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OpenTrials
Completed

NCT Number: NCT06795984

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

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.

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Key information

Age range

21 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Calla Ivf Center

Oradea, Bihor County, 410103, Romania

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Calla IVF Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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