Sarah Kimmins has long been interested in environment-gene interactions, its impact on male fertility, and the health of the next generation. Over more than a decade of research partnered with fertility clinics, she became aware that there was an absolute need for improved male fertility diagnosis and realized that what they were studying – the heritable sperm epigenome – could be the basis for a new diagnostic and therapeutic technology. That is where the story of her spinoff company HisTurn begins.
Male infertility is not a niche condition – it is a worldwide disease. According to recent studies, global male fertility rates are in decline, having reportedly fallen nearly 50% in the past 50 years. Despite these alarming figures, the standard approach to assess male infertility has not changed for more than 50 years and is still based on a subjective analysis of semen concentration, morphology, and motility. The parameters currently used for semen analysis are inadequate and don’t provide accurate information on a man’s chance to conceive. Kimmins wants to change that.
The real cost of traditional fertility treatments
Traditional fertility treatments tend to focus on women as both the cause of infertility and the target for medical intervention. In her book “Conceiving Masculinity: Male Infertility, Medicine, and Identity,” Dr Liberty Barnes posits that notions of gender inherited from earlier generations have negatively influenced the organization and development of male infertility medicine over the past century, ultimately providing a disservice to both men and women trying to conceive.
Kimmins is well aware of how this inequality in the field is affecting women around the world. “Women bear the burden of undergoing fertility treatments, even if it is caused by male factors,” she said.
This isn’t without cost; Kimmins explained that every round of treatment, such as hormone injections and egg retrievals, comes with a health risk for the woman. This includes increased risk of stroke and, in the long-term (although understudied), even cancer. Beyond this, fertility treatment can be traumatic taking both an emotional and financial toll. Treatment costs up to $60,000 and couples who have difficulty conceiving often have higher rates of depression and anxiety. Indeed, most couples will spend years exploring different treatment methods, starting with unmedicated intrauterine insemination, going all the way to in vitro fertilization, all with no guarantee of success.
Kimmins was determined to come up with a better solution for infertile couples based on equality in care. “Currently men have a limited role in treating infertility,” said Kimmins. “That drew me to see if we could develop something better to not only diagnose infertility, but also treat male infertility.”
Making (it) HisTurn
Based on decades of epigenetic research using animal models, clinical samples and aided by machine learning, Kimmins’ team was able to identify epigenetic signatures found in sperm related to fertility status and lifestyle factors that could impact embryo development and child health.
HisTurn’s test will provide an individual fertility prediction score associated with clinical treatment outcomes that takes into account potentially reversible lifestyle factors (cannabis use, toxicant exposure, and being overweight) that, if addressed, may improve fertility status and treatment outcomes. The goal is to provide clinicians and patients with personalized treatment recommendations that have the most potential for success.
Currently Kimmins and her team are validating the accuracy of the test, and they aim to commence clinical trials in 2024. Kimmins is clear about wanting to ensure the best possible version of the test is ready to be put on the market when the time comes.
“We want to put out a gold standard,” explained Kimmins. “There are a lot of tests in the fertility space with questionable use and accuracy and so we really want to put out a test that is going to be reliable, that's accurate, that can actually guide treatment.” Looking to the future, Kimmins hopes HisTurn will be internationally available at fertility clinics for couples undergoing treatment, and via e-commerce and even pharmacies for men interested to learn more about their current sperm quality and fertility status.
The McGill Innovation Fund (MIF), which is the largest entrepreneurial fund of its kind at McGill, has been crucial in helping HisTurn progress towards commercialization. “The MIF has provided invaluable information and advice to help shepherd us through from the report of invention stage to IP and identifying routes for commercialization” said Kimmins, “You know, as scientists, we don't necessarily have the requisite technology translation experience, although we do run research teams, and secure millions in funding and that bears a lot of similarity to running a business. We would not have progressed as quickly to where we are now without the MIF advising structure.”
The MIF has helped provide guidance to HisTurn on everything from incorporating and patenting law in Quebec, to identifying funding avenues and helping navigate the financial landscape as a new startup. HisTurn was awarded support in the Develop stage of the MIF, a funding tier that provides $50,000 (in the first cohort of the MIF, Professor Kimmins' team was awarded $25,000 as an early-stage project).
Turning to the future
Kimmins research comes at a time when scientists are just starting to realize the impact of environmental factors on male fertility, and when public awareness surrounding the issue is still limited. “I find that the public knowledge around male infertility is very rudimentary,” clarified Kimmins. “For example, men don't know that as they age, there's a higher risk of infertility. Men don't know that how they live their life, and their overall health can really impact their fertility and long-term reproductive health.”
Building on her expertise in epigenetics, Sarah wishes to expand even further into the personalized medicine space, beyond male infertility diagnosis and treatment. The technology they are testing could also be developed and applied for diagnosis and personalized treatment of other diseases including cancer.
In the long run, Kimmins believes HisTurn will help better guide couples in their infertility journey. It allows for the possibility of what she describes as “an informed patient decision-making process with the clinician regarding treatment plans based on prediction of success.”
“It’s a human rights issue,” said Kimmins, “that is due to unequal access to treatment between men and women.” Kimmins believes that her technology will help advance fertility treatment practice and with the support of the MIF she plans to make that vision a reality.