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Optimal Catheter Placement During Sonohysterography: Comparison of Cervical to Uterine Placement

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: September 23, 2007
Last updated: October 1, 2015
Last verified: September 2007
The primary objective of this investigation was to evaluate if the location of placement of the SIS balloon into either the uterine cavity or the cervical canal affected discomfort perceived during the examination.

Condition Intervention
Catheter Placement and Perceived Pain.
Procedure: cervical vs. uterine placement of balloon catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Optimal Catheter Placement During Sonohysterography: A Randomized Clinical Trial Comparing Cervical to Uterine Placement

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Measure: perceived discomfort [ Time Frame: during sonohysterography procedure ]

Secondary Outcome Measures:
  • Measure: Time required to perform procedure; Measure: Volume of media required to perform procedure [ Time Frame: during sonohysterography procedure ]

Enrollment: 69
Study Start Date: December 2004
Study Completion Date: August 2005
Detailed Description:
The use of sonography combined with intrauterine saline instillation, termed sonohysterography

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Female patients undergoing SIS for diagnostic uterine cavity evaluation at our university's Reproductive Endocrine Infertility Program.

Exclusion Criteria:

  • previous hysterectomy, current pregnancy, active PID, patulous or stenotic cervical os noted on previous history or physical exam.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00534963

Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Steven Lindheim, MD University of Wisconsin Department of Reproductive Endocrinology and Infertility
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison Identifier: NCT00534963     History of Changes
Other Study ID Numbers: H-2004-0066
Study First Received: September 23, 2007
Last Updated: October 1, 2015

Keywords provided by University of Wisconsin, Madison:
sonohysterography, catheter placement processed this record on May 23, 2017