Real-World Safety and Effectiveness of Ganirelix for Ovarian Stimulation in Chinese Women: A Multicenter, Prospective, Single-Arm, Observational Study

Background: This study aimed to evaluate the safety and effectiveness of ganirelix acetate for Chinese women undergoing ovarian stimulation (OS) in real-world clinical practice. Methods: This multicenter (16), prospective, single-arm, observational, post-authorization safety study included 1025 Chinese women receiving at least one dose of ganirelix during OS. Safety endpoints were collected until 5 weeks after embryo transfer. The investigator assessed the causality and seriousness of an adverse event (AE). Effectiveness and neonatal outcomes were collected from medical records and phone call follow-ups. The study had a probability of >95% to observe an AE occurring at 0.3% with a sample size of 1000. Results: The occurrence of overall AEs, drug-related AEs, and serious AEs (SAEs) was 12.1% (124/1025), 1.3% (13/1025), and 2.4% (25/1025), respectively. None of the SAEs were drug related, according to the investigator. Two (0.2%) patients discontinued treatment due to an AE. The most reported AE was ovarian hyperstimulation syndrome (4.8%, 49/1025), among which 21 cases were reported as SAE. The proportion of patients with a premature luteinizing hormone (LH) rise >10 IU/L) was 2.5% (26/1025), and one patient had a premature ovulation. The live birth rate was 34.9% (358/1025) per start cycle with a cumulative live birth rate of 42.1% (432/1025). Neonatal malformations occurred in 1.3% (7/523) of the neonates. Conclusions: This study indicates that the safety profile and effectiveness of ganirelix were clinically acceptable, and no new safety signals emerged in real-world clinical practice for Chinese women with OS. The study was registered on Chinadrugtrial.org (identifier: CTR20150284) (http://www.chinadrugtrials.org.cn) and ENCePP.eu (identifier: EUPAS8737) (https://catalogues.ema.europa.eu).