Warming Contrast Media for Hysterosalpingography

Study Overview
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Brief Summary
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The purpose of this study is to compare the use of warm-media with cold-media in performing hysterosalpingography (HSG).

Detailed Description
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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.

Official Title
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Comparison of the Warm and Cold Contrast Media for Hysterosalpingography: a Prospective, Randomized Study

Conditions
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Infertility

Intervention / Treatment
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* Procedure: warming the contrast media


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: warm media<br>Subjects undergo HSG using a warm media heated with a 37℃ water-bathing | Procedure: warming the contrast media<br>* warm the contrast media with 37℃ water-bathing<br>* Other names: warm media;|
| No Intervention: cold media<br>the contrast media under room temperature without heat | Procedure: warming the contrast media<br>* warm the contrast media with 37℃ water-bathing<br>* Other names: warm media;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of vasovagal episodes | vasovagal episodes include nausea, Vomit, Sweating, Weakness and bradycardia occurred in HSG | from the injection of the media to a half hour after HSG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within the first 30 seconds after the constra media spill out | 
| Visual analogue scale pain score after HSG | 10cm Visual analogue scale pain score after HSG | a half hour after HSG |