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. 2020 Feb 11;2020(2):CD001122. doi: 10.1002/14651858.CD001122.pub5

Bayram 2004.

Methods Parallel randomised controlled trial. Multicentre (n = 25 centres) in The Netherlands
Timing: February 1998 to October 2001
Participants 168 women randomised
Time of randomisation: during diagnostic laparoscopy, after determining eligibility.
 Invited to participate: 213 consecutive women. 45 excluded (27 refused, 3 too obese for surgery, 1 had language barrier, 5 became pregnant while awaiting laparoscopy, 9 excluded during diagnostic laparoscopy due to endometriosis (1), adhesions (5), tubal occlusion (2) or infeasibility of electrocautery (1)).
Mean age 29 years, mean duration of infertility was 2.8 years and the mean BMI was 27 kg/m2. Infertility was primary in 76% of women
 Inclusion criteria: women with clomiphene‐resistant PCOS (150 mg clomiphene) with chronic anovulation
 Exclusion criteria: women with tubal obstruction, other causes of infertility including severe male‐factor infertility, aged > 40 years
Interventions Laparoscopic electrocautery of the ovaries strategy: each ovary was punctured 5 to 10 times depending on its size. If the woman ovulated in 6 subsequent cycles, no further treatment was given. If ovulatory cycles were not established 8 weeks after surgery or the woman became anovulatory again then clomiphene citrate was given in increasing doses. If the woman still remained anovulatory, rFSH was given in increasing, doses starting at 75 IU daily (n = 83)
 versus
 6 cycles of rFSH. Women were treated until 6 subsequent cycles were achieved within 6 months (n = 85)
Outcomes Primary: ongoing pregnancy rate within 12 months, defined as a viable pregnancy of at least 12 weeks
 Secondary: live birth, miscarriage, multiple pregnancy, cost‐related quality of life
Followed up to 1 year
Notes Analyses on an intention‐to‐treat basis
 Powered to detect a 10% difference in ongoing pregnancy rate
No conflict of interest
Funding: Serono Benelux provided financial support for rFSH during the first eight months of the study when this drug was not funded by the health services. FvdV was supported by a grant from the Health Insurance Funds Council (OG 97/007), Amstelveen, Netherlands.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated block randomisation, stratified by centre
Allocation concealment (selection bias) Low risk Telephone call to central office
Blinding of participants and personnel (performance bias) 
 All outcomes High risk There was no evidence of blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No details
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All women randomised were analysed in the primary study
Selective reporting (reporting bias) Low risk The original protocol was supplied by the authors. All the outcomes mentioned in the protocol were presented in the published report
Other bias Low risk No evidence of other risk of bias