Effect of Shockwaves on Fallopian Tubes Adhesion

Not Applicable

Not yet recruiting

• Conditions: Fallopian Tube Adhesion
• Interventions: Drug: Chitosan; Device: shockwave therapy

• Registration Number: NCT06755528
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-12-25
• Study First Submitted QC: 2024-12-25
• Study Start: 2024-12-30
• Status Verified: 2025-01
• Study First Posted: 2025-01-01
• Last Update Submitted: 2025-01-04
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-02-28
• Study Completion: 2025-03-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical therapy and Shockwave therapy group	shockwave therapy	The participants will receive medical therapy plus shockwave therapy (1 session per week for 4 weeks).
Medical therapy group	Chitosan	The participants will receive medical therapy for fallopian tube adhesions as prescribed by the gynecologist
Medical therapy and Shockwave therapy group	Chitosan	The participants will receive medical therapy plus shockwave therapy (1 session per week for 4 weeks).

Primary Outcome Measures

Name	Time	Method
Assessment of Fallopian tube adhesions	4 weeks	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)
Detection of Fallopian tube patency	4 weeks	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)