Objective: The study assessed the efficacy of low dose ketoconazole in addition to clomiphene citrate (CC) and hMG on ovulation induction.
Materials and methods:A double blind, randomized, clinical trial was performed on fifty infertile patients with PCOS who had failed to respond to a daily dose of hMG and 100 mg CC for controlled ovarian hyperstimulation in Vali-e-Asr Reproductive Health Research Center.These patients were randomly divided into two equal groups receiving ketoconazole or placebo.All patients received CC and hMG for controlled ovarian hyperstimulation.Number of mature follicles, estradiol and progesterone levels at the time of hCG adminstration, endometrial thickness, ovarian hyperstimulation syndrome(OHSS), pregnancy rate, abortion, multiple pregnancies were measured. SPSS 11 software was used for statistical analysis. Statistical significance was defined as P < 0.05.
Results: No significant statistical differences existed in the number of mature follicles, estradiol and progesterone levels prior to hCG administration ,endometrial thickness, OHSS and pregnancy rate between two groups. Estradiol level was lower among those receiving ketoconazole. No abortion and multiple pregnancy were found.
Conclusion: Ketoconazole may suppress steroid production in resistant PCOS patients undergoing CC and hMG induction. But it has no effects on follicular maturation and OHSS prevention.