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

NCT04079959 | Unknown

• 1 other identifier: 2019.277
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

women who are undergoing frozen embryo transfer

endometrial biopsy will be done one cycle before the frozen embryo transfer

Procedure: endometrial biopsy

Interventions

endometrial biopsy PROCEDURE

. 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 The inner piton of the device is then withdrawn to create suction, and the endometrial sample is obtained by moving the pipette up and down approximately 2-3 cm within the uterine cavity.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.

women who are undergoing frozen embryo transfer

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Endometrial biopsies will be collected for all the participants
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing frozen embryo transfer.

You may qualify if:

• Women undergoing frozen embryo transfer.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

endometrial samples will be stored

Study Officials

• Xiaoyan Chen, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wing Ching Cheung, PhD

CONTACT

85235051764; cosycheung@cuhk.edu.hk

Xiaoyan Chen, PhD

CONTACT

85235051764; chenxiaoyan@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 6, 2019
• Study Start: September 15, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

HK (1)