Table IV.
Secondary and other efficacy endpoints (ITT population)
| r-hFSH/r-hLH (n = 462) | r-hFSH (n = 477) | Odds ratio* (95% CI) unless otherwise indicated | P-value | |
|---|---|---|---|---|
| Cancelled cycles,†n (%) | 35 (7.6) | 32 (6.7) | 1.12 (0.68, 1.85) | 0.654 |
| Biochemical pregnancy, n (%) | 80 (17.3) | 114 (23.9) | 0.68 (0.49, 0.94) | 0.020 |
| Clinical pregnancy, n (%) | 65 (14.1) | 80 (16.8) | 0.83 (0.58, 1.20) | 0.320 |
| Ongoing pregnancy, n (%) | 51 (11.0) | 59 (12.4) | 0.90 (0.60, 1.35) | 0.599 |
| Implantation rate, n/N (%)‡ | 79/538 (14.7) | 93/597 (15.6) | 0.93 (0.67, 1.29)§ | 0.675 |
| Live birth, n (%) | 49 (10.6) | 56 (11.7) | 0.91 (0.60, 1.38) | 0.663 |
| Total FSH dose administered (IU), mean (SD) | 3997.7 (1188.33)‖ | 4113.6 (1193.93) | –119.3 (–269.9, 31.3)§ | 0.120 |
| Number of MII oocytes in ICSI patients, mean (SD) | 2.9 (2.07)¶ | 3.1 (2.14)** | Unadjusted: –0.24 (–0.64, 0.15) | Unadjusted: 0.063 |
| Adjusted for over-dispersion: –0.24 (–0.72, 0.23) | Adjusted for over-dispersion: 0.124 |
*r-hFSH/r-hLH versus r-hFSH.
†All cycle cancellations were due to lack of ovarian response.
‡n is the number of foetal sacs identified by transvaginal ultrasound and N is the total number of embryos transferred.
§Data are mean difference between groups (95% CI).
**381 patients receiving r-hFSH underwent ICSI and data were not available for 15 of these patients.
||Data missing for 10 patients. ¶360 patients receiving r-hFSH plus r-hLH underwent ICSI, and data are not available for 13 of these patients. ITT, intention-to-treat; MII, metaphase II; r-hFSH, recombinant human FSH; r-hLH, recombinant human LH.