Table 3.
Efficacy and safety in the Chinese population by AMH group
| Variable | AMH < 15 pmol/L | AMH ≥ 15 pmol/L | ||||
|---|---|---|---|---|---|---|
| Follitropin delta (n = 77) | Follitropin alfa (n = 86) | P-value | Follitropin delta (n = 301) | Follitropin alfa (n = 295) | P-value | |
| Gonadotropin use | ||||||
| Duration of stimulation (days) | 8.8 ± 1.4 | 8.6 ± 1.6 | 0.309a | 9.2 ± 1.9 | 8.9 ± 1.5 | 0.047a |
| Total dose (μg) | 105.8 ± 16.7 | 110.2 ± 33.5 | 0.568a | 69.2 ± 19.2 | 110.4 ± 30.6 | < 0.001a |
| Average daily dose (μg/day) | 12.0 ± 0.0 | 12.6 ± 1.7 | 0.279a | 7.5 ± 1.7 | 12.3 ± 1.6 | < 0.001a |
| Number of follicles at end of stimulation | ||||||
| Total number of follicles | 10.3 ± 4.3 | 9.6 ± 4.4 | 0.302a | 13.4 ± 5.8 | 15.6 ± 6.4 | < 0.001a |
| Follicles ≥ 12 mm | 8.8 ± 4.0 | 8.1 ± 4.1 | 0.238a | 11.2 ± 5.2 | 13.1 ± 5.6 | < 0.001a |
| Follicles ≥ 17 mm | 4.0 ± 1.4 | 3.8 ± 1.3 | 0.309a | 4.3 ± 1.9 | 4.7 ± 2.1 | 0.119a |
| Endocrine profile at end of stimulation | ||||||
| FSH (IU/l) | 17.0 | 13.3 | < 0.001b | 10.4 | 12.1 | < 0.001b |
| LH (IU/l) | 2.0 | 2.3 | 0.124b | 1.6 | 1.8 | 0.036b |
| Estradiol (pmol/l) | 6898 | 6239 | 0.179b | 7029 | 10,204 | < 0.001b |
| Progesterone (nmol/l) | 3.1 | 2.7 | 0.215b | 2.2 | 3.2 | < 0.001b |
| Progesterone > 3.18 nmol/L | 42 (54.5%) | 39 (45.9%) | 0.345c | 79 (26.6%) | 151 (52.1%) | < 0.001c |
| Inhibin A (ng/l) | 341.3 | 310.2 | 0.159b | 366.6 | 500.8 | < 0.001b |
| Inhibin B (ng/l) | 654.3 | 658.0 | 0.788b | 1153.0 | 1320.2 | < 0.001b |
| Cancellations | ||||||
| Cycle cancellation | 0 (0.0%) | 1 (1.2%) | 1.000c | 12 (4.0%) | 4 (1.4%) | 0.073c |
| Cycle or transfer cancellation | 6 (7.8%) | 5 (5.8%) | 0.757c | 50 (16.6%) | 66 (22.4%) | 0.079c |
| Oocytes and embryos | ||||||
| Women with at least one oocyte retrieved | 76 (98.7%) | 85 (98.8%) | 1.000c | 288 (95.7%) | 290 (98.3%) | 0.092c |
| Oocytes retrieved (n) | 9.2 ± 4.9 | 7.7 ± 3.6 | 0.068a | 10.5 ± 6.4 | 13.9 ± 7.8 | < 0.001b |
| Fertilized oocytes (n) | 6.0 ± 3.3 | 5.0 ± 2.9 | 0.057a | 6.4 ± 4.5 | 8.5 ± 5.2 | < 0.001a |
| Fertilization rated (%) | 66.0 ± 21.6 | 66.3 ± 22.9 | 0.914a | 62.5 ± 23.2 | 61.8 ± 21.1 | 0.280a |
| Day 3 embryos (n) | 6.9 ± 3.8 | 5.7 ± 3.0 | 0.070a | 7.4 ± 4.9 | 9.7 ± 5.7 | < 0.001a |
| Day 3 good-quality embryos (n) | 3.6 ± 2.9 | 3.4 ± 2.3 | 0.800a | 4.6 ± 3.9 | 5.9 ± 4.5 | < 0.001a |
| OHSS | ||||||
| Any OHSS | 4 (5.2%) | 1 (1.2%) | 0.190c | 30 (10.0%) | 35 (11.9%) | 0.512c |
| Early OHSS (any grade)e | 3 (3.9%) | 0 (0.0%) | 0.103c | 15 (5.0%) | 28 (9.5%) | 0.039c |
| Late OHSS (any grade)f | 1 (1.3%) | 1 (1.2%) | 1.000c | 15 (5.0%) | 7 (2.4%) | 0.127c |
| Preventive interventionsg for early OHSS | 0 (0.0%) | 1 (1.2%) | 1.000c | 6 (2.0%) | 15 (5.1%) | 0.047c |
| Early OHSS and/or preventive interventions | 3 (3.9%) | 1 (1.2%) | 0.345c | 20 (6.6%) | 41 (13.9%) | 0.004c |
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
aWilcoxon test
bMultiplicative ANCOVA with treatment as factor and the log transformed day 1 level as covariate
cFishers exact test
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