Corticosteroids do not influence ovarian responsiveness to gonadotropins in patients with premature ovarian failure: A randomized, placebo-controlled trial

Objective: To determine the effect of corticosteroids on ovarian responsiveness to exogenous gonadotropirs in patients with idiopathic premature ovarian failure (POF). Design: Placebo-controlled, randomized, double-blind, multicenter study. Setting: Two tertiary care academic centers for reproductive endocrinology and fertility and two general teaching hospitals. Patient(s): One hundred patients with idiopathic POF intended to enter the study. The study was discontinued after 36 patients failed to ovulate. Intervention(s): Endocrine and immune parameters were tested on days 1 and 15. On day I, subjects were randomized to receive either 9 mg of dexamethasone daily or placebo. From day 5 onward, 300 IU of hMG daily was added for 10 days in both groups. The dosage of dexamethasone was decreased stepwise n the second week and discontinued after day 15. Patients were monitored by transvaginal ultrasonography and by determining serum E2 levels. Main Outcome Measure(s): Ovulation rate. Fifty patients would have to be included in each study group to detect a statistically significant difference of 20% in the ovulation rate between the two groups with α = 0.05 and β = 0.1 (one-tailed test). Result(s): No ovulation was recorded in the first 36 patients. Interim analysis showed that the 95% confidence intervals of an ovulation rate of 0 were 0-17% for the dexamethasone arm (n = 19) and 0-19%, for the placebo arm (n = 17). Because the preset objective (a difference of 20%) would never be reached, the study was discontinued. Conclusion(s): Corticosteroids do not influence ovarian responsiveness to gonadotropins in patients with idiopathic POF.