Table 2 Baseline demographics and patient characteristics (ITT population)
Characteristic | Ovaleap® (n = 153) | Gonal-f® (n = 146) |
|---|---|---|
Age, years, mean (SD) | 31.6 (3.1) | 31.7 (3.2) |
Age, n (%) | ||
< 30 years | 35 (22.9) | 36 (24.7) |
30 to 34 years | 93 (60.8) | 75 (51.4) |
> 34 years | 25 (16.3) | 35 (24.0) |
Weight, kg, mean (SD) | 63.8 (10.2) | 63.1 (9.2) |
BMI, kg/m2, mean (SD) | 22.8 (2.9) | 22.6 (2.9) |
Smoker, n (%) | 18 (11.8) | 19 (13.0) |
Alcohol consumption, n (%) | 33 (21.6) | 23 (15.8) |
Duration of infertility, in months at baseline, mean (SD) | 43.6 (26.2) | 46.6 (29.0) |
Causes of infertilitya, n (%) | ||
Male factor | 86 (56.2) | 77 (52.7) |
Idiopathic | 39 (25.5) | 41 (28.1) |
Tubal factor | 26 (17.0) | 30 (20.5) |
Endometriosis | 10 (6.5) | 10 (6.8) |
Other | 6 (3.9) | 10 (6.8) |
Pregnancy history, n (%) | ||
Previous pregnancy | 45 (29.4) | 51 (34.9) |
Previous miscarriage | 22 (14.4) | 35 (24.0) |
Previous still birth | 4 (2.6) | 1 (0.7) |
Previous live birth | 27 (17.6) | 20 (13.7) |
Total ovarian volume, mL | ||
Mean (SD) | 19.0 (50.7) | 15.5 (11.8) |
Median | 12.0 | 12.6 |
Basal antral follicles ≥ 5 mm, mean (SD) | n = 153 | n = 145 |
Right ovary | 5.3 (3.4) | 5.2 (4.3) |
Left ovary | 5.0 (3.2) | 4.8 (4.3) |
Basal FSH levels, mU/mL, mean (SD) | 7.0 (1.6) | 7.3 (2.3) |