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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Conventional IVF
  Conventional In Vitro Fertilization (IVF) procedure and standard assisted reproductive treatments.
• Процедура Lower abdominal liposuction and preparation of SVF
  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 ob
• Процедура Ovarian injection
  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 adv

Первичные конечные точки

• The cumulative clinical pregnancy rate in half a year [Срок оценки: half a year after treatment]

Вторичные конечные точки (8)

• Serum level of Anti-Mullerian hormone (AMH) [Срок оценки: half a year after treatment]
• Antral follicles count (AFC) [Срок оценки: half a year after treatment]
• Serum level of sex hormone (E2 and FSH) [Срок оценки: half a year after treatment]
• Ovarian volume [Срок оценки: half a year after treatment]
• Menstrual status [Срок оценки: half a year after treatment]
• Pregnancy outcome [Срок оценки: 2 years after treatment]
• Health status of offspring [Срок оценки: 2 years after treatment]
• Adverse reactions [Срок оценки: 2 years after treatment]

Критерии участия

Критерии включения

• 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 intact uterus and bilateral adnexa.
• Voluntary participation and informed consent obtained.

Критерии исключения

• 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 screening period.
• Women with severe illnesses that are not suitable for pregnancy, such as diseases of the 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 immunosuppressants for≥3 weeks within 6 months before administration and women who used systemic glucocorticoids (prednisone≥20 mg/d or equivalent dose) or other immunosuppressants within 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Third Hospital — Пекин

Публикации

• Zhang Y, Liu H, Lou Y, Li J, Liu C, Zhang H, Zhang C, Guo Q, Liu X, Yang W, Li J, Tian T, Zeng L, Xu H, Yang S, Zhen X, Bi H, Yang R, Yu Y, Ma C, Li R, Liu P, Qiao J. Efficacy and safety of autologous adipose tissue-derived stromal vascular fraction in patients with premature ovarian insufficiency: protocol for a single-centre randomised controlled trial. BMJ Open. 2025 Apr 3;15(4):e093804. doi: 1 PMID 40180397

Идентификаторы

NCT: NCT06481969 · SF2024-2-40911

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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