Trial · Interventional
CompletedPhase 3Registry dataTo Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 317 participants (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
China
- Start
- 29 Aug 2023
- Primary completion
- 2 May 2025
- Completion
- 2 May 2025
- First posted
- 16 Aug 2023
- Last update posted
- 15 Sept 2025
- Conditions
- Infertile Female Subjects Undergoing Controlled Ovarian Hyperstimulation to Suppress Premature LH Surge and Prevent Early Ovulation
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects
NCT0599437829 Aug 2023 to 2 May 2025
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- SHR7280;Ganirelix Acetate Injection simulantDrug
- SHR7280 simulant; Ganirelix Acetate InjectionDrug
Arms2
Experimental
Experimental group
Active comparator
Control group
Primary outcomes2
Outcomes the sponsor listed as primary.
Number of oocyte retrieved per COH cycle
Time frame · On oocyte retrieval 1 day
Registry description
number of oocytes obtained after one COH cycle;
Inhibition rate of premature LH surge
Time frame · the hCG injection 1 day
Registry description
premature LH surge is defined as: LH ≥ 10 IU/L and progesterone P ≥ 1 ng/mL (3.18 nmol/L);
Secondary outcomes(6)
2PN rate
Time frame · 16-18 hours (h) after fertilization
Registry description
number of 2 pronuclei(2PN) oocytes/ number of oocytes retrieved or number of MII oocytes×100%;
High quality embryo rate
Time frame · 3 days after fertilization
Registry description
number of high-quality embryos/ cleavage number×100%;
Chemical pregnancy rate
Time frame · on chemical pregnancy test 1 day
Registry description
number of pregnancy cycles/ number of transplantation cycles×100%;
Clinical pregnancy rate
Time frame · on clinical pregnancy test 1 day
Registry description
number of clinical pregnancy cycles/ number of transplantation cycles×100%;
Persistent pregnancy rate
Time frame · on persistent pregnancy test 1 day
Registry description
number of clinical pregnancy cycles/ number of transplantation cycles×100%;
Adverse drug events
Time frame · Day 1 to persistent pregnancy test day/ or End-of-trial visit 1 day
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 20 Years up to 40 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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