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临床试验/NCT03777358
NCT03777358Unknown不适用

A Prospective Study Comparing Three-dimensional Ultrasonography Versus Hysteroscopy in Evaluation of Uterine Cavity in Infertile Women

Hatem AbuHashim1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年1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
300
试验地点
1
主要终点
Diagnostic accuracy of 3D-TVS

研究概览

简要总结

Hysteroscopy has now become a gold-standard technique carried out for uterine cavity assessment in infertile women. Apart from direct visualizing of the endometrium by the naked eye, pathologies missed by other modalities of investigation can be picked up and managed appropriately. Unfortunately, the procedure itself is not free from complications e.g. perforation, cervical laceration, bleeding, limited access in cases of cervical stenosis and considered as an invasive procedure.

Two-dimensional transvaginal ultrasonography (2D-TVS)and Three-dimensional TVS (3D-TVS) are non-invasive methods for evaluating the uterine cavity. The3D-TVS is superior to 2D-TVS in identifying uterine cavity abnormalities due to its ability to obtain a view of three different planes of the uterus, which could be used to locate the position of intracavitary pathology. Reports vary regarding the diagnostic accuracy of 3D-TVS that was reported to have 41.3-81.5% sensitivity and 94.6-98.7% specificity. So it became clear that 3D-TVS is a non-invasive and safe diagnostic tool for evaluation of the uterine cavity abnormalities but its sensitivity, specificity and accuracy still a matter of debate and warrants more evaluation.

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

  • Infertile women (primary or secondary)
  • Age between 18 and 40 years.

排除标准

  • age<18 years and˃ 40 years.
  • pelvic inflammatory disease.
  • .Active uterine bleeding

结局指标

主要结局

Diagnostic accuracy of 3D-TVS

时间窗: At 1 week postmenstrual

The diagnostic accuracy of 3D-TVS in comparison with hysteroscopy for evaluation of uterine cavity abnormalities in infertile women.

次要结局

未报告次要终点

研究者

发起方
Hatem AbuHashim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hatem AbuHashim

Professor

Mansoura University

研究点 (1)

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