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Not yet recruitingNCT07178652IMMUN-ORUpdated Sep 17, 2025

Preeclampsia and Defective Placentation in Oocyte Donation: Importance of HLA-C and KIR

An observational study in Preeclampsia (PE) Risk and Oocyte Donation, sponsored by Universitair Ziekenhuis Brussel. Not yet recruiting. Open to female participants. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by Universitair Ziekenhuis Brussel · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,325
Sex
Female
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Study 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. 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.

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Conditions studied

  • Preeclampsia (PE) Risk
  • Oocyte Donation

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In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's planned enrollment of 2,325 is above the median of 163 across 380 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated for oocyte donation at the Brussels IVF center.

Inclusion criteria

  • Every live birth delivery post oocyte donation (mother, child, donor).

Exclusion criteria

Exclusion Criteria:

  • Unknown HLA-C/KIR typing of acceptor, donor or offspring (resumlts of all 3 parties must be present to participate.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,325 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. Preeclampsia development.

    The development of PE throughout the pregnancy conceived through oocyte donation.

    Time frame: From 20 weeks gestation until 6 weeks postpartum.

Secondary outcomes

  1. 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).

    Time frame: From 20 weeks gestation until 6 weeks postpartum in pregnancies conceived through oocyte donation.

  2. 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.

    Time frame: From 20 weeks gestation until 6 weeks postpartum in pregnancies conceived through oocyte donation.

  3. Incidence of eclampsia, placental abruption, HELLP syndrome

    The occurence of eclampsia, placental abruption and HELLP syndrome in pregnancies conceived through oocyte donation.

    Time frame: From conception until 6 weeks postpartum in pregnancies conceived through oocyte donation.

  4. Obstetrical complications

    Incidence of obstetrical complications such as gestational hypertension, IUGR, PPROM, ...

    Time frame: From conceptions until birth in pregnancies conceived through oocyte donation.

  5. Delivery characteristics

    Details about delivery such as preterm birth, the incidence and indication for caesarean sections, neonatal birth weights, neonatal birth defects, neonatal complications, ...

    Time frame: From conception until birth in pregnancies conceived through oocyte donation.

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07178652
Lead sponsor
Universitair Ziekenhuis Brussel
Responsible party
Neelke De Munck (Head of the ART lab, Universitair Ziekenhuis Brussel) — Principal investigator
First posted
Sep 17, 2025
Start date
Sep 2025 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Aug 2029 (estimated)
Last update
Sep 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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