Autologous Adipose-derived Stromal Vascular Fraction Therapy for Refractory Endometrial Infertility
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion of patients with endometrial thickness of 6 mm or greater
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
AD-SVF therapy
AD-SVF intrauterine infusion therapy
干预措施: AD-SVF (Biological)
结局指标
主要结局
Proportion of patients with endometrial thickness of 6 mm or greater
时间窗: 6 months after AD-SVF intrauterine infusion therapy
During the late proliferative phase, the endometrial thickness between anterior and posterior uterine walls is measured to be at least 6 mm through a median sagittal section of the uterus at least once.
次要结局
- Menstrual flow score at the 2nd month post-treatment(2 months after AD-SVF intrauterine infusion therapy)
- Menstrual flow score at the 6th month post-treatment(6 months after AD-SVF intrauterine infusion therapy)
- Chemical pregnancy(9 months after AD-SVF intrauterine infusion therapy)
- Clinical pregnancy(9 months after AD-SVF intrauterine infusion therapy)
研究者
Yali Hu
M.D., Ph.D.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School