Palomba 2010.
| Methods | Randomised trial conducted in Italy Timing: February 2003 to May 2004 |
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| Participants | 50 participants Inclusion: Anovulatory, clomiphene‐resistant, with PCOS, seeking pregnancy Exclusion: < 18 or > 35 years, BMI > 35 kg/m2, neoplastic, metabolic, endocrine, hepatic, renal , and cardiovascular disorders, or other concurrent medical illnesses; and current or previous use of any drug that affected hormone levels, metabolism or appetite. Organic or pelvic diseases, previous pelvic surgery, suspected peritoneal factor infertility/ subfertility, and tubal or male‐factor infertility or subfertility that was excluded by hysterosalpingogram and semen analysis. Wanting to start a diet or a specific programme of physical activity, cigarette smokers or alcoholic beverage abusers |
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| Interventions | LOD followed by 6 cycles of observation (n = 25), versus Clomiphene citrate (incremental dose) plus metformin (850 mg increasing to 1700g daily) for 6 cycles (n = 25) Follow‐up for 6 months |
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| Outcomes | Live birth, pregnancy rates, multiple pregnancy, miscarriage, ovulation rate, adverse events, compliance, cost | |
| Notes | Conflict of interest: not stated Clinical trial registration number: NCT00558077 No funding |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "achieved using online software (www.randomization.it)" |
| Allocation concealment (selection bias) | Low risk | Concealed in sealed dark envelopes until the interventions were assigned |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details but blinding unlikely due to differences in the interventions |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 women (1 in the LOD group and 2 in the CC + metformin group) were lost to follow‐up because they missed a follow‐up visit |
| Selective reporting (reporting bias) | Low risk | We found the registered protocol on ClinicalTrials.gov (NCT00558077). All the outcomes mentioned in the protocol were presented in the published report |
| Other bias | Low risk | No evidence of other risk of bias |