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

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.
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.
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.
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.
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
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.