Abstract
BACKGROUND: Follitropin delta (hrFSH) is the first recombinant follicle-stimulating hormone produced in a human cell line and more closely resembles native human FSH than follitropin alfa/beta (rFSH). Its efficacy and safety have been demonstrated in numerous clinical trials. However, to date, no real-world study has evaluated the reproductive outcomes associated with controlled ovarian stimulation (COS) with hrFSH compared to rFSH. METHODS: This study was a retrospective analysis of real-world data prospectively collected by the German IVF Registry (D-I-R; Deutsches IVF-Register). Data from women undergoing COS in Germany between 2017 and 2022 were included, specifically from centers using both hrFSH and rFSH for COS (N = 74). Propensity score matching (PSM) was used to match groups to minimize potential confounders. Matching criteria included age, year of stimulation, stimulation protocol, reproductive procedure, treatment indication, preconditions, and patient sterility factors. Outcomes were number of oocytes retrieved, pregnancy rate (PR) and cumulative PR (followed up to 12/31/2022 and 12/31/2021, respectively), and LBR and cumulative LBR (followed up to 12/31/2021 and 12/31/2020, respectively). RESULTS: Before and after matching, the mean number of oocytes retrieved was similar between the two groups. Prior to matching, there was no statistically significant difference in PR or LBR per embryo transfer (ET) between women who received hrFSH or those who received rFSH (PR: 38.0% vs. 36.8%; p = 0.1090; LBR: 29.4% vs. 28.2%; p = 0.1103). When examining the cumulative pregnancy rates (PR) and live birth rates (LBR) for all fresh and frozen/thawed embryo transfers (FET) following the initial oocyte retrieval, notable differences emerged between the groups. The use of hrFSH was linked to higher percentages compared to rFSH, with cumulative PR at 68.0% versus 64.9% (p < 0.05) and cumulative LBR at 57.3% versus 51.9% (p < 0.01). After matching, the cumulative LBR remained significantly higher when hrFSH was used for ovarian stimulation compared to rFSH (57.4% vs. 50.7%; p < 0.05). CONCLUSION: In this large retrospective analysis of a prospectively collected real-world data set, the higher cumulative LBR with hrFSH compared to rFSH supports the use of an individualized fertility treatment approach based on hrFSH.