Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency
NCT Number: NCT06481969
Acronym: aSVF-POI
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Premature Ovarian Insufficiency
Interventions: PROCEDURE: Conventional IVF|PROCEDURE: Lower abdominal liposuction and preparation of SVF|PROCEDURE: Ovarian injection
Sponsor: Rui Yang
Sex: FEMALE
Age: ADULT
Enrollment: 260
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-12-30
Locations: Peking University Third Hospital, Beijing, Beijing, 100191, China

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.

Primary Outcome Measures: The cumulative clinical pregnancy rate in half a year, Percentage of patients with clinical pregnancy within half a year after treatment, half a year after treatment
Secondary Outcome Measures: Serum level of Anti-Mullerian hormone (AMH), Efficacy rate (%) = The number of patients with two consecutive increases in serum level of AMH after treatment / total number of included patients×100%, half a year after treatment|Antral follicles count (AFC), Efficacy rate (%) = The number of patients with bilateral ovarian AFC increases by at least 2 after treatment / total number of included patients×100%, half a year after treatment|Serum level of sex hormone (E2 and FSH), Efficacy rate (%) = The number of patients with two consecutive increases/decreases in serum level of E2/FSH after treatment / total number of included patients×100%, half a year after treatment|Ovarian volume, Ovarian volume will be recorded before and after treatment. Paired sample t-test or independent sample t-test will be used to compare the changes in ovarian volume between the control and SVF treatment groups, P \< 0.05 will be recorded as significant change in ovarian volume., half a year after treatment|Menstrual status, The frequency, duration and volume of menses within half a year after treatment will be recorded to evaluate whether the menstrual status of patients have improved. Menstrual recovery rate (%) = The number of patients with menstrual recovery after treatment / total number of included patients × 100%., half a year after treatment|Pregnancy outcome, Live births or miscarriage of patients with successful pregnancy within half a year will be followed up. Live birth defined as the delivery of at least one viable fetus after 24 weeks gestation. Miscarriage defined as a loss of pregnancy before 24 weeks gestation. Live birth rate (%) = The number of patients with live births after treatment / total number of included patients×100%. Miscarriage rate (%) = The number of patients with miscarriage after treatment / total number of included patients×100%., 2 years after treatment|Health status of offspring, The health status (survival, physiological and intellectual development) of offspring will be followed up via telephone for 2 years., 2 years after treatment|Adverse reactions, The frequency, date of onset, duration and severity of any local and systemic adverse reactions will be observed and recorded during the entire follow-up period. Incidence rate of adverse reactions (%) = The number of patients with adverse reactions after treatment / total number of included patients×100%., 2 years after treatment