跳至主要内容
临床试验/NCT05763498
NCT05763498招募中不适用

Uterine Junctional Zone Evaluation on 3D Ultrasound and Its Relation to Major Adverse Obstetrical Outcomes in Assisted Reproductive Technology

Centro Hospitalar Lisboa Norte3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年2月24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
200
试验地点
3
主要终点
Pre-eclampsia

研究概览

简要总结

The junctional zone (JZ) is an internal layer of the myometrium, with unique characteristics that allow its visualization as a hypoechogenic structure in three-dimensional (3D) ultrasound.

While there is a growing realization that the origins of major obstetrical complications associated with defective deep placentation, such as pre-term labour, fetal growth restriction and pre-eclampsia, may lie in the very early pregnancy events, the underlying mechanisms are not understood.

详细描述

During pregnancy, unique vascular changes occur, associated with decidualization of the maternal tissues in response to trophoblast invasion, first in the endometrium and subsequently in the myometrial JZ. The JZ broadly represents the inner third of the myometrium that, together with its overlying endometrium, is involved in placentation.

Defective deep placentation, defined by the absent or incomplete remodelling of the JZ segment of the spiral arteries, may be associated with a spectrum of obstetrical complications, ranging from late miscarriage and pre-term labour to fetal growth restriction and pre-eclampsia.

Thus, the primary site of vascular pathology in pregnancies lies not in the placenta or decidua but in the JZ. To understand how impaired remodelling of the myometrial JZ prior to conception may predispose to subsequent defective deep placentation, it is important to first describe the structural and functional changes in the JZ at the time of embryo implantation, and subsequently analyse the distinguishing features of defective deep placentation associated with different pregnancy disorders.

Thus, non-invasive assessment of the JZ prior to conception may turn out to be useful in identifying those women at risk of major obstetrical complications.

This project aims to evaluate the relationship between the characteristics of the ZJ in 3D ultrasound, and major adverse obstetrical outcomes in assisted reproductive technology (ART) treatments, namely in vitro fertilization cycles, intracytoplasmic sperm injection and frozen embryo transfer (FET).

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

入选标准

  • Women followed in the infertility clinic aged between 18 and 42 years in cycles of IVF, ICSI or endometrial preparation for frozen embryo transfer

排除标准

  • adenomyosis
  • endometriosis

结局指标

主要结局

Pre-eclampsia

时间窗: 40 weeks

Pre-eclampsia rate

pre-term labour

时间窗: 37 weeks

pre-term labour rate

Fetal growth restriction

时间窗: 40 weeks

Fetal growth restriction rate

次要结局

  • High-risk first trimester screening for pre-eclampsia(12 weeks)

研究者

发起方
Centro Hospitalar Lisboa Norte
申办方类型
Other
责任方
Principal Investigator
主要研究者

Isabel Pereira

M.D.

Centro Hospitalar Lisboa Norte

研究点 (3)

Loading locations...

相似试验