Effect of Shockwaves on Fallopian Tubes Adhesion

NCT ID: NCT06755528

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-30
• Study Completion Date: 2025-03-07

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

Conditions

Fallopian Tube Adhesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Medical therapy group

The participants will receive medical therapy for fallopian tube adhesions as prescribed by the gynecologist

Group Type: ACTIVE_COMPARATOR

Chitosan

Intervention Type: DRUG

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

Medical therapy and Shockwave therapy group

The participants will receive medical therapy plus shockwave therapy (1 session per week for 4 weeks).

Group Type: EXPERIMENTAL

Chitosan

Intervention Type: DRUG

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

shockwave therapy

Intervention Type: DEVICE

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.

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Shorouk Fawzy Mohamed

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nabil Fekry, PHD

Role: STUDY_DIRECTOR

Al-Agoza Police Hospital

Soheir El-kosery, Professor

Role: STUDY_CHAIR

Cairo University

Central Contacts

Shorouk F. Mohamed, PHD

Role: CONTACT

Shoroukfawzy84@gmail.com

+201122071380

Afaf Botla, Professor

Role: CONTACT

drafafmohamed@cu.edu.eg

+201283126608

Other Identifiers

P.T.REC/012/003490

Identifier Type: -

Identifier Source: org_study_id