Effectiveness and safety of follitropin alfa (Ovaleap®) for ovarian stimulation using a GnRH antagonist protocol in real-world clinical practice: a multicenter, prospective, open, non-interventional assisted reproductive technology study

Abstract

Background: The use of recombinant human follicle-stimulating hormone (r-hFSH) in ovarian stimulation protocols for infertility treatment in assisted reproductive technology (ART) clinical practice is well established. More recent advancements include the availability of biosimilar r-hFSH products, which expand the choices available to healthcare practitioners and patients. Better understanding of how such a product contributes to routine clinical practice is valuable to help prescribers make informed treatment choices. The objective of this study was to examine the effectiveness and safety of ovarian stimulation (OS) with follitropin alfa (Ovaleap®) for routine IVF or intracytoplasmic sperm injection treatment in gonadotropin-releasing hormone (GnRH) antagonist cycles in real-world ART clinical practice.Methods: This non-interventional, multicenter, prospective study was initiated in 34 specialized reproductive medicine centers in Germany. Eligible women were 18-40 years old with a body mass index < 30 kg/m 2 , menstrual cycle 24-35 days and anti-Müllerian hormone ≥1 ng/mL, who were undergoing a first OS cycle exclusively with Ovaleap® during routine ART using a GnRH antagonist protocol. Primary effectiveness outcomes were number of retrieved oocytes after OS and clinical pregnancy rate (CPR). Secondary outcomes included fertilization rate, number of transferred embryos, live birth delivery rate, safety, and user satisfaction with the Ovaleap® pen.

Safety of Ovaleap® (Follitropin Alfa) in Infertile Women Undergoing Superovulation for Assisted Reproductive Technologies: A Multinational Comparative, Prospective Cohort Study

“…Adjustment for each risk factor or potential confounder in the univariate logistic regression analysis further corroborated the finding of no difference in OHSS incidence between Ovaleap ® and Gonal-f ® treatments. These results are consistent with those reported in the clinical development program of Ovaleap ® and in a post marketing study ( 9 , 10 , 13 ). Moreover, little difference was observed between the cohorts within each severity grading and OHSS severity level incidence proportions were compatible with the background rate described in the literature ( 4 , 5 ).…”

“…reported in the clinical development program of Ovaleap ® and in a post marketing study (9,10,13). Moreover, little difference was observed between the cohorts within each severity grading and OHSS severity level incidence proportions were compatible with the background rate described in the literature (4,5).…”

Effectiveness and Safety of Recombinant Human Follicle-Stimulating Hormone (Follitrope™) in Inducing Controlled Ovarian Stimulation in Infertile Women in Real-World Practice: a Prospective Cohort Study

“…Other clinical outcomes such as fertilization and implantation rates were also within the range of the results of previous studies [1,15,16,[18][19][20]. Furthermore, the clinical pregnancy rate (32.3% in the GnRH agonist group and 39.9% in the GnRH antagonist group) in this study was similar to the clinical pregnancy rate of 41.4% found in a similar observational study in which rhFSH (follitropin alpha) was administered according to the GnRH antagonist protocol in real-world clinical practice [4]. The ongoing pregnancy rate confirmed at least 10 weeks after ovum pick-up (18.3% in the GnRH agonist group and 28.1% in the GnRH antagonist group) was slightly lower than the clinical pregnancy rate.…”

“…Among the assisted reproductive techniques used for the treatment of infertility, in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) are the most commonly used [1,2]. Controlled ovarian hyperstimulation is a key factor in IVF/ICSI, and recombinant human follicle-stimulating hormone (rhFSH), which is produced as a highly purified FSH preparation and has a greater availability and decreased variability, is mainly used for this purpose [3][4][5][6].…”

Comparative assessment of the DNA damage caused in cumulus cells by Corneumon®, Gonal-F®, Pergoveris® and Puregon® in women undergoing assisted reproduction techniques, and its impact on reproductive outcomes

“…After the rst rhFSH-α preparation (Gonal-F®) was produced using recombinant DNA technology, several rhFSH have been approved by the corresponding authorities for multifollicular development in women undergoing ART, an even when the full primary structures of the different rhFSH are identical, differences in the expressing cell lines and manufacturing process can lead to variations in glycosylation pro les that could lead to variations in the e cacy among the various rhFSH [13]. For this reason, several studies have been undertaken to evaluate the effectiveness and safety of different rhFSH in inducing COH in infertile women [17][18][19][20][21].…”