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NCT Number: NCT04075786

Survey of Dysmorphic Uterus Knowledge Among Gynecologists.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None.

Treatment and study plan

Survey

Other

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).

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Laganà, M.D.

CONTACT

[email protected]

3296279579 ext. +39

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Collaborators

  • University of Miami

Registry information

Acronym: DUS-1

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Sep 3, 2019
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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