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

Fernandez 2015.

Methods Parallel randomised controlled trial conducted in France
Timing: June 2009 to June 2012
Participants 40 of 252 women randomised, as trial stopped early. Mean age in LOD group was 28 ± 3 years and in the metformin + FSH group was 27 ± 3 years
Inclusion criteria: Clomiphene‐resistant, polycystic ovaries
Exclusion criteria: Other causes of infertility including tubal factors, male factor, > 36 years of age, thyroid dysfunction
Interventions LOD: Bipolar needle, 10 punctures at 100 to 130 W 8 mm depth and 2 mm diameter. (n = 19), versus
Recombinant FSH plus metformin: 3 months treatment by metformin (start dose 500 g up to a max 1500 g a day) followed by 3 hyperstimulation by FSH + insemination
Follow‐up for 6 months
Outcomes Pregnancy, BMI, hormone levels, follicle count, changing strategy during the study follow‐up
Notes No conflict of interest
Clinical trial registration number: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Central randomisation through a website
Allocation concealment (selection bias) Unclear risk Centralised randomisation
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No details
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No details
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Planned to recruit 126 women but only recruited 40 before trial stopped. 4 women failed to consent and 2 women were lost to follow‐up. Not stated which group they were allocated to. States that all women were analysed regardless of the group they were randomised to
Selective reporting (reporting bias) Unclear risk We could not retrieve the original protocol. All outcomes prespecified in the paper appear to have been reported
Other bias Unclear risk Trial stopped early due to "difficulty in the inclusion criteria with absence of final agreement by team included".