NCT05994378

To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 317 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertile Female Subjects Undergoing Controlled Ovarian Hyperstimulation to Suppress Premature LH Surge and Prevent Early Ovulation

Interventions

Type	Name	Description
DRUG	SHR7280；Ganirelix Acetate Injection simulant	SHR7280 200mg Q12h and Ganirelix Acetate Injection simulant 0.5mL qd;
DRUG	SHR7280 simulant； Ganirelix Acetate Injection	SHR7280 simulant 200mg Q12h and Ganirelix Acetate Injection 0.5mL:0.25mg qd;

Timeline

• Start date: 2023-08-29
• Primary completion: 2025-05-02
• Completion: 2025-05-02
• First posted: 2023-08-16
• Last updated: 2025-09-15

Locations

1 site across 1 country: China