Insulin sensitizing agent improves clinical pregnancy rate and insulin resistant parameters in polycystic ovarian syndrome patients with acanthosis nigricans: a randomized controlled study
Objective: To investigate the effect of adding metformin to clomiphene citrate (CC) in polycystic ovarian syndrome (PCOS) patients with acanthosis nigricans (AN) who were previously not responding to CC.
Material and Methods: A double blinded randomized controlled trial (NCT02562664) included 66 PCOS women with acanthosis nigricans who were CC resistant (at least 3 months). Day 3 follicle stimulating hormone (FSH) level, fasting insulin, fasting glucose and homeostatic model assessment were used to quantify insulin resistance. Participants were randomly assigned to either group I (CC with placebo tablets) or group II (CC with metformin) for three cycles. Insulin resistance parameters as well as clinical pregnancy rate had been evaluated in both groups. The statistical analysis was done using Chi- square and Fischer exact tests.
Results: The demographic data was comparable in both groups, however; there was higher cumulative pregnancy rate after three cycles of stimulation in group II (18/33) (54.5%) in comparison with group I (7/33) (21.1%) (P=0.03). There was a significant improvement in the insulin resistance parameters after three months of combining clomiphene citrate with metformin as compared with CC alone.
Conclusion: Adding metformin to CC in clomiphene citrate resistant PCOS patients who have acanthosis nigricans improves the pregnancy rate and insulin resistant parameters.