P-590 Similar mean follitropin delta daily/total doses yield satisfactory ICSI outcomes in different subgroups of maternal age and body mass index: a “real-world” experience with Rekovelle®

Abstract

Abstract Study question Can similar mean follitropin delta daily/total doses yield satisfactory ICSI outcomes in different subgroups of maternal age and body mass index (BMI)? Summary answer Similar mean follitropin delta daily/total doses yield satisfactory number of oocytes and maturity rates, and pregnancy rates in different subgroups of maternal age and BMI. What is known already Rekovelle® (follitropin delta) is a novel recombinant human FSH (rFSH) expressed from a host cell line of human fetal retinal origin (PER.C6®) and is the first commercially available rFSH product derived from human cell lines. Rekovelle® allows the individualization of the initial dose of gonadotropin using predictive response factors to COS, such as anti-müllerian hormone (AMH) levels and body weight. In clinical practice different approaches can be adopted to obtain the most satisfactory response to controlled ovarian stimulation (COS). The objective of this study was to describe data on “real-world” Rekovelle® administration, regarding the response to COS and ICSI outcomes. Study design, size, duration This non-interventional study based on secondary use of data included patients undergoing ICSI in a private university-affiliated IVF center from Jan/2018 to Dec/2021. Each patient or cycle had to meet the following inclusion criteria: pre-menopausal women, undergoing COS with Rekovelle® (16 ug) daily for ICSI; diagnosed with infertility, or with partners diagnosed with male infertility factors, eligible for ICSI using fresh sperm from partner ejaculation; presenting with both ovaries. Participants/materials, setting, methods Ovarian response to stimulation and ICSI outcomes were described for 362 ICSI cycles. The primary outcome measures were the numbers of retrieved oocytes and maturity rates, and the secondary outcome were the ongoing pregnancy rates per fresh and per fresh and/or frozen-thawed embryo transfer. The results obtained with the population enrolled in the ESTHER-1 trial (extern), and a population stimulated with follitropin alpha 300 IU (on site) were recorded (data not shown, to be presented). Main results and the role of chance The mean total dose of follitropin delta administered in subgroups of age and BMI were as follows: age ≤35 y-old 156µg, 36-39 y-old 158 µg, and ≥40 y-old 157µg, and BMI: <18.5 165µg, 18.5-24.9 156µg, 25.0-24.9 159µg, and ≥30 171µg. Patients in the Follitropin delta group showed acceptable outcomes in different age and BMI groups (Table1). Adequate embryo morphokinetic development and euploidy rates were also observed, suggesting that the modified protocol does not interfere with oocyte/embryo competences and embryo implantation potential. This was further corroborated by satisfactory cumulative pregnancy rates. Limitations, reasons for caution Given its descriptive nature, we have focused on the number and maturity stage of retrieved oocytes instead of clinical ICSI outcomes. The use of historical cohort groups is another drawback. Despite the eligibility criteria for inclusion in the analysis, potential differences in the baseline characteristics cannot be ruled out. Wider implications of the findings Patients in different subgroups of age and BMI stimulated with similar mean follitropin delta daily and total doses showed satisfactory number of retrieved oocytes and maturity rates, and cumulative pregnancy rates without increasing OHSS, providing a rationale for conducting clinical trials to confirm the benefits of using this modified protocol. Trial registration number N/A