Lisi 2012.
Methods | A prospective, randomized, open‐label, multicentre study.
Randomisation method: using block randomization (Block of 1:1).
Power analysis: not stated. Study period: June 2009 to December 2010. Sample size: 150 patients. Conflicts of interest: the authors declare no conflict of interest. |
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Participants | Women with infertility caused by tubal factors, male factors or of unknown cause, at their first or second attempt of IVF or ICSI. Age: < 40 years old. FSH: < 10 IU/l on day 3 of their cycle. AFC: not stated. Exclusion criteria: patients with endometriosis or polycystic ovarian syndrome and patients with a body mass index above 28.0 or below 18.0. Baseline characteristics to compare: age, FSH, LH, E2. |
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Interventions | Long luteal started pituitary downregulation with GnRH agonist. Standard treatment: rFSH (Gonal F, Merck‐Serono, Geneva, Switzerland) at a starting dose of 150 IU for 6 days and at the 7th day of rFSH the dose was adjusted according to individual response. Experimental treatment: 75 IU of rLH daily for 4 days (total dose 300 IU) and rFSH (starting from day 2 of rLH administration) at a fixed starting dose of 150 IU for the first 6 days and, at the 7th day of rFSH dose of rFSH was adjusted according to the individual response. |
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Outcomes | Primary endpoint: not stated. Endpoints: oocytes retrieved per patient (total), oocytes metaphase II insemination/per patient (total), 2PN oocytes (fertilisation rate) embryos, total (cleavage rate), embryos, total grades I and II (%), no. of patients receiving embryos (%), no. of embryos transferred per starting patients (total), no. of hCG positive (% of patients receiving embryos), no. of clinical pregnancies (% of patients receiving embryos), no. of foetal hearts (implantation rate). |
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Notes | Funding: not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence was said to have been generated using block randomization but what was used in generating the block was not reported. |
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 | 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 | High risk | Although there were no losses to follow‐up in the trial, not all participants were analyzed for the outcome of interest in this review (clinical pregnancy rate). |
Selective reporting (reporting bias) | Low risk | Outcome measures were prespecified in the methods section. |
Other bias | Low risk | Baseline demographic characteristics similar between the two treatment groups. |