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NOT YET RECRUITING
NCT07901218
NA

Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Diminished Ovarian Reserve

Sponsor: Peking University Third Hospital

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

DRUG

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