Abstract

Polycystic Ovary Syndrome (PCOS) is the association of hyperandrogenism with chronic anovulation in women without specific underlying diseases of the adrenal or pituitary glands. We performed a randomized, placebo-controlled trial over 50 Clomiphene Citrate (CC) resistant PCOS women to determine metformin-therapy effects on metabolic disorders in patients with polycystic ovary syndrome who are resistant to CC. Participants were randomized in two groups with 25 cases in each group. One group received metformin, 500 mg three times daily, for 3 months and another one (Placebo group) received vitamin B1, 300 mg daily, for 3 months. Information on screening tests (2nd day of menstrual cycle) was obtained at baseline and after treatment (if there was no pregnancy after 3 months of treatment). In both groups, with anovulation after 3 months of treatment, CC treatment was begun at 100 mg daily for 5 days. Serum progesterone (P) levels were obtained in monthly visits and serum P level≥16 nmol mL-1 was considered to indicate ovulation. Main Outcome Measures were ovulation and pregnancy rates and correction of metabolic disorders. There was no ovulation in this study, but some metabolic disorders were improved. In anovulatory women with PCOS who were resistant to CC, metformin use improved some metabolic disorders due to PCOS, but there was no increased ovulation rate and further investigations are needed.