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Trial Title:
Effect of Laser Puncture Versus Ultraviolet Radiation on Women With Polycystic Ovarian Syndrome
NCT ID:
NCT05986838
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Metformin
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
aser puncture
Description:
laser puncture (3 sessions per week)
Arm group label:
laser puncture group
Intervention type:
Device
Intervention name:
ultraviolet radiatio
Description:
ultraviolet radiation (3 sessions per week)
Arm group label:
Ultraviolet treatment group
Intervention type:
Drug
Intervention name:
Metformin
Description:
for 3 months
Arm group label:
Metformin only group
Arm group label:
Ultraviolet treatment group
Arm group label:
laser puncture group
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
Detailed 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
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Minimum age:
20 Years
Maximum age:
35 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Kasr Alainy medical school
Address:
City:
Cairo
Zip:
12111
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Ahmed Maged, MD
Phone:
01005227404
Email:
prof.ahmedmaged@gmail.com
Start date:
August 30, 2023
Completion date:
April 2024
Lead sponsor:
Agency:
Cairo University
Agency class:
Other
Source:
Cairo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05986838
