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

Allegra 2011.

Methods Prospective randomised study, single centre.
Randomisation method: not stated.
Power analysis: not stated.
Study period: not stated.
Sample size: 102 women.
Conflict of interest: not stated.
Participants Normagonadotropic women undergoing ICSI.
Age 38 to 44 years.
FSH ≥ 9 mIU/ml.
Exclusion criteria: basal FSH ≥ 16 mIU/ml, women age ≥ 44 years, severe endometriosis, severe male factor, secondary infertility ≤ 3 years.
Baseline characteristics to compare: age, BMI, menstrual cycle length, antral follicle count.
Interventions Luteal started pituitary downregulation with GnRH agonist. The supplementation of the luteal phase was assured by the administration of progesterone.
Standard treatment: rFSH alone, 225‐450 IU daily.
Experimental treatment: rFSH, 225‐450 IU daily and rLH 75 IU daily from the day in which at least one follicle
 ≥ 14 mm was detected.
Outcomes Primary endpoint:
  • not stated


Secondary endpoints:
  • level of E2 on the day of HCG

  • clinical pregnancy, not defined

Notes Abstract only.
Funding: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information was reported on random sequence generation.
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 blinding of outcome assessors 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 Unclear risk Although dropouts and reasons for withdrawals were given, proportions were not and reasons were not uniform between treatment groups and analysis was not on ITT basis.
Selective reporting (reporting bias) Unclear risk Methods section not detailed enough to make conclusive judgement.
Other bias Low risk Baseline demographic characteristics were similar between the two treatment groups.