Fully human glyco-optimized recombinant FSH (follitropin epsilon) – a randomized, comparator-controlled phase II clinical trial

Georg Griesinger; Bruno Dietrich; Lars Stöckl; Kelvin Eckert; Steffen Goletz; Andreas Tandler-Schneider

doi:10.1016/j.rbmo.2019.09.003

Fully human glyco-optimized recombinant FSH (follitropin epsilon) – a randomized, comparator-controlled phase II clinical trial

Georg Griesinger^*, Bruno Dietrich, Lars Stöckl, Kelvin Eckert, Steffen Goletz, Andreas Tandler-Schneider

^*Korrespondierende/r Autor/-in für diese Arbeit

Klinik für Frauenheilkunde und Geburtshilfe

12 Zitate (Scopus)

Abstract

Research question: The study aimed to determine the standard treatment dose of follitropin epsilon for ovarian stimulation in the context of IVF treatment. Design: A total of 247 women aged 18-37 years were treated with either 52.5, 75, 112.5 or 150 IU follitropin epsilon daily, or 150 IU every other day, or 150 IU follitropin alfa daily in a long gonadotrophin-releasing hormone agonist protocol. The study was performed as a randomized, assessor-blinded, comparator-controlled, six-armed phase II trial in eight fertility clinics in two European countries. Results: The primary results were as follow. First, none of the doses of follitropin epsilon showed superiority for the main outcome measure, i.e. number of follicles ≥12 mm in size. Follitropin epsilon 75 IU produced results most similar to those of follitropin alfa 150 IU. In terms of secondary results, stronger effects of follitropin epsilon 112.5 IU compared with follitropin alfa 150 IU were seen for secondary outcome measures such as hormone concentrations (oestradiol, inhibin B and progesterone) and oocyte number. Conclusions: Follitropin epsilon 75 IU daily results in a similar ovarian response to a standard dose of 150 IU follitropin alfa. This dose could be tested in a phase III trial.

Originalsprache	Englisch
Zeitschrift	Reproductive BioMedicine Online
Jahrgang	40
Ausgabenummer	2
Seiten (von - bis)	331-341
Seitenumfang	11
ISSN	1472-6483
DOIs	https://doi.org/10.1016/j.rbmo.2019.09.003
Publikationsstatus	Veröffentlicht - 02.2020

Fördermittel

The authors wish to acknowledge all the work of the staff from the participating study centres: Fertility Center Berlin, Reproductive Care, Berlin, Germany; Praxisklinik Sydow, Reproduction Institute, Berlin, Germany; Bielefeld Fertility Center, Private Reproduction Institute, Bielefeld, Germany; Kaali Institute, Reproduction Institute, Budapest, Hungary; Interdisziplin?res Kinderwunschzentrum, Private Reproductive Care Unit, D?sseldorf, Germany; University Hospital Heidelberg, Gynaecologic Endocrinology and Fertility Disorders, Heidelberg, Germany; Universit?res Kinderwunschzentrum L?beck und Manhagen, Luebeck, Germany; and PANNON, Reproduction Institute, Tapolca, Hungary. Declaration: This study was funded by the pharmaceutical company Glycotope GmbH (Berlin, Germany), which developed follitropin epsilon. B.D., L.S., K.E., and S.G. are or were employees of Glycotope GmbH. L.S. and S.G. are shareholders of Glycotope GmbH. The authors report no other financial or commercial conflicts of interest related to the study.

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Zentren: Zentrum für Präimplantationsdiagnostik (PID)

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10.1016/j.rbmo.2019.09.003

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@article{29d893cd8d4c440292d0d596fe814abb,

title = "Fully human glyco-optimized recombinant FSH (follitropin epsilon) – a randomized, comparator-controlled phase II clinical trial",

abstract = "Research question: The study aimed to determine the standard treatment dose of follitropin epsilon for ovarian stimulation in the context of IVF treatment. Design: A total of 247 women aged 18-37 years were treated with either 52.5, 75, 112.5 or 150 IU follitropin epsilon daily, or 150 IU every other day, or 150 IU follitropin alfa daily in a long gonadotrophin-releasing hormone agonist protocol. The study was performed as a randomized, assessor-blinded, comparator-controlled, six-armed phase II trial in eight fertility clinics in two European countries. Results: The primary results were as follow. First, none of the doses of follitropin epsilon showed superiority for the main outcome measure, i.e. number of follicles ≥12 mm in size. Follitropin epsilon 75 IU produced results most similar to those of follitropin alfa 150 IU. In terms of secondary results, stronger effects of follitropin epsilon 112.5 IU compared with follitropin alfa 150 IU were seen for secondary outcome measures such as hormone concentrations (oestradiol, inhibin B and progesterone) and oocyte number. Conclusions: Follitropin epsilon 75 IU daily results in a similar ovarian response to a standard dose of 150 IU follitropin alfa. This dose could be tested in a phase III trial.",

author = "Georg Griesinger and Bruno Dietrich and Lars St{\"o}ckl and Kelvin Eckert and Steffen Goletz and Andreas Tandler-Schneider",

note = "Funding Information: The authors wish to acknowledge all the work of the staff from the participating study centres: Fertility Center Berlin, Reproductive Care, Berlin, Germany; Praxisklinik Sydow, Reproduction Institute, Berlin, Germany; Bielefeld Fertility Center, Private Reproduction Institute, Bielefeld, Germany; Kaali Institute, Reproduction Institute, Budapest, Hungary; Interdisziplin?res Kinderwunschzentrum, Private Reproductive Care Unit, D?sseldorf, Germany; University Hospital Heidelberg, Gynaecologic Endocrinology and Fertility Disorders, Heidelberg, Germany; Universit?res Kinderwunschzentrum L?beck und Manhagen, Luebeck, Germany; and PANNON, Reproduction Institute, Tapolca, Hungary. Declaration: This study was funded by the pharmaceutical company Glycotope GmbH (Berlin, Germany), which developed follitropin epsilon. B.D., L.S., K.E., and S.G. are or were employees of Glycotope GmbH. L.S. and S.G. are shareholders of Glycotope GmbH. The authors report no other financial or commercial conflicts of interest related to the study. Publisher Copyright: {\textcopyright} 2019 The Authors Copyright: Copyright 2020 Elsevier B.V., All rights reserved.",

year = "2020",

month = feb,

doi = "10.1016/j.rbmo.2019.09.003",

language = "English",

volume = "40",

pages = "331--341",

journal = "Reproductive BioMedicine Online",

issn = "1472-6483",

publisher = "Elsevier Ltd",

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TY - JOUR

T1 - Fully human glyco-optimized recombinant FSH (follitropin epsilon) – a randomized, comparator-controlled phase II clinical trial

AU - Griesinger, Georg

AU - Dietrich, Bruno

AU - Stöckl, Lars

AU - Eckert, Kelvin

AU - Goletz, Steffen

AU - Tandler-Schneider, Andreas

N1 - Funding Information: The authors wish to acknowledge all the work of the staff from the participating study centres: Fertility Center Berlin, Reproductive Care, Berlin, Germany; Praxisklinik Sydow, Reproduction Institute, Berlin, Germany; Bielefeld Fertility Center, Private Reproduction Institute, Bielefeld, Germany; Kaali Institute, Reproduction Institute, Budapest, Hungary; Interdisziplin?res Kinderwunschzentrum, Private Reproductive Care Unit, D?sseldorf, Germany; University Hospital Heidelberg, Gynaecologic Endocrinology and Fertility Disorders, Heidelberg, Germany; Universit?res Kinderwunschzentrum L?beck und Manhagen, Luebeck, Germany; and PANNON, Reproduction Institute, Tapolca, Hungary. Declaration: This study was funded by the pharmaceutical company Glycotope GmbH (Berlin, Germany), which developed follitropin epsilon. B.D., L.S., K.E., and S.G. are or were employees of Glycotope GmbH. L.S. and S.G. are shareholders of Glycotope GmbH. The authors report no other financial or commercial conflicts of interest related to the study. Publisher Copyright: © 2019 The Authors Copyright: Copyright 2020 Elsevier B.V., All rights reserved.

PY - 2020/2

Y1 - 2020/2

N2 - Research question: The study aimed to determine the standard treatment dose of follitropin epsilon for ovarian stimulation in the context of IVF treatment. Design: A total of 247 women aged 18-37 years were treated with either 52.5, 75, 112.5 or 150 IU follitropin epsilon daily, or 150 IU every other day, or 150 IU follitropin alfa daily in a long gonadotrophin-releasing hormone agonist protocol. The study was performed as a randomized, assessor-blinded, comparator-controlled, six-armed phase II trial in eight fertility clinics in two European countries. Results: The primary results were as follow. First, none of the doses of follitropin epsilon showed superiority for the main outcome measure, i.e. number of follicles ≥12 mm in size. Follitropin epsilon 75 IU produced results most similar to those of follitropin alfa 150 IU. In terms of secondary results, stronger effects of follitropin epsilon 112.5 IU compared with follitropin alfa 150 IU were seen for secondary outcome measures such as hormone concentrations (oestradiol, inhibin B and progesterone) and oocyte number. Conclusions: Follitropin epsilon 75 IU daily results in a similar ovarian response to a standard dose of 150 IU follitropin alfa. This dose could be tested in a phase III trial.

AB - Research question: The study aimed to determine the standard treatment dose of follitropin epsilon for ovarian stimulation in the context of IVF treatment. Design: A total of 247 women aged 18-37 years were treated with either 52.5, 75, 112.5 or 150 IU follitropin epsilon daily, or 150 IU every other day, or 150 IU follitropin alfa daily in a long gonadotrophin-releasing hormone agonist protocol. The study was performed as a randomized, assessor-blinded, comparator-controlled, six-armed phase II trial in eight fertility clinics in two European countries. Results: The primary results were as follow. First, none of the doses of follitropin epsilon showed superiority for the main outcome measure, i.e. number of follicles ≥12 mm in size. Follitropin epsilon 75 IU produced results most similar to those of follitropin alfa 150 IU. In terms of secondary results, stronger effects of follitropin epsilon 112.5 IU compared with follitropin alfa 150 IU were seen for secondary outcome measures such as hormone concentrations (oestradiol, inhibin B and progesterone) and oocyte number. Conclusions: Follitropin epsilon 75 IU daily results in a similar ovarian response to a standard dose of 150 IU follitropin alfa. This dose could be tested in a phase III trial.

UR - https://www.scopus.com/pages/publications/85078146320

U2 - 10.1016/j.rbmo.2019.09.003

DO - 10.1016/j.rbmo.2019.09.003

M3 - Journal articles

C2 - 31982355

AN - SCOPUS:85078146320

SN - 1472-6483

VL - 40

SP - 331

EP - 341

JO - Reproductive BioMedicine Online

JF - Reproductive BioMedicine Online

IS - 2

ER -

Fully human glyco-optimized recombinant FSH (follitropin epsilon) – a randomized, comparator-controlled phase II clinical trial

Abstract

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Strategische Forschungsbereiche und Zentren

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