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

NCT06795984 | Completed

• 1 other identifier: CALLAIVF KIR HLAC
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy Rate IVF; Blastocyst IVF

Outcome Measures

Primary Outcomes (1)

• the relationship between endometrial CD56+ NK cells, KIR AA genotypes, and IVF success.

  The value of CD56 NK cell and KIR AA in patients undergoing IVF and pregnancy rate

  12 months

Study Arms (2)

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

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

Interventions

Establishing the correlation between KIR AA and KIR non-AA and CD56 endometrial cells and IVF succes OTHER

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 AA (Group A); KIR non AA (Group B)

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: females undergoing IVF with endometrial biopsy for CD56
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Calla IVF Center: lead

Study Sites (1)

Calla Ivf Center

Oradea, Bihor County, 410103, Romania

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: August 12, 2023
• Primary Completion: August 15, 2024
• Study Completion: December 11, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

RO (1)