Clomiphene citrate plus N-acetyl cysteine versus clomiphene citrate for augmenting ovulation in the management of unexplained infertility: a randomized double-blind controlled trial.

Author(s): Badawy A, Baker El Nashar A, El Totongy M

Affiliation(s): Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt. ambadawy@yahoo.com

Publication date & source: 2006-09, Fertil Steril., 86(3):647-50. Epub 2006 Jul 10.

Publication type: Randomized Controlled Trial

OBJECTIVE: To compare clomiphene citrate with N-acetyl cysteine vs. clomiphene citrate alone for augmenting ovulation in management of unexplained infertility. DESIGN: Prospective randomized double-blind controlled trial. SETTING: Department of obstetrics and gynecology in a university medical faculty in Egypt. PATIENT(S): Four hundred four patients as a study group (clomiphene citrate plus N-acetyl cysteine group) and 400 patients as a control group (clomiphene citrate-alone group). All women had unexplained infertility. INTERVENTION(S): Patients in the study group were treated with clomiphene citrate (50-mg tablets) twice per day and with N-acetyl cysteine (1,200 mg/d orally) for 5 days starting on day 2 of the cycle. Patients in the control group were treated with clomiphene citrate with sugar powder. MAIN OUTCOME MEASURE(S): The primary outcomes were number and size of growing follicles, serum E(2), serum P, and endometrial thickness. The secondary outcome was the occurrence of pregnancy. RESULT(S): There were no statistically significant differences between the two groups in the number of follicles sized >18 mm, mean E(2) levels, serum P, or endometrial thickness. Pregnancy rate was comparable in both groups (22.2% vs. 27%). Miscarriage rate was comparable in both groups (6.7% in the study group vs. 7.4% in the control group). CONCLUSION(S): N-Acetyl cysteine is ineffective in inducing or augmenting ovulation in patients with unexplained infertility and cannot be recommended as an adjuvant to clomiphene citrate in such patients.