Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

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

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

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 2015, 'A multi-centre phase 3 study comparing efficacy and safety of Bemfola(®) versus Gonal-f(®) in women undergoing ovarian stimulation for IVF', Reproductive BioMedicine Online, vol. 30, no. 5, pp. 504-13. https://doi.org/10.1016/j.rbmo.2015.01.005

APA

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. (2015). A multi-centre phase 3 study comparing efficacy and safety of Bemfola(®) versus Gonal-f(®) in women undergoing ovarian stimulation for IVF. Reproductive BioMedicine Online, 30(5), 504-13. https://doi.org/10.1016/j.rbmo.2015.01.005

CBE

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. 2015. A multi-centre phase 3 study comparing efficacy and safety of Bemfola(®) versus Gonal-f(®) in women undergoing ovarian stimulation for IVF. Reproductive BioMedicine Online. 30(5):504-13. https://doi.org/10.1016/j.rbmo.2015.01.005

MLA

Vancouver

Author

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. / A multi-centre phase 3 study comparing efficacy and safety of Bemfola(®) versus Gonal-f(®) in women undergoing ovarian stimulation for IVF. In: Reproductive BioMedicine Online. 2015 ; Vol. 30, No. 5. pp. 504-13.

Bibtex

@article{388f67cb596d4fb382048733f07027e6,
title = "A multi-centre phase 3 study comparing efficacy and safety of Bemfola({\textregistered}) versus Gonal-f({\textregistered}) 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 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.",
author = "M Rettenbacher and Andersen, {A N} and Garcia-Velasco, {J A} and M Sator and P Barri and S Lindenberg and {van der Ven}, K and Y Khalaf and U Bentin-Ley and A Obruca and G Tews and M Schenk and T Strowitzki and N Narvekar and K Sator and B Imthurn",
note = "Copyright {\textcopyright} 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.",
year = "2015",
month = may,
doi = "10.1016/j.rbmo.2015.01.005",
language = "English",
volume = "30",
pages = "504--13",
journal = "Reproductive BioMedicine Online",
issn = "1472-6483",
publisher = "Reproductive Healthcare Ltd",
number = "5",

}

RIS

TY - JOUR

T1 - A multi-centre phase 3 study comparing efficacy and safety of Bemfola(®) versus Gonal-f(®) in women undergoing ovarian stimulation for IVF

AU - Rettenbacher, M

AU - Andersen, A N

AU - Garcia-Velasco, J A

AU - Sator, M

AU - Barri, P

AU - Lindenberg, S

AU - van der Ven, K

AU - Khalaf, Y

AU - Bentin-Ley, U

AU - Obruca, A

AU - Tews, G

AU - Schenk, M

AU - Strowitzki, T

AU - Narvekar, N

AU - Sator, K

AU - Imthurn, B

N1 - Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

PY - 2015/5

Y1 - 2015/5

N2 - 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.

AB - 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.

U2 - 10.1016/j.rbmo.2015.01.005

DO - 10.1016/j.rbmo.2015.01.005

M3 - Journal article

C2 - 25735918

VL - 30

SP - 504

EP - 513

JO - Reproductive BioMedicine Online

JF - Reproductive BioMedicine Online

SN - 1472-6483

IS - 5

ER -

ID: 46175828