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


METHODS
Prospective randomized double-blind controlled trial.


METHODS
Department of obstetrics and gynecology in a university medical faculty in Egypt.


METHODS
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.


METHODS
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.
Badawy
Ahmed
A
Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt. ambadawy@yahoo.com
Baker El Nashar
Abu
A
El Totongy
Mohamed
M
D000111:Acetylcysteine / Q000008:administration & dosage*; D000328:Adult; D002996:Clomiphene / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D004534:Egypt / Q000453:epidemiology; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage; D006801:Humans; D007247:Infertility, Female / Q000453:epidemiology* / Q000473:pathology / Q000628:therapy*; D010062:Ovulation Induction / Q000379:methods / Q000706:statistics & numerical data*; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology*; D016896:Treatment Outcome
D004338:Drug Combinations; D005300:Fertility Agents, Female; D002996:Clomiphene; D000111:Acetylcysteine