Hysteroscopic Assessment of Fallopian Tubal Patency

Infertility Clinical Trial

Official title:

Hysteroscopic Assessment of Fallopian Tubal Patency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005263
• Other study ID #: 2013-0230
• Status: Completed
• Phase: N/A
• First received: December 3, 2013
• Last updated: November 6, 2017
• Start date: December 2013
• Est. completion date: November 6, 2017

Study information

• Verified date: November 2017
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 621
• Est. completion date: November 6, 2017
• Est. primary completion date: October 16, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Menorrhagia

Intervention

Procedure:
• Salpingography
Infusion of typically 1-2 mL of air bubbles in to the uterine cavity to assess whether they disappear through the ostia in to the Fallopian tubes.

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hysteroscopic assessment of tubal patency	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	2 years