Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT06481969
Eligibility Criteria:
Inclusion Criteria:
* Women aged ≥20 and ≤39 years who have childbearing requirements.
* Cessation of menstruation or oligomenorrhea for at least 4 months
* Serum level of basal follicle stimulating hormone (FSH) \>25 U/L at least 2 times (during the second to fourth day of the menstrual cycle or during amenorrhea; The interval between the two tests is 4 weeks)
* Serum level of Anti-Mullerian hormone (AMH) ≤1.1 ng/ml
* Women with intact uterus and bilateral adnexa.
* Voluntary participation and informed consent obtained.
Exclusion Criteria:
* Women with autoimmune diseases.
* Women with abnormal and uncontrolled thyroid function.
* Women with tumors in bilateral adnexa that are not clearly benign or malignant.
* Women with a history of malignant tumors, radiation therapy or chemotherapy.
* Women with a history of venous thrombosis or pulmonary embolism during the screening period.
* Women with severe illnesses that are not suitable for pregnancy, such as diseases of the circulatory system, urinary system, digestive system, endocrine system, respiratory system, immune system, mental or neurological system, etc.
* Women who continuously used systemic glucocorticoids or other immunosuppressants for≥3 weeks within 6 months before administration and women who used systemic glucocorticoids (prednisone≥20 mg/d or equivalent dose) or other immunosuppressants within 3 days before administration.
* Women who are allergic to the active ingredients or excipients of test drugs.
* Women with a family history of severe genetic diseases or gynecologic malignancies.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
39 Years
Study:
NCT06481969
Study Brief:
Protocol Section:
NCT06481969