Minimal stimulation or clomiphene citrate as first-line therapy in women with polycystic ovary syndrome: a randomized controlled trial.

AIM: To compare the efficacy of minimal stimulation and clomiphene citrate (CC) as a first-line treatment for anovulatory infertility associated with polycystic ovary syndrome (PCOS).

METHODS

One hundred and thirteen women with PCOS were selected in this randomized controlled trial. Patients received minimal stimulation protocol consisted of 5 days CC (100 mg/day) then 150 IU of highly purified uFSH on cycle day 9 (n = 58, 159 cycles) or CC only (n = 55, 153 cycles) for up to three cycles. Outcome measures were: clinical pregnancy rate per cycle, number of growing and mature follicles, serum E2, endometrial thickness at the hCG day, serum P, ovulation and miscarriage rates.

RESULTS

There were no differences between both groups regarding the clinical pregnancy rate per cycle and per woman (8.8% vs. 7.8 % and 24.1% vs. 21.8%; p = 0.23, p = 0.36, respectively). One twin pregnancy occurred in each group. Miscarriage rate was comparable (14.3% vs. 16.7%; p = 0.38). No differences were found regarding the number of follicles, serum P, ovulation rate, E2 and endometrial thickness at the hCG day (7.8 ± 0.5 vs. 7.6 ± 0.6 mm; p = 0.52).

CONCLUSIONS

Ovulation induction with minimal stimulation is not more effective than CC alone for achieving pregnancy when used as initial treatment in PCOS patients.