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

October 24, 2017 updated by: University of Wisconsin, Madison

Optimal Catheter Placement During Sonohysterography: A Randomized Clinical Trial Comparing Cervical to Uterine Placement

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure: perceived discomfort
Time Frame: during sonohysterography procedure
during sonohysterography procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure: Time required to perform procedure; Measure: Volume of media required to perform procedure
Time Frame: during sonohysterography procedure
during sonohysterography procedure

Collaborators and Investigators

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

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Steven Lindheim, MD, University of Wisconsin Department of Reproductive Endocrinology and Infertility

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2004

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

September 23, 2007

First Submitted That Met QC Criteria

September 23, 2007

First Posted (Estimate)

September 26, 2007

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-2004-0066

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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