Comparison of Three Cannulas for Hysterosalpingography

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rebecca Usadi, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT00956774
First received: August 10, 2009
Last updated: February 13, 2013
Last verified: February 2013

August 10, 2009
February 13, 2013
February 2009
February 2010   (final data collection date for primary outcome measure)
pain scores [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00956774 on ClinicalTrials.gov Archive Site
  • the total duration of the procedure [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • direct fluoroscopic time [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • rates of vasovagal reaction [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • diagnostic quality of images obtained [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Three Cannulas for Hysterosalpingography
Comparison of Three Cannulas for Hysterosalpingography: A Prospective, Randomized Study

The aim of this study is to compare the three commonly used hysterosalpingography (HSG) injection devices on the basis of patient pain perception, total fluoroscopic and procedural time, and side effects in a prospective, randomized study. An important and novel secondary outcome is the comparison of the quality of images obtained with these three devices. The investigators hypothesize that the balloon catheter and cervical vacuum cup will be less painful than the acorn tipped cannula and that there will be no difference in image quality between the three groups.

This study is a prospective, randomized trial of women undergoing HSG as part of their infertility evaluation. At the time of scheduling, the patient will be randomized to either the cervical vacuum cup, balloon catheter (H/S catheter set, UA Medical, Biotech America), or the acorn-tipped cannula using stratified blocked randomization. 100 subjects will be randomized to one of the three cannulas. Patients will be stratified into 4 groups representative of the four reproductive endocrinologists in order to overcome any potential interoperator bias.

Four reproductive endocrinologists will perform the HSG procedures in a standardized fashion. Fluoroscopy will ensure proper location of the cannula and check for uterine filling of contrast. Digital images will document tubal filling and spilling of contrast. The patient will be rolled to right and left side to confirm free spillage of contrast in the peritoneal cavity. The last image will be taken after the balloon tip is deflated or the cannulas are removed to best evaluate the lower uterine segment.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Infertility
  • Procedure: HSG with acorn-tipped cannula
    Use of acorn-tipped cannula for HSG to evaluate tubal patency
  • Procedure: HSG with cervical vacuum cup
    cup placed over cervix to create vacuum pressure.
  • Procedure: HSG with balloon catheter
    balloon inserted via catheter into cervic for dilation.
  • Active Comparator: Balloon Catheter
    Intervention: Procedure: HSG with balloon catheter
  • Active Comparator: Cervical Vacuum Cup
    Intervention: Procedure: HSG with cervical vacuum cup
  • Active Comparator: acorn-tipped cannula
    Intervention: Procedure: HSG with acorn-tipped cannula
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women undergoing HSG at an academic medical center

Exclusion Criteria:

  • Contrast media allergy
  • Prior LEEP (Loop Electrosurgical Excision Procedure) or other cervical procedure
  • Contraindication to NSAID use
  • Known active pelvic infection
  • Active vaginal bleeding
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00956774
Comparison of 3 Cannulas - HSG
No
Rebecca Usadi, Carolinas Healthcare System
Carolinas Healthcare System
Not Provided
Principal Investigator: Sara Lane, MD Carolinas Medical Center
Carolinas Healthcare System
February 2013

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