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

Last updated: February 26, 2024
Sponsor: Tanta University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Endometrial Biopsy

Clinical Study ID

NCT04867759
uNK in ICSI failure
  • Ages 20-40
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Endometrial Biopsy
Phase:
Study Start date:
May 01, 2021
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • Adel Elgergawy

    Tanta, 3111
    Egypt

    Active - Recruiting

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