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Is MRKH syndrome caused by intrauterine blood exchange between sex-discordant twins?


- candidate number24588
- NTR NumberNTR5961
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jul-2016
- Secondary IDs57503 ABR-nummer van de CCMO
- Public TitleIs MRKH syndrome caused by intrauterine blood exchange between sex-discordant twins?
- Scientific TitleMRKH syndrome caused by Intrauterine Placental Transfusion between sex-discordant twins?
- ACRONYMMIPT study
- hypothesisOur 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.
- Healt Condition(s) or Problem(s) studiedMRKH-syndrome
- Inclusion criteria- Diagnosed with MRKH syndrome
- Age ≥ 18 years
- Exclusion criterianone
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 11-jan-2017
- planned closingdate1-aug-2017
- Target number of participants96
- Interventions96 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.
- Primary outcomeThe primary outcome is the difference in occurrence of microchimerism (with an extra male cell line) in MRKH patients vs. controls.
- Secondary outcomeThe secondary outcome is the presence of chimerism in non-hematopoietic tissue (buccal cells) in MRKH patients.
- TimepointsOnly one visit is necessary for blood sampling, buccal smear sampling and filling in a questionnaire (about medical history, family history, intoxications, BMI, age)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Henrike Peters
- CONTACT for SCIENTIFIC QUERIES C.B. Lambalk
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- Publications
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD8-jul-2016 - 7-feb-2017


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