<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/NCT03289403</url>
  </required_header>
  <id_info>
    <org_study_id>ICSI/ Autoimmune thyroiditis</org_study_id>
    <nct_id>NCT03289403</nct_id>
  </id_info>
  <brief_title>The Role of Immunomodulatory Treatment in Success of ICSI in Patients With Autoimmune Thyroiditis</brief_title>
  <official_title>The Role of Immunomodulatory Treatment in Success of ICSI in Patients Who Have Infertility With Autoimmune Thyroiditis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aljazeera Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aljazeera Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the work is to determine whether the use of immunomodulatory drugs could improve&#xD;
      the reproductive of outcome of infertile patients who have autoimmune thyroiditis with&#xD;
      positive autoimmune antibodies undergoing IVF-ET.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2018</start_date>
  <completion_date type="Actual">October 20, 2019</completion_date>
  <primary_completion_date type="Actual">September 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Number of Participants Who Achieved clinical Pregnancy</measure>
    <time_frame>6 weeks after embryo transfer</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants Who Achieved Ongoing Pregnancy</measure>
    <time_frame>18 weeks after embryo transfer</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Infertility</condition>
  <condition>Autoimmune Thyroiditis</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D and immunomodulatory drugs(prednisolone, hydroxychloroquine, azathioprin, IV immunoglobulins)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Immunomodulatory</intervention_name>
    <description>Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle.&#xD;
Moreover, patients will receive a treatment course of immunomodulatory drugs for 3 -6 months before ICSI cycle:&#xD;
Prednisnlone 40mg for 2 weeks to be lowered gradually till become 5mg after 6 weeks and to be continued&#xD;
Hydroxychloroquine according to body weight, patients who develop hypersensitivity will be shifted to Azathioprin.&#xD;
Immunoglobulins will be used in cases not responding to treatment.</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thyroxine</intervention_name>
    <description>Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle.&#xD;
Patients will not receive immunomodulatory drugs</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infertility patients who have autoimmune thyroiditis With positive autoimmune&#xD;
             thyroiditis and TSH level above 2 IU.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients who have other autoimmune diseases especially antiphospholipid syndrome,&#xD;
             hepatitis c viral disease.&#xD;
&#xD;
        Patients who have any medical disorders ( eg. D.M. HTN .Epilepsy ….)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed M Sayed, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Aljazeera (Al Gazeera) hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aljazeera (Al Gazeera) hospital</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Thyroiditis</mesh_term>
    <mesh_term>Thyroiditis, Autoimmune</mesh_term>
    <mesh_term>Hashimoto Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03289403
org study id: ICSI/ Autoimmune thyroiditis
nct id: NCT03289403
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of the work is to determine whether the use of immunomodulatory drugs could improve
      the reproductive of outcome of infertile patients who have autoimmune thyroiditis with
      positive autoimmune antibodies undergoing IVF-ET.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Number of Participants Who Achieved clinical Pregnancy
time frame: 6 weeks after embryo transfer
measure: The Number of Participants Who Achieved Ongoing Pregnancy
time frame: 18 weeks after embryo transfer
arm group label: Study group
arm group type: Experimental
description: Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D and immunomodulatory drugs(prednisolone, hydroxychloroquine, azathioprin, IV immunoglobulins)
arm group label: Control group
arm group type: Active Comparator
description: Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D.
intervention type: Drug
intervention name: Immunomodulatory
description: Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle.
Moreover, patients will receive a treatment course of immunomodulatory drugs for 3 -6 months before ICSI cycle:
Prednisnlone 40mg for 2 weeks to be lowered gradually till become 5mg after 6 weeks and to be continued
Hydroxychloroquine according to body weight, patients who develop hypersensitivity will be shifted to Azathioprin.
Immunoglobulins will be used in cases not responding to treatment.
arm group label: Study group
intervention type: Drug
intervention name: Thyroxine
description: Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle.
Patients will not receive immunomodulatory drugs
arm group label: Control group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Ahmed M Sayed, Prof.
role: Study Chair
affiliation: Aljazeera (Al Gazeera) hospital
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Infertility
mesh term: Thyroiditis
mesh term: Thyroiditis, Autoimmune
mesh term: Hashimoto Disease
sharing ipd: No