InfertilityPhase 1/2NCT01339338
Warming Contrast Media for Hysterosalpingography
A Phase 1/2 study testing warming the contrast media in people with Infertility, run by Taizhou Hospital at 1 site in China.
Trial summary
The purpose of this study is to compare the use of warm-media with cold-media in performing hysterosalpingography (HSG). Read more about this study
- Who is it for?
- Ages 16 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- warming the contrast media
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Jun 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- infertile women who seeking for HSG testing
Who cannot join
- suspect of pregnancy
- acute low reproductive duct infection
- a known hypersensitivity to iodine
- genital bleeding
- genital malignancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Taizhou Hospital of zhejiang Province
Taizhou, Zhejiang, 317000
YiYang Zhu, MD, 86-057-6519-1400, yiangz@sohu.com
Xianhua Lin
About this study
Official title: 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).
Read the 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.
- Conditions
- Infertility
- Being tested
- warming the contrast media
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warming the contrast mediaProcedure or surgery
Also called warm media
warm the contrast media with 37℃ water-bathing
| Study group | Role | What they receive |
|---|---|---|
| warm media | Experimental | Subjects undergo HSG using a warm media heated with a 37℃ water-bathing Receives: Procedure: warming the contrast media |
| cold media | No intervention | the contrast media under room temperature without heat Receives: Procedure: warming the contrast media |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of vasovagal episodes
vasovagal episodes include nausea, Vomit, Sweating, Weakness and bradycardia occurred in HSG
Measured: from the injection of the media to a half hour after HSG
Secondary outcomes (2)
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.
Measured: 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
Measured: a half hour after HSG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startJan 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital
- Sponsor type
- University, hospital or other
- Investigators
- YiYang Zhu, MD, Study director, Centra for Reproductive Medicine of Taizhou hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339338
- Sponsor's protocol ID
- Taizhou200935
- Status last verified
- Apr 2011
- First submitted
- 12 Apr 2011
- Last updated
- 20 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 22459631
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Warm and Cold Contrast Media for Hysterosalpingography: a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT01339338
- Acronym / sponsor ID
- Taizhou200935
- Conditions
- Infertility
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Taizhou HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 20 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| warm media | Experimental | Procedure: warming the contrast mediaSubjects undergo HSG using a warm media heated with a 37℃ water-bathing |
| cold media | No intervention | Procedure: warming the contrast mediathe contrast media under room temperature without heat |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- infertile women who seeking for HSG testing
Key exclusion criteria (5 listed)
- suspect of pregnancy
- acute low reproductive duct infection
- a known hypersensitivity to iodine
- genital bleeding
- genital malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| warming the contrast mediaAlso: warm mediawarm the contrast media with 37℃ water-bathing | Procedure or surgery | cold media, warm media |
Primary outcome
incidence of vasovagal episodes
Time frame: from the injection of the media to a half hour after HSG
vasovagal episodes include nausea, Vomit, Sweating, Weakness and bradycardia occurred in HSG
2 secondary outcomes
Visual analogue scale pain score during HSG
Time frame: within the first 30 seconds after the constra media "spill out"
Visual analogue scale pain score after HSG
Time frame: a half hour after HSG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2011.
- Derived from this study: PubMed 22459631Zhu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YiYang Zhu, MD study director
Centra for Reproductive Medicine of Taizhou hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing warming the contrast media in people with Infertility, run by Taizhou Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Yang Zhu, MD (86-057-6519-1400, yiangz@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of vasovagal episodes (time frame: from the injection of the media to a half hour after HSG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01339338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2011.