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Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Diminished Ovarian Reserve
Sponsor: Peking University Third Hospital
Summary
A multi-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 DOR.
Key Details
Gender
FEMALE
Age Range
20 Years - 39 Years
Study Type
INTERVENTIONAL
Enrollment
260
Start Date
2026-11-01
Completion Date
2029-12-30
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Lower abdominal liposuction and preparation of SVF
After lower abdominal liposuction (the liposuction volume is about 200 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 transplanted into the patient's bilateral ovaries by a reproductive endocrinologist. Briefly, both ovaries will be intramedullary injected on multiple sites using a 17-gauge single-lumen needle. A total of 1-2×107 cells from autologous adipose tissue will be injected into each ovary. Approximately 330±10µL of SVF suspension will be administered at each point, 1mL per ovary in total. Following the infusion procedure, the pelvis will be thoroughly examined via ultrasonography in order to check for total vascular integrity. Anaesthetic drugs will not be used during this procedure, but analgesics may be administered if necessary. After the injection, patients will be required to lie flat for 2h to monitor for any AEs.
Conventional ART treatment
Conventional assisted reproductive technology (ART) treatment including in vitro fertilisation and embryo transfer (IVF-ET) and intracytoplasmic sperm injection (ICSI) ; Standard assisted reproductive treatments.
Hormone Replacement Therapy (HRT)
If necessary, oral administration of hormones such as Fenbolone can be given for replacement therapy.
Locations (4)
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Peking University Third Hospital
Beijing, China
General Hospital of Ningxia Medical University
Ningxia, China
Shanghai Zhongshan Hospital
Shanghai, China