clinical trial · NCT05994378
To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects
Jiangsu HengRui Medicine Co., Ltd.·phase3·completed·n = 317
Infertile Female Subjects Undergoing Controlled Ovarian Hyperstimulation to Suppress Premature LH Surge and Prevent Early OvulationSHR7280；Ganirelix Acetate Injection simulantSHR7280 simulant； Ganirelix Acetate Injection
brief summary
This study is a multi-center, randomized, double-blind, positive drug-controlled, non-inferiority Phase III clinical trial. The study will enroll approximately 316 infertile female subjects undergoing controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment.
started
Aug 29, 2023
primary completion
May 2, 2025
completion
May 2, 2025
last updated
Sep 15, 2025
official title
To Compare the Efficacy and Safety of Oral SHR7280 Tablets With Ganirelix Acetate Injection in Female Subjects With Infertility Receiving Controlled Ovarian Hyperstimulation Therapy: A Multi-center, Randomized, Parallel-Group, Double-Blind, Dual-Simulation, Non-Inferiority Phase III Clinical Study
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol