Sarojini Nadimpally and Gargi Mishra 
In-vitro fertilisation (IVF) as assisted reproductive technology (ART) has been in vogue for quite a few decades now. While IVF has been hailed as a significant scientific advancement, with many advantages, here are some limitations which bear keeping in mind in discussions about the possibilities and extent of its use in the present and the future.. It is in this context that we discuss in-vitro gametogenesis (IVG) – a new experimental reproductive technology that is currently being developed and refined, and thus debated on a number of different fronts.
The concerns about reproductive autonomy, ethics, and equity ought to be at the forefront of any discussion of advanced and experimental reproductive technologies, including IVG. Although IVG is not currently under research in India, this technology is gaining more attention in the global scientific community. Thus, it becomes imperative to engage with it critically.
Researchers claim that IVG would reduce the risks of IVF procedures by creating sperm and oocytes (eggs) directly in a lab, unlike in the case of the IVF, which requires the retrieval of eggs from ovaries, and hormonal injections. The retrieval of eggs can be painful and risky.
Therefore, unlike traditional methods, which rely on naturally produced sperm and eggs , IVG enables the creation of these reproductive cells, known as gametes (reproductive cell – sperm and egg), artificially. This can be in a laboratory from ordinary body cells such as those from the skin. These cells are changed, or “reprogrammed,” into a special type of cell called stem cells, which can turn into almost any kind of cell in the body. In the lab, these stem cells are further transformed into sperm or eggs. The lab-made (or artificial) sperm and eggs then combine to form an embryo outside the body. This embryo can later be placed into the uterus of the woman, which can grow into a baby. This is the process which is known as in-vitro gametogenesis or IVG.
At the Third International Summit on Human Genome Editing in London in March 2023, a presentation outlined technological advancements in IVG. Skin cells taken from the tails of mice were successfully developed into gametes leading to the growth of healthy mice.One of the pioneers in the field of lab-grown oocytes and sperm is Katsuhiko Hayashi, who led the work at Kyushu University in Japan. Relatedly, scientists have also grown embryo-like structures in the lab, made entirely from human stem cells, that are more advanced than any previous efforts.
Some companies and academic institutions with significant private funding are already planning to translate the work for human use. Biotech startups in the United States, funded by venture capitalists and tech investors, have been marketing IVG as a radical new technology that will be available in a few years.
While still an experimental technology, IVG is being reported as “a milestone for human IVG research and its potential translation into reproductive medicine.” However, this transformation of human reproduction with advanced genetic technologies raises serious ethical, moral, and legal issues, even if they are still in the experimental stage.
Scientific claims
Researchers have presented IVG as aspirational, claiming that it drastically changes the way families, genetics, and reproduction are conceived and opens up reproductive possibilities for many hitherto excluded from the ability to have genetically related children.
IVG may also enable older individuals, same-sex persons, and transgender people to have genetically related children without using donor gametes. IVG proponents contend that it gives older women the opportunity to become mothers later in life, as well as women going through an early menopause – which is not the case with the IVF.
India’s Assisted Reproductive Technologies (Regulation) Act, 2021(ART) Act and Surrogacy (Regulation) Act, 2021 defines eligibility criteria for access to ARTs and surrogacy in India. Notably, they include age, nationality, marital status, sexual identity, and (implicitly) gender.
The focus on IVG is that IVF is not a foolproof way to overcome infertility, especially for women 35 years of age or older who want to have their own child. Also, according to the ART Act, only women and men between 21 and 55 years of age are eligible to access ARTs. The Surrogacy Act requires the intending couple to be a woman aged 23 to 50 and a man aged 25 to 55 years. And, therefore, the apparent advantage of the IVG, which allows women at a later stage of their life to conceive, may have little to limited impact in India.
Furthermore, the ART Act has legal limitations for oocyte (naturally – and not artificially produced sperms or eggs) retrieval. According to the law, an egg donor shall donate eggs only once in her life, and no more than seven eggs shall be retrieved from the donor. Similarly, the Surrogacy (Regulation) Rules, 2022, puts a cap on embryo transfer. One embryo is allowed to be transferred into the uterus of a surrogate mother, while up to three embryos may be transferred only in special circumstances.
With IVG, researchers claim they can create a large number of sperms and eggs, and embryos, in the lab, potentially providing an ‘opportunity’ to persons experiencing difficulties in producing sperms or eggs, naturally, to conceive through IVF.
The IVG is, thus, perceived as an expanded opportunity for ‘non-normative’ reproduction for same-sex partnerships and transgender or intersex individuals who want a child. It does not need natural reproductive cells and is genetically related to both partners. However, some same-sex couples would still require a surrogate to carry the pregnancy.
Additionally, IVG could generate multiple sperms and eggs, potentially improving success rates for those facing infertility challenges or unable to produce viable sperms or eggs naturally.
IVG could also be claimed to offer a solution for persons with genetic disorders who wish to have children without passing on their condition. Overall, IVG has the potential to expand options for family-making and address a wide range of reproductive concerns. It could ‘benefit’ diverse populations seeking to start or expand their families.
Concerns
Beginning with IVF in the 1970s, concepts surrounding birth, genetics, reproduction, and family-making have been challenged and transformed, sparking debates about fertility, genetics, family, kinship, and parenthood. Research on infertility, ART, and surrogacy has led to a rethinking of biotechnological reproduction. The use of IVG for genetic parenthood raises concerns about reinforcing genetic essentialism and undermining non-traditional families based on adoption or gametes or other forms of family.
Advocating the use of these experimental procedures in the name of genetic relatedness may also exacerbate existing inequalities for those already experiencing marginalisation. For example, researchers have claimed that IVG provides equity for same-sex couples and individuals, but legal frameworks still prioritise heterosexual couples. In many countries like India, LGBTI persons are not allowed to access surrogacy legally.
The Surrogacy Rules in India allow only married couples of Indian origin to access surrogacy. The Act denies the rights of homosexual couples to commission a child and refuses to acknowledge such couples as ‘legitimate’. Thus, the current legal framework limits surrogacy to cis-heterosexual married couples and operates within a cis-heteronormative framework that prioritises and, indeed, normalises a certain experience of childbearing and family-making over all others. If equity were a goal, IVF and surrogacy would be regulated differently.
Furthermore, IVG’s ability to create large numbers of embryos in a lab allows people to choose from dozens of potential embryos, enhancing embryo screening potential. This further enables the selection or rejection of embryos based on the likelihood of genetic diseases, chromosomal abnormalities, and even characteristics such as skin and eye colour, intelligence, or height.
While some of these genetic diseases might be patently ‘undesirable’, the procedure raises questions about the desirability of specific traits and genes. There are enough examples historically where the existing reproductive technologies have been misused to promote eugenic selections and discrimination against people with disabilities, intensifying societal disparities and race and caste based discrimination.
Caution over optimism
IVG has the potential to revolutionise families, genetics, and reproduction, but there is a significant gap between speculation about its benefits and the actual outcomes of research studies. Additionally, ongoing research will be necessary to understand this technology’s long-term effects and consequences on society as a whole. It is crucial to consider the potential impact on future generations and ensure that safeguards are in place to protect the rights and well-being of children created through IVG.
As IVG research progresses, carefully considering this technology’s ethical implications and potential consequences will be crucial. Furthermore, it is important to address discussions about the legal rights and status of children created through IVG.
As this technology advances, it will be essential to have open and transparent conversations about the ethical, social, and legal implications of IVG. These conversations should involve diverse people, including ethicists, scientists, policymakers, and the general public. These discussions and critical analyses can help navigate the complex science, ethics, and policy nexus around IVG. These discussions should distinguish between concepts like therapy and enhancement or disability and disease rather than rely solely on the scientific community to characterise the claims with IVG.
Although IVG is still a new technology, its probable risks and potential for misuse in a regulatory vacuum call for caution rather than any call for optimism.
Sarojini Nadimpally is a social scientist and public health researcher; Gargi Mishra is a lawyer and public health researcher. Authors work on the issues of infertility, ARTs, surrogacy, and genetic technologies.
The authors would like to acknowledge Sandhya Srinivasan, Vrinda Marwah, Keertana K.T., and Adsa Fatima for their inputs.