NCT Number: NCT06481969
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.
Interested in participating?
Request Info20 year–39 year
Female
Interventional
Not applicable
Beijing, Beijing Municipality, 100191, China
Location status: Recruiting
Chenhong Liu, Bachelor
CONTACT
Hongsen Bi, M.D.
CONTACT
Jia Li, M.D.
CONTACT
Jialin Li, Bachelor
CONTACT
Lina Yi, Bachelor
CONTACT
Rui Yang, M.D.
CONTACT
Tian Tian, M.D.
CONTACT
Xiaojuan Liu, M.D.
CONTACT
Xiumei Zhen, M.D.
CONTACT
Yanru Lou, Bachelor
CONTACT
Yaodong Zhang, Bachelor
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Conventional In Vitro Fertilization (IVF) procedure and standard assisted reproductive treatments.
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.
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.
Time frame: half a year after treatment
Percentage of patients with clinical pregnancy within half a year after treatment
Time frame: half a year after treatment
Efficacy rate (%) = The number of patients with two consecutive increases in serum level of AMH after treatment / total number of included patients×100%
Time frame: half a year after treatment
Efficacy rate (%) = The number of patients with bilateral ovarian AFC increases by at least 2 after treatment / total number of included patients×100%
Time frame: half a year after treatment
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%
Time frame: half a year after treatment
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.
Time frame: half a year after treatment
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%.
Time frame: 2 years after treatment
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%.
Time frame: 2 years after treatment
The health status (survival, physiological and intellectual development) of offspring will be followed up via telephone for 2 years.
Time frame: 2 years after treatment
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%.
Contact information is provided by the study sponsor or research team.
Rui Yang, M.D.
CONTACT
Yaodong Zhang, Bachelor
CONTACT
Rui Yang
Other
Acronym: aSVF-POI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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