Hardarson 2008.
Study characteristics | ||
Methods |
Study design: randomised controlled trial Duration and location of the trial: between November 2003 and February 2007 in Sweden Sample size calculation: a sample size with power calculation was performed 56 and 53 participants were randomised into the PGT‐A and control group, respectively. |
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Participants |
Inclusion criteria: couples with infertility of female or male origin, intending to undergo IVF or ICSI, who had signed a written consent form and in which the age of the woman was ≥38 years were eligible for randomisation. The couple had to have at least 3 embryos of GQE, only 2 GQE were required if the participant only wanted 1 embryo back. Exclusion criteria: patients who had previously been randomised to either of the 2 study groups in this trial |
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Interventions |
Type of biopsy: cleavage stage biopsy. Biopsy on embryos with at least 6 cells and less than 20% fragmentation. Mostly 1 blastomere removed. Genetic analysis: FISH analysis for chromosomes X, Y, 13, 18, 21 |
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Outcomes | live birth rate Miscarriage rate Ongoing pregnancy rate Clinical pregnancy rate Proportion of women reaching embryo transfer Mean number of embryos per transfer |
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Notes |
Treatment procedure: IVF or ICSI Embryo transfer policy: maximum 2 embryos for transfer |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization into two groups was performed using a computerized randomization program" |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: concealment of allocation not stated |
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: 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 | High risk | Judgement comment: high risk of within‐study bias due to the difference in day of embryo transfer between study arms (day 5 for intervention and day 3 for control) Funding: sponsored by the Swedish Medical Research Council and Serono Nordic AB |