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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00534963
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : October 26, 2017
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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 or disease Intervention/treatment Phase
Catheter Placement and Perceived Pain Procedure: cervical vs. uterine placement of balloon catheter Not Applicable

Detailed Description:
The use of sonography combined with intrauterine saline instillation, termed sonohysterography

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Optimal Catheter Placement During Sonohysterography: A Randomized Clinical Trial Comparing Cervical to Uterine Placement
Study Start Date : December 2004
Actual Study Completion Date : August 2005

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

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

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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.

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 identifier (NCT number): NCT00534963

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

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
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by University of Wisconsin, Madison:
sonohysterography, catheter placement