A prospective, double-blind, randomized, placebo-controlled clinical trial of bromocriptin in clomiphene-resistant patients with polycystic ovary syndrome and normal prolactin level

Abstract

Objective: The purpose of this study was to examine the effects of of bromocriptin combined with clomiphene citrate in clomiphene-resistant patients with polycystic ovary syndrome and normal prolactin level.

Design: Prospective, double-blind, controlled study.

Setting: University teaching hospital.

Patients: One hundred polycystic ovary patients and normal prolactin (PRL) who were clomiphene citrate resistant.

Interventions: Treatment group received 150 mg clomiphene citrate on days 5-9 and 7.5 mg bromocriptin continuously. Control group received the same protocol of clomiphene citrate combined with placebo.

Main outcome measures: Hormonal status, follicular monitoring, ovulation rate.

Results: Follicular development (follicular size greater than 15 mm) was observed in 12 (25.5%) and eight (15.1%) women in treatment and placebo group respectively ( P=0.29). The serum prolactin level was within normal limits in all patients before treatment. After 3 and 6 months of treatment with bromocriptin, there was a significant decrease in serum level of prolactin ( P=0.000001). No any significant differences was seen in ovulation, and serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), dehydroepiandrosterone sulfate (DHEAS), progesterone (P) between treatment and placebo group after treatment.

Conclusions: The only significant effect of long-term bromocriptin therapy in clomiphene citrate resistant polycystic ovary women was to lower the serum prolactin concentration. It was also concluded that 10-15% of patients with polycystic ovaries experienced occasional ovulatory cycles and pregnancy whether or not they were on treatment.