CClinicalTrials.gg
CompletedNCT06795984Updated Jan 28, 2025

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

An observational study in Pregnancy Rate IVF and Blastocyst IVF, sponsored by Calla IVF Center. Completed at 1 site in Romania. Open to female participants aged 21 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-01-28.

Sponsored by Calla IVF Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
21 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Pregnancy Rate IVF
  • Blastocyst IVF
03

In context

Lead sponsor

Calla IVF Center is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 40 Years
Sexes eligible
Female
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.

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

Exclusion Criteria:

  • uterine abnormalities,
  • systemic autoimmune diseases,
  • severe male infertility factors.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherEstablishing 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.

06

What researchers measure

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

    Time frame: 12 months

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Study locations

1 site
  • Calla Ivf Center
    Oradea, Bihor 410103, Romania
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06795984
Lead sponsor
Calla IVF Center
Responsible party
Sponsor
First posted
Jan 28, 2025
Start date
Aug 12, 2023
Primary completion
Aug 15, 2024
Completion
Dec 11, 2024
Last update
Jan 28, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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