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

Inclusion Criteria:

1. Married infertile female subjects aged 20 to 39 years with indications for in vitrofertilization-embryo transfer (IVF-ET) or intracytoplasmic sperm injection (ICSI);

2. Body mass index (BMI) 18 ~ 28kg/m2 (both exclusive) and weight 45Kg ~ 75Kg (bothinclusive);

3. Regular menstrual cycle (24 ~ 35 days, both inclusive) for the last 3 months priorto screening;

4. Anticipated normal ovarian response;

5. Willingness of the subject to undergo fresh cycle transfer with one or two embryosat a time in the first IVF-ET cycle；

6. Normal cervical cytology results (TCT) or with limited clinically significancewithin 1 year prior to screening or on the screening visit; or subjects withatypical squamous cells of undetermined significance (ASC-US) of TCT tested negativefor 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 cycleswithout achieving clinical pregnancy；

2. Previous IVF/ ICSI failure due to sperm/fertilization problems and no improvement inrelated 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 Golanclassification (e.g., those with moderate to severe OHSS during previous COH cycles,polycystic ovary syndrome (PCOS), or with previous cancelled COH cycles due toOHSS);

5. Subjects with decreased ovarian reserve;

6. TSH test result above or equal to 2.5 mIU/L for subjects with prior hypothyroidismor 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 HIVantibodies, positive for syphilis spirochete antibodies; positive for Hepatitis Cvirus (HCV) antibodies and positive HCV-RNA test; positive for Hepatitis B surfaceantigen (HBsAg) and HBV-DNA ≥ 1×103 kIU/L (or IU/mL);

10. Use of fertility regulators within one month before ovarian stimulation, such asclomiphene citrate, letrozole, gonadotropins (Gn), metformin, hormonal drugs (including oral contraceptives, estrogens, progestogens, etc.).

11. Past medical history or gynecological ultrasound indicates clinically significantconditions;

12. ALT and AST levels at the screening visit or the start of ovarian stimulation weremore than twice the upper limit of normal;

13. Positive serum β-hCG test results on the screening visit or the start day of ovarianstimulation;

14. Blood or blood component donation within one month before screening, or a blood lossequivalent to at least 200 mL, or a blood transfusion within two months;

15. Severe infection, severe trauma, or major surgery within six months beforescreening;

16. Any disease or symptom that can affect systemic function and may affect theabsorption, accumulation, metabolism, or excretion of the test drug (e.g., chronicintestinal 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 ofthem carry a chromosomal abnormality deemed clinically significant by theresearcher, or suffer from a known monogenic hereditary disease or a severe diseasewith 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% orhigher 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 knownallergy to any component of the test drug or non-test drug; contraindication orallergy 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 monthsbefore screening, or still in the follow-up period of a clinical study beforescreening, 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 cellskin 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 thisstudy.