Effect of Time‐Restricted Eating and Oral Contraceptives on Polycystic Ovary Syndrome: An Open‐Label, Randomized Trial

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Background Polycystic ovary syndrome (PCOS) represents a prevalent endocrinopathy among women of reproductive age, characterized by ovulatory dysfunction and metabolic dysregulation. While oral contraceptives (OC) are first‐line therapy for PCOS‐related hyperandrogenism and menstrual irregularities, they demonstrate limited efficacy in improving metabolic parameters and restoring ovulation. This study evaluated whether combining time‐restricted eating (TRE) with OC enhances reproductive and metabolic outcomes. Methods In this 12‐week randomized trial, 140 women with PCOS (18–40 years) were assigned to OC with 8 h TRE (8 a.m.–4 p.m.) or OC alone. The primary outcome was ovulation rate and menstrual patterns, with secondary outcomes including weight, body mass index (BMI), waist circumference, fertility hormones, and metabolic factors. Data were analyzed via intention‐to‐treat with chi‐square tests, logistic regression, and ANCOVA‐adjusted models. Results In the OC + TRE group, post‐withdrawal ovulation (assessed after the 12‐week intervention and discontinuation of OC therapy) was significantly higher (70% vs. 48.6%, p = 0.010), especially in participants with insulin resistance (HOMA‐IR > 2.5). Reduced fasting insulin (Δ‐FINS < 0) correlated with increased ovulation likelihood (OR = 4.250; 95% CI: 1.368–13.202).OC + TRE yielded greater weight loss (−3.5 kg vs. −0.8 kg, p < 0.001), BMI, body fat, and waist circumference reductions versus OC alone. Menstrual regularity and metabolic syndrome prevalence did not differ between groups. Conclusion Combining TRE with OC therapy enhanced ovulation, particularly in insulin‐resistant participants, likely via reduced fasting insulin. This approach also achieved greater weight, BMI, body fat, and waist circumference reductions than OC alone, underscoring its potential for managing both reproductive and metabolic aspects of PCOS. Trial Registration: Chinese Clinical Trial Registry (ChiCTR): ChiCTR2300078263