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

Cairo University (CU)

Status: Enrolling

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin; Device: ultraviolet radiatio; Device: aser puncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05986838

69

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups

laser puncture group

Active Comparator group

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

Treatment:

Device: aser puncture

Drug: Metformin

Ultraviolet treatment group

Active Comparator group

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

Treatment:

Drug: Metformin

Device: ultraviolet radiatio

Metformin only group

Active Comparator group

Treatment:

Drug: Metformin