Immunological and Cardiovascular Phenotyping of Oocyte-donation Pregnancies

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

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia; Oocyte-donation Pregnancies

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Florian Herse, DSc; Phone Number: +49 30 450 540 434; Email: florian.herse@charite.de
• Study Contact Backup: Name: Judith Altmann, MD; Email: judith.altmann@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13125
    • Recruiting
    • Experimental and Clinical Research Center (ECRC)
    • Contact: Florian Herse, PhD; Phone Number: +49 30 450 540 434; Email: florian.herse@charite.de
    • Principal Investigator: Florian Herse, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

• oocyte donation pregnancies
• IVF or ICSI pregnanies
• spontaneous conception pregnancies

Description

Inclusion Criteria:

• pregnancy

Exclusion Criteria:

• severe auto immune disorders

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
healthy oocyte-donation pregnancy; healthy pregnancy
preeclamptic oocyte-donation pregnancy; preeclampsia
healthy IVF or ICSI pregnancy; healthy pregnancy
preeclamptic IVF or ICSI pregnancy; preeclampsia
healthy spontaneous conception pregnancy; healthy pregnancy
preeclamptic spontaneous conception pregnancy; preeclampsia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: ED-S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No