- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05741671
Sonographic Features of Fibroids Before and During Non-surgical Therapy and/or Expectant Management (MYOVASC)
Rationale: 20-30% of women of reproductive age have leiomyomas, causing symptoms like dysmenorrhea and pelvic pain which both effect quality of life.[1-4] The natural behaviour of uterine fibroids is to grow between 7 to 84% in 3 to 12 months.[5-7] Non-surgical options to treat uterine fibroids are non-hormonal or hormonal medical therapies and minimally invasive interventional radiologic techniques. Exogenous hormone exposure including COC, POP or Mirena give in conflicting literature minimal growth to 60% volume shrinkage. [8, 9]] Selective progesterone receptor modulators (SPRM) eg. Esmya and GnRH-analogues intent to reduce fibroids volume after several months; GnRH-agonists provide a 31-63% shrinkage and less frequently applied GnRH-antagonists 14.3 - 42.7%.[10-16] Esmya gives a volume reduction varying between 10 to 48%.[17] Radiological technique like embolization decreases dominant fibroid volume with 40-70%.[1, 18-22] UAE fails in case of devascularized or minimal vascularized fibroids.[23] Ablation techniques show shrinkage up to a maximum of 90% depending e.g. which treatment.[24-41] Clear prognostic models to predict the effect on fibroid related symptoms and volume reduction are lacking. We postulate higher vascularity to be related to 1) larger fibroid growth during the natural course or during exogenous hormonal exposure; 2) more effective shrinkage during progestogens, GnRH-analogues, SPRM and UAE; but 3) less effective after ablation therapy.
Objectives: To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRM or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy.
Study design: Observational cohort study during 5 years in the outpatient clinic.
Patientselection: Women ≥18 years with 1 to 3 fibroids with a maximal diameter ≥ 3cm and ≤ 10cm diagnosed on ultrasound examination, planned for expectant or non-surgical management. Study objectives: The primary outcome is volume reduction after 3 to 12 month depending on the study group. The secondary outcome include UFS-QOL, EQ-5D score, PBAC, hemoglobin level, treatment failure rate and (re)intervention rate.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No risks are associated with the participation of this observational study since the outcome measures include vaginal ultrasound, questionaires and a hemoglobin test. These measurements are also applied in daily practice, the burden for the patient is time. Extra in the context of the study are questionnaires which last a maximum of 5-15 minutes. The treatment considering the fibroid(s) is independent of this research.
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Judith Huirne, Prof.
- Phone Number: 0031205664167
- Email: j.huirne@amsterdamumc.nl
Study Contact Backup
- Name: Marjolein Spiering
- Phone Number: 0031205665625
- Email: m.spiering@amsterdamumc.nl
Study Locations
-
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Noord-Holland
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Amsterdam, Noord-Holland, Netherlands, 1105AZ
- Recruiting
- Amsterdam UMC
-
Contact:
- Judith Huirne, Prof.
- Email: j.huirne@amsterdamuc.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 1 to 3 fibroids
- maximal diameter ≥1.5 cm and ≤ 10 cm
- diagnosed on ultrasound examination with informed consent
planned for expectant management or non-surgical management in the follwing groups:
- Women with uterine fibroids without treatment (during natural course);
- Women with uterine fibroids using exogenous hormone exposure for at least 3 months: e.g. COC, POP, DP or LNG-IUD;
- Women with uterine fibroids before and after/during treatment with SPRMs or GnRH-analogues;
- Women with uterine fibroids before and after/during treatment with exogenous hormones;
- Women with uterine fibroids before and after embolization;
Women with uterine fibroids before and after ablation therapy*.
- In case of embolization or ablation: inclusion in case of multiple fibroids is allowed, if ≥ 1 fibroid is accessible for transvaginal ultrasound.
Exclusion Criteria:
- Any fibroid treatment in the last 3 months in case of (3) SPRMs or GnRH-analogues (except for exogenous hormone exposure) or (1) no treatment Age < 18 years
- Fibroids not accessible for transvaginal ultrasonography
- Suspicion for malignancy
- Postmenopausal
- Severe adenomyosis
- Pregnancy
- Contra-indication for the planned treatment
- Use of aromatase inhibitors or tamoxifen Infertility treatment with use of clomifene and/or follicle-stimulating hormone Breastfeeding
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
natural course
To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy . Primary outcome: Natural behaviour - 1 year |
Extra in the context of the study are questionnaires which last a maximum of 5-15 minutes.
The treatment considering the fibroid(s) is independent of this research.
the Also the outcome measures include vaginal ultrasound, questionaires and a hemoglobin test.
These measurements are applied in daily practice, as standard care.
|
during long-term use of exogenous hormone exposure
To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy . Primary outcome: Long-term exogenous hormonal exposure - 1 year |
Extra in the context of the study are questionnaires which last a maximum of 5-15 minutes.
The treatment considering the fibroid(s) is independent of this research.
the Also the outcome measures include vaginal ultrasound, questionaires and a hemoglobin test.
These measurements are applied in daily practice, as standard care.
|
Selective progesterone receptor modulators treatment or GnRH-analogues treatment
To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy . Primary outcome: SPRMs or GnRH-analogues - 3 months |
Extra in the context of the study are questionnaires which last a maximum of 5-15 minutes.
The treatment considering the fibroid(s) is independent of this research.
the Also the outcome measures include vaginal ultrasound, questionaires and a hemoglobin test.
These measurements are applied in daily practice, as standard care.
|
after initiation exogenous hormonal exposure
To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy . Primary outcome: Initiation of exogenous hormonal exposure - 1 year |
Extra in the context of the study are questionnaires which last a maximum of 5-15 minutes.
The treatment considering the fibroid(s) is independent of this research.
the Also the outcome measures include vaginal ultrasound, questionaires and a hemoglobin test.
These measurements are applied in daily practice, as standard care.
|
embolization therapy
To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy . Primary outcome: Embolization - 6 months |
Extra in the context of the study are questionnaires which last a maximum of 5-15 minutes.
The treatment considering the fibroid(s) is independent of this research.
the Also the outcome measures include vaginal ultrasound, questionaires and a hemoglobin test.
These measurements are applied in daily practice, as standard care.
|
ablation therapy
To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy . Primary outcome: Ablation therapy - 6 months |
Extra in the context of the study are questionnaires which last a maximum of 5-15 minutes.
The treatment considering the fibroid(s) is independent of this research.
the Also the outcome measures include vaginal ultrasound, questionaires and a hemoglobin test.
These measurements are applied in daily practice, as standard care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Volume change
Time Frame: Baseline, 3 and 12 months, in embolization and ablation group after 6 months
|
Three directions on 2D ultrasound in centimeters.
|
Baseline, 3 and 12 months, in embolization and ablation group after 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire Utreine Fibroid Specific Quality of Life
Time Frame: Baseline, 3, 12 and 24 months, in embolization and ablation group after 6 months
|
UFS-Qol.
Total health-related quality of life (29 items, 29-145 points).
Or seven subscales: 'symptom severity' (8 items, 8-40 points), 'concern' (5 items, 5-25 points), 'activities' (7 items, 7-35 points), 'energy/mood' (7 items, 7-35 points), 'control' (5 items, 5-25 points), 'self-conscious' (3 items, 3-15 points), 'sexual function' (2 items, 2-10 points).
The higher, the lower the quality of life.
|
Baseline, 3, 12 and 24 months, in embolization and ablation group after 6 months
|
Questionnaire EuroQol 5 Dimensions
Time Frame: Baseline, 3, 12 and 24 months, in embolization and ablation group after 6 months
|
EQ-5D.
Range 0 - 1.
The higher, the lower the quality of life.
|
Baseline, 3, 12 and 24 months, in embolization and ablation group after 6 months
|
Questionnaires Picterial Bloodloss Assessment Chart
Time Frame: Baseline, 3, 12 and 24 months, in embolization and ablation group after 6 months
|
PBAC.
Range 0 to no maximum.
PBAC > 150 is heavy menstrual bleeding.
The higher, the more bloodloss.
|
Baseline, 3, 12 and 24 months, in embolization and ablation group after 6 months
|
Questionnaire re-intervention rate
Time Frame: Baseline, 3, 12 and 24 months, in embolization and ablation group after 6 months
|
Percentage of patients who underwent re-intervention (e.g.
embolization, operation, etc) for their fibroid(s) in follow-up period.
Range: 0-100%, the higher, the more re-interventions.
|
Baseline, 3, 12 and 24 months, in embolization and ablation group after 6 months
|
Questionnaire treatment failure rate
Time Frame: Baseline, 3, 12 and 24 months, in embolization and ablation group after 6 months
|
Percentage of patients who started additional treatment (e.g.
medication, etc) for their fibroid(s) in follow-up period.
Range: 0-100%, the higher, the more treatment failures.
|
Baseline, 3, 12 and 24 months, in embolization and ablation group after 6 months
|
Haemoglobin
Time Frame: Baseline, 3 and 12 months, in embolization and ablation group after 6 months
|
According to local protocol, standard care, mmol/L (range 0-20).
A lower haemoglobin level corresponds with more menstrual bloodloss and/or anemia.
|
Baseline, 3 and 12 months, in embolization and ablation group after 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017.494
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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