Comparison of Three Cannulas for Hysterosalpingography

April 19, 2022 updated by: Wake Forest University Health Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain scores
Time Frame: 15 minutes
15 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
the total duration of the procedure
Time Frame: 15 minutes
15 minutes
direct fluoroscopic time
Time Frame: 15 minutes
15 minutes
rates of vasovagal reaction
Time Frame: 15 minutes
15 minutes
diagnostic quality of images obtained
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Sara Lane, MD, Carolinas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (ESTIMATE)

August 11, 2009

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Comparison of 3 Cannulas - HSG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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