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

NCT07178652 | Not Yet Recruiting

• 1 other identifier: EC 2023-228
• Study Type: observational
• Target: 2,325
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Preeclampsia (PE) Risk; Oocyte Donation

Outcome Measures

Primary Outcomes (1)

• Preeclampsia development.

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

  From 20 weeks gestation until 6 weeks postpartum.

Secondary Outcomes (5)

• Development of early onset PE versus late onset PE.

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

• Preterm PE versus Term PE or PP PE

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

• Incidence of eclampsia, placental abruption, HELLP syndrome

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

• Obstetrical complications

  From conceptions until birth in pregnancies conceived through oocyte donation.

• Delivery characteristics

  From conception until birth in pregnancies conceived through oocyte donation.

Study Arms (2)

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for oocyte donation at the Brussels IVF center.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Biospecimen

Retention: SAMPLES WITH DNA

Cheek swab for DNA extraction

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the ART lab

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 17, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2029
• Last Updated: September 17, 2025

Record last verified: 2025-09