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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT02912104
Eligibility Criteria:
Inclusion Criteria:
1. ≥18 and\<45 years old.
2. Female patients with documented diagnosis of POF: \<40 years old, at least 4 months of amenorrhea not due to pregnancy, two FSH levels above 40 IU/L, at least one month apart.
3. Not in other trial within 3 months prior to the start of this trial.
4. Willing to participate in this trial and to give informed consent/assent before any procedures are performed in this trial.
Exclusion Criteria:
1. History of, or evidence of current malignancy within the past 5 years.
2. Severe functional impairment of vital organs.
3. Abnormal karyotype.
4. Coagulation disorders.
5. Severe pelvic adhesions.
6. Uncontrolled acute or chronic gynecologic inflammation.
7. Congenital adrenal cortical hyperplasia.
8. Cushing's syndrome.
9. Thyroid dysfunction.
10. Pituitary adenoma.
11. Pituitary amenorrhea or Hypothalamic amenorrhea.
12. Thrombophlebitis, venous thrombosis or artery thrombosis.
13. History of Oophorocystectomy.
14. Currently pregnant or breast-feeding.
15. Currently receiving other treatment that might affect the efficacy and safety of stem cells.
16. History of severe drug allergy.
17. Active infection detected by chest X-ray/CT.
18. HIV, TPAb positive.
19. Mental illness.
20. Currently participating in any other clinical trial that uses interventional drugs or examinations.
21. Patients that are deemed, by the investigator, inappropriate to participate in this trial.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02912104
Study Brief:
Protocol Section:
NCT02912104