Ultrasonographic Appearance of the Endometrium After Ulipristalacetate Use and Endometrial Changes

Uterine Fibroid Clinical Trial

Official title:

Ultrasonographic Appearance of the Endometrium After Saline Infusion in Women Presenting With a Thickened Endometrium After the Use of Ulipristalacetate.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04576039
• Other study ID #: PAEC
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: September 2020
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

If endometrial thickening is visualised (>10mm) after the use of ulipristalacetate in case of medical treatment for uterine fibroids a saline infusion and sonographic examination will be performed to evaluate the endometrium and exclude intra-uterine pathology.

Description:

When ultrasonographic examination during follow up of a treatment with ulipristalacetate shows a thickening of the endometrium of 10mm or more ( thickening described in 10% of ulipristalacetate users and is completely benign), a saline infusion can help to exclude pathology in the uterine cavity. Saline infusion helps to better delineate the uterine cavity and endometrium. If fibroids or polyps are present in the uterine cavity they will clearly be seen.

This study was set up to describe how the endometrial changes after Esmya use appear on saline infusion sonography. This study can help to recognize ultrasonographic images in women presenting with thickened endometrium after Ulipristalacetate use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women with thickened endometrium on ultrasound (defined as double endometrium thickness of =10mm) at the end of their treatment with ulipristalacetate.

• Normal double endometrium thickness before the use of ESMYA (<10mm)

• BMI >18 - < 30

Exclusion Criteria:

• Known type 0 or 1 fibroids

• Known intrauterine pathology

Related Conditions & MeSH terms

• Endometrial Cyst
• Leiomyoma
• Uterine Fibroid

Intervention

Diagnostic Test:
• saline infusion sonography
Instillation of 10cc of saline infusion in the uterine cavity while performing an ultrasonic evaluation of the uterine cavity and endometrium.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis UZBrussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ultrasonographic morphology of the endometrium at saline infusion sonography	thickness and appearance of the endometrium	1 week
Secondary	diagnostic ability to exclude intrauterine pathology	presence yes or no of intra uterine pathology as polyps or fibroids	1week