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. |
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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. |
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Interventions | Patients undergoing assisted fertilisation programmes treated with a GnRH agonist. Standard treatment: rLH and rFSH. Experimental treatment: rFSH alone. |
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Outcomes | Primary endpoint:
Secundary endpoints:
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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. |