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NCT04731012 Clinical Trial

Immunological and Cardiovascular Phenotyping of Oocyte-donation Pregnancies

Preeclampsia Clinical Trial

Official title:
Immunological and Cardiovascular Phenotyping of Oocyte-donation Pregnancies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04731012
Other study ID # ED-S
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 1, 2025

Study information
Verified date January 2021
Source Charite University, Berlin, Germany
Contact Florian Herse, DSc
Phone +49 30 450 540 434
Email florian.herse@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators conduct a study to evaluate the underlying causes of preeclampsia in oocyte-donation pregnancies.

Description:

A detailed medical history, questionnaires as well as blood, urine and placental samples will be used to analyse several factors leading to the high risk of preeclampsia in oocyte-donation pregnancies.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 1, 2025
Est. primary completion date December 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - pregnancy Exclusion Criteria: - severe auto immune disorders

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Experimental and Clinical Research Center (ECRC) Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Preeclampsia in oocyte-donation pregnancies is caused by an altered composition of immune cells in placenta and blood. T-Cell populations are altered in preeclampsia. HLA-mismatch of mother and donor oocyte lead to a "host-versus-graft" reaction. T-, B- and Natural killer cells are altered in placental tissue of oocyte-donation pregnancies. 01.01.2020 - 01.12.2025
Secondary Preeclampsia in oocyte-donation pregnancies is caused by an activation of pro-inflammatory factors and endothelial dysfunction. Altered Natural killer cells and B-cells in oocyte-donation pregnancies lead to endothelial dysfunction. Pro-inflammatory factors are higher in OD pregnancy and can be measured in placental tissue via single-cell sequencing. 01.01.2020 - 01.12.2025
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