PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)
Recruiting now
Conditions studied: Pre-eclampsia, Oocyte Donation, Pre-Eclampsia; Complicating Pregnancy, Pre-Eclampsia; Mild, Pre-Eclampsia, Severe, Pre-eclampsia or Eclampsia With Pre-existing Hypertension, ART, Neonatal Morbidity, Neonatal Mortality, Placental Abruption, Gestational Diabetes, Preterm Labor, Post-partum Hemorrhage (PPH), Intrauterine Growth Restriction (IUGR), Hypertensive Disorders of Pregnancy
In brief
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.
Key facts
- Study ID
- NCT07263490
- Run by
- Copenhagen University Hospital, Hvidovre
- People needed
- 462
- Starts
- 2024-10-21
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 years
- BMI < 35 kg/m2
- Normal wet smear within the past three years
- Both nulli- and multiparous
- Singletons and multiple gestations
You may not qualify if…
- 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 it is running
- Copenhagen Fertility Center — Copenhagen, Denmark (enrolling)
- Trianglen Fertility Clinic — Hellerup, Denmark (enrolling)
- Fertility Clinic, Herlev / Gentofte Hospital — Herlev, Denmark (enrolling)
- Sellmer Klinik — København S, Denmark (enrolling)
- Fertility Clinic, Rigshospitalet — København Ø, Denmark (enrolling)
- Aleris Fertility — Søborg, Denmark (enrolling)
Full record on ClinicalTrials.gov
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