Table 2.
Time to Pregnancy for Both hCG Detected and Clinically Confirmed Pregnancy by Treatment Arm and Eligibility Stratum in the EAGeR Trial
| hCG Detected Pregnancya |
Clinically Confirmed Pregnancyb |
|||||
|---|---|---|---|---|---|---|
| LDA | Placebo | P Value | LDA | Placebo | P Value | |
| No. Participants Randomized | 615 | 613 | 615 | 613 | ||
| Intention-to-treat populationc | ||||||
| OVERALL | ||||||
| No. of participants | 608 | 606 | 608 | 606 | ||
| Achieved pregnancy - No. (%) | 410 (67) | 382 (63) | 378 (62) | 350 (58) | ||
| Median TTP (95% CI) | 3 (3, 4) | 4 (3, 4) | .11 | 4 (3, 4) | 4 (4, 4) | .13 |
| Fecundability Odds Ratio (95% CI) | 1.14 (0.97, 1.33) | 1.13 (0.96, 1.33) | ||||
| ORIGINAL | ||||||
| No. of participants | 272 | 269 | 272 | 269 | ||
| Achieved pregnancy - No. (%) | 196 (72) | 173 (64) | 183 (67) | 160 (59) | ||
| Median TTP (95% CI) | 3 (3, 3) | 4 (3, 4) | .03 | 3 (3, 4) | 4 (3, 5) | .04 |
| Fecundability Odds Ratio (95% CI) | 1.28 (1.02, 1.62) | 1.29 (1.02, 1.63) | ||||
| EXPANDED | ||||||
| No. of participants | 336 | 337 | 336 | 337 | ||
| Achieved pregnancy - No. (%) | 214 (64) | 209 (62) | 195 (58) | 190 (56) | ||
| Median TTP (95% CI) | 4 (3, 4) | 4 (3, 4) | .79 | 4 (4, 5) | 4 (3, 5) | .92 |
| Fecundability Odds Ratio (95% CI) | 1.03 (0.83, 1.27) | 1.01 (0.81, 1.26) | ||||
Analyses performed using Cox proportional hazards models for discrete survival time. Women not achieving pregnancy within 6 cycles were censored as a TTP = 6, while women who withdrew early from the trial, and who did not achieve pregnancy, were censored at the date of withdrawal. 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 not eligible for the original stratum, and with one or two prior pregnancy losses of any gestational age occurring any time prior to enrollment.
Pregnancy identified by hCG positive pregnancy test or from augmented hCG testing of spot and daily urine samples.
Pregnancy identified by 6.5-week ultrasound.
Among 1228 participants, there were 14 withdrawals, whose last visit day was at randomization leaving no observable time “at risk” of pregnancy; thus, these women were excluded from the TTP analyses leaving 1214 women (608 LDA, 606 placebo) included in the TTP analyses.