Levi‐Setti 2006.
| Methods | Prospective randomized study, single centre. Randomisation method: by computer‐generated list. Power analysis: a sample size of 38 women was necessary to detect a difference of 2 oocytes with a power of 80%. Study period: not stated. Sample size: 40. Conflict of interests: not stated. |
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| Participants | Women with an indication for ICSI, male factor, normal menstrual cycle 25‐35 days, BMI < 25, no more than 3 previous cycles. Age: < 37. AFC: not stated. FSH < 12. Basal characteristics to compare: age, basal FSH, BMI, duration of infertility and number of previous cycles. |
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| Interventions | Pituitary downregulation with GnRH antagonist in short protocol. Standard treatment: rFSH alone. Experimental treatment: rFSH and rLH combined. |
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| Outcomes | Primary endpoint: mean number of retrieved MII oocytes. Secondary endpoints: serum oestrogen mean total number of oocytes, fertilisation rate, embryo‐quality, ongoing pregnancy rate (defined as pregnancies > 12 weeks gestation), implantation rate. |
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| Notes | No data on cryo‐survival. No data on multiple pregnancies. Funding: not stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated list |
| Allocation concealment (selection bias) | Unclear risk | No information was reported on allocation concealment. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Non‐blinding is not likely to affect the outcomes of interest as they are objectively assessed. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No information was provided on whether or not outcome assessors were blinded but non‐blinding of outcome assessment is not likely to affect outcomes of interest as they are objectively assessed. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up. |
| Selective reporting (reporting bias) | Low risk | Outcome measures were prespecified in the methods section. |
| Other bias | Low risk | Baseline demographic characteristics similar between the two groups. |