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/NCT06020742</url>
    </required_header>
    <id_info>
      <org_study_id>RDL2022-25</org_study_id>
      <nct_id>NCT06020742</nct_id>
    </id_info>
    <brief_title>Automitochondrial Transplantation Improves Live Birth in Elderly Patients With Low Prognosis After Repeated IVF Failure</brief_title>
    <acronym>ACTILB</acronym>
    <official_title>Automitochondrial Transplantation Improves Live Birth in Elderly Patients With Low Prognosis After Repeated IVF Failure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University People's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University People's Hospital</source>
    <oversight_info>
      <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 to this clinical trial is to study the effectiveness and safety of automitochondrial&#xD;
        transplantation of urine derived stem cells(USCs) in in elderly patients with low prognosis&#xD;
        after repeated IVF failure. The main questions it aims to answer are:&#xD;
  &#xD;
        (1）test the effectiveness and safety of automitochondrial transplantation of urine derived&#xD;
        stem cells (2) establish intracytoplasmic sperm injection(ICSI) mitochondrial transplantation&#xD;
        platform Participants will be asked to:1)urine collections to further culture of autologous&#xD;
        USCs 2)ovarian stimulation、trigger eggs、ICSI with autologous mitochondria 3）embryo transfer&#xD;
        4)accept pregnancy follow-up at given point&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">February 9, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>live birth rate</measure>
      <time_frame>1year after embryo transfer</time_frame>
      <description>Live birth rate per embryo transfer cycle (defined as live delivery after ≧28 weeks)</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Infertility, Female</condition>
    <condition>Mitochondrial</condition>
    <condition>Elderly</condition>
    <condition>Assisted Reproductive Technique</condition>
    <arm_group>
      <arm_group_label>MT transfer</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Autologous USC mitochondrial oocyte transplantation</intervention_name>
      <description>Mitochondria are isolated from urine derived stem cells from fresh middle urine of the subjects, and injected into the cytoplasm of mature oocytes together with sperm</description>
      <arm_group_label>MT transfer</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 1) At least 35 years old&#xD;
  &#xD;
            2. 2) Repeated IVF failure: more than or equal to 2 egg retrieval with poor embryo&#xD;
               quality, no transplanted embryos or failed embryo transfer (more than or equal to 4&#xD;
               embryos)&#xD;
  &#xD;
            3. 3) Egg number ≤9&#xD;
  &#xD;
            4. 4) Participate voluntarily and sign informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1: Infertility caused by severe oligospermia, severe intrauterine adhesions, genital tract&#xD;
          malformations, thyroid dysfunction and other endocrine, immune system, tumor and genetic&#xD;
          diseases&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Peking University People's hospital</name>
        <address>
          <city>Peking</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
      <investigator_full_name>Han Hongjing</investigator_full_name>
      <investigator_title>chief physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infertility</mesh_term>
      <mesh_term>Infertility, Female</mesh_term>
    </condition_browse>
    <!-- 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/NCT06020742
  org study id: RDL2022-25
  nct id: NCT06020742
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal to this clinical trial is to study the effectiveness and safety of automitochondrial
        transplantation of urine derived stem cells(USCs) in in elderly patients with low prognosis
        after repeated IVF failure. The main questions it aims to answer are:
  
        (1）test the effectiveness and safety of automitochondrial transplantation of urine derived
        stem cells (2) establish intracytoplasmic sperm injection(ICSI) mitochondrial transplantation
        platform Participants will be asked to:1)urine collections to further culture of autologous
        USCs 2)ovarian stimulation、trigger eggs、ICSI with autologous mitochondria 3）embryo transfer
        4)accept pregnancy follow-up at given point
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: live birth rate
  time frame: 1year after embryo transfer
  description: Live birth rate per embryo transfer cycle (defined as live delivery after ≧28 weeks)
  arm group label: MT transfer
  arm group type: Experimental
  intervention type: Procedure
  intervention name: Autologous USC mitochondrial oocyte transplantation
  description: Mitochondria are isolated from urine derived stem cells from fresh middle urine of the subjects, and injected into the cytoplasm of mature oocytes together with sperm
  arm group label: MT transfer
  criteria: 
  gender: Female
  minimum age: 35 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Peking University People's Hospital
  investigator full name: Han Hongjing
  investigator title: chief physician
  mesh term: Infertility
  mesh term: Infertility, Female