Endometrial Leucocytes Around the Time of Embryo Implantation in Women Undergoing in IVF-ET

• Conditions: Pregnancy Related
• Interventions: Procedure: endometrial biopsy

• Registration Number: NCT04079959
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Study Start: 2019-09-15
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-23
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Women undergoing frozen embryo transfer.

Exclusion Criteria

• 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
• BMI >35

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
women who are undergoing frozen embryo transfer	endometrial biopsy	endometrial biopsy will be done one cycle before the frozen embryo transfer

Primary Outcome Measures

Name	Time	Method
immune cell counting	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	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

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong