Immune Cell Populations in the Endometrium
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorJagiellonian University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 18-45 years
idiopathic infertility
at least 2 miscarriages
other benign gynecological conditions subjected to endometrial sampling
Disqualifiers
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
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Percentage distribution of immune system cells in peripheral blood
Diagnostic testAssessment 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 testAssessment of the percentage distribution of the immune system cell population in endometrium by flow cytometry
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Infertility2 interventions
Group B: Normal fertility2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
up to 6 months2
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
Time frame
up to 6 months3
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
Time frame
up to 6 months4
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
Time frame
up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov