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. 2017 May 24;2017(5):CD005070. doi: 10.1002/14651858.CD005070.pub3

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.
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.
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.
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).
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.