Descriptive analysis of Rekovelle® “real-world” experience

Abstract

Objective(s) To describe the data on “real-world” Rekovelle® administration concerning the response to controlled ovarian stimulation (COS) and clinical intracytoplasmic sperm injection (ICSI) outcomes. Study design This non-interventional study based on secondary use of data included 763 patients undergoing ICSI treatment in a private university-affiliated IVF center from January 2018 to December 2021. Patients undergoing COS with Follitropin delta were given 16mcg Rekovelle® daily (n = 362). Ovarian response to stimulation and laboratory and clinical outcomes of ICSI were described. Two cohorts of patients were added as references: the population included in the ESTHER-1 trial (extern), and a population undergoing COS with follitropin alpha (on-site). Results Patients in the Follitropin delta group showed acceptable outcomes in terms of number of follicles and oocytes, oocyte maturity rate, blastocyst development, and clinical outcomes, irrespective of subgroups of age and BMI. Embryos from women using follitropin delta showed morphokinetic development that seemed equivalent to those from implanted embryos previously reported, demonstrating high implantation potential. This was further corroborated by satisfactory cumulative implantation rates observed for this group of patients. The modified protocol seems to not interfere with oocyte and embryo competence since euploidy rates were also within the expected ranges. OHSS frequencies and rates also seemed acceptable. Conclusions Descriptive data showed that using a starting 16 ug follitropin delta dose for COS results in satisfactory retrieved oocytes and maturity rates across patients in different age ranges and BMI, leading to reasonable cumulative pregnancy rates without increasing OHSS.