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Hysteroscopic Assessment of Fallopian Tubal Patency

Primary Purpose

Infertility, Menorrhagia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Salpingography
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility focused on measuring Hysteroscopy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Mississippi Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Salpingography

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 3, 2013
Last Updated
November 6, 2017
Sponsor
University of Mississippi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02005263
Brief Title
Hysteroscopic Assessment of Fallopian Tubal Patency
Official Title
Hysteroscopic Assessment of Fallopian Tubal Patency
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 16, 2017 (Actual)
Study Completion Date
November 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Menorrhagia
Keywords
Hysteroscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
621 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salpingography
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Salpingography
Other Intervention Name(s)
Parryscope technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hysteroscopic assessment of tubal patency
Description
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
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 - 50 years old Able to give consent Must have a uterus 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 Negative test prior to procedure Exclusion Criteria: Pregnancy Active lower and upper genital tract infection Patients with allergies to hysterosalpingogram contrast will not be exposed to a contrast material to which they are allergic Premenarchal or postmenopausal Unable to read English at a 6th grade level or above History of endometrial Ablation Asherman's syndrome > Stage 1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P. Parry, MD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28843382
Citation
Parry JP, Riche D, Rushing J, Linton B, Butler V, Lindheim SR. Performing the Parryscope technique gently for office tubal patency assessment. Fertil Steril. 2017 Oct;108(4):718. doi: 10.1016/j.fertnstert.2017.07.1159. Epub 2017 Aug 31.
Results Reference
derived

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Hysteroscopic Assessment of Fallopian Tubal Patency

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