Corticosteroids do not influence ovarian responsiveness to gonadotropins in patients with premature ovarian failure: a randomized, placebo-controlledtrial

Objective: To determine the effect of corticosteroids on ovarian responsive ness to exogenous gonadotropins in patients with idiopathic premature ovari an 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 1, subjects were randomized to receive either 9 mg of dexamethas one 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 in the second week and discontinued after day 15. Patients were monitored b y transvaginal ultrasonography and by determining serum E-2 levels. Main Outcome Measure(s): Ovulation rate. Fifty patients would have to be in cluded in each study group to detect a statistically significant difference of 20% in the ovulation rate between the two groups with alpha = 0.05 and beta = 0.1 (one-tailed test). Result(s): No ovulation was recorded in the first 36 patients. Interim anal ysis showed that the 95% confidence intervals of an ovulation rate of 0 wer e 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 r eached, the study was discontinued. Conclusion(s): Corticosteroids do not influence ovarian responsiveness to g onadotropins in patients with idiopathic POF. (C) 1998 by American Society for Reproductive Medicine.