Effect of Laser Puncture Versus Ultraviolet Radiation on Women With Polycystic Ovarian Syndrome

Not Applicable

Recruiting

• Conditions: Polycystic Ovary Syndrome
• Interventions: Device: aser puncture; Device: ultraviolet radiatio; Drug: Metformin

• Registration Number: NCT05986838
• Lead Sponsor: Cairo University

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 Timeline

• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-14
• Study Start: 2023-08-30
• Status Verified: 2024-02
• Primary Completion: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-09
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laser puncture group	aser puncture	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
Ultraviolet treatment group	ultraviolet radiatio	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
Metformin only group	Metformin	-
Ultraviolet treatment group	Metformin	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
laser puncture group	Metformin	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

Primary Outcome Measures

Name	Time	Method
LH/FSH ratio	1 month after treatment	LH/FSH ratio measured in venous sample on day 3 of the menstrual cycle

Secondary Outcome Measures

Name	Time	Method
Serum 25-hydroxyvitamin D concentration	1 month after treatment	25-hydroxyvitamin D measured in venous sample

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt