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

NCT05986838 | Recruiting

• 1 other identifier: 69
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• LH/FSH ratio

  LH/FSH ratio measured in venous sample on day 3 of the menstrual cycle

  1 month after treatment

Secondary Outcomes (1)

• Serum 25-hydroxyvitamin D concentration

  1 month after treatment

Study Arms (3)

laser puncture group

ACTIVE COMPARATOR

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

Device: aser puncture; Drug: Metformin

Ultraviolet treatment group

ACTIVE COMPARATOR

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

Device: ultraviolet radiatio; Drug: Metformin

Metformin only group

ACTIVE COMPARATOR

Drug: Metformin

Interventions

aser puncture DEVICE

laser puncture (3 sessions per week)

laser puncture group

ultraviolet radiatio DEVICE

ultraviolet radiation (3 sessions per week)

Ultraviolet treatment group

Metformin DRUG

for 3 months

Metformin only group; Ultraviolet treatment group; laser puncture group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Obese nulli gravid PCOS women
• BMI 30-40 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Ahmed M Maged

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Maged

CONTACT

+201005227404; Ahmedmaged@cu.edu.eg

Wafaa Kamal

CONTACT

01006914119; wafaa_kamal37@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: August 30, 2023
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)