<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/NCT03819998</url>
  </required_header>
  <id_info>
    <org_study_id>Fetuin</org_study_id>
    <nct_id>NCT03819998</nct_id>
  </id_info>
  <brief_title>Serum Fetuin Level in Polycystic Ovary Syndrome</brief_title>
  <official_title>Serum Fetuin Level as a Marker in Polycystic Ovary Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aljazeera Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Research Centre, Egypt</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aljazeera Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      polycystic ovary syndrome is a common gynecological problem&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Understanding the pathophysiology and the cause is of much importance for proper management&#xD;
      of this problem&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Anticipated">February 5, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The number of women who will have high level of fetuin A and has PCOS</measure>
    <time_frame>within a week</time_frame>
    <description>Evaluation of women who have PCOS in relation to fetuin A level</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Polycystic Ovary</condition>
  <arm_group>
    <arm_group_label>PCOS group</arm_group_label>
    <description>women who have PCOS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>women who donnot have PCOS</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>measurement of Fetuin-A level in serum</intervention_name>
    <description>Fetuin A level will be measured in blood of the PCOS women</description>
    <arm_group_label>PCOS group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <other_name>Fwtuin A level</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        women who have PCOS and have symptoms of hyperandrogenism and irregular cycles&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women who have PCOS in group 1 and who donnot have PCOS in group 2 with age between 20&#xD;
             -42 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women above 42 years old&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women with polycystic ovary syndrome</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mahmoud Alalfy, PhD</last_name>
    <phone>01002611058</phone>
    <email>mahmoudalalfy@ymail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Algazeerah and Kasralainy hospital</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mahmoud Alalfy, master</last_name>
      <phone>+201002611058</phone>
      <email>mahmoudalalfy@ymail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ahmed Elgazzar, M.D</last_name>
      <phone>+201014005959</phone>
    </contact_backup>
    <investigator>
      <last_name>Mahmoud Alalfy, master</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>August 4, 2019</last_update_submitted>
  <last_update_submitted_qc>August 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03819998
org study id: Fetuin
nct id: NCT03819998
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
polycystic ovary syndrome is a common gynecological problem
Understanding the pathophysiology and the cause is of much importance for proper management
      of this problem
observational model: Case-Control
time perspective: Prospective
measure: The number of women who will have high level of fetuin A and has PCOS
time frame: within a week
description: Evaluation of women who have PCOS in relation to fetuin A level
arm group label: PCOS group
description: women who have PCOS
arm group label: control group
description: women who donnot have PCOS
intervention type: Diagnostic Test
intervention name: measurement of Fetuin-A level in serum
description: Fetuin A level will be measured in blood of the PCOS women
arm group label: PCOS group
arm group label: control group
other name: Fwtuin A level
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Women with polycystic ovary syndrome
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahmoud Alalfy, PhD
phone: 01002611058
email: mahmoudalalfy@ymail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Egypt
responsible party type: Sponsor
mesh term: Polycystic Ovary Syndrome