Actively Recruiting
Led by Rui Yang · Updated on 2024-11-14
260
Participants Needed
1
Research Sites
N/A
Total Duration
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.
CONDITIONS
Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months
Participants receive either autologous adipose stromal vascular fraction (SVF) treatment involving lower abdominal liposuction, SVF preparation, and ovarian injection, or conventional IVF treatment according to clinical routine.
6 visits and 3 follow-up phone calls over 2 years
Duration - Up to 2 years after treatment
Participants are monitored for pregnancy outcomes, health status of offspring, and any adverse reactions up to 2 years after treatment.
3 follow-up phone calls
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
R
Rui Yang, M.D.
Y
Yaodong Zhang, Bachelor
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Yaodong Zhang, Hui Liu, Yanru Lou...
https://pubmed.ncbi.nlm.nih.gov/40180397