Effect of the Bioheat Patch on Pain Following the HyFoSy Procedure
Launched by ASSAF-HAROFEH MEDICAL CENTER · Jul 22, 2025
Trial Information
Current as of July 27, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether using a warming patch called the Bioheat patch can help reduce pain after a procedure called HyFoSy, which is used to check the fallopian tubes in women who are having trouble getting pregnant. The goal is to see if this warm patch can make the experience more comfortable compared to a patch that doesn’t provide heat.
Women between 20 and 45 years old who are scheduled to have the HyFoSy procedure and do not have skin problems, allergies to patch ingredients, or active pelvic infections may be eligible to join. After the procedure, participants will be randomly split into two groups: one will use the warm Bioheat patch, and the other will use a non-heating patch for comparison. The patch is worn over underwear on the lower belly, heats up within 15 minutes, and stays warm for up to 8 hours. Participants will be asked to rate their pain through a quick questionnaire sent by text message within 6 hours after the procedure. The patch has been found to be safe when used as directed, with no reports of burns or skin irritation. This study aims to find an easy and safe way to help women feel better after this common fertility test.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • Active genital infection
- • Skin issues in lower abdomen
- • Sensitivity to heat
- • Any medical condition preventing local heat use
About Assaf Harofeh Medical Center
Assaf-Harofeh Medical Center is a prominent healthcare institution located in Israel, renowned for its commitment to advancing medical research and improving patient care. As a key sponsor of clinical trials, the center focuses on a diverse range of therapeutic areas, leveraging its state-of-the-art facilities and interdisciplinary expertise to facilitate innovative studies. With a dedicated team of experienced researchers and clinicians, Assaf-Harofeh Medical Center is dedicated to fostering scientific breakthroughs that enhance treatment outcomes and contribute to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported