Preeclampsia and Defective Placentation in Oocyte Donation: Importance of HLA-C and KIR
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Preeclampsia (PE) Risk, Oocyte Donation. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Preeclampsia development. [Time frame: From 20 weeks gestation until 6 weeks postpartum.]
Secondary outcome measures (5)
- 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.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07178652 · EC 2023-228