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

Endometrial Leucocytes Around the Time of Embryo Implantation in Women Undergoing in Vitro Fertilization- Embryo Transfer (IVF-ET)

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related
• Intervention / Treatment: Procedure: endometrial biopsy

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Xiaoyan Chen, PhD; Phone Number: 85235051764; Email: chenxiaoyan@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: Xiaoyan Chen, PhD; Phone Number: 85235053199; Email: chenxiaoyan@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women undergoing frozen embryo transfer.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Procedure: endometrial biopsy; . Endometrial samples are obtained using a biopsy catheter as follows: the Pipette is inserted through the cervical os and advanced gently until resistance is felt. The inner piton of the device is then withdrawn to create suction, and the endometrial sample is obtained by moving the pipette up and down approximately 2-3 cm within the uterine cavity. The device is rotated 360° to ensure adequate coverage of the area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
immune cell counting	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.	up to 2 months
Quantification of endometrial immune cells spatial distribution	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	up to 2 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Xiaoyan Chen, PhD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019.277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Please contact the principle investigator if there is any enquiry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No