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

NCT ID: NCT05986838

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2024-04-30

Brief Summary

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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

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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

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

aser puncture

Intervention Type DEVICE

laser puncture (3 sessions per week)

Metformin

Intervention Type DRUG

for 3 months

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

Group Type ACTIVE_COMPARATOR

ultraviolet radiatio

Intervention Type DEVICE

ultraviolet radiation (3 sessions per week)

Metformin

Intervention Type DRUG

for 3 months

Metformin only group

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

for 3 months

Interventions

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aser puncture

laser puncture (3 sessions per week)

Intervention Type DEVICE

ultraviolet radiatio

ultraviolet radiation (3 sessions per week)

Intervention Type DEVICE

Metformin

for 3 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed M Maged, MD

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed M Maged

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed M Maged

Role: CONTACT

+201005227404

Wafaa Kamal

Role: CONTACT

01006914119

Facility Contacts

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Ahmed Maged, MD

Role: primary

01005227404

Other Identifiers

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69

Identifier Type: -

Identifier Source: org_study_id

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