Use of preimplantation genetic testing for polygenic disorders (PGT-P): an Ethics Committee opinion

This document discusses the ethical implications as well as the current limits and potential benefits of the use of preimplantation genetic testing for polygenic disorders. It should not be used for nonmedical trait selection. Trait selection is not within the scope of reproductive medicine and will not be discussed in this document. (Fertil Steril ® 2026;125:24–30. ©2025 by American Society for Reproductive Medicine.)

El resumen está disponible en Español al final del artículo.

Keywords: Genetics, preimplanation genetic testing, polygenic disorders, trait selection, embryo

KEY POINTS

• Preimplantation Genetic Testing for Polygenic disorders (PGT-P), also known as polygenic embryo screening (PES), aims to estimate the genetic likelihood that an embryo will develop certain multifactorial diseases using a polygenic scoring system. This document addresses the potential use of PGT-P to inform decisions regarding embryo selection to theoretically decrease the risk of multifactorial diseases and disease predispositions in the next generation.
• PGT-P used for trait selection (e.g., height, intelligence, eye color) is not within the scope of reproductive medicine and will not be addressed in this document.
• PGT-P remains a nascent and unproven technology that is not recommended for clinical use and should not be offered as a clinical service at this time.
• PGT-P should only be performed under the supervision of IRBs, and clinical use should occur only after safety, efficacy, ethical, and societal concerns have been addressed.
• No technology can guarantee healthy offspring.

Preimplantation genetic testing (PGT) has evolved significantly since its inception, marking a pivotal advancement in reproductive medicine. It aims to identify genetic variations in embryos before implantation with the goal of improving the health of the resulting offspring and necessitates in vitro fertilization (IVF). It was developed in the early 1990s as a technique to screen embryos for specific genetic diseases (1). Preimplantation genetic testing initially focused on the following: sex determination to avoid the transfer of embryos affected by X-linked diseases; and monogenic disorders caused by single-gene mutations, such as cystic fibrosis or Huntington’s disease. Over time, PGT expanded to include screening for chromosomal abnormalities and structural rearrangements with the goal of improving IVF success rates and decreasing spontaneous abortions by selecting euploid embryos for transfer (2). The potential to screen embryos for polygenic traits, conditions influenced by hundreds or thousands of genes, has emerged more recently, driven by advancements in genomic sequencing and computational analysis. Preimplantation genetic testing for polygenic disorders (PGT-P), which is also referred to as polygenic embryo screening, is an emerging predictive tool designed to be used in the field of reproductive genetics to assess the genetic predisposition of an embryo for conditions whose inheritance is multifactorial in nature, such as cardiovascular disease and type 1 diabetes (3, 4). It involves analyzing multiple genetic variants across the genome to calculate a numerical score that can be used to deselect embryos with the aim of decreasing the risk of passing on specific polygenic conditions, disease predispositions, or traits. The use of PGT-P raises several ethical concerns, which will be discussed in this document (5).

Several professional organizations, including the American College of Medical Genetics, the European Society of Human Genetics, and the European Society of Human Reproduction and Embryology, have highlighted that implementing PGT-P at the present time would be both ethically and clinically premature (6–10). One investigator highlights the insufficiency of retrospective data to definitively prove the clinical validity and utility of embryo selection, and the need for prospective, longitudinal studies focusing on the predictive accuracy of polygenic risk scores in embryos and their long-term health outcomes to fully establish the clinical value of PGT-P (11). Polygenic inheritance is, by its very nature, complex. Our understanding of the interplay between genetic and environmental influences is incomplete, raising concerns about the current and future accuracy and reliability of predictive models for polygenic traits. Ethical concerns regarding the deterministic selection of embryos based on perceived traits, potential impacts on genetic diversity, and disparities in access underscore the need for cautious implementation if, and when, safety and efficacy concerns are addressed (5, 7).

The IVF required for PGT-P is not without risk (11). In 2018, the Ethics Committee of American Society for Reproductive Medicine (ASRM) published an opinion about the use of preimplantation genetic testing for monogenic disease, which highlights many of the considerations, risks, and costs associated with PGT and IVF (12). With PGT-P, there is no guarantee that the embryo with the lowest predicted risk will implant or result in a live birth. This may have a psychological impact on intended parents who may feel conflicted about transferring ‘‘suboptimal’’ embryos. This could lead individuals and couples to undergo multiple cycles of IVF with the goal of trying to obtain embryos with the lowest risk, raising concerns that include possible embryo damage, misdiagnosis, mosaicism, imprinting, monozygotic twinning, and a false sense of security regarding the health of resulting children. Additionally, many IVF cycles do not result in sufficient number of embryos for embryo rankings to meaningfully impact the outcomes. Given all these factors, performing IVF for the sole purpose of PGT-P raises ethical concerns.

Limitations of PGT-P

Polygenic risk scores provide probabilistic rather than deterministic predictions of disease risk. There is uncertainty about the accuracy and reliability of these scores, particularly regarding their predictive value across diverse populations and in relation to complex, multifactorial diseases influenced by both genetic and environmental factors. The databases used to create algorithms for PGT-P derive from samples that are most often collected from adults of Western European Caucasian origin, thereby potentially limiting the generalizability of the data. Simply knowing an individual’s genetic makeup is insufficient to predict future disease development in a given individual, as both environmental factors and epigenetics influence whether and to what extent a given disease will manifest over time. The genetic risks an individual faces today may not accurately reflect risks when the resulting children would be expected to develop these diseases many decades into the future. The conditions tested by PGT-P are also impacted by factors such as diet, lifestyle, and environment, with polygenic risk scoring only accounting for 5%– 10% of clinical variation (11, 13, 14). Not accounting for the social and environmental determinants of health can lead to the selection or rejection of embryos on the basis of incomplete risk assessments. It is important to recognize that the phenotypes produced by gene-environment interactions in today’s older adults may differ widely from those that might manifest in contemporaneous newborns decades into the future (5). The polygenic risk scores data use a study population under different environmental influences from those of the population to which it is being offered (11, 15). Additionally, the genetic basis of many polygenic diseases are not fully understood, thereby limiting the accuracy and the clinical utility of the testing. Pleiotropy, defined as the condition in which one gene influences two or more seemingly unrelated phenotypic traits, complicates the interpretation and prediction of genetic findings (16). Selecting embryos on the basis of one desired trait may inadvertently impact other traits influenced by partly overlapping or the same genes. The American College of Medical Genetics provides an in-depth statement that provides further clinical considerations for the utility of PGT-P for embryo selection (7).

Ethical considerations

Embryo selection. There are two potential uses of PGT-P which are as follows: to decrease disease risk by selecting against embryos with a higher risk for developing a specific health-impacting condition; and to select for positive or deselect for negative traits that do not impact health. Preimplantation genetic testing for polygenic disorder for trait selection should not be used. It is not within the scope of reproductive medicine, and will therefore not be addressed in this document. Determining which embryo to transfer on the basis of disease risk is a personal decision entrenched in lived history and values and cannot be made simply (14). By focusing on disease predispositions, there is a risk of inadvertently limiting genetic diversity and perpetuating societal biases. This selective approach could impact future generations’ abilities to express a wide range of beneficial traits, which may contribute to a more nuanced understanding of human diversity. Ethical considerations include the implications for autonomy, justice, and the broader societal values that influence decisions about which traits are deemed desirable or undesirable (11). Systems and tools should be developed to help clinicians counsel patients on how to select embryos for implantation that are based on both disease risk and the personal values of the intended parents. Additionally, guidelines should be developed to support patients in deciding how many IVF cycles they should attempt and how many embryos they should create before proceeding with an embryo transfer.

Absolute vs. relative risk. Polygenic diseases, by definition, involve multiple genes, making it difficult to provide accurate absolute risk estimates regarding clinical outcomes. The interplay of various genetic factors may not be fully understood, leading to uncertainty in risk assessments. Absolute risk in the context of PGT-P quantifies the actual probability of developing the condition on the basis of specific genetic information. It indicates the likelihood of an individual embryo being affected by the disease. In contrast, relative risk compares the risk of developing the disease in individuals with certain genetic profiles with that of the general population (5). This measure helps to ascertain how much more or less likely individuals with specific genetic traits are at risk compared with others. Although absolute risk provides clarity on the likelihood of disease in tested embryos, and relative risk contextualizes genetic contributions, there are limitations to how both approaches are used in decision making. Polygenic diseases involve multiple genes and environmental factors, making precise risk estimates challenging (6,17). Relative risk can sometimes exaggerate the perception of risk, especially if the general population risk is low. Small reductions in absolute risk correspond to large reductions in relative risk when the risk of a particular clinical outcome is low to begin with (16). For example, although the relative risk reduction of developing type 1 diabetes in offspring of biological parents with European ancestry is seemingly substantial at 35%, the absolute risk reduction for this disease is only 0.12% points, primarily because of the condition’s low prevalence in the US population (0.34%) (16). Patients may misinterpret relative risk figures as definitive indicators of their health outcomes, resulting in unnecessary anxiety or decision making in the absence of a full understanding of the clinical situation. For those with a family history of polygenic conditions, the absolute risk for any embryo they create will generally be higher than the relative risk in the population at large. Patients should understand that PGT-P does not prevent disease development, and that absolute risk reduction is dependent on the baseline risk existing in the reproductive dyad. Additionally, PGT-P does not account for environmental and lifestyle factors that often play a significant role in the development of polygenic diseases. This omission can skew both absolute and relative risk perceptions.

Lack of embryos suitable for transfer. Preimplantation genetic testing for polygenic disease can lead to the possibility of identifying genetic risks or predicted traits that would result in the rejection by intended parents of a significant number of embryos for transfer. There is no technology that can guarantee healthy offspring. Additionally, tools should be developed to weigh disease severity in decision making regarding the prioritization of embryos for transfer. Such decisions cannot be made in a vacuum and should take into account the individual values of the intended parents and their lived experiences. This process may lead to ethical dilemmas regarding embryo selection, as well as emotional and psychological impacts on those undergoing fertility treatments. The reduction in the number of embryos deemed suitable for transfer could potentially limit the chances of successful pregnancy and live birth, adding to the complexity and stress of the IVF process (6). For example, the identification of embryos with a lower predicted risk for certain conditions may reduce the number considered suitable for transfer, potentially limiting the chances of achieving a successful pregnancy and desired family size (6). The technology is being marketed as a tool to assess embryos on the basis of estimated genetic risk for certain conditions, with the implication that selecting embryos with lower predicted risk may increase the likelihood of healthier offspring. However, pregnancy is not guaranteed with the use of any technology, and patients may ultimately need to consider transferring embryos with higher predicted risks. Furthermore, the practice of ranking embryos for transfer on the basis of polygenic risk estimates raises ethical concerns, particularly if presented in a way that could be perceived as directive, potentially undermining patient autonomy in reproductive decision making.

Disease hierarchy, access to care, and disparities. Polygenic embryo risk scores may inadvertently create a nonbinary hierarchy of disease by prioritizing the prevention or mitigation of certain conditions over others. This occurs in part because only select conditions are included in testing panels, meaning some diseases are assessed whereas others are excluded. As a result, the technology may unintentionally reinforce societal biases or devalue the importance of addressing health concerns that are not represented in the panel. Assessing embryos on the basis of predicted genetic risk for certain health conditions can also raise concerns when considering the birth order of siblings. For example, if earlier transfers are based on perceived lower risk, siblings born later may be viewed as inherently less healthy, which could have unintended social or psychological implications within families. The emphasis on screening for specific diseases or traits could stigmatize individuals and families affected by those conditions, potentially affecting their self-perception and societal acceptance (17). Conversely, the focus on certain diseases or traits in PGT-P may lead to disparities in access to reproductive technologies, where individuals affected by less prioritized conditions may have limited options for genetic testing and intervention. There is a risk that PGT-P could contribute to discrimination against individuals with disabilities by deselecting embryos affected by certain diseases, thereby limiting research funding and clinical experience with these conditions.

Access to polygenic embryo screening may exacerbate existing disparities in healthcare and limit reproductive options. Preimplantation genetic testing for polygenic disorders can be expensive, is not covered by insurance, and is available only to those who can afford it, thereby exacerbating socioeconomic disparities in access to advanced reproductive technologies, particularly among marginalized and underserved populations (18). Additionally, there are disparities in genetic knowledge and understanding among different populations, which can affect who may benefit from PGT-P and who may be disadvantaged because of limited access to information or resources.

Current datasets often fail to capture the full spectrum of genetic variation across ethnic, racial, and sex-based groups (7,17, 19, 20), raising the risk of biased predictions and disparities in outcomes for individuals from underrepresented populations. This underrepresentation is particularly problematic given that families from diverse backgrounds may increasingly seek access to this technology. Moreover, although concerns about gene-environment interactions decades into the future are often raised, given that the environments in which these offspring will grow up and age are unknown, it is equally important to acknowledge that the long-term predictive validity of these tests cannot be meaningfully assessed until those future decades arrive. Only then will we begin to understand how accurate these scores truly are in forecasting adult-onset conditions, further underscoring the uncertainty and ethical complexity. This highlights the importance of efforts to increase diversity in genomic research and database representation to ensure equitable access and effectiveness for all individuals.

Addressing these concerns requires careful consideration of ethical guidelines, cost-effective analysis, sufficient diversity in databases, equitable access to genetic counseling and PGT-P services, and ongoing efforts to ensure that advancements in reproductive technologies benefit all individuals and communities fairly. Healthcare providers and individuals may face ethical dilemmas in deciding which diseases or traits justify genetic testing and intervention, raising questions about fairness, justice, and the moral implications of prioritizing certain genetic outcomes over others. Ethical evaluation should consider the broader societal implications of using these technologies and strive to minimize any negative effects on individuals or marginalized communities, and the perpetuation of biases and inequalities related to traits deemed desirable or undesirable.

Psychosocial impacts. There may be unintended psychological impacts for both the prospective parents and the resulting offspring from the use of PGT-P. Learning about potential risks or conditions may cause anxiety, stress, or guilt, particularly if there are limited options for addressing or mitigating those risks. The use of PGT-P may influence parental decisions that limit a child’s autonomy in shaping their own identity and potential. It may also inadvertently impact offspring behavior, for instance, if they perceive a reduced genetic risk and therefore engage in risky environmental behaviors. Additionally, there are concerns that these scores might influence the ways in which parents raise their children. Such parental influence could potentially impact the child’s opportunity for an open future (21). For example, parents might encourage or restrict access to opportunities or environments on the basis of PGT-P scores that conflict with the child’s desires.

Counseling and informed consent. Although the ASRM does not currently recommend PGT-P, the ability to effectively communicate the potential benefits and known limitations of PGT-P to those who might wish to consider the technology in the future is a prerequisite for the informed consent process. The dichotomy between what information patients wish to glean from PGT-P and what is clinically available is important to acknowledge and discuss (22, 23). Patients may hope for comprehensive solutions and definitive answers regarding their reproductive choices. However, the current clinical offerings may only provide limited efficacy and safety information, making it challenging to meet patients’ expectations.

Given the many unknowns regarding the utility of PGT-P in its current state, conveying uncertainty is a critical element of informed consent. Concerns arise regarding the extent to which prospective parents understand the implications of polygenic embryo risk scoring as they look to make informed decisions on the basis of available information (24). Patients may wish to have access to every possible piece of information regarding potential genetic risks and outcomes. However, the complexity of polygenic inheritance means that not all data can be provided confidently, creating a gap between desires for complete information and the limitations of what can be accurately communicated (17). Future uncertainties and the evolving understanding regarding ways in which selected traits may manifest in offspring can complicate informed consent, as outcomes may not align with initial expectations. Those contemplating childbearing who wish to consider undergoing PGT-P may feel pressured to make decisions about embryo selection on the basis of complex genetic information, impacting their autonomy in reproductive choices. Ensuring that individuals fully comprehend the predictive nature of the scores, the potential limitations, and the consequences of embryo selection is crucial to respect autonomy as well as informed consent. Additionally, the results of PGT-P panels may reveal familial disease risks that were previously unknown, having implications for both the intended parents and their genetic relatives. At this time, there is neither research nor guidelines on how such information might impact clinical management.

Counseling should help the intended parents understand that the clinical utility of PGT-P is still unproven, with limited evidence to support its use. Without clear clinical evidence, there is a risk of making decisions on the basis of incomplete or unreliable information (14). Preimplantation genetic testing for polygenic disorder must be done in conjunction with IVF, and all existing concerns and considerations associated with IVF are also relevant here. Patients should be made aware that IVF often results in a limited number of embryos, thereby limiting their ability to rank embryos. Individuals may have a limited euploid embryo yield and may not have more than one embryo from which to choose. Counseling should also explain that no test can eliminate the risk of a disease or guarantee the delivery of healthy offspring. Counseling discussions should consider the future state and the potential treatability for diseases of concern. Although patient autonomy is a foundational principle in reproductive medicine and genetic counseling, it must be exercised within a framework that ensures patients are making informed decisions on the basis of accurate, meaningful, and ethically sound information. The ability of individuals to choose whether to use PGT-P should be respected; however, autonomy alone is not a sufficient justification for the widespread clinical implementation of a technology that remains scientifically and ethically unsettled.

Currently, evidence supporting the clinical utility, longterm safety, and predictive validity of PGT-P is lacking. The scores are based on probabilistic associations that may not translate into meaningful outcomes, especially given the lack of diversity in genomic datasets and the unknown influence of future environmental factors. Without comprehensive data, there is a risk that patients could be misled, intentionally or unintentionally, into believing that PGT-P offers guarantees or reliable protection against complex diseases, when in fact the technology is still in an early stage of development.

Moreover, premature clinical use raises significant ethical concerns, including the potential for exacerbating health disparities, reinforcing ableist assumptions, and undermining the nondirective ethos of genetic counseling. As such, although patient choice is important, it should not override the need for careful, evidence-based evaluation of emerging technologies. Until PGT-P is supported by rigorous data on efficacy, safety, and ethical impact, its use should remain within research settings under strict oversight, rather than being offered as a routine part of reproductive care.

Research considerations. Research on PGT-P should only be undertaken under an institutional review board protocol. It should focus on validating the clinical utility of PGT-P, particularly in predicting the onset and progression of complex diseases influenced by multiple genetic factors. It should also address the ethical implications of its utilization. Such studies should aim to identify ways to reduce inequalities and ensure that PGT-P, if found beneficial, is widely accessible to diverse populations. Clinical use should occur only after safety, efficacy, ethical, and societal concerns have been addressed.

CONCLUSION

Innovation is important and fundamental for clinical practice, and PGT-P presents a novel approach that has the potential to address future risks in offspring. However, at this time, the Committee concludes that PGT-P should not be offered clinically, given a number of as yet unresolved clinical uncertainties and ethical issues which it poses. A proactive and comprehensive regulatory framework is essential to guide its development and ultimate utilization. To advance consideration of this technology for clinical use, close collaboration between scientists, policymakers, and ethicists, alongside transparent public engagement, is needed to balance the benefits and limitations of PGT-P. Further research is essential to validate the utility and address the ethical concerns of PGT-P, ensuring that it meets rigorous standards of safety, efficacy, ethical, and societal concerns before clinical use can be justified (25).

Acknowledgments

This report was developed under the direction of the Ethics and Practice Committees of the American Society for Reproductive Medicine (ASRM) as a service to its members and other practicing clinicians. Although this document reflects appropriate management of a problem encountered in the practice of reproductive medicine, it is not intended to be the only approved standard of practice or to dictate an exclusive course of treatment. Other plans of management may be appropriate, taking into account the needs of the individual patient, available resources, and institutional or clinical practice limitations. The Ethics and Practice Committees and the Board of Directors of the ASRM have approved this report.

This document was reviewed by ASRM members, and their input was considered in the preparation of the final document. The following members of the ASRM Ethics Committee participated in the development of this document: Sigal Klipstein, M.D.; Sina Abhari, M.D.; Paula Amato, M.D.; Aishwarya Arjunan, M.S., M.P.H.; Tolulope Bakare, M.D.; Kim Bergman, Ph.D.; Michelle Bayefsky, M.D.; Zeki Beyhan, Ph.D.; Katherine Cameron, M.D.; Susan Crockin, J.D.; Jessica Goldstein, R.N.; Insoo Hyun, Ph.D.; Jennifer Kawwass, M.D.; Jeanne O’Brien, M.D.; Torie Comeaux Plowden, M.D., M.P.H.; Gwendolyn Quinn, Ph.D.; Robert Rebar, M.D.; Jared Robins, M.D., M.B.A.; Chevis N Shannon, Dr.P.H., M.P.H., M.B.A.; and Sean Tipton, M.A. The following members of the ASRM Practice Committee participated in the development of this document: Clarisa Gracia, M.D., M.S.C.E.; Robert Brannigan, M.D.; Rebecca Flyckt, M.D.; Karl Hansen, M.D., Ph.D.; Tarun Jain, M.D.; Suleena Kalra, M.D., M.S.C.E.; Bruce Pier, M.D.; Torie C. Plowden, M.D., M.P.H.; Denny Sakkas, Ph.D.; Suneeta Senapati, M.D.; Ryan Smith, M.D.; and Mark Trolice, M.D., M.B.A.

The Ethics and Practice Committees acknowledge the special contribution of Aishwarya Arjunan, M.S., M.P.H. in the preparation of this document. All Committee members disclosed commercial and financial relationships with manufacturers or distributors of goods or services used to treat patients. Members of the Committees who were found to have conflicts of interest on the basis of the relationships disclosed did not participate in the discussion or development of this document.

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