Summary of findings 3. TLS utilising embryo selection software compared to conventional incubation and assessment for embryo incubation and assessment in assisted reproduction.
TLS utilising embryo selection software compared to conventional incubation and assessment for embryo incubation and assessment in assisted reproduction | |||||
Patient or population: couples undergoing ART Setting: fertility clinic Intervention: TLS utilising embryo selection software Comparison: conventional incubation and assessment | |||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | |
Risk with conventional incubation and assessment | Risk with TLS utilising embryo selection software | ||||
Live birth or ongoing pregnancy | 475 per 1000 | 504 per 1000 (455 to 554) | OR 1.12 (0.92 to 1.36) | 1617 (3 RCTs) | Very lowa |
Miscarriage | 108 per 1000 | 71 per 1000 (52 to 98) | OR 0.63 (0.45 to 0.89) | 1617 (3 RCTs) | Very lowb |
Stillbirth | No events occurred in the only study reporting this outcome. | ‐ | 600 (1 RCT) |
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Clinical pregnancy | 605 per 1000 | 593 per 1000 (545 to 640) | OR 0.95 (0.78 to 1.16) | 1617 (3 RCTs) | Very lowc |
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; OR: odds ratio; RCT: randomised controlled trial; TLS: time‐lapse system | |||||
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect |
aWe downgraded our assessment of the quality of the evidence for live birth twice for very serious risk of bias (high risk of both performance bias and selection bias in two studies, and of other bias in the third study). In one study, the randomisation of participants was undertaken by the principal investigator, and allocation concealment was not described. In another study, some participants could request the intervention, and this request was granted. In the third study, the day of transfer varied between the two study arms. We also downgraded our assessment of the quality of the evidence once for serious indirectness, as one included study undertook multiple embryo transfers per woman and included women receiving donor oocytes from younger women. Although further downgrading was not possible, there was also serious inconsistency (I2 = 86%), possibly secondary to differing embryo transfer policies across the studies: one study had blastocyst transfers, one had varied days of transfer, and one had day 3 transfer for the intervention arm and day 5 transfer for the control arm. bWe downgraded our assessment of the quality of the evidence for miscarriage twice for very serious risk of bias (as outlined above) and once for serious indirectness secondary to one included study including miscarriages of biochemical pregnancies as well as clinical pregnancies. The authors of the study were unable to separate these miscarriage data. cWe downgraded our assessment of the quality of the evidence for clinical pregnancy twice for very serious risk of bias and once for serious indirectness, as one included study undertook multiple embryo transfers per woman and included women receiving donor oocytes from younger women. Although further downgrading was not possible, there was also serious inconsistency (I2 = 89%), possibly secondary to differing embryo transfer policies across the studies: one study had blastocyst transfers, one had varied days of transfer, and one had day 3 transfer for the intervention arm and day 5 transfer for the control arm.