跳至主要内容
临床试验/NCT05609799
NCT05609799已完成不适用

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

Aalborg University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Volume of NK cells (CD56bright)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

盲法说明

No treatment intervention, only a blood sample is collected

入排标准

年龄范围
18 Years 至 41 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • - 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.

排除标准

  • < 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

结局指标

主要结局

Volume of NK cells (CD56bright)

时间窗: 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

时间窗: 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 Th17 cells

时间窗: 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

时间窗: 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

Volume of Th2 cells

时间窗: 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 NK cells (CD56dim)

时间窗: 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 Th1 cells

时间窗: 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-

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Caroline Nørgaard-Pedersen

dr.med.

Aalborg University Hospital

研究点 (2)

Loading locations...

相似试验

Distribution of Immune Cells Subsets in Healthy... | 临床试验