Study of Autologous Adipose Stromal Vascular Fraction Injection to Treat Premature Ovarian Insufficiency in Women Aged 20 to 39

What this Trial Is About

Researchers are investigating the use of autologous adipose stromal vascular fraction SVF to improve pregnancy outcomes in women with premature ovarian insufficiency POI. This single-center, prospective, randomized controlled trial aims to evaluate the safety and effectiveness of SVF treatment compared to conventional reproductive care in infertile patients with POI. The study will enroll 260 women diagnosed with POI and is sponsored by Rui Yang. Participants will be randomly assigned to one of two groups. The experimental group will undergo lower abdominal liposuction to collect fat tissue, from which SVF will be prepared and then injected into both ovaries under ultrasound guidance. The control group will receive standard assisted reproductive treatments without SVF. Both groups will receive conventional in vitro fertilization IVF procedures and related reproductive care. Treatment and follow-up will span approximately two years, including six visits and three phone follow-ups. During the study, researchers will monitor various outcomes such as the cumulative clinical pregnancy rate within six months, hormone levels, follicle counts, ovarian volume, menstrual status, pregnancy outcomes, and offspring health over two years. Safety will also be assessed by tracking any adverse reactions. Participants will undergo tests, hormone measurements, ultrasounds, and questionnaires to evaluate these outcomes and monitor their health throughout the study period.

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