Skip to main content

Table 3 Secondary outcomes related to r-hFSH dosing (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) Odds Ratio (95 % CI) P-value
Total r-hFSH dose, IU, mean (SD) 1536 (496) 1614 (485) N/A 0.065
Dose adaptation, n (%)     
 Total 78 (51.0) 85 (58.2) 0.75 (0.47–1.18) 0.215
 Dose increase 55 (35.9) 63 (43.2) 0.74 (0.47–1.18) 0.202
 Dose decrease 23 (15.0) 22 (15.1) 1.02 (0.52–1.98) 0.964
Duration of r-hFSH stimulation, days     
 Mean (SD) 9.3 (1.8) 9.7 (1.6) N/A 0.131
 Median (range) 9 (5–16) 10 (6–16)   
  1. r-hFSH recombinant human follicle stimulating hormone, SD standard deviation, N/A not applicable