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临床试验/NCT07263490
NCT07263490招募中不适用

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

Copenhagen University Hospital, Hvidovre12 个研究点 分布在 1 个国家目标入组 462 人开始时间: 2024年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
462
试验地点
12
主要终点
Pre-eclampsia

研究概览

简要总结

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.

详细描述

INTRODUCTION AND BACKGROUND Maternal age at conception has increased globally, leading to a higher proportion of pregnancies among women aged ≥35 years. In Denmark, the average maternal age at first birth has risen from 24 years in 1970 to 30 years in 2021. As female fecundity declines markedly after age 35, the need for assisted reproductive technology (ART) is increasing.

The success rate of ART using autologous oocytes decreases significantly after age 40, making oocyte donation (OD) a relevant option for women with diminished ovarian reserve or poor oocyte quality. OD was first introduced in 1984 to treat infertility due to premature ovarian failure and is now used for various indications including Turner syndrome, previous oophorectomy, gonadotoxic therapy, and certain genetic disorders.

OD has been legal in Denmark since 2007 and double gamete donation since 2018. Healthy women under 36 years can donate oocytes anonymously or non-anonymously. The number of OD procedures in Denmark has increased from 124 in 2011 to 2,782 in 2022, resulting in 756 deliveries in 2021. The rise is attributed to delayed motherhood, legal changes, and increased donor compensation.

Several studies have demonstrated that pregnancies following OD are associated with a higher risk of obstetric complications, including pre-eclampsia (PE), intrauterine growth restriction, preterm birth, cesarean section, placental abruption, and postpartum hemorrhage. The risk appears to be even higher in double gamete donation pregnancies. The mechanisms behind these associations remain unclear but are thought to involve immune maladaptation due to exposure to non-self paternal and donor antigens.

PE complicates approximately 3-8% of pregnancies and is defined as new-onset hypertension (≥140/90 mmHg) with proteinuria (≥300 mg/24 h) and/or signs of organ dysfunction after 20 weeks of gestation. Risk factors include prior PE, chronic hypertension, renal disease, diabetes, autoimmune disease, multifetal gestation, nulliparity, advanced maternal age, high BMI, long interpregnancy interval, and family history of PE.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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
  • Alcohol/drug abuse

研究组 & 干预措施

Preg OD

Women pregnant after treatment with oocyte donation

Preg IVF

Women pregnant after IVF treatment with autologous oocytes

结局指标

主要结局

Pre-eclampsia

时间窗: During pregnancy and in the following two weeks post-partum

Development of pre-eclampsia

Biochemical markers for pre-eclampsia

时间窗: From early pregnancy untill delivery

Analysis of bloodtests for biochemical markers of pre-eclampsia

次要结局

  • 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)
  • Asphyxia(During delivery or in the first 24 hours post-partum)
  • Neonatal morbidity(From delivery untill 28 days post-partum)
  • Neonatal mortality(From delivery untill 28 days post-partum)

研究者

发起方
Copenhagen University Hospital, Hvidovre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pernille Fog Svendsen

Associate Professor

Copenhagen University Hospital, Hvidovre

研究点 (12)

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