Table 2.
Efficacy and safety in the Chinese population
| Variable | Follitropin delta (n = 378) | Follitropin alfa (n = 381) | P-value |
|---|---|---|---|
| Gonadotropin use | |||
| Duration of stimulation (days) | 9.2 ± 1.8 | 8.8 ± 1.5 | 0.025a |
| Total dose (μg) | 76.7 ± 23.8 | 110.4 ± 31.2 | < 0.001a |
| Average daily dose (μg/day) | 8.5 ± 2.3 | 12.4 ± 1.6 | < 0.001a |
| Number of follicles at end of stimulation | |||
| Total number of follicles | 12.8 ± 5.6 | 14.2 ± 6.5 | 0.005a |
| Follicles ≥ 12 mm | 10.7 ± 5.0 | 12.0 ± 5.7 | 0.006a |
| Follicles ≥ 17 mm | 4.3 ± 1.8 | 4.5 ± 2.0 | 0.359a |
| Endocrine profile at end of stimulation | |||
| FSH (IU/l) | 11.5 | 12.4 | < 0.001b |
| LH (IU/l) | 1.7 | 1.9 | 0.011b |
| Estradiol (pmol/l) | 7001 | 9130 | < 0.001b |
| Progesterone (nmol/l) | 2.3 | 3.1 | < 0.001b |
| Progesterone > 3.18 nmol/L | 121 (32.4%) | 190 (50.7%) | < 0.001c |
| Inhibin A (ng/l) | 361.2 | 449.3 | < 0.001b |
| Inhibin B (ng/l) | 1022.6 | 1134.7 | 0.002b |
| Cancellations | |||
| Cycle cancellation | 12 (3.2%) | 5 (1.3%) | 0.085c |
| Cycle or transfer cancellation | 56 (14.8%) | 71 (18.6%) | 0.126c |
| Oocytes and embryos | |||
| Women with at least one oocyte retrieved | 364 (96.3%) | 375 (98.4%) | 0.068c |
| Oocytes retrieved (n) | 10.3 ± 6.2 | 12.5 ± 7.5 | < 0.001a |
| Fertilized oocytes (n) | 6.4 ± 4.2 | 7.7 ± 5.0 | < 0.001a |
| Fertilization rated (%) | 63.2 ± 22.8 | 62.8 ± 21.5 | 0.365a |
| Day 3 embryos (n) | 7.3 ± 4.7 | 8.8 ± 5.5 | < 0.001a |
| Day 3 good-quality embryos (n) | 4.4 ± 3.8 | 5.3 ± 4.2 | 0.002a |
| OHSS | |||
| Any OHSS | 34 (9.0%) | 36 (9.4%) | 0.764c |
| Early OHSS (any grade)e | 18 (4.8%) | 28 (7.3%) | 0.115c |
| Late OHSS (any grade)f | 16 (4.2%) | 8 (2.1%) | 0.098c |
| Preventive interventionsg for early OHSS | 6 (1.6%) | 16 (4.2%) | 0.025c |
| Early OHSS and/or preventive interventions | 23 (6.1%) | 42 (11.0%) | 0.011c |
Note: Values are means, mean ± SD, or n (%), unless otherwise stated
AMH Anti-Müllerian hormone, number of patients with observations, FSH Follicle-stimulating hormone, LH Luteinising hormone, OHSS Ovarian hyperstimulation syndrome, SD Standard deviation
aVan Elteren test adjusted for AMH group
bMultiplicative ANCOVA with treatment and AMH group as factors and the log transformed day 1 level as covariate
cLogistic regression model with treatment and AMH group as factors
dIn women with at least one oocyte retrieved
eOnset ≤ 9 days after triggering of final follicular maturation
fOnset ≥ 10 days after triggering of final follicular maturation
gPreventive interventions included cycle cancellation due to excessive ovarian response and triggering of final follicular maturation with GnRH agonist