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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04867759
Other study ID # uNK in ICSI failure
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date December 1, 2024

Study information

Verified date February 2024
Source Tanta University
Contact Ayman Dawoog, MD
Phone +202020972067
Email ayman.dawood@med.tanta.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 1, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Adel Elgergawy Tanta

Sponsors (3)

Lead Sponsor Collaborator
Tanta University Benha University, Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of uNK cells Measurement of level of uNK cells by flowcytometry 4 months
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