Effect of Shockwaves on Fallopian Tubes Adhesion

NCT06755528 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/003490
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Fallopian Tube Adhesion

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Medical therapy group

ACTIVE COMPARATOR

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

Drug: Chitosan

Medical therapy and Shockwave therapy group

EXPERIMENTAL

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

Drug: Chitosan; Device: shockwave therapy

Interventions

Chitosan 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; Medical therapy group

shockwave therapy 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.

Medical therapy and Shockwave therapy group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Chitosan; Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Chitin; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Nabil Fekry, PHD

  Al-Agoza Police Hospital

  STUDY DIRECTOR

• Soheir El-kosery, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Shorouk F. Mohamed, PHD

CONTACT

+201122071380; Shoroukfawzy84@gmail.com

Afaf Botla, Professor

CONTACT

+201283126608; drafafmohamed@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 1, 2025
• Study Start: December 30, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 7, 2025
• Last Updated: January 7, 2025

Record last verified: 2025-01