<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/NCT01735331</url>
  </required_header>
  <id_info>
    <org_study_id>BEHGynObs-3</org_study_id>
    <nct_id>NCT01735331</nct_id>
  </id_info>
  <brief_title>Vascular Endothelial Growth Factor Levels at Hysteroscopic Biopsies Which Taken From Recurrent Pregnancy Loss</brief_title>
  <official_title>Vascular Endothelial Growth Factor Levels at Hysteroscopic Biopsies Which Taken From Recurrent Pregnancy Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bagcilar Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bagcilar Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is determine vascular endothelial growth factor levels and&#xD;
      angiogenesis/vascularity from hysteroscopic endometrial biopsies which taken from patients&#xD;
      who has Recurrent Pregnancy Loss.The endometrial vascular endothelial growth factor levels&#xD;
      will be measured by immunohistochemical staining methods due to office hysteroscopic&#xD;
      endometrial biopsy after the menstruation at follicular phase of menstrual cycle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective,observational,single-center study.Ethical approval was obtained&#xD;
      from the Institutional Review Board.This study will be completed 30 patients with Habitual&#xD;
      Abortus.&#xD;
&#xD;
      Endometrial vascular endothelial growth factor levels will be measured using Flk-1 / Kinase&#xD;
      Domain Receptor / Vascular endothelial growth factor receptor-2, Ab-1 (Rabbit PAb), Vascular&#xD;
      Endothelial Growth Factor (VEGF) Ab-7 (VG1), Cluster of Differentiation 34 (Endothelial Cell&#xD;
      Marker) Ab-1 (QBEnd/10), Vascular endothelial growth factor receptor-1 (N-term) (FLT1)&#xD;
      antibody kits. All assays will be performed according to the manufacturer's instructions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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 primary outcome measure of this study is to determine endometrial vascular endothelial growth factor levels in patient with Recurrent Pregnancy Loss</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Recurrent Pregnancy Loss Without Current Pregnancy</condition>
  <arm_group>
    <arm_group_label>VEGF level</arm_group_label>
    <description>VEGF level in hysteroscopic endometrial biopsy of the patients with recurrent pregnancy loss.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>Patients with Abnormal Uterine Bleeding</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The patients with Recurrent Pregnancy Loss&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Recurrent Pregnancy Loss who accept to join the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients whose age of &lt;18 and &gt;45&#xD;
&#xD;
          -  Patients with have any pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>TANER A. USTA, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bagcilar Training and Research Hospital,Istanbul,Turkey.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bagcilar Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>November 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>August 6, 2015</last_update_submitted>
  <last_update_submitted_qc>August 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vascular endothelial growth factor, Recurrent Pregnancy Loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Spontaneous</mesh_term>
    <mesh_term>Fetal Death</mesh_term>
    <mesh_term>Abortion, Habitual</mesh_term>
    <mesh_term>Recurrence</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/NCT01735331
org study id: BEHGynObs-3
nct id: NCT01735331
lead sponsor: 
has dmc: No
The aim of this study is determine vascular endothelial growth factor levels and
      angiogenesis/vascularity from hysteroscopic endometrial biopsies which taken from patients
      who has Recurrent Pregnancy Loss.The endometrial vascular endothelial growth factor levels
      will be measured by immunohistochemical staining methods due to office hysteroscopic
      endometrial biopsy after the menstruation at follicular phase of menstrual cycle.
This study is a prospective,observational,single-center study.Ethical approval was obtained
      from the Institutional Review Board.This study will be completed 30 patients with Habitual
      Abortus.

      Endometrial vascular endothelial growth factor levels will be measured using Flk-1 / Kinase
      Domain Receptor / Vascular endothelial growth factor receptor-2, Ab-1 (Rabbit PAb), Vascular
      Endothelial Growth Factor (VEGF) Ab-7 (VG1), Cluster of Differentiation 34 (Endothelial Cell
      Marker) Ab-1 (QBEnd/10), Vascular endothelial growth factor receptor-1 (N-term) (FLT1)
      antibody kits. All assays will be performed according to the manufacturer's instructions.
observational model: Case-Control
time perspective: Prospective
measure: The primary outcome measure of this study is to determine endometrial vascular endothelial growth factor levels in patient with Recurrent Pregnancy Loss
time frame: 3 months
arm group label: VEGF level
description: VEGF level in hysteroscopic endometrial biopsy of the patients with recurrent pregnancy loss.
arm group label: control group
description: Patients with Abnormal Uterine Bleeding
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: TANER A. USTA, M.D.
role: Principal Investigator
affiliation: Bagcilar Training and Research Hospital,Istanbul,Turkey.
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Abortion, Spontaneous
mesh term: Fetal Death
mesh term: Abortion, Habitual
mesh term: Recurrence