Use of Rosiglitazone for Clomiphene Resistant Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial

Background: Polycystic ovary syndrome (PCOS) is a condition with an imbalance in the milieu of the sex hormones. This might lead to menstrual disturbances, anovulation and infertility in women.Methods: This two-treatment parallel-design study included a triple blind, randomized controlled trial with low dose (2mg) Rosiglitazone, which was conducted over two years at an infertility clinic of a reputed private hospital in India. Forty patients with PCOS, who failed to ovulate with Clomiphene citrate 100mg, were randomly selected and treated with two different doses of Rosiglitazone for two cycles. The Intervention Group received 2mg while the Control Group received 4mg of Rosiglitazone. Comparisons were done by non-parametric Mc Nemar’s test and p <0.05 was considered as statistically significant.Results: In this study, 12(42.9%) participants receiving 2mg of Rosiglitazone ovulated at the end of second cycle as compared to 16(57.1%) in the group receiving 4mg. The cumulative ovulation rate for both the groups was high (70.0%) after the second cycle. It was seen that 3(60.0%) participants receiving 2mg of Rosiglitazone became pregnant at the end of second cycle as compared to 2(40.0%) in the group receiving 4mg. The cumulative pregnancy rate was 12.5%. The insulin resistance got corrected in 10(40.0%) participants receiving 2mg of Rosiglitazone at the end of second cycle as compared to 15(60.0%) by the group receiving 4mg. This suggested that insulin resistance correction was dose dependent. Abnormal testosterone levels got corrected in 15(48.4%) participants in the group receiving 2mg of Rosiglitazone as compared to 16(51.6%) by the group receiving 4mg at the end of the second cycle. Conclusion: Low dose (2mg) Rosiglitazone had improved the ovulation rate in the Clomiphene citrate resistant PCOS women. However, the cumulative pregnancy rate was not so encouraging as compared to good ovulation rate. These findings were equivalent to the 4mg of Rosiglitazone regimen. There was no significant adverse effect seen amongst the participants.