Effect of Shockwaves on Fallopian Tubes Adhesion

Cairo University (CU)

Status: Not yet enrolling

Conditions: Fallopian Tube Adhesion

Treatments: Drug: Chitosan; Device: shockwave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06755528

P.T.REC/012/003490

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: Female

Ages: 25 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Medical therapy group

Active Comparator group

Description:

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

Treatment:

Drug: Chitosan

Medical therapy and Shockwave therapy group

Experimental group

Description:

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

Treatment:

Device: shockwave therapy

Drug: Chitosan