Academic Journal
A 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 |
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| Authors: | Rettenbacher, M., Andersen, A.N., Garcia-Velasco, J.A. |
| Source: | Репродуктивная эндокринология, Iss 58, Pp 118-124 (2021) Reproductive Endocrinology; No. 58 (2021); 118-124 Репродуктивная эндокринология; № 58 (2021); 118-124 Репродуктивна ендокринологія; № 58 (2021); 118-124 |
| Publisher Information: | Publishing Office TRILIST, 2021. |
| Publication Year: | 2021 |
| Subject Terms: | изъятые ооциты, стимуляція яєчників, оплодотворение in vitro, рекомбінантний фолікулостимулюючий гормон, Gynecology and obstetrics, стимуляция яичников, ICSI, oocytes retrieved, ovarian stimulation, 3. Good health, рекомбинантный фолликулостимулирующий гормон, 03 medical and health sciences, интрацитоплазматическая инъекция спермы, 0302 clinical medicine, IVF, інтрацитоплазматична ін'єкція сперми, ivf, RG1-991, запліднення in vitro, вилучені ооцити, icsi, r-FSH, r-fsh |
| Description: | 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. |
| Document Type: | Article |
| File Description: | application/pdf |
| ISSN: | 2411-1295 2309-4117 |
| DOI: | 10.18370/2309-4117.2021.58.118-124 |
| Access URL: | http://reproduct-endo.com/article/download/232940/231713 https://doaj.org/article/957e8f5399d84e5caa7f6b220bbb49a1 http://reproduct-endo.com/article/view/232940 |
| Rights: | CC BY |
| Accession Number: | edsair.doi.dedup.....6276b8cdeabc07c0eb37ea10fcc2778c |
| Database: | OpenAIRE |
| ISSN: | 24111295 23094117 |
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| DOI: | 10.18370/2309-4117.2021.58.118-124 |