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Recruiting NCT07263490

PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)

Trial Parameters

Condition Pre-eclampsia
Sponsor Copenhagen University Hospital, Hvidovre
Study Type OBSERVATIONAL
Phase N/A
Enrollment 462
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-10-21
Completion 2027-10-31

Brief 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 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

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