NCT07263490 PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)
| NCT ID | NCT07263490 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Copenhagen University Hospital, Hvidovre |
| Condition | Pre-eclampsia |
| Study Type | OBSERVATIONAL |
| Enrollment | 462 participants |
| Start Date | 2024-10-21 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 462 participants in total. It began in 2024-10-21 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Frequently Asked Questions
Who can join the NCT07263490 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pre-eclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07263490 currently recruiting?
Yes, NCT07263490 is actively recruiting participants. Visit ClinicalTrials.gov or contact Copenhagen University Hospital, Hvidovre to inquire about joining.
Where is the NCT07263490 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Hellerup, Denmark, Herlev, Denmark, København S, Denmark and 2 additional locations.
Who is sponsoring the NCT07263490 clinical trial?
NCT07263490 is sponsored by Copenhagen University Hospital, Hvidovre. The trial plans to enroll 462 participants.