Healthy participants with abnormal uterine bleeding or infertility and suspected for having a intrauterine abnormality Urological and Genital Diseases
Conditions
Interventions
Intervention group: The use of ExEmgel.
Control group: The use of Endosgel.
Both gels are used in daily practice (in the VU University Medical Center [VUmc]) during GIS.
Sponsors
VU University Medical Center (Netherlands)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Woman with abnormal uterine bleeding or infertility and suspected for having an intrauterine abnormality 2. Age 20-80 yr
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC of continuous registered pain score (continuous VAS) during gel installation and following sonography. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain score (AUC using continuous pain registration) of the entire procedure and of specific parts of the procedure 2. Subjective reported VAS score 3. Image quality Various prognostic factors will be registered. | — |
Countries
Netherlands
Outcome results
None listed