A Randomized Trial of a Structured Lifestyle Intervention for Improving Fertility Outcomes in Women with Polycystic Ovary Syndrome Undergoing Ovulation Induction
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Abstract
Background: Polycystic ovary syndrome is a leading cause of anovulatory infertility and is frequently associated with obesity, insulin resistance, menstrual dysfunction, and reduced response to fertility treatment. Structured lifestyle intervention may improve reproductive outcomes by targeting modifiable metabolic drivers of ovulatory dysfunction. Objective: To evaluate whether a structured lifestyle intervention added to standard ovulation induction improves ovulation, clinical pregnancy, live birth, and metabolic outcomes among women with PCOS-related infertility. Methods: A parallel-group randomized controlled trial was conducted in tertiary infertility clinics in Central Punjab, Pakistan, between August 2025 and February 2026. Eighty women aged 18–35 years with PCOS-related infertility and BMI 25–40 kg/m² were randomized to structured lifestyle intervention plus standard ovulation induction (n=40) or standard care alone (n=40). The 16-week intervention included individualized dietary counseling and supervised physical activity. Results: Complete outcome data were available for 73 participants. Compared with controls, the intervention group showed higher ovulation (83.8% vs 58.3%, p=0.016), clinical pregnancy (48.6% vs 25.0%, p=0.036), and live birth rates (40.5% vs 19.4%, p=0.047). Greater reductions were observed in BMI, waist circumference, and HOMA-IR, and menstrual regularity was more frequent in the intervention group. Conclusion: Structured lifestyle intervention added to ovulation induction improved fertility and metabolic outcomes in women with PCOS-related infertility.
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