RESUMO
To assess the clinical efficacy of ketoconazole [KCZ] as an inhibitory enzyme on ovarian steroidogenesis, in prevention of ovarian hyper- stimulation syndrome [OHSS] during assisted reproductive technology [ART] in patients with polycystic ovarian syndrome [PCOS]. We included 58 PCOS patients, enrolled for in-vitro fertilization or intracytoplasmic sperm injection in a randomized clinical trial between November 2000 and October 2001 in the Royan Institute, Tehran, Iran. Twenty-eight patients received KCZ during the stimulation phase and 30 patients were controls. We compared serum E2 levels, number of lead follicles, number of retrieved oocytes, fertilization rate, occurrence of OHSS and cancellation rate using student's t-test, Chi-square and Fisher exact test. We found no significant differences between the 2 groups in the peak serum estradiol level, the number of lead follicles, oocytes, and fertilization rate. One patient in the control group had clinical symptoms of severe ovarian hyperstimulation, and none from the treated group. This study reveals no significant effect of KCZ on the incidence of OHSS during ART cycles; however, also no significant negative effects of KCZ on the number and maturity of oocytes or on fertilization rate