Roy 2010.
| Methods | Prospective randomised trial conducted in India Timing: January 2006 to January 2009 |
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| Participants | Women from a gynaecological clinic. Mean age of rosiglitazone group was 27.32 ± 4.25 and for LOD group was 28.42 ± 3.65 years Inclusion: Age between 20 and 40 years, having primary infertility with clomiphene‐resistant PCOS, documented patent tubes on hysterosalpingography and no other infertility factor, normal semen parameters in partner Exclusion: Other PCOS‐like syndromes such as Cushings syndrome, congenital adrenal hyperplasia, androgen producing tumours, hyperprolactinaemia and hypothyroidism |
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| Interventions | All participants had laparoscopy Unilateral LOD using 5 punctures + multivitamins twice daily + CC (n = 25), versus Rosiglitazone 4 mg twice daily + CC (n = 25). Treatment continued for 6 months after laparoscopy |
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| Outcomes | Ovulation, pregnancy, number of follicles, serum E2, endocrine parameters | |
| Notes | No conflict of interest Clinical trial registration number: not stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "using online software to generate a random number table" |
| Allocation concealment (selection bias) | Unclear risk | Quote: "opening sealed envelopes containing numbers from the computer generated random table" Comment: Method looks okay but unclear if envelopes were opaque and if they were opened sequentially |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor was blinded to allocation group |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 5 women were lost to follow‐up, an additional 2 women refused to participate before randomisation and therefore 43 were analysed. The reasons for loss to follow‐up are not described |
| Selective reporting (reporting bias) | Unclear risk | We could not retrieve the original protocol. The outcomes listed in the Methods section were reported in the Results |
| Other bias | Low risk | No evidence of other risk of bias |