NCT01339338

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 20, 2011

Status Verified

April 1, 2011

Enrollment Period

1.4 years

First QC Date

April 12, 2011

Last Update Submit

April 19, 2011

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Visual analogue scale pain score during HSG

    within the first 30 seconds after the constra media "spill out"

  • Visual analogue scale pain score after HSG

    a half hour after HSG

Study Arms (2)

warm media

EXPERIMENTAL

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

Procedure: warming the contrast media

cold media

NO INTERVENTION

the contrast media under room temperature without heat

Procedure: warming the contrast media

Interventions

warming the contrast mediaPROCEDURE

warm the contrast media with 37℃ water-bathing

Also known as: warm media
cold mediawarm media

Eligibility Criteria

Age16 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • infertile women who seeking for HSG testing

You may not qualify if:

  • suspect of pregnancy
  • acute low reproductive duct infection
  • a known hypersensitivity to iodine
  • genital bleeding
  • genital malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taizhou Hospital of zhejiang Province

Taizhou, Zhejiang, 317000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22459631DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • YiYang Zhu, MD

    Centra for Reproductive Medicine of Taizhou hospital

    STUDY DIRECTOR

Central Study Contacts

Yi-Yang Zhu, MD

CONTACT

86-057-6519-1400yiangz@sohu.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2011

First Posted

April 20, 2011

Study Start

January 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 20, 2011

Record last verified: 2011-04

Locations

CN(1)