Efficacy of Adding N-acetyl-cysteine to Clomiphene Citrate in PCOS Woman Who Had Ovarian Drilling: Randomized Controlled Trial

Abstract

This study consisted of 68 women attending at infertility outpatient clinic of Ain Shams University/Maternity Hospital. Patients were diagnosed as having PCOS according to the Rotterdam criteria for diagnosis of PCOS. All patients had previously received CC and were diagnosed as having CC resistance. The aim of this study is to assess the efficacy of adding NAC to CC to improve pregnancy rate in PCOS women who had LOD. Inclusion Criteria: 1. Age: 18 – 38 years old. 2. Infertility (primary or secondary) for at least 1 year. 3. Normal Husband’s semen analysis, according to the following WHO criteria (WHO, 2000). 4. Normal uterine cavity and patent both tubes [via hysterosalpingogram (HSG), hysteroscopy and/or laparoscopy]. 5. Diagnosis of PCOS was made according to revised 2003 European Society for Human Reproduction and Embryology/American Society for Reproductive Medicine (ESHRE/ASRM) Rotterdam criteria. 6. Women were diagnosed as clomiphene citrate resistant before laparoscopic drilling. 7. Laparoscopic ovarian drilling was done immediately before starting the study. Exclusion Criteria: 1. Other causes of infertility like hypothalamic amenorrhea, premature ovarian failure, congenital adrenal hyperplasia, abnormal TSH and Prolactin levels. 2. Women who previously received hormonal therapy for at least 3 months before enrolment in the study. 3. Additional criteria, evaluated during laparoscopy, were tubal obstruction, extensive adhesion of ovaries or fallopian tubes and endometriosis. After they underwent LOD, patients were randomized into 2 groups: - Group(1): 32 women who were given CC 100 mg/d of clomiphene citrate orally with NAC 1,200 mg/day. - Group(2):32 women who were given CC+placebo for 5 days, starting from cycle day 2 to cycle day 6 for 3 consecutive cycles. Ovulation monitoring by transvaginal ultrasonographic folliculometry was done. Once the dominant follicle reached a size of ≥ 18 mm, the number of follicles and the endometrial thickness were assessed and HCG 10.000 IU was given intramuscular to trigger ovulation and timed intercourse was advised. Study Outcomes: • The primary outcome was the biochemical pregnancy rate. • Secondary outcomes included: • Number of mature follicles. • Endometrial thickness at triggering ovulation. • Clinical pregnancy rate. • Early miscarriage rate. • Multiple pregnancy rates. • Maternal side effects and satisfaction.