NCT00534963

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2004

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

First QC Date

September 23, 2007

Last Update Submit

October 24, 2017

Conditions

Catheter Placement and Perceived Pain

Keywords

sonohysterography, catheter placement

Outcome Measures

Primary Outcomes (1)

  • Measure: perceived discomfort

    during sonohysterography procedure

Secondary Outcomes (1)

  • Measure: Time required to perform procedure; Measure: Volume of media required to perform procedure

    during sonohysterography procedure

Interventions

cervical vs. uterine placement of balloon catheterPROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • previous hysterectomy, current pregnancy, active PID, patulous or stenotic cervical os noted on previous history or physical exam.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Spieldoch RL, Winter TC, Schouweiler C, Ansay S, Evans MD, Lindheim SR. Optimal catheter placement during sonohysterography: a randomized controlled trial comparing cervical to uterine placement. Obstet Gynecol. 2008 Jan;111(1):15-21. doi: 10.1097/01.AOG.0000295865.93719.3f.

    PMID: 18165388DERIVED

Study Officials

  • Steven Lindheim, MD

    University of Wisconsin Department of Reproductive Endocrinology and Infertility

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2007

First Posted

September 26, 2007

Study Start

December 1, 2004

Study Completion

August 1, 2005

Last Updated

October 26, 2017

Record last verified: 2017-10