New Therapeutic Approaches to Treat Asherman's Syndrome and Endometrial Atrophy Based in BM Stem Cells Autologous Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Implantation Rate
研究概览
简要总结
The purpose of this study is to determine whether Bone Marrow Stem Cell transplantation may improve Assisted Reproduction Techniques (ART) outcomes in refractive Asherman's Syndrome or Atrophic Endometrium.
详细描述
This novel technique refers to the use of CD133+ autologous bone marrow stem-cells to regenerate the endometrium in patients with Asherman's Syndrome, Endometrial Atrophy or any condition that produce a destruction of the endometrium or its de novo creation in a bioengineered uterus.
It requires a previous mobilization in the peripheral blood of CD133+ autologous bone marrow stem cells, subsequent apheresis and transplant of the same cells in the spiral arterioles of the uterus with the aim to regenerate de novo the endometrium. This technique represents a new therapeutical approach for the treatment of endometrial regeneration problems such Asherman Syndrome and the endometrial atrophy since currently no specific treatment for these endometrial pathologies exist.
A prospective experimental non controlled study has been designed in order to assess the effectiveness of these technique as a new tool for treat Asherman's Syndrome and Endometrial Atrophy.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed of Asherman Syndrome and absence of pregnancy after treatment
- •Endometrial atrophy (<6mm) with Implantation Failure
- •Age 20-45 years-old
- •Normal liver, heart and kidney function
- •Presence of menstrual bleeding with Natural Cycle or HRT
- •Absence of psychiatric pathology and ability to accomplish the treatment
- •β-hCG negative
- •Absence of SDT
排除标准
- •Absence of peripheral vein access
- •Lack of accomplish inclusion criteria
结局指标
主要结局
Implantation Rate
时间窗: 6 months
Implantation rate is the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred in a given period.
Ongoing pregnancy rate
时间窗: 9 months
Ongoing pregnancy rate is the percentage of all cycles that lead to presence of heartbeat in Ultrasound scan at the end of the first trimester
Live-birth rate
时间窗: 15 months
Live birth rate is the percentage of all cycles that lead to live birth, and is the pregnancy rate adjusted for miscarriages and stillbirths.
次要结局
- Endometrial thickness prior to the treatment(0)
- Endometrial Thickness after treatment(3-6 months)