Status:
RECRUITING
Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency
Lead Sponsor:
Rui Yang
Conditions:
Premature Ovarian Insufficiency
Eligibility:
FEMALE
20-39 years
Phase:
NA
Brief Summary
A single-center, prospective, randomised controlled clinical trial (1:1 treatment ratio), designed to investigate the efficacy and safety of autologous SVF in improving the pregnancy outcome of infert...
Detailed Description
A single-center, large-scale, prospective, randomized controlled clinical trial will enroll 260 patients diagnosed with POI based on the inclusion and exclusion criteria from Peking University Third H...
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.
Key Trial Info
Start Date :
July 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06481969
Start Date
July 23 2024
End Date
December 30 2026
Last Update
November 14 2024
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191