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

Objective: 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.