Infertility, FemaleNCT06826365
Immune Cell Populations in the Endometrium
An observational study of Infertility, Female and Recurrent Miscarriage, run by Jagiellonian University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Female, Recurrent Miscarriage, Gynecologic Disease
- What is being tested?
- Percentage distribution of immune system cells in peripheral blood and Percentage distribution of immune system cells in endometrium
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
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).
Who may be able to join
- age 18-45 years
- idiopathic infertility
- at least 2 miscarriages
- other benign gynecological conditions subjected to endometrial sampling
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Jagiellonian Univeristy
Krakow
Iwona Gawron, Ph.D., M.D., +48 124248570, iwona.gawron@gmail.com
About this study
Official title: Analysis of Immune Cell Populations in the Endometrium and Peripheral Blood in Women With Reduced and Normal Fertility
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.
Read the 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.
- Being tested
- Percentage distribution of immune system cells in peripheral blood, Percentage distribution of immune system cells in endometrium
- Keywords
- Idiopathic infertility, Endometrial immunology, Endometrial aspiration biopsy, Recurrent miscarriage
- Medical subject headings
- Infertility, Female, Abortion, Habitual, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Infertility | Women aged 18-45 with idiopathic infertility/recurrent miscarriages Receives: Diagnostic Test: Percentage distribution of immune system cells in peripheral blood; Diagnostic 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 Receives: Diagnostic Test: Percentage distribution of immune system cells in peripheral blood; Diagnostic Test: Percentage distribution of immune system cells in endometrium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Jul 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Magdalena Gawron, Jagiellonian University
- Investigators
- Kazimierz Pityński, Prof., PhD, Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826365
- Sponsor's protocol ID
- 1072.6120.301.2022
- Status last verified
- Mar 2026
- First submitted
- 8 Feb 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Immune Cell Populations in the Endometrium and Peripheral Blood in Women With Reduced and Normal Fertility
- ClinicalTrials.gov ID
- NCT06826365
- Acronym / sponsor ID
- 1072.6120.301.2022
- Keywords
- Idiopathic infertility, Endometrial immunology, Endometrial aspiration biopsy, Recurrent miscarriage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infertility | – | Diagnostic Test: Percentage distribution of immune system cells in peripheral blood, Diagnostic Test: Percentage distribution of immune system cells in endometriumWomen aged 18-45 with idiopathic infertility/recurrent miscarriages |
| Normal fertility | – | Diagnostic Test: Percentage distribution of immune system cells in peripheral blood, Diagnostic Test: Percentage distribution of immune system cells in endometriumWomen aged 18-45 with a history of normal pregnancy obtained by spontaneous fertilization |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- 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).
Key inclusion criteria (4 listed)
- age 18-45 years
- idiopathic infertility
- at least 2 miscarriages
- other benign gynecological conditions subjected to endometrial sampling
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percentage distribution of immune system cells in peripheral bloodAssessment of the percentage distribution of the immune system cell population in peripheral blood by flow cytometry | Diagnostic test | Infertility, Normal fertility |
| Percentage distribution of immune system cells in endometriumAssessment of the percentage distribution of the immune system cell population in endometrium by flow cytometry | Diagnostic test | Infertility, Normal fertility |
Primary outcome
Assessment of the percentage of Non-classical monocytes CD16++/ CD14- (% monocytes) in peripheral blood
Time frame: up to 6 months
Comparison of the percentage of Non-classical monocytes CD16++/ CD14- (% monocytes) in both study arms - in the group with normal and reduced fertility
Assessment of the percentage of Intermediate monocytes CD16+/CD14+ (% monocytes) in peripheral blood by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of Intermediate monocytes CD16+/CD14+ (% monocytes) in both study arms - in the group with normal and reduced fertility
Assessment of the percentage of Classical monocytes CD16-/CD14++ (% monocytes) in peripheral blood by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of Classical monocytes CD16-/CD14++ (% monocytes) in both study arms - in the group with normal and reduced fertility
Assessment of the percentage of plasmocytes (% leukocytes) in peripheral blood by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of plasmocytes (% leukocytes) in both study arms - in the group with normal and reduced fertility
Assessment of Macrophages M1/M2 CD163+/CD206- (% monocytoid cells) ratio in peripheral blood
Time frame: up to 6 months
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
Assessment of the percentage of CD3+ lymphocytes (% lymphocytes) in peripheral blood by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of CD3+ lymphocytes (% lymphocytes) in both study arms - in the group with normal and reduced fertility
Assessment of the percentage of B lymphocytes (% lymphocytes) in peripheral blood by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of B lymphocytes (% lymphocytes) in both study arms - in the group with normal and reduced fertility
Assessment of the percentage of Total NK (% lymphocytes) in peripheral blood by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of Total NK (% lymphocytes) in both study arms - in the group with normal and reduced fertility
Assessment of the percentage of NK CD56++/CD16- (% NK) in peripheral blood
Time frame: up to 6 months
Comparison of the percentage of NK CD56++/CD16- (% NK) in both study arms - in the group with normal and reduced fertility
Assessment of the percentage of NK CD56+/CD16+ (% NK) in peripheral blood by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of NK CD56+/CD16+ (% NK) in both study arms - in the group with normal and reduced fertility fertility
Assessment of the percentage of NK CD56+/CD16++ (% NK) in peripheral blood by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of NK CD56+/CD16++ (% NK) in both arms of the study - in the group with normal and reduced fertility
Assessment of the percentage of NK CD56-/CD16++ (% NK) in peripheral blood by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of NK CD56-/CD16++ (% NK) in both arms of the study - in the group with normal and reduced fertility
Assessment of the percentage of Non-classical monocytes CD16++/ CD14- (% monocytes) in endometrium by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of Non-classical monocytes CD16++/ CD14- (% monocytes) in both study arms - in the group with normal and reduced fertility
ssessment of the percentage of Intermediate monocytes CD16+/CD14+ (% monocytes) in endometrium by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of Intermediate monocytes CD16+/CD14+ (% monocytes) in both study arms - in the group with normal and reduced fertility
Assessment of the percentage of Classical monocytes CD16-/CD14++ (% monocytes) in endometrium by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of Classical monocytes CD16-/CD14++ (% monocytes) in both study arms - in the group with normal and reduced fertility
Assessment of the ratio of Macrophages M1/M2 CD163+/CD206- (% monocytoid cells) in endometrium by flow cytometry
Time frame: up to 6 months
Comparison of the ratio of Macrophages M1/M2 CD163+/CD206- (% monocytoid cells) in both study arms - in the group with normal and reduced fertility
Assessment of the percentage of plasmocytes (% leukocytes) in endometrium by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of plasmocytes (% leukocytes) in both study arms - in the group with normal and reduced fertility
Assessment of the percentage of CD3+ lymphocytes (% lymphocytes) in endometrium by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of CD3+ lymphocytes (% lymphocytes) in both study arms - in the group with normal and reduced fertility
Assessment of the percentage of B lymphocytes (% lymphocytes) in endometrium by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of B lymphocytes (% lymphocytes) in both study arms - in the group with normal and reduced fertility
Assessment of the percentage of Total NK (% lymphocytes) in endometrium by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of Total NK (% lymphocytes) in both study arms - in the group with normal and reduced fertility
Assessment of the percentage of NK CD56++/CD16- (% NK) in endometrium by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of NK CD56++/CD16- (% NK) in both study arms - in the group with normal and reduced fertility
Assessment of the percentage of NK CD56+/CD16+ (% NK) in endometrium by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of NK CD56+/CD16+ (% NK) in both study arms - in the group with normal and reduced fertility fertility
Assessment of the percentage of NK CD56+/CD16++ (% NK) in endometrium by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of NK CD56+/CD16++ (% NK) in both arms of the study - in the group with normal and reduced fertility
Assessment of the percentage of NK CD56-/CD16++ (% NK) in endometrium by flow cytometry
Time frame: up to 6 months
Comparison of the percentage of NK CD56-/CD16++ (% NK) in both arms of the study - in the group with normal and reduced fertility
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kazimierz Pityński, Prof., PhD study chair
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Recurrent Miscarriage, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iwona Gawron, PhD, MD (+48 124248570, iwona.gawron@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the percentage of Non-classical monocytes CD16++/ CD14- (% monocytes) in peripheral blood (time frame: up to 6 months). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.