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Hysteroscopic Assessment of Fallopian Tubal Patency

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ClinicalTrials.gov Identifier: NCT02005263
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
John Preston Parry, MD, MPH, University of Mississippi Medical Center

Study Description
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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
Infertility Menorrhagia Procedure: Salpingography Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : December 2013
Actual Primary Completion Date : October 16, 2017
Actual Study Completion Date : November 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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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 Name: Parryscope technique


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005263


Locations
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United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
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Principal Investigator: John P. Parry, MD University of Mississippi Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: December 9, 2013    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017
Keywords provided by John Preston Parry, MD, MPH, University of Mississippi Medical Center:
Hysteroscopy
Additional relevant MeSH terms:
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Infertility
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
 Hemorrhage
Pathologic Processes
Menstruation Disturbances