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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

Tracking Information
First Submitted Date  ICMJE December 3, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date November 8, 2017
Study Start Date  ICMJE December 2013
Actual Primary Completion Date October 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
Assess the benefits of a modified office hysteroscopy technique [ Time Frame: 2 years ]
Change History Complete list of historical versions of study NCT02005263 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hysteroscopic Assessment of Fallopian Tubal Patency
Official Title  ICMJE Hysteroscopic Assessment of Fallopian Tubal Patency
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Infertility
  • Menorrhagia
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Procedure: Salpingography
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2017)
621
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2013)
500
Actual Study Completion Date  ICMJE November 6, 2017
Actual Primary Completion Date October 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02005263
Other Study ID Numbers  ICMJE 2013-0230
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Preston Parry, MD, MPH, University of Mississippi Medical Center
Study Sponsor  ICMJE University of Mississippi Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John P. Parry, MD University of Mississippi Medical Center
PRS Account University of Mississippi Medical Center
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP