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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
History of Changes
  Purpose

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.


Condition Intervention
Infertility
 Procedure: HSG with acorn-tipped cannula
Procedure: HSG with cervical vacuum cup
Procedure: HSG with balloon catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Three Cannulas for Hysterosalpingography: A Prospective, Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • pain scores [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 114
Study Start Date: February 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Balloon Catheter Procedure: HSG with balloon catheter
balloon inserted via catheter into cervic for dilation.
Active Comparator: Cervical Vacuum Cup Procedure: HSG with cervical vacuum cup
cup placed over cervix to create vacuum pressure.
Active Comparator: acorn-tipped cannula Procedure: HSG with acorn-tipped cannula
Use of acorn-tipped cannula for HSG to evaluate tubal patency

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956774

Locations
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Sara Lane, MD Carolinas Medical Center
  More Information

No publications provided

Responsible Party: Rebecca Usadi, Associate Professor, Reproductive Endocrinology and Infertility, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT00956774     History of Changes
Other Study ID Numbers: Comparison of 3 Cannulas - HSG
Study First Received: August 10, 2009
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
HSG
Cannula
HSG procedure
infertility evaluation

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013