Is There a Correlation Between Endometrial CD56 Levels and the Unfavorable KIR AA Genotype in IVF Implantation Success?

January 22, 2025 updated by: Calla IVF Center
This prospective observational study was conducted over 12 months and involved 80 IVF patients aged 20-40 years. Patients were divided into two groups based on KIR genotype (KIR AA and non-KIR AA). Endometrial biopsies were collected during the mid-luteal phase for immunohistochemical analysis of CD56+ NK cell levels. Statistical analyses, including logistic regression and ROC curve evaluation, assessed the relationship between CD56 levels, KIR genotype, and implantation success.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Bihor
      • Oradea, Bihor, Romania, 410103
        • Calla Ivf Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

A total of 80 patients were included, with 40 in each group (KIR AA and non-KIR AA). All participants provided written informed consent, and the study protocol was approved by the institutional ethics committee.

Description

Inclusion Criteria:

  • Female patients aged 20-40 years.
  • Normal uterine cavity confirmed by hysteroscopy or sonohysterography.
  • At least three previous failed IVF cycles or a history of recurrent pregnancy loss (RPL).

Exclusion Criteria:

  • uterine abnormalities,
  • systemic autoimmune diseases,
  • severe male infertility factors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
KIR AA (Group A)
In any pregnancy, the maternal KIR genotype could be AA (mostly inhibitory KIRs), AB, or BB (mostly activating KIRs). A KIR AA haplotype is defined as cen-A and tel-A
Other: Establishing the correlation between KIR AA and KIR non-AA and CD56 endometrial cells and IVF succes
The analysis aimed to compare CD56 levels between patients with the KIR AA genotype and those without. A multiple linear regression model was used to determine the predictive value of CD56+ levels, KIR genotype, and age on the number of blastocysts.
KIR non AA (Group B)
In any pregnancy, the maternal KIR genotype could be AA (mostly inhibitory KIRs), AB, or BB (mostly activating KIRs). KIR Bb haplotype is described as cenB/telB, cenA/telB, or cenB/telA
Other: Establishing the correlation between KIR AA and KIR non-AA and CD56 endometrial cells and IVF succes
The analysis aimed to compare CD56 levels between patients with the KIR AA genotype and those without. A multiple linear regression model was used to determine the predictive value of CD56+ levels, KIR genotype, and age on the number of blastocysts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the relationship between endometrial CD56+ NK cells, KIR AA genotypes, and IVF success.
Time Frame: 12 months
The value of CD56 NK cell and KIR AA in patients undergoing IVF and pregnancy rate
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calla IVF Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2023

Primary Completion (Actual)

August 15, 2024

Study Completion (Actual)

December 11, 2024

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CALLAIVF KIR HLAC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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