RecruitingNCT07263490

PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)

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


Sponsor

Copenhagen University Hospital, Hvidovre

Enrollment

462 participants

Start Date

Oct 21, 2024

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

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

Exclusion Criteria18

  • 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

Locations(6)

Copenhagen Fertility Center

Copenhagen, Denmark

Trianglen Fertility Clinic

Hellerup, Denmark

Fertility Clinic, Herlev / Gentofte Hospital

Herlev, Denmark

Sellmer Klinik

København S, Denmark

Fertility Clinic, Rigshospitalet

København Ø, Denmark

Aleris Fertility

Søborg, Denmark

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NCT07263490


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