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

Recruiting

• Conditions: fibroid; myoma; 10038595

• Registration Number: NL-OMON50341
• Lead Sponsor: Gynaecologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 580

Inclusion Criteria

- <=3 fibroids (except for embolization or ablation: multiple fibroids are
allowed, if >= 1 fibroid is accessible for transvaginal ultrasound)
- Maximal diameter >=1.5 cm and <= 10 cm
- Diagnosed on ultrasound examination
- Informed consent
- No or non-surgical treatment

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 < 18 years
- Fibroids not accessible for transvaginal ultrasonography
- Suspicion for malignancy
- Postmenopause
- 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 & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Volume reduction per study group after:<br /><br>1. Natural behaviour - 1 year<br /><br>2. Long-term exogenous hormonal exposure - 1 year<br /><br>3. SPRMs e.g. Esmya or GnRH-analogues - 3 months<br /><br>4. Initiation of exogenous hormonal exposure - 1 year<br /><br>5. Embolization - 6 months<br /><br>6. Ablation therapy - 6 months</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>All study groups:<br /><br>1. UFS-Qol<br /><br>2. EQ-5D score<br /><br>3. PBAC-score<br /><br>4. Haemoglobin level<br /><br>5. Treatment failure rate<br /><br>6. (Re)intervention rate</p><br>