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Clinical Trials in Denmark / NCT07263490
Recruiting Observational

PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)

NCT07263490 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Hvidovre
Phase
Observational
Started
2024-10-21
Last updated
2026-04-13

Condition(s) studied

Pre-eclampsiaOocyte DonationPre-Eclampsia; Complicating PregnancyPre-Eclampsia; MildPre-Eclampsia, SeverePre-eclampsia or Eclampsia With Pre-existing HypertensionARTNeonatal MorbidityNeonatal MortalityPlacental AbruptionGestational DiabetesPreterm LaborPost-partum Hemorrhage (PPH)Intrauterine Growth Restriction (IUGR)Hypertensive Disorders of Pregnancy

Study summary

The aim of this prospective observational cohort study is to investigate the pathophysiological mechanisms behind and risk of pre-eclampsia in women pregnant after fertility treatment with oocyte donation. The participants are included in of of two cohorts. One includes women pregnant after oocyte donation whereas the other includes women pregnant after IVF treatment with autologous oocytes.

Participants will be followed throughout pregnancy with blood samples, blood pressure, clinical controls and ultrasound examinations. Clinical outcomes will be registered post-partum.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Pre-eclampsia — During pregnancy and in the following two weeks post-partum
    Development of pre-eclampsia
  • Biochemical markers for pre-eclampsia — From early pregnancy untill delivery
    Analysis of bloodtests for biochemical markers of pre-eclampsia

Trial sites (6)

FacilityCityRegionStatus
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

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Intraoperative Perfusion Index and Mortality Active, not recruiting
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GRACE - Graduated Response for Advanced COPD With Enhanced Support Recruiting

Other trials for the same condition

The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study Active, not recruiting
Oral Health and Adverse Pregnancy Complications Recruiting
Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07263490 on ClinicalTrials.gov ↗ ← All trials in Denmark