Infertile Female Subjects Undergoing Controlled Ovarian Hyperstimulation to Suppress Premature LH Surge and Prevent Early OvulationPhase 3NCT05994378

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

A Phase 3 study testing SHR7280；Ganirelix Acetate Injection simulant and SHR7280 simulant； Ganirelix Acetate Injection in people with Infertile Female Subjects Undergoing Controlled Ovarian Hyperstimulation to Suppress Premature LH Surge and Prevent Early Ovulation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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)… Read more about this study

Who is it for?: Ages 20 to 40 years, women only
Conditions the study is for: Infertile Female Subjects Undergoing Controlled Ovarian Hyperstimulation to Suppress Premature LH Surge and Prevent Early Ovulation
What is being tested?: SHR7280；Ganirelix Acetate Injection simulant and SHR7280 simulant； Ganirelix Acetate Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 317 participants
Where: 1 siteChina
Study dates: 29 Aug 2023to 2 May 2025
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

Married infertile female subjects aged 20 to 39 years with indications for in vitro fertilization-embryo transfer (IVF-ET) or intracytoplasmic sperm injection (ICSI);
Body mass index (BMI) 18 ~ 28kg/m2 (both exclusive) and weight 45Kg ~ 75Kg (both inclusive);
Regular menstrual cycle (24 ~ 35 days, both inclusive) for the last 3 months prior to screening;
Anticipated normal ovarian response;
Willingness of the subject to undergo fresh cycle transfer with one or two embryos at a time in the first IVF-ET cycle；
Normal cervical cytology results (TCT) or with limited clinically significance within 1 year prior to screening or on the screening visit; or subjects with atypical squamous cells of undetermined significance (ASC-US) of TCT tested negative for high-risk types of human papillomavirus (HPV);
Informed consent of subjects and their spouses;

Who cannot join

Prior to screening, individuals underwent three or more IVF/ICSI-ET COH cycles without achieving clinical pregnancy；
Previous IVF/ ICSI failure due to sperm/fertilization problems and no improvement in related medical condition;
Subjects with more than 2 times of spontaneous abortion;
Subjects at high risk of OHSS, judged by the investigator according to the Golan classification (e.g., those with moderate to severe OHSS during previous COH cycles, polycystic ovary syndrome (PCOS), or with previous cancelled COH cycles due to OHSS);
Subjects with decreased ovarian reserve;
TSH test result above or equal to 2.5 mIU/L for subjects with prior hypothyroidism or subclinical hypothyroidism on screening visit;

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Any pregnancy that occurred within 3 months prior to screening visit;
Unexplained abnormal vaginal bleeding;
Infectious disease screening indicates any of the following: positive for HIV antibodies, positive for syphilis spirochete antibodies; positive for Hepatitis C virus (HCV) antibodies and positive HCV-RNA test; positive for Hepatitis B surface antigen (HBsAg) and HBV-DNA ≥ 1×103 kIU/L (or IU/mL);
Use of fertility regulators within one month before ovarian stimulation, such as clomiphene citrate, letrozole, gonadotropins (Gn), metformin, hormonal drugs (including oral contraceptives, estrogens, progestogens, etc.).
Past medical history or gynecological ultrasound indicates clinically significant conditions;
ALT and AST levels at the screening visit or the start of ovarian stimulation were more than twice the upper limit of normal;
Positive serum β-hCG test results on the screening visit or the start day of ovarian stimulation;
Blood or blood component donation within one month before screening, or a blood loss equivalent to at least 200 mL, or a blood transfusion within two months;
Severe infection, severe trauma, or major surgery within six months before screening;
Any disease or symptom that can affect systemic function and may affect the absorption, accumulation, metabolism, or excretion of the test drug (e.g., chronic intestinal diseases, Crohn's disease, ulcerative colitis).
Major systemic diseases, endocrine or metabolic abnormalities;
Thromboembolic diseases or a history of thromboembolic diseases;
The subject or her spouse requires oocyte or sperm donation, or either or both of them carry a chromosomal abnormality deemed clinically significant by the researcher, or suffer from a known monogenic hereditary disease or a severe disease with genetic susceptibility requiring pre-implantation genetic testing (PGT);
Smoking (more than 5 cigarettes or equivalent tobacco daily) or alcohol abuse (drinking ≥14 units of alcohol weekly: 1 unit = 360 mL beer, or 25 mL of 40% or higher spirits, or 1 glass of wine, 180 mL) within three months before screening;
History of drug abuse or drug dependence;
Allergic constitution or allergy to two or more foods or drugs, including a known allergy to any component of the test drug or non-test drug; contraindication or allergy to GnRH agonists or GnRH antagonists, recombinant or urinary FSH, hCG, progesterone drugs;
Participation in any drug or medical device clinical trial within three months before screening, or still in the follow-up period of a clinical study before screening, or within the 5 half-lives of the test drug (whichever is longer);
Malignant tumor or history of malignant tumor (except basal cell or squamous cell skin cancer, in situ cancer), or a high risk of malignant tumor onset/recurrence;
Known history of severe mental illness, or inability to understand the purpose, methods, etc., of this clinical trial, or non-compliance with research procedures;
Any other reasons deemed by the researcher as unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University Third Hospital
Beijing, Beijing Municipality, 100191

Other trials in China

About this study

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

Conditions: Infertile Female Subjects Undergoing Controlled Ovarian Hyperstimulation to Suppress Premature LH Surge and Prevent Early Ovulation
Being tested: SHR7280；Ganirelix Acetate Injection simulant, SHR7280 simulant； Ganirelix Acetate Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHR7280；Ganirelix Acetate Injection simulantDrug
SHR7280 200mg Q12h and Ganirelix Acetate Injection simulant 0.5mL qd;
SHR7280 simulant； Ganirelix Acetate InjectionDrug
SHR7280 simulant 200mg Q12h and Ganirelix Acetate Injection 0.5mL:0.25mg qd;

Study groups in NCT05994378
Study group	Role	What they receive
Experimental group	Experimental	Not described Receives: Drug: SHR7280；Ganirelix Acetate Injection simulant
Control group	Active comparator	Not described Receives: Drug: SHR7280 simulant； Ganirelix Acetate Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of oocyte retrieved per COH cycle
number of oocytes obtained after one COH cycle;
Measured: On oocyte retrieval 1 day
Inhibition rate of premature LH surge
premature LH surge is defined as: LH ≥ 10 IU/L and progesterone P ≥ 1 ng/mL (3.18 nmol/L);
Measured: the hCG injection 1 day

Secondary outcomes (6)

2PN rate
number of 2 pronuclei(2PN) oocytes/ number of oocytes retrieved or number of MII oocytes×100%;
Measured: 16-18 hours (h) after fertilization
High quality embryo rate
number of high-quality embryos/ cleavage number×100%;
Measured: 3 days after fertilization
Chemical pregnancy rate
number of pregnancy cycles/ number of transplantation cycles×100%;
Measured: on chemical pregnancy test 1 day
Clinical pregnancy rate
number of clinical pregnancy cycles/ number of transplantation cycles×100%;
Measured: on clinical pregnancy test 1 day
Persistent pregnancy rate
number of clinical pregnancy cycles/ number of transplantation cycles×100%;
Measured: on persistent pregnancy test 1 day
Adverse drug events
Measured: Day 1 to persistent pregnancy test day/ or End-of-trial visit 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Aug 20232 May 2025

First posted16 Aug 2023
Study start29 Aug 2023
Primary completion2 May 2025
Study completion2 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Infertile Female Subjects Undergoing Controlled Ovarian Hyperstimulation to Suppress Premature LH Surge and Prevent Early OvulationStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 317 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05994378
Sponsor's protocol ID: SHR7280-302
Status last verified: Sep 2025
First submitted: 9 Aug 2023
Last updated: 15 Sep 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05994378
Acronym / sponsor ID: SHR7280-302
Conditions: Infertile Female Subjects Undergoing Controlled Ovarian Hyperstimulation to Suppress Premature LH Surge and Prevent Early Ovulation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 317 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 29 Aug 2023 (actual)
Primary completion: 2 May 2025 (actual)
Study completion: 2 May 2025 (actual)
First posted: 16 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental group	Experimental	Drug: SHR7280；Ganirelix Acetate Injection simulant
Control group	Active comparator	Drug: SHR7280 simulant； Ganirelix Acetate Injection

Who may qualify

Ages: 20 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Married infertile female subjects aged 20 to 39 years with indications for in vitro fertilization-embryo transfer (IVF-ET) or intracytoplasmic sperm injection (ICSI);
Body mass index (BMI) 18 ~ 28kg/m2 (both exclusive) and weight 45Kg ~ 75Kg (both inclusive);
Regular menstrual cycle (24 ~ 35 days, both inclusive) for the last 3 months prior to screening;
Anticipated normal ovarian response;
Willingness of the subject to undergo fresh cycle transfer with one or two embryos at a time in the first IVF-ET cycle；

Key exclusion criteria (26 listed)

Prior to screening, individuals underwent three or more IVF/ICSI-ET COH cycles without achieving clinical pregnancy；
Previous IVF/ ICSI failure due to sperm/fertilization problems and no improvement in related medical condition;
Subjects with more than 2 times of spontaneous abortion;
Subjects at high risk of OHSS, judged by the investigator according to the Golan classification (e.g., those with moderate to severe OHSS during previous COH cycles, polycystic ovary syndrome (PCOS), or with previous cancelled COH cycles due to OHSS);
Subjects with decreased ovarian reserve;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SHR7280；Ganirelix Acetate Injection simulantSHR7280 200mg Q12h and Ganirelix Acetate Injection simulant 0.5mL qd;	Drug	Experimental group
SHR7280 simulant； Ganirelix Acetate InjectionSHR7280 simulant 200mg Q12h and Ganirelix Acetate Injection 0.5mL:0.25mg qd;	Drug	Control group

Primary outcome

Number of oocyte retrieved per COH cycle
Time frame: On oocyte retrieval 1 day
number of oocytes obtained after one COH cycle;
Inhibition rate of premature LH surge
Time frame: the hCG injection 1 day
premature LH surge is defined as: LH ≥ 10 IU/L and progesterone P ≥ 1 ng/mL (3.18 nmol/L);

6 secondary outcomes

2PN rate
Time frame: 16-18 hours (h) after fertilization
High quality embryo rate
Time frame: 3 days after fertilization
Chemical pregnancy rate
Time frame: on chemical pregnancy test 1 day
Clinical pregnancy rate
Time frame: on clinical pregnancy test 1 day
Persistent pregnancy rate
Time frame: on persistent pregnancy test 1 day
Adverse drug events
Time frame: Day 1 to persistent pregnancy test day/ or End-of-trial visit 1 day

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of oocyte retrieved per COH cycle (time frame: On oocyte retrieval 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05994378.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.