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Hysteroscopic Assessment of Fallopian Tubal Patency

Sponsor
University of Mississippi Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02005263
Collaborator
(none)
621
Enrollment
1
Location
1
Arm
47.2
Duration (Months)
13.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Salpingography
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
621 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Hysteroscopic Assessment of Fallopian Tubal Patency
Study Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Oct 16, 2017
Actual Study Completion Date :
Nov 6, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Mississippi Medical Center Jackson Mississippi United States 39216

    Sponsors and Collaborators

    • University of Mississippi Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    John Preston Parry, MD, MPH, Assistant Professor, University of Mississippi Medical Center
    ClinicalTrials.gov Identifier:
    NCT02005263
    Other Study ID Numbers:
    • 2013-0230
    First Posted:
    Dec 9, 2013
    Last Update Posted:
    Nov 8, 2017
    Last Verified:
    Nov 1, 2017
    Keywords provided by John Preston Parry, MD, MPH, Assistant Professor, University of Mississippi Medical Center
    Hysteroscopy
    Additional relevant MeSH terms:
    Infertility
    Menorrhagia

    Study Results

    No Results Posted as of Nov 8, 2017