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The predictive value of 3D transvaginal sonography including Power Doppler in the evaluation of fibroid growth, and as a predictor of fibroid response to GnRHa therapy.


- candidate number12049
- NTR NumberNTR3349
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-mrt-2012
- Secondary IDs12/092 METC VUmc
- Public TitleThe predictive value of 3D transvaginal sonography including Power Doppler in the evaluation of fibroid growth, and as a predictor of fibroid response to GnRHa therapy.
- Scientific TitleThe predictive value of 3D transvaginal sonography including Power Doppler in the evaluation of fibroid growth, and as a predictor of fibroid response to GnRHa therapy.
- ACRONYMMYOVASC
- hypothesisWe hypothesize that the vascularity of the fibroid is associated with:
1. Growth potential of the fibroid;
2. The fibroid size reduction after GnRHa treatment.
- Healt Condition(s) or Problem(s) studiedUterine leiomyomata, Growth, Power doppler
- Inclusion criteriaWomen with at least one and maximum three fibroids, without medication or with the intention to start with Lucrin.
- Exclusion criteria1. More than 3 fibroids;
2. Surgery of the fibroid within 3 months.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 5-mrt-2012
- planned closingdate5-mrt-2013
- Target number of participants100
- InterventionsPatients participating in the study will be asked to complete a questionnaire and a menstrual chart at three moments. All patients will receive a 3D sweep in addition to the routine performed 2D transvaginal sonography.
- Primary outcomePrimary outcome is percentage change in fibroid volume and change in VI parameters after 3, 6 and 12 months.
- Secondary outcomeSecondary outcome is change in UFS score (fibroid specific QOL), EQ-5D score and PBAC score (validated menstrual chart).
- TimepointsAll patients will be asked to fill in the menstrual chart and questionaire at baseline , 3, 6 and 12 months. They will also receive a 3D power doppler sonography (Vascular indiced: VI, FI, VFI can be calculated) at baseline, 3, 6 and 12 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES L.L. Nieuwenhuis
- CONTACT for SCIENTIFIC QUERIES L.L. Nieuwenhuis
- Sponsor/Initiator VU University Medical Center, Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Department of Obstetrics and Gynaecology
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD14-mrt-2012 - 25-mrt-2012


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