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Reprod Biomed Online. 2015 May;30(5):504-13. doi: 10.1016/j.rbmo.2015.01.005. Epub 2015 Jan 27.

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

Author information

1
Finox AG, Burgdorf, Switzerland. Electronic address: manfred.rettenbacher@finox.ch.
2
Rigshospitalet, Copenhagen University Hospital, Fertility Clinic, Copenhagen, Denmark.
3
IVI Madrid, Madrid, Spain.
4
Fertilitätszentrum Döbling and AKH, Wien, Austria.
5
Institut Universitari Dexeus, Barcelona, Spain.
6
Copenhagen Fertility Center, Copenhagen, Denmark.
7
Universitätsklinikum Bonn, Bonn, Germany.
8
Guy's and St Thomas' NHS Foundation Trust, London, UK.
9
Dansk Fertilitetsklinik, Copenhagen, Denmark.
10
Kinderwunschzentrum Privatspital Goldenes Kreuz, Wien, Austria.
11
Landes-Frauenklinik und Kinderklinik, Linz, Austria.
12
Das Kinderwunsch Institut, Dobl bei Graz, Austria.
13
Universtitäts-Frauenklinik, Heidelberg, Germany.
14
Assisted Conception Unit Kings College Hospital, London, UK.
15
Fertilitätszentrum Döbling, Wien, Austria.
16
Universitätsspital Zürich, Switzerland.

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.

KEYWORDS:

IVF-ICSI; oocytes retrieved; ovarian stimulation; r-FSH

PMID:
25735918
DOI:
10.1016/j.rbmo.2015.01.005
[Indexed for MEDLINE]
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