Fallopian Tube Adhesion
Conditions
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
Interventions
DRUGChitosan
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
DEVICEshockwave 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Contacts
Primary ContactShorouk F. Mohamed, PHD
Backup ContactAfaf Botla, Professor
Outcome results
None listed