UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY. This Study Will Compare the Intrauterine Pathology Detection Rate Between Standard of Care Hydrosonography, and a New Visual Saline Infusion Device Providing Direct Visualization of the Uterus.

Launched by CENTER FOR REPRODUCTIVE HEALTH & GYNECOLOGY · Apr 30, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Uterine Evaluation for the Identification of Pathology," is studying how well a new device called the Visual Saline Infusion Device (VSI) works in finding problems inside the uterus compared to a standard method called hydrosonography. Both methods are used to look for issues that might affect women's fertility, but the VSI allows doctors to see the inside of the uterus more clearly. This study aims to find out which method is better at detecting these problems.

To participate in this trial, women aged 18 to 45 who need an evaluation of their uterine cavity may be eligible. However, those with certain infections, a positive pregnancy test, or an intrauterine device (IUD) in place would not qualify. If you decide to take part, you'll undergo a procedure where either the new VSI device or the standard hydrosonography will be used to check your uterus. This trial is currently recruiting participants, and it could help improve how doctors diagnose and treat uterine conditions in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients requiring a uterine cavity evaluation
• • 2. Premenopausal women between ages of 18-45
• Exclusion Criteria:
• 1. Positive test or history of any of the following conditions:
• • 1a. Chlamydial pelvic infection
• • 1b. Gonorrheal pelvic infection. 2. Positive Pregnancy Test 3. IUD currently in place