Immune Cell Populations in the Endometrium

March 17, 2026 updated by: Iwona Magdalena Gawron, Jagiellonian University

Analysis of Immune Cell Populations in the Endometrium and Peripheral Blood in Women With Reduced and Normal Fertility

Specialized immunological studies in the diagnostics of idiopathic infertility and recurrent miscarriages have limited applicability, as the role of the immune system in these conditions is not thoroughly understood. In ovulatory cycles, changes occur in the populations of uterine lymphocytes, which may influence the receptivity of the endometrium and the implantation of the embryo. Particularly notable are the changes in natural killer (NK) cells, which reach their peak during the luteal phase and regulate the invasion of the trophoblast. The dominant NK cells exhibit a CD56bright phenotype and differ in cytokine profiles from peripheral blood cells. Cyclical changes also affect macrophages and T lymphocytes; however, it is unclear whether their proportions differ in women with reduced fertility. There is a need to investigate how the composition of lymphocytes in blood influences the populations in the endometrium. The aim of this study is to analyze the correlation between peripheral and endometrial lymphocytes in women with idiopathic infertility and recurrent miscarriages, compared to fertile women.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A cross-sectional study will be conducted among women aged 18-45 years undergoing aspiration biopsy as part of the diagnosis of: i) idiopathic infertility, ii) recurrent miscarriages, iii) other conditions requiring histopathological examination of the endometrium (control).

A 2 ml endometrial biopsy will be collected using the NEXODIS suction cannula on day 20-22 of the cycle, after confirmation of a negative result of B-human chorionic gonadotropin in the blood, and divided into 2 parts: 1 ml will be secured and sent for cytometric examination. At the same time, a peripheral blood sample (10 ml) will be collected in accordance with the SU in-hospital procedure and sent for cytometric examination.

Labeled blood cells and isolated single endometrial cells will be analyzed by flow cytometry using the FACSCanto2 system (BD Biosciences, USA). Blood cells will be stained directly with a panel of antibodies, and endometrial samples will be crushed and filtered before staining to isolate single cells. Then, the stained cells will be washed, erythrocytes will be lysed and centrifuged. It is planned to use a panel of monoclonal antibodies conjugated with fluorochromes, recognising the following markers: CD45, CD56, CD16, CD3, CD64, CD206, CD163, CD80, CD86 and CD138. The study population will be characterised in terms of age, BMI, gynecological data (surgeries, course of the menstrual cycle, nature of bleeding, ultrasound data) and obstetric data (pregnancies, deliveries, miscarriages). Characteristics of the study population, results of cytometric, histopathological, immunohistochemical endometrial and blood cytometric tests and their mutual correlation will be analysed using standard statistical methods.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Krakow, Poland
        • Recruiting
        • Jagiellonian Univeristy
        • Contact:

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

Women undergoing endometrial aspiration biopsy for the diagnosis of: i) idiopathic infertility, ii) recurrent miscarriages, iii) other conditions requiring histopathological examination of the endometrium (control).

Description

Inclusion Criteria:

  • age 18-45 years
  • idiopathic infertility
  • at least 2 miscarriages
  • other benign gynecological conditions subjected to endometrial sampling

Exclusion Criteria:

  • miscarriage within last 3 months
  • abdominal/uterine surgery within last 3 months
  • viral/bacterial infection within last 3 months
  • antibiotic therapy within last 3 months

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
Infertility
Women aged 18-45 with idiopathic infertility/recurrent miscarriages
Diagnostic test: Percentage distribution of immune system cells in peripheral blood
Assessment of the percentage distribution of the immune system cell population in peripheral blood by flow cytometry
Diagnostic test: Percentage distribution of immune system cells in endometrium
Assessment of the percentage distribution of the immune system cell population in endometrium by flow cytometry
Normal fertility
Women aged 18-45 with a history of normal pregnancy obtained by spontaneous fertilization
Diagnostic test: Percentage distribution of immune system cells in peripheral blood
Assessment of the percentage distribution of the immune system cell population in peripheral blood by flow cytometry
Diagnostic test: Percentage distribution of immune system cells in endometrium
Assessment of the percentage distribution of the immune system cell population in endometrium by flow cytometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the percentage of Non-classical monocytes CD16++/ CD14- (% monocytes) in peripheral blood
Time Frame: up to 6 months
Comparison of the percentage of Non-classical monocytes CD16++/ CD14- (% monocytes) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of Intermediate monocytes CD16+/CD14+ (% monocytes) in peripheral blood by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of Intermediate monocytes CD16+/CD14+ (% monocytes) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of Classical monocytes CD16-/CD14++ (% monocytes) in peripheral blood by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of Classical monocytes CD16-/CD14++ (% monocytes) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of plasmocytes (% leukocytes) in peripheral blood by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of plasmocytes (% leukocytes) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of Macrophages M1/M2 CD163+/CD206- (% monocytoid cells) ratio in peripheral blood
Time Frame: up to 6 months
Comparison of the Macrophages M1/M2 CD163+/CD206- (% monocytoid cells) ratio in peripheral blood in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of CD3+ lymphocytes (% lymphocytes) in peripheral blood by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of CD3+ lymphocytes (% lymphocytes) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of B lymphocytes (% lymphocytes) in peripheral blood by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of B lymphocytes (% lymphocytes) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of Total NK (% lymphocytes) in peripheral blood by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of Total NK (% lymphocytes) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of NK CD56++/CD16- (% NK) in peripheral blood
Time Frame: up to 6 months
Comparison of the percentage of NK CD56++/CD16- (% NK) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of NK CD56+/CD16+ (% NK) in peripheral blood by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of NK CD56+/CD16+ (% NK) in both study arms - in the group with normal and reduced fertility fertility
up to 6 months
Assessment of the percentage of NK CD56+/CD16++ (% NK) in peripheral blood by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of NK CD56+/CD16++ (% NK) in both arms of the study - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of NK CD56-/CD16++ (% NK) in peripheral blood by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of NK CD56-/CD16++ (% NK) in both arms of the study - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of Non-classical monocytes CD16++/ CD14- (% monocytes) in endometrium by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of Non-classical monocytes CD16++/ CD14- (% monocytes) in both study arms - in the group with normal and reduced fertility
up to 6 months
ssessment of the percentage of Intermediate monocytes CD16+/CD14+ (% monocytes) in endometrium by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of Intermediate monocytes CD16+/CD14+ (% monocytes) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of Classical monocytes CD16-/CD14++ (% monocytes) in endometrium by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of Classical monocytes CD16-/CD14++ (% monocytes) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the ratio of Macrophages M1/M2 CD163+/CD206- (% monocytoid cells) in endometrium by flow cytometry
Time Frame: up to 6 months
Comparison of the ratio of Macrophages M1/M2 CD163+/CD206- (% monocytoid cells) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of plasmocytes (% leukocytes) in endometrium by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of plasmocytes (% leukocytes) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of CD3+ lymphocytes (% lymphocytes) in endometrium by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of CD3+ lymphocytes (% lymphocytes) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of B lymphocytes (% lymphocytes) in endometrium by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of B lymphocytes (% lymphocytes) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of Total NK (% lymphocytes) in endometrium by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of Total NK (% lymphocytes) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of NK CD56++/CD16- (% NK) in endometrium by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of NK CD56++/CD16- (% NK) in both study arms - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of NK CD56+/CD16+ (% NK) in endometrium by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of NK CD56+/CD16+ (% NK) in both study arms - in the group with normal and reduced fertility fertility
up to 6 months
Assessment of the percentage of NK CD56+/CD16++ (% NK) in endometrium by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of NK CD56+/CD16++ (% NK) in both arms of the study - in the group with normal and reduced fertility
up to 6 months
Assessment of the percentage of NK CD56-/CD16++ (% NK) in endometrium by flow cytometry
Time Frame: up to 6 months
Comparison of the percentage of NK CD56-/CD16++ (% NK) in both arms of the study - in the group with normal and reduced fertility
up to 6 months

Collaborators and Investigators

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

Sponsor

Jagiellonian University

Investigators

  • Study Chair: Kazimierz Pityński, Prof., PhD, Jagiellonian University

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)

July 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

February 8, 2025

First Submitted That Met QC Criteria

February 8, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1072.6120.301.2022

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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