Warming Contrast Media for Hysterosalpingography

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

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

Study Overview

• Status: Unknown
• Conditions: Infertility
• Intervention / Treatment: Procedure: warming the contrast 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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yi-Yang Zhu, MD; Phone Number: 86-057-6519-1400; Email: yiangz@sohu.com

Study Locations

• China
  • Zhejiang
    • Taizhou City, Zhejiang, China, 317000
      • Recruiting
      • Taizhou Hospital of Zhejiang Province
      • Contact: YiYang Zhu, MD; Phone Number: 86-057-6519-1400; Email: yiangz@sohu.com
      • Principal Investigator: Xianhua Lin
      • Principal Investigator: YingZi Mao
      • Principal Investigator: Qunxi Cai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: warm media

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taizhou Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ANTICIPATED): June 1, 2011
• Study Completion (ANTICIPATED): June 1, 2011

Study Registration Dates

• First Submitted: April 12, 2011
• First Submitted That Met QC Criteria: April 19, 2011
• First Posted (ESTIMATE): April 20, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 20, 2011
• Last Update Submitted That Met QC Criteria: April 19, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Taizhou200935