Optimal Catheter Placement During Sonohysterography: Comparison of Cervical to Uterine Placement
Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT00534963
Collaborator
(none)
69
8
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Detailed Description
The use of sonography combined with intrauterine saline instillation, termed sonohysterography
Study Design
Study Type:
Interventional
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
:
Dec 1, 2004
Actual Study Completion Date
:
Aug 1, 2005
Outcome Measures
Primary Outcome Measures
- Measure: perceived discomfort [during sonohysterography procedure]
Secondary Outcome Measures
- Measure: Time required to perform procedure; Measure: Volume of media required to perform procedure [during sonohysterography procedure]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
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
Locations
No locations specified.Sponsors and Collaborators
- University of Wisconsin, Madison
Investigators
- Principal Investigator: Steven Lindheim, MD, University of Wisconsin Department of Reproductive Endocrinology and Infertility
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00534963
Other Study ID Numbers:
- H-2004-0066
First Posted:
Sep 26, 2007
Last Update Posted:
Oct 26, 2017
Last Verified:
Oct 1, 2017
Keywords provided by University of Wisconsin, Madison