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

Nyboe Andersen 2008.

Methods Prospective randomized, open‐label study, multicentred.
Randomisation: sealed envelopes in blocks of 10 and sequentially numbered.
Power analysis: with a power of 77% and P < 0.05, 400 patients were needed per arm.
Study period: August 2003 to November 2004.
Sample size: 526.
Conflicts of interest: not stated.
Participants Women with a regular menstrual cycle, undergoing their first, second or third cycle of IVF or ICSI.
Age: < 40.
FSH (cd2‐5) < 10 IU/l.
Exclusion criteria: not stated.
Baseline characteristics to compare: age, duration of infertility, cycle number, indication IVF/ICSI.
Interventions Luteal started pituitary downregulation with a long agonist protocol.
Standard treatment: rFSH alone.
Experimental treatment: rFSH with rLH from Day 6 of stimulation.
Outcomes Primary endpoint: ongoing pregnancy rate.
Secondary endpoints: total dose rFSH, number of stimulation days, number of oocytes retrieved.
Notes The planned sample size was not reached. BMI was not stated.
Funding: Serono Nordic provided Luveris (rLH), and funded the central measurements of serum LH. The statistical Unit, Serono International, Switzerland, did the statistical analysis.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The process used in random sequence generation was not reported.
Allocation concealment (selection bias) Low risk Allocation was concealed in sealed envelope.
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 assessors is not likely to affect outcomes of interest as they are objectively assessed.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropouts.
Selective reporting (reporting bias) High risk Only the primary endpoint is stated in the methods section.
Other bias Unclear risk Insufficient information to make a conclusive judgement.