Does humoral and/or cellular rejection play a role in recurrent miscarriage of unknown etiology?Can biomarkers of humoral and/or cellular rejection be used for the detection of patients who are likely to suffer a miscarriage in a next pregnancy?
ID
Source
Brief title
Condition
- Autoimmune disorders
- Abortions and stillbirth
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pathofysiology, with focus on immunology of recurrent miscarriages.
Secondary outcome
Pregnancy outcome
Background summary
Recurrent miscarriage is commonly defined as three or more consecutive
miscarriages prior to the 20th week. It is a common problem affecting 1 to 2%
of all fertile couples and is a highly heterogeneous condition. An underlying
cause may be identified in about 25-50% of cases. Therefore 50-75% of the
couples are left with the burden of continuous uncertainty and clinicians
without means to treat these women. In the last decade several therapies are
investigated however none of these therapies has been proven effective.
In the first part of this project we aim to determine different immunological
causes of recurrent miscarriage of unknown etiology. These results will help to
identify these patients and to eventually develop effective therapies.
Study objective
Does humoral and/or cellular rejection play a role in recurrent miscarriage of
unknown etiology?
Can biomarkers of humoral and/or cellular rejection be used for the detection
of patients who are likely to suffer a miscarriage in a next pregnancy?
Study design
1) A biobank of new couples attending the recurrent miscarriage clinic
2) A prospective cohort study to perform functional test with maternal
peripheral blood mononuclear cells
Study burden and risks
No experimental medication will be used.
Women will be treated according to local hospital protocol. No additional
physical examination is needed for this study.
Blood samples will be taken from the subjects and their partners.In addition
women will be asked to collect menstrual fluid during their period.
Partners will also be asked to collect semen one time. No additional risks or
burden are expected from the study.
Albinusdreef 2
Leiden 9600RC
NL
Albinusdreef 2
Leiden 9600RC
NL
Listed location countries
Age
Inclusion criteria
Recurrent miscarriages ( >2 subsequently)
Age < 40
Age >18
Exclusion criteria
Uterus anomalies
Parental chromosomal abnormalities
Cervix insufficiency
Patient mentally or lagally incapacity
Untreated thyroid disease
Poor balance or treatment of DM
History of recent alcohol or drugsabuse
ART (assisted reproductive technology) pregnancies
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL38275.058.11 |