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The myoma vascularity study: Sonographic features of fibroids before and during non-surgical therapy and/or expectant management.

The myoma vascularity study: Sonographic features of fibroids before and during non-surgical therapy and/or expectant management. - MYOVASC

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50341
Enrollment
580
Registered
2018-09-20
Start date
2018-09-24
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fibroid myoma

Interventions

None listed

Sponsors

Gynaecologie
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - = 1 fibroid is accessible for transvaginal ultrasound) - Maximal diameter >=1.5 cm and

Exclusion criteria

Exclusion criteria: - Any fibroid treatment in the last 3 months in case of (3) SPRM e.g. Esmya or GnRH-analogues (except for exogenous hormone exposure) or (1) no treatment - Age

Design outcomes

Primary

MeasureTime frame
Volume reduction per study group after: 1. Natural behaviour - 1 year 2. Long-term exogenous hormonal exposure - 1 year 3. SPRMs e.g. Esmya or GnRH-analogues - 3 months 4. Initiation of exogenous hormonal exposure - 1 year 5. Embolization - 6 months 6. Ablation therapy - 6 months

Secondary

MeasureTime frame
All study groups: 1. UFS-Qol 2. EQ-5D score 3. PBAC-score 4. Haemoglobin level 5. Treatment failure rate 6. (Re)intervention rate

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)