PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients) - Investigating Matching, Biomarkers and Outcomes.
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
- 否
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
Pernille Fog Svendsen
Associate Professor
Copenhagen University Hospital, Hvidovre
