<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/NCT03792997</url>
  </required_header>
  <id_info>
    <org_study_id>Hawaa-6</org_study_id>
    <nct_id>NCT03792997</nct_id>
  </id_info>
  <brief_title>A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells</brief_title>
  <official_title>A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benha University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hawaa Fertility Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Benha 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>
      patients with previous failed ART cycles with high peripheral NK cells will be divided into 2&#xD;
      groups: one group of patients with previous failed ART cyles will undergo standard treatment&#xD;
      but the other group will have in addition lipid emulsion &amp;prednisolone &amp; LMWH&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      patients with previous failed ART cycles with high peripheral NK cells will be divided into 2&#xD;
      groups: one group of patients with previous failed ART cyles will undergo standard treatment&#xD;
      but the other group will have in addition lipid emulsion begin in the cycle before embryo&#xD;
      transfer &amp;prednisolone begin with the start of lipid emulsion &amp; LMWH begin with the day of ET&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 10, 2021</completion_date>
  <primary_completion_date type="Actual">December 15, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>chemical pregnancy rate</measure>
    <time_frame>14 days</time_frame>
    <description>quantitative serum test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical pregnancy rate</measure>
    <time_frame>6 weeks of pregnancy</time_frame>
    <description>gestational sac and fetal echo by ultrasound</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Unexplained Infertility</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>regular treatment with embryo transfer in the form of progesterone I.M. &amp; Supp. in addition to low dose aspirin &amp; folic acid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>regular treatment with embryo transfer in the form of progesterone I.M. &amp; Supp. in addition to low dose aspirin &amp; folic acid but the investigators add in this arm lipid emulsion &amp; prednisolone &amp; LMWH</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>combination therapy for high peripheral NK cells</intervention_name>
    <description>lipid emulsion &amp; prednisolone &amp; LMWH</description>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with high peripheral NK cells &gt; 10% unexplained infertility cases cases with&#xD;
             endometriosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uterine factors poor responders&lt; 3 MII oocytes severe male factor &amp; Azospermia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Infertile females undergoing ART cycles</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>37 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ahmed sa saad, MD, ph D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hawaa Fertility Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banha University- Hawaa Fertility center</name>
      <address>
        <city>Banha</city>
        <state>Qalyubiya</state>
        <zip>13512</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>December 13, 2021</last_update_submitted>
  <last_update_submitted_qc>December 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Benha University</investigator_affiliation>
    <investigator_full_name>Ahmed Saad</investigator_full_name>
    <investigator_title>Assistant professor of Ob. &amp; Gyn.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>study protocol, statistical analysis &amp; results</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>1 month after publication, for 6 months</ipd_time_frame>
    <ipd_access_criteria>for researchers doing metanalysis.by contacting us by email</ipd_access_criteria>
  </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/NCT03792997
org study id: Hawaa-6
nct id: NCT03792997
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
patients with previous failed ART cycles with high peripheral NK cells will be divided into 2
      groups: one group of patients with previous failed ART cyles will undergo standard treatment
      but the other group will have in addition lipid emulsion &prednisolone & LMWH
patients with previous failed ART cycles with high peripheral NK cells will be divided into 2
      groups: one group of patients with previous failed ART cyles will undergo standard treatment
      but the other group will have in addition lipid emulsion begin in the cycle before embryo
      transfer &prednisolone begin with the start of lipid emulsion & LMWH begin with the day of ET
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: chemical pregnancy rate
time frame: 14 days
description: quantitative serum test
measure: clinical pregnancy rate
time frame: 6 weeks of pregnancy
description: gestational sac and fetal echo by ultrasound
arm group label: control
arm group type: Active Comparator
description: regular treatment with embryo transfer in the form of progesterone I.M. & Supp. in addition to low dose aspirin & folic acid
arm group label: study
arm group type: Experimental
description: regular treatment with embryo transfer in the form of progesterone I.M. & Supp. in addition to low dose aspirin & folic acid but the investigators add in this arm lipid emulsion & prednisolone & LMWH
intervention type: Combination Product
intervention name: combination therapy for high peripheral NK cells
description: lipid emulsion & prednisolone & LMWH
arm group label: control
arm group label: study
criteria: 
gender: Female
gender based: Yes
gender description: Infertile females undergoing ART cycles
minimum age: 20 Years
maximum age: 37 Years
healthy volunteers: No
last name: ahmed sa saad, MD, ph D
role: Principal Investigator
affiliation: Hawaa Fertility Center
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Benha University
investigator full name: Ahmed Saad
investigator title: Assistant professor of Ob. & Gyn.
mesh term: Infertility
sharing ipd: Yes
ipd description: study protocol, statistical analysis & results
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: 1 month after publication, for 6 months
ipd access criteria: for researchers doing metanalysis.by contacting us by email