Survey of Dysmorphic Uterus Knowledge Among Gynecologists. (DUS-1)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dysmorphic Uterus
• Intervention / Treatment: Other: Survey

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Antonio Laganà, M.D.; Phone Number: +39 3296279579; Email: antoniosimone.lagana@uninsubria.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Gynecologists in active clinical practice and resident (in training) gynecologists

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gynecologists; Gynecologists in active clinical practice and resident (in training) gynecologists.	Other: Survey; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of concordance between anticipated and actual diagnosis of dysmorphic uteri	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.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria
• Collaborators: University of Miami
• Investigators: Study Director: Jose Carugno, M.D., University of Miami; Study Director: Luis Alonso, M.D., Centro Gutenberg, Malaga

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2023
• Primary Completion (ANTICIPATED): March 1, 2025
• Study Completion (ANTICIPATED): April 1, 2027

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (ACTUAL): September 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Infertility; Hysteroscopy; 3D ultrasound; Uterine malformations
• Other Study ID Numbers: Dysmorphic Uterus Survey-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No