Barrenetxea 2008.
Methods | Prospective randomized study, single centre. Randomisation: computer‐generated block randomization. Allocation: sealed envelopes. Power analyses: 10% difference in clinical pregnancy rate. Sample size: 84. Study period: January to June 2005. Conflict of interest: not stated. |
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Participants | Women with an indication for IVF and poor ovarian reserve. Age > 40 year. FSH cycle day 3 > 10. Available baseline characteristics to compare: mean age, BMI, duration of infertility, basal FSH. |
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Interventions | Follicular started pituitary downregulation with a GnRH agonist 0.5 mg/day leuprolide. Standard treatment: from cycle day 2 onward 375 rFSH. Experimental treatment from stimulation day 7 until stimulation day 10 150 IU rLH, from stimulation day 10 onward daily additional 75 IU rLH until ovulation triggering with hCG. |
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Outcomes | Primary endpoints:
Secondary endpoints:
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Notes | No data on live births. 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' block randomization. |
Allocation concealment (selection bias) | Low risk | Allocations were concealed in 'sealed envelopes'. |
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 | Those who administered the intervention were not blinded but non blinding of outcome assessment is not likely to affect the outcomes of interest as they are objectively assessed. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information to make a conclusive judgement. |
Selective reporting (reporting bias) | Unclear risk | No data on live births. |
Other bias | Low risk | Baseline demographic characteristics similar between groups. |