A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF
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 in...
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Article (Journal) |
| Language: | English |
| Published: |
13 January 2015
|
| In: |
Reproductive biomedicine online
Year: 2015, Volume: 30, Issue: 5, Pages: 504-513 |
| ISSN: | 1472-6491 |
| DOI: | 10.1016/j.rbmo.2015.01.005 |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1016/j.rbmo.2015.01.005 Verlag, Volltext: http://www.sciencedirect.com/science/article/pii/S1472648315000474 
|
| Author Notes: | M. Rettenbacher, A.N. Andersen, J.A. Garcia-Velasco, M. Sator, P. Barri, S. Lindenberg, K. van der Ven, Y. Khalaf, U. Bentin-Ley, A. Obruca, G. Tews, M. Schenk, T. Strowitzki, N. Narvekar, K. Sator, B. Imthurn |
| Summary: | 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. |
|---|---|
| Item Description: | Im Titel ist "®" hochgestellt Gesehen am 19.05.2017 |
| Physical Description: | Online Resource |
| ISSN: | 1472-6491 |
| DOI: | 10.1016/j.rbmo.2015.01.005 |