Immune cells in the uterine lining
Official title: Analysis of Immune Cell Populations in the Endometrium and Peripheral Blood in Women With Reduced and Normal Fertility
Run by Jagiellonian University · NCT06826365 · Data updated 2026-11-12
This project will test whether the types of immune cells in blood match the immune cells in the uterine lining in women aged 18–45 with unexplained infertility, recurrent miscarriage, or other benign gynecologic reasons who are having an endometrial biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Jagiellonian University Academic / other |
| Locations | 1 site (Krakow) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT06826365 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women 18–45 who are not pregnant and who are undergoing endometrial aspiration for unexplained infertility, recurrent miscarriage, or other benign gynecologic indications, and who meet the timing and exclusion criteria, are ideal candidates.
✕Probably not a fit
Women with a miscarriage, abdominal/uterine surgery, active infection or antibiotic therapy within the past three months, or those whose fertility problems have a known non-immune cause are unlikely to benefit from findings of this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a cross-sectional analysis of women aged 18–45 undergoing endometrial aspiration for idiopathic infertility, recurrent miscarriage, or other benign gynecologic indications as a control group. On cycle day 20–22, after a negative beta-hCG, a 2 ml endometrial biopsy (NEXODIS suction) and a 10 ml peripheral blood sample will be collected; endometrial tissue will be processed to single cells and 1 ml reserved for flow cytometry. Labeled blood cells and isolated endometrial cells will be stained with a panel of monoclonal antibodies (CD45, CD56, CD16, CD3, CD64, CD206, CD163, CD80, CD86, CD138) and analyzed on a FACSCanto2 flow cytometer to quantify NK cells, T cells, macrophages and other populations. Results will compare immune cell distributions between blood and endometrium and between diagnostic groups, with clinical characterization by age, BMI, gynecologic and obstetric history.
Why it matters
Potential benefit: If clear blood–endometrium correlations are found, this could lead to better diagnostic markers or targeted approaches for women with implantation failure or recurrent pregnancy loss.
How similar studies have gone: Prior observational work has described distinctive CD56bright uterine NK cells and cyclical shifts in endometrial immune populations, but these findings have not yet produced widely accepted clinical tests or treatments.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Jagiellonian Univeristy
Krakow, Poland Recruiting
Study contacts
- Study coordinator: Iwona Gawron, PhD, MD
- Email: iwona.gawron@uj.edu.pl
- Phone: +48 124248570
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.