Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency

Last updated: November 12, 2024
Sponsor: Rui Yang
Overall Status: Active - Recruiting

Phase

N/A

Condition

Perimenopause

Treatment

Lower abdominal liposuction and preparation of SVF

Ovarian injection

Conventional IVF

Clinical Study ID

NCT06481969
SF2024-2-40911
  • Ages 20-39
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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; Theinterval between the two tests is 4 weeks)

  • Serum level of Anti-Mullerian hormone (AMH) ≤1.1 ng/ml

  • Women with intact uterus and bilateral adnexa.

  • Voluntary participation and informed consent obtained.

Exclusion

Exclusion Criteria:

  • 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.

  • Women with a history of venous thrombosis or pulmonary embolism during the screeningperiod.

  • Women with severe illnesses that are not suitable for pregnancy, such as diseases ofthe circulatory system, urinary system, digestive system, endocrine system,respiratory system, immune system, mental or neurological system, etc.

  • Women who continuously used systemic glucocorticoids or other immunosuppressantsfor≥3 weeks within 6 months before administration and women who used systemicglucocorticoids (prednisone≥20 mg/d or equivalent dose) or other immunosuppressantswithin 3 days before administration.

  • Women who are allergic to the active ingredients or excipients of test drugs.

  • Women with a family history of severe genetic diseases or gynecologic malignancies.

Study Design

Total Participants: 260
Treatment Group(s): 3
Primary Treatment: Lower abdominal liposuction and preparation of SVF
Phase:
Study Start date:
July 23, 2024
Estimated Completion Date:
December 30, 2026

Study Description

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.

Connect with a study center

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Active - Recruiting

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