EFFECTS OF LASER PUNCTURE VERSUS ULTRAVIOLET ON POLYCYSTIC OVARIAN WOMEN

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05986838

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Device: aser puncture Device: ultraviolet radiatio Drug: Metformin	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

EFFECTS OF LASER PUNCTURE VERSUS ULTRAVIOLET ON POLYCYSTIC OVARIAN WOMEN

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Device: aser puncture laser puncture (3 sessions per week) Drug: Metformin for 3 months
Active Comparator: 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	Device: ultraviolet radiatio ultraviolet radiation (3 sessions per week) Drug: Metformin for 3 months
Active Comparator: Metformin only group	Drug: Metformin for 3 months

Arm

Intervention/Treatment

Active Comparator: 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

Device: aser puncture

laser puncture (3 sessions per week)

Drug: Metformin

for 3 months

Active Comparator: 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

Device: ultraviolet radiatio

ultraviolet radiation (3 sessions per week)

Drug: Metformin

for 3 months

Active Comparator: Metformin only group

Drug: Metformin

for 3 months

Outcome Measures

Primary Outcome Measures

LH/FSH ratio [1 month after treatment]
LH/FSH ratio measured in venous sample on day 3 of the menstrual cycle

Secondary Outcome Measures

Serum 25-hydroxyvitamin D [1 month after treatment]
25-hydroxyvitamin D measured in venous sample

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Alainy medical school	Cairo		Egypt	12111

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Ahmed M Maged, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed M Maged, MD, professor, Cairo University

ClinicalTrials.gov Identifier:

NCT05986838

Other Study ID Numbers:

First Posted:

Aug 14, 2023

Last Update Posted:

Aug 14, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Metformin

Study Results

No Results Posted as of Aug 14, 2023