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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04079959
• Other study ID #: 2019.277
• Status: Recruiting
• Start date: September 15, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2020
• Source: Chinese University of Hong Kong
• Contact: Wing Ching Cheung, PhD
• Phone: 85235051764
• Email: cosycheung[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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