Real-World Safety and Effectiveness of Ganirelix for Ovarian Stimulation in
Chinese Women: A Multicenter, Prospective, Single-Arm, Observational Study
#MMPMID41142490
Li J
; Gong F
; Geng L
; Wang X
; Wei Z
; Liu J
; Zeng Y
; Wang J
; Gordon K
; Chen S
; Yang R
; Li R
Womens Health Rep (New Rochelle)
2025[]; 6
(1
): 1119-1126
PMID41142490
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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).
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