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". |