Endometrial Leucocytes Around the Time of Embryo Implantation in Women Undergoing in Vitro Fertilization- Embryo Transfer (IVF-ET)
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- immune cell counting
研究概览
简要总结
Uterine natural killer (uNK) cells have been implicated to play a role in female reproductive performance. Serval studies showed an increased uNK cell density in the endometrium of women with reproductive failure. In this study, we wish to investigate the density and clustering of four different immune cells.
详细描述
Implantation is a process whereby the embryo attaches itself to the endometrium. In humans, the endometrium has a specific period of uterine receptivity, which occurs 5-7 days after ovulation and remains receptive for ~4 days (cycle days 20-24), when embryo implantation starts. Implantation failure refers to the failure of the embryo to reach a stage when intrauterine gestational sac is recognized by ultrasonography. It occurs when the embryo is abnormal or when endometrial function is impaired.
Uterine natural killer (uNK) cells have been implicated to play a role in female reproductive performance. They comprise 70-80% of the total leukocyte population in the endometrium during implantation and early pregnancy. Several studies showed an increased uNK cell density in the endometrium of women with reproductive failure. To better understand the contribution of various immune factors to endometrial function and future pregnancy, it is proposed to examine the major immune cells in the same specimen to measure the relative magnitude of the cell density changes and the degree of clustering between two immune cell types.
The aim of this study is to investigate the endometrial leucocytes profile around the time of embryo implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing frozen embryo transfer.
排除标准
- •Women older than 40 years
- •Women who have any uterine anomaly or intrauterine pathology such as:
- •Endometrial polyp or/ and Large fibroid with a diameter >4 cm
- •Visible hydrosalpinx on transvaginal ultrasound scans
结局指标
主要结局
immune cell counting
时间窗: up to 2 months
The counting method will be performed according to an agreed and published standardized protocol by a multicenter working group designed to reduce variance of results between centres. Ten images of 40X magnification fields will be analyzed for each sample. The first field to be captured should be selected at random, ensuring that it contained the luminal epithelial border. Subsequent fields should be obtained by moving one field to the left or right of the original field, keeping the luminal epithelial border in view.
Quantification of endometrial immune cells spatial distribution
时间窗: up to 2 months
In each 200 times under the microscope vision, based on the X and Y position of each single cell which InForm system could provide, the relative spatial distribution of each individual endometrial immune cell will be considered as a bivariate point pattern
次要结局
未报告次要终点
研究者
Chen Xiaoyan
Research Assistant Professor
Chinese University of Hong Kong