<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/NCT04455256</url>
  </required_header>
  <id_info>
    <org_study_id>tgk-xbp</org_study_id>
    <nct_id>NCT04455256</nct_id>
  </id_info>
  <brief_title>Evaluation of Endoplasmic Reticulum Stress in Patients With Recurrent Pregnancy Loss</brief_title>
  <official_title>Endoplasmic Reticulum Stress in Recurrent Pregnancy Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research Hospital</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>
      To evaluate endoplasmic reticulum stress in women with recurrent pregnancy loss and those who&#xD;
      had healthy births in the same age group. The level of the unfolded protein X box binding&#xD;
      protein 1 (XBP-1) is measured. It is aimed to show the effect of endoplasmic reticulum stress&#xD;
      on recurrent pregnancy loss.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2020</start_date>
  <completion_date type="Actual">July 7, 2020</completion_date>
  <primary_completion_date type="Actual">July 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>Show the effect of endoplasmic reticulum stress on recurrent pregnancy loss</measure>
    <time_frame>3 months</time_frame>
    <description>Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Recurrent Pregnancy Loss</condition>
  <condition>Endoplasmic Reticulum Stress</condition>
  <arm_group>
    <arm_group_label>recurrent pregnancy loss group</arm_group_label>
    <description>Women between the ages of 18 and 45 who had a history of miscarriage under 3 weeks and above 22 weeks were included in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>women who had healthy birth</arm_group_label>
    <description>Women between the ages of 18-45 who have not had a history of pregnancy loss and who have had at least one healthy birth and no known chronic diseases are included in this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>x box binding protein</intervention_name>
    <description>Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured.</description>
    <arm_group_label>recurrent pregnancy loss group</arm_group_label>
    <arm_group_label>women who had healthy birth</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Loss of 3 or more pregnancy between the ages of 18 and 45 and women who have given at least&#xD;
        1 healthy birth in the same age group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  with three or more miscarriages before 20 th week of gestation&#xD;
&#xD;
          -  had no chronic or acute inflammatory disease&#xD;
&#xD;
          -  used no steroids, anti-inflammatory, or antioxidant medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  had inflammatory diseases&#xD;
&#xD;
          -  had systemic disease&#xD;
&#xD;
          -  Anatomical abnormalities, infectious, endocrine, or genetic etiologies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pinar Yalcin Bahat</name>
      <address>
        <city>Istanbul</city>
        <state>İ̇stanbul</state>
        <zip>34000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Pınar Yalcin bahat</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>Abortion, Spontaneous</mesh_term>
    <mesh_term>Fetal Death</mesh_term>
    <mesh_term>Abortion, Habitual</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04455256
org study id: tgk-xbp
nct id: NCT04455256
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate endoplasmic reticulum stress in women with recurrent pregnancy loss and those who
      had healthy births in the same age group. The level of the unfolded protein X box binding
      protein 1 (XBP-1) is measured. It is aimed to show the effect of endoplasmic reticulum stress
      on recurrent pregnancy loss.
observational model: Case-Control
time perspective: Prospective
measure: Show the effect of endoplasmic reticulum stress on recurrent pregnancy loss
time frame: 3 months
description: Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured.
arm group label: recurrent pregnancy loss group
description: Women between the ages of 18 and 45 who had a history of miscarriage under 3 weeks and above 22 weeks were included in this group.
arm group label: women who had healthy birth
description: Women between the ages of 18-45 who have not had a history of pregnancy loss and who have had at least one healthy birth and no known chronic diseases are included in this group.
intervention type: Other
intervention name: x box binding protein
description: Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured.
arm group label: recurrent pregnancy loss group
arm group label: women who had healthy birth
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Pınar Yalcin bahat
investigator title: Principal Investigator
mesh term: Abortion, Spontaneous
mesh term: Fetal Death
mesh term: Abortion, Habitual
mesh term: Recurrence
sharing ipd: Yes