Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency
NCT ID: NCT06481969
Last Updated: 2024-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
260 participants
INTERVENTIONAL
2024-07-23
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A-SVF group
Qualified participants will be randomized into either of two groups. Participants in this group will undergo lower abdominal liposuction, preparation of SVF and ovarian injection, other standard assisted reproductive treatments are similar and parallel between two groups.
Lower abdominal liposuction and preparation of SVF
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.
Ovarian injection
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.
Group B-Control group
Qualified participants will be randomized into either of two groups. Participants in this group will be treated according to the current clinical routine of the reproductive center, other standard assisted reproductive treatments are similar and parallel between two groups.
Conventional IVF
Conventional In Vitro Fertilization (IVF) procedure and standard assisted reproductive treatments.
Interventions
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Conventional IVF
Conventional In Vitro Fertilization (IVF) procedure and standard assisted reproductive treatments.
Lower abdominal liposuction and preparation of SVF
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.
Ovarian injection
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
39 Years
FEMALE
No
Sponsors
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Rui Yang
OTHER
Responsible Party
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Rui Yang
Clinical associate professor
Principal Investigators
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Rui Yang, M.D.
Role: STUDY_DIRECTOR
Peking University Third Hospital
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xiumei Zhen, M.D.
Role: backup
Jia Li, M.D.
Role: backup
Hongsen Bi, M.D.
Role: backup
Xiaojuan Liu, M.D.
Role: backup
Tian Tian, M.D.
Role: backup
Yanru Lou, Bachelor
Role: backup
Chenhong Liu, Bachelor
Role: backup
Jialin Li, Bachelor
Role: backup
Lina Yi, Bachelor
Role: backup
References
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Zhang Y, Liu H, Lou Y, Li J, Liu C, Zhang H, Zhang C, Guo Q, Liu X, Yang W, Li J, Tian T, Zeng L, Xu H, Yang S, Zhen X, Bi H, Yang R, Yu Y, Ma C, Li R, Liu P, Qiao J. Efficacy and safety of autologous adipose tissue-derived stromal vascular fraction in patients with premature ovarian insufficiency: protocol for a single-centre randomised controlled trial. BMJ Open. 2025 Apr 3;15(4):e093804. doi: 10.1136/bmjopen-2024-093804.
Other Identifiers
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SF2024-2-40911
Identifier Type: -
Identifier Source: org_study_id
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