Clinical trial NCT01339338: Warming Contrast Media for Hysterosalpingography
Official title: Comparison of the Warm and Cold Contrast Media for Hysterosalpingography: a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Infertility
Lead sponsor: Taizhou Hospital
Sponsor class: OTHER
First posted: 2011-04-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: incidence of vasovagal episodes
timeFrame: from the injection of the media to a half hour after HSG
Secondary outcomes:
measure: Visual analogue scale pain score during HSG
timeFrame: within the first 30 seconds after the constra media "spill out"
measure: Visual analogue scale pain score after HSG
timeFrame: a half hour after HSG
Other outcomes:
Locations:
city: Taizhou City
country: China
facility: Taizhou Hospital of zhejiang Province
state: Zhejiang
Study officials:
affiliation: Centra for Reproductive Medicine of Taizhou hospital
name: YiYang Zhu, MD
role: STUDY_DIRECTOR
References:
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.