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Could a pill replace IVF shots? new study tests oral drug

NCT ID NCT05994378

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial tested whether an oral tablet called SHR7280 works as well as the standard injection (ganirelix) for preventing early ovulation in women undergoing IVF. The study involved 317 infertile women aged 20-39. If effective, the pill could offer a more convenient option, but it is not a cure for infertility—it is a tool to improve the success of IVF procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SHR7280 (oral tablet) and ganirelix acetate (injection)
What this could lead to
If successful, this could offer a more convenient oral alternative to daily injections for women undergoing IVF, potentially reducing discomfort and simplifying treatment.
What could go wrong
This is a non-inferiority trial, meaning it aims to show SHR7280 is not worse than the existing injection, not necessarily better. The results may not apply to all infertility patients, and oral medications can have different side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

317 people

The number who actually took part.

Started

Aug 2023

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Married infertile female subjects aged 20 to 39 years with indications for in vitro fertilization-embryo transfer (IVF-ET) or intracytoplasmic sperm injection (ICSI); 2. Body mass index (BMI) 18 \~ 28kg/m2 (both exclusive) and weight 45Kg \~ 75Kg (both inclusive); 3. Regular menstrual cycle (24 \~ 35 days, both inclusive) for the last 3 months prior to screening; 4. Anticipated normal ovarian response; 5. Willingness of the subject to undergo fresh cycle transfer with one or two embryos at a time in the first IVF-ET cycle; 6. 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); 7. Informed consent of subjects and their spouses; Exclusion Criteria: 1. Prior to screening, individuals underwent three or more IVF/ICSI-ET COH cycles without achieving clinical pregnancy; 2. Previous IVF/ ICSI failure due to sperm/fertilization problems and no improvement in related medical condition; 3. Subjects with more than 2 times of spontaneous abortion; 4. 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); 5. Subjects with decreased ovarian reserve; 6. TSH test result above or equal to 2.5 mIU/L for subjects with prior hypothyroidism or subclinical hypothyroidism on screening visit; 7. Any pregnancy that occurred within 3 months prior to screening visit; 8. Unexplained abnormal vaginal bleeding; 9. 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); 10. 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.). 11. Past medical history or gynecological ultrasound indicates clinically significant conditions; 12. ALT and AST levels at the screening visit or the start of ovarian stimulation were more than twice the upper limit of normal; 13. Positive serum β-hCG test results on the screening visit or the start day of ovarian stimulation; 14. 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; 15. Severe infection, severe trauma, or major surgery within six months before screening; 16. 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). 17. Major systemic diseases, endocrine or metabolic abnormalities; 18. Thromboembolic diseases or a history of thromboembolic diseases; 19. 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); 20. 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; 21. History of drug abuse or drug dependence; 22. 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; 23. 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); 24. 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; 25. Known history of severe mental illness, or inability to understand the purpose, methods, etc., of this clinical trial, or non-compliance with research procedures; 26. Any other reasons deemed by the researcher as unsuitable for participation in this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.