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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075786
Recruitment Status : Not yet recruiting
First Posted : September 3, 2019
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
University of Miami
Information provided by (Responsible Party):
Antonio Simone Laganà, Università degli Studi dell'Insubria

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.


Condition or disease Intervention/treatment
Dysmorphic Uterus Other: Survey

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
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

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).




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Gynecologists in active clinical practice and resident (in training) gynecologists
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075786


Contacts
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Contact: Antonio Laganà, M.D. 3296279579 ext +39 antoniosimone.lagana@uninsubria.it

Sponsors and Collaborators
Università degli Studi dell'Insubria
University of Miami
Investigators
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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
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Responsible Party: Antonio Simone Laganà, Principal Investigator, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT04075786    
Other Study ID Numbers: Dysmorphic Uterus Survey-1
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Simone Laganà, Università degli Studi dell'Insubria:
Uterine malformations
Hysteroscopy
3D ultrasound
Infertility