PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)

ConditionsPre-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

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorCopenhagen University Hospital, Hvidovre

About this trial

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

Qualifiers

Age > 18 years

BMI < 35 kg/m2

Normal wet smear within the past three years

Both nulli- and multiparous

Disqualifiers

Age < 18 years

BMI > 35 kg/m2

HIV/ hepatitis

Essential hypertension

Trial design

Treatments tested in this trial

Not listed

Trial groups

462 Participants

are grouped into 2 trial groups

Locations

Copenhagen Fertility Center2400, Copenhagen Denmark

Trianglen Fertility Clinic2900, Hellerup Denmark

Fertility Clinic, Herlev / Gentofte Hospital2730, Herlev Denmark

Fertility Clinic, Rigshospitalet2100, København Ø Denmark

Sponsors and collaborators

Copenhagen University Hospital, Hvidovre

Lead sponsor

Ferring Pharmaceuticals

Collaborator

Gedeon Richter Ltd.

Collaborator

Source ClinicalTrials.gov