<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/NCT04492098</url>
  </required_header>
  <id_info>
    <org_study_id>MAIT-RPL</org_study_id>
    <nct_id>NCT04492098</nct_id>
  </id_info>
  <brief_title>Mucosal-Associated Invariant T Cells in Cases of Miscarriage</brief_title>
  <official_title>Analysis of Mucosal-Associated Invariant T (MAIT) Cells in Cases of Spontaneous and Recurrent Miscarriage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Miscarriage is the most frequently encountered complication of pregnancy ranging from 10% to&#xD;
      30%. The etiology of recurrent spontaneous miscarriage (RSM) in 40%-50% of cases cannot be&#xD;
      identified. Immunological disturbances have been suggested to play an important role.&#xD;
&#xD;
      Previous studies have focused that women with miscarriage have elevated NK cell numbers and&#xD;
      activity both in the periphery and in the endometrium. Also, NK cells in women with RSM&#xD;
      displayed an imbalance of Killer cell Ig-like receptors (KIRs) in favor of activating KIR&#xD;
      leading to an unbalanced activation of dNK cytotoxicity and higher risk of miscarriage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2021</start_date>
  <completion_date type="Actual">December 1, 2022</completion_date>
  <primary_completion_date type="Actual">October 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The percentages of MAIT cells and MAIT cells expressing CD56 and CD16 in comparison with NK cells and NKT cells in both blood and decidua</measure>
    <time_frame>24 hours</time_frame>
    <description>All markers will be measured by flow cytometry</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Miscarriage</condition>
  <arm_group>
    <arm_group_label>study group</arm_group_label>
    <description>women with spontaneous miscarriage</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MAIT cells</intervention_name>
    <description>1- Decidual tissues will be washed in phosphate buffer saline (PBS), and then preserved in Rosewell Park Memorial Institute (RPMI) 1640 medium supplemented with 100 U/mL penicillin, 100 mg/mL streptomycin and 5% fetal bovine serum (GIBCO BRL, Thermo Fisher Scientific, USA) until transfer to the laboratory. At the flow cytometry laboratory, the tissue samples will be minced finely and enzymatically digested by adding 3 ml collagenase enzyme type Ia and 2 ml PBS for 40 minutes at 37°C in shaking water path at 100 r.p.m. Cell suspensions obtained will be filtered, then the pellet after centrifugation will be treated with red blood cells lysing solution and washed with PBS.</description>
    <arm_group_label>study group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All pregnant women presented with spontaneous miscarriage&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Regular marital life with the same partner.&#xD;
&#xD;
          -  Regularly menstruating before current pregnancy.&#xD;
&#xD;
          -  Spontaneous conception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with Polycystic ovarian syndrome or any endocrinal abnormalities like DM,&#xD;
             thyroid disorders.&#xD;
&#xD;
          -  History of abnormal uterine cavity proved by sonohysterography or hysteroscopy before&#xD;
             pregnancy.&#xD;
&#xD;
          -  Women with positive consanguinity.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ahmed Abbas</name>
      <address>
        <city>Assiut</city>
        <state>Cairo</state>
        <zip>002</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>January 30, 2023</last_update_submitted>
  <last_update_submitted_qc>January 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Mohamed Abbas</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>
  </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/NCT04492098
org study id: MAIT-RPL
nct id: NCT04492098
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Miscarriage is the most frequently encountered complication of pregnancy ranging from 10% to
      30%. The etiology of recurrent spontaneous miscarriage (RSM) in 40%-50% of cases cannot be
      identified. Immunological disturbances have been suggested to play an important role.

      Previous studies have focused that women with miscarriage have elevated NK cell numbers and
      activity both in the periphery and in the endometrium. Also, NK cells in women with RSM
      displayed an imbalance of Killer cell Ig-like receptors (KIRs) in favor of activating KIR
      leading to an unbalanced activation of dNK cytotoxicity and higher risk of miscarriage.
observational model: Other
time perspective: Cross-Sectional
measure: The percentages of MAIT cells and MAIT cells expressing CD56 and CD16 in comparison with NK cells and NKT cells in both blood and decidua
time frame: 24 hours
description: All markers will be measured by flow cytometry
arm group label: study group
description: women with spontaneous miscarriage
intervention type: Diagnostic Test
intervention name: MAIT cells
description: 1- Decidual tissues will be washed in phosphate buffer saline (PBS), and then preserved in Rosewell Park Memorial Institute (RPMI) 1640 medium supplemented with 100 U/mL penicillin, 100 mg/mL streptomycin and 5% fetal bovine serum (GIBCO BRL, Thermo Fisher Scientific, USA) until transfer to the laboratory. At the flow cytometry laboratory, the tissue samples will be minced finely and enzymatically digested by adding 3 ml collagenase enzyme type Ia and 2 ml PBS for 40 minutes at 37°C in shaking water path at 100 r.p.m. Cell suspensions obtained will be filtered, then the pellet after centrifugation will be treated with red blood cells lysing solution and washed with PBS.
arm group label: study group
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Mohamed Abbas
investigator title: principal investigator
mesh term: Abortion, Spontaneous