Immune Cell Populations in the Endometrium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Percentage distribution of immune system cells in peripheral blood, Percentage distribution of immune system cells in endometrium.
- Who it may be relevant to
- Registry conditions: Infertility, Female, Recurrent Miscarriage, Gynecologic Disease. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Analysis of Immune Cell Populations in the Endometrium and Peripheral Blood in Women With Reduced and Normal Fertility
Overview
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.
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.
Interventions
- 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
Primary outcome measures
- Assessment of the percentage of Non-classical monocytes CD16++/ CD14- (% monocytes) in peripheral blood [Time frame: 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]
- Assessment of the percentage of Classical monocytes CD16-/CD14++ (% monocytes) in peripheral blood by flow cytometry [Time frame: up to 6 months]
- Assessment of the percentage of plasmocytes (% leukocytes) in peripheral blood by flow cytometry [Time frame: up to 6 months]
- Assessment of Macrophages M1/M2 CD163+/CD206- (% monocytoid cells) ratio in peripheral blood [Time frame: up to 6 months]
- Assessment of the percentage of CD3+ lymphocytes (% lymphocytes) in peripheral blood by flow cytometry [Time frame: up to 6 months]
- Assessment of the percentage of B lymphocytes (% lymphocytes) in peripheral blood by flow cytometry [Time frame: up to 6 months]
- Assessment of the percentage of Total NK (% lymphocytes) in peripheral blood by flow cytometry [Time frame: up to 6 months]
- Assessment of the percentage of NK CD56++/CD16- (% NK) in peripheral blood [Time frame: 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Poland · 1 center
- Jagiellonian Univeristy — Krakow
Identifiers
NCT: NCT06826365 · 1072.6120.301.2022