A DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY OF KETOCONAZOLE FOR REDUCING THE RISK OF OVARIAN HYPERSTIMULATION SYNDROME

Background: In order to evaluate the role of ketoconazole in the prevention of ovarian hyperstimulation syndrome (OHSS) in women with polycystic ovary syndrome (PCOS) undergoing ovarian stimulation with gonadotropins, a prospective, randomized, double-blind, placebo controlled study was done on one-hundred and nine PCOS women that had been referred to be treated by gonadotropins.
Methods: All 109 women were assigned for random allocation. Group A (50 patients) received two ampoules of hMG beginning on day 2 or 3 of the cycle and ketoconazole (50 mg/every 48 hours) starting on the first day of hMG treatment. Group B (51 patients) received the same protocol of hMG combined with one tablet of placebo every 48 hours. Main outcome measures were follicular development, E2 levels, and pregnancy rate.
Results: The total number of hMG ampoules and duration of treatment to attain ovarian stimulation was higher in group A (p<0.0001). Serum E2 level and number of patients with dominant follicles on day 9 of the cycle were higher in group B (p<0.0001). There was no significant difference between serum E2 level and total number of follicles at the time of hCG administration in the two groups. The cancellation rate and OHSS rate were similar in the two groups.
Conclusion: Ketoconazole has no effect in prevention of OHSS in PCOS patients undergoing ovarian stimulation. It may however reduce the rate of folliculogenesis and steroidogenesis.

Keywords
Polycystic ovary syndrome, ovarian hyperstimulation syndrome, ketoconazole.