Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Diminished Ovarian Reserve

Condition(s) studied

Investigational drug(s) / intervention(s)

Lower abdominal liposuction and preparation of SVF: After lower abdominal liposuction (the liposuction volume is about 200 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: Under ultrasound guidance, the SVF suspension will be transplanted into the patient's bilateral ovaries by a reproductive endocrinologist. Briefly, both ovaries will be intramedullary injected on multiple sites using a 17-gauge single-lumen needle. A total of 1-2×107 cells from autologous adipose tissue will be injected into each ovary. Approximately 330±10µL of SVF suspension will be administered at each point, 1mL per ovary in total. Following the infusion procedure, the pelvis will be thoroughly examined via ultrasonography in order to check for total vascular integrity. Anaesthetic drugs will not be used during this procedure, but analgesics may be administered if necessary. After the injection, patients will be required to lie flat for 2h to monitor for any AEs.

Conventional ART treatment: Conventional assisted reproductive technology (ART) treatment including in vitro fertilisation and embryo transfer (IVF-ET) and intracytoplasmic sperm injection (ICSI) ; Standard assisted reproductive treatments.

Hormone Replacement Therapy (HRT): If necessary, oral administration of hormones such as Fenbolone can be given for replacement therapy.

Study summary

A multi-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 DOR.

Eligibility

Primary outcome measure(s)

• The cumulative clinical pregnancy rate within 6 months in women with DOR undergoing IVF — Within 6 months after treatment
  This will be calculated as: cumulative clinical pregnancy rate (%)= number of participants obtain clinical pregnancy within 6 months / total number of participants×100%. Clinical pregnancy refers to the condition where ultrasound can detect one or more viable gestational sacs.

Trial sites (4)

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