xml: <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/NCT06036576</url>
    </required_header>
    <id_info>
      <org_study_id>15 Al-KindyCM</org_study_id>
      <nct_id>NCT06036576</nct_id>
    </id_info>
    <brief_title>Thyroxine Therapy for Recurrent Pregnancy Loss in Hypothyroid Women</brief_title>
    <official_title>Thyroid-Stimulating Hormone Levels and Recurrent Pregnancy Loss: Influence of Thyroxine Supplementation on Pregnancy Outcomes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Kindy College of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Al-Elwyiah Maternity Teaching Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Al-Kindy College of Medicine</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to investigate the influence of thyroxine supplementation&#xD;
        on pregnancy outcomes in women with varying levels of Thyroid-Stimulating Hormone (TSH), who&#xD;
        have experienced recurrent pregnancy loss in the first trimester. The main questions it aims&#xD;
        to answer are:&#xD;
  &#xD;
          -  Does thyroxine treatment improve pregnancy outcomes in women with TSH levels between 2.5&#xD;
             mU/L and 4 mU/L?&#xD;
  &#xD;
          -  Is the effect of thyroxine treatment different in women with TSH levels higher than 4&#xD;
             mU/L?&#xD;
  &#xD;
        Participants will be grouped based on their TSH levels, into two groups - those with TSH&#xD;
        levels between 2.5 mU/L and 4 mU/L, and those with TSH levels higher than 4 mU/L. They will&#xD;
        then be given thyroxine treatment.&#xD;
  &#xD;
        Researchers will compare these two groups to see if the pregnancy outcomes differ based on&#xD;
        the different TSH levels and thyroxine treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective clinical trial that aims to investigate the impact of thyroxine&#xD;
        supplementation on the outcomes of pregnancies in women who have experienced recurrent&#xD;
        pregnancy loss in the first trimester. The study will specifically focus on the role of&#xD;
        Thyroid-Stimulating Hormone (TSH) levels in these outcomes.&#xD;
  &#xD;
        Participants in the study will include women who have suffered recurrent pregnancy loss in&#xD;
        the first trimester and exhibit varying levels of TSH. For the purpose of this research,&#xD;
        these participants will be categorized into two groups based on their TSH levels: the first&#xD;
        group will consist of women with TSH levels between 2.5 mU/L and 4 mU/L, and the second group&#xD;
        will include those with TSH levels higher than 4 mU/L.&#xD;
  &#xD;
        All participants will receive thyroxine treatment, with dosages and treatment plans as&#xD;
        determined by their respective healthcare providers. The main purpose of this trial is to&#xD;
        examine two key questions:&#xD;
  &#xD;
        Does thyroxine treatment lead to improved pregnancy outcomes in women with TSH levels between&#xD;
        2.5 mU/L and 4 mU/L? How does the effect of thyroxine treatment on pregnancy outcomes differ&#xD;
        in women with TSH levels higher than 4 mU/L? The primary outcomes of interest in this study&#xD;
        will be pregnancy success rates, defined as a viable pregnancy beyond the first trimester.&#xD;
        Secondary outcomes might include measurements such as gestational age at delivery, birth&#xD;
        weight, and any complications that may arise during pregnancy.&#xD;
  &#xD;
        This trial aims to provide valuable insights into the potential benefits of thyroxine&#xD;
        treatment for women with varying levels of TSH who have experienced recurrent pregnancy loss.&#xD;
        The results could contribute to the development of more effective treatment protocols and&#xD;
        ultimately improve pregnancy outcomes for these women.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2022</start_date>
    <completion_date type="Actual">July 20, 2023</completion_date>
    <primary_completion_date type="Actual">May 30, 2023</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pregnancy Success Rate</measure>
      <time_frame>Assessed at the end of the first trimester (approximately 12 weeks of gestation) for each participant.</time_frame>
      <description>The primary outcome measure will be the rate of successful pregnancies, defined as a viable pregnancy beyond the first trimester, among participants in each group. This outcome will be compared between the two groups to determine the impact of thyroxine treatment on successful pregnancies in women with varying levels of TSH.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Gestational Age at Delivery</measure>
      <time_frame>Assessed at the time of delivery for each participant.</time_frame>
      <description>The gestational age at delivery will be recorded and compared between the two groups. This metric provides information about whether thyroxine treatment affects the timing of delivery in this population.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Birth Weight</measure>
      <time_frame>Assessed at the time of delivery for each participant.</time_frame>
      <description>The birth weight of the baby will be measured and compared between the two groups. This can provide further information on the potential effects of thyroxine treatment on pregnancy outcomes.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">77</enrollment>
    <condition>Recurrent Early Pregnancy Loss</condition>
    <condition>Thyroid Diseases</condition>
    <arm_group>
      <arm_group_label>Thyroid Stimulating Hormone 2.5-4 mU/L</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This arm consists of participants who have experienced recurrent pregnancy loss in the first trimester and have TSH levels ranging between 2.5 mU/L and 4 mU/L. These participants will receive levothyroxine treatment of 1.6 micrograms per kg per day</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Thyroid Stimulating Hormone more than 4 mU/L</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This arm consists of participants who have experienced recurrent pregnancy loss in the first trimester and have TSH levels more than 4 mU/L. These participants will receive levothyroxine treatment of 1.6 micrograms per kg per day</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Levothyroxine Pill</intervention_name>
      <description>all participants will receive levothyroxine treatment of 1.6 micrograms per kg per day early in the morning on empty stomach.</description>
      <arm_group_label>Thyroid Stimulating Hormone 2.5-4 mU/L</arm_group_label>
      <arm_group_label>Thyroid Stimulating Hormone more than 4 mU/L</arm_group_label>
      <other_name>Euthyrox 50 Mcg Tablet, Merck</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women aged 18 to 40 years old.&#xD;
  &#xD;
            -  Diagnosis of recurrent pregnancy loss, defined as two or more pregnancy losses in the&#xD;
               first trimester.&#xD;
  &#xD;
            -  Confirmed thyroid function test results with TSH levels either between 2.5 and 4 or&#xD;
               higher than 4.&#xD;
  &#xD;
            -  Willing and able to give informed consent for participation in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women who are currently taking thyroid medication before the study starts.&#xD;
  &#xD;
            -  Presence of other causes of recurrent pregnancy loss such as antiphospholipid&#xD;
               syndrome, uterine abnormalities, genetic/chromosomal disorders, etc.&#xD;
  &#xD;
            -  Presence of other severe chronic diseases like heart disease, kidney disease,&#xD;
               uncontrolled diabetes, etc.&#xD;
  &#xD;
            -  Known allergy or intolerance to thyroxine.&#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>Sarah Al-Musawi, C.A.B.O.G</last_name>
      <role>Study Chair</role>
      <affiliation>Al-Kindy College of Medicine</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>AL-Elwiyah Maternity Teaching Hospital</name>
        <address>
          <city>Baghdad</city>
          <zip>10011</zip>
          <country>Iraq</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iraq</country>
    </location_countries>
    <verification_date>February 2022</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Miscarriage</keyword>
    <keyword>Hypothyroidism</keyword>
    <keyword>Thyroid Stimulating Hormone</keyword>
    <keyword>Thyroxin</keyword>
    <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>Thyroid Diseases</mesh_term>
      <mesh_term>Recurrence</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036576
  org study id: 15 Al-KindyCM
  nct id: NCT06036576
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to investigate the influence of thyroxine supplementation
        on pregnancy outcomes in women with varying levels of Thyroid-Stimulating Hormone (TSH), who
        have experienced recurrent pregnancy loss in the first trimester. The main questions it aims
        to answer are:
  
          -  Does thyroxine treatment improve pregnancy outcomes in women with TSH levels between 2.5
             mU/L and 4 mU/L?
  
          -  Is the effect of thyroxine treatment different in women with TSH levels higher than 4
             mU/L?
  
        Participants will be grouped based on their TSH levels, into two groups - those with TSH
        levels between 2.5 mU/L and 4 mU/L, and those with TSH levels higher than 4 mU/L. They will
        then be given thyroxine treatment.
  
        Researchers will compare these two groups to see if the pregnancy outcomes differ based on
        the different TSH levels and thyroxine treatment.
  This is a prospective clinical trial that aims to investigate the impact of thyroxine
        supplementation on the outcomes of pregnancies in women who have experienced recurrent
        pregnancy loss in the first trimester. The study will specifically focus on the role of
        Thyroid-Stimulating Hormone (TSH) levels in these outcomes.
  
        Participants in the study will include women who have suffered recurrent pregnancy loss in
        the first trimester and exhibit varying levels of TSH. For the purpose of this research,
        these participants will be categorized into two groups based on their TSH levels: the first
        group will consist of women with TSH levels between 2.5 mU/L and 4 mU/L, and the second group
        will include those with TSH levels higher than 4 mU/L.
  
        All participants will receive thyroxine treatment, with dosages and treatment plans as
        determined by their respective healthcare providers. The main purpose of this trial is to
        examine two key questions:
  
        Does thyroxine treatment lead to improved pregnancy outcomes in women with TSH levels between
        2.5 mU/L and 4 mU/L? How does the effect of thyroxine treatment on pregnancy outcomes differ
        in women with TSH levels higher than 4 mU/L? The primary outcomes of interest in this study
        will be pregnancy success rates, defined as a viable pregnancy beyond the first trimester.
        Secondary outcomes might include measurements such as gestational age at delivery, birth
        weight, and any complications that may arise during pregnancy.
  
        This trial aims to provide valuable insights into the potential benefits of thyroxine
        treatment for women with varying levels of TSH who have experienced recurrent pregnancy loss.
        The results could contribute to the development of more effective treatment protocols and
        ultimately improve pregnancy outcomes for these women.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pregnancy Success Rate
  time frame: Assessed at the end of the first trimester (approximately 12 weeks of gestation) for each participant.
  description: The primary outcome measure will be the rate of successful pregnancies, defined as a viable pregnancy beyond the first trimester, among participants in each group. This outcome will be compared between the two groups to determine the impact of thyroxine treatment on successful pregnancies in women with varying levels of TSH.
  measure: Gestational Age at Delivery
  time frame: Assessed at the time of delivery for each participant.
  description: The gestational age at delivery will be recorded and compared between the two groups. This metric provides information about whether thyroxine treatment affects the timing of delivery in this population.
  measure: Birth Weight
  time frame: Assessed at the time of delivery for each participant.
  description: The birth weight of the baby will be measured and compared between the two groups. This can provide further information on the potential effects of thyroxine treatment on pregnancy outcomes.
  arm group label: Thyroid Stimulating Hormone 2.5-4 mU/L
  arm group type: Active Comparator
  description: This arm consists of participants who have experienced recurrent pregnancy loss in the first trimester and have TSH levels ranging between 2.5 mU/L and 4 mU/L. These participants will receive levothyroxine treatment of 1.6 micrograms per kg per day
  arm group label: Thyroid Stimulating Hormone more than 4 mU/L
  arm group type: Active Comparator
  description: This arm consists of participants who have experienced recurrent pregnancy loss in the first trimester and have TSH levels more than 4 mU/L. These participants will receive levothyroxine treatment of 1.6 micrograms per kg per day
  intervention type: Drug
  intervention name: Levothyroxine Pill
  description: all participants will receive levothyroxine treatment of 1.6 micrograms per kg per day early in the morning on empty stomach.
  arm group label: Thyroid Stimulating Hormone 2.5-4 mU/L
  arm group label: Thyroid Stimulating Hormone more than 4 mU/L
  other name: Euthyrox 50 Mcg Tablet, Merck
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sarah Al-Musawi, C.A.B.O.G
  role: Study Chair
  affiliation: Al-Kindy College of Medicine
  facility: 
  country: Iraq
  responsible party type: Sponsor
  mesh term: Abortion, Spontaneous
  mesh term: Fetal Death
  mesh term: Abortion, Habitual
  mesh term: Thyroid Diseases
  mesh term: Recurrence
  sharing ipd: No