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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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04079959
Enrollment
120
Registered
2019-09-06
Start date
2019-09-15
Completion date
2023-12-31
Last updated
2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related

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.

Interventions

PROCEDUREendometrial 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.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years

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

Design outcomes

Primary

MeasureTime frameDescription
immune cell countingup to 2 monthsThe 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 distributionup to 2 monthsIn 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

Countries

Hong Kong

Contacts

Primary ContactWing Ching Cheung, PhD
cosycheung@cuhk.edu.hk85235051764
Backup ContactXiaoyan Chen, PhD
chenxiaoyan@cuhk.edu.hk85235051764

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026