Comparison of clomiphene citrate, metformin, or the combination of both for first-line ovulation induction, achievement of pregnancy, and live birth in Asian women with polycystic ovary syndrome: a randomized controlled trial

Objective: To determine the first-fine medication to be used in anovulatory patients with polycystic ovary syndrome (PCOS) for ovulation induction and preganancy achievement. Design: Randomized controlled trial. Setting: Infertility unit of a public hospital. Patient(s): One hundred fifteen newly diagnosed patients with PCOS based on ESHRE/ASRM criteria. Intervention(s): These patients were assigned to three groups: group 1 (38 patients) received 500 mg of metformin three times a day; group 2 (39 patients) received clomiphene citrate (CC) at an incremental dose; group 3 (38 patients) received both medications. Main Outcome Measure(S): Rates of ovulation, pregnancy (PR), and live birth. Result(S): The ovulation rate was 23.7% in the metformin group, 59% in the CC group, and 68.4% in the combination treatment group. This was translated into a similar PR and live birth rate, which were higher in the CC and combination groups compared to the metformin group (PR: 7.9%, 15.4%, and 21.1%; live birth rate: 7.9%, 15.4%, and 18.4% in metformin, CC, and combination treatment groups, respectively), although statistically the differences were not significant. There were no multiple pregnancies and the rate of spontaneous first trimester loss was similar to the general population. Conclusion(s): Clomiphene citrate should be the first-line treatment for ovulation induction in anovulatory patients with PCOS. (Fertil Steril(R) 2009;91:514-21. (C)2009 by American Society for Reproductive Medicine.)