Distribution of Immune Cells Subsets in Healthy Females

NCT05609799 | Completed

• 1 other identifier: CNPOBC2020b
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

immune system

Outcome Measures

Primary Outcomes (7)

• Volume of NK cells (CD56dim)

  CD3- CD56dim CD16+

  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-

  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

  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-

  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-

  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-

  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

  lutheal phase, day 20-28 in the menstrual cycle. The sample is collected at 9-10 AM and analysis is initiated within 60min.

Study Arms (1)

Healthy females

OTHER

One blood sample is collected on healthy females in reproductive age. The sample will be analyzed for volumen of leucocyte subsets.

Other: Blood sample

Interventions

Blood sample OTHER

Quantifying the volume of leucocyte subsets: NK-cells, B-cells, and T-cell subsets, including Treg, Th1, Th2 and Th17 in EDTA

Healthy females

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

• The Centre for Recurrent Pregnancy Loss of Western Denmark, Department of Obstetrics and Gynaecology, Aalborg University Hospital,

Aalborg, 9000, Denmark

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Caroline Nørgaard-Pedersen, dr.med

  Aalborg University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No treatment intervention, only a blood sample is collected
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr.med.

Model Details: 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.

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 8, 2022
• Study Start: November 1, 2022
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: November 24, 2025

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: within 3 months
• Access Criteria: upon reasonable request

Locations

DK (1)