Table 2.
Primary and secondary endpoints
| ITT/PP | TLI | COI | RRTLI/COI | RDTLI/COI | p-value* | |
|---|---|---|---|---|---|---|
| Number of randomized oocytes | ITT | n = 338 | n = 338 | – | – | 1.0 |
| PP | n = 297 | n = 303 | – | – | 0.73 | |
| Number of four-cells day 2 | ITT | n = 92 | n = 113 | 0.81 (0.65;1.02) | −6.2 % (−13.1;0.7) | 0.08 |
| PP | n = 84 | n = 107 | 0.80 (0.63;1.01) | −7.0 % (−14.4;4.0) | 0.07 | |
| Number of 7–8 cells day 3 | ITT | n = 78 | n = 81 | 0.96 (0.73;1.26) | −0.9 % (−7.3;5.5) | 0.79 |
| PP | n = 73 | n = 78 | 0.95 (0.72;1.26) | −1.1 % (−8.1;5.8) | 0.74 | |
| Number of blastocysts day 5a | ITT | n = 88 | n = 81 | 1.09 (0.84;1.41) | 2.1 % (−4.5;8.6) | 0.53 |
| PP | n = 83 | n = 78 | 1.09 (0.83:1.41) | 2.0 % (−4.9;9.3) | 0.54 |
aBlastocyst development of embryos with delayed cleavage explained the higher number of blastocysts day 5 compared with 7–8 cell embryos day 3
RR Risk Ratio; RD Risk Difference
TLI Time-lapse incubator; COI Conventional incubator
ITT Assessed by intention-to-treat; PP Assessed per protocol
*Time-lapse incubator compared with conventional incubator