Warmed HSG for Infertility
(HEAT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether using warmed dye during an HSG (a test to check if fallopian tubes are open) can reduce pain and false results. Cold dye in these tests sometimes causes painful cramping and can falsely indicate blocked tubes. Women without fibroids, pelvic inflammatory disease, or past reproductive surgeries who plan to undergo HSG might be suitable candidates. Participants will receive either the warmed dye or the standard room-temperature dye to determine which is more effective. As an Early Phase 1 trial, this research aims to understand how the warmed dye works in people, offering participants a chance to contribute to innovative medical advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that the Warmed HSG treatment is likely to be safe for humans?
In previous studies, patients who underwent an HSG (a type of X-ray for checking the uterus and fallopian tubes) with warm contrast dye reported less pain than those who had the procedure with dye at room temperature. This suggests that warm dye might make the procedure more comfortable. No evidence indicates major safety issues with warm dye, but it is important to note that this trial remains in its early stages. Early trials primarily focus on assessing a treatment's safety for people, meaning researchers are still learning about any possible side effects. So far, results appear promising for comfort, but more research is needed to fully understand the safety.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about the Warmed HSG (hysterosalpingography) technique because it has the potential to enhance the effectiveness of fertility assessments. Unlike the standard HSG procedure, which uses room-temperature contrast dye, the Warmed HSG involves warming the contrast medium. This warming may improve patient comfort and possibly increase the success rate of identifying blockages in the fallopian tubes. By optimizing the conditions of the procedure, researchers hope to provide a more comfortable and potentially more accurate diagnostic tool for those struggling with infertility.
What evidence suggests that warmed HSG is effective for reducing pain and proximal tubal occlusion in infertility?
This trial will compare warmed contrast dye with standard room-temperature contrast dye in hysterosalpingograms (HSG) for infertility. Research has shown that warmed contrast dye can reduce pain and cramping for patients. Specifically, studies found that warming the dye to body temperature lessens discomfort during the procedure. This reduction in pain is crucial, as it can prevent false results for blocked fallopian tubes, which sometimes occur due to cramping. Overall, using warmed contrast may enhance test accuracy and improve patient comfort.23567
Who Is on the Research Team?
LaTasha Craig, MD
Principal Investigator
University of Oklahoma Health Center
Are You a Good Fit for This Trial?
This trial is for women experiencing infertility who need a hysterosalpingogram (HSG), a test to check if fallopian tubes are open. Participants should have normal uterine anatomy and no other conditions that could affect the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the HSG procedure with either warm or cold contrast media
Follow-up
Participants complete a post-procedure pain questionnaire and are informed of their HSG results
What Are the Treatments Tested in This Trial?
Interventions
- Warmed HSG
Trial Overview
The HEAT Study is testing whether using warmed contrast dye during an HSG can reduce pain and prevent false signs of blocked fallopian tubes, which can happen due to spasms during the procedure.
How Is the Trial Designed?
2
Treatment groups
Active Control
HSG constrast will be warmed.
HSG contrast will be standard, room-temperature
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oklahoma
Lead Sponsor
Citations
Comparison of fertility outcomes between oil‑based and ...
The oil-based contrast medium enhances fertility outcomes compared with the water-based contrast medium in patients receiving HSG.
Comparison of warm and cold contrast media for ...
In conclusion, the results of this study suggest that warming the contrast medium to body temperature for HSG is associated with less pain and fewer vasovagal ...
Oil-Based or Water-Based Contrast for ...
A meta-analysis of three trials showed higher rates of ongoing pregnancy after hysterosalpingography performed with oil contrast than after no intervention.
A meta-analysis of fertility and adverse outcomes in oil
Our meta-analysis revealed that the pregnancy rate in patients who had HSG with OBCM was 1.51 times greater than in those who had WBCM. This ...
Fertility-enhancing effect of oil-based contrast agents ...
Conclusion: The HSG procedure with oil-based contrast agents shows a fertility-enhancing effect when compared to water-based contrast agents.
Comparison of warm and cold contrast media for ...
Result(s): Patients' VAS pain scores during HSG were significantly lower in the warm media group initially but showed no statistical difference at 30 minutes ...
Complications after hysterosalpingography with oil- or water ...
An HSG with oil-based contrast increases pregnancy rates in women with unexplained infertility. However, there have been some concerns regarding ...
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