en 34041008 <p>Background: This phase IV routine care study evaluated ovarian responses when using a biosimilar follitropin alfa r-hFSH (Bemfola^&reg;) for controlled ovarian stimulation (COS) in women undergoing assisted reproductive technology (ART) treatment who were pituitary-suppressed with a gonadotrophin-releasing hormone (GnRH) antagonist.<br /> Methods: This multicenter, prospective, non-comparative, non-interventional study (Germany/Austria) was conducted with 885 women (Mean age of 34.0&plusmn;4.4 years) for whom COS with Bemfola^&reg; and GnRH-antagonist for pituitary suppression were applied&nbsp; 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).<br /> Results: Among 986 ART cycles, COS was given for 9.9&plusmn;1.8 days (First-day r-hFSH dose of 220.7&plusmn;68.9 <em>IU</em>; mean total dose of 2184.3&plusmn;837.5 <em>IU</em>). It was revealed that 99.1% of cycles resulted in follicular puncture, with mean of 10.7&plusmn;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&plusmn;1.3 and average number of transferred embryos was 1.76&plusmn;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.<br /> Conclusion: COS with Bemfola^&reg; 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.</p> Assisted reproductive technology, Biosimilar pharmaceuticals, Follitropin alfa, Gonadotropin-releasing hormone antagonist 116 125 https://www.jri.ir/article/120104 https://www.jri.ir/documents/fullpaper/en/120104.pdf GeorgGriesingerSektion Für Gynaekologische Endokrinologie und Reproduktionsmedizin, Klinik Für Frauenheilkunde & Geburtshilfe (Gynaekologie), Universitaetsklinikum Schleswig-Holstein-Campus Luebeck, Luebeck, Germanygeorg.griesinger@uni-luebeck.de112144ThiloSchillMVZ Kinderwunschzentrum Langenhagen-Wolfsburg, Langenhagen, Germany112145MichaelSatorKinderwunsch im Zentrum GmbH, Tulln an der Donau, Australia112146MichaelSchenkDas Kinderwunsch Institut Schenk GmbH, Dobl b. Graz, Australia112147Jan-SteffenKrüsselUniversitaeres interdisziplinäres Kinderwunschzentrum Duesseldorf (UniKiD), Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Duesseldorf, Duesseldorf, Germany112148