Ultrasonographic Appearance of the Endometrium After Ulipristalacetate Use and Endometrial Changes

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: Uterine Fibroid; Endometrial Cyst

Treatments: Diagnostic Test: saline infusion sonography

Study type: Interventional

Funder types: Other

Identifiers

NCT04576039

PAEC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

presenting with thickened endometruim

Experimental group

Description:

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.

Treatment:

Diagnostic Test: saline infusion sonography