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ID
Source
Brief title
Health condition
Not applicable
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of NK cells with activating and inhibitory receptors in peripheral blood
Secondary outcome
Percentage of NK cells with activating and inhibitory receptors in menstrual blood
Background summary
The human the menstrual cycle is a complex physiological process with profound effects on many organs and systems in the body including the immune system. Part of the innate immune system, peripheral blood NK cells show dynamic changes in number as well as cytotoxicity during the menstrual cycle, but the exact nature and consequence of these changes in not yet understood. In the present study, we characterize the variation in the natural killer cell receptors associated with different phases of the menstrual cycle in women with a natural menstrual cycle and also in men. We compare activating and inhibitory peripheral natural killer cell receptors at strictly defined follicular (day 7) and luteal (day 21) phases of the menstrual cycle. The results will advance our understanding of the timing and consequence of the natural hormonal cycle on immune environment.
Study objective
The purpose of this pilot study is to describe the changes in NK cell percentages and therefore is hypothesis generating rather than hypothesis testing
Study design
Women and men will be asked to visit the TVDC to sample peripheral blood with a venapunction at day 1, 7 and 21 of the menstrual cycle during 2 consecutive cycles. Furthermore, women will be asked to sample menstrual blood at day 1 of the menstrual cycle during 2 consecutive cycles.
Intervention
None
Inclusion criteria
Group 1: healthy women (no chronic medical conditions like chronic hypertension, chronic kidney failure, chronic immune conditions (SLE) or chronic medication use) with a regular natural menstrual cycle of 28 days (+/- 3 days), defined by no contraceptive use or healthy women with a copper spiral
Group 2: healthy men (no chronic medical conditions, like chronic hypertension, chronic kidney failure, chronic immune conditions (SLE) or chronic medication use)
Exclusion criteria
- Current or recent (<2 weeks) symptomatic infection
- Previous pregnancy with complications, such as repeated miscarriages, preeclampsia, or diabetes gravidarum
- Unable to give mentally capable consent in Dutch
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8701 |
| Other | METC azM/UM : METC19-054 |