Along with the article about the ascension of FemTechs in the healthcare market, produced by the Life Sciences, Healthcare and Cannabis team at Campos Mello Advogados in cooperation with DLA Piper at the beginning of the month to celebrate the International Women’s Day, today’s analysis will demonstrate the relevance behind the recent studies that have been successful in making it possible to reverse or delay the aging of eggs by using techniques that, although incipient, represent a great opportunity for advancement, improvement and investment within the next years. 

Researchers from the Hebrew University of Jerusalem, located in Israel – country that has progressively gained notoriety in research and development space –, identified that the egg aging, which is caused by the gradual genetic damage accumulation over the years, can be fought by an anti-viral that blocks that damage during viral infections together with an anti-viral used to treat HIV patients[1].

In the experimental phase, the anti-viral drugs reached a positive result by rescuing the damaged aged gametes and raising their maturation rate up to 28.6%, bringing the expectation that, by a decade, fertility can be extended among older women, especially those who, after age 40, find it difficult to get pregnant.  

It is important to highlight that this is an incipient study that will be submitted to further evaluation, especially on the actual capacity to restore the fertility of human eggs. 

Once it becomes a Phase III trial in humans, a number of legal and ethical issues generally associated with clinical research, such as scientific misconduct and how best to ensure safety of subjects participating in a trial, must also be pondered, as the activities undertaken in the course of a clinical trial are subject to regulation by various government authorities. This relies on the fact that the progress of a clinical trial from the initial design through closeout implicates a number of legal and operational issues. Many of those arise even before the trial begins and include, for example, designing the clinical trial protocol to meet sponsor goals and regulatory hard requirements, obtaining the regulatory approvals, engaging CROs, sites, PIs, and also ensuring funding for the trial.  

Concerns about the ethical conduct in a Phase III trial is also key in the routine operations, requiring from the parties involved in not only knowledge about the regulations but also familiarity with the objectives of the study.

Yet auguring the unquestionable existence of several legal and clinical obstacles to be overcome in this matter, the study was received with a very good perspective of improvement and enforcement.

It is known that the development and dissemination of contraceptive methods, as well as economic crises and the strengthening of women's power of choice, together with the significant presence of women in the 21st century labor market, are some of the factors responsible for the worldwide drop in fertility that has also gained particular acceleration in this decade due to the difficulties and restrictions imposed by the coronavirus pandemic.

According to the University of Washington’ study findings, the forecast for 2100 is that at least 20 countries will have their population reduced by half and 93.8% of the countries under analysis will have a fertility rate lower than 2.1 children per woman[2]. This data is in accordance with Brazilian Institute of Geography and Statistics (“IBGE”) estimates, which in mid-November 2021 recorded the biggest drop in the number of births in Brazil since 2016, caused by the increase of the national pandemic scenario[3]. 

Faced with such a significant decline in birth rates in recent years, new techniques that allow reversing or delaying aging in human egg cells appear as unquestionably opportune alternatives for women who, no matter how many years go by, still choose motherhood, and as skillful tools to solve, or at least reduce, the problem behind the aging in eggs – above all, the frightening population decline at a global level.

References:

[1] The Times of Israel. “In breakthrough, Jerusalem lab says older human eggs can be made young again”. Published on March 8, 2022. Available online at  https://www.timesofisrael.com/in-breakthrough-jerusalem-lab-says-older-human-eggs-can-be-made-young-again/ >

[2] The Lancet. “Fertility, mortality, migration, and population scenarios for 195 countries and territories from 2017 to 2100: a forecasting analysis for the Global Burden of Disease Study”. Published on July 14, 2020. Available online at  https://www.thelancet.com/article/S0140-6736(20)30677-2/fulltext >

[3] Valor Econômico. “Brasil registra maior queda de nascimentos desde 2016, ano da epidemia de zika, diz IBGE”. Published on November 18, 2021. Available online at

https://valor.globo.com/brasil/noticia/2021/11/18/brasil-registra-maior-queda-de-nascimentos-desde-2016-ano-da-epidemia-de-zika-diz-ibge.ghtml >