NCT06481969

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Rui Yang · Academic / Other
• Sex: Female
• Age: 20 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A single-center, large-scale, prospective, randomized controlled clinical trial will enroll 260 patients diagnosed with POI based on the inclusion and exclusion criteria from Peking University Third Hospital. Eligible participants will be randomized to two groups at a ratio of 1:1- SVF protocol, and conventional protocol.The participation in this study will be approximately 2 years with a total of 6 visits and 3 follow-up phone calls.

Conditions

• Premature Ovarian Insufficiency

Interventions

Type	Name	Description
PROCEDURE	Conventional IVF	Conventional In Vitro Fertilization (IVF) procedure and standard assisted reproductive treatments.
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2024-07-23
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2024-07-01
• Last updated: 2024-11-14

Locations

1 site across 1 country: China