Preeclampsia (PE) RiskIMMUN-ORNCT07178652
Preeclampsia and Defective Placentation in Oocyte Donation: Importance of HLA-C and KIR
An observational study of Preeclampsia (PE) Risk and Oocyte Donation, run by Universitair Ziekenhuis Brussel.
Trial summary
The IMMUN-OR study aims to study HLA-C/KIR combinations when looking at the risk of development of preeclampsia (PE) in pregnancies after oocyte donation. With the use of oocyte donation currently on the rise, the importance of identifying risk factors for the higher frequency of PE development is clear. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preeclampsia (PE) Risk, Oocyte Donation
- How many people
- 2,325 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated for oocyte donation at the Brussels IVF center.
Who may be able to join
- Every live birth delivery post oocyte donation (mother, child, donor).
Who cannot join
- Unknown HLA-C/KIR typing of acceptor, donor or offspring (resumlts of all 3 parties must be present to participate.
About this study
The IMMUN-OR study aims to study HLA-C/KIR combinations when looking at the risk of development of preeclampsia (PE) in pregnancies after oocyte donation. With the use of oocyte donation currently on the rise, the importance of identifying risk factors for the higher frequency of PE development is clear. Certain HLA-C/KIR combinations have already been linked to higher risk of obstetric complications. This study will look at these combinations within the specific situation of oocyte donation. This will further investigate the importance of the immunological interface when looking at PE. Participants will be chosen from a database of all the live births after oocyte donation at our center. The research team will contact the mother, child and donor. If all three agree to participate, they will be invited to our center, where the research team will take a cheek swab. This swab will then be used to isolate a DNA sample. With these samples, we can determine the HLA-C/KIR combination for each threesome. When all samples have been collected, two groups are made based off their health outcome: one group that did develop PE during their pregnancy, and one group that did not develop PE. The different HLA-C/KIR combinations will be compared, and the research team will look to discover if one combination is linked to a higher occurrence of PE development.
- Conditions
- Preeclampsia (PE) Risk, Oocyte Donation
- 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 |
|---|---|---|
| PE | Patients who develop PE during their pregnancy after oocyte donation. | |
| No PE | Patients who do not develop PE during their pregnancy after oocyte donation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preeclampsia development.
The development of PE throughout the pregnancy conceived through oocyte donation.
Measured: From 20 weeks gestation until 6 weeks postpartum.
Secondary outcomes (5)
Development of early onset PE versus late onset PE.
The development of PE before 34 weeks gestation (= early onset PE) or after 34 weeks of gestation (= late onset PE).
Measured: From 20 weeks gestation until 6 weeks postpartum in pregnancies conceived through oocyte donation.
Preterm PE versus Term PE or PP PE
Development of preterm PE (<37 weeks gestation), term PE (>37 weeks gestation) and postpartum PE (after birth) throughout a pregnancy conceived through oocyte donation.
Measured: From 20 weeks gestation until 6 weeks postpartum in pregnancies conceived through oocyte donation.
Incidence of eclampsia, placental abruption, HELLP syndrome
The occurence of eclampsia, placental abruption and HELLP syndrome in pregnancies conceived through oocyte donation.
Measured: From conception until 6 weeks postpartum in pregnancies conceived through oocyte donation.
Obstetrical complications
Incidence of obstetrical complications such as gestational hypertension, IUGR, PPROM, ...
Measured: From conceptions until birth in pregnancies conceived through oocyte donation.
Delivery characteristics
Details about delivery such as preterm birth, the incidence and indication for caesarean sections, neonatal birth weights, neonatal birth defects, neonatal complications, ...
Measured: From conception until birth in pregnancies conceived through oocyte donation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia (PE) RiskStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neelke De Munck, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178652
- Sponsor's protocol ID
- EC 2023-228
- Acronym
- IMMUN-OR
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preeclampsia and Defective Placentation in Oocyte Donation: Importance of HLA-C and KIR
- ClinicalTrials.gov ID
- NCT07178652
- Acronym / sponsor ID
- IMMUN-OR / EC 2023-228
- Conditions
- Preeclampsia (PE) Risk, Oocyte Donation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,325 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 17 Sep 2025 (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 IMMUN-OR study aims to study HLA-C/KIR combinations when looking at the risk of development of preeclampsia (PE) in pregnancies after oocyte donation. With the use of oocyte donation currently on the rise, the importance of identifying risk factors for the higher frequency of PE development is clear. Certain HLA-C/KIR combinations have already been linked to higher risk of obstetric complications. This study will look at these combinations within the specific situation of oocyte donation. This will further investigate the importance of the immunological interface when looking at PE. Participants will be chosen from a database of all the live births after oocyte donation at our center. The research team will contact the mother, child and donor. If all three agree to participate, they will be invited to our center, where the research team will take a cheek swab. This swab will then be used to isolate a DNA sample. With these samples, we can determine the HLA-C/KIR combination for each threesome. When all samples have been collected, two groups are made based off their health outcome: one group that did develop PE during their pregnancy, and one group that did not develop PE. The different HLA-C/KIR combinations will be compared, and the research team will look to discover if one combination is linked to a higher occurrence of PE development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PE | – | –Patients who develop PE during their pregnancy after oocyte donation. |
| No PE | – | –Patients who do not develop PE during their pregnancy after oocyte donation. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated for oocyte donation at the Brussels IVF center.
Key inclusion criteria (1 listed)
- Every live birth delivery post oocyte donation (mother, child, donor).
Key exclusion criteria (1 listed)
- Unknown HLA-C/KIR typing of acceptor, donor or offspring (resumlts of all 3 parties must be present to participate.
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 development.
Time frame: From 20 weeks gestation until 6 weeks postpartum.
The development of PE throughout the pregnancy conceived through oocyte donation.
5 secondary outcomes
Development of early onset PE versus late onset PE.
Time frame: From 20 weeks gestation until 6 weeks postpartum in pregnancies conceived through oocyte donation.
Preterm PE versus Term PE or PP PE
Time frame: From 20 weeks gestation until 6 weeks postpartum in pregnancies conceived through oocyte donation.
Incidence of eclampsia, placental abruption, HELLP syndrome
Time frame: From conception until 6 weeks postpartum in pregnancies conceived through oocyte donation.
Obstetrical complications
Time frame: From conceptions until birth in pregnancies conceived through oocyte donation.
Delivery characteristics
Time frame: From conception until birth in pregnancies conceived through oocyte donation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
Related trials for Preeclampsia (PE) Risk
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
RecruitingObservational study
Hyperspectral Imaging for Prediction of Preeclampsia
Preeclampsia (PE) Risk, Preeclampsia
RecruitingObservational study
A Study to Find and Confirm Blood-based Markers (Called Proteins) That May Show Early Heart Changes in Women With Preeclampsia, Even Before Symptoms Appear, and the Use of Heart Ultrasound (Echocardiography) to Look at Patterns of How the Heart Changes During Pregnancy in Women With Preeclampsia
Cardiovascular Biomarkers, Preeclampsia (PE) Risk
RecruitingObservational study
Cardiometabolic Disease and Substrate Metabolism
Preeclampsia, Gestational Diabetes Mellitus (GDM)
RecruitingObservational study
The Combined First Trimester Screening
Preeclampsia (PE), Fetal Growth Restriction
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia (PE) Risk and Oocyte Donation, run by Universitair Ziekenhuis Brussel.
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: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preeclampsia development. (time frame: From 20 weeks gestation until 6 weeks postpartum.). 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 17 Sep 2025.