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Completed

NCT Number: NCT04576039

Ultrasonographic Appearance of the Endometrium After Ulipristalacetate Use and Endometrial Changes

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.

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Key information

Conditions

Uterine Fibroid Endometrial Cyst Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis UZBrussel

Jette, Brussels Capital, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

saline infusion sonography

Diagnostic Test

Instillation of 10cc of saline infusion in the uterine cavity while performing an ultrasonic evaluation of the uterine cavity and endometrium.

Primary outcomes

  1. ultrasonographic morphology of the endometrium at saline infusion sonography

    Time frame: 1 week

    thickness and appearance of the endometrium

Secondary outcomes

  1. diagnostic ability to exclude intrauterine pathology

    Time frame: 1week

    presence yes or no of intra uterine pathology as polyps or fibroids

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2020
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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