Rubio 2013.
| Study characteristics | ||
| Methods |
Study design: randomised controlled trial Duration and location of the trial: between 2004 and December 2011, private infertility clinic, Valencia, Spain Sample size: a sample size calculation was performed 90 women randomised |
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| Participants |
Inclusion criteria: FSH levels < 10 IU/mL, E2 < 65 pg/mL, antral follicle count 8 or more, and 5 or more metaphase II (MII) oocytes in previous cycles. Women < 40 years; 3 or more implantation failures in previous IVF/ICSI cycle with transfer of at least 2 good‐quality, fresh embryos in each cycle; and no abnormality in the infertility work‐up performed Exclusion criteria: any abnormality detected in the previous infertility work‐up; hydrosalpinx; previous ectopic pregnancies or miscarriages; presence of myomas, adhesions, or polyps; previous ET with high difficulty or bleeding, or both; patients with other indications for PGD/PGS; and patients with fewer than 5 MII oocytes in a single cycle |
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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 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: 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) | Unclear risk | Judgement comment: concealment of allocation not reported |
| 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: number of randomised participants is the number of analysed participants |
| 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: unclear whether this was a sponsored trial |