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

  • Rettenbacher M Finox AG, Burgdorf, Switzerland. Electronic address: manfred.rettenbacher@finox.ch.
  • Andersen AN Rigshospitalet, Copenhagen University Hospital, Fertility Clinic, Copenhagen, Denmark.
  • Garcia-Velasco JA IVI Madrid, Madrid, Spain.
  • Sator M Fertilitätszentrum Döbling and AKH, Wien, Austria.
  • Barri P Institut Universitari Dexeus, Barcelona, Spain.
  • Lindenberg S Copenhagen Fertility Center, Copenhagen, Denmark.
  • van der Ven K Universitätsklinikum Bonn, Bonn, Germany.
  • Khalaf Y Guy's and St Thomas' NHS Foundation Trust, London, UK.
  • Bentin-Ley U Dansk Fertilitetsklinik, Copenhagen, Denmark.
  • Obruca A Kinderwunschzentrum Privatspital Goldenes Kreuz, Wien, Austria.
  • Tews G Landes-Frauenklinik und Kinderklinik, Linz, Austria.
  • Schenk M Das Kinderwunsch Institut, Dobl bei Graz, Austria.
  • Strowitzki T Universtitäts-Frauenklinik, Heidelberg, Germany.
  • Narvekar N Assisted Conception Unit Kings College Hospital, London, UK.
  • Sator K Fertilitätszentrum Döbling, Wien, Austria.
  • Imthurn B Universitätsspital Zürich, Switzerland.
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  • 2015-03-05
Published in:
  • Reproductive biomedicine online. - 2015
IVF-ICSI
oocytes retrieved
ovarian stimulation
r-FSH
Female
Fertilization in Vitro
Humans
Ovulation Induction
English 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.
Language
  • English
Open access status
hybrid
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https://sonar.ch/global/documents/211947
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