PreeclampsiaNCT04731012
Immunological and Cardiovascular Phenotyping of Oocyte-donation Pregnancies
An observational study of Preeclampsia and Oocyte-donation Pregnancies, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The investigators conduct a study to evaluate the underlying causes of preeclampsia in oocyte-donation pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Oocyte-donation Pregnancies
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2020to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: * oocyte donation pregnancies * IVF or ICSI pregnanies * spontaneous conception pregnancies
Who may be able to join
- pregnancy
Who cannot join
- severe auto immune disorders
Trial locations and contacts
1 site in 1 country.
Judith Altmann, MD contact
Germany1 site, 1 recruiting
- Recruiting
Experimental and Clinical Research Center (ECRC)
Berlin, 13125
Florian Herse, PhD, +49 30 450 540 434, florian.herse@charite.de
Florian Herse, PhD
About this study
The investigators conduct a study to evaluate the underlying causes of preeclampsia in oocyte-donation pregnancies.
Read the 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.
- Conditions
- Preeclampsia, Oocyte-donation Pregnancies
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 01.01.2020 - 01.12.2025
Secondary outcomes (1)
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.
Measured: 01.01.2020 - 01.12.2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Jan 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florian Herse, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731012
- Sponsor's protocol ID
- ED-S
- Status last verified
- Jan 2021
- First submitted
- 21 Sep 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological and Cardiovascular Phenotyping of Oocyte-donation Pregnancies
- ClinicalTrials.gov ID
- NCT04731012
- Acronym / sponsor ID
- ED-S
- Conditions
- Preeclampsia, Oocyte-donation Pregnancies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators conduct a study to evaluate the underlying causes of preeclampsia in 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * oocyte donation pregnancies * IVF or ICSI pregnanies * spontaneous conception pregnancies
Key inclusion criteria (1 listed)
- pregnancy
Key exclusion criteria (1 listed)
- severe auto immune disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preeclampsia in oocyte-donation pregnancies is caused by an altered composition of immune cells in placenta and blood.
Time frame: 01.01.2020 - 01.12.2025
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.
1 secondary outcome
Preeclampsia in oocyte-donation pregnancies is caused by an activation of pro-inflammatory factors and endothelial dysfunction.
Time frame: 01.01.2020 - 01.12.2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Altmann, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Oocyte-donation Pregnancies, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florian Herse, DSc (+49 30 450 540 434, florian.herse@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preeclampsia in oocyte-donation pregnancies is caused by an altered composition of immune cells in placenta and blood. (time frame: 01.01.2020 - 01.12.2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.