Gel instillation sonohysterography (GIS) using Endosgel versus ExEmgel, comparison of pain and image quality (Gel contrast echoscopie gebruikmakende van Endosgel versus ExEmgel, vergelijking van pijn en beeldkwaliteit)
Completed
- Conditions
- Healthy participants with abnormal uterine bleeding or infertility and suspected for having a intrauterine abnormalityUrological and Genital Diseases
- Registration Number
- ISRCTN84882393
- Lead Sponsor
- VU University Medical Center (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 70
Inclusion Criteria
1. Woman with abnormal uterine bleeding or infertility and suspected for having an intrauterine abnormality
2. Age 20-80 yr
Exclusion Criteria
1. Pregnancy or premenopausal women in the luteal phase without use of contraception
2. Pelvic Inflammatory Disease (PID)
3. Risk of malignancy
4. Contraindication for the use of NSAIDS
5. Known allergy for chlorhexidine
6. Inability to understand Dutch or English
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC of continuous registered pain score (continuous VAS) during gel installation and following sonography.
- Secondary Outcome Measures
Name Time Method 1. Pain score (AUC using continuous pain registration) of the entire procedure and of specific parts of the procedure<br>2. Subjective reported VAS score <br>3. Image quality<br>Various prognostic factors will be registered.