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

ObjectiveTo compare clomiphene citrate with N-acetyl cysteine vs. clomiphene citrate alone for augmenting ovulation in management of unexplained infertility.DesignProspective randomized double-blind controlled trial.SettingDepartment 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 E2, 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 E2 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.