Van der Houwen 2011.
Methods | Prospective randomized multicentre study. Randomisation method: Not stated. Power analysis: Not stated. Study period: Not stated. Sample size: A total of 249 patients. Conflicts of interest: Not stated |
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Participants | Women who were undergoing IVF or ICSI. Age: 35 years or older. FSH: not stated. AFC: not stated. Exclusion criteria: not stated. Baseline characteristics to compare: not specified. |
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Interventions | Short pituitary downregulation protocol with GnRH antagonist with 225 IU rFSH started on cd 3. Standard treatment: rFSH alone. Experimental treatment: rFSH and rLH (Luveris 150 IU/day). |
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Outcomes | Primary endpoint: Not stated. Endpoints: Implantation rate (the chance of an individual embryo to implant), clinical pregnancy rate (defined as hCG > 50 IU) and ongoing pregnancy rate (defined as a pregnancy diagnosed by ultrasonographic visualisation with at least one foetus of 12 or more weeks of gestational age). |
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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 | 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 | It was stated that data analysis was on ITT basis. |
Selective reporting (reporting bias) | Low risk | All the outcomes reported were prespecified in the methods section. |
Other bias | Unclear risk | No sufficient information was reported to make a conclusive judgement. |