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临床试验/NCT02710006
NCT02710006已完成不适用

Feasibility and Reliability of Assessing Uterine Cavity Volume by SonoAVC in Women With Reproductive Failure.

Ludwin & Ludwin Gynecology, Private Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Concordance correlation coefficient in uterine cavity automated volume calculation

研究概览

简要总结

The purpose of this trial is to evaluate the feasibility and reliability of automatic volume calculation of uterine cavity in women with reproductive failures. 3D volumes of uterus and uterine cavity will be acquired during three-dimensional ultrasonography and sonohysterography. After that independent observers will measure offline the uterine cavity volume using automatic volume calculation using SonoAVC general software, and VOCAL software.

详细描述

INTRODUCTION

The uterus is one of key organs in reproduction and fetal development. A distorted shape and size of uterine cavity may to have significant impact on the reproductive failures (Chan et al., 2011; Saravelos et al., 2008). Current definitions and classification for uterine morphology and its congenital malformation are still controversial (Grimbizis et al., 2013; 2015; Ludwin and Ludwin, 2015a, b). This is an important barrier for studies evaluating the effectiveness of interventions for women with such conditions (Ludwin et al., 2015 a, b).

The uterine cavity volume is a specific feature of each individual uterus, and together with shape of uterine cavity may play one of the crucial roles in etiology of reproductive failures. To the investigators' knowledge the uterine cavity volume has never been studied in this context (Ludwin et al., 2016).

Recently, the technique of uterine cavity imaging, volume estimation, and quantification of deformity degree using automatic volume calculation (called SonoHysteroAVC; using SonoAVC software; GE Medical Systems, Zipf, Austria) during three-dimensional sonohysterography has been described (Ludwin et al., 2016). Uterine volume estimation is also potentially possible using Virtual Organ Computer-aided AnaLysis (VOCAL™; GE Medical Systems, Zipf, Austria), as for endometrial volume calculation (Martins et al., 2011).

The investigators believe that SonoHysteroAVC technique might improve the knowledge about uterine anatomy, the diagnostic accuracy of uterine cavity shape imaging, and the management of women with different morphological shapes of the uterine cavity. (Ludwin et al., 2016).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • infertility (12 months trying to conceive without success) and/or two previous miscarriages

排除标准

  • unknown pregnancy (ultrasound examination)
  • menopause
  • precancerous conditions and cancers of female genital tract
  • refused consent

结局指标

主要结局

Concordance correlation coefficient in uterine cavity automated volume calculation

时间窗: up to 12 months

the concordance correlation coefficient measures the agreement between two variables to evaluate reliability

Limits of agreement (LoA) in uterine cavity volume estimation

时间窗: up to 12 months

Limits of agreement are an estimate of the interval within which a proportion of the differences between measurements lie.

Time needed for uterine cavity volume analysis

时间窗: up to 12 months

Time needed for performing of uterine cavity volume calculation in offline analysis

Time needed for acquisition

时间窗: up to 12 months

Time needed for performing of three-dimensional sonohysterography and for uterine cavity 3D dataset acquisition (time of real-time three-dimensional sonohysterography)

次要结局

未报告次要终点

研究者

发起方
Ludwin & Ludwin Gynecology, Private Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Artur Ludwin

Artur Ludwin MD, PhD

Ludwin & Ludwin Gynecology, Private Medical Center

研究点 (2)

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