PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)

NCT07263490 | Recruiting

• 2 other identifiers: H-22068878p-2024-17237
• Study Type: observational
• Target: 462
• Locations: 1 country
• Sites: 6

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.

Conditions

Pre-eclampsia; Oocyte Donation; Pre-Eclampsia; Complicating Pregnancy; Pre-Eclampsia; Mild; 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; Pre-Eclampsia, Severe

Keywords

Pre-eclampsia; Preeclampsia; ART; Gestational hypertension; Oocyte donation; Egg donation; Gamete donation

Outcome Measures

Primary Outcomes (2)

• Pre-eclampsia

  Development of pre-eclampsia

  During pregnancy and in the following two weeks post-partum

• Biochemical markers for pre-eclampsia

  Analysis of bloodtests for biochemical markers of pre-eclampsia

  From early pregnancy untill delivery

Secondary Outcomes (8)

• Post-partum hemorrhage

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

• Gestational diabetes

  During pregnancy untill delivery.

• Preterm delivery

  Early delivery before gestational week 37

• Placental abruption

  During pregnancy and delivery

• Intrauterine growth retardation (IUGR)

  From pregnancy is obtained untill delivery

Study Arms (2)

Preg OD

Women pregnant after treatment with oocyte donation

Preg IVF

Women pregnant after IVF treatment with autologous oocytes

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: As this study explores risks during pregnancy and in delivery, the study is limited to persons with a uterus.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age \> 18 years
• BMI \< 35 kg/m2
• Normal wet smear within the past three years
• Both nulli- and multiparous
• Singletons and multiple gestations

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: collaborator
• Gedeon Richter Ltd.: collaborator
• Copenhagen University Hospital, Hvidovre: lead

Study Sites (6)

Copenhagen Fertility Center

Copenhagen, 2400, Denmark

RECRUITING

Trianglen Fertility Clinic

Hellerup, 2900, Denmark

RECRUITING

Fertility Clinic, Herlev / Gentofte Hospital

Herlev, 2730, Denmark

RECRUITING

Sellmer Klinik

København S, 2300, Denmark

RECRUITING

Fertility Clinic, Rigshospitalet

København Ø, 2100, Denmark

RECRUITING

Aleris Fertility

Søborg, 2860, Denmark

RECRUITING

Related Publications (16)

• Tian 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 BACKGROUND

• Brosens 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 BACKGROUND

• Bartsch 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 BACKGROUND

• Brennan LJ, Morton JS, Davidge ST. Vascular dysfunction in preeclampsia. Microcirculation. 2014 Jan;21(1):4-14. doi: 10.1111/micc.12079.

  PMID: 23890192 BACKGROUND

• Mayrink 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 BACKGROUND

• Berntsen 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 BACKGROUND

• Preaubert 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.

  PMID: 29309921 BACKGROUND

• Nejdet S, Bergh C, Kallen K, Wennerholm UB, Thurin-Kjellberg A. High risks of maternal and perinatal complications in singletons born after oocyte donation. Acta Obstet Gynecol Scand. 2016 Aug;95(8):879-86. doi: 10.1111/aogs.12904. Epub 2016 Apr 28.

  PMID: 27060438 BACKGROUND

• Rodriguez-Wallberg KA, Berger AS, Fagerberg A, Olofsson JI, Scherman-Pukk C, Lindqvist PG, Nasiell J. 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. Gynecol Endocrinol. 2019 Apr;35(4):314-319. doi: 10.1080/09513590.2018.1528577. Epub 2019 Jan 9.

  PMID: 30626251 BACKGROUND

• Storgaard M, Loft A, Bergh C, Wennerholm UB, Soderstrom-Anttila V, Romundstad LB, Aittomaki K, Oldereid N, Forman J, Pinborg A. Obstetric and neonatal complications in pregnancies conceived after oocyte donation: a systematic review and meta-analysis. BJOG. 2017 Mar;124(4):561-572. doi: 10.1111/1471-0528.14257. Epub 2016 Sep 5.

  PMID: 27592694 BACKGROUND

• Serhal PF, Craft IL. Oocyte donation in 61 patients. Lancet. 1989 May 27;1(8648):1185-7. doi: 10.1016/s0140-6736(89)92762-1.

  PMID: 2566746 BACKGROUND

• Hogan RG, Wang AY, Li Z, Hammarberg K, Johnson L, Mol BW, Sullivan EA. Oocyte donor age has a significant impact on oocyte recipients' cumulative live-birth rate: a population-based cohort study. Fertil Steril. 2019 Oct;112(4):724-730. doi: 10.1016/j.fertnstert.2019.05.012. Epub 2019 Jun 24.

  PMID: 31248619 BACKGROUND

• Wang YA, Farquhar C, Sullivan EA. Donor age is a major determinant of success of oocyte donation/recipient programme. Hum Reprod. 2012 Jan;27(1):118-25. doi: 10.1093/humrep/der359. Epub 2011 Nov 2.

  PMID: 22048992 BACKGROUND

• Ginsburg ES, George JS. Older but not wiser: the impact of increasing paternal age on donor oocyte recipient success. Fertil Steril. 2021 Aug;116(2):337-338. doi: 10.1016/j.fertnstert.2021.06.031. Epub 2021 Jul 10. No abstract available.

  PMID: 34253325 BACKGROUND

• Lutjen P, Trounson A, Leeton J, Findlay J, Wood C, Renou P. The establishment and maintenance of pregnancy using in vitro fertilization and embryo donation in a patient with primary ovarian failure. Nature. 1984 Jan 12-18;307(5947):174-5. doi: 10.1038/307174a0.

  PMID: 6690997 BACKGROUND

• Matthews TJ, Hamilton BE. Delayed childbearing: more women are having their first child later in life. NCHS Data Brief. 2009 Aug;(21):1-8.

  PMID: 19674536 BACKGROUND

Related Links

• Webpage for the Danish Society for Fertility Treatment
• Danish Society For Obstetricians and Gynecologists, guideline on pregnancy after oocyte donation

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples six times throughout the participants' pregnancies. Samples will be analyzed for pre-eclampsia markers.

MeSH Terms

Conditions

Pre-Eclampsia; Pregnancy Complications; Lymphoma, Follicular; Abruptio Placentae; Diabetes, Gestational; Obstetric Labor, Premature; Postpartum Hemorrhage; Fetal Growth Retardation; Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Obstetric Labor Complications; Placenta Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 4, 2025
• Study Start: October 21, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (6)