Palomba 2010.
Methods | A randomised controlled trial | |
Participants | 50 women who were CC‐resistant were recruited between February 2003 and May 2004, conducted in 2 university hospitals in Naples, Italy | |
Interventions | The participants were randomised to clomiphene + metformin (6 cycles) (n = 25) versus LOD alone (n = 25) and followed up for 6 months. LOD was by 3 ‐ 6 punctures of 3 mm diameter and 4 ‐ 5 mm depth, for 2 ‐ 3 seconds at 40 W) | |
Outcomes | Amenorrhoea at cycle day 35. No operative complications were identified, no drug‐related adverse effects resulting in treatment discontinuation. |
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Notes | Funding source: "Authorship and contribution to the article is limited to the 8 authors indicated. There was no outside funding or technical assistance with the production of this article" Declarations of interest: Not stated. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization |
Allocation concealment (selection bias) | Low risk | "concealed in sealed dark envelopes until intervention was assigned" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not stated but not possible with study design |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 were lost to follow‐up |
Selective reporting (reporting bias) | Low risk | None detected |
Other bias | Low risk | None detected |