Table 3.
Cycle | Overall |
Original |
Expanded |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
LDA n = 608 |
Placebo n = 606 |
LDA n = 272 |
Placebo n = 269 |
LDA n = 336 |
Placebo n = 337 |
|||||||
Cycle-Specific | Cumulative | Cycle-Specific | Cumulative | Cycle-Specific | Cumulative | Cycle-Specific | Cumulative | Cycle-Specific | Cumulative | Cycle-Specific | Cumulative | |
hCG detected pregnancy (n = 792) | ||||||||||||
1 | 23.5 | 23.5 | 21.3 | 21.3 | 24.3 | 24.3 | 25.3 | 25.3 | 22.9 | 22.9 | 18.1 | 18.1 |
2 | 15.5 | 39.0 | 17.3 | 38.5 | 18.5 | 42.7 | 14.2 | 39.5 | 13.0 | 35.9 | 19.7 | 37.8 |
3 | 13.6 | 52.6 | 10.8 | 49.3 | 16.4 | 59.1 | 9.7 | 49.3 | 11.2 | 47.2 | 11.6 | 49.5 |
4 | 7.7 | 60.3 | 9.1 | 58.4 | 6.8 | 65.9 | 8.4 | 57.7 | 8.5 | 55.7 | 9.6 | 59.1 |
5 | 6.5 | 66.9 | 5.5 | 63.9 | 5.3 | 71.2 | 5.7 | 63.5 | 7.6 | 63.2 | 5.2 | 64.3 |
6 | 6.1 | 73.0 | 3.2 | 67.1 | 5.8 | 77.1 | 3.4 | 66.8 | 6.2 | 69.5 | 3.1 | 67.5 |
Pb | 0.11 | 0.03 | 0.79 | |||||||||
Clinically confirmed pregnancy (n = 728) | ||||||||||||
1 | 20.4 | 20.4 | 18.3 | 18.3 | 22.1 | 22.1 | 22.7 | 22.7 | 19.0 | 19.0 | 14.8 | 14.8 |
2 | 15.0 | 35.4 | 16.4 | 34.7 | 18.2 | 40.2 | 13.1 | 35.8 | 12.4 | 31.4 | 19.2 | 34.0 |
3 | 12.7 | 48.0 | 10.1 | 44.9 | 15.1 | 55.4 | 9.0 | 44.8 | 10.6 | 42.0 | 11.1 | 45.1 |
4 | 7.0 | 55.0 | 9.4 | 54.3 | 5.1 | 60.5 | 8.9 | 53.7 | 8.6 | 50.6 | 9.8 | 55.0 |
5 | 7.0 | 62.0 | 4.45 | 58.8 | 6.2 | 66.7 | 4.6 | 58.3 | 7.6 | 58.2 | 4.3 | 59.3 |
6 | 5.5 | 67.5 | 3.3 | 62.1 | 5.5 | 72.2 | 3.8 | 62.1 | 5.5 | 63.8 | 2.9 | 62.2 |
Pb | 0.13 | 0.04 | 0.92 |
Women were block randomized into two strata based on eligibility criteria at enrollment: original, women with exactly one prior pregnancy loss <20 weeks' gestation, which occurred in the 12 months preceding enrollment; expanded, women with one or two prior pregnancy losses of any gestational age occurring any time prior to enrollment.
Among 1228 participants, there were 14 withdrawals whose last visit day was at randomization and thus were excluded from the time to pregnancy analyses.
P value represents LDA vs placebo, log rank test of cumulative pregnancy rate.