Background: The rate of obesity among women of reproductive potential in Ireland has doubled in recent decades, severely impacting fertility and leading to increased rates of adverse pregnancy outcomes. Access to fertility treatments remains limited for women living with obesity and although international guidelines advocate for the treatment of the disease of obesity before conception, effective obesity management interventions are lacking. Research question: “Is it feasible to recruit and retain women, not eligible for assisted reproductive technology because they are living with obesity, to a digital programme that integrates obesity pharmacotherapy and behavioural change?” Aim: To evaluate the feasibility and acceptability of a digital obesity management programme that integrates pharmacotherapy and behavioural change in women living with obesity, who are not eligible for publicly funded assisted reproductive technology. Methods: This open-label feasibility RCT will recruit 60 women with obesity (BMI 30–40 kg/m2 ) and infertility from public fertility clinics and primary care networks in Ireland. Participants will be randomly assigned to either a digital intervention group, receiving Tirzepatide alongside structured behavioural change support, or a control group accessing current standard of care with weight management resources from the national health service. Primary outcome is feasibility (recruitment, retention, intervention adherence, acceptability, determination of sample size for definitive trial). Secondary outcomes include anthropometric, reproductive, metabolic, behaviour change, mental health, quality of life, access to fertility services. Women with lived experience of obesity and
infertility (n=3) have shaped the research question, study design, and outcome measures. Conclusions: This study will provide evidence to inform a decision to progress to a definitive RCT to assess how such an intervention can improve reproductive health and address gaps in obesity management prior to conception, with the potential to enhance fertility and reduce adverse pregnancy outcomes, addressing a critical unmet need in female health.
