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 |
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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 |
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Outcomes | Number of follicles > 18 mm Endometrial thickness Ovulation rates Pregnancy rates Adverse effects including multiple pregnancy Ovarian hyperstimulation syndrome |
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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 |
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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 |