By Lisa Jarvis / Bloomberg Opinion
Anyone who has undergone IVF will tell you that the process can be daunting. It involves weeks of mood-altering, bloat-inducing hormone injections to retrieve eggs so they can be fertilized in a lab before being implanted. That’s followed by weeks of holding your breath to find out if all the discomfort, anxiety and many thousands of dollars will have been worth it.
Finally, a cluster of biotech firms is reimagining that process, bringing previously fantastical science to a field that has been ignored for too long. With fertility rates dropping and more women opting to postpone parenthood, the need to make assisted reproductive health care more accessible and affordable couldn’t be more urgent.
What better sign of that momentum than a birth announcement? Gameto, a biotech company working on a less cumbersome IVF process, announced this week the arrival of a child born in Peru from an egg “matured” in a lab (rather than in a woman’s body) using its technology.
It’s an admittedly small step. Many more babies will need to be born for this new technology to prove itself and be widely embraced. And it won’t magically solve everyone’s infertility struggles.
Still, a small step toward better options should be embraced; especially considering how many people aren’t able to access the existing ones. In 2021, about 2.3 percent of babies born in the U.S. — more than 86,000 — were conceived through some form of assisted reproductive technology; nearly all of those involving IVF. And while that number has grown significantly over the last decade, in no small part due to the higher success rate of the process, it is minuscule compared to the millions of women experiencing infertility in the U.S.
Gameto is trying to help nudge those numbers by making one part of the process easier. While working in the lab of famed Harvard geneticist and entrepreneur George Church, the company’s chief scientific officer, Christian Kramme, figured out the right recipe — meaning, the right combination of genes to tune up or down — to coax pluripotent stem cells into becoming ovarian-like cells. Eggs retrieved after two or three days of hormone injections are nestled in with those ovarian-like cells, which send the right hormonal cues to prompt healthy maturation. Then, just like conventional IVF, the egg is fertilized before being frozen or implanted in the uterus.
In theory, this process could save women a week and a half of expensive shots, not to mention spare them the side effects and life disruption of the lengthier process. (Most women must undergo two to three rounds of treatment to conceive successfully).
The idea of maturing eggs in a lab isn’t new. As Gameto Chief Executive Officer Dina Radenkovic points out, more than 10,000 babies have been born using some form of in vitro maturation since the early 1990s. Yet that’s a tiny number compared to the more than 10 million babies that have been born via IVF in the last 45 years. The statistic underscores the limitations of current IVM methods, which expose immature eggs to hormones or proteins. Pregnancy rates are much lower than with conventional IVF, and few people have adopted the technique.
Gameto believes turning the maturation to ovarian-like cells to orchestrate the process can turn people on to IVM. That will take a lot of convincing. Success with IVF is a bit of a numbers game, yet by nature, fewer eggs are retrieved with Gameto’s process. Radenkovic says her company’s early data suggests that their process’ smaller number of eggs yields the same number of embryos as a typical IVF cycle. And more data is coming. The product is cleared for use in multiple countries, and the U.S. Food and Drug Administration is expected to allow Phase 3 studies to begin in the first quarter of 2025.
While promising, it won’t be for everyone until that is proven on a larger scale; not only with frozen embryos but with enough babies born using the technology to give people a sense of its success rate. Some people will continue to want as many shots on goal as possible. A couple undergoing IVF because both parents carry a mutation for a severe genetic disease, for example, walks into the process knowing a substantial portion of the embryos created will not be useable. Similarly, someone freezing their eggs will want to weigh the convenience of a shorter retrieval process with fewer eggs to choose from later.
Still, that new options are in the works is an important advance for the millions experiencing infertility or wanting to preserve their fertility. Other biotech companies, meanwhile, are chasing far more ambitious goals ranging from prolonging fertility to creating human eggs from scrapes of skin cells, avoiding the ovaries altogether.
While we wait for those to progress, plenty of things could happen right now to make life much easier for those people and prepare the health care system for future technologies.
As anyone who has undergone IVF knows, the process is expensive and often not covered by insurance. A single cycle can cost anywhere from $15,000 to more than $30,000. Yet, according to the International Foundation of Employee Benefit Plans, only about a third of U.S. employers covered IVF in 2024, and just 16 percent paid for a woman to freeze her eggs. That’s a vast improvement over a decade ago when those numbers were in the single digits, but we still have a long way to go.
With so many millions of people struggling with infertility, help needs to come from all corners; from scientific advances and from a health care system that recognizes the personal and societal importance of making it easier to have a family.
Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, health care and the pharmaceutical industry. Previously, she was executive editor of Chemical & Engineering News.
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