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Warming Contrast Media for Hysterosalpingography

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01339338
Enrollment
300
Registered
2011-04-20
Start date
2010-01-31
Completion date
2011-06-30
Last updated
2011-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

PROCEDUREwarming the contrast media

warm the contrast media with 37℃ water-bathing

Sponsors

Taizhou Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of vasovagal episodesfrom the injection of the media to a half hour after HSGvasovagal episodes include nausea, Vomit, Sweating, Weakness and bradycardia occurred in HSG

Secondary

MeasureTime frameDescription
Visual analogue scale pain score during HSGwithin the first 30 seconds after the constra media spill outassessing 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 HSGa half hour after HSG10cm Visual analogue scale pain score after HSG

Countries

China

Contacts

Primary ContactYi-Yang Zhu, MD
yiangz@sohu.com86-057-6519-1400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026