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.
| Original language | English |
|---|---|
| Journal | Reproductive BioMedicine Online |
| Volume | 40 |
| Issue number | 2 |
| Pages (from-to) | 331-341 |
| Number of pages | 11 |
| ISSN | 1472-6483 |
| DOIs | |
| Publication status | Published - 02.2020 |
Funding
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.
Research Areas and Centers
- Centers: Center for Pre-Implantation Diagnostics (PID)
