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Survey of Dysmorphic Uterus Knowledge Among Gynecologists.

Survey of Dysmorphic Uterus Knowledge Among Gynecologists.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04075786
Acronym
DUS-1
Enrollment
300
Registered
2019-09-03
Start date
2023-11-30
Completion date
2027-04-30
Last updated
2021-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmorphic Uterus

Keywords

Uterine malformations, Hysteroscopy, 3D ultrasound, Infertility

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.

Interventions

OTHERSurvey

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).

Sponsors

University of Miami
CollaboratorOTHER
Università degli Studi dell'Insubria
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Degree of concordance between anticipated and actual diagnosis of dysmorphic uteriThrough study completion, an average of 1 yearDegree 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.

Contacts

Primary ContactAntonio Laganà, M.D.
antoniosimone.lagana@uninsubria.it3296279579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026