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/NCT06018454</url>
    </required_header>
    <id_info>
      <org_study_id>202208644</org_study_id>
      <nct_id>NCT06018454</nct_id>
    </id_info>
    <brief_title>Preimplantation Genetic Testing for Aneuploidy Counseling</brief_title>
    <acronym>PGT-A</acronym>
    <official_title>Preimplantation Genetic Testing for Aneuploidy (PGT-A) Counseling for Patients Undergoing in Vitro Fertilization (IVF)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eyup Hakan Duran</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Iowa</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>
        Purpose: To evaluate preimplantation genetic testing counseling interventions on patients&#xD;
        undergoing in vitro fertilization treatment.&#xD;
  &#xD;
        Preimplantation genetic testing for aneuploidy (PGT) allows patients undergoing in vitro&#xD;
        fertilization (IVF) to screen embryos for genetic disorders. Preimplantation genetic testing&#xD;
        for aneuploidy (PGT-A) is the testing most commonly ordered, and it screens for whole&#xD;
        chromosome and large partial chromosome duplications or deletions. Currently, patient&#xD;
        counseling varies based on the clinic, ranging from appointments to group seminars with a&#xD;
        genetic counselor (GC), geneticist or reproductive endocrinology and infertility (REI)&#xD;
        physicians for education regarding PGT. Patient knowledge regarding PGT has been varied with&#xD;
        some studies indicating sufficient knowledge, while other studies have shown a potential lack&#xD;
        of knowledge. One study indicated a third of patients had regret regarding their decision of&#xD;
        whether or not to use PGT-A during IVF and another study indicated patients who choose to&#xD;
        undergo PGT did so for reasons that were not evidence based. Additionally, educational&#xD;
        materials have been illustrated to be inconsistent and with inappropriate literacy in regards&#xD;
        to PGT counseling. One study has shown the potential of improvement with written intervention&#xD;
        amongst providers and patients in regards to PGT related to a single genetic condition. The&#xD;
        investigators hope to assess the efficacy of PGT-A educational and counseling interventions&#xD;
        on patients undergoing IVF.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Procedures: Patients undergoing IVF for the first time will be randomized to one of three&#xD;
        groups&#xD;
  &#xD;
          1. Provider counseling (current standard care) with pre-test&#xD;
  &#xD;
          2. Handout on PGT-A and provider counseling (current standard care + educational&#xD;
             intervention) with pre-test&#xD;
  &#xD;
          3. Handout on PGT-A, provider counseling and brief genetic counselor counseling (current&#xD;
             standard of care + educational and counseling interventions) with pre-test&#xD;
  &#xD;
        All patients will receive provider counseling(current standard of care) on PGT-A during their&#xD;
        new IVF clinic visit. All groups will take a pre-test on PGT-A prior to receiving provider&#xD;
        counseling and (if in an intervention group) prior to receiving handout or handout with brief&#xD;
        counseling on PGT-A from a genetic counselor. At the end of their clinic visit, all&#xD;
        participants will complete a post-test on PGT-A.&#xD;
  &#xD;
        Two weeks after their clinic visit, all participants will receive a 2nd post-test on PGT-A&#xD;
        and the SURE questionnaire to assess retained knowledge about PGT-A and decisional conflict&#xD;
        about their choice to use PGT-A in their treatment cycle.&#xD;
  &#xD;
        As there is not a validated knowledge survey for PGT-A, investigators have developed their&#xD;
        own for pre- and post-tests. In order to validate the survey prior to using it in this study,&#xD;
        investigators plan to enroll the first 100 participants in a pilot study to validate the&#xD;
        instrument. The number needed for validation will depend on how much pilot participants&#xD;
        scores vary between pre and post test. Participants in the pilot portion of the study will be&#xD;
        asked to complete a pre-test on PGT-A, read the informational handout about PGT-A, and then&#xD;
        complete a post test on PGT-A prior to their IVF appointment. Statisticians will analyze the&#xD;
        pilot data as received, and will inform investigators when a sufficient number has been&#xD;
        reached for survey validation. Once validated, the pilot arm of the study will be closed and&#xD;
        will begin enrolling participants in the randomized trial portion described above.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 20, 2022</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Patients randomized with computer generated block randomization of ratio 1:1:1 to randomize women to either 10 minute genetic counseling intervention with handout, handout, or no interventions. Randomization allocation will be performed prior to study initiation through the Institute for Clinical and Translational Science (ICTS) via REDCap software.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>PGT-A Knowledge scores</measure>
      <time_frame>Prior to new IVF visit</time_frame>
      <description>Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PGT-A Knowledge scores</measure>
      <time_frame>Immediately following new IVF visit</time_frame>
      <description>Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PGT-A Knowledge scores</measure>
      <time_frame>Two weeks post IVF visit.</time_frame>
      <description>Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Decisional conflict as measured by the SURE questionnaire.</measure>
      <time_frame>Two weeks post IVF visit.</time_frame>
      <description>A validated questionnaire assessing patient decisional conflict on a scale of 0 to 4. Zero indicating no decisional conflict and 1 or greater indicating increasing levels of decisional conflict.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Patient Education</condition>
    <arm_group>
      <arm_group_label>Provider counseling with pre-test</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Counseling regarding PGT-A only with a provider(current standard of care), pre-test provided.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Handout on PGT-A and provider counseling with pre-test</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Counseling regarding PGT-A with a provider and review of a handout(educational intervention), pre-test provided.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Handout on PGT-A, provider counseling and brief genetic counselor counseling with pre-test</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Counseling regarding PGT-A only with a provider, review of a handout(educational intervention) and genetic counseling (counseling intervention), pre-test provided.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Handout on PGT-A</intervention_name>
      <description>Educational handout on PGT-A</description>
      <arm_group_label>Handout on PGT-A and provider counseling with pre-test</arm_group_label>
      <arm_group_label>Handout on PGT-A, provider counseling and brief genetic counselor counseling with pre-test</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Handout on PGT-A and genetic counseling</intervention_name>
      <description>Handout on PGT-A and genetic counseling session with a genetic counselor on PGT-A</description>
      <arm_group_label>Handout on PGT-A, provider counseling and brief genetic counselor counseling with pre-test</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing in vitro fertilization (IVF)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have previously undergone IVF would be excluded.&#xD;
  &#xD;
            -  Patients who have previously discussed PGT with a genetic counselor would be excluded.&#xD;
  &#xD;
            -  Patients who do not speak English will be excluded.&#xD;
  &#xD;
            -  Patients who are employees of the clinic would be excluded.&#xD;
  &#xD;
            -  Patients who have an indication for PGT-M or PGT-SR would be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Prapti Singh, DO</last_name>
      <role>Study Director</role>
      <affiliation>University of Iowa</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hakan Duran, MD</last_name>
      <phone>319-356-4645</phone>
      <email>hakan-duran@uiowa.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Karen Summers, MPH</last_name>
      <phone>319-356-8862</phone>
      <email>karen-summers@uiowa.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Iowa</name>
        <address>
          <city>Iowa City</city>
          <state>Iowa</state>
          <zip>52245</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Prapti Singh</last_name>
        <phone>202-679-1983</phone>
        <email>prapsingh@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Gebhart MB, Hines RS, Penman A, Holland AC. How do patient perceived determinants influence the decision-making process to accept or decline preimplantation genetic screening? Fertil Steril. 2016 Jan;105(1):188-93. doi: 10.1016/j.fertnstert.2015.09.022. Epub 2015 Oct 24.</citation>
      <PMID>26474735</PMID>
    </reference>
    <reference>
      <citation>Lee I, Alur-Gupta S, Gallop R, Dokras A. Utilization of preimplantation genetic testing for monogenic disorders. Fertil Steril. 2020 Oct;114(4):854-860. doi: 10.1016/j.fertnstert.2020.05.045.</citation>
      <PMID>33040985</PMID>
    </reference>
    <reference>
      <citation>Kaing A, Rosen MP, Quinn MM. Perceptions, motivations and decision regret surrounding preimplantation genetic testing for aneuploidy. Hum Reprod. 2020 Sep 1;35(9):2047-2057. doi: 10.1093/humrep/deaa154.</citation>
      <PMID>32756971</PMID>
    </reference>
    <reference>
      <citation>Quinn MM, Juarez-Hernandez F, Dunn M, Okamura RJ, Cedars MI, Rosen MP. Decision-making surrounding the use of preimplantation genetic testing for aneuploidy reveals misunderstanding regarding its benefit. J Assist Reprod Genet. 2018 Dec;35(12):2155-2159. doi: 10.1007/s10815-018-1337-8. Epub 2018 Oct 18.</citation>
      <PMID>30334131</PMID>
    </reference>
    <reference>
      <citation>McGowan ML, Burant CJ, Moran R, Farrell R. Patient education and informed consent for preimplantation genetic diagnosis: health literacy for genetics and assisted reproductive technology. Genet Med. 2009 Sep;11(9):640-5. doi: 10.1097/GIM.0b013e3181ac6b52.</citation>
      <PMID>19652605</PMID>
    </reference>
    <reference>
      <citation>Early ML, Kumar P, Marcell AV, Lawson C, Christianson M, Pecker LH. Literacy assessment of preimplantation genetic patient education materials exceed national reading levels. J Assist Reprod Genet. 2020 Aug;37(8):1913-1922. doi: 10.1007/s10815-020-01837-z. Epub 2020 May 29.</citation>
      <PMID>32472448</PMID>
    </reference>
    <reference>
      <citation>Early ML, Strodel RJ, Lake IV, Ruddy JA, Saba JA, Singh SM, Lanzkron S, Mack JW, Meier ER, Christianson MS, Pecker LH. Acceptable, hopeful, and useful: development and mixed-method evaluation of an educational tool about reproductive options for people with sickle cell disease or trait. J Assist Reprod Genet. 2022 Jan;39(1):183-193. doi: 10.1007/s10815-021-02358-z. Epub 2021 Nov 22.</citation>
      <PMID>34806131</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 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">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Iowa</investigator_affiliation>
      <investigator_full_name>Eyup Hakan Duran</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aneuploidy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06018454
  org study id: 202208644
  nct id: NCT06018454
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Purpose: To evaluate preimplantation genetic testing counseling interventions on patients
        undergoing in vitro fertilization treatment.
  
        Preimplantation genetic testing for aneuploidy (PGT) allows patients undergoing in vitro
        fertilization (IVF) to screen embryos for genetic disorders. Preimplantation genetic testing
        for aneuploidy (PGT-A) is the testing most commonly ordered, and it screens for whole
        chromosome and large partial chromosome duplications or deletions. Currently, patient
        counseling varies based on the clinic, ranging from appointments to group seminars with a
        genetic counselor (GC), geneticist or reproductive endocrinology and infertility (REI)
        physicians for education regarding PGT. Patient knowledge regarding PGT has been varied with
        some studies indicating sufficient knowledge, while other studies have shown a potential lack
        of knowledge. One study indicated a third of patients had regret regarding their decision of
        whether or not to use PGT-A during IVF and another study indicated patients who choose to
        undergo PGT did so for reasons that were not evidence based. Additionally, educational
        materials have been illustrated to be inconsistent and with inappropriate literacy in regards
        to PGT counseling. One study has shown the potential of improvement with written intervention
        amongst providers and patients in regards to PGT related to a single genetic condition. The
        investigators hope to assess the efficacy of PGT-A educational and counseling interventions
        on patients undergoing IVF.
  Procedures: Patients undergoing IVF for the first time will be randomized to one of three
        groups
  
          1. Provider counseling (current standard care) with pre-test
  
          2. Handout on PGT-A and provider counseling (current standard care + educational
             intervention) with pre-test
  
          3. Handout on PGT-A, provider counseling and brief genetic counselor counseling (current
             standard of care + educational and counseling interventions) with pre-test
  
        All patients will receive provider counseling(current standard of care) on PGT-A during their
        new IVF clinic visit. All groups will take a pre-test on PGT-A prior to receiving provider
        counseling and (if in an intervention group) prior to receiving handout or handout with brief
        counseling on PGT-A from a genetic counselor. At the end of their clinic visit, all
        participants will complete a post-test on PGT-A.
  
        Two weeks after their clinic visit, all participants will receive a 2nd post-test on PGT-A
        and the SURE questionnaire to assess retained knowledge about PGT-A and decisional conflict
        about their choice to use PGT-A in their treatment cycle.
  
        As there is not a validated knowledge survey for PGT-A, investigators have developed their
        own for pre- and post-tests. In order to validate the survey prior to using it in this study,
        investigators plan to enroll the first 100 participants in a pilot study to validate the
        instrument. The number needed for validation will depend on how much pilot participants
        scores vary between pre and post test. Participants in the pilot portion of the study will be
        asked to complete a pre-test on PGT-A, read the informational handout about PGT-A, and then
        complete a post test on PGT-A prior to their IVF appointment. Statisticians will analyze the
        pilot data as received, and will inform investigators when a sufficient number has been
        reached for survey validation. Once validated, the pilot arm of the study will be closed and
        will begin enrolling participants in the randomized trial portion described above.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients randomized with computer generated block randomization of ratio 1:1:1 to randomize women to either 10 minute genetic counseling intervention with handout, handout, or no interventions. Randomization allocation will be performed prior to study initiation through the Institute for Clinical and Translational Science (ICTS) via REDCap software.
  primary purpose: Other
  masking: None (Open Label)
  measure: PGT-A Knowledge scores
  time frame: Prior to new IVF visit
  description: Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
  measure: PGT-A Knowledge scores
  time frame: Immediately following new IVF visit
  description: Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
  measure: PGT-A Knowledge scores
  time frame: Two weeks post IVF visit.
  description: Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
  measure: Decisional conflict as measured by the SURE questionnaire.
  time frame: Two weeks post IVF visit.
  description: A validated questionnaire assessing patient decisional conflict on a scale of 0 to 4. Zero indicating no decisional conflict and 1 or greater indicating increasing levels of decisional conflict.
  arm group label: Provider counseling with pre-test
  arm group type: No Intervention
  description: Counseling regarding PGT-A only with a provider(current standard of care), pre-test provided.
  arm group label: Handout on PGT-A and provider counseling with pre-test
  arm group type: Experimental
  description: Counseling regarding PGT-A with a provider and review of a handout(educational intervention), pre-test provided.
  arm group label: Handout on PGT-A, provider counseling and brief genetic counselor counseling with pre-test
  arm group type: Experimental
  description: Counseling regarding PGT-A only with a provider, review of a handout(educational intervention) and genetic counseling (counseling intervention), pre-test provided.
  intervention type: Other
  intervention name: Handout on PGT-A
  description: Educational handout on PGT-A
  arm group label: Handout on PGT-A and provider counseling with pre-test
  arm group label: Handout on PGT-A, provider counseling and brief genetic counselor counseling with pre-test
  intervention type: Other
  intervention name: Handout on PGT-A and genetic counseling
  description: Handout on PGT-A and genetic counseling session with a genetic counselor on PGT-A
  arm group label: Handout on PGT-A, provider counseling and brief genetic counselor counseling with pre-test
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Prapti Singh, DO
  role: Study Director
  affiliation: University of Iowa
  last name: Hakan Duran, MD
  phone: 319-356-4645
  email: hakan-duran@uiowa.edu
  last name: Karen Summers, MPH
  phone: 319-356-8862
  email: karen-summers@uiowa.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  citation: Gebhart MB, Hines RS, Penman A, Holland AC. How do patient perceived determinants influence the decision-making process to accept or decline preimplantation genetic screening? Fertil Steril. 2016 Jan;105(1):188-93. doi: 10.1016/j.fertnstert.2015.09.022. Epub 2015 Oct 24.
  PMID: 26474735
  citation: Lee I, Alur-Gupta S, Gallop R, Dokras A. Utilization of preimplantation genetic testing for monogenic disorders. Fertil Steril. 2020 Oct;114(4):854-860. doi: 10.1016/j.fertnstert.2020.05.045.
  PMID: 33040985
  citation: Kaing A, Rosen MP, Quinn MM. Perceptions, motivations and decision regret surrounding preimplantation genetic testing for aneuploidy. Hum Reprod. 2020 Sep 1;35(9):2047-2057. doi: 10.1093/humrep/deaa154.
  PMID: 32756971
  citation: Quinn MM, Juarez-Hernandez F, Dunn M, Okamura RJ, Cedars MI, Rosen MP. Decision-making surrounding the use of preimplantation genetic testing for aneuploidy reveals misunderstanding regarding its benefit. J Assist Reprod Genet. 2018 Dec;35(12):2155-2159. doi: 10.1007/s10815-018-1337-8. Epub 2018 Oct 18.
  PMID: 30334131
  citation: McGowan ML, Burant CJ, Moran R, Farrell R. Patient education and informed consent for preimplantation genetic diagnosis: health literacy for genetics and assisted reproductive technology. Genet Med. 2009 Sep;11(9):640-5. doi: 10.1097/GIM.0b013e3181ac6b52.
  PMID: 19652605
  citation: Early ML, Kumar P, Marcell AV, Lawson C, Christianson M, Pecker LH. Literacy assessment of preimplantation genetic patient education materials exceed national reading levels. J Assist Reprod Genet. 2020 Aug;37(8):1913-1922. doi: 10.1007/s10815-020-01837-z. Epub 2020 May 29.
  PMID: 32472448
  citation: Early ML, Strodel RJ, Lake IV, Ruddy JA, Saba JA, Singh SM, Lanzkron S, Mack JW, Meier ER, Christianson MS, Pecker LH. Acceptable, hopeful, and useful: development and mixed-method evaluation of an educational tool about reproductive options for people with sickle cell disease or trait. J Assist Reprod Genet. 2022 Jan;39(1):183-193. doi: 10.1007/s10815-021-02358-z. Epub 2021 Nov 22.
  PMID: 34806131
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Iowa
  investigator full name: Eyup Hakan Duran
  investigator title: Principal investigator
  mesh term: Aneuploidy
  sharing ipd: No