Egg donation advertisements: addressing the regulatory gap.

Egg donation is a procedure that is powerfully advertised as a beneficial experience with limited mention of the associated risks. Egg donor recruitment advertisements target young and financially insecure women and can serve as a catalyst for interest in egg donation. In the absence of explicit egg donation advertisement regulations and without counterbalancing information from other sources, potential donors may not be able to recognize how advertisements can be misleading. In this paper, we enumerate two types of misleading information in egg donor recruitment advertisements that can influence the decision to donate that might not exist otherwise: (1) the focus on financial benefits and (2) the minimization of health risks. We draw upon existing Federal Drug Administration and Federal Trade Commission regulations that govern other types of medical advertisements and demonstrate their suitability to govern egg donor recruitment advertisements. We conclude that similar regulations could address the regulatory gap in which egg donation advertisements are situated by ensuring that information is balanced and not overly persuasive, thus better protecting the autonomy of egg donors.

Egg donation, Egg donor advertisements, Reproductive decision-making, Reproductive ethics, Reproductive technology, Bioethics, Healthcare regulation

In many Western countries, all components of egg donation—treatment, recruitment, and payment of donors—are nationally regulated. In the United States (U.S.), the laws governing egg donation only regulate the screening and testing of donors, leaving the rights and interests of egg donors largely unprotected in the face of rising demand for donor eggs [1]. This is particularly troubling because egg donors are undergoing a medical procedure not for their health, but for financial compensation [2]. Our focus in this paper is unregulated egg donor recruitment advertisements that downplay health risks in their targeted demographic of young women. Egg donors are typically recruited through egg banks, egg donation agencies, and fertility clinics that market egg donation in advertising materials and via information on their public-facing websites [3]. Most individuals initially learn about egg donation through public advertising, such as through online and social media targeted marketing, and in some cases, egg donor recruiters will attend college events to speak about the benefits of egg donation [4, 5]. Given that individuals often make decisions about whether to donate their eggs based on the information first presented to them, it is noteworthy that advertisements are their introduction to egg donation [6]. In the absence of egg donation advertisement regulations and without counterbalancing information from other sources, potential donors may not be able to recognize how the advertisements can be misleading. We recognize that donors undergo an informed consent process in the clinic once they have agreed to donate, but it is problematic that misleading information during recruitment serves as the catalyst for their initial interest. In other words, some of the most vulnerable individuals, such as young, financially insecure donors, may be the most susceptible to influence and thus most likely to have their autonomy undermined [7]. We enumerate two types of misleading information that engender interest in egg donation and can influence the decision to donate that might not exist otherwise [8]: (1) the focus on financial benefits and (2) the minimization of health risks. Given that a radical overhaul of assisted reproductive technologies regulations in the U.S. is unlikely, here we present a less drastic intervention that draws on existing regulatory structures. Since there are no regulations targeting egg donation advertisements, we propose oversight of egg donor recruitment advertisements under existing Federal Drug Administration (FDA) and Federal Trade Commission (FTC) purview. FDA and FTC regulations currently aim to protect patients from misrepresented pharmaceutical advertisements and safeguard the welfare of research subjects in research recruitment advertisements. We demonstrate the suitability of these regulations to govern egg donor recruitment advertisements and argue that implementing federal guidelines would help to safeguard potential donors. Limited egg donation regulations We begin by describing egg donation regulation. In the U.S., few regulations exist to protect egg donor welfare, which has allowed egg donation to become a free-market and a self-regulated industry. The only federal regulations governing egg donation focus on testing for communicable diseases as part of the broader FDA eligibility regulations for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products [9]. These laws establish federal donor eligibility determinations and ensure that individuals meet certain health criteria before they can donate their eggs [9]. The majority of states do not have specific laws regarding the use of donor eggs, and instead, rely on a set of professional guidelines created by the American Society for Reproductive Medicine (ASRM). ASRM clinical practice guidelines go beyond the FDA eligibility requirements and set out further recommendations for egg donor screening and selection. The guidance document contains few recommendations in the interest of protecting egg donors, including a minimum donor age of 21 and a maximum of 6 donation cycles per donor [10]. ASRM previously recommended a compensation limit of $5,000 to $10,000 for each donor egg cycle. However, this guidance was removed in 2014 following a legal dispute against ASRM ‘price fixing’in Kamakahi v American Society for Reproductive Medicine [11]. This leaves clinics and egg banks the right to determine egg donation payments, with reported payments of up to $250,000 [12]. Though ASRM guidelines set professional standards for egg donation, since compliance is voluntary, several studies reveal these guidelines are not always followed. In fact, the lack of compliance with ASRM guidelines is commonplace, with organizations failing to place limits on the maximum number of donations [13], and allowing individuals under the age of 21 to donate [7]. The Society for Assisted Reproductive Technology (SART) is an affiliated society to ASRM and offers guidance for fertility clinics regarding the reporting and interpretation of pregnancy rates resulting from assisted reproduction [14]. 86% of IVF clinics in the USA are SART members and must adhere to ASRM guidelines and SART reporting policies. While SART fertility clinics could be more likely to follow ASRM guidelines to ensure the retention of their membership, studies show that not all clinics are compliant [15]. Additionally, egg donation agencies and egg banks who act as third parties matching donors and recipients are not bound by these rules. Overall, the ease with which egg donation organizations and fertility clinics can disregard guidelines that are in the interest of persevering donor health and welfare is a significant regulatory failure. Unregulated egg donation advertisements Within this context of minimal regulation, egg donation advertisements are also largely unregulated. A notable exception is the state of California, requiring egg donor recruitment advertisements that feature information about compensation must also include warnings about health risks [16]. However, there are no federal regulations explicitly overseeing egg donation advertisements. While First Amendment rights have given significant latitude for advertisers to market healthcare freely, certain medical advertisements are regulated by the FDA and FTC due to concerns about misinformation impacting public welfare [17]. These laws specifically apply to pharmaceutical drugs, medical devices and products and purchasable healthcare-related services, focusing on healthcare claims that are likely to affect consumers' choices [17]. Egg donor recruitment advertisements do not fall under FDA or FTC advertising protections. This is because the act of donating eggs is not a service that egg donors purchase, and the individuals these adverts are targeting are not consumers in the process. It could be argued that egg donation is a purchasable healthcare service in relation to advertisements that are targeted toward prospective parents who wish to use egg donation services. However, the language of “donor” precludes “payment,” and instead, egg donors are “compensated” for their time, making egg donation advertisements that are targeted toward prospective parents also a grey area. Thus, egg donation advertisements fall outside of federal legal purview. As with egg donation more broadly, ASRM provides soft policy guidance for egg donor recruitment advertising: “Oocyte donation advertising and remuneration representations made by any entity or individual recruiting donors should be accurate and transparent” [18]. ASRM recognizes that presenting only the benefits of egg donation and not the risks is problematic, stating, “If compensation is noted in advertisements, the existence of risks and burdens also should be acknowledged” [18]. However, ASRM policies lack legal backing and their advertising guidance is not always followed, as illustrated by several egg donation advertisements that fail to adhere to these requirements [19, 20]. Although SART updated its policy for assisted reproductive technology advertising in 2022, the changes do not address egg donor recruitment advertising. Rather, SART requires member clinics to comply with FTC guidelines that require truth in donor success rate reporting which serves to protect intended parents [21]. SART’s advertising policy states, “The advertisement must not lead patients or the public to believe that the chances of success are greater than they really are” [21]. It is clear that the audience being protected here is intended parents, not egg donors. Indeed, the goal of this guidance is to ensure that intended parents receive accurate information so they can make informed decisions. However, ensuring the same protections for egg donors is overlooked. Potential harms due to limited regulation of egg donation advertisements We now turn to how egg donors receive most of their information from assisted reproductive agencies and how this information has the potential to be misleading due to a potential conflict of interest as a for-profit entity. We examine two ways egg donor recruitment advertisements may be misleading: (1) the focus on financial benefits, and (2) the minimization of health risks. Since medical marketing has the potential to influence behaviors and choices which can result in significant health consequences, egg donation advertisements that over-emphasize the benefits of donation and omit the potential health risks could adversely encourage individuals to donate their eggs [22]. Focus on financial benefits Egg donor recruitment advertisements are usually targeted toward young women in their twenties who are financially insecure [23]. However, some advertisements endorse donor eligibility for individuals under the age of 21 [7]. The amount of financial compensation for egg donation varies, with egg donation agencies more likely to offer a range of compensation than fertility clinics, who typically offer a fixed sum payment to donors [13]. Some egg donation websites advertise compensation of up to $60,000 for a single cycle [24]. Egg donor recruitment advertisements use rhetoric that targets the financial concerns and aspirations of young women. For example, some advertisements liken egg donation to a well-paying “summer job” and offer potential donors the chance to pay off student loans, travel the world, or purchase property through donation [23, 25]. Marketing material also includes the promise of personalized gifts, benefits, and other supplementary perks alongside compensation, as well as encouraging repeat donations where individuals can ‘earn’ additional compensation [21, 26]. As they are trying to recruit women at the most competitive colleges, some of the highest-paying reproductive agencies market egg donation in a similar manner to egg freezing for one’s future self and draw upon feminist language around empowerment and agency [27, 28] For example, “prepare for your future,” “build your own future,” and “invest in your future” [26, 29, 30]. This language insinuates notions of choice, power, and possibility, allowing egg donation to be perceived as the means by which any future desires are attainable. Given the advertising strategies for egg donor recruitment, financial compensation is a significant motivator for individuals to donate their eggs, with high compensation rates leading to an increased desire to learn more about egg donation [8]. In a study of 155 egg donors, only 11% of donors reported that they would have donated their eggs if there had been no financial compensation [31]. In another study, 18.8% of individuals indicated solely financial motivations for donating, and 58.8% labeled remuneration as very significant to their decision [4]. Additionally, 94.4% of student egg donor participants noted that financial compensation was a significant factor in their decision to donate their eggs [4]. Consequently, the emphasis on financial incentives may pique an individual’s initial interest in donating and could unduly influence their initial choice to donate. Moreover, as egg donation can be advertised to individuals under the age of 21, younger individuals may not fully comprehend the risks of egg donation if they are largely presented with the benefits [7]. Advertisements that focus heavily on the financial benefits of egg donation could therefore take away from allowing individuals to make an initial risk–benefit assessment, potentially leading to significant health consequences [13]. This is particularly concerning as once an individual begins the egg donation process, evidence shows that they are less likely to withdraw [3]. Minimization of health risks In addition to focusing on financial benefits, egg donor recruitment advertisements tend to minimize mention of potential harms. Egg donors undergo ovarian stimulation involving several weeks of hormone injections, followed by egg retrieval which involves surgery under anesthesia [32]. Some are concerned about how little is known about the impact of donation on egg donors [32, 33]. Studies have predominantly focused on the short-term risks of egg retrieval, which include infection, bleeding, ovarian hyperstimulation syndrome, torsion, and possible psychological effects [33]. Some conditions such as ovarian hyperstimulation syndrome (OHSS) has been found to increase in donors with high levels of egg production [34]. The long-term risks of egg retrieval are less known [33]. Due to their similarities, data has been gathered from within the IVF population to suggest that the egg retrieval process could expose individuals to reproductive cancers and infertility, given hyperstimulation of tissue can lead to malignant transformation [35]. In addition, there is a link between total endogenous estrogen exposure and breast and endometrial cancers [35]. However, there is speculation that this data may not mirror the risks posed to younger egg donors who may respond differently to stimulation protocols and produce higher quantities of eggs [35]. More recently, a significant number of young egg donors have reported endometriosis, infertility, diminished ovarian reserve, and cancer within the first 1–3 years post-donation [5]. While more research on the long-term risks of egg retrieval is required, if individuals are not aware of the possible physical harms, they could be vulnerable to potentially unknown and understudied risks. Studies show that many advertisements fail to mention the associated risks with egg retrieval [19, 23]. In an analysis of 424 egg donation advertisements, 97% listed the benefits of becoming an egg donor, all of which included financial compensation and only 16% of advertisements disclosed the risks of egg donation alongside the benefits [36]. The extent of risk information may also vary depending on whether the information is being presented by an egg bank, egg donation agency, or fertility clinic. For example, egg donor agencies are more likely than other reproductive agencies to omit information about the risks of donation on their websites [13]. Coupled with high financial incentives, the lack of risk information in egg donor recruitment advertisements can be misleading by presenting the process as minimally risky. Failing to include risk information undermines informed decision-making [36]. Although donors should be fully informed of the risks of egg donation face-to-face in the clinic before they donate, as with the other areas of egg donation, there is no federal oversight of the informed consent process [2]. The competing interests between the egg donor and the fee-paying recipient, who is most often viewed as the primary patient, can leave egg donors with less protection than is usually offered for medical procedures [3]. Only a few states—California, New York, and Arizona—have specific laws requiring egg donors to be provided with information about all of the possible risks [16, 37, 38]. ASRM provides some guidance on informed consent, suggesting that donors receive “all relevant information necessary to make an informed decision,” including information about the benefits and the risks of the process [10]. However, there is no enforceability mechanism in these guidelines, with studies demonstrating that risk information egg donors receive face-to-face in the clinic is not always comprehensive [4]. There can also be variations in the presented risk information, with some clinics downplaying or excluding risks entirely [32]. This has resulted in some donors being unaware of the risks of donating their eggs prior to donation, with one study finding that 20 percent of donors were unaware of the associated medical risks, including two-thirds of donors who were unaware of the link between egg donation and ovarian hyperstimulation [4]. Moreover, donors are less likely to be aware of long-term risks [32]. While outside the scope of this paper, the informed consent process requires increased oversight and standardization, including data from the available studies detailing the known and possible health risks to donors. Recommendations for future regulation In this section, we begin by mentioning recommendations that have been discussed in the literature for regulating egg donation more broadly and explaining why they fall short of protecting egg donors from misleading egg donation advertisements. We then examine FDA and FTC guidelines that govern medical and research advertising and argue that implementing similar guidelines for egg donation advertisements could help to better safeguard potential donors. One solution to addressing egg donor advertising concerns, as discussed in the literature, is for all reproductive agencies to adopt ASRM advertising guidelines, with more severe penalties for non-compliance [36]. Yet, as previously discussed, ASRM lacks the legal authority to ensure enforcement and voluntary compliance can be low. Another option discussed in the literature is the development of comprehensive regulations that could govern egg donation. This would include implementing formal oversight of assisted reproduction, such as the United Kingdom’s Human Fertilisation and Embryology Authority, which could provide enforceable regulations relating to all aspects of egg donation [4, 39]. Although broader regulation to govern each step of the egg donation process is certainly needed, a radical overhaul of assisted reproductive technologies regulations is both time-consuming and complex, making this unlikely. We present a more practical regulatory intervention that draws upon existing regulatory structures: FDA and FTC advertising oversight. The FDA and the FTC regulations protect individuals against misrepresented pharmaceutical advertising for prescription drugs and over-the-counter drugs, respectively [40, 41]. The FDA requires that pharmaceutical advertisements for prescription drugs include a summary of all risks, present a fair balance of risks and benefits, provide evidence for any claims made, and do not significantly influence an individual toward taking the drug [42, 43]. The FTC has jurisdiction over direct-to-consumer goods advertisements and similarly ensures that claims made about over-the-counter pharmaceutical products must be truthful, cannot be deceptive or unfair, and any claims must be evidence-based [44]. In their guidance for health products, the FTC focuses on consumer interpretation rather than the marketer’s intent [44]. They view advertising from the standpoint of the intended audience [44]. Consequently, information must not be likely to influence consumer behavior [44]. FTC oversight has also focused on the advertisement of certain health services, such as IVF, ensuring that claims are not misleading or misrepresent success rates to prospective parents [17]. As previously mentioned, egg donor advertising does not fall under the purview of FTC and FDA requirements as egg donation is not a good that consumers can purchase, nor can it be classified as a healthcare service since the egg donor is not seeking out the procedure for their own healthcare benefit. Rather, egg donation stands alone as a unique medical procedure. Medical procedures are usually outside the scope of the FDA and FTC. This is typically not an issue because specific medical procedures are generally not advertised in the same way as prescription drugs and the communication of risks in these contexts is usually protected by the informed consent process [45]. In contrast, egg donation is a procedure that is powerfully advertised to potential donors as a beneficial experience with limited mention of the associated risks [20]. As egg donation advertising directly correlates with interest in egg donation, omitting certain information may be misleading and warrants specific regulatory oversight [6]. As the FDA already has jurisdiction over the screening of donated eggs, overseeing egg donation advertisements could add to these existing regulations.The language used in FDA and FTC pharmaceutical and health product regulations could help guide future egg donation advertising regulations by requiring truthful advertising, comprehensive risk disclosure, and considering interpretation. Legally enforcing these requirements for egg donor recruitment advertisements would likely allow individuals to make a more informed decision about donating their eggs by ensuring substantial risk information is initially disclosed. The language used in the regulation governing advertisements for research recruitment may also aid future egg donation advertising regulations. As in research ethics, egg donation raises concerns about exploitation and undue inducement when people, especially vulnerable individuals, participate in medical treatment or research trials that do not benefit them [46]. However, in the research sphere, FDA regulations ensure significant oversight of research advertisements in an attempt to protect the welfare of study subjects [47]. The regulations consider direct advertising for study subjects to be the start of the informed consent process [47]. They require that advertising materials must be reviewed by an Institutional Review Board (IRB), not be unduly coercive, and should not overstate the benefits versus risks of participation [47]. In addition, if the research study includes payment, the potential for compensation may be advertised, but not emphasized through large or bolded text [47]. The regulations underscore the significance of complying with these regulations when a study may involve subjects who are likely to be vulnerable to undue influence [47]. In this way, egg donation may be more analogous to some research activities, such as clinical research trials, due to participants undergoing a potentially risky medical endeavor that is of no medical benefit to them and often for financial compensation. Yet, potential egg donors lack the protection that potential research subjects acquire. If the regulations used to govern advertisements for research recruitment were applied to egg donation, advertisements could be limited to only that which prospective donors need to determine their eligibility. By viewing egg donation advertisements as the start of the informed consent process, risk information would not be omitted. Additionally, coercive language and financial incentives could be eliminated, thus better protecting the welfare of egg donors. Regulating the information in egg donation advertisements could provide initial protection to donors for two reasons. First, earlier intervention, rather than at a later stage in the process, allows individuals to make informed risk–benefit decisions before entering the medical realm [36]. In other words, implementing protections at the advertising stage will shape how information is communicated when potential donors first receive it, which tends to be the most influential [36]. Second, regulating advertisements may be the most effective way to corroborate that potential egg donors receive relevant risk information, at least initially. Public-facing advertisements are easier to monitor than the informed consent process which often happens face-to-face in the clinic, and likely would require more investigative work from regulators to ensure compliance. Advertising regulations could address both the issue of initial risk disclosure and ensure continued compliance.

One limitation of federal advertising regulations is that in most cases, the FDA and FTC do not require that marketing material be submitted for approval before the advertisements are used. It is only after the advertisements have been violated that organizations are required to remove them [43]. In the context of egg donation advertisements, this would allow risk omission and the overstating of benefits to continue until violations are recognized. To address this, regulations could enforce the approval of advertisements before they are published, similar to how advertisements for clinical research must be approved by IRBs. This would ensure information received by potential egg donors in advertisements is compliant. However, this relies on federal regulations having the capacity to pre-screen every egg donation advertisement. An organization such as ASRM may be better suited for this role and could be granted the authority to certify that advertisements fulfill regulatory requirements. A secondary limitation to these recommendations is that regulating egg donation advertisements would not be a solution for all issues in third-party assisted reproductive medicine. The promise of substantial remuneration from egg donation will likely cause many donors to overlook the associated risks, especially low-income donors, even with more honest advertising. However, it is unlikely that donor compensation will be limited in the wake of the Kamakahi case, allowing the lucrative egg donor market to be prioritized over egg donor health [48]. Removing any mention of compensation from donor recruitment may provide better protection for vulnerable donors who can be easily swayed by advertisements offering high monetary compensation. This is the current practice in Spain where compensation is prohibited from being included in donor recruitment advertisements [12]. In the absence of sufficient industry-level regulations, federal advertising regulations for egg donor recruitment could address some of these issues and provide initial protections for egg donors.

This paper has identified how egg donor recruitment advertisements can be misleading by overemphasizing the financial benefits while minimizing potential risks. The lack of regulation can impair informed consent and has the potential to take advantage of young women facing financial hardships. To address the regulatory gap, we argue that egg donor recruitment advertisements should be governed by federal advertising regulations such as those set out by the FTC and FDA. Governance of egg donation advertisements is unlikely to mitigate all of the issues engendered by unregulated egg donation practices in the U.S. However, our proposal could better safeguard potential donors by ensuring that the information presented is balanced and not overly persuasive, thus better protecting the autonomy of egg donors. Author contribution HC conceived the research. HC wrote the manuscript. LCE made secondary revisions to the manuscript. All authors read and approved the manuscript. Data availability Not applicable. Declarations Ethical approval Not applicable. Conflict of interest The authors disclose no competing interests. Footnotes Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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