RESUMO
Background: Studies have demonstrated the efficacy of metformin [MTF] in reducing insulin resistance and N-acetyl cysteine [NAC] in inhibiting oxidative stress which are involved in the pathogenesis of polycystic ovarian syndrome [PCOS]. We aimed to compare the effects of MTF and NAC combination on serum metabolite and hormonal levels during the course of ovulation induction in PCOS individual candidates of intracytoplasmic sperm injection [ICSI]
Materials and Methods: In this prospective randomized clinical trial, placebo con- trolled pilot study, 80 patients of polycystic ovarian syndrome at the age of 25-35 years were divided into 4 groups [n=20]: i. NAC=treated with N-acetyl cysteine [600 mg three times daily], ii. MTF=treated with metformin [500 mg three times daily], iii. MTF+NAC=treated with N-acetyl cysteine plus metformin [the offered doses] and iv. placebo [PLA]. A total number of 20 patients [6 from MTF group, 4 from NAC group, 6 from MTF+NAC group and 4 from PLA group] were dropped of the study. The drugs were administrated from day 3 of menses of previous cycle until ovum pick-up
Results: Serum levels of luteinizing hormone [LH], total testosterone, cholesterol and triglyceride, insulin and leptin significantly reduced in the MTF and NAC groups compared to the placebo [p<0.01]. But levels of LH, total testosterone, cholesterol and triglyceride had no significant reduction in the MTF+NAC groups compared to the placebo. The serum levels of malonyldialdehyde [MDA], insulin and leptin reduced significantly after treatment in the MTF+NAC group compared to the placebo [p<0.05]
Conclusion: Considering the adverse effect of combination therapy, we proposed the conadministration might have no beneficial effect for PCOS patient during course of ovulation induction of ICSI [Registration Number: IRCT201204159476N1]