An observational study in Infertility, Female, Recurrent Miscarriage and Gynecologic Disease, sponsored by Jagiellonian University. Recruiting at 1 site in Poland. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Jagiellonian University · Observational
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.
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.
552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.
This study's planned enrollment of 50 is below the median of 161 across 162 observational studies indexed under Infertility, Female.
Browse Infertility, Female studies →Jagiellonian University is the lead sponsor of 161 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Women aged 18-45 with idiopathic infertility/recurrent miscarriages
Diagnostic Test: Percentage distribution of immune system cells in peripheral blood · Diagnostic Test: Percentage distribution of immune system cells in endometrium
Women aged 18-45 with a history of normal pregnancy obtained by spontaneous fertilization
Diagnostic Test: Percentage distribution of immune system cells in peripheral blood · Diagnostic Test: Percentage distribution of immune system cells in endometrium
Assessment of the percentage distribution of the immune system cell population in peripheral blood by flow cytometry
Assessment of the percentage distribution of the immune system cell population in endometrium by flow cytometry
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 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 6 months
Started Jul 2025 (actual). Primary completion is estimated for Jun 2026, 11 months after the start.
Of 85 non-industry observational studies under Infertility, Female, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 69. This study's planned 11 months is below that.
Counting every sponsor, half of 88 studies reached it within 36 months; a quarter within 18 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
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