Fallopian Tube AdhesionNCT06755528
Effect of Shockwaves on Fallopian Tubes Adhesion
A study testing Chitosan and shockwave therapy in people with Fallopian Tube Adhesion, run by Cairo University.
Trial summary
The purpose of this study is to determine the effect of shock waves on fallopian tube adhesions. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Fallopian Tube Adhesion
- What is being tested?
- Chitosan and shockwave therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 7 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Shockwaves on Fallopian Tubes Adhesion: a Randomized Controlled Trial
The purpose of this study is to determine the effect of shock waves on fallopian tube adhesions.
Read the 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
- Being tested
- Chitosan, shockwave therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChitosanDrug
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 therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Medical therapy group | Active comparator | The participants will receive medical therapy for fallopian tube adhesions as prescribed by the gynecologist Receives: 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). Receives: Drug: Chitosan; Device: shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start30 Dec 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion7 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube AdhesionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shorouk Fawzy Mohamed, Cairo University
- Investigators
- Nabil Fekry, PHD, Study director, Al-Agoza Police HospitalSoheir El-kosery, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755528
- Sponsor's protocol ID
- P.T.REC/012/003490
- Status last verified
- Jan 2025
- First submitted
- 25 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shockwaves on Fallopian Tubes Adhesion: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06755528
- Acronym / sponsor ID
- P.T.REC/012/003490
- Conditions
- Fallopian Tube Adhesion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 7 Mar 2025 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical therapy group | Active comparator | Drug: ChitosanThe participants will receive medical therapy for fallopian tube adhesions as prescribed by the gynecologist |
| Medical therapy and Shockwave therapy group | Experimental | Drug: Chitosan, Device: shockwave therapyThe participants will receive medical therapy plus shockwave therapy (1 session per week for 4 weeks). |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChitosanThe 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 | Drug | Medical therapy and Shockwave therapy group, Medical therapy group |
| shockwave therapyThe 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. | Device | Medical therapy and Shockwave therapy group |
Primary outcome
Assessment of Fallopian tube adhesions
Time frame: 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
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
Related trials for Fallopian Tube Adhesion
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nabil Fekry, PHD study director
Al-Agoza Police Hospital
Soheir El-kosery, Professor study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Chitosan and shockwave therapy in people with Fallopian Tube Adhesion, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shorouk F. Mohamed, PHD (+201122071380, Shoroukfawzy84@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Fallopian tube adhesions (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.