Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) on the Endometrial Cells Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in the numbers of certain ednometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior intrauterine PBMC administration
研究概览
简要总结
The behaviour of the endometrium during its receptive phase is highly dependent on the endometrial cell type composition. Each cell type has its role in the endometrial preparation for the invading embryo. Alteration in the immune cells dialogue could be the main reason for unsuccessful implantation in certain patients. Immune cell homeostasis is often improved by intrauterine administration of autologous PBMC.
There have been numerous reports on the positive effects of the intrauterine administration of autologous PBMC on the IVF outcomes (embryo implantation and ongoing pregnancy success). However, there is little data on the direct effect of the PBMC administration on the cell composition of the endometrium. This study will focus on the changes in the endometrial cell populations by PBMC treatment that could lead to IVF outcome improvement.
The aim of this project is to analyze the effect of intrauterine administration of autologous PBMC on the endometrial cell populations and on the IVF outcome parameters (implantation and ongoing pregnancy success as IVF outcome variables).
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participating in Assisted Reproduction Treatment
- •Presenting altered endometrial immune profile
- •Having primary infertility
- •Having regular menstrual cycles
- •Embryo transfer of euploid embryos
排除标准
- •Uterine pathologies
- •Endometrial Bacterial infections
- •Active endometrial inflammation
- •Polycystic ovary syndrome
- •Presence of auto anti-bodies such as anti-TPO, anti-TG, ACA, APA, ANA, and anti-dsDNA
- •Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S
- •Cancer diagnostics
- •Positive HIV, HCV or HBV tests
研究组 & 干预措施
Endometrial cell composition
The cell composition and their quantities will be compared before and after intrauterine administration of PBMC in the endometrial biopsies.
干预措施: Intrauterine administration of autologous peripheral blood mononuclear cells (PBMC) (Biological)
结局指标
主要结局
Change in the numbers of certain ednometrial cell populations (immune cells, stem cells, senescent cells) from their levels one month prior intrauterine PBMC administration
时间窗: One month following intrauterine PBMC administration
Immunohistochemical analysis
Change in the distance between the endometrial immune cells, stem cells and senescent cells in the endometrial stroma from their initial distances one month prior intrauterine PBMC administration
时间窗: One month following intrauterine PBMC administration
Spatial analysis with Visual analysis software
Change in the percentages of the immune cells in the endometrial stroma from their levels one month prior intrauterine PBMC administration
时间窗: One month following intrauterine PBMC administration
Flowcytometric analysis
次要结局
- Embryo implantation rate(Two weeks following embryo transfer)
- Clinical pregnancy rate(Six to 8 weeks of gestation)