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RecruitingNCT05986838Updated Feb 9, 2024

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

An interventional study of aser puncture and ultraviolet radiatio in Polycystic Ovary Syndrome, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-02-09.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2024, 2 years 8 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study 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

Read the 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

02

Conditions studied

  • Polycystic Ovary Syndrome
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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 · Drug: Metformin

  • 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 · Drug: Metformin

  • Active comparator
    Metformin only group

    Drug: Metformin

Interventions

  • Deviceaser puncture

    laser puncture (3 sessions per week)

  • Deviceultraviolet radiatio

    ultraviolet radiation (3 sessions per week)

  • DrugMetformin

    for 3 months

06

What researchers measure

Primary outcomes

  1. LH/FSH ratio

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

    Time frame: 1 month after treatment

Secondary outcomes

  1. Serum 25-hydroxyvitamin D concentration

    25-hydroxyvitamin D measured in venous sample

    Time frame: 1 month after treatment

07

Study locations

1 of 1 sites recruiting
  • Kasr Alainy medical school
    Cairo, 12111, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05986838
Lead sponsor
Cairo University
Responsible party
Ahmed M Maged, MD (professor, Cairo University) — Principal investigator
First posted
Aug 14, 2023
Start date
Aug 30, 2023
Primary completion
Feb 2024 (estimated)
Completion
Apr 2024 (estimated)
Last update
Feb 9, 2024

Study contacts

Ahmed M Maged
Contact
Ahmedmaged@cu.edu.eg
+201005227404
Wafaa Kamal
Contact
wafaa_kamal37@yahoo.com
01006914119
Ahmed M Maged
principal investigator · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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