Debrock 2010.
| Study characteristics | ||
| Methods |
Study design: randomised controlled trial Duration and location of the trial: between June 2002 and January 2007 in Belgium Sample size calculation: not stated 94 women randomised |
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| Participants |
Inclusion criteria: women 35 years or older, with at least 2 fertilised oocytes available on day 1 after oocyte retrieval, and with at least 2 embryos consisting of 6 or more cells at day 3 after oocyte retrieval Exclusion criteria: NA |
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| Interventions |
Type of biopsy: cleavage stage biopsy. Biopsy on embryos with at least 6 blastomeres on day 3. 2 blastomeres with a nucleus were gently aspirated from each embryo. Genetic analysis: performed by FISH analysis for chromosomes X, Y, 13, 16, 18, 21, 22 |
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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: IVF and ICSI Embryo transfer policy: before 1 July 2003 a maximum of 2 to 3 embryos were transferred, after that only 1 embryo was transferred in the first trial in women less than 36 years old. Maximum 3 embryos for transfer |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Judgement comment: method of randomisation with sealed envelopes |
| Allocation concealment (selection bias) | Unclear risk | Judgement comment: "sealed" envelopes, but not stated if 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: flow chart of attrition including reasons |
| Selective reporting (reporting bias) | Low risk | Judgement comment: no suggestion of selective reporting |
| Other bias | Low risk | Judgement comment: no sources of bias detected. Unclear whether this was a sponsored trial |