Nyboe Andersen 2008.
Methods | Prospective randomized, open‐label study, multicentred. Randomisation: sealed envelopes in blocks of 10 and sequentially numbered. Power analysis: with a power of 77% and P < 0.05, 400 patients were needed per arm. Study period: August 2003 to November 2004. Sample size: 526. Conflicts of interest: not stated. |
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Participants | Women with a regular menstrual cycle, undergoing their first, second or third cycle of IVF or ICSI. Age: < 40. FSH (cd2‐5) < 10 IU/l. Exclusion criteria: not stated. Baseline characteristics to compare: age, duration of infertility, cycle number, indication IVF/ICSI. |
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Interventions | Luteal started pituitary downregulation with a long agonist protocol. Standard treatment: rFSH alone. Experimental treatment: rFSH with rLH from Day 6 of stimulation. |
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Outcomes | Primary endpoint: ongoing pregnancy rate. Secondary endpoints: total dose rFSH, number of stimulation days, number of oocytes retrieved. |
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Notes | The planned sample size was not reached. BMI was not stated. Funding: Serono Nordic provided Luveris (rLH), and funded the central measurements of serum LH. The statistical Unit, Serono International, Switzerland, did the statistical analysis. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The process used in random sequence generation was not reported. |
Allocation concealment (selection bias) | Low risk | Allocation was concealed in sealed envelope. |
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 assessors is not likely to affect outcomes of interest as they are objectively assessed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts. |
Selective reporting (reporting bias) | High risk | Only the primary endpoint is stated in the methods section. |
Other bias | Unclear risk | Insufficient information to make a conclusive judgement. |