<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/NCT04477863</url>
  </required_header>
  <id_info>
    <org_study_id>Genomic Prediction Inc 609</org_study_id>
    <nct_id>NCT04477863</nct_id>
  </id_info>
  <brief_title>Follow-up With Preimplantation Genetic Testing Patients</brief_title>
  <official_title>Follow-up With Preimplantation Genetic Testing Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genomic Prediction Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Genomic Prediction Inc.</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>
      The main purpose of this study is to perform longitudinal evaluations of clinical outcomes&#xD;
      and personal perspectives following utilization of preimplantation genetic testing (PGT).&#xD;
      Patients indicating willingness to participate in research during informed consent to perform&#xD;
      PGT will be eligible for inclusion. A licensed genetic counselor will conduct a recorded&#xD;
      interview.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: To perform longitudinal studies of clinical outcomes and personal perspectives&#xD;
      following utilization of PGT.&#xD;
&#xD;
      Background: Preimplantation Genetic Testing (PGT) is a commercially available adjunct to in&#xD;
      vitro fertilization (IVF) and is now performed in over 40% of treatment cycles in the United&#xD;
      Sates (Society for Assisted Reproductive Technology Annual Report, 2018). Several clinical&#xD;
      genetics entities offer PGT services, including Genomic Prediction Clinical Laboratory (CLIA#&#xD;
      31D2152380, CAP# 8488628). It is common practice to perform interviews with, and record&#xD;
      reviews of patients following clinical interventions. Results may provide instrumental&#xD;
      information for the scientific and medical community to improve clinical care. We would like&#xD;
      to review medical records in order to recruit patients to participate in longitudinal studies&#xD;
      of clinical outcomes and personal perspectives following utilization of PGT.&#xD;
&#xD;
      Study Design and Methods: Patients indicating willingness to participate in research during&#xD;
      informed consent to perform PGT will be eligible for inclusion. Patients who opted out of&#xD;
      participating in research during informed consent to perform PGT will be ineligible for&#xD;
      inclusion. Clinical PGT consent forms will be reviewed to identify patients that indicated&#xD;
      willingness to participate in research. Eligible patients will be counseled on the study and&#xD;
      consented for participation by a licensed genetic counselor. A total of 10,000 patients will&#xD;
      be recruited. Following patient recruitment and informed consent, patient records and results&#xD;
      of patient interviews may be used for publication in peer-reviewed scientific journals,&#xD;
      presentation at scientific conferences or company meetings. As it is in standard practice,&#xD;
      all external communication of results will maintain de-identification of all protected health&#xD;
      information of all subjects (HIPAA guidelines). A licensed genetic counselor will conduct a&#xD;
      recorded interview. Patient PGT, family history, and ethnicity data and information may be&#xD;
      included in cohort analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 11, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2050</completion_date>
  <primary_completion_date type="Anticipated">July 11, 2050</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient perspectives on PGT</measure>
    <time_frame>2 years</time_frame>
    <description>Analysis of interview responses</description>
  </primary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Infertility</condition>
  <condition>Genetic Disease</condition>
  <condition>IVF</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follow-up Interview</intervention_name>
    <description>Non Applicable</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who undergo IVF and Preimplantation Genetic Testing&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients indicating willingness to participate in research during informed consent to&#xD;
             perform PGT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who opted out of participating in research during informed consent to perform&#xD;
             PGT&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Nathan R Treff, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Genomic Prediction</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Talia Metzgar, RN</last_name>
    <phone>(973) 529-4223</phone>
    <email>Talia@genomicprediction.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bhavini Rana</last_name>
    <phone>(973) 529-4223</phone>
    <email>bhavini@genomicprediction.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Genomic Prediction Clinical Laboratory</name>
      <address>
        <city>North Brunswick</city>
        <state>New Jersey</state>
        <zip>08902</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Talia Metzgar, RN</last_name>
      <phone>973-529-4223</phone>
      <email>Talia@genomicprediction.com</email>
    </contact>
    <contact_backup>
      <last_name>Bhavini Rana</last_name>
      <phone>(973) 529-4223</phone>
      <email>bhavini@genomicprediction.com</email>
    </contact_backup>
    <investigator>
      <last_name>Nathan Treff, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.sartcorsonline.com/rptCSR_PublicMultYear.aspx?reportingYear=2018.</url>
    <description>SART Preliminary National Summary Report for 2018</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>February 21, 2023</last_update_submitted>
  <last_update_submitted_qc>February 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PGT</keyword>
  <keyword>Follow-up</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Genetic Diseases, Inborn</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Following patient recruitment and informed consent, patient records and results of patient interviews may be used for publication in peer-reviewed scientific journals, presentation at scientific conferences or company meetings.</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>August 2020</ipd_time_frame>
  </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/NCT04477863
org study id: Genomic Prediction Inc 609
nct id: NCT04477863
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to perform longitudinal evaluations of clinical outcomes
      and personal perspectives following utilization of preimplantation genetic testing (PGT).
      Patients indicating willingness to participate in research during informed consent to perform
      PGT will be eligible for inclusion. A licensed genetic counselor will conduct a recorded
      interview.
Purpose: To perform longitudinal studies of clinical outcomes and personal perspectives
      following utilization of PGT.

      Background: Preimplantation Genetic Testing (PGT) is a commercially available adjunct to in
      vitro fertilization (IVF) and is now performed in over 40% of treatment cycles in the United
      Sates (Society for Assisted Reproductive Technology Annual Report, 2018). Several clinical
      genetics entities offer PGT services, including Genomic Prediction Clinical Laboratory (CLIA#
      31D2152380, CAP# 8488628). It is common practice to perform interviews with, and record
      reviews of patients following clinical interventions. Results may provide instrumental
      information for the scientific and medical community to improve clinical care. We would like
      to review medical records in order to recruit patients to participate in longitudinal studies
      of clinical outcomes and personal perspectives following utilization of PGT.

      Study Design and Methods: Patients indicating willingness to participate in research during
      informed consent to perform PGT will be eligible for inclusion. Patients who opted out of
      participating in research during informed consent to perform PGT will be ineligible for
      inclusion. Clinical PGT consent forms will be reviewed to identify patients that indicated
      willingness to participate in research. Eligible patients will be counseled on the study and
      consented for participation by a licensed genetic counselor. A total of 10,000 patients will
      be recruited. Following patient recruitment and informed consent, patient records and results
      of patient interviews may be used for publication in peer-reviewed scientific journals,
      presentation at scientific conferences or company meetings. As it is in standard practice,
      all external communication of results will maintain de-identification of all protected health
      information of all subjects (HIPAA guidelines). A licensed genetic counselor will conduct a
      recorded interview. Patient PGT, family history, and ethnicity data and information may be
      included in cohort analyses.
observational model: Other
time perspective: Other
measure: Patient perspectives on PGT
time frame: 2 years
description: Analysis of interview responses
intervention type: Other
intervention name: Follow-up Interview
description: Non Applicable
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Nathan R Treff, PhD
role: Principal Investigator
affiliation: Genomic Prediction
last name: Talia Metzgar, RN
phone: (973) 529-4223
email: Talia@genomicprediction.com
last name: Bhavini Rana
phone: (973) 529-4223
email: bhavini@genomicprediction.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
url: https://www.sartcorsonline.com/rptCSR_PublicMultYear.aspx?reportingYear=2018.
description: SART Preliminary National Summary Report for 2018
responsible party type: Sponsor
mesh term: Infertility
mesh term: Genetic Diseases, Inborn
sharing ipd: Yes
ipd description: Following patient recruitment and informed consent, patient records and results of patient interviews may be used for publication in peer-reviewed scientific journals, presentation at scientific conferences or company meetings.
ipd info type: Clinical Study Report (CSR)
ipd time frame: August 2020