Staessen 2008.
Study characteristics | ||
Methods |
Study design: randomised controlled trial Duration and location of the trial: between October 2004 and December 2006 in the University Hospital, Dutch‐speaking Brussels Free University Sample size: 240 women randomised |
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Participants |
Inclusion criteria: women below 36 years of age Exclusion criteria: patients with an abnormal karyotype or non‐motile sperm were excluded |
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Interventions |
Type of biopsy: cleavage stage biopsy Genetic analysis: genetic analysis with FISH analysis |
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Outcomes | live birth rate Miscarriage rate Ongoing pregnancy rate Clinical pregnancy rate Multiple pregnancy rate Proportion of women reaching embryo transfer Mean number of embryos per transfer |
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Notes |
Treatment procedure: ICSI only Embryo transfer policy: ICSI only. Single embryo transfer Note: study recruitment was terminated prematurely on basis of interim analysis |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Judgement comment: randomised ‐ no details |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: concealment of allocation not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Judgement comment: clinicians and embryologists who performed the embryo transfer were blinded only with respect to the patients' participation in the study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Judgement comment: non‐blinding not likely to affect objective outcomes |
Incomplete outcome data (attrition bias) All outcomes | High risk | Judgement comment: data on dropouts not reported |
Selective reporting (reporting bias) | Low risk | Judgement comment: no suggestion of selective reporting |
Other bias | Low risk | Judgement comment: no suggestion of other bias Funding: grant from the Belgium Fund for Scientific Research Flanders (FWO‐Vlaanderen) |