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/NCT05966571</url>
    </required_header>
    <id_info>
      <org_study_id>1576/prot 1</org_study_id>
      <nct_id>NCT05966571</nct_id>
    </id_info>
    <brief_title>Ovarian Innervation Study in Patients With Polycystic Ovary Syndrome (PCOS)</brief_title>
    <official_title>Ovarian Innervation Study in Patients With Polycystic Ovary Syndrome (PCOS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Albanian University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Albanian 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>
        Polycystic Ovary Syndrome (PCOS) is a complex endocrine disorder characterized by&#xD;
        hyperandrogenism, insulin resistance, and ovulatory dysfunction. One of the diagnostic&#xD;
        criteria for PCOS is the presence of polycystic ovaries, which are enlarged ovaries with&#xD;
        multiple follicles on ultrasound. However, the mechanisms that lead to the development of&#xD;
        polycystic ovaries in PCOS are not completely understood. One potential area of investigation&#xD;
        is the role of ovarian innervation in the pathophysiology of PCOS. Therefore, the aim of this&#xD;
        study is to evaluate the ovarian innervation in PCOS patients through ovarian biopsy&#xD;
        sampling.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a cross-sectional study that will involve the recruitment of patients diagnosed with&#xD;
        PCOS. The study will be conducted at a tertiary care center Koco Gliozheni Maternity, Faculty&#xD;
        of Medicine of Tirana, Department of Obstetrics and Gynecology with expertise in gynecology&#xD;
        and endocrinology and will then be examined with the aid of the department of Biology and&#xD;
        Physiology of the University of Perugia. The study protocol will be approved by the&#xD;
        institutional ethics committee, and written informed consent will be obtained from all&#xD;
        participants.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Quantify nerve fibers</measure>
      <time_frame>day 0</time_frame>
      <description>identify and quantify the nerve fibers in the ovarian stroma and follicles</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Identifying nerual markers</measure>
      <time_frame>day 0</time_frame>
      <description>Identification of neural markers such as Protein Gene Product 9.5 (PGP 9.5), by useing antibodies (es. neurotransmitters such as tyrosine hydroxylase (TH), vasoactive intestinal peptide (VIP), and neuropeptide Y).</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Polycystic Ovary Syndrome</condition>
    <arm_group>
      <arm_group_label>PCOS women</arm_group_label>
      <description>Ovarian biopsy will be performed on PCOS women meeting the inclusion criteria undergoing surgery for other reasons . A sample of the ovarian tissue will be of a few millimeters in size and taken on only one of the ovaries.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Ovary Biopsie</intervention_name>
      <description>Ovarian biopsy will be performed on patients meeting the inclusion criteria undergoing surgery for other reasons. Ovarian biopsy will be of a few millimeters in size and taken on only one of the ovaries.</description>
      <arm_group_label>PCOS women</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          PCOS Patients who meet the inclusion criteria will undergo a detailed medical history,&#xD;
          physical examination, and laboratory investigations including hormonal evaluation as&#xD;
          necessary (testosterone, sex hormone-binding globulin, luteinizing hormone,&#xD;
          follicle-stimulating hormone, prolactin, thyroid-stimulating hormone, and cortisol).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Diagnosis of PCOS based on the Rotterdam criteria,&#xD;
  &#xD;
            -  No use of hormonal contraception or medications for at least 3 months prior to the&#xD;
               study,&#xD;
  &#xD;
            -  No history of ovarian cancer.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of pelvic inflammatory disease or other pelvic infections,&#xD;
  &#xD;
            -  Use of medications that may affect ovarian function or innervation, such as&#xD;
               antipsychotics or antidepressants&#xD;
  &#xD;
            -  Presence of ovarian cysts &gt; 5 cm on ultrasound&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Elko Gliozheni, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elko Gliozheni, Dr</last_name>
      <phone>+355692057185</phone>
      <email>Elkogliozheni@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Bernard Fioretti, Prof</last_name>
      <phone>+393282924573</phone>
      <email>bernard.fioretti@unipg.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of medicine of Tirana</name>
        <address>
          <city>Tirana</city>
          <zip>1000</zip>
          <country>Albania</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elko Gliozheni, Dr</last_name>
        <phone>+355692057185</phone>
        <email>Elkogliozheni@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Orion Gliozheni, Prof</last_name>
        <phone>+355692029313</phone>
        <email>gliozheniorion@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Albania</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Albanian University</investigator_affiliation>
      <investigator_full_name>Elko Gliozheni</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Polycystic Ovary Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <!-- 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/NCT05966571
  org study id: 1576/prot 1
  nct id: NCT05966571
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Polycystic Ovary Syndrome (PCOS) is a complex endocrine disorder characterized by
        hyperandrogenism, insulin resistance, and ovulatory dysfunction. One of the diagnostic
        criteria for PCOS is the presence of polycystic ovaries, which are enlarged ovaries with
        multiple follicles on ultrasound. However, the mechanisms that lead to the development of
        polycystic ovaries in PCOS are not completely understood. One potential area of investigation
        is the role of ovarian innervation in the pathophysiology of PCOS. Therefore, the aim of this
        study is to evaluate the ovarian innervation in PCOS patients through ovarian biopsy
        sampling.
  This is a cross-sectional study that will involve the recruitment of patients diagnosed with
        PCOS. The study will be conducted at a tertiary care center Koco Gliozheni Maternity, Faculty
        of Medicine of Tirana, Department of Obstetrics and Gynecology with expertise in gynecology
        and endocrinology and will then be examined with the aid of the department of Biology and
        Physiology of the University of Perugia. The study protocol will be approved by the
        institutional ethics committee, and written informed consent will be obtained from all
        participants.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Quantify nerve fibers
  time frame: day 0
  description: identify and quantify the nerve fibers in the ovarian stroma and follicles
  measure: Identifying nerual markers
  time frame: day 0
  description: Identification of neural markers such as Protein Gene Product 9.5 (PGP 9.5), by useing antibodies (es. neurotransmitters such as tyrosine hydroxylase (TH), vasoactive intestinal peptide (VIP), and neuropeptide Y).
  arm group label: PCOS women
  description: Ovarian biopsy will be performed on PCOS women meeting the inclusion criteria undergoing surgery for other reasons . A sample of the ovarian tissue will be of a few millimeters in size and taken on only one of the ovaries.
  intervention type: Procedure
  intervention name: Ovary Biopsie
  description: Ovarian biopsy will be performed on patients meeting the inclusion criteria undergoing surgery for other reasons. Ovarian biopsy will be of a few millimeters in size and taken on only one of the ovaries.
  arm group label: PCOS women
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: No
  last name: Elko Gliozheni, Dr
  role: Principal Investigator
  affiliation: University of Medicine
  last name: Elko Gliozheni, Dr
  phone: +355692057185
  email: Elkogliozheni@gmail.com
  last name: Bernard Fioretti, Prof
  phone: +393282924573
  email: bernard.fioretti@unipg.it
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Albania
  responsible party type: Principal Investigator
  investigator affiliation: Albanian University
  investigator full name: Elko Gliozheni
  investigator title: Principal Investigator
  mesh term: Polycystic Ovary Syndrome
  mesh term: Syndrome