Warming Contrast Media for Hysterosalpingography
Primary Purpose
Infertility
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
warming the contrast media
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- infertile women who seeking for HSG testing
Exclusion Criteria:
- suspect of pregnancy
- acute low reproductive duct infection
- a known hypersensitivity to iodine
- genital bleeding
- genital malignancy
Sites / Locations
- Taizhou Hospital of zhejiang ProvinceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
warm media
cold media
Arm Description
Subjects undergo HSG using a warm media heated with a 37℃ water-bathing
the contrast media under room temperature without heat
Outcomes
Primary Outcome Measures
incidence of vasovagal episodes
vasovagal episodes include nausea, Vomit, Sweating, Weakness and bradycardia occurred in HSG
Secondary Outcome Measures
Visual analogue scale pain score during HSG
assessing the average pain score during HSG,Immediately after the constra media "spill out" the tubal fimbria and spread into periotneum.
Visual analogue scale pain score after HSG
10cm Visual analogue scale pain score after HSG
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01339338
Brief Title
Warming Contrast Media for Hysterosalpingography
Official Title
Comparison of the Warm and Cold Contrast Media for Hysterosalpingography: a Prospective, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Taizhou Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the use of warm-media with cold-media in performing hysterosalpingography (HSG).
Detailed Description
As an essential step of the infertile work-up, hysterosalpingography remains widely used in many country since it was first reported at 1914. Although HSG is a non-invasive and safety procedure, it still has some adverse. Lower abdominal pain and vasovagal episodes are mainly acute reactions to the contrast media of HSG, the later include nausea, Vomit, Sweating, Weakness and even bradycardia, occur in 16-54% of patients undergoing HSG.
Many techniques were developed to reduce adverse reactions or alleviate the pain in using of contrast media, include previous analgesia, pretreatment with corticosteroids and using non-ionic contrast media for HSG. However, in a recently Cochrane's review, reported it lack of benefit for using any pain relief medication in HSG.
Pre-Warming the hands and instruments makes physical examination more comfortable for the patients. Local active warming can valid lessen the acute pelvic pain. Experiences from the peritoneal dialysis and the laparoscopy surgical reveal that warm dialysis solution or air insufflation can decrease the pain of operation. A randomize study on Sonohysterography (SHG), another technique for exam tubal and uterine cavity diseases, cue that warming of Echovist contrast media to body temperature is a simple and effective intervention in reducing discomfort at the time exam.Because the less volume of medium injected during the HSG and the iodine medias may have different properties to the Echovist media, whether this intervention is also valid in HSG remains unknown.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
warm media
Arm Type
Experimental
Arm Description
Subjects undergo HSG using a warm media heated with a 37℃ water-bathing
Arm Title
cold media
Arm Type
No Intervention
Arm Description
the contrast media under room temperature without heat
Intervention Type
Procedure
Intervention Name(s)
warming the contrast media
Other Intervention Name(s)
warm media
Intervention Description
warm the contrast media with 37℃ water-bathing
Primary Outcome Measure Information:
Title
incidence of vasovagal episodes
Description
vasovagal episodes include nausea, Vomit, Sweating, Weakness and bradycardia occurred in HSG
Time Frame
from the injection of the media to a half hour after HSG
Secondary Outcome Measure Information:
Title
Visual analogue scale pain score during HSG
Description
assessing the average pain score during HSG,Immediately after the constra media "spill out" the tubal fimbria and spread into periotneum.
Time Frame
within the first 30 seconds after the constra media "spill out"
Title
Visual analogue scale pain score after HSG
Description
10cm Visual analogue scale pain score after HSG
Time Frame
a half hour after HSG
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
infertile women who seeking for HSG testing
Exclusion Criteria:
suspect of pregnancy
acute low reproductive duct infection
a known hypersensitivity to iodine
genital bleeding
genital malignancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Yang Zhu, MD
Phone
86-057-6519-1400
Email
yiangz@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YiYang Zhu, MD
Organizational Affiliation
Centra for Reproductive Medicine of Taizhou hospital
Official's Role
Study Director
Facility Information:
Facility Name
Taizhou Hospital of zhejiang Province
City
Taizhou City
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YiYang Zhu, MD
Phone
86-057-6519-1400
Email
yiangz@sohu.com
First Name & Middle Initial & Last Name & Degree
Xianhua Lin
First Name & Middle Initial & Last Name & Degree
YingZi Mao
First Name & Middle Initial & Last Name & Degree
Qunxi Cai
12. IPD Sharing Statement
Citations:
PubMed Identifier
22459631
Citation
Zhu YY, Mao YZ, Wu WL. Comparison of warm and cold contrast media for hysterosalpingography: a prospective, randomized study. Fertil Steril. 2012 Jun;97(6):1405-9. doi: 10.1016/j.fertnstert.2012.02.039. Epub 2012 Mar 27.
Results Reference
derived
Learn more about this trial
Warming Contrast Media for Hysterosalpingography
We'll reach out to this number within 24 hrs