GeneticsNCT02225171
Physicians' Experiences With and Attitudes Toward Non-Medical Sex Selection Through Preimplantation Genetic Diagnosis
An observational study of Genetics and Attitudes, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2014to 31 Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 15 physicians each will be interviewed from the specialties of reproductive endocrinology and obstetrics/gynecology.@@@
Who may be able to join
- Participants must:
- speak English
- be at least 18 years of age
- currently be practicing in a clinical setting in the US
- have familiarity with PGD i.e. have discussed PGD with a patient or colleague in any context
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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....
Read the detailed description
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.
- Keywords
- Assisted Reproductive Technology, Behavior, Health Care Provider, Ethical Concerns, Decision Making, Natural History
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Physicians | 15 physicians each will be interviewed from the specialties of reproductive endocrinology and obstetrics/gynecology. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiences
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.
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study start23 Aug 2014
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeneticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lori Erby, Ph.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225171
- Sponsor's protocol ID
- 999914166
- Other IDs
- 14-HG-N166
- Status last verified
- Dec 2023
- First submitted
- 23 Aug 2014
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physicians' Experiences With and Attitudes Toward Non-Medical Sex Selection Through Preimplantation Genetic Diagnosis
- ClinicalTrials.gov ID
- NCT02225171
- Acronym / sponsor ID
- 999914166
- Keywords
- Assisted Reproductive Technology, Behavior, Health Care Provider, Ethical Concerns, Decision Making, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 23 Aug 2014 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physicians | – | –15 physicians each will be interviewed from the specialties of reproductive endocrinology and obstetrics/gynecology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 15 physicians each will be interviewed from the specialties of reproductive endocrinology and obstetrics/gynecology.@@@
Key inclusion criteria (5 listed)
- speak English
- be at least 18 years of age
- currently be practicing in a clinical setting in the US
- have familiarity with PGD i.e. have discussed PGD with a patient or colleague in any context
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Experiences
Time frame: Enrollment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Erby, Ph.D. principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetics and Attitudes, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiences (time frame: Enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.