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

NCT04867759 | Recruiting

• 1 other identifier: uNK in ICSI failure
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Repeated Implantation Failure; ICSI Failure; uNatural Killer Cells

Outcome Measures

Primary Outcomes (1)

• Level of uNK cells

  Measurement of level of uNK cells by flowcytometry

  4 months

Study Arms (2)

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

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

Interventions

Endometrial Biopsy PROCEDURE

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; Study group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with repeated implantation faikure

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead
• Mansoura University: collaborator
• Benha University: collaborator

Study Sites (1)

Adel Elgergawy

Tanta, 3111, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endometrial biopsy

Central Study Contacts

Ayman Dawoog, MD

CONTACT

+202020972067; ayman.dawood@med.tanta.edu.eg

Adel Elgergawy, MD

CONTACT

+201002057250; dradelali775@gmail.com

Study Design

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

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: April 30, 2021
• Study Start: May 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 months

Locations

EG (1)