Comparison of Metformin and Simvastatin Administration in Women With Polycystic Ovary Syndrome Before Intra-Cytoplasmic Sperm Injection Cycle: A Prospective, Randomized, Clinical Trial Study.

BACKGROUND: Drugs administration as a pretreatment regiment before ICSI cycle in PCOs patients could enhance the success rate.

OBJECTIVES: The aim of this study was to compare the effectiveness of metformin with Simvastatin in patients with polycystic ovary syndrome (PCOs) candidates for intra-cytoplasmic sperm injection (ICSI) before starting the cycle.

PATIENTS AND METHODS: In this prospective, double blind, randomized clinical trial the efficacy of these drugs was evaluated in 40 women with PCO syndrome (20 patients in each group; A: simvastatin and B: metformin) candidates for ICSI. In the both groups, metformin and simvastatin administrated for eight weeks before starting the ICSI cycle. Endocrine, metabolic and clinical parameters were measured before and after drug therapy; also, the results of ICSI cycle evaluated in the both groups.

RESULTS: Both drugs improved hirsutism score significantly, but simvastatin better than metformin (Group A, 24.5 ± 3.6 P: 0.0001 VS Group B, 22.9 ± 5.9 P: 0.003). The reduction in body mass index (BMI) was not significant in the groups. Simvastatin reduced some biochemical parameters such as FSH, LH, testosterone, total cholesterol, LDL and increased HDL level significantly, whereas metformin decreased FSH, TG, testosterone and total cholesterol significantly. Overall, respectively 35% and 30% of patients treated with metformin and Simvastatin became pregnant. There was no significant difference between the effects of these two drugs on ICSI cycle results like oocyte in meiosis2 (M2) phase (1.35 ± 1.6 vs. 2 ± 3.87, P value: 0.4) and the number of Grade A, embryo (1.2 ± 1.3 vs. 1.1 ± 1.4, P value: 0.7).

CONCLUSIONS: Simvastatin effectively improved hyperandrogenism signs and symptoms in patients with PCO, but this effect as a pretreatment regiment was not more expressive than metformin in ICSI cycle outcome.