Abstract: We included nine RCTs (N = 2955 infertile couples). The quality of the evidence ranged from very low to low. The main limitations were high risk of bias in the included studies, imprecision, indirectness, and inconsistency. There were no data on cumulative live birth or ongoing pregnancy rate or cumulative clinical pregnancy rate. TLS with conventional morphological assessment of still TLS images versus conventional incubation and assessment It is unclear whether there is any difference between interventions in rates of live birth or ongoing pregnancy (odds ratio (OR) 0.91, 95% confidence interval (CI) 0.67 to 1.23, 3 RCTs, N = 826, I2 = 33%, low-quality evidence) or in miscarriage rates (OR 1.90, 95% CI 0.99 to 3.61, 3 RCTs, N = 826, I2 = 0%, low-quality evidence). The evidence suggests that if the rate of live birth or ongoing pregnancy associated with conventional incubation and assessment is 35%, the rate with the use of TLS with conventional morphological assessment of still TLS images would be between 27% and 40%, and if the miscarriage rate with conventional incubation is 4%, the rate associated with conventional morphological assessment of still TLS images would be between 4% and 14%. It is unclear whether there is a difference between the interventions in rates of stillbirth (OR 1.00, 95% CI 0.13 to 7.49, 1 RCT, N = 76, low-quality evidence) or clinical pregnancy (OR 1.06, 95% CI 0.79 to 1.41, 4 RCTs, N = 875, I2 = 0%, low-quality evidence). TLS utilising embryo selection software versus TLS with conventional morphological assessment of still TLS images All findings for this comparison were very uncertain due to the very low-quality of the evidence. No data were available on live birth, but one RCT reported ongoing pregnancy. It is unclear whether there is any difference between the interventions in rates of ongoing pregnancy (OR 0.61, 95% CI 0.32 to 1.20, 1 RCT, N = 163); miscarriage (OR 1.39, 95% CI 0.64 to 3.01, 2 RCTs, N = 463, I2 = 0%); or clinical pregnancy (OR 0.97, 95% CI 0.67 to 1.42, 2 RCTs, N = 463, I2 = 0%). The evidence suggests that if the rate of ongoing pregnancy associated with TLS with conventional morphological assessment of still TLS images is 47%, the rate associated with TLS utilising embryo selection software would be between 22% and 52%, and if the miscarriage rate associated with conventional morphological assessment of still TLS images is 5%, the rate associated with TLS utilising embryo selection software would be between 4% and 15%. No studies reported stillbirth. TLS utilising embryo selection software versus conventional incubation and assessment The findings for this comparison were also very uncertain due to the very low quality of the evidence. It is unclear whether there is any difference between the interventions in rates of live birth (OR 1.12, 95% CI 0.92 to 1.36, 3 RCTs, N = 1617, I2 = 84%). There was very low-quality evidence that TLS might reduce miscarriage rates (OR 0.63, 95% CI 0.45 to 0.89, 3 RCTs, N = 1617, I2 = 0%). It is unclear whether there is any difference between the interventions in rates of clinical pregnancy (OR 0.95, 95% CI 0.78 to 1.16, 3 RCTs, N = 1617, I2 = 89%). The evidence suggests that if the rate of live birth associated with conventional incubation and assessment is 48%, the rate with TLS utilising embryo selection software would be between 46% and 55%, and if the miscarriage rate with conventional incubation and assessment is 11%, the rate associated with TLS would be between 5% and 10%. No stillbirths occurred in the only study reporting this outcome. There is insufficient good-quality evidence of differences in live birth or ongoing pregnancy, miscarriage and stillbirth, or clinical pregnancy to choose between TLS, with or without embryo selection software, and conventional incubation. As the evidence is of low or very low-quality, our findings should be interpreted with caution.

Plain-language summary: The evidence is current to January 2019. We included nine studies (randomised controlled trials, that is studies in which participants are assigned to one of two or more treatment groups using a random method) of 2955 infertile couples undergoing IVF or ICSI. There were three different study designs: (1) TLS with conventional assessment of still TLS images versus conventional incubation and assessment; (2) TLS utilising embryo selection software versus TLS with conventional assessment of still TLS images; and (3) TLS utilising embryo selection software versus conventional incubation and assessment. TLS with conventional assessment of still TLS images versus conventional incubation and assessment All the evidence for this comparison was low-quality. It is unclear whether there is any difference between the interventions in rates of livebirth or ongoing pregnancy or miscarriage. The evidence suggests that if the rate of livebirth or ongoing pregnancy associated with conventional incubation and assessment is 35%, the rate with use of TLS with conventional morphological assessment of still TLS images would be between 27% and 40%, and if the miscarriage rate with conventional incubation is 4%, the rate associated with conventional morphological assessment of still TLS images would be between 4% and 14%. It is unclear whether there is a difference between interventions in rates of stillbirth or clinical pregnancy. TLS utilising embryo selection software versus TLS with conventional assessment of still TLS images All findings for this comparison were very uncertain due to very low-quality evidence. No data were available on livebirth, but one study reported ongoing pregnancy. It is unclear whether there is any difference between interventions in rates of ongoing pregnancy, miscarriage, or clinical pregnancy. The evidence suggests that if the rate of ongoing pregnancy associated with TLS with conventional morphological assessment of still TLS images is 47%, the rate associated with TLS utilising embryo selection software would be between 22% and 52%, and if the miscarriage rate associated with conventional morphological assessment of still TLS images is 5%, the rate associated with TLS utilising embryo selection software would be between 4% and 15%. No studies reported stillbirth. TLS utilising embryo selection software versus conventional incubation and assessment All findings for this comparison were very uncertain due to the very low-quality of the evidence. It is unclear whether there is any difference between interventions with respect to rates of livebirth or clinical pregnancy. The evidence suggests lower rates of miscarriage in the TLS group for the outcome of miscarriage. The evidence suggests that if the livebirth rate associated with conventional incubation is 48%, the rate with the use of TLS would be between 46% and 55%, and if the miscarriage rate with conventional incubation is 11%, the rate associated with TLS would be between 5% and 10%. There is no good evidence showing that TLS is more or less effective than conventional methods of embryo incubation. Patients may wish to take part in randomised controlled trials on TLS in order to add to the existing evidence base and to help guide assisted reproductive technology patients in the future. The quality of the evidence ranged from very low to low. The main limitations were high risk of bias in the included studies, imprecision, indirectness, and inconsistency.