Warming Contrast Media for Hysterosalpingography

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Taizhou Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taizhou Hospital
ClinicalTrials.gov Identifier:
NCT01339338
First received: April 12, 2011
Last updated: April 19, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Infertility
Procedure: warming the contrast media
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Comparison of the Warm and Cold Contrast Media for Hysterosalpingography: a Prospective, Randomized Study

Resource links provided by NLM:


Further study details as provided by Taizhou Hospital:

Primary Outcome Measures:
  • incidence of vasovagal episodes [ Time Frame: from the injection of the media to a half hour after HSG ] [ Designated as safety issue: Yes ]
    vasovagal episodes include nausea, Vomit, Sweating, Weakness and bradycardia occurred in HSG


Secondary Outcome Measures:
  • Visual analogue scale pain score during HSG [ Time Frame: within the first 30 seconds after the constra media "spill out" ] [ Designated as safety issue: No ]
    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 [ Time Frame: a half hour after HSG ] [ Designated as safety issue: No ]
    10cm Visual analogue scale pain score after HSG


Estimated Enrollment: 300
Study Start Date: January 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: warm media
Subjects undergo HSG using a warm media heated with a 37℃ water-bathing
Procedure: warming the contrast media
warm the contrast media with 37℃ water-bathing
Other Name: warm media
No Intervention: cold media
the contrast media under room temperature without heat
Procedure: warming the contrast media
warm the contrast media with 37℃ water-bathing
Other Name: warm media

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

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339338

Contacts
Contact: Yi-Yang Zhu, MD 86-057-6519-1400 yiangz@sohu.com

Locations
China, Zhejiang
Taizhou Hospital of zhejiang Province Recruiting
Taizhou City, Zhejiang, China, 317000
Contact: YiYang Zhu, MD     86-057-6519-1400     yiangz@sohu.com    
Principal Investigator: Xianhua Lin            
Principal Investigator: YingZi Mao            
Principal Investigator: Qunxi Cai            
Sponsors and Collaborators
Taizhou Hospital
Investigators
Study Director: YiYang Zhu, MD Centra for Reproductive Medicine of Taizhou hospital
  More Information

No publications provided by Taizhou Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: YiYang Zhu/Centra for Reproductive Medicine, Taizhou hospital of Zhejiang Province
ClinicalTrials.gov Identifier: NCT01339338     History of Changes
Other Study ID Numbers: Taizhou200935
Study First Received: April 12, 2011
Last Updated: April 19, 2011
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013