An observational study in Dysmorphic Uterus, sponsored by Università degli Studi dell'Insubria. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-29.
Sponsored by Università degli Studi dell'Insubria · Observational
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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.
2,087 studies on the registry are indexed under Infertility; 355 are open to participants now.
This study's planned enrollment of 300 is above the median of 200 across 591 observational studies indexed under Infertility.
Browse Infertility studies →Università degli Studi dell'Insubria is the lead sponsor of 68 studies on the registry; 8 are open to participants now.
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Gynecologists in active clinical practice and resident (in training) gynecologists
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Exclusion Criteria:
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).
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.
Time frame: Through study completion, an average of 1 year
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2023; primary completion for Mar 2025, 16 months later.
Of 209 non-industry observational studies under Infertility, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 100. This study's planned 16 months is below that.
Counting every sponsor, half of 240 studies reached it within 39 months; a quarter within 16 and three quarters within 99.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Università degli Studi dell'Insubria