No registrations found.
ID
Source
Brief title
Health condition
MRKH syndrome
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the difference in occurrence of microchimerism (with an extra male cell line) in MRKH patients vs. controls.
Secondary outcome
The secondary outcome is the presence of chimerism in non-hematopoietic tissue (buccal cells) in MRKH patients.
Background summary
The aim of this study is to determine whether male microchimerism is present in patients with MRKH syndrome. This would be a result of intrauterine cell trafficking - and possible AMH transfer- from male to female co-twin.
Study design: Observational case control study.
In the course of this study we ask the subjects for one visit to the outpatient clinic or a home visit for blood sampling, collecting of a buccal smear and a short questionnaire.
Study objective
Our hypothesis is that MRKH patients are exposed to high concentrations AMH in utero, coming from their male co-twin (possible vanished twin). This AMH-exchange is possible because of intrauterine blood exchange between two fetuses. This blood exchange results in male (micro)chimerism in blood. Our aim is to study the presence of this male microchimerism in adult patients with MRKH.
Study design
Only one visit is necessary for blood sampling, buccal smear sampling and filling in a questionnaire (about medical history, family history, intoxications, BMI, age)
Intervention
96 patients with MRKH will be included. The controlgroup exists of 96 healthy women, already sampled. No interventions. Blood samples will be analyzed for Y-chromosome-specific real-time quantitative polymerase chain reaction.
Henrike Peters
Postbus 7057
Amsterdam 1007 MB
The Netherlands
0204440561
h.peters@vumc.nl
Henrike Peters
Postbus 7057
Amsterdam 1007 MB
The Netherlands
0204440561
h.peters@vumc.nl
Inclusion criteria
- Diagnosed with MRKH syndrome
- Age ≥ 18 years
Exclusion criteria
none
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5806 |
| NTR-old | NTR5961 |
| Other | ABR-nummer van de CCMO : 57503 |