Hysteroscopic Assessment of Fallopian Tubal Patency

Not Applicable

Completed

• Conditions: Infertility; Menorrhagia
• Interventions: Procedure: Salpingography

• Registration Number: NCT02005263
• Lead Sponsor: University of Mississippi Medical Center

Brief Summary

Disease of the fallopian tubes is one of the most common reasons for infertility. The most common test, a hysterosalpingogram, tends to be painful,inconvenient, and frequently misses concurrent uterine disease. We propose using a less painful technique (through modified office hysteroscopy) for tubal assessment that can be performed in the office rather than hospital radiology and that uses gold standard technology for identifying coexisting uterine conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-09
• Primary Completion: 2017-10-16
• Status Verified: 2017-11
• Study Completion: 2017-11-06
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 621

Inclusion Criteria

1. 18 - 50 years old
2. Able to give consent
3. Must have a uterus
4. Must have documented negative testing for gonorrhea and chlamydia within the past year or previously negative when tested with a current partner in a monogamous relationship
5. Negative test prior to procedure

Exclusion Criteria

1. Pregnancy
2. Active lower and upper genital tract infection
3. Patients with allergies to hysterosalpingogram contrast will not be exposed to a contrast material to which they are allergic
4. Premenarchal or postmenopausal
5. Unable to read English at a 6th grade level or above
6. History of endometrial Ablation
7. Asherman's syndrome > Stage 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Salpingography	Salpingography	Infusion of air bubbles through Fallopian tubes with hysteroscopic visualization; typically 1-2 mL is infused. This is less than that typically used in the established technique of sonosalpingography.

Primary Outcome Measures

Name	Time	Method
Hysteroscopic assessment of tubal patency	2 years	Patients undergoing the procedure will be informed based on the findings as to whether or not it is believed that their Fallopian tubes are patent

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States