- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07351747
Effect of Laser Acupoints on Fallopian Tube Obstruction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Fallopian tube obstruction is a significant health concern that affects a substantial number of women worldwide, often leading to infertility and other reproductive issues. The fallopian tubes, essential components of the female reproductive system, play a crucial role in the process of conception by facilitating the transport of ova from the ovaries to the uterus.
The laser's focused light energy, when directed at specific acupoints linked to reproductive health, is hypothesized to activate the body's energy pathways or meridians, thereby facilitating healing and restoration of normal tubal function.
Although acupoint therapy shows promise, laser acupoint therapy offers potential advantages over traditional acupuncture by utilizing low-level lasers, which may enhance the treatment's efficacy. Laser acupoint therapy is noninvasive and painless, making it articularly appealing for patients who have a fear of needles or are sensitive to pain.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hadeer E Shalaby, MBBCH
- Phone Number: 00201554488336
- Email: hadeershaalaaby@yahoo.com
Study Locations
-
-
Kafrelsheikh
-
Kafr ash Shaykh, Kafrelsheikh, Egypt, 33516
- Recruiting
- Kafrelsheikh University (Faculty of Physical Therapy)
-
Sub-Investigator:
- Fayiz F Elshamy, MD
-
Contact:
- Hadeer E Shalaby, MBBCH
- Phone Number: 00201554488336
- Email: hadeershaalaaby@yahoo.com
-
Sub-Investigator:
- Mostafa F Ellkany, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 20-35 years - nulliparous.
- Women diagnosed with fallopian tube obstruction.
- Body mass index less than 30 kg/m2.
- Consent to participate in the study.
- General good health with no major co-existing medical conditions that could interfere with the treatment or outcomes.
- No prior fertility treatments [e.g., In vitro fertilization (IVF), intrauterine insemination (IUI)] within the last 6 months.
- Ability to attend all scheduled sessions and follow-up assessments.
Exclusion Criteria:
- Currently pregnant or breastfeeding.
- History of pelvic surgery within the past year.
- Presence of severe systemic diseases such as active cancer or severe cardiovascular diseases.
- History of allergic reactions or adverse responses to acupuncture or laser therapies.
- Currently undergoing hormonal therapy or use of hormonal contraceptives.
- Current or recent history of genital tract infections, including sexually transmitted. infections, which could affect the reproductive system.
- Presence of significant uterine anomalies diagnosed through imaging that could impact fertility.
- Polycystic Ovary Syndrome (PCOS).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group (Group A)
Patients will receive laser acupoints therapy addition to standard care.
|
Patients will receive laser acupoints therapy addition to standard care.
|
|
Placebo Comparator: Control Group (Group B)
Patients will receive placebo laser acupoints therapy in addition to standard care.
|
Patients will receive placebo laser acupoints therapy in addition to standard care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tubal patency
Time Frame: 3 months post-treatment
|
Hysterosalpingography (HSG) will be used to assess tubal patency.
It is a radiographic technique where a contrast material is injected into the uterine cavity, and X-ray images are taken to evaluate the shape of the uterus and the status of the fallopian tubes.
HSG will be applied before the treatment and again three months post-treatment to evaluate changes in tubal patency HSG will be applied before treatment and after 3 months post-treatment.
|
3 months post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anti-Müllerian Hormone (AMH) Test
Time Frame: 3 months post-treatment
|
A blood test will be used to measure the level of Anti-Müllerian Hormone (AMH), which is an indicator of the remaining quantity of eggs and ovarian function.
This test will be conducted before the treatment and at the third month of treatment to monitor any changes in ovarian reserve.
|
3 months post-treatment
|
|
Quantitative Pregnancy Test
Time Frame: 3 months post-treatment
|
A blood test that will be measured the specific level of Human Chorionic Gonadotropin (hCG), which is produced during pregnancy.
This test will be performed every month.
|
3 months post-treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Adnexal Diseases
- Fallopian Tube Diseases
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Quality of Health Care
- Quality Indicators, Health Care
- Standard of Care
Other Study ID Numbers
- KFSIRB200-711
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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