Effect of Shockwaves on Fallopian Tubes Adhesion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chitosan, shockwave therapy.
- Who it may be relevant to
- Registry conditions: Fallopian Tube Adhesion. Basic parameters: 25 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Shockwaves on Fallopian Tubes Adhesion: a Randomized Controlled Trial
Overview
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
Interventions
- 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 - 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.
Primary outcome measures
- Assessment of Fallopian tube adhesions [Time frame: 4 weeks]
- Detection of Fallopian tube patency [Time frame: 4 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06755528 · P.T.REC/012/003490