Uterine Natural Killer (uNK) Cell Expression in Patients With Repeated ICSI Failures: A Multicenter Cohort Study (UNK)

uterine NK (uNK) cells are characterized by a high expression of CD56 (CD56brihgt), lack of CD16 expression, high secretion of cytokines and rather low cytotoxic activity. It has been shown that uNK cells increase in number during the late secretory phase and during early pregnancy. This study was designed to assess the possible role of uNK cells in repeated ICSI failure.

Study Overview

• Status: Recruiting
• Conditions: Repeated Implantation Failure; ICSI Failure; uNatural Killer Cells
• Intervention / Treatment: Procedure: Endometrial Biopsy

Detailed Description

For occurrence of the "window of implantation", the endometrium must proliferate, increase in thickness, then, after ovulation, adequately respond to progesterone, and become receptive. Ultrasound examination of the thickness and appearance of the endometrium is an easily performed means of assessing morphological changes occurring in the endometrium during the follicular phase, and is thus used as a measure to predict successful implantation. Indeed, several studies have reported a strong association between endometrial thickness and successful implantation. However, others failed to confirm such an association. The minimal adequate endometrial thickness for successful implantation, as measured in the late proliferative phase, varies between studies, with a range of 6-8 mm. However, although rare, some investigators have reported successful implantation in an endometrium of no more than 5 mm thickness.

Uterine NK cell testing can only be done via an endometrial biopsy. Uterine natural killer cells never come into direct contact with the fetal cells-they only have direct access to placental cells.The biopsy is performed on day 21 of your menstrual cycle, when the NK cell count is at its highest. The procedure is done at outpatient clinics and results take about two weeks to receive. If your NK cell activity reading is greater than 14 % on day 21 biopsy, then diagnosed with high levels of NK cell activity.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Adel Elgergawy, MD; Phone Number: +201002057250; Email: dradelali775@gmail.com
• Study Contact Backup: Name: Ayman Dawoog, MD; Phone Number: +202020972067; Email: ayman.dawood@med.tanta.edu.eg

Study Locations

• Egypt
  • Tanta, Egypt, 3111
    • Recruiting
    • Adel Elgergawy
    • Contact: Adel Elgergawy, MD; Phone Number: +201002057250; Email: dradelali775@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with repeated implantation faikure

Description

Inclusion Criteria:

• Patients with IVF/ICSI failures more than 2 times
• Age 20-40 years

Exclusion Criteria:

• prior uterine surgery
• immunological disease
• previous testing to uNK cells

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; On outpatient basis, we will take a uterine sample on mid-luteal phase day 21 by Novac curette or pipelle aspirator. Samples of endometrium will be kept in formaline solution and will be sent to National Institute of research and medical sceinces at Alexandria University to be tested for uNK Cells CD56.	Procedure: Endometrial Biopsy; On outpatient basis, we will take a uterine sample on mid-luteal phase day 21 by Novac curette or pipelle aspirator. Samples of endometrium will be kept in formaline solution and will be sent to National Institute of research and medical sceinces at Alexandria University to be tested for uNK Cells CD56.
Control group; On outpatient basis, we will take a uterine sample on mid-luteal phase day 21 by Novac curette or pipelle aspirator. Samples of endometrium will be kept in formaline solution and will be sent to National Institute of research and medical sceinces at Alexandria University to be tested for uNK Cells CD56.	Procedure: Endometrial Biopsy; On outpatient basis, we will take a uterine sample on mid-luteal phase day 21 by Novac curette or pipelle aspirator. Samples of endometrium will be kept in formaline solution and will be sent to National Institute of research and medical sceinces at Alexandria University to be tested for uNK Cells CD56.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of uNK cells	Measurement of level of uNK cells by flowcytometry	4 months

Collaborators and Investigators

• Sponsor: Tanta University
• Collaborators: Mansoura University; Benha University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: uNK in ICSI failure

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On valuable request
• IPD Sharing Time Frame: 3 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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