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

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.