Preeclampsia and Defective Placentation in Oocyte Donatio... | NCT07178652

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

NCT07178652

Sponsor

Universitair Ziekenhuis Brussel

Status

Not yet recruiting

Last Update Posted

Sep 17, 2025Actual

Enrollment

2,325Estimated

Phase

Not provided

Conditions

Preeclampsia (PE) Risk
Oocyte Donation

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2025Estimated

Primary Completion Date

Dec 2026Estimated

Completion Date

Aug 2029Estimated

First Submitted Date

Sep 2, 2025

First Submission Date that Met QC Criteria

Sep 10, 2025

First Posted Date

Sep 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2025

Last Update Posted Date

Sep 17, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Neelke De Munck, Head of the ART lab, Universitair Ziekenhuis BrusselPrincipal Investigator

Lead Sponsor

Universitair Ziekenhuis BrusselOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,325Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Preeclampsia development.	The development of PE throughout the pregnancy conceived through oocyte donation.	From 20 weeks gestation until 6 weeks postpartum.

Secondary Outcomes

Measure	Description	Time Frame
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).	From 20 weeks gestation until 6 weeks postpartum in pregnancies conceived through oocyte donation.
Preterm PE versus Term PE or PP PE

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients treated for oocyte donation at the Brussels IVF center.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided