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. 2020 Sep 8;2020(9):CD005291. doi: 10.1002/14651858.CD005291.pub3

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
Participants Inclusion criteria: women below 36 years of age
Exclusion criteria: patients with an abnormal karyotype or non‐motile sperm were excluded
Interventions Type of biopsy: cleavage stage biopsy
Genetic analysis: genetic analysis with FISH analysis
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
Notes Treatment procedure: ICSI only
Embryo transfer policy: ICSI only. Single embryo transfer
Note: study recruitment was terminated prematurely on basis of interim analysis
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)