Bayram 2004.
| Methods | Parallel randomised controlled trial. Multicentre (n = 25 centres) in The Netherlands Timing: February 1998 to October 2001 |
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| 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 |
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| 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 |
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| 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. |
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| 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 |