Jansen 2008.
| Study characteristics | ||
| Methods |
Study design: randomised controlled trial Duration and location of the trial: between August 2004 and November 2006 in Sydney, Australia Sample size calculation: not performed 101 women randomised |
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| Participants |
Inclusion criteria: women below 38 years of age in their first or second IVF with no cancelled cycles because of poor response, agreement to elective single embryo transfer, with at least 8 follicles of 1 cm or more on day 8 to 10 of stimulation Exclusion criteria: women with fewer than 4 embryos with eat least 7 cells on day 3, and women with fewer than 2 blastocysts for biopsy were excluded |
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| Interventions |
Type of biopsy: blastocyst stage biopsy, biopsy of the trophectoderm. Biopsies consisted of 2–9 trophectoderm cells. Genetic analysis: FISH analysis for chromosomes X, Y, 13, 18, 21 |
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| Outcomes | live birth rate Miscarriage rate Clinical pregnancy rate Proportion of women reaching embryo transfer |
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| Notes |
Treatment procedure: method for fertilisation not reported Embryo transfer policy: single embryo transfer Note: the trial was suspended and then terminated earlier when it was unable to show an advantage for PGS |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Judgement comment: randomised but no further details |
| Allocation concealment (selection bias) | Unclear risk | Judgement comment: used "sealed envelopes", no details as to whether they were opaque |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Judgement comment: no blinding |
| 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: all randomised participants analysed. Also data on women who were withdrawn from the study before randomisation because of suboptimal responses to stimulation, and data on women who were eligible but elected not to take part in the study |
| Selective reporting (reporting bias) | Low risk | Judgement comment: no suggestion of selective reporting |
| Other bias | Low risk | Judgement comment: no sources of bias detected Funding: unclear whether this was a sponsored trial |