Marrs 2003.
Methods | Prospective randomized, open‐label study, multicentred.
Randomisation method: a computer‐generated randomization sequence.
Power analysis: a group of 280 patients would give 80% power to detect the expected a difference of 8.2% in obtained number of metaphase II oocytes. Study period: not stated. Sample size: 431. Conflict of interests: not stated. |
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Participants | Patients with normal ovulatory cycles, the presence of both ovaries, a male partner and an ICSI indication. Age: between 18 and 40 years. FSH: < 11.2. Exclusion criteria: clinically significant systemic disease; smoking more than 10 cigarettes a day; any contraindication to pregnancy; serum/plasma LH; FSH ratio > 2; more than 2 previous ICSI cycles in which gonadotrophin stimulation was used. Baseline characteristics to compare: Age, BMI, duration of infertility, previous assisted reproduction cycles rFSH+rLH. |
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Interventions | Luteal started pituitary downregulation with GnRH agonist.When serum E2 < 75 pg/ml 225 IU rFSH was started. Standard treatment: rFSH dosage alone. Experimental treatment: rFSH in combination with 150 IU rLH until hCG. |
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Outcomes | Primary endpoint: number of metaphase II oocytes retrieved. Secondary endpoints: cancellation rate, fertilisation rate, rFSH dose used, number of embryo's obtained, biochemical, clinical pregnancy rate, implantation rate and live birth rate. |
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Notes | No data on multiple pregnancies. No data on cryo‐survival. Funding: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A computer‐generated randomization sequence. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
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 whether or not outcome assessors were blinded 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 | Low risk | Numbers of women analyzed at the end of study were the same as those randomized at the beginning. |
Selective reporting (reporting bias) | Low risk | Outcome measures were prespecified in the methods section. |
Other bias | Unclear risk | Baseline demographic characteristics were similar between the two groups. |