<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/NCT03269916</url>
  </required_header>
  <id_info>
    <org_study_id>SixthSunYetSen</org_study_id>
    <nct_id>NCT03269916</nct_id>
  </id_info>
  <brief_title>Fertility and Ovarian Reserve Function in the Patient With Inflammatory Bowel Disease</brief_title>
  <official_title>Fertility and Ovarian Reserve Function in the Patient With Inflammatory Bowel - a Cross-sectional Survey and Case Control Study</official_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>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      ECCO consensus, the fertility would decline in activity inflammatory bowel disease(IBD),&#xD;
      because of anus lesions and pelvic abscess, or who underwent surgery, especially in patients&#xD;
      with ileal pouch anal anastomosis (IPAA) storage.The study on fertility in inflammatory bowel&#xD;
      disease were almost epidemiological investigation, the lack of objective evaluation of&#xD;
      fertility, and controversial.This study will explore the fertility, ovarian reserve function&#xD;
      and the pregnancy outcomes in patients with IBD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2018</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The AMH of IBD patients is lower than that of healthy women</measure>
    <time_frame>1 month</time_frame>
    <description>AMH is used to assess ovarian reserve function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The E2 of IBD patients is lower than that of healthy women</measure>
    <time_frame>1 month</time_frame>
    <description>E2 is used to assess ovarian reserve function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The FSH of IBD patients is lower than that of healthy women</measure>
    <time_frame>1 month</time_frame>
    <description>FSH is used to assess ovarian reserve function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The AFC of IBD patients is lower than that of healthy women</measure>
    <time_frame>1 month</time_frame>
    <description>AFC is used to assess ovarian reserve function</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Fertility Disorders</condition>
  <condition>Ovarian Reserve Function</condition>
  <condition>Pregnancy Outcomes</condition>
  <arm_group>
    <arm_group_label>IBD patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IBD patients, 17-40 years old, female</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>17-40 years old , female, without any gynecological disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anti Mueller hormone</intervention_name>
    <description>used to assess ovarian reserve parameters</description>
    <arm_group_label>IBD patients</arm_group_label>
    <arm_group_label>healthy control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Estrogen</intervention_name>
    <description>used to assess ovarian reserve parameters</description>
    <arm_group_label>IBD patients</arm_group_label>
    <arm_group_label>healthy control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follicle-Stimulating Hormone</intervention_name>
    <description>used to assess ovarian reserve parameters</description>
    <arm_group_label>IBD patients</arm_group_label>
    <arm_group_label>healthy control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Antral alveolar cell count</intervention_name>
    <description>used to assess ovarian reserve parameters</description>
    <arm_group_label>IBD patients</arm_group_label>
    <arm_group_label>healthy control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Inflammatory bowel disease&#xD;
&#xD;
          2. 17-40 years old&#xD;
&#xD;
          3. female&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. in pregnancy or lactation&#xD;
&#xD;
          2. a drug that has been or is being used known to affect ovarian function, such as&#xD;
             cyclophosphamide&#xD;
&#xD;
          3. reproductive system diseases unrelated to disease or treatment of inflammatory bowel&#xD;
             disease, such as hysterectomy, pelvic radiotherapy after surgery, after ovariectomy,&#xD;
             polycystic ovary syndrome, endometriosis, ovarian granulosa cell tumor&#xD;
&#xD;
          4. other endocrine diseases, such as prolactin, hyperthyroidism, lead to endocrine&#xD;
             disorders;&#xD;
&#xD;
          5. malignant tumor&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min Zhi, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>The Sixth Affiliated Hospital of Zhongshan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>xiang peng, MM</last_name>
    <phone>18302076916</phone>
    <email>stefaniepx@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Sixth Affiliated Hospital of Zhongshan University</name>
      <address>
        <city>GuangZhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>xiang peng, MM</last_name>
      <phone>18302076916</phone>
      <email>stefaniepx@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</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>Attending doctor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hormones</mesh_term>
    <mesh_term>Follicle Stimulating Hormone</mesh_term>
    <mesh_term>Estrogens</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03269916
org study id: SixthSunYetSen
nct id: NCT03269916
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
ECCO consensus, the fertility would decline in activity inflammatory bowel disease(IBD),
      because of anus lesions and pelvic abscess, or who underwent surgery, especially in patients
      with ileal pouch anal anastomosis (IPAA) storage.The study on fertility in inflammatory bowel
      disease were almost epidemiological investigation, the lack of objective evaluation of
      fertility, and controversial.This study will explore the fertility, ovarian reserve function
      and the pregnancy outcomes in patients with IBD.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: The AMH of IBD patients is lower than that of healthy women
time frame: 1 month
description: AMH is used to assess ovarian reserve function
measure: The E2 of IBD patients is lower than that of healthy women
time frame: 1 month
description: E2 is used to assess ovarian reserve function
measure: The FSH of IBD patients is lower than that of healthy women
time frame: 1 month
description: FSH is used to assess ovarian reserve function
measure: The AFC of IBD patients is lower than that of healthy women
time frame: 1 month
description: AFC is used to assess ovarian reserve function
arm group label: IBD patients
arm group type: Experimental
description: IBD patients, 17-40 years old, female
arm group label: healthy control
arm group type: Other
description: 17-40 years old , female, without any gynecological disease
intervention type: Other
intervention name: Anti Mueller hormone
description: used to assess ovarian reserve parameters
arm group label: IBD patients
arm group label: healthy control
intervention type: Other
intervention name: Estrogen
description: used to assess ovarian reserve parameters
arm group label: IBD patients
arm group label: healthy control
intervention type: Other
intervention name: Follicle-Stimulating Hormone
description: used to assess ovarian reserve parameters
arm group label: IBD patients
arm group label: healthy control
intervention type: Other
intervention name: Antral alveolar cell count
description: used to assess ovarian reserve parameters
arm group label: IBD patients
arm group label: healthy control
criteria: 
gender: Female
minimum age: 17 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Min Zhi, PHD
role: Study Chair
affiliation: The Sixth Affiliated Hospital of Zhongshan University
last name: xiang peng, MM
phone: 18302076916
email: stefaniepx@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
investigator full name: pengxiang
investigator title: Attending doctor
mesh term: Hormones
mesh term: Follicle Stimulating Hormone
mesh term: Estrogens
sharing ipd: Undecided