Flaxseed intervention and reproductive endocrine profiles in patients with polycystic ovary syndrome: an open-labeled randomized controlled clinical trial

Introduction: Polycystic Ovary Syndrome (PCOS), affecting 6-15% of women of reproductive age, is characterized by hormonal imbalances and metabolic disturbances. Flaxseed, rich in omega-3 fatty acids and phytoestrogens, may offer a natural approach to improve reproductive hormone profiles in PCOS patients. This study is aimed at evaluating the effects of flaxseed supplementation on reproductive endocrine profiles in women with PCOS.  Methods: In this open-labeled, randomized controlled trial, 70 women with PCOS were randomly assigned to either the intervention group (n=35), receiving 30 grams of milled flaxseed daily along with lifestyle modifications, or the control group (n=35), receiving only lifestyle modifications, for 12 weeks. The primary outcome was the change in follicle-stimulating hormone (FSH) levels. Secondary outcomes included changes in serum concentrations of luteinizing hormone (LH), the LH/FSH ratio, anti-Müllerian hormone (AMH), estradiol, dehydroepiandrosterone sulfate (DHEAS), and androstenedione.  Results: After 12 weeks, the flaxseed group showed a significant increase in FSH levels compared to the control group. FSH levels increased from 9.72 ± 11.95 µU/mL at baseline to 10.59 ± 12.14 µU/mL after the intervention (p = 0.027). The mean treatment effect was 0.87 (95% CI: 0.086 to 1.75). The LH/FSH ratio also significantly decreased in the flaxseed group (mean treatment effect: -0.341, 95% CI: -0.63 to -0.08, p = 0.031). No significant changes were observed in AMH, LH, estradiol, DHEAS, or androstenedione levels.  Conclusion: Flaxseed supplementation may benefit women with PCOS by increasing FSH levels and decreasing the LH/FSH ratio, suggesting its potential as a complementary intervention for managing hormonal disturbances in PCOS.