<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/NCT02998827</url>
  </required_header>
  <id_info>
    <org_study_id>E2016023</org_study_id>
    <nct_id>NCT02998827</nct_id>
  </id_info>
  <brief_title>Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sixth Affiliated Hospital, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sixth Affiliated Hospital, Sun Yat-sen University</source>
  <brief_summary>
    <textblock>
      The effectiveness of thalidomide in treating inflammatory bowel disease has been widely&#xD;
      recognized. Meanwhile, many serious adverse drug reactions were notified， but no reports on&#xD;
      ovarian reserve function.Therefore, this study was to investigate the influence of&#xD;
      thalidomide on function of ovarian reserve.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It will be divided two groups of patients according to the treatment itself . One group was&#xD;
      treated by thalidomide, the other was other treatment excluding. It will detect the function&#xD;
      of ovarian reserve before and after treatment in both two groups, to investigate the&#xD;
      influence of thalidomide on function of ovarian reserve.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>November 2016</start_date>
  <primary_completion_date type="Anticipated">November 2017</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>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>difference AMH between thalidomide group and other treatment group</measure>
    <time_frame>1 year</time_frame>
    <description>Anti-mullerian hormone（AMH）, as an important index to monitor the function of ovarian reserve, is majorly secreted by preantral follicles and antral follicles without fluctuation during menstrual cycle, not affected by hormone, and its change is earlier than sex hormone.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>difference AFC between thalidomide group and other treatment group</measure>
    <time_frame>1 year</time_frame>
    <description>The foundational follicles at 5- 10 mm of both ovaries were determined and the sum of antral follicles of both sides of ovaries was as antral follicles communicate (AFC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>difference E2 between thalidomide group and other treatment group</measure>
    <time_frame>1 year</time_frame>
    <description>estradiol，a kind of hormone</description>
  </primary_outcome>
  <primary_outcome>
    <measure>difference FSH between thalidomide group and other treatment group</measure>
    <time_frame>1 year</time_frame>
    <description>Follicle stimulating hormone,a kind of hormone</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>thalidomide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>use thalidomide tablet by mouth, every night for at least 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>other treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the treatment include infliximab, azathioprine or enteral nutrition at least 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thalidomide</intervention_name>
    <arm_group_label>thalidomide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>infliximab, azathioprine</intervention_name>
    <description>other treatment include infliximab, azathioprine</description>
    <arm_group_label>other treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>enteral nutrition</intervention_name>
    <arm_group_label>other treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-50 years old Diagnosis of patients with CD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or lactation Period of women have fertility program during the study&#xD;
             Treatment not foot eight weeks after last IFX Central or peripheral nerve disease&#xD;
             Abnormal in liver and renal function Heart function failure Malignant tumor Active&#xD;
             tuberculosis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 19, 2016</last_update_submitted>
  <last_update_submitted_qc>December 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sixth Affiliated Hospital, Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>pengxiang</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>Crohn Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thalidomide</mesh_term>
    <mesh_term>Infliximab</mesh_term>
    <mesh_term>Azathioprine</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>October 5, 2021</submitted>
    <returned>November 2, 2021</returned>
    <submitted>January 17, 2022</submitted>
    <returned>March 16, 2022</returned>
  </pending_results>
  <!-- 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/NCT02998827
org study id: E2016023
nct id: NCT02998827
lead sponsor: 
The effectiveness of thalidomide in treating inflammatory bowel disease has been widely
      recognized. Meanwhile, many serious adverse drug reactions were notified， but no reports on
      ovarian reserve function.Therefore, this study was to investigate the influence of
      thalidomide on function of ovarian reserve.
It will be divided two groups of patients according to the treatment itself . One group was
      treated by thalidomide, the other was other treatment excluding. It will detect the function
      of ovarian reserve before and after treatment in both two groups, to investigate the
      influence of thalidomide on function of ovarian reserve.
allocation: Non-Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: difference AMH between thalidomide group and other treatment group
time frame: 1 year
description: Anti-mullerian hormone（AMH）, as an important index to monitor the function of ovarian reserve, is majorly secreted by preantral follicles and antral follicles without fluctuation during menstrual cycle, not affected by hormone, and its change is earlier than sex hormone.
measure: difference AFC between thalidomide group and other treatment group
time frame: 1 year
description: The foundational follicles at 5- 10 mm of both ovaries were determined and the sum of antral follicles of both sides of ovaries was as antral follicles communicate (AFC)
measure: difference E2 between thalidomide group and other treatment group
time frame: 1 year
description: estradiol，a kind of hormone
measure: difference FSH between thalidomide group and other treatment group
time frame: 1 year
description: Follicle stimulating hormone,a kind of hormone
arm group label: thalidomide
arm group type: Experimental
description: use thalidomide tablet by mouth, every night for at least 6 months
arm group label: other treatment
arm group type: Active Comparator
description: the treatment include infliximab, azathioprine or enteral nutrition at least 6 months
intervention type: Drug
intervention name: Thalidomide
arm group label: thalidomide
intervention type: Drug
intervention name: infliximab, azathioprine
description: other treatment include infliximab, azathioprine
arm group label: other treatment
intervention type: Other
intervention name: enteral nutrition
arm group label: other treatment
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
investigator full name: pengxiang
investigator title: Principal Investigator
mesh term: Crohn Disease
mesh term: Thalidomide
mesh term: Infliximab
mesh term: Azathioprine
submitted: October 5, 2021
returned: November 2, 2021
submitted: January 17, 2022
returned: March 16, 2022