A prospective, double-blind, randomized, placebo-controlled clinical trial of bromocriptine in clomiphene-resistant patients with polycystic ovary syndrome and normal prolactin level.
OBJECTIVE
To evaluate the effects of administration of bromocriptine combined with clomiphene citrate (CC) in CC-resistant patients with polycystic ovary syndrome (PCOS) and normal prolactin (PRL) level.


METHODS
Prospective double-blind, placebo-controlled, randomized.


METHODS
Referral university hospitals.


METHODS
One hundred women with PCOS and normal PRL who failed to ovulate with a routine protocol of CC.


METHODS
Treatment group received 150 mg of CC from day 5 to 9 and 7.5 mg bromocriptine continuously, with hCG 10,000 units on day 16 or 17. Control group received the same protocol of CC combined with placebo.


METHODS
Follicular development, hormonal changes, ovulation rate, pregnancy rate.


RESULTS
Follicular development (follicular size greater than 15 mm) was observed in 12 (25.5%) and 8 (15.1%) women in the 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 bromocriptine, there was a significant decrease in serum level of prolactin (p = 0.000001). No significant differences were seen in ovulation, pregnancy rate, or serum levels of FSH, LH, DHEAS, and progesterone between treatment and placebo groups after treatment.


CONCLUSIONS
The only significant effect of long-term bromocriptine therapy in CC-resistant women with PCOS was to lower the serum PRL concentration. It is also concluded that 10%-15% of patients with PCOS experienced occasional ovulatory cycles and pregnancy whether or not they were on treatment.
Parsanezhad
Mohammad Ebrahim
ME
Department of Obstetrics and Gynecology, Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.
Alborzi
Saeed
S
Jahromi
Bahia Namavar
BN
D000328:Adult; D001971:Bromocriptine / Q000627:therapeutic use*; D002996:Clomiphene / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D004351:Drug Resistance; D004359:Drug Therapy, Combination; D005260:Female; D005300:Fertility Agents, Female / Q000494:pharmacology / Q000627:therapeutic use*; D006727:Hormone Antagonists / Q000627:therapeutic use*; D006801:Humans; D007247:Infertility, Female / Q000097:blood / Q000188:drug therapy*; D008598:Menstruation / Q000187:drug effects; D006080:Ovarian Follicle / Q000187:drug effects; D010062:Ovulation Induction / Q000379:methods; D011085:Polycystic Ovary Syndrome / Q000097:blood / Q000188:drug therapy*; D011374:Progesterone / Q000097:blood; D011388:Prolactin / Q000097:blood
D005300:Fertility Agents, Female; D006727:Hormone Antagonists; D002996:Clomiphene; D001971:Bromocriptine; D011374:Progesterone; D011388:Prolactin