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

NCT ID: NCT06795984

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-12
• Study Completion Date: 2024-12-11

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

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

Intervention Type: 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 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

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Calla IVF Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Calla Ivf Center

Oradea, Bihor County, Romania

Countries

Romania

Other Identifiers

CALLAIVF KIR HLAC

Identifier Type: -

Identifier Source: org_study_id