PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)
Recruiting · NCT07263490 · Observational (researchers observe without assigning treatment) · Lead sponsor: Copenhagen University Hospital, Hvidovre
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
6 locations listed.
- Copenhagen Fertility Center - Copenhagen, Denmark
- Trianglen Fertility Clinic - Hellerup, Denmark
- Fertility Clinic, Herlev / Gentofte Hospital - Herlev, Denmark
- Sellmer Klinik - København S, Denmark
- Fertility Clinic, Rigshospitalet - København Ø, Denmark
- Aleris Fertility - Søborg, Denmark