Pre-eclampsia risk in pregnancies after oocyte donation
PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients) - Investigating Matching, Biomarkers and Outcomes.
We will follow pregnant women who used donated eggs and women who used their own eggs to see if pregnancies after oocyte donation lead to a higher risk of pre-eclampsia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 462 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Copenhagen University Hospital, Hvidovre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 6 sites (Copenhagen and 5 other locations) |
| Trial ID | NCT07263490 on ClinicalTrials.gov |
What this trial studies
This prospective observational cohort study enrolls two groups: pregnancies after oocyte donation and pregnancies after IVF with autologous oocytes. Participants are followed throughout pregnancy with regular blood samples, blood pressure measurements, clinical examinations, and ultrasound scans, and clinical outcomes are recorded after delivery. The study will analyze biomarkers and routine obstetric data to explore pathophysiological mechanisms and differences in pre-eclampsia risk between the cohorts. Data collection is standardized across participating fertility clinics and the university hospital sites.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged over 18 with BMI under 35 who conceived via oocyte donation or via IVF with their own eggs and who meet the study's health eligibility criteria.
Not a fit: Women who are not pregnant, who conceived naturally, or who have exclusion conditions (for example HIV/hepatitis, essential hypertension, uncontrolled thyroid disease, recent cancer treatment, smoking or substance abuse) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could clarify why oocyte donation pregnancies have higher pre-eclampsia risk and support better monitoring or targeted preventive care for these pregnancies.
How similar studies have performed: Previous observational studies have consistently reported higher pre-eclampsia rates after oocyte donation, but the underlying mechanisms remain incompletely understood.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * BMI \< 35 kg/m2 * Normal wet smear within the past three years * Both nulli- and multiparous * Singletons and multiple gestations Exclusion Criteria: * Age \< 18 years * BMI \> 35 kg/m2 * HIV/ hepatitis * Essential hypertension * Chronic kidney disease * Undiagnosed vaginal bleeding * Uterine malformations * Persisting ovarian cysts * Tumors in hypothalamus, pituitary, thyroid, or adrenal glands. * Previous breast cancer * Known BRCA 1 or 2 gene * Unregulated thyroid disease * Cardiovascular disease * Breast feeding * Present or previous chemotherapy/radiation therapy * Present or previous malignant disease * Smoking * Alcohol/drug abuse
Where this trial is running
Copenhagen and 5 other locations
- Copenhagen Fertility Center — Copenhagen, Denmark (Recruiting)
- Trianglen Fertility Clinic — Hellerup, Denmark (Recruiting)
- Fertility Clinic, Herlev / Gentofte Hospital — Herlev, Denmark (Recruiting)
- Sellmer Klinik — København S, Denmark (Recruiting)
- Fertility Clinic, Rigshospitalet — København Ø, Denmark (Recruiting)
- Aleris Fertility — Søborg, Denmark (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.