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Table 2 Baseline demographics and patient characteristics (ITT population)

From: Randomized, active-controlled, comparative phase 3 efficacy and safety equivalence trial of Ovaleap® (recombinant human follicle-stimulating hormone) in infertile women using assisted reproduction technology (ART)

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)
  1. ITT intent-to-treat, SD standard deviation, BMI body mass index, FSH follicle-stimulating hormone
  2. aMultiple causes per patient are possible