InfertilityNCT00391781
Warm Contrast Media for Pain Reduction During Hystersalpingography
A study testing Temperature of contrast medium in people with Infertility, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to compare between body-temperature to room-temperature contrast media used during hysterosalpingography. We hypothesize that warmed medium will reduce pain associated with the procedure. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Temperature of contrast medium
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Dec 2006to Dec 2008
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis: infertility
- sex: female
- age: 18-45
Who cannot join
- active pelvic inflammotory disease
- known sensitivity to contrast medium
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
women's health center, Ramot Eshkol
Jerusalem
Avi Tsafrir, MD, 050-8573805, avits@szmc.org.il
About this study
Official title: Prospective Randomised Controlled Trian of Warmed vs. Room Temperature Contrast Media for Hystersalpingography
The aim of this study is to compare between body-temperature to room-temperature contrast media used during hysterosalpingography. We hypothesize that warmed medium will reduce pain associated with the procedure.
Read the detailed description
Infertility occurs in about 15% of all couples. One of the common methods for evaluation of mechanical infertility is hysterosalpingography (HSG). Several reports have shown that this common procedure is associated with moderate pain, i.e. around 5 on a visual analog scale (VAS)of 1-10. It is therefore important to find modes for pain reduction for HSG. According to a report on sonohydrosonograpy, a similar technique using sonography, insertion of media warmed to body temperature into the uterus significantly reduced the pain during the procedure compared with media at room-temprature. The use of room-temperature media is the routine in our institution, as well as in many others. A comparison between the media at different temperatures has not been reported so far.
We plan to perform a prospective trial in which patients referred for HSG will be randomized to the procedure using either warmed or room-temperature media. we will asses pain levels using VAS during the procedure.
- Conditions
- Infertility
- Being tested
- Temperature of contrast medium
- Keywords
- mechanical infertility, hysterosalpingogram, hysterosalpingography
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature of contrast mediumProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study startDec 2006
- Study completionDec 2008
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Avi Tsafrir, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391781
- Sponsor's protocol ID
- WARMHSG.CTIL
- Status last verified
- Aug 2007
- First submitted
- 23 Oct 2006
- Last updated
- 26 Sep 2007
- Results posted
- No
Publications
Nirmal D, Griffiths AN, Jose G, Evans J. Warming Echovist contrast medium for hysterocontrastsonography and the effect on the incidence of pelvic pain. A randomized controlled study. Hum Reprod. 2006 Apr;21(4):1052-4. doi: 10.1093/humrep/dei440. Epub 2005 Dec 22.
PubMed 16373408
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Controlled Trian of Warmed vs. Room Temperature Contrast Media for Hystersalpingography
- ClinicalTrials.gov ID
- NCT00391781
- Acronym / sponsor ID
- WARMHSG.CTIL
- Conditions
- Infertility
- Keywords
- mechanical infertility, hysterosalpingogram, hysterosalpingography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Dec 2006
- Study completion
- Dec 2008
- First posted
- 24 Oct 2006 (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 aim of this study is to compare between body-temperature to room-temperature contrast media used during hysterosalpingography. We hypothesize that warmed medium will reduce pain associated with the procedure.
Detailed description
Infertility occurs in about 15% of all couples. One of the common methods for evaluation of mechanical infertility is hysterosalpingography (HSG). Several reports have shown that this common procedure is associated with moderate pain, i.e. around 5 on a visual analog scale (VAS)of 1-10. It is therefore important to find modes for pain reduction for HSG. According to a report on sonohydrosonograpy, a similar technique using sonography, insertion of media warmed to body temperature into the uterus significantly reduced the pain during the procedure compared with media at room-temprature. The use of room-temperature media is the routine in our institution, as well as in many others. A comparison between the media at different temperatures has not been reported so far.
We plan to perform a prospective trial in which patients referred for HSG will be randomized to the procedure using either warmed or room-temperature media. we will asses pain levels using VAS during the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis: infertility
- sex: female
- age: 18-45
Key exclusion criteria (2 listed)
- active pelvic inflammotory disease
- known sensitivity to contrast medium
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 |
|---|---|---|
| Temperature of contrast medium | Procedure or surgery | – |
Primary outcome
Pain level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2007.
- Background: PubMed 16373408Nirmal D, Griffiths AN, Jose G, Evans J. Warming Echovist contrast medium for hysterocontrastsonography and the effect on the incidence of pelvic pain. A randomized controlled study. Hum Reprod. 2006 Apr;21(4):1052-4. doi: 10.1093/humrep/dei440. Epub 2005 Dec 22.
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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.
Avi Tsafrir, MD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temperature of contrast medium in people with Infertility, run by Shaare Zedek Medical Center at 1 site in Israel.
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 3 inclusion and 2 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 26 Sep 2007. 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 Israel. 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.
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 Avi Tsafrir, MD (972-508685802, avits@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level. 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 NCT00391781, 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 26 Sep 2007.