Uterine FibroidNCT04576039
Ultrasonographic Appearance of the Endometrium After Ulipristalacetate Use and Endometrial Changes
A study testing saline infusion sonography in people with Uterine Fibroid and Endometrial Cyst, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Fibroid, Endometrial Cyst
- What is being tested?
- saline infusion sonography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Known type 0 or 1 fibroids
- Known intrauterine pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Appearance of the Endometrium After Saline Infusion in Women Presenting With a Thickened Endometrium After the Use of Ulipristalacetate.
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.
Read the 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.
- Conditions
- Uterine Fibroid, Endometrial Cyst
- Being tested
- saline infusion sonography
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: saline infusion sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasonographic morphology of the endometrium at saline infusion sonography
thickness and appearance of the endometrium
Measured: 1 week
Secondary outcomes (1)
diagnostic ability to exclude intrauterine pathology
presence yes or no of intra uterine pathology as polyps or fibroids
Measured: 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Jan 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Cosyns, Universitair Ziekenhuis Brussel
- Investigators
- Catherine Degreef, PhD, Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576039
- Sponsor's protocol ID
- PAEC
- Status last verified
- Sep 2020
- First submitted
- 29 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Appearance of the Endometrium After Saline Infusion in Women Presenting With a Thickened Endometrium After the Use of Ulipristalacetate.
- ClinicalTrials.gov ID
- NCT04576039
- Acronym / sponsor ID
- PAEC
- Conditions
- Uterine Fibroid, Endometrial Cyst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| presenting with thickened endometruim | Experimental | Diagnostic Test: saline infusion sonographywomen 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Known type 0 or 1 fibroids
- Known intrauterine pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saline infusion sonographyInstillation of 10cc of saline infusion in the uterine cavity while performing an ultrasonic evaluation of the uterine cavity and endometrium. | Diagnostic test | presenting with thickened endometruim |
Primary outcome
ultrasonographic morphology of the endometrium at saline infusion sonography
Time frame: 1 week
thickness and appearance of the endometrium
1 secondary outcome
diagnostic ability to exclude intrauterine pathology
Time frame: 1week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Degreef, PhD study chair
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saline infusion sonography in people with Uterine Fibroid and Endometrial Cyst, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasonographic morphology of the endometrium at saline infusion sonography (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.