Table 1.
Demographics and baseline characteristics of study population
| Characteristics | Follitropin delta group (n = 378) | Follitropin alfa group (n = 381) |
|---|---|---|
| Age (years) | 30.6 ± 3.6 | 30.8 ± 3.6 |
| < 35 | 312 (82.5%) | 313 (82.2%) |
| 35–37 | 55 (14.6%) | 52 (13.6%) |
| 38–40 | 11 (2.9%) | 16 (4.2%) |
| Body weight (kg) | 56.0 ± 8.0 | 56.5 ± 7.9 |
| BMI (kg/m2) | 21.8 ± 2.7 | 22.0 ± 2.8 |
| Infertility history | ||
| Duration of infertility (months) | 42.2 ± 24.4 | 45.3 ± 28.2 |
| Primary infertility | 244 (64.6%) | 223 (58.5%) |
| Reason for infertility | ||
| Unexplained infertility | 74 (19.6%) | 66 (17.3%) |
| Tubal infertility | 197 (52.1%) | 204 (53.5%) |
| Male factor | 98 (25.9%) | 106 (27.8%) |
| Endometriosis stage I/II | 5 (1.3%) | 2 (0.5%) |
| Other | 4 (1.1%) | 3 (0.8%) |
| Endometrial thickness (mm) | 6.1 ± 2.2 | 6.1 ± 2.1 |
| Ovarian volume (cm3) | 5.0 ± 2.2 | 4.9 ± 2.5 |
| AFCa | 15.4 ± 6.2 | 15.0 ± 5.6 |
| Endocrine profileb | ||
| AMH (pmol/l)c | 25.9 ± 13.6 | 26.1 ± 16.1 |
| AMH < 15 pmol/l | 77 (20.4%) | 86 (22.6%) |
| AMH ≥ 15 pmol/l | 301 (79.6%) | 295 (77.4%) |
| FSH (IU/l) | 7.3 (6.1–8.5) | 7.2 (6.2–8.2) |
| LH (IU/l) | 3.7 (2.9–4.8) | 3.7 (2.8–4.9) |
| Estradiol (pmol/l) | 140 (113.1–164.5) | 142.2 (112.1–176.4) |
| Progesterone (nmol/L) | 0.8 (0.8–2.1) | 0.8 (0.8–2.1) |
| Inhibin A (ng/L) | 5.0 (4.0–6.5) | 5.3 (4.0–6.5) |
| Inhibin B (ng/L) | 81.0 (62.0–101.5) | 82.0 (67.0–101.0) |
| Algorithmic dose (µg/day)d | 8.5 ± 2.3 | 8.8 ± 2.4 |
Note: Values are means ± SD, median (25%-75% percentiles) or n (%), unless otherwise stated. Data are for all patients unless otherwise stated
AFC Antral follicle count, AMH Anti-Müllerian hormone, BMI Body mass index, FSH Follicle-stimulating hormone, LH Luteinising hormone, n number of patients with observations, SD Standard deviation
aThis measurement reports the total number of antral follicles with a diameter of ≥ 2 mm for both ovaries combined, assessed by transvaginal ultrasound at the day of starting ovarian stimulation
bThe AMH values are based on the screening samples, while the remining endocrine parameters are based on the samples taken on stimulation day 1 before start of stimulation
cThe serum concentration of AMH was assessed by a central laboratory using the Elecsys® AMH Plus immunoassay from Roche Diagnostics
dThe algorithmic dose is the calculated using the follitropin delta algorithm based on the serum AMH concentration at screening and the body weight at randomization. The µg dose is rounded to the nearest 1/3 µg and applying a minimum dose of 6 µg and a maximum dose of 12 µg