NCT06481969 Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency
| NCT ID | NCT06481969 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rui Yang |
| Condition | Premature Ovarian Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2024-07-23 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 260 participants in total. It began in 2024-07-23 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 infertile patients with POI.
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.
Contact & Investigator
Rui Yang, M.D.
STUDY DIRECTOR
Peking University Third Hospital
Frequently Asked Questions
Who can join the NCT06481969 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 39 Years, studying Premature Ovarian Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06481969 currently recruiting?
Yes, NCT06481969 is actively recruiting participants. Contact the research team at yrjeff@126.com for enrollment information.
Where is the NCT06481969 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06481969 clinical trial?
NCT06481969 is sponsored by Rui Yang. The principal investigator is Rui Yang, M.D. at Peking University Third Hospital. The trial plans to enroll 260 participants.