Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391781
Status:
UNKNOWN
Last Update Posted:
2007-09-26
First Post:
2006-10-23
Brief Title:
Warm Contrast Media for Pain Reduction During Hystersalpingography
Sponsor:
Shaare Zedek Medical Center
Organization:
Shaare Zedek Medical Center
Study Overview
Official Title:
Prospective Randomised Controlled Trian of Warmed vs Room Temperature Contrast Media for Hystersalpingography
Status:
UNKNOWN
Status Verified Date:
2007-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to compare between body-temperature to room-temperature contrast media used during hysterosalpingography We hypothesize that warmed medium will reduce pain associated with the procedure
Detailed Description:
Infertility occurs in about 15 of all couples One of the common methods for evaluation of mechanical infertility is hysterosalpingography HSG Several reports have shown that this common procedure is associated with moderate pain ie around 5 on a visual analog scale VASof 1-10 It is therefore important to find modes for pain reduction for HSG According to a report on sonohydrosonograpy a similar technique using sonography insertion of media warmed to body temperature into the uterus significantly reduced the pain during the procedure compared with media at room-temprature The use of room-temperature media is the routine in our institution as well as in many others A comparison between the media at different temperatures has not been reported so far
We plan to perform a prospective trial in which patients referred for HSG will be randomized to the procedure using either warmed or room-temperature media we will asses pain levels using VAS during the procedure
We plan to perform a prospective trial in which patients referred for HSG will be randomized to the procedure using either warmed or room-temperature media we will asses pain levels using VAS during the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None