<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/NCT04443283</url>
  </required_header>
  <id_info>
    <org_study_id>PCCMRP</org_study_id>
    <nct_id>NCT04443283</nct_id>
  </id_info>
  <brief_title>The Effect of Latent Tuberculosis Infection on the Pregnancy Outcome of IVF-ET</brief_title>
  <official_title>A Prospective Cohort Study on the Effect of Latent Infection of Tuberculosis on the Pregnancy Outcome of IVF-ET in Infertile Patients With Radiographic Lesions Suggesting Old Healed Tuberculosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluate the effect of latent infection of tuberculosis on the pregnancy outcome&#xD;
      of IVF-ET in infertile patients with radiographic lesions suggesting old healed tuberculosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      China is one of the countries with high burden of tuberculosis (TB) defined by WHO. IVF-ET is&#xD;
      an effective method to treat infertility. Chest X-ray is a routine examination before IVF-ET,&#xD;
      which can exclude active tuberculosis. However, for patients with chest X-ray showing old&#xD;
      healed tuberculosis, the relationship between latent tuberculosis infection (LTBI) and&#xD;
      pregnancy outcomes is unknown. In this study, a prospective cohort study was carried out in&#xD;
      infertile women who were planning to receive IVF-ET. IGRA were tested in patients with old&#xD;
      tuberculosis in chest X-ray. A cohort of IGRA positive and IGRA negative was constructed. The&#xD;
      pregnancy outcomes were followed up prospectively and the relationship between latent&#xD;
      infection of tuberculosis and pregnancy outcomes was analyzed. The primary outcome was&#xD;
      clinical pregnancy rate, miscarriage rate and live birth rate. Secondary outcomes were&#xD;
      tuberculosis reactivation during pregnancy period and in 3 months after delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>clinical pregnancy rate</measure>
    <time_frame>30 days after the ET procedure</time_frame>
    <description>Clinical pregnancy was defined as the observation of a gestational sac on ultrasonography. The clinical pregnancy rate was defined as clinical pregnancy per embryo transfer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>miscarriage rate</measure>
    <time_frame>40 weeks after the ET procedure</time_frame>
    <description>Miscarriage was defined as a pregnancy loss before 28 weeks of gestation (calculated among women who became pregnant). The miscarriage rate was defined as miscarriages per clinical pregnancy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>live birth rate</measure>
    <time_frame>40 weeks after the ET procedure</time_frame>
    <description>Live birth was defined as delivery of a living foetus (or living foetuses) beyond 28 weeks of gestation. The live birth rate was defined as live birth per embryo transfer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>tuberculosis reactivation</measure>
    <time_frame>40 weeks after the ET procedure</time_frame>
    <description>tuberculosis during pregnancy period and in 3 months after delivery</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Infertility</condition>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>LTBI Group</arm_group_label>
    <description>IGRA(+)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No LTBI Group</arm_group_label>
    <description>IGRA(+)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>This is a observation study, with no intervention</description>
    <arm_group_label>LTBI Group</arm_group_label>
    <arm_group_label>No LTBI Group</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      collect seum sample to detect some inflammatory factors&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants were recruited between January 1, 2019, and December 30, 2020, at Peking&#xD;
        University Third Hospital, a tertiary referral hospital in Beijing, China. A&#xD;
        board-certified radiologist reviewed CXRs and, if available, chest computed tomography (CT)&#xD;
        scans, of women who referred to the reproductive center for IVF-ET. The patients who had&#xD;
        chest imaging abnormalities consistent with old healed TB were admitted or referred to the&#xD;
        respiratory clinic and enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients who referred to the reproductive center for IVF-ET&#xD;
&#xD;
          -  Chest radiography showed old healed tuberculosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active tuberculosis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ji Qiao, MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Reproductive Medicine Centre，Peking University Third Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>infertility</keyword>
  <keyword>IVF-ET</keyword>
  <keyword>old tuberculosis</keyword>
  <keyword>pregnancy outcome</keyword>
  <keyword>latent tuberculosis infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Latent Tuberculosis</mesh_term>
    <mesh_term>Infertility</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/NCT04443283
org study id: PCCMRP
nct id: NCT04443283
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluate the effect of latent infection of tuberculosis on the pregnancy outcome
      of IVF-ET in infertile patients with radiographic lesions suggesting old healed tuberculosis
China is one of the countries with high burden of tuberculosis (TB) defined by WHO. IVF-ET is
      an effective method to treat infertility. Chest X-ray is a routine examination before IVF-ET,
      which can exclude active tuberculosis. However, for patients with chest X-ray showing old
      healed tuberculosis, the relationship between latent tuberculosis infection (LTBI) and
      pregnancy outcomes is unknown. In this study, a prospective cohort study was carried out in
      infertile women who were planning to receive IVF-ET. IGRA were tested in patients with old
      tuberculosis in chest X-ray. A cohort of IGRA positive and IGRA negative was constructed. The
      pregnancy outcomes were followed up prospectively and the relationship between latent
      infection of tuberculosis and pregnancy outcomes was analyzed. The primary outcome was
      clinical pregnancy rate, miscarriage rate and live birth rate. Secondary outcomes were
      tuberculosis reactivation during pregnancy period and in 3 months after delivery.
observational model: Cohort
time perspective: Prospective
measure: clinical pregnancy rate
time frame: 30 days after the ET procedure
description: Clinical pregnancy was defined as the observation of a gestational sac on ultrasonography. The clinical pregnancy rate was defined as clinical pregnancy per embryo transfer.
measure: miscarriage rate
time frame: 40 weeks after the ET procedure
description: Miscarriage was defined as a pregnancy loss before 28 weeks of gestation (calculated among women who became pregnant). The miscarriage rate was defined as miscarriages per clinical pregnancy.
measure: live birth rate
time frame: 40 weeks after the ET procedure
description: Live birth was defined as delivery of a living foetus (or living foetuses) beyond 28 weeks of gestation. The live birth rate was defined as live birth per embryo transfer.
measure: tuberculosis reactivation
time frame: 40 weeks after the ET procedure
description: tuberculosis during pregnancy period and in 3 months after delivery
arm group label: LTBI Group
description: IGRA(+)
arm group label: No LTBI Group
description: IGRA(+)
intervention type: Other
intervention name: No intervention
description: This is a observation study, with no intervention
arm group label: LTBI Group
arm group label: No LTBI Group
collect seum sample to detect some inflammatory factors
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ji Qiao, MD.
role: Principal Investigator
affiliation: Reproductive Medicine Centre，Peking University Third Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Infections
mesh term: Tuberculosis
mesh term: Latent Tuberculosis
mesh term: Infertility
sharing ipd: No