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

NCT ID: NCT04079959

Last Updated: 2020-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-15

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Pregnancy Related

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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women who are undergoing frozen embryo transfer

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

endometrial biopsy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Chen Xiaoyan

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoyan Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Wing Ching Cheung, PhD

Role: CONTACT

85235051764

Xiaoyan Chen, PhD

Role: CONTACT

85235051764

Facility Contacts

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Xiaoyan Chen, PhD

Role: primary

85235053199

Wing Ching Cheung, PhD

Role: backup

85235051764

Other Identifiers

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2019.277

Identifier Type: -

Identifier Source: org_study_id

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