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Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Rettenbacher, M; Andersen, AN; Garcia-Velasco, JA; 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.
A multi-centre phase 3 study comparing efficacy and safety of Bemfola(®) versus Gonal-f(®) in women undergoing ovarian stimulation for IVF.
Reprod Biomed Online. 2015; 30(5):504-513
Doi: 10.1016/j.rbmo.2015.01.005
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- Co-authors Med Uni Graz
- Schenk Michael
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- 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. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.
- Find related publications in this database (using NLM MeSH Indexing)
- Female -
- Fertilization in Vitro -
- Humans -
- Ovulation Induction - methods
- Find related publications in this database (Keywords)
- IVF-ICSI
- oocytes retrieved
- ovarian stimulation
- r-FSH