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/NCT06021340</url>
    </required_header>
    <id_info>
      <org_study_id>2023.066</org_study_id>
      <nct_id>NCT06021340</nct_id>
    </id_info>
    <brief_title>What To-be-discard Biomaterials From ART Cycles Can Tell us About the Treatment Cycle Outcome?</brief_title>
    <official_title>What To-be-discard Biomaterials From ART Cycles Can Tell us About the Treatment Cycle Outcome?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chinese University of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chinese University of Hong Kong</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>
        Various to-be-discard material from IVF treatment cycle will be collect and examined, aiming&#xD;
        to identify potential reasons of successful outcome or cycle failure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Usually around 2/3 of IVF material will be discarded at the end of each treatment cycle,&#xD;
        including immature oocytes, abnormal fertilized zygotes, poor grading embryos, spent culture&#xD;
        medium, etc. Next generation sequencing will be performed for DNA / RNA analysis including&#xD;
        the length and the quantity, RNA-seq will be applied for transcriptome profiling, and protein&#xD;
        profile will be investigated in a pool sample. By applying various diagnostic tools against&#xD;
        those to-be-discard biomaterials, we aim to identify potential underlying reasons of&#xD;
        indicating either for an IVF failure or a successful cycle, and try to develop a non-invasive&#xD;
        testing method for embryo quality check; better detection of the embryo implantation&#xD;
        potential and eventually further increase the IVF clinical outcome.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 4, 2023</start_date>
    <completion_date type="Anticipated">June 2027</completion_date>
    <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>DNA/RNA sequencing data</measure>
      <time_frame>Through study completion, around 3 year</time_frame>
      <description>DNA / RNA analysis including the length and the quantity, RNA-seq will be applied for transcriptome profiling. Next generation sequencing will be performed to determine the sequence of DNA/RNA for our collected samples.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Proteomic profile</measure>
      <time_frame>Through study completion, around 3 year</time_frame>
      <description>Protein profile will be investigated in a pool sample, treated samples will go for mass spectrometry (MS) data acquisition and finally destined for data analysis and interpretation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Blastocyst formation rate</measure>
      <time_frame>5 days after fertilization</time_frame>
      <description>Number of blastocysts out of fertilized oocytes observed 5 days after fertilization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical pregnancy rate</measure>
      <time_frame>Around 5 weeks after embryo transfer</time_frame>
      <description>Clinical pregnancy confirmed by ultrasound</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Live birth rate</measure>
      <time_frame>Around 9 months after embryo transfer</time_frame>
      <description>Birth of a living infant after embryo transfer</description>
    </secondary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>IVF</condition>
    <condition>Infertility</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        IVF cycle to-be-discard biomaterials including follicular fluid, seminal plasma, immature&#xD;
        oocytes, abnormal fertilized zygote, unfertilized zygote, arrested embryos, poor quality&#xD;
        blastocysts, spent culture medium.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Study population will include patients attending the Assisted Reproductive Technolohy (ART)&#xD;
          Unit of the Chinese University of Hong Kong for ART treatment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients attending the Assisted Reproductive Technology (ART) Unit of the Chinese&#xD;
               University of Hong Kong for ART treatment.&#xD;
  &#xD;
            -  Participant able to give voluntary, written, informed consent to participate in the&#xD;
               study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient using donor gamete in IVF treatment&#xD;
  &#xD;
            -  Patient refuses to join and failed to giving consent for any reasons&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Yiu Leung D Chan, DPhil</last_name>
      <role>Principal Investigator</role>
      <affiliation>CUHK</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yiu Leung D Chan, DPhil</last_name>
      <phone>(852) 3505 3199</phone>
      <email>drdcyl16@cuhk.edu.hk</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Chinese University of Hong Kong and Prince of Wales Hospital</name>
        <address>
          <city>Hong Kong</city>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yiu Leung D Chan, DPhil</last_name>
        <phone>(852) 3505 3199</phone>
      </contact>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 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>Chinese University of Hong Kong</investigator_affiliation>
      <investigator_full_name>Yiu Leung David Chan</investigator_full_name>
      <investigator_title>Assited Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infertility</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/NCT06021340
  org study id: 2023.066
  nct id: NCT06021340
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Various to-be-discard material from IVF treatment cycle will be collect and examined, aiming
        to identify potential reasons of successful outcome or cycle failure.
  Usually around 2/3 of IVF material will be discarded at the end of each treatment cycle,
        including immature oocytes, abnormal fertilized zygotes, poor grading embryos, spent culture
        medium, etc. Next generation sequencing will be performed for DNA / RNA analysis including
        the length and the quantity, RNA-seq will be applied for transcriptome profiling, and protein
        profile will be investigated in a pool sample. By applying various diagnostic tools against
        those to-be-discard biomaterials, we aim to identify potential underlying reasons of
        indicating either for an IVF failure or a successful cycle, and try to develop a non-invasive
        testing method for embryo quality check; better detection of the embryo implantation
        potential and eventually further increase the IVF clinical outcome.
  observational model: Other
  time perspective: Prospective
  measure: DNA/RNA sequencing data
  time frame: Through study completion, around 3 year
  description: DNA / RNA analysis including the length and the quantity, RNA-seq will be applied for transcriptome profiling. Next generation sequencing will be performed to determine the sequence of DNA/RNA for our collected samples.
  measure: Proteomic profile
  time frame: Through study completion, around 3 year
  description: Protein profile will be investigated in a pool sample, treated samples will go for mass spectrometry (MS) data acquisition and finally destined for data analysis and interpretation.
  measure: Blastocyst formation rate
  time frame: 5 days after fertilization
  description: Number of blastocysts out of fertilized oocytes observed 5 days after fertilization
  measure: Clinical pregnancy rate
  time frame: Around 5 weeks after embryo transfer
  description: Clinical pregnancy confirmed by ultrasound
  measure: Live birth rate
  time frame: Around 9 months after embryo transfer
  description: Birth of a living infant after embryo transfer
  IVF cycle to-be-discard biomaterials including follicular fluid, seminal plasma, immature
        oocytes, abnormal fertilized zygote, unfertilized zygote, arrested embryos, poor quality
        blastocysts, spent culture medium.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Yiu Leung D Chan, DPhil
  role: Principal Investigator
  affiliation: CUHK
  last name: Yiu Leung D Chan, DPhil
  phone: (852) 3505 3199
  email: drdcyl16@cuhk.edu.hk
  facility: 
  status: Recruiting
  contact: 
  country: Hong Kong
  responsible party type: Principal Investigator
  investigator affiliation: Chinese University of Hong Kong
  investigator full name: Yiu Leung David Chan
  investigator title: Assited Professor
  mesh term: Infertility