hormone (LH) levels and ovarian volume. Follicle number will be evaluated by pathologists in the histologic tissue sections. Furthermore, subjective outcome will be assessed with standardized questionnaires. Study setting This study will be conducted at the gynecologic outpatient clinic (Division of General Gynecology and Gynecologic Oncology, Department of Obstetrics and Gynecology, Medical University of Vienna). Enrollment, treatment and data collection will be standardized by all sites according to the approved study protocol. Participants and recruitment The study population will consist of women aged between 18 and 45 years who are referred to our gynecologic outpatient clinic due to endometrioma. Women with bilateral endometrioma and an indication for surgery can be included in this trial. Intervention Laparoscopic‐assisted cystectomy of endometrioma will be performed using up to four 5‐mm ports, including an umbilical port and additional ports as dictated by each individual surgery. The robotic‐assisted resection of endometriosis will be performed using the da Vinci Surgical System Si (Intuitive Surgical) using up to five ports as needed. An umbilical port was placed for the laparoscope (10/12 mm), a 5‐mm port for the assistant, and two or three ports (5/8 mm) for the robotic arms. Superficial and deep endometriosis resection will be performed in the usual standard fashion. All superficial lesions suspicious for endometriosis (pigmented and nonpigmented) will be completely resected until non‐diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non‐diseased margins are visualized in the tissue surrounding the defect. Cystectomy will be performed for endometriomas. Additional procedures are performed as needed to completely resect all endometriosis lesions. The fascia of any port ≥10 mm will be reapproximated. A cystoscopy will be performed when deemed appropriate by the surgeon. If bowel resection and re‐anastomosis are necessary this will be performed together with a General Surgeon. Participating surgeons will be defined as high‐volume surgeons in endometriosis surgery and will also be part of the endometriosis core team. Histological confirmation of endometriosis will be performed. Postoperative Management: The patients are instructed to rest for 2 weeks after the operation (not to work, do sport, do the cleaning, and carry more than five kilos). They are allowed to return to work after 2 weeks and to take part in sports or have intercourse after 6 weeks. Follow‐up visits are scheduled after 6 months in our outpatient clinic due to our study protocol. For the postoperative medical treatment of endometriosis, combined oral contraceptive, a GnRH agonist or Dienogest will be administered to all patients who do not desire pregnan . Patients desiring pregnancy will either be advised to attempt spontaneous conception or will be sent to our in‐house ART department depending on their age, disease extent, preoperative AMH levels and male factors. Data collection At baseline, the following data will be collected: demographics and medical history data (age, body mass index, parity, menopausal and hormone therapy status, current smoking, previous adnexal surgery, and medical comorbidities (diabetes mellitus, connective tissue disorders)). Previous endometriosis‐specific treatments and responses will be assessed. Patients will be asked to complete the Endometriosis Health Profile (EHP) EHP‐30 25. A gynecological examination will be performed at each visit. Ovarian reserve will be evaluated using antral follicle count (AFC), anti‐Mullerian hormone (AMH), follicle‐stimulating hormone (FSH), and luteinizing hormone (LH) levels, and ovarian volume. Preferentially, LH and FSH will be evaluated in the first 2 to 5 days of the menstrual cycle. The patients will be asked to rate their satisfaction with the appearance of their scars on a 10‐point Likert scale (with 1 being very unsatisfied and 10 being very satisfied).

Wharton, L., et al. (2022). "Do vaginal pessaries used to treat pelvic organ prolapse impact on sexual function? A systematic review and meta-analysis." International Urogynecology Journal 33(2): 221-233.
	Introduction and Hypothesis: Pelvic organ prolapse (POP) is common and associated with sexual dysfunction. Vaginal pessaries are an effective treatment for POP, but their impact on sexual function is not well established. The aim of this systematic review and meta-analysis was to establish the impact of vaginal pessaries used for POP on female sexual function.; Methods: Systematic review of the literature following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and checklist. A comprehensive search was conducted across Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews, EMBASE, MEDLINE, CINAHL, ClinicalTrials.gov , The WHO International Clinical Trials Registry Platform, ProQuest Dissertations & Theses, Open Grey and Scopus Citation Database. Randomised controlled trials and cohort studies that assessed sexual function in women pre- and post-pessary treatment for POP were included, assessed for risk of bias and their results synthesised.; Results: A total of 1,945 titles and abstracts were screened, 104 full-text articles were assessed for eligibility, 14 studies were included in the narrative analysis and 7 studies were included in the meta-analysis. The results suggest that, in sexually active women, there is no evidence of a deterioration in sexual function and some evidence of an improvement.; Discussion: This review offers reassurance that in sexually active women who successfully use a pessary for treatment of their prolapse, there is no deterioration in sexual function. There is some evidence of an improvement in sexual function, but given the clinical heterogeneity in the studies included, caution should be taken in generalising these findings. (© 2022. The International Urogynecological Association.)

Wheat Joy, E. (2021). "BOTOX® at the Time of Prolapse Surgery for OAB." ClinicalTrials.gov.
	After being informed about the study and the potential risks, women scheduled for prolapse surgery will be screened for bothersome overactive bladder symptoms. Those that qualify and choose to enroll will be randomized to receive either bladder BOTOX® or a placebo at the time of their surgery. Neither the patient nor the investigators will know if the patient receives BOTOX® or a placebo. Subjects will complete questionnaires and bladder diaries both before and after surgery to determine efficacy and patient satisfaction. Potential adverse events, such as urinary tract infections and urinary retention, will be monitored throughout the study.

Whitaker, L. H. R., et al. (2023). Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding: the UCON randomised controlled trial and mechanism of action study.
	BACKGROUND: Heavy menstrual bleeding affects one in four women and negatively impacts quality of life. The levonorgestrel-releasing intrauterine system is an effective long-term treatment but is discontinued by many due to unpredictable bleeding, or adverse effects. The selective progesterone receptor modulator ulipristal acetate is used to treat symptomatic fibroids but long-term efficacy for the symptom of heavy menstrual bleeding, irrespective of presence of fibroids, is unknown. OBJECTIVES: To determine whether ulipristal acetate is more effective at reducing the burden of heavy menstrual bleeding than levonorgestrel-releasing intrauterine system after 12 months of treatment in women with and without fibroids. We investigated mechanism of action of ulipristal acetate in a subset of 20 women. DESIGN: Randomised, open-label, parallel group, multicentre trial with embedded mechanistic study. SETTING: Ten UK hospitals. PARTICIPANTS: Women with heavy menstrual bleeding aged 18 and over with no contraindications to levonorgestrel-releasing intrauterine system or ulipristal acetate. INTERVENTIONS: Three 12-week treatment cycles of 5 mg ulipristal acetate daily, separated by 4-week treatment-free intervals, or continuous levonorgestrel-releasing intrauterine system following allocation in a 1 : 1 ratio using a web-based minimisation procedure. MAIN TRIAL OUTCOME MEASURES: Primary outcome was quality-of-life measured by menorrhagia multi-attribute scale at 12 months. Secondary outcomes included menstrual bleeding and patient satisfaction. Impact on fibroid size, endometrial appearance and liver function was also collected. MECHANISTIC STUDY OUTCOME: Cellular markers for endometrial cell structure and function, determined from endometrial biopsies; volume of uterus and fibroids and microcirculation parameters were determined from magnetic resonance images. RESULTS: Sample size was increased from 220 to 302 as a result of temporary halt to recruitment due to concerns of ulipristal acetate hepatoxicity. Subsequent withdrawal of ulipristal acetate and the COVID-19 pandemic led to a premature closure of recruitment, with 118 women randomised to each treatment and 103 women completing 12-month menorrhagia multi-attribute scale scores prior to this point. Primary outcome scores substantially improved in both arms, but at 12 months there was no evidence of a difference between those receiving three cycles of ulipristal acetate [median score category: 76–99, interquartile range (51–75 to 100), n = 53] and levonorgestrel-releasing intrauterine system [median score category: 76–99, interquartile range (51–75 to 100), n = 50; adjusted odds ratio 0.55, 95% confidence interval 0.26 to 1.17; p = 0.12]. Rates of amenorrhoea were much higher in those allocated ulipristal acetate compared with the levonorgestrel-releasing intrauterine system (12 months: 64% vs. 25%, adjusted odds ratio 7.12, 95% confidence interval 2.29 to 22.2). There was no evidence of a difference in other participant-reported outcomes. There were no cases of endometrial malignancy and no hepatotoxicity due to ulipristal acetate use. MECHANISTIC STUDY RESULTS: Ulipristal acetate produced a reversible reduction in endometrial cell proliferation, as well as reversible alteration of other endometrial cellular markers. Ulipristal acetate did not produce a reduction in the volume of the uterus irrespective of coexisting fibroids, nor an effect on uterine microvascular blood flow. LIMITATIONS: The urgent safety measures and premature closure of recruitment impacted final sample size. CONCLUSIONS: We found no evidence of a difference in quality of life between the two treatments, but ulipristal acetate was superior to levonorgestrel-releasing intrauterine system at inducing amenorrhoea. Ulipristal acetate currently has restricted availability due to concerns regarding hepatotoxicity. FUTURE WORK: There is a need to develop new, safe, effective and fertility-sparing medical treatments for heavy menstrual bleeding. The observed acceptability and effectiveness of ulipri tal acetate warrants further research into the selective progesterone receptor modulator class of pharmacological agents. STUDY REGISTRATION: This trial is registered as ISRCTN 20426843.

Whitehead Christine, V. (2022). "Platelet Rich Plasma for Insufficient Endometrium." ClinicalTrials.gov.
	No Results Available Other: Platelet Rich Plasma Intrauterine infusion|Other: Normal saline Intrauterine infusion Endometrial Thickness during frozen embryo transfer|Sustained implantation rate Female Not Applicable 62 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment RMA-2022-04 December 2025

Whitehouse, K., et al. (2020). "Medical regimens for abortion at 12 weeks and above: a systematic review and meta-analysis." Contraception X 2: 100037.
	BACKGROUND: Mifepristone and misoprostol are recommended for second-trimester medical abortion, but consensus is unclear on the ideal regimen. OBJECTIVES: The objectives were to systematically review randomized controlled trials (RCTs) investigating efficacy, safety and satisfaction of medical abortion at ≥ 12 weeks' gestation. DATA SOURCES: We searched PubMed, Popline, Embase, Global Index Medicus, Cochrane Controlled Register of Trials and International Clinical Trials Registry Platform from January 2008 to May 2017. STUDY ELIGIBILITY PARTICIPANTS AND INTERVENTIONS: We included RCTs on medical abortion at ≥ 12 weeks' gestation using mifepristone and/or misoprostol. We excluded studies with spontaneous abortion, fetal demise and mechanical cervical ripening and those not reporting ongoing pregnancy (OP). STUDY APPRAISAL AND SYNTHESIS METHODS: After extracting prespecified data and assessing risk of bias in accordance with the Cochrane handbook, we used Revman5 software to combine data and GRADE to assess certainty of evidence. RESULTS: We included 43 of the 1894 references identified. Combination mifepristone-misoprostol had lower rates of OP [risk ratio (RR) 0.12, 95% confidence interval (CI) 0.04-0.35] vs. misoprostol only. A 24-h interval between mifepristone and misoprostol had lower OP rate at 24 h than simultaneous dosing (RR 3.13, 95% CI 1.23-7.94). Every 3-h dosing had lower OP rate at 48 h (RR 0.39, 95% CI 0.17-0.88). LIMITATIONS: Direct comparisons of buccal misoprostol to sublingual or vaginal routes after mifepristone were limited. Evidence from clinical trials on how to best manage women with prior uterine incisions was lacking. CONCLUSION: Our analysis supports the use of mifepristone 200 mg 1 to 2 days before misoprostol 400 mcg vaginally every 3 h at ≥ 12 weeks' gestation. IMPLICATIONS: Where available, providers should use mifepristone plus misoprostol for second-trimester medical abortion. Vaginal misoprostol appears to be most efficacious with fewest side effects, but sublingual and buccal routes are also acceptable.

Wiedemann, A. (2022). "Systematic evaluation of a CE certified digital therapy companion for patients suffering from overactive bladder (OAB) with or without urinary incontinence (UI) or in combination with stress urinary incontinence (mixed incontinence)." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Intervention 1: Control Intervention 2: INKA‐App CONDITION: overactive bladder PRIMARY OUTCOME: Change from baseline in mean number of micturitions per day (average from 3‐day bladder protocol) after 12 weeks using the INKA app as compared to control group without INKA app. SECONDARY OUTCOME: Change from baseline to 4 weeks based on 3‐day bladder protocol; ‐ in the mean number of micturitions per day (average from 3‐day bladder protocol) Change from baseline to 4 and to 12 weeks based on 3‐day bladder protocol; ‐ in the mean urine volume (ml) per micturition; ‐ in the mean number of PADs (n) used per day; ‐ in the mean intensity of urge (score 0‐4); ‐ in the mean number of micturitions (n) during the day (6 am ‐ 10 pm); ‐ in the mean number of micturitions (n) during night (10 pm ‐ 6 am); ‐ in the mean number of urine leakage (n) per day Change from baseline to 4 and to 12 weeks based on the pad test; ‐ in the mean amount of urine loss in g per day Change from baseline to 4 and to 12 weeks based on questionnaires; ‐ in the overall score of the quality‐of‐life questionnaire ICIQOABqol; ‐ in the total score of the questionnaire ICIQ‐OAB; ‐ in the total score of the questionnaire ICIQ‐UI‐SF INCLUSION CRITERIA: 1. Diagnosis of OAB for = 4 weeks with or without UI or mixed incontinence due to overactive bladder combined with stress incontinence if overactive bladder is the predominant symptom 2. Sex: male/female 3. Age: 18 years or older 4. Patients receiving stable pharmacological treatment for included indications for at least =4 weeks before screening visit 5. Ability to read and write German 6. Ownership and familiarity to a smartphone and capability to use it in daily life, to react on push messages 7. Informed consent to study participation and data processing

Wieland, L. S., et al. (2019). "Yoga for treating urinary incontinence in women." The Cochrane Database of Systematic Reviews 2019(2): CD012668.
	Background Urinary incontinence in women is associated with poor quality of life and diHiculties in social, psychological and sexual functioning. The condition may aHect up to 15% of middle-aged or older women in the general population. Conservative treatments such as lifestyle interventions, bladder training and pelvic floor muscle training (used either alone or in combination with other interventions) are the initial approaches to the management of urinary incontinence. Many women are interested in additional treatments such as yoga, a system of philosophy, lifestyle and physical practice that originated in ancient India. Objectives To assess the eHects of yoga for treating urinary incontinence in women. Search methods We searched the Cochrane Incontinence and Cochrane Complementary Medicine Specialised Registers. We searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov to identify any ongoing or unpublished studies. We handsearched Proceedings of the International Congress on Complementary Medicine Research and the European Congress for Integrative Medicine. We searched the NHS Economic Evaluation Database for economic studies, and supplemented this search with searches for economics studies in MEDLINE and Embase from 2015 onwards. Database searches are up-to-date as of 21 June 2018. Selection criteria Randomised controlled trials in women diagnosed with urinary incontinence in which one group was allocated to treatment with yoga. 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 each reported outcome. Any disagreements were resolved by consensus. We planned to combine clinically comparable studies in Review Manager 5 using random-eHects meta-analysis and to carry out sensitivity and subgroup analyses. We planned to create a table listing economic studies on yoga for incontinence but not carry out any analyses on these studies. Main results We included two studies (involving a total of 49 women). Each study compared yoga to a diHerent comparator, therefore we were unable to combine the data in a meta-analysis. A third study that has been completed but not yet fully reported is awaiting assessment. One included study was a six-week study comparing yoga to a waiting list in 19 women with either urgency urinary incontinence or stress urinary incontinence. We judged the certainty of the evidence for all reported outcomes as very low due to performance bias, detection bias, and imprecision. The number of women reporting cure was not reported. We are uncertain whether yoga results in satisfaction with cure or improvement of incontinence (risk ratio (RR) 6.33, 95% confidence interval (CI) 1.44 to 27.88; an increase of 592 from 111 per 1000, 95% CI 160 to 1000). We are uncertain whether there is a diHerence between yoga and waiting list in condition-specific quality of life as measured on the Incontinence Impact Questionnaire Short Form (mean diHerence (MD) 1.74, 95% CI -33.02 to 36.50); the number of micturitions (MD -0.77, 95% CI -2.13 to 0.59); the number of incontinence episodes (MD -1.57, 95% CI -2.83 to -0.31); or the bothersomeness of incontinence as measured on the Urogenital Distress Inventory 6 (MD -0.90, 95% CI -1.46 to -0.34). There was no evidence of a diHerence in the number of women who experienced at least one adverse event (risk diHerence 0%, 95% CI -38% to 38%; no diHerence from 222 per 1000, 95% CI 380 fewer to 380 more). The second included study was an eight-week study in 30 women with urgency urinary incontinence that compared mindfulness-based stress reduction (MBSR) to an active control intervention of yoga classes. The study was unblinded, and there was high attrition from both study arms for all outcome assessments. We judged the certainty of the evidence for all reported outcomes as very low due to performance bias, attrition bias, imprecision and indirectness. The number of women reporting cure was not reported. We are uncertain whether women in the yoga group were less likely to report improvement in incontinence at eight weeks compared to women in the MBSR group (RR 0.09, 95% CI 0.01 to 1.43; a decrease of 419 from 461 per 1000, 95% CI 5 to 660). We are uncertain about the eHect of MBSR compared to yoga on reports of cure or improvement in incontinence, improvement in condition-specific quality of life measured on the Overactive Bladder Health-Related Quality of Life Scale, reduction in incontinence episodes or reduction in bothersomeness of incontinence as measured on the Overactive Bladder Symptom and Quality of Life-Short Form at eight weeks. The study did not report on adverse eHects.Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Wilfried, D., et al. (2021). "Effectiveness of Menosan® Salvia officinalis in the treatment of a wide spectrum of menopausal complaints. A double-blind, randomized, placebo-controlled, clinical trial." Heliyon 7(2): e05910.
	OBJECTIVE: To evaluate efficacy and safety of fresh Salvia officinalis extract tablets in relieving typical symptoms in menopausal women and to gain insight in the mode of action by measuring altered cerebral wave intensities. METHODS: Randomized 80 menopausal women from 48 - 65 years of age received Menosan® tablets [3'400 mg ethanolic extract of freshly harvested Salvia officinalis L.] or placebo under double-blind conditions for 4 weeks. An efficacy analysis evaluated the developments of the menopausal rating scale [MRS], hot flush severity score [HFS] and quantitative electroencephalography [qEEG] intensities in the per protocol population. Results were further corroborated by data from the intention to treat population including late postmenopausal women. RESULTS: Salvia off. distinctly reduced MRS by 39.2% from 15.3 ± 6.87 to 9.3 ± 5.75 and significantly in comparison to placebo (p = 0.002). The HFS score decreased by 55.3% from 15.9 ± 13.77 to 7.1 ± 7.41, reaching significance on week 3 onwards (p = 0.028). Clinical effects of Salvia off. correlated with relevant reduction of frontal lobe beta2 wave qEEG intensities at electrodes F3/4/7/8 and are underpinned by secondary parameters and ITT analysis. Salvia off. within 4 weeks significantly reduced the somato-vegetative (e.g. hot flushes) and psychological MRS subscale (e.g. physical and mental exhaustion) subscale (p < 0.05) without a significant effect on the genito-urinary subscale. A positive impact of Salvia off. compared to placebo was furthermore seen on sleep quality, discontent and fatigue (p < 0.05) as evidenced by sleep and profile of mood state questionnaires.Tolerability was uniformly rated as very good for Salvia off. extract and placebo, with an overall incidence of three adverse events in total, none of which treatment-related. CONCLUSION: The results support the use of Salvia off. for the specific treatment of a wide range of somato-vegetative and psychological symptoms as experienced by menopausal women and correlate this effect to a restoration of associated dysbalanced brain waves.The study was registered as EudraCT-No 2016-005033-77.

William, S., et al. (2021). "Non-metformin insulin sensitising drugs for subfertility in polycystic ovary syndrome." PROSPERO International prospective register of systematic reviews.
	
Wilson, C. A., et al. (2021). "Brexanolone and related neurosteroid GABA(A) positive allosteric modulators for postnatal depression." The Cochrane Database of Systematic Reviews 2021(5): CD014624.
	Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To assess the effectiveness and safety of brexanolone and related neurosteroid GABAA positive allosteric modulators in comparison with any other treatment (pharmacological, psychological, or psychosocial), placebo, or treatment as usual for postnatal depression (PND).Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Winarto, H., et al. (2022). "Adjuvant chemoradiotherapy versus chemotherapy or radiotherapy in advanced endometrial cancer: a systematic review and meta-analysis." PeerJ 10: e14420.
	Background: Endometrial cancer is one of the most common gynecological cancer in the world. However, the available adjuvant therapies, chemotherapy (CT) and radiotherapy (RT), demonstrated several limitations when used alone. Therefore, we conducted a meta-analysis to investigate the clinical effectiveness of chemoradiotherapy (CRT) based on overall survival (OS) and disease-free survival (DFS).; Methods: A literature search was performed on five databases and one clinical trial registry to obtain all relevant articles. Search for studies was completed on September 9, 2021. A meta-analysis was conducted to determine the overall hazard ratio with the 95% Confidence Interval.; Results: A total of 17 articles with 23,975 patients in the CRT vs RT group and 50,502 patients in the CRT vs CT group were included. The OS Hazard Ratios (HR) of CRT compared to RT was 0.66 (95% CI [0.59-0.75]; P < 0.00001). Compared to CT, the OS HR was 0.70 (95% CI [0.64-0.78]; P < 0.00001). CRT also significantly improved the DFS compared to CT only (HR 0.79, 95% CI [0.64-0.97]; P = 0.02) However, CRT did not improve the DFS compared to RT only, with HR of 0.71 (95% CI [0.46-1.09]; P = 0.12).; Conclusion: Adjuvant CRT can significantly improve OS compared to CT or RT alone and improve the DFS compared to CT alone in patients with advanced endometrial cancer. Further research is needed to identify the optimal CRT regimen, and to whom CRT will be most beneficial.; Competing Interests: The authors declare that they have no competing interests. (© 2022 Winarto et al.)

Winata, I. G. S., et al. (2023). "The role of hysteroscopy in patients with recurrent implantation failure before starting in vitro fertilization: a systematic review and meta-analysis." The Trocar 4(3): 10-25.
	Objective: Recurrent Implantation Failure (RIF)

Winokur Ronald, S. (2024). "Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices." ClinicalTrials.gov.
	No Results Available Diagnostic Test: Transcatheter Venography|Procedure: Bilateral ovarian vein embolization Change in Visual Analog Scale (VAS) for pelvic pain|Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale|Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Pain Intensity Scale|Change in Patient Global Impression of Change (PGIC)|Change in EuroQol five-dimension (EQ-5D) scale Female Not Applicable 40 Other|Industry Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment 23-08026405 June 2026

Wojniusz, S. (2021). "Somatocognitive Therapy in Treatment of Provoked (Localized) Vestibulodynia - Randomized Clinical Trial (ProLoVe Study)." ClinicalTrials.gov.
	No Results Available Other: Somatocognitive physiotherapy|Other: Treatment as usual Change in female sexual function index (FSFI) (Rosen et al. 2000)|Change in Participant Perceived Improvement (PGIC) (Dworkin et al. 2005)|Change in the tampon test (Foster et al. 2009)|Change in recalled pain intensity during intercourse|Change in Vulvar Pain Assessment Questionnaire (VPAQ) (Dargie et al. 2017) - life interference|Change in Vulvar Pain Assessment Questionnaire (VPAQ) (Dargie et al. 2017) - coping strategies|Change in vulvodynia related self-efficacy|Change in pain catastrophizing scale (Fernandes et al. 2012)|Change in Rumination Response Scale (RRS-10) (Parola et al. 2017)|Change in Hopkins Symptoms Check List (HSCL-25) (Derogatis et al.1974)|Change in EQ-5D-5L (Herdman et al. 2011) Female Not Applicable 128 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment 29295 December 31, 2025

Wolf Jean, P. (2021). "Improvement of Live Babies Rates After ICSI, Using cpFT." ClinicalTrials.gov.
	Supplementation of the incubation medium with cFEE should improve the implantation rate and ART outcome. As in France ICSI is widely used to achieve good fertilization rates, we decided to use ICSI to fertilize the egg, and the peptide: 1. to improve chromosome segregation during meiosis, and 2. to improve in vitro embryogenesis after ICSI. Hence the protocol includes an oocyte preincubation step prior to ICSI and a co incubation of the embryo with the molecule during blastocyst formation. Hence our protocol includes: 1. ‐ a preincubation of the decoronized oocytes with the peptide prior to ICSI, and 2. ‐ a coincubation of the developing embryo with the molecule. The principal criteria will be the live baby rate after the first embryo transfer (using the best embryo). As the oocyte loses its strength as the women is getting older, the main criteria will be evaluated for women under 37 years old. Randomization: every couple will be randomly assigned to the Control or the Treated group. Treated group: After egg retrieval, the oocyte will be decoronized and incubated prior to ICSI procedure into CSCM‐C (Irvine) medium supplemented with the molecule. Control group: similar protocol of incubation but without the molecule. After ICSI the zygote will be incubated until the blastocyste stage in CSCM‐C medium (Irvine). Embryo transfer will be limited to only one blastocyst, fresh or delayed after cryopreservation.

Woodley Stephanie, J., et al. (2020). "Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women." The Cochrane Database of Systematic Reviews 5: CD007471.
	Background: About one-third of women have urinary incontinence (UI) and up to one-tenth have faecal incontinence (FI) after childbirth. Pelvic floor muscle training (PFMT) is commonly recommended during pregnancy and after birth for both preventing and treating incontinence. This is an update of a Cochrane Review previously published in 2017.; Objectives: To assess the effects of PFMT for preventing or treating urinary and faecal incontinence in pregnant or postnatal women, and summarise the principal findings of relevant economic evaluations.; Search Methods: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP, and handsearched journals and conference proceedings (searched 7 August 2019), and the reference lists of retrieved studies.; Selection Criteria: We included randomised or quasi-randomised trials in which one arm included PFMT. Another arm was no PFMT, usual antenatal or postnatal care, another control condition, or an alternative PFMT intervention. Populations included women who, at randomisation, were continent (PFMT for prevention) or incontinent (PFMT for treatment), and a mixed population of women who were one or the other (PFMT for prevention or treatment).; Data Collection and Analysis: We independently assessed trials for inclusion and risk of bias. We extracted data and assessed the quality of evidence using GRADE.; Main Results: We included 46 trials involving 10,832 women from 21 countries. Overall, trials were small to moderately-sized. The PFMT programmes and control conditions varied considerably and were often poorly described. Many trials were at moderate to high risk of bias. Two participants in a study of 43 pregnant women performing PFMT for prevention of incontinence withdrew due to pelvic floor pain. No other trials reported any adverse effects of PFMT. Prevention of UI: compared with usual care, continent pregnant women performing antenatal PFMT probably have a lower risk of reporting UI in late pregnancy (62% less; risk ratio (RR) 0.38, 95% confidence interval (CI) 0.20 to 0.72; 6 trials, 624 women; moderate-quality evidence). Antenatal PFMT slightly decreased the risk of UI in the mid-postnatal period (more than three to six months' postpartum) (29% less; RR 0.71, 95% CI 0.54 to 0.95; 5 trials, 673 women; high-quality evidence). There was insufficient information available for the late postnatal period (more than six to 12 months) to determine effects at this time point (RR 1.20, 95% CI 0.65 to 2.21; 1 trial, 44 women; low-quality evidence). Treatment of UI: compared with usual care, there is no evidence that antenatal PFMT in incontinent women decreases incontinence in late pregnancy (very low-quality evidence), or in the mid-(RR 0.94, 95% CI 0.70 to 1.24; 1 trial, 187 women; low-quality evidence), or late postnatal periods (very low-quality evidence). Similarly, in postnatal women with persistent UI, there is no evidence that PFMT results in a difference in UI at more than six to 12 months postpartum (RR 0.55, 95% CI 0.29 to 1.07; 3 trials; 696 women; low-quality evidence). Mixed prevention and treatment approach to UI: antenatal PFMT in women with or without UI probably decreases UI risk in late pregnancy (22% less; RR 0.78, 95% CI 0.64 to 0.94; 11 trials, 3307 women; moderate-quality evidence), and may reduce the risk slightly in the mid-postnatal period (RR 0.73, 95% CI 0.55 to 0.97; 5 trials, 1921 women; low-quality evidence). There was no evidence that antenatal PFMT reduces the risk of UI at late postpartum (RR 0.85, 95% CI 0.63 to 1.14; 2 trials, 244 women; moderate-quality evidence). For PFMT started after delivery, there was uncertainty about the effect on UI risk in the late postnatal period (RR 0.88, 95% CI 0.71 to 1.09; 3 trials, 826 women; moderate-quality evidence). Faecal incontinence: eight trials reported FI outcomes. In postnatal women with persistent FI, it was u certain whether PFMT reduced incontinence in the late postnatal period compared to usual care (very low-quality evidence). In women with or without FI, there was no evidence that antenatal PFMT led to a difference in the prevalence of FI in late pregnancy (RR 0.64, 95% CI 0.36 to 1.14; 3 trials, 910 women; moderate-quality evidence). Similarly, for postnatal PFMT in a mixed population, there was no evidence that PFMT reduces the risk of FI in the late postnatal period (RR 0.73, 95% CI 0.13 to 4.21; 1 trial, 107 women, low-quality evidence). There was little evidence about effects on UI or FI beyond 12 months' postpartum. There were few incontinence-specific quality of life data and little consensus on how to measure it.; Authors' Conclusions: This review provides evidence that early, structured PFMT in early pregnancy for continent women may prevent the onset of UI in late pregnancy and postpartum. Population approaches (recruiting antenatal women regardless of continence status) may have a smaller effect on UI, although the reasons for this are unclear. A population-based approach for delivering postnatal PFMT is not likely to reduce UI. Uncertainty surrounds the effects of PFMT as a treatment for UI in antenatal and postnatal women, which contrasts with the more established effectiveness in mid-life women. It is possible that the effects of PFMT might be greater with targeted rather than mixed prevention and treatment approaches, and in certain groups of women. Hypothetically, for instance, women with a high body mass index (BMI) are at risk of UI. Such uncertainties require further testing and data on duration of effect are also needed. The physiological and behavioural aspects of exercise programmes must be described for both PFMT and control groups, and how much PFMT women in both groups do, to increase understanding of what works and for whom. Few data exist on FI and it is important that this is included in any future trials. It is essential that future trials use valid measures of incontinence-specific quality of life for both urinary and faecal incontinence. In addition to further clinical studies, economic evaluations assessing the cost-effectiveness of different management strategies for FI and UI are needed. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Woodward, A., et al. (2019). "The effects of physical exercise on cardiometabolic outcomes in women with polycystic ovary syndrome not taking the oral contraceptive pill: a systematic review and meta-analysis." Journal of Diabetes and Metabolic Disorders 18(2): 597-612.
	Purpose: Women with polycystic ovary syndrome (PCOS) exhibit many metabolic abnormalities that are associated with an increased cardiovascular disease risk. Exercise may promote improvements in lipid profile and insulin sensitivity in women with PCOS. There is however, a knowledge gap on the optimal dose of exercise, regarding duration, intensity, type, and frequency of exercise. The aim of this systematic review and meta-analysis was to define effective types of exercise to improve cardiometabolic profile in PCOS.; Methods: We included randomised controlled trials (RCT), quasi-RCT, and controlled clinical trials focusing on reproductive-aged women diagnosed with PCOS. Eligible interventions included those with at least two weeks of supervised exercise sessions. Primary outcomes were blood lipids, blood glucose, blood pressure, measures of abdominal adiposity, and inflammation markers. Secondary outcomes were total and free testosterone, sex hormone binding globulin, and measures of insulin resistance. Nine electronic databases were searched from inception to present for English language publications. The Cochrane Risk Assessment tool was used to assess bias in the included studies. Outcomes were quantitatively synthesised and a meta- analysis was performed. Pooled effect estimates and 95% confidence intervals were presented.; Results: This systematic review identified three trials, including 231 participants with PCOS, that examined the effect of structured, supervised exercise on cardiometabolic outcomes. Analysis of pooled data indicated statistical favourable effects of exercise on total cholesterol, fasting glucose, waist circumference and waist-to-hip ratio, systolic blood pressure, C-reactive protein, total testosterone, and sex hormone binding globulin using post-intervention scores.; Conclusions: Moderate aerobic exercise interventions ≥3 months in duration, with a frequency of 3/week for at least 30-min, may have favourable effects on various cardiometabolic risk factors in women with PCOS. However, results should be interpreted with caution. Many of the outcomes were based on studies with serious methodological limitations, and only one "gold-standard" RCT was identified.PROSPERO ID: CRD42018086117.; Competing Interests: Conflict of interestThe authors declare they have no conflicts of interest. (© The Author(s) 2019.)

Wu, D., et al. (2023). "Quality of life in ovarian cancer patients treated with bevacizumab: a meta-analysis." Expert Opinion on Drug Safety: 1-8.
	Introduction: Bevacizumab is widely used in ovarian cancer due to its ability to extend survival. The addition of bevacizumab to chemotherapy may increase the toxicities that affect quality of life (QOL). To investigate the impact of bevacizumab on QOL during the increased survival, we conducted a meta-analysis of randomized controlled trial (RCT).; Methods: We systematically searched PubMed, Embase, Cochrane Library, Web of Science and ClinicalTrials.gov. for RCTs comparing the QOL of bevacizumab plus chemotherapy (BEV-CT) versus chemotherapy (CT) in ovarian cancer. The primary outcome was the difference in change in QOL from baseline to follow-up between groups.; Results: Four RCTs involving 3454 patients were included in this meta-analysis. There was no difference in change in QOL between patients treated with BEV-CT and CT at the end of follow-up (pooled SMD= -00.05; 95%CI = -00.34 to 0.23; P = 0.71). Subgroup analyses showed similar results in the frontline and recurrent setting of ovarian cancer.; Conclusions: This is the first meta-analysis investigating QOL in ovarian cancer patients treated with bevacizumab. The extended survival associated with bevacizumab is not accompanied by a significant deterioration in QOL. Combined with the efficacy and safety outcomes, these results further support the clinical benefit of bevacizumab for ovarian cancer.

Wu, D., et al. (2023). "Economic Evaluation of Neoadjuvant Versus Adjuvant Chemotherapy in Cancer Treatment: A Systematic Review and Meta-Analysis." Value in Health Regional Issues 41: 15-24.
	Objectives: In the absence of evidence on whether neoadjuvant (NAC) or adjuvant chemotherapy (AC) is more beneficial for various tumor treatments, economic evaluation (EE) can assist medical decision making. There is limited evidence on their cost-effectiveness and their prospective evaluation is less likely in the future. Therefore, a systematic review and meta-analysis about EE for NAC versus AC in solid tumor help compare these therapies from various perspectives.; Methods: Various databases were searched for studies published from inception to 2021. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines and economic-specific guidelines. The data were pooled using a random effects model when possible.; Results: The retrieval identified 15 EE studies of NAC versus AC in 8 types of cancer. NAC is the dominant strategy for pancreatic, head and neck, rectal, prostate cancers and colorectal liver metastases. For ovarian cancer, NAC is cost-effective with a lower cost and higher or similar quality-adjusted life-year. There were no significant differences in cost and outcomes for lung cancer. For stage IV or high-risk patients with ovarian or prostate cancer, NAC was cost-effective but not for patients who were not high risk.; Conclusions: The EEs results for NAC versus AC were inconsistent because of their different model structures, assumptions, cost inclusions, and a shortage of studies. There are multiple sources of heterogeneity across EEs evidence synthesis. More high-quality EE studies on NAC versus AC in initial cancer treatment are necessary.; Competing Interests: Author Disclosures Links to the individual disclosure forms provided by the authors are available here. (Copyright © 2023 International Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Wu, H., et al. (2021). "Endometrial preparation for frozen-thawed embryo transfer cycles: a systematic review and network meta-analysis." Journal of Assisted Reproduction and Genetics 38(8): 1913-1926.
	Purpose: To compare the effects of different endometrial preparation protocols for frozen-thawed embryo transfer (FET) cycles and present treatment hierarchy.; Methods: Systematic review with meta-analysis was performed by electronic searching of MEDLINE, the Cochrane Library, Embase, ClinicalTrials.gov and Google Scholar up to Dec 26, 2020. Randomised controlled trials (RCTs) or observational studies comparing 7 treatment options (natural cycle with or without human chorionic gonadotrophin trigger (mNC or tNC), artificial cycle with or without gonadotropin-releasing hormone agonist suppression (AC+GnRH or AC), aromatase inhibitor, clomiphene citrate, gonadotropin or follicle stimulating hormone) in FET cycles were included. Meta-analyses were performed within random effects models. Primary outcome was live birth presented as odds ratio (OR) with 95% confidence intervals (CIs).; Results: Twenty-six RCTs and 113 cohort studies were included in the meta-analyses. In a network meta-analysis, AC ranked last in effectiveness, with lower live birth rates when compared with other endometrial preparation protocols. In pairwise meta-analyses of observational studies, AC was associated with significant lower live birth rates compared with tNC (OR 0.81, 0.70 to 0.93) and mNC (OR 0.85, 0.77 to 0.93). Women who achieved pregnancy after AC were at an increased risk of pregnancy-induced hypertension (OR 1.82, 1.37 to 2.38), postpartum haemorrhage (OR 2.08, 1.61 to 2.78) and very preterm birth (OR 2.08, 1.45 to 2.94) compared with those after tNC.; Conclusion: Natural cycle treatment has a higher chance of live birth and lower risks of PIH, PPH and VPTB than AC for endometrial preparation in women receiving FET cycles. (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Wu, J. (2021). "Comparing KIM to TVT Exact Sling." ClinicalTrials.gov.
	Midurethral slings (MUS) are recognized as a minimally invasive treatment of SUI. The retropubic route of MUS placement has a cure rate of 89.1% with long term subjective cure rates ranging from 51‐88%. The Neomedic Knotless Incontinence Mesh (KIM) sling is a tension‐free macroporous monofilament polypropylene knotless mesh designed to be resistant to elongation and deformation over time. The KIM sling also offers a reusable trocar, which results in less waste and cost‐ savings. KIM sling trocars are available for the retropubic route or trans‐obturator (TOT) route. While studies have been performed comparing the TOT approach of the KIM sling to other slings, no studies have been performed to date with the retropubic (RP) approach. The RP and TOT approaches to MUS have been shown to be equivalent in the treatment of SUI. Since the same mesh material of the KIM sling is used for both the TOT and RP approach, it can be hypothesis that the RP route would show similar treatment success rates. A type 1 macroporous (> 75um) polypropylene mesh is the most appropriate material for vaginal implantation. However, literature has suggested that the design and weave of synthetic mesh material can also have a significant effect on efficacy and safety; therefore, the novel design of the KIM may be beneficial to reduce complications. If there is similar efficacy with the RP approach of the KIM sling to the TVT Exact, there will be benefit of reduced costs and the potential for less complications. With this study, the objective is to show non‐inferiority of the KIM sling to the Gynecare TVT Exact.

Wu, J., et al. (2020). "Effectiveness of acupuncture in polycystic ovary syndrome: A systematic review and meta-analysis of randomized controlled trials." Medicine 99(22): e20441.
	Objective: To evaluate the effectiveness of acupuncture in reproductive-age females with polycystic ovary syndrome (PCOS).; Methods: We searched the Pubmed, Web of Science, Embase, Cochrane, China National Knowledge Infrastructure (CNKI), Wanfang Data, and Chongqing VIP databases for the relevant literature. The meta-analysis was performed with a random-effects model with RevMan 5.3. The primary outcomes of interest included the rate of live birth, pregnancy and ovulation, and the secondary outcomes included the recovery of menstrual period and hormone levels. Results were expressed as the relative risk (RR) for the discrete data and the mean difference (MD) for the continuous outcomes with a 95% confidence interval (CI).; Results: Twenty two studies with 2315 participants were included in this systematic review and meta-analysis. A pooled analysis showed a recovery of the menstrual period (5 trials; 364 participants; SMD, -0.52; 95% CI [-0.89, -0.14]; I = 67%; P = .0007; low certainty) in the acupuncture group. Furthermore, there were significant decreases in the luteinizing hormone (LH) (13 trials; 917 participants; MD, -0.92; 95% CI [-1.43, -0.41]; I = 60%; P = .0004; very low certainty) and testosterone (13 trials; 923 participants; SMD, -0.46; 95% CI [-0.73, -0.20]; I = 75%; P = .0006; very low certainty) in the acupuncture group. No significant differences were observed in the rates of live birth, pregnancy, and ovulation, and no significant differences were observed in the LH/follicle-stimulating hormone (FSH) ratio.; Conclusions: There was insufficient evidence to support that acupuncture could promote live birth, pregnancy, and ovulation. However, acupuncture could promote the recovery of menstrual cycles as well as downregulate the levels of LH and testosterone in patients with PCOS.; Study Registration: PROSPERO CRD42019128574.

Wu, L., et al. (2023). "Oral contraceptives (OCs) in combination with metformin versus OCs alone on metabolism in nonobese polycystic ovary syndrome: A meta-analysis and systematic review of randomized controlled trials." Clinical Endocrinology 99(1): 3-16.
	Background: To compare OCs(oral contraceptives) + metformin and OCs alone for metabolic effects in nonobese polycystic ovary syndrome (PCOS) patients.; Methods: The search was performed in PubMed, EMBASE, the Cochrane Library and clinicaltrials.gov for all published studies up to 30 April 2022 and was limited to English-language articles. All randomized controlled trials (RCTs) comparing OCs + metformin and OCs alone for reproductive-age women with PCOS were included. Data were processed using Revman 5.3 software.; Results: Of 396 studies identified, 14 RCTs were included for analysis comprising 707 women. OCs+metformin significantly modified fasting glucose (MD = -0.21 [95% confidence interval (CI) = -0.31, -0.12], p < .00001) and fasting insulin (MD = -2.54 [95%CI = -4.04, -1.04], p = .0009) at study completion compared with OCs alone in nonobese PCOS subjects. There was no statistic difference in the homoeostasis model assessment of insulin resistance (HOMA-IR), high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol or triglycerides at study end between the two groups.; Conclusions: Metformin, via its positive effects on insulin clearance, in combination with OCs, improved glucose metabolism and offered a good treatment alternative in nonobese women with PCOS. (© 2023 John Wiley & Sons Ltd.)

Wu, Q., et al. (2019). "Efficacy of hyperthermic intraperitoneal chemotherapy in patients with epithelial ovarian cancer: a meta-analysis." International Journal of Hyperthermia 36(1): 562-572.
	Objective: The role of hyperthermic intraperitoneal chemotherapy (HIPEC) in epithelial ovarian cancer (EOC) is still controversial. Present analysis aims to evaluate the survival benefit of HIPEC in treatment of EOC patients. Methods: Articles related to 'HIPEC' and 'ovarian cancer' were comprehensively searched in four databases (PubMed, EMBASE, MEDLINE and Cochrane Library) up to 4 February 2018. Eligible studies were identified depending on the selection criteria. The survival outcome and adverse events were collected. The relationship between HIPEC and survival of EOC was assessed using random-effects models. Results: A total of 1464 patients from 17 trials were subjected to analysis. The pooled results showed that HIPEC significantly improved overall survival (OS, HR = 0.50, 95% CI 0.36-0.69; p = 0.000) and progression-free survival (PFS, HR = 0.57, 95% CI 0.47-0.69; p = 0.000) among EOC patients when compared with no HIPEC controls. Similar results were observed in each year rate of survival. Subgroup analysis didn't lead to the opposite results, except no significant increased 1-year of OS in primary EOC and 1- and 2-year of PFS in recurrent EOC treated with HIPEC were observed. No significant difference existed in the adverse events and mortality between HIPEC and no HIPEC. Conclusions: HIPEC is associated with improved OS and PFS in both primary and recurrent EOC. However, no significant increased 1- and 2-year of PFS were reached in recurrent EOC treated with HIPEC. Further prospective randomized controlled trials are warranted.

Wu, X., et al. (2021). "Electromyographic Biofeedback for Stress Urinary Incontinence or Pelvic Floor Dysfunction in Women: A Systematic Review and Meta-Analysis." Advances in Therapy 38(8): 4163-4177.
	Electromyographic biofeedback (EMG-BF) can be regarded as an adjuvant to pelvic floor muscle (PFM) training (PFMT) for the management of stress urinary incontinence (SUI). This meta-analysis aimed to compare the efficacy of PFMT with and without EMG-BF on the cure and improvement rate, PFM strength, urinary incontinence score, and quality of sexual life for the treatment of SUI or pelvic floor dysfunction (PFD). PubMed, EMBASE, the Cochrane Library, Web of Science, Wanfang, and CNKI were systematically searched for studies published up to January 2021. The outcomes were the cure and improvement rate, symptom-related score, pelvic floor muscle strength change, and sexual life quality. Twenty-one studies (comprising 1967 patients with EMG-BF + PFMT and 1898 with PFMT) were included. Compared with PFMT, EMG-BF + PFMT had benefits regarding the cure and improvement rate in SUI (OR 4.82, 95% CI 2.21-10.51, P < 0.001; I2 = 85.3%, Pheterogeneity < 0.001) and in PFD (OR 2.81, 95% CI 2.04-3.86, P < 0.001; I2 = 13.1%, Pheterogeneity = 0.331), and in quality of life using the I-QOL tool (SMD 1.47, 95% CI 0.69-2.26, P < 0.001; I2 = 90.1%, Pheterogeneity < 0.001), quality of sexual life using the FSFI tool (SMD 2.86, 95% CI 0.47-5.25, P = 0.019; I2 = 98.7%, Pheterogeneity < 0.001), urinary incontinence using the ICI-Q-SF tool (SMD - 0.62, 95% CI - 1.16, - 0.08, P = 0.024), PFM strength (SMD 1.72, 95% CI 1.08-2.35, P < 0.001; I2 = 91.4%, Pheterogeneity < 0.001), and urodynamics using Qmax (SMD 0.84, 95% CI 0.57-1.10, P < 0.001; I2 = 0%, Pheterogeneity = 0.420) and MUCP (SMD 1.54, 95% CI 0.66-2.43, P = 0.001; I2 = 81.8%, Pheterogeneity = 0.019). There was limited evidence of publication bias. PFMT combined with EMG-BF achieves better outcomes than PFMT alone in SUI or PFD management.Copyright © 2021, The Author(s).

Wu, Y., et al. (2021). "Acupuncture for glucose and lipid metabolic disorders of polycystic ovarian syndrome: A systematic review protocol." PloS One 16(8): e0255732.
	Background: Polycystic ovary syndrome (PCOS) is a common gynecological disease that is often accompanied by some metabolic abnormality such as insulin resistance and dyslipidemia. As a non-pharmacological therapy, acupuncture is widely used for the treatment of PCOS, but the effectiveness for insulin resistance and lipid metabolic disorder remains controversial.; Objectives: To assess the effectiveness and safety of acupuncture for insulin resistance and lipid metabolic disorder of women with PCOS.; Search Methods: Eight databases will be searched from inception to June 2021, three clinical trial registration platforms will be searched for relevant trials.; Selection Criteria: Randomized controlled trials (RCTs) of acupuncture therapy for insulin resistance and lipid metabolic of PCOS will be included.; Data Collection and Analysis: Study screening, data collection, and analysis will be performed by two or more reviewers independently. We will calculate mean difference (MD), standard mean difference (SMD) with 95% confidence intervals (CIs). Data synthesis will be performed with RevMan V.5.3 software and with Stata V.15.0 software when necessary.; Prospero Registration Number: CRD42020177846.; Competing Interests: The authors have declared that no competing interests exist.

Wu, Y., et al. (2020). "Association of Metformin With Pregnancy Outcomes in Women With Polycystic Ovarian Syndrome Undergoing In Vitro Fertilization: A Systematic Review and Meta-analysis." JAMA Network Open 3(8): e2011995.
	Importance: Metformin is widely used among women with polycystic ovary syndrome (PCOS). However, its associations with outcomes of in vitro fertilization or intracytoplasmic sperm injection and embryo transfer (IVF/ICSI-ET) in women with PCOS remain controversial.; Objective: To assess whether metformin is associated with improved outcomes of IVF/ICSI-ET in women with PCOS.; Data Sources: PubMed, Embase, and Cochrane were searched from database inception to January 31, 2020.; Study Selection: Only randomized clinical trials (RCTs) were included. Eligible studies enrolled women with PCOS undergoing infertility treatment with IVF/ICSI-ET and reported at least 1 outcome of IVF/ICSI-ET.; Data Extraction and Synthesis: This study followed the Preferred Reporting Items for Systematic Reviews and Meta analyses guidelines. Two authors independently extracted the data. Study quality was evaluated using the GRADE system. Treatment effect was quantified using odds ratios (ORs) with 95% CIs using random-effect models with the Mantel-Haenszel method.; Main Outcomes and Measures: Ovarian hyperstimulation syndrome (OHSS), clinical pregnancy rate, and live birth rate.; Results: A total of 12 RCTs, which collectively included 1123 women with PCOS undergoing infertility treatment with IVF/ICSI-ET, were identified. The risk of OHSS in women randomized to metformin was lower than in women not randomized to metformin (OR, 0.43; 95% CI, 0.24-0.78), although this difference was not significant for women with PCOS with a body mass index of less than 26 (OR, 0.67; 95% CI, 0.30-1.51). There was no significant difference in clinical pregnancy rate (OR, 1.24; 95% CI, 0.82-1.86) or live birth rate (OR, 1.23; 95% CI, 0.74-2.04) in the total population studied. However, in a post hoc analysis among women with a body mass index of 26 or greater, metformin treatment was associated with increased clinical pregnancy rates (OR, 1.71; 95% CI, 1.12-2.60).; Conclusions and Relevance: In this study, metformin treatment was associated with a decreased risk of OHSS but had no association with the overall clinical pregnancy rate or live birth rate among women with PCOS undergoing IVF/ICSI-ET. Metformin treatment should be carefully considered for women with PCOS undergoing IVF/ICSI-ET and may be more preferred for women with a body mass index greater than 26.

Wyne, M., et al. (2023). "Effects of Hypocaloric Diet, Exercise and Vitamin E supplementation on Ovulation in Overweight and Obese Women with Polycystic Ovary Syndrome: A Systematic Review." PROSPERO International prospective register of systematic reviews.
	
Xi, H., et al. (2021). "Effect of combined aerobic and resistance exercise on blood pressure in postmenopausal women: A systematic review and meta-analysis of randomized controlled trials." Experimental Gerontology 155: 111560.
	Objective: The purpose of this study is to evaluate the effects of combined aerobic and resistance exercise on blood pressure (BP) in postmenopausal women. The results of this study will provide an effective means for postmenopausal women to control BP and reduce the morbidity and mortality of cardiovascular disease (CVD).; Methods: Eligible studies were searched in five electronic databases until November 2020, and 11 randomized controlled trials that met the inclusion criteria were included in this systematic review and meta-analysis. The random-effects model was used to calculate overall effect sizes of weighted mean differences (WMD) and 95% confidence interval (CI). This study was registered in PROSPERO with the registration number: CRD42021225546.; Results: Compared with the control group, the aerobic combined resistance exercise significantly decreased the systolic blood pressure (SBP) and diastolic blood pressure (DBP) by 0.81 mmHg (95% CI, -1.34 to -0.28) and 0.62 mmHg (95% CI, -1.11 to -0.14), respectively. The results of the meta-analysis also indicated that a significant reduction in brachial-to-ankle pulse wave velocity (baPWV) of - 1.18 m/s (95% CI, -1.81 to -0.56) and heart rate (HR) of -0.22 beats/min (95% CI: -0.42 to -0.02) after combined aerobic and resistance exercise intervention. Subgroup analysis showed that postmenopausal women ≥60 years of age who were overweight or had a normal baseline BP were more sensitive to the combined aerobic and resistance exercise. When combined aerobic and resistance exercise frequency < 3 times/week, weekly exercise time ≥ 150 min, or the duration of exercise lasted for 12 weeks, the SBP and DBP of postmenopausal women could be reduced more effectively.; Conclusions: The present study indicates that combined aerobic and resistance exercise can significantly reduce BP in postmenopausal women. Accordingly, combined aerobic and resistance exercise may be an effective way to prevent and manage hypertension in postmenopausal women. (Copyright © 2021 Elsevier Inc. All rights reserved.)

Xia, W., et al. (2023). "The Timing and Dose-effect of Acupuncture on Pregnancy Outcomes for Infertile Women undergoing in Vitro Fertilization and Embryo Transfer (IVF-ET) : A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Xiang, X., et al. (2021). "Efficacy of chemotherapy versus chemoradiotherapy for locally advanced endometrial cancer: a systematic review and meta-analysis." Precision Radiation Oncology 5(1): 43-49.
	Objective: This meta-analysis evaluates the efficacy of chemoradiotherapy versus chemotherapy in patients with locally advanced endometrial cancer (EC). Method(s): A systematic search in PubMed, Embase, and the Cochrane Library was performed, according to the PRISMA statement, for the past 10 years to May 28 2020 to identify studies on chemoradiotherapy versus chemotherapy in patients with locally advanced EC. Two independent observers evaluated the identified studies. The obtained data were analyzed using the RevMan 5.3 software. Result(s): Five studies involving 1346 patients with locally advanced EC were identified and included in this meta-analysis according to the inclusion criteria. All studies reported the recurrence-free survival, and found that patients who received chemoradiotherapy had a better recurrence-free survival than those who received chemotherapy only (hazard ratio 1.53, 95% confidence interval 1.01-2.05, P < 0. Data on overall survival were provided in three studies; the meta-analysis showed that patients who received chemoradiotherapy had a better overall survival than those who received chemotherapy only (hazard ratio 1.80, 95% confidence interval 1.07-2.53; P < 0.001), and their difference was significant. Toxicity details were reported in the Gynecologic Oncology Group-258 trial. In summary, constitutional symptoms, fatigue, gastrointestinal events, renal or genitourinary events, and musculoskeletal events were more frequent in patients who received chemoradiotherapy, whereas hematological adverse events were more frequent and more severe in those who received chemotherapy only. Conclusion(s): The meta-analysis showed that patients receiving chemoradiotherapy had a better overall survival and recurrence-free survival than those who received chemotherapy only. Large-scale randomized controlled trials are necessary for the future.Copyright © 2021 The Authors. Precision Radiation Oncology published by John Wiley & Sons Australia, Ltd on behalf of Shandong Cancer Hospital & Institute.

Xiangping, P., et al. (2023). "The efficacy and safety of integrating oriental medicine with Assisted Reproductive Technology: A Systematic Review and Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Xiao, C., et al. (2021). "Non-surgical management of tubal ectopic pregnancy A systematic review and meta-analysis." Medicine 100(50): E27851.
	Background: Ectopic pregnancy (EP) is a common cause of acute abdominal pain in the field of gynecology. Because the majority of women with EP are hemodynamically stable, non-surgical therapy is a viable option. The goal of this study was to determine the most effective non-surgical therapy for hemodynamically stable EP. Method(s): We performed a systematic review and meta-analysis. We searched PubMed, LILACS, SciELO, CINAHL, Embase, and the Cochrane library in May 2020, with no starting date restrictions.Studies were restricted to randomized controlled trials, which were included if the target population contained women with tubal EP and the intervention was non-surgical management. The primary outcome measure was treatment success defined by a decrease in serum hCG to a level ranging from five mIU/mL to 50 mIU/ mL. Secondary outcome measures were side effects, time needed to treat, number of injections and operative rate. Result(s): We conducted a meta-analysis of 15 studies that included 1573 women who were diagnosed with EP and managed non-surgically. There was no significant difference in treatment success in the matched groups; however, single-dose MTX was associated with fewer side effects than multiple-dose (relative risk 0.48, 95% confidence interval 0.28-0.80, P = .006) and two-dose therapies (relative risk 0.74, 95% confidence interval 0.55-1.00, P = .05). Conclusion(s): We highly recommend that single-dose MTX without mifepristone be used first-line in patients who require conservative therapy due to the inherent negative effects of mifepristone. An EP woman with a low -hCG level that is falling or plateauing should receive expectant treatment to reduce adverse effects.Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

Xiao, K., et al. (2023). "The safety and acceptability of using telehealth for follow-up of patients following cancer surgery: A systematic review." European Journal of Surgical Oncology 49(1): 9-15.
	Introduction: Although virtual consultations have played an increasing role in delivery of healthcare, the COVID-19 pandemic has hastened their adoption. Furthermore, virtual consultations are now being adopted in areas that were previously considered unsuitable, including post-operative visits for patients undergoing major surgical procedures, and surveillance following cancer operations. This review aims to examine the feasibility, safety, and patient satisfaction with virtual follow-up appointments after cancer operations. Method(s): A systematic review was conducted along PRISMA guidelines. Studies where patients underwent surgical resection of a malignancy with at least one study arm describing virtual follow-ups were included. Studies were assessed for quality. Outcomes including adverse events, detection of recurrence and patient and provider satisfaction were assessed and compared for those undergoing virtual or in-person post-operative visits. Result(s): Eleven studies, with 3369 patients were included. Cancer types included were gynecological, colorectal, esophageal, lung, thyroid, breast, prostate and major HPB resections. Detection of recurrence and readmission rates were similar when comparing virtual consultations with in-person visits. Most studies showed high patient and healthcare provider satisfaction with virtual consultations following cancer resection. Concerns were raised about the integration of virtual consultations into workflows in fee-for-service settings, where reimbursement for virtual care may be an issue. Conclusion(s): Virtual follow-up care can provide timely and safe consultations in surgical oncology. Virtual consultations are as safe as in-person visits for assessing complications and recurrence. Where appropriate, virtual consultations can safely be integrated into the post-operative care pathway for those undergoing resection of malignancy.Copyright © 2022 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology

Xiao, L., et al. (2022). "The efficacy and safety of Shenghua Decoction combined with Mifepristone and Misoprostol in the treatment of missed miscarriage: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Xiaoqi, Z. and W. Jingying (2024). "Effects of treating bacterial vaginosis in pregnancy on pregnant women and neonates: a meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Xiaoqing, S., et al. (2023). "Effect of music intervention on perinatal depression: A meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Xie, Z. Y., et al. (2019). "The effects of acupuncture on pregnancy outcomes of in vitro fertilization: A systematic review and meta-analysis." BMC Complementary and Alternative Medicine 19(1): 131.
	Background: The effects of acupuncture on in vitro fertilization (IVF) outcomes remain controversial. And the variation in participant, interventions, outcomes studied, and trial design may relate to the efficacy of adjuvant acupuncture. Method(s): We searched digital databases for relevant studies, including Embase, PubMed, Cochrane Library and some Chinese databases up to December 2018, for randomized controlled trials (RCTs) evaluating the effects of acupuncture on women undergoing IVF. We included studies with intervention groups using needling, and control groups consisting of no acupuncture or sham (placebo) acupuncture. Primary outcomes were clinical pregnancy rate (CPR) and live birth rate (LBR). Meta-regression and subgroup analysis were conducted on the basis of eight pre-specified covariates to investigate the variances of the effects of adjuvant acupuncture on pregnancy rates and the sources of heterogeneity. Result(s): Twenty-seven studies with 6116 participants were included. The pooled clinical pregnancy rate (CPR) from all of acupuncture groups was significantly greater than that of control groups (RR 1.21, 95% CI: 1.07-1.38), whereas the pooled live birth rate (LBR) was not. Meta-regression subgroup analysis showed a more significant benefit of acupuncture for repeated IVF cycle proportion (number of women with a history of prior unsuccessful IVF attempt divided by number of women included in each trial) >= 50% group (CPR: RR 1.60, 95% CI: 1.28-2.00; LBR: RR 1.42, 95% CI: 1.05-1.92), and this covariate explained most of the heterogeneity (CPR and LBR: adjusted R 2 = 100 and 87.90%). Similar results were found between CPR and number of acupuncture treatments (CPR: p = 0.002, adjusted R 2 = 51.90%), but not LBR. Conclusion(s): Our analysis finds a benefit of acupuncture for IVF outcomes in women with a history of unsuccessful IVF attempt, and number of acupuncture treatments is a potential influential factor. Given the poor reporting and methodological flaws of existing studies, studies with larger scales and better methodologies are needed to verify these findings.Copyright © 2019 The Author(s).

Xijing, L., et al. (2023). "Effect of preconception weight loss on pregnancy outcomes in patients with polycystic ovary syndrome." PROSPERO International prospective register of systematic reviews.
	
Xin, L., et al. (2023). "Efficacy and safety of oral gonadotropin-releasing hormone antagonists in moderate-to-severe endometriosis-associated pain: a systematic review and network meta-analysis." Archives of Gynecology and Obstetrics 308(4): 1047-1056.
	Purpose: The aim of this NMA is to comprehensively analyze evidence of oral GnRH antagonist in the treatment of moderate-to-severe endometriosis-associated pain.; Methods: Literature searching was performed to select eligible studies published prior to April 2022 in PubMed, Cochrane, Embase and Web of Science. Randomized controlled trials involving patients who suffered from moderate-to-severe endometriosis-associated pain and treated with oral nonpeptide GnRH antagonists or placebo were included.; Results: Elagolix 400 mg and ASP1707 15 mg were most efficient in reducing pelvic pain, dysmenorrhea and dyspareunia. Relugolix 40 mg was best in reducing the analgesics use. The rates of any TEAEs and TEAEs-related discontinuation were highest in relugolix 40 mg and elagolix 250 mg, respectively, while rates of hot flush and headache were highest in relugolix 40 mg and elagolix 150 mg. Significantly decreased spinal BMD was observed in elagolix 250 mg.; Conclusion: Oral GnRH antagonists were effective in endometriosis-associated pain in 12w, and most of the efficiency and safety outcomes were expressed in a dose-dependent manner, but linzagolix 75 mg was an exception. (© 2023. The Author(s).)

Xin, L., et al. (2021). "The effect of coenzyme Q10 supplementation on women with diminished ovarian reserve (DOR) in IVF cycle: :a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Xinyu, Q., et al. (2022). "GnRH antagonist for the treatment of endometriosis associated pain: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Xinyu, X. and Y. Xia (2023). "The postoperative efficacy of other surgeries in pelvic organ prolapse uterus-preserving technique and sacrospinous hysteropexy: a meta-analysis and systematic review." PROSPERO International prospective register of systematic reviews.
	
Xinyuan, L., et al. (2023). "Autologous intrauterine platelet-rich plasma for infertile females with thin endometrium: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Xiong, T., et al. (2023). "Statins for women with polycystic ovary syndrome not actively trying to conceive." The Cochrane Database of Systematic Reviews 7: CD008565.
	Background: Statins are lipid-lowering agents with pleiotropic actions. Experts have proposed that in addition to improving the dyslipidaemia associated with polycystic ovary syndrome (PCOS), statins may also exert other beneficial metabolic and endocrine effects, such as reducing testosterone levels. This is an update of a Cochrane Review first published in 2011.; Objectives: To assess the efficacy and safety of statin therapy in women with PCOS who are not actively trying to conceive.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group specialised register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHLs, and four ongoing trials registers on 7 November 2022. We also handsearched relevant conference proceedings and the reference lists of relevant trials for any additional studies, and we contacted experts in the field for any further ongoing studies.; Selection Criteria: We included randomised controlled trials (RCTs) that evaluated the effects of statin therapy in women with PCOS not actively trying to conceive. Eligible comparisons were statin versus placebo or no treatment, statin plus another agent versus the other agent alone, and statin versus another agent. We performed statistical analysis using Review Manager 5, and we assessed the certainty of the evidence using GRADE methods.; Data Collection and Analysis: We used standard Cochrane methodology. Our primary outcomes were resumption of menstrual regularity and resumption of spontaneous ovulation. Our secondary outcomes were clinical and physiological measures including hirsutism, acne severity, testosterone levels, and adverse events.; Main Results: Six RCTs fulfilled the criteria for inclusion. They included 396 women with PCOS who received six weeks, three months, or six months of treatment; 374 women completed the studies. Three studies evaluated the effects of simvastatin and three studies evaluated the effects of atorvastatin. We summarised the results of the studies under the following comparisons. Statins versus placebo (3 RCTs) One trial measured resumption of menstrual regularity as menstrual cycle length in days. We are uncertain if statins compared with placebo shorten the mean length of the menstrual cycle (mean difference (MD) -2.00 days, 95% confidence interval (CI) -24.86 to 20.86; 37 participants; very low-certainty evidence). No studies reported resumption of spontaneous ovulation, improvement in hirsutism, or improvement in acne. We are uncertain if statins compared with placebo reduce testosterone levels after six weeks (MD 0.06, 95% CI -0.72 to 0.84; 1 RCT, 20 participants; very low-certainty evidence), after 3 months (MD -0.53, 95% CI -1.61 to 0.54; 2 RCTs, 64 participants; very low-certainty evidence), or after 6 months (MD 0.10, 95% CI -0.43 to 0.63; 1 RCT, 28 participants; very low-certainty evidence) Two studies recorded adverse events, and neither reported significant differences between the groups. Statins plus metformin versus metformin alone (1 RCT) The single RCT included in this comparison measured resumption of menstrual regularity as the number of spontaneous menses per six months. We are uncertain if statins plus metformin compared with metformin improves resumption of menstrual regularity (MD 0.60 menses, 95% CI 0.08 to 1.12; 69 participants; very low-certainty evidence). The study did not report resumption of spontaneous ovulation. We are uncertain if statins plus metformin compared with metformin alone improves hirsutism measured using the Ferriman-Gallwey score (MD -0.16, 95% CI -0.91 to 0.59; 69 participants; very low-certainty evidence), acne severity measured on a scale of 0 to 3 (MD -0.31, 95% CI -0.67 to 0.05; 69 participants; very low-certainty evidence), or testosterone levels (MD -0.03, 95% CI -0.37 to 0.31; 69 participants; very low-certainty evidence). The study reported that no significant adverse events occurred. Statins plus oral contraceptive pill versus oral contraceptive pill alone (1 RCT) The single RCT included in this comparison did not report resumption of menstrual regularity or ontaneous ovulation. We are uncertain if statins plus the oral contraceptive pill (OCP) improves hirsutism compared with OCP alone (MD -0.12, 95% CI -0.41 to 0.17; 48 participants; very low-certainty evidence). The study did not report improvement in acne severity. We are also uncertain if statins plus OCP compared with OCP alone reduces testosterone levels, because the certainty of the evidence was very low (MD -0.82, 95% CI -1.38 to -0.26; 48 participants). The study reported that no participants experienced significant side effects. Statins versus metformin (2 RCTs) We are uncertain if statins improve menstrual regularity compared with metformin (number of spontaneous menses per six months) compared to metformin (MD 0.50 menses, 95% CI -0.05 to 1.05; 1 RCT, 61 participants, very low-certainty evidence). No studies reported resumption of spontaneous ovulation. We are uncertain if statins compared with metformin reduce hirsutism measured using the Ferriman-Gallwey score (MD -0.26, 95% CI -0.97 to 0.45; 1 RCT, 61 participants; very low-certainty evidence), acne severity measured on a scale of 0 to 3 (MD -0.18, 95% CI -0.53 to 0.17; 1 RCT, 61 participants; very low-certainty evidence), or testosterone levels (MD -0.24, 95% CI -0.58 to 0.10; 1 RCT, 61 participants; very low-certainty evidence). Both trials reported that no significant adverse events had occurred. Statins versus oral contraceptive pill plus flutamide (1 RCT) According to the study report, no participants experienced any significant side effects. There were no available data for any other main outcomes.; Authors' Conclusions: The evidence for all main outcomes of this review was of very low certainty. Due to the limited evidence, we are uncertain if statins compared with placebo, or statins plus metformin compared with metformin alone, improve resumption of menstrual regularity. The trial evaluating statin plus OCP versus OCP alone reported neither of our primary outcomes. No other studies reported resumption of spontaneous ovulation. We are uncertain if statins improve hirsutism, acne severity, or testosterone. All trials that measured adverse events reported no significant differences between the groups. (Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Xiongmin, G., et al. (2023). "Efficacy and safety of dienogest in the treatment of endometriosis: a systematic review and RCT based meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Xu, F., et al. (2021). "Clinical assessment of prophylactic chemotherapy in treating with hydatidiform mole: A protocol for systematic review and meta-analysis." Medicine 100(24): e26341.
	Background: Hydatidiform mole (HM) is more common as molar pregnancy. It is a disease classified under the category of gestational trophoblastic diseases, which could metastasize after originating in the placenta. A majority of females suffering from molar pregnancies are curable by evacuating retained products of conception and the patient's fertility is preserved. In some cases, the growth perseveres and leads to gestational trophoblastic neoplasia, which is an extremely malicious condition that needs chemo-based treatment. There is a possibility to lessen the risk of gestational trophoblastic disease in females with HM through the administration of prophylactic chemo. Yet, there is controversy regarding prophylactic chemotherapy administered pre-or-post removal of HM to curtail the malignant sequelae. Therefore, we will conduct this research to assess both the efficacy as well as security of using prophylactic chemotherapy to treat HM.; Methods: In the preliminary review, the authors will search for randomized controlled trials involving prophylactic chemotherapy to treat HM. The literature search is carried out in the following electronic databases from their inception to May 2021: Chinese National Knowledge Infrastructure, Chinese BioMedical Literature, and WanFang database are the three Chinese language databases. Web of Science, PubMed, Cochrane Library, and EMBASE are the four English language databases. The authors will also perform a manual search through the bibliographies in related literature to find extra articles and ongoing studies. Two independent authors will assess the literature according to an inclusion criteria, use a specialized data collection table to extract data, and use the Cochrane 'Risk of bias' tool for evaluating any possible bias risk in the selected articles. Data synthesis and statistical operations are completed with the RevMan software (v. 5.3).; Results: The present systematic analysis provides a rationalized synthesis of existing evidence related to the use of prophylactic chemotherapy in the treatment of HM.; Conclusion: Our findings will summarize the current evidences for prophylactic chemotherapy in the treatment of HM.; Ethics and Dissemination: An ethics approval is nonrequired because pre published results will be used.; Registration Number: DOI 10.17605/OSF.IO/6QV52 (https://osf.io/6qv52/).; Competing Interests: The authors report no conflicts of interest. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Xu, K., et al. (2021). "Effects of moxibustion on reproduction and metabolism of polycystic ovary syndrome: a protocol for meta-analysis and systematic review." BMJ Open 11(8): e049039.
	Introduction: Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathy in women of reproductive age. Recently, moxibustion, as a complementary and alternative therapy, has been commonly used in assisted reproduction and improvement of metabolic abnormalities in patients with PCOS. Currently, intervention efficacy of the use of moxibustion in PCOS treatment still remains controversial due to lack of high-quality evidence. Consequently, this study protocol was designed to objectively review and evaluate the effectiveness and safety of moxibustion treatment for PCOS.; Methods and Analysis: Electronic searches will be carried out from inception to May 2021 in the online databases of The Cochrane Library, PubMed, EMBASE, Chinese Biomedical Literature, Chongqing VIP Chinese Science and Technology Periodical Database (VIP) and China National Knowledge Infrastructure. The Chinese Clinical Trial Registry Center and Clinical Trials will be used for searching ongoing trials. Randomised controlled trials and the first period in randomised cross-over trials involving any type of moxibustion for patients with PCOS will be included. Primary outcomes will be the ovulation rate, pregnancy rate and sex hormone levels, and secondary outcomes will be changes in clinical symptoms and metabolic indicators, total effective rate and the incidences of side effects and adverse events. Briefly, two reviewers will independently conduct study selection and data extraction, and the risk of bias will be assessed. Prior to the formal meta-analysis, the heterogeneity of included studies will be assessed. Review Manager Statistical Software (RevMan) V.5.3 will be used for data processing. Finally, the Grading of Recommendations Assessment, Development and Evaluation method will be applied to evaluate the quality of evidence.; Ethics and Dissemination: Ethical approval is not necessary since this study is designed as a systematic review. This study will be disseminated by a peer-review journal or conference presentation.; 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.)

Xu, N., et al. (2022). "Curative Effect of Heat-sensitive Moxibustion on Primary Dysmenorrhea: A Meta-Analysis." Evidence-based Complementary and Alternative Medicine 2022: 1281336.
	Background. Primary dysmenorrhea (PD) refers to functional dysmenorrhea, typically characterized by cyclical, pronounced lower abdominal pain and seriously affects a woman's work and quality of life. Some studies have reported that heat-sensitive moxibustion (HSM) is expected to alleviate the clinical symptoms. This systematic review aimed to evaluate the current evidence regarding the efficacy and safety of HSM on PD. Methods. 7 databases including PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), Wan Fang Data Knowledge Service Platform (Wan Fang Data), and China Science and Technology Journal Database (VIP) were searched for clinical randomized controlled trials. Meanwhile, Revman 5.3 software was used to evaluate the methodological quality of the included literature. The confidence interval (CI) of either relative risk or mean difference was set to 95%. Besides, the heterogeneity of the research results is tested by I2. Results. 19 studies were ultimately included in this meta-analysis. All of them were declared as random controlled trials. 18 studies reported the total effective rate of the test group and the control group, which was significantly higher (RR: 0.92; 95% CI: 0.85,0.99; P=0.031<0.05) than the control group. It is demonstrated that the VAS score of the test group, totally 9 studies included, was significantly lower (SMD: -0.98; 95% CI: -1.15, -0.81; P<0.001). The meta-analysis of 6 studies showed the symptom score of the test group was significantly lower (SMD: -0.67; 95% CI: -0.87, -0.47; P<0.001). There were the CMSS results of 3 studies which were significantly lower (SMD: -0.88; 95% CI: -1.13, -0.62; P<0.001). Combined with the results of subgroup analysis, compared with the control group, the test group had advantages in the VAS score, symptom score, and CMSS score. Conclusions. The result has revealed the effectiveness and feasibility of HSM in treating PD, especially in improving the total effective rate and reducing the VAS score, symptom score, and CMSS score.Copyright © 2022 Ningning Xu et al.

Xu, P., et al. (2022). "The effectiveness of eHealth interventions on female pelvic floor dysfunction: a systematic review and meta-analysis." International Urogynecology Journal 33(12): 3325-3354.
	Introduction and Hypothesis: eHealth interventions represent a promising novel strategy in pelvic floor management for women. Nevertheless, the effectiveness of eHealth interventions among women with or at risk of pelvic floor dysfunction (PFD) has not been adequately discussed to date. This study aimed to determine the effectiveness of eHealth interventions in preventing and treating PFD among women.; Methods: Eleven electronic databases were searched for randomized controlled trials (RCTs) from inception until August 28, 2021.; Results: Twenty-four RCTs were included in this meta-analysis that included 3691 women. The meta-analysis showed that eHealth interventions were not only vital for preventing PFD (pregnant women: pooled OR = 0.25, 95% CI: 0.14 to 0.45, p < 0.001; postnatal women: pooled OR = 0.19, 95% CI: 0.06 to 0.60, p = 0.005), but also for reducing the severity of PFD (pooled SMD = -0.63, 95% CI: -1.20 to -0.06, p = 0.031). In addition, compared with traditional care, eHealth interventions showed significant positive effects on several outcome indicators, including quality of life (pooled SMD = 0.49, 95% CI: 0.19 to 0.80, p = 0.002), pelvic floor type I muscle strength (pooled OR = 1.92, 95% CI: 1.30 to 2.82, p = 0.001), pelvic floor type II muscle strength (pooled OR = 2.04, 95% CI: 1.38 to 3.01, p < 0.001), sexual function (pooled SMD = 0.51, 95% CI: 0.29 to 0.73, p < 0.001), satisfaction (pooled OR = 3.93, 95% CI: 2.73 to 5.66, p < 0.001), and self-efficacy (pooled SMD = 2.62, 95% CI: 2.12 to 3.13, p < 0.001).; Conclusions: eHealth interventions are an effective emerging treatment and preventive modality for female PFD. Higher quality, larger scale, and strictly designed RCTs are warranted to evaluate the effectiveness of eHealth interventions on female pelvic floor management. (© 2022. The International Urogynecological Association.)

Xu, X., et al. (2019). "Comparative efficacy of targeted maintenance therapy for newly diagnosed epithelial ovarian cancer: a network meta-analysis." Cancer Management and Research 11: 4119-4128.
	Background: The number of published randomized clinical trials (RCTs) using targeted maintenance therapy for newly diagnosed epithelial ovarian cancer is increasing. Our objective was to evaluate the comparative effectiveness of each maintenance therapy using a network meta-analysis. Materials and methods: A systematic search for RCTs was conducted using Medline, Embase, and CENTRAL databases followed by a Bayesian network meta-analysis. The primary outcome was progression-free survival (PFS) and the secondary outcome was overall survival (OS). Pooled hazard ratios (HRs) with 95% credible intervals (95% CrIs) were used to estimate outcomes. Results: A total of 11 RCTs involving 6631 patients were included. Network meta-analysis showed that pure maintenance therapy with pazopanib resulted in a significantly better PFS compared with placebo (HR, 0.77; 95% CrI, 0.65-0.92). Bevacizumab-throughout treatment was also associated with a better PFS (HR, 0.76, 95% CrI, 0.69-0.84). However, anti-CA-125 monoclonal antibodies (abagovomab and oregovomab) showed no significant survival benefit. Moreover, combined analysis showed that targeted-throughout was not significantly superior to pure targeted maintenance therapy for PFS and OS. Stratified analysis showed paralleled results with no significant difference between pazopanib pure maintenance and bevacizumab-throughout treatments. Conclusion: Our study showed a survival advantage conferred by pazopanib and bevacizumab as maintenance therapy in newly diagnosed epithelial ovarian cancer. Further clinical trials are essential to both determine the effect of bevacizumab in the maintenance stage and identify the specific subgroup(s) that benefit.; Competing Interests: The authors report no conflicts of interest in this work.

Xu, X., et al. (2021). "Comparison of the effect of traditional Chinese medicine injection combined with chemotherapy and chemotherapy alone on the prognosis, quality of life and immune function in patients with ovarian carcinoma: A protocol for systematic review and network meta-analysis." Medicine 100(41): e27395.
	Background: The effectiveness of traditional Chinese medicine (TCM) in assisting the reduction of the toxic effects of chemotherapy and enhancing the efficacy of chemotherapy is gradually being recognized. Traditional Chinese medicine injection (TCMJ) has been widely used as a promising adjuvant drug in the treatment of ovarian carcinoma. However, the exact clinical efficacy and safety of TCMJ have not been well studied due to the wide variety. This study aims to conduct a network meta-analysis of randomized controlled trials (RCTs) about comparing the effect of TCMJ combined with chemotherapy and chemotherapy alone on the treatment of ovarian cancer, thus summarizing the effects of TCMJ on the prognosis, quality of life and immune function of ovarian carcinoma patients, and providing a reference for developing therapeutic regimens for ovarian carcinoma.; Methods: Randomized controlled trials reporting the effect of TCMJ combined with chemotherapy and chemotherapy alone on the prognosis, quality of life and immune function in patients with ovarian carcinoma published before September 2021 will be screened out from online databases like PubMed, Web of Science, Scopus, Cochrane Library, Embase, China Scientific Journal Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and Wanfang Database. Subsequently, 2 researchers will be independently responsible for literature screening, data extraction and assessment of their quality. All data will be processed by R.4.1.0.; Results: The results of this meta-analysis will be submitted to a peer-reviewed journal for publication.; Conclusions: Evidence-based medicine supports the efficacy and safety of TCMJ combined with chemotherapy for the treatment of ovarian carcinoma, which is better than that of chemotherapy alone.; Ethics and Dissemination: Ethical approval was not required for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences, and shared on social media platforms.; Osf Registration Number: DOI 10.17605/OSF.IO/P93VJ.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Xu, Y., et al. (2020). "Effect of hormone therapy on muscle strength in postmenopausal women: a systematic review and meta-analysis of randomized controlled trials." Menopause 27(7): 827-835.
	Objective: This study aimed to evaluate the overall effects of hormone therapy (HT) on muscle strength in postmenopausal women through a systematic review and meta-analysis.; Methods: PubMed, Web of Science, Embase, and the Cochrane Central Register of Controlled Trials were systematically searched from the inception dates to August 2019. Randomized controlled trials (RCTs) that compared the effects of HT with either no therapy or placebo on muscle strength in postmenopausal women were eligible. The quality of studies was assessed using the Cochrane risk of bias tool. Measurements of changes in muscle strength compared to baseline were extracted for pooled analysis. The effect size was calculated as standardized mean differences using a random effects model.; Results: We identified nine studies with a combined population of 2,476 postmenopausal women. The studies included were assessed to be of good quality overall. The results showed that HT was not associated with muscle strength gain in postmenopausal women (standardized mean difference = 0.352; 95% confidence interval, -0.098 to 0.803; P = 0.125; I = 95.3%). The changes in muscle strength in women receiving HT were not significant. The results were unchanged when stratified by treatment type, muscle group, and treatment duration.; Conclusions: The use of HT was not associated with the improvement of muscle strength in postmenopausal women. This finding suggested that HT might not improve muscle strength or that the effect size was too small to identify significant therapeutic efficacy.

Xu, Y., et al. (2021). "Comparative Efficacy and Safety of PARP Inhibitors as Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer: A Network Meta-Analysis." Frontiers in Oncology 10: 573801.
	This meta-analysis investigated the comparative efficacy and safety of PARP inhibitor monotherapy as maintenance treatment in platinum sensitive recurrent ovarian cancer (ROC). Electronic databases were systematically searched for relevant RCTs. The primary endpoint was PFS. The results were stratified based on three categories: BRCA mutated patients, HRD patients, and overall population. The secondary outcome were discontinuations due to adverse events and grade 3 or 4 adverse events in maintenance phase. Five eligible RCTs were included in the network meta-analysis. For patients with BRCA mutated ovarian cancer, olaparib-throughout (HR = 0.21 with 95% CrI: 0.081-0.55), rucaparib (HR = 0.23 with 95% CrI: 0.16-0.34), olaparib (HR = 0.27 with 95% CrI: 0.20-0.35), and niraparib (HR = 0.26 with 95% CrI: 0.17-0.41) were all highly effective in comparison with placebo at improving PFS. For HRD patients, both rucaparib (HR = 0.32 with 95% CrI: 0.24-0.42) and niraparib (HR = 0.38 with 95% CrI: 0.24-0.60) were all highly effective in comparison with placebo at improving PFS. For the overall population, olaparib-throughout (HR = 0.51 with 95% CrI: 0.34-0.76), rucaparib (HR = 0.37 with 95% CrI: 0.30-0.45), olaparib (HR = 0.35 with 95% CrI: 0.25-0.49), and niraparib (HR = 0.38 with 95% CrI: 0.30-0.48) were all highly effective in comparison with placebo at improving PFS. Regarding grade 3 or 4 adverse events, the incidence of grade 3 or 4 toxicity reactions to rucaparib and niraparib were significantly higher than in the olaparib group. In terms of discontinuations due to adverse events, the treatment discontinuations were not significantly different between the three drugs. In summary, all the included maintenance treatment regimens are effective regardless of BRCA mutational status, and no statistically significant differences between rucaparib, niraparib and Olaparib in terms of PFS. In terms of safety profile, the three drugs present manageable adverse events. Clinicians should consider potential adverse events related to each of these interventions in clinical practice, and the adverse events are generally manageable.; 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 Xu, Ding, Tian, Bi, Han and Wang.)

Xu, Y. and J. Qiao (2021). "Comparison of in vitro maturation and in vitro fertilization for polycystic ovary syndrome patients: a systematic review and meta-analysis." Annals of Translational Medicine 9(15): 1235.
	Background: There are two common treatments for polycystic ovary syndrome (PCOS): in vitro fertilization (IVF) and in vitro maturation (IVM). Our study aimed to assess the clinical effects and safety of IVM versus IVF for PCOS.; Methods: We searched randomized controlled trials and retrospective cohort studies comparing IVM versus IVF for PCOS. Data were extracted from eligible studies. We sought to evaluate fertilization rate, clinical pregnancy rate, live birth rate, and miscarriage. Results were expressed as risk ratio (RR) with 95% confidence intervals (CIs).; Results: Eight studies with a total of 1,579 patients were included in the present study. According to the heterogeneity analysis, there were no differences between the IVM group and IVF group in terms of fertilization rate, clinical pregnancy rate and miscarriage. Additionally, the IVF group had a higher live birth rate than the IVM group (overall P=0.0007). Sensitivity analysis and funnel plot showed that our study was robust and based on the funnel plot this article had low publication bias.; Discussion: The findings of the present study indicated that IVM had similar clinical effects compared with IVF in patients with PCOS. However, IVM might be a suitable option for PCOS in terms of cost and successful pregnancy rate.; Competing Interests: Conflicts of Interest: Both authors have completed the ICMJE uniform disclosure form (available at https://dx.doi.org/10.21037/atm-21-3037). The authors have no conflicts of interest to declare. (2021 Annals of Translational Medicine. All rights reserved.)

Xu, Y., et al. (2020). "Efficacy of herbal medicine (cinnamon/fennel/ginger) for primary dysmenorrhea: a systematic review and meta-analysis of randomized controlled trials." The Journal of International Medical Research 48(6): 300060520936179.
	Objective: To assess the efficacy of herbal medicine (cinnamon/fennel/ginger) for treating primary dysmenorrhea.; Methods: Relevant studies were searched in multiple databases. The weighted mean difference (WMD) was used as the effect indicator for measurement data, and each effect size was given estimates and 95% confidence intervals (CIs).; Results: Nine studies with 647 patients were selected. Compared with the results in the control group, pain intensity was significantly relieved in the trial group when assessed by the intervention (cinnamon vs. placebo: WMD = 1.815, 95% CI = 1.330-2.301; fennel vs. placebo: WMD = 0.528, 95% CI = 0.119-6.829; ginger vs. placebo: WMD = 2.902, 95% CI = 2.039-3.765), observation period (one cycle: WMD = 2.061, 95% CI = 0.815-3.307; one cycles: WMD = 1.831, 95% CI = 0.973-2.690), and study quality (high quality: WMD = 2.224, 95% CI = 1.488-2.960). Pain duration was significantly shorter in the trial group (cinnamon vs. placebo: WMD = 16.200, 95% CI = 15.271-17.129). No publication bias was observed for either outcome.; Conclusions: For primary dysmenorrhea, cinnamon/fennel/ginger effectively reduced pain intensity, and cinnamon shortened the duration of pain. Further studies are needed to confirm our results.

Xue, D., et al. (2023). "Hormonal treatment for endometriosis-associated pain: a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Xuemei, Q., et al. (2023). "The effect of GnRH-a on pregnancy outcome after conservative surgery in women with endometriosis: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Xuesong, D. and Z. Xinyue (2023). "Does minimally invasive radical hysterectomy modified with "no-look no-touch" technique influence the survival outcome in patients with early-stage cervical cancer: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Xueying, L., et al. (2024). "Systematic review and meta-analysis of different controlled ovarian hyperstimulation protocols in IVF among patients with DOR." PROSPERO International prospective register of systematic reviews.
	
Xumin, Z. and F. Yanxin (2021). "Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage&#xff1a;a Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Yakut, Y. (2022). "Investigation of the Effects of Stabilization Exercises and Pelvic Floor Muscle Training on Pain and Urinary Parameters in Individuals With Chronic Low Back Pain With Urinary Incontinence." ClinicalTrials.gov.
	The rehabilitation period in the study was determined as 2 months. Participants will receive treatment with a supervisor 1 or 2 days a week. On other days, they will continue as a home program.

Yalcinkaya, Ö. and E. Gozuyesil (2024). "The effect of therapeutic touch on sleep quality and fatigue in menopausal women." Explore 20(2): 222-230.
	Background and Aims: The management of well-known and common complaints such as insomnia and fatigue experienced in the menopausal period has the potential to affect many aspects of life in women during this period positively. This research was carried out to determine the effect of therapeutic touch on sleep quality and fatigue in menopausal women.; Methods: This randomized controlled experimental study was conducted with 48 (24 in the intervention group and 24 in the control group) women who sought treatment in the gynecological outpatient clinic of a public hospital. According to the study procedure, while the intervention group received therapeutic touch, the control group received SHAM therapeutic touch for 10 min a day for five consecutive days. Data were collected through the Personal Information Form, the Pittsburgh Sleep Quality Index, and the Piper Fatigue Scale.; Results: The median post-test total sleep quality score was significantly lower in the intervention group than in the control group (p=0.010). However, the mean total fatigue scores did not differ significantly between the groups (p=0.917).; Conclusions: The results of this study showed that therapeutic touch was effective in improving sleep quality, but it did not affect fatigue in menopausal women. (Copyright © 2023 Elsevier Inc. All rights reserved.)

Yamada, H., et al. (2022). "Intravenous immunoglobulin treatment in women with four or more recurrent pregnancy losses: A double-blind, randomised, placebo-controlled trial." EClinicalMedicine 50: 101527.
	Background: There is no effective treatment for women with unexplained recurrent pregnancy loss (RPL). We aimed to investigate whether treatment with a high dose of intravenous immunoglobulin (IVIG) in early pregnancy can improve pregnancy outcomes in women with unexplained RPL.; Methods: In a double-blind, randomised, placebo-controlled trial, women with primary RPL of unexplained aetiology received 400 mg/kg of IVIG daily or placebo for five consecutive days starting at 4-6 weeks of gestation. They had experienced four or more miscarriages except biochemical pregnancy loss and at least one miscarriage of normal chromosome karyotype. The primary outcome was ongoing pregnancy rate at 22 weeks of gestation, and the live birth rate was the secondary outcome. We analysed all women receiving the study drug (intention-to-treat, ITT) and women except those who miscarried due to fetal chromosome abnormality (modified-ITT). This study is registered with ClinicalTrials.gov number, NCT02184741.; Findings: From June 3, 2014 to Jan 29, 2020, 102 women were randomly assigned to receive IVIG ( n = 53) or placebo ( n = 49). Three women were excluded; therefore 50 women received IVIG and 49 women received placebo in the ITT population. The ongoing pregnancy rate at 22 weeks of gestation (31/50 [62·0%] vs. 17/49 [34·7%]; odds ratio [OR] 3·07, 95% CI 1·35-6·97; p = 0·009) and the live birth rate (29/50 [58·0%] vs. 17/49 [34·7%]; OR 2·60, 95% CI 1·15-5·86; p = 0·03) in the IVIG group were higher than those in the placebo group in the ITT population. The ongoing pregnancy rate at 22 weeks of gestation (OR 6·27, 95% CI 2·21-17·78; p < 0·001) and the live birth rate (OR 4·85, 95% CI 1·74-13·49; p = 0·003) significantly increased in women who received IVIG at 4-5 weeks of gestation as compared with placebo, but these increases were not evident in women who received IVIG at 6 weeks of gestation. Four newborns in the IVIG group and none in the placebo group had congenital anomalies ( p = 0·28).; Interpretation: A high dose of IVIG in very early pregnancy improved pregnancy outcome in women with four or more RPLs of unexplained aetiology.; Funding: The Japan Blood Products Organization.; Competing Interests: We declare no competing interests. (© 2022 The Author(s).)

Yamashita, R., et al. (2021). "Effect of Vitamin-Containing Amino Acid Supplements on Menopausal Symptoms and Age-Related Skin Changes: A Randomised, Double-Blind, Placebo-Controlled Study." Dermatology and Therapy 11(5): 1681-1692.
	INTRODUCTION: Women aged ≥ 45 years are known to experience various menopausal symptoms due to reduced oestrogen levels. Changes associated with cutaneous ageing, such as wrinkles and sagging, are also prominent in women in this age group. Numerous studies have evaluated the usefulness of individual basic nutrients and essential components, such as amino acids and vitamins, in menopausal women. The aim of this study was to comprehensively assess the effects of supplements containing amino acid and vitamin combinations on menopausal symptoms and age-related changes in the skin. METHODS: This is a randomised, placebo-controlled study on the effects of a supplement containing three types of amino acids [leucine, glutamine and arginine (LGA)] and 11 types of vitamins in 37 middle-aged women. The participants ingested either the test substance or a placebo twice daily for 8 consecutive weeks, at the end of which time the efficacy and safety of the test substance were assessed based on subjective symptoms of fatigue, Simplified Menopausal Index (SMI) score, the grade and number of wrinkles at the corners of the eyes, results of an analysis of the stratum corneum of the cheek and blood test results. RESULTS: None of the participants experienced adverse events, and all items assessed in our survey of subjective symptoms of fatigue showed a significant decrease in the test substance group (LGA group). Additionally, the SMI score of the LGA group was significantly lower than that of the placebo group. The LGA group showed significant improvement in the grade of the wrinkles in the corners of the eyes and the number of wrinkles, and the stratum corneum cell area declined significantly in the LGA group compared to the placebo group at the end of the study. CONCLUSION: These results indicate that the vitamin-containing amino acid supplement improved menopausal symptoms and age-related changes in the skin (wrinkles). TRIAL REGISTRATION: UMIN000029830.

Yan, H., et al. (2022). "Oral gonadotropin-releasing hormone antagonists for treating endometriosis-associated pain: a systematic review and network meta-analysis." Fertility and Sterility 118(6): 1102-1116.
	Objective: To review the use of oral gonadotropin-releasing hormone (GnRH) antagonists and synthesize their efficacy and safety parameters for the treatment of endometriosis-associated pain.; Design: Systematic review and network meta-analysis.; Setting: Not applicable.; Patient(s): Premenopausal women with endometriosis who had experienced moderate or severe pain.; Intervention(s): The Web of Science, Embase, Scopus, and MEDLINE were searched until April 10, 2022. Only randomized controlled trials were included. The risk of bias in the included studies was assessed using the Cochrane Risk of Bias tool 2. A Bayesian random-effects network meta-analysis was used to perform indirect comparisons. I 2 was used to assess the global heterogeneity. Relative treatment estimates were performed. Treatment ranking was performed through the surface under the cumulative ranking curve. The certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation framework.; Main Outcome Measure(s): Endometriosis-associated pain, dysmenorrhea, dyspareunia, and noncyclic pelvic pain reduction.; Result: (s): Five studies and 6 randomized controlled trials, including a total of 2,796 women and 10 different doses of oral GnRH antagonist treatments, were eligible for inclusion. All studies were considered to have a low risk of bias. Almost all efficacy- and safety-related outcomes showed a dose-response relationship. Regarding endometriosis-associated pain, the top 3 treatments were elagolix 400 mg, linzagolix 75 mg, and linzagolix 200 mg, with mean differences of -1.26 (95% credible interval [CrI], -1.70 to -0.79), -0.98 (95% CrI, -1.84 to -0.15), and -0.98 (95% CrI, -1.90 to -0.064), respectively. The top 3 treatments to decrease dysmenorrhea were relugolix 40 mg, elagolix 400 mg, and relugolix 20 mg, with mean differences of -1.60 (95% CrI, -2.07 to -1.14), -1.25 (95% CrI, -1.56 to -0.95), and -1.10 (95% CrI, -1.59 to -0.62), respectively. However, only high-dose treatments were significantly associated with most quality of life- and adverse effect-related outcomes. Relugolix 40 and 20 mg and elagolix 400 mg, with odds ratios of 6.88 (95% CrI, 2.18-24.58), 1.60 (95% CrI, 0.62-4.13), and 1.85 (95% CrI, 1.05-3.30), had a significantly increased incidence of adverse events.; Conclusion: (s): Oral GnRH antagonists are effective for endometriosis-associated pain and dysmenorrhea and the patient global impression. The incidence of ovarian hypoestrogenic effects in a short-term duration was significant in a dose-effect response, particularly the highest dose.; Clinical Trial Registration Number: International Prospective Register of Systematic Reviews registration number CRD42022332904. (Copyright © 2022 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Yan, J., et al. (2021). "Clinical evidence on Acupuncture for Women with Pelvic pain:A Systematic Review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Yan, J., et al. (2021). "Acupuncture for Pelvic Girdle Pain in Pregnancy: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
yan, l. and y. tiantian (2021). "Comparison of the efficacy of different doses of Metformin on polycystic ovary syndrome during adolescence: a meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Yan, Q., et al. (2021). "The role of acupuncture in the treatment of women with pain in endometriosis: A protocol for systematic review and meta-analysis." Medicine 100(49): e27582.
	Background: Given the high numbers of recent cases related to Endometriosis, acupuncture has become a first line of treatment to alleviate the discomfort caused by endometriosis. Numerous studies have reported that acupuncture has a distinct effect when treating the discomfort caused by endometriosis. The primary advantages include various treatment methods, simple administration, minimal adverse reactions, and having no impact on the intrauterine environment. This study aims to elucidate the role of acupuncture in treating pain associated with endometriosis.; Methods: The authors will search 6 online-based databases to find Randomized Controlled Trials related to determining the role of acupuncture in treating pain from endometriosis. The assessed primary outcomes include the clinical effective rate, variation in the level of pain, and variation in peripheral blood CA-125 level. A comprehensive meta-analysis statistical software will be used to conduct all analyses.; Results: This study will assess the role of acupuncture when it is used to treat pain arising from endometriosis.; Conclusion: The conclusions presented in the metanalysis will present a scientific-based theoretical framework and a standardized clinical guidance for treating endometriosis-related pain.; Ethics and Dissemination: This systematic review and meta-analysis does not require an ethics approval as it does not collect any primary data from patients.; Osf Registration Number: September 28, 2021.osf.io/htukv. (https://osf.io/htukv/).; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Yan, X., et al. (2022). "Low molecular weight heparin or LMWH plus aspirin in the treatment of unexplained recurrent miscarriage with negative antiphospholipid antibodies: A meta-analysis of randomized controlled trial." European Journal of Obstetrics, Gynecology, and Reproductive Biology 268: 22-30.
	Objective: Unexplained recurrent miscarriage (uRM) has caused serious distress to women of childbearing age, and effective treatment is particularly important. The aim of this meta-analysis is to compare the efficacy of low molecular weight heparin (LMWH) and LMWH combined with aspirin for uRM.; Methods: Databases including PubMed, Web of Science, Embase, Scopus and the Cochrane Library databases were electronically searched to identify randomized controlled trials that reported the LMWH or LMWH combined with aspirin for women with uRM and negative antiphospholipid antibodies (aPL). The retrieval time is limited from inception to June 2021. Two reviewers independently screened literature, extracted data, and assessed risk bias of included studies. Meta-analysis was performed by using STATA 12.0 software.; Results: A total of 7 studies involving 1849 patients were included. The meta-analysis results showed that compared with the control group, both LMWH and LMWH + aspirin interventions showed no substantial influence on miscarriage rate (LMWH: RR = 0.69, 95%CI: 0.34-1.39, P = 0.293, LMWH + aspirin: RR = 0.62, 95%CI: 0.30-1.27, P = 0.19) and the occurrence of pre-eclampsia (LMWH: RR = 1.1, 95%CI: 0.53-2.31, P = 0.792; LMWH + aspirin: RR = 1.49, 95%CI: 0.25-8.79, P = 0.662). LMWH therapy had no influence on the live births (RR = 0.99, 95%CI: 0.92-1.06, P = 0.72). Subgroup analysis showed that enoxaparin is not effective in women with uRM and negative aPL (miscarriage rate: RR = 0.82, 95%CI: 0.31-2.19, P = 0.695; pre-eclampsia: RR = 1.03, 95%CI: 0.46-2.33, P = 0.936).; Conclusions: LMWH and LMWH combined with aspirin therapy cannot improve the pregnancy outcome of women with uRM and negative aPL. However, the above conclusions are still required to be verified through more RCTs due to the limited quantity of included studies. (Copyright © 2021 Elsevier B.V. All rights reserved.)

Yan, X., et al. (2023). "Pregnancy rate and outcomes after uterine artery embolization for women: a systematic review and meta-analysis with trial sequential analysis." Frontiers in Medicine 10: 1283279.
	Objective: The assessment of the relative impacts of uterine artery embolization (UAE) treatment for female patients is a critical field that informs clinical decisions, yet there is a noticeable scarcity of high-quality, long-term comparative studies. This meta-analysis aimed to focus on the pregnancy rate and outcomes in female patients following UAE and to conduct subgroup analyses based on different patient populations or various control treatments. Method(s): A systematic literature search was conducted on 2 August 2023 through the Web of Science, PubMed, Embase, and the Cochrane Library of Clinical Trials for all potential studies. Relative risks (RRs) with 95% confidence intervals (CIs) were applied to compare pregnancy rates and outcomes between the UAE group and the control group. Heterogeneity was evaluated statistically by using the chi-square-based Cochran's Q test and Higgins I2 statistics, and 95% prediction interval (PI). Software R 4.3.1 and Stata 12.0 were used for meta-analysis. The trial sequential analysis (TSA) was performed with TSA v0.9.5.10 Beta software. Result(s): A total of 15 eligible studies (11 cohort studies, 3 randomized controlled trials, and 1 non-randomized clinical trial) were included in this meta-analysis. The overall results revealed that UAE significantly decreased postoperative pregnancy rate [RR (95% CI): 0.721 (0.531-0.979), 95% PI: 0.248-2.097] and was associated with an increased risk of postoperative PPH [RR (95% CI): 3.182 (1.319-7.675), 95% PI: 0.474-22.089]. Analysis grouped by population indicated that UAE decreased the risk of preterm delivery [RR (95% CI): 0.326 (0.128-0.831), p = 0.019] and cesarean section [RR (95% CI): 0.693 (0.481-0.999), p = 0.050] and increased the risk of placenta previa [RR (95% CI): 8.739 (1.580-48.341), p = 0.013] in patients with UFs, CSP, and PPH, respectively. When compared with myomectomy, HIFU, and non-use of UAE, UAE treatment was associated with the reduced risks of preterm delivery [RR (95% CI): 0.296 (0.106-0.826)] and cesarean section [(95% CI): 0.693 (0.481-0.999), p = 0.050] and increased placenta previa risk [RR (95% CI): 10.682 (6.859-16.636)], respectively. Conclusion(s): UAE treatment was associated with a lower postoperative pregnancy rate and increased risk of PPH. Subgroup analysis suggested that UAE was shown to decrease the risk of preterm delivery and cesarean section and increase placenta previa risk. Systematic review registration:https://www.crd.york.ac.uk/prospero/, Identifier CRD42023448257.Copyright © 2023 Yan, Zhou, He and Liu.

Yan, Y., et al. (2021). "Efficacy of progesterone on threatened miscarriage: an updated meta-analysis of randomized trials." Archives of Gynecology and Obstetrics 303(1): 27-36.
	Purpose: The efficacy of progesterone supplementation in the treatment of threatened miscarriage is controversial. This meta-analysis was to evaluate the correlation between progesterone and improving pregnancy outcomes in women with threatened miscarriage.; Methods: We searched PubMed, EMBASE, and the Cochrane Library for relevant randomized controlled trials (RCTs) to demonstrate the efficacy of progesterone on the threatened miscarriage pregnancy. The outcomes were miscarriage, preterm birth, and live birth.; Results: Nine RCTs comparing 4907 patients were included in this study. Compared with placebo or no treatment, progesterone supplementation had a relationship with a reduction in the rate of miscarriage [RR 0.70 95% Cl (0.52, 0.94)]. There was no significant difference between progesterone supplementation and placebo or no treatment in preterm birth [RR 0.87 95% Cl (0.52, 1.47) and live birth (RR 1.02 95% Cl (0.98, 1.07)].; Conclusion: Progesterone supplementation did not significantly improve the incidence of preterm and live birth, so progesterone treatment of threatened miscarriage may be unhelpful.

yan, z., et al. (2023). "How effective are non-pharmacological treatments for women with primary dysmenorrhea at easing the abdominal pain? A network meta-analysis and systematic review." PROSPERO International prospective register of systematic reviews.
	
Yan, Z. and J. Peng (2021). "Comparison of Poly (ADP-ribose) Polymerase Inhibitors (PARPis) as frist-line Maintenance Therapy for Patients with Newly Diagnosed Advanced Ovarian Cancer: Systematic Review and Network Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Yanan, G., et al. (2022). "Effects of Mind-Body Therapies on Infertile Women : a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Yang, H., et al. (2022). "Effect of non-pharmacological interventions for overweight/obese women with polycystic ovary syndrome on ovulation and pregnancy outcomes: a protocol for a systematic review and network meta-analysis." BMJ Open 12(6): e059090.
	Introduction: Most overweight/obese women with polycystic ovary syndrome (PCOS) have infertility issues which are difficult to treat. Non-pharmacological interventions used for the management of infertility include lifestyle interventions, acupuncture therapies and nutritional supplements. These interventions have been reported to be beneficial in alleviating infertility among overweight women with PCOS. However, effect and safety of these non-pharmacological interventions vary, and there is no standard method of clinical application. Therefore, it is necessary to conduct a systematic review and network meta-analysis (NMA) to rank these non-pharmacological interventions in terms of effect and determine which one is more effective for clinical application.; Methods and Analysis: We will retrieve eight databases including Cochrane Library, Medline, Embase, PsycINFO, Chinese National Knowledge Infrastructure, WanFang Data, the Chongqing VIP Database and China Biology Medicine disc from their inceptions onwards. In addition, four clinical trial registries and the related references will be manually retrieved. The primary outcome will be clinical pregnancy. Live birth, ovulation, pregnancy loss, multiple pregnancy and adverse events related to interventions will be considered as the secondary outcomes. STATA software V.15.0 and Aggregate Data Drug Information System V.1.16.8 will be used to conduct pairwise meta-analysis and NMA. The Grading of Recommendations Assessment, Development and Evaluation system will be adopted to evaluate the certainty of evidence.; Ethics and Dissemination: Ethical approval will not be required because the study will not include the original information of participants. The results will be published in a peer-reviewed journal or disseminated in relevant conferences.; Prospero Registration Number: CRD42021283110.; 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.)

Yang, L., et al. (2024). "Efficacy of intracytoplasmic sperm injection in women with non-male factor infertility: A systematic review and meta-analysis." Acta Obstetricia et Gynecologica Scandinavica 103(1): 30-41.
	Introduction: The use of intracytoplasmic sperm injection (ICSI) has dramatically increased in patients with non-male factor infertility during the last decades. However, whether ICSI provides a significant benefit over in vitro fertilization (IVF) in these patients is still controversial. In this study, we aimed to investigate the efficacy of ICSI on reproductive outcomes with non-male factor infertility and to provide updated evidence for clinical practice. Material(s) and Method(s): We searched Medline, Embase, and the Cochrane Central Register of Controlled Trials from inception to March 2023. Randomized controlled trials (RCTs) comparing the efficacy between ICSI and IVF in patients with non-male factor infertility were included. The main outcomes were the live birth rate (LBR), fertilization rate (FR), and total fertilization failure (TFF). The pooled estimates were calculated using the random-effects models as relative risk (RR) with 95% confidence intervals (CIs). This systematic review and meta-analysis was registered in PROSPERO (CRD42023427004). Result(s): We included 18 RCTs with 3249 cycles and 30 994 oocytes. The results demonstrated that ICSI reduced the risk of TFF (RR = 0.26, 95% CI: 0.13-0.50, I2 = 58%) and increased FR per oocyte inseminated/injected (RR = 1.14, 95% CI: 1.08-1.20, I2 = 69%), but it did not improve LBR (RR = 1.11, 95% CI: 0.94-1.30, I2 = 0%) or other outcomes compared with IVF. However, the difference in fertilization failure reduction between ICSI and IVF may be explained by different randomization methods (randomization based on patients vs. sibling oocytes). When considering only studies with randomization based on patients, we found no evidence of the difference between the groups (RR = 0.72, 95% CI: 0.48-1.06, I2 = 0%). Furthermore, no differences were observed in subgroup analyses based on other factors, including female age, study period, and controlled ovarian stimulation protocols. Conclusion(s): Our findings suggest that ICSI leads to no difference in reproductive outcomes compared to IVF in patients with non-male factor infertility. Considering the cost and safety of ICSI, we have no evidence to support the routine use of ICSI in these populations. High-quality RCTs with large sample sizes will be needed to confirm our results and explore clinical and neonatal outcomes.Copyright © 2023 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).

Yang, M., et al. (2023). "Mindfulness-Based Interventions for Postpartum Depression: A Systematic Review and Meta-Analysis." Iranian Journal of Public Health 52(12): 2496-2505.
	Background: We aimed to investigate the intervention effect of mindfulness-based interventions (MBIs) in patients with postpartum depression.; Methods: The method of computer and manual keyword retrieval was used to search PubMed, Web of Science, Cochrane Library. Literature included in the study was assessed for quality and meta-analysis was performed using RevMan 5.3 software.; Results: Twelve articles were finally included in the study and the meta-analysis showed that 6 articles used the Edinburgh Postnatal Depression Scale (EPDS) to compare MBIs with conventional therapy, and the statistical heterogeneity between the combined results was low ( P =0.18, I 2 =32%). The level of depression in postpartum depression patients was lower in the MBIs group than in the conventional group [MD=3.13, 95%CI (2.57, 3.70), P <0.00001]. Based on the Beck Depression Inventory (BDI), the comparison between MBIs and conventional therapy had low statistical heterogeneity between the combined results ( P =0.56, I 2 =0%). The level of depression in patients with postpartum depression who received MBIs was significantly lower than in the conventional care group [MD=5.89, 95%CI (4.88, 6.91), P <0.00001]. Subgroup analysis showed that the best intervention duration for MBIs for postpartum depression was within 4 weeks (SMD=-1.785), each session ≦60 minutes (SMD=-1.435), and participants had to complete the best three times per week (SMD=-2.185).; Conclusion: MBIs can alleviate depression in women, thereby facilitating their adjustment to new life. It is recommended to practice mindfulness meditation for 30 minutes per day. (Copyright© 2023 Yang et al. Published by Tehran University of Medical Sciences.)

Yang, P., et al. (2020). "The effect of growth hormone supplementation in poor ovarian responders undergoing IVF or ICSI: a meta-analysis of randomized controlled trials." Reproductive Biology and Endocrinology 18(1): 76.
	Purpose: The aim of this meta-analysis was to evaluate the effect of growth hormone (GH) supplementation in poor responders undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).; Methods: PubMed, MEDLINE and Cochrane Library databases were searched for the identification of relevant randomized controlled trials. Outcome measures were live birth rate, clinical pregnancy rate, miscarriage rate, cycle cancelation rate, number of retrieved oocytes and total dose of gonadotropin.; Results: Fifteen randomized controlled trails (RCTs) involving 1448 patients were eligible for the analysis. GH supplementation improved live birth rate (RR, 1.74; 95% CI, 1.19-2.54), clinical pregnancy rate (RR, 1.65; 95% CI, 1.31-2.08) and retrieved oocytes number (SMD, 0.72; 95% CI, 0.28-1.16), while reducing cancelled cycles rate (RR, 0.62; 95% CI, 0.44-0.85) and dose of Gonadotropin (SMD,-1.05 95% CI, - 1.62 - -0.49) for poor ovarian response patients. Besides, there was no significant difference in the miscarriage rate between GH group and control group.; Conclusions: Based on the limited available evidence, growth hormone supplementation seems to improve IVF/ICSI outcomes for poor ovarian responders. Further randomized controlled trials with large sample sizes are required to clarify the effect of GH adjuvant therapy in the treatment of women with poor ovarian response.

Yang, S., et al. (2019). "The Effect of Statins on Levels of Dehydroepiandrosterone (DHEA) in Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis." Medical Science Monitor 25: 590-597.
	<strong>BACKGROUND</strong> Currently, statins are used to treat polycystic ovary syndrome (PCOS). This systematic review and meta-analysis aimed to investigate the effect of statins on serum or plasma levels of dehydroepiandrosterone (DHEA) in women with PCOS. <strong>MATERIAL AND METHODS</strong> Databases that were searched included PubMed, Embase, and the Cochrane Library from their inception to August of 2018. Published randomized controlled trials (RCTs) were identified that evaluated the impact of statins on plasma DHEA levels in women with PCOS. The Cochrane risk of bias tool was used to assess the quality of the included RCTs. A random-effects model was used to analyze the pooled results. <strong>RESULTS</strong> Meta-analysis was performed on data from ten published studies that included 735 patients and showed that statin treatment could significantly reduce plasma DHEA levels when compared with controls (SMD, -0.43; 95% CI, -0.81-0.06; p=0.02; I²=82%). Statins were significantly more effective than placebo in reducing the levels of DHEAs. Subgroup analysis based on statin type showed that atorvastatin significantly reduced DHEA levels (SMD, -0.63; 95% CI, -1.20 - -0.05; p=0.03; I²=38%) but simvastatin did not significantly reduce DHEA levels (SMD: -0.14; 95% CI, -0.49-0.28; p=0.43; I²=77%). Subgroup analysis based on duration of treatment showed no significant difference between 12 weeks of statin treatment (SMD, -0.61; 95% CI, -1.23-0.02; p=0.06; I²=85%) and 24 weeks (SMD, -0.34; 95% CI -0.95-0.28; p=0.29; I²=83%). <strong>CONCLUSIONS</strong> Meta-analysis showed that statins significantly reduced the levels of DHEA when compared with placebo in patients with PCOS.

Yang, S., et al. (2022). "The Effect of Oral Antidiabetic Drugs on Improving the Endocrine and Metabolic States in Women with Polycystic Ovary Syndrome: A Systematic Review and Network Meta-analysis." Drugs 82(14): 1469-1480.
	Background: Polycystic ovary syndrome (PCOS) is the most common endocrine condition in women, impacting several aspects of a woman's life, including reproductive, mental, cardiovascular, and metabolic health. Antidiabetic drugs may have beneficial effects on the endocrine and metabolic states in women with PCOS.; Objective: This study aimed to compare the effects of oral antidiabetic drugs on reproductive hormones, metabolic and anthropometric markers, and menstrual frequency, in patients with PCOS using network meta-analysis.; Methods: PubMed, EMBASE, and CENTRAL were searched for studies published up to May 31, 2021. Randomised clinical trials enrolling participants with PCOS were included, for which sodium-glucose cotransporter 2 (SGLT-2) inhibitors, metformin (Met), dipeptidyl peptidase 4 (DPP-4) inhibitors, alpha-glucosidase inhibitors, glucagon-like peptide 1 receptor agonists (GLP-1 RAs), and thiazolidinediones (TZDs) (alone or in combination) were compared with either each other, placebo, or no treatment. A network meta-analysis using a Bayesian approach was performed. The outcomes included changes in endocrine outcomes, metabolic results, menstrual frequency, and anthropometric findings. All research was conducted according to a protocol registered in the PROSPERO database (CRD42021248314).; Results: In total, we retrieved 3383 studies, of which 47 articles enrolling 2626 participants were included for the network meta-analysis. In comparison to the control groups, Met (MD - 0.41, 95% CI - 0.73 to - 0.09) was more beneficial in reducing serum total testosterone, and GLP-1RAs+Met (MD - 5.44, 95% CI - 10.06 to - 0.89) reduced free androgen index (FAI) more effectively. Thiazolidinediones (MD 9.33, 95% CI 0.15 to 17.99) had a greater effect on sex hormone-binding globulin (SHBG) than Met. For decreasing androstenedione, Met (MD - 1.87, 95% CI - 2.73 to - 1.01), DPP-4 inhibitors (MD - 2.64, 95% CI - 4.77 to - 0.49), GLP-1RAs (MD - 3.06, 95% CI - 5.53 to - 0.62), and GLP-1RAs+Met (MD - 2.97, 95% CI - 5.85 to - 0.09) were more effective than TZDs. The confidence in evidence was often low or very low.; Conclusions: In this network meta-analysis, GLP-1 receptor agonists in combination with metformin appear to be preferable for improving hyperandrogenaemia. Metformin and TZDs offer the added benefit of improving fasting blood glucose (FBG) and low-density lipoprotein-cholesterol (LDL-C) when compared to the control groups. Metformin combined with GLP-1 receptor agonists or TZDs could be associated with a beneficial effect on menstrual recovery. (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Yang, S.-L., et al. (2020). "Effect of neoadjuvant chemotherapy followed by surgery for FIGO stage I-II cervical cancer: a meta-analysis." The Journal of International Medical Research 48(8): 300060520945507.
	Objective: In this meta-analysis, we aimed to evaluate the oncological outcomes of preoperative neoadjuvant chemotherapy followed by radical surgery compared with radical surgery alone for treatment of International Federation of Gynecology and Obstetrics (FIGO) stage I-II cervical cancer.; Method: We searched for studies comparing the safety and efficacy of neoadjuvant chemotherapy plus surgery versus surgery alone in treatment outcomes of locally advanced cervical cancer. Meta-analysis was used to calculate the pooled odds ratios with corresponding 95% confidence intervals (CI).; Results: Sixteen studies were included in our analysis. Pooled analysis of overall survival rate [odds ratio (OR) = 1.09, 95% CI: 0.83-1.43] and progression-free survival rate (OR = 1.10, 95% CI: 0.77-1.57) showed that preoperative neoadjuvant chemotherapy did not have a benefit compared with surgery alone in terms of survival rates. The pooled results for postoperative parameters indicated that preoperative neoadjuvant chemotherapy followed by radical surgery was associated with a high rate of vascular space involvement (OR = 0.25, 95% CI: 0.17-0.35) and parametrial infiltration (OR = 0.60, 95% CI: 0.45-0.79).; Conclusions: This meta-analysis indicated that surgery following neoadjuvant chemotherapy for FIGO stage I-II cervical cancer and surgery alone had similar oncological outcomes.

Yang, S. Y., et al. (2020). "The effects of diagnostic hysteroscopy on the reproductive outcomes of infertile women without intrauterine pathologies: a systematic review and meta-analysis." Korean Journal of Women Health Nursing 26(4): 300-317.
	PURPOSE: Hysteroscopy can be used both to diagnose and to treat intrauterine pathologies. It is well known that hysteroscopy helps to improve reproductive outcomes by treating intrauterine pathologies. However, it is uncertain whether hysteroscopy is helpful in the absence of intrauterine pathologies. This study aimed to confirm whether hysteroscopy improves the reproductive outcomes of infertile women without intrauterine pathologies. METHODS: We conducted a systematic review of 11 studies retrieved from Ovid-MEDLINE, Ovid-Embase, and the Cochrane Library. Two independent investigators extracted the data and used risk-of-bias tools (RoB 2.0 and ROBINS-I) to assess their quality. RESULTS: Diagnostic hysteroscopy prior to in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) was associated with a higher clinical pregnancy rate (CPR) and live birth rate (LBR) than non-hysteroscopy in patients with recurrent implantation failure (RIF) (odds ratio, 1.79 and 1.46; 95% confidence interval, 1.40-2.30 and 1.08-1.97 for CPR and LBR, respectively) while hysteroscopy prior to first IVF was ineffective. The overall meta-analysis of LBR showed statistically significant findings for RIF, but a subgroup analysis showed effects only in prospective cohorts (odds ratio, 1.40 and 1.47; 95% confidence interval, 0.62-3.16 and 1.04-2.07 for randomized controlled trials and prospective cohorts, respectively). Therefore, the LBR should be interpreted carefully and further research is needed. CONCLUSION: Although further research is warranted, hysteroscopy may be considered as a diagnostic and treatment option for infertile women who have experienced RIF regardless of intrauterine pathologies. This finding enables nurses to educate and support infertile women with RIF prior to IVF/ICSI.

Yang, W.-J., et al. (2019). "The effectiveness of music therapy for postpartum depression: A systematic review and meta-analysis." Complementary Therapies in Clinical Practice 37: 93-101.
	
Yang, X., et al. (2021). "Comparison between curative concurrent chemoradiotherapy followed by adjuvant chemotherapy and curative concurrent chemoradiotherapy alone in patients with locally advanced cervical carcinoma: A meta-analysis." European Journal of Gynaecological Oncology 42(5): 1029-1038.
	Objective: In the studies of locally advanced cervical carcinoma (LACC), the efficacy of adjuvant chemotherapy (ACT) after curative concurrent chemoradiotherapy (CCRT) has not been clearly investigated. This paper aimed to evaluate the impact of CCRT followed by ACT compared with the impact of CCRT alone in the treatment of LACC. Data sources, methods of study selection: The Web of Science, Cochrane Library, EMBASE, and PubMed were systematically reviewed to find eligible studies up to 28 February 2020. The pooled analysis was conducted through random- or fixed-effect models. Clinical endpoints such as overall survival (OS), progression-free survival (PFS), local failure rate (LFR), distant metastasis (DM), as well as adverse events (AEs) were examined as evaluation indexes. Tabulation, integration and results: Three retrospective studies and two randomized trials were enrolled in this meta-analysis comprising 1172 patients (CCRT arm: 588; CCRT + ACT arm: 584). No significant differences were discovered in OS (hazard ratio [HR] = 0.94, 95% confidence interval [CI]: 0.46, 1.94, p = 0.88) and PFS (HR = 0.91, 95% CI: 0.50, 1.67, p = 0.76) between CCRT followed by ACT and CCRT alone. The pooled RRs for LFR (RR = 0.64, 95% CI: 0.44, 0.92, p = 0.02) and DM (RR = 0.50, 95% CI: 0.35, 0.71, p < 0.05) showed that the application of CCRT followed by ACT decreased LFR and DM compared with CCRT alone. However, CCRT followed by ACT arm had more acute hematologic toxicities (anemia, neutropenia, thrombocytopenia) and grade 3-4 proctitis (all p < 0.05), than CCRT arm; no statistic differences were found in late toxicities (cystitis and proctitis) between the two arms (p > 0.05). Conclusion(s): This study suggested that CCRT followed by ACT did not prolong OS and PFS. It decreased LFR and DM compared with CCRT alone. CCRT followed by ACT raised the incidence of acute hematologic toxicities and proctitis but did not increase late toxicities. Further study is needed in CCRT followed ACT for LACC.Copyright ©2021 The Author(s). Published by IMR Press.

Yang, X. and L. Shi (2021). "A systematic review and meta-analysis of effectiveness and safety of electroacupuncture for the female urinary incontinence." PROSPERO International prospective register of systematic reviews.
	
Yang, Y. and I. T. Chia (2022). "Should Photobiomodulation be Considered When Treating Primary Dysmenorrhea? A system review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question Should Photobiomodulation be Considered When Treating Primary Dysmenorrhea? Searches data taken from PudMed, Embase, ClinicalKey, CINAHL & CJTD and Cochrane Controlled Trial Register forward and backward citations for studies published between each database’s inception and August 26, 2022, with the earliest records being from February 2009 English, Chinese, Deutsch Types of study to be included RCTs Condition or domain being studied Primary dysmenorrhea refers to the presence of recurrent, crampy, lower abdominal pain occurring during menses and the absence of demonstrable disease. Above 59.7% to 93% high school females reported they had experiences of dysmenorrhea. A lot of women reported have good experiences after treating with acupuncture[12]. But some of them are afraid of the feeling i.e. pain or soreness when the needles puncture in or the hematoma and infection risk[13]. Photobiomodulation(PBM) such as low level laser acupuncture[14], infrared light therapy[15] were report effective and common use for the whole word. However, the effect of PBM to treat primary dysmenorrhea still inconclusive, we aim to focus on the overall efficacy of PBM in treating primary dysmenorrhea, Participants/population Inclusion criteria was women with primary dysmenorrhea. Exclusion criteria were secondary dysmenorrhea which due to other systemic disease or symptom such as cancers, constipation, urinary infection or herniated Intervertebral Disc. Intervention(s), exposure(s) the efficacy of PBM i.e. low level laser therapy, low level light therapy, far-infrared ray, infrared ray, near-infrared ray for the treatment of primary dysmenorrhea involved; Comparator(s)/control Placebo, NSAIDs, DSG/EE. Context (a) the efficacy of PBM i.e. low level laser therapy, low level light therapy, far-infrared ray, infrared ray, near-infrared ray for the treatment of primary dysmenorrhea involved; (b) sufficient data be made available, including the numeric rating score(NRS), the overall improvement of dysmenorrhea.;(c) a full text of the study could be acquired. If there was more than on publication resulting from the same patient cohort, the most recent publication would be used for analysis. Main outcome(s) VAS Measures of effect SMD Additional outcome(s) Clinical improvement, Measures of effect OR Data extraction (selection and coding) (a) the efficacy of PBM i.e. low level laser therapy, low level light therapy, far-infrared ray, infrared ray, near-infrared ray for the treatment of primary dysmenorrhea involved; (b) sufficient data be made available, including the numeric rating score(NRS), the overall improvement of dysmenorrhea.;(c) a full text of the study could be acquired. If there was more than on publication resulting from the same patient cohort, the most recent publication would be used for analysis Risk of bias (quality) assessment We used Cochrane risk-of-bias tool to evaluate enrolled studies Strategy for data synthesis The Odd Ratios (ORs) of clinical response of clinical response to primary dysmenorrhea in the PBM group, compared with the control group, comprised the primary outcome. The Standardized Mean Differences (SMDs) in pain scores (visual analog scale, numeric rating scale) between the PBM and reference groups comprised the secondary outcome.A employed to pool both individual SMDs and ORs. We use Comprehensive Meta- analysis (CMA) software, version 3(Biostate, Englewood, NJ, USA) for analyses, and random effect model was employed to pool both individual SMs and ORs. I² test was conducted to determine the heterogeneity between trials, with value> 50% being regarded as considerable heterogeneity. To examine potential publication bias, funnel plots and Egger’s test were used[18]. Statistical significance was defined as p-value < 0.05, except for the determination of publication bias, which employed p-value < 0.01. Analysis of subgroups or subsets The study design are diverse that 9 of all studies designed to compare PBM to placebo[14, 15, 19, 20, 26-30]. One compared PBM to (Traditional Chinese Medicine)TCM[23], one was PBM + moxibustion to TCM[24]. One was PBM + moxibustion to NSAIDs[25], two studies compared PBM to NSAIDs[21, 22] and one was PBM to DSG/EE[31]. Contact details for further information YANG YACHEN u9930117@gmail.com Organisational affiliation of the review Taichung Veterans General Hospital Review team members and their organisational affiliations Dr YANG YACHEN. Taichung Veterans General Hospital Dr Chia-I Tsai. Department of Chinese Medicine, Taichung Veterans General Hospital, Taichung, Taiwan Type and method of review Meta-analysis, Systematic review Anticipated or actual start date 14 November 2022 Anticipated completion date 14 December 2022 Funding sources/sponsors There is no financial fundation Conflicts of interest None known Language English Country Taiwan Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Dysmenorrhea; Female; Humans Date of registration in PROSPERO 25 November 2022 Date of first submission 14 November 2022 Stage of review at time of this submission The review has not started

Yang, Y., et al. (2020). "The efficacy and safety of the addition of poly ADP-ribose polymerase (PARP) inhibitors to therapy for ovarian cancer: a systematic review and meta-analysis." World Journal of Surgical Oncology 18(1): 151.
	Background: The purpose of this study was to explore the efficacy and tolerability of poly ADP-ribose polymerase (PARP) inhibitors in patients with ovarian cancer.; Methods: The meta-analysis searched the PubMed, Web of Science, EBSCO, and Cochrane libraries from inception to February 2020 to identify relevant studies. And the main results of this study were long-term prognosis and treatment-related adverse events.; Results: The results showed that the addition of PARP inhibitors could significantly prolong progression-free survival (PFS) and overall survival (OS) for patients with ovarian cancer (HR 0.44, 95% CI 0.34-0.53, p < 0.001; HR, 0.79, 95% CI 0.65-0.94, p < 0.001, respectively). In the BRCA 1/2 mutation patients, the HR of PFS was 0.29 (p < 0.001), and the HR was 0.51 (p < 0.001) in the no BRCA 1/2 mutation patients. The HR of PFS was 0.40 (p < 0.001) in the homologous recombination deficiency (HRD) mutation patients, while the HR was 0.80 (p < 0.001) in the no HRD mutation patients. Moreover, the analysis found that the use of PARP inhibitors did not significantly increase the risk of all grade adverse events (AEs) (RR = 1.04, p = 0.16). But the incidence of grade 3 or higher AEs was increased (RR = 1.87, p = 0.002). In general, the AEs were mainly manifested in the blood system.; Conclusions: PARP inhibitors can improve the prognosis of ovarian cancer patients with and without genetic mutations (BRCA 1/2 or HRD). Furthermore, PARP inhibitors were tolerable to patients when added to their current therapy, although it inevitably adds the grade 3 and higher AEs.

Yang, Y., et al. (2021). "Tanshinone for polycystic ovary syndrome: A protocol of systematic review and meta-analysis." Medicine 100(3): e24287.
	Backgrounds: Polycystic ovary syndrome (PCOS) constitutes an endocrine and metabolic disorder characterized by hyperandrogenemia, ovulation disorders, and polycystic ovary. Existing therapy is low efficacy and has significant side effects. In traditional Chinese medicine, tanshinone was used for PCOS women. Here, we will investigate the safety, as well as the efficacy of tanshinone in treating polycystic ovary syndrome.; Methods: Two researchers will independently research eligible randomized controlled trials in 6 repositories: PubMed, CINAHL, Web of Science, EMBASE, China National Knowledge Infrastructure (CNKI), as well as Cochrane Library, from their onset to present. The languages will constitute either English or Chinese, and we will carry out article selection, data mining, and conduct an evaluation of the risk of bias by the Cochrane tool of risk of bias. All analyses will be conducted by using the Cochrane Review Manager software (RevMan 5.3).; Results and Conclusion: This study will provide the latest research evidence on the efficacy, as well as safety of tanshinone for PCOS patients.; Registration Number: INPLASY2020100017.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Yang, Y., et al. (2023). "Efficacy and safety of olaparib in advanced ovarian cancer: a meta-analysis." Journal of Obstetrics and Gynaecology 43(1): 2151883.
	This study aimed to evaluate the efficacy and safety of olaparib for the treatment of advanced ovarian cancer. All studies that assessed the efficacy and safety of olaparib in advanced ovarian cancer were searched in PubMed, Embase, and Web of Science from their inception to 20 September 2022. The analysis included six studies and 2016 patients. Olaparib could significantly prolong the progression-free survival (PFS) of patients compared to that of the control group (HR = 0.49, 95% CI = 0.36 - 0.68). However, no statistically significant differences were detected in overall survival (OS) and objective response rate (ORR) between the olaparib and control groups. Olaparib treatment increased the number of grade ≥3 adverse events (AEs) in patients with advanced ovarian cancer compared with that in the control group. Olaparib significantly prolonged PFS in patients with advanced ovarian cancer; however, no statistically significant differences were detected in OS and ORR. In terms of safety, olaparib has manageable adverse effects.

Yanhui, L., et al. (2022). "A Network Meta-analysis of Letrozole-related regimens in the Treatment of Endometriosis." PROSPERO International prospective register of systematic reviews.
	Review question The purpose of this network meta-analysis of randomized controlled trial is to evaluate the optimal use of letrozole for endometriosis. Searches Eight databases including PubMed, Embase, Cochrane Library, Web of Science, Chinese Biomedical Literature, CNKI and Wanfang were searched for clinical randomized controlled studies related to the treatment of endometriosis by letrozole. The search period was established until December 31, 2021. Search strategy https://www.crd.york.ac.uk/PROSPEROFILES/327816_STRATEGY_20220423.pdf Types of study to be included Randomized controlled trial.blind method and follow-up unlimited Condition or domain being studied Endometriosis refers to the implantation of active endometrial tissue (glands and stroma) outside the uterine cavity. It is an aggressive, recurrent chronic estrogen-dependent benign disease. Patients may have secondary dysmenorrhea, chronic pelvic pain, painful intercourse, anal falling pain, infertility, pelvic nodules or masses and other gynecological symptoms. Endometriosis has extensive lesions and various forms. It has the ability of tumor invasion and metastasis and is highly recurrent. It is known as the "deathless cancer" and has a serious impact on women's health, work, study and quality of life. Endometriosis has always been a hot and difficult research topic for obstetricians and gynecologists. Letrozole is a highly selective non-steroidal aromatase inhibitor, which can specifically competitively bind to aromatase binding sites, reduce estrogen synthesis, and narrow ectopic lesions. Currently, letrozole can be used alone in the treatment of endometriosis. Letrozole in combination with didrogesterone, mifistone, getrienone, GnRHa, metformin, etc., may also be used, but there is no clear evidence directly on which regimen is best. Participants/population Patients with endometriosis diagnosed by clinical symptoms, signs, ultrasound or laparoscopy Intervention(s), exposure(s) Letrozole was used for treatment Comparator(s)/control Letrozole is used in combination with other drugs or other medications Context No history of allergy or contraindication to letrozole and related drugs Main outcome(s) The primary outcome measure was efficiency. Significant effect: clinical symptoms such as pain and sexual discomfort disappeared completely or no pelvic mass was found in B ultrasound examination. Effective: After b-ultrasonography examination, pelvic mass was reduced, and occasionally pain or significant pain relief. Ineffective: pelvic mass did not shrink, pain did not relieve or worsen. Effective = (effective + effective)/Total number of people ×100%. Measures of effect odds ratios Additional outcome(s) The levels of estrogen and carcinoembryonic antigen 125(CA125) after treatment, adverse reactions. Measures of effect Continuous variables were evaluated by Mean different(MD) and dichotomous variables by odds ratios(OR). Data extraction (selection and coding) Two researchers independently search, screen, extract data, and cross-check the literature. If there is any disagreement, the third researcher with more experience will help solve it if necessary. Data extraction included: title, first author, publication journal and year, trial site, study time, fund, diagnosis method of endometriosis, intervention measures, sample size, inclusion and exclusion criteria, randomness, age of subjects, duration of disease, and corresponding outcome indicators. Risk of bias (quality) assessment The risk of bias was assessed using the risk assessment tool of bias provided by the Cochrane Collaboration. The main evaluation areas include :(1) generation of random sequences; (2) Distribution hiding; (3) Implementation bias: subjects and experimentalists were blinded; (4) Measurement bias: blind method was performed on the results evaluator or subject; (5) Follow-up bias: whether the outcome indicators are complete; (6) Reporting bias: selective reporting of research results; (7) Other bias: other sources of bias. Strategy for data synthesis Meta-analysis was performed on studies with multiple direct comparisons using RevMan 5.3 software provided by the Cochrane Collaboration. The dichotomous variables were described by Odds ratio (OR) and 95% confidence interval (95%CI). Continuous variables were described by mean difference (MD) and 95%CI. When P≤0.05, the difference was considered statistically significant. χ² test was used for heterogeneity test among studies. When P > 0.1 and I²≤50%, heterogeneity among studies was small, and fixed-effect model was more reliable for meta-analysis. When P≤0.1 or I² > 50%, the heterogeneity among studies was large, and the random effect model was used for meta analysis. Stata 15.0 software network and MVMETA program package were used for network meta-analysis and comparison to obtain the best treatment plan. Dichotomous variables were described by odds ratio (OR) and 95% confidence interval (95%CI). Continuous variables were described by mean difference (MD) and 95% confidence interval (95%CI). When P≤0.05, the difference was considered statistically significant. Analysis of subgroups or subsets Sensitivity analysis or subgroup analysis Contact details for further information Aiping 1045112444@qq.com Organisational affiliation of the review Center of Reproductive Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. https://www.gxmuyfy.cn/ Review team members and their organisational affiliations Yanhui Li. Center of Reproductive Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. Ming Liao. Center of Reproductive Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. Huangqun Yan. Center of Reproductive Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. Jiaxu Li. Center of Reproductive Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. Rong Deng. Center of Reproductive Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. Collaborators Aiping Qin. Center of Reproductive Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. Type and method of review Intervention, Network meta-analysis, Systematic review Anticipated or actual start date 23 April 2022 Anticipated completion date 31 July 2022 Funding sources/sponsors no Grant number(s) State the funder, grant or award number and the date of award no Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Endometriosis; Female; Humans; Letrozole; Network Meta-Analysis; Nitriles; Triazoles Date of registration in PROSPERO 10 May 2022 Date of first submission 23 April 2022

Yanping, Z., et al. (2023). "PD-1/PD-L1 inhibitors in the treatment of common gynecologic malignancies: A meta-analysis of efficacy and safety." PROSPERO International prospective register of systematic reviews.
	Review question The main goal of clinical trials is to establish the effectiveness and safety of the drug in a carefully selected group of patients. However, there are still differences from real-world applications. The actual application of PD-1/PD-L1 inhibitor needs more attention. This study conducted a meta-analysis of randomized controlled trials on the actual application of PD-1/PD-L1 inhibitors in common gynecologic malignancies. Searches We comprehensively searched Chinese databases (CNKI, Wanfang Data, SinoMed, China Science and Technology Journal Database) and foreign databases (PubMed, Web of Science, Embase, Cochrane Library) for eligible publications, and conducted web searches for clinical trials on ClinicalTrials.gov. We used the following keywords: "cervical cancer," "ovarian cancer," "endometrial cancer," "common gynecologic malignancies," and "PD-1/PD-L1." The final search date was before November 24, 2023, with no time limit on the search. In addition, we manually checked the reference lists of relevant studies to determine whether other articles should be included. Two researchers completed this search process together. Types of study to be included clinical controlled trials Condition or domain being studied Common gynecologic malignancies include cervical cancer, ovarian cancer, and endometrial cancer. According to GLOBOCAN's estimates of global cancer incidence and mortality in 2020, both the new cases and deaths from cervical cancer rank fourth among female cancers worldwide; the new cases and deaths from ovarian cancer rank eighth, and the incidence of endometrial cancer ranks sixth. Cervical cancer is one of the leading causes of death in women globally. Current treatment methods for cervical cancer mainly include surgery, radiation therapy, and chemotherapy. Ovarian cancer encompasses various pathological types, with epithelial ovarian cancer being the most common. Upon diagnosis, the 5-year survival rate for epithelial ovarian cancer is approximately 46%, with primary treatment consisting mainly of surgery and systemic therapy. Although fallopian tube cancer and primary peritoneal cancer have low incidence rates, their biological behavior is similar to that of epithelial ovarian cancer, and their treatment principles follow those for epithelial ovarian cancer. The main treatment method for endometrial cancer is surgical treatment, with the 5-year overall survival rate for early-stage endometrial cancer being approximately 81%, whereas for stage IVA and IVB endometrial cancer, the 5-year overall survival rates are only 17% and 15%, respectively. Participants/population Patients with cervical cancer, endometrial cancer, and ovarian cancer (including fallopian tube cancer and primary peritoneal cancer). Intervention(s), exposure(s) These articles are manually screened for relevance, first by removing duplicate publications, and then checking the abstract if the title is not enough to exclude. If a publication appears to meet the inclusion criteria after reading the abstract, it will be marked for full text inspection. The inclusion criteria for the experimental group are patients receiving PD-1/PD-L1 inhibitor treatment, including PD-1/PD-L1 inhibitor monotherapy, combination with chemotherapy, radiation therapy, targeted therapy, and anti-angiogenic agents. Comparator(s)/control The control group receives a placebo, chemotherapy, radiation therapy, or other combination therapies. Exclusion criteria 1) Reviews, conference abstracts, case reports, letters, guidelines, meta-analyses, expert opinions, animal experiments, and cell experiments; 2) Studies that duplicate the same trial publications; 3) Literature that cannot provide the required data; 4) Non-randomized phase II or III clinical studies. Main outcome(s) mOS, mPFS , ORR and the incidence of adverse events. Additional outcome(s) complete response 、partial response、stable disease、disease control rate、treatment-related adverse events、Immune-related adverse events、common adverse events of grade 3 or higher (≥3 and occurring at a rate of ≥10% in either group). Data extraction (selection and coding) Two researchers independently extracted relevant information from each study: first author, year of publication, demographic characteristics of participants include age, gender, ECOG performance status, FIGO staging, grouping scheme, sample size, median os, median pfs, HR, the incidence of grade ≥3 AEs. We downloaded the full text. If in doubt, ask the original author for help. Risk of bias (quality) assessment ROB2's overall assessment is based on a comprehensive evaluation of five domains to determine the extent of risk bias. These domains include: 1. Selection bias; 2. Performance bias; 3. Reporting bias; 4. Bias due to confounding; Overall bias risk, and each domain is scored as low risk, high risk, or unclear risk. Strategy for data synthesis Based on the recommendations of the Cochrane collaboration, quantitative synthesis of the indicators included in the study. In meta-analysis, I²> 50% is considered heterogeneous. In the absence of significant heterogeneity, a fixed-effect model is used; otherwise, a random-effect model is used. Performing sensitivity analyze and subgroup analyze for the included studies to find the reason of heterogeneity. Analysis of subgroups or subsets None Contact details for further information Yanping Zhang zyzyp12333@163.com Organisational affiliation of the review North Sichuan Medical College Review team members and their organisational affiliations Miss Yanping Zhang. North Sichuan Medical College Hualun Shen. Affiliated Hospital of North Sichuan Medical College Juan Zhang. Affiliated Hospital of North Sichuan Medical College Fan Yang. Affiliated Hospital of North Sichuan Medical College Biao Xian. Affiliated Hospital of North Sichuan Medical College Liangxin Zhai. North Sichuan Medical College Kexing Li. North Sichuan Medical College Type and method of review Intervention, Meta-analysis, Systematic review Anticipated or actual start date 01 October 2023 Anticipated completion date 31 January 2024 Funding sources/sponsors None

Yao, C., et al. (2022). "Interleukin-2 evaluating the effectiveness of drug therapy for pelvic inflammatory disease: a systematic review of a randomized clinical trial." PROSPERO International prospective register of systematic reviews.
	Review question The aim of this systematic review of a randomized clinical trial is to evaluate the efficacy of drug therapy for pelvic inflammatory disease. Searches We will search randomised clinical trials with published language limited to Chinese or English. The following electronic databases are searched (from their inception to December 2021): the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, Chinese National Knowledge Infrastructure Databases (CNKI), Chinese Science and Technology Periodical Database (VIP), Chinese Biomedical Literature Database (SinoMed), and Wan Fang Database. Types of study to be included We will include randomised clinical trials (RCT), regardless of blinding or publication type. Condition or domain being studied Pelvic inflammatory disease (PID) is a common inflammatory disease of the female upper genital tract, including endometritis, salpingitis, oophoritis, parametritis, tubo-ovarian abscess and pelvic peritonitis. The age is mainly concentrated from 25 to 35 years old.The common causative agents are sexually transmitted organisms (especially Chlamydia trachomatis and Neisseria gonorrhea), genital mycoplasmas, and microorganisms including anaerobic and aerobic bacteria.There are three states of PID, which are subclinical , asymptomatic or typical signs of severe infection. The most common symptoms and signs are lower abdominal pain (usually bilateral), abnormal vaginal or cervical discharge, dyspareunia, adnexal tenderness, and cervical motion tenderness upon bimanual vaginal examination. PID may damage the fallopian tubes and tissues in and near the uterus and ovaries. Delay in diagnosis and treatment of acute PID may lead to long-term serious sequelae including infertility, ectopic pregnancy and chronic pelvic pain and recurrence of PID. 10% to 20% women with acute PID may become infertile, 40% will develop chronic pelvic pain, and 10% will have an ectopic pregnancy. Participants/population Women with a clinical diagnosis of pelvic inflammatory disease by Interleukin-2 evaluating the effectiveness of drug therapy will be considered for this review. Intervention(s), exposure(s) We will include those trials by Interleukin-2 evaluating the effectiveness of drug therapy for pelvic inflammatory disease . The drug therapy include single herb, Chinese patent medicine, practitioner-prescribed herbal formula, or herbal extract injection. Chinese herbal medicine is no limitation on dosage, administration regimen and duration. Comparator(s)/control The control includes those trials by Interleukin-2 evaluating the effectiveness of drug therapy for pelvic inflammatory disease . The control group include two groups, one group is treated with integrated traditional Chinese and Western medicine, the other group is treated with western medicine. The two groups are no limitation on dosage, administration regimen and duration. Context No setting restrictions. Main outcome(s) (1) Data analysis of Interleukin-2 of participants with PID cured: cure is defined as disappearance of all clinical symptoms and signs of PID, normal laboratory index as assessed by laboratory test or as defined by outcome assessors; (2) Data analysis of Interleukin-2 to disappearance of symptoms and/or clinical signs; (3) adverse events. Additional outcome(s) Not applicable Data extraction (selection and coding) Two authors (Lin Wang, He He) will independently identify studies that potentially meet the eligibility criteria in this review based on title and/or abstract. The full articles of the potentially eligible studies will be retrieved and assessed independently by two authors (Lin Wang, He He). Any disagreement will be resolved by consensus and discussion with a third author (Xiao-Chun Jiang).A predesigned structured data extraction form will be used for extracting data from the included trials by two authors (Lin Wang, He He) independently. Extracted data will include: publication year, diagnostic criteria, sample size (total number and numbers in each group), baseline characteristics of participants, intervention and control, outcomes, funding. Uncertain or missing information will be sought by contacting the trial authors. We will resolve any differences in opinion through discussion with a third author (Xiao-Chun Jiang). Risk of bias (quality) assessment The risk of bias of each included studies will be assessed by two authors independently using the Cochrane Risk of Bias Tool. Six domains will be assessed: random sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other sources of bias. The quality of each trial will be categorised into low/unclear/high risk of bias. Disagreement about the risk of bias between two authors will be resolved by consensus or consultation with the third author (Xiao-Chun Jiang). Strategy for data synthesis The effect estimate for dichotomous outcome will be presented as risk ratio (RR) with its 95% confidence interval (CI), whereas the continuous data will be presented as mean difference (MD) with its 95% CI. Standardized mean difference (SMD) with its 95% CI will be calculated if the scales used for outcome measures differ. Heterogeneity will be assessed by using the χ² test and the I² statistic.We will consider an I² value greater than 50% to be an indicator of substantial heterogeneity. A random-effect model will be applied for pooling if there is significant heterogeneity. Otherwise, we will use a fixed-effect model. We will conduct sensitivity analysis to explore the influence of trial quality on effect estimates if necessary. Publication bias will be detected using a funnel plot analysis if more than ten trials are identified. All data analyses will be performed using RevMan 5.3 software provided by the Cochrane Collaboration. Analysis of subgroups or subsets Subgroup analyses will be performed for different Chinese herbal medicines if the data are available. Contact details for further information Yao Chen chenyao.1973@163.com Organisational affiliation of the review Department of Gynecology, Xianyang Central Hospital http://www.xy120.net/ Review team members and their organisational affiliations Ms Yao Chen. Department of Gynecology, Xianyang Central Hospital Professor Xiao-Chun Jiang. Department of Gynecology, Xianyang Central Hospital Ms Lin Wang. Department of Gynecology, Xianyang Central Hospital Ms He He. Department of Gynecology, Xianyang Central Hospital Ms Pei Wang. Department of Gynecology, Xianyang Central Hospital Ms Hui Zhang. Department of Gynecology, Xianyang Central Hospital Ms Bin-Yu Zhang. Department of Gynecology, Xianyang Central Hospital Ms Dong-Mei Gao. Department of Gynecology, Xianyang Central Hospital Type and method of review Meta-analysis, Systematic review Anticipated or actual start date [1 change] 01 April 2022 Anticipated completion date [1 change] 30 May 2022 Funding sources/sponsors This review is supported by the Key R & D project of Science and Technology Department of Shaanxi Province, China Grant number(s) State the funder, grant or award number and the date of award The preject number is 2019SF-030. Conflicts of interest None known Language English Country China Stage of review [1 change] Review Ongoing

Yao, H., et al. (2022). "The efficacy of intravaginal electrical stimulation (IVES) in treating female with urinary incontinence symptom from meta-analysis of nine randomized controlled trials." Frontiers in Neurology 13: 933679.
	Background: Urinary incontinence (UI) is a common disease in the middle-aged and elderly women, and physical therapy has gradually become the mainstream treatment of UI. We conducted a meta-analysis to evaluate the efficacy of intravaginal electrical stimulation (IVES) in the treatment of UI. Method(s): From January 2006 to December 2021, we finally selected nine randomized controlled trials (RCTs) including 657 participants from PubMed, EMBASE, and Cochrane databases to evaluate the efficacy of IVES in the treatment of female UI. Continuous data were represented by mean difference and 95% CI, while dichotomous data were represented by odds ratio and 95% CI. All the data were analyzed by the Review Manager Version 5.4. Result(s): Compared with the control group, there were significant improvements in urine pad test (P = 0.01), urinary incontinence frequency (P = 0.04), some indicators in the incontinence quality of life questionnaire and King's health questionnaires, and subjective feeling of cure (P = 0.009) in the IVES group. However, in other indicators reflecting UI, there was no significant difference between the IVES group and the control group. In addition, subgroup analysis showed that IVES and IVES combined with training could significantly reduce the weight of the urine pad, which reflected the improvement of urine leakage. Conclusion(s): This meta-analysis proved that IVES can partially improve the symptoms of female patients with UI compared with the control group. However, it still needs to be further evaluated through more high-quality research in the future.Copyright © 2022 Yao, Zhang, Sun, Tang, Wu and Zhou.

Yaqin, H., et al. (2024). "Meta analysis of the therapeutic effect of electrical stimulation combined with pelvic floor muscle training on female pelvic floor muscle dysfunction." PROSPERO International prospective register of systematic reviews.
	
Yasmin, s., et al. (2023). "Autologous Platelet-Rich Plasma Administration’s Efficacy In Patients With Low Ovarian Reserve: A Systematic Review And Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	
Yasushi, H. (2022). "A clinical trial to investigate the efficacy of Lactobacillus-containing vaginal suppository for the endometrial microbiota in the recurrent implantation failure patients." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: The study subjects will be assigned to two groups, the unapproved drug Lactobacillus‐containing vaginal suppository or placebo, to receive the vaginal suppository one capsule once a day, vaginally for 12 consecutive days. CONDITION: Recurrent implantation failure patients with chronic endometritis and abnormal endometrial microbiot PRIMARY OUTCOME: Amount of change in the occupancy of Lactobacillus spp. in the endometrial microbiota SECONDARY OUTCOME: 1. Improvement of chronic endometritis (change in the number of CD138 positive cells).; 2. Cure rate of abnormal endometrial microbiota.; 3. Amount of change in the occupancy of Lactobacillus spp.; in the endometrial microbiota at the end of the singleblind period and the open‐label period in the placebo group.; 4. Improvement of chronic endometritis in the placebo group at the end of the single‐blind period and the open‐label period (change in the number of CD138‐positive cells).; 5. Incidence of adverse events. INCLUSION CRITERIA: 1. Females between the ages of 18 and 42 years old at the time of obtaining consent 2. Those who underwent two or more previous failed cycles in which morphologically embryos were transferred. 3. Those who provide written informed consent for participation in this trial. 4. Those who can use the ePRO system. 5. Patients who can attend outpatient clinics according to the research schedule. 6. Those with >= 1 CD138 positive cell/10 HPF in the endometrial stroma on endometrial biopsy. 7. Those with < 90% Lactobacillus spp. in the endometrial microbiota analysis.

Ye, M., et al. (2022). "Efficacy of cognitive therapy and behavior therapy for menopausal symptoms: a systematic review and meta-analysis." Psychological Medicine 52(3): 433-445.
	Background: T long-term effects of cognitive therapy and behavior therapy (CTBT) for menopausal symptoms are unknown, and whether the effects are different between natural menopause and treatment-induced menopause are currently unclear. Therefore, we sought to conduct an accurate estimate of the efficacy of CTBT for menopausal symptoms.; Methods: We conducted searches of Cochrane Library, EMBASE, PsycINFO, PubMed, and Web of Science databases for studies from 1 January 1977 to 1 November 2021. Randomized controlled trials (RCTs) comparing intervention groups to control groups for menopausal symptoms were included. Hedge's g was used as the standardized between-group effect size with a random-effects model.; Results: We included 14 RCTs comprising 1618 patients with a mean sample size of 116. CTBT significantly outperformed control groups in terms of reducing hot flushes [g = 0.39, 95% confidence interval (CI) 0.23-0.55, I2 = 45], night sweats, depression (g = 0.50, 95% CI 0.34-0.66, I2 = 51), anxiety (g = 0.38, 95% CI 0.23-0.54, I2 = 49), fatigue, and quality of life. Egger's test indicated no publication bias.; Conclusions: CTBT is an effective psychological treatment for menopausal symptoms, with predominantly small to moderate effects. The efficacy is sustained long-term, although it declines somewhat over time. The efficacy was stronger for natural menopause symptoms, such as vasomotor symptoms, than for treatment-induced menopause symptoms. These findings provide support for treatment guidelines recommending CTBT as a treatment option for menopausal symptoms.

Ye, W., et al. (2021). "Efficacy and safety of moxibustion in the treatment of infertility with polycystic ovary syndrome: A protocol of systematic review and meta-analysis." Medicine 100(11): e24529.
	Background: Polycystic ovary syndrome (PCOS) is one of the common diseases of reproductive endocrine metabolism in gynecology, and it is also a common and difficult disease affecting female reproductive endocrine health. PCOS characterized by insulin resistance and hyperandrogenemia, the clinical manifestations are polychaemia, acne, obesity, infertility, menstrual disorders and so on. Clinical treatment of patients with PCOS ovulatory dysfunction infertility is mainly treated with ovulation-promoting drugs, insulin sensitizer, hyperandrogenemia drugs and other drugs Healing. It is found that the sensitivity of patients to ovulation promotion is poor, and it is often necessary to increase the dosage of drugs to increase ovulation rate, thus increasing the risk of ovarian hyperstimulation syndrome, and the recurrence rate is higher after withdrawal. Moxibustion therapy has shown strong advantages in the treatment of PCOS, and the curative effect is accurate. Therefore, this paper will carry out a systematic evaluation and meta-analysis of the efficacy and safety of moxibustion therapy in the treatment of PCOS.; Methods: We will search 8 electronic databases, including PubMed, Embase, Web of Science, Cochrane Library, the China National Knowledge Infrastructure (CNKI), Chinese Science and Technology Periodical Database (VIP), Wanfang Database (WF), and Chinese Biomedical Literature Database (CBM). We will search above electronic databases from the beginning to January 2021, without any language restriction. Ovulation rate and pregnancy rate will be accepted as the primary outcomes. The changes of Sex hormone levels, including Luteinizing hormone, follicle-stimulating hormone, serum estradiol, total testosterone will be used as secondary outcomes. RevMan 5.3 software will be used for statistical analysis. The result about the curative effect and safety of moxibustion therapy for PCOS will be presented as risk ratio for dichotomous data and mean differences with a 95% confidence interval for continuous data.; Results: Only when we finish this meta-analysis can we get the result.; Conclusions: The results of this study will provide reliable evidence for the efficacy and safety of moxibustion therapy in the treatment of PCOS.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Ye, Z.-R., et al. (2023). "The Effectiveness and Safety of Exenatide Versus Metformin in Patients with Polycystic Ovary Syndrome: A Meta-Analysis of Randomized Controlled Trials." Reproductive Sciences 30(8): 2349-2361.
	Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects women of childbearing age, resulting in reproductive dysfunction, hyperinsulinemia, and obesity. While several drugs are currently approved for use in these patients, their relative effectiveness remains controversial. The purpose of this meta-analysis was to evaluate the reproductive efficacy and safety of exenatide, a glucagon-like peptide-1 receptor agonist, versus metformin, an insulin sensitizer, in the treatment of patients with PCOS. Nine randomized controlled trials (RCTs) were included, comprising 785 PCOS patients, of whom 385 received exenatide and 400 received metformin. Compared with metformin, exenatide was significantly more effective in treating these patients, as demonstrated by increased pregnancy rate (relative risk (RR) = 1.93, 95% confidence interval (CI) 1.28 to 2.92, P = 0.002), greater ovulation rate (RR = 1.41, 95% CI 1.11 to 1.80, P = 0.004), decreased body mass index (mean difference = - 1.72 kg/m 2 , 95% CI - 2.27 to - 1.18, P = 0.00001), and improved insulin resistance (standard mean difference = - 0.62, 95% CI - 0.91 to - 0.33, P < 0.0001). There was no significant difference in the occurrence of adverse events (gastrointestinal reactions, hypoglycemia, etc.) between the two therapies. However, given the moderate to high quality and possible bias of the included studies, the available evidence is inconclusive. More high-quality studies are needed to assess the effects of exenatide in order to provide stronger evidence for its use in this patient population. (© 2023. The Author(s).)

Yen, H., et al. (2021). "Metformin Therapy for Acne in Patients with Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis." American Journal of Clinical Dermatology 22(1): 11-23.
	Background: Acne is one of the cutaneous manifestations of polycystic ovary syndrome (PCOS). There is limited evidence on metformin use for treatment of acne in PCOS patients.; Objective: Our aim was to conduct a systematic review and meta-analysis to evaluate the efficacy of metformin for treatment of PCOS-related acne.; Methods: On November 23, 2019, we searched PubMed, the Cochrane Library, and Embase databases for human clinical studies in any language. The keywords included 'acne' and 'polycystic ovary syndrome' combined with 'metformin,' 'biguanide,' or 'glucophage.' We included randomized controlled trials (RCTs), non-randomized controlled trials (NRCTs), and open-label studies on patients with PCOS treated with metformin. We calculated standardized mean differences (SMDs) for acne scores and odds ratios (ORs) for presence of acne, with 95% confidence intervals (CIs). Quality assessment was performed using the Cochrane Collaboration risk of bias instrument for RCTs. NRCTs and open-label studies were assessed using the adapted methodological index for nonrandomized studies (MINORS).; Results: We included 51 studies on 2405 PCOS patients. Metformin as adjuvant therapy led to greater improvement of acne scores than the same therapy without metformin (SMD - 0.256; 95% CI - 0.439 to - 0.074). Pooling pre- and post-metformin therapy data showed significant decrease of acne scores after metformin use (SMD - 0.712; 95% CI - 0.949 to - 0.476). Presence of acne decreased significantly after metformin treatment (OR 0.362; 95% CI 0.271 to 0.485).; Limitations: There was heterogeneity across some studies due to different acne assessment scales, metformin dosages, and treatment durations.; Conclusions: For PCOS patients, metformin as stand-alone or adjuvant therapy was associated with improvement of acne. More randomized controlled trials are needed to validate these results.; Registration: PROSPERO registration number CRD42020159656.

Yeşilyurt Seda, Y. (2023). "360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence." ClinicalTrials.gov.
	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.

Yeudiel, S.-S., et al. (2021). "Inositols treatment in women with polycystic ovary syndrome and their effect on acne lesions: a systematic review." PROSPERO International prospective register of systematic reviews.
	
Yexing, L., et al. (2022). "Effects of ultra-long GnRH agonist downregulation on in vitro fertilization/intracytoplasmic sperm injection outcomes in patients with adenomyosis: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Yi, M., et al. (2021). "Effects of exogenous melatonin on sleep quality and menopausal symptoms in menopausal women: a systematic review and meta-analysis of randomized controlled trials." Menopause 28(6): 717-725.
	Importance: Because of the bothersome symptoms during women's menopausal period and the severe side effects of hormone therapy, it is meaningful to find new breakthroughs in improving menopausal women's quality of life.; Objective: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating melatonin intake on the improvement of sleep quality, general menopausal symptom, mood states, as well as interaction of estradiol levels and body mass index (BMI) in menopausal women.; Evidence Review: We used the search terms "melatonin" together with "menopause" or "post-menopause" or "peri-menopause" in multiple databases online including PubMed, Web of Science, Embase, Clinical trial, Cochrane Library, and China National Knowledge Infrastructure from the first publication year to October 2020. Interesting data included characteristics of the study design, study participants, intervention, and outcome measures. Risk of biases in RCTs was evaluated with the Cochrane tool. Fixed-effect models and random-effect models were used for meta-analysis according to heterogeneity. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed in our study.; Findings: Eight cohorts (n = 812) evaluating the effects of melatonin in menopausal women were included. Melatonin was used in every study with differences existing in dose (1 mg - 5 mg) and duration (3 to 12 mo). Improved physical symptoms (standard mean difference [SMD] -0.376; 95% CI, -0.599 to -0.153, P = 0.001) merged in four RCTs. Melatonin treatment resulted in no benefits to sleep quality (SMD -0.659; 95% CI, -1.535 to 0.217, P = 0.141) and general menopause symptoms (SMD -0.625; 95% CI, -1.354 to 0.105, P = 0.093) in four and three RCTs, respectively. More specifically, melatonin did not solve the psychological (SMD -0.026; 95% CI, -0.372 to 0.321, P = 0.884, I2 = 70.3%), sexual (SMD -0.661; 95% CI, -1.416 to 0.093, P = 0.086) and vasomotor (SMD -0.256; 95% CI, -0.701 to 0.188, P = 0.258) issues. No significant changes were observed in anxiety (SMD 0.018; 95% CI, -0.519 to 0.556, P = 0.946), depression (SMD 0.133; 95% CI, -0.435 to 0.702, P = 0.646), BMI (weighted mean difference 0.029 kg/m2; 95% CI, -0.183 to 0.240, P = 0.790) or estradiol levels (weighted mean difference 0.016 pg/mL; 95% CI, -1.220 to 1.252, P = 0.980).; Conclusions: Melatonin seems to improve physical symptoms in menopausal women, but the general menopausal symptoms, sleep quality, mood state, estradiol levels, and BMI did not improve under melatonin intervention. However, multiple large-scale clinical randomized trials are needed to validate our conclusions.; Competing Interests: Financial disclosure/conflicts of interest: None reported. (Copyright © 2021 by The North American Menopause Society.)

Yidi, W. and T. Zunhao (2021). "A systematic review of the effectiveness of metformin combined with letrozole in the treatment of infertility patients with polycystic ovary syndrome for ovulation induction, pregnancy and improvement of basic indicators." PROSPERO International prospective register of systematic reviews.
	
Yiding, H., et al. (2022). "Comparative efficiency and acceptability of multiple treatments for premenstrual symptom and premenstrual dysphoric disorder: a systematic review and network meta-analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	
Yıldırım, P., et al. (2022). "Pilates-based therapeutic exercise for pregnancy-related low back and pelvic pain: A prospective, randomized, controlled trial." Turkish Journal of Physical Medicine and Rehabilitation 69(2): 207-215.
	Objectives: In this study, we aimed to clarify the impact of a Pilates-based therapeutic exercise on disability, pain, mood, and sleep quality in patients with pregnancy-related lumbopelvic pain (LPP).; Patients and Methods: In the single-blinded randomized controlled study conducted between January 2018 and June 2018, 34 pregnant women (mean age: 29.7±6.2 years; range, 18 to 40 years) in the second trimester (week 14-24) with LPP were randomly assigned to a control group and a Pilates group. All patients underwent usual prenatal care. In addition, the selected Pilates exercise was carried out twice a week for 60-min per session for 12 weeks in the Pilates group. The control group was not prescribed an exercise regimen; however, they were not discouraged from exercising. The primary outcome was disability; secondary outcomes were LPP, mood, and sleep quality. Disability [Roland-Morris Disability Questionnaire (RMDQ)], LPP [Visual Analog Scale (VAS)], mood [Hospital Anxiety and Depression Scale, Anxiety (HADS-A) and Depression (HADS-D) subscales], and sleep quality [Pittsburgh Sleep Quality Index (PSQI)] were measured before and after 12 weeks. Adverse effects and adherence were recorded to determine exercise safety and compliance. The intention-to-treat analysis was applied.; Results: The between-group effect sizes were moderate for the RMDQ and VAS scales (d=0.4 and d=0.7, respectively) and small for the HADS-A and HADS-D scales (both d=0.2). The intention-to-treat analysis demonstrated that there was a statistically significant difference in disability, pain, and mood in favor of the Pilates group (p0.05).; Conclusion: Adding Pilates to usual prenatal care should be considered a promising treatment option for pregnancy-related LPP.; Competing Interests: Conflict of Interest: The authors declared no conflicts of interest with respect to the authorship and/or publication of this article. (Copyright © 2023, Turkish Society of Physical Medicine and Rehabilitation.)

Yildiz, E. and R. Acaroğlu (2022). "The Effect of Massage and Progressive Relaxation Exercises on Pain Intensity and Menstrual Symptoms in Students With Primary Dysmenorrhea: A Randomized Controlled Trial." Holistic Nursing Practice 36(5): 284-294.
	A total of 97 female students, 50 in the intervention group and 47 in the control group, were included in this pretest-posttest design randomized controlled study. Massage and progressive relaxation exercises are self-administered practices that are easy to adopt, with no side effects, and have beneficial effects on pain, sweating, fatigue, and gastrointestinal and central nervous system signs. So, it can be asserted that when applied together, massage and progressive relaxation exercises could be more effective in reducing menstrual symptoms than applying them separately. (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Yildiz, N., et al. (2021). "Efficacy of intravaginal electrical stimulation added to bladder training in women with idiopathic overactive bladder: A prospective randomized controlled trial." International braz j urol 47(6): 1150-1159.
	PURPOSE: To evaluate the efficacy of intravaginal electrical stimulation (IVES) added to bladder training (BT) on incontinence-related quality of life (QoL) and clinical parameters in women with idiopathic overactive bladder (OAB). MATERIALS AND METHODS: Sixty-two women with idiopathic OAB were randomized into two groups using the random numbers generator as follows: Group 1 received BT alone (n:31), and Group 2 received BT+IVES (n:31). IVES was performed for twenty minutes three days a week over a course of eight weeks for a total of 24 sessions. Patients were evaluated in terms of incontinence severity (24-hour pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes and number of pads), symptom severity (OAB-V8), incontinence-related QoL (IIQ-7), treatment success (positive response rate), cure/improvement rate and treatment satisfaction (Likert scale). RESULTS: A statistically significant improvement was found in all parameters for all groups at the end of the treatment compared to the baseline values except pelvic floor muscles strength in Group 1 (p < 0.05). At the end of treatment, incontinence severity, frequency of voiding, nocturia, incontinence episodes, number of pads, symptom severity, and QoL were significantly improved in Group 2 compared to Group 1 (p < 0.05). Treatment satisfaction, cure/improvement, and positive response rates were significantly higher in group 2 compared to Group 1 (p < 0.05). CONCLUSION: We conclude that BT+IVES were more effective than BT alone on both incontinence-related QoL and clinical parameters in women with idiopathic OAB.

Yilmaz, G. (2023). Comparison of the Effect of Exercises on Vasomotor Symptoms in Middle Aged Women.
	No Results Available Other: Resistance and Aerobic Training Change in vasomotor sypmtoms|Change in the Menopause-specific Quality of Life (MENQOL) Questionnaire|Change in the Menopause Rating Scale (MRS)|Change in the Pittsburgh Sleep Quality Index (PSQI) Female Not Applicable 36 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Supportive Care E-10840098-772.02-754 February 14, 2024

Ying, H., et al. (2022). "Comparison of fertility outcomes for High-intensity Focused Ultrasound ablation between laparoscopic treatment of uterine fibroids: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Ying, L., et al. (2023). "First-line surgery vs first line ART in patients with deep infiltrating endometriosis: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Ying, Z., et al. (2022). "PARP Inhibitors Rising as an Epoch-Making Strategy in First-Line Maintenance Therapy of Ovarian Cancer: A Systematic Review and Meta-Analysis." Cancer Investigation 40(10): 889-900.
	Background: To illustrate the accurate location of Poly-ADP-ribose polymerase inhibitor (PARPi) as the first-line maintenance therapy in advanced ovarian cancer (AOC).; Methods: Search for eligible studies and calculate clinical outcomes.; Results: PARPi as a first-line maintenance treatment significantly prolonged the BRCAmut population and the homologous recombination deficiency (HRD) positive population.; Conclusion: PARPi as first-line maintenance therapy significantly improves the progression-free survival in AOC, especially in the BRCAmut and HRD positive populations. PARPi has been becoming the standard first-line maintenance therapy for AOC.

Ying, Z., et al. (2021). "Comparative efficiency and acceptability of different kinds of combined oral contraceptives on hyperandrogenemia in polycystic ovary syndrome patients: A network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Ying, Z. and T. Xi-tong (2022). "The effect of exercise on glycemic control and lipid profile in polycystic ovary syndrome: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Yingjie, H. and H. A. I. Huang (2022). "[The efficacy of Fu's subcutaneous needling for primary dysmenorrhoea: a meta-analysis] 傅氏皮下针刺对原发性痛经的疗效&#xff1a;Meta分析." PROSPERO International prospective register of systematic reviews.
	
Yiqing, W., et al. (2022). "Effect of statins on ovulation function of Polycystic ovary syndrome: a meta analysis and systematic review." PROSPERO International prospective register of systematic reviews.
	
Yishan, W. and Z. Hongfei (2022). "Acupuncture and Western medicine in the treatment of primary dysmenorrhea&#xff1a;a Meta analysis." PROSPERO International prospective register of systematic reviews.
	
Yisma, E., et al. (2024). "Effect of Behavioral Activation for Women with Postnatal Depression: A Systematic Review and Meta-Analysis." Nursing Reports 14(1): 78-88.
	Evidence shows that behavioral activation (BA), a simple form of psychological therapy, is as effective as the more complex psychological therapy-cognitive behavioral therapy (CBT)-in treating general depression. However, it remains unclear whether BA when compared with treatment-as-usual (TAU) has greater contributions in reducing postnatal depression. This systematic review compared the effect of BA versus TAU in reducing depression symptoms among postnatal women. Five databases (MEDLINE, Embase, Emcare, Cochrane Library, and PsycINFO) were searched. Risk of bias was assessed using the Cochrane Collaboration's 'risk-of-bias 2 tool'. A random-effects meta-analysis was conducted to examine the effect of BA on postnatal depression. Of 2844 initial studies, only two randomized control trials (RCTs) met the inclusion criteria. The overall quality of evidence of these two RCTs was low. When compared to TAU, meta-analysis showed that BA was associated with reduced depression symptoms in postnatal women (standard mean difference -0.56; 95% confidence interval -0.76 to -0.37). This review suggests that BA might be more effective than TAU for alleviating postnatal depression. However, due to concerns about evidence quality, these findings should be interpreted cautiously.

yiting, l., et al. (2023). "Correlation between acupuncture dose and pregnancy outcome in women with Polycystic ovary syndrome in vitro fertilization: a systematic review." PROSPERO International prospective register of systematic reviews.
	Review question To systematically review RCTs to determine whether acupuncture has a dose-dependent effect on pregnancy outcome in patients with PCOS undergoing IVF-ET. Searches EMbase (via Ovid), MEDLINE (via Ovid), and Cochrane Library; and four Chinese databases: China National Knowledge Infrastructure(CNKI), WanFang database(WF), the Chinese Science and Technology Periodical Database(VIP), and Chinese Biological Medicine(CBM). Types of study to be included RCTs Condition or domain being studied Polycystic ovary syndrome (PCOS) is the most common metabolic disease with reproductive endocrine disorders in women of childbearing age, with a prevalence of approximately 6% to 10%. The main clinical manifestations are oligomenorrhea or amenorrhea, acne, hirsutism, etc. Nearly 72% of PCOS patients suffer from infertility. Participants/population Exclusion criteria for this review:Patients with other combined diseases were excluded, such as (1) those with other combined endocrine diseases, such as ovarian or adrenal tumors, thyroid disease, diabetes mellitus, hyperprolactinemia, etc.; (2)tumor patients with ovarian hypofunction caused by radiotherapy or chemotherapy; (3) those with ovarian hypofunction caused by taking hormones, immunosuppressive drugs, etc.; (4) those with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system;(5)Long-term, as well as those who are overly sensitive to stimuli, those who have been taking (receiving) other medications (treatments) for a long time, those with coagulation disorders that prevent acupuncture treatment, those with severe adverse reactions to acupuncture, and those with skin infections at the acupuncture site. inclusion criteria:Women diagnosed with PCOS according to 2003 Rotterdam criteria and receiving IVF-ET in progress (no restrictions on patient's age, race, duration, etc.). Intervention(s), exposure(s) inclusion of interventions:Traditional acupuncture or electroacupuncture on the true acupoints or meridians. exclusion of interventions:To more accurately evaluate the efficacy of acupuncture, we excluded treatments combining acupuncture with Chinese herbs. Comparator(s)/control Sham acupuncture, no intervention, or acupuncture treatment at the same time as the treatment group, but at a different dose. Main outcome(s) clinical pregnancy rate Additional outcome(s) live birth rate(LBR) Data extraction (selection and coding) Two reviewers independently selected the studies searched in the databases, downloaded citations, and imported them into NoteExpress software Version 3.0 (Aegean Music Technology Co, Beijing, China) for data management. The reviewers eliminated duplicate studies by the software, and read the abstract, title, and keywords to further select potentially eligible articles that met the criteria. They resolve any discrepancies that occur through discussion with third reviewer Risk of bias (quality) assessment we assessed the risk of RCT bias using Risk bias assessment tool RoB2 Strategy for data synthesis we propose the following four Chinese clinical practice based criteria to calculate the dose[13]: (1) The numbers of acupuncture points at each acupuncture treatment. (2) de qi response; (3) frequency of treatments per week;(4) The total number of treatments.According to the final total score tallied by scoring system, we classified them into three groups: low dosage (LD, range≤5), medium dosage (MD, range 5-7), and high dosage (HD, range＞7). Two acupuncturists to assess the dose of acupuncture treatment and one acupuncturist calculated the dose of acupuncture for each of the screened studies and categorized the results as high, medium, or low doses. The acupuncturist did not know the results. Analysis of subgroups or subsets not sit subgroups Contact details for further information yiting li lyt9962122@163.com Organisational affiliation of the review Chengdu unversity of traditional chinese medicine https://www.cdutcm.edu.cn/ Review team members and their organisational affiliations Ms yiting li. Chengdu unversity of traditional chinese medicine Ms lei huang. Chengdu unversity of traditional chinese medicine Dr han yang. Chengdu unversity of traditional chinese medicine Collaborators Ms lei huang. Chengdu unversity of traditional chinese medicine Dr han yang. Chengdu unversity of traditional chinese medicine Type and method of review Cost effectiveness, Intervention, Living systematic review, Meta-analysis, Methodology, Systematic review Anticipated or actual start date 16 February 2023 Anticipated completion date 17 March 2023 Funding sources/sponsors Chengdu unversity of traditional chinese medicine Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Acupuncture Therapy; Female; Fertilization in Vitro; Humans; Polycystic Ovary Syndrome; Pregnancy; Pregnancy Outcome Date of registration in PROSPERO 27 February 2023 Date of first submission 16 February 2023 Stage of review at time of this submission The review has not started

Yogev, Y. (2021). "Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion." ClinicalTrials.gov.
	Randomizedtrial comparing success and complication rates of operative hysteroscopy versus traditional dilation and curettage (D&C) in the management of first trimester missed abortion.

Yonghong, L., et al. (2021). "Outcome of local oestrogen treatment for pelvic organ prolapse: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question The aim of this meta-analysis of randomized controlled trials is to evaluate the efficacy and safety of local oestrogen treatment for pelvic organ prolapse. Searches We will search articles in three electronic database including PubMed, EMBASE 、Cochrane Library and Web of Science. All the English publications until 14 April 2021 will be searched without any restriction of countries or article type. Reference list of all selected articles will independently screened to identify additional studies left out in the initial search. Types of study to be included Randomized controlled trial Condition or domain being studied Pelvic organ prolapse (POP) is the descent of one or more of the anterior vaginal wall, posterior vaginal wall, the uterus (cervix) or the apex of the vagina (after hysterectomy). It is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an aging population. In postmenopausal women lack of oestrogen is hypothesised to weaken the pelvic floor muscles. Participants/population Adults with pelvic organ prolapse (as diagnosed by a clinician, or using any recognized diagnostic criteria) will be included. Intervention(s), exposure(s) Local oestrogen treatment was the main intervention (e.g. administered intra-vaginally, including creams, tablets, ovules/pessaries and rings.). Comparator(s)/control Control group did not receive any estrogen treatment. Context Main outcome(s) patient reported symptoms of POP (sense of pressure or bulge vaginally, abdominal or back pain, urinary or bowel symptoms), improvement or cure of symptoms associated with POP, and clinicians observed improvement or cure of POP using the POP-Q system Measures of effect The effect measures were risk ratio (RR) for dichotomous data and mean difference (MD) for continuous data, with 95% confidence intervals (CI). Data analysis was performed using Review Manager software following the guidance the Cochrane Reviewers’ Handbook Additional outcome(s) satisfaction with treatment outcome, postponement or no need for other treatments like pelvic floor muscle training, mechanical devices or surgery, disease-specific quality of life questionnaire (Urogenital Distress Inventory (UDI)) Measures of effect The effect measures were risk ratio (RR) for dichotomous data and mean difference (MD) for continuous data, with 95% confidence intervals (CI). Data analysis was performed using Review Manager software following the guidance the Cochrane Reviewers’ Handbook Data extraction (selection and coding) Two authors will independently extract data. Any disagreement will be resolved by discussion until consensus is reached or by consulting a third author. The following data will be extracted: author, year of publication, country where the study was conducted, study period, original inclusion criteria, total number of people included in the study, doses of oestrogen and time of application, and mean cervical length. Risk of bias (quality) assessment Two reviewers will independently assesses the quality of the selected studies according to the Cochrane Collaboration’s tool for randomized controlled trials. Items will be evaluated in the three categories: Low risk of bias, unclear bias and high risk of bias. The following characteristics will be evaluated: Random sequence generation (selection Bias) Allocation concealment (selection bias) Blinding of participants and personnel (performance bias) Incomplete outcome data (attrition bias) Selective reporting (reporting bias) Other biases Results from these questions will be graphed and assessed using Review Manager 5.3 Strategy for data synthesis Risk ratio (RR) for both fixed and random effects models (weighting by inverse of variance) will be used. A continuity correction will also be used for cells with zero values. Between-study heterogeneity will be assessed using the χ² (Cochran Q) and I² statistics. According to the Cochrane handbook, the I² will be considered non- important(<30%)，moderate(30%-60%) and substantial (>60%). Results will be assessed using forest plots and presented as RRs for the main outcome and secondary outcomes. An influence analysis will be performed to ascertain the results of the meta-analysis by excluding each of the individual studies. Publication bias will be assessed by a funnel plot for meta-analysis and quantified by the Egger method. Statistical analysis will be conducted using STATA software for Mac v15.0 (Stata Corp., College Station, Texas) [module “meta”]. Analysis of subgroups or subsets We will consider subgroups such as BMI, type of operation, mode of childbirth Contact details for further information Xia Yu 410445562@qq.com Organisational affiliation of the review ChengDu women's and Children's central hospital http://www.wcch.cn Review team members and their organisational affiliations Dr Yonghong Lin. ChengDu women's and Children's central hospital Dr Li He. ChengDu women's and Children's central hospital Dr Li Wang. ChengDu women's and Children's central hospital Dr Xia Yu. ChengDu women's and Children's central hospital Dr Chunyuan Wang. ChengDu women's and Children's central hospital Dr Qin Zhou. ChengDu women's and Children's central hospital Dr Bingqian Xue. ChengDu women's and Children's central hospital Mr Yuzhi Huang. Southwest CAAC Air Traffic Control Bureau Type and method of review Intervention, Meta-analysis, Systematic review Anticipated or actual start date 17 April 2021 Anticipated completion date 31 May 2021 Funding sources/sponsors This work was supported by the Chengdu science and technology bureau: technology innovation research and development project. Grant number(s) State the funder, grant or award number and the date of award 2020-yf05-00200-sn Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Estrogens; Humans; Pelvic Organ Prolapse Date of registration in PROSPERO 15 May 2021 Date of first submission 14 April 2021 Stage of review at time of this submission Stage

Yoon, S.-H., et al. (2020). "Gabapentin for the treatment of hot flushes in menopause: a meta-analysis." Menopause 27(4): 485-493.
	Objective: Gabapentin is used to treat vasomotor symptoms (VMS) in postmenopausal women with contraindications to hormonal therapy or who prefer alternatives. We investigated the efficacy and tolerability of gabapentin for treating menopausal hot flushes via a meta-analysis.; Methods: We searched the PubMed, MEDLINE, EMBASE, and CENTRAL databases for English-language articles published until June, 2018. The following search terms were used: "menopause," "hot flushes," "vasomotor symptoms," "gabapentin," and "non-hormonal therapy." Primary outcomes were frequency, duration, and composite score of hot flushes. Secondary outcomes were adverse effects and dropout rate. We estimated the standardized mean difference (SMD) and combined odds ratio (OR) using fixed or random-effects models, depending on study heterogeneity. Subgroup and meta-regression analyses of gabapentin dosage were performed.; Results: We included seven randomized controlled trials that compared single-agent gabapentin with placebo for treating hot flushes in the meta-analysis. Women who received gabapentin reported a significantly greater reduction in the frequency (SMD 2.99 [95% confidence interval 2.01-3.98], P < 0.001), duration (0.89 [0.49-1.30], P < 0.001), and composite score (2.31 [1.50-3.11], P < 0.001) of hot flushes. Adverse events were significantly more frequent among those taking gabapentin than among those taking the placebo (OR 1.58 [0.98-2.18], P < 0.001; and 1.19 [0.43-1.95], P = 0.002 for dizziness and unsteadiness, respectively).; Conclusions: Gabapentin could be used to treat VMS in postmenopausal women with contraindications to hormonal therapy. Future studies should investigate the lowest effective dose of gabapentin to minimize adverse effects. : Video Summary:http://links.lww.com/MENO/A521.

Yousef, M. and S. Sina (2023). "Effects of acupuncture on endometriosis pain: An updated systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question How much effect does the use of acupuncture have on the average pain in women with endometriosis? Searches This is a systematic review and meta-analysis to determine what effect the use of acupuncture has on average pain in women with endometriosis. We used the Cochrane Menstrual Disorders and Subfertility Group (MDSG) search strategy. We will identify reports that describe (or may have described) randomised controlled trials of acupuncture for the treatment of endometriosis using the following strategy 1. The MDSG Specialised Register of Controlled Trials was searched for trials that mentioned endometriosis in the title, abstract, or key words. 2. The following electronic databases were searched (from inception to February 2022) -The Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library), -PubMed -EMBASE -Scopus -Web of Science Related keywords and their synonyms (selected from MeSH) were then identified and the search strategy will be formulated in the desired databases. The main keywords included acupuncture, endometriosis and chronic pelvic pain, with synonyms including acupuncture therapy, acupuncture analgesia, acupuncture points endometriosis, endometrioma, endometriomas, endometrioses, chronic pelvic pain. In addition to searching international databases, a manual search will be performed to obtain relevant articles by re-examining the sources of the final selected studies. The entire search process will be carried out by two authors completely independently. The searches will be conducted with a time limit from inception to February 2022. Types of study to be included Randomized Control Trials Condition or domain being studied Women with Endometriosis Participants/population Women with Endometriosis Intervention(s), exposure(s) Acupuncture Therapy Comparator(s)/control Comparison groups like sham Acupuncture, Western medicine, or Traditional Chinese Medicine. Main outcome(s) The mean and standard devation of pain. Measures of effect Standardized Mean Differences Additional outcome(s) None

Yu, C. Y., et al. (2023). "Core stabilization exercise in prenatal and postnatal women with urinary incontinence: A systematic review and meta-analysis of randomized controlled trials." American Journal of Physical Medicine & Rehabilitation 102(11): 990-999.
	OBJECTIVE: To evaluate the effect size of core stabilization exercise for prenatal and postnatal women through measures of urinary symptoms, voiding function, pelvic floor muscle strength and endurance, quality of life, and pain scores. DESIGN: The PubMed, EMBASE, Cochrane Library, and Scopus databases were searched. Randomized controlled trials were selected and subjected to meta-analysis and risk of bias assessment. RESULTS: Ten Randomized controlled trials were selected, and 720 participants were included. Ten articles using seven outcomes were analyzed. Relative to the control groups, the core stabilization exercise groups exhibited superior results for urinary symptoms (standardized mean difference [SMD] = -0.65, 95% confidence interval [CI] = -0.97-0.33), pelvic floor muscle strength (SMD = 0.96, 95% CI = 0.53,1.39), pelvic floor muscle endurance (SMD = 0.71, 95% CI = 0.26,1.16), quality of life (SMD = -0.9, 95% CI = -1.23-0.58), transverse muscle strength (SMD = -0.45, 95% CI = -0.9,-0.01), and voiding function (SMD = -1.07, 95% CI = -1.87-0.28). CONCLUSION: Core stabilization exercises are safe and beneficial for alleviating urinary symptoms, improving quality of life, strengthening pelvic floor muscles, and improving transverse muscle function in prenatal and postnatal women with urinary incontinence.

Yu, F., et al. (2023). "A Systematic Review and Meta-analysis of randomized controlled trials on the effectiveness of manual therapy in the treatment of Myofascial Pelvic Pain." PROSPERO International prospective register of systematic reviews.
	Review question Myofascial pelvic pain has complex mechanisms and causes, which may be related to psychosocial, endocrine, neurological, muscular, drug and obstetric and gynecological diseases. At present, physical treatment is mainly used to treat female pelvic myofascial pain, and there is no specific treatment. The treatment of female pelvic myofascial pain varies from country to country, with some countries using botulinum toxin a treatment and some countries using electrical stimulation treatment, and there are few randomized controlled trials on the effect of manual massage on female pelvic myofascial pain, the aim of this review is to clarify whether manual treatments are effective for myofascial pelvic pain. Searches a comprehensive systematic search of online databases for literature was conducted since the establishment of the library till May 2023 including Cochrane Library, PubMed, Web of Science, MEDLINE, Embase, CINAHL, EBSCO, WanFang Database, VIP, CBM and CNKI.English MeSH terms include “Pelvic pain”，“chronic pelvic pain”,“myofascial pelvic pain”,“Musculoskeletal Manipulations”,“massage”,“myofascial therapy”. Chinese terms include“pen qiang ji jin mo teng tong”,“pen qiang gong neng zhang ai”,“pen di ji jing luan", “shou fa”,“an mo",“tui na". All the publications will be searched without any restriction of countries, but all article types will be restricted to randomized control, reference list of all selected articles will independently screened to identify additional studies left out in the initial search. Types of study to be included RCT Condition or domain being studied Myofascial Pelvic Pain mostly refers to fascial pain and muscle stiffness in the legs, buttocks, and lumbosacral region of patients, and belongs to a category of chronic pelvic pain, which has a complex pathogenesis and is a common disease in women after childbirth.Myofascial Pelvic Pain is mostly caused by fascial and pelvic floor muscle injuries, has highly sensitive trigger points, and the pain can involve the bladder, rectum, vagina, and pelvic bone, which seriously reduces the patients' life The quality of life of patients is seriously reduced. The awareness of MFPP among clinicians is low. The treatment methods for Myofascial Pelvic Pain are traditional, main treatments are pelvic floor health education, Kegel exercises, biofeedback therapy, local injections, and oral pain medication, but the treatment is not effective. Participants/population Female patients with myofascial pelvic pain, age ≥ 18 years; Intervention(s), exposure(s) the observation group was treated with manipulation on the basis of conventional treatment, without restricting the type of manipulation. Comparator(s)/control Control group with basic treatment or blank control Main outcome(s) pain score Measures of effect we obtain a plloed RR and OR analytical statistics for relative ratio (RR)/odds ratio (OR) and standardized mean difference (SMD) with 95% confidence intervals (95% CIs) were used to determine clinical outcomes for the dichotomous and continuous methods. Additional outcome(s) total treatment efficiency、Myoelectric assessment of pelvic floor muscles、Assessment of pelvic floor muscle strength Measures of effect we obtain a plloed RR and OR analytical statistics for relative ratio (RR)/odds ratio (OR) and standardized mean difference (SMD) with 95% confidence intervals (95% CIs) were used to determine clinical outcomes for the dichotomous and continuous methods.

Yu, H., et al. (2022). "Efficacy and quality of life evaluation of acupuncture for mixed urinary incontinence in women: a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question S：Only RCTs will be included. Observational, cohort, case–control, case series, and laboratory studies will be excluded. Randomized controlled trials published as conference abstracts, papers, or monographs will be eligible if the data required for analysis and evaluation are available from the authors. P：Include only randomized controlled trials of adult patients (aged≥18 years).The diagnosis of MUI should meet the diagnostic criteria of the International Incontinence Society (ICS) or "Diagnosis and Treatment of Urinary Incontinence" I：Acupuncture therapies included acupuncture, electro-acupuncture, auricular acupuncture, warm acupuncture, etc., without restrictions of acupuncture operation methods, acupoint selection, duration of treatment, and follow-up period. C：include randomized controlled trials using placebo, western medicine, rehabilitation training, electrical stimulation. O：Primary outcome measures included ICIQ-SF score, number of incontinence episodes, and 1-h pad test.Secondary outcomes were safety and adverse event rates. Searches Computer search for clinical randomized controlled trials of acupuncture in the treatment mixed urinary incontinence in databases such as PubMed, Web of Science, EMbase, Cochrane Library, SinoMed, CNKI, WF, VIP and other databases. The retrieval time is from the establishment of the database to September 30th, 2022. No restrictions on language or type of publication will be applied. Types of study to be included Only RCTs will be included. Observational, cohort, case–control, case series, and laboratory studies will be excluded. Randomized controlled trials published as conference abstracts, papers, or monographs will be eligible if the data required for analysis and evaluation are available from the authors. Condition or domain being studied Mixed urinary incontinence refers to involuntary outflow of urine related not only to urgent urination, but also to laughter, sneezing, and cough. Mixed urinary incontinence is characterized by both urination urgency, hearing the sound of running water, emotional tension, drinking water or no obvious reason in the case of urine leakage, that is, urgent urinary incontinence symptoms; Because cough, sneeze, running, laughing and other abdominal pressure increased urine leakage, that is, stress urinary incontinence symptoms. Epidemiological survey shows that the incidence of female urinary incontinence in China is 30.9%. MUI accounts for 29% to 61% of the total incidence of urinary incontinence. MUI is considered as "social cancer", which is mostly seen in middle-aged and elderly women. Although it does not pose a direct threat to life safety, MUI exerts a subtle influence on the physical and mental health of patients. Prolonged urine immersion and irritation can lead to skin swelling, itching, pain and infection, which can easily cause urinary tract infection and affect renal function. At the same time, it also brings a series of psychological and social problems. Long-term urinary incontinence troubles, often have great psychological pressure, such as anxiety, depression and so on. Participants/population Include only randomized controlled trials of adult patients (aged≥18 years).The diagnosis of MUI should meet the diagnostic criteria of the International Incontinence Society (ICS) or "Diagnosis and Treatment of Urinary Incontinence" Intervention(s), exposure(s) Acupuncture therapies included acupuncture, electro-acupuncture, auricular acupuncture, warm acupuncture, etc., without restrictions of acupuncture operation methods, acupoint selection, duration of treatment, and follow-up period. Comparator(s)/control Include randomized controlled trials using placebo, western medicine, rehabilitation training, electrical stimulation. Main outcome(s) Primary outcome measures included ICIQ-SF score, number of incontinence episodes, and 1-h pad test. Additional outcome(s) Secondary outcomes were safety and adverse event rates.

Yu, H., et al. (2021). "Efficacy and safety of acupuncture and moxibustion in the treatment of urge urinary incontinence: A systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	
yu, L., et al. (2022). "Acupuncture for Infertile Women Undergoing in vitro Fertilization and Embryo Transfer: A network meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question: Acupuncture and moxibustion have been used in clinical practice for a long time to improve the success rate of in vitro fertilization and embryo transfer (IVF-ET). There have been many systematic reviews to evaluate the effectiveness and safety of acupuncture and moxibustion in improving the success rate of IVF-ET, which all indicate that acupuncture and moxibustion can effectively improve the success rate of IVF-ET. However, there are many methods of acupuncture and moxibustion application in clinic, and there is no study to compare the effectiveness of different acupuncture and moxibustion Searches: Electronic databases including EMBASE, PubMed, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Chinese Scientific Journal Database, Wanfang Database will be searched for relevant randomized controlled trials from their inception to the search data without language and publication status. Types of study to be included: Randomized controlled trials comparing acupuncture and moxibustion with other therapies. Condition or domain being studied: The prevalence rate of infertility is 15% in the reproductive period. In vitro fertilization and embryo transfer (IVF-ET) is an effective treatment method for subfertility couples. Currently, the average success rates per IVF cycle remain low. For many women, cycles need to be repeated to succeed. The IVF-ET cycle is time-consuming and costly. The direct and indirect costs of one cycle of IVF-ET are equivalent to $10, 000 to 25, 000, so it is essential to enhance the success rate of IVF-ET. The mechanisms of acupuncture in IVF-ET have been reported to enhance hormonal balance, inhibit uterine motility, increase blood flow to uterine and ovarian areas, and downregulate various stress responses. Nowadays, some systematic reviews (SRs) of acupuncture in IVF-ET have been published to evaluate its effectiveness and safety, and all indicated that acupuncture and moxibustion can effectively improve the success rate of IVF-ET. However, there are many methods of acupuncture and moxibustion application in clinic, and there is no study to compare the effectiveness of different acupuncture and moxibustion. Participants/population: Female patients diagnosed with infertility and undergoing IVF-ET would be included. There were no restrictions in diagnosis criteria or participant age. IVF-ET with intracytoplasmic sperm injection (ICSI) was allowed. Intervention(s), exposure(s): Acupuncture with moxibustion, acupuncture, moxibustion, electroacupuncture, etc. Comparator(s)/control: Sham acupuncture, no adjunctive treatment, or other no acupuncture and moxibustion intervention. Main outcome(s): Clinical pregnancy rate. Measures of effect: Before and after intervention. Additional outcome(s): adverse events. Measures of effect: Before and after intervention.

Yu, Q., et al. (2023). "Auricular therapy for primary dysmenorrhea: A protocol for systematic review and meta-analysis of randomized controlled trials." Medicine 102(13): e33382.
	Background: Primary dysmenorrhea (PD) is a common problem among women. It is defined as any degree of perceived cramping pain during menstruation without any evident pathology. Auricular therapy (AT), a widely used alternative medical treatment method as part of traditional Chinese acupuncture, lacks reliable evidence to support its safety and effectiveness for PD. We aimed to conduct a meta-analysis to investigate the efficacy and safety of AT in PD and to investigate possible factors impacting the particular efficacy of AT in PD by meta-regression.; Methods: This protocol followed the PRISMA guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols. The following 9 sources will be searched for randomized control trials of AT for PD: the Cochrane Central Register of Controlled Trials, PubMed, Medline, Embase, Web of Science, Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure, Chinese Science and Technology Periodicals (VIP) database and WanFang Database from inception to January 1, 2023. Primary outcomes include visual rating scales and clinical efficacy rates, while secondary outcomes include endocrine hormone indicators related to PD and adverse events. Two reviewers will work independently on study selection, data extraction, and coding, including the risk of bias assessment in the included studies. While conducting a meta-analysis, Review Manager version 5.3 will be employed. Otherwise, a descriptive analysis will be performed. The results will be displayed as a risk ratio with 95% confidence intervals for dichotomous data as well as weight mean difference or standardized mean difference with 95% confidence intervals for continuous data.; Results: This study's protocol will investigate the efficacy and safety of AT in the treatment of PD in a systematic way.; Conclusion: This systematic evaluation will objectively and systematically assess the efficacy and safety of AT in PD based on the available evidence, as well as provides clinicians with evidence to support the treatment of the disease.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.)

Yu, S., et al. (2022). "Clinical and Patient Reported Outcomes of Pre- and Postsurgical Treatment of Symptomatic Uterine Leiomyomas: A 12-Month Follow-up Review of TRUST, a Surgical Randomized Clinical Trial Comparing Laparoscopic Radiofrequency Ablation and Myomectomy." Journal of Minimally Invasive Gynecology 29(6): 726-737.
	Study Objective: The objective of this study was to determine the efficacy, safety, and healthcare resource use of laparoscopic radiofrequency ablation (LAP-RFA) compared with myomectomy in patients with symptomatic uterine leiomyomas (ULs).; Design: This was a secondary analysis of the original postmarket randomized, multicenter, longitudinal, comparative TRUST (Treatment Results of Uterine Sparing Technologies) United States trial in patients with symptomatic ULs. After the procedure, subjects were followed over a 12-month period.; Setting: Multicenter trial, including hospitals with or without an academic affiliation, surgery centers, and fertility centers performing outpatient procedures for uterine myomas.; Participants: A total of 57 patients were randomized to either LAP-RFA (n = 30) or myomectomy (n = 27).; Interventions: LAP-RFA or myomectomy (laparoscopic or abdominal).; Measurements and Main Results: The main outcome measures of this study were part of the secondary outcomes of the original TRUST trial. The primary outcome of this study was the reduction of UL symptoms and the improvement in patient-reported outcomes scores over time. Secondary outcomes included postprocedure hospitalization, length of stay, complications, reinterventions, and recovery time. There was a significant improvement in UL symptoms at 3 and 12 months after the procedure within each treatment group, and these improvements were similar between treatment groups. There was a significant reduction in UL symptoms per month between baseline and 12-months after the procedure for both LAP-RFA and myomectomy of 72% and 85%, respectively. A significant improvement was seen in all patient-reported outcomes scores over time for both groups. At 3 and 12 months after the procedure, the percentages of patients who were hospitalized in the LAP-RFA group were 74% and 49% lower than those of patients in the laparoscopic myomectomy group, respectively, with the 3-month difference being statistically significant. The length of hospital stay was significantly shorter in the LAP-RFA group compared with the myomectomy group (8.0 ± 5.7 hours vs 18.8 ± 14.6 hours; p < .05). Doctors recommended taking significantly less time off before returning to work for the patients in the LAP-RFA group compared with those in the myomectomy group (10.3 ± 5.1 days vs 14.5 ± 5.4 days; p < .05). The total number of days until back to normal activity was significantly lower in the LAP-RFA group compared with the myomectomy group (16.3 ± 15.2 days vs 26.5 ± 15.9 days; p < .05).; Conclusion: The results from this 12-month follow-up study suggest that LAP-RFA is a safe, effective, uterine-sparing alternative to laparoscopic myomectomy in the treatment of ULs. These data points build on previously published studies showing that LAP-RFA has lower healthcare resource use overall, including lower postprocedure hospitalization rate and shorter length of stay. In clinical practice, LAP-RFA is a promising treatment approach to ULs for women. (Copyright © 2022. Published by Elsevier Inc.)

Yu, X., et al. (2023). "Effect of the combination of trastuzumab, paclitaxel and carboplatin in the treatment of uterine serous carcinoma: A systematic review and meta-analysis." Tropical Journal of Pharmaceutical Research 22(7): 1519-1524.
	Purpose: To systematically review the efficacy of paclitaxel-carboplatin versus trastuzumab in combination with paclitaxel/carboplatin for the treatment of uterine serous carcinoma (USC) with high Her2/neu expression, in order to obtain an evidence-based reference for clinical treatment. Method(s): Publications were obtained from China Knowledge Network (CNKI), VIP database (VIP), Wanfang database, PubMed, Embase, Cochrane Library, and Web of Science. The retrieval period was from the establishment of database to May 2022, and the efficacy of paclitaxel-carboplatin combination with trastuzumab (study group) versus paclitaxel-carboplatin (control group) for the treatment of Her2/neu high-expressing USC was collected. Two reviewers independently screened, extracted data, and evaluated the quality of evidence of included studies. RevMan 5.3 statistical software was used for meta-analysis. Outcomes included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and adverse events. Result(s): Meta-analysis showed that the study group had significantly longer OS than control group (p = 0.004), and PFS of study group was significantly longer than that of control group (p < 0.0001). In terms of ORR, there was no difference between the two groups (p = 0.42). However, in terms of total and high-risk adverse events, the number of patients with adverse events in study group was higher than in control group (p = 0.05), (p = 0.0001). Conclusion(s): Paclitaxel-carboplatin combination with trastuzumab significantly prolongs OS and PFS in USC patients with high Her2/neu expression, but it may increase the incidence of adverse events.Copyright © 2023 The authors. This work is licensed under the Creative Commons Attribution 4.0 International License.

Yu, Y., et al. (2023). "The therapeutic effects of rFSH versus uFSH/uHMG on ovarian stimulation in women undergoing assisted reproductive technology: a meta-analysis of randomized controlled trials." Archives of Gynecology and Obstetrics.
	Purpose: This systematic review and meta-analysis aimed to compare the therapeutic effects of rFSH versus uFSH/uHMG on ovarian stimulation in women undergoing assisted reproductive technology.; Methods: The databases of PubMed, Embase, and the Cochrane Library were systematically searched to retrieve data on eligible trials from inception until July 2022. The relative risks (RRs) or weighted mean differences (WMDs) with 95% confidence intervals (CIs) were applied to assess categorical and continuous outcomes, and the pooled results were calculated using the random-effects model. Sensitivity, subgroup, and publication bias analyses were also performed.; Results: Forty-eight trials that enrolled 10,127 women were included in this quantitative meta-analysis. There were no significant differences between rFSH and uFSH/uHMG in the clinical pregnancy rate (RR: 1.01; 95% CI 0.95-1.07; P = 0.760), live birth rate (RR: 0.98; 95% CI 0.91-1.06; P = 0.665), multiple pregnancy rate (RR: 0.92; 95% CI 0.77-1.09; P = 0.320), miscarriage rate (RR: 1.17; 95% CI 0.94-1.46; P = 0.151), and the incidence of ovarian hyperstimulation syndrome (RR: 1.25; 95% CI 0.91-1.70; P = 0.164). In addition, the administration of rFSH was associated with a higher number of oocyte retrieval compared with that of uFSH/uHMG (WMD: 0.61; 95% CI 0.03-1.20; P = 0.038), while no significant differences were found between rFSH and uFSH/uHMG in the dosage of gonadotrophin (WMD: 14.80; 95% CI - 136.97 to 166.57; P = 0.848) and the duration of ovarian stimulation (WMD: - 0.26; 95% CI - 0.62 to 0.10; P = 0.152). Thus, the exploratory analyses revealed several potential differences in the effects of rFSH versus uFSH/uHMG on ovarian stimulation.; Conclusion: The administration of rFSH significantly increased the number of oocytes retrieved, whereas there were no significant differences between the efficacies of rFSH and uFSH/uHMG for pregnancy outcomes. (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Yuan, J., et al. (2021). "Efficacy of omega-3 polyunsaturated fatty acids on hormones, oxidative stress, and inflammatory parameters among polycystic ovary syndrome: a systematic review and meta-analysis." Annals of Palliative Medicine 10(8): 8991-9001.
	Background: There is a close relationship between hormones, oxidative stress, and inflammatory factors and polycystic ovary syndrome (PCOS). This meta-analysis was conducted to evaluate the changes in hormones, oxidative stress, and inflammatory factors of PCOS patients who were supplemented with omega-3 polyunsaturated fatty acids (n-3 PUFAs).; Methods: The databases of PubMed, Cochrane Library, Embase, and Web of Science were searched from inception to February 2021. We have included all randomized controlled trials (RCTs) that reported the n-3 PUFA treatment in PCOS. Weighted mean differences (WMD) and 95% confidence interval (CI) were calculated, and either the fixed effects model or random effects model was used.; Results: 314 studies were initially identified, and 10 RCTs with 610 patients were finally included in the current study. Results suggested that PCOS patients with n-3 PUFAs supplementation may have a reduction in C-reactive protein (CRP; -8.97 mg/dL; 95% CI: -17.66 to -0.28 mg/dL; P=0.04; I2=99%); serum malondialdehyde (MDA; -0.40 mg/dL; 95% CI: -0.56 to -0.25 mg/dL; P<0.00001; I2=42); luteinizing hormone (LH; -1.33 mg/dL; 95% CI: -2.63 to -0.04 mg/dL; P=0.04; I2=0%); serum total testosterone (TT; -0.11 mg/dL; 95% CI: -0.18 to -0.04 mg/dL; P=0.02; I2=73%); and an increase in total antioxidant capacity (TAC; 72.24 mg/dL; 95% CI: 22.32 to 122.16 mg/dL; P=0.005; I2=50%) and serum sex hormone binding globulin (SHBG; 0.68 mg/dL; 95% CI: 0.06 to 1.31 mg/dL; P=0.03; I2=0%).However, no effect on glutathione (GSH; -12.63 mg/dL; 95% CI: -50.34 to 25.07 mg/dL; P=0.51; I2=56%), dehydroepiandrosterone sulfate (DHEAS; -0.01 mg/dL; 95% CI: -1.53 to 1.50 mg/dL; P=0.99; I2=78%), free androgen index (FAI; 0.00 mg/dL; 95% CI: -0.03 to 0.03 mg/dL; P=0.99; I2=0%), or follicle-stimulating hormone (FSH; 0.37 mg/dL; 95% CI: -0.55 to 1.29 mg/dL; P=0.43; I2=61) was found.; Conclusions: This meta-analysis showed that supplementation of n-3 PUFAs in PCOS women can significantly improve CRP, MDA, LH, TT, TAC, and SHBG, but did not affect the concentrations of GSH, DHEAS, FAI, or FSH.

Yuan, L. and L. Ge (2023). "Effects of mindfulness intervention on endometriosis pain: a systematic review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question Meta-analysis of the effects of mindfulness intervention on endometriosis pain Searches Six databases including Web of Science, PubMed, EBSCO, Cochrane, CNKI and Wan fang were searched from 2013 to 2023, and the search languages were Chinese and English. Types of study to be included The population I'm looking at is women with endometriosis, and the intervention that these women are going to receive is a mindfulness intervention, a randomized controlled trial, a comparative study, The studies to be excluded were 1, non-human studies 2, non-controlled studies 3, the study was not basically endometriosis 4, the data could not be extracted 5, and there was no available data on the effect of the mindfulness intervention on pain in the study. Condition or domain being studied I would like to study the effect of a mindfulness intervention on pain in endometriosis, a gynecological condition that refers to the endometrial tissue that normally grows in the lining of the uterus and appears in sites outside the uterus such as ovaries, fallopian tubes, pelvic peritoneum, etc. These endometrioid tissues change with the menstrual cycle, causing inflammation, bleeding, pain, and adhesions. The etiology of endometriosis is still unclear and may be related to genetic, immune, hormonal and environmental factors. The main symptom of endometriosis is pelvic pain, which is usually associated with the menstrual period, but may also cause painful intercourse, painful defecation or urination, excessive bleeding, or infertility. The diagnosis of endometriosis needs to be established by laparoscopy and tissue biopsy. Treatments include medical and surgical treatments, as well as psychotherapy with a mindfulness intervention that I will study, with the aim of relieving symptoms, controlling the growth of ectopic tissue, and improving fertility. Participants/population The population I'm looking at is women with endometriosis, and the intervention that these women are going to receive is a mindfulness intervention, a randomized controlled trial, a comparative study, The studies to be excluded were 1, non-human studies 2, non-controlled studies 3, the study was not basically endometriosis 4, the data could not be extracted 5, and there was no available data on the effect of the mindfulness intervention on pain in the study. Intervention(s), exposure(s) The intervention was to relieve endometriosis pain through mindfulness training Comparator(s)/control The control group received routine nursing Main outcome(s) The outcome indicators that I want to focus on are intervention time, intervention effect, intervention tool, intervention method and intervention period Additional outcome(s) The degree of endometriosis pain relief, and whether the patient chose mindfulness training to relieve pain after the experimental period

Yuan, L., et al. (2021). "Shaofu Zhuyu decoction for primary dysmenorrhea: A protocol for systematic review and meta-analysis." Medicine 100(23): e26226.
	Background: Primary dysmenorrhea (PD), one of the common gynecological diseases, is more common in adolescent women. According to epidemiological investigation, the incidence of PD accounts for about 60% of all patients with dysmenorrhea, and its symptoms seriously affect the normal working life of women, so it is important to find a more safe and effective treatment. In recent years, traditional Chinese medicine has made a lot of achievements in the treatment of female PD, among which a number of clinical studies have shown that Shaofu Zhuyu decoction (SFZY) can significantly improve the symptoms of dysmenorrhea and improve the therapeutic effect. Therefore, we intend to conduct a systematic review to further clarify the efficacy and safety of SFZY in the treatment of PD.; Methods: We will search each database from the built-in until May 2021. The English literature mainly searches Cochrane Library, PubMed, excerpt medica database, and Web of Science, while the Chinese literature comes from China National Knowledge Infrastructure, Chinese biomedical literature database, VIP, and Wanfang database. Simultaneously we will retrieval clinical registration tests and grey literatures. This study only screen the clinical randomized controlled trials about XFZY for PD to assess its efficacy and safety. The 2 researchers worked independently on literature selection, data extraction, and quality assessment. The dichotomous data is represented by relative risk, and the continuous is expressed by mean difference (MD) or standard mean difference, eventually the data is synthesized using a fixed effect model or a random effect model depending on whether or not heterogeneity exists. The clinical efficacy and the score of dysmenorrhea symptoms were evaluated as the main outcomes. The artery pulsatility index (API), resistance index (RI), peak systolic/diastolic peak (S/D) were secondary outcomes. Finally, meta-analysis was conducted by RevMan software version 5.3.; Results: This study will provide high-quality evidence for treatment of PD with SFZY in terms of effectiveness and safety.; Conclusion: This systematic review aims to provide new options for SFZY treatment of PD in terms of its efficacy and safety.; Ethics and Dissemination: This study does not require ethical approval. We will disseminate our findings by publishing results in a peer-reviewed journal.; Osf Registration Number: DOI: 10.17605/OSF.IO/DXZHR.; Competing Interests: The authors have no conflicts of interests to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Yuan, X. and W. Zhang (2023). "The Use of Intravenous Immunoglobulin Intervention in Antiphospholipid Antibody Positive Women with High Risk for Miscarriage: A Systematic Review." PROSPERO International prospective register of systematic reviews.
	Review question Evaluate the feasibility of intravenous immune globulin treatment during pregnancy among women with antiphospholipid syndrome and to assess the impact of intravenous immune globulin treatment on obstetric and neonatal outcome. Searches A comprehensive search of PubMed, Web of Science, Embase, Scopus and MEDLINE databases was performed to identify relevant studies published from 2000 to 2023. The following search terms were used: “pregnancy loss” OR “Aortions, Spontaneous” OR “Miscarriage” AND “antiphospholipid antibodies” OR “aPL” AND “Antibodies, Intravenous” OR “intravenous immunoglobulin” OR “IVIG” OR “Immunoglobulins, Intravenous” AND “Randomized Controlled Trial”. Types of study to be included RCT Condition or domain being studied Recurrent miscarriage refers to the occurrence of two or more consecutive pregnancy losses before the 20th week of gestation. Antiphospholipid antibodies (aPL) are a group of autoantibodies that can be detected in individuals with various autoimmune disorders. Participants/population In the trial, patients in the trial group were diagnosed with abortion in aPL-positive are included and their age, race and course of disease are not limited. Intervention(s), exposure(s) Participants receiving intravenous immunoglobulin, regardless of dosing regimen Comparator(s)/control Participants who received any of the following：No intervention or placebo (saline, albumin, vitamins, etc.) Main outcome(s) Live birth(gestational age(GA) ≥ 37 weeks) Additional outcome(s) Pregnancy loss (i.e., miscarriages when GA<20 weeks and stillbirths when GA≥20 weeks) , preterm delivery(20 weeks≤GA<37 weeks), adverse events( like neonatal intensive care unit admission )

Yuanhong, S. U. N., et al. (2023). "Effect of pharmacological intervention on pregnancy rates in women with polycystic ovary syndrome: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	Citation YUANHONG SUN, JIARUI CHEN, HUHAO PENG. Effect of pharmacological intervention on pregnancy rates in women with polycystic ovary syndrome: a systematic review and meta-analysis.. PROSPERO 2023 CRD42023475650 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023475650 Review question There are a variety of drugs for the treatment of polycystic ovary syndrome. Which drug or combination of drugs will have a positive effect on a woman's conception rate? Searches SinoMed, CNKI, Vipp, Wanfang, PubMed, Web of Science, Embase, Cochrane Library. The above database was searched for clinical trials of drugs in the treatment of polycystic ovary syndrome in the past 10 years. The language of the articles included Chinese and English, and the treatment drugs were the existing first-line drugs and Chinese herbal medicine combined with first-line drugs. Types of study to be included Random Controlled Trials (RCTs) Condition or domain being studied Polycystic ovary syndrome in women Participants/population Inclusion: Women diagnosed with polycystic ovary syndrome according to currently accepted criteria Exclusion:Men and healthy women and polycystic ovary syndrome patients under 18 years of age Intervention(s), exposure(s) The medication interventions that will be investigated in this study include but are not limited to oral contraceptives, metformin, clomiphene citrate, letrozole, gonadotropins, and insulin-sensitizing agents. These interventions will be compared against a control group that did not receive any medication intervention but may have received lifestyle modifications or placebo treatment. The control group in this study will consist of PCOS patients who did not receive any medication intervention but may have been offered lifestyle modifications or placebo treatment in some studies. The control group will be used to compare the effect of medication intervention on the pregnancy rates in PCOS patients and to evaluate the efficacy of different medication interventions. The inclusion criteria for the control group will be consistent with those for the medication intervention group, ensuring appropriate comparability between the groups. Comparator(s)/control Placebo. A group of hospital in-patients who were get PCOS. Main outcome(s) Hormones associated with female pregnancy and pregnancy success after prolonged observation Measures of effect relative risks, odds ratios, risk difference Additional outcome(s) Weight changes, glucose tolerance levels, and hirsutism improved Measures of effect relative risks, odds ratios

yuanqian, w. and y. zhifeng (2023). "The effect of acupuncture on the treatment of polycystic ovary syndrome: A meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question What is the effect of acupuncture on the treatment of polycystic ovary syndrome? Searches A systematic literature search was conducted using PubMed, Embase, and CNKI databases, searching for published literature as of September 2023. The language is limited to English and Chinese. Types of study to be included All randomized controlled trial of acupuncture treatment for polycystic ovary syndrome will be included in the study. The exclusion criteria are as following: (1) non-human studies; (2) non-comparative studies; (3) studies that did not include PCOS; (4) studies without available data can be extracted; (5) non-original studies (letters, reviews, editorials). Condition or domain being studied Polycystic ovary syndrome (PCOS) is a common disease caused by complex endocrine and metabolic abnormalities in women of childbearing age, which is characterized by chronic anovulation and hyperandrogenemia. Acupuncture has been widely used to alleviate pain and treat neurological and other diseases. Some literature suggests that acupuncture may have a positive effect on the treatment of polycystic ovary syndrome. Participants/population The included population was women diagnosed with polycystic ovary syndrome, and acupuncture was used in the treatment. The exclusion criteria are as following: (1) non-human studies; (2) non-comparative studies; (3) studies that did not include PCOS; (4) studies without available data can be extracted; (5) non-original studies (letters, reviews, editorials). Intervention(s), exposure(s) acupuncture, including regular acupuncture and electroacupuncture Comparator(s)/control Sham-acupuncture or other physical therapy methods Main outcome(s) The main evaluation indicators for patients are live birth rate, ovulation rate, and pregnancy rate Additional outcome(s) The additional evaluation indicators for patients are luteinizing hormone (LH), LH/follicular stimulating hormone (FSH) ratio, testosterone Data extraction (selection and coding) A data extraction form will be developed based on the Cochrane handbook checklist of items to consider for data collection (section 7.3.a of the handbook). Two authors will independently extract the data from included studies. Disagreements will be resolved by discussion between the two reviewers and reviewing of the trial information. When needed the trial authors will be contacted for clarifications. Risk of bias (quality) assessment Two reviewers will independently assess risk of bias based on the following domains from recommendations from the Cochrane handbook: 1. Adequate sequence generation; 2. Allocation concealment; 3. Blinding; 4. Incomplete outcome data and how it was addressed; 5. Selective reporting of the outcome; 6. Any other biases. results of bias assessment will be presented in a figure and a graph indicating low, high or unclear risk of bias for each of the 6 items in each trial. Sensitivity analysis will be conducted based on the bias assessment to assess robustness of results Strategy for data synthesis Relative Risk (RR) and its 95% confidence intervals (95% CI) will be calculated for the outcome new onset atrial fibrillation in each included trial based on intention to treat (ITT). Due to expected heterogeneity among the trials, Meta-analysis using the random-effects model will be conducted to pool RR. Analysis of subgroups or subsets None

Yuanyuan, W., et al. (2023). "Intracytoplasmic sperm injection (ICSI) versus conventional in vitro fertilisation (IVF): a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question This systematic review and meta-analysis aimed to identify all randomized controlled trials (RCTs) comparing the effect of ICSI or conventional IVF among individuals and/or couples experiencing infertility. Searches We have developed a search strategy to identify relevant studies. First, ten online academic databases were searched with no language restrictions from the inception of the databases to October 23, 2023: PubMed, EMBASE, MEDLINE, Web of Science, Cochrane Library, ProQuest Dissertations & Theses Global, Scopus, CINAHL Plus, Chinese Wanfang Database, and Chinese CNKI Database, using a combination of free text and controlled vocabulary (ie, MeSH terms) for each database. Types of study to be included Inclusion criteria are original RCTs that compare at minimum one of the pregnancy outcomes or perinatal outcomes (complete fertilization failure, fertilization rate, ongoing pregnancy rate, cumulative pregnancy rate, preterm birth, clinical pregnancy rate, cumulative clinical pregnancy rate, live birth rate, cumulative live birth rate, spontaneous abortion rate, low birth weight, birth defects, neonatal death) between IVF and ICSI groups, full-text access in the electronic library databases of Peking University, and written in English or Chinese. We will exclude ongoing studies, intervention development studies, protocols, editorials, commentaries, book/book chapters, reviews/meta-analysis, conference papers, abstracts only, brief communications, studies using only qualitative methods. Condition or domain being studied Infertility Infertility is defined as 'the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse' in the International Classification of Disease – 11th version (ICD-11) Participants/population Infertile population Intervention(s), exposure(s) Intracytoplasmic sperm injection (ICSI), a technique where a single sperm is injected mechanically into an oocyte in vitro to achieve fertilisation. Comparator(s)/control In vitro fertilisation (IVF), a technique where the oocyte and multiple selected sperm are cultured in a laboratory dish, simulating the fertilization process in vivo to achieve fertilisation. Main outcome(s) Complete fertilization failure, fertilization rate, ongoing pregnancy rate, cumulative pregnancy rate, preterm birth, clinical pregnancies, cumulative clinical pregnancies, live birth rate, cumulative live birth rate, spontaneous abortion rate, low birth weight, birth defects, neonatal deaths. Measures of effect Risk ratio Additional outcome(s) None Measures of effect None Data extraction (selection and coding) Data will be extracted based on the inclusion and exclusion criteria described above. The estimates of pregnancy outcomes (complete fertilization failure, fertilization rate, ongoing pregnancy rate, cumulative pregnancy rate, preterm birth, clinical pregnancy rate, cumulative clinical pregnancy rate, live birth rate, cumulative live birth rate, spontaneous abortion rate, low birth weight, birth defects, neonatal death), characteristics of samples(age, types of infertility, causes of infertility, duration of infertility, etc.), characteristics of the study (study design, randomization unit, etc.) and definition of each outcome will be extracted. A table will be designed to synthesize all data. Risk of bias (quality) assessment The study quality will be assessed by two reviewers with the Cochrane Collaboration's Risk of Bias tool. Strategy for data synthesis Meta-analyses will be performed to synthesize the difference of pregnancy outcomes between IVF and ICSI patients. Risk Ratio will be calculated from data reported in the selected studies. We will exclude studies in which raw data were missing or unclear. Higgins' I² statistic and Q test will be used to detect the heterogeneity across studies. A random-effects model will be used to calculate pooled estimates and the 95% confidence interval (CI). Egger's test and the funnel plots will be used to assess potential publication bias. Analysis of subgroups or subsets Subgroup analyses will be performed to investigate the sources of heterogeneity. Subgroup analyses will be categorized by characteristics of samples (age, types of infertility, causes of infertility, duration of infertility, etc.), characteristics of the study (study design, randomization unit, etc.), study region, the definition of the outcome, and the risk of bias (high, moderate, or low).

Yuanzhuo, C., et al. (2021). "Is ablation or fulguration effective for Hunner-type interstitial cystitis&#xff1a;a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question To investigate the safety and efficacy of ablation or fulguration for Hunner-type interstitial cystitis Searches Search headings were used: interstitial cystitis, bladder pain syndrome, Hunner lesions, Hunner-type, ablation, fulguration, safety, efficacy, painful bladder syndrome. Types of study to be included Study types were randomized controlled trials or non-randomized controlled trials including retrospective cohort and prospective cohort. Studies were published in English. Condition or domain being studied Interstitial cystitis (IC), defined as the condition with chronic pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by other urinary symptoms, such as persistent urge to void or urinary frequency in the absence of confusable diseases. The prevalence of interstitial cystitis is increasing around the world over past 40 years, with an incidence of about 0.01 to 6.5%, and females are about five times more likely to be affected than males. Participants/population Including criteria: Patients over 18 years of age diagnosed with HIC on cystoscopic examination (at cystoscopy, a circumscribed, reddened mucosal area with small vessels radiating towards a central scar in the bladder1). Exclusion criteria were: 1) Patients with non-Hunner lesion or other pathological types interstitial cystitis; 2) Lack of evaluation indicators required for analysis. Intervention(s), exposure(s) The surgical intervention method was ablation or fulguration with or without hydrodistension. Comparator(s)/control self control （baseline date） Main outcome(s) Outcome indicators included at least one of the following items: voiding diary (including micturition frequency, urinary urgency, nocturia), pain score and quality of life questionnaires. Additional outcome(s) None Data extraction (selection and coding) Two reviewers browsed the included articles’ title and abstract to extract data by using a pre-designed form. Any disagreement during data extraction was resolved by reaching a consensus between two reviewers or by the help of a third reviewer. The pre-designed form included the following information: title, authors, years of publication, sample size, study type, randomization, the demographic characteristics of the participants, outcome measurements and their results. Risk of bias (quality) assessment We assess the risk of bias of included RCT studies using guideline suggested by Cochrane Collaboration5. The main contents include: sequence generation, allocation concealment, blinding, incomplete data assessment, selective outcome reporting and other sources of bias. Therefore, the risk of bias in studied included will be estimated as “high”, “unclear” and “low” risk of bias. The quality of retrieved retrospective studies was assessed using Methodological index for non-randomized studies (minors). Authors were contacted for date and method details if they were not reported in the articles adequately. Any differences in procedure of bias assessment will be dissolved by discussion between two reviewers or by consultation with the third reviewer. Strategy for data synthesis Study results were meta-analyzed using Mantel-Haenszel fixed effects model Initially. heterogeneity between studies was assessed by the χ² test and quantified by the I² statistic. If the I² values more than 50%, random effects model was used. Weighted mean difference (WMD) and risk ratios (RR) were applied for continuous and dichotomous outcomes, respectively. Corresponding 95% confidence intervals (CI) were applicable to all results. The I² reported as an indicator was used to assess the proportion of total variability due to heterogeneity combined study. I² values of 25%, 50%, and 75% generally denote a small, moderate, and high proportion of variability, respectively. If any outcomes had high heterogeneity, sensitivity analysis would be applied to find the source of heterogeneity. Publication bias was shown on funnel Plots only if more than seven studies were included. All analysis was implemented by Review Manager software version 5.4. Analysis of subgroups or subsets The subgroup may including ablation/fulguration with hydrodistention and without hydrodistention Contact details for further information Yuanzhuo Chen chenyuanzhuo@vip.qq.com Organisational affiliation of the review West China Hospital, Sichuan University Review team members and their organisational affiliations Dr Yuanzhuo Chen. West China Hospital, Sichuan University Liao Peng. West China Hospital, Sichuan University Boya Li. West China Hospital, Sichuan University Jiawei Chen. West China Hospital, Sichuan University Type and method of review Intervention, Meta-analysis, Systematic review Anticipated or actual start date 01 July 2021 Anticipated completion date 02 September 2021 Funding sources/sponsors This study was supported by 1.3.5 project (ZY2017310) for disciplines of excellence, West China Hospital, Sichuan University; Natural Science Foundation of China (No.8177063) and Huohua Project of Sichuan University (2018). Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Cystitis, Interstitial; Humans; Pain; Urinary Bladder Date of registration in PROSPERO 02 September 2021 Date of first submission 03 August 2021

Yudha Pratama, P., et al. (2021). "Laparoscopic myomectomy versus open myomectomy in uterine fibroid treatment: A meta-analysis." Laparoscopic, Endoscopic, and Robotic Surgery 4(3): 66-71.
	Objective: Uterine fibroids are the most commonly occurring benign solid tumors in women, and laparoscopic or open myomectomy constitutes the primary option for treatment. However, both methods are under debate currently in terms of efficacy and safety. In this meta-analysis we assessed the efficacy and safety of the two procedures. Method(s): We conducted a comprehensive literature search of PubMed, ScienceDirect, and the Cochrane Library in December 2020. The search terms included "open myomectomy", "myomectomies", "laparoscopic", and "uterine fibroids". We then selected the randomized control trials published from 1996 to 2019 and compared laparoscopic and open myomectomies. Result(s): We included 10 studies of 449 patients who underwent laparoscopic myomectomy and 449 patients who underwent open myomectomy. The data revealed that laparoscopic myomectomy was associated with reduced blood loss (MD = -34.43; 95% CI, -34.92 to -33.94; p < 0.001), an attenuated decline in hemoglobin (MD = -1.04; 95% CI, -1.14 to -0.93; p < 0.001), less post-operative pain at 24 h (MD = -0.51; 95% CI, -0.83 to -0.19; p = 0.002), and fewer overall complications (OR = 0.42; 95% CI, 0.24 to 0.71; p = 0.001) relative to open myomectomy; but the former possessed a longer operative time (MD = 12.96; 95% CI, 9.94 to 15.97; p < 0.001). There were no significant differences in pregnancy rate (OR = 1.39; 95% CI, 0.72 to 2.68; p = 0.33) or recurrence rate of postoperative uterine fibroids (OR = 1.15; 95% CI, 0.60 to 2.18; p = 0.67) between the two groups. Conclusion(s): Laparoscopic myomectomy displayed superior results compared to open myomectomy, although the former involved a longer operating time.Copyright © 2021 Zhejiang University

Yuehong, L. and X. Zhoulan (2021). "Use of metformin to treat pregnant women with polycystic ovary syndrome: meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question To evaluate the Use of metformin to treat pregnant women with polycysticovary syndrome. Searches PubMed, EMBASE, Cochrane Library, Web of Science, and Google Scholar Types of study to be included Randomized controlled trial, case control study, cohort study Condition or domain being studied Polycystic ovary syndrome (PCOS) is associated with increased prevalence of pregnancy complications, including pre-eclampsia, gestational diabetes, low birth-weight, miscarriage, and preterm birth. Use metformin during pregnant maybe can (maybe can't) keep from these complications. Participants/population Inclusion: pregnant women with polycystic ovary syndrome (as diagnosed according to the Rotterdam 2003 criteria). Exclusion: pregnant women without polycystic ovary syndrome or PCOS women didn't get pregnant. Intervention(s), exposure(s) Inclusion: metformin using during pregnancy for women with PCOS Exclusion: metformin not for women with PCOS or use not during pregnant Comparator(s)/control placebo. A group of patients with PCOS who didn't take metformin Main outcome(s) Change in the prevalence of pregnancy complications, including pre-eclampsia, gestational diabetes, low birth-weight, miscarriage, and preterm birth. Measures of effect odds ratios Additional outcome(s) Hypertension in pregnancy, Measures of effect odds ratios Data extraction (selection and coding) Two authors will independently extract data. Any disagreemnet will be resolved by discussion untill consensus is reached or by consulting a third author. The following data will be extracted: author, year of publication, country where the study was conducted, study period, original inclusion criteria, total number of people included in the study, dose of metformin and time of application, and the prevalence of pregnancy complications. Risk of bias (quality) assessment Two reviewers will independently assesses the quality of the selected studies according to the Cochrane Collaboration's tool for randomized controlled trials. The following characteristics will be evaluated: Random sequence generation (selection Bias), Allocation concealment (selection Bias), blinding of participants and personnel (performance bias), Incomplete outcome data (attrition bias), Selective reporting (reporting bias), other biases. Results from these questions will be graphed and assessed using Review Manager 5.3. Strategy for data synthesis Odd ratio (OR) will be used. Between-study heterogeneity will be assessed using the Q Cochrane and I² statistics. Results will be assessed using forest plots. Analysis of subgroups or subsets none Contact details for further information Yuehong Lu 346175211@qq.com Organisational affiliation of the review Shaoxing Women and Children’s Hospital Review team members and their organisational affiliations Miss Yuehong Lu. Shaoxing Women and Children's Hospital, Shaoxing, China Miss Zhoulan Xia. Shaoxing Women and Children's Hospital, Shaoxing, China Type and method of review Intervention, Meta-analysis, Systematic review Anticipated or actual start date 10 February 2021

Yuehong, L. and X. Zhoulan (2021). "The use of progestin- primed ovarian stimulation in patients with polycystic ovary syndrome undergoing assisted reproductive technology: a systematic review and meta-analyses." PROSPERO International prospective register of systematic reviews.
	eview question The aim of this meta-analysis is to evaluate the efficacy and safety of progestin- primed ovarian stimulation in patients with polycystic ovary syndrome undergoing assisted reproductive technology. Searches We will search PubMed, Embase, the Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI) and Wanfang Data until 16 March 2021, without language limitations. Reference list of all selected articles will independently screened to identify additional studies left out in the initial search. Types of study to be included Randomized clinical trials will be included irrespective of blinding, publication status or language. Condition or domain being studied Polycystic ovarian syndrome (PCOS) is a prevalent endocrine disorder. In vitro fertilization (IVF) is one of the important therapy for women with PCOS. Progestin-primed ovarian stimulation (PPOS) was proposed by the Yanping Kuang M.D. group in 2015. Oral administration of exogenous progesterone (P), such as medroxyprogesterone acetate (MPA) and dydrogesterone (DYG), beginning in the early follicular phase is used with gonadotropin during controlled ovarian stimulation (COS). But the effectiveness of PPOS in patients with PCOS is still controversial. Participants/population Patients with polycystic ovary syndrome who were undergoing assisted reproductive technology and using a PPOS protocol for ovarian stimulation. Intervention(s), exposure(s) Use progestin-primed ovarian stimulation (PPOS) for ovarian stimulation is the main intervention. Comparator(s)/control Patients with polycystic ovary syndrome who were undergoing assisted reproductive technology and using other protocols for ovarian stimulation. Main outcome(s) Clinical pregnancy rate, Live birth rate, Incidence of ovarian hyperstimulation syndrome (OHSS) Measures of effect The risk ratio (RR) and 95% confidence intervals (CIs) . Additional outcome(s) Dose of gonadotrophin for injection, Number of retrieved oocytes, Number of obtained embryos. Measures of effect The mean difference (MD) will be calculated. Data extraction (selection and coding) Two authors will independently extract data. Any disagreement will be resolved by discussion until consensus is reached or by consulting a third author.The following data will be extracted: author, year of publication, country where the study was conducted, study period, original inclusion criteria, total number of people included in the study and time of application. Risk of bias (quality) assessment Two authors will independently assess the quality of the selected studies according to the Cochrane Collaboration’s tool for randomized controlled trials. Items will be evaluated in three categories: Low risk of bias, unclear bias and high risk of bias. The following characteristics will be evaluated: Random sequence generation (selection bias), Allocation concealment (selection bias), Blinding of participants and personnel (performance bias), Incomplete outcome data (attrition bias), Selective reporting (reporting bias), other biases results from these questions will be graphed and assessed using Review Manager 5.3. Strategy for data synthesis Odd ratio (OR) will be used. Between-study heterogeneity will be assessed using the Q Cochrane and I² statistics. Results will be assessed using forest plots. Analysis of subgroups or subsets We will consider subgroups such as the types of progestin, the protocol of assisted reproductive technology (in vitro fertilization or intracytoplasmic sperm injection)

Yuehong, L. and X. Zhoulan (2022). "Effect of GnRH agonist pretreatment for Frozen-Thawed Embryo Transfer: A systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question The aim of this meta-analysis is to evaluate the effect of GnRH agonist pretreatment for Frozen-Thawed Embryo Transfer. Searches we will search, with no time restrictions, the following databases for relevant English literature: The MEDLINE, Embase, Cochrane Library (CENTRAL), Web of Science. Types of study to be included RCTs and clinical trails Condition or domain being studied frozen-thawed embryo transfer with GnRHa pretreatment was shown to be suitable for specific patient subgroups such as women with endometriosis or adenomyosis, as it is thought to transiently suppress the hypothalamic–pituitary–gonadal axis and exert a hypo-estrogenic effect, but there have been no definitive conclusions. Participants/population Participants who received frozen-thawed embryo transfer with or without GnRHa pretreatment. Intervention(s), exposure(s) Endometrial preparation before FET with GnRHa pretreatment. Comparator(s)/control Endometrial preparation before FET without GnRHa pretreatment. Main outcome(s) Clinical pregnancy rate, Live birth rate Measures of effect OR Additional outcome(s) miscarriage rate Measures of effect OR Data extraction (selection and coding) Two authors will independently extract data, a third review author resolve any disagreement between the two authors. Risk of bias (quality) assessment Two authors will independently assess the methodological quality of the eligible studies. The Cochrane collaboration tools will be used to assess the risk of bias in randomized controlled trials. Newcastle–Ottawa Scale (NOS) will be used to assess the quality of nonrandomized studies. Strategy for data synthesis We will express continuous variables by the difference in means (MD) and dichotomous variables as odds radio (OR), calculate the 95% confidence interval (CI) for all of the indicators, and considere P < 0.05 statistically significant. We will use Higgins I² values to assess statistical heterogeneity between studies. Analysis of subgroups or subsets We will consider subgroups such as clinic type, different methods for endometrial preparation. Contact details for further information Zhoulan Xia zjwlxzl@163.com Organisational affiliation of the review Shaoxing Women and Children’s Hospital Review team members and their organisational affiliations Miss Yuehong Lu. Shaoxing Women and Children's Hospital Miss Zhoulan Xia. Shaoxing Women and Children's Hospital Type and method of review Meta-analysis, Systematic review Anticipated or actual start date 07 May 2022 Anticipated completion date 29 August 2022

Yueyue, L., et al. (2022). "The Clinical Efficacy and Safety of Platinum-based drugs Improving Recurrent ovarian cancer: A Network Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	] or "Nedaplatin" [Title/Abstract] Abstract] or "Oxaliplatin" [Title/Abstract] and "randomizedcontrolledtrial" [Filter] Types of study to be included Inclusion criteria: (1) Randomized controlled trials (RCTs) and semi-randomized controlled trials of all drug treatments. (2) Patients with recurrent ovarian cancer diagnosed according to established diagnostic criteria. (3) There are no restrictions on the age of patients. (4) The language is not restricted. Exclusion criteria (1) Document duplication. (2) The research includes incomplete or incorrect data. (3) Animal experiments. (4) Review the literature. Condition or domain being studied Improvement in recurrent ovarian cancer More and more treatment strategies are being used to treat recurrent ovarian cancer, but it is not clear which is the best. At present, a systematic review and meta-analysis of drugs used to treat recurrent ovarian cancer have been carried out. Traditional meta-analysis only provides a comparison of the advantages and disadvantages of the two treatments, but a variety of treatment strategies are used in clinical practice. Therefore, these traditional meta-analysis results cannot meet current clinical needs. It is especially important to compare the effectiveness and safety of multiple interventions immediately. Therefore, this study will use the network meta-analysis method to compare multiple interventions, and rank the various interventions according to the degree of improvement of each efficacy indicator. Participants/population Patients with recurrent ovarian cancer of any age diagnosed according to established diagnostic criteria. Intervention(s), exposure(s) Some drugs commonly used to treat recurrent ovarian cancer. These drugs include: Cis-platinum, Lobaplatin, Carboplatin, Paraplatin, Nedaplatin, Oxaliplatin, Paclitaxel. Comparator(s)/control Control group: drug treatment (for example: Cis-platinum); treatment as usual (Paclitaxel was treated in combination with cisplatin, carboplatin, loplatin, nedaplatin, oxaliplatin or platinum alone). Main outcome(s) Total effective rate Additional outcome(s) None Data extraction (selection and coding) The study retrieval process will be carried out by two reviewers independently, and cross-checked. Discussion will be entered into if any differences in opinion arise. Risk of bias (quality) assessment We will use the Cochrane risk of bias tool for the assessment of bias, ensuring strict adherence to usage guidelines. The following will be considered: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome date, selective reporting and other bias. Each item will be evaluated using three levels: "low", "high" and "unclear". The quality evaluation will be carried out by two reviewers independently, and cross-checked, and any differences resolved through discussion. The quality assessment for the included studies will be made into an information sheet and attached to the completed article. In addition, we will explore the stability of the research results through a sensitivity analysis, and funnel plots, Egger's test, and Begg's test will be used to assess for any bias in the results. Strategy for data synthesis Stata 13.0 software and RevMan5.3 software provided by Cochrane Collaboration will be utilized for the meta-analysis. Odds ratio (OR) will be adopted for dichotomous variables, expressed with 95% CI. The I² and χ² tests will be used to evaluate heterogeneity. In addition, we will explore the stability of the research results through a sensitivity analysis. Funnel tests, Egger's test, and Begg's test will also be used to test for bias in the results. Analysis of subgroups or subsets Due to the variety of interventions, the sizes of the samples, and the ages of the patients, we plan to conduct a meta-regression on the abovementioned three conditions to explore the sources of heterogeneity. In addition, we will also explore the stability of the research results through a sensitivity analysis. Contact details for further information Yueyue Li 1294329226@qq.com Organisational affiliation of the review Chengdu University of TCM Review team members and their organisational affiliations Dr Yueyue Li. Chengdu University of TCM Professor Wenjun Zou. Professor Liping Qu. Dr Liangyan Deng. Dr Tao Wang. Type and method of review Intervention, Network meta-analysis, Systematic review

Yujie, S., et al. (2022). "Acupuncture for female subfertility." PROSPERO International prospective register of systematic reviews.
	Review question To determine whether acupuncture compared with placebo, no treatment or standard treatment improves reproductive, oocyte and endometrial outcomes for subfertile women. Searches We electronically searched Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, and Web of Science. The publication time is from the start of each database up to October 26, 2022. A systematic literature search was conducted using the combination of the following Medical Subject Heading (MeSH) terms: ("acupuncture") and ("infertility" or "embryo transfe" or "fertilization in vitro" or "sperm injections, intracytoplasmic" or "embryo implantation") and ("randomized controlled trial" or "control clinical trial" or "randomized" or "placebo" or "randomly" or "trial"). A manual search for conference proceedings relevant to this topic, references from relevant reports of clinical trials and review articles was performed to retrieve all potentially relevant published and unreported material. Meeting proceedings of the European Society of Human Reproduction and Embryology and the American Society for Reproductive Medicine were also hand-searched to account for the most relevant studies. Types of study to be included Published and unpublished randomised controlled trials (RCTs) were included in the review. We excluded non-randomised studies (for example studies with evidence of inadequate sequence generation such as alternate days, patient numbers) as they are associated with a high risk of bias. We did not include crossover trials with no first phase data. Condition or domain being studied Infertility is explicitly defined as a failure to become pregnant within 12 months of having regular, unprotected, heterosexual intercourse; it affects approximately 48.5 million couples worldwide. Complementary therapies are widely used by patients with infertility. Although assisted reproductive technology (ART) has helped millions of women to achieve a pregnancy, the overall effect is still far from satisfactory. Acupuncture is a vital portion of Traditional Chinese Medicine. Accumulating studies suggest that acupuncture can regulate the neuroendocrine immune system, improve endometrial receptivity, and reduce adverse reactions, thereby achieving better therapeutic effects. However, other randomized controlled trials (RCTs) hold distinct points, which find no significant benefits of acupuncture adjuvant to embryo transfer and the mechanism of its effects cannot be converged. In addition, there is little consensus on the application duration, let alone the appropriate population that would truly benefit from the treatment. Therefore, we aim to compile data from clinical studies with the use of a rigorous ethodology to offer a better understanding of the impact of acupuncture in the reproductive, oocyte and endometrial outcomes in women with subfertility. Participants/population Inclusion criteria: • primary (subfertility in couples who have never conceived) or secondary subfertility (couples who have subfertility after previously having children); • women undergoing ART; • any type of acupuncture at any or all time points before, during, or after ART with the intention to improve the ART outcome. Exclusion criteria:Trials that enrolled women with medical illness deemed a contraindication for acupuncture treatment or severe gynecological diseases (e.g. abnormalities in uterine anatomy, uterine malformations, intrauterine adhesions or endometriosis), or any severe cardiovascular or cerebrovascular diseases, or psychiatric or neurological problems. Intervention(s), exposure(s) We included studies using either traditional acupuncture, in which needles were inserted in classical meridian points, or contemporary acupuncture in which the needles were inserted in non-meridian or trigger points. The source of stimulation could be the hand, fine needle, moxibustion with warming needle, or electrical stimulation. We excluded studies of acupuncture treatment without needling, such as point injection, acupressure, laser acupuncture, tap-pricking, or cupping on pricked superficial blood vessels. We excluded trials comparing different acupuncture treatments alone. Comparator(s)/control Needling in the control groups could either be with a sham needle (for example Streitberger placebo needle, Asiamed, Pullach, Germany, where skin penetration does not occur because the tip of the needle is blunted) or normal acupuncture needles, needling an area not recommended by TCM practitioners for fertility treatment. The other type of control group had no needling treatment. Main outcome(s) 1.Live birth rate, defined as pregnancy beyond 24 weeks' gestation; 2.Clinical pregnancy rate (per cycle) as the presence of a gestational sac on transvaginal ultrasound; 3. Ongoing pregnancy rate (per cycle) as a pregnancy beyond 12 weeks' gestation; 4. Miscarriage rate (per clinical pregnancy) as fetal loss before the 20th week of gestation. Measures of effect Dichotomous variables will be analyzed by means of odds ratio (OR) with 95% confidence interval (CI). Continuous data will be expressed as mean±SD and tested for difference between means (MD), also with 95% CI. Additional outcome(s) 1. Quality of oocytes and embryos; 2. Endometrial thickness, pattern and volume; 3. Adverse events. Measures of effect Dichotomous variables will be analyzed by means of odds ratio (OR) with 95% confidence interval (CI). Continuous data will be expressed as mean±SD and tested for difference between means (MD), also with 95% CI. Data extraction (selection and coding) Two review authors (Y.S. and X.S.) will independently review titles and abstracts of trials for eligibility. We obtained the full texts of trials that we considered for inclusion. We sought further information from the authors oftrials that did not contain suJ icient information to make a decision about eligibility. We resolved any disagreements by reference to a third review author. We documented the selection process with a PRISMA flow chart. Two authors (Y.S. and X.S.) independently extract data with the use of a standardized prepiloted form containing information about study features (design, country, and study period), populations (sample size and age range), intervention (therapy duration, type and dosage), and IVF protocol, outcomes. Risk of bias (quality) assessment Three reviewers (Y.S., M.W. and X.S.) assessed the methodological quality of eligible trials via the Cochrane Collaboration’s tool. Studies were evaluated as having a low, unclear or high risk of bias based on the following domains: selection bias, performance bias, detection bias, attrition bias, reporting bias and other bias. The quality of evidence (QoE) was graded in light of the study design, study quality, inconsistency, indirectness and imprecision via the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach。 Strategy for data synthesis Statistical analysis was performed by Review Manager 5.4.1 in accordance with the guidelines described in the Cochrane Handbook for Systematic Reviews of Interventions. P< 0.05 was taken to indicate statistical significance. For dichotomous data, the results were expressed as odds ratios (ORs) with 95% confidence intervals (CIs). For continuous data, the results were pooled for meta-analysis as the mean difference (MD) with 95% CIs. Statistical heterogeneity within comparisons was evaluated by Cochran’s Q test and quantified by the I² (I²) statistic. I² values <40% might not be important, values of 30–60% indicate moderate heterogeneity, values of 50–90% indicate substantial heterogeneity and values of 75–100% indicate considerable heterogeneity. The random-effects method was preferred for calculating summary effect measures since clinical heterogeneity was inevitable. If statistical data were missing from the included studies, we sought further details from the original authors. If participants were lost to follow-up due to failed oocyte retrieval or fertilization, all of them were included in the groups that they were initially assigned to when analyzing LBR and CPR. Both meta-regression and subgroup analyses were performed to explain potential sources of heterogeneity between studies. We performed the meta-regression analysis on outcomes with at least 10 observations, as it was very unlikely that this analysis would produce useful findings unless it included a substantial number of studies. To examine the robustness of pooled estimates, sensitivity analyses were performed by removing: outlying results, studies with large sample sizes or one trial at a time. The potential publication bias of primary outcomes was investigated by Egger's test and visual inspection of funnel plots. Analysis of subgroups or subsets 还进行了亚组分析，以根据预定义的因素（即给药的剂量和时间，卵巢刺激方案，不孕症的原因以及有/不假针灸）探索干预给药的中介作用。 Contact details for further information Yujie Shang 15951976978@163.com Organisational affiliation of the review Central South University Review team members and their organisational affiliations Dr Yujie Shang. Central South University Dr Minghua Wu. Central South University Dr Xiumei Sun. Second Affiliated Hospital of Xuzhou Medical University Type and method of review Systematic review Anticipated or actual start date 24 October 2022 Anticipated completion date 30 November 2022 Funding sources/sponsors None. Conflicts of interest None known Language English Country China Stage of review Review Ongoing

Yujie, S., et al. (2022). "Antioxidant therapy improves oocyte function." PROSPERO International prospective register of systematic reviews.
	Review question To determine whether antioxidants compared with placebo, no treatment/standard treatment or another antioxidant improve fertility outcomes for subfertile women. Searches We electronically searched Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, and Web of Science. The publication time is from the start of each database up to September 12, 2022. A systematic literature search was conducted using the combination of the following Medical Subject Heading (MeSH) terms: ("antioxidant") and ("embryo transfe" or "fertilization in vitro" or "sperm injections, intracytoplasmic" or "embryo implantation") and ("randomized controlled trial" or "control clinical trial" or "randomized" or "placebo" or "randomly" or "trial"). A manual search for conference proceedings relevant to this topic, references from relevant reports of clinical trials and review articles was performed to retrieve all potentially relevant published and unreported material. Meeting proceedings of the European Society of Human Reproduction and Embryology and the American Society for Reproductive Medicine were also hand-searched to account for the most relevant studies. Types of study to be included Randomised controlled trials (RCTs) and cross-over trials (only first-phase data were used in the analysis) will be included. Condition or domain being studied Subfertility (also commonly referred to as infertility), defined as "a disease characterized by the failure to establish a clinical pregnancy after 12 months of regular, unprotected sexual intercourse or due to an impairment of a person's capacity to reproduce either as an individual or with his/her partner", is common and affects one in six couples, which is a recognized cause of psychological distress in both men and women, and meanwhile leads to substantial physical, psychological and financial burden. Poor quality of oocytes, along with ovulatory dysfunction, are the most common causes of female subfertilitydy. Hence, evidence-based therapeutic solutions that effectively and safely address oocyte dysfunction should be a priority. Antioxidant therapy is being used in different clinical scenarios, such as polycystic ovary syndrome, poor ovarian response, advanced reproductive age, and poor oocyte or embryo quality. Nevertheless, it is still considered to be an off-label use of a drug and its role in oocyte development and function has yet to be determined. Therefore, we aimed to compile data from clinical studies with the use of a rigorous ethodology to offer a better understanding of the impact of antioxidant therapies in the fertility outcomes and oocyte function in women with subfertility. Participants/population Inclusion criteria: Trials that included subfertile women who had been referred to a fertility clinic and might or might not be undergoing assisted reproductive techniques (ART) such as in vitro fertilisation (IVF), intrauterine insemination (IUI) or intracytoplasmic sperm injection (ICSI). Exclusion criteria:Trials that enrolled women with severe gynecological diseases (e.g. abnormalities in uterine anatomy, uterine malformations, intrauterine adhesions or endometriosis), or any severe cardiovascular or cerebrovascular diseases, or psychiatric or neurological problems, or vitamin deficiency. Intervention(s), exposure(s) Inclusion criteria: Any type of antioxidant therapies versus control: placebo (plus or minus a co-intervention) or no treatment/ standard treatment (standard treatment includes folic acid < 1 mg); Individual or combined antioxidants versus any antioxidant (head-to-head trials). Exclusion criteria: Interventions that included antioxidants alone versus fertility drugsb (including metformin and clomiphene citrate) as controls. Comparator(s)/control The control group will receive placebo, or no treatment/ standard treatment without antioxidant supplementation. Main outcome(s) 1.Live birth rate, defined as pregnancy beyond 24 weeks' gestation; 2.Clinical pregnancy rate (per cycle) as the presence of a gestational sac on transvaginal ultrasound; 3. Ongoing pregnancy rate (per cycle) as a pregnancy beyond 12 weeks' gestation; 4. Miscarriage rate (per clinical pregnancy) as fetal loss before the 20th week of gestation; 5.Oocytes quality: number of collected oocytes, MII oocytes and transferred embryos. Measures of effect Dichotomous variables will be analyzed by means of odds ratio (OR) with 95% confidence interval (CI). Continuous data will be expressed as mean±SD and tested for difference between means (MD), also with 95% CI. Additional outcome(s) 1. Serum levels of AMH, E2, FSH, LH, P; 2. Endometrial thickness, pattern and volume; 3. Adverse events. Measures of effect Dichotomous variables will be analyzed by means of odds ratio (OR) with 95% confidence interval (CI). Continuous data will be expressed as mean±SD and tested for difference between means (MD), also with 95% CI. Data extraction (selection and coding) Two review authors (Y.S. and X.S.) will independently review titles and abstracts of trials for eligibility. We obtained the full texts of trials that we considered for inclusion. We sought further information from the authors oftrials that did not contain suJ icient information to make a decision about eligibility. We resolved any disagreements by reference to a third review author. We documented the selection process with a PRISMA flow chart. Two authors (Y.S. and X.S.) independently extract data with the use of a standardized prepiloted form containing information about study features (design, country, and study period), populations (sample size and age range), intervention (therapy duration, type and dosage), and IVF protocol, outcomes. Risk of bias (quality) assessment Three reviewers (Y.S., M.W. and X.S.) assessed the methodological quality of eligible trials via the Cochrane Collaboration’s tool. Studies were evaluated as having a low, unclear or high risk of bias based on the following domains: selection bias, performance bias, detection bias, attrition bias, reporting bias and other bias. The quality of evidence (QoE) was graded in light of the study design, study quality, inconsistency, indirectness and imprecision via the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach。 Strategy for data synthesis Statistical analysis was performed by Review Manager 5.4.1 in accordance with the guidelines described in the Cochrane Handbook for Systematic Reviews of Interventions. P< 0.05 was taken to indicate statistical significance. For dichotomous data, the results were expressed as odds ratios (ORs) with 95% confidence intervals (CIs). For continuous data, the results were pooled for meta-analysis as the mean difference (MD) with 95% CIs. Statistical heterogeneity within comparisons was evaluated by Cochran’s Q test and quantified by the I² (I²) statistic. I² values <40% might not be important, values of 30–60% indicate moderate heterogeneity, values of 50–90% indicate substantial heterogeneity and values of 75–100% indicate considerable heterogeneity. The random-effects method was preferred for calculating summary effect measures since clinical heterogeneity was inevitable. If statistical data were missing from the included studies, we sought further details from the original authors. If participants were lost to follow-up due to failed oocyte retrieval or fertilization, all of them were included in the groups that they were initially assigned to when analyzing LBR and CPR. Both meta-regression and subgroup analyses were performed to explain potential sources of heterogeneity between studies. We performed the meta-regression analysis on outcomes with at least 10 observations, as it was very unlikely that this analysis would produce useful findings unless it included a substantial number of studies. To examine the robustness of pooled estimates, sensitivity analyses were performed by removing: outlying results, studies with large sample sizes or one trial at a time. The potential publication bias of primary outcomes was investigated by Egger’s test and visual inspection of funnel plots. Analysis of subgroups or subsets Subgroup analyses were also conducted to explore mediating effects of intervention administration according to predefined factors, namely, the dosage and time of administration, ovarian stimulation protocols and the mean age of participants. Contact details for further information Yujie Shang 15951976978@163.com Organisational affiliation of the review Central South University Review team members and their organisational affiliations Dr Yujie Shang. Central South University Dr Minghua Wu. Central South University Dr Xiumei Sun. Second Affiliated Hospital of Xuzhou Medical University Type and method of review Intervention, Meta-analysis, Systematic review Anticipated or actual start date 12 September 2022 Anticipated completion date 31 October 2022 Funding sources/sponsors None. Conflicts of interest Language 英语 (there is not an English language summary) Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Antioxidants; Female; Fertility; Humans; Live Birth; Oocytes; Pregnancy; Pregnancy Rate Date of registration in PROSPERO 22 September 2022 Date of first submission 12 September 2022

Yujiu, M. and T. Jichun (2023). "Different controlled ovarian stimulation protocols in PCOS patients undergoing IVF/ICSI: a systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question The objective of this study is to compare the effectiveness of ovarian stimulation protocol on pregnancy outcomes in PCOS women undergoing ART. This comparison will provide a rationale for selecting the optimal ovarian stimulation protocol in this patient population. Searches The following bibliographic data bases were searched through Ovid interface: MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Web of Science. Types of study to be included RCT Condition or domain being studied Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder affecting up to 20% of reproductive-aged women. Assisted reproductive technology (ART), specifically in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI), is used as a third-line treatment for infertility in PCOS patients. Participants/population Inclusion criteria: 1. Studies involving patients diagnosed with polycystic ovary syndrome (PCOS). 2. Studies utilizing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) as the assisted reproductive technology. 3. Studies comparing different protocols for controlled ovarian stimulation. 4. Studies reporting data on pregnancy outcomes, including clinical pregnancy, live birth rate, miscarriage rate, or other relevant pregnancy-related outcomes. Exclusion criteria: 1. Age >40. 2. Other factors affecting ovulation and pregnancy, such as endometriosis, tubal obstruction, male infertility, genetic defects, and so on. Intervention(s), exposure(s) GnRH-a long protocol Comparator(s)/control GnRH-a short protocol, GnRH antagonist protocol, PPOS protocol, Mild stimulation protocol, Gn protocol Main outcome(s) the incidence of OHSS, clinical pregnancy rate (CPR) Measures of effect RR, WMD Additional outcome(s) the rates of miscarriage, ectopic pregnancy, live birth, and multiple pregnancies Measures of effect RR, WMD Data extraction (selection and coding) Data extraction was performed independently by two reviewers using a predefined data extraction form, based on the relevant templates provided in the Cochrane Handbook for Systematic Reviews. Any disagreements were resolved through discussion or by reaching a consensus with a third reviewer. The extracted data included study characteristics (such as first author, publication year, study drug and control treatments, and case number) and patient characteristics (including inclusion criteria, background treatments, mean age, and body mass index). In cases where the available information was insufficient, the reviewers contacted the primary authors to obtain and verify the necessary data. Risk of bias (quality) assessment The quality assessment of eligible RCTs was independently conducted by two authors using the Cochrane Collaboration risk of bias tool, which assessed five domains (sequence generation, allocation concealment, blinding, detection bias, and attrition bias) Strategy for data synthesis For dichotomous data, the numbers of events was used to calculate the Mantel-Haenszel risk ratio (RR). For quantitative results, it was presented as the mean ± SD. P was evaluated statistically using the I 2 statistic. If the I 2 value was >50%, showing higher heterogeneity, a random effects model was used. If the I 2 value was <50%, showing lower heterogeneity, a fixed effects model was used. 95% confidence intervals (CIs) was presented for all outcomes. Potential publication bias was examined qualitatively by funnel plot. Statistical analyses were performed by Stata/MP v17.0. Analysis of subgroups or subsets Analysis of subgroups: according to the types of GnRH-A protocol. Contact details for further information Yujiu Ma mayujiu918@163.com Organisational affiliation of the review Second Department of Reproduction, Reproductive Center, Shengjing Hospital of China Medical University, Shenyang 110022, Liaoning Province, China; Key Laboratory for Reproductive Disorder and Fertility Remodeling of Liaoning Province, Shenyang 110022, Liaoning Province, China Review team members and their organisational affiliations Miss Yujiu Ma. Second Department of Reproduction, Reproductive Center, Shengjing Hospital of China Medical University, Shenyang 110022, Liaoning Province, China; Key Laboratory for Reproductive Disorder and Fertility Remodeling of Liaoning Province, Shenyang 110022, Liaoning Province, China Jichun Tan. Second Department of Reproduction, Reproductive Center, Shengjing Hospital of China Medical University, Shenyang 110022, Liaoning Province, China; Key Laboratory for Reproductive Disorder and Fertility Remodeling of Liaoning Province, Shenyang 110022, Liaoning Province, China Type and method of review Network meta-analysis, Systematic review Anticipated or actual start date 01 June 2023 Anticipated completion date 12 October 2023 Funding sources/sponsors The study was granted from the National Key Research and Development Program (2022YFC2702905), the Major Special Construction Plan for Discipline Construction Project of China Medical University (3110118033), and the Shengjing Freelance Researcher Plan of Shengjing Hospital of China Medical University. Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Humans Date of registration in PROSPERO 10 July 2023 Date of first submission 29 June 2023

Yumi, W., et al. (2022). "Efficacy and Safety of Thread-Embedding Acupuncture as an Adjunct Treatment for Premature Ovarian Insufficiency - A protocol of Systematic Review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question Is thread embedding acupuncture safe and effective in treating patients with Premature ovarian insufficiency? Searches Cochrane Central Register of Controlled Trials (CENTRAL) PubMed Web of Science EMBASE China National Knowledge Infrastructure (CNKI) - Chinese datebase Wanfang Database - Chinese datebase Oriental Medicine Advanced Searching Integrated System (OASIS) - Korean datebase Korean Medical Database (KMbase) - Korean datebase Studies published from the database’s inception to January 2022 will be retrieved. Types of study to be included This systematic review will be limited to RCTs Condition or domain being studied Premature ovarian insufficiency (POI), also known as premature ovarian failure (POF), is characterized by the loss of ovarian function and the cessation of menstruation before age 40. POI is a major cause of ovarian hormone deficiency and female infertility. The signs and symptoms of premature ovarian insufficiency closely resemble menopause or estrogen deficiency, but it is important to note that these conditions are not the same. Women with POI can have irregular or occasional periods and might even become pregnant. But women with premature menopause will stop menstruation and can not become pregnant. POI has a significant negative impact on the quality of life and psychological health. The symptoms of POI include amenorrhea, infertility, hot flashes, night sweats, irritability, depression, and decreased libido. Other less common symptoms include low energy, dry eyes, hair loss, urinary incontinence, cold intolerance, cognitive changes, and joint pain. POI is associated with prolonged periods of decreased estrogen levels and long-term severe health complications. These complications include increased risk of heart disease, osteoporosis, depression, and infertility. Participants/population Patients enrolled is diagnosed as POI according to “The ESHRE Guideline Group on POI.” Patients should meet all of the following criteria: women younger than 40 years old, amenorrhea or oligoamenorrhea for at least 4 months; an elevated serum follicle-stimulating hormone (FSH) levels (>25 IU/L) on at least 2 separate occasions apart (>4 weeks). Intervention(s), exposure(s) Thread-embedding acupuncture (TEA) is a form of acupuncture therapy that implants absorbable medical thread into specific acupoints to create continuous effects of stimulation. Comparator(s)/control The Control group may include: hormone therapy, conventional acupuncture, or no treatment. Main outcome(s) hormone levels of E2, FSH, and LH after treatment; adverse events. Additional outcome(s) None Data extraction (selection and coding) Literature screening, data extraction, and risk of bias evaluation will be performed by two reviewers (YW and YW) and will be cross-checked. The titles of the studies will be read as the first step in selecting the literature. After excluding non-relevant literature, the abstracts and full texts of the remaining studies will be read to determine inclusion. In cases of duplicate publications, we will select the original publication. A third researcher (HY) will assist in the evaluation in case of disagreement. Details of the selection process are shown in the PRISMA flow chart (Figure 1). We will collect the following information from each included trial: study characteristics (e.g., authors, year of publication, article title, article type, the research methodology); participant characteristics (e.g., diagnostic criteria, patient age, course of the disease, sample size in each group); intervention characteristics (e.g., type, frequency of acupuncture, duration, HRT drug); and outcome measures. Risk of bias (quality) assessment The risk of bias in the included studies will be assessed according to the Cochrane Collaboration Risk of Bias Tool. The tool covers six domains: sequence generation, allocation concealment, blinding of participants, blinding of outcome assessors, incomplete outcome data, and selective outcome reporting. The risk of bias for each domain will be rated as “low risk,” “high risk,” or “unclear risk.” Strategy for data synthesis For dichotomous data, we will present results as a summary risk ratio (RR) with 95% confidence intervals (CIs). For continuous data, we will use the standardized mean difference (SMD) with 95% CI. We will perform a traditional pairwise meta-analysis using R V.4.1.2 software via the meta V5.1-1 package (https://cran.r-project.org/web/packages/meta/). The I² statistic was calculated to quantify the extent of between-trials heterogeneity, with I² >50% indicating considerable heterogeneity. If we find important heterogeneity, we will explore the possible sources. Analysis of subgroups or subsets If sufficient studies are available, we will perform meta-regression or subgroup analyses by using the following effect modifiers as possible sources of heterogeneity: age, body mass index (BMI), baseline FSH level, baseline AMH level, baseline AFC level. To assess the robustness of the results obtained by the model, we will do sensitivity analyses for the following: overall quality of the studies (low versus high risk of overall bias); use of fixed-effect versus random-effects model; and different effect measures (risk versus odds ratio). Contact details for further information Yumi Wu wyumi8@gmail.com Organisational affiliation of the review Institute of Acupuncture and Moxibustion of China Academy of Chinese Medical Sciences http://www.acuworld.ac.cn/ Review team members and their organisational affiliations Dr Yumi Wu. Institute of Acupuncture and Moxibustion of China Academy of Chinese Medical Sciences Mr Yanyao Wang. New York College of Traditional Chinese Medicine Professor Huanfang Xu. Institute of Acupuncture and Moxibustion of China Academy of Chinese Medical Sciences Professor Yigong Fang. Institute of Acupuncture and Moxibustion of China Academy of Chinese Medical Sciences Dr Huisheng Yang. Institute of Acupuncture and Moxibustion of China Academy of Chinese Medical Sciences Dr Shoudong Wang. The TCM Clinic of China Academy of Chinese Medical Sciences Type and method of review Meta-analysis, Systematic review Anticipated or actual start date 01 January 2022 Anticipated completion date 01 June 2022 Funding sources/sponsors This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Conflicts of interest Language English Country China, United States of America Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Acupuncture Therapy; Humans; Meta-Analysis as Topic; Research Design; Systematic Reviews as Topic Date of registration in PROSPERO 20 February 2022 Date of first submission 21 January 2022

Yumi, W., et al. (2024). "Clinical Efficacy Research of Acupuncture in Polycystic Ovary Syndrome - A Meta-analysis and Systematic Review Study." PROSPERO International prospective register of systematic reviews.
	Review question How is the clinical efficacy of acupuncture in polycystic ovary syndrome? Searches PubMed、Embase、Cochrane、Web of Science、China National Knowledge Infrastructure (CNKI), Wanfang Database, VIP Database Types of study to be included RCT Condition or domain being studied Polycystic ovary syndrome (PCOS), as a major cause of anovulatory infertility, seriously affects the physical and mental health of women. Acupuncture is considered a potentially effective approach for treating PCOS and has been widely used. However, currently, the results of interventional studies on the effectiveness and safety of acupuncture in the treatment of PCOS are not consistent, and the quality of these studies has not been fully assessed. Participants/population Inclusion: Adults with PCOS (as diagnosed using any recognised diagnostic criteria). Exclusion: Adolescents (under 18 years of age) Intervention(s), exposure(s) The study population included individuals aged ≥18 years who met the gold standard criteria outlined in the 2023 "Guidelines for the Diagnosis and Treatment of Polycystic Ovary Syndrome with Integrated Traditional Chinese and Western Medicine": Menstrual abnormalities such as oligomenorrhea, anovulation, or amenorrhea. Clinical manifestations of hyperandrogenism and/or elevated androgen levels. Polycystic ovarian morphology (PCOM). Patients meeting at least 2 of the above criteria and excluding other causes of ovulatory disorders (including thyroid dysfunction, premature ovarian failure, hypothalamic-pituitary amenorrhea, hyperprolactinemia, etc.), as well as diseases causing hyperandrogenism (including Cushing's syndrome, non-classical congenital adrenal hyperplasia, endocrine tumors secreting androgens, etc.), were diagnosed with polycystic ovary syndrome (PCOS) and treated with acupuncture. Intervention measures in the experimental group included any acupuncture therapy such as acupuncture, electroacupuncture, moxibustion, ear acupuncture, abdominal acupuncture, embedding therapy, etc. Articles published in either Chinese or English were considered for inclusion. Incomplete or duplicated data and articles for which full text could not be obtained were excluded from the study. Comparator(s)/control The Control group may include: hormone therapy, conventional acupuncture, or no treatment. Main outcome(s) Outcome indicators included hormone levels such as follicle-stimulating hormone (FSH), luteinizing hormone (LH), LH/FSH ratio, estradiol, testosterone, dehydroepiandrosterone sulfate Additional outcome(s) Not applicable Data extraction (selection and coding) After importing the retrieved literature into NoteExpress for deduplication, two trained researchers (Researcher A and Researcher B) independently conducted preliminary screening of the literature based on inclusion/exclusion criteria by carefully reading the titles and abstracts. Subsequently, full-text articles were further screened, and data extraction was performed independently by the researchers using a unified data extraction form (including author, publication year, country/region, study population, sample size, average age, treatment modalities/intervention measures of interest, outcome indicators, and assessment tools). Cross-validation was conducted between the two researchers. In case of discrepancies in the selection process or data extraction, a third arbitrator (Arbitrator C) was consulted for discussion and resolution. Finally, literature that met the criteria was determined. Risk of bias (quality) assessment Two researchers (Researcher A and Researcher B) independently assessed the quality of each study literature retrieved based on Cochrane Handbook 5.1.0. Any discrepancies in quality assessment after discussion were referred to a third arbitrator (Arbitrator C) for resolution. Cochrane literature quality assessment includes seven items: randomization methods, allocation concealment, blinding (blinding of participants and personnel), blinding of outcome assessment, completeness of outcome data, selective reporting bias, and other biases. Studies explicitly mentioning low risk were rated as "A" quality; studies mentioning inconsistent evaluation criteria were rated as high risk; studies with unclear information were rated as not mentioned. If all the above items meet the low-risk criteria, the quality grade is "A"; if some items meet the criteria, the quality grade is "B"; if none of the items meet the low-risk standards, the quality grade is "C". Strategy for data synthesis The meta-analysis was conducted using R software version 4.3.2. All outcome variables in this study were continuous variables. Mean differences (MD) were used to analyze outcome variables with the same measurement method and units. Standardized mean differences (SMD) were used when measurement methods or units differed. Confidence intervals (CI) were calculated for outcome indicators. Heterogeneity analysis was performed using the χ2 test. If p > 0.1, indicating high heterogeneity (I² > 50%), a random-effects model was used. Conversely, if p ≤ 0.10 (I² ≤ 50%), a fixed-effects model was employed. A significance level of p < 0.05 was considered statistically significant. Analysis of subgroups or subsets If heterogeneity was high for a particular outcome indicator, sensitivity analysis was conducted. This involved systematically removing studies containing that outcome indicator to assess whether heterogeneity changed. If heterogeneity remained largely unchanged after removal, the results were considered robust. Conversely, if significant changes in heterogeneity occurred, the studies contributing to this change were considered potential sources of heterogeneity. Contact details for further information Yumi Wu wyumi8@gmail.com Organisational affiliation of the review Institute of Acupuncture and Moxibustion of China Academy of Chinese Medical Sciences Review team members and their organisational affiliations Dr Yumi Wu. Institute of Acupuncture and Moxibustion of China Academy of Chinese Medical Sciences Dr Yi Gong Fang. Institute of Acupuncture and Moxibustion of China Academy of Chinese Medical Sciences Dr Huan Fang Xu. Institute of Acupuncture and Moxibustion of China Academy of Chinese Medical Sciences Professor Shou Dong Wang. The Out-Patient Department of TCM of China Academy of Chinese Medical Science Type and method of review Meta-analysis, Systematic review Anticipated or actual start date 26 February 2024 Anticipated completion date 31 May 2024 Funding sources/sponsors This study is funded by the "14th Five-Year Plan" National Key Research and Development Program of China (No. 2022YFC3500504) and Chinese Academy of Traditional Chinese Medicine Science Technology Innovation Project (No. CI2021A03502). Conflicts of interest Language Chinese-Simplified, English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms MeSH headings have not been applied to this record Date of registration in PROSPERO 24 February 2024 Date of first submission 14 February 2024 Stage of review at time of this submission The review has not started

Yun, B. S., et al. (2024). "Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)." Journal of Gynecologic Oncology.
	BACKGROUND: Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, well-planned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests. METHODS: The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m²), 4-6 times administered intravenously. The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05421650; Clinical Research Information Service Identifier: KCT0007137.

Yunan, H., et al. (2023). "Subcutaneous G-CSF is superior to intrauterine perfusion in patients with RIF: a systematic review and network meta-analysis of RCTs." PROSPERO International prospective register of systematic reviews.
	Review question In this Network Meta-analysis, we aimed to evaluate which form of administration was better for subcutaneous injection or intrauterine perfusion in patients with Recurrent implantation failure (RIF) on pregnancy outcomes, such as implantation rate (IR), clinical pregnancy rate (CPR), Live birth rate (LBR) and miscarriage rate (MR). The control group was given subcutaneous injection or intrauterine perfusion of normal saline. And, the study design included RCTs. P: RIF I: subcutaneous G-CSF, intrauterine G-CSF C: Control group O: IR/CPR/LBR/MR S: RCTs Searches Three investigators independently searched PubMed, Embase, the Cochrane Library (CENTRAL), Web of Science and China National Knowledge Internet (CNKI), from inception to 10th, April, 2023 with language in English and Chinese. Types of study to be included RCT Condition or domain being studied Recurrent implantation failure (RIF) is a condition can not be ignored in ART, and the cause of RIF is also unknown. With the increasing emphasis on RIF, immunotherapy may become a potential avenue for the treatment of RIF, and G-CSF belongs to one of the methods of immunotherapy. However, the best of the delivery methods for G-CSF has not been reported. Participants/population Inclusion criteria: (1) RIF was defined as two or more IVF/ICSI failures with at least four high-quality embryos transferred; (2) The experimental group was treated with G-CSF and the control group was treated with placebo or no treatment; and (3) the study at least reported one of pregnancy outcomes, such as implantation rate (IR), clinical pregnancy rate (CPR), live birth rate (LBR), and miscarriage rate (MR). Exclusion criteria: (1) using a donor's gametes; (2) combining with other general or surgical diseases; (3) non-RCT studies; (4) self-control or no control group; (5) no available data; (6) less than 20 participants in the trial group or control group. Intervention(s), exposure(s) All interventions included subcutaneous G-CSF injection, intrauterine perfusion of G-CSF, granulocyte-colony stimulating factor. Comparator(s)/control Non-treated control groups Main outcome(s)

Yunan, L., et al. (2021). "Effect of Elagolix on Endometriosis-Associated Pain: A Systematic Review and Meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question The effect of elagolix on endometriosis-associated pain is controversial. We conducted this systematic review and meta-analysis to evaluate whether elagolix could reduce endometriosis-associated pain in women while providing the scientific evidence for clinical treatment. Searches Databases such as the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, Web of Science, Chinese Biomedical Database (CBM), China National Knowledge Infrastructure (CNKI), VIP information database and Wanfang Data were searched from inception to November 30, 2020 Types of study to be included Randomized controlled trials (RCTs) with unlimited languages. Condition or domain being studied Endometriosis is one of the most common benign gynaecological diseases, affecting approximately 10% of women in reproductive age and 50% of infertile patients. It is characterised by the growth of endometrial tissue (glands and stroma) outside the uterine cavity, most frequently on the ovaries, rectovaginal septum, and uterosacral ligaments. Endometriosis, associated with pelvic inflammation, is most commonly manifested by dysmenorrhoea, dyspareunia, gastrointestinal problems, deep pelvic pain as well as infertility, which negatively affect the quality of life in women. Currently, Laparoscopic surgery is the gold standard for the diagnosis and treatment of endometriosis, and it can be used to distinguish the disease stage and remove endometriotic tissues such as peritoneal implants, deep nodules, and ovarian cysts. However, this management strategies can only relieve symptoms and delay recurrence, but unable to cure the disease fundamentally. The clinical benefits are controversial. Participants/population The inclusion criteria: (1) parallel controlled RCTs, (2) evaluation of the effects of elagolix on endometriosis-associated pain, (3) women were women aged 18 to 49 years, with diagnosis of endometriosis by laparoscopic visualization, (4) studies with elagolix/matching placebo as a cointervention in both intervention/control arms were also considered, and (5) the outcomes should refer to the following aspects: dysmenorrhea, nonmenstrual pelvic pain, dyspareunia scores, the percentage of days with prescription analgesic, patient global impression of change scores, changes in quality of life, hot flashes, bone mineral density, estradiol levels, amenorrhea, pregnancy rate, and lipid measurements. The exclusion criteria were as follows: (1) quasi-randomized trials, cohort or case-control studies, reviews, meta-analyses, case reports, animal or cell experiments, (2) women are excluded if they had a history of unresponsiveness to GnRH agonist, (3) studies with unavailable data and unreported target outcomes. Intervention(s), exposure(s) Women were randomly assigned to receive 150 mg of elagolix once daily (lower-dose group), 200 mg of elagolix twice daily (higher-dose group) in the experimental group while placebo was used only in the control group. Comparator(s)/control Placebo was used only in the control group. Main outcome(s) Dysmenorrhea and Nonmenstrual Pelvic Pain. Measures of effect Statistical analysis was performed by Review Manager 5.3. The results were pooled for meta-analysis as the mean difference (MD) with 95% confidence intervals if all studies reported the same scales. When data were reported on different methods or scales, the standardized mean difference (SMD) was calculated. P < 0.05 represented statistical significance. Additional outcome(s) Dyspareunia Scores, The Percentage of Days with Prescription Analgesic, Patient Global Impression of Change Scores, Changes in Quality of Life, Hot Flashes, Bone Mineral Density, Estradiol Levels, Amenorrhea, Pregnancy Rate, and Lipid Measurements. Measures of effect Statistical analysis was performed by Review Manager 5.3. For dichotomous data, the results were expressed as RR with 95% confidence intervals. For continuous data, the results were pooled for meta-analysis as the mean difference (MD) with 95% confidence intervals if all studies reported the same scales. When data were reported on different methods or scales, the standardized mean difference (SMD) was calculated. P < 0.05 represented statistical significance. Data extraction (selection and coding) Two reviewers performed data extraction independently. Data were cross-checked to minimize potential errors, and disagreements were handled through discussion with the corresponding author. The following information was extracted from the included trials: (1) study characteristics, including first author, year of publication and location, (2) participants, including sample size and diagnostic criteria in patients, (3) interventions, including dosage of elagolix, frequency, and duration of treatment, and (4) outcome data at baseline and follow-up. Risk of bias (quality) assessment Two authors assessed the methodological quality of eligible trials via a Cochrane Collaboration tool. Studies were evaluated as low, unclear risk, or high bias based on the following domains: selection bias, performance bias, detection bias, attrition bias, reporting bias and other bias. We judged studies with data loss over 20% as having a high risk of attrition bias. If ≥ 1 feature was unclear, the risk of bias was unclear. If ≥ 1 feature was negative, the study was allocated a high risk of bias Strategy for data synthesis Statistical analysis was performed by Review Manager 5.3 in accordance with the guidelines described in the Cochrane Handbook for Systematic Reviews of Interventions. The random-effects method was preferred for calculating summary effect measures since clinical heterogeneity was inevitable. Statistical heterogeneity within comparisons was evaluated by Cochran’s Q test and quantified by the I² (I²) statistic. I² values < 50% were deemed moderate, those 50% to 75% were deemed substantial, and those > 75% were deemed considerable heterogeneity. Egger’s test and funnel plots were generated to investigate the potential publication bias when there were more than ten trials included in the analysis; otherwise, the power of tests would be too low to distinguish chance from real asymmetry. Analysis of subgroups or subsets The Course of Treatment, Stage of Disease, Age, and Degree of Pain. Contact details for further information Yunan Liu 461919899@qq.com Organisational affiliation of the review None Review team members and their organisational affiliations [1 change] Dr Yunan Liu. Affiliated Hospital of Nanjing University of Chinese Medicine Dr Xiaojing Hu. The First Affiliated Hospital of Henan University of CM Dr Yujie Shang. Affiliated Hospital of Nanjing University of Chinese Medicine Dr Bei Liu. Affiliated Hospital of Nanjing University of Chinese Medicine Professor Huifang Zhou. Affiliated Hospital of Nanjing University of Chinese Medicine Type and method of review Intervention, Meta-analysis, Systematic review Anticipated or actual start date 07 November 2020 Anticipated completion date 01 April 2021 Funding sources/sponsors [1 change] National Natural Science Foundation of China (81774354) Jiangsu Province Graduate Practice Innovation Program (SJCX20_0511) Conflicts of interest Language English Country China Stage of review [1 change] Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Endometriosis; Female; Humans; Hydrocarbons, Fluorinated; Pain; Pyrimidines; elagolix Date of registration in PROSPERO 13 January 2021 Date of first submission 10 November 2020

Yunli, Z., et al. (2022). "Progestogens in women with threatened miscarriage or recurrent miscarriage: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question Whether progestogens are benefit for preveting miscarriage in women with threatened miscarriage or recurrent miscarriage. Searches We will search on EMBASE, MEDLINE, and the Cochrane Central Registry of Controlled Trials and identify all relevant RCTs comparing progestogens with placebo or no treatment for pregnant women with threatened miscarriage or recurrent miscarriage. We will not restrict for the language. Types of study to be included RCTs Condition or domain being studied Threatened miscarriage or recurrent miscarriage Participants/population Pregnant women with threatened miscarriage or recurrent miscarriage. Intervention(s), exposure(s) Progestogens Comparator(s)/control Placebo or no treatment Main outcome(s) the number of patients with miscarriage; the number of live births; the number of preterm births; the number of stillbirths; the number of newborns with congenital abnormalities. Additional outcome(s) the number of pregnant women with severe adverse events. Data extraction (selection and coding) Two reviewers will independently extract the following items with resolution of disagreements as necessary by discussion or adjudication by a third reviewer: study characteristics (author, year of publication, country, sample size, type of funding, whether the study protocol had been previously published); patients characteristics (age); interventions’ characteristics; follow-up time and all interested outcomes. Risk of bias (quality) assessment We will evaluate the risk of bias on an outcome-by-outcome basis using a modified version of the Cochrane risk of bias tool. Strategy for data synthesis We will analyze data using R. As all of our target outcomes are binary outcomes, we will present results as relative risk (RR) and associated 95% CIs. Analysis of subgroups or subsets age of patients; type of miscarriage; gestation age; type of treatment; body mass index (BMI); previous miscarriages. Contact details for further information Yunli Zhao yunlizhao948@outlook.com Organisational affiliation of the review The Center of Gerontology and Geriatrics, West China Hospital, Sichuan University, and National Clinical Research Center for Geriatrics, China. Review team members and their organisational affiliations Dr Yunli Zhao. The Center of Gerontology and Geriatrics, West China Hospital, Sichuan University, and National Clinical Research Center for Geriatrics, China. Ya Gao. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada Gordon Guyatt. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada Type and method of review Intervention, Meta-analysis, Systematic review Anticipated or actual start date 04 July 2022 Anticipated completion date 15 August 2022 Funding sources/sponsors None Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Abortion, Habitual; Abortion, Threatened; Female; Humans; Progestins Date of registration in PROSPERO 15 July 2022 Date of first submission 03 July 2022 Stage of review at time of this submission The review has not started

Yunlu, P. and F. Xiaoling (2023). "Sexual hormonal influence of HIIT in PCOS: a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question P: PCOS patients; I: HIIT C: non-HIIT; O: hormonal and metabolic parameters (SHBG, FAI, AMH, testosterone, HOMA-IR, etc.); S: comparative studies, mainly randomized controlled trials. Question: Can HIIT benefit PCOS patients on hormonal and metabolic parameters? Searches Database: PubMed, Embase, Cochrane Library, Web of Science were searched. Maior terms to build the search strategy: PCOS, High-Intensity Interval Training, RCT, etc. Date: Articles should be published until October 2023. There is no limitation on language, but an English abstract must be provided for non-English articles. Types of study to be included comparative studies, mainly randomized controlled trials. Condition or domain being studied The Polycystic Ovary Syndrome (PCOS) is a prevalent gynecological endocrine disorder, and its associated disruption of sex hormone levels significantly impacts the health of patients. As an emerging exercise modality, further investigation through meta-analysis and other methodologies is required to elucidate the impact of High-Intensity Interval Training (HIIT) on hormone levels in PCOS patients. This will enhance our understanding of the potential application value of HIIT in PCOS treatment and provide valuable insights for future research directions. Participants/population Inclusion criteria: women aged 18–45 (pre-menopausal) and with a diagnosis of PCOS via any established diagnostic criteria. Exclusion criteria:(1) pregnancy, smoking, illness or injury that prevented or limited exercise performance and existing participation in regular physical activity. (2) Those taking anti-hypertensive, insulin sensitizers, dietary supplements, weight loss medication or hormonal contraceptive medications in the 3 months prior to enrolment were excluded. Intervention(s), exposure(s) high-intensity interval training Comparator(s)/control Comparison groups consisted of a non-HIIT control group. Main outcome(s) Hormonal and metabolic parameters (SHBG, FAI, AMH, testosterone, HOMA-IR, etc.) Additional outcome(s) Not planned yet. Data extraction (selection and coding) A data extraction template will be prospectively developed based on the Cochrane Consumers and Communication Review Group's data extraction template and is likely to include five domains. Two reviewers will extract all data from each included study independently with disagreements in data collection being resolved by discussion and consensus. A third reviewer will be consulted to mediate where necessary. Risk of bias (quality) assessment Every included study will be assessed for bias using Cochrane ROB assessment tool. Strategy for data synthesis We evaluated heterogeneity between studies using the I² statistic (<25%, low heterogeneity, 25–50%, moderate heterogeneity, and >50%, high heterogeneity). If heterogeneity remained high, we excluded the analyses and reported the results of synthesis narrative. Data were reported as mean difference with 95% CI, and we used random-effects models. For studies with two or more groups of the comparator (another exercise type or control group) in the meta-analysis, we used data of the control groups only. The meta-analysis was conducted using Stata15.0 for data analysis and to generate figures following standard guidelines. If the P value<0.05, it means that the study has statistical significance. We will use Egger's weighted regression method to evaluate the P value for publication bias, and funnel plots to investigate publication bias if the number of included studies is greater than ten. Analysis of subgroups or subsets Not planned yet. Contact details for further information Yunlu Ping p18846810862@163.com Organisational affiliation of the review The First Affiliated Hospital of Heilongjiang University of Chinese Medicine Review team members and their organisational affiliations Dr Yunlu Ping. Heilongjiang University of Chinese Medicine Dr Xiaoling Feng. The First Affiliated Hospital of Heilongjiang University of Chinese Medicine Type and method of review Intervention, Meta-analysis, Narrative synthesis, Systematic review Anticipated or actual start date 01 September 2023 Anticipated completion date 01 July 2024 Funding sources/sponsors National Natural Science Foundation of China (General Program)NO.81973894; NO.82174421 Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms MeSH headings have not been applied to this record Date of registration in PROSPERO 02 November 2023 Date of first submission 23 October 2023

Yunting, C. and L. Xuefang (2021). "The Role of high intensity focused ultrasound combined with GnRH-α in the Management of Adenomyosis:A Systematic Review and Meta-Analysis of Studies." PROSPERO International prospective register of systematic reviews.
	Review question To evaluate high intensity focused ultrasound combined with GnRH-α in the Management of Adenomyosis Searches The following six electronic bibliographic databases were searched using a comprehensive search strategy developed by an information specialist: (1) Ovid MEDLINE, (2) Ovid EMBASE, (3) PubMed (Non-MEDLINE records only), (4) CNKI-Chinese national knowledge infrastructure, (5) CBM-Chinese biomedical literature database ,(6)Wanfang database,(7) VIP database. We will include all relevant RCTs of TCPM for Endometriosis published inChinese or English.Search performed from inception to April 2019 without restriction on language or geographic origin. Types of study to be included The literature, at home and abroad, is the full text of the complete original data, and the research type is clinical controlled trial (CCT) or randomized controlled trial (RCT) Condition or domain being studied Adenomyosis (AM) is a pathological condition of interstitial and endometrial glands in the myometrium. AM is not a disease that is easy to cure, and the current mainstream treatment methods includes drugs, uterine artery embolization, placement of LNG-IUD, conservative treatment such as high-intensity focused ultrasound (HIFU) and surgical treatment. Due to the nature of the disease, medication including GnRH-a, gestrinone, oral contraceptives, progesterone, danazol, and mifepristone, can reduce the size of the uterus and symptoms, but patients can easily experience relapse after the withdrawal. Currently, the most effective treatment is hysterectomy, but it is difficult for young women who want to preserve their fertility to accept. The application of HIFU in adenomyosis has also been developed and studied, and it has been shown to be safe and effective against uterine fibroids and adenomyosis. How to maximize the quality of life of AM patients is the direction that scholars are exploring, there are reviews have been identified of high intensity focused ultrasound combined with GnRH-α in the Management of Adenomyosis. Participants/population Patients with endometriosis. Endometriosis sites the patients received are not limited. Intervention(s), exposure(s) HIFU combined with GnRH-a treatment was set as the experimental group, Comparator(s)/control Receive HIFU alone as a control group. Main outcome(s) lesion size, Additional outcome(s) uterine size, dysmenorrhea score (VAS – 0 to 10), menstrual blood volume score, CA125. Data extraction (selection and coding) Titles and abstracts of studies retrieved using the search strategy and those from additional sources will be screened independently by two review authors to identify studies that potentially meet the inclusion criteria outlined above. The full text of these potentially eligible studies will be retrieved and independently assessed for eligibility by two review team members. We were not blinded to the names of the authors, institutions or journals of the published studies. Any disagreement between them over the eligibility of articular studies will be resolved through discussion with a third reviewer. A standardised, pre-piloted form will be used to extract data from the included studies for assessment of study quality and evidence synthesis. Extracted information will include: study setting; study design; study population and participant demographics; details of the intervention and control conditions; outcomes; follow-up period. Two review authors will extract data independently, discrepancies will be identified and resolved through discussion (with a third reviewer where necessary). Risk of bias (quality) assessment Two authors will independently assess the methodological quality of all the included studies using RevMan 5.3.0, according to the criteria for judging the risk of bias in the ‘Risk of bias’ assessment tool as set out in the Cochrane Handbook. The judgment of the risk of bias will be categorized as low, unclear, or high, and a kappa score will be used. Strategy for data synthesis Narrative synthesis will be used to describe the type of trials, target population characteristics, intervention content, type of outcome, withdraw rate and follow-up rate. RevMan 5.3.0 provided by the Cochrane Collaboration will be used to quantitative synthesis. A meta-analysis will be performed to analyze the results of the trials if the patient, intervention, control, and outcomes are the same or similar and the data are sufficiently homogeneous. Continuous outcomes will be expressed as weighted mean difference (WMD) and dichotomous data will be expressed as relative risk (RR), while 95% confidence intervals (CI) will be calculated for both. Heterogeneity will be assessed using both the ?² test and the I² statistic. It indicates substantial heterogeneity when I² value is more than 50%. We will pool data using fixed effects model when heterogeneity is not significant; otherwise we will use random effects model. Funnel plots will be generated to detect publication bias when more than ten trials are identified. We will use the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) summary of findings table to minimize bias in our findings and recommendations. Analysis of subgroups or subsets If the necessary data are available, subgroup analyses will be done for people with different medical treatment Contact details for further information Yunting Chen s1cytt@163.com Organisational affiliation of the review Guangzhou university of Chinese medicine Review team members and their organisational affiliations Miss Yunting Chen. Guangzhou university of Chinese medicine Xuefang Liang. The Second Affiliated Hospital of Guangzhou University of Chinese Medicine/Guangdong Provincial Hosptial of TCM, Guangzhou Guangdong 510120, China Type and method of review Systematic review Anticipated or actual start date 01 June 2021 Anticipated completion date 29 June 2021 Funding sources/sponsors None Conflicts of interest Language Chinese-Simplified, English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Adenomyosis; Female; Gonadotropin-Releasing Hormone; High-Intensity Focused Ultrasound Ablation; Humans; Treatment Outcome Date of registration in PROSPERO 30 June 2021 Date of first submission 31 May 2021

Yunyun, Z. and M. Zuoxiong (2021). "Acupuncture ameliorates negative emotion in PCOS patients: a protocol for systematic review and meta analysis." PROSPERO International prospective register of systematic reviews.
	Review question To eveluate the effectiveness and safety of acupuncture ameliorating negative emotion in PCOS patients. Searches The following electronic databases will be searched from the respective dates of database inception to May 01, 2021: The Cochrane Library, PubMed, Web of Science, EMBASE, China Science and Technology Journal (VIP), China National Knowledge Infrastructure(CNKI), Wanfang and Chinese Biomedical Literature Database(CBM) and other sources. All published English and Chinese RCTs will be included. Search strategy: #1 MeSH Major Topic: Randomized controlled trial #2 MeSH Major Topic: Randomized clinical trial #3 MeSH Major Topic: Controlled clinical trial #4 MeSH Major Topic: Randomly #5 MeSH Major Topic: Trial #6 Or/1-5 #7 MeSH Major Topic: PCOS #8 MeSH Major Topic: polycystic ovary syndrome #9 MeSH Major Topic: ovary polycystic disease #10 MeSH Major Topic: ovary syndrome #11 MeSH Major Topic: hyperandrogenemia #12 MeSH Major Topic: oligo-amenorrhea #13 MeSH Major Topic: oligoamenorrhea #14 MeSH Major Topic: oligoanovulatory #15 MeSH Major Topic: oligohypomenorrhea #16 MeSH Major Topic: amenorrhea #17 MeSH Major Topic: amenorrhoea #18 MeSH Major Topic: hirsutism #19 MeSH Major Topic: Stein Leventhal Syndrome #20 Or/7-19 #21 MeSH Major Topic: acupuncture #22 MeSH Major Topic: electroacupuncture #23 MeSH Major Topic: acupoint #24 MeSH Major Topic: acupressure #25 MeSH Major Topic: acupressure-acupuncture therapy #26 MeSH Major Topic: electro-acupuncture #27 MeSH Major Topic: moxibustion #28 MeSH Major Topic: fire needle #29 MeSH Major Topic: needle-knife #30 MeSH Major Topic: auricular point #31 MeSH Major Topic: superficial needling #32 MeSH Major Topic: scalp acupuncture #33 MeSH Major Topic: abdominal acupuncture #34 MeSH Major Topic: balance acupuncture #35 MeSH Major Topic: traditional medicine #36 MeSH Major Topic: traditional Chinese medicine #37 MeSH Major Topic: traditional Chinesemedicine combined with western medicine #38 Or/21-37 #39 6, 20 and 38 Types of study to be included Randomized controlled(clinical) trials. Condition or domain being studied Women with PCOS. Participants/population Women with polycystic ovary syndrome. Only studies with women diagnosed with polycystic ovary syndrome based on the score of Self-Rating Depression Scale or Self-Rating Anxiety Scale reaching mild depression or anxiety or above.Age between 18 and 70 years old. There will be no restriction of race or other restrictions. Intervention(s), exposure(s) Various types of acupuncture will be included. Comparator(s)/control Control included sham acupuncture, active control, including western medicines, Chinese medicines, and dietary supplements, waiting-for-treatment, no treatment. Main outcome(s) The degree of depression and anxiety. Measures of effect Self-Rating Depression Scale(SDS), Self-Rating Anxiety Scale(SAS). Additional outcome(s) Satisfaction of sexual life, the level of estrogen/adrenaline/insulin/sex hormone, quality of life. Measures of effect Oral Glucose Tolerance Test Insulin(OGTT), Life Satisfaction Rating Scales (LSR). Data extraction (selection and coding) Two independent reviewers will search the database. The titles and abstracts will be reviewed and the articles that do not fit the eligibility criteria will be excluded. If the title or abstract appeared to meet the eligibility criteria, the full texts of the articles will obtain for further evaluation. Data will be extracted independently by the two reviewers, using a pre-designed form in which characteristics of participants, interventions, comparisons, and main outcomes. Discrepancies between the reviewers will be resolved by the third reviewer or the consensus among all reviewers. Risk of bias (quality) assessment We conducted the selection of studies by using criteria from the Cochrane Handbook for Systematic Reviews of Interventions. The criteria consist of 7 items: random sequence generation, allocation concealment, blinding of participants and researchers, blinding of outcome assessment, incomplete outcome data, selective outcome reporting, and other sources of bias. Strategy for data synthesis All statistical analyses will be conducted using the Cochrane Collaboration’s software programme Review Manager (RevMan) version 5.3. The dichotomous variable (e.g. live birth rate) measure will be summarized by risk ratio (RR) with a 95% confidence interval (CI). For the continuous variables (e.g. insulin level), the results will be pooled and expressed as mean differences (MD) using inverse variance methods and the random-effects model with 95% confidence intervals (CI). Heterogeneity among studies will be assessed using Cochran’s Q and I² statistic. When P>0.1, I² <50%, we will use a fixed effect model; when P<0.1, I² >50%, we will explore the reasons for heterogeneity. Analysis of subgroups or subsets A subgroup analysis will be conducted according to SAS, SDS and BMI. Contact details for further information Youkang Dong dykheaven@126.com Organisational affiliation of the review The First Affiliated Hospital of Yunnan Chinese Medicine University/Yunnan Provincial Hospitalof Traditional Chinese Medicine. http://www.yn-tcm-hospital.com Review team members and their organisational affiliations Yunyun Zhao. School of Acupuncture-Tuina and Rehabilitation,Yunnan University of Chinese Medicine Zuoxiong Miao. School of Acupuncture-Tuina and Rehabilitation, Yunnan University of Chinese Medicine Type and method of review Meta-analysis, Systematic review Anticipated or actual start date 01 May 2021 Anticipated completion date 01 May 2023 Funding sources/sponsors National Natural Science Foundation;Technology Department-Applied Basic Research Joint Special Funds of the Yunnan University of Chinese Medicine. Grant number(s) State the funder, grant or award number and the date of award No.81860884;No. 2019FF002 (-024. Conflicts of interest None known Language English Country China Stage of review Review Completed published Subject index terms status Subject indexing assigned by CRD Subject index terms Acupuncture Therapy; Emotions; Female; Humans; Polycystic Ovary Syndrome Date of registration in PROSPERO 27 January 2021 Date of first submission 04 January 2021 Stage of review at time of this submission The review has not started

Yusi, H., et al. (2023). "Different endometrial preparation protocols on pregnancy outcomes in frozen-thawed embryo transfer in patients with adenomyosis: systematic review and network meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question There are many endometrial preparation protocols to improve pregnancy outcomes before FET for patients with adenomyosis, and their effectiveness and safety are worth affirming. But are there differences between different pre-treatment protocols in improving FET results? And what is the most effective endometrial preparation method for frozen embryo transfer? Searches We will search, with no time restrictions, the following databases for relevant English literature: PubMed, Embase, Cochrane Library, MEDLINE, Web of Science, Scopus, SpringerLink, EBSCO, and searched from database establishment to May 1, 2023. Types of study to be included Randomized controlled trials and clinical trials comparing the efficacy of different endometrial preparation for interventional frozen-thawed embryo transfer, nonrandomized trials, reviews, case reports, editorials, commentaries, and animal experiments will be excluded. Condition or domain being studied Adenomyosis, endometrial preparation, Frozen-thawed embryo transfer. Participants/population Participants who received frozen-thawed embryo transfer with different endometrial pretreatment. Intervention(s), exposure(s) All kinds of endometrial preparation before FET Comparator(s)/control All kinds of endometrial preparation before FET Context The success rate of frozen-thawed embryo transfer (FET) is still only 30 – 50%, and it is urgent to improve the success rate of patient transfer. Acupuncture and moxibustion is considered to improve ovarian function to a certain extent, promote follicular development, improve endometrial thickness and morphology, improve endometrial receptivity and facilitate embryo implantation and development, and relieve anxiety, thereby improving pregnancy outcomes. However, because of the wide variety of acupuncture therapy, it was selected to compare the differences in the efficacy of different acupuncture therapy-assisted FET by reticular meta-analysis. Main outcome(s) Implantation rate, Biochemical pregnancy rate (BPR), Clinical pregnancy rate, Live birth rate Measures of effect Binary variable/count data were used to express the effect size with odds ratio (OR) and 95% confidence interval (CI). Additional outcome(s) miscarriage rate Measures of effect Binary variables/enumeration data were expressed as effect size using odds ratio (OR) and 95% confidence interval (CI); continuous variables/measurement data were expressed as effect size using mean difference (MD) and 95% CI confidence interval (95% CI). Data extraction (selection and coding) According to the established literature inclusion and exclusion criteria, two investigators independently completed literature screening by reading the title, abstract, and full text in turn, and then cross-checked the results, and if there were differences, they were handed over to the corresponding author for consultation and decision. Establish the literature information extraction table in Excel 2010, and the extraction information includes: title, author, publication time, journal name, inclusion and exclusion criteria, relevant information of risk of bias evaluation, sample size, age, disease course, endometrial preparation protocol, intervention measures, course of treatment and outcome indicators. Risk of bias (quality) assessment The included literatures were evaluated according to the "risk of bias assessment tool" recommended by Cochrane5.1. Including seven aspects: ① generation of random sequence, ② allocation concealment, ③ implementation of blind method, ④ implementation of blind method for result evaluation, ⑤ integrity of result data, ③ selective reporting of study results, and ② presence of other biases. For each evaluation item, its risk bias was classified into three categories: low risk, unclear risk, and high risk. RevMan 5.3 software was used to draw the literature quality evaluation diagram. Strategy for data synthesis We will analyze the included studies using the NMA technique. We will compare the Main outcomes using ADDIS software 1.16.5 and Stata software 15.0. NMA is a technique recommended by the International Society for Pharmacoeconomics and Outcome Research (ISPOR) to compare outcomes between different treatments. NMA uses a Bayesian approach and allows comparisons among all treatment arms of the studies, including direct and indirect comparisons simultaneously. To obtain the pooled effect sizes, a random-effect model based on the Markov chain Monte Carlo (MCMC) simulation method was built using a Bayesian approach. A consistency model will be drawn for each evaluated outcome and treatments’ relative effect sizes were calculated using odds ratios (OR) for binary outcomes and mean difference (MD) for continuous outcomes. Results will be reported with 95% credibility intervals (CrI). Rank probabilities will be also built to increase the estimate precision of the relative effect sizes of comparisons, enabling conclusions to be drawn for each outcome of interest. These ranks account for all treatments and order them according to their probability of being the best, second best and so on. The robustness of the models will be estimated using node splitting analysis, which reveals possible differences among direct and indirect comparisons of a particular node and its ramifications in the network; p values <0.05 reveal inconsistencies in the network that should be further investigated. Analysis of subgroups or subsets We will consider subgroups such as types of clinical trails, different methods for endometrial preparation. Contact details for further information HAN YUSI hanyusi2689@163.com Organisational affiliation of the review Shandong University of Traditional Chinese Medicine Review team members and their organisational affiliations Miss Yusi Han. Shandong University of Traditional Chinese Medicine Jianwei Zhang. The Affiliated Hospital of Shandong University of Traditional Chinese Medicine Xiangyu Ren. Jinan Municipal Hospital of Traditional Chinese Medicine Type and method of review Meta-analysis, Network meta-analysis, Systematic review Anticipated or actual start date 13 March 2023 Anticipated completion date 01 June 2023 Funding sources/sponsors None Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Adenomyosis; Embryo Transfer; Endometrium; Female; Humans; Meta-Analysis as Topic; Pregnancy; Pregnancy Outcome; Systematic Reviews as Topic Date of registration in PROSPERO 24 March 2023 Date of first submission 13 March 2023

Yuting, C. and F. Xiaoyin (2023). "A systematic review and meta-analysis of autologous and allogeneic stem cell therapy for premature ovarian insufficiency." PROSPERO International prospective register of systematic reviews.
	Review question The meta-analysis aimed to compare the efficacy and safety of autologous and allogeneic stem cells in the treatment of premature ovarian insufficiency. Searches We will search articles in three electronic database including PubMed, EMBASE and Cochrane Library. All the English publications until 30 September 2023 will be searched without any restriction of countries or article type.Our search scope was all studies of stem cell therapy for POI. Types of study to be included Prospective studies and Randomized controlled trials Condition or domain being studied Primary ovarian insufficiency (POI) is a syndrome characterized by reduced or absent ovarian function (hypogonadism) and elevated levels of gonadotropin. The etiology of POI is complex, involving genetic, immune, environmental and iatrogenic factors. The prevalence of POI is about 1-3%. Treatments for POI include psychotherapy, life management, hormone replacement therapy (HRT), and traditional Chinese Medicine (TCM). Although HRT can relieve the symptoms of estrogen deficiency, there is still no effective treatment for ovarian function reversal. With the development of regenerative medicine, more and more researchers began to pay attention to the application of stem cells in POI treatment. Stem cells, which have self-renewal and regeneration functions, have the potential to become a new treatment for POI. Stem cells can differentiate into ovarian cells in the POI microenvironment, supplementing the number of normal ovarian cells. The ovarian cells regenerated by stem cells can secrete estrogen, maintain hormonal balance, and improve symptoms caused by decreased ovarian function in women. Autologous mesenchymal stem cells and allogeneic mesenchymal stem cells have different therapeutic effects on POI. There have been no systematic reviews and meta-analyses to evaluate the efficacy and safety of clinical trials of autologous and allogeneic stem cells in patients with POI. Participants/population Inclusion Criteria The inclusion criteria were as follows: (a) the patient has confirmed the diagnosis of POI; (b) all patients with POI treated with autologous or allogeneic stem cells; (c) complete results, including at least one outcome of resumption of menstruation, hormones level (FSH, AMH), antral follicle, ovarian volume, pregnancy; (d) all results consistent with the design and reporting of prospective and randomized controlled studies. Exclusion Criteria Exclusion criteria were as follows: (a) duplicate studies in the three databases; (b) the selected subjects were animals such as mice, rats, and rabbits, among others; (c) the selected object was a review; (d) despite matching with the MeSH terms and free words, the content was not specific to stem cell therapy for POI; (e) the title and abstract were relevant to the topic, but the full text could not be found. Intervention(s), exposure(s) Stem cell therapy is the main intervention, including autologous and allogeneic mesenchymal stem cells. Comparator(s)/control Patients with POI receive hormone therapy or no treatment at all. Main outcome(s) resumption of menstruation, hormones level (FSH, AMH), antral follicle, ovarian volume, pregnancy Additional outcome(s) fever, rash, pelvic bleeding, headache, infectious diseases, neoplasms, abnormal liver function and abnormal renal function Data extraction (selection and coding) The authors jointly identified medical subject title (MeSH) terms and other search terms for article retrieval. Two authors independently and systematically searched PubMed, Embase, and Cochrane databases (until 30 September 2023) and extracted data. In the event of a dispute, the two authors negotiate until a consensus is reached or a third author is invited to make a final judgment. The content extracted from each article includes (a) the first author, the year and country studied; (b) patient's age, main symptoms and previous treatment; (c) Changes in menstruation, hormone levels (FSH, AMH), sinus follicles, ovarian volume, pregnancy before and after treatment; (d) Type of stem cells (autologous or allogeneic) and dose of stem cell therapy; (e) Side effects, such as fever, rash, pelvic bleeding, headache, infectious diseases, tumors, abnormal liver function, abnormal kidney function. Risk of bias (quality) assessment Two authors will independently assess risk of bias based on the following domains from recommendations from the Cochrane handbook:1. Adequate sequence generation;2. Allocation concealment;3. Blinding;4. Incomplete outcome data and how it was addressed;5. Selective reporting of the outcome;6. Any other biases. Results of bias assessment will be presented in a figure and a graph indicating low, high or unclear risk of bias for each of the 6 items in each trial. Strategy for data synthesis In the meta-analysis, Q test and I² test were used to analyze the heterogeneity of the studies. If P>0.1 in Q test and I²<50% in I² test indicates no heterogeneity, the fixed effects model (MantelHaenszel method) is used for analysis, and the random effects model (Der Simonian-Laird method) is used for analysis. RRS and 95%CI were used to compare ovarian function improvement and adverse events between autologous stem cells and allogeneic stem cells, and to evaluate the efficacy and safety of autologous stem cells and allogeneic stem cells. If 95%CI includes 1, there is no statistical significance; otherwise, there is statistical significance. Heterogeneity analysis was performed by Stata17 software. Analysis of subgroups or subsets The number of stem cells was classified to compare the efficacy and safety of different doses of stem cells in the treatment of POI. Contact details for further information Yinmei Dai fcyydym@163.com Organisational affiliation of the review Department of Gynecology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University/Beijing Maternal and Child Health Care Hospital, Beijing, China Review team members and their organisational affiliations Dr Yuting Cao. Department of Gynecology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University/Beijing Maternal and Child Health Care Hospital, Beijing, China Dr Xiaoyin Fan. Department of Gynecology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University/Beijing Maternal and Child Health Care Hospital, Beijing, China Type and method of review Meta-analysis, Systematic review Anticipated or actual start date 30 September 2023 Anticipated completion date 30 November 2023 Funding sources/sponsors There is no funding for our research. Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Female; Hematopoietic Stem Cell Transplantation; Humans; Menopause, Premature; Primary Ovarian Insufficiency; Stem Cell Transplantation Date of registration in PROSPERO 27 August 2023 Date of first submission 17 August 2023

Yuxi, Z., et al. (2023). "Radical surgery versus radiotherapy in early staged cervical cancer with lymph node metastasis: a meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question The aim of this meta-analysis is to compare the prognosis early staged cervical cancer with lymph node metastasis treated by Radical surgery versus radiotherapy Searches All published articles in English from January 1991 to August 2023 were searched in PubMed, Embase, Cochrane Library, Web of Science (WOS), and Open Access Library (OALib) databases to retrieve research articles comparing the prognosis of radical surgery and radiotherapy in the treatment of cervical cancer with lymph node metastasis. Two researchers independently screened the literature using a combination of MESH terms and free words. The search keywords included "cervical cancer," "cervical neoplasm," "cervix neoplasm," "cervix cancer," "lymph node metastasis," "lymph node involvement," "nodal involvement," "nodal metastasis," "positive lymph node," "radical surgery," "radical hysterectomy," "radiotherapy," "radiochemotherapy," "concurrent radiochemotherapy," "chemoradiation," and "concurrent chemoradiation." Types of study to be included Randomized controlled trial or cohort study Condition or domain being studied Cervical cancer causes approximately 300000 deaths annually worldwide. Due to the lack of organized screening and human papillomavirus vaccination programs, nearly 90% of cervical cancer occurs in low-income and middle-income countries. The treatment of cervical cancer mainly includes surgery, radiotherapy and chemotherapy, or a combination of both. For women with early clinical cervical cancer, the standard treatment methods are radical hysterectomy and bilateral pelvic lymph node resection. For women with obvious early cervical cancer, one of the most controversial topics in management algorithms is the treatment of patients with regional lymph node involvement identified during surgery. Participants/population The study population consisted of newly diagnosed cervical cancer patients with lymph node involvement or metastasis. Intervention(s), exposure(s) radical hysterectomy with systemic lymph node dissection followed by adjuvant radiation Comparator(s)/control radiotherapy or concurrent radiochemotherapy Main outcome(s) Recurrence, death, overall survival (OS), disease-free survival (DFS) Measures of effect Odds ratios Additional outcome(s) Adverse events (AEs) Measures of effect Odds ratios Data extraction (selection and coding) Two researchers independently extracted data from the literature. The extracted data from each researcher were cross-checked, and any disagreements were resolved through discussion or with the assistance of a third researcher. The extracted information from each included article included the first author's name, publication date, study location, sample size, demographic information, treatment modalities and adjuvant treatment. The extracted outcomes from each article include recurrence, death, overall survival (OS), disease-free survival (DFS) and adverse events (AEs). Risk of bias (quality) assessment If the included studies were randomized controlled trials, the Cochrane bias risk assessment tools were used to assess the quality of the included literature. If the studies were cohort studies, the Newcastle-Ottawa Scale (NOS) assessment tool was used to evaluate the quality of the included literature. Strategy for data synthesis Statistical analysis was performed using Review Manager 5.4 software. For categorical data, the effect measures were expressed as odds ratios (OR) with 95% confidence intervals (CI). For continuous data, the effect measures were expressed as mean differences (MD), along with their corresponding point estimates. The Q-test was used to assess heterogeneity among the included articles, and the I² was calculated to quantify the degree of heterogeneity. I² ≤ 50% and P > 0.05 indicated no significant heterogeneity, and a fixed-effect model was used. I² > 50% or P < 0.05 indicated a significant heterogeneity, and a random-effects model (REM) was used. The symmetry of the funnel plot was assessed to evaluate publication bias among the included articles. Asymmetric distribution in the plot suggested possible publication bias. The Egger's test was used for quantitative analysis of publication bias, and a P-value < 0.05 indicated statistically significant publication bias. Analysis of subgroups or subsets We conducted subgroup analysis for different types of adverse events to understand the differences of adverse events in different systems. Contact details for further information Lingying Wu wulingying@csco.org.cn Organisational affiliation of the review Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College Review team members and their organisational affiliations Dr Yuxi Zhao. Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College Dr Jian Li. Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College Dr Jia Zeng. Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College Jusheng An. Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College Dr Lingying Wu. Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College Type and method of review Intervention, Meta-analysis, Prognostic, Systematic review Anticipated or actual start date 15 September 2023 Anticipated completion date 31 October 2023 Funding sources/sponsors None Conflicts of interest Language English Country China Stage of review Review Ongoing Subject index terms status Subject indexing assigned by CRD Subject index terms Female; Humans; Lymph Nodes; Lymphatic Metastasis; Neck; Prognosis; Uterine Cervical Neoplasms Date of registration in PROSPERO 10 September 2023 Date of first submission 30 August 2023

Zaat, T., et al. (2021). "Fresh versus frozen embryo transfers in assisted reproduction." The Cochrane Database of Systematic Reviews 2: CD011184.
	Background: In vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatments conventionally consist of a fresh embryo transfer, possibly followed by one or more cryopreserved embryo transfers in subsequent cycles. An alternative option is to freeze all suitable embryos and transfer cryopreserved embryos in subsequent cycles only, which is known as the 'freeze all' strategy. This is the first update of the Cochrane Review on this comparison.; Objectives: To evaluate the effectiveness and safety of the freeze all strategy compared to the conventional IVF/ICSI strategy in women undergoing assisted reproductive technology.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and two registers of ongoing trials from inception until 23 September 2020 for relevant studies, checked references of publications found, and contacted study authors to obtain additional data.; Selection Criteria: Two review authors (TZ and MZ) independently selected studies for inclusion, assessed risk of bias, and extracted study data. We included randomised controlled trials comparing a 'freeze all' strategy with a conventional IVF/ICSI strategy including a fresh embryo transfer in women undergoing IVF or ICSI treatment.; Data Collection and Analysis: The primary outcomes were cumulative live birth rate and ovarian hyperstimulation syndrome (OHSS). Secondary outcomes included effectiveness outcomes (including ongoing pregnancy rate and clinical pregnancy rate), time to pregnancy and obstetric, perinatal and neonatal outcomes.; Main Results: We included 15 studies in the systematic review and eight studies with a total of 4712 women in the meta-analysis. The overall evidence was of moderate to low quality. We graded all the outcomes and downgraded due to serious risk of bias, serious imprecision and serious unexplained heterogeneity. Risk of bias was associated with unclear blinding of investigators for preliminary outcomes of the study during the interim analysis, unit of analysis error, and absence of adequate study termination rules. There was an absence of high-quality evidence according to GRADE assessments for our primary outcomes, which is reflected in the cautious language below. There is probably little or no difference in cumulative live birth rate between the 'freeze all' strategy and the conventional IVF/ICSI strategy (odds ratio (OR) 1.08, 95% CI 0.95 to 1.22; I 2 = 0%; 8 RCTs, 4712 women; moderate-quality evidence). This suggests that for a cumulative live birth rate of 58% following the conventional strategy, the cumulative live birth rate following the 'freeze all' strategy would be between 57% and 63%. Women might develop less OHSS after the 'freeze all' strategy compared to the conventional IVF/ICSI strategy (OR 0.26, 95% CI 0.17 to 0.39; I 2 = 0%; 6 RCTs, 4478 women; low-quality evidence). These data suggest that for an OHSS rate of 3% following the conventional strategy, the rate following the 'freeze all' strategy would be 1%. There is probably little or no difference between the two strategies in the cumulative ongoing pregnancy rate (OR 0.95, 95% CI 0.75 to 1.19; I 2 = 31%; 4 RCTs, 1245 women; moderate-quality evidence). We could not analyse time to pregnancy; by design, time to pregnancy is shorter in the conventional strategy than in the 'freeze all' strategy when the cumulative live birth rate is comparable, as embryo transfer is delayed in a 'freeze all' strategy. We are uncertain whether the two strategies differ in cumulative miscarriage rate because the evidence is very low quality (Peto OR 1.06, 95% CI 0.72 to 1.55; I 2 = 55%; 2 RCTs, 986 women; very low-quality evidence) and cumulative multiple-pregnancy rate (Peto OR 0.88, 95% CI 0.61 to 1.25; I 2 = 63%; 2 RCTs, 986 women; very low-quality evidence). The risk of hypertensive disorders of pregnancy (Peto OR 2.15, 95% CI 1.42 to 3.25; I 2 = 29%; 3 RCTs, 3940 women; low-quality evidence), having a large-for-gestational-age baby (Peto OR 1.96, 95% CI 1.51 to 2 55; I 2 = 0%; 3 RCTs, 3940 women; low-quality evidence) and a higher birth weight of the children born (mean difference (MD) 127 g, 95% CI 77.1 to 177.8; I 2 = 0%; 5 RCTs, 1607 singletons; moderate-quality evidence) may be increased following the 'freeze all' strategy. We are uncertain whether the two strategies differ in the risk of having a small-for-gestational-age baby because the evidence is low quality (Peto OR 0.82, 95% CI 0.65 to 1.05; I 2 = 64%; 3 RCTs, 3940 women; low-quality evidence).; Authors' Conclusions: We found moderate-quality evidence showing that one strategy is probably not superior to the other in terms of cumulative live birth rate and ongoing pregnancy rate. The risk of OHSS may be decreased in the 'freeze all' strategy. Based on the results of the included studies, we could not analyse time to pregnancy. It is likely to be shorter using a conventional IVF/ICSI strategy with fresh embryo transfer in the case of similar cumulative live birth rate, as embryo transfer is delayed in a 'freeze all' strategy. The risk of maternal hypertensive disorders of pregnancy, of having a large-for-gestational-age baby and a higher birth weight of the children born may be increased following the 'freeze all' strategy. We are uncertain if 'freeze all' strategy reduces the risk of miscarriage, multiple pregnancy rate or having a small-for-gestational-age baby compared to conventional IVF/ICSI. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Zbucka-Krętowska, M. (2023). "Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility." ClinicalTrials.gov.
	No Results Available Drug: Metformin Hydrochloride|Drug: Placebo Effects of metformin on fertility and the possibility of becoming pregnant,as measured by pregnancy test strips and β-hCG levels|Evaluation of the effect of metformin therapy on endometrial function.|Molecular analysis of endometrial tissues using Next Generation Sequencing (NGS) technology|Intra-tissue metabolic profiling of steroids|Oxidative stress evaluation by using total oxidative capacity (TOC) and total antioxidant capacity (TAC)|Quality of Life questionary evaluation SF-36, FertiQoL Female Phase 2 200 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment 2021/ABM/03/00006 September 30, 2027

Zelcer, M. (2023). "Waitlist management for persistent pelvic pain patients waiting to see a specialist gynaecology clinic in Melbourne, Australia." International Clinical Trials Registry Platform (ICTRP).
	INTERVENTION: Patients referred by their GP to the Gynaecology specialist clinic as the Mercy Hospital for Women with persistent pelvic pain will be identified and contacted for participation in this study. Consenting patients will be randomly allocated equally to the study's control or active arm. Active arm: patients will be triaged and placed on the waitlist the same as the control group, however the GP will be also sent education and guidelines on how to manage the patient’s persistent pelvic pain (PPP) prior to the first appointment. In this group it will be communicated with the GP that it is expected that the GP will initiate treatment according to these guidelines prior to the patient being seen in clinic from this point, patients will be seen by their GPs as per the GP's discretion. The aim of management whilst on the waitlist will be to manage the PPP by stopping their periods and becoming amenorrhoeic. GPs will have the ability to communicate routinely with the specialist clinic via an email address for any questions which will be checked weekly by a clinician from the clinic. Like the control group, patients in the active group will eventually be seen in the gynaecology specialist clinic at the Mercy as per waitlist times. They would however been managed while waiting for their initial visit in clinic. GPs will be provided with a hormone management plan aimed to create amenorrhoea, or as close to as possible, and with as few side effects as possible. This is a standard guideline in the treatment of persistent pelvic pain that includes: Combined oral Contraceptive Pill (OCP), Progesterone only option and long‐acting reversible contraceptives (IUD). Intervention period depends on the Mercy's gynaecology specialist clinic waitlist times, currently this is esti CONDITION: Anaesthesiology ‐ Pain management Persistent Pelvic Pain; ; Persistent Pelvic Pain Public Health ‐ Health service research PRIMARY OUTCOME: A reduction in patient's most bothersome pain symptom from referral to first appointment in clinic, in the active group compared to the control group using a Visual Analogue Scale (VAS) of 0‐10 where 0 represents 'no pain' and 10 'most imaginable pain'. ; [Baseline, 6 months and 12 months (first appointment in clinic) post‐commencement of intervention/post randomisation.] INCLUSION CRITERIA: • Patients aged 18 years or older referred to the general gynaecology clinic whose primary or secondary complain is persistent pelvic pain (pain occurring for >3 months) • English speakers • Pre‐menopausal SECONDARY OUTCOME: Number of GP appointments/ED visits/inpatient hospitalizations due to persistent pelvic pain in the active group compared with the control group. This will be assessed through audit of patient medical records.[6 and 12 months (first visit to clinic) post‐commencement of intervention/post randomisation.] The number of patients not requiring specialist appointment due to adequate management of pain prior to first appointment in the active group compared with the control group. This will be assessed by following up on patients who do not attend their first appointment to determine the reason for non‐attendance.[12 months (first appointment in clinic) after intervention where patients who do not attend their first appointment will be contacted to determine the reason for non‐attendance.]

Zeneli, D. (2021). "Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis." ClinicalTrials.gov.
	This is a randomized, double‐blind, placebo‐controlled clinical investigation. The objective of the study is to confirm the efficacy of Multi‐Gyn ActiGel Plus to treat BV as compared to a placebo control. Treatment arm 1: Multi‐Gyn ActiGel Plus Treatment arm 2: placebo gel Both the Multi‐Gyn ActiGel Plus and the placebo will be applied twice a day for 7 consecutive days. Visit 2 will be performed at 3 weeks after start of treatment A phone call will take place, at 5 weeks after start of treatment for subject with clinical cure at Visit 2. The total duration per subject is estimated 5 weeks and the total study duration is 13 months. Sample size is 100 subjects per treatment arm.

Zeng, H., et al. (2023). "Metformin combined with spironolactone vs. metformin alone in polycystic ovary syndrome: a meta-analysis." Frontiers in Endocrinology 14: 1223768.
	Aims: Due to its high heterogenicity and unclear etiology, there is currently no specific treatment for polycystic ovary syndrome (PCOS). Metformin, as an insulin sensitizer, combined with spironolactone, an antiandrogen medication, may exert complementary effects on PCOS. We therefore performed a meta-analysis of trials in which metformin combined with spironolactone was applied to treat PCOS to evaluate the efficacy and safety of the combination therapy.; Methods: We retrieved the PubMed, Embase, Scopus, Cochrane Library, CNKI, CBM, Wangfang, and VIP databases for literatures published from their inception to December 16, 2022 on the effects of metformin combined with spironolactone in the treatment of PCOS. Inclusion criteria according to P.I.C.O.S criteria were: PCOS patients, metformin combined with spironolactone interventions, metformin alone control group, and randomized controlled trials with the following outcome data: body mass index (BMI), hirsutism score, luteinizing hormone (LH), follicle-stimulating hormone (FSH), total testosterone (TT), fasting blood glucose (FBG), Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), and side effects including nausea, vomiting, diarrhea and drug withdrawal.; Results: Our results revealed that metformin combined with spironolactone significantly reduced BMI and TT, but that it exerted no significant effects on hirsutism score, or on FSH or LH concentrations. Combined treatment also resulted in a significant diminution in FBG and insulin resistance using the HOMA-IR when the interventional time was greater than 6 months. In addition, the combination did not have a higher occurrence of adverse reactions than metformin alone.; Conclusion: Compared with metformin alone, metformin combined with spironolactone therapy may be more effective in reducing BMI and serum androgen levels, but the combination showed no significant effect on the hirsutism score or gonadotropin hormone levels, and was not associated with an elevation in side-effects. Moreover, when the treatment course was greater than 6 months, combination therapy reduced FBG and improved insulin resistance more effectively than metformin alone. However, more research is needed to determine the most effective course of treatment.; Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42022355515.; 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 Zeng, Zhang, Huang, Wu, Ren, Zhou, Huang and Ye.)

Zeng, P., et al. (2021). "Efficacy and safety of traditional Chinese herbal medicine in the treatment of threatened abortion: A protocol for systematic review and meta-analysis." Medicine 100(5): e23288.
	Background: Threatened abortion (TA) is the commonest complication that occurs in early pregnancy, especially in 8-12 gestational weeks when the secretion of estrogen and progesterone shifts from corpus luteum to placental. Conventional therapies are little evidence of their value. In China, traditional Chinese herbal medicine has been widely used for the treatment of TA for a long time. The lack of strong scientific evidences make this a priority area for research. We aim to evaluate the efficacy and safety of traditional Chinese herbal medicine in the treatment of TA, provide medical staffs with more useful information, and provide patients with better advises.; Methods: We will search 8 databases and additional sources, including the Web of Science, PubMed, Cochrane Library, Embase, CBM, Wanfang, VIP, CNKI, and WHO ICTRP, ChiCTR, Clinical Trials, Grey Literature Database, for potentially eligible studies. Literature search, screening and retrieval are performed independently by two researchers. In the event of a dispute, a third party will be consulted to support the judgment. We will use RevmanV.5.3 to perform a fixed-effect meta-analysis for clinical homogeneity study data, and the level of evidence will be assessed using the GRADE method.; Results: This systematic review and meta-analysis will put a high-quality synthesis of the efficacy and safety of traditional Chinese herbal medicine in the treatment of TA.; Conclusion: The conclusion of this systematic review will provide evidence to assess traditional Chinese herbal medicine therapy whether is an efficacy and safe intervention to treat TA.; Ethics and Dissemination: Since this article does not contain patient personal information, ethical approval is not required. The contract is distributed by a peer-reviewed journal or conference report.; Registration Number: 10.17605/OSF.IO/DG3T8.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Zeng, Z., et al. (2022). "Evaluation of the efficacy of laparoscopic-assisted radical vaginal hysterectomy and abdominal radical hysterectomy for treating cervical cancer: a meta-analysis." Videosurgery and other Miniinvasive Techniques 17(1): 69-82.
	Introduction: Laparoscopic-assisted radical vaginal hysterectomy (LARVH) and abdominal radical hysterectomy (ARH) are commonly used for cervical cancer treatment. However, the clinical application of LARVH versus ARH in treating cervical cancer remains controversial.; Aim: To investigate the efficacy of LARVH versus ARH in treating cervical cancer via comparing several inductors by pooling related studies.; Material and Methods: Eligible articles from PubMed, Embase, and the Cochrane library were screened using established search terms. Consecutive variables were pooled using weighted mean difference (WMD) and 95% confidence interval (CI). Categorical variables were pooled using odds ratio (OR) and 95% CI.; Results: A total of 13 articles were included in this meta-analysis, comprising 579 patients who underwent LARVH and 810 who underwent ARH. LARVH required a longer operation time (WMD = 50.97, 95% CI: 38.34, 63.59, p < 0.001) than ARH. However, compared to patients who underwent ARH, those who underwent LARVH had less bleeding volume (WMD = - 311.21, 95% CI: - 482.77, - 139.64, p < 0.001), required a shorter hospital stay (WMD = - 3.38, 95% CI: - 5.00, - 1.76, p < 0.001), and had a lower risk of urinary tract infection (OR = 0.34, 95% CI: 0.13, 0.89, p = 0.028). Additionally, patients who underwent LARVH showed a slightly lower recurrence rate (OR = 0.549, 95% CI: 0.302, 0.998, p = 0.049) than patients who underwent ARH. However, subgroup analysis results were not in agreement with the pooled results and indicated an unstable outcome.; Conclusions: Owing to these reasons, LARVH has more application prospects than ARH in treating cervical cancer.; Competing Interests: The authors declare no conflict of interest. (Copyright: © 2021 Fundacja Videochirurgii.)

Zhang, A. L., et al. (2022). "Chinese Herbal Medicine for induced abortion in early pregnancy (before 14 weeks' gestation)." The Cochrane Database of Systematic Reviews 2022(10): CD014609.
	Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To evaluate the efficacy and safety of Chinese herbal medicine for induced abortion in early pregnancy (before 14 weeks' gestation).Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Zhang, B., et al. (2023). "Vitamin D supplementation in the treatment of polycystic ovary syndrome: A meta-analysis of randomized controlled trials." Heliyon 9(3): e14291.
	Background: Vitamin D level is closely associated with the development of polycystic ovary syndrome (PCOS). We aimed to systematically evaluate the effects of vitamin D supplementation on patients with PCOS, to provide reliable evidence to the clinical treatment of PCOS.; Methods: We searched PubMed, Medline, EMbase, Cochrane Library, Web of Science, WanFang, China national knowledge infrastructure(CNKI) and Weipu databases for randomized controlled trials (RCTs) on vitamin D supplementation for the treatment of PCOS. Two reviewers independently screened literature, extracted data and evaluated the risk of bias of included RCTs. RevMan 5.3 software was used for meta-analysis.; Results: 13 RCTs with 840 PCOS patients were included finally. Meta-analyses indicated that vitamin D supplementation increase the serum vitamin D level[mean difference(MD) = 17.81, 95% confidence interval(CI) (10.65, 24.97)] and endometrial thickness [MD = 1.78, 95%CI (0.49, 3.06), P = 0.007], reduce the serum hs-CRP [MD = -0.54, 95%CI (-1.00, -0.08)], parathyroid hormone[MD = -14.76, 95%CI (-28.32, -1.19)], total cholesterol[MD = -12.00, 95%CI (-18.36, -5.56)] and total testosterone level [MD = -0.17, 95%CI (-0.29, -0.05)] (all p < 0.05). No significant differences in the SHBG level [MD = 1.33, 95%CI (-2.70, 5.36)] and mF-G score [MD = 0.04, 95%CI (-0.79, 0.86)] between vitamin D and control group were found (all p > 0.05). Egger's tests showed that there were no publication biases in every synthesized result (all P > 0.05).; Conclusion: Vitamin D may be helpful to improve the endocrine and metabolism-related indexes in patients with PCOS. More high-quality studies with larger sample size are warranted to further evaluate the role of vitamin D supplementation in patients with PCOS. (© 2023 Published by Elsevier Ltd.)

Zhang, C., et al. (2023). "Effect of vaginal energy-based treatment on female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials." World Journal of Urology 41(2): 405-411.
	PURPOSE: To evaluate the efficacy and safety of vaginal energy-based therapies in treating female SUI. METHOD(S): The PubMed, EMBASE, Web of Science, and Scopus databases were searched up to September 2022 to identify RCTs comparing energy-based therapies with placebo intervention in treating female SUI. The primary outcome was International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score. Secondary outcomes included the 1-h pad test and cure rate. RESULT(S): A total of 577 patients from 6 studies were included in the meta-analysis. Energy-based therapies did not significantly improve the ICIQ-SF score at all visits (<=1 month: SMD, -0.39; 95% CI - 0.80 to 0.03; P=0.07; 3 months: SMD, - 1.32; 95% CI - 4.07 to 1.43; P=0.35; 6 months: SMD, - 0.39; 95% CI - 0.91 to 0.12; P=0.14). The subgroup analysis showed that there was no significant improvement in ICIQ-SF score in the CO2 laser group compared to the placebo group at all visits (<=1 month: SMD, - 0.13; 95% CI - 0.59 to 0.34; P=0.59; 3 months: SMD, - 1.50; 95% CI - 3.91 to 0.92; P=0.22; 6 months: SMD, 0.13; 95% CI - 0.47 to 0.72; P=0.67). Meta-analysis was not performed in Er: YAG laser and radiofrequency therapy due to insufficient trials. CONCLUSION(S): Based on the limited clinical evidence, our meta-analysis showed no prior efficacy of energy-based therapy over placebo intervention. However, the results of this meta-analysis should be taken with caution due to the limited amount of available evidence and the heterogeneity among the included studies. PROSPERO REGISTRATION NUMBER: CRD42022360471.Copyright © 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Zhang, C., et al. (2023). "Effect of thunder-fire moxibustion on pain relief in women with primary dysmenorrhea:A protocol for a systematic review and meta-analysis." PROSPERO International prospective register of systematic reviews.
	Review question The main drugs for the treatment of Primary dysmenorrhea (PD) can cause side effects and it is necessary to find a treatment with better clinical efficacy and fewer side effects. We aimed to assess the efficacy and safety of TFM in people with PD through this review. Searches These databases including(PubMed, Cochrane Central Register of Controlled Trials, EMBASE, China National Knowledge Infrastructure Database (CNKI), WanFang Database (WF), Chinese Scientific Journal Database (VIP), and Chinese Biomedical Literature Database (CBM) from inception to March 2023 will be searched. Types of study to be included We included all randomised controlled trials of thunder-fire for PD. There are no restrictions on countries. Condition or domain being studied Primary dysmenorrhea (PD) most common population with the onset of PD is adolescents and young adults, 50%-90% of women are affected, and they described the pain as moderate to severe, making up half of them. Studies show that approximately 42 percent of young women have limited daily activities, and 17 percent miss school or work for one to two days . Despite the high prevalence of PD and the fact that many women also experience great pain, treating pain as a normal part of the menstrual cycle and therefore undertreated or even neglected can have significant negative impacts on academic performance during school and higher education with significant socio-economic consequences. Participants/population Patients with PD diagnosed with recurrent, crampy, abdominal pain are included. It is not limited by gender, race, region, duration of disease, severity of the disease. Intervention(s), exposure(s) The treatment group was treated with thunder moxibustion, and there were no restrictions on the number of acupuncture points, thunder fire moxibustion method, duration and frequency. However, clinical trials of lightning fire as an adjunct treatment will be excluded. Comparator(s)/control The control group received therapies other than TFM, such as western medicine, acupuncture, cupping, no treatment, placebo, or pseudo-total focus (TFM). Care measures should be consistent in both groups. Main outcome(s) Pain scores include a digital rating scale or visual analogue scale (VAS)[17]with lower scores indicating less pain. Additional outcome(s) Secondary outcomes were as follows: dysmenorrhea symptoms, visual analogue scale (VAS), clinical response rate, incidence of adverse effects, and quality of life.Quality of life was measured using the Validation Scale (SF) 36. Methods of analyzing the symptoms of dysmenorrhea.

Zhang, C., et al. (2023). "Effects of GLP-1 on ovarian dysfunction in polycystic ovary syndrome: A protocol for systematic review and meta-analysis." Medicine 102(2): e32312.
	Background: Polycystic ovary syndrome (PCOS) is a frequent endocrine disorder in women, it is the principal cause of infertility and amenorrhea. Due to its high recurrence rate, poor prognosis and serious complications, more works on the research of PCOS are needed. Therefore, we performed a protocol for systematic review and meta-analysis to investigate the efficacy and safety of glucagon-like peptide-1 receptor agonists on ovarian dysfunction in PCOS.; Methods: This study protocol has been registered in the PROSPERO and the registration number is CRD42020188247. The procedure of this protocol will be conducted according to the Preferred Reporting Item for Systematic Review and Meta-analysis Protocols guidance. A comprehensive search of several databases from 1966 to November 2022 will be conducted. The databases includes Ovid Medline In-Process & Other Non-Indexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and PubMed. The risk of bias of the included studies will be assessed using the Cochrane tool of risk of bias. All statistical analyses will be conducted using the software program Review Manager version 5.3.; Results: The results of this systematic review will be published in a peer-reviewed journal.; Conclusion: This systematic review will provide evidence to judge whether glucagon-like peptide-1 receptor agonist is superior to metformin in patients with PCOS.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Zhang, C., et al. (2022). "Acupuncture for emotional disorder and quality of life in patients with polycystic ovary syndrome-A protocol for a systematic review and meta-analysis." MedRxiv.
	Background : Infertility, obesity, hairiness, acne and other symptoms of polycystic ovary syndrome can easily lead to emotional disorders, such as anxiety and depression, and also affect the patients' quality of life. A large number of studies have shown that acupuncture has a good effect on polycystic ovary syndrome, but there is no evidence that acupuncture can relieve the affective disorders and improve the quality of life in patients with polycystic ovary syndrome. Objective(s): To assess the effectiveness and safety of acupuncture for emotional disorder and quality of life in patients with PCOS. Methods and analysis: From inception to July 31, 2022, a total of four English-language databases (PubMed, Embase, Web of science and the Cochrane Central Register of Controlled Trials) and four Chinese-language databases (the China National Knowledge Infrastructure, Wanfang, VIP, Chinese Biomedical) were searched. The randomized clinical trial (RCT) of acupuncture for polycystic ovary syndrome was selected for inclusion in the study. Statistical analysis will be performed by using the Cochrane Review Manager (RevMan 5.4) software. The strength of the evidence will be assessed according to the Grading of Recommendations Assessment,Development,and Evaluation (GRADE). Result(s) and Conclusion(s):This study will systematically evaluate the efficacy and safety of acupuncture for emotional disorder and quality of life in patients with polycystic ovary syndrome.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 4.0 International license.

Zhang, C. and W. Zhao (2022). "The efficacy and safety of angiogenesis inhibitors for recurrent ovarian cancer: a meta‑analysis." Journal of Ovarian Research 15(1): 99.
	Objective: To investigate the efficacy and safety of angiogenesis inhibitors in the treatment of recurrent ovarian cancer (OC).; Methods: Electronic databases including PubMed, Web of Science, and the Cochrane Library were searched to find eligible studies until August 10, 2021. The data on overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) were pooled. Furthermore, grade ≥ 3 adverse events (AEs) were investigated.; Results: A total of 13 studies with 3953 patients were included. Compared with control group, angiogenesis inhibitors resulted in significant improvement in PFS (hazard ratio (HR) = 0.61, 95%CI, 0.54-0.69), OS (HR = 0.88, 95%CI, 0.81-0.95), and ORR (odds ratio (OR) = 2.15, 95% CI, 1.74-2.65). However, angiogenesis inhibitors were associated with a higher risk of grade ≥ 3 AEs (relative risk (RR), 1.20, 95% CI, 1.04-1.38).; Conclusion: Angiogenesis inhibitors can improve ORR, PFS, and OS in patients with recurrent OC, but they can increase the incidence of AEs ≥ 3. (© 2022. The Author(s).)

Zhang, C. Y., et al. (2021). "Sacrocolpopexy compared with transvaginal mesh surgery: a systematic review and meta-analysis." BJOG 128(1): 14-23.
	Background: The use of mesh is controversial in the treatment of female pelvic organ prolapse.; Objectives: To systematically review the outcomes of sacrocolpopexy compared with transvaginal mesh surgery and to provide evidence-based suggestions.; Search Strategy: The MEDLINE, EMBASE, Cochrane Library and clinicaltrials.gov databases were searched on 21 November 2018.; Selection Criteria: Randomised controlled trials and prospective and retrospective cohort studies were included.; Data Collection and Analysis: Data were extracted by one reviewer and examined by a second reviewer for accuracy. Odds ratios and 95% CI were calculated using random-effects models.; Main Results: Twenty comparative studies were included. The meta-analysis was performed with subgroups. The summary odds ratios of the randomised controlled group were 1.84 (95% CI 0.79-4.29, I 2 = 75%) for anatomical success, 1.41 (95% CI 0.47-4.24, I 2 = 38%) for subjective success, 0.42 (95% CI 0.18-0.98, I 2 = 0%) for mesh complications, 0.61 (95% CI 0.20-1.91, I 2 = 0%) for prolapse reoperation and 0.44 (95% CI 0.23-0.88, I 2 = 0%) for de novo dyspareunia. The mean differences were 0.77 (95% CI 0.31-1.23, I 2 = 66%) for total vaginal length and -1.28 (95% CI -2.00 to -0.55, I 2 = 66%) for point C after surgery.; Conclusions: Very-low-quality evidence indicated that the anatomical and subjective success rates of sacrocolpopexy were similar to those of transvaginal mesh surgery; sacrocolpopexy might be more beneficial than transvaginal mesh surgery in terms of mesh-related complication rates, prolapse recurrence and de novo dyspareunia. However, additional high-quality randomised trials with long-term follow-up durations are needed.; Tweetable Abstract: Sacrocolpopexy is beneficial after surgical anatomical changes and has decreased rates of mesh-related complications and dyspareunia. (© 2020 Royal College of Obstetricians and Gynaecologists.)

Zhang, F. and X. Song (2022). "Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer: A Meta-analysis of Randomized Controlled Trials." American Journal of Clinical Oncology 45(11): 465-474.
	Background: Laparoscopic radical hysterectomy (LRH) and open abdominal radical hysterectomy (ARH) have been used for cervical cancer treatment. We aimed to perform a meta-analysis to compare the efficacy and safety of LRH and ARH in the treatment of cervical cancer to provide reliable evidence to the clinical cervical cancer treatment.; Methods: Two investigators independently searched PubMed and other databases for randomized controlled trials (RCTs) comparing LRH and ARH for cervical cancer treatment up to May 31, 2022. The risk of bias assessment tool recommended by Cochrane library was used for quality assessment. RevMan 5.3 software was used for meta-analysis.; Results: Fourteen RCTs with a total of 1700 patients with cervical cancer were finally included. Meta-analyses indicated that compared with ARH, LRH reduced the intraoperative blood loss (mean difference [MD]=-58.08; 95% CI, -70.91, -45.24), the time to first passage of flatus (MD=-14.50; 95% CI, -16.55, -12.44) (all P <0.05), and increase the number of lymph nodes removed (MD=3.47; 95% CI, 0.51, 6.43; P =0.02). There were no significant differences in the duration of surgery (MD=27.62; 95% CI, -6.26, 61.49), intraoperative complications (odd ratio [OR]=1.10; 95% CI, 0.17, 7.32), postoperative complications (OR=0.78; 95% CI, 0.33, 1.86), relapse rate (OR=1.45; 95% CI, 0.56, 3.74), and survival rate (OR=0.75; 95% CI, 0.52, 1.08) between LRH group and ARH group (all P >0.05).; Conclusions: LRH has more advantages over ARH in the treatment of cervical cancer. Still, the long-term effects and safety of LRH and ARH need more high-quality, large-sample RCTs to be further verified.; Competing Interests: The authors declare no conflicts of interest. (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Zhang, H., et al. (2019). "Hysteroscopic Resection of Endometrial Polyps and Assisted Reproductive Technology Pregnancy Outcomes Compared with No Treatment: A Systematic Review." Journal of Minimally Invasive Gynecology 26(4): 618-627.
	Endometrial polyps are frequently encountered in the uterine cavity of infertile women. There is much debate regarding the treatment of endometrial polyps in patients who are undergoing assisted reproductive technology (ART). A systematic review was performed by searching PubMed, Embase, and the Cochrane Library for retrospective or prospective studies that compared the effect of hysteroscopic resection of polyps with no treatment on pregnancy outcomes of patients who underwent ART. The primary outcomes were clinical pregnancy, live birth, miscarriage, and implantation rates after ART. Eight studies with a total of 2267 patients were included. The results showed that hysteroscopic resection of endometrial polyps (mean size <2 cm) was associated with an increased rate of clinical pregnancy in patients who underwent intrauterine insemination. No clear benefit was observed for clinical pregnancy, live birth, miscarriage, or implantation rates in patients who underwent in vitro fertilization/intracytoplasmic sperm injection cycles. In conclusion, the effect of hysteroscopic polypectomy on pregnancy outcomes of patients who have undergone ART remains unclear. More prospective, randomized controlled trials are warranted to determine appropriate treatment. (Copyright © 2018. Published by Elsevier Inc.)

Zhang, H.-R., et al. (2023). "Pregnancy Benefit of Acupuncture on in vitro Fertilization: A Systematic Review and Meta-Analysis." Chinese Journal of Integrative Medicine 29(11): 1021-1032.
	Background: Currently, more and more infertility couples are opting for combined acupuncture to improve success rate of in vitro fertilization (IVF). However, evidence from acupuncture for improving IVF pregnancy outcomes remains a matter of debate.; Objective: To quantitatively summarized the evidence of the efficacy of acupuncture among women undergoing IVF by means of systematic review and meta-analysis.; Methods: Four English (PubMed, Web of Science, EMBASE, and Cochrane Register of Controlled Clinical Trials) and Four Chinese databases (Wanfang Databases, Chinese National Knowledge Infrastructure, Chinese Science and Technology Periodical Database, and SinoMed) were searched from database inception until July 2, 2023. Randomized controlled trials (RCTs) that evaluated the acupuncture's effects for women undergoing IVF were included. The subgroup analysis was conducted with respect to the age of participants, different acupuncture types, type of control, acupuncture timing, geographical origin of the study, whether or not repeated IVF failure, and acupuncture sessions. Sensitivity analyses were predefifined to explore the robustness of results. The primary outcomes were clinical pregnancy rate (CPR) and live birth rate (LBR), and the secondary outcomes were ongoing pregnancy rate and miscarriage rate. Random effects model with I 2 statistics were used to quantify heterogeneity. Publication bias was estimated by funnel plots and Egger's tests.; Results: A total of 58 eligible RCTs representing 10,968 women undergoing IVF for pregnant success were identifified. Pooled CPR and LBR showed a signifificant difference between acupuncture and control groups [69 comparisons, relative risk (RR) 1.19, 95% confifidence intervals (CI) 1.12 to 1.25, I 2 =0], extremely low evidence; 23 comparisons, RR 1.11, 95%CI 1.02 to 1.21, I 2 =14.6, low evidence, respectively). Only transcutaneous electrical acupoint stimulation showed a positive effect on both CPR (16 comparisons, RR 1.17, 95%CI 1.06 to 1.29; I 2 =0, moderate evidence) and LBR (9 comparisons, RR 1.20, 95%CI 1.04 to 1.37; I 2 =8.5, extremely low evidence). Heterogeneity across studies was found and no studies were graded as high-quality evidence.; Conclusion: Results showed that the convincing evidence levels on the associations between acupuncture and IVF pregnant outcomes were relatively low, and the varied methodological design and heterogeneity might inflfluence the fifindings. (Registration No. PROSPERO CRD42021232430). (© 2023. The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag GmbH Germany, part of Springer Nature.)

Zhang, J. (2022). "Automated Intracytoplasmic Sperm Injection (ICSIA)." ClinicalTrials.gov.
	No Results Available Device: Investigational device named ICSIA|Device: Manual ICSI Survival rates|Fertilization rates|Blastocyst rates|Euploidy rates|Clinical pregnancy rates Female Not Applicable 10 Industry|Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Other 09-21-2021_V1.0 November 30, 2024

Zhang, J., et al. (2023). "Efficacy of dehydroepiandrosterone priming in women with poor ovarian response undergoing IVF/ICSI: a meta-analysis." Frontiers in Endocrinology 14: 1156280.
	Background: Dehydroepiandrosterone (DHEA) may improve the outcomes of patients with poor ovarian response (POR) or diminished ovarian reserve (DOR) undergoing IVF/ICSI. However, the evidence remains inconsistent. This study aimed to investigate the efficacy of DHEA supplementation in patients with POR/DOR undergoing IVF/ICSI.; Methods: PubMed, Web of Science, Cochrane Library, China National Knowledge Infrastructure (CNKI) were searched up to October 2022.; Results: A total of 32 studies were retrieved, including 14 RCTs, 11 self-controlled studies and 7 case-controlled studies. In the subgroup analysis of only RCTs, DHEA treatment significantly increased the number of antral follicle count (AFC) (weighted mean difference : WMD 1.18, 95% confidence interval(CI): 0.17 to 2.19, P= 0.022), while reduced the level of bFSH (WMD -1.99, 95% CI: -2.52 to -1.46, P <0.001), the need of gonadotropin (Gn) doses (WMD -382.29, 95% CI: -644.82 to -119.76, P= 0.004), the days of stimulation (WMD -0.90, 95% CI: -1.34 to -0.47, P <0.001) and miscarriage rate (relative risk : RR 0.46, 95% CI: 0.29 to 0.73, P= 0.001). The higher clinical pregnancy and live birth rates were found in the analysis of non-RCTs. However, there were no significant differences in the number of retrieved oocytes, the number of transferred embryos, and the clinical pregnancy and live birth rates in the subgroup analysis of only RCTs. Moreover, meta-regression analyses showed that women with lower basal FSH had more increase in serum FSH levels (b=-0.94, 95% CI: -1.62 to -0.25, P= 0.014), and women with higher baseline AMH levels had more increase in serum AMH levels (b=-0.60, 95% CI: -1.15 to -0.06, P= 0.035) after DHEA supplementation. In addition, the number of retrieved oocytes was higher in the studies on relatively younger women (b=-0.21, 95% CI: -0.39 to -0.03, P= 0.023) and small sample sizes (b=-0.003, 95% CI: -0.006 to -0.0003, P= 0.032).; Conclusions: DHEA treatment didn't significantly improve the live birth rate of women with DOR or POR undergoing IVF/ICSI in the subgroup analysis of only RCTs. The higher clinical pregnancy and live birth rates in those non-RCTs should be interpreted with caution because of potential bias. Further studies using more explicit criteria to subjects are needed.; Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier CRD 42022384393.; 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 Zhang, Jia, Diao, Ma, Liu and Cui.)

Zhang, J., et al. (2021). "Ultrasound-guided transvaginal ovarian needle drilling for clomiphene-resistant polycystic ovarian syndrome in subfertile women." The Cochrane Database of Systematic Reviews 11: CD008583.
	Background: Ovulatory disturbance is a key diagnostic feature of polycystic ovarian syndrome (PCOS), leading to infertility and correspondingly heavy disease burden. Many therapeutic strategies have been used to induce ovulation for women with PCOS who are infertile. Ultrasound-guided transvaginal ovarian needle drilling (UTND) is a novel surgical method used to induce ovulation for women with clomiphene-resistant PCOS at the outpatient clinic. OBJECTIVES: To evaluate the efficacy and safety of UTND for subfertile women with clomiphene-resistant PCOS.; Search Methods: We searched the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, and other databases to December 2020. We checked conference abstracts, reference lists, and clinical trials registries. We also contacted experts and specialists in the field for any additional trials .; Selection Criteria: We planned to include randomised controlled trials comparing UTND to laparoscopic ovarian drilling, and UTND combined with gonadotropins to gonadotropins, in women of reproductive age with clomiphene-resistant PCOS and infertility.; Data Collection and Analysis: Two review authors independently screened the trials identified by the search for inclusion, assessed methodological quality and risk of bias, and extracted data. The primary outcomes were live birth rate and incidence of surgical complications (bleeding and infection). Secondary outcomes included pregnancy rate, ovulation rate, and ovarian hyperstimulation syndrome. We planned to calculate odds ratios with 95% confidence intervals for dichotomous data. We would assess overall quality of the evidence by applying the GRADE criteria.; Main Results: We did not identify any trials for inclusion in the review. We were unable to assess the benefit or harm of applying UTND for women with clomiphene-resistant PCOS, as no studies could be included in the current review. We moved the previously included trials to studies awaiting classification due to concerns regarding methodology.; Authors' Conclusions: Since we did not identify any studies for inclusion, we were unable to assess the benefit or harm of applying UTND for women with clomiphene-resistant PCOS. (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Zhang, J., et al. (2022). "Sodium-glucose cotransporter-2 inhibitors for improving endocrine and metabolic profiles in overweight and obese individuals with polycystic ovary syndrome: a meta-analysis protocol." BMJ Open 12(4): e058260.
	Introduction: Polycystic ovary syndrome (PCOS) is a heterogeneous reproductive endocrine disorder. Several ongoing trials test sodium-glucose cotransporter-2 (SGLT-2) inhibitors for women with PCOS. However, their effectiveness has not been fully elucidated owing to the lack of high-confidence evidence. Our group agrees with the statement that SGLT-2 inhibition could treat PCOS as it is supported by reports demonstrating the benefits of SGLT-2 inhibition on metabolic status and weight control. Moreover, the functions of chronic inflammation amelioration and cardiovascular system protection make it a more attractive candidate for PCOS therapy. Therefore, to provide physicians with a reference, we intend to perform a meta-analysis on the efficacy and safety of SGLT-2 inhibitors on the endocrine and metabolic profiles of patients with PCOS.; Methods and Analysis: We will search for randomised controlled trials performed until September 2022 using PubMed, Web of Science, EMBASE, the Cochrane Library, Google Scholar, the PhRMA Clinical Study Results Database (www.; Clinicaltrials: gov), the China National Knowledge Infrastructure, the Wanfang, the Weipu and the Chinese biomedical literature databases. The outcomes will include androgen-associated outcomes, body fat, glucose and lipid homoeostasis, inflammatory outcomes and adverse events. In addition, two investigators will independently assess methodological quality using the revised Cochrane risk-of-bias tool 2. The analysis will be performed using RevMan V.5.3 software, and subgroup and sensitivity analyses and a meta-regression will be used to determine the heterogeneity source.; Ethics and Dissemination: Ethical approval is not required because this is a meta-analysis. We will disseminate these results by publishing them in a peer-reviewed journal.; Prospero Registration Number: CRD42021281176.; 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.)

Zhang, J., et al. (2021). "The effectiveness of coenzyme Q10, vitamin E, inositols, and vitamin D in improving the endocrine and metabolic profiles in women with polycystic ovary syndrome: a network Meta-analysis." Gynecological Endocrinology 37(12): 1063-1071.
	Objective: This research evaluated the efficacy of oral nutritional agents including CoQ10, vitamin E, inositols and vitamin D on androgen-associated hormones, glycolipid metabolism and body weight in women with PCOS.; Method: A multi-database search was performed from inception to December 2020. Using multi-variate random effects method, a NMA was conducted by synthesizing data pooled from RCTs. It was registered with PROSPERO (registration number CRD42021230292).; Results: Twenty-three RCTs and 1291 participants were included. Based on NMA, CoQ10, vitamin E, CoQ10 combined with vitamin E, and inositols were successful in decreasing TT as compared with PA; vitamin E was superior to other agents. Vitamin E and inositols were successful in increasing SHBG levels; inositols were stronger than vitamin E. CoQ10 alone or combined with vitamin E, and inositols were successful in decreasing HOMA-IR. Inositols had the best results among included nutraceuticals to ameliorate HOMA-IR, FBG, FINS, TG, TC, and LDL-C and correlated to improvements in BMI. There was no significant difference between the CoQ10 or vitamin E group and the PA group in ameliorating lipid metabolism, and vitamin D had no positive effects in ameliorating hyperandrogenism, BMI, glycolipid metabolism profiles compared with PA.; Conclusion: For women with PCOS, inositols supplementation have some certain advantages in increasing SHBG and improving glycolipid metabolism when compared with nutraceuticals like CoQ10, vitamin E, vitamin D. Besides, vitamin E may be a better option in reducing TT and increasing SHBG. CoQ10 alone or combined with vitamin E can be helpful in decreasing HOMA-IR as well.

Zhang, J., et al. (2023). "The Efficacy and Safety of Single-Incision Mini-Slings for Stress Urinary Incontinence: A Network Meta-Analysis." Urology Journal 20(4): 191-202.
	PURPOSE: To evaluate the efficacy and safety of single-incision mini-sling for stress urinary incontinence based on network Meta-analysis. MATERIALS AND METHODS: We searched PubMed, Embase, and Cochrane libraries from August 2008 to August 2019. Randomized controlled trials comparing two or more indicators of Miniarc (Single Incision Mini-slings), Ajust (Adjustable Single-Incision Sling), C-NDL (Contasure-Needleless), TFS (Tissue Fixation System), Ophria (Transobturator Vaginal Tap), TVT-O (Transobturator Vaginal Tape), and TOT (Trans-obturatortape) in treating female stress urinary incontinence were collected. RESULT(S): Totally, 3,428 patients from 21 studies were included. Ajust had the highest subjective cure rate (Rank=0.52), while Ophira had the worst (Rank=0.67). TFS had the highest objective cure rate, and the worst was found in Ophira. TFS required the shortest operating time (Rank=0.40), while TVT-O required the longest operating time (Rank=0.47). Miniarc had the least bleeding (Rank=0.47), while TVT-O had the most bleeding (Rank=0.37). C-NDL had the shortest postoperative hospital stay (Rank=0.77), while Ajust had the longest postoperative hospital stay (Rank=0.36). For postoperative complications, TFS performed best in groin pain (Rank=0.84), urinary retention (Rank=0.78), and repeat surgery (Rank=0.45). TVT-O performed worst in groin pain (Rank=0.36), and urinary retention (Rank=0.58). Miniarc had the highest repeat surgery rate (Rank=0.35). Ajust had the lowest probability of tap erosion (Rank=0.30), while Ophira had the highest tap erosion level (Rank=0.45). Miniarc showed the greatest advantage in urinary tract infections (Rank=0.84) and de novo urgency (Rank=0.60), while C-NDL had the highest incidence of urethral infections (Rank=0.51). Ophira performed worst in de novo urgency (Rank=0.60). C-NDL performed the best in sexual intercourse pain (Rank=0.79) while Ajust was the worst (Rank=0.49). CONCLUSION(S): In view of comprehensive efficacy and safety, we recommend that TFS or Ajust should be selected first for single-incision sling and the application of Ophria should be minimized.

Zhang, J., et al. (2020). "Variation of laparoscopic ovarian drilling for clomiphene-resistant patients with polycystic ovary syndrome and infertility: A meta-analysis." Journal of Minimally Invasive Gynecology 27(5): 1048-1058.
	OBJECTIVE: To evaluate novel surgical variations of laparoscopic ovarian drilling (LOD) and compare with standard bilateral LOD. DATA SOURCES: Electronic databases were searched including Cochrane database, CENTRAL, Ovid MEDLINE, Embase, PsycINFO, PubMed, Virtual Health Library, OpenSIGLE, ClinicalTrials.gov, ISRCTN, The Chinese Clinical Trial Register in February 2019. METHODS OF STUDY SELECTION: Randomized controlled trials (RCTs) evaluating LOD for patients with clomiphene-resistant polycystic ovary syndrome (PCOS) and infertility, reporting reproductive outcomes, surgical complications, serum indexes, menses resumption, and ultrasound results were included. Quality and risk of bias were evaluated by two authors, respectively. RESULTS: Twenty RCTs with 1615 patients were included. Evaluation of the quality of evidence for each study was based on each study's limitations of 5 outcome domains described by the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) and found to be moderate to very low. Live births were only reported by four studies. Unilateral LOD did not differ with bilateral LOD in reproductive outcomes, such as pregnancy (p = .11, I2 = 75%), ovulation (p = .08, I2 = 0%), miscarriage (p = .61), and menstruation resumption (p = .06). There was insufficient evidence regarding efficacy and safety of novel methods of LOD, such as transvaginal hydrolaparoscopy (one RCT) and micro-LOD (three RCTs). Evidence regarding the suitable number of ovarian punctures, duration of drilling, and anti-Mullerian hormone or antral follicle numbers following LOD was inconclusive. CONCLUSIONS: Unilateral LOD seems to be suitable replacement for conventional bilateral LOD for clomiphene citrate-resistant PCOS, although more studies involving long-term reproductive efficacy, adverse events, and varying forms of LOD are warranted.

Zhang, J. Q., et al. (2022). "Short period-administration of myo-inositol and metformin on hormonal and glycolipid profiles in patients with polycystic ovary syndrome: a systematic review and updated meta-analysis of randomized controlled trials." European Review for Medical and Pharmacological Sciences 26(6): 1792-1802.
	Objective: This meta-analysis aims to perform an updated meta-analysis to evaluate myo-inositol (myo-ins) and the classical insulin sensitizer metformin in terms of efficacy and safety for treating women with polycystic ovary syndrome (PCOS).; Materials and Methods: A comprehensive literature search was performed using PubMed, Web of Science, EMBASE, Cochrane Library, PhRMA Clinical Study Results, Wan Fang, and CNKI databases; the database was searched from inception to June 2021. The random effects model was chosen to synthesize the effect sizes of individual trails. The registration number is CRD42021239786.; Results: Nine randomized controlled trials (RCTs) and 612 patients were included in the analysis. Compared with metformin, myo-ins might be more effective in lowering triglycerides (TG) levels (SMD -0.49, 95% CI -0.74 to -0.24, p=0.0001, I2 = 0%) and avoiding side effects (RR=0.14, 95% CI 0.08-0.24, p<0.00001, I2 = 2%), while no significant differences were observed in other relevant indexes, such as total testosterone (TT) and sex-hormone binding globulin (SHBG).; Conclusions: Compared with metformin, the suitable supplemental dosage of myo-ins may be helpful in lowering levels of TG and avoiding adverse events (AEs).

Zhang, L., et al. (2023). "Effect of SGLT2 Inhibitors on Improving Glucolipid Metabolism and Reproductive Hormone Status in Overweight/Obese Women with PCOS: A Systematic Review and Meta-Analysis." Reproductive Sciences.
	Background: Obesity, insulin resistance, and hyperandrogenemia are commonly seen in women with polycystic ovary syndrome (PCOS), and these three conditions form a vicious cycle leading to reproductive and metabolic abnormalities. Metformin improves the symptoms of PCOS by increasing insulin sensitivity but is not therapeutically optimal. Recent studies have reported that sodium-glucose co-transporter protein receptor inhibitors improve insulin resistance and reduce the weight of patients with PCOS. We performed a meta-analysis to assess the influence of sodium-glucose co-transporter protein-2 (SGLT2) inhibitors on anthropometric, glycolipid metabolism and reproductive outcomes after therapy of overweight/obese women with PCOS.; Methods: We searched the relevant literature published up to April 2023. Information on the effect of SGLT2 inhibitors on overweight/obese patients with PCOS was extracted independently by two reviewers. Review Manager 5.3 was used for meta-analysis.; Results: Five randomized controlled trials that met our criteria were retrieved. Our meta-analysis demonstrated that in overweight/obese patients with PCOS, SGLT2 inhibitors treatment was significantly superior to metformin treatment in terms of reducing body weight (P = 0.02, I 2 = 36%), decreasing dehydroepiandrosterone sulfate concentrations [SMD = -0.42, 95% CI (-0.76, -0.07), I 2 = 22%, P = 0.02], and reducing the incidence of nausea [RR = 0.35, 95% CI (0.21, 0.60), I 2 = 71%, P = 0.0001].; Conclusions: SGLT2 inhibitors are a possible alternative therapy for treating overweight/obese women with PCOS who do not respond favorably to metformin treatment. However, further large randomized controlled trials and cost-effectiveness analyses are warranted to guide the implementation of SGLT2 inhibitors treatment in this population. (© 2023. The Author(s), under exclusive licence to Society for Reproductive Investigation.)

Zhang, Q., et al. (2022). "Comparative efficacy and acceptability of pharmacotherapies for postpartum depression: A systematic review and network meta-analysis." Frontiers in Pharmacology 13: 950004.
	Purpose: To evaluate the efficacy and tolerability of pharmacotherapies for postpartum depression (PPD). Method: We performed a computerized search of MEDLINE (Ovid and PubMed), Embase, Cochrane Library, Web of Science, and Google Scholar to identify eligible randomized controlled trials (RCTs) before 31 March 2022. We calculated standardized mean differences (SMDs) for continuous outcomes and odds ratios (ORs) for dichotomous outcomes with the random-effects model. The tolerability of antidepressants in terms of early dropouts was investigated. The surface under the cumulative ranking curve (SUCRA) was used for ranking the outcomes. Quality assessment of the included studies was performed using the Cochrane Collaboration's tool. Results: A total of 11 studies with 944 participants were included in this network meta-analysis, involving nine antidepressants. With respect to efficacy, only estradiol and brexanolone were significantly more effective than the placebo ( p < 0.05), and the calculated SUCRA indicated that estradiol (94.3%) had the highest probability ranking first for reducing the PPD, followed by paroxetine (64.3%) and zuranolone (58.8%). Regarding tolerability, a greater percentage of patients treated with brexanolone experienced early dropout as compared to those treated with most other antidepressants. Conclusion: Only estradiol and brexanolone showed significantly higher efficacy than the placebo. According to the SUCRA ranking, estradiol, paroxetine, and zuranolone were the three best antidepressants. Concerning acceptability in terms of early dropouts, brexanolone was less well-tolerated than other antidepressants.; 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 Zhang, Dai and Li.)

Zhang, S., et al. (2021). "The efficacy and safety of Kuntai capsule combined with leuprorelin acetate in the treatment of endometriosis: A protocol for systematic review and meta-analysis." Medicine 100(11): e25080.
	Background: Endometriosis (EMS) is one of the common diseases in women, which seriously affects the quality of life of women. Leuprorelin acetate can control the development of EMS, but long-term use can cause perimenopausal symptoms in women. Clinical studies have shown that Kuntai capsule combined with leuprorelin acetate is effective in the treatment of EMS, which can relieve perimenopausal symptoms, but it lacks of evidence-based medical evidence. Therefore, this study aims to systematically evaluate the efficacy and safety of Kuntai capsule combined with leuprorelin acetate in the treatment of EMS.; Methods: CNKI, VIP, Wanfang, Chinese Biomedical Literature Database, PubMed, The Cochrance Library, Embase, Web of Science, and other databases were searched by computer to collect randomized controlled trials of Kuntai capsule combined with leuprorelin acetate in the treatment of EMS. The retrieval time was from the establishment of the database to February 2021. Two researchers screened the literatures and extracted the data and meta-analysis was performed using RevMan 5.3 software.; Results: This study evaluated the efficacy and safety of Kuntai capsule combined with leuprorelin acetate in the treatment of EMS by clinical effective rate, serum sex hormone levels estradiol, follicle-stimulating hormone, luteinizing hormone, visual analogue scale, Kupperman score and incidence of adverse reactions.; Conclusion: This study will provide reliable evidence-based evidence for the clinical application of Kuntai capsule combined with leuprorelin acetate in the treatment of EMS.; Ethics and Dissemination: Private information from individuals will not be published. This systematic review also does not involve endangering participant rights. Ethical approval will not be required. The results may be published in a peer-reviewed journal or disseminated at relevant conferences.; Osf Registration Number: DOI 10.17605/OSF.IO/AZU47.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Zhang, T., et al. (2023). "Efficacy and Safety of Coenzyme Q10 Supplementation in the Treatment of Polycystic Ovary Syndrome: a Systematic Review and Meta-analysis." Reproductive Sciences 30(4): 1033-1048.
	The aim of this study is to evaluate the efficacy and safety of coenzyme Q10 supplementation in the treatment of polycystic ovary syndrome (PCOS). We first searched PubMed, Wanfang Data, CNKI, Embase, ClinicalTrial.gov, and other databases. The retrieval time from the establishment of the database to January 2021. We collected relevant randomized controlled trials (RCTs) about coenzyme Q10 in the treatment of PCOS. Risk of bias assessment and meta-analysis of RCTs were performed using RevMan 5.0 software. This systematic review and meta-analysis include a total of 9 RCTs involving 1021 patients. The results show that the addition of coenzyme Q10 may improve insulin resistance (HOMA-IR (WMD - 0.67 [- 0.87, - 0.48], P < 0.00001); fasting insulin (WMD - 1.75 [- 2.65, - 0.84], P = 0.0002); fasting plasma glucose (WMD - 5.20 [- 8.86, - 1.54], P = 0.005)), improve sex hormone levels (FSH (SMD - 0.45 [0.11, 0.78], P = 0.009); testosterone (SMD - 0.28 [- 0.49, - 0.06], P = 0.01)), and improve blood lipids (triglycerides (SMD - 0.49 [- 0.89, - 0.09], P = 0.02); total cholesterol (SMD - 0.35 [- 0.56, - 0.14], P = 0.001); LDL-C (SMD - 0.22 [- 0.43, - 0.01], P = 0.04); HDL-C (SMD 0.22 [0.01, 0.43], P = 0.04)). Only one RCT reported adverse events, and they found that patients had no adverse effects or symptoms following supplementation. Based on the current evidence, it could be considered that the addition of CoQ10 is a safe therapy to improve PCOS by improving insulin resistance (reduce HOMA-IR, FINS, FPG), increasing sex hormone levels (increase FSH, reduce testosterone), and improving blood lipids (reduce TG, TC, LDL-C, and increased HDL-C). (© 2022. The Author(s), under exclusive licence to Society for Reproductive Investigation.)

Zhang, X., et al. (2019). "The Effect of Low Carbohydrate Diet on Polycystic Ovary Syndrome: A Meta-Analysis of Randomized Controlled Trials." International Journal of Endocrinology 2019: 4386401.
	Objective: To assess the effect of a low carbohydrate diet (LCD) on women with polycystic ovary syndrome (PCOS).; Methods: Data from randomized controlled trials (RCTs) were obtained to perform a meta-analysis of the effects of LCD in PCOS patients. The primary outcomes included the changes in BMI, homeostatic model assessment for insulin resistance (HOMA-IR), and blood lipids, including total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), follicle-stimulating hormone (FSH), luteotropic hormone (LH), total testosterone (T), and sex hormone-binding globulin (SHBG).; Results: Eight RCTs involving 327 patients were included. In comparison with the control group, the LCD decreased BMI (SMD = -1.04, 95% CI (-1.38, -0.70), P < 0.00001), HOMA-IR (SMD = -0.66, 95% CI (-1.01, -0.30), P < 0.05), TC (SMD = -0.68, 95% CI (-1.35, -0.02), P < 0.05), and LDL-C (SMD = -0.66, 95% CI (-1.30, -0.02), P < 0.05). Stratified analyses indicated that LCD lasting longer than 4 weeks had a stronger effect on increasing FSH levels (MD = 0.39, 95% CI (0.08, 0.71), P < 0.05), increasing SHBG levels (MD = 5.98, 95% CI (3.51, 8.46), P < 0.05), and decreasing T levels (SMD = -1.79, 95% CI (-3.22, -0.36), P < 0.05), and the low-fat and low-CHO LCD (fat <35% and CHO <45%) had a more significant effect on the levels of FSH (MD = 0.40, 95% CI (0.09, 0.71), P < 0.05) and SHBG (MD = 6.20, 95% CI (3.68, 8.72), P < 0.05) than the high-fat and low-CHO LCD (fat >35% and CHO <45%).; Conclusion: Based on the current evidence, LCD, particularly long-term LCD and low-fat/low-CHO LCD, may be recommended for the reduction of BMI, treatment of PCOS with insulin resistance, prevention of high LDL-C, increasing the levels of FSH and SHBG, and decreasing the level of T level. Together, the analyzed data indicate that proper control of carbohydrate intake provides beneficial effects on some aspects of PCOS and may represent one of the important interventions improving the clinical symptoms of affected patients.; Competing Interests: The authors declare that there are no conflicts of interest regarding the publication of this paper. (Copyright © 2019 Xiaoshuai Zhang et al.)

Zhang, Y., et al. (2023). "The Efficacy and Safety of Pazopanib Plus Chemotherapy in Treating Recurrent or Persistent Ovarian Cancer: A Systematic Review and Meta-Analysis." American Journal of Clinical Oncology 46(6): 254-262.
	Background: Patients with recurrent or persistent ovarian cancer often have poor prognoses, and their optimal treatment regimen remains unclear. Inhibition of angiogenesis is a valuable strategy for treating ovarian cancer, and the drug pazopanib is a potent, multitarget tyrosine kinase inhibitor. However, treatment with pazopanib in combination with chemotherapy remains controversial. We performed a systematic review and meta-analysis to clarify the efficacy and side effects of pazopanib combined with chemotherapy in the treatment of advanced ovarian cancer.; Methods: The PubMed, Embase, and Cochrane databases were systematically searched for relevant randomized controlled trials published up to September 2, 2022. The primary outcomes of eligible studies included overall response rate (ORR), disease control rate, 1-year progression-free survival (PFS) rate, 2-year PFS rate, 1-year overall survival (OS) rate, 2-year OS rate, and adverse events.; Result: Outcomes from a total of 518 recurrent or persistent ovarian cancer patients from 5 studies were analyzed in this systematic review. Pooled results showed that pazopanib plus chemotherapy, when compared with chemotherapy alone, significantly improved the ORR (pooled risk ratio=1.400; 95% CI, 1.062-1.846; P = 0.017) but not the disease control rate, 1-year PFS, 2-year PFS, 1-year OS, or 2-year OS. Moreover, pazopanib increased the risk of neutropenia, hypertension, fatigue, and liver dysfunction.; Conclusion: Pazopanib plus chemotherapy improved patient ORR but did not improve survival; it also increased the occurrence of several adverse events. Further large-sample clinical trials are needed to verify these results to guide pazopanib use in patients with ovarian cancer.; Competing Interests: The authors declare no conflicts of interest. (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Zhang, Y., et al. (2020). "Adjuvant treatment strategies in ovarian stimulation for poor responders undergoing IVF: a systematic review and network meta-analysis." Human Reproduction Update 26(2): 247-263.
	Background: Despite great advances in assisted reproductive technology, poor ovarian response (POR) is still considered as one of the most challenging tasks in reproductive medicine.; Objective and Rationale: The aim of this systemic review is to evaluate the role of different adjuvant treatment strategies on the probability of pregnancy achievement in poor responders undergoing IVF. Randomized controlled trials (RCTs) comparing 10 adjuvant treatments [testosterone, dehydroepiandrosterone (DHEA), letrozole, recombinant LH, recombinant hCG, oestradiol, clomiphene citrate, progesterone, growth hormone (GH) and coenzyme Q10 (CoQ10)] were included.; Search Methods: Relevant studies published in the English language were comprehensively selected using PubMed, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL) until 11 July 2018. We included studies that investigated various adjuvant agents, including androgen and androgen-modulating agents, oestrogen, progesterone, clomiphene citrate, GH and CoQ10, during IVF treatment and reported subsequent pregnancy outcomes. The administration of GnRH analogs and gonadotrophins without adjuvant treatment was set as the control. We measured study quality based on the methodology and categories listed in the Cochrane Collaboration Handbook. This review protocol was registered with PROSPERO (CRD42018086217).; Outcomes: Of the 1124 studies initially identified, 46 trials reporting on 6312 women were included in this systematic review, while 19 trials defining POR using the Bologna criteria reporting 2677 women were included in the network meta-analysis. Compared with controls, DHEA and CoQ10 treatments resulted in a significantly higher chance of clinical pregnancy [odds ratio (OR) 2.46, 95% CI 1.16 to 5.23; 2.22, 1.08-4.58, respectively]. With regard to the number of retrieved oocytes, HCG, oestradiol and GH treatments had the highest number of oocytes retrieved [weighted mean difference (WMD) 2.08, 0.72 to 3.44; 2.02, 0.23 to 3.81; 1.72, 0.98 to 2.46, compared with controls, respectively]. With regard to the number of embryos transferred, testosterone and GH treatment led to the highest number of embryos transferred (WMD 0.72, 0.11 to 1.33; 0.67, 0.43 to 0.92; compared with controls, respectively). Moreover, GH resulted in the highest oestradiol level on the HCG day (WMD 797.63, 466.45 to 1128.81, compared with controls). Clomiphene citrate, letrozole and GH groups used the lowest dosages of gonadotrophins for ovarian stimulation (WMD 1760.00, -2890.55 to -629.45; -1110.17, -1753.37 to -466.96; -875.91, -1433.29 to -282.52; compared with controls, respectively). CoQ10 led to the lowest global cancelation rate (OR 0.33, 0.15 to 0.74, compared with controls).; Wider Implications: For patients with POR, controlled ovarian stimulation protocols using adjuvant treatment with DHEA, CoQ10 and GH showed better clinical outcomes in terms of achieving pregnancy, and a lower dosage of gonadotrophin required for ovulation induction. Furthermore, high-level RCT studies using uniform standards for POR need to be incorporated into future meta-analyses. (© 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.)

Zhang, Y., et al. (2022). "Efficacy and safety of Gemogenovatucel-T (Vigil) immunotherapy for advanced ovarian carcinoma: A systematic review and meta-analysis of randomized controlled trials." Frontiers in Oncology 12: 945867.
	In recent years, many clinical trials have shown the safety and efficacy of Gemogenovatucel-T (Vigil) in the treatment of advanced OC patients. The purpose of this study was to explore the safety and efficacy of Gemogenovatucel-T (Vigil) in the first-line maintenance of advanced ovarian carcinoma based on the randomized controlled trials (RCTs). Randomized controlled trials (RCTs) on Gemogenovatucel-T (Vigil) immunotherapy for advanced ovarian carcinoma were searched in PubMed, Embase, Cochrane Library and Web of Science up to December 31, 2021. The following study characteristics were investigated: baseline study characteristics, overall survival, recurrence free survival, recurrence free survival median time, and complication. A total of 36 articles were obtained, and seven suitable RCTs with a total sample size of 322 patients were eventually included in this meta-analysis. Overall survival (OS): from time of randomization: HR=0.48 (95% CI: 0.32 to 0.72), Z=3.55, P<0.001; from time of tissue procurement: HR=0.51 (95% CI : 0.33 to 0.78), Z =3.07, P =0.002. Recurrence free survival (RFS): from time of randomization: HR=0.43 (95% CI : 0.30 to 0.62), Z =4.61, P <0.001; from time of tissue procurement: HR=0.45 (95% CI : 0.31 to 0.65), Z =4.26, P <0.001. RFS median time: from time of randomization: HR=1.57 (95% CI : 1.16 to 2.11), Z =2.95, P =0.003; from time of tissue procurement: HR=2.16 (95% CI : 1.12 to 4.17), Z =2.29, P =0.022. This study found that Gemogenovatucel-T (Vigil) immunotherapy provided significant OS and RFS benefits, particularly in advanced OC patients with BRCA wild type. At the same time, treatment with the Gemogenovatucel-T (Vigil) is safer than other treatment modalities and does not have any toxic effects.; Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier (CRD42022300367).; 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 Zhang, Zhang, Zhao, Wang and Feng.)

Zhao, D. and L. Tao (2023). "The efficacy of invasive interventions for endometriosis symptoms: A networkmeta‐analysis." PROSPERO International prospective register of systematic reviews.
	Review question P: patients with endometriosis undergoing invasive surgeries I: various invasive interventions C: comparation of the effects of different invasive interventions O: pain score of patients and the recurrence rate of endometriosis S: RCTs will be included Searches Data bases: Chocrane libarary, PubMed and Embase Search dates: the end date is 30 December 2023 Restrictions: (1) studies were designed as randomized controlled trials (RCTs); (2) patients were women with endometriosis; (3) the intervention of the arms must be any invasive treatments aiming at endometriosis; (4) all trials reporting the sympotoms of endometriosis (pain scores, pain recurrence or cyst recurrence) including at least one pair of direct control group Types of study to be included RCT Condition or domain being studied For endometriosis, about 20% to 25% patients are asymptomatic and other patients suffered nonspecific symptoms, including pelvic pain and dysmenorrhea. Although the increasing knowledge of the pathogenesis has allowed the development of new non-hormonal drugs, non-drug treatment are also necessary. In some cases, invasive surgeries may be the only methods to relieve the pain symptom. Participants/population Patients with endometriosis undergoing invasive surgeries Intervention(s), exposure(s) various invasive interventions Comparator(s)/control comparation of the effects of different invasive interventions Main outcome(s) pain score of patients Additional outcome(s) recurrence rate of endometriosis

Zhao, H., et al. (2022). "A pairwise and network meta-analysis comparing the efficacy and safety of progestogens in threatened abortion." International Journal of Gynaecology and Obstetrics 156(3): 383-393.
	Background: Progesterone is widely used to prevent threatened miscarriage.; Objective: To determine the efficacy and safety of progestogens in the treatment of threatened miscarriage.; Search Strategy: PubMed, Cochrane Library, EMBASE, CNKI, CBM, and WanFang databases were searched for randomized controlled trials (RCTs) published from the date of inception of the database to August 2020. The search terms included "abortion, threatened," "progesterone," and "progestogens."; Selection Criteria: A network meta-analysis was conducted of all the RCTs on threatened abortion so far to compare the efficacy and safety of different progestogens in the treatment of threatened abortion.; Data Collection and Analysis: Odds ratios for dichotomous data with 95% confidence intervals were calculated and the data were pooled using a random-effects model. The surface under the cumulative ranking area (SUCRA) was calculated for efficacy and safety with different interventions.; Main Results: A total of 59 RCTs with 10 424 participants were included. Oral dydrogesterone (DYD) had the lowest risk of miscarriage (SUCRA 100.0%), followed by vaginal progesterone (SUCRA 67.9%). Oral micronized progesterone had the highest risk of miscarriage (SUCRA 15.7%).; Conclusion: Oral DYD is effective in the treatment of threatened miscarriage. The results of the present study can help patients make informed decisions about treatment options for threatened miscarriage. (© 2021 International Federation of Gynecology and Obstetrics.)

Zhao, H., et al. (2021). "Comparative efficacy of oral insulin sensitizers metformin, thiazolidinediones, inositol, and berberine in improving endocrine and metabolic profiles in women with PCOS: a network meta-analysis." Reproductive Health 18(1): 171.
	Background: Multiple oral insulin-sensitizing agents, such as metformin, thiazolidinediones, inositols, and berberine, have been proven safe and efficacious in improving the endocrine, metabolic, and reproductive abnormalities seen in polycystic ovary syndrome (PCOS), providing more options for healthcare providers and patients. These oral insulin sensitizers are more convenient, practical, and economic than agents that need to be injected. A comparison of the clinical effectiveness of the four different classes of oral insulin sensitizers in PCOS has not been explored, leading to clinical uncertainty about the optimal treatment pathway. The present study aims to compare the effects of oral insulin sensitizers on endocrine and metabolic profiles in women with PCOS.; Methods: We identified randomized controlled trials for PCOS from a variety of databases, published from January 2005 to October 2020. Outcomes included changes in menstrual frequency, improvements in hyperandrogenism and glucolipid metabolism and adverse side effects. A random-effects network meta-analysis was performed.; Results: Twenty-two trials comprising 1079 patients with PCOS were included in this study. Compared with metformin, treatment with myo-inositol + D-chiro-inositol was associated with a greater improvement in menstrual frequency (odds ratio 14.70 [95% confidence interval (CI) 2.31-93.58]). Myo-inositol + D-chiro-inositol and metformin + thiazolidinediones combination therapies were superior to respective monotherapies in reducing total testosterone levels. Thiazolidinediones, metformin + thiazolidinediones, and myo-inositol + D-chiro-inositol were associated with a lower insulin resistance index (HOMA-IR) compared with that in metformin alone (mean differences: - 0.72 [95% CI (- 1.11)-(- 0.34)] to - 0.89 [95% CI (- 1.460)-(- 0.32)]). Metformin + thiazolidinediones treatment was associated with lower triglyceride levels compared with that in metformin and thiazolidinediones monotherapy, while thiazolidinediones was superior to metformin in increasing high-density lipoprotein cholesterol and decreasing fasting plasma glucose, triglycerides, low-density lipoprotein cholesterol, and gastrointestinal adverse events.; Conclusions: Ours is the first study to report that for women with PCOS, myo-inositol combined with D-chiro-inositol and metformin combined with thiazolidinediones appear superior to metformin alone in improving insulin resistance and decreasing total testosterone. Myo-inositol combined with D-chiro-inositol is particularly efficacious in menstrual recovery. Thiazolidinediones and metformin combined with thiazolidinediones improve lipid metabolism better than metformin alone. Trial registration PROSPERO CRD42020211524. (© 2021. The Author(s).)

Zhao, J., et al. (2022). "Effects of antioxidant intervention in patients with polycystic ovarian syndrome: A systematic review and meta-analysis." Medicine 101(32): e30006.
	Background: The role of antioxidant intervention in polycystic ovary syndrome (PCOS) patients has been increasingly investigated in recent years. In order to further clarify whether antioxidant therapy is beneficial for PCOS patients and the emphasis of its effects, this study provides a systematic review and meta-analysis of randomized controlled trials examining the effect of antioxidant intervention on PCOS.; Methods: Enrolled study designs related to antioxidant interventions and PCOS, published from 1999 to 2020, were searched from EMBASE, PubMed, and Web of Science databases to sort out proven studies on antioxidant interventions and PCOS. Data were reported as weighted mean difference (WMD) or standard mean difference with associated confidence intervals of 95%. The analysis was conducted using Stata version 16.0.; Results: Twenty-three studies were included in total. Antioxidant intervention had a positive impact on homeostasis model assessment of insulin resistance (WMD = -0.37, P = .011) and Triglycerides (WMD = -25.51, P < .001). And antioxidant intervention did not improve testosterone levels significantly (WMD = -0.20, P = .2611). Subgroup analysis showed that except for the D-chiro-inosito subgroup, no difference in body mass index was observed between the intervention group and the control group.; Conclusions: This meta-analysis demonstrates the efficacy of antioxidant intervention in patients with PCOS, demonstrating that antioxidant intervention has a significant effect on insulin resistance and lipid metabolism improvement. However, antioxidant intervention therapy has no discernible impact on testosterone levels or body mass index. Omega-3 may be a more effective antioxidant intervention for PCOS. In addition, this meta-analysis provides important reference opinions and treatment recommendations for PCOS.; Competing Interests: The authors have no funding and conflicts of interest to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Zhao, J.-F., et al. (2021). "Vitamin D improves levels of hormonal, oxidative stress and inflammatory parameters in polycystic ovary syndrome: a meta-analysis study." Annals of Palliative Medicine 10(1): 169-183.
	Background: Hyperandrogenism (HA), inflammation, and oxidative damage play key roles in the pathophysiology of polycystic ovary syndrome (PCOS). Whether vitamin D adjuvant therapy improves hormonal, inflammation, and oxidative damage in PCOS patients has aroused widespread interest, but the results are controversial. To evaluate the effect of vitamin D supplementation on hormonal, oxidative stress, and inflammatory parameters in patients with PCOS.; Methods: A literature search was conducted in Medline, the Cochrane Library, EMBASE, and Web of Science for studies related to PCOS and vitamin D supplementation. All reports of randomized controlled trials (RCTs) published before December 2019 were identified. The fixed-effects model or random-effects model was used to calculate pooled estimates of standardized differences in means (SMD) with 95% confidence intervals (CI).; Results: A total of 956 identified studies were retrieved, and eighteen RCTs involving 1,060 participants were ultimately included in the current meta-analysis. The pooled results demonstrated that vitamin D supplementation in patients with PCOS resulted in a significant improvement in serum total testosterone (TT), high sensitivity C-reactive protein (hs-CRP), total antioxidant capacity (TAC), and malondialdehyde (MDA). No significant effect on free testosterone (FT), dehydroepiandrosterone sulfate (DHEA-S), sex hormone-binding globulin (SHBG), free androgen index (FAI), nitric oxide (NO), and total glutathione (GSH) levels was found. Subgroup analysis showed that vitamin D supplementation reduced hs-CRP and MDA irrespective of the treatment course, type of vitamin D intervention, supplementation frequency, and dosage. Twelve weeks of vitamin D supplementation improved TT and TAC while low-dose vitamin D supplementation (≤1,000 IU/day) improved TT and DHEA-S. Vitamin D co-supplementation reduced TT, FT, and DHEA-S, while a daily supplementation regime improved TT, DHEA-S, and TAC in patients with PCOS.; Conclusions: The current meta-analysis demonstrates that vitamin D supplementation in patients with PCOS resulted in an improvement in the levels of TT, hs-CRP, TAC, and MDA, but did not affect FT, DHEA-S, SHBG, FAI, NO, and GSH levels. Vitamin D co-supplementation, low-dose vitamin D supplementation (≤1,000 IU/day), and daily supplementation frequency appeared to be more conducive to improving hormones, inflammation, and oxidative stress in PCOS patients.

Zhao, L., et al. (2021). "Effectiveness of Telehealth Interventions for Women With Postpartum Depression: Systematic Review and Meta-analysis." JMIR mHealth and uHealth 9(10): e32544.
	Background: Postpartum depression (PPD) is a prevalent mental health problem with serious adverse consequences for affected women and their infants. Clinical trials have found that telehealth interventions for women with PPD result in increased accessibility and improved treatment effectiveness. However, no comprehensive synthesis of evidence from clinical trials by systematic review has been conducted.; Objective: The aim of this study is to evaluate the effectiveness of telehealth interventions in reducing depressive symptoms and anxiety in women with PPD. To enhance the homogeneity and interpretability of the findings, this systematic review focuses on PPD measured by the Edinburgh Postnatal Depression Scale (EPDS).; Methods: PubMed, The Cochrane Library, CINAHL, PsycINFO, CNKI, and Wanfang were electronically searched to identify randomized controlled trials (RCTs) on the effectiveness of telehealth interventions for women with PPD from inception to February 28, 2021. Data extraction and quality assessment were performed independently by two researchers. The quality of included studies was assessed using the Cochrane risk-of-bias tool, and meta-analysis was performed using RevMan 5.4 software.; Results: Following the search, 9 RCTs with a total of 1958 women with PPD were included. The EPDS (mean difference=-2.99, 95% CI -4.52 to -1.46; P<.001) and anxiety (standardized mean difference=-0.39, 95% CI -0.67 to -0.12; P=.005) scores were significantly lower in the telehealth group compared with the control group. Significant subgroup differences were found in depressive symptoms according to the severity of PPD, telehealth technology, specific therapy, and follow-up time (P<.001).; Conclusions: Telehealth interventions could effectively reduce the symptoms of depression and anxiety in women with PPD. However, better designed and more rigorous large-scale RCTs targeting specific therapies are needed to further explore the potential of telehealth interventions for PPD.; Trial Registration: PROSPERO CRD42021258541; https://www.crd.york.ac.uk/prospero/display&#95;record.php?RecordID=258541. (©Liuhong Zhao, Jingfen Chen, Liuying Lan, Ni Deng, Yan Liao, Liqun Yue, Innie Chen, Shi Wu Wen, Ri-hua Xie. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 07.10.2021.)

Zhao, X., et al. (2022). "Acupuncture with or without acupoint application for primary dysmenorrhea: protocol for a systematic review and meta-analysis." MedRxiv.
	Introduction Dysmenorrhea is the most common gynaecological symptom reported by women. Ninet y percent of women presenting for primary care experience some menstrual pain. Pop ulation surveys suggest that, although prevalence rates vary considerably by geographic al location, complaints of dysmenorrhea are widespread in diverse populations. This st udy will evaluate the results of randomized controlled trials to determine the efficacy and safety of acupuncture with or without acupoint application for the treatment of d ysmenorrhea. Methods Eight databases, including China National Knowledge Infrastructure, Chinese Scientific Journal Database, Cochrane Central Register of Controlled Trials, Embase, MEDLINE, PubMed, Wanfang Database, and Web of Science, will be searched using English and Chinese search strategies. In addition, manual retrieval of research papers, conference papers, ongoing experiments, and internal reports, among others, will supplement electr onic retrieval. All eligible studies published on or before December 12, 2021 will be selected. To enhance the effectiveness of the study, only clinical randomized controlle d trials related to the use of acupuncture with or without acupoint application for the treatment of dysmenorrhea will be included. Analysis The Visual Analog Scale will be the primary outcome measure, whereas the McGill p ain questionnaire, SF-36 Scale, Self-Rating Anxiety, and Self-Rating Depression scale will be the secondary outcomes. Side effects and adverse events will be included as s afety evaluations. To ensure the quality of the systematic evaluation, study selection, d ata extraction, and quality assessment will be independently performed by two authors, and a third author will resolve any disagreement. Ethics and dissemination This systematic review will evaluate the efficacy and safety of acupuncture with or wi thout acupoint application for the treatment of dysmenorrhea. Since all included data will be obtained from published articles, it does not require ethical approval and will be published in a peer-reviewed journal. INPLASY registration number: INPLASY202230051.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 4.0 International license.

Zheng, G., et al. (2022). "Determining the optimal treatment perscription for Infertility patients in chronic endometritis." PROSPERO International prospective register of systematic reviews.
	Review question Which is the most optimal treatment perscription for pregnancy outcome of Infertility patients in chronic endometritis？ Searches We searched PubMed, Te Cochrane Library, Embase, and Web of Science; all of which were established until december 2021. Types of study to be included RCT, case-control study or cohort study. Condition or domain being studied Chronic endometritis (CE) is a case of a persistent endometrial infammation caused by infectious agents.CE is described as a chronic disorder due to its long duration and persistent nature, with potentially slow progression and complex causality, severely compromising reproductive potential of patients. More conclusive diagnostic criteria are still under investigation and data concerning therapeutic approaches are constantly emerging in literature.But the most positive approach is not certain.Treatment time is limited for infertility patients.Therefore, determining the most effective treatment prescription is necessary. Participants/population Women with fertility needs in chronic endometritis Intervention(s), exposure(s) All treatment measures for chronic endometritis，such as antibiotics, probiotics, immunomodulators, hormones, etc. Comparator(s)/control Another measure for treating chronic endometritis or no treatment; Main outcome(s) The main outcome is the pregnancy outcome.The live birth rate is the best outcome.But we would choose the continuous pregnancy rate as the most primary outcome if the literature is insufficient. Additional outcome(s) The recovery rate of chronic endometritis.

Zheng, R., et al. (2021). "The effect of acupuncture on glucose metabolism and lipid profiles in patients with PCOS: A systematic review and meta-analysis of randomized controlled trials." Evidence-based Complementary and Alternative Medicine 2021: 5555028.
	Objective. To evaluate the effectiveness of acupuncture on glucose metabolism and lipid profiles in patients with polycystic ovary syndrome (PCOS). Methods. Databases, including the China National Knowledge Infrastructure (CNKI), the China Science and Technology Journal Database (VIP), Wanfang, PubMed, and the Cochrane Library were searched for the relevant literature, with the retrieval deadline being February 2020. Two reviewers independently screened, selected, and extracted the data and validated the results. The methodological quality of the included studies was evaluated with the risk of bias tool, and the meta-analysis was performed using the RevMan 5.3.5 software. Results. A total of 737 patients with PCOS from 10 randomized controlled trials were included in the meta-analysis. A pooled analysis showed significant decreases in body mass index (mean difference (MD) = -1.47, 95% CI -2.35 to -0.58, P < 0.001) and waist-to-hip ratio (MD = -0.04, 95% CI [-0.06, -0.02], P < 0.001) in the acupuncture group along with significant improvements in fasting plasma glucose (MD = -0.38, 95% CI [-0.70, -0.07], P = 0.02), homeostasis model assessment of insulin resistance (MD = -0.22, 95% CI [-0.41, -0.02], P = 0.03), and triglycerides (MD = -0.26, 95% CI [-0.48, -0.04], P = 0.02). No significant differences were observed in the Ferriman-Gallwey score, 2 h fasting plasma glucose, fasting insulin, 2 h fasting insulin, serum total cholesterol, low-density lipoprotein cholesterol, or high-density lipoprotein cholesterol. Conclusion. Acupuncture is relatively effective and safe in improving glucose metabolism and insulin sensitivity in patients with PCOS. The included studies were generally of not bad methodological quality, but further large-scale, long-term randomized controlled trials with rigorous methodological standards are still warranted.Copyright © 2021 Ruqun Zheng et al.

Zheng, S.-H., et al. (2023). "Antioxidant vitamins supplementation reduce endometriosis related pelvic pain in humans: a systematic review and meta-analysis." Reproductive Biology and Endocrinology 21(1): 79.
	Objective: This study aimed to clarify the effect of antioxidant vitamins supplementation on endometriosis-related pain.; Methods: A systematic search of PubMed, Web of Science, Cochrane Library, Scopus, and China National Knowledge Infrastructure (CNK) databases was conducted to identify relevant studies published in English and Chinese up to 16 March 2023. The search terms used were "endometriosis" OR "endometrioma" OR "endometrium" AND "antioxidant" OR "Vitamin C" OR "Vitamin E" OR "Vitamin D" OR "25-OHD" OR "25(OH)D" OR "25-hydroxyvitamin D". Eligible studies were randomized controlled trials (RCTs) that assessed pain scores using the Visual Analogue Scale (VAS). Mean differences or odds ratios (ORs) with 95% confidence intervals (CIs) were calculated to evaluate the effect of antioxidant vitamins supplementation on endometriosis. The quality of the included studies was assessed using the Cochrane Risk of Bias Tool. The study was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines.; Results: A total of 13 RCTs involving 589 patients were included in this meta-analysis. We identified 11 studies that evaluated the effect of antioxidant vitamins supplementation on endometriosis-related pain. The results indicated that the supplementation of antioxidant vitamins can effectively alleviate endometriosis-related pain. Subgroup analysis showed that the supplementation of vitamin E (with or without vitamin C) had a positive effect on improving clinical pelvic pain in patients with chronic pelvic pain. Conversely, supplementation of vitamin D was associated with a reduction in pelvic pain in endometriosis patients, but the difference was not statistically significant compared to the placebo. Additionally, we observed changes in oxidative stress markers following vitamin supplementation. Plasma malondialdehyde (MDA) concentration decreased in patients with endometriosis after antioxidant vitamin supplementation, and the plasma MDA level was inversely correlated with the time and dose of vitamin E and C supplementation. Furthermore, the inflammatory markers in peritoneal fluid, including RANTES, interleukin-6, and monocyte chemoattractant protein-1, significantly decreased after antioxidant therapy. These findings suggest that antioxidant vitamins may alleviate pain in endometriosis patients by reducing inflammation.; Conclusions: The included studies support the potential role of antioxidant vitamins in the management of endometriosis. Supplementation with antioxidant vitamins effectively reduced the severity of dysmenorrhea, improved dyspareunia and pelvic pain, and enhanced quality of life in these patients. Therefore, antioxidant vitamin therapy could be considered as an alternative treatment method, either alone or in combination with other approaches, for endometriosis-related pain.; Trial Registration: PROSPERO registration number: CRD42023415198. (© 2023. BioMed Central Ltd., part of Springer Nature.)

Zheng, W., et al. (2019). "Brexanolone for postpartum depression: A meta-analysis of randomized controlled studies." Psychiatry Research 279: 83-89.
	Objectives: To systematically examine the effectiveness, tolerability, and safety of brexanolone infusion in treating postpartum depression (PPD).; Methods: Randomized controlled trials (RCTs) were included.; Results: Two articles reporting 3 RCTs with 4 active arms (n = 267) covering 156 women with PPD receiving brexanolone infusion and 111 women with PPD on placebo were included. Compared with placebo, women suffering from PPD who received brexanolone had significantly greater response that started after 24 h (risk ratio (RR)=1.34, 95%CI 1.03-1.73), peaked at 36 h (RR = 1.50, 95%CI 1.06-2.13, P = 0.02) and lasted until Day 7 (RR = 1.32, 95%CI 1.01-1.73). Similarly, PPD women treated with brexanolone had significantly greater remission starting at 24 h (RR = 1.86, 95%CI 1.03-3.34), peaking at 60 h (RR = 2.20, 95%CI 1.31-3.70) and lasting until 72 h (RR = 1.96, 95%CI 1.41-2.72). Brexanolone infusion led to significantly higher rate of discontinuation for any reasons (RR = 2.68, 95%CI 1.35-5.32). Discontinuation due to intolerability and adverse drug reactions was similar between the active agent and placebo.; Conclusion: A single brexanolone infusion appears to have ultra-rapid antidepressant effect for PPD, lasting for up to 1 week. The short and long-term therapeutic effect of brexanolone needs to be examined in large-scale RCTs. (Copyright © 2019 Elsevier B.V. All rights reserved.)

Zheng, X., et al. (2023). "Safety and Effectiveness of secnidazole (Solosec) in Trichomoniasis: A Systematic Review and Meta-Analysis of randomized controlled trials." PROSPERO International prospective register of systematic reviews.
	Review question secnidazole (Solosec) is safe and effective in the treatment of Trichomoniasis: A Systematic Review and Meta-Analysis of randomized controlled trials. Searches We will conduct a comprehensive search across the following electronic bibliographic databases: Cochrane Central Register of Controlled Trials (Ovid), Embase (Ovid), MEDLINE (Ovid), MEDLINE In-Process (Ovid), PubMed, Web of Science, AMED (Ovid), and PsycINFO. Additionally, we will explore ongoing studies through ClinicalTrials.gov (http://ClinicalTrials.gov/). The search strategy will exclusively encompass keywords associated with secnidazole and Trichomoniasis. There will be no language restrictions. Types of study to be included Literature that includes the comparison of outcomes between patients treated with secnidazole and those receiving a placebo for Trichomoniasis. The study participants are diagnosed with Trichomoniasis and are undergoing secnidazole treatment. The Inclusion criteria were as following: (1)Randomized controlled trials (2)Eligible patients were adult females or postmenarchal adolescent girls ≥12 years of age in general good health. The exclusion criteria were as following: (1) non-human studies; (2) non-comparative studies; (3) pregnant or lactating; (4) studies without available data can be extracted; (5) non-original studies (letters, reviews, editorials). (6)had symptomatic vulvovaginal candidiasis or an active genital herpes outbreak. (7) received a course of antibacterial or antifungal therapy within the past 14 days, or had a known allergy to nitroimidazoles. Condition or domain being studied Trichomoniasis is the most prevalent non-viral sexually transmitted infection (STI) worldwide, affecting approximately 156 million people globally, including 5.3% of women and 0.6% of men aged 15–49 years and 3.7 million people in the United States . Trichomoniasis is associated with many adverse gynecologic outcomes, including vaginitis, cervicitis, pelvic inflammatory disease, cervical cancer, and infertility. In men, trichomoniasis is associated with epididymitis, non-gonococcal urethritis, and prostatitis and may also lead to infertility. secnidazole is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties. In clinical trials Solosec™ demonstrated efficacy for the treatment of BV with only a single, oral, two-gram dose, with excellent safety, tolerability and adherence. Single-dose 2-g oral secnidazole (SEC), newly approved by the U.S. Food and Drug administration (FDA) for treatment of trichomoniasis, is a potent 5-nitroimidazole with selective toxicity against various micro-organisms. In comparison to the only other FDA-approved treatments for trichomoniasis in the United States – metronidazole and tinidazole – SEC has favorable pharmacokinetics, including a longer half-life and a lower minimal lethal concentration. Participants/population Literature that includes the comparison of outcomes between patients treated with secnidazole and those receiving a placebo for Trichomoniasis. The study participants are diagnosed with Trichomoniasis and are undergoing secnidazole treatment. The Inclusion criteria were as following: (1)Randomized controlled trials (2)Eligible patients were adult females or postmenarchal adolescent girls ≥12 years of age in general good health. The exclusion criteria were as following: (1) non-human studies; (2) non-comparative studies; (3) pregnant or lactating; (4) studies without available data can be extracted; (5) non-original studies (letters, reviews, editorials). (6)had symptomatic vulvovaginal candidiasis or an active genital herpes outbreak. (7) received a course of antibacterial or antifungal therapy within the past 14 days, or had a known allergy to nitroimidazoles. Women with HIV and those with BV (based on all 4 Amsel criteria per FDA trial guidance: presence of homogenous, white/gray vaginal discharge; ≥20% clue cells per highpower field on wet mount; positive whiff test; vaginal pH ≥4.7) were not excluded. Intervention(s), exposure(s) Taking secnidazole throughout the full course of treatment. Comparator(s)/control Taking an equivalent amount of placebo. Main outcome(s) 1) Clinical cure rate depending on Amsel criteria 2) Microbiological cure rate Measures of effect For binary outcomes, such as, Clinical cure rate, we plan to calculate the Odds Ratio (OR) with 95% confidence interval (CI). For continuous outcomes, we plan to calculate the mean difference (MD) with 95% CI. Additional outcome(s) Adverse events such as yeast infection, valvovaginal pruritius, nausea, or increase liver enzymes. Measures of effect For binary outcomes, such as, Clinical cure rate, we plan to calculate the Odds Ratio (OR) with 95% confidence interval (CI). For continuous outcomes, we plan to calculate the mean difference (MD) with 95% CI.

Zheng, X., et al. (2022). "The Dose-Related Efficacy of Acupuncture on Endometrial Receptivity in Infertile Women: A Systematic Review and Meta-Analysis." Frontiers in Public Health 10: 858587.
	Background: Progress has been achieved by using acupuncture widely for poor endometrial receptivity (PER). However, different acupuncture dosages may lead to controversy over efficacy.; Objective: To evaluate the evidence-based conclusions of dose-related acupuncture on infertile women with PER.; Method: References were retrieved from nine databases from inception to 26 February 2022. This meta-analysis included randomized controlled trials (RCTs) that investigated the dose-related efficacy of acupuncture for PER with outcomes of endometrium receptivity (ER) parameters by transvaginal sonography (TVS) and the subsequent pregnancy outcomes in three acupuncture-dose groups: the high-dosage group (three menstrual cycles), the moderate-dosage group (one menstrual cycle), and the low-dosage group (two or four days). Since there remained sufficient heterogeneity among the three subsets, we prespecified seven subgroup variables (four clinical and three methodological) to investigate the heterogeneities.; Results: A total of 14 RCTs (1,564 women) of moderate or low overall quality were included. The results were different when the dosage of acupuncture was restricted. For the moderate or high-dosage group, CPR and part of ER parameters were improved in the acupuncture group (i.e., CPR: OR = 2.00, 95% CI [1.24, 3.22], p = 0.004, I 2 = 0% in one menstrual cycle; OR = 2.49, 95%CI [1.67, 3.72], p < 0.05, I 2 = 0% in three menstrual cycles). However, for the low-dosage group, no statistical difference was observed in CPR (OR = 0.07, 95% CI [-0.10, 0.23], p = 0.44, I 2 = 82%) and a part of the ER parameters. In subgroup analysis, four subgroup variables (the routine treatment, risk of performance bias, duration of acupuncture treatment, and the age of participants) could explain some of the heterogeneities across all trials.; Conclusion: The finding indicated that the trend of relatively more acupuncture dosage showed better effects for poor endometrial receptivity among PER women. It remains a potential heterogeneity in our studies. Further high-quality trials with a homogeneity trial design need to be conducted.; 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 Zheng, Yu, Liu, Yang, Wang, Yang, Lv and Yang.)

Zheng, Y., et al. (2023). "Efficacy and safety of different subsequent therapies after fertility preserving surgery for endometriosis: A systematic review and network meta-analysis." Medicine 102(31): e34496.
	Background: Endometriosis (EMT) is a benign and common estrogen-dependent disease. Hormonal therapy improves pain symptoms in most women with EMT. However, in many cases, laparoscopic fertility preservation surgery is considered a common treatment for EMT. The present study aimed to evaluate the efficacy and safety of dienogest, leuprolide, danazol, gestrinone, mifepristone and levonorgestrel intrauterine system (LNG-IUS) in relieving symptoms and delaying the recurrence of EMT cysts after fertility protection surgery.; Methods: We searched PubMed, the Cochrane Library, Web of Science, EMBase, China National Knowledge Infrastructure, VIP Database, China Biology Medicine disc, WanFang Data databases to collect randomized controlled trials (RCT) related to dienogest, leuprolide, danazol, gestrinone, mifepristone and LNG-IUS as a follow-up treatment after fertility preserving surgery for EMT. After literature screening, data extraction and quality evaluation, effective rate, recurrence rate, pregnancy rate and adverse reaction rate were used as outcome indicators to evaluate the efficacy and safety of drugs. Evidence networks included in the study were drawn and publication bias was assessed. The drugs most likely to be the best postoperative treatment were explored through mixed comparison of different drugs and efficacy ranking.; Result: Effective rate: dienogest, leprerelin, gestrinone and LNG-IUS were better than placebo after EMT fertility preservation surgery; dienogest was superior to mifepristone and danazol. LNG-IUS is superior to danazol. LNG-IUS has the highest potential for improving the effectiveness of EMT symptoms. Recurrence rate: the application of dienogest, leuprolide, gestrinone, mifepristone and LNG-IUS after EMT fertility preservation surgery was lower than that of placebo; dienogest and LNG-IUS were lower than danazol. The recurrence rate of dinorgestrel was the last place with the highest performance. Pregnancy rate: in the cases with fertility requirements, dienogest and,leuprolide were better than placebo after EMT fertility preservation surgery; dienogest was superior to danazol, gestrinone and mifepristone. Leuprolide is superior to danazol and gestrinone. The first rank of dienogest pregnancy rate was the highest. Adverse reaction rate: the application of dienogest, leuprolide, danazol, gestrinone, mifepristone and LNG-IUS after EMT fertility preservation surgery was higher than that of placebo. After placebo, LNG-IUS had the highest adverse reaction rate.; Conclusion: For patients after fertility preserving surgery for EMT, the recurrence rate of dienogest was the last place with highest preference. The first rank of dienogest pregnancy was the highest.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.)

Zhi, X., et al. (2022). "Tuina for perimenopausal insomnia: A protocol for systematic review and meta-analysis." Medicine 101(2): e28498.
	Background: Insomnia in perimenopausal women has a negative impact on quality of life and increases health care costs. With the increasing incidence of the disease, Tuina has been accepted by perimenopausal women. The purpose of this study is to explore the effectiveness and safety of Tuina for perimenopausal insomnia.; Methods: We will search 9 electronic databases: Chinese Biomedical Literature Database, Cochrane Library, China National Knowledge Infrastructure, EMBASE, MEDLINE, Web of Science, PubMed, Wan fang, Chinese Scientific Journal Database, and 1 clinical trials register platform: WHO International Clinical Trials Registry Platform. All relevant randomized controlled trial using Tuina for perimenopausal insomnia will be included. Two reviewers will independently screen date, and meta-analysis will be performed with RevMan (V5.3.5) software.; Results: This study will provide an evidence of Tuina for perimenopausal insomnia.; Conclusion: This study will provide a reliable evidence for the evaluation of the efficacy and side effects of Tuina in the treatment of perimenopausal insomnia.; Prospero Registration Number: CRD42021259017.; Ethics and Dissemination: This systematics review will evaluate the efficacy and safety of tuina in the treatment of perimenopausal insomnia. Since all the data included were published, the systematic review did not require ethical approval.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Zhong, H. Z., et al. (2022). "Chinese patent medicines combined with hormone replacement therapy for premature ovarian failure: A Bayesian network meta-analysis." Frontiers in Medicine 9: 1043390.
	Objective: The objective of this study was to compare the efficacy differences between Chinese patent medicines combined with hormone replacement therapy (HRT) in the treatment of premature ovarian failure (POF) by the Bayesian network meta-analysis (NMA) method. Method(s): Randomized controlled trials (RCTs) reporting Chinese patent medicine combined with HRT for POF included Medline (via PubMed), Embase, Cochrane Library, China National Knowledge Infrastructure Database (CNKI), Wanfang Database (Wanfang), VIP Database (VIP), and China Biology Medicine Database (CBM) from the inception of the databases to July 2022. Two researchers independently screened the articles, extracted data, and evaluated the quality. The literature that met the inclusion criteria was screened out, the quality and risk of bias of the included studies were assessed according to the Cochrane 5.1 manual and RevMan 5.4, and NMA was performed using Stata 15.0 and R software. Result(s): Sixty-four RCTs involving 5,675 individuals containing 12 oral Chinese patent medicines combined with HRT were enrolled into the current NMA. The results showed that when compared with patients using only HRT, the total clinical response rate is greater in patients using HRT combined with one of these 12 oral Chinese patent medicines. Among them, Zuogui pills + HRT [odds ratio (OR) = 3.92; 95% credible interval (CrI) = 0.86, 23.84; SUCRA = 73.76%] is most likely to be the best intervention, and the suboptimal intervention is Guishen pills + HRT (OR = 3.22, 95% CrI = 1.16, 9.44, SUCRA = 70.60%). Conclusion(s): Chinese patent medicines combined with HRT were more effective than HRT alone in the treatment of POF. Zuogui pills are good at decreasing follicle-stimulating hormone (FSH) and luteinizing hormone (LH) and more effective in the improvement of total clinical response rate; Xuefu Zhuyu capsule is also good at decreasing FSH. Ziheche capsule is an expert in improving estradiol level; Kuntai capsule shows the lowest incidence of adverse reactions. However, the quality of the literature included in this study is relatively low, so it may affect the results of the study. Therefore, higher quality and multi-center trial would be necessary for supporting these results. Systematic review registration: [www.crd.york.ac.uk/prospero], identifier [CRD42022350587].Copyright © 2022 Zhong, Li, Yin, Bin, Zhou and Wei.

Zhong, L., et al. (2022). "The effect of consolidation chemotherapy after concurrent chemoradiation on the prognosis of locally advanced cervical cancer: a systematic review and meta-analysis." Journal of Obstetrics and Gynaecology 42(5): 830-837.
	To verify the role of consolidation chemotherapy after concurrent chemoradiotherapy for bulky and locally advanced cervical cancer, a meta-analysis was performed. Based on articles published up to Jun 2020 a literature search in PubMed, EMBASE and Cochrane Library was conducted to identify eligible studies. A total of 4 articles consisting of 1659 patients were enrolled. The pooled results revealed that overall survival (OS) of patients treated with consolidation chemotherapy after concurrent chemoradiotherapy (CCRT + CT) was significantly superior to concurrent chemoradiotherapy (CCRT) alone (HR = 0.78, 95% CI: 0.69-0.88, p < .0001). The meta-analysis reviewed that the progression-free survival rate (PFS) of patients treated with CCRT + CT was significantly superior to CCRT alone (HR = 0.80, 95% CI: 0.73-0.87, p < .00001). The pooled results revealed a significant reduction of local recurrence rate for the CCRT + CT group (RR = 0.66, 95% CI: 0.55-0.79, p < .00001). The pooled meta-analysis also showed a significant reduction of distant recurrence rate for the CCRT + CT group (RR = 0.55, 95% CI: 0.44-0.69, p < .00001). The pooled results of grade 3/4 bone marrow suppression were calculated as OR and presented with a 95% CI (OR = 15.85; 95% CI: 9.48, 26.5, p < .00001), indicating patients who received CCRT + CT are more likely to suffer 3/4 bone marrow suppression than those treated with CCRT alone. In conclusion, patients who received chemoradiation with consolidation chemotherapy showed a significantly longer PFS, longer OS, lower local recurrence rate and distant recurrence rate compared to traditional concurrent chemoradiotherapy.Impact statement What is already known on this subject? Since CCRT was recommended as the standard treatment for cervical cancer, there was still a 20-30% chance of local recurrence, and 18-25% of distant recurrence for cervical cancer patients. Aiming to completely eradicate potential undetected micrometastases, consolidation chemotherapy came into the area of interest. We conducted a meta-analysis to verify the role of consolidation chemotherapy in cervical cancer. What do the results of this study add? The addition of consolidation CT resulted in a longer overall survival rate (OS) and progression-free survival rate (PFS), mainly due to control of local and distant relapses, especially the latter one. Toxicity followed consolidation CT increased but still clinically manageable. What are the implications of these findings for clinical practice and/or further research? In the future, we need more clinical studies with high quality to verify the role of consolidation CT in cervical cancer, and further to optimise the criteria for it.

Zhong, Q. and J. Huang (2021). "The effects of liraglutide in the pregnancy rate of Polycystic Ovary Syndrome: a Meta-Analysis." PROSPERO International prospective register of systematic reviews.
	Review question The aim of this meta-analysis of randomized controlled trials is to evaluate Liraglutide in the efficacy of the pregnancy rate for PCOS patients Searches We will search, with no time restrictions, the following databases for relevant English language literature: PubMed (MEDLINE), the Cochrane Central Register of Controlled Trials (CENTRAL), and the Web of Science. The search string will be built as follows: (liraglutide) AND (pregnancy rate OR pregnant outcomes OR birth rates OR pregnancy rates) AND (PCOS). The electronic database search will be supplemented by a manual search of the reference lists of included articles. Types of study to be included Randomised controlled trials only Condition or domain being studied This meta-analysis assess the efficacy and pregnancy rate of liraglutide in patients with polycystic ovarian syndrome. Participants/population Patients with polycystic ovarian syndrome. Intervention(s), exposure(s) liraglutide Comparator(s)/control 埃蒂尼斯特拉迪醇赛普罗酮片剂或二甲双酚或氯米芬或其他药物 Context (1) randomised controlled studies; (2) include patients with polycystic ovarian syndrome; (3) compare liraglutide plus basa treat versus basal treat alone; (4) include liraglutide (5) report at least one of the primary outcomes of interest Main outcome(s) The primary outcomes of interest were: (1) ovulation and pregnancy conditions: (a) ovulation rate (b) pregnancy rate (2)hormone indicators: (a)Follicle stimulating hormone (b)Luteinizing hormone (c)testosterone (3)metabolic indicators: (a)Fasting blood glucose (b)Glycosylated hemoglobin (c)Body Mass Index (4) Safety profile: (a) Proportion of patients with: (i) symptomatic hypoglycaemia (ii) nausea (iii) vomiting (iv) diarrhoea.

Zhong, Z., et al. (2022). "Electroacupuncture for the treatment of perimenopausal syndrome: a systematic review and meta-analysis of randomized controlled trials." Acupuncture in Medicine 40(2): 111-122.
	Objective: To assess the efficacy, comparative effectiveness and safety of electroacupuncture (EA) in the treatment of perimenopausal syndrome (PMS).; Methods: Nine databases were searched until June 2019. Only relevant randomized controlled trials (RCTs) of EA for PMS were included.; Results: Twelve trials involving 746 women were included. EA and hormone therapy (HT) did not significantly differ in terms of effective rate (risk ratio (RR) = 0.98, 95% confidence interval (CI) = 0.93 to 1.04), Kupperman index (KI) (mean difference (MD) = -0.25, 95% CI = -0.76 to 0.26) and serum levels of follicle-stimulating hormone (FSH) (MD = -3.80, 95% CI = -11.59 to 3.98) or luteinizing hormone (LH) (MD = -2.51, 95% CI = -10.72 to 5.70). Serum estradiol (E 2 ) levels were significantly lower in EA versus HT groups (MD = -60.58, 95% CI = -71.93 to -49.23). Compared with sham EA, EA had a significantly greater effect on reductions in KI (MD = -4.71, 95% CI = -6.57 to -2.86) and hot flushes score/24 h (MD = -2.43, 95% CI = -2.93 to -1.93). There were no significant differences between EA and manual acupuncture (MA) in terms of effective rate (RR = 1.14, 95% CI = 0.98 to 1.33) or serum FSH (MD = -2.87, 95% CI = -29.65 to 23.91), LH (MD = 2.73, 95% CI = -9.65 to 15.11) or E 2 (MD = 26.80, 95% CI = -12.06 to 65.65). However, it seemed that EA had a better effect than MA on KI (MD = -2.44, 95% CI = -4.80 to -0.08). Subgroup analyses indicated that EA may have more of a benefit in the pre-menopausal state (hot flushes score/24 h: MD = -1.66, 95% CI = -3.49 to 0.17) compared to post-menopause (p > 0.05).; Conclusion: The effect of EA appeared broadly similar to HT and MA in the treatment of PMS, although EA-associated reductions in KI were superior to MA and sham EA, suggesting effects beyond placebo. The evidence base is limited by a small number of eligible studies, risk of bias and clinical/statistical heterogeneity, limiting our ability to draw firm conclusions. As such, additional larger scale, high-quality RCTs are needed.

Zhou, C., et al. (2022). "The effectiveness of mHealth interventions on postpartum depression: A systematic review and meta-analysis." Journal of Telemedicine and Telecare 28(2): 83-95.
	Introduction: Postpartum depression (PPD) is a common psychiatric condition during the postnatal period that negatively impacts the well-being of both the mother and her infant. This study describes a systematic review and preliminary meta-analysis to assess the efficacy of mobile health (mHealth) interventions, which is defined as the use of portable electronic devices to support public health and medical practice, in addressing depressive symptoms among postpartum women.; Methods: Databases including PubMed, PsycINFO, the Cochrane Library, Embase and ClinicalTrials.gov were searched for randomized controlled trials (RCTs) assessing the effectiveness of mHealth interventions on PPD from database inception to December 2019.; Results: The initial search identified 754 studies, of which, 11 studies fulfilled the inclusion criteria. These studies evaluated four types of distinct mHealth interventions and involved 2424 participants across six countries. Pooled results demonstrated that compared to the controls, the Edinburgh Postnatal Depression Scale score decreased in the mHealth intervention group (mean difference: -1.09, 95% confidence interval: -1.39 to -0.79).; Discussion: Our study suggested that mHealth interventions may be a promising tool to complement routine clinical care in the prevention and treatment of PPD, but the clinical effectiveness of mHealth interventions needs to be better established. While most studies focused on telephone-based interventions, recent researches have also suggested the superiority and effectiveness of short messaging service (SMS) and smartphone applications, but the exact efficacy needs further evaluation. Therefore, more high-quality RCTs on app-based and SMS-based interventions are needed before the large-scale roll-out of these interventions in clinical practice.

Zhou, F. and L. Kemin (2023). "First-line monodrug chemotherapy in low-risk gestational trophoblastic neoplasia: a network meta-analysis." Frontiers in Oncology 13: 1276771.
	Objective: The efficacy of the first-line monodrug chemotherapy has been generally established for low-risk GTN. Most patients can achieve a complete response after the first-line monodrug chemotherapy. However, which monodrug chemotherapy regimen is better for individual patients with GTN is not yet certain. This study aimed to assess the efficacy of first-line monodrug chemotherapy in low-risk gestational trophoblastic neoplasia (GTN). Method(s): Databases, including PubMed, Embase, Web of Science, and Cochrane Library, were searched from inception to November 1, 2022, for case-control studies on first-line monodrug chemotherapy in GTN. Network meta-analysis was performed to compare the efficacy outcome of six monodrug chemotherapy regimens in GTN, with a complete response rate as the endpoint. Result(s): Twenty-four studies were considered eligible, including 9 randomized controlled trials (RCTs) and 15 non-RCTs. A total of 3344 patients with low-risk GTN were involved. Six monodrug chemotherapy regimens were included and analyzed. In descending order of efficacy, these six regimens were VP-16 (5 days), ACT-D (5 days), MTX (5 days), ACT-D (1.25 mg/m2), MTX (8 days), and MTX (30-50 mg/m2) in all study, and five regimens were ACT-D (5 days), MTX (5 days), ACT-D (1.25 mg/m2), MTX (8 days), and MTX (30-50 mg/m2) in RCT. Conclusion(s): Among the six first-line monodrug chemotherapy regimens for low-risk GTN in all study, VP-16 (5 days) was the best in terms of efficacy. And five regimens in RCT, ACT-D was the best. However, the finding needs to be validated through more high-quality clinical studies.Copyright © 2024 Zhou and Kemin.

Zhou, J., et al. (2023). "Effects of n-3 polyunsaturated fatty acid on metabolic status in women with polycystic ovary syndrome: a meta-analysis of randomized controlled trials." Journal of Ovarian Research 16(1): 54.
	This meta-analysis was conducted to summarize the effects of n-3 polyunsaturated fatty acid (n-3 PUFA) on metabolic status including insulin metabolism and lipid metabolism in women with polycystic ovary syndrome (PCOS) by randomized controlled trials (RCTs). Four mainstream databases including PubMed, Cochrane Library, Embase and Web of Science were searched from their inception to October 2021. The registration number of this study was CRD42021285233. The quality assessment was performed referring the Cochrane Risk of Bias Tool. Mean differences (MD) and 95% confidence intervals (CIs) were generated for continuous variables by meta-analysis. Subgroup analyses were performed based on study duration (≤ 8 weeks or > 8 weeks), the source of n-3 PUFA (marine derived or plant origins) and dosage of n-3 PUFA (≤ 1000 mg/d or > 1000 mg/d). Eventually, 11 RCTs reporting 816 patients were enrolled. Compared with control group, n-3 PUFA treatment decreased waist circumference (MD = -2.76, 95% CI: -3.82 to -1.69; p < 0.00001), fasting plasma glucose (MD = -3.91, 95% CI: -5.69 to -2.13; p < 0.0001), fasting insulin (MD = -2.45, 95% CI: -3.19 to -1.71; p < 0.00001), homeostatic model assessment of insulin resistance (MD = -0.45, 95% CI: -0.80 to -0.11; p = 0.01), triglyceride (MD = -9.33, 95% CI: -10.56 to -8.10; p < 0.00001), total cholesterol (MD = -12.32, 95% CI: -19.15 to -5.50; p = 0.0004), low-density lipoprotein cholesterol (MD = -10.53, 95% CI: -19.31 to -1.75; p = 0.02), and increase quantitative insulin sensitivity check index (MD = 0.01, 95% CI: 0.01 to 0.02; p < 0.00001), Adiponectin (MD = 1.46, 95% CI: 1.12 to 1.80; p < 0.00001) in PCOS patients. However, n-3 PUFA failed to change body weight, body mass index, high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol and hs-CRP in the overall analysis. Further subgroup analyses showed that supplements of n-3 PUFA for more than 8 weeks is more conducive to improve the metabolic status in insulin resistance and lipid profiles. The meta-analysis demonstrates that n-3 PUFA may be an effective intervention for alleviating metabolic status in PCOS. Hence, we recommend PCOS patients replenish n-3 PUFA with duration > 8 weeks regardless of the source and the dosage to retard the pathogenesis of PCOS related metabolic diseases. (© 2023. The Author(s).)

Zhou, L., et al. (2023). "Effects of GLP1RAs on pregnancy rate and menstrual cyclicity in women with polycystic ovary syndrome: a meta-analysis and systematic review." BMC Endocrine Disorders 23(1): 245.
	Purpose: This study was aimed to assess the effectiveness of Glucagon-like peptide 1 receptor agonists on pregnancy rate, menses, anthropometric and hormonal parameters in PCOS patients.; Methods: We conducted searches of the published literature in PubMed, EMBASE, Cochrane Library, Web of Science up to September 2022. Data from randomized controlled trials were obtained to assess the effects of GLP1RAs in PCOS women. Weighted mean difference, standardized mean difference, and risks ratio were employed for effect size estimation using a random-effects model.; Results: A total of 840 patients with 469 individuals in GLP1RAs group and 371 individuals in control group from 11 RCTs were included. GLP1RAs usage was associated with an improvement in natural pregnancy rate (RR: 1.72, 95% CI 1.22 to 2.43, P = 0.002, I 2 = 0%) and menstrual regularity (SMD: 1.72, 95% CI 0.60 to 2.85, P < 0.001, I 2 = 95.6%). There were no statistically significant differences in total pregnancy rate, IVF pregnancy rate between two groups, but total PR elevated in a short time after GLP1RAs as shown in subgroup analysis. Randomization to GLP1RAs treatment was associated with great improvement in HOMA-IR, BMI, WC, SHBG and a slight reduction in TT compared to control group. A decrease in TBF was seen in European population. GLP1RAs monotherapy was not superior to metformin when it came to fT, DHEAS, FAI.; Conclusions: Prescription of GLP1RAs improves natural pregnancy rate, menstrual cyclicity and insulin sensitivity, anthropometrics, hormonal indexes in PCOS women. (© 2023. The Author(s).)

Zhou, P., et al. (2020). "The effect of intralipid on pregnancy outcomes in women with previous implantation failure in in vitro fertilization/intracytoplasmic sperm injection cycles: A systematic review and meta-analysis." European Journal of Obstetrics and Gynecology and Reproductive Biology 252: 187-192.
	Several recent studies have investigated the relationship between intravenous intralipid and in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes in women with previous implantation failure. We conducted a systematic review and meta-analysis to evaluate the effects of intravenous intralipid on pregnancy outcomes in women with previous implantation failure. Ovid MEDLINE, the Cochrane Library, Embase and ClinicalTrials.gov were searched up to August 5th, 2019. Randomized controlled trials comparing intravenous intralipid with placebo or no treatment during IVF/ICSI cycles in women with at least one implantation failure were included. Results were presented as risk ratio (RR) with 95 % confidence intervals (CIs). Four studies with 544 participants were included. Live birth rate was statistically higher among the groups of women who received intravenous intralipid (RR 1.98, 95 % CI 1.39-2.80, quality of evidence: low). Intralipid infusion could significantly improve clinical pregnancy rate (RR 1.74, 95 % CI 1.27-2.40, quality of evidence: low). When excluding two studies only published as conference abstracts, there were no significant differences in terms of live birth (RR 1.78, 95 % CI 0.95-3.34, heterogeneity: I2 = 25.5 %, quality of evidence: low, Fig. 4A) and clinical pregnancy (RR 1.66, 95 % CI 0.90-3.08, heterogeneity: I2 = 47.7 %, quality of evidence: low, Fig. 4B). Adverse events were reported to be rare, but three congenital anomalies were observed in women receiving intravenous intralipid. Administering intravenous intralipid during IVF/ICSI cycles may improve live birth and clinical pregnancy in women with previous implantation failure, such benefit is not significant excluding studies with high risk of bias in the analysis, more studies are needed to evaluate its efficacy and safety especially congenital malformations.Copyright © 2020 Elsevier B.V.

Zhou, S., et al. (2024). "Comparison of poly (ADP-ribose) polymerase inhibitors (PARPis) as maintenance therapy for newly-diagnosed and platinum-sensitive recurrent ovarian cancer with BRCA mutational status: a systematic review and network meta-analysis." Expert Review of Anticancer Therapy 24(1-2): 59-69.
	Background: Poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors (PARPi) treatment for ovarian cancer (OC) are ever-changing. This study aimed to compare the efficacy and overall safety of available PARPi as maintenance therapy for BRCA mutation status in patients with newly diagnosed and platinum-sensitive recurrent (PSR) OC patients. Research design and methods: Relevant RCTs were systematically retrieved from PubMed and Embase until 31 May 2022. Progression-free survival (PFS) and overall survival (OS) based on BRCA mutation status and adverse events (AEs) regardless of mutation were efficacy and safety endpoints. Result(s): In newly diagnosed BRCAm-OC patients, olaparib (HR: 0.33; 95% confidence interval [CI]: 0.25, 0.43) and other PARPis [niraparib (HR: 0.40; 95% CI: 0.29, 0.55), rucaparib (HR: 0.40; 95% CI: 0.21, 0.76) and veliparib (HR: 0.44; 95% CI: 0.28, 0.69)] had a statistically significant effect on PFS versus placebo. In BRCAm-PSROC patients, Olaparib exhibited significant benefit (HR: 0.69; 95% CI: 0.54, 0.88) for OS compared to other PARPis. In BRCAwt-PSR OC patients, Olaparib showed a favorable OS benefit than other PARPis (HR: 0.84; 95% CI: 0.57,1.22). Overall, safety profile of all PARPis was acceptable. Conclusion(s): All PARPis showed significant benefit, with olaparib showing greater benefit in newly diagnosed and PSR OC women. Registration: CRD42021288932.Copyright © 2024 Informa UK Limited, trading as Taylor & Francis Group.

Zhou, S., et al. (2023). "A comparison of the efficacy of acupuncture-related therapies for female chronic pelvic pain: A Bayesian network meta-analysis." PROSPERO International prospective register of systematic reviews.
	Types of study to be included Randomized Controlled Trials (RCTs). Condition or domain being studied Chronic pelvic pain (CPP) which means the pain occurred in the pelvic region longer than six months, is a common, burdensome, and costly condition that disproportionately affects women. Many diseases are potential gynecologic etiologies of CPP (ie, endometriosis, adenomyosis, leiomyomas, adnexal pathology, and vulvar disorders). Treating chronic pelvic pain is complex and challenging. Conventional treatment usually uses NSAIDs to relieve pain, but once the medication is stopped, it can recur. In addition, for primary diseases, pain relief is generally achieved by treating them. Acupuncture-related therapy was an acceptable, well-tolerated treatment and it may reduce pelvic pain and improve quality of life. Either single or combined application of acupuncture-related therapy can play a complementary and synergistic role in the existing Western medicine treatment scheme. Participants/population Inclusion criteria: The patients we included were female patients who were clinically diagnosed with chronic pelvic pain. The diagnostic criteria refer to the "Chronic Pelvic Pain: ACOG Practice Bulletin, Number 218" (2020 Edition) Exclusion criteria: Quasi-randomized or non-randomized controlled trials will be excluded. Clinical studies with a sample size of less than 30 will be excluded. literature that cannot extract complete data on outcome measures will be excluded. Intervention(s), exposure(s) interventions: acupuncture-related therapy or combined with Western medicine. Comparator(s)/control comparison: acupuncture-related therapy or Western medicine or blank group. Context 1. The subjects were clinically diagnosed with chronic pelvic pain, and no restrictions on the age, ethnicity, and region of the patient. 2. Observation group or control group combined with other treatment methods 3. Literature that cannot extract complete outcome indicators or the full text cannot be obtained will be excluded. 4. The research that includes experimental research, experience summary, summary, case report, etc will be excluded. Main outcome(s) the effective rate of clinical comprehensive effect Measures of effect [recovery number of cases + efficiency number of cases] / total number of cases Additional outcome(s) Secondary outcome measures include VAS scores of lower abdominal pain and lumbosacral pain, Traditional Chinese Medicine Syndrome Score, score of local signs and symptoms, WHOQOL-BREF, and adverse effects rate. Measures of effect adverse effects rate (adverse events / total number of cases)

Zhou, X., et al. (2022). "Acupuncture effects on in-vitro fertilization pregnancy outcomes: A meta-analysis." Complementary Therapies in Clinical Practice 46: 101525.
	Background: The effects of acupuncture on in-vitro fertilization outcomes remain controversial. This study aimed to perform a meta-analysis to assess the effectiveness of acupuncture as an adjuvant therapy to embryo transfer compared to sham-controls or no adjuvant therapy controls on improving pregnancy outcomes in women undergoing in-vitro fertilization.; Methods: A systematic literature search up to January 2021 was performed and 29 studies included 6623 individuals undergoing in-vitro fertilization at the baseline of the study; 3091 of them were using acupuncture as an adjuvant therapy to embryo transfer, 1559 of them were using sham-controls, and 1441 of them were using no adjuvant therapy controls. They reported a comparison between the effectiveness of acupuncture as an adjuvant therapy to embryo transfer compared to sham-controls or no adjuvant therapy controls on improving pregnancy outcomes in women undergoing in-vitro fertilization. Odds ratio (OR) with 95% confidence intervals (CIs) were calculated assessing the effectiveness of acupuncture as an adjuvant therapy to embryo transfer compared to sham-controls or no adjuvant therapy controls using the dichotomous method with a random or fixed-effect model.; Results: Significantly higher outcomes with acupuncture were observed in biochemical pregnancy (OR, 1.98; 95% CI, 1.55-2.53, p < 0.001); clinical pregnancy (OR, 1.70; 95% CI, 1.46-1.98, p < 0.001); ongoing pregnancy (OR, 1.78; 95% CI, 1.41-2.26, p < 0.001); and live birth (OR, 1.58; 95% CI, 1.15-2.18, p = 0.005) compared to no adjuvant therapy controls. However, no significant difference were found between acupuncture and no adjuvant therapy controls in miscarriage (OR, 0.96; 95% CI, 0.48-1.92, p = 0.91). No significant difference was observed with acupuncture in biochemical pregnancy (OR, 1.16; 95% CI, 0.65-2.08, p = 0.62); clinical pregnancy (OR, 1.13; 95% CI, 0.83-1.54, p = 0.43); ongoing pregnancy (OR, 1.04; 95% CI, 0.66-1.62, p = 0.87); live birth (OR, 1.02; 95% CI, 0.73-1.42, p = 0.90), and miscarriage (OR, 1.16; 95% CI, 0.86-1.55, p = 0.34) compared to sham-controls.; Conclusions: Using acupuncture as an adjuvant therapy to embryo transfer may improve the biochemical pregnancy, clinical pregnancy, ongoing pregnancy, and live birth outcomes compared to no adjuvant therapy controls. However, no significant difference was found between acupuncture as an adjuvant therapy to embryo transfer and sham-controls in any of the measured outcomes. This relationship forces us to recommend the use of acupuncture as adjuvant therapy in women undergoing in-vitro fertilization and inquire further studies comparing acupuncture and sham-controls to reach the best procedure. (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Zhou, X., et al. (2022). "Effect of Vitamin D Supplementation on In Vitro Fertilization Outcomes: A Trial Sequential Meta-Analysis of 5 Randomized Controlled Trials." Frontiers in Endocrinology 13: 852428.
	Despite numerous studies indicating an imperative role of vitamin D for reproduction, the importance of vitamin D supplementation on in vitro fertilization (IVF) outcomes remains controversial. We therefore performed this meta-analysis to investigate the IVF outcomes of vitamin D supplementation in infertile women with vitamin D deficiency. We systematically searched PubMed, Embase and the Cochrane library for identifying all relevant studies published before August 2021. Pregnancy rate was defined as the primary outcome while good quality embryo, fertilization rate, ongoing pregnancy, and miscarriage were secondary outcomes. We used Review Manager 5.3 (RevMan) to conduct meta-analysis and examined the robustness of the primary outcome by trial sequential analysis. Five studies were included in the final analysis and it suggested that vitamin D supplementation was associated with improved chemical pregnancy rate (risk ratio [RR] = 1.53, 95% confidence interval [CI] = 1.06 to 2.20, p = 0.02) but not benefited in improving clinical pregnancy rate (RR = 1.34, 95% CI = 0.81 to 2.24, p = 0.25) and all secondary outcomes. Trial sequential analysis suggested further studies are needed to confirm this conclusion. We concluded that vitamin D supplementation should be prescribed to improve chemical pregnancy in infertile women with vitamin D deficiency and more studies are required to further confirm this finding.; 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 Zhou, Wu, Luo, Shao, Guo, Deng and Wu.)

zhou, x., et al. (2022). "Effect of acupuncture on clinical outcome of patients with repeated implant failure." PROSPERO International prospective register of systematic reviews.
	Review question Acupuncture on clinical pregnancy outcomes in patients with repeated implant failure Searches We searched PubMed, Embase, Cochrane Library, Web of Science, Clinical Trials.gov, BIOSIS Previews, CNKI, CBM, VIP database, WANFANG, KCI, J-Stage; from beginning to now on; no language restrictions. Types of study to be included We will include randomized controlled trials (RCTs). Other types of studies are excluded. Condition or domain being studied The process of embryo planting in the uterine cavity is like planting seed in the soil. The seed is like "embryo", and the endometrium is like "soil". The fertility of the soil plays a decisive role in the whole process of planting. Low endometrial receptivity is one of the main reasons for embryo implantation failure. Endometrial thickness, blood flow and related hormone levels are important indicators to judge endometrial receptivity. Acupuncture therapy has advantages in improving endometrial receptivity. Participants/population We include patients with low endometrial receptivity. Non-RCT design, duplicate studies , animal experiments, literature reviews, studies comparing different types of acupuncture, case reports or expert opinions and studies without integrated data are excluded. Intervention(s), exposure(s) We will use acupuncture as the intervention, with or without other treatment. Comparator(s)/control Mock TEAS, medicine, moxibustion, sham acupuncture, routine treatment, or no treatment. Context Main outcome(s) We set the Pregnancy Rate as the primary outcomes. Additional outcome(s) Endometrial thickness, blood estrogen level and progesterone level

Zhou, Y. and W. Guo (2023). "Efficacy and Safety of Paclitaxel and Carboplatin for Platinum-Sensitive Ovarian Cancer: A Systematic Review and Meta-Analysis." Journal of Clinical Pharmacy and Therapeutics 2023: 1951412.
	Purpose. Paclitaxel and carboplatin are novel anticancer drugs that have emerged in recent years, while there is still a lack of clinical consensus on these two drugs. The study conducted a meta-analysis and systematic review to analyze the efficacy and safety of paclitaxel and carboplatin for platinum-sensitive ovarian cancer. Methods. A systematic search was carried out in three databases of the Cochrane Library, Embase, and PubMed from the inception of each database to March 2021, and defined the progression-free survival and overall survival as the primary outcomes. Data analysis was performed using STATA 15.1. Results. Altogether, five randomized controlled trials (RCTs) were included in the meta-analysis, involving 2,740 patients, including 1317 in the CD (carboplatin doxorubicin) group and 1423 in the CP (carboplatin plus paclitaxel) group. It was found that pooled OS demonstrated no significant differences between the CD group and CP group (HR = 1.02, 95% CI = 0.89-1.18, P = 0.340), and the differences were not statistically significant in progression-free survival (HR = 0.84, 95% CI = 0.71-0.99, P = 0.140), thrombocytopenia (OR = 0.23, 95% CI = 0.09-0.58, P = 0.775), and grade II alopecia between the two groups (OR = 9.41, 95% CI = 6.57-13.47, P = 0.215). Conclusion. Current evidence suggests that paclitaxel and carboplatin do not produce more satisfactory results with respect to overall survival and reduction of side effects in treating platinum-sensitive ovarian cancer, and further studies are needed.Copyright © 2023 Yan Zhou and Wei Guo.

Zhu, D., et al. (2022). "Effects of metformin on pregnancy outcome, metabolic profile, and sex hormone levels in women with polycystic ovary syndrome and their offspring: a systematic review and meta-analysis." Annals of Translational Medicine 10(7): 418.
	Background: Researches of the efficacy and safety of metformin on long-term pregnancy outcomes remains conflicted. We performed an updated systematic review and meta-analysis to systematically investigate the effect of metformin treatment on pregnancy outcome, metabolic profile, and sex hormone characteristics in women with polycystic ovary syndrome (PCOS) and their offspring.; Methods: The PubMed, Embase, and Cochrane Library databases were searched from inception to July 10, 2021 with the keywords "metformin", "PCOS", and "pregnancy". Randomized controlled studies reported pregnant related outcomes after metformin intervention among PCOS women were included, while abstracts and reviews were excluded. Two authors independently identified trials, extracted data and assessed risk of bias with Cochrane Reviewer's Handbook 5.0. Random effects models were used to evaluate the pooled risk ratios (RR) and 95% confidence intervals (95% CI) of pregnancy outcome, metabolic profile, and sex hormone levels.; Results: Eighteen studies were included. The majority of trials were in medium methodological quality. In terms of pregnancy complications among women with PCOS, metformin treatment was associated with a significantly reduced risk of preterm delivery (RR =0.37, 95% CI: 0.23-0.61), pregnancy-induced hypertension (PIH) and preeclampsia (RR =0.45, 95% CI: 0.24-0.83) and macrosomia (RR =0.26, 95% CI: 0.11-0.64). In terms of offspring, metformin significantly associated with larger head circumference (MD =0.29, 95% CI: 0.13-0.45) and higher long-term body mass index (BMI) measures (MD =0.37, 95% CI: 0.17-0.56). In terms of metabolic profile and sex hormone characteristics, a significant decrease in homeostatic model assessment for insulin resistance (HOMA2-IR) scores was found in mothers (MD =-0.32, 95% CI: -0.63 to -0.02), whereas a significant increase of sex hormone binding globulin (SHBG) levels was detected in offspring (MD =0.33, 95% CI: 0.01-0.65).; Discussion: Although the relative low quality of randomized controlled trials (RCTs) and limited results made it difficult to draw a definite conclusion, our study showed that metformin treatment during pregnancy can reduce the risk of pregnancy complications but may have impacts on increasing SHBG levels and long-term BMI in offspring.; Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://atm.amegroups.com/article/view/10.21037/atm-22-909/coif). The authors have no conflicts of interest to declare.

Zhu, F., et al. (2023). "TEAS, DHEA, CoQ10, and GH for poor ovarian response undergoing IVF-ET: a systematic review and network meta-analysis." Reproductive Biology and Endocrinology 21(1): 64.
	BACKGROUND: Assisted reproductive technology (ART) has brought good news to infertile patients, but how to improve the pregnancy outcome of poor ovarian response (POR) patients is still a serious challenge and the scientific evidence of some adjuvant therapies remains controversial. AIM: Based on previous evidence, the purpose of this systematic review and network meta-analysis was to evaluate the effects of DHEA, CoQ10, GH and TEAS on pregnancy outcomes in POR patients undergoing in vitro fertilization and embryo transplantation (IVF-ET). In addition, we aimed to determine the current optimal adjuvant treatment strategies for POR. METHODS: PubMed, Embase, The Cochrane Library and four databases in China (CNKI, Wanfang, VIP, SinoMed) were systematically searched up to July 30, 2022, with no restrictions on language. We included randomized controlled trials (RCTs) of adjuvant treatment strategies (DHEA, CoQ10, GH and TEAS) before IVF-ET to improve pregnancy outcomes in POR patients, while the control group received a controlled ovarian stimulation (COS) regimen only. This study was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The surface under the cumulative ranking curve (SUCRA) was used to provide a pooled measure of cumulative ranking for each outcome. RESULTS: Sixteen RCTs (2323 women) with POR defined using the Bologna criteria were included in the network meta-analysis. Compared with the control group, CoQ10 (OR 2.22, 95% CI: 1.05 to 4.71) and DHEA (OR 1.92, 95% CI: 1.16 to 3.16) had obvious advantages in improving the clinical pregnancy rate. CoQ10 was the best in improving the live birth rate (OR 2.36, 95% CI: 1.07 to 5.38). DHEA increased the embryo implantation rate (OR 2.80, 95%CI: 1.41 to 5.57) and the high-quality embryo rate (OR 2.01, 95% CI: 1.07 to 3.78) and number of oocytes retrieved (WMD 1.63, 95% CI: 0.34 to 2.92) showed a greater advantage, with GH in second place. Several adjuvant treatment strategies had no significant effect on reducing the cycle canceling rate compared with the control group. TEAS was the least effective of the four adjuvant treatments in most pooled results, but the overall effect appeared to be better than that of the control group. CONCLUSION: Compared with COS regimen, the adjuvant use of CoQ10, DHEA and GH before IVF may have a better clinical effect on the pregnancy outcome of POR patients. TEAS needs careful consideration in improving the clinical pregnancy rate. Future large-scale RCTs with direct comparisons are needed to validate or update this conclusion. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022304723.

Zhu, H., et al. (2022). "Efficacy and safety of external therapy of TCM for primary dysmenorrhea: A protocol for systematic review and meta-analysis." Medicine 101(18): e29155.
	Background: Primary dysmenorrhea (PD) is a painful disease that severely affects the daily lives of young women. External therapy using traditional Chinese medicine (TCM) is widely used in the clinical treatment of this disease and has achieved a good effect. There are many kinds of TCM external therapies, but the effectiveness, safety, and advantages of various methods have not been confirmed by high-quality meta-analyses. The purpose of this study was to evaluate the efficacy and safety of representative TCM external therapies in patients with PD.; Methods: Published randomized controlled trials that assessed the efficacy of these interventions in patients with PD were included. We searched the following electronic databases: PubMed, Cochrane Library, Embase, Web of Science, China Science and Technology Journal, China National Knowledge Infrastructure, Wanfang, and Chinese Biomedical Literature Database and other sources. The main outcomes included menstrual pain intensity and the clinical effectiveness rate. The secondary outcomes were the quality of life and safety. The meta-analysis will be performed using the Review Manager version 5.3 software.; Results: We will provide more practical results investigating the efficacy of external TCM therapy with high clinical frequency for PD patients in several respects, including the improvement of menstrual pain intensity, quality of life, and safety.; Conclusion: This review systematically reviews the effectiveness and safety of common TCM external therapies for PD and provides clinicians with the best treatment options.; Ethics and Dissemination: This systematic review aimed to evaluate the efficacy and safety of external TCM therapy for PD. Since all data included were published, the systematic review did not require ethical approval.; Registration Number: CRD42021297078.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Zhu, J., et al. (2023). "Oxytocin and Women Postpartum Depression: A Systematic Review of Randomized Controlled Trials." Neuropsychiatric Disease and Treatment 19: 939-947.
	Previous studies have demonstrated that oxytocin was a viable therapy option for postpartum depression. However, the role remains controversial. To evaluate the efficacy of oxytocin on women postpartum depression, we searched PubMed, Web of Science, Cochrane Library, and EmBase for literatures from inception of the database to April 18th, 2022. Randomized controlled trials (RCTs) that investigated the effects of oxytocin on postpartum depression were selected for this study. Six RCTs (195 women) were gathered. The effects of oxytocin were roughly divided into emotion and cognition. The modulation of oxytocin to women's emotion was demonstrated in four of the trials. The results were conflicting: One trial showed that oxytocin alleviated the depressive mood; two trials showed that oxytocin had no effect (but reduce negative thoughts in healthy mothers, or decrease the narcissistic trait); another trial showed that oxytocin aggravated depression. Women's cognition was shown to be regulated by oxytocin in four of the trials. In general, oxytocin enhanced postpartum depressive women's perception of their relationship with the infants. This systematic review showed that the effect of oxytocin on postpartum depression is still uncertain. We partly support that exogenous oxytocin might improve the cognition of women with postpartum depression to their infants, while the effect on emotion is still controversial. Further RCTs with larger samples and more diversified evaluation criteria are needed to better reveal its efficacy on postpartum depression.; Competing Interests: The authors report no conflicts of interest in this work. (© 2023 Zhu et al.)

Zhu, P., et al. (2022). "The clinical effectiveness and safety of traditional Chinese medicine Jinfeng pill in adjuvant treatment of infertility with polycystic ovary syndrome: A protocol for systematic review and meta-analysis." Medicine 101(4): e28676.
	Background: Polycystic ovary syndrome (PCOS) is the main cause of infertility in women, the essence of which is an endocrine disorder syndrome with abnormal sugar metabolism and reproductive dysfunction, and the incidence rate of about 6% of women. Traditional Chinese medicine (TCM) Jinfeng pill has achieved very good clinical results in the treatment of infertility with PCOS, but there is currently a lack of strong evidence-based medical evidence. This study uses meta-analysis method to analyze the clinical effectiveness and safety of TCM Jinfeng pill in the treatment of infertility with PCOS, hoping to provide help for the clinical treatment of infertility with PCOS.; Methods: Using the computer to retrieve SinoMed, CNKI, VIP, WANFANG Database, as well as Public, The Cochrane library, Medline (Ovid SP), Embase and other foreign language databases, while manually retrieving the relevant magazine supplements, special issues, professional materials, network information, and so on. The retrieval time is from the beginning of each database to June 2021. The selected literature is evaluated using the Cochrane System Rating Manual Bias Risk Tool. Statistical analysis and graphics of the inclusion literature are performed using Review Manager 5.3 statistical software.; Results: All the results of this study on the clinical effectiveness and safety of TCM Jinfeng pill in adjuvant treatment of infertility with PCOS will be published in a peer-reviewed academic journal of medicine.; Ethics and Dissemination: The type of study is systematic evaluation, the whole process of research does not involve human trials, the data used in the institute are obtained through published literature, so ethical review is not suitable for this study.; Osf Registration Number: 10.17605/OSF.IO/JEP2D. (https://osf.io/jep2d).; Conclusion: Our research will provide evidence-based medical evidence on whether the TCM Jinfeng pill is effective and safe in the treatment of infertility with PCOS.; Competing Interests: The authors have no conflicts of interest to disclose. (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Zigman, J. S., et al. (2022). "Continuing posterior tibial nerve stimulation after twelve weekly sessions: a randomized controlled trial." Urogynaecologia 34(1): 251.
	Posterior Tibial Nerve Stimulation (PTNS) is a treatment option for refractory Overactive Bladder (OAB). There is currently no evidence to support which maintenance schedule is most effective. The objective of this study is to compare patient-reported outcomes between monthly maintenance therapy and sessions scheduled Per patient request (PRN). We hypothesized that there is no difference in these measures between groups. After completing 12 sessions of PTNS, patients were randomized to monthly or PRN maintenance. Quality of life, patient satisfaction, and degree of symptom bother were assessed with validated questionnaires. Thirty six patients were randomized: 19 to monthly follow-up, and 17 to PRN follow-up. The PRN group demonstrated a significantly higher quality of life (p=0.04) with a large effect size (0.82). Over a three-month period, there was no significant difference in the average number of visits between the monthly and PRN groups, with an average of 1.79 (+/-1.18) and 1.24 (+/-1.35) visits, respectively (p=0.20). After six months of maintenance therapy, 42% of patients in the monthly group and 53% of patients in PRN group elected to continue therapy (p=0.27). There was no significant difference between the groups with regard to treatment satisfaction (p=0.62) or percent change in OAB symptoms (p=0.13). There is no difference between monthly and PRN follow-up in terms of patient satisfaction and symptom bother. However, the PRN group scored higher on the quality of life measure. PRN maintenance may optimize care for patients treating Overactive Bladder Syndrome with posterior tibial nerve stimulation.Copyright © the Author(s), 2022.

Ziling, L., et al. (2023). "Effectiveness of Core stability exercise versus general exercise in postpartum women with pelvic girdle pain or lumbar-pelvic pain: a systematic review with meta-analysis." PROSPERO International prospective register of systematic reviews.
	
Ziv, E., et al. (2024). "Vaginal microflora following the use of a disposable home-use vaginal device and a commercially available ring pessary for pelvic organ prolapse management: a randomized controlled trial." Archives of Gynecology and Obstetrics 309(2): 571-579.
	Purpose: To investigate whether ProVate, a novel, disposable, self-inserted vaginal device for pelvic organ prolapse management, clinically affects the vaginal microflora, as compared with a commercially available ring pessary, to assess its microbiological safety. Method(s): This interventional, prospective, multi-center, open-label, randomized, controlled, statistically powered (noninferiority), home-use, crossover study was conducted at seven sites. Participants were randomized into either group A (using ProVate and then a new reusable commercially available ring pessary [control]) or B (using control device and then ProVate) with a 1:1 ratio. Noninferiority of ProVate over the control was evaluated for the primary endpoint, which was based on meeting one of the failure criteria: significant change in Lactobacillus spp., Gardnerella vaginalis, Candida morphotypes, or Staphylococcus aureus levels compared to the baseline (significant change: Nugent score >= 7 or > 1 scale unit increase in S. aureus or Candida morphotype), bothersome vaginal infection symptoms, or symptoms requiring treatment for infection. Result(s): The study included 58 participants (mean age: 64.5 years, 91.4% postmenopausal). There were no significant microfloral changes in terms of the four microorganisms mentioned above, the rate of Nugent score >= 7 after use was low and comparable between the two devices, and the rate of patients with a > 1 unit-scale change (increase or decrease) from the baseline to the end-of-use phase in any studied microorganism was comparable between the devices. The failure rate was 15.5% for ProVate and 15.5% for control while using 383 ProVate devices over 1647 days or one control device throughout the study. Two patients had bothersome vaginal complaints and one had overt vaginal infection in the control group, but no such cases were observed in the ProVate group. Conclusion(s): The primary endpoint of possible vaginal microbial changes, bothersome vaginal symptoms, or treatment-requiring vaginal complaints while using ProVate was successfully met. Our findings show that the vaginal microflora is comparable when using either ProVate or commercially available ring pessary (control) with a relatively low rate of vaginal infections. Trial registration details: ClinicalTrials.gov; URL: https://www.clinicaltrials.gov/ct2/show/NCT03345121?term=NCT03345121&draw=2&rank=1 ; No. NCT03345121; Registration date, November 17, 2017; initial enrollment started on August 20, 2017.Copyright © 2023, The Author(s).

Zivanovic, O. (2022). "Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer." ClinicalTrials.gov.
	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).

Zöhre, P. (2023). "The Effect of Relaxation and Stretching Exercises on Pain and Quality of Life in Women With Primary Dysmenorrhea." ClinicalTrials.gov.
	No Results Available Other: Stretching|Other: Relaxation Visual Analogue Scale|The Menstruation Symptom Questionnaire|Short Form 12 Health Survey|Measurement with Algometer Female Not Applicable 20 Other Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment Pyeditepe August 30, 2023

Zola, P., et al. (2022). "Effectiveness of Intensive Versus Minimalist Follow-Up Regimen on Survival in Patients With Endometrial Cancer (TOTEM Study): A Randomized, Pragmatic, Parallel Group, Multicenter Trial." Journal of Clinical Oncology 40(33): 3817-3827.
	Purpose: In the absence of clear evidence from randomized trials, the intensity of follow-up regimens after surgical treatment of endometrial cancer is highly variable in clinical practice. To reduce this uncertainty, we conducted a randomized trial to test whether an intensive (INT) versus a minimalist (MIN) follow-up regimen improves overall survival (OS) in patients undergoing operation for endometrial cancer.; Methods: The TOTEM study was a large, pragmatic randomized trial, conducted in 42 hospitals (in Italy and France) including patients surgically treated for endometrial cancer, in complete clinical remission, International Federation of Gynecology and Obstetrics stage I-IV. After stratification by center and risk of relapse (low or high), patients were randomly assigned (1:1) to INT or MIN hospital-based follow-up regimens. The study was powered to demonstrate an absolute improvement of 5% of the 5-year OS with the INT regimen.; Results: In total, 1,871 patients were randomly assigned between November 2008 and July 2018, and 1,847 patients (98.7%) were available for the final analysis (60% low risk). After a median follow-up of 69 months, the 5-year OS was 90.6% in the INT and 91.9% in the MIN arms (hazard ratio, 1.13, 95% CI, 0.86 to 1.50, P = .380). No differences in OS were found in subgroup analyses considering age, cancer treatment, risk of relapse, and degree of adherence of the center to the scheduled follow-up. The probability of detecting a relapse was slightly higher in the INT arm (hazard ratio, 1.17; 95% CI, 0.92 to 1.48; P = .194).; Conclusion: An INT follow-up in endometrial cancer-treated patients does not improve OS, even in high-risk patients. According to available evidence, there is no need to routinely add vaginal cytology, laboratory, or imaging investigations to the MIN regimens used in this trial.

Zolton, J. R., et al. (2020). "Gonadotropins versus oral ovarian stimulation agents for unexplained infertility: a systematic review and meta-analysis." Fertility and Sterility 113(2): 417-425.e411.
	Objective: To compare live birth and multiple gestation in patients diagnosed with unexplained infertility undergoing intrauterine insemination after ovarian stimulation (OS-IUI) with oral medications versus gonadotropins. Design(s): Systemic review and meta-analysis. Setting(s): Not applicable. Patient(s): Patients undergoing OS-IUI for treatment of unexplained infertility. Intervention(s): Clomiphene, letrozole, or gonadotropins for OS-IUI. Main Outcome Measure(s): Live birth and multiple gestation. Result(s): Eight total trials were identified that met the inclusion criteria and comprised 2,989 patients undergoing 6,590 cycles. One study reported a significant increase in both live births and multiple gestations with the use of gonadotropins, two studies found an increased likelihood of live birth with the use of gonadotropins, and two studies found an increased risk of twins with gonadotropins. The relative risk of live birth in subjects receiving gonadotropins was 1.09. The relative risk of multiple gestation in subjects receiving gonadotropins was 1.06. Clinical pregnancy was higher in protocols with lax cancellation policies or higher gonadotropin doses, with subsequent increased relative risks of multiple gestations of 1.20 and 1.15, respectively. Singleton births per subject were similar between the two groups. The results did not change in per-protocol, per cycle, or fixed-effect model sensitivity analyses. Conclusion(s): For every birth gained with the use of gonadotropins, a similar increased risk of multiple gestation occurs. The randomized data do not support the use of gonadotropin for OS-IUI in women with unexplained infertility. Clinical Trial Registration Number: Prospero CRD4201911998Copyright © 2019

Zorzato, P. C., et al. (2024). "Intrauterine manipulator during hysterectomy for endometrial cancer: a systematic review and meta-analysis of oncologic outcomes." American Journal of Obstetrics and Gynecology 230(2): 185-198.e184.
	Objective: This study aimed to assess the effects on oncologic outcomes of intrauterine manipulator use during laparoscopic hysterectomy for endometrial cancer. Data Sources: A systematic literature search was performed by an expert librarian in multiple electronic databases from inception to January 31, 2023. Study Eligibility Criteria: We included all studies in the English language that compared oncologic outcomes (recurrence-free, cause-specific, or overall survival) between endometrial cancer patients who underwent total laparoscopic or robotic hysterectomy for endometrial cancer with vs without the use of an intrauterine manipulator. Studies comparing only peritoneal cytology status or lymphovascular space invasion were summarized for completeness. No selection criteria were applied to the study design. Method(s): Four reviewers independently reviewed studies for inclusion, assessed their risk of bias, and extracted data. Pooled hazard ratios with 95% confidence intervals were estimated for oncologic outcomes using the random effect model. Heterogeneity was quantified using the I2 tests. Publication bias was assessed by funnel plot and Egger test. Result(s): Out of 350 identified references, we included 2 randomized controlled trials and 12 observational studies for a total of 14 studies and 5,019 patients. The use of an intrauterine manipulator during hysterectomy for endometrial cancer was associated with a pooled hazard ratio for recurrence of 1.52 (95% confidence interval, 0.99-2.33; P=.05; I2=31%; chi square P value=.22). Pooled hazard ratio for recurrence was 1.48 (95% confidence interval, 0.25-8.76; P=.62; I2=67%; chi square P value=.08) when only randomized controlled trials were considered. Pooled hazard ratio for overall survival was 1.07 (95% confidence interval, 0.65-1.76; P=0.79; I2=44%; chi square P value=.17). The rate of positive peritoneal cytology or lymphovascular space invasion did not differ using an intrauterine manipulator. Conclusion(s): Intrauterine manipulator use during hysterectomy for endometrial cancer was neither significantly associated with recurrence-free and overall survival nor with positive peritoneal cytology or lymphovascular space invasion, but further prospective studies are needed.Copyright © 2023 The Author(s)

Zsiros, E. (2022). "Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer." ClinicalTrials.gov.
	PRIMARY OBJECTIVES: I. Determine the safety of anti‐CD40 agonist monoclonal antibody CDX‐1140 (CDX‐1140) combined with pembrolizumab and bevacizumab in patients with recurrent ovarian cancer (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0). II. Determine the objective response rate (ORR) per immune related response criteria (immune‐modified Response Evaluation Criteria in Solid Tumors [iRECIST]). SECONDARY OBJECTIVES: I. Determine progression free survival (PFS), disease control rate (DCR) and overall survival (OS). II. Changes in quality of life measures during the clinical trial (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire‐Core 30 [QLQ‐C30], EORTC QLQ‐Ovarian Cancer Module [OV28] and Multidimensional Fatigue Symptom Inventory‐Short Form (MFSI‐SF)]. EXPLORATORY OBJECTIVES: I. Pharmacokinetic (PK)/anti‐drug antibody (ADA) analysis for CDX‐1140. II. Evaluate the immunologic and phenotypic changes in blood samples. III. To obtain data on changes in tumor microenvironment prior to and subsequent to therapy and, to screen for potential biomarkers to predict clinical benefit. IV. Microbiome analysis from stool, tumor tissue. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive pembrolizumab intravenously (IV) over 30 minutes and bevacizumab IV over 30‐90 minutes on day 1. Cycles repeat every 3 weeks until disease progression or development of unacceptable toxicity. ARM II: Patients receive pembrolizumab IV over 30 minutes, bevacizumab IV over 30‐90 minutes, and CDX‐1140 IV over 90 minutes on day 1. Cycles repeat every 3 weeks until disease progression or development of unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 6 months for 2 years.

Zsiros, E. (2023). "APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion." ClinicalTrials.gov.
	No Results Available Biological: Bevacizumab|Biological: Pegcetacoplan|Biological: Pembrolizumab|Other: Quality-of-Life Assessment|Other: Questionnaire Administration Accumulation of effusion (Phase 2b)|Overall survival|Progression free survival (PFS)|Best response|Overall response rate|Disease control rate|Quality of life (QOL) scores Female Phase 2 40 Other|NIH Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment I 798120|NCI-2021-04265|1R01CA267690-01A1 April 30, 2027

Zullo, F., et al. (2020). "In-bag manual versus uncontained power morcellation for laparoscopic myomectomy." The Cochrane Database of Systematic Reviews 5: CD013352.
	Background: Uterine leiomyomas, also referred to as myomas or fibroids, are benign tumours arising from the smooth muscle cells of the myometrium. They are the most common pelvic tumour in women. The estimated rate of leiomyosarcoma, found during surgery for presumed benign leiomyomas, is about 0.51 per 1000 procedures, or approximately 1 in 2000. Treatment options for symptomatic uterine leiomyomas include medical, surgical, and radiologically-guided interventions. Laparoscopic myomectomy is the gold standard surgical approach for women who want offspring, or otherwise wish to retain their uterus. A limitation of laparoscopy is the inability to remove large specimens from the abdominal cavity through the laparoscope. To overcome this challenge, the morcellation approach was developed, during which larger specimens are broken into smaller pieces in order to remove them from the abdominal cavity via the port site. However, intracorporeal power morcellation may lead to scattering of benign tissues, with the risk of spreading leiomyoma or endometriosis. In cases of unsuspected malignancy, power morcellation can cause unintentional dissemination of malignant cells, and lead to a poorer prognosis by upstaging the occult cancer. A strategy to optimise women's safety is to morcellate the specimens inside a bag. In-bag morcellation may avoid the dissemination of tissue fragments.; Objectives: To evaluate the effectiveness and safety of protected in-bag extracorporeal manual morcellation during laparoscopic myomectomy compared to intra-abdominal uncontained power morcellation.; Search Methods: On 1 July 2019, we searched; the Cochrane Gynaecology and Fertility Group Specialized Register of Controlled Trials, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS, PubMed, Google Scholar, and two trials registers. We reviewed the reference lists of all retrieved full-text articles, and contacted experts in the field for additional and ongoing trials.; Selection Criteria: We included all randomised controlled trials comparing in-bag extracorporeal manual morcellation versus intracorporeal uncontained power morcellation during laparoscopic myomectomy in premenopausal women.; Data Collection and Analysis: We followed standard Cochrane methods. Two review authors independently reviewed the eligibility of trials, extracted data, and evaluated the risk of bias. Data were checked for accuracy. The summary measures were reported as risk ratios (RR) or mean differences (MD) with 95% confidence interval (CI). The outcomes of interest were a composite of intraoperative and postoperative complications, operative times, ease of morcellation, length of hospital stay, postoperative pain, conversion to laparotomy, and postoperative diagnosis of leiomyosarcoma. Results for the five main outcomes follow.; Main Results: We included two trials, enrolling 176 premenopausal women with fibroids, who underwent laparoscopic myomectomy. The experimental group received in-bag manual morcellation, during which each enucleated myoma was placed into a specimen retrieval bag, and manually morcellated with scalpel or scissors. In the control group, intracorporeal uncontained power morcellation was used to reduce the size of the myomas. No intraoperative complications, including accidental morcellation of the liver, conversion to laparotomy, endoscopic bag disruption, bowel injury, bleeding, accidental injury to any viscus or vessel, were reported in either group in either trial. We found very low-quality evidence of inconclusive results for total operative time (MD 9.93 minutes, 95% CI -1.35 to 21.20; 2 studies, 176 participants; I² = 35%), and ease of morcellation (MD -0.73 points, 95% CI -1.64 to 0.18; 1 study, 104 participants). The morcellation operative time was a little longer for the in-bag manual morcellation group, however the quality of the evidence was very low (MD 2.59 minutes, 95% CI 0.45 to 4.72; 2 studies, 176 participants; I² = 0%). There were no postoperative diagnoses of leiomyosarcoma made in either group in either trial. We are very uncert in of any of these results. We downgraded the quality of the evidence due to indirectness and imprecision, because of limited sites in high-income settings and countries, small sample sizes, wide confidence intervals, and few events.; Authors' Conclusions: There are limited data on the effectiveness and safety of in-bag morcellation at the time of laparoscopic myomectomy compared to uncontained power morcellation. We were unable to determine the effects of in-bag morcellation on intraoperative complications as no events were reported in either group. We are uncertain if in-bag morcellation improves total operative time or ease of morcellation compared to control. Regarding morcellation operative time, the quality of the evidence was also very low and we cannot be certain of the effect of in-bag morcellation compared to uncontained morcellation. No cases of postoperative diagnosis of leiomyosarcoma occurred in either group. We found only two trials comparing in-bag extracorporeal manual morcellation to intracorporeal uncontained power morcellation at the time of laparoscopic myomectomy. Both trials had morcellation operative time as primary outcome and were not powered for uncommon outcomes such as intraoperative complications, and postoperative diagnosis of leiomyosarcoma. Large, well-planned and executed trials are needed. (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)