RecruitingNot ApplicableNCT06481969

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

Sponsor

Rui Yang

Enrollment

260 participants

Start Date

Jul 23, 2024

Study Type

INTERVENTIONAL

Conditions

Premature Ovarian Insufficiency

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

Sex: FEMALEMin Age: 20 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Conventional IVF, a procedure called Lower abdominal liposuction and preparation of SVF, and others for people with premature ovarian insufficiency. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 20 Years to 39 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREConventional IVF

Conventional In Vitro Fertilization (IVF) procedure and standard assisted reproductive treatments.

PROCEDURELower 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.

PROCEDUREOvarian 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.