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临床试验/NCT04075786
NCT04075786尚未招募不适用

Survey of Dysmorphic Uterus Knowledge Among Gynecologists.

Università degli Studi dell'Insubria0 个研究点目标入组 300 人开始时间: 2023年11月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
主要终点
Degree of concordance between anticipated and actual diagnosis of dysmorphic uteri

研究概览

简要总结

Uterine malformations were initially described by Cruveilhier and Von Rokitansky in the 1800s. Many proposed classifications had been presented over the years, although only two are mostly used worldwide: the first proposed by the American Fertility Society (AFS) and the one recently published by European Society on Gynecologic Endoscopy / European Society of Human Reproductive Endocrinology (ESGE/ESHRE). Both classifications describe a special type of uterus, with an abnormally shaped narrow uterine cavity. This type of uterus was initially defined, before the use of ultrasound, as "hypoplasic uterus" by K. Menge and K.V. Oettingen in 1930. Subsequently, the AFS in its classification defined it as type VII as Diethylstilbestrol-related and the ESGE/ESHRE classification defined it as class U1a or T-shaped uterus.

At present there are no clear diagnostic criteria for this type of uterus and the only parameter widely accepted is that of "narrow uterine cavity due to thickened lateral walls". The purpose of this study is to conduct a survey of gynecologists in active clinical practice and resident (in training) gynecologists to establish the degree of concordance when cataloging 3D ultrasound images of normal or dysmorphic uteri, with the aim to identify common parameters that allow to identify the dysmorphic uterus with narrowing of the side walls.

The study will be carried out in two stages: in an initial step, participants will complete a survey evaluating their knowledge of uterine malformations and their involvement in assisted reproduction in their current clinical practice.

In the second step, participants will then watch a video of hysteroscopies and 3D ultrasound images of different cases highlighting the hysteroscopic/ultrasound correlation of the different variants of the uterus with narrowing of the side walls. Each participant will be shown 40 (forty) 3D ultrasound images of uterus of normal women without infertility and 40 (forty) infertile women with uterus with narrowing in the middle third diagnosed by hysteroscopy + 3D ultrasound and associated infertility (in T, Y or I shape). Once the survey is finished, the degree of concordance will be evaluated, with the aim to identify common parameters of diagnosis of dysmorphic uterus by 3D ultrasound.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Practicing gynecologist specialist or fellow/resident (in training);
  • Knowledge of the ESGE/AFS and T-Y-I uterine anomalies classification.

排除标准

  • 未提供

结局指标

主要结局

Degree of concordance between anticipated and actual diagnosis of dysmorphic uteri

时间窗: Through study completion, an average of 1 year

Degree of concordance will be expressed as the percentage of the investigated population that will identify correctly the diagnosis of dysmorphic uteri, distinguishing them from normal-shaped uteri, looking at the images obtained by ultrasound and hysteroscopy.

次要结局

未报告次要终点

研究者

发起方
Università degli Studi dell'Insubria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Simone Laganà

Principal Investigator

Università degli Studi dell'Insubria

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