NCT06826365

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jul 2025Jun 2026

First Submitted

Initial submission to the registry

February 8, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

February 8, 2025

Last Update Submit

March 17, 2026

Conditions

Infertility, FemaleRecurrent MiscarriageGynecologic Disease

Keywords

Idiopathic infertilityEndometrial immunologyEndometrial aspiration biopsyRecurrent miscarriage

Outcome Measures

Primary Outcomes (24)

  • Assessment of the percentage of Non-classical monocytes CD16++/ CD14- (% monocytes) in peripheral blood

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

Study Arms (2)

Infertility

Women aged 18-45 with idiopathic infertility/recurrent miscarriages

Diagnostic Test: Percentage distribution of immune system cells in peripheral bloodDiagnostic Test: Percentage distribution of immune system cells in endometrium

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 bloodDiagnostic Test: Percentage distribution of immune system cells in endometrium

Interventions

Percentage distribution of immune system cells in peripheral bloodDIAGNOSTIC_TEST

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

InfertilityNormal fertility
Percentage distribution of immune system cells in endometriumDIAGNOSTIC_TEST

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

InfertilityNormal fertility

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jagiellonian Univeristy

Krakow, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

* 1 ml endometrial sample * 10 ml peripheral blood sample

MeSH Terms

Conditions

Infertility, FemaleAbortion, HabitualGenital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityAbortion, SpontaneousPregnancy Complications

Study Officials

  • Kazimierz Pityński, Prof., PhD

    Jagiellonian University

    STUDY CHAIR

Central Study Contacts

Iwona Gawron, PhD, MD

CONTACT

+48 124248570iwona.gawron@uj.edu.pl

Robert Jach, Prof., PhD

CONTACT

+48 124248570jach@cm-uj.krakow.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD, Principal Investigator

Study Record Dates

First Submitted

February 8, 2025

First Posted

February 14, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations

PL(1)