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NCT Number: NCT06826365

Immune Cell Populations in the Endometrium

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.

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Key information

Conditions

Infertility, Female Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynecologic Disease Infertility Pregnancy Complications Recurrent Miscarriage Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

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

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

Treatment and study plan

Percentage distribution of immune system cells in peripheral blood

Diagnostic Test

Assessment of the percentage distribution of the immune system cell population in peripheral blood by flow cytometry

Percentage distribution of immune system cells in endometrium

Diagnostic Test

Assessment of the percentage distribution of the immune system cell population in endometrium by flow cytometry

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Iwona Gawron, PhD, MD

CONTACT

[email protected]

+48 124248570

Robert Jach, Prof., PhD

CONTACT

[email protected]

+48 124248570

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2025
Registry last updated
Mar 19, 2026

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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