The Role of Metformin in Infertile Polycystic Ovary Syndrome: Monotherapy, Combination with Oral Ovulation Induction Agents, and Adjuvant Therapies
Year: 2026
Type: dataset
Abstract: Full Protocol Template Title: The Changing Role of Metformin in Oral Ovulation Induction for PCOS: A 30-Year Evidence-Based Systematic Review and Meta-Analysis Protocol Authors: Hatice Banu Atay (Corresponding Author, Mersin University, Department of Obstetrics & Gynecology Background: Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive-aged women, frequently associated with anovulatory infertility. Metformin, an insulin-sensitizing agent, has been widely studied as monotherapy and in combination with oral ovulation induction agents. Despite decades of research, its role in infertility management remains debated. This protocol outlines a systematic review and meta-analysis to evaluate the reproductive outcomes of metformin in PCOS. Objectives: To assess the efficacy of metformin, alone or in combination with oral ovulation induction agents (clomiphene citrate, letrozole, myoinositol, lifestyle modification), compared with non-metformin regimens, in improving ovulation, clinical pregnancy, and live birth rates in women with PCOS. Methods: Eligibility criteria: Randomized controlled trials (RCTs) including reproductive-aged women with PCOS (Rotterdam criteria), presenting with anovulatory infertility. Interventions: Metformin monotherapy or in combination with CC, letrozole, myoinositol, lifestyle modification, or in CC-resistant patients. Comparators: Placebo, CC alone, letrozole alone, or other non-metformin regimens. Outcomes: Primary—ovulation, clinical pregnancy, live birth. Secondary—menstrual regulation, hormonal/metabolic changes, endometrial thickness, follicle development, adverse effects. Search strategy: PubMed, Scopus, Google Scholar (1994–2026). Data extraction & risk of bias: Independent review using Cochrane RoB tool. Certainty of evidence: GRADE framework. Statistical analysis: RevMan software, random-effects meta-analysis, heterogeneity assessed with I² statistic. Registration: This protocol is registered with PROSPERO (ID: [senin ID’in]) and will be archived in Zenodo for transparency and reproducibility. Funding & Conflicts of Interest: No external funding. Authors declare no conflicts of interest. Keywords: Polycystic ovary syndrome, PCOS, infertility, metformin, clomiphene citrate, letrozole, ovulation induction, systematic review, meta-analysis.
Author: Atay, Hatice Banu
Institution: Mersin Üniversitesi
Language: English
Subfield: Reproductive Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7204195952