IVF Industry Regulation in the United States: Changes Are Needed to Protect Embryonic Children and their Families

This is Issue 101 of the On Point Series. 

Executive Summary

• Federal, state, and professional regulations provide a very limited patchwork of protections for IVF patients, let alone their unborn children created through the procedure.

• There is a need for improved regulation of the IVF industry, both federally and at the state level, considering there are no industry regulations apart from unenforceable recommendations by professional societies.

• Federal policies that could improve the regulation of IVF include (among others) protecting excess human embryos from destruction; requiring the reporting of adverse events and the number of human embryos created and discarded, donated, or frozen per cycle; ensuring that patients provide fully informed consent; and researching the effects of IVF on the health of the women and children involved.

• In addition to implementing the protections and reporting above regarding human embryos and patient health, specific state policies that could also improve the regulation of IVF include (among others) adopting and enforcing the CDC’s “model program for the certification of embryo laboratories” or a similar program that includes health and safety standards; certifying and regularly inspecting IVF providers; and requiring reporting of data relevant to the safety and health of all involved in or conceived through IVF.

In LePage v. The Center for Reproductive Medicine, the Alabama Supreme Court held that the plaintiffs, parents of embryonic children who were killed by a patient at a hospital where the embryos were kept in a cryogenic nursery, can sue the hospital and the fertility clinic that was responsible for the embryos’ care. Writing for the Court, Justice Mitchell explicitly refrained from opining on any legal, moral, or ethical issues pertaining to in vitro fertilization (“IVF”).^[1] Yet, within a week, three fertility clinics had paused providing IVF in response to the Court’s decision. This prompted Alabama legislators to hurriedly draft and pass legislation that immunizes fertility clinics and personnel from civil or criminal liability so that the clinics would resume IVF. This recklessly drafted legislation, which is now law, provides immunity to fertility clinics and clinicians that no other medical facilities or practitioners enjoy.

Further, because abortion advocates and many in the fertility industry and media have lied about the scope of LePage and have led the public to believe that IVF is at risk of being banned, “protecting” IVF has become a national campaign issue. If the present unnecessary panic leads to the enactment of a federal law^[2] that authorizes taxpayer funding for IVF, mandates private insurance coverage for IVF, prohibits oversight or regulation of the fertility industry by states, and/or insulates the industry from the courts without consideration of embryo safety, the results for families seeking IVF may be catastrophic. Billions in new taxpayer and private insurance dollars should not be pumped into IVF clinics that lack enforceable reporting requirements, safety protocols, and ethical guidelines. And, without question, injured families should never be stripped of their rights to seek redress in courts.

This paper examines the current legal and regulatory landscape related to IVF in the United States, specifically: (I) the grossly misunderstood Alabama Supreme Court decision in LePage v. The Center for Reproductive Medicine, (II) the fertility industry’s draconian reaction to the decision, (III) the rushed response by Alabama lawmakers, (IV) current IVF regulatory shortcomings, and (V) how the federal and state governments should address concerns now.

I. LePage et al. v. The Center for Reproductive Medicine, P.C.[3]

 On February 16, 2024, the Alabama Supreme Court held that three sets of parents could sue under Alabama’s Wrongful Death of a Minor Act following the deaths of their embryonic children.  These parents had conceived children through in vitro fertilization (“IVF”) at The Center for Reproductive Medicine, P.C. (“the Center”), which kept their embryos alive in a “cryogenic nursery” that was in the same building as the Mobile Infirmary Medical Center (“hospital”). In December 2020, a hospital patient entered the Center’s cryogenic nursery, removed the plaintiffs’ embryos, and then dropped them, killing them.^[4]

Justice Mitchell wrote for the Court that the “Wrongful Death of a Minor Act applies to all unborn children, regardless of their location,” and thus applies to embryos conceived through IVF and kept in cryogenic nurseries.^[5] The Wrongful Death of a Minor Act provides a civil remedy to parents “[w]hen the death of a minor child is caused by the wrongful act, omission, or negligence of any person, persons, or corporation, or the servants or agents of either…”^[6] The Court in LePage held that the 1872 Act had been consistently interpreted to protect unborn children and, “under existing black-letter law,” there was no exception to the Act for “extrauterine children – that is, unborn children who are located outside of a biological uterus at the time they are killed.”^[7]

Importantly, the outcome of this case was not based on any changes in abortion law in Alabama. In fact, the cases cited by the Court which had affirmed parents’ rights to seek civil redress following the wrongful deaths of their unborn children were decided years before the U.S. Supreme Court overturned Roe v. Wade and the state enacted stronger protections for unborn infants.^[8] The decision in LePage affirms Alabama’s long history of defending parental rights when a third party commits a wrongful act, omission, or negligence that results in the death of a child, born or unborn.

Justice Mitchell also clarified that the Court’s decision does not implicate the regulation or legality of IVF:

The parties to these cases have raised many difficult questions, including ones about the ethical status of extrauterine children, the application of the 14th Amendment to the United States Constitution to such children, and the public-policy implications of treating extrauterine children as human beings. But the Court today need not address these questions because, as explained below, the relevant statutory text is clear: the Wrongful Death of a Minor Act applies on its face to all unborn children, without limitation.^[9]

Indisputably, IVF is a delicate process and does not guarantee a long life for extrauterine embryos. Fertility clinics cannot promise positive outcomes to IVF patients, and the Alabama Supreme Court’s opinion does not require that guarantee; the decision simply affirms that the parents of an extrauterine embryo, like the parents of any other born or unborn child, can sue when someone intentionally or negligently kills their child. Further, this ruling pertains to civil actions; neither the Wrongful Death of a Minor Act nor the LePage decision impose criminal liability for the wrongful deaths of extrauterine children.

In short, the Court’s ruling does not inhibit responsible fertility clinics—those with policies and practices in place to avoid wrongful acts, omissions, or negligence that could result in the death of an embryo—from continuing to provide IVF.

II. The Fertility Industry’s Draconian Response

 Despite the narrowness of the Court’s decision, three IVF providers in Alabama, including the defendant clinic in LePage, stopped providing IVF services within days of the ruling. A Spokesperson for one provider, the University of Alabama at Birmingham, told reporters that they needed to consider if patients and physicians could be prosecuted criminally or be required to pay punitive damages “for following the standard of care for IVF treatments.”^[10] Again, LePage is not a criminal case and provides that only practitioners who wrongfully or negligently kill an embryo may be sued by the embryo’s parents.

Notably, some IVF providers in Alabama did not close their doors in response to the Court’s decision. A doctor from the Fertility Institute of North Alabama told NBC News that he did not see a reasonable need to pause IVF services, and Huntsville Reproductive Medicine likewise continued IVF.^[11] Even some abortion advocates, who consistently speak out in alarm anytime an unborn child is recognized as a human being, acknowledged the limited scope of the decision.^[12]

Fundamentally, abortion advocates and ardent opponents of safety regulations for IVF believe that the recognition of an embryo as a child—in any context—is a threat to both abortion and IVF, even when that recognition is codified in a statute that affords rights to an embryo’s parents, not the embryo. This persistent opposition to the recognition of embryos as children drove these advocates to mislead the public^[13] about the scope of LePage and ultimately led to the passage of Alabama SB 159, a “solution” that will harm the very families they claim to represent.

III. SB 159: A Rushed Response from the Alabama Legislature

 Eleven days after the Alabama Supreme Court’s decision in LePage, Alabama State Senator Tim Melson introduced Senate Bill 159,^[14] a sweeping grant of immunity from civil or criminal liability for IVF clinics and practitioners. Two days later, it passed the Senate. Six days later, it passed the House, and the Senate’s agreement with the House’s changes and Governor Kay Ivey’s signature were secured on the same day.^[15] This extraordinarily rushed legislative response, driven by intense pressure from IVF providers and ill-informed activists and politicians, obtained the desired result: the IVF providers that had halted IVF services have resumed their work.^[16] However, the fallout from this law may be devastating for many families seeking IVF in Alabama.

SB 159 provides that no action, suit, or criminal prosecution may be brought for damage to or death of an embryo against an individual or entity when providing or receiving services related to in vitro fertilization. Any action against the manufacturer of goods (e.g., freezers) used to facilitate in vitro fertilization or the transport of stored embryos is limited to compensatory damages calculated as the price paid for the impacted in vitro cycle, and no criminal prosecution is permitted against such a manufacturer. The law expressly supersedes all other provisions of Alabama law, including Alabama’s Wrongful Death of a Minor Act.

Critically, SB 159 does not require immunized providers to meet a standard of care. There is no exception to immunity for negligent, reckless, or even wanton behavior that results in the death of an embryo. IVF providers can literally handle human embryos however they please without fear of legal repercussion if their actions or omissions negligently or maliciously result in the embryos’ deaths. Yuval Levin and O. Carter Snead, former staff members of the President’s Council on Bioethics (see part IV below), wrote in March that by providing “blanket civil and criminal immunity … the legislature created a bizarre anomaly. No other branch of medicine, and no other facet of the health-care industry, enjoys such freedom to act with impunity.”^[17] In practice, SB 159 will protect only one type of constituent—the negligent or malicious IVF provider.

Governor Kay Ivey characterized the law as a “stopgap”^[18] to encourage clinics to resume or continue providing IVF, implying that Alabama lawmakers will continue to evaluate the appropriate response to LePage. However, legal immunity, once given, is difficult to take away. The state legislature could have requested an opinion from Alabama’s Attorney General confirming that IVF remained legal in Alabama after LePage, while lawmakers carefully investigated whether additional regulations of fertility clinics are in fact needed to protect patients. The plaintiffs in the case, as patients who sought in vitro fertilization to grow their families, are certainly not asking that the process be banned or that fertility clinics close. Instead, their story highlights the need for better protections for parents and the tiny humans housed in these buildings.

 IV. IVF: The Unregulated Frontier in Fertility Treatment

 While negative reactions to LePage were swift and crossed partisan lines,^[19] the Alabama Legislature’s response has also received considerable criticism across the political and ideological spectrum, with diverse authors in major publications sharing both deep reservations about granting blanket immunity to IVF providers and concern about the lack of regulation in fertility care. Author Emi Nietfeld, in an article for The Atlantic, lamented that SB 159 granted IVF clinics “sweeping immunity, regardless of what egregious errors they may make.”^[20] This grant of immunity is disconcerting considering that, “[f]or the most part, the industry is self-regulated by professional bodies that have no enforcement power, besides referring reckless doctors to state medical boards.” Nietfeld noted that in the debate over IVF regulation, “[u]nconsidered are all the patients who want IVF to be legal and also want it to be regulated like any other medical practice.”^[21]

Concerns about the lack of regulation for IVF extend back decades. In 2001, President George W. Bush created the President’s Council on Bioethics (“PCBE”), composed of individuals with diverse ideologies, to advise the President “on bioethical issues that may emerge as a consequence of advances in biomedical science and technology.”^[22] In March 2004, the PCBE issued a report addressing assisted-reproductive technology (“ART”), which includes IVF, titled “Reproduction and Responsibility: The Regulation of New Biotechnologies” (“report”).^[23] Twenty years later, in their March 2024 article for The Atlantic, former PCBE staff members Yuval Levin and O. Carter Snead wrote that the report took up IVF “in terms that continue to resonate.”^[24] Levin and Snead explained how the “misguided conflation of abortion and reproductive technologies has left the regulation of the fertility industry strangely underdeveloped. Parents, children, clinics, and practitioners have been left, in turn, lacking even basic information, protections, and boundaries.”^[25]

A. IVF’s Regulatory History

Federal

In 1981, the first child conceived with ART (specifically IVF) in the United States was born. While definitions of ART vary somewhat, a recent Centers for Disease Control and Prevention (CDC) report states:

ART includes all fertility treatments in which either eggs or embryos are handled outside a woman’s body. In general, ART procedures involve surgically removing eggs from a woman’s ovaries, combining them with sperm in the laboratory, and returning them to a female patient or gestational carrier, or donating them to another patient. … ART includes but is not limited to in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), zygote intrafallopian transfer (ZIFT), tubal embryo transfer, egg and embryo cryopreservation, egg and embryo donation, and gestational surrogacy.^[26]

According to the CDC, “as ART use increased throughout the 1980s, there was growing concern about the quality of ART information that infertility patients were receiving.”^[27] Congress responded by passing the Fertility Clinic Success Rate and Certification Act (“FCSRCA”)^[28] in 1992, which requires clinics performing ART to annually report data to the CDC for all procedures performed, but does not include penalties for failing to do so. Through the National ART Surveillance System (“NASS”), the CDC maintains a list of all ART clinics and tracks clinic closings and reorganizations. This information is also tracked by the primary professional organization for IVF providers, the Society for Assisted Reproductive Technology (“SART”),^[29] which is an affiliate of the American Society for Reproductive Medicine (“ASRM”).^[30] While “a small number” of ART clinics do not report data to the CDC, the CDC estimates that information about more than 95% of all ART cycles in the U.S. can be found in NASS.^[31]

The data reported by ART providers include patient demographics, obstetrical and medical history, parental infertility diagnosis, clinical parameters of the ART procedure, and information regarding resultant pregnancies and births (e.g., birth weight, plurality, and maturity). According to the CDC, clinics “are required to verify all reported data” and the CDC “conducts data validation through yearly audits and site visits” of “a sample of reporting clinics” (emphasis added).^[32] The CDC works closely with SART and ASRM (the professional organizations for IVF providers) and both “are involved in framing the surveillance and research questions and in collecting and reporting data from member clinics.”^[33] Notably, this process does not require IVF providers to report accidents, adverse events, or legal or regulatory actions brought against clinics.

The FCSRCA also required that the Secretary of Health and Human Services (“Secretary”), through the CDC, develop a “model program for the certification of embryo laboratories.” The Secretary is not permitted to “establish any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine in assisted reproductive technology programs.”^[34] States can voluntarily choose to adopt the model program, which was published in the Federal Register in 1999, and includes definitions, administrative requirements, and embryo laboratory standards.^[35] The CDC recognizes two nonfederal laboratory accreditation programs which are administered by (1) the College of American Pathologists and the American Society for Reproductive Medicine (“CAP/ASRM”),^[36] and (2) The Joint Commission (“TJC”), ^[37] formerly known as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), which also accredits hospitals. This recognition is not an endorsement, but the CDC provides accrediting information from these programs in annual Success Rates Reports.^[38]

The FCSRCA does not require a clinic to seek certification from a state or an independent accreditation program, nor does it include penalties for failing to do so. In fact, the FCSRCA implementing regulations explicitly state that “CDC will defer implementation of the approval of State certification programs or accreditation organizations, as well as Federal validation inspections of embryo laboratories certified by States adopting the model or accredited by an accreditation program for embryo laboratories” (emphasis added).^[39]

In sum, under federal law, IVF provider reporting “requirements” are not enforced and do not include information on accidents, adverse events, or legal or regulatory actions against clinics. Also, the Secretary cannot exercise any control over how IVF clinics are run, and the CDC has chosen not to review or approve state certification programs or conduct inspections of IVF laboratories.^[40]

State

States also perform a limited role in monitoring or regulating IVF. The physicians who provide the care must meet the same standards as physicians in other specialties. Given that physicians are licensed and disciplined by state medical boards or other agencies, complaints against negligent, unprofessional, or incompetent IVF providers can be referred to the state.^[41] While the regulation of doctors and facilities are generally police powers exercised by the states, the FCSRCA oddly provides that a state which adopts the Secretary’s model certification program “may not establish any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine in assisted reproductive technology programs.”^[42] This provision likely acts as a deterrent to state regulation and oversight of IVF.

Nongovernmental

The third source of oversight for IVF providers is nongovernmental. As stated above, CAP and ASRM developed a Reproductive Laboratory Accreditation Program (“RLAP”) for embryology laboratories,^[43] which also “served as the basis for many of the standards in the [federal] proposed model program.”^[44] Hospital-based ART programs can be accredited through a similar program administered by JCAHO, which accredits hospitals.^[45] In 2021, the CDC verified that 89% of reporting clinics had lab accreditation.^[46]

ASRM, a “specialty society for physicians that focus on infertility,” has an “Ethics Committee” and a “Practice Committee” that issues regular reports and “guidelines on minimal standards for providing ART, informed consent, and on the number of embryos to be transferred in IVF procedures.”^[47] However, this “guidance” cannot require clinics to adhere to the ethics and practice guidelines. Some argue that ASRM, which has made the dubious claim that “ART is already one of the most highly regulated of all medical practices in the United States,”^[48] is focused on advancing the business of fertility clinics without the intrusion of government regulation.^[49]

As of 2021, SART, which is an affiliate of ASRM, had a membership composed of 80% of all reporting ART clinics, according to the most recent CDC report.^[50] SART membership requires that clinics “report their outcomes to the CDC as well as to SART, have accredited embryology laboratories, adhere to the Ethics and Practice Committee guidelines of ASRM, and have appropriately trained staff.”  However, a failure to meet these requirements does not shut down member clinics even if they lose their membership in SART.^[51]

 In short, federal, state, and professional regulations provide a very limited patchwork of protections for patients seeking IVF, let alone their unborn children created through IVF. IVF clinic cooperation is voluntary and critical data pertaining to the practice of IVF are absent from reports, making patient-informed consent impossible. Specific deficiencies in IVF regulation are discussed in more detail below.

B. IVF’s Regulatory Inadequacies

1. Failure to protect human embryos from harm whose parents do not want them any longer

The purpose of IVF is to start or grow a family, and the process “requires consideration of both the parents and the children, at all stages of the children’s development and at every step of the parents’ treatment process.”^[52] These considerations include the embryonic children who are ultimately not selected by their parents for transfer. IVF clinics try to maximize a patient’s likelihood of carrying a child to term. As a result, there are often more embryonic children created than a patient desires to carry. Some human embryos are donated for medical research that will destroy them in the process, donated to other families for transfer, or are discarded, while others are stored in cryogenic nurseries. In the United States, there may be more than 1 million embryonic children housed in cold storage either abandoned or waiting while their parents decide their fates.^[53] Given that the purpose of IVF is to bring children into the world, it is incongruous for the process to lead to the intentional destruction of embryonic children who are not selected for transfer. When undertaken, IVF should always be a life-affirming process, where fewer embryos are created to avoid ethical quagmires, information on embryo adoption is provided during the informed consent process and is facilitated upon request,^[54] and embryos are not discarded like medical waste.

Further, while the pairing of IVF and genetic testing to select either a male or female embryo for transfer “is illegal in Canada, Australia, and every European nation besides Cyprus, except in rare cases to avoid passing on X-chromosome-linked diseases,” it is “big business in the United States.”^[55] In 2018, “an estimated 75 percent of American clinics offered sex selection for nonmedical reasons, with the majority allowing people to undergo IVF solely to pick a son or daughter.”^[56] According to Jeffrey Steinberg, who helped pioneer sex-selection in IVF, “trait selection comprises 5 to 10 percent of the American IVF market, or up to $90 million annually.”^[57] Polygenic tests, which are banned in most countries, are available in the United States to parents who want to use “raw genetic data to pick embryos based on whatever criteria they want.”^[58] These blatantly eugenic practices, which result in the destruction of embryonic children who lack traits desirable to parents, should be banned.

2. Failure to enforce reporting requirements and collect critical data

 Today there are around 500 fertility clinics in the United States that provide ART,^[59] and approximately 2.3% of all infants born in the U.S. each year are conceived via ART.^[60] The CDC continues to affirm the necessity of monitoring ART: “while ART relieves the burden of infertility for many couples, it presents significant public health challenges due to the substantial risk for multiple birth delivery, which is associated with poor maternal and inf ant health outcomes. For this reason, it is important to monitor the safety and effectiveness of ART procedures in the United States.”^[61]

However, because neither the FCSRCA nor any other federal law penalizes clinics for failing to report to the CDC, roughly 10% of clinics^[62] in 2021 did not report and those presently reporting may stop at any time. While the data collected by the CDC are important, this lack of enforcement results in incomplete information. Further, even if an enforcement mechanism were added to the FCSRCA reporting requirement, the law does not require reporting of accidents, adverse events, or legal or regulatory actions brought against clinics. Dov Fox, a professor of law at the University of San Diego, told NBC that that there are regulatory gaps that can lead to devastating mistakes. Fox stated:

In fertility medicine, it’s very different than any other field, where we regulate very closely what’s called ‘never events,’ … These are major, avoidable mistakes. Things like blood transfusion on the wrong person, or a surgery on the wrong body part or the wrong patient. There, we require mandatory disclosure and we figure out what went wrong and how to fix it. We have nothing like that for what you might call ‘never events’ in reproductive technology.^[63]

Given the absence of reporting requirements for accidents or adverse events, it is impossible to know how many “never events” occur each year. Instead, some of the most egregious failures become publicly known only through litigation and the press. A 2020 study uncovered at least 133 lawsuits filed in the United States between 2009 and 2019 that related to “destroyed or damaged embryos” (more than 65% of the lawsuits followed 2018 embryo storage tank failures in California and Ohio).^[64] The authors summarize the regulatory vacuum this way:

No public or private body tracks errors or accidents aside from the popular media, and such cases tend to be settled within the legal system without further disclosure. Clinic reporting of success rates and utilization is voluntary, and there are no rules to mandate the reporting of errors in handling or processing specimens. Adverse events still look rare compared with the total number of cases reported to CDC that involve frozen embryos. The main importance of these events lies in their devastating impact on families and individuals, and the events’ prospects for reshaping the legal environment.^[65]

Levin and Snead suggested that the following additional reporting laws and regulations are needed:

• A “mechanism for reliable auditing or meaningful enforcement of reporting requirements;”
• A “comprehensive, uniform, and enforceable mechanism for data collection, monitoring, or oversight of how the new reproductive biotechnologies affect the well-being of the children conceived with their aid, the egg donors, or the gestational mothers;”
• Data on “types or rate of adverse health outcomes to mothers or children (beyond noting the percentage of term, normal-weight, and singleton births) or on the costs of procedures;”
• “Information about adverse effects involved in novel practices;” and,
• A requirement to collect and make available information to prospective parents “about what effects extended cryogenic preservation might have on the children who are ultimately born.”^[66]

The CDC likewise acknowledges that “[l]ong-term follow-up of ART-conceived infants through integration of existing maternal and infant health surveillance systems and registries with data available from NASS might help researchers monitor adverse outcomes at the population level.”^[67] Yet there is no indication that this type of investigation is forthcoming.

3. Failure to certify and inspect for health and safety standards

 The need for fertility clinic regulations is starkly evident in the wake of Alabama’s new law that denies court access for families injured by fertility clinics. When fertility clinics do not fear litigation, enforceable regulations are necessary to prevent the proliferation of substandard clinics. However, as discussed above, the Secretary opted out of conducting validation inspections of ART clinics and states have likewise failed to adopt comprehensive certification programs with health and safety standards for ART providers. The CDC has recognized two private certification programs which purport to require clinics to meet standards to maintain certification. However, as noted in a letter from members of the U.S. Senate Health, Education, Labor, and Pensions Committee to the Inspector General of the U.S. Department of Health and Human Services, tragic “never events” that have occurred in fertility clinics in recent years, including massive cryogenic storage tank failures, embryo implantations in the wrong patients, and transfers of embryos that clinicians knew were not viable,^[68] occurred in embryo laboratories accredited by CAP/ASRM.^[69]

In two unrelated incidents, cryogenic storage tanks failed at the Pacific Fertility Center in San Francisco, California and University Hospitals Fertility Center in Cleveland, Ohio in the same weekend in March 2018, leading to the destruction and death of 7,500 eggs and embryos. In 2021, the California Center for Reproductive Health and In Vitrotech Labs in Los Angeles, California confused two embryos, placing them in the wrong patients. The mistake was discovered by DNA tests several months after the babies were born.^[70]

In 2023, Bloomberg investigated Kindbody, the operator of 33 ART clinics, and discovered “multiple instances of accidental embryo destruction, mislabeled embryos, and labs with faulty heating, ventilation, and air conditioning systems.” In April 2024, 11 couples sued Ovation Fertility in Newport Beach, California, “for using hydrogen peroxide instead of distilled water during the incubation process and for relying on ‘inexperienced, cheap, unqualified, and untrained employees to cut corners and maximize profits.’” Tragically, despite knowing that the embryos were not viable, the clinic transferred over two dozen embryos into their patients and delayed telling the patients for over a month.^[71]

An inspection by an accrediting organization or a government agency may or may not have prevented these tragedies, but these failures are devastating enough to warrant government investigations and the serious consideration of mandatory certification requirements, inspections, and penalties for failing to meet certain standards.

4. Failure to establish research standards on fertility treatments, ART innovations, and embryo care

 While more comprehensive and enforceable reporting requirements, including reporting of adverse events, and rigorous clinic safety inspections could potentially reduce the occurrence of patently negligent events in IVF clinics, there are deeper, more fundamental problems with the fertility industry. To start, IVF may be overused. Jack Wilkinson, Ph.D., et al. wrote that while “in some populations, first-line treatments such as intrauterine insemination (for unexplained or mild male factor infertility) or ovulation induction (for anovulatory infertility) have a high success rate … IVF is often used as the default first-line treatment for patients presenting with various kinds of subfertility.”^[72] In other words, fertility clinics may be subjecting women to invasive and often ineffective ART treatments when less invasive and less expensive treatments may work.^[73] Patients who have not achieved pregnancy should be offered opportunities to explore other approaches, including Restorative Reproductive Medicine which “seeks to cooperate with or restore the normal physiology and anatomy of the human reproductive system,”^[74] before they turn to ART.

Further, despite the growing use of ART, little research has been done to determine its impact on women and unborn children. Levin and Snead wrote that ART is not “subject to the kinds of rules and norms that govern clinical research or the development and sale of new drugs and medical devices.”^[75] In The Atlantic, Emi Nietfeld was told by Wanda Ronner, professor of obstetrics and gynecology at the University of Pennsylvania School of Medicine, that there is a dearth of information on fertility drugs and how they impact the women who take them.^[76] Nietfeld learned that “[u]nlike new cancer drugs and novel surgeries, which go through multiple rounds of trials before receiving FDA approval, ‘a lot of innovation in fertility is clinical.’” These clinical experiments are “[u]sually performed on small samples of patients” and “‘don’t even require going through the research process.’ This means patients [] are left with sparse information about efficacy; instead, they are often test subjects themselves.”^[77]

This absence of research “rules and norms” is troubling given that IVF practitioners are constantly “innovating.” In the last 40 years, wrote STAT senior science writer Sharon Begley, fertility clinics have invented “nearly three dozen [] ‘add-ons,’ or supplementary procedures.”^[78] These procedures are “purportedly science-based options that increase the chance of having a baby,” but according to an analysis of four papers published in Fertility and Sterility, the journal of ASRM, “there is little to no evidence that the vast majority of IVF add-ons do any such thing.”^[79] Tragically, these add-ons may even lower the chances of having a baby through IVF.^[80] Yet, according to Jack Wilkinson, Ph.D., et al., the authors of one of the papers, “regulation of IVF add-ons is consistently minimal. Usually, new fertility interventions are rapidly adopted on the basis of case reports, rather than following formal regulatory review.”^[81] The FDA does not require a “full benefit/risk evaluation” for any fertility interventions.^[82] This lack of evaluation is heartbreaking given that patients who desperately want children and are offered these options are likely to try them even when there is little to no research demonstrating their effectiveness.

In another paper reviewed in the analysis, Sarah Armstrong, et al., wrote, “[C]urrently, we have a menu of add-ons in the laboratory that has confused and mislead [sic] over the past decade. We could do better as our patients deserve it.”^[83] Likewise, Mohan S. Kamath, et al., wrote that “it is imperative that any perceived benefits [of add-ons] should be backed by robust evidence … Until such evidence is available, use of clinical adjuncts in routine clinical practice should be avoided. Apart from the added costs incurred by the patients or the health provider, there could also be detrimental, unquantified side effects. It is imperative that clinicians are well versed in the risks, benefits, and unknowns of any intervention that is applied to patients.”^[84]

There is also insufficient research to understand the impact of IVF on the children created through the process. There are no “federally funded longitudinal studies” on “a correlation between IVF and an increased incidence of birth defects and other maladies,” even when the CDC has observed such a correlation.^[85] Further, while “[i]t has been well established over the short term that ART pregnancies are associated with a higher prevalence of pregnancy and perinatal complications,” studies that have been conducted on the longer-term effects of IVF “come with many limitations.”^[86] There are “[l]ow numbers of participants … which often makes subgroup analyses for diverse types of ART or diverse types of infertility not feasible.” Also, “studies are often limited by short follow-up periods because of the difficulty and costs involved in longitudinal study designs.”^[87]

Scientists do know, however, that the transfer of multiple embryos at one time is one of the greatest contributing factors to poor outcomes for women seeking IVF and their children. In its 2021 Data Brief released in December 2023, the CDC recommended avoiding multiple embryo transfers:

Reducing the number of embryos transferred and increasing the use of single embryo transfer procedures, when clinically appropriate, can help reduce multiple births and related adverse health consequences for both mothers and infants. Risks to mothers from multiple-birth pregnancy include higher rates of caesarean delivery, gestational hypertension, and gestational diabetes. Infants from multiple births are at increased risk for numerous adverse sequelae such as preterm births, birth defects, and developmental disabilities.^[88]

CDC further stated that “[t]he best outcome of ART is the birth of one healthy infant. Among younger patients undergoing their first ART cycle, the best outcome can be achieved when a single embryo is selected for transfer.”^[89]ASRM and SART likewise recommend the transfer of a single embryo in most circumstances: “The American Society for Reproductive Medicine’s … guidance for the limits to the number of embryos to be transferred during in vitro fertilization (IVF) cycles aims to promote singleton gestation and reduce the number of multiple pregnancies while maximizing the cumulative live birth rates.”^[90] In the guidance, ASRM notes that “even twin gestations have significant additional morbidity compared with that of singletons.”^[91]

Yet, ASRM argues that “[s]trict limitations on the number of embryos transferred, which may be required by law in some countries, do not allow treatment plans to be individualized after careful consideration of each patient’s own unique circumstances.”^[92] The committee opinion acknowledges that such “unique circumstances” are often “financial considerations”:

Elective placement of multiple embryos is often influenced by financial considerations. … Financial pressures may be a coercive tipping point in favor of multiple embryo transfer. In contrast, if patients are informed of the risks inherent in two or high-order pregnancy and these financial pressures are removed or at least alleviated, most patients would opt to maximize their chance of a singleton, safe pregnancy and birth.^[93]

The CDC likewise argues that when patients have insurance coverage, they “may be willing to transfer fewer embryos during each procedure than they would if they were paying for treatments on their own because there is less financial pressure to conceive in a single treatment cycle … .”^[94] These observations, however, prompt the question of who is in charge in the fertility clinic. If transferring multiple embryos at once is contrary to CDC and ASRM recommendations because of the risks posed to women and their future children, practitioners should refuse to do so even when financially limited patients request it. ASRM claims that “self-policing” by SART is “influential” and that “standards set by members of the profession for the practice of reproductive medicine are widely followed and successful.”^[95] However, the fact that ART practitioners, against their better medical judgments, continue to permit patients to dictate how many embryos are transferred out of financial concerns is troubling and indicates a need for enforceable restrictions on the number of embryos transferred at a time.

There should also be enforceable guidelines and regulations regarding how embryos are preserved and handled. Professor Dov Fox explained that the tanks used to house frozen embryos are “not regulated any better than kitchen appliances or farm tools.”^[96] Wanda Ronner, professor of obstetrics and gynecology at the University of Pennsylvania School of Medicine, told Emi Nietfeld, “We don’t even have independent, peer-reviewed research funded by the NIH to say ‘What’s the most effective way to make sure the embryo is okay to transfer?’ or even ‘What temperature to freeze the embryos?’”^[97] The absence of research, regulations, and guidance on these and other critical concerns have contributed to the occurrences of “never events.”

V. Conclusion: How the federal and state governments should address in vitro fertilization now

 Given the failure of federal and state lawmakers and the ART industry to establish enforceable standards to protect families seeking IVF, these families should have access to legal redress when their embryos die from negligent or wanton behavior. The plaintiffs in LePage are not asking the court to ban IVF, a procedure that each couple has used to grow their families. Rather, they are seeking a civil remedy because the wrongful act, omission, or negligence of an IVF provider allegedly led to the deaths of their unborn children. Likewise, the Alabama Supreme Court did not issue a decision banning IVF. Rather, the Court held that an Alabama wrongful death statute provides a cause of action for the parents of wrongfully killed extrauterine unborn children, just as it does for all other parents.

If cooler heads had prevailed, after obtaining an opinion from Alabama’s Attorney General confirming that IVF remained legal in Alabama, Alabama lawmakers would have conducted a thorough investigation of whether the state needs to enact protections for families seeking IVF and the children created through this process. Instead, a hastily enacted law has immunized the IVF industry and will harm the very families it claims to represent. However, Alabama lawmakers can still conduct these investigations, as can the legislatures in other states. Further, congressional committees should certainly hold hearings before supporting any plan to use taxpayer dollars to fund or mandate private insurance funding for IVF.

Recommendations

Based on the research in this paper:

1. Congress should investigate and consider amending the Fertility Clinic Success Rate and Certification Act or passing new legislation that includes:

• A requirement that HHS develop guidelines and recommendations for fertility treatments that do not require the creation of more embryonic children than are to be transferred and that prevent the destruction of embryonic children who are not transferred.

• A prohibition on or strict regulation of the use of genetic testing to select embryos for transfer.

• Penalties for ART providers that fail to report data to the CDC.

• Additional mandatory reporting requirements that include:
  • Adverse events from any ART treatments.
  • Accidents that result in injury to or death of an embryo.
  • Regulatory or legal actions brought against ART providers.
  • The costs of IVF and other ART services and the methods of payment collected, including insurance payments.
  • The number of embryos created in each IVF cycle, and the number of those embryos discarded (i.e., killed), frozen, or transferred.

• A requirement that the CDC evaluate whether the “model program for the certification of embryo laboratories” needs to be updated.

• Either penalties for states that do not adopt the CDC “model program for the certification of embryo laboratories” or incentives for states to adopt it.

• Penalties for clinics that fail to obtain certification from a state or CDC-recognized nonfederal laboratory accreditation program.

• Rigorous informed consent requirements that include information on less invasive treatments that may be tried before IVF and that are updated regularly to reflect the latest research.

• A requirement that HHS conduct studies to investigate critical questions related to ART, including:
  • The quality and availability of diagnostic and restorative reproductive medicine (RRM) and/or other “first-line” treatments as an alternative to or precursor to trying IVF. In particular, whether patients are informed about and given opportunities to seek restored fertility prior to IVF, and whether there is sufficient insurance coverage for alternatives to IVF.
  • The health of children born through ART, including long-term health outcomes, their gestational mothers, and egg donors.
  • The health of children born after cryogenic preservation, including long-term health outcomes.
  • Whether there is a correlation between IVF and an increased occurrence of birth defects and other health concerns.
  • Ethical questions related to the use of genetic testing in the selection of embryos for transfer.
  • Methods of ART that
    • Result in the creation of fewer embryos,
    • Are less invasive for mothers, and/or
    • Are less costly.

• A requirement that the CDC establish research requirements for ART procedures that are like those that apply to new drugs and medical devices.

• The removal of any language that discourages or forbids state oversight and regulation of ART.

2. States should:

• Require the state department of health to develop guidelines and recommendations for fertility treatments that do not require the creation of more embryonic children than are to be transferred and that prohibit the destruction of embryonic children who are not transferred.

• Prohibit or strictly regulate the use of genetic testing to select embryos for transfer.

• Adopt and enforce the CDC “model program for the certification of embryo laboratories” or a similar program that includes health and safety standards, with penalties for clinics that fail to obtain certification from the state.

• Certify and regularly inspect IVF providers, penalizing those that do not meet regulatory standards.

• Require reporting that both mirrors current federal reporting requirements and requires the following additional reporting:
  • Adverse events from any ART treatments.
  • Accidents that result in injury to or death of an embryo.
  • Regulatory or legal actions brought against ART providers.
  • The costs of IVF and other ART services and the methods of payment collected, including insurance payments.
  • The number of embryos created in each IVF cycle, and the number of those embryos discarded (i.e., killed), frozen, or transferred.

• Penalize IVF providers that do not report.

• Adopt rigorous informed consent requirements that include information on less invasive treatments that may be tried before IVF and that are updated regularly to reflect the latest research.

3. States should not provide blanket immunity to ART providers.

Mary E. Harned, J.D. is an associate scholar with the Charlotte Lozier Institute.

[1] In vitro fertilization (“IVF”) is the most widely used form of assisted reproductive technology (“ART”). See “Oversight of Assisted Reproductive Technology,” American Society for Reproductive Medicine, (2010, 2021), https://www.asrm.org/advocacy-and-policy/media-and-public-affairs/oversite-of-art/#:~:text=ASRM%20also%20produces%20ethics%20and,of%20data%20to%20the%20CDC. Discussions regarding IVF regulation and oversight generally apply to other forms of ART unless otherwise stated.

[2] On August 29, 2024, former President Trump announced that “under the Trump Administration your government will pay for—or your insurance company will be mandated to pay for—all costs associated with IVF treatment.” The Editorial Board, “Donald Trump’s IVF Entitlement,” The Wall Street Journal (Aug. 30, 2024), https://www.wsj.com/opinion/donald-trump-ivf-coverage-healthcare-republicans-election-4ba62cab. Vice President Harris has criticized the U.S. Senate for not passing a federal bill that was written to “protect” IVF and was hastily introduced after LePage. “Statement from Vice President Harris on Senate Republicans’ Vote to Once Again Block Nationwide Protections for IVF” (Sept. 17, 2024),  https://www.whitehouse.gov/briefing-room/statements-releases/2024/09/17/statement-from-vice-president-harris-on-senate-republicans-vote-to-once-again-block-nationwide-protections-for-ivf/.

[3] LePage v. Ctr. For Reprod. Med., P.C., 2024 Ala. LEXIS 60 (Ala., Feb. 16, 2024). Available at: https://cases.justia.com/alabama/supreme-court/2024-sc-2022-0579.pdf?ts=1708115406.

[4] LePage, p. 5

[5] LePage, p. 3

[6] Ala. Code § 6-5-391 (1975). Available at: https://alison.legislature.state.al.us/code-of-alabama.

[7] LePage, p. 3

[8]  See Mack v. Carmack, 79 So. 3d 597, 611 (Ala. 2011); Hamilton v. Scott, 97 So. 3d 728, 735 (Ala. 2012).

[9] LePage, p. 7. Justice Mitchell also wrote, “It is not the role of this Court to craft a new limitation based on our own view of what is or is not wise public policy. That is especially true where, as here, the People of this State have adopted a Constitutional amendment directly aimed at stopping courts from excluding ‘unborn life’ from legal protection. Art. I, § 36.06, Ala. Const. 2022” (LePage, p. 22). Further, the judges are required to “conform” their “rulings ‘to the expressions of the legislature, to the letter of the statute,’ and to the Constitution, ‘without indulging a speculation, either upon the impolicy, or the hardship, of the law” (internal citation omitted, LePage, pp. 21-22).

[10] Aria Bendix, “Three Alabama clinics pause IVF services after court rules that embryos are children,” NBC News (Feb. 21, 2024), https://www.nbcnews.com/health/health-news/university-alabama-pauses-ivf-services-court-rules-embryos-are-childre-rcna139846.

[11] Ibid.

[12] Ibid.; Kim Chandler, “More Alabama IVF providers pause treatment after court ruling on frozen embryos,” AP (Feb. 22, 2024), https://apnews.com/article/alabama-frozen-embryos-ruling-ivf-pause-3ea72dd4494cad3f65c57e751e4c5c3b.

[13] E.g., ACLU statement: “This ruling has terrifying implications for people in Alabama who are planning to have children and for the fertility clinics that provide necessary services. This ruling endangers the fertility clinics in Alabama that provide IVF, those that have embryos stored, and the future of family planning in our state. Furthermore, this ruling, along with Alabama’s strict ban on abortions, means for many, it is the state, not the person, who can decide whether they can become pregnant.” Available at https://www.aclualabama.org/en/news/alabama-courts-extreme-ruling-puts-ivf-treatments-risk; President Biden: “And now, a court in Alabama put access to some fertility treatments at risk for families who are desperately trying to get pregnant. The disregard for women’s ability to make these decisions for themselves and their families is outrageous and unacceptable.” Available at https://www.whitehouse.gov/briefing-room/statements-releases/2024/02/22/statement-from-president-joe-biden-on-alabama-court-decision/.

[14] Available at: https://alison.legislature.state.al.us/files/pdf/SearchableInstruments/2024RS/SB159-enr.pdf.

[15] AL SB159, https://legiscan.com/AL/bill/SB159/2024.

[16] The defendant in LePage plans to end IVF services at the end of 2024 over “litigation concerns.” Sara Moniuszko, “Alabama hospital to stop IVF services at end of the year due to ‘litigation concerns,’” CBS News (Apr. 4, 2024), https://www.cbsnews.com/news/alabama-hospital-to-stop-ivf-embryos-mobile-infirmary/.

[17] Yuval Levin & O. Carter Snead, “The Real Lessons of the Alabama IVF Ruling,” The Atlantic (Mar. 15, 2024), https://www.theatlantic.com/ideas/archive/2024/03/alabama-ivf-ruling-regulation/677747/.

[18] Kenzi Abou-Sabe, et al., “Law protecting Alabama IVF may do more harm than good, critics say,” NBC News (Mar. 9, 2024), https://www.nbcnews.com/news/law-protecting-alabama-ivf-may-harm-good-critics-say-rcna142288#.

[19] For a broader discussion of the public outrage over the LePage decision that was based on, at best, a misunderstanding of the court decision and, at worst, the intentional distortion of the truth by the fertility industry, see Richard M. Doerflinger, “A Fact-Free Campaign Against Parents and Unborn Children in Alabama,” On Point Series 100, Charlotte Lozier Institute (Apr. 2024). https://lozierinstitute.org/a-fact-free-campaign-against-parents-and-unborn-children-in-alabama/.

[20] Emi Nietfeld, “America’s IVF Failure,” The Atlantic (May 2, 2024), https://www.theatlantic.com/ideas/archive/2024/05/america-ivf-regulation-failures/678259/.

[21] Ibid.

[22] “Former Bioethics Commissions, [2001-2009] President’s Council on Bioethics (PCBE),” https://bioethicsarchive.georgetown.edu/pcbe/reports/past_commissions/index.html.

[23] The President’s Council on Bioethics, “Reproduction and Responsibility: The Regulation of New Biotechnologies,” (March 2004), https://repository.library.georgetown.edu/bitstream/handle/10822/559381/_pcbe_final_reproduction_and_responsibility.pdf?sequence=1&isAllowed=y.

[24] Levin & Snead, “The Real Lessons of the Alabama IVF Ruling.”

[25] Ibid.

[26] “State-Specific Assisted Reproductive Technology Surveillance, United States; 2021 Data Brief”, CDC, (December 2023), https://www.cdc.gov/art/state-specific-surveillance/2021/index.html. The CDC reports on “procedures initiated with the intent to transfer at least one embryo, including procedures that used thawed embryos for transfer.” However, “[a]ll cycles in which egg or embryo banking (freezing) was performed for future ART cycles were excluded.”

[27] “Policy Documents: The Fertility Clinic Success Rate and Certification Act,” United States Centers for Disease Control and Prevention (CDC), https://www.cdc.gov/art/nass/policy.html.

[28] Section 2(a) of P.L. 102–493 (42 U.S.C. § 263a-1(a)). Available at: https://www.govinfo.gov/content/pkg/STATUTE-106/pdf/STATUTE-106-Pg3146.pdf.

[29] https://www.sart.org/.

[30] https://www.asrm.org/.

[31] “National ART Surveillance,” CDC, https://www.cdc.gov/art/nass/index.html.

[32] Ibid.

[33] Ibid. The CDC also collaborates with the American Urological Association, RESOLVE—the National Infertility Association, Path2Parenthood, and Livestrong Fertility.

[34] Section 3(i)(1) of P.L. 102–493 (42 U.S.C. § 263a-1(a)), https://www.govinfo.gov/content/pkg/STATUTE-106/pdf/STATUTE-106-Pg3146.pdf.

[35] Federal Register, Vol. 64, No. 139, 39382-39391 (Jul. 21, 1999), available at https://www.govinfo.gov/content/pkg/FR-1999-07-21/html/99-18405.htm.

[36] https://www.cap.org/.

[37] https://www.jointcommission.org/.

[38] “Policy Documents,” CDC.

[39] Federal Register, Vol. 64, No. 139, 39382 (Jul. 21, 1999), https://www.govinfo.gov/content/pkg/FR-1999-07-21/html/99-18405.htm.

[40] In the report “Oversight of Assisted Reproductive Technology,” the American Society for Reproductive Medicine discusses additional laws or regulations that impact IVF, including FDA requirements for egg and sperm donations (there are “rigorous inspection[s] of the facilities in which these tissues are handled”), citing  21 CFR 1271, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271. However, CDC annual reports do not name the certified embryo laboratories that deviated from these federal regulations and consequently have received warning letters from the FDA.  See Letter from Senator Bill Cassidy, M.D., et al to Christi Grimm, Inspector General of HHS (June 20, 2024): “The warning letters can be found in FDA’s Warning Letter database, available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters. These warning letters are generally sent by the Office of Biological Product operations for violations of requirements that apply to human cells, tissues, and cellular and tissue-based products,” https://www.help.senate.gov/imo/media/doc/2024-06-20_letter_from_bc_et_al_to_hhs_oig_re_ivf_finalpdf.pdf. Also, the Centers for Medicare and Medicaid (“CMS”), under the Clinical Laboratory Improvement Act (“CLIA”), regulate laboratories to a point—the regulations apply to lab tests used to diagnose infertility, but not to procedures performed in embryology labs (including IVF). See “Oversight of Assisted Reproductive Technology,” ASRM.

[41] See “Oversight of Assisted Reproductive Technology,” ASRM.

[42] Section 3(i)(2) of P.L. 102–493 (42 U.S.C. § 263a-1(a)), https://www.govinfo.gov/content/pkg/STATUTE-106/pdf/STATUTE-106-Pg3146.pdf.

[43] “Oversight of Assisted Reproductive Technology,” ASRM.

[44] Federal Register, Vol. 64, No. 139, 39375 (Jul. 21, 1999).

[45] “Oversight of Assisted Reproductive Technology,” ASRM.

[46] “2021 National ART Summary,” CDC, https://www.cdc.gov/art/reports/2021/summary.html.

[47] “Oversight of Assisted Reproductive Technology,” ASRM.

[48] Ibid.

[49] Michael Ollove, “States not eager to regulate fertility industry,” Stateline (Mar. 18, 2015), https://stateline.org/2015/3/18/states-not-eager-to-regulate-fertility-industry/.

[50] “Assisted Reproductive Technology (ART) Data, National Data,” CDC, https://nccd.cdc.gov/drh_art/rdPage.aspx?rdReport=DRH_ART.ClinicInfo&rdRequestForward=True&ClinicId=9999&ShowNational=1.

[51] “Oversight of Assisted Reproductive Technology,” ASRM.  Another source of nongovernmental regulation that applies to physicians generally is physician board certification.

[52] Levin & Snead, “The Real Lessons of the Alabama IVF Ruling.”

[53] Ibid., citing Amy Dockser Marcus, “More Than a Million Embryos Are in Cold Storage. What Should Happen to Them?” WSJ (Dec. 25, 2023), https://www.wsj.com/lifestyle/relationships/adoption-invitro-foster-care-surrogacy-17400499.

[54] See, e.g., snowflakes embryo adoption program, https://nightlight.org/snowflakes-embryo-adoption-donation/.

[55] Nietfeld, “America’s IVF Failure.”

[56] Ibid.

[57] Ibid.

[58] Ibid.

[59] “National ART Surveillance,” CDC.

[60] “ART Success Rates,” CDC, https://www.cdc.gov/art/artdata/index.html.

[61] “National ART Surveillance,” CDC.

[62] “State-Specific Assisted Reproductive Technology Surveillance, United States, 2021 Data Brief,” CDC, https://www.cdc.gov/art/state-specific-surveillance/2021/index.html. “In 2021, a total of 501 fertility clinics in the United States performed ART procedures and 453 (90.4%) provided data to CDC.”

[63] Doha Madani & Jo Ling Kent, “Couple says fertility clinic that mixed up their embryos put them ‘through living hell,’” NBC (Jul. 10, 2019) (emphasis added), https://www.nbcnews.com/news/us-news/couple-says-fertility-clinic-mixed-their-embryos-put-them-through-n1028396#.

[64] Kenzi Abou-Sabe, et al., “Law protecting Alabama IVF may do more harm than good, critics say,” NBC News (Mar. 9, 2024), https://www.nbcnews.com/news/law-protecting-alabama-ivf-may-harm-good-critics-say-rcna142288#.

[65] Gerard Letterie & Dov Fox. “Lawsuit frequency and claims basis over lost, damaged, and destroyed frozen embryos over a 10-year period,” F. S. Rep. 2020 Sep; 1(2):87-82 (Jul. 9, 2020), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8244326/#:~:text=One-hundred%20and%20thirty-three,were%20filed%20in%20state%20court.

[66] Levin & Snead, “The Real Lessons of the Alabama IVF Ruling.”

[67] “State-Specific Assisted Reproductive Technology Surveillance, United States; 2021 Data Brief”, CDC , citing Mneimneh AS, Boulet SL, Sunderam S, et al., “States Monitoring Assisted Reproductive Technology (SMART) Collaborative: data collection, linkage, dissemination, and use,” J Womens Health. 2013;22:571–577.

[68] Letter from Senator Bill Cassidy, M.D., et al to Christi Grimm, Inspector General of HHS (June 20, 2024), https://www.help.senate.gov/imo/media/doc/2024-06-20_letter_from_bc_et_al_to_hhs_oig_re_ivf_finalpdf.pdf.

[69] Letter from Senator Bill Cassidy, M.D., citing “2021 Assisted Reproductive Technology Fertility Clinic and National Summary Report,” U.S. CTRS. FOR DISEASE CONTROL & PREVENTION, 34-71 (2023), https://www.cdc.gov/art/reports/2021/pdf/Report-ART-Fertility-Clinic-National-Summary-H.pdf.

[70] Letter from Senator Bill Cassidy.

[71] Ibid.

[72] Jack Wilkinson, et al., “Do a la carte menus serve infertility patients? The ethics and regulation of invitro fertility add-ons,” Fertil Steril. 2019;112:973–7, https://www.fertstert.org/article/S0015-0282(19)32454-9/fulltext, citing Gunn DD, Bates GW. “Evidence-based approach to unexplained infertility: a systematic review,” Fertil Steril 2016; 105: 1566-74.e1; ESHRE Capri Workshop Group. “A prognosis-based approach to infertility: understanding the role of time. Hum Reprod 2017;32:1556–9; Kamphuis EI, Bhattacharya S, van der Veen F, Mol BW, Templeton A, for Evidence Based IVFG. “Are we overusing IVF?” BMJ 2014;348:g252.

[73] Ibid.

[74] International Institute for Restorative Reproductive Medicine, “Frequently Asked Questions,” https://iirrm.org/general-faq/.

[75] Levin & Snead, “The Real Lessons of the Alabama IVF Ruling.”

[76] Nietfeld, “America’s IVF Failure.”

[77] Ibid., quoting Sonia Suter, a law professor at George Washington University and a co-author of Reproductive Technologies and the Law.

[78] Sharon Begley, “From assisted hatching to embryo glue, most IVF “add-ons” rest on shaky science, studies find,” STAT (Nov. 5, 2019), https://www.statnews.com/2019/11/05/ivf-add-ons-shaky-science-studies/.

[79] Ibid.

[80] Ibid.

[81] Jack Wilkinson, et al., “Do a la carte menus serve infertility patients? The ethics and regulation of invitro fertility add-ons.”

[82] Ibid.

[83] Sarah Armstrong, et al., “Add-ons in the laboratory: hopeful, but not aways helpful,” Fertil Steril. 2019;112(6):994–9.

[84] Mohan S. Kamath, et al., “Clincal adjuncts in in vitro fertilization: a growing list,” Fertil Steril. 2019;112(6):978–86.

[85] Levin & Snead, “The Real Lessons of the Alabama IVF Ruling.”

[86] R.J. Hart and L.A. Wijs, “The longer-term effects of IVF on offspring from childhood to adolescence,” Front Reprod Health. 2022;4:1045762, doi: 10.3389/frph.2022.1045762.

[87] Ibid.

[88] “2021 Data Brief,” CDC, citing “Practice Committee of the American Society for Reproductive Medicine and Practice Committee of the Society for Assisted Reproductive Technology. Guidance on the limits to the number of embryos to transfer: a committee opinion.,” Fertil Steril. 2021;116(4):651­–654; American College of Obstetricians and Gynecologists, “Multifetal gestations: twin, triplet, and higher-order multifetal pregnancies. Practice Bulletin No. 231,” Obstet Gynecol. 2021;137:e145–e162; MacKay AP, Berg CJ, King JC, et al., “Pregnancy-related mortality among women with multifetal pregnancies,” Obstet Gynecol. 2006;107(3):563–568; Di Tommaso M, Sisti G, Colombi I, et al., “Influence of assisted reproductive technologies on maternal and neonatal outcomes in early preterm deliveries,” J Gynecol Obstet Hum Reprod. 2019;48(10):845–848; Dawson AL, Tinker SC, Jamieson DJ, et al., “Twinning and major birth defects, National Birth Defects Prevention Study, 1997-2007,” J Epidemiol Community Health. 2016;70(11):1114–1121.

[89] “ART and Multiple Births,” CDC, https://www.cdc.gov/art/key-findings/multiple-births.html.

[90] “Guidance on the limits to the number of embryos to transfer: a committee opinion,” Fertility and Sterility, Vol. 116, No. 3, September 2021 0015-0282, https://www.asrm.org/globalassets/_asrm/practice-guidance/practice-guidelines/pdf/guidance_on_the_limits_to_the_number_of_embryos_to_transfer.pdf.

[91] Ibid., p. 651, citing Santana DS, Cecatti JG, Surita FG, Silveira C, Costa ML, Souza JP, et al., “Twin pregnancy and severe maternal outcomes: the World Health Organization multicountry survey on maternal and newborn health,” Obstet Gynecol 2016;127:631–41.

[92] Ibid., p. 652.

[93] Ibid., citing Jain T, Harlow BL, Hornstein MD. “Insurance coverage and outcomes of in vitro fertilization,” N Engl J Med 2002;347:661–6; Johnston J, Gusmano MK, Patrizio P. “In search of real autonomy for fertility patients,” Health Econ Policy Law 2015;10:243–50.

[94] “ART and Insurance,” CDC, https://www.cdc.gov/art/key-findings/insurance.html.

[95] “Oversight of Assisted Reproductive Technology,” ASRM, p. 11.

[96] Naomi Cahn & Dena Sharp, “The fertility industry is poorly regulated – and would-be parents can lose out on having children as a result,” The Conversation (Aug. 23, 2021), https://theconversation.com/the-fertility-industry-is-poorly-regulated-and-would-be-parents-can-lose-out-on-having-children-as-a-result-163792.  

[97] Nietfeld, “America’s IVF Failure.”