Registration is open for the 2024 ASRM Scientific Congress & Expo

Menu
Close Close Icon

Transferring embryos with genetic anomalies detected in preimplantation testing: an Ethics Committee Opinion (2018)


KEY POINTS

  • Preimplantation genetic testing (PGT) can be used to investigate the genetic composition of preimplantation embryos. Patients whose embryos undergo such testing, which includes both preimplantation genetic screening (PGS) and preimplantation genetic diagnosis (PGD), should be informed about the risks, benefits, and uncertainties of any given technique, including the fact that normal results do not guarantee that the resulting offspring will be genetically normal (a false negative) and that anomalous results do not guarantee that offspring will be genetically abnormal (a false positive).
  • Patient requests for the transfer of embryos with a known genetic anomaly linked to a serious healthaffecting disorder are rare but do occur in the clinical setting.
  • Valid and reasoned arguments exist to support provider decisions to either assist in transferring genetically anomalous embryos or to decline to assist in such transfers. Principles of reproductive liberty, physician autonomy, professional conscience, nonmaleficence, procreative beneficence, and child welfare are potentially invoked in decision making in this area.
  • Many genetic disorders produce highly variable phenotypes in affected individuals, creating uncertainty about the health status of any live-born child as a result of embryo transfer and live birth. This uncertainty is an important factor that counsels in favor of individualized decision making rather than categorical directives once a genetic anomaly is detected.
  • In circumstances in which a child is highly likely to be born with a life-threatening condition that causes severe and early debility with no possibility of reasonable function, it is ethically acceptable for a provider to decline a patient's request to transfer such embryos. Physician assistance in the transfer of embryos in this category is ethically problematic and therefore highly discouraged.
  • In circumstances in which a child is highly likely to be born with a condition that is treatable or effectively manageable through medical interventions, it is ethically acceptable for providers to transfer such embryos upon patient request. Provider refusals to transfer embryos in this category also fall within appropriate ethical boundaries so long as they are made and applied in a nonarbitrary manner that does not discriminate against the patient on any basis.
  • Fertility clinics are strongly encouraged to make available consultation by mental health professionals, genetic counselors, or other relevant experts upon patient request or as needed.
  • Fertility clinics are strongly encouraged to draft and make available to all patients written policies on whether or not the program agrees to the transfer of embryos with known healthaffecting genetic anomalies. To the extent possible, these policies should be the product of an informed, deliberative, and collaborative process that includes all relevant clinic personnel.


INTRODUCTION

The burgeoning field of embryonic genetics enables prospective parents to learn about the genetic makeup of their preimplantation embryos, information that can both aid and complicate their reproductive decision making. Sophisticated diagnostic techniques involving embryo biopsy can currently detect several hundred genetic anomalies associated with a range of diseases whose health impacts span from benign to lethal (1). Moreover, advances in whole-genome sequencing of embryos suggest that in the near future prospective parents will have access to even more information about the genetic makeup of their preimplantation embryos, including the detection of aneuploidies, gene mutations, and mitochondrial abnormalities (2, 3). Generally, patients and their partners who utilize these genetic technologies do so for the purpose of maximizing their chances of birthing a healthy child. Preimplantation embryos that express genetic anomalies associated with significant health-affecting disorders are typically not selected for transfer into the uterus but instead are donated for research, cryopreserved, or discarded. In some cases, however, patients may request that embryos with known genetic anomalies be transferred. Such requests may be the result of prospective parents actively seeking to birth a child with a condition that one or both of the intended parents express, or it may be that all the viable embryos produced are genetically anomalous and thus represent the patient's only opportunity for biologic parenthood. Whether intentional or incidental, the discovery and request for transfer of embryos likely to result in the birth of offspring with health-affecting conditions pose ethical dilemmas for physicians and their staff, patients, and society.

This opinion proceeds in three parts. First, it discusses the clinical circumstances in which providers detect health-affecting conditions in embryos, revealing that in most cases such detection is incidental to a general request for preimplantation genetic testing but in rare cases patients actively seek to birth a child with a known genetic anomaly. Second, newly emerging data surrounding the accuracy of embryonic genetic testing are set out, not to direct clinical practices but rather to highlight the difficulties and complexities surrounding decision-making once an embryo is deemed genetically abnormal. Finally, this opinion discusses at least four separate interests that are potentially invoked when a patient requests transfer of genetically anomalous embryos. These interests are: 1) the patient's reproductive autonomy; 2) the welfare of any resulting offspring; 3) the provider's professional conscience; and 4) the impact on third parties, including the patient's family as well as the larger society. Each of these interests is considered in the context of an ethical analysis that sets out arguments for honoring patient requests and arguments for declining such requests.


DETECTION OF GENETICALLY ANOMALOUS EMBRYOS

The utilization of PGT through the techniques of preimplantation genetic PGS and PGD is an important component in many patients’ assisted reproductive efforts. According to the Centers for Disease Control, 6% of all in vitro fertilization (IVF) cycles performed in 2013 included the use of PGD, translating into approximately 10,000 procedures during that calendar year (4). Patient motivation for utilizing embryonic genetic testing varies. In one study looking at indications for PGD and PGS usage, researchers found that the primary reason patients opted for genetic testing was to detect aneuploidy, followed by elective sex selection, then diagnosis for a specific genetic abnormality, and finally to perform translocation analysis (5). Whatever the motivating indication, preimplantation genetic testing results can provide patients the specific information they seek, or it can yield unanticipated genetic information correlated with a health-affecting condition.

The detection of a genetically anomalous embryo in an IVF cycle can be an unwelcome occurrence for prospective parents. Anecdotal evidence suggests that most patients whose embryos contain a serious health-affecting genetic anomaly choose not to transfer those embryos, electing either discard or cryopreservation (6). Under certain circumstances, however, patients will request that such embryos be transferred, even when counseled about the near certainty their children will manifest symptoms of a serious genetic disorder. Three main reasons for such requests are: 1) the affected embryos are the only embryos the patient and/or her partner produced, thus providing the only opportunity for biologic parenthood; 2) the patient and/or her partner have religious or psychosocial beliefs that inform their decision to treat all their embryos with equal respect, thus permitting the transfer of genetically anomalous embryos in the face of some or no other healthy embryos; and 3) the intended parents themselves express the genetic anomaly and wish to rear children with the same characteristics. This latter scenario is sometimes referred to as ‘‘intentional diminishment’’ and primarily involves selection for sensory or mobility disorders such as deafness or achondroplasia (dwarfism) (7).

While each of the above-mentioned rationales could motivate patient requests for transfer of genetically abnormal ebryos, logic suggests the first scenario in which all embryos are affected is the most likely to present in clinical practice. Patients whose religious beliefs or other values would guide them to seek transfer of genetically anomalous embryos may be less likely to seek embryonic testing than patients for whom this information would impact decision making. While such patients may ‘‘want to know’’ in order to prepare for the birth of an affected child, other approaches to prenatal diagnostic testing are likely to be preferable. In cases in which a certain genetic anomaly is intentionally sought, patients are likely to have discussed this reproductive plan with their provider, giving the clinician an a priori opportunity to consider whether to assist or decline to assist in their reproductive efforts.

No specific formal law in the United States governs the transfer of genetically anomalous embryos. Survey research and anecdotal reports suggest that such requests are made by a very small number of patients and clinics vary in their willingness to accommodate such requests. A 2008 survey of genetic testing practices in US fertility clinics reports that 3% of clinics that provide PGT permit the technology to be used to select an embryo for the presence of a disability (8). Other clinics, in published policies, make clear they will not participate in the transfer of certain genetically anomalous embryos, citing Down syndrome and Turner syndrome as specific examples (9). Law and policymakers outside the United States have issued formal regulations on the acceptability of transferring embryos with known health-affecting conditions. In the United Kingdom, the Human Fertilisation & Embryology Authority prohibits the selection of an embryo known to ‘‘have a gene, chromosome or mitochondrial abnormality involving a significant risk that [the child] will develop a serious physical or mental disability, a serious illness, or a serious medical condition’’ (10). An exception, however, is made where there is no other embryo suitable for transfer; in such cases an anomalous embryo may be transferred.

Assisted reproductive technology (ART) clinics that offer genetic detection services should be aware of the range of choices their patients may seek to make, both in requesting genetic analysis and in seeking subsequent transfer of their embryos. Providers are encouraged to develop and make available to patients written policies regarding the testing and transferring of embryos, especially when those policies preclude patients from exercising one or more potential choices. Developing policies that best reflect a clinic's preferred approach can be a complex and difficult task. In developing transfer policies, clinics should research and consider the most up-to-date data surrounding the availability and accuracy of genetic testing technologies. Below we discuss some of the clinical uncertainties surrounding embryo testing as they impact decision making about embryo transfer. Thereafter, we set out some of the arguments that could inform a clinic's decision to assist or decline to assist in the transfer of embryos with serious health-affecting genetic anomalies. The Committee is cognizant that the term ‘‘serious health-affecting genetic anomaly’’ is subject to individual patient and provider interpretation and assessment, and that genetic disorders can vary in their penetrance, time of onset, and symptomology, but believes that certain normative thresholds do exist to shape and support guidance in most instances.


THE IMPACT OF CLINICAL UNCERTAINTY IN GENETIC TESTING OF EMBRYOS

The uncertainties of life find no refuge at its beginnings. Genetic testing of embryos can produce results that are indeterminate, inaccurate, or both. While the results obtained in genetic screening and testing of embryos are highly reliable as a percentage of biopsies performed, a certain number of misdiagnoses and adverse outcomes have been reported (11). The causes of misdiagnosis include confusion of embryo and cell number, transfer of the wrong embryo, maternal or paternal contamination, allele dropout, use of incorrect and inappropriate probes or primers, probe or primer failure, and chromosomal mosaicism. Each of these events could produce a false-negative result in which the patient is told an embryo is normal when it is not, or a false-positive result in which the patient is told an embryo is abnormal when it is not. Providers who offer genetic testing of embryos have a duty to inform patients about the limitations of testing and the possibility of misdiagnosis, as such information is clearly material to a patient's decision making and thus captured within the doctrine of informed consent.

In the specific scenario of a false-positive result stemming from chromosomal mosaicism—the situation in which an embryo contains two distinct cell lines (including the potential for both a euploid and an aneuploid cell line)—clinicians are beginning to discuss and publish reports of healthy offspring being born after PGS results indicating mosaicism. In one study, 18 women who produced only mosaic embryos were offered transfer of those embryos; of those transfers, six resulted in the birth of singleton, chromosomally healthy infants. The study authors hypothesized that the mosaic embryos either self-corrected or the aneuploid cell line had migrated to the trophectoderm and thus did not inhabit the developing infant (12). Whatever the mechanism, the ability of embryos initially classified as genetically abnormal after genetic testing to then produce genetically normal offspring is both fascinating and confounding. Additional research may illuminate the extent to which mosaic embryos should no longer be considered highly likely to result in the birth of a chromosomally abnormal infant.

Further institutional review board-guided research is clearly warranted. Pending evidence-based clinical recommendations, providers may struggle with how best to inform and treat their patients. Arguments for and against transferring genetically anomalous-presenting embryos cluster around a host of factors, including whether there are other embryos that are deemed normal in the cohort under consideration, whether the anomaly is lethal—meaning it is highly likely to either not implant or result in an early miscarriage—and what preferences the patient has expressed. At the time genetic testing results are obtained, it generally is not possible to know whether those results include false positives or false negatives; therefore, providers are best served by developing transfer policies that, unless they have reason to believe otherwise, assume the clinical accuracy of a given result. What follows is a framework for developing clinic policies to either assist or refuse to assist in the transfer of embryos presumed to be genetically anomalous.


ARGUMENTS FOR HONORING PATIENT REQUESTS FOR TRANSFER

Arguments for honoring patient requests to transfer embryos with serious health-affecting genetic anomalies dwell primarily, though not exclusively, in the realm of reproductive liberty and patient autonomy. Additional arguments focus on the overall benefit to the affected child from being born as opposed to never being born. Described more fully below, these positions might be labeled by their governing value: 1) reproductive liberty, 2) equal protection, 3) preemptive dispositional authority, and 4) the benefits of existence.

The importance and accompanying legal protections surrounding patient autonomy and reproductive liberty in the practice of reproductive medicine have long guided patient/physician relationships in the field. This Committee has acknowledged that some requests for assistance in reproduction may include features that are material to a patient's decision making for reasons that are deeply private and deserving of respect (13). Parents who request transfer of genetically anomalous embryos may so choose because it is their only opportunity for biologic parenthood, or they are willing to rear a child with an impaired health status, or they desire a child who mirrors their own health experience, or they are unwilling to discard, donate for research, or cryopreserve. Each of these rationales is compatible with the exercise of reproductive liberty, and infringements by physicians should be avoided. According robust protection of reproductive liberty may be particularly vital in the disability community where discrimination and barriers to ART access have been previously documented (14).

Applying an equality model lens, an argument arises that physicians, governments, and society should make no distinction in the treatment of fertile and infertile prospective parents. Just as fertile individuals are free to conceive and birth a child with serious, even lethal, health conditions without third-party interference, individuals who seek or require assistance in reproduction should likewise enjoy this same freedom. The notion that certain individuals should be prohibited from reproducing or forced to terminate ongoing pregnancies because their offspring are deemed ‘‘unworthy’’ of participation in the human race is deeply repugnant to our contemporary values, harkening to long-rejected eugenics-era tenets (15). Treating all prospective parents and their potential offspring as equally worthy is consistent with honoring patient requests to transfer genetically anomalous embryos.

A third argument rests on the issue ofwho possesses dispositional authority over preimplantation embryos. Embryos awaiting possible transfer are, by definition, extracorporeal and thus theoretically subject to claims of control by the intended parents, progenitors (in the case of gamete donation), or clinic personnel. While disputes between intended parents and physicians as to the disposition of embryos are rare, in at least one case a court awarded full control to the intended parents, deeming the fertility clinic to occupy the role of bailee whose sole responsibility was to exercise reasonable care over the bailment subject (16). Applying this holding to instances in which the wisdom of transfer is disputed, patients could assert their superior dispositional authority over the embryos in question, and correspondingly obtain transfer as an exercise of their established legal rights, dominion, and control.

A final argument in favor of honoring patient requests for embryo transfer derives from philosophical precepts that illuminate the comparative value of human existence versus nonexistence. If one views human life, no matter its quality or quantity, as an absolute good, then its deprivation could be said to work an overall harm—to those denied the opportunity to parent that child and possibly to society. A slight variation of this view would be to deem certain lives not worth living, due to extreme pain and suffering or lack of any interactive cognitive abilities, and thus not bringing such a person into existence would not be deemed an overall harm. In the context of embryo transfer, there may be a clash of values between the provider and the intended parents as to whether that prospective child would have a life not worth living. Complicating this analysis are the unknowns about the life the child will actually lead and the weight, if any, to be accorded the parents' preference for existence over nonexistence. This argument attaches to each embryo regardless of the availability of one or more embryos for transfer. It is the value of the embryo and its potential to evolve into a resulting child that is at stake, not the relative health or well-being of that offspring compared to other possible lives. The presentation of these philosophical quandaries in clinical practice by no means guarantees their resolution; rather, highlighting the declared interests and potential benefits and harms to the patient and the child to be born may facilitate a provider's understanding of the complexities inherent in the transfer of genetically anomalous embryos.

Arguments in favor of honoring patient requests for transfer of genetically anomalous embryos can gain and lose in strength depending upon a host of clinical factors, including whether other unaffected embryos are available for transfer, whether the child is highly likely to be born with a life-threatening condition that causes severe and early debility with no possibility of reasonable function, whether the intended parents are desirous of raising a child with conditions similar to their own, and whether the intended parents are in accord with each other about the appropriateness of transfer. Providers who agree to honor patient requests for transfer of genetically anomalous embryos should discuss the limits, if any, of their willingness to provide treatment as well as the expected health complications a resulting child is likely to experience. This latter duty can be fulfilled by referral to a specialist trained in the particular disease process at issue.


ARGUMENTS FOR DECLINING PATIENT REQUESTS FOR TRANSFER

Arguments for declining patient requests for genetically anomalous embryo transfer collect around the principles of physician autonomy and professional duties, and the welfare of ART offspring. A minor but extant additional factor is the possibility of incurring legal or professional liability in the future for assisting a patient in a way that works harm to another. The governing values that comprise these arguments might be summarized as: 1) physician autonomy and professional conscience, 2) reproductive nonmaleficence, 3) procreative beneficence, 4) offspring and societal well-being, and 5) liability avoidance.

The concept that a physician is free to determine whether or not to enter into a doctor-patient relationship with a prospective patient is embedded in medical ethics and health law. The American Medical Association recognizes physician autonomy in the selection of patients as a basic principle of medical ethics (17). Once a relationship is formed, physicians are not obligated tomeet every patient demand, with particular examples arising in the context of nonbeneficial treatment or treatment that poses harm to another (18, 19). Further, physicians’ values, personal backgrounds, and professional experiences—informing their professional conscience—might counsel against transferring a particular embryo even in the face of a sincerely held patient belief that the child should be given an opportunity to be born. Exercises of physician autonomy and professional conscience that are nonarbitrary and do not discriminate against the patient on any basis, and that can be accomplished without inflicting harm or abandonment upon the patient, should be accommodated. Solutions might include transferring the patient to another willing provider or transferring the affected embryo(s) to a clinic willing to make the requested transfer.

The precept of reproductive nonmaleficence describes a physician's obligation not to inflict harmin the course of delivering reproductive health care (19, 20). Transferring an embryo that is highly likely to result in the birth of a child with a serious disease or disability can be interpreted as the physician causing harm by facilitating the birth of an unhealthy person. At the same time, it should be acknowledged that the physician is not responsible for causing the genetic anomaly and it is the anomaly that directly causes harm to the resulting child. A further interpretation of the principle of nonmaleficence might include a duty to prevent or avoid harm (19, 20). Under this configuration, a stronger argument can be made that assisting in the transfer of genetically anomalous embryos violates the principle of nonmaleficence because the physician can avoid the harm to an affected child by refusing to transfer the particular embryo.

Philosophical discourse offers a counterpoint to the ‘‘do no harm’’ principle in the form of a theory dubbed procreative beneficence. This theory posits that prospective parents (in conjunction with their reproductive medicine collaborators) have a moral duty to select the child, of the possible children they could have, who is expected to have the best life, based on available information (21). This edict to ‘‘do good, whenever possible’’ argues against transferring genetically anomalous embryos when at least one unaffected embryo remains for possible transfer. Such is the policy adopted in the United Kingdom that prohibits the selection of a health-affected genetically anomalous embryo, except when there is no other embryo ‘‘suitable for transfer’’ (1). The acknowledged weakness of procreative beneficence is in determining what constitutes the ‘‘best child’’ and the ‘‘best life.’’ If the intended parents alone are vested with this decisional authority, their good faith judgment about what would constitute their best child may be preemptive of a provider's conflicting view. A decision to transfer an abnormal rather than a normal embryo would, however, still be considered in violation of procreative beneficence,  which measures the ‘‘best life’’ in terms of health and well-being.

Child welfare concerns occupy an important role in reproductive medicine. This Committee has previously addressed offspring health and well-being as a factor in provider decision making about whether to agree or decline to provide treatment under certain circumstances (22). When a provider has a substantial basis for thinking that treating an intended parent will result in significant harm to a future child, this Committee has supported such treatment denials. Similarly, when an embryo is highly likely to give rise to a child who will suffer significantly from a disease or disorder, a strong argument exists that providers can ethically decline to participate in the embryo's transfer. Additional concerns about harms to society from the birth of children with diseases or disabilities can be made, but are highly problematic as arguable affronts to principles of justice and nondiscrimination. The value of child welfare concerns as a basis for declining embryo transfer are further complicated by the possibility of a provider's mistaken judgment about the likely capabilities or quality of life of the prospective child.

Finally, it is reasonable for providers to have concerns about potential legal or professional liability for assisting in the transfer of embryos that result in the birth of a seriously health-affected child. While the intended parents may agree to waive any future claims against an assisting physician, no such waiver can be made on behalf of a future child or a professional licensing authority or society charged with maintaining high standards within the practice of reproductive medicine. Legal scholars have postulated that civil and even criminal claims may be available against providers who knowingly assist in the birth of a genetically unhealthy child whose status was known prior to embryo transfer (23, 24). The prospect of future liability should not deter a provider from acting in the best interest of his or her patient. At the same time, providers who are in a legitimate position to exercise discretion over treatment decisions may reasonably consider their potential liability for providing or refusing to provide care. Such liability could attach when care is provided or when it is withheld.


RECOMMENDATIONS

Patient requests to transfer embryos known to express serious health-affecting genetic anomalies raise clinical, ethical, and legal dilemmas that impact a variety of ART stakeholders, including patients and their partners, providers, offspring, and society. The rare but small chance that an embryo deemed abnormal through genetic testing will result in the birth of a genetically normal child, coupled with the phenotypic variability associated with some genetic disorders, creates challenges for providers striving to counsel patients about the risks and benefits of their reproductive options. Additionally, patient preferences, values surrounding health and disease, expectations, and options for parenthood impact their decision whether or not to seek transfer, or some other disposition, when an embryo is deemed genetically anomalous.

Valid and reasoned arguments exist to support provider decisions to assist in transferring genetically anomalous embryos, and in declining to assist in such transfers. Principles of reproductive liberty, physician autonomy, and child welfare are invoked in this clinical setting, creating challenges in the prioritization and application of these and other principles as clinics work to establish guiding policies. Fertility clinics are strongly encouraged to draft and make available to all patients their written policies on the transfer of embryos with known health-affecting genetic anomalies. To the extent possible, these policies should be the product of an informed, deliberative, and collaborative process that includes all relevant clinic personnel. Furthermore, patients should be made aware of these policies prior to starting a treatment cycle that may result in the creation of genetically anomalous embryos, so that they are fully informed of their options as early as possible.

The Ethics Committee concludes that in circumstances in which a child is highly likely to be born with a lifethreatening condition that causes severe and early debility with no possibility of reasonable function, it is ethically acceptable to refuse to transfer such embryos upon patient request. Physician assistance in the transfer of embryos in this category is ethically problematic and therefore highly discouraged. This conclusion is consonant with prior Committee analysis that physicians may be morally obligated to withhold services when significant harm to future children is likely (22). In other circumstances in which a child is highly likely to be born with a condition that is treatable or effectively manageable through medical interventions, it is ethically acceptable for providers to adopt a policy that they will transfer such embryos upon patient request. Providers who agree to honor patient requests for transfer of embryos in this category should discuss the limits, if any, of their willingness to provide treatment as well as the expected health complications a resulting child is likely to experience. Provider refusals to transfer embryos in this category also fall within appropriate ethical boundaries so long as they are made and applied in a nonarbitrary manner that does not discriminate against the patient on any basis. The presence or absence of one or more unaffected or healthy embryos can be taken into account in generating clinic policies. Finally, clinics are strongly encouraged to make available consultation by mental health professionals, genetic counselors, or other relevant specialists and experts upon patient request or as needed.


Acknowledgments:

This report was developed by the Ethics Committee of the American Society for Reproductive Medicine as a service to its members and other practicing clinicians. While this document reflects the views of members of that Committee, it is not intended to be the only approved standard of practice or to dictate an exclusive course of treatment in all cases. This report was approved by the Ethics Committee of the American Society for Reproductive Medicine and the Board of Directors of the American Society for Reproductive Medicine.

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. All Committee members disclosed commercial and financial relationships with manufacturers or distributors of goods or services used to treat patients. Members of the Committee who were found to have conflicts of interest based on the relationships disclosed did not participate in the discussion or development of this document.

Judith Daar, J.D.; Jean Benward, M.S.W.; Lee Collins, J.D.; Joseph Davis, D.O.; Leslie Francis, Ph.D., J.D.; Elena Gates, M.D.; Elizabeth Ginsburg, M.D.; Sigal Klipstein, M.D.; Barbara Koenig, Ph.D.; Andrew La Barbera, Ph.D., H.C.L.D.; Laurence McCullough, Ph.D.; Richard Reindollar, M.D.; Mark Sauer, M.D.; Rebecca Sokol, M.D., M.P.H.; Sean Tipton, M.A.; Lynn Westphal, M.D.

REFERENCES

  1. Human Fertilisation and Embryology Authority. PGD conditions licensed by the HFEA. Available at: http://guide.hfea.gov.uk/pgd/. Accessed January 20, 2017.
  2. Wells D, Kaur K, Glassner M, Grifo J, Fragouli E, Munne S. Whole–genome sequencing technology for the assessment of embryo genetics and viability. Fertil Steril 2013;100:S132–3.
  3. Deleye L, Dheedene A, De Coninck D, Sante T, Christodoulou C, Heindryckx B, et al. Shallow whole genome sequencing is well suited for the detection of chromosomal aberrations in human blastocysts. Fertil Steril 2015;104:1276–85.
  4. Centers for Disease Control and Prevention. 2012 assisted reproductive technology national summary report, Available at: http://www.cdc.gov/art/pdf/2012–report/national–summary/art_2012_national_summary_report.pdf;2014, Accessed January 20, 2017.
  5. Ginsburg ES, Baker VL, Racowsky C, Wantman E, Goldfarb J, Stern JE. Use of preimplantation genetic diagnosis and preimplantation genetic screening in the United States: a Society for Assisted Reproductive Technology Writing Group paper. Fertil Steril 2011;96:865–8.
  6. Sanghavi DM. Wanting babies like themselves, some parents choose genetic defects. NY Times 2006;F5 2006.
  7. Cohen IG. Intentional diminishment, the non–identity problem, and legal liability. Hastings L J 2008–09;60:347–75.
  8. Baruch S, Kaufman D, Hudson KL. Genetic testing of embryos: practices and perspectives of US in vitro fertilization clinics. Fertil Steril 2008;89:1053–8.
  9. Center for Human Reproduction. Transferring supposedly chromosomally ‘‘abnormal’’ embryos in an IVF cycle, Available at: https://www.centerforhumanreprod.com/fertility/transferring–supposedly–chromosomally–abnormal–embryos–ivf–cycle/; 2014, Accessed January 20, 2017.
  10. Human Fertilisation and Embryology Authority. Embryo testing and sex selection. Available at: http://www.hfea.gov.uk/496.html. Accessed June 17, 2015.
  11. Wilton L, Thornhill A, Traeger–Synodinos J, Sermon KD, Harper JC. The causes of misdiagnosis and adverse outcomes in PGD. Hum Reprod 2008;24:1221–8.
  12. Greco E, Minasi MG. Healthy babies after intrauterine transfer of mosaic aneuploidy blastocysts. New Eng J Med 2015;373:2089–90.
  13. Ethics Committee of the American Society for Reproductive Medicine. Use of reproductive technology for sex selection for nonmedical reasons. Fertil Steril 2015;103:1418–22.
  14. National Council on Disabilities. Rocking the cradle: ensuring the rights of parents with disabilities and their children, Available at: http://www.ncd.gov/publications/2012/Sep272012/; 2012, Accessed January 20, 2017.
  15. Lombardo PA. Three generations: No imbeciles. Baltimore, MD: Johns Hopkins University Press; 2008.
  16. York v. Jones, 717 F. Supp. 421 (E.D. Va. 1989).
  17. American Medical Association, Principles of Medical Ethics IX (adopted June 1957, revised 1980, 2001). Available at: http://www.cirp.org/library/ethics/AMA/. Accessed January 20, 2017.
  18. Ethics Committee of the American Society for Reproductive Medicine. Fertility treatment when the prognosis is very poor or futile: a committee opinion. Fertil Steril 2012;98:e6–9.
  19. Kolthoff M. Assisted reproduction and primum non nocere. Virtual Mentor 2007;9:605–10.
  20. Beauchamp T, Childress J. Principles of Biomedical Ethics. 5th ed. New York, NY: Oxford University Press; 2001:112–5.
  21. Savulescu J. Procreative beneficence: why we should select the best children. Bioethics 2001;15:413–26.
  22. Ethics Committee of the American Society for Reproductive Medicine. Child–rearing ability and the provision of fertility services. Fertil Steril 2013;100:50–3.
  23. Smolensky KR. Creating children with disabilities: parental tort liability for preimplantation genetic intervention. Hastings L.J. 2008;60:299–346.
  24. Appel JM. Genetic screening and child abuse: can PGS rise to the level of criminality? U.M.K.C. L. Rev 2011;80:373–98.

Topic Resources

View more on the topic of genetic screening/testing

Use of preimplantation genetic testing for monogenic adult-onset conditions: an Ethics Committee opinion (2024)

Preimplantation genetic testing for monogenic diseases for adult-onset conditions is ethically permissible for various conditions, including when the condition is fully penetrant or confers disease predisposition. View the Committee Opinion
Coding Icon

Codes for Embryo Biopsy

When doing a preimplantation genetic test (PGT) biopsy, can you bill for each day a biopsy is performed or can you only bill once for the cycle? View the Answer
Podcast Icon

Fertility and Sterility On Air - Live from ESHRE 2024: Part 2

Explore fresh embryo transfers, progesterone elevation, and day-seven embryo utility from experts at ESHRE 2024. Cutting-edge fertility insights await! Listen to the Episode
Document Icon

The use of preimplantation genetic testing for aneuploidy: a committee opinion (2024)

PGT-A use in the U.S. is rising, but its value as a routine IVF screening test is unclear, with mixed results from various studies. View the Committee Opinion
Podcast Icon

Fertility and Sterility On Air - TOC: July 2024

Articles this month include: predicting ART complications, laser assisted hatching on vitrified blastocysts, predictive models of miscarriage and more.
Listen to the Episode
Podcast Icon

Fertility and Sterility On Air - TOC: May 2024

Topics this month include Iatrogenic and demographic determinants of the national plural birth increase, outcomes between ICSI and IVF with PGT-A. Listen to the Episode
Videos Icon

Journal Club Global: Recent clinical trials in Fertility and Sterility from the Asia Pacific region

Join ASPIRE 2024 for a Journal Club Global on PGT-A and IVF. Learn from top experts discussing recent clinical trial data and pregnancy outcomes View the Video
Coding Icon

Coding for an endometrial biopsy/Mock cycle

We had patients request us to bill their insurance for the two monitoring visits and the Endo BX and change the diagnosis code to something that is payable.  View the Answer
Podcast Icon

Fertility and Sterility On Air - Unplugged: March 2024

Topics include: melatonin and implantation (4:38), whole-genome screening of embryos, and bioengineering assisted reproductive technology. Listen to the Episode
Videos Icon

Journal Club Global: Cost effectiveness analyses of PGT-A

Infertility treatments can be financially burdensome, often without insurance coverage, making understanding the cost effectiveness of PGT-A crucial. View the Video
Coding Icon

Coding PGT requisitions to the PGT lab

Do you have any recommended codes to use for PGT requisitions to the PGT lab?   View the Answer
Document Icon

Clinical management of mosaic results from preimplantation genetic testing for aneuploidy of blastocysts: a committee opinion (2023)

This document incorporates studies about mosaic embryo transfer and provides evidence-based considerations for embryos with mosaic results on PGT-A. View the Committee Opinion
Videos Icon

Journal Club Global - Revisiting the STAR trial: The Fellows debate PGT-A

We are excited to host a debate covering the pros and cons of PGT-A and how new technologies should be validated before clinical implementation. View the Video
Coding Icon

Sperm DNA Fragmentation

Is there a CPT code for HALO DNA Fragmentation for sperm? View the Answer
Coding Icon

Results Review

What CPT code is most appropriate to submit for Physician Time to review CCS/PGS/PGD results? View the Answer
Coding Icon

ICSI and Embryo Biopsy

How to bill for ICSI or embryo biopsies that occur in different days?  View the Answer
Coding Icon

Embryo Biopsy

Have any new codes been introduced for the lab portion of PGT? View the Answer
Coding Icon

Embryo Biopsy Embryologist Travel Costs

Can we bill insurance for the biopsy procedure? Can we bill for travel expenses? View the Answer
Coding Icon

Genetic Counseling

Does ASRM have any guidance for how to bill for genetic counseling services provided by a genetic counselor?
View the Answer
Coding Icon

Assisted Zona Hatching

Can assisted hatching and embryo biopsy for PGT-A; PGT-M or PGT-SR be billed during the same cycle? View the Answer
Document Icon

Indications and management of preimplantation genetic testing for monogenic conditions: a committee opinion (2023)

ASRM has updated its opinion on PGT for monogenic conditions, providing guidance on clinical and technical complexities. View the Committee Opinion
Videos Icon

Journal Club Global - PGT-A - Can non-invasive approaches based on spent medium analysis

PGT-A by trophectoderm biopsy aims to select available euploid embryos for transfer. View the Video
Document Icon

ASRM müllerian anomalies classification 2021

The Task Force set goals for a new classification and chose to base it on the iconic AFS classification from 1988 because of its simplicity and recognizability. View the Committee Opinion
Videos Icon

Journal Club Global - Accuracy of Preimplantation Genetic Testing for Aneuploidies

One of the highest aspirations in reproductive medicine is to develop a technology allowing for ID of embryos that have true reproductive potential.
View the Video
Document Icon

Reproductive and hormonal considerations in women at increased risk for hereditary gynecologic cancers: Society of Gynecologic Oncology and American Society for Reproductive Medicine Evidence-Based Review (2019)

Providers who care for women at risk for hereditary gynecologic cancers must consider the impact of these conditions. View the Joint Statement
Document Icon

Disclosure of sex when incidentally revealed as part of preimplantation genetic testing (PGT): an Ethics Committee opinion (2018)

Clinics may develop a policy to disallow selecting which embryos to transfer based on sex and choose to use only embryo quality as selection criteria. View the Committee Opinion
Document Icon

Use of preimplantation genetic testing for monogenic defects (PGT-M) for adult-onset conditions: an Ethics Committee opinion (2018)

Preimplantation genetic testing for monogenic diseases for adult-onset conditions is ethically permissible for a range of conditions including when the condition is serious and no safe, effective interventions are available. View the Committee Document
Document Icon

Transferring embryos with genetic anomalies detected in preimplantation testing: an Ethics Committee Opinion (2018)

Patient requests for transfer of embryos with genetic anomalies linked to serious health-affecting disorders detected in preimplantation testing are rare but do exist. View the Committee Document
Document Icon

Best practices of ASRM and ESHRE: a journey through reproductive medicine (2012)

ASRM and ESHRE are the two largest societies in the world whose members comprise the major experts and professionals working in reproductive medicine. View the Committee Joint Guideline
Membership Icon

Preimplantation Genetic Testing Special Interest Group (PGTSIG)

The ASRM PGTSIG coordinates research, education, and training in preimplantation genetic diagnosis (PGT). Learn more about the PGTSIG

Topic Resources

View more on the topic of embryo transfer
Coding Icon

How to bill for an FET

Is there a new update to the 89272 code that allows its use without View the Answer
Podcast Icon

Fertility and Sterility On Air - TOC: August 2024

Stay informed with Fertility and Sterility On Air, discussing the latest research on reproductive medicine, obesity, Turner syndrome, and cutting-edge fertility treatments. Listen to the Episode
Coding Icon

Billing Physician vs Service Physician

What physician’s name must be on the treatment notes and who we are permitted to bill to insurance for:   View the Answer
Podcast Icon

Fertility and Sterility On Air - Live from ESHRE 2024: Part 2

Explore fresh embryo transfers, progesterone elevation, and day-seven embryo utility from experts at ESHRE 2024. Cutting-edge fertility insights await! Listen to the Episode
Coding Icon

Who to bill for gestational carrier services if intended parents have insurance?

I wanted to inquire about guidelines for billing services to a surrogate’s insurance company if intended parents purchased the insurance coverage.  View the Answer
Podcast Icon

Fertility and Sterility On Air - TOC: June 2024

Covering articles on embryo transfer, PIEZO-ICSI, pregnancy outcomes, oocyte maturity, estradiol levels, and ovarian carcinoma and more! Listen to the Episode
Podcast Icon

Fertility and Sterility On Air - TOC: May 2024

Topics this month include Iatrogenic and demographic determinants of the national plural birth increase, outcomes between ICSI and IVF with PGT-A. Listen to the Episode
Coding Icon

Coding for an endometrial biopsy/Mock cycle

We had patients request us to bill their insurance for the two monitoring visits and the Endo BX and change the diagnosis code to something that is payable.  View the Answer
PR Bulletin Icon

IVF-assisted pregnancies constitute 2.5% of all births in 2022

In 2022, the number of babies born from IVF increased from 89,208 in 2021 to 91,771 in 2022. This means that 2.5% of births in the US are a result of ART.

View the Press Release
Videos Icon

Journal Club Global - Actualización en la suplementación con progesterona en fase lútea para transferencias de embriones congelados

Efectividad del rescate de progesterona en mujeres que presentan niveles bajos de progesterona circulante alrededor del día de la transferencia de embriones View the Video
Videos Icon

Journal Club Global: Transferencia de embriones frescos versus congelados: ¿Cuál es la mejor opción

Los resultados de nuevas técnicas de investigación clínica que utilizan información de bancos nacionales de vigilancia médica.   View the Video
Coding Icon

CPT 89253 and 89254 for Assisted hatching

Can I bill CPT codes 89253 and 89254 together? If yes, do I need a modifier on any of the codes? View the Answer
Coding Icon

US Embryo Transfer

At the meeting, we learned about the CPT code 76705-Ultasound guidance for embryo transfer, can this code be billed with CPT code 76942? View the Answer
Coding Icon

US Embryo Transfer in Surgery Center

Can we use code 76998 for the ultrasound guidance as this patient is being seen in the Surgery Center? View the Answer
Coding Icon

US Embryo Transfer-Transmyometrial

How would you code for an ultrasound- guided transvaginal-transmyometrial test transfer of embryo catheter? View the Answer
Coding Icon

Uterine Sounding

Is there any specific CPT code(s) for uterine sounding? (Referring to cannulating the cervix and “sounding” or measuring the uterine height)  View the Answer
Coding Icon

Trial Transfer

Can you advise the proper coding process for a trial transfer? View the Answer
Coding Icon

IVF Lab vs Physician Practice Billing

We are planning to open an IVF lab that is not contracted with insurance companies. View the Answer
Coding Icon

In Vitro Maturation

Have CPT codes been established for maturation in vitro? View the Answer
Coding Icon

IVF Case Rates

What ICD-10 codes apply to case rates? View the Answer
Coding Icon

Monitoring FET

What is the correct diagnosis code to use on the follicle ultrasound (76857) for a patient who is undergoing frozen embryo transfer (FET)? View the Answer
Coding Icon

Embryo Thawing/Warming

Is it allowable to bill 89250 for the culture of embryos after thaw for a frozen embryo transfer (FET) cycle? View the Answer
Coding Icon

Endometrial Biopsy/Scratch

What CPT code should be used for a “scratch test”?  View the Answer
Coding Icon

D&C Under Ultrasound Guidance

What are the CPT codes and ICD-10 codes for coding a surgical case for a patient with history of Stage B adenocarcinoma of the cervix ... View the Answer
Coding Icon

Elective Single Embryo Transfer

Has any progress been made in creating/obtaining a specific CPT code for an elective single embryo transfer (eSET)?  View the Answer
Coding Icon

Assisted Hatching Billed With Embryo Biopsy

Do you know if both assisted hatching (89253) and embryo biopsy for PGS/PGD/CCS (89290/89291) can be billed during the same cycle?  View the Answer
Coding Icon

Embryo Transfer

A summary of Embryo Transfer codes collected by the ASRM Coding Committee View the Coding Summary
Videos Icon

Journal Club Global Live from PCRS - Non-Invasive Embryo Selection Techniques

The next great frontier in reproductive medicine is how to non-invasively select an embryo with the highest reproductive potential for transfer. View the Video
Videos Icon

Journal Club Global - Should Fellows Perform Live Embryo Transfers in Fellowship?

Few things are more taboo in reproductive medicine fellowship training than allowing fellows to perform live embryo transfers. View the Video
Videos Icon

Journal Club Global Live from ASRM - Optimal Management of the Frozen Embryo Transfer Cycle: Insights From Recent Literature

Three recent papers published in the Fertility and Sterility family of journals, all explore different aspects of optimizing frozen embryo transfer cycles. View the Video
Document Icon

Guidance on the limits to the number of embryos to transfer: a committee opinion (2021)

ASRM's guidelines for the limits on the number of embryos to be transferred during IVF cycles have been further refined ... View the Committee Opinion
Document Icon

Compassionate transfer: patient requests for embryo transfer for nonreproductive purposes (2020)

A patient request to transfer embryos into her body in a location or at a time when pregnancy is highly unlikely ... View the Committee Opinion
Document Icon

Blastocyst culture and transfer in clinically assisted reproduction: a committee opinion (2018)

The purposes of this document is to review the literature regarding the clinical application of blastocyst transfer. View the Committee Opinion
Document Icon

Transferring embryos with genetic anomalies detected in preimplantation testing: an Ethics Committee Opinion (2018)

Patient requests for transfer of embryos with genetic anomalies linked to serious health-affecting disorders detected in preimplantation testing are rare but do exist. View the Committee Document
Document Icon

Performing the embryo transfer: a guideline (2017)

A systematic review of the literature was conducted which examined each of the major steps of embryo transfer. Recommendations made for improving pregnancy rates are based on interventions demonstrated to be either beneficial or not beneficial. (Fertil Steril® 2017;107:882–96. ©2017 by American Society for Reproductive Medicine.) View the Committee Guideline
Document Icon

ASRM standard embryo transfer protocol template: a committee opinion (2017)

Standardization improves performance and safety of embryo transfer View the Committee Opinion

Ethics Opinions

Ethics Committee Reports are drafted by the members of the ASRM Ethics Committee on the tough ethical dilemmas of reproductive medicine.

Use of preimplantation genetic testing for monogenic adult-onset conditions: an Ethics Committee opinion (2024)

Preimplantation genetic testing for monogenic diseases for adult-onset conditions is ethically permissible for various conditions, including when the condition is fully penetrant or confers disease predisposition.
Ethics Committee teaser

Family members as gamete donors or gestational carriers: an Ethics Committee opinion (2024)

The use of adult intrafamilial gamete donors and gestational surrogates is ethically acceptable when all participants are fully informed and counseled.
Ethics Committee teaser

Financial ‘‘risk-sharing’’ or refund programs in assisted reproduction: an Ethics Committee opinion (2023)

Financial ‘‘risk-sharing’’ fee structures in programs charge patients a higher initial fee but provide reduced fees for subsequent cycles.
Ethics Committee teaser

Planned oocyte cryopreservation to preserve future reproductive potential: an Ethics Committee opinion (2023)

Planned oocyte cryopreservation is an ethically permissible procedure that may help individuals avoid future infertility.

More Resources

MAC 2021 teaser
ASRM Academy on the Go

ASRM MAC Tool 2021

The ASRM Müllerian Anomaly Classification 2021 (MAC2021) includes cervical and vaginal anomalies and standardize terminology within an interactive tool format.

View the MAC Tool
EMR Phrases teaser
Practice Guidance

EMR Shared Phrases/Template Library

This resource includes phrases shared by ASRM physician members to provide a template for individuals to create their own EMR phrases.

View the library
Practice Committee Documents teaser

ASRM Practice Documents

These guidelines have been developed by the ASRM Practice Committee to assist physicians with clinical decisions regarding the care of their patients.

View ASRM Practice Documents
Ethics Committee teaser

ASRM Ethics Opinions

Ethics Committee Reports are drafted by the members of the ASRM Ethics Committee on the tough ethical dilemmas of reproductive medicine.

View ASRM Ethics Opinions
Coding Corner general teaser
Practice Guidance

Coding Corner Q & A

The Coding Corner Q & A is a list of previously submitted and answered questions from ASRM members about coding. Answers are available to ASRM Members only.

View the Q & A
Covid-19 teaser
Practice Guidance

COVID-19 Resources

A compendium of ASRM resources concerning the Novel Corona virus (SARS-COV-2) and COVID-19.

View the resources
Couple looking at laptop for online patient education materials

Patient Resources

ReproductiveFacts.org provides a wide range of information related to reproductive health and infertility through patient education fact sheets, infographics, videos, and other resources.

View Website