Pelvic PainB-HyPNCT07081971
Effect of the Bioheat Patch on Pain Following the HyFoSy Procedure
A study testing Bioheat Patch in people with Pelvic Pain and Infertility, run by Assaf-Harofeh Medical Center.
Trial summary
This randomized controlled trial (RCT) evaluates the efficacy of Bioheat thermal patches in reducing post-procedural pain following Hysterosalpingo Foam Sonography (HyFoSy). HyFoSy is a common ultrasound-based diagnostic procedure to assess tubal patency and uterine cavity structure in women undergoing fertility… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Pain, Infertility, Pain Management
- What is being tested?
- Bioheat Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-45 scheduled for HyFoSy
- No dermatologic conditions at the patch site
- No allergies to patch ingredients, or heat
- No active pelvic infections
Who cannot join
- Active genital infection
- Skin issues in lower abdomen
- Sensitivity to heat
- Any medical condition preventing local heat use
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Prof. Yaakov Melcer Prof. Yaakov Melcer Principal Investigator shamir Medical, MD contact
About this study
This randomized controlled trial (RCT) evaluates the efficacy of Bioheat thermal patches in reducing post-procedural pain following Hysterosalpingo Foam Sonography (HyFoSy).
HyFoSy is a common ultrasound-based diagnostic procedure to assess tubal patency and uterine cavity structure in women undergoing fertility workup. While generally less painful than HSG, many patients still report moderate to severe cramping and discomfort during and after the test.
Read more
Thermal therapy has demonstrated effectiveness in reducing musculoskeletal and gynecological pain. Bioheat patches, approved by the Israeli Ministry of Health for menstrual pain relief, emit safe, low-grade heat (approximately 37-38°C) and may provide a non-invasive pain management strategy post-HyFoSy.
Participants (n=80) will be women aged 20-45 undergoing HyFoSy. They will be randomly assigned to either the Bioheat intervention group or a placebo patch group, applied externally to the lower abdomen. The heat-producing patch contains iron and other safe materials that react with oxygen to emit continuous heat without electricity. Infrared radiation from the patch components may also promote local vasodilation and muscle relaxation.
Pain assessment will use the validated Visual Analog Scale (VAS), collected post-procedure via follow-up SMS and phone contact. The study aims to quantify reduction in perceived pain, and potentially improve patient satisfaction with HyFoSy. Safety has been pre-established, with no reported adverse skin effects when used as instructed.
Study duration is six months, following ethics approval at the OB-GYN ultrasound department of Shamir Medical Center.
- Conditions
- Pelvic Pain, Infertility, Pain Management, Gynecologic Procedures
- Being tested
- Bioheat Patch, Placebo Patch
- Medical subject headings
- Pelvic Pain, Infertility, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioheat PatchOther
Bioheat Patch for pain relif
Placebo PatchOther
placebo Patch
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: 40 women will receive the active Bioheat patch. | Experimental | Not described Receives: Other: Bioheat Patch |
| Control Group: 40 women will receive a non-heating placebo patch | Experimental | Not described Receives: Other: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity measured by Visual Analog Scale (VAS)
Pain will be assessed using the VAS (range: 0-10; 0 = no pain, 10 = worst imaginable pain). Participants will self-report their score via questionnaire within 6 hours after the procedure.
Measured: Up to 6 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (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 Pelvic PainStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yaakov Melcer, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081971
- Sponsor's protocol ID
- 0130-25-ASF
- Acronym
- B-HyP
- Status last verified
- Jul 2025
- First submitted
- 21 May 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Melcer Y, Nimrodi M, Levinsohn-Tavor O, Gal-Kochav M, Pekar-Zlotin M, Maymon R. Analgesic Efficacy of Intrauterine Lidocaine Flushing in Hysterosalpingo-foam Sonography: A Double-blind Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Aug;28(8):1484-1489. doi: 10.1016/j.jmig.2020.11.019. Epub 2020 Nov 26.
PubMed 33249268
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Bioheat Patch on Pain Following the HyFoSy Procedure
- ClinicalTrials.gov ID
- NCT07081971
- Acronym / sponsor ID
- B-HyP / 0130-25-ASF
- Conditions
- Pelvic Pain, Infertility, Pain Management, Gynecologic Procedures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Jul 2025 (actual)
- 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.
This randomized controlled trial (RCT) evaluates the efficacy of Bioheat thermal patches in reducing post-procedural pain following Hysterosalpingo Foam Sonography (HyFoSy).
HyFoSy is a common ultrasound-based diagnostic procedure to assess tubal patency and uterine cavity structure in women undergoing fertility workup. While generally less painful than HSG, many patients still report moderate to severe cramping and discomfort during and after the test.
Thermal therapy has demonstrated effectiveness in reducing musculoskeletal and gynecological pain. Bioheat patches, approved by the Israeli Ministry of Health for menstrual pain relief, emit safe, low-grade heat (approximately 37-38°C) and may provide a non-invasive pain management strategy post-HyFoSy.
Participants (n=80) will be women aged 20-45 undergoing HyFoSy. They will be randomly assigned to either the Bioheat intervention group or a placebo patch group, applied externally to the lower abdomen. The heat-producing patch contains iron and other safe materials that react with oxygen to emit continuous heat without electricity. Infrared radiation from the patch components may also promote local vasodilation and muscle relaxation.
Pain assessment will use the validated Visual Analog Scale (VAS), collected post-procedure via follow-up SMS and phone contact. The study aims to quantify reduction in perceived pain, and potentially improve patient satisfaction with HyFoSy. Safety has been pre-established, with no reported adverse skin effects when used as instructed.
Study duration is six months, following ethics approval at the OB-GYN ultrasound department of Shamir Medical Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: 40 women will receive the active Bioheat patch. | Experimental | Other: Bioheat Patch |
| Control Group: 40 women will receive a non-heating placebo patch | Experimental | Other: Placebo Patch |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-45 scheduled for HyFoSy
- No dermatologic conditions at the patch site
- No allergies to patch ingredients, or heat
- No active pelvic infections
Key exclusion criteria (4 listed)
- Active genital infection
- Skin issues in lower abdomen
- Sensitivity to heat
- Any medical condition preventing local heat use
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 |
|---|---|---|
| Bioheat PatchBioheat Patch for pain relif | Other | Intervention Group: 40 women will receive the active Bioheat patch. |
| Placebo Patchplacebo Patch | Other | Control Group: 40 women will receive a non-heating placebo patch |
Primary outcome
Change in pain intensity measured by Visual Analog Scale (VAS)
Time frame: Up to 6 hours post-procedure
Pain will be assessed using the VAS (range: 0-10; 0 = no pain, 10 = worst imaginable pain). Participants will self-report their score via questionnaire within 6 hours after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Background: PubMed 33249268Melcer Y, Nimrodi M, Levinsohn-Tavor O, Gal-Kochav M, Pekar-Zlotin M, Maymon R. Analgesic Efficacy of Intrauterine Lidocaine Flushing in Hysterosalpingo-foam Sonography: A Double-blind Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Aug;28(8):1484-1489. doi: 10.1016/j.jmig.2020.11.019. Epub 2020 Nov 26.
- Individual participant dataSharing planned: No
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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.
Prof. Yaakov Melcer Prof. Yaakov Melcer Principal Investigator shamir Medical, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing Bioheat Patch in people with Pelvic Pain and Infertility, run by Assaf-Harofeh Medical Center.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Yaakov Melcer Prof. Yaakov Melcer Principal Investigator shamir Medical, MD (+972547781821, ymeltcer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity measured by Visual Analog Scale (VAS) (time frame: Up to 6 hours post-procedure). 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 NCT07081971, 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 30 Jul 2025.