Female Subjects Undergoing COH in ART to Prevent Early OvulationPhase 2NCT05082233

Identify Effective Doses of SHR7280 Tablets in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)

A Phase 2 study testing SHR7280 tablets in people with Female Subjects Undergoing COH in ART to 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

Who is it for?: Ages 20 to 39 years, women only
Conditions the study is for: Female Subjects Undergoing COH in ART to Prevent Early Ovulation
What is being tested?: SHR7280 tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 1 siteChina
Study dates: 6 Mar 2022to 3 Aug 2023
Phase: Phase 2
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 39 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 monosperm microinjection (ICSI) techniques.
Body mass index (BMI) of 18 to 28 kg/m2.
Regular menstrual cycle (24 to 35 days) for the last 3 months prior to screening.
Screening serum sex hormone levels must be performed on day 2 to 3 in the menstrual cycle and meet basal serum follicle stimulating hormone (FSH) < 10 IU/L; LH, estradiol (E2), progesterone (P), prolactin (PRL), and total testosterone levels within the normal laboratory range, or the investigator considers the abnormality without clinical significance; 1.2 ng/mL < anti-müllerian hormone (AMH) < 4.0 ng/mL.
Expected normal ovarian response.
Clinical feasible and willingness of the subject to undergo fresh cycle transfer with one or two embryos at a time in the first IVF-ET cycle.
Able and willing to provide a written informed consent.

Who cannot join

Subjects underwent 3 or more controlled ovarian stimulation cycles of IVF/ICSI-ET prior to screening without achieving clinical pregnancy.
Previous IVF or ART failure due to sperm/fertilization problems and no improvement in related medical condition.
Subjects had spontaneous abortion≥2 times.
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 superovulatory cycles, polycystic ovary syndrome (PCOS) [refer to the 2018 Chinese PCOS guidelines] [1], or with previous cancelled cycles due to OHSS).
Note: The 2018 Chinese PCOS guideline specifies the diagnostic criteria as meeting 1 of the following 2 items: ① hyperandrogenic manifestations or irregular menstruation: scanty or amenorrhea menstruation or irregular uterine bleeding are required for the diagnosis. ②Other diseases that may cause hyperandrogenism or abnormal ovulation should be excluded.
Subjects with low ovarian function meeting at least one of the following items: poor previous ovarian response (≤3 ovums obtained with previous conventional adequate Gn stimulation regimen); less than 7 follicles of 2-9 mm diameter (AFC) count visible on vaginal ultrasound in both ovaries; anti-mullerian hormone (AMH) < 1.1 ng/mL.

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Any pregnancy that occurred within 3 months prior to screening date.
Subjects with clinically significant abnormal cervical findings within 6 months prior to screening (TCT).
Note: Human papillomavirus (HPV) testing may be used as an adjunct in subjects with atypical squamous cells of undefined significance (ASC-US). Subjects may be included in the study if only the high-risk HPV strains test was negative.
Unexplained abnormal vaginal bleeding.
Persons who have donated blood or blood components within 1 month prior to screening, or have lost at least the equivalent of 200 mL of blood, or have received a blood transfusion within 2 months.
Subjects had a serious infection, severe trauma or major surgical procedure within 6 months prior to screening.
Use of clomiphene citrate, letrozole, gonadotropins (Gn), metformin, or oral contraceptives within 1 month prior to receiving ovarian stimulation.
Abnormal blood alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values on screening visit or ovarian stimulation day 1 visit.
Positive serum beta-hCG test result on day 1 of screening visit or ovarian stimulation.
Positive results for infectious diseases (including hepatitis B virus surface antigen, hepatitis C virus antibodies, human immunodeficiency virus antibodies, and syphilis spirochete antibodies).
Subjects with clinically significant abnormalities of the uterus and ovaries judged by the investigator, (e.g., submucosal fibroids, interstitial fibroids larger than 3 cm or less than 3 cm but affecting the morphology of the uterine cavity, untreated endometrial polyps, uterine adhesions, uterine malformations, ASRM stage III-IV endometriosis).
Any disease or condition that can affect the function of body systems and may affect the absorption, excessive accumulation, affect metabolism, or alter the excretion pattern of the study drug (e.g., chronic bowel disease, Crohn's disease, ulcerative colitis).
Subjects with clinically significant systemic disease, endocrine or metabolic abnormalities.
Previous or current thromboembolic disease.
Subjects or their spouses with structural chromosomal abnormalities, or with known monogenic genetic disorders or serious diseases with genetic susceptibility requiring preimplantation genetic testing (PGT).
History of tobacco or alcohol abuse within 3 months prior to screening: tobacco addiction (more than 5 cigarettes or equivalent per day); alcohol abuse (greater or equal to 14 units of alcohol per week: 1 unit = 360 mL of beer, or 25 mL of spirits 40% or more in strength, or 1 glass of wine, 180 mL).
History of substance abuse, drug dependence.
Allergy or allergy to two or more foods or drugs, including known history of allergy to the study drug or any component of the study drug.
Subjects that have participated in a clinical trial of any drug or medical device within 3 months prior to screening, or are still within the follow-up period of a clinical study or within 5 half-lives of the trial drug (depends on the longer one) prior to screening
History of malignant tumors of the ovaries, breast, uterus, hypothalamus, pituitary gland, etc.
Subjects with serious mental disease or who are unable to understand the purpose and methods of this clinical trial.
Any other reason deemed by the investigator to be 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: A Multicentre, Open-label, ph2 Clinical Study to Investigate the Efficacy, Safety, and Tolerance of Different Doses of Oral SHR7280 Tablets in Controlled Ovarian Hyperstimulation for Chinese Female Subjects Undergoing Assisted Reproductive Technology (ART)

This study is a multicentre, open-label phase II dose-finding clinical trial that will recruit approximately 120 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI). We set up three SHR7280 tablets dose groups of 300 mg BID, 200 mg BID, and 200 mg QD with 40 subjects in each group, besides, a group of 400mg bid is set as an alternative.

Conditions: Female Subjects Undergoing COH in ART to Prevent Early Ovulation
Being tested: SHR7280 tablets

What participants receive

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

SHR7280 tabletsDrug
Treatment group A:SHR7280 tablets ; 300mg BID； Treatment group B:SHR7280 tablets ; 200mg BID； Treatment group C:SHR7280 tablets ; 200mg QD； Treatment group D:SHR7280 tablets ; 400mg BID；

Study groups in NCT05082233
Study group	Role	What they receive
SHR7280 tablets	Experimental	Treatment group A: oral SHR7280 tablets; 300mg bid p.o.; Treatment group B: oral SHR7280 tablets; 200mg bid p.o.; Treatment group C: oral SHR7280 tablets; 200mg qd p.o.; Treatment group D: oral SHR7280 tablets; 400mg bid p.o.; as an alternative. Receives: Drug: SHR7280 tablets

What is being measured

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

Inhibition rate of early LH serge with different oral doses of SHR7280 tablets from the 1st day of study drug administration to the date of hCG injection
Measured: Through the whole period of oral administration of SHR7280, generally 5-7 days)

Secondary outcomes (7)

The proportion of embryos with 2 protoplasts in the cytoplasm 16-18 hours (h) after fertilization (2PN rates).
Measured: On embryo transfer day, 3 days after oocyte retrieval
Quality embryo rates
Measured: On embryo transfer day, 3 days after oocyte retrieval.
Clinical pregnancy rates.
Measured: On pregnancy test day
Total dose of gonadotropin (Gn) administered and duration of gonadotropin treatment
Measured: Through the whole period of controlled ovarian stimulation, generally 9-11 days
Adverse drug events
Measured: Through study completion, follow-up period may be up to 40 weeks if the patient gets a successful clinical pregnancy and a full term delivery
Population PK endpoints: analysis of plasma SHR7280 concentration data, population pharmacokinetic modeling, and calculation of key pharmacokinetic parameters of SHR7280 in subjects
Measured: Blood samples were collected within 30 minutes before,, 1-3 hours after and 5-8 hours after the oral administration of SHR7280 in the morning on hCG injection day, generally the 9th day to the 11st day of the period of controlled ovarian stimulation
PD endpoints: serum E2, luteinizing hormone (LH) and progesterone (P) concentrations at each time point
Measured: 30 minutes before the oral administration of SHR7280 every morning during SHR7280 treatment period

Timeline

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

6 Mar 20223 Aug 2023

First posted18 Oct 2021
Study start6 Mar 2022
Primary completion3 Aug 2023
Study completion3 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Female Subjects Undergoing COH in ART to 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05082233
Sponsor's protocol ID: SHR7280-201
Status last verified: Feb 2024
First submitted: 29 Sep 2021
Last updated: 20 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Chi H, Song Y, Jin L, Song X, Wang X, Ma Q, Cao Y, Liang X, Tan J, Guan Y, Diao F, Li Y, Li Z, Sun Y, Shu C, Chen H, Shen K, Qiao J. SHR7280, an oral gonadotropin-releasing hormone antagonist, for the prevention of premature luteinizing hormone surge in controlled ovarian hyperstimulation: a dose-finding, phase 2 trial. Hum Reprod. 2025 Jul 1;40(7):1357-1365. doi: 10.1093/humrep/deaf082.
PubMed 40373184

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre, Open-label, ph2 Clinical Study to Investigate the Efficacy, Safety, and Tolerance of Different Doses of Oral SHR7280 Tablets in Controlled Ovarian Hyperstimulation for Chinese Female Subjects Undergoing Assisted Reproductive Technology (ART)
ClinicalTrials.gov ID: NCT05082233
Acronym / sponsor ID: SHR7280-201
Conditions: Female Subjects Undergoing COH in ART to Prevent Early Ovulation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 6 Mar 2022 (actual)
Primary completion: 3 Aug 2023 (actual)
Study completion: 3 Aug 2023 (actual)
First posted: 18 Oct 2021 (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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SHR7280 tablets	Experimental	Drug: SHR7280 tabletsTreatment group A: oral SHR7280 tablets; 300mg bid p.o.; Treatment group B: oral SHR7280 tablets; 200mg bid p.o.; Treatment group C: oral SHR7280 tablets; 200mg qd p.o.; Treatment group D: oral SHR7280 tablets; 400mg bid p.o.; as an alternative.

Who may qualify

Ages: 20 to 39 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 monosperm microinjection (ICSI) techniques.
Body mass index (BMI) of 18 to 28 kg/m2.
Regular menstrual cycle (24 to 35 days) for the last 3 months prior to screening.
Screening serum sex hormone levels must be performed on day 2 to 3 in the menstrual cycle and meet basal serum follicle stimulating hormone (FSH) < 10 IU/L; LH, estradiol (E2), progesterone (P), prolactin (PRL), and total testosterone levels within the normal laboratory range, or the investigator considers the abnormality without clinical significance; 1.2 ng/mL < anti-müllerian hormone (AMH) < 4.0 ng/mL.
Expected normal ovarian response.

Key exclusion criteria (28 listed)

Subjects underwent 3 or more controlled ovarian stimulation cycles of IVF/ICSI-ET prior to screening without achieving clinical pregnancy.
Previous IVF or ART failure due to sperm/fertilization problems and no improvement in related medical condition.
Subjects had spontaneous abortion≥2 times.
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 superovulatory cycles, polycystic ovary syndrome (PCOS) [refer to the 2018 Chinese PCOS guidelines] [1], or with previous cancelled cycles due to OHSS).
Note: The 2018 Chinese PCOS guideline specifies the diagnostic criteria as meeting 1 of the following 2 items: ① hyperandrogenic manifestations or irregular menstruation: scanty or amenorrhea menstruation or irregular uterine bleeding are required for the diagnosis. ②Other diseases that may cause hyperandrogenism or abnormal ovulation should be excluded.

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 tabletsTreatment group A:SHR7280 tablets ; 300mg BID； Treatment group B:SHR7280 tablets ; 200mg BID； Treatment group C:SHR7280 tablets ; 200mg QD； Treatment group D:SHR7280 tablets ; 400mg BID；	Drug	SHR7280 tablets

Primary outcome

Inhibition rate of early LH serge with different oral doses of SHR7280 tablets from the 1st day of study drug administration to the date of hCG injection
Time frame: Through the whole period of oral administration of SHR7280, generally 5-7 days)

7 secondary outcomes

The proportion of embryos with 2 protoplasts in the cytoplasm 16-18 hours (h) after fertilization (2PN rates).
Time frame: On embryo transfer day, 3 days after oocyte retrieval
Quality embryo rates
Time frame: On embryo transfer day, 3 days after oocyte retrieval.
Clinical pregnancy rates.
Time frame: On pregnancy test day
Total dose of gonadotropin (Gn) administered and duration of gonadotropin treatment
Time frame: Through the whole period of controlled ovarian stimulation, generally 9-11 days
Adverse drug events
Time frame: Through study completion, follow-up period may be up to 40 weeks if the patient gets a successful clinical pregnancy and a full term delivery
Population PK endpoints: analysis of plasma SHR7280 concentration data, population pharmacokinetic modeling, and calculation of key pharmacokinetic parameters of SHR7280 in subjects
Time frame: Blood samples were collected within 30 minutes before,, 1-3 hours after and 5-8 hours after the oral administration of SHR7280 in the morning on hCG injection day, generally the 9th day to the 11st day of the period of controlled ovarian stimulation
PD endpoints: serum E2, luteinizing hormone (LH) and progesterone (P) concentrations at each time point
Time frame: 30 minutes before the oral administration of SHR7280 every morning during SHR7280 treatment period

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 20 Feb 2024.
Derived from this study: PubMed 40373184Chi H, Song Y, Jin L, Song X, Wang X, Ma Q, Cao Y, Liang X, Tan J, Guan Y, Diao F, Li Y, Li Z, Sun Y, Shu C, Chen H, Shen K, Qiao J. SHR7280, an oral gonadotropin-releasing hormone antagonist, for the prevention of premature luteinizing hormone surge in controlled ovarian hyperstimulation: a dose-finding, phase 2 trial. Hum Reprod. 2025 Jul 1;40(7):1357-1365. doi: 10.1093/humrep/deaf082.
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?

A Phase 2 study testing SHR7280 tablets in people with Female Subjects Undergoing COH in ART to Prevent Early Ovulation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

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 28 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 20 Feb 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Inhibition rate of early LH serge with different oral doses of SHR7280 tablets from the 1st day of study drug administration to the date of hCG injection (time frame: Through the whole period of oral administration of SHR7280, generally 5-7 days)). 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 NCT05082233, which also lists 1 linked publication.

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 20 Feb 2024.