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PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)

ConditionsPre-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
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

This trial does not accept healthy volunteers

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 population

Study population consists of women undergoing fertility treatment with IVF with either donated oocytes (Preg OD cohort) or autologous oocytes (Preg IVF cohort)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

462 Participants
are grouped into 2 trial groups
Group A: Preg OD
Group B: Preg IVF

Trial outcomes

Primary outcomes

1

Pre-eclampsia

Development of pre-eclampsia

Time frame
During pregnancy and in the following two weeks post-partum
2

Biochemical markers for pre-eclampsia

Analysis of bloodtests for biochemical markers of pre-eclampsia

Time frame
From early pregnancy untill delivery

Secondary outcomes

1

Post-partum hemorrhage

Excessive bleeding (above 1000 mL) post-partum

Time frame
From delivery to 24 hours post-partum (Primary post-partum hemorrhage)
2

Gestational diabetes

Time frame
During pregnancy untill delivery.
3

Preterm delivery

Delivery before gestational week 37.

Time frame
Early delivery before gestational week 37
4

Placental abruption

Abruption of placenta

Time frame
During pregnancy and delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Copenhagen University Hospital, Hvidovre

Lead sponsor

Ferring Pharmaceuticals

Collaborator

Gedeon Richter Ltd.

Collaborator

Source ClinicalTrials.gov
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