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Effect of the Bioheat Patch on Pain Following the HyFoSy Procedure

NCT07081971 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-07-30

No results posted yet for this study

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

Interventions

OTHER

Bioheat Patch

Bioheat Patch for pain relif

OTHER

Placebo Patch

placebo Patch

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-12-30
Completion
2025-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07081971 on ClinicalTrials.gov