Ultrasonographic Appearance of the Endometrium After Ulipristalacetate Use and Endometrial Changes

Not Applicable

Completed

• Conditions: Uterine Fibroid; Endometrial Cyst
• Interventions: Diagnostic Test: saline infusion sonography

• Registration Number: NCT04576039
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-09-29
• Last Update Submitted: 2020-09-29
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Study First Posted: 2020-10-05
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
presenting with thickened endometruim	saline infusion sonography	women presenting with thickened endometrium after the use of ulipristalacetate will undergo a saline infusion in the uterus and immediate ultrasonographic control to visualise the morphology of the endometrium.

Primary Outcome Measures

Name	Time	Method
ultrasonographic morphology of the endometrium at saline infusion sonography	1 week	thickness and appearance of the endometrium

Secondary Outcome Measures

Name	Time	Method
diagnostic ability to exclude intrauterine pathology	1week	presence yes or no of intra uterine pathology as polyps or fibroids

Trial Locations

Locations (1)

Universitair Ziekenhuis UZBrussel; 🇧🇪 Jette, Brussels, Belgium