Effect of Laser Puncture Versus Ultraviolet Radiation on Women With Polycystic Ovarian Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- LH/FSH ratio
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
laser puncture group
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
Intervention: aser puncture (Device)
laser puncture group
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
Intervention: Metformin (Drug)
Ultraviolet treatment group
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
Intervention: ultraviolet radiatio (Device)
Ultraviolet treatment group
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
Intervention: Metformin (Drug)
Metformin only group
Intervention: Metformin (Drug)
Outcomes
Primary Outcomes
LH/FSH ratio
Time Frame: 1 month after treatment
LH/FSH ratio measured in venous sample on day 3 of the menstrual cycle
Secondary Outcomes
- Serum 25-hydroxyvitamin D concentration(1 month after treatment)
Investigators
Ahmed M Maged, MD
professor
Cairo University