to characterize the endometrial immune environment in patients with SLE
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences between immune cell subsets in menstrual blood in SLE compared to
healthy controls
Secondary outcome
Differences between immune cell subsets in peripheral blood in SLE compared to
healthy controls
MxA levels as marker for interferon production
NET formation
Different cytokine levels in menstrual and peripheral blood
Background summary
Systemic lupus erythematosus (SLE) affect predominantly women of childbearing
age. SLE is a heterogeneous autoimmune disease characterized by interferon
upregulation and production of autoantibodies (1). SLE have been associated
with a higher risk of adverse pregnancy outcomes (APO) like intrauterine fetal
death, fetal growth restriction (FGR), preterm birth, low birth weight, and
preeclampsia (2). Type I interferon signature and complement activation in
peripheral blood have been linked to APO risk in SLE.
The menstrual cycle is governed by a sophisticated interaction involving
endometrial cells, immune cells, cytokines and sex hormones. It is known that
the endometrial immune environment prepares its immune balance to accept the
embryo and facilitates implantation (5). Receptive endometrium is characterized
by a slightly pro-inflammatory response, complement cascade pathway activation,
and an adequate interaction between extracellular vesicles, endometrial
epithelial cells and the blastocyst (6). Therefore, an optimal balance between
pro-inflammatory factors and the tolerogenic adaptive immune response in the
endometrial tissue is pivotal for subsequent modifications of the luminal
epithelium of the endometrium and proper embryo implantation.
It has been shown that preconceptional disease activity can predict APO in
patients with SLE, which stress the importance of remission of the underlying
disease. However, not all APO are explained with these preconceptional,
disease-related factors. There could be local immune changes in the endometrial
environment in patients with SLE that increase the risk for pregnancy
complications. Endometrial immune profiling is a new method to analyze the
immune cell distribution and cytokine production in endometrial tissue samples
or menstrual blood by different techniques such as multiparameter flow
cytometry or gene expression analysis. It has already been suggested as a new
screening strategy for personalized care for couples with repeated embryo
implantation failures using assisted-reproductive therapy (ART).
Study objective
to characterize the endometrial immune environment in patients with SLE
Study design
cross-sectional, observational pilot study in patients with SLE.
Study burden and risks
All patients will receive standard care and treatment during follow up.
Procedures that will be solely done for research purposes are: extra blood
withdrawal and collection of menstrual blood during one period. The knowledge
generated in this project will be useful to propose innovative and personalized
interventions to achieve better pregnancy outcomes in patients with SLE.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
SLE patients
- Fulfilling ACR or SLICC or EULAR/ACR criteria for SLE
- No use of hormonal or intrauterine device anti-contraceptive
- Premenopausal
- Written informed consent
- > 18 years old and *wilsbekwaam*
Healthy women
- No systemic autoimmune disease
- No use of hormonal or intrauterine device anti-contraceptive
- Premenopausal
- Written informed consent
- > 18 years old and *wilsbekwaam*
Exclusion criteria
- Other autoimmune diseases
- History of abnormal uterine cavity, major gynaecological surgery such as
hysterectomy or salpingectomy,, endometriosis or previous reproductive-assisted
invasive therapy
- Malignancies
- In case of healthy controls: repeated pregnancy loss or known difficulties to
become pregnant (infertility)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL85601.042.23 |