Table II.
Outcomes of the ITT and the PP analysis.
| Flushing group | Aspiration only group | Mantel–Haenzel risk difference (% [95% CI]) † | P-value | |
|---|---|---|---|---|
| n (%) | n (%) | |||
| ITT analysis | n = 83 | n = 81 | ||
| Retrieved oocytes | 69 (83) | 51 (63) | 20.6 [7.1, 33.2] | 0.005 |
| Mature oocytes (MII) | 64 (77) | 48 (59) | 18.2 [3.9, 31.7] | 0.02 |
| Fertilization | 53 (64) | 38 (47) | 16.9 [1.5, 31.5] | 0.05 |
| Embryo transfers (transfer rate) | 52 (63) | 38 (47) | 15.7 [0.3, 30.4] | 0.06 |
| Implantation rate | 12 (15) | 10 (12) | 1.9 [−8.4, 12.1] | 0.89 |
| Clinical pregnancies/cycle | 9 (11) | 9 (11) | −0.5 [−9.9, 9.0] | 0.93 |
| Live birth/cycle** | 7 (8) | 8 (10) | −1.66 [−10.4, 7.1] | 0.72 |
| n = 52 | n = 38 | |||
| Clinical pregnancies/transfer* | 9 (17) | 9 (24) | −7.9 [−24.5, 8.8] | 0.51 |
| Live birth/transfer* | 7 (14) | 8 (21) | −9.1 [−24.7, 6.5] | 0.38 |
| PP analysis | n = 81 | n = 78 | ||
| Retrieved oocytes | 67 (83) | 49 (63) | 20.7 [7, 33.4] | 0.006 |
| Mature oocytes (MII) | 63 (78) | 46 (59) | 19.4 [4.8, 33] | 0.015 |
| Fertilization | 52 (64) | 36 (46) | 18.2 [2.6, 32.9] | 0.033 |
| Embryo transfers (transfer rate) | 51 (63) | 36 (46) | 17 [1.3, 31.8] | 0.048 |
| Implantation rate | 12 (15) | 10 (13) | 2.1 [−8.6, 12.6] | 0.88 |
| Clinical pregnancies/cycle | 9 (11) | 9 (12) | −0.4 [−10.2, 9.4] | 0.94 |
| Live birth/cycle** | 7 (9) | 8 (10) | −1.6 [−10.6, 7.4] | 0.70 |
| n = 51 | n = 36 | |||
| Clinical pregnancies/transfer* | 9 (18) | 9 (25) | −8.4 [−25.9, 9.0] | 0.49 |
| Live birth/transfer* | 7 (14) | 8 (22) | −9.5 [−25.9, 6.8] | 0.38 |
ITT, intention-to-treat; MII, metaphase II; PP, per-protocol.
*
Implantation rate per transfer is based on the subset analysis of women having had an embryo transfer.
**
Live birth rate per initiated cycle is part of the post hoc analysis.
†
With flushing—aspiration only, stratified for age and stimulation protocol.