Back to resultsEFFECTS OF LASER PUNCTURE VERSUS ULTRAVIOLET ON POLYCYSTIC OVARIAN WOMEN
Primary Purpose
Polycystic Ovary Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
aser puncture
ultraviolet radiatio
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
Inclusion Criteria: Obese nulli gravid PCOS women BMI 30-40 kg/m2 Exclusion Criteria: hyperprolactinemia BMI > 40 kg/m2 Endocrinological disorders such as thyroid disease, Cushing's syndrome, Coagulopathy Recent use of oral contraceptive pills Recent use of any photosensitizing medications, such as aspirin, tetracycline, chlorothiazide, or psoralen suspicious of neoplasms
Sites / Locations
- Kasr Alainy medical school
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
laser puncture group
Ultraviolet treatment group
Metformin only group
Arm Description
gallium Arsenide infrared (GaAlAs) laser, using a wavelength at 904nm with a Maximum power output is 150 mW and a power density at 0.417 W/cm2 as well as an energy density of 4 J/cm2 will be employed for 2 minutes on specific acupuncture points
The therapist will place the UV arc lamp at a height of 60 to 80 cm above the lower abdomen region, perpendicular to the skin. Each woman's lamp will be switched on and given an individual timer by the minimum effective dose
Outcomes
Primary Outcome Measures
LH/FSH ratio
LH/FSH ratio measured in venous sample on day 3 of the menstrual cycle
Secondary Outcome Measures
Serum 25-hydroxyvitamin D
25-hydroxyvitamin D measured in venous sample
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05986838
Brief Title
EFFECTS OF LASER PUNCTURE VERSUS ULTRAVIOLET ON POLYCYSTIC OVARIAN WOMEN
Official Title
EFFECTS OF LASER PUNCTURE VERSUS ULTRAVIOLET ON POLYCYSTIC OVARIAN WOMEN
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Obese women with polycystic ovarian syndrome aged between 25 and 35 years old will be divided into three groups. For three months, group (A) will receive laser puncture (3 sessions per week), along with a metformin supplementation, group (B) will receive ultraviolet radiation (3 sessions per week), along with a metformin supplementation, while group (C) will receive only metformin supplementation. The follicular size will be measured using ultrasound, while, female sex hormones, and serum 25-hydroxyvitamin D levels will bel evaluated using blood analysis
Detailed Description
Obese women with polycystic ovarian syndrome aged between 25 and 35 years old will be divided into three groups. For three months, group (A) will receive laser puncture (3 sessions per week), along with a metformin supplementation, group (B) will receive ultraviolet radiation (3 sessions per week), along with a metformin supplementation, while group (C) will receive only metformin supplementation. The follicular size will be measured using ultrasound, while, female sex hormones, and serum 25-hydroxyvitamin D levels will bel evaluated using blood analysis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
laser puncture group
Arm Type
Active Comparator
Arm Description
gallium Arsenide infrared (GaAlAs) laser, using a wavelength at 904nm with a Maximum power output is 150 mW and a power density at 0.417 W/cm2 as well as an energy density of 4 J/cm2 will be employed for 2 minutes on specific acupuncture points
Arm Title
Ultraviolet treatment group
Arm Type
Active Comparator
Arm Description
The therapist will place the UV arc lamp at a height of 60 to 80 cm above the lower abdomen region, perpendicular to the skin. Each woman's lamp will be switched on and given an individual timer by the minimum effective dose
Arm Title
Metformin only group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
aser puncture
Intervention Description
laser puncture (3 sessions per week)
Intervention Type
Device
Intervention Name(s)
ultraviolet radiatio
Intervention Description
ultraviolet radiation (3 sessions per week)
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
for 3 months
Primary Outcome Measure Information:
Title
LH/FSH ratio
Description
LH/FSH ratio measured in venous sample on day 3 of the menstrual cycle
Time Frame
1 month after treatment
Secondary Outcome Measure Information:
Title
Serum 25-hydroxyvitamin D
Description
25-hydroxyvitamin D measured in venous sample
Time Frame
1 month after treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Obese nulli gravid PCOS women
BMI 30-40 kg/m2
Exclusion Criteria:
hyperprolactinemia
BMI > 40 kg/m2 Endocrinological disorders such as thyroid disease, Cushing's syndrome, Coagulopathy
Recent use of oral contraceptive pills
Recent use of any photosensitizing medications, such as aspirin, tetracycline, chlorothiazide, or psoralen suspicious of neoplasms
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Maged
Phone
+201005227404
Email
Ahmedmaged@cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Wafaa Kamal
Phone
01006914119
Email
wafaa_kamal37@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Maged
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EFFECTS OF LASER PUNCTURE VERSUS ULTRAVIOLET ON POLYCYSTIC OVARIAN WOMEN
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