Clinical trial NCT04075786: Survey of Dysmorphic Uterus Knowledge Among Gynecologists.
Official title: Survey of Dysmorphic Uterus Knowledge Among Gynecologists.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dysmorphic Uterus
Keywords: Uterine malformations
Hysteroscopy
3D ultrasound
Infertility
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
Collaborators: name: University of Miami
First posted: 2019-09-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gynecologists in active clinical practice and resident (in training) gynecologists

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.


Eligibility 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.

Primary outcomes:
measure: Degree of concordance between anticipated and actual diagnosis of dysmorphic uteri
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: Jose Carugno, M.D.
role: STUDY_DIRECTOR
affiliation: Centro Gutenberg, Malaga
name: Luis Alonso, M.D.
role: STUDY_DIRECTOR
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà, M.D.
role: STUDY_CHAIR
References: