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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON19987

Enrollment

100

Registered

2012-03-14

Start date

2012-03-05

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Uterine Fibroids, growth, power doppler

Interventions

Patients 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 trans

Eligibility

Inclusion criteria

Inclusion criteria: Women with at least one and maximum three fibroids, without medication or with the intention to start with Lucrin.

Exclusion criteria

Exclusion criteria: 1. More than 3 fibroids; 2. Surgery of the fibroid within 3 months.

Design outcomes

Primary

Measure	Time frame
Primary outcome is percentage change in fibroid volume and change in VI parameters after 3, 6 and 12 months.	—

Secondary

Measure	Time frame
Secondary outcome is change in UFS score (fibroid specific QOL), EQ-5D score and PBAC score (validated menstrual chart).	—

Contacts

Public ContactL.L. Nieuwenhuis

Flevo hospital Hospitaalweg 1

lonieuwenhuis@flevoziekenhuis.nl+31 (0)36 8689295

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)