<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/NCT01688284</url>
  </required_header>
  <id_info>
    <org_study_id>UNKTRPL</org_study_id>
    <nct_id>NCT01688284</nct_id>
  </id_info>
  <brief_title>The Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage</brief_title>
  <official_title>The Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Woman's Health University Hospital, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Woman's Health University Hospital, Egypt</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>
      The aim of the study is to evaluate the role of uterine natural killer cell(uNK)in recurrent&#xD;
      pregnancy losses and the correlation between the numbers of it and embryo toxicity by&#xD;
      measuring the level of the Th2 cytokines in normal reproductive profile and in patients with&#xD;
      Recurrent Pregnancy Losses (RPL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Office hysteroscopy examination of the patients at the luteal phase of the natural cycle&#xD;
      (day17 to day 20),with endometrial biopsy using pipple curette from the region of the fundus,&#xD;
      the biopsy sent to flow cytometry laboratory in South Egypt Cancer Institute to be examined&#xD;
      for:&#xD;
&#xD;
      1.1. Phenotypic analysis of uterine natural killer cells:&#xD;
&#xD;
      1.2. Induction and detection of intracellular cytokines by flow Cytometry:&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>March 2010</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the role of uterine natural killer cell(uNK)in recurrent pregnancy losses and the correlation between the numbers of it and embryo toxicity by measuring the level of the Th2 cytokines in normal reproductive profile and in patients with RPL.</measure>
    <time_frame>two years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>to set in the horizon the role of immunomodulators as a treatment for RPL and implantation failure</measure>
    <time_frame>two years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Recurrent Pregnancy Losses</condition>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients with recurrent miscarriages</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OFFICE HYSTEROSCOPY</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Office hysteroscopic endometrial biopsy at the luteal phase of the menestrual cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>office hysteroscopy</intervention_name>
    <description>Endometrial wash and biopsy is taken at the day around implantation window (day 14_to day 22)of the menstrual cycle from patients of recurrent miscarriages to evaluate the levels of uterine natural killer cells compared to control of females of normal reproductive outcome</description>
    <arm_group_label>No treatment</arm_group_label>
    <arm_group_label>OFFICE HYSTEROSCOPY</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women with unexplained recurrent miscarriages (2 or more consecutive).&#xD;
&#xD;
          2. All patients have normal uterine cavity diagnosed by HSG and /or hysteroscopy, normal&#xD;
             semen analysis, normal thrombophilic profiles, no history of malformed&#xD;
&#xD;
          3. normal fetus in the previous miscarriages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age above forty years old .&#xD;
&#xD;
          2. Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG&#xD;
             or IgM]); other recognised thrombophilic conditions (testing according to usual clinic&#xD;
             practice).&#xD;
&#xD;
          3. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography,&#xD;
             hysterosalpingogram, or hysteroscopy).&#xD;
&#xD;
          4. Fibroids distorting uterine cavity .&#xD;
&#xD;
          5. Abnormal parental karyotype .&#xD;
&#xD;
          6. Other identifiable causes of recurrent miscarriages (tests initiated only if&#xD;
             clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus&#xD;
             (SLE).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alaa M Ismail, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>women health hospital,assiut university,egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Women Health Hospital</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>January 6, 2021</last_update_submitted>
  <last_update_submitted_qc>January 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Woman's Health University Hospital, Egypt</investigator_affiliation>
    <investigator_full_name>alaa eldeen mahmoud ismail</investigator_full_name>
    <investigator_title>Assistant professor ob/gyn,specialest of infertility and fetal medicine</investigator_title>
  </responsible_party>
  <keyword>uterine natural killer cells</keyword>
  <keyword>recurrent miscarriages</keyword>
  <keyword>alloimmunity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Spontaneous</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/NCT01688284
org study id: UNKTRPL
nct id: NCT01688284
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate the role of uterine natural killer cell(uNK)in recurrent
      pregnancy losses and the correlation between the numbers of it and embryo toxicity by
      measuring the level of the Th2 cytokines in normal reproductive profile and in patients with
      Recurrent Pregnancy Losses (RPL).
Office hysteroscopy examination of the patients at the luteal phase of the natural cycle
      (day17 to day 20),with endometrial biopsy using pipple curette from the region of the fundus,
      the biopsy sent to flow cytometry laboratory in South Egypt Cancer Institute to be examined
      for:

      1.1. Phenotypic analysis of uterine natural killer cells:

      1.2. Induction and detection of intracellular cytokines by flow Cytometry:
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: the role of uterine natural killer cell(uNK)in recurrent pregnancy losses and the correlation between the numbers of it and embryo toxicity by measuring the level of the Th2 cytokines in normal reproductive profile and in patients with RPL.
time frame: two years
measure: to set in the horizon the role of immunomodulators as a treatment for RPL and implantation failure
time frame: two years
arm group label: No treatment
arm group type: Active Comparator
description: patients with recurrent miscarriages
arm group label: OFFICE HYSTEROSCOPY
arm group type: Active Comparator
description: Office hysteroscopic endometrial biopsy at the luteal phase of the menestrual cycle
intervention type: Device
intervention name: office hysteroscopy
description: Endometrial wash and biopsy is taken at the day around implantation window (day 14_to day 22)of the menstrual cycle from patients of recurrent miscarriages to evaluate the levels of uterine natural killer cells compared to control of females of normal reproductive outcome
arm group label: No treatment
arm group label: OFFICE HYSTEROSCOPY
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alaa M Ismail, MD
role: Principal Investigator
affiliation: women health hospital,assiut university,egypt
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Woman's Health University Hospital, Egypt
investigator full name: alaa eldeen mahmoud ismail
investigator title: Assistant professor ob/gyn,specialest of infertility and fetal medicine
mesh term: Abortion, Spontaneous
mesh term: Abortion, Habitual
mesh term: Recurrence