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Comparison of Three Cannulas for Hysterosalpingography

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ClinicalTrials.gov Identifier: NCT00956774
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Rebecca Usadi, Carolinas Healthcare System

Brief Summary:
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 or disease Intervention/treatment
Infertility Procedure: HSG with acorn-tipped cannula Procedure: HSG with cervical vacuum cup Procedure: HSG with balloon catheter

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  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Three Cannulas for Hysterosalpingography: A Prospective, Randomized Study
Study Start Date : February 2009
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

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



Primary Outcome Measures :
  1. pain scores [ Time Frame: 15 minutes ]

Secondary Outcome Measures :
  1. the total duration of the procedure [ Time Frame: 15 minutes ]
  2. direct fluoroscopic time [ Time Frame: 15 minutes ]
  3. rates of vasovagal reaction [ Time Frame: 15 minutes ]
  4. diagnostic quality of images obtained [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

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

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