NCT04576039

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

September 29, 2020

Last Update Submit

September 29, 2020

Conditions

Uterine FibroidEndometrial Cyst

Outcome Measures

Primary Outcomes (1)

  • ultrasonographic morphology of the endometrium at saline infusion sonography

    thickness and appearance of the endometrium

    1 week

Secondary Outcomes (1)

  • diagnostic ability to exclude intrauterine pathology

    1week

Study Arms (1)

presenting with thickened endometruim

EXPERIMENTAL

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.

Diagnostic Test: saline infusion sonography

Interventions

saline infusion sonographyDIAGNOSTIC_TEST

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

presenting with thickened endometruim

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Known type 0 or 1 fibroids
  • Known intrauterine pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis UZBrussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Catherine Degreef, PhD

    Universitair Ziekenhuis Brussel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 5, 2020

Study Start

January 1, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

October 5, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)