Survey of Dysmorphic Uterus Knowledge Among Gynecologists. (DUS-1)
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|ClinicalTrials.gov Identifier: NCT04075786|
Recruitment Status : Not yet recruiting
First Posted : September 3, 2019
Last Update Posted : March 24, 2020
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.
|Condition or disease||Intervention/treatment|
|Dysmorphic Uterus||Other: Survey|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Survey of Dysmorphic Uterus Knowledge Among Gynecologists.|
|Estimated Study Start Date :||November 2023|
|Estimated Primary Completion Date :||March 2025|
|Estimated Study Completion Date :||April 2027|
Gynecologists in active clinical practice and resident (in training) gynecologists.
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 (T, Y or I shaped).
- Degree of concordance between anticipated and actual diagnosis of dysmorphic uteri [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075786
|Contact: Antonio Laganà, M.D.||3296279579 ext +email@example.com|
|Study Director:||Jose Carugno, M.D.||University of Miami|
|Study Director:||Luis Alonso, M.D.||Centro Gutenberg, Malaga|
|Study Chair:||Antonio Simone Laganà, M.D.||Università degli Studi dell'Insubria|