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Procedure

Visual Saline Infusion for Female Infertility

N/A
Recruiting
Led By Sam Najmabadi, MD
Research Sponsored by Center for Reproductive Health & Gynecology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Premenopausal women between ages of 18-45
Patients requiring a uterine cavity evaluation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of procedure and 24-48 hours post to procedure
Awards & highlights

Study Summary

This trial aims to compare the accuracy of a new device called Visual Saline Infusion Device (VSI) with the standard method, Hydrosonography, in identifying uterine problems in women of

Who is the study for?
This trial is for women of reproductive age who may have uterine abnormalities affecting fertility. Participants should not be currently pregnant, and must be willing to undergo diagnostic procedures to examine the inside of their uterus.Check my eligibility
What is being tested?
The study is comparing two methods used to detect problems inside the uterus: a new device that allows doctors to see directly into the uterus with saline infusion (VSI), versus the usual method using sound waves in water (Hydrosonography).See study design
What are the potential side effects?
Potential side effects from these procedures could include discomfort or pain during insertion, cramping similar to menstrual cramps, light vaginal bleeding, and less commonly infection or injury to the uterus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 18-45 and have not gone through menopause.
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I need a check-up of the inside of my uterus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected on day of procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and collected on day of procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intrauterine pathology detection rate with Hydrosonography
Intrauterine pathology detection rate with Visual Saline Infusion
Secondary outcome measures
Adverse events rate
Fluid used during distention
Pain during procedure
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Visual Saline InfusionExperimental Treatment1 Intervention
Visual Saline Infusion is intended to perform direct visual evaluation of the intrauterine space using a 2.7mm, steerable tip catheter with a camera.
Group II: HydrosonographyActive Control1 Intervention
Hydrosonography is the standard of care for intrauterine evaluation. It is performed by inserting a slim 2 mm catheter into the uterine cavity and infusing saline solution to expand the uterus, and using abdominal ultrasound to detect intrauterine pathology.

Find a Location

Who is running the clinical trial?

Center for Reproductive Health & GynecologyLead Sponsor
Butterfly Biosciences, IncUNKNOWN
Sam Najmabadi, MDPrincipal InvestigatorCenter for Reproductive Health & Gynecology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals older than 65 years eligible to participate in this study?

"To be eligible for this trial, individuals must be between 18 and 55 years of age."

Answered by AI

Which individuals are eligible to take part in this research investigation?

"Individuals aged between 18 and 55 experiencing infertility are eligible for participation in this medical study, which aims to enroll approximately 100 participants."

Answered by AI

Are new participants currently being actively enrolled in this clinical trial?

"Affirmative, the details on clinicaltrials.gov reveal that this particular medical trial is actively pursuing individuals to participate. Initially disclosed on April 25th, 2024, and last revised on April 30th, 2024, the study aims to recruit a total of 100 subjects distributed among two locations."

Answered by AI

What is the primary objective that this medical study aims to achieve?

"The key aim of this research endeavor focuses on the detection rate of intrauterine pathology using Visual Saline Infusion, during a brief procedure lasting between 2 to 5 minutes. Secondary objectives encompass quantifying the volume of fluid required for uterine distention, cataloging both expected and unforeseen adverse events, as well as assessing pain levels experienced by participants utilizing the Wong Baker pain scale through interviews conducted by our investigative team."

Answered by AI

What is the current number of participants being enlisted for this clinical trial?

"Indeed, as per the details on clinicaltrials.gov, this investigation is actively seeking volunteers. The initial posting of the trial was made on April 25th, 2024, with the most recent update recorded on April 30th, 2024. A total of 100 participants are sought from two designated sites for enrollment in this study."

Answered by AI

Who else is applying?

What site did they apply to?
Center for Reproductive Health & Gynecology
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Have failed IUI and 2 embryos implanted but ended in chemical.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
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.
2024. "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.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06394752.
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~67 spots leftby May 2025
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