Enhanced Ovarian Folliclular Development by Metformin Does Not Correlate with Pregnancy Rate: A Randomized Trial

BACKGROUND: Polycystic ovary syndrome (PCOS) is a common, complex endocrine disorder for women of productive age. A high incidence of ovulation failure in women with PCOS is related to insulin resistance. Some studies have assessed the effects of hyperinsulinemia and insulin resistance in relationship with insulin sensitizing agents such as Metformin (Met). These medicines have been suggested new scope for ovulation stimulation enhancement with Clomiphene Citrate (CC) in PCOs women. The aim of this study is to compare the effectiveness of adding Met to CC in women with PCOS. MATERIALS AND METHODS: This multicenter, single-blind, randomized controlled trial study was performed on 334 PCOS patients from 2007 to 2009. Patients were randomly divided into two groups and ovulation induction was performed with either CC alone or CC + Met. The treatment was continued for three cycles, then the mature follicle and pregnancy rates were evaluated. RESULTS: In the CC + Met group, 68% had at least one dominant follicle in the first cycle that was significant (p<0.001), and 31.7% had one in the second cycle. In the CC group 54.5% in the first cycle, 31.7% second cycle, and 6.9% ovulated in the third cycle. The pregnancy rate was 28.7% in CC + Met group and 24.6% in the CC group, with no significant differences between the two groups. CONCLUSION: Adding Met to CC is significant for ovulation, but it does not enhance the pregnancy rate (Registration Number: IRCT138904174306N1).