Ashrafinia 2009.
Methods | A randomised controlled trial | |
Participants | 126 women with PCOS were randomised from March 2006 until February 2008, between the ages of 15 and 45 years, with a history of infertility for at least 1 year and 3 treatment cycles with no response to CC (CC‐resistant), conducted in Tehran, Iran | |
Interventions | Participants received metformin treatment (n = 63) or underwent LOD (n = 63) | |
Outcomes | The primary outcome measure was menstrual regularity. The levels of FSH, LH, free testosterone and the level of hirsutism assessed using the Ferriman Gallwey score were included. No harms reported. |
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Notes | Funding source: Not stated Declarations of interest: 'None'. Authors contacted requesting further information. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Low risk | The groups were allocated using serially‐numbered opaque envelopes |
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 | All randomised women were analyzed |
Selective reporting (reporting bias) | Low risk | None detected |
Other bias | Low risk | None detected |