Trial Outcomes & Findings for TiLE (Time Lapse Eeva) Clinical Trial (NCT NCT02417441)

A total of 976 subjects were enrolled, out of which 970 subjects were randomized and started the study.

Race and Ethnicity were not collected from any participant.

Implantation rate was calculated by dividing the number of intrauterine gestational sacs by the number of embryos transferred multiplied by 100.

Clinical pregnancy was confirmed by the presence of a gestational sac with heartbeat as assessed by ultrasonography. Clinical pregnancy rate was measured as the number of clinical pregnancies divided by number of embryo transfer (ET) cycles multiplied by 100.

Ongoing pregnancy was defined as having a positive fetal heart beat (FHB) as assessed by ultrasonography at gestational week 10-12. Number of subjects with ongoing pregnancy status has been reported, where "Yes" indicates participants with positive ongoing pregnancy status and "No" indicates participants with negative ongoing pregnancy status .

Multiple pregnancy rate was defined as a clinical pregnancy with greater than equals to (\>=) 2 fetal sacs as assessed by ultrasonography. Multiple Pregnancies rate was measured by number of multiple pregnancies divided by number of embryo transfer cycles multiplied by 100.

Utilization rate was defined as the sum of number of transferred and frozen embryos divided by number of normally fertilized oocytes multiplied by 100.

Spontaneous miscarriage rate was measured by the number of spontaneous miscarriages as communicated during medical appointment or by telephone contact divided by number of clinical pregnancies multiplied by 100.

Eeva Conformity was reported as the number of subjects who were compliant to use Eeva in embryo assessment in the "Early Embryo Viability Assessment + morphological grading" group. Eeva-compliance subgroup refers to subjects whose embryos were assessed by embryologists following the recommendation of Eeva system and the instructions for use (IFU) of Eeva. Subgroup analysis revealed a high incidence of Eeva noncompliance in the experimental group, which compromised the quality of this study. Only "Early Embryo Viability Assessment + Morphological Grading" reporting arm was applicable for this outcome measure.

Eeva Conformity was reported as the number of subjects who were compliant to use Eeva in embryo assessment in the "Early Embryo Viability Assessment + morphological grading" group. Eeva-compliance subgroup refers to subjects whose embryos were assessed by embryologists following the recommendation of Eeva system and the IFU of Eeva. Subgroup analysis revealed a high incidence of Eeva noncompliance in the experimental group, which compromised the quality of this study. Only "Early Embryo Viability Assessment + Morphological Grading" reporting arm was applicable for this outcome measure.

Number of sites with subjects reporting fetal heart beat (FHB) positive implantation rate (IR) were reported. Overall combined data for "Early Embryo Viability Assessment + Morphological Grading" and "Morphological Grading" arm was planned to be reported.