Research on the manufacture of egg-like and sperm-like cells for the purpose of producing laboratory-crafted human children is proceeding rapidly. The objective is to turn ordinary body cells of prospective parents into artificial eggs and sperm. Though ostensibly developed to facilitate reproduction in individuals for whom this capability is impaired or unavailable, the use of laboratory produced eggs and sperm represent an opening for the routine production and commercialization of “designer babies.”[1] These are individuals whose hereditary components are technologically modified to meet one or more specified objectives.

Researchers refer to creating eggs and sperm (gametes) in the laboratory as in vitro gametogenesis or IVG. The experimental process begins with “somatic” or body cells, e.g., from adult blood or skin. These cells are not those that evolved to produce gametes during embryonic development. The somatic cells are modified with extra DNA or RNA, or by exposing them to proteins or drugs, which has the effect of turning some of them into induced pluripotent stem cells (iPSCs). The iPSCs are next exposed to other biomolecules or drugs, to convert them into cells resembling the specialized cells of the body, such as eggs or sperm. Molecular tests of artificially differentiated cells invariably show them to be not identical to their natural counterparts (also see below).[2]

Promoters suggest that IVG would make it possible for medically infertile people to have biologically related children without seeking authentic eggs or sperm from a donor. Additionally, advocates for the technology’s clinical use argue that it will help people have biologically related children who are not medically infertile but who could be considered “socially” infertile. This category would include same sex couples or gay individuals as well as people past the age of viable medical reproduction.[3] The technology would also make it possible for a fertile person wanting to become a single parent of a biologically related child to do so without gametes (egg or sperm) donated by an identifiable second person (solo IVG).

If it works, the technology will also make it possible to assist a “uni-parent” to reproduce; that is, a person from whom both synthetic eggs and sperm are derived. There are also possibilities for assisting “multiplex parenting” where more than two individuals want to have genetic ties to a single child.[4] For all these categories, the preferencing of genetically related children over adopted children is implicit.

The technology, should it find its way into fertility clinics, may reduce the number of donor gametes that are necessary, but it is likely to vastly increase the need for women to serve as surrogates, especially for same-sex males seeking to reproduce genetically, unless the creation of artificial wombs, currently an actively researched prospect, becomes a reality.[5] Proponents of IVG, acknowledging the health risks and discomfort associated with egg extraction, count as a benefit the expected reduced demand for women’s eggs. They fail to note, however, that for many decades the fertility industry has ignored calls for it to include health warnings on advertisements seeking young women to supply eggs and to investigate the long-term health risks for egg donors by establishing a national health registry.[6] This does not bode well for how the increased number of surrogates would be targeted, especially in impoverished and patriarchal countries where patterns of coercive paternalism work against the ability of women to consent freely to function as surrogates.

From April 19-21, 2023, The US National Academies of Sciences (NAS) held a three-day workshop titled, “In Vitro Derived Human Gametes as Reproductive Technology: Scientific, Ethical, and Regulatory Implications: A Workshop”[7]. Here, we offer a critique of that NAS workshop.[8]

We observe, first, that there was no sustained discussion at the workshop about whether clinical application of this exotic technology should be allowed. Instead, the event’s unquestioned presumption was that the technology would advance to clinical use. While some invitees evinced concerns about moving forward with this technology, no one put forth a vigorous challenge to employing gametogenesis in fertility clinics. Some debate may have occurred in break-out sessions, but the proceedings of those were not shared with the public. In the plenary sessions, however, no one articulated significant opposition to the idea that commercial laboratories should be permitted to manufacture synthetic embryos for implantation and eventual birth. Our analysis of workshop deliberations suggests that, confined by structure and topical framing, while reservations about IVG may have been aired they were not debated. Based on the state of the relevant science and the lack of any pressing health need we conclude that IVG for reproductive purposes should be strongly opposed.

Corralling cautions and setting the agenda

The framing of the workshop’s agenda and labelling of its subsections discouraged consideration of whether synthetic gametes should be used to create functionally equivalent human embryos for implantation.[9] Indeed, Yale University reproductive scientist Hugh Taylor enthused early on that, impressed by how quickly the field was evolving, he was confident that it was not a matter of ‘if’ this technology would be available for clinical practice but ‘when.’ He speculated that availability of dozens, hundreds, or even thousands of embryos would increase opportunities for expanding embryo screening. That creating large numbers of embryos makes it possible to select for “desirable” traits was acknowledged as problematic, but did not dampen enthusiasm for moving forward.[10] Boosters of the technology must have been gratified to hear Peter Marks, director of the Center for Biologics Evaluation and Research of the Food and Drug Administration (FDA), share with them the advice he likes his staff to offer lawmakers: “[y]ou’re not going to put the genie back in the bottle.  It’s going to progress, whether it progresses here in the US or elsewhere.  If we don’t get into this…you’re just putting ourselves behind the 8 ball of [not] being able to take some leadership in making sure it’s done correctly.” No one rejoined that the US could alternatively take leadership in curtailing its progress and avert a global scramble to the ethical bottom. Indeed, as the workshop wound down, Stanford Law Professor and bioethicist, Hank Greely, had heard nothing to dissuade him from the optimistic view that it was a matter of, “when this ultimately gets adopted.”

The agenda’s printed objectives for the social, ethical, and legal consideration of IVG and for how to engage the public, channeled critique into categories that presumed that fertility clinics would, eventually, offer IVG. Operative concepts included imagining pathways to clinical trials, facilitating governance of the technology, identifying challenges to securing equitable patient access, identifying “stakeholders,” and highlighting best practices.

During discussions, concerns were raised about how IVG amplified the possibility of eugenic outcomes, and was likely to exacerbate social inequities, especially in the global south where the demand for women to serve as surrogates would increase. There was also mention of the importance of ensuring safety for children born in this way. Notwithstanding all this, no one argued that ethical concerns about IVG were of a sufficient magnitude to support calls for a moratorium, a ban, or a prohibition of any aspect of IVG. A few non-scientist attendees lamented the lack of a presentation from a disability rights perspective, the intended panelist having cancelled owing to health concerns. Perhaps a more powerful consideration of how eugenic proclivities inhere in the very idea of IVG would have emerged had the cancellation not occurred.

Some concern was expressed about how the “genetic essentialism” of IVG carried an implied devaluing of children born using donor gametes. Yale Law School lecturer, Katherine Kraschel, noted that the gay community is not a monolith. Where some might welcome opportunities to have biologically related children as do their heterosexual counterparts, others, with an eye to challenging entrenched values, may be discomfited by the devaluing of children conceived using donor gametes.[11] But no one made a sustained case for how this technology, marketed as preferencing the desirability of biologically related children, socially de-values adopted children, whether to gay or straight families, around the globe. Their status was implicitly sub-texted by gametogenic promoters as a substandard substitute for “the real thing.”

Only briefly referenced, but not discussed much less debated, is that embryo selection at the scale expected is eugenics. Moreover, manipulative intervention to bring about traits (in addition to those already offered through conventional prenatal selection in reproductive markets, such as sex, eye color, and presumed life prospects) will be unavoidable given the inherent commodification of the enterprise. Eugenics is not a possibility that can be avoided. It is inherent in the undertaking and is already underway. [12]

Conflicts of interest

Biographies of presenters listed academic affiliations and scientific institutional or science society affiliations. None, however, listed bio-companies that scientists either founded or with which they were affiliated. Similarly, the biographical summaries of legal-bioethical presenters, some of whose presentations were clearly facilitating moving the technology into clinical use, listed no connections to named commercial bio-labs. Once the workshop was underway, a few presenters made disclosures of their corporate ties or funding sources.[13] How these might function to compromise neutral analysis of the technology was also not discussed. One funder of the workshop itself was also a funder of ongoing IVG research.[14] There was no assessment of how those who stand to profit lavishly from the normalization of commercially produced gamete-like cells might be compromised as presumed sources of balanced social and ethical analysis of the technology. There was no recognition that clinicians operate as part of a multi-billion-dollar IVF industry that constitutes a massive global profit-focused concern. Fortune Business Insights, which conducts market studies of global businesses, reports that the global market for in vitro fertilization is estimated to reach USD 36.39 billion by 2026.[15] The American Society for Reproductive Medicine (ASRM), a self-described professional society, possesses powerful and operational lobbying capacity. One workshop conferee was its president-elect. Another, also a member of the planning committee, was an ASRM past president. A balanced analysis of IVG might include their points of view and input. But to avoid explicitly discussing the influence such connections may have on the conference framing, structure, and proposed policies suggests that disclosure of a conflict of interest is considered by the NAS to magically neutralize the effects of its possession. Registering any concern to the contrary did not appear to be an option.

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