Humaidan 2004.
Methods | Prospective randomized study, open‐label, single centre. Randomisation method: by means of a computer programme generating random numbers in sealed unlabelled envelopes. Power analysis: 100 cycles were needed to obtain a statistical significant difference of 10% in pregnancy rates (not defined) in favour of rLH. Study period: From November 2001 to October 2002. Sample size: 231. Conflict of interests: not stated. |
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Participants | Normo‐ovulatory women undergoing IVF or ICSI. Age: < 40 AFC: not stated FSH: < 10 IU/l Baseline characteristics to compare: age, BMI, the number of previous IVF attempts. |
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Interventions | Luteal started pituitary downregulation with a GnRH agonist Suprefact 0.5 mg subcutaneous daily for 14 days, then to 0.2 mg subcutaneous. The rFSH dose depended on age (< 35 150 IU/l > 35 225 IU/l), BMI and ovarian volume. On stimulation day 8 patients were randomized. Standard treatment: rFSH alone (adjusted if necessary). Experimental treatment: rFSH in combination with LH in a 2:1 ratio. |
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Outcomes | Primary endpoint: clinical pregnancy rate (defined as positive foetal heart beat 5 weeks after embryo transfer) Secondary endpoints: rFSH dose used, number of oocytes retrieved total days of stimulation, implantation rate. |
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Notes | No data on ongoing pregnancy or life birth rate, no data on cryo‐survival or multiple pregnancies. No data on cancellation rate. The duration of infertility not stated. 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 random numbers. |
Allocation concealment (selection bias) | Low risk | Sealed, unlabelled 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 | 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 | Low risk | No loss to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | Outcome measures were prespecified in the methods section. |
Other bias | Low risk | Baseline demographic characteristics were similar between the two treatment groups. |