Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency
Rui Yang
260 participants
Jul 23, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria9
- 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.
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Interventions
Conventional In Vitro Fertilization (IVF) procedure and standard assisted reproductive treatments.
After lower abdominal liposuction (the liposuction volume is about 100 ml), the preparation and quality inspection of SVF will be completed by a laboratory with good manufacturing practice-approved facilities immediately. The adipose tissue will be cut into pieces of about 1mm3, and the equal volume of 0.1% collagenase I will be added to digest the adipose tissue. The digestion will be terminated after 40 minutes, followed by isolation, filtration, centrifugation, resuspension and dilution to obtain the SVF suspension. The test items, including bacteria, fungi, viruses and endotoxin, will be tested, and the expression of SVF surface markers, including CD45, CD34, CD31, CD11b, CD44, CD73, CD105 and CD90, will be detected by flow cytometry to ensure the quality of the SVF suspension. After about 4 hours of quality control and detection, the SVF suspension will be transported to the operating room on ice in a sealed incubator.
Under ultrasound guidance, the SVF suspension will be injected into patients' bilateral ovaries. SVF with a total amount of (1\~2)×107 cells from autologous fat tissue will be transplanted into each side of ovary. There are 3 injection points on each side of ovary, and 330±10μl SVF suspension will be administered at each point. The administration volume of each ovary will be 1ml in total. After injection, the patients will be required to lie flat for 2 hours to observe whether there would be adverse events.
Locations(1)
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NCT06481969