prospective, double-blind, randomized, placebo-controlled clinical trial of dexamethasone during the follicular phase in clomiphene resistant patients with polycystic ovary syndrome and normal DHEAS

ABSTRACT

In order to evaluate the effects of short course administration of dexamethasone [DEX] combined with clomiphene citrate [CC] in CC-resistant patients with polycystic ovary syndrome [PCOS] and normal DHEAS, a prospective, double blind, placebo controlled, randomized study was undertaken at referral university hospitals. Two-hundred and thirty women with PCOS and normal DHEAS who failed to ovulate with a routine protocol of CC received 200 mg of CC from day 5 to 9 and 2 mg of DEX from day 5 to 14 of the menstrual cycle. The control group received the same protocol of CC combined with placebo. Follicular development, hormonal status, ovulation rate, and pregnancy rate were evaluated. Mean follicular diameters were 18.4124 +/- 2.4314 mm and 13.8585 +/- 2.0722 mm [p<0.001] for treatment and placebo group respectively. Eighty-eight% of treatment and 20% of the control group had evidence of ovulation. The difference of cumulative pregnancy rate in treatment and control groups was statistically significant [p<0.0001]. Hormonal levels, follicular development and cumulative pregnancy rate improved with the addition of DEX to CC in CC-resistant patients with PCOS and normal DHEAS. This regimen is recommended before any gonadotropin therapy or surgical intervention