Clinical trial · Observational
PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)
PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients) - Investigating Matching, Biomarkers and Outcomes.
NCT07263490CI-TRIAL-00107976PRIORrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (15)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ART | — | UNRESOLVED | — |
| Gestational Diabetes | — | UNRESOLVED | — |
| Hypertensive Disorders of Pregnancy | — | UNRESOLVED | — |
| Intrauterine Growth Restriction (IUGR) | — | UNRESOLVED | — |
| Neonatal Morbidity | — | UNRESOLVED | — |
| Neonatal Mortality | — | UNRESOLVED | — |
| Oocyte Donation | — | UNRESOLVED | — |
| Placental Abruption | — | UNRESOLVED | — |
| Post-partum Hemorrhage (PPH) | — | UNRESOLVED | — |
| Pre-eclampsia | — | UNRESOLVED | — |
| Pre-Eclampsia; Complicating Pregnancy | — | UNRESOLVED |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Preg OD
- description
- Women pregnant after treatment with oocyte donation
- label
- Preg IVF
- description
- Women pregnant after IVF treatment with autologous oocytes
Primary outcomes (2)
- measure
- Pre-eclampsia
- timeFrame
- During pregnancy and in the following two weeks post-partum
- description
- Development of pre-eclampsia
- measure
- Biochemical markers for pre-eclampsia
- timeFrame
- From early pregnancy untill delivery
- description
- Analysis of bloodtests for biochemical markers of pre-eclampsia
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (16)
- BACKGROUNDTian X, Aiyer KTS, Kapsenberg JM, Roelen DL, van der Hoorn ML, Eikmans M. Uncomplicated oocyte donation pregnancies display an elevated CD163-positive type 2 macrophage load in the decidua, which is associated with fetal-maternal HLA mismatches. Am J Reprod Immunol. 2022 Jan;87(1):e13511. doi: 10.1111/aji.13511. Epub 2021 Dec 4. PMID 34738274
- BACKGROUNDBrosens I, Pijnenborg R, Vercruysse L, Romero R. The "Great Obstetrical Syndromes" are associated with disorders of deep placentation. Am J Obstet Gynecol. 2011 Mar;204(3):193-201. doi: 10.1016/j.ajog.2010.08.009. Epub 2010 Nov 20. PMID 21094932
- BACKGROUNDBartsch E, Medcalf KE, Park AL, Ray JG; High Risk of Pre-eclampsia Identification Group. Clinical risk factors for pre-eclampsia determined in early pregnancy: systematic review and meta-analysis of large cohort studies. BMJ. 2016 Apr 19;353:i1753. doi: 10.1136/bmj.i1753. PMID 27094586
- BACKGROUNDBrennan LJ, Morton JS, Davidge ST. Vascular dysfunction in preeclampsia. Microcirculation. 2014 Jan;21(1):4-14. doi: 10.1111/micc.12079. PMID 23890192
- BACKGROUNDMayrink J, Souza RT, Feitosa FE, Rocha Filho EA, Leite DF, Vettorazzi J, Calderon IM, Sousa MH, Costa ML, Baker PN, Cecatti JG; Preterm SAMBA study group. Incidence and risk factors for Preeclampsia in a cohort of healthy nulliparous pregnant women: a nested case-control study. Sci Rep. 2019 Jul 2;9(1):9517. doi: 10.1038/s41598-019-46011-3. PMID 31266984
- BACKGROUNDBerntsen S, Larsen EC, la Cour Freiesleben N, Pinborg A. Pregnancy outcomes following oocyte donation. Best Pract Res Clin Obstet Gynaecol. 2021 Jan;70:81-91. doi: 10.1016/j.bpobgyn.2020.07.008. Epub 2020 Jul 15. PMID 32741624
- BACKGROUNDPreaubert L, Vincent-Rohfritsch A, Santulli P, Gayet V, Goffinet F, Le Ray C. Outcomes of pregnancies achieved by double gamete donation: A comparison with pregnancies obtained by oocyte donation alone. Eur J Obstet Gynecol Reprod Biol. 2018 Mar;222:1-6. doi: 10.1016/j.ejogrb.2017.12.026. Epub 2017 Dec 15.