Hysteroscopic Assessment of Fallopian Tubal Patency

November 6, 2017 updated by: John Preston Parry, MD, MPH, University of Mississippi Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

621

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Parryscope technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hysteroscopic assessment of tubal patency
Time Frame: 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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Investigators

  • Principal Investigator: John P. Parry, MD, University of Mississippi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

October 16, 2017

Study Completion (Actual)

November 6, 2017

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Actual)

November 8, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-0230

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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