Effect of the Bioheat Patch on Pain Following the HyFoSy Procedure

NCT07081971 | Not Yet Recruiting

• 1 other identifier: 0130-25-ASF
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Pelvic Pain; Infertility; Pain Management; Gynecologic Procedures

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6 hours post-procedure

Study Arms (2)

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

Interventions

Bioheat Patch OTHER

Bioheat Patch for pain relif

Intervention Group: 40 women will receive the active Bioheat patch.

Placebo Patch OTHER

placebo Patch

Control Group: 40 women will receive a non-heating placebo patch

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Active genital infection
• Skin issues in lower abdomen
• Sensitivity to heat
• Any medical condition preventing local heat use

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Related Publications (1)

• 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.

  PMID: 33249268 BACKGROUND

MeSH Terms

Conditions

Pelvic Pain; Infertility; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases; Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Prof. Yaakov Melcer Prof. Yaakov Melcer Principal Investigator shamir Medical, MD

CONTACT

+972547781821; ymeltcer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor yaakov melcer

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: July 24, 2025
• Study Start: August 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share