A randomized double-blinded placebo-controlled trial on the effect of dehydroepiandrosterone for 16 weeks on ovarian response markers in women with primary ovarian insufficiency.

CONTEXT: Preliminary reports have shown encouraging effects of dehydroepiandrosterone (DHEA) in women with poor ovarian reserve undergoing assisted reproduction and primary ovarian insufficiency (POI), although data from randomized controlled trials are limited. The present study assesses the effect of DHEA on ovarian response markers in women with POI.

OBJECTIVE: The objective of the study was to evaluate whether DHEA for 16 wk would improve ovarian response markers in women with POI.

DESIGN: This was a randomized, double-blinded, placebo-controlled study.

SETTING: The study was conducted at a tertiary reproductive unit.

PATIENTS: Twenty-two women with unexplained POI participated in the study.

INTERVENTIONS: Eligible subjects were randomized into the DHEA group (n = 10), who received DHEA (LiveWell, 25 mg three times a day), or the placebo group (n = 12), who received placebo for 16 wk according to a computer-generated randomization list. Ovarian response markers included serum anti-mullerian hormone (AMH), FSH levels, and antral follicle count (AFC) as well as follicles of 10 mm or greater in diameter, and hormonal profiles were measured at 4-wk intervals until 4 wk after completion of treatment. Any returns of menses and side effects from treatment were recorded.

MAIN OUTCOME MEASURES: The primary outcome was serum AMH level.

RESULTS: No significant change in serum AMH and FSH levels had been detected throughout the study. AFC and ovarian volume were significantly higher at wk 12 and 20, respectively, in the DHEA group. Significantly more women having at least one follicle of 10 mm or greater at wk 12, 16, and 20 were found in the DHEA group. Serum testosterone and DHEA sulfate levels along with higher estradiol levels were significantly higher in the DHEA group.

CONCLUSION: This randomized, double-blinded, placebo-controlled trial found higher AFC and ovarian volume at wk 12 and 20, respectively, in the DHEA group, although there were no significant changes in serum AMH and FSH levels. Further trials using a longer duration of DHEA should be considered to evaluate the long-term effect of DHEA in women with POI.