A randomized controlled trial of the effect of rosiglitazone and clomiphene citrate versus clomiphene citrate alone in overweight/obese women with polycystic ovary syndrome

Background: In women suffering from polycystic ovary syndrome, correction of hyperinsulinemia results in enhanced responsiveness to ovulation induction agents. The effect of rosiglitazone was investigated on ovulation induction in obese women with PCOS. Materials and methods: A randomized controlled trial was set up. One hundred women were randomly assigned. Group A (n = 46) received rosiglitazone 4 mg b.i.d. plus clomiphene citrate (CC) 100 mg on cycle days 3–7. Group B (n = 45) received CC only. Primary outcome was ovulation. Secondary outcomes included pregnancy as well as changes in fasting glucose and insulin. Results: Both groups were similar with respect to background and hormonal characteristics (age, duration of infertility, BMI, WHR, FSH, LH, E2, testosterone, fasting glucose and insulin). The cumulative ovulation rate over 12 weeks was significantly higher in group A (81.8%) than in group B (55.2%) (p < 0.001), whereas the difference in cumulative pregnancy rate was not statistically significant (30.4% versus 28.8%, respectively) in groups A and B (p = 0.946). Fasting insulin levels significantly declined after rosiglitazone therapy (p < 0.001) without change in glucose levels this resulted in normalization of the mean glucose to insulin ratio. Conclusions: Short term administration of rosiglitazone to overweight and obese PCOS women results in enhancement of CC induced ovulation as well as improvement of insulin sensitivity.