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In order to evaluate the role ofketoconazole 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 refeiTed to be treated by gonadotropins.Methods: Alll09 women were assigned for random allocation. Group A (50 patients) received two ampoules ofhMG beginning on day 2 or 3 of the cycle and ketoconazole (50 mg/every 48 hours) starting on the first day ofhMG treatment. Group B (51 patients) received the same protocol ofhMG combined with one tablet of placebo every 48 hours. Main outcome measures were follicular development, E2levels, and pregnancy rate.Results: The total number ofhMG ampoules and duration oftreatment to attain ovarian stimulation was higher in group A (p<O.OOO 1 ). Serum E2level and number of patients with dominant follicles on day 9 of the cycle were higher in group B (p<O.OOO 1 ). There was no significant difference between semm E2level and total number of follicles at the time ofhCG 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.