HealthyNCT05609799
Distribution of Immune Cells Subsets in Healthy Females
A study testing Blood sample in people with Healthy, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
This study aims to evaluate the distribution of different lymphocyte subsets and other immune biomarkers in peripheral blood in healthy Danish females of reproductive age and to make a research biobank for future research. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2022to 17 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Healthy women of fertile age (18-41 years) with a regular menstrual cycle (22-35 days) who are in the luteal phase of their menstrual cycle at the time collecting the blood sample (day 20 to 28 of cycle and serum progesterone > 20 nmol/l at the day of blood sample). The group should consist of an approximately 1:1 ratio of women with ≥1 previous liveborn child and women with no previous pregnancy.
Who cannot join
- < 18 years old or >41 years old
- History of ≥1 known pregnancy loss including both spontaneous and missed abortions. An induced abortion is accepted if it was performed more than 2 years before study participation.
- Pregnancy within last 6 months
- Treatment with drugs acting on the immune system or hormonal contraceptive drugs either acting systemically or locally (intrauterine device releasing progesterone).
- Known disease with influence on the immune system and/or endocrine system
- Previously received a blood transfusion
Trial locations and contacts
1 site in 1 country.
Denmark1 site
• The Centre for Recurrent Pregnancy Loss of Western Denmark, Department of Obstetrics and Gynaecology, Aalborg University Hospital,
Aalborg, 9000
About this study
Official title: The Distribution of Leucocyte Subsets in Healthy Danish Females of Reproductive Age
This study aims to evaluate the distribution of different lymphocyte subsets and other immune biomarkers in peripheral blood in healthy Danish females of reproductive age and to make a research biobank for future research. This data will serve as a reference to an ongoing study as well as future studies investigating the impact of the immune system on diseases affecting females in reproductive age.
Read the detailed description
A blood sample will be collected from 37 healthy Danish females of reproductive age; part of material will be analysed immediately and part of it will be stored in a research biobank for future research. The samples are collected by clinicians at the Department of Gynaecology at Aalborg University Hospital (AaUH), and these samples are on the same day delivered to at the Department of Clinical Biochemistry (DCB) and Department of Clinical Immunology (DCI) at AaUH, that will perform the sample analyses. The DCI will store the biobank material.
The blood samples will be collected in EDTA-, citrate- and heparin-stabilised tubes. A white blood cell differential count, progesterone level measurement, and the leukocyte subset analysis will be performed by personnel at the DCB and DCI at AaUH.
Serum-progesterone level will be measured on the same day or the day before the blood samples for immunology testing and biobank is collected to ensure that the participant has ovulated and is in the luteal phase. Only blood samples with a serum progesterone level >20 nmol/l will be accepted for the study and included in the biobank. The result of the serum-progesterone measurement may come after the immunology analyses have started, but if the progesterone level is <20 nmol/l, further analyses will be cancelled, and the biobank material will be destroyed.
The white blood cell differential count (WBC) will be obtained from the Sysmex XN-1000 blood analyser. The analysis for NK-cells, B-cells, and T-cell subsets, including Treg, Th1, Th2 and Th17 in EDTA stabilised samples will be performed by the DCI on a flow cytometer using antibodies specific for surface markers that are exclusive for each leukocyte subset.
Blood for the research biobank comprises the remaining tubes. The serum and plasma in these three tubes will after immediate centrifugation be aliquoted and stored in tubes at -80 C in a locked freezer.
- Conditions
- Healthy
- Being tested
- Blood sample
- Keywords
- immune system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Quantifying the volume of leucocyte subsets: NK-cells, B-cells, and T-cell subsets, including Treg, Th1, Th2 and Th17 in EDTA
| Study group | Role | What they receive |
|---|---|---|
| Healthy females | Other | One blood sample is collected on healthy females in reproductive age. The sample will be analyzed for volumen of leucocyte subsets. Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of NK cells (CD56dim)
CD3- CD56dim CD16+
Measured: lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.
Volume of NK cells (CD56bright)
CD3- CD56bright CD16-
Measured: lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.
Volume of B-cells
CD3- CD19+ B cells
Measured: lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.
Volume of Th1 cells
CD3+CD4+ CXCR3+ CCR6- CCR10-
Measured: lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.
Volume of Th2 cells
CD3+CD4+ CCR4+ CCR6- CCR10-
Measured: lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.
Volume of Th17 cells
CD3+CD4+ CCR4+ CCR6+ CCR10-
Measured: lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.
Volume of Treg cells
CD25+CD127low
Measured: lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Nov 2022
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group of healthy females. A blood sample is collected in the luteal phase; parts are saved for a biobank for future studies and parts are analyzed immediately for leucocyte subsets. This group will serve as a reference to other studies on (immunological) diseases in women of reproductive age.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Nørgaard-Pedersen, Aalborg University Hospital
- Investigators
- Caroline Nørgaard-Pedersen, dr.med, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609799
- Sponsor's protocol ID
- CNPOBC2020b
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Distribution of Leucocyte Subsets in Healthy Danish Females of Reproductive Age
- ClinicalTrials.gov ID
- NCT05609799
- Acronym / sponsor ID
- CNPOBC2020b
- Conditions
- Healthy
- Keywords
- immune system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 8 Nov 2022 (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.
This study aims to evaluate the distribution of different lymphocyte subsets and other immune biomarkers in peripheral blood in healthy Danish females of reproductive age and to make a research biobank for future research. This data will serve as a reference to an ongoing study as well as future studies investigating the impact of the immune system on diseases affecting females in reproductive age.
Detailed description
A blood sample will be collected from 37 healthy Danish females of reproductive age; part of material will be analysed immediately and part of it will be stored in a research biobank for future research. The samples are collected by clinicians at the Department of Gynaecology at Aalborg University Hospital (AaUH), and these samples are on the same day delivered to at the Department of Clinical Biochemistry (DCB) and Department of Clinical Immunology (DCI) at AaUH, that will perform the sample analyses. The DCI will store the biobank material.
The blood samples will be collected in EDTA-, citrate- and heparin-stabilised tubes. A white blood cell differential count, progesterone level measurement, and the leukocyte subset analysis will be performed by personnel at the DCB and DCI at AaUH.
Serum-progesterone level will be measured on the same day or the day before the blood samples for immunology testing and biobank is collected to ensure that the participant has ovulated and is in the luteal phase. Only blood samples with a serum progesterone level >20 nmol/l will be accepted for the study and included in the biobank. The result of the serum-progesterone measurement may come after the immunology analyses have started, but if the progesterone level is <20 nmol/l, further analyses will be cancelled, and the biobank material will be destroyed.
The white blood cell differential count (WBC) will be obtained from the Sysmex XN-1000 blood analyser. The analysis for NK-cells, B-cells, and T-cell subsets, including Treg, Th1, Th2 and Th17 in EDTA stabilised samples will be performed by the DCI on a flow cytometer using antibodies specific for surface markers that are exclusive for each leukocyte subset.
Blood for the research biobank comprises the remaining tubes. The serum and plasma in these three tubes will after immediate centrifugation be aliquoted and stored in tubes at -80 C in a locked freezer.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group of healthy females. A blood sample is collected in the luteal phase; parts are saved for a biobank for future studies and parts are analyzed immediately for leucocyte subsets. This group will serve as a reference to other studies on (immunological) diseases in women of reproductive age.
| Arm | Type | Receives |
|---|---|---|
| Healthy females | Other | Other: Blood sampleOne blood sample is collected on healthy females in reproductive age. The sample will be analyzed for volumen of leucocyte subsets. |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- - Healthy women of fertile age (18-41 years) with a regular menstrual cycle (22-35 days) who are in the luteal phase of their menstrual cycle at the time collecting the blood sample (day 20 to 28 of cycle and serum progesterone > 20 nmol/l at the day of blood sample). The group should consist of an approximately 1:1 ratio of women with ≥1 previous liveborn child and women with no previous pregnancy.
Key exclusion criteria (6 listed)
- < 18 years old or >41 years old
- History of ≥1 known pregnancy loss including both spontaneous and missed abortions. An induced abortion is accepted if it was performed more than 2 years before study participation.
- Pregnancy within last 6 months
- Treatment with drugs acting on the immune system or hormonal contraceptive drugs either acting systemically or locally (intrauterine device releasing progesterone).
- Known disease with influence on the immune system and/or endocrine system
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 |
|---|---|---|
| Blood sampleQuantifying the volume of leucocyte subsets: NK-cells, B-cells, and T-cell subsets, including Treg, Th1, Th2 and Th17 in EDTA | Other | Healthy females |
Primary outcome
Volume of NK cells (CD56dim)
Time frame: lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.
CD3- CD56dim CD16+
Volume of NK cells (CD56bright)
Time frame: lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.
CD3- CD56bright CD16-
Volume of B-cells
Time frame: lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.
CD3- CD19+ B cells
Volume of Th1 cells
Time frame: lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.
CD3+CD4+ CXCR3+ CCR6- CCR10-
Volume of Th2 cells
Time frame: lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.
CD3+CD4+ CCR4+ CCR6- CCR10-
Volume of Th17 cells
Time frame: lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.
CD3+CD4+ CCR4+ CCR6+ CCR10-
Volume of Treg cells
Time frame: lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.
CD25+CD127low
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Yes. upon reasonable request
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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. This study is not recruiting at the moment.
Caroline Nørgaard-Pedersen, dr.med principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Healthy, run by Aalborg University Hospital at 1 site in Denmark.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 24 Nov 2025. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of NK cells (CD56dim) (time frame: lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.). The study lists 7 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 24 Nov 2025.