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.
Women aged ≥20 and ≤39 years who have childbearing requirements.
Cessation of menstruation or oligomenorrhea for at least 4 months
Serum level of basal follicle stimulating hormone (FSH) >25 U/L at least 2 times (during the second to fourth day of the menstrual cycle or during amenorrhea; The interval between the two tests is 4 weeks)
Serum level of Anti-Mullerian hormone (AMH) ≤1.1 ng/ml
Women with autoimmune diseases.
Women with abnormal and uncontrolled thyroid function.
Women with tumors in bilateral adnexa that are not clearly benign or malignant.
Women with a history of malignant tumors, radiation therapy or chemotherapy.
Parallel
Conventional IVF
Procedure/SurgeryConventional In Vitro Fertilization (IVF) procedure and standard assisted reproductive treatments.
Lower abdominal liposuction and preparation of SVF
Procedure/SurgeryAfter 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.
Ovarian injection
Procedure/SurgeryUnder 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.
The cumulative clinical pregnancy rate in half a year
Percentage of patients with clinical pregnancy within half a year after treatment
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%
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%
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%
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.
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Rui Yang
Lead sponsor
Peking University Third Hospital
Sponsor institution
