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Table 3 Total Ovaleap® Dose and Duration of Stimulation and Number of Oocytes Retrieved

From: Safety and efficacy of Ovaleap® (recombinant human follicle-stimulating hormone) for up to 3 cycles in infertile women using assisted reproductive technology: a phase 3 open-label follow-up to Main Study

  

Previous Treatment in Main Study

 

Total Group

Ovaleap®

Gonal-f®

Cycle 2

N = 147

N = 80

N = 67

 Total Ovaleap® dose, IU

   

  Mean (SD)

1998 (771)

1925 (706)

2086 (840)

  Median (range)

1875 (450–4313)

1763 (1013–3750)

2025 (450–4313)

 Duration of Ovaleap® stimulation, days

   

  Mean (SD)

9.9 (1.8)

9.7 (1.8)

10.0 (1.9)

  Median (range)

10.0 (4.0–14.0)

10.0 (5.0–14.0)

10.0 (4.0–14.0)

 Number of oocytes retrieveda

  

  Mean (SD)

12.1 (5.9)

12.0 (5.8)

12.1 (6.0)

  Median (range)

11.0 (2.0–36.0)

11.0 (3.0–29.0)

11.0 (2.0–36.0)

Cycle 3

N = 61

N = 34

N = 27

 Total Ovaleap® dose, IU

   

  Mean (SD)

2113 (939)

1883 (687)

2402 (1132)

  Median (range)

1875 (750–5400)

1800 (750–3450)

2100 (788–5400)

 Duration of Ovaleap® stimulation, days

   

  Mean (SD)

9.9 (1.7)

9.6 (1.7)

10.3 (1.7)

  Median (range)

10.0 (5.0–14.0)

9.0 (5.0–13.0)

10.0 (7.0–14.0)

 Number of oocytes retrievedb

  

  Mean (SD)

13.5 (6.5)

12.3 (6.2)

15.0 (6.5)

  Median (range)

12.0 (3.0–33.0)

11.0 (3.0–30.0)

12.0 (6.0–33.0)

  1. SD standard deviation
  2. aTotal Group N = 146; Ovaleap® N = 80; Gonal-f® N = 66
  3. bTotal Group N = 60; Ovaleap® N = 33; Gonal-f® N = 27