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. 2017 Jul 28;2017(7):CD007807. doi: 10.1002/14651858.CD007807.pub3
Methods Randomised placebo‐controlled double‐blind trial
Participants Infertile women with PCOS undergoing timed intercourse (n = 180)
Women were aged 20 – 35 years
Inclusion criteria: infertility duration < 10 years, BMI < 35 kg/m2, both participant tubes confirmed by hysterosalpingography or laparoscopy and with partner’s normal semen analysis results (total volume > 2 cc, concentration > 20 million/ml, total motility > 50%, normal morphology > 14%)
Exclusion criteria: thyroid dysfunction, hyperprolactinaemia, hypercorticism, history of large ovarian cyst formation (> 6 cm), history of visual disturbance caused by clomiphene citrate and finally history of asthma and or allergy to medications. Women who had received any hormonal medications (except progesterone for withdrawal bleeding) or medications affecting glucose metabolism for at least 3 months before the study were also excluded; also no sexual dysfunction
Interventions 1. NAC 1.2 g: 1 sachet a day (divided into 2 doses per day) + clomiphene citrate 100 mg: 1 tablet a day (n = 90)
2. Placebo + clomiphene citrate 100 mg/day divided and given in 2 doses a day given for 5 days starting at day 3 of the cycle. Timed intercourse occurred after an hCG trigger (n = 90)
8 women in the 1st group and 4 in the 2nd group left the study due to inappropriate drug intake or discontinued cycle; also 1 woman dropped out of the placebo group due to developing an ovarian cyst
Outcomes Number of follicles > 18 mm
Endometrial thickness
Ovulation rates
Pregnancy rates
Adverse effects including multiple pregnancy
Ovarian hyperstimulation syndrome
Notes Trial carried out in the Shahid Beheshti University of Medical Sciences IVF Center, Taleghani Hospital, Iran between January 2008 and December 2009
Informed consent
Power calculation
Ethics approved
Reprint request to: Dr Azadeh Akbari Sene, IVF Center, Infertility and Reproductive Health Research Center, Taleghani Hospital, Velenjak st, Tehran, Iran. Email: doctor_asturias@yahoo.com. RM‐P sent an email 12th December 2015. No reply
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Then patients were randomly divided into two groups".
Allocation concealment (selection bias) Unclear risk Unknown
Blinding (performance bias and detection bias) All outcomes Low risk Double‐blind. In the 2nd group in addition to 100 mg daily CC, participants received a placebo (oral rehydration solution powder) from day 3 until day 7. ORS powder was given to the participants in the same packets as NAC
Incomplete outcome data (attrition bias) All outcomes Low risk Dropouts were explained
Selective reporting (reporting bias) Low risk All outcomes described in the text were reported
Other bias Low risk No other bias found