<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/NCT02225171</url>
  </required_header>
  <id_info>
    <org_study_id>999914166</org_study_id>
    <secondary_id>14-HG-N166</secondary_id>
    <nct_id>NCT02225171</nct_id>
  </id_info>
  <brief_title>Physicians' Experiences With and Attitudes Toward Non-Medical Sex Selection Through Preimplantation Genetic Diagnosis</brief_title>
  <official_title>Physicians' Experiences With and Attitudes Toward Non-Medical Sex Selection Through Preimplantation Genetic Diagnosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Human Genome Research Institute (NHGRI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</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>
      Preimplantation genetic diagnosis (PGD) is an assisted reproductive technology (ART) by which&#xD;
      embryos, created through in vitro fertilization (IVF), can be screened for genetic conditions&#xD;
      or traits before they are implanted into a woman s uterus. Within the past few years, a&#xD;
      controversial non-medical use of PGD has gained recognition as having possible significant&#xD;
      ethical implications. Non-medical sex selection (NMSS) describes the use of PGD technology to&#xD;
      choose the sex of a child for social, as opposed to medical, reasons. In the US and a select&#xD;
      few other countries, it is legal to use NMSS for family balancing, or the intentional&#xD;
      selection of an underrepresented sex to balance a family where the majority of the children&#xD;
      are of one sex. Proponents of family balancing believe that NMSS is an expression of&#xD;
      reproductive autonomy and is ethically acceptable on those grounds. Opponents are more likely&#xD;
      to cite beneficence (toward the existing children and the potential future child) and justice&#xD;
      (resource allocation and access, for example) as the basis for concerns around NMSS and&#xD;
      family balancing specifically. In the US and other countries, healthcare providers (HCPs) are&#xD;
      often the gatekeepers to this technology. There is little research exploring the experiences&#xD;
      of HCPs with PGD and NMSS. The Moral Experience framework (Hunt and Carnevale, 2011) is&#xD;
      useful for understanding the potential concerns of HCPs as well as their feelings and&#xD;
      behaviors evoked by lived and hypothetical experiences around NMSS. Also of interest is how&#xD;
      HCPs feel that decisions about NMSS are made and their preferences as to how they should be&#xD;
      made. Finally, there is concern that NMSS may be the first in a line of non-medical uses for&#xD;
      PGD and that a slippery slope toward what some describe as designer babies will follow. We&#xD;
      are interested in eliciting the traits that HCPs believe are hypothetically appropriate or&#xD;
      inappropriate for PGD and how they make the distinction. Interviews with HCPs (OBGYNs and&#xD;
      reproductive endocrinologists) on these topics will be transcribed and subjected to thematic&#xD;
      analysis in order to identify common themes. An understanding of the experiences and&#xD;
      attitudes of this stakeholder population can help clarify current issues at individual,&#xD;
      societal, and global levels and future directions for research and policy....&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preimplantation genetic diagnosis (PGD) is an assisted reproductive technology (ART) by which&#xD;
      embryos, created through in vitro fertilization (IVF), can be screened for genetic conditions&#xD;
      or traits before they are implanted into a woman s uterus. Within the past few years, a&#xD;
      controversial non-medical use of PGD has gained recognition as having possible significant&#xD;
      ethical implications. Non-medical sex selection (NMSS) describes the use of PGD technology to&#xD;
      choose the sex of a child for social, as opposed to medical, reasons. In the US and a select&#xD;
      few other countries, it is legal to use NMSS for family balancing, or the intentional&#xD;
      selection of an underrepresented sex to balance a family where the majority of the children&#xD;
      are of one sex. Proponents of family balancing believe that NMSS is an expression of&#xD;
      reproductive autonomy and is ethically acceptable on those grounds. Opponents are more likely&#xD;
      to cite beneficence (toward the existing children and the potential future child) and justice&#xD;
      (resource allocation and access, for example) as the basis for concerns around NMSS and&#xD;
      family balancing specifically. In the US and other countries, healthcare providers (HCPs) are&#xD;
      often the gatekeepers to this technology. There is little research exploring the experiences&#xD;
      of HCPs with PGD and NMSS. The Moral Experience framework (Hunt and Carnevale, 2011) is&#xD;
      useful for understanding the potential concerns of HCPs as well as their feelings and&#xD;
      behaviors evoked by lived and hypothetical experiences around NMSS. Also of interest is how&#xD;
      HCPs feel that decisions about NMSS are made and their preferences as to how they should be&#xD;
      made. Finally, there is concern that NMSS may be the first in a line of non-medical uses for&#xD;
      PGD and that a slippery slope toward what some describe as designer babies will follow. We&#xD;
      are interested in eliciting the traits that HCPs believe are hypothetically appropriate or&#xD;
      inappropriate for PGD and how they make the distinction. Interviews with HCPs (OBGYNs and&#xD;
      reproductive endocrinologists) on these topics will be transcribed and subjected to thematic&#xD;
      analysis in order to identify common themes. An understanding of the experiences and&#xD;
      attitudes of this stakeholder population can help clarify current issues at individual,&#xD;
      societal, and global levels and future directions for research and policy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2014</start_date>
  <completion_date type="Actual">December 31, 2014</completion_date>
  <primary_completion_date type="Actual">December 31, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Experiences</measure>
    <time_frame>Enrollment</time_frame>
    <description>This study seeks to describe the experiences of healthcare providers around pre- implantation genetic diagnosis (PGD) for non-medical sex selection (NMSS), with a particular focus on potential ethical concerns, their role in the decision-making process, and their views on future appropriate and inappropriate non-medical uses of PGD.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">14</enrollment>
  <condition>Genetics</condition>
  <condition>Attitudes</condition>
  <arm_group>
    <arm_group_label>Physicians</arm_group_label>
    <description>15 physicians each will be interviewed from the specialties of reproductive endocrinology and obstetrics/gynecology.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        15 physicians each will be interviewed from the specialties of reproductive endocrinology&#xD;
        and obstetrics/gynecology.@@@&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        Participants must:&#xD;
&#xD;
          -  speak English&#xD;
&#xD;
          -  be at least 18 years of age&#xD;
&#xD;
          -  currently be practicing in a clinical setting in the US&#xD;
&#xD;
          -  have familiarity with PGD i.e. have discussed PGD with a patient or colleague in any&#xD;
             context&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lori Erby, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Human Genome Research Institute (NHGRI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Human Genome Research Institute (NHGRI), 9000 Rockville Pike</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 31, 2023</verification_date>
  <study_first_submitted>August 23, 2014</study_first_submitted>
  <study_first_submitted_qc>August 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>September 9, 2023</last_update_submitted>
  <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Assisted Reproductive Technology</keyword>
  <keyword>Behavior</keyword>
  <keyword>Health Care Provider</keyword>
  <keyword>Ethical Concerns</keyword>
  <keyword>Decision Making</keyword>
  <keyword>Natural History</keyword>
  <!-- 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/NCT02225171
org study id: 999914166
secondary id: 14-HG-N166
nct id: NCT02225171
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Preimplantation genetic diagnosis (PGD) is an assisted reproductive technology (ART) by which
      embryos, created through in vitro fertilization (IVF), can be screened for genetic conditions
      or traits before they are implanted into a woman s uterus. Within the past few years, a
      controversial non-medical use of PGD has gained recognition as having possible significant
      ethical implications. Non-medical sex selection (NMSS) describes the use of PGD technology to
      choose the sex of a child for social, as opposed to medical, reasons. In the US and a select
      few other countries, it is legal to use NMSS for family balancing, or the intentional
      selection of an underrepresented sex to balance a family where the majority of the children
      are of one sex. Proponents of family balancing believe that NMSS is an expression of
      reproductive autonomy and is ethically acceptable on those grounds. Opponents are more likely
      to cite beneficence (toward the existing children and the potential future child) and justice
      (resource allocation and access, for example) as the basis for concerns around NMSS and
      family balancing specifically. In the US and other countries, healthcare providers (HCPs) are
      often the gatekeepers to this technology. There is little research exploring the experiences
      of HCPs with PGD and NMSS. The Moral Experience framework (Hunt and Carnevale, 2011) is
      useful for understanding the potential concerns of HCPs as well as their feelings and
      behaviors evoked by lived and hypothetical experiences around NMSS. Also of interest is how
      HCPs feel that decisions about NMSS are made and their preferences as to how they should be
      made. Finally, there is concern that NMSS may be the first in a line of non-medical uses for
      PGD and that a slippery slope toward what some describe as designer babies will follow. We
      are interested in eliciting the traits that HCPs believe are hypothetically appropriate or
      inappropriate for PGD and how they make the distinction. Interviews with HCPs (OBGYNs and
      reproductive endocrinologists) on these topics will be transcribed and subjected to thematic
      analysis in order to identify common themes. An understanding of the experiences and
      attitudes of this stakeholder population can help clarify current issues at individual,
      societal, and global levels and future directions for research and policy....
Preimplantation genetic diagnosis (PGD) is an assisted reproductive technology (ART) by which
      embryos, created through in vitro fertilization (IVF), can be screened for genetic conditions
      or traits before they are implanted into a woman s uterus. Within the past few years, a
      controversial non-medical use of PGD has gained recognition as having possible significant
      ethical implications. Non-medical sex selection (NMSS) describes the use of PGD technology to
      choose the sex of a child for social, as opposed to medical, reasons. In the US and a select
      few other countries, it is legal to use NMSS for family balancing, or the intentional
      selection of an underrepresented sex to balance a family where the majority of the children
      are of one sex. Proponents of family balancing believe that NMSS is an expression of
      reproductive autonomy and is ethically acceptable on those grounds. Opponents are more likely
      to cite beneficence (toward the existing children and the potential future child) and justice
      (resource allocation and access, for example) as the basis for concerns around NMSS and
      family balancing specifically. In the US and other countries, healthcare providers (HCPs) are
      often the gatekeepers to this technology. There is little research exploring the experiences
      of HCPs with PGD and NMSS. The Moral Experience framework (Hunt and Carnevale, 2011) is
      useful for understanding the potential concerns of HCPs as well as their feelings and
      behaviors evoked by lived and hypothetical experiences around NMSS. Also of interest is how
      HCPs feel that decisions about NMSS are made and their preferences as to how they should be
      made. Finally, there is concern that NMSS may be the first in a line of non-medical uses for
      PGD and that a slippery slope toward what some describe as designer babies will follow. We
      are interested in eliciting the traits that HCPs believe are hypothetically appropriate or
      inappropriate for PGD and how they make the distinction. Interviews with HCPs (OBGYNs and
      reproductive endocrinologists) on these topics will be transcribed and subjected to thematic
      analysis in order to identify common themes. An understanding of the experiences and
      attitudes of this stakeholder population can help clarify current issues at individual,
      societal, and global levels and future directions for research and policy.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Experiences
time frame: Enrollment
description: This study seeks to describe the experiences of healthcare providers around pre- implantation genetic diagnosis (PGD) for non-medical sex selection (NMSS), with a particular focus on potential ethical concerns, their role in the decision-making process, and their views on future appropriate and inappropriate non-medical uses of PGD.
arm group label: Physicians
description: 15 physicians each will be interviewed from the specialties of reproductive endocrinology and obstetrics/gynecology.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lori Erby, Ph.D.
role: Principal Investigator
affiliation: National Human Genome Research Institute (NHGRI)
facility: 
country: United States
responsible party type: Sponsor