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

Author(s): Parsanezhad ME, Alborzi S, Namavar Jahromi B

Affiliation(s): Department of Obstetrics and Gynecology, Medical School, Shiraz University of Medical Sciences, Shiraz, Iran. parsame@sums.ac.ir

Publication date & source: 2004-01, Arch Gynecol Obstet., 269(2):125-9. Epub 2002 Oct 24.

Publication type: Clinical Trial; Randomized Controlled Trial

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.