Survey of Dysmorphic Uterus Knowledge Among Gynecologists.

NCT04075786 | Not Yet Recruiting

• 1 other identifier: Dysmorphic Uterus Survey-1
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dysmorphic Uterus

Keywords

Uterine malformations; Hysteroscopy; 3D ultrasound; Infertility

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Gynecologists

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

Other: Survey

Interventions

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).

Gynecologists

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead
• University of Miami: collaborator

MeSH Terms

Conditions

Uterine Anomalies; Infertility

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jose Carugno, M.D.

  University of Miami

  STUDY DIRECTOR

• Luis Alonso, M.D.

  Centro Gutenberg, Malaga

  STUDY DIRECTOR

• Antonio Simone Laganà, M.D.

  Università degli Studi dell'Insubria

  STUDY CHAIR

Central Study Contacts

Antonio Laganà, M.D.

CONTACT

3296279579; antoniosimone.lagana@uninsubria.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: September 3, 2019
• Study Start: November 1, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 29, 2021

Record last verified: 2021-04