MRI Evaluation of Maternal Cardiovascular Response to Pregnancy in IVF Women Following Autologous Natural Cycle FET, Programmed FET and After Donor Embryo Transfer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Maternal cardiovascular adaption to pregnancy
研究概览
简要总结
Aim of the study is to explore the effect of a lacking corpus luteum on maternal cardiovascular and metabolic adaption to pregnancy by the use of magnetic resonance imaging (MRI).
详细描述
The use of programmed frozen embryo transfer cycle (FET) in IVF women is associated with an increased risk of obstetric complications (pregnancy-induced hypertension, preeclampsia, postpartum hemorrhage and placenta accreta) compared to FET in natural cycle.
The lack of corpus luteum in programmed cycles and the subsequent absence of circulating vasoactive substances may lead to an impaired cardio-vascular adaption to pregnancy and thereby an increased risk of pregnancy-induced hypertension and preeclampsia.
The cardiovascular and metabolic adaption to pregnancy is evaluated throughout pregnancy by use of Magnetic Resonance Imaging (MRI) as well as non-invasive measurements by use of elastography and seismocardiography.
Patients are screened for preeclampsia throughout pregnancy with measurements of blood pressure, urine samples as well as blood samples.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Autologous embryo transfer in programmed FET-cycle or modified-natural FET-cycle or
- •Planned donor egg transfer in programmed FET-cycle or modified-natural FET-cycle
- •Age < 40 years
- •BMI < 35
- •Primary diagnosis being unexplained infertility, male infertility or tubal factor
- •Singleton blastocyst transfer
排除标准
- •Essential hypertension
- •Diabetes Mellitus (type 1 or 2)
- •Known cardiac disease
- •Antiphospholipid syndrome, Lupus erythematosus, rheumatoid disease
- •Preelampsia, gestational hypertension, gestational diabetes or severe intrauterine growth restriction (IUGR) in any previous pregnancy
- •Multiple pregnancy
- •Severe claustrophobia or any other contraindications to MRI
结局指标
主要结局
Maternal cardiovascular adaption to pregnancy
时间窗: From early pregnancy to six months postpartum
Placental function and fetal oxygenation estimated by longitudinal T2* weighted placental and fetal MRI
时间窗: From early pregnancy to six months postpartum
Maternal metabolic adaption to pregnancy
时间窗: From early pregnancy to six months postpartum
次要结局
未报告次要终点
研究者
Lise Haaber Thomsen
MD, Consultant
Aalborg University Hospital