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

Ruvolo 2007.

Methods Prospective randomized trial, single centre.
Randomisation: computer‐generated randomization list.
Power analysis: the sample size of 30 patients in each treatment group was calculated to have 80% power to detect a mean difference of 2.0, with a significance level of 0.01.
Study period: from September 2004 to February 2005.
Sample size: 60.
Conflict of interests: not stated.
Participants Women with low response in a failed previous IVF cycle.
Age: not stated.
FSH: < 12 IU/mL.
Baseline characteristics to compare: mean age, BMI.
Interventions Patients undergoing assisted fertilisation programmes treated with a GnRH agonist.
Standard treatment: rLH and rFSH.
Experimental treatment: rFSH alone.
Outcomes Primary endpoint:
  • apoptosis rate of cumulus cells


Secundary endpoints:
  • pregnancy rate

  • total dose rFSH

  • number of oocytes retrieved

  • number of GV‐MI oocytes

Notes Funding: this study is supported in part by the Italian Ministero Istruzione Universita Ricerca, Roma, Italy
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was realised in blocks of three, using computer‐generated random number tables.
Allocation concealment (selection bias) Unclear risk Not stated.
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 Not reported although 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 Low risk Numbers of women analyzed at the end of study were the same as those randomized at the beginning.
Selective reporting (reporting bias) Unclear risk Outcome measures were specified in the methods section.
Other bias Low risk Baseline demographic characteristics similar between the two treatment groups.