NCT05609799

Distribution of Immune Cells Subsets in Healthy Females

The Distribution of Leucocyte Subsets in Healthy Danish Females of Reproductive Age

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 41 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Blood sample	Quantifying the volume of leucocyte subsets: NK-cells, B-cells, and T-cell subsets, including Treg, Th1, Th2 and Th17 in EDTA

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-02-17
• Completion: 2023-02-17
• First posted: 2022-11-08
• Last updated: 2025-11-24

Locations

1 site across 1 country: Denmark