xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05986838</url>
    </required_header>
    <id_info>
      <org_study_id>69</org_study_id>
      <nct_id>NCT05986838</nct_id>
    </id_info>
    <brief_title>EFFECTS OF LASER PUNCTURE VERSUS ULTRAVIOLET ON POLYCYSTIC OVARIAN WOMEN</brief_title>
    <official_title>EFFECTS OF LASER PUNCTURE VERSUS ULTRAVIOLET ON POLYCYSTIC OVARIAN WOMEN</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Obese women with polycystic ovarian syndrome aged between 25 and 35 years old will be divided&#xD;
        into three groups. For three months, group (A) will receive laser puncture (3 sessions per&#xD;
        week), along with a metformin supplementation, group (B) will receive ultraviolet radiation&#xD;
        (3 sessions per week), along with a metformin supplementation, while group (C) will receive&#xD;
        only metformin supplementation. The follicular size will be measured using ultrasound, while,&#xD;
        female sex hormones, and serum 25-hydroxyvitamin D levels will bel evaluated using blood&#xD;
        analysis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Obese women with polycystic ovarian syndrome aged between 25 and 35 years old will be divided&#xD;
        into three groups. For three months, group (A) will receive laser puncture (3 sessions per&#xD;
        week), along with a metformin supplementation, group (B) will receive ultraviolet radiation&#xD;
        (3 sessions per week), along with a metformin supplementation, while group (C) will receive&#xD;
        only metformin supplementation. The follicular size will be measured using ultrasound, while,&#xD;
        female sex hormones, and serum 25-hydroxyvitamin D levels will bel evaluated using blood&#xD;
        analysis&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>LH/FSH ratio</measure>
      <time_frame>1 month after treatment</time_frame>
      <description>LH/FSH ratio measured in venous sample on day 3 of the menstrual cycle</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Serum 25-hydroxyvitamin D</measure>
      <time_frame>1 month after treatment</time_frame>
      <description>25-hydroxyvitamin D measured in venous sample</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Polycystic Ovary Syndrome</condition>
    <arm_group>
      <arm_group_label>laser puncture group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>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</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ultraviolet treatment group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>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</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Metformin only group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>aser puncture</intervention_name>
      <description>laser puncture (3 sessions per week)</description>
      <arm_group_label>laser puncture group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ultraviolet radiatio</intervention_name>
      <description>ultraviolet radiation (3 sessions per week)</description>
      <arm_group_label>Ultraviolet treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Metformin</intervention_name>
      <description>for 3 months</description>
      <arm_group_label>Metformin only group</arm_group_label>
      <arm_group_label>Ultraviolet treatment group</arm_group_label>
      <arm_group_label>laser puncture group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Obese nulli gravid PCOS women&#xD;
  &#xD;
            -  BMI 30-40 kg/m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  hyperprolactinemia&#xD;
  &#xD;
            -  BMI &gt; 40 kg/m2 Endocrinological disorders such as thyroid disease, Cushing's syndrome,&#xD;
               Coagulopathy&#xD;
  &#xD;
            -  Recent use of oral contraceptive pills&#xD;
  &#xD;
            -  Recent use of any photosensitizing medications, such as aspirin, tetracycline,&#xD;
               chlorothiazide, or psoralen suspicious of neoplasms&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahmed M Maged</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ahmed M Maged</last_name>
      <phone>+201005227404</phone>
      <email>Ahmedmaged@cu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Wafaa Kamal</last_name>
      <phone>01006914119</phone>
      <email>wafaa_kamal37@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kasr Alainy medical school</name>
        <address>
          <city>Cairo</city>
          <zip>12111</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Ahmed M Maged, MD</investigator_full_name>
      <investigator_title>professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Metformin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05986838
  org study id: 69
  nct id: NCT05986838
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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
  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
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: LH/FSH ratio
  time frame: 1 month after treatment
  description: LH/FSH ratio measured in venous sample on day 3 of the menstrual cycle
  measure: Serum 25-hydroxyvitamin D
  time frame: 1 month after treatment
  description: 25-hydroxyvitamin D measured in venous sample
  arm group label: laser puncture group
  arm group type: Active Comparator
  description: 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
  arm group label: Ultraviolet treatment group
  arm group type: Active Comparator
  description: 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
  arm group label: Metformin only group
  arm group type: Active Comparator
  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
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 20 Years
  maximum age: 35 Years
  healthy volunteers: No
  last name: Ahmed M Maged
  role: Principal Investigator
  affiliation: Cairo University
  last name: Ahmed M Maged
  phone: +201005227404
  email: Ahmedmaged@cu.edu.eg
  last name: Wafaa Kamal
  phone: 01006914119
  email: wafaa_kamal37@yahoo.com
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Ahmed M Maged, MD
  investigator title: professor
  mesh term: Polycystic Ovary Syndrome
  mesh term: Metformin
  sharing ipd: No