Actively Recruiting

Age: 18Years +
FEMALE
ID07263490

PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients) - Investigating Matching, Biomarkers and Outcomes.

Led by Copenhagen University Hospital, Hvidovre · Updated on 2026-04-13

462

Participants Needed

6

Research Sites

30 weeks

Total Duration

On this page

Sponsors

C

Copenhagen University Hospital, Hvidovre

Lead Sponsor

F

Ferring Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research investigates the causes and risks of pre-eclampsia in women who become pregnant after fertility treatments involving oocyte donation. The study compares two groups: women pregnant after oocyte donation and women pregnant after IVF using their own eggs. The study aims to understand immune and vascular factors involved in pre-eclampsia and to evaluate pregnancy and newborn outcomes in these women. Participants are followed throughout pregnancy with regular blood samples, blood pressure checks, clinical visits, and ultrasound exams. Early pregnancy visits include informed consent and baseline data collection. Follow-up visits occur at gestational weeks 12-14, 18-20, 28, 34, and 38, with blood samples and clinical assessments. Blood pressure is monitored weekly from week 28 until delivery. After birth, clinical outcomes such as delivery details and newborn health are recorded. Participants provide medical history and lifestyle information at enrollment. Researchers measure pre-eclampsia occurrence, biochemical markers, immune markers, and pregnancy complications. Data is collected securely, and participant confidentiality is maintained. The study includes postpartum monitoring and aims to establish a biobank for future research. Total participation spans from early pregnancy through delivery and postpartum data collection.

CONDITIONS

Brief Title

PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years
  • Body mass index (BMI) less than 35 kg/m2
  • Normal wet smear test within the past three years
  • Includes both women who have never given birth and those who have
  • Includes both singleton and multiple pregnancies
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Body mass index (BMI) greater than 35 kg/m2
  • HIV or hepatitis infection
  • 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 mutation
  • Unregulated thyroid disease
  • Cardiovascular disease
  • Breastfeeding
  • Current or past chemotherapy or radiation therapy
  • Current or past malignant disease
  • Smoking
  • Alcohol or drug abuse

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 2 weeks before inclusion visit

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Monitoring

Duration - From gestational week 10-12 until delivery

Participants are monitored throughout pregnancy with serial blood sampling, blood pressure measurements, clinical assessments, and ultrasound examinations to study pre-eclampsia risk and related outcomes.

6 scheduled visits: inclusion (week 10-12), weeks 12-14, 18-20, 28, 34, and 38; plus weekly blood pressure measurements starting at week 28 until delivery

Postpartum Follow-up

Duration - From delivery to 28 days postpartum

Clinical outcome data are collected after delivery, including maternal and neonatal health information.

Data collected from medical records; no additional visits required

Trial Site Locations

Total: 6 locations

1

Copenhagen Fertility Center

Copenhagen, Denmark, 2400

Actively Recruiting

2

Trianglen Fertility Clinic

Hellerup, Denmark, 2900

Actively Recruiting

3

Fertility Clinic, Herlev / Gentofte Hospital

Herlev, Denmark, 2730

Actively Recruiting

4

Sellmer Klinik

København S, Denmark, 2300

Actively Recruiting

5

Fertility Clinic, Rigshospitalet

København Ø, Denmark, 2100

Actively Recruiting

6

Aleris Fertility

Søborg, Denmark, 2860

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Uncomplicated oocyte donation pregnancies display an elevated CD163-positive type 2 macrophage load in the decidua, which is associated with fetal-maternal HLA mismatches.

Xuezi Tian, Kaveri T S Aiyer, Johanna M Kapsenberg...

https://pubmed.ncbi.nlm.nih.gov/34738274

Clinical risk factors for pre-eclampsia determined in early pregnancy: systematic review and meta-analysis of large cohort studies.

Emily Bartsch, Karyn E Medcalf, Alison L Park...

https://pubmed.ncbi.nlm.nih.gov/27094586

Incidence and risk factors for Preeclampsia in a cohort of healthy nulliparous pregnant women: a nested case-control study.

Jussara Mayrink, Renato T Souza, Francisco E Feitosa...

https://pubmed.ncbi.nlm.nih.gov/31266984

Outcomes of pregnancies achieved by double gamete donation: A comparison with pregnancies obtained by oocyte donation alone.

Lise Preaubert, Aurélie Vincent-Rohfritsch, Pietro Santulli...

https://pubmed.ncbi.nlm.nih.gov/29309921

Increased incidence of obstetric and perinatal complications in pregnancies achieved using donor oocytes and single embryo transfer in young and healthy women. A prospective hospital-based matched cohort study.

Kenny A Rodriguez-Wallberg, Ann-Sofie Berger, Antonia Fagerberg...

https://pubmed.ncbi.nlm.nih.gov/30626251