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临床试验/NCT04930913
NCT04930913Unknown不适用

The Value of Three-dimensional Ultrasound Applying in Pre and Postoperative Assessment and Prognosis of Intrauterine Adhesions

Fu Xing Hospital, Capital Medical University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
1
主要终点
Endometrial volume

研究概览

简要总结

In this prospective, multicenter, large-scale study,the investigators wish to examine the accuracy of several three-dimensional ultrasound anatomical and vascular parameters in diagnosing IUA when compared to the gold standard of hysteroscopy,and to assess the value of 3D US applying in prognosis of intrauterine adhesions.

详细描述

  1. Study Design This is a prospective, multicenter, large-scale diagnostic testing. We use hysteroscopy finding as standard reference.
  2. Study population 600 patients from three tertiary hospitals suspected of having IUA will be prospectively recruited. Thorough assessment including previous reproductive and surgical history as well as menstrual pattern will be performed.
  3. Study Procedure 3.1 Diagnosis

IUA will be diagnosed in coronal plane, based on a suggestion reported by a Taiwanese study. The morphological characteristics of the endometrium suggesting IUA include as follow:

  • marginal irregularity (in coronal plane)
  • defects (interrupted endometrial line)
  • obliteration (undetectable endometrium suggesting extensive adhesion)
  • fibrosis or calcification (hyperechoic lesion without posterior shadowing, or with posterior shadowing) 3.2 Ultrasound
  • Transvaginal Ultrasound will be performed in luteal phase.
  • Using E10 Voluson GE with 3D/4D TV probe.
  • Scan and rendering will be performed in a standardized technique (omniview mode).
  • Several parameters will be measured including endometrial volume, uterine volume, vascularization (VI FI VFI).

3.3 Hysteroscopy

  • Hysteroscopic exam will be used as the gold standard for the diagnosis of intrauterine adhesions.
  • hysteroscopy will confirm the presence, extent, and morphological characteristics of adhesions and the quality of the endometrium.

研究设计

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

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women aged 20-40
  • oligomenorrhea or amenorrhea
  • BMI 18-30
  • regular menstruation
  • written consent obtained

排除标准

  • Hypothalamic amenorrhea, pituitary amenorrhea and ovarian amenorrhea
  • Patients with uterine fibroids, adenomyosis, uterine malformation and endometrial polyps
  • Patients with uterine artery embolization
  • History of endometrial hyperplasia
  • Irregular menstruation
  • Patients with severe complications
  • Patients with hypoovarian function

结局指标

主要结局

Endometrial volume

时间窗: 1 year

Endometrial volume will be measured in in luteal phase by 3D US

次要结局

未报告次要终点

研究者

发起方
Fu Xing Hospital, Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaowu Huang

Director of department

Fu Xing Hospital, Capital Medical University

研究点 (1)

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