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Recruiting NCT06481969

Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency

Trial Parameters

Condition Premature Ovarian Insufficiency
Sponsor Rui Yang
Study Type INTERVENTIONAL
Phase N/A
Enrollment 260
Sex FEMALE
Min Age 20 Years
Max Age 39 Years
Start Date 2024-07-23
Completion 2026-12-30
Interventions
Conventional IVFLower abdominal liposuction and preparation of SVFOvarian injection

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 sys

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