Nazzaro 2012.
Methods | Randomised controlled trial. Randomisation method: not stated. Power analysis: not stated. Study period: not stated. Sample size: 422 patients. Conflict of interests: not stated. |
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Participants | Women without ovulatory dysfunction at their first IVF/ICSI cycle. Age: 35‐42 years. FSH: not stated. AFC: maximum 3 per ovary. Exclusion criteria: not stated. Baseline characteristics to compare: not stated. |
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Interventions | Pituitary downregulation with GnRH‐a starting on day two of the menstrual cycle. Standard treatment: rFSH administration (225 IU/day). Experimental treatment: rFSH (225 IU/day) + rLH (rLH 150 IU/day). |
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Outcomes | Primary endpoint: not stated. Endpoints: number of (MFII) oocytes, fertilisation rate, mean high grade embryos, mean number of frozen embryos, implantation rate (fresh+thawed embryos) and clinical pregnancy rate. |
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Notes | Abstract only. Funding: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information was reported on random sequence generation. |
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 the blinding of outcome assessors 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 | Unclear risk | No information was reported on withdrawals/dropouts and methods used in data analysis. |
Selective reporting (reporting bias) | Unclear risk | Methods section not detailed enough to make a definite judgement on selective outcome reporting. |
Other bias | Unclear risk | Insufficient information to make a conclusive judgement. |