Effect of Shockwaves on Fallopian Tubes Adhesion

Effect of Shockwaves on Fallopian Tubes Adhesion: a Randomized Controlled Trial

The purpose of this study is to determine the effect of shock waves on fallopian tube adhesions.

Study Overview

• Status: Not yet recruiting
• Conditions: Fallopian Tube Adhesion
• Intervention / Treatment: Device: shockwave therapy; Drug: Chitosan

Detailed Description

Tubal factor infertility accounts for approximately 40% of the cases of female infertility. Identifiable causes of tubal infertility are post-infectious tubal damage, endometriosis-related adhesions, and postsurgical adhesion formation.

Although surgical management is considered as a common choice for treating blocked tubes or adhesion it has many complications such as: infection, creation of more scar tissue, damage to organs and bleeding.

Shock waves is a modality that exerts an anti-inflammatory action and regenerative effect as well biological model. Shock waves can be nowadays considered an effective, safe, versatile, repeatable, noninvasive therapy for the treatment of many musculo-skeletal diseases, and for some pathological conditions where regenerative effects are desirable, especially when some other noninvasive/conservative therapies have failed.

For these reasons and complications of surgery, This study aims to examine the effect of shockwaves therapy on fallopian tubes adhesion

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Afaf Botla, Professor; Phone Number: +201283126608; Email: drafafmohamed@cu.edu.eg
• Study Contact Backup: Name: Shorouk F. Mohamed, PHD; Phone Number: +201122071380; Email: Shoroukfawzy84@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Their ages will be ranged from 25 to 35 years old.
• Their body mass index (BMI) will be less than 35kg/m².
• All women will be diagnosed with fallopian tubes adhesion by the physician.
• They have regular menstrual cycles.
• All Patients have secondary infertility and they have previous caesarean section).

Exclusion Criteria:

• Any gynecological diseases (uterine prolapse, retroversion flexion of the uterus or chronic pelvic pain).
• Leukemia or tumor (spinal or pelvic tumor).
• Diabetes mellitus, hypertension, heart diseases, cardiovascular diseases and skin diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Medical therapy group; The participants will receive medical therapy for fallopian tube adhesions as prescribed by the gynecologist	Drug: Chitosan; The participants will receive medications for fallopian tube adhesions (Chitosan (glucosamine (GIcN) and N-acetylglucosamine (GIcNAc) units,1 tablet per day) as prescribed by the gynecologist
Experimental: Medical therapy and Shockwave therapy group; The participants will receive medical therapy plus shockwave therapy (1 session per week for 4 weeks).	Device: shockwave therapy; The participants will receive shockwave with the following parameters: sonic pulses characterized by: high peak pressure, up to 100 mpa (500 bar) or even more, rapid rise in pressure (<10 ns), short duration (<10 μs) and a broad range of frequency. The energy flux density was 0.09 to 0.16 mJ/mm2; with a frequency of 5 Hz and 2000 impulses, i session per week for 4 weeks.; Drug: Chitosan; The participants will receive medications for fallopian tube adhesions (Chitosan (glucosamine (GIcN) and N-acetylglucosamine (GIcNAc) units,1 tablet per day) as prescribed by the gynecologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Fallopian tube adhesions	Pelvic abdominal ultrasound (ultrasound scanning system, SN.w7c1882026) will be used to assess fallopian tube adhesions for all participants in both groups before and after the treatment protocol (4 weeks)	4 weeks
Detection of Fallopian tube patency	Hysterosalpingography (DMC GmbH, 22335 Hamburg): it is a radiologic procedure that will be used to assess fallopian tube patency ( if the fallopian tube is opened or not) for all women in both groups before and after the treatment protocol (4 weeks)	4 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Soheir El-kosery, Professor, Cairo University; Study Director: Nabil Fekry, PHD, Al-Agoza Police Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): March 7, 2025

Study Registration Dates

• First Submitted: December 25, 2024
• First Submitted That Met QC Criteria: December 25, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cicatrix; Fibrosis; Tissue Adhesions; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants; Antimetabolites; Chelating Agents; Sequestering Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Chitosan
• Other Study ID Numbers: P.T.REC/012/003490

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No