Warming Contrast Media for Hysterosalpingography

NCT ID: NCT01339338

Last Updated: 2011-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-06-30

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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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warm media

Subjects undergo HSG using a warm media heated with a 37℃ water-bathing

Group Type EXPERIMENTAL

warming the contrast media

Intervention Type PROCEDURE

warm the contrast media with 37℃ water-bathing

cold media

the contrast media under room temperature without heat

Group Type NO_INTERVENTION

warming the contrast media

Intervention Type PROCEDURE

warm the contrast media with 37℃ water-bathing

Interventions

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warming the contrast media

warm the contrast media with 37℃ water-bathing

Intervention Type PROCEDURE

Other Intervention Names

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warm media

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Taizhou Hospital

OTHER

Sponsor Role lead

Responsible Party

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Taizhou hospital of Zhejiang Province

Principal Investigators

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YiYang Zhu, MD

Role: STUDY_DIRECTOR

Centra for Reproductive Medicine of Taizhou hospital

Locations

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Taizhou Hospital of zhejiang Province

Taizhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi-Yang Zhu, MD

Role: CONTACT

86-057-6519-1400

Facility Contacts

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YiYang Zhu, MD

Role: primary

86-057-6519-1400

References

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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.

Reference Type DERIVED
PMID: 22459631 (View on PubMed)

Other Identifiers

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Taizhou200935

Identifier Type: -

Identifier Source: org_study_id

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