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...
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
13 January 2015
|
| In: |
Reproductive biomedicine online
Year: 2015, Jahrgang: 30, Heft: 5, Pages: 504-513 |
| ISSN: | 1472-6491 |
| DOI: | 10.1016/j.rbmo.2015.01.005 |
| Online-Zugang: | Verlag, Volltext: http://dx.doi.org/10.1016/j.rbmo.2015.01.005 Verlag, Volltext: http://www.sciencedirect.com/science/article/pii/S1472648315000474 
|
| Verfasserangaben: | 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 |
MARC
| LEADER | 00000caa a2200000 c 4500 | ||
|---|---|---|---|
| 001 | 1558831118 | ||
| 003 | DE-627 | ||
| 005 | 20230428071126.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 170519s2015 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.rbmo.2015.01.005 |2 doi | |
| 035 | |a (DE-627)1558831118 | ||
| 035 | |a (DE-576)488831113 | ||
| 035 | |a (DE-599)BSZ488831113 | ||
| 035 | |a (OCoLC)1340975637 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 33 |2 sdnb | ||
| 100 | 1 | |a Rettenbacher, Manfred |e VerfasserIn |0 (DE-588)1132365325 |0 (DE-627)887790410 |0 (DE-576)488830915 |4 aut | |
| 245 | 1 | 2 | |a A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF |c 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 |
| 264 | 1 | |c 13 January 2015 | |
| 300 | |a 10 | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Im Titel ist "®" hochgestellt | ||
| 500 | |a Gesehen am 19.05.2017 | ||
| 520 | |a 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. | ||
| 650 | 4 | |a IVF-ICSI | |
| 650 | 4 | |a oocytes retrieved | |
| 650 | 4 | |a ovarian stimulation | |
| 650 | 4 | |a r-FSH | |
| 700 | 1 | |a Strowitzki, Thomas |d 1959- |e VerfasserIn |0 (DE-588)118055917 |0 (DE-627)079216099 |0 (DE-576)17102141X |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Reproductive biomedicine online |d Cambridge : [Verlag nicht ermittelbar], 2000 |g 30(2015), 5, Seite 504-513 |w (DE-627)334373506 |w (DE-600)2057455-1 |w (DE-576)255486855 |x 1472-6491 |7 nnas |a A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF |
| 773 | 1 | 8 | |g volume:30 |g year:2015 |g number:5 |g pages:504-513 |g extent:10 |a A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.rbmo.2015.01.005 |x Verlag |x Resolving-System |3 Volltext |
| 856 | 4 | 0 | |u http://www.sciencedirect.com/science/article/pii/S1472648315000474 |x Verlag |3 Volltext |
| 951 | |a AR | ||
| 992 | |a 20170519 | ||
| 993 | |a Article | ||
| 994 | |a 2015 | ||
| 998 | |g 118055917 |a Strowitzki, Thomas |m 118055917:Strowitzki, Thomas |d 910000 |d 910400 |e 910000PS118055917 |e 910400PS118055917 |k 0/910000/ |k 1/910000/910400/ |p 13 | ||
| 999 | |a KXP-PPN1558831118 |e 2969803801 | ||
| BIB | |a Y | ||
| SER | |a journal | ||
| JSO | |a {"person":[{"role":"aut","given":"Manfred","display":"Rettenbacher, Manfred","family":"Rettenbacher"},{"display":"Strowitzki, Thomas","family":"Strowitzki","given":"Thomas","role":"aut"}],"language":["eng"],"origin":[{"dateIssuedDisp":"13 January 2015","dateIssuedKey":"2015"}],"note":["Im Titel ist \"®\" hochgestellt","Gesehen am 19.05.2017"],"type":{"bibl":"article-journal","media":"Online-Ressource"},"title":[{"title_sort":"multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF","title":"A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF"}],"recId":"1558831118","name":{"displayForm":["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"]},"physDesc":[{"extent":"10 S."}],"relHost":[{"id":{"eki":["334373506"],"issn":["1472-6491"],"zdb":["2057455-1"]},"pubHistory":["1.2000 -"],"recId":"334373506","note":["Gesehen am 21.02.20"],"origin":[{"publisherPlace":"Cambridge ; [Erscheinungsort nicht ermittelbar]","dateIssuedDisp":"2000-","dateIssuedKey":"2000","publisher":"[Verlag nicht ermittelbar] ; Elsevier"}],"titleAlt":[{"title":"RBM online"}],"type":{"bibl":"periodical","media":"Online-Ressource"},"title":[{"subtitle":"RBM online ; an international journal devoted to rapid publication of peer-reviewed biomedical research on human conception and the human embryo","title_sort":"Reproductive biomedicine online","title":"Reproductive biomedicine online"}],"part":{"issue":"5","year":"2015","text":"30(2015), 5, Seite 504-513","pages":"504-513","extent":"10","volume":"30"},"language":["eng"],"disp":"A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVFReproductive biomedicine online"}],"id":{"doi":["10.1016/j.rbmo.2015.01.005"],"eki":["1558831118"]}} | ||
| SRT | |a RETTENBACHMULTICENTR1320 | ||