AD-SVF Therapy for Refractory Endometrial Infertility

Официальное название

Autologous Adipose-derived Stromal Vascular Fraction Therapy for Refractory Endometrial Infertility

Обзор

The purpose of this study is to initially explore the efficacy of adipose-derived stromal vascular fraction (AD-SVF) therapy in the treatment of refractory endometrial infertility.

Подробное описание

Patients with refractory thin endometrium (endometrial thickness \< 6 mm at late proliferative phase or after high-dose estrogen therapy) and/or moderate to severe intrauterine adhesion are recruited for fertility. After detailed explanation of the treatment plan, written informed consent will be obtained from the patients. The subjects undergo liposuction performed by plastic surgeons to obtain adipose tissue, from which AD-SVF is isolated and extracted for intrauterine infusion therapy. Six months post-AD-SVF treatment, the improvement in menstrual volume and endometrial thickness will be assessed during follow-up visits. The subjects will be advised, based on their personal inclination, to attempt conception (hysteroscopic surgery will be repeated if necessary), and their early pregnancy outcomes will be documented in subsequent follow-ups.

Вмешательства

• Биопрепарат AD-SVF
  AD-SVF is isolated and extracted from adipose tissue for intrauterine infusion therapy.

Первичные конечные точки

• Proportion of patients with endometrial thickness of 6 mm or greater [Срок оценки: 6 months after AD-SVF intrauterine infusion therapy]

Вторичные конечные точки (4)

• Menstrual flow score at the 2nd month post-treatment [Срок оценки: 2 months after AD-SVF intrauterine infusion therapy]
• Menstrual flow score at the 6th month post-treatment [Срок оценки: 6 months after AD-SVF intrauterine infusion therapy]
• Chemical pregnancy [Срок оценки: 9 months after AD-SVF intrauterine infusion therapy]
• Clinical pregnancy [Срок оценки: 9 months after AD-SVF intrauterine infusion therapy]

Критерии участия

Критерии включения

• refractory thin endometrium (endometrial thickness < 6 mm on the day of ovulation or the day of endometrial transformation during a hormone replacement cycle) and/or moderate to severe intrauterine adhesion；
• Inability to undergo autologous bone marrow stem cells-scaffold (BMSC) transplantation due to failed bone marrow aspiration, or lack of significant effect following the BMSC treatment;
• with fertility intentions;
• normal ovarian function or availability of cryopreserved embryos;
• 18kg/m\^2 < body mass index (BMI) < 30kg/m\^2;

Критерии исключения

• Chromosomal karyotype abnormalities in one spouse;
• Severe endometriosis, uterine fibroids affecting the uterine cavity morphology, or uterine malformations;
• Abnormalities in coagulation function, hepatic or renal function, or other underlying conditions deemed by the investigator to potentially impact the study's progression (uncontrolled hypertension, diabetes, autoimmune diseases, etc.);
• Contraindications for pregnancy;
• Contraindications for hormonal cycle therapy;
• History of pelvic tumors;
• Simultaneous participation in other clinical studies.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanjing Drum Tower Hospital — Нанкин

Идентификаторы

NCT: NCT07230600 · SC2025-006-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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