Clinical Study of Stem Cells in the Treatment of Thin Endometrium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- the change of endometrial thickness
研究概览
简要总结
This is a non-blind self-control trial. We mainly compare the changes of endometrial thickness，changes in menstrual flow, and improvement in pregnancy before and after stem cell treatment in patients with thin endometrium.
详细描述
According to the medical history and the results of the examination, the selected cases were screened and the informed consent was signed. After hysteroscopy, the collagen/umbilical cord mesenchymal stem cell was spread on a foley catheter, and placed in the uterine cavity, and 5 ml of saline was filled into the balloon. B-ultrasound confirmed that the stent was attached to the uterine wall. The balloon was removed in situ after 1 week. We mainly compare the endometrial thickness before and 6 months after surgery.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •According to the GCP regulations, obtain the informed consent of the subject, volunteer for the test, and have signed the informed consent form.
- •Women aged 20-40 years with fertility requirements
- •Infertility patients who are treated in this hospital
- •After more than 2 times of hysteroscopic adhesion separation surgery, the uterine cavity morphology has basically returned to normal. The patient has a normal menstrual cycle or an estrogenic dose of 6 mg per day, and the highest thickness of the endometrium is 5.5 mm in 6 cycles by ultrasound.
- •or receive adjuvant reproductive treatment, the endometrial thickness is less than 5.5mm for unknown reasons, the treatment of estrogen, colony stimulating factor, aspirin, sildenafil and other drugs up to 8mg / day is invalid.
- •HBVAg negative, HCV negative, HIV negative, syphilis negative
- •Normal bone marrow morphology, normal blood routine
- •Previously failed to receive relevant stem cell therapy
排除标准
- •Those who cannot accept the treatment observation process required by the test
- •There are contraindications for hysteroscopic surgery;
- •congenital uterine malformation; severe adenomyosis; uterine fibroids that may affect embryo implantation; the investigators judged that there are other uterine factors that are not suitable for embryo implantation
- •Patients with chromosomal abnormalities
- •contraindications to estrogen therapy; systemic diseases such as thrombosis, cardiopulmonary disease, hematopoietic diseases, malignant tumors, etc.
- •Patients without fertility requirements
研究组 & 干预措施
stem cell therapy
干预措施: umbilical cord mesenchymal stem cells combined with collagen scaffold (Drug)
结局指标
主要结局
the change of endometrial thickness
时间窗: Change from Baseline endometrial thickness at 6 months
B-ultrasound measures and compares the endometrial thickness of the luteal phase before and after administration.
次要结局
- pregnancy rate(pregnancy rate at 1 year)
- live birth rate(live birth rate at 1 year)
- abortion rate(abortion rate at 1 year)
研究者
Xiaona Lin
senior doctor
Sir Run Run Shaw Hospital