Meyer 2009.
| Study characteristics | ||
| Methods |
Study design: randomised controlled trial Duration and location of the trial: between June 2004 and November 2006, private infertility clinic, Illinois, USA Sample size calculation: a sample size with power calculation was performed 47 women randomised An intention‐to‐treat analysis was performed. |
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| Participants |
Inclusion criteria: women below 39 years of age with a normal ovarian reserve, a body mass index below 30 kg/m², a normal uterus, no more than 2 previous failed IVF cycles with at least 4 embryos containing at least 5 cells with less than 40% fragmentation Exclusion criteria: smoking history, the presence of a hydrosalpinx or uterine anomaly, a history of more than 2 previous spontaneous pregnancy losses, and the presence of severe male factor infertility |
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| Interventions |
Type of biopsy: cleavage stage biopsy, mostly 1 blastomere removed Genetic analysis: FISH analysis for chromosomes X, Y, 13, 16, 17, 18, 21, 22 |
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| Outcomes | live birth rate Miscarriage rate Clinical 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: maximum embryos for transfer not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Judgement comment: computer‐generated randomisation |
| Allocation concealment (selection bias) | Low risk | Judgement comment: sealed, opaque envelopes randomisation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Judgement comment: not blinded |
| 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 | Low risk | Judgement comment: 4 participants declined transfers for reasons not related to the study, all other participants randomised were analysed |
| 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: supported in part by Serono |