A Comparative Study on Therapeutic Effect of Metformin and Sitagliptin/metformin in Infertile Women with Polycystic Ovary Syndrome (PCOS) undergoing intracytoplasmic sperm injection (ICSI)

Abstract
Objective: The aim of this study was to investigate the effects of sitagliptin/metformin (sitaformin), metformin and sitagliptin on PCOS patients undergoing ICSI.
Design: A randomized, placebo-controlled pilot study
Intervention (s): Participants were randomly assigned to receive metformin, sitagliptin, sitaformin or placebo Treatment was carried out 2 months before the start of the ovulation cycle and continued until the day of ovum pick up.
Result(s): The serum levels of homeostatic model assessment for insulin resistance (HOMA-IR) and free androgen index (FAI) decreased significantly in the treated groups compared to the placebo. The serum and the follicular fluid (FF) levels of leptin also decreased significantly in the sitaformin group when compared to the metformin and sitagliptin groups. Moreover, the serum and FF levels of anti-mullerian hormone (AMH) and malondialdehyde (MDA) had a significant decrease in the sitaformin and sitagliptin group compared to the placebo. The mRNA expression and protein levels of GDF9 and BMP15 in the cumulus cells increased significantly in the sitaformin group compared to metformin and sitagliptin groups. The expression level of GDF9 and BMP15 mRNA were positively correlated with the fertilization rate and grade I embryos.
Conclusion (s): Sitaformin improves hormonal factors and levels of GDF9 and BMP15 in PCOS compared to metformin and sitagliptin, which can increase the rate of fertilization and grade I embryos.