Clinical efficacy of follitropin alfa in GnRH-antagonist protocols: A prospective observational phase IV study on the use of biosimilar follitropin alfa r-hFSH in assisted reproductive technology in a routine care setting

Georg Griesinger; Thilo Schill; Michael Sator; Michael Schenk; Jan Steffen Krüssel

doi:10.18502/jri.v22i2.5798

Clinical efficacy of follitropin alfa in GnRH-antagonist protocols: A prospective observational phase IV study on the use of biosimilar follitropin alfa r-hFSH in assisted reproductive technology in a routine care setting

Georg Griesinger^*, Thilo Schill, Michael Sator, Michael Schenk, Jan Steffen Krüssel

^*Corresponding author for this work

Department of Gynecology and Obstetrics

University of Düsseldorf

7 Citations (Scopus)

Abstract

Background: This phase IV routine care study evaluated ovarian responses when using a biosimilar follitropin alfa r-hFSH (Bemfola^®) for controlled ovarian stimulation (COS) in women undergoing assisted reproductive technology (ART) treatment who were pituitary-suppressed with a gonadotrophin-releasing hormone (GnRH) antagonist. Methods: This multicenter, prospective, non-comparative, non-interventional study (Germany/Austria) was conducted with 885 women (Mean age of 34.0±4.4 years) for whom COS with Bemfola^® and GnRH-antagonist for pituitary suppression were applied as part of in vitro fertilization (IVF) treatment with/without intracytoplasmic sperm injection (ICSI) observing routine clinical-practice protocols. Primary endpoint was the number of retrieved cumulus-oocyte-complexes (COCs). Results: Among 986 ART cycles, COS was given for 9.9±1.8 days (First-day r-hFSH dose of 220.7±68.9 IU; mean total dose of 2184.3±837.5 IU). It was revealed that 99.1% of cycles resulted in follicular puncture, with mean of 10.7±6.6 oocytes retrieved. Successful fertilization took place after IVF/ICSI in 93.8% of follicular punctures. Freeze-all was performed in 14.2% of cycles. Fresh embryo transfer was performed in 76.9% of cycles with follicular puncture; mean day of transfer was 3.5±1.3 and average number of transferred embryos was 1.76±0.50. Clinical pregnancy rate was 30.2% of embryo-transfer cycles and 23.4% of started cycles. Sixty-nine reports of ovarian hyperstimulation syndrome (7.0% of started cycles) were documented. Conclusion: COS with Bemfola^® in GnRH-antagonist IVF/ICSI protocols in a routine care setting led to an appropriate ovarian response allowing oocyte retrieval in 99.1% of initiated cases.

Original language	English
Journal	Journal of Reproduction and Infertility
Volume	22
Issue number	2
Pages (from-to)	116-124
Number of pages	9
ISSN	2228-5482
DOIs	https://doi.org/10.18502/jri.v22i2.5798
Publication status	Published - 04.2021

Funding

This study was sponsored by Gedeon Richter, Germany and prepared in line with Good Publishing Practice-3 (GPP-3) recommendations. The authors thank Drs Kathy Croom, Steve Clissold and Peter Weber (Content Ed Net, Germany) for editorial support. The authors also thank the Bem-fola® Study group listed below for their contribution, and without whose help this publication would not be possible: Tim Cordes and Andreas Thiemann (Kinderwunschzentrum Altonaer Stras-se, Hamburg); Stefan Dieterle (Kinderwunschzen-trum, Dortmund); Georg Griesinger (Universitäres Kinderwunschzentrum UKSH, Lübeck); Jörg Hennefründ and Saskia Katmann (Tagesklinik, Oldenburg); Swetlana Hoffmann (MVZ für Gy-näkologie Helle-Mitte, Berlin); Axel Kamischke, Alexander Niehoff, Kathrin Reinermann and Sandra Weis (MVZ Kinderwunschzentrum, Münster); Thomas Katzorke (Novum Zentrum für Repro-duktionsmedizin, Essen); Jan-Steffen Krüssel and Barbara Mikat-Drozdzynski (UniKid UKD, Düs-seldorf); Dieter B. Mayer-Eichberger (Kinder-wunschpraxis Villa Haag, Stuttgart); Daniel Noss and Julia Bauer (MVZ Reproduktionsmedizin, München); Kazem Nouri and Sabine Hauer (Uni-versitätsklinik für Frauenheilkunde, Wien); Hans-Ulrich Pauer (Kinderwunschzentrum an der Oper, München); Gerhard Pohlig (Team Kinderwunsch, Oldenburg); Rainer Rau (Kinderwunschzentrum, Aalen); Michael Sator (Kinderwunsch im Zen-trum, Tulln a. d. Donau); Michael Schenk and Gregor Weiss (Kinderwunschinstitut, Dobl b. Graz); Thilo Schill (MVZ Kinderwunschzentrum, Langenhagen); Bernd Seifert and Tanja Ignatov (MVZ KITZ, Regensburg); Michael Sommergru-ber, Martina Kusmitsch and Vlatka Tomic (Uni-klinikum, Salzburg); Erwin Strehler (Praxisklinik Frauenstrasse, Ulm); Sascha Tauchert (IVF Saar, Saarbrücken); Sören von Otte (Universitäres Kin-derwunschzentrum, Kiel); Volker Ziller (Uniklini-kum, Marburg).

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Research Areas and Centers

Centers: Center for Pre-Implantation Diagnostics (PID)

Access to Document

10.18502/jri.v22i2.5798

Fingerprint

Dive into the research topics of 'Clinical efficacy of follitropin alfa in GnRH-antagonist protocols: A prospective observational phase IV study on the use of biosimilar follitropin alfa r-hFSH in assisted reproductive technology in a routine care setting'. Together they form a unique fingerprint.

Cite this

Griesinger, G., Schill, T., Sator, M., Schenk, M., & Krüssel, J. S. (2021). Clinical efficacy of follitropin alfa in GnRH-antagonist protocols: A prospective observational phase IV study on the use of biosimilar follitropin alfa r-hFSH in assisted reproductive technology in a routine care setting. Journal of Reproduction and Infertility, 22(2), 116-124. https://doi.org/10.18502/jri.v22i2.5798

@article{cdbce8fa9b834cd7b22e6966d63d1c53,

title = "Clinical efficacy of follitropin alfa in GnRH-antagonist protocols: A prospective observational phase IV study on the use of biosimilar follitropin alfa r-hFSH in assisted reproductive technology in a routine care setting",

abstract = "Background: This phase IV routine care study evaluated ovarian responses when using a biosimilar follitropin alfa r-hFSH (Bemfola{\textregistered}) for controlled ovarian stimulation (COS) in women undergoing assisted reproductive technology (ART) treatment who were pituitary-suppressed with a gonadotrophin-releasing hormone (GnRH) antagonist. Methods: This multicenter, prospective, non-comparative, non-interventional study (Germany/Austria) was conducted with 885 women (Mean age of 34.0±4.4 years) for whom COS with Bemfola{\textregistered} and GnRH-antagonist for pituitary suppression were applied as part of in vitro fertilization (IVF) treatment with/without intracytoplasmic sperm injection (ICSI) observing routine clinical-practice protocols. Primary endpoint was the number of retrieved cumulus-oocyte-complexes (COCs). Results: Among 986 ART cycles, COS was given for 9.9±1.8 days (First-day r-hFSH dose of 220.7±68.9 IU; mean total dose of 2184.3±837.5 IU). It was revealed that 99.1\% of cycles resulted in follicular puncture, with mean of 10.7±6.6 oocytes retrieved. Successful fertilization took place after IVF/ICSI in 93.8\% of follicular punctures. Freeze-all was performed in 14.2\% of cycles. Fresh embryo transfer was performed in 76.9\% of cycles with follicular puncture; mean day of transfer was 3.5±1.3 and average number of transferred embryos was 1.76±0.50. Clinical pregnancy rate was 30.2\% of embryo-transfer cycles and 23.4\% of started cycles. Sixty-nine reports of ovarian hyperstimulation syndrome (7.0\% of started cycles) were documented. Conclusion: COS with Bemfola{\textregistered} in GnRH-antagonist IVF/ICSI protocols in a routine care setting led to an appropriate ovarian response allowing oocyte retrieval in 99.1\% of initiated cases.",

author = "Georg Griesinger and Thilo Schill and Michael Sator and Michael Schenk and Kr{\"u}ssel, \{Jan Steffen\}",

year = "2021",

month = apr,

doi = "10.18502/jri.v22i2.5798",

language = "English",

volume = "22",

pages = "116--124",

journal = "Journal of Reproduction and Infertility",

issn = "2228-5482",

publisher = "Avicenna Research Institute",

number = "2",

}

Griesinger, G, Schill, T, Sator, M, Schenk, M & Krüssel, JS 2021, 'Clinical efficacy of follitropin alfa in GnRH-antagonist protocols: A prospective observational phase IV study on the use of biosimilar follitropin alfa r-hFSH in assisted reproductive technology in a routine care setting', Journal of Reproduction and Infertility, vol. 22, no. 2, pp. 116-124. https://doi.org/10.18502/jri.v22i2.5798

Clinical efficacy of follitropin alfa in GnRH-antagonist protocols: A prospective observational phase IV study on the use of biosimilar follitropin alfa r-hFSH in assisted reproductive technology in a routine care setting. / Griesinger, Georg; Schill, Thilo; Sator, Michael et al.
In: Journal of Reproduction and Infertility, Vol. 22, No. 2, 04.2021, p. 116-124.

Research output: Journal Articles › Journal articles › Research › peer-review

TY - JOUR

T1 - Clinical efficacy of follitropin alfa in GnRH-antagonist protocols: A prospective observational phase IV study on the use of biosimilar follitropin alfa r-hFSH in assisted reproductive technology in a routine care setting

AU - Griesinger, Georg

AU - Schill, Thilo

AU - Sator, Michael

AU - Schenk, Michael

AU - Krüssel, Jan Steffen

PY - 2021/4

Y1 - 2021/4

N2 - Background: This phase IV routine care study evaluated ovarian responses when using a biosimilar follitropin alfa r-hFSH (Bemfola®) for controlled ovarian stimulation (COS) in women undergoing assisted reproductive technology (ART) treatment who were pituitary-suppressed with a gonadotrophin-releasing hormone (GnRH) antagonist. Methods: This multicenter, prospective, non-comparative, non-interventional study (Germany/Austria) was conducted with 885 women (Mean age of 34.0±4.4 years) for whom COS with Bemfola® and GnRH-antagonist for pituitary suppression were applied as part of in vitro fertilization (IVF) treatment with/without intracytoplasmic sperm injection (ICSI) observing routine clinical-practice protocols. Primary endpoint was the number of retrieved cumulus-oocyte-complexes (COCs). Results: Among 986 ART cycles, COS was given for 9.9±1.8 days (First-day r-hFSH dose of 220.7±68.9 IU; mean total dose of 2184.3±837.5 IU). It was revealed that 99.1% of cycles resulted in follicular puncture, with mean of 10.7±6.6 oocytes retrieved. Successful fertilization took place after IVF/ICSI in 93.8% of follicular punctures. Freeze-all was performed in 14.2% of cycles. Fresh embryo transfer was performed in 76.9% of cycles with follicular puncture; mean day of transfer was 3.5±1.3 and average number of transferred embryos was 1.76±0.50. Clinical pregnancy rate was 30.2% of embryo-transfer cycles and 23.4% of started cycles. Sixty-nine reports of ovarian hyperstimulation syndrome (7.0% of started cycles) were documented. Conclusion: COS with Bemfola® in GnRH-antagonist IVF/ICSI protocols in a routine care setting led to an appropriate ovarian response allowing oocyte retrieval in 99.1% of initiated cases.

AB - Background: This phase IV routine care study evaluated ovarian responses when using a biosimilar follitropin alfa r-hFSH (Bemfola®) for controlled ovarian stimulation (COS) in women undergoing assisted reproductive technology (ART) treatment who were pituitary-suppressed with a gonadotrophin-releasing hormone (GnRH) antagonist. Methods: This multicenter, prospective, non-comparative, non-interventional study (Germany/Austria) was conducted with 885 women (Mean age of 34.0±4.4 years) for whom COS with Bemfola® and GnRH-antagonist for pituitary suppression were applied as part of in vitro fertilization (IVF) treatment with/without intracytoplasmic sperm injection (ICSI) observing routine clinical-practice protocols. Primary endpoint was the number of retrieved cumulus-oocyte-complexes (COCs). Results: Among 986 ART cycles, COS was given for 9.9±1.8 days (First-day r-hFSH dose of 220.7±68.9 IU; mean total dose of 2184.3±837.5 IU). It was revealed that 99.1% of cycles resulted in follicular puncture, with mean of 10.7±6.6 oocytes retrieved. Successful fertilization took place after IVF/ICSI in 93.8% of follicular punctures. Freeze-all was performed in 14.2% of cycles. Fresh embryo transfer was performed in 76.9% of cycles with follicular puncture; mean day of transfer was 3.5±1.3 and average number of transferred embryos was 1.76±0.50. Clinical pregnancy rate was 30.2% of embryo-transfer cycles and 23.4% of started cycles. Sixty-nine reports of ovarian hyperstimulation syndrome (7.0% of started cycles) were documented. Conclusion: COS with Bemfola® in GnRH-antagonist IVF/ICSI protocols in a routine care setting led to an appropriate ovarian response allowing oocyte retrieval in 99.1% of initiated cases.

UR - https://www.scopus.com/pages/publications/85109306201

UR - https://www.mendeley.com/catalogue/0fbcdd1c-adee-30dc-b3a6-f7baf37081aa/

U2 - 10.18502/jri.v22i2.5798

DO - 10.18502/jri.v22i2.5798

M3 - Journal articles

AN - SCOPUS:85109306201

SN - 2228-5482

VL - 22

SP - 116

EP - 124

JO - Journal of Reproduction and Infertility

JF - Journal of Reproduction and Infertility

IS - 2

ER -

Griesinger G, Schill T, Sator M, Schenk M, Krüssel JS. Clinical efficacy of follitropin alfa in GnRH-antagonist protocols: A prospective observational phase IV study on the use of biosimilar follitropin alfa r-hFSH in assisted reproductive technology in a routine care setting. Journal of Reproduction and Infertility. 2021 Apr;22(2):116-124. doi: 10.18502/jri.v22i2.5798

Clinical efficacy of follitropin alfa in GnRH-antagonist protocols: A prospective observational phase IV study on the use of biosimilar follitropin alfa r-hFSH in assisted reproductive technology in a routine care setting

Abstract

Funding

UN SDGs

Research Areas and Centers

Access to Document

Other files and links

Fingerprint

Cite this