A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF

Abstract Bemfola (follitropin alfa) (Finox AG, Switzerland), a new recombinant FSH, has a comparable pharmacological profile to that of Gonal-f (Merck Serono, Germany), the current standard for ovarian stimulation. A randomized, multi-centre, Phase 3 study in women undergoing IVF or intracytoplasmic...

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Published in:Reproductive biomedicine online 2015-05, Vol.30 (5), p.504-513
Main Authors: Rettenbacher, M, Andersen, A.N, Garcia-Velasco, J.A, Sator, M, Barri, P, Lindenberg, S, van der Ven, K, Khalaf, Y, Bentin-Ley, U, Obruca, A, Tews, G, Schenk, M, Strowitzki, T, Narvekar, N, Sator, K, Imthurn, B
Format: Article
Language:English
Subjects:
Female
Fertilization in Vitro
Humans
IVF-ICSI
Obstetrics and Gynecology
oocytes retrieved
ovarian stimulation
Ovulation Induction - methods
r-FSH
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Summary:Abstract Bemfola (follitropin alfa) (Finox AG, Switzerland), a new recombinant FSH, has a comparable pharmacological profile to that of Gonal-f (Merck Serono, Germany), the current standard for ovarian stimulation. A randomized, multi-centre, Phase 3 study in women undergoing IVF or intracytoplasmic sperm injection ( n = 372) showed Bemfola yielding similar efficacy and safety profiles to Gonal-f. Women aged 20–38 years of age were randomized 2:1 to receive a single, daily, subcutaneous 150 IU dose of either Bemfola or Gonal-f. This study tested equivalence in the number of retrieved oocytes using a pre-determined clinical equivalence margin of ±2.9 oocytes. Compared with Gonal-f, Bemfola treatment resulted in a statistically equivalent number of retrieved oocytes (Bemfola 10.8 ± 5.11 versus Gonal-f 10.6 ± 6.06, mean difference: 0.27 oocytes, 95% confidence interval: −1.34, 1.32) as well as a similar clinical pregnancy rate per embryo transfer in first and second cycles (Bemfola: 40.2% and 38.5%, respectively; Gonal-f: 48.2% and 27.8%, respectively). No difference in severe ovarian hyperstimulation syndrome was observed between treatment groups (Bemfola: 0.8%; Gonal-f: 0.8%). This study demonstrates similar clinical efficacy and safety profiles between Bemfola and Gonal-f, and suggests that Bemfola can be an appropriate alternative in ovarian stimulation protocols.
ISSN:1472-6483
1472-6491
DOI:10.1016/j.rbmo.2015.01.005