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ID
Source
Brief title
Health condition
Unexplained recurrent miscarriages
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of NK cells with an activating phenotype in peripheral blood
Secondary outcome
- Percentage of NK cells with an activating phenotype in menstrual blood
- VO2 max: measured in millilitres per kilogramme of body weight per minute
- Lifestyle questionnaire: Simple Lifestyle Indicator Questionnaire (SLIQ) score
- Total body water: fat free mass in kilogramme of body weight
Background summary
The uterus allows implantation of the embryo during pregnancy. In particular, the immunological environment of the uterus is of great importance, since it must be able to tolerate foreign paternal antigens. Earlier research has shown that the immune cell population in the uterus is unique and that particularly natural killer (NK) cells play a special role in creating a tolerant immunological environment of the uterus for pregnancy. Despite exciting advances in understanding the role of natural killer cells during pregnancy, considerably more work needs to be done to establish a specific role for natural killer cells in unexplained recurrent miscarriages (URM). Therefore, in this innovative study we will try to provide further insight in the role of NK cells in URM by studying 20 unique NK cell markers. These will be studied both systemically in peripheral blood and locally in menstrual blood. Furthermore, this study will provide more information on the influence of physical health. In this way, we hope to expand understanding of the specific role of NK cells in URM.
Study objective
We hypothesize a higher percentage of NK cells with an activating phenotype in women with URM hereby causing rejection of implantation of the embryo. We expect a similar trend in
menstrual blood. We expect that an activating NK cell phenotype is related to poor physical health (unhealthy lifestyle factors and low VO2max).
Study design
Women who are willing to participate in the study will first be asked to fill out a lifestyle questionnaire, next peripheral blood will be sampled with a venapunction and last VO2max will be
measured during cycling. On the same day, participants will be asked to sample their urine and menstrual blood during their next menstrual cycle and return it to the hospital. The duration of the study for one participant is, depending on the moment of their menstrual cycle, maximal + 5 weeks from the visit when measurements take place.
Intervention
None
Inclusion criteria
Group 1:
Recurrent (>2) unexplained miscarriages, defined by normal parental karyotype, no maternal
thrombophilia and no uterine abnormality
Group 2:
Previous uncomplicated pregnancy, defined by healthy live birth after 37 weeks of gestation
without major obstetric complications
Exclusion criteria
- Current or recent (<3 months ago) pregnancy
- Current or recent (<2 weeks) symptomatic genital infection such as chlamydia, gonorrea or pelvic inflammatory disease.
- Younger than 18 or older than 36 years
- Unable to give consent in Dutch
Design
Recruitment
IPD sharing statement
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 | NL8287 |
Other | METC azM/UM : METC18-026 |