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NCT05986838 Clinical Trial

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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05986838
Other study ID # 69
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 30, 2023
Est. completion date April 2024

Study information
Verified date February 2024
Source Cairo University
Contact Ahmed M Maged
Phone +201005227404
Email Ahmedmaged@cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date April 2024
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• aser puncture
laser puncture (3 sessions per week)
• ultraviolet radiatio
ultraviolet radiation (3 sessions per week)
Drug:
• Metformin
for 3 months

Locations
Country Name City State
Egypt Kasr Alainy medical school Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary LH/FSH ratio LH/FSH ratio measured in venous sample on day 3 of the menstrual cycle 1 month after treatment
Secondary Serum 25-hydroxyvitamin D concentration 25-hydroxyvitamin D measured in venous sample 1 month after treatment
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