In July 2022, Fertiga attended the 38th annual ESHRE meeting (European Society of Human Reproduction and Embryology) in Milan to present its latest results.
The Belgian fertility company did so by using a comprehensive poster. The poster is titled “Cumulus cell analysis as a non-invasive oocyte selection strategy to reduce the number of oocytes/embryos cultured and increase pregnancy rates”.
The Aurora Test is a predictor of the most competent embryo. Generally, the test has been used to select transferable Day 3-embryos. A retrospective analysis of Van Vaerenbergh et al. (2021) investigated whether the Aurora Test could also be applied to select oocytes on Day 1. Therefore, a subset of 80 patients was selected. On average, these patiets had 8 large pre-ovulatory follicles on trigger day and at least 4 2PN-oocytes. The team then studied the effect of processing only the three highest-ranking oocytes with the Aurora Test. These were then compared to the processing of all oocytes.
The study concludes that cumulus cell analysis may reduce culture work and improve the outcome in ICSI eSET. By performing the Aurora Test, patients benefit from a higher pregnancy rate in the fresh transfer cycle. The oocyte selection strategy results in a reduction of embryo culture and evaluation work.
August brought us exciting news from a VUB spin-off: Fertiga. The innovative VUB spin-off is thriving. They are active in the health sector and develop life-changing innovations. With this pioneering research and through the support of VUB TechTransfer, the VUB tackles today’s challenges and creates an impact on society.
One try, one child Fertiga is a spin-off company from one of the global IVF leading centers, UZ Brussel in Belgium. UZ Brussel has been pioneering IVF, with the first ICSI baby worldwide born in 1992 from the Center of Reproductive Medicine of UZ Brussels.
Fertiga is developing the Aurora test that doubles the chances of becoming pregnant after just one fertility treatment: it improves the prediction of which egg has the highest potential for pregnancy.
“One try, one child. That should always be the goal.” – Elien Van Hecke, co-founder.
The company is currently planning a large-scale randomized clinical trial with patients from fertility centers in several different countries. The results of this study will hopefully help convince governments to make the test refundable for would-be parents.
“This innovation saves people much time and emotional heartbreak… According to the World Health Organization, 1 in 6 couples suffer from problems with infertility.” – Elien Van Hecke, Fertiga
Fertiga, a spin-off company of the Vrije Universiteit Brussel (VUB), launched an innovation last year. Their Aurora test will considerably improve the efficiency of ICSI treatments. A study with 633 patients showed that the test helped to double the pregnancy success rate of the first embryo transfer from 29 to 61 percent.
Aurora test doubles pregnancy chances in assisted conception
Assisted conception techniques have matured in the last few decades, with Belgian scientists playing a big part in the progress. The Aurora test, developed by the Belgian start-up Fertiga, now further improves the odds for couples wanting to be parents: the test doubles the chances of becoming pregnant after just one fertility treatment.
This article was authored by Andy Furniere.
Last July, the first person to be conceived via in vitro fertilization (IVF) celebrated her 43rd birthday. Things have changed considerably since Louise Brown was born in the UK: assisted reproduction has become increasingly common and new methods are improving the rates of successful pregnancies.
An important contributing breakthrough was achieved about 30 years ago at the University Hospital Brussels (UZ Brussel), when the first Intracytoplasmic Sperm Injection (ICSI) baby was born. In classical IVF, the egg and sperm are left in a petri dish to fertilize on their own. In ICSI, a single sperm cell is injected directly into an egg cell, making the procedure the most common and successful treatment for male infertility.
“This innovation saves people much time and emotional heartbreak… According to the World Health Organization, 1 in 6 couples suffer from problems with infertility.” – Elien Van Hecke, Fertiga
Doubling the chance of pregnancy
Fertiga, a spin-off company of the Vrije Universiteit Brussel (VUB), launched an innovation last year which considerably improve the efficiency of ICSI treatments: the Aurora test. A study with 633 patients showed that the test helped to double the pregnancy success rate of the first embryo transfer from 29 to 61 percent.
“This innovation saves people much time and emotional heartbreak,” says Elien Van Hecke, co-founder and Chief Commercial Officer (CCO) of Fertiga. “In Belgium, ICSI and IVF treatments are largely refunded by the social security system, but in countries where this is not the case the test can also save people a lot of money.”
Cumulus cells point to the best egg
The Aurora test improves the prediction of which egg has the highest potential to develop into a healthy baby. “This prediction is traditionally only based on a morphological evaluation of embryos: a visual inspection of the embryo’s characteristics under a microscope. This evaluation however doesn’t show the full picture, because the most ‘beautiful’ or well-formed embryo is not necessarily the healthiest embryo.”
The Aurora test complements these conventional assessments by analyzing crucial factors determining the quality of the egg itself. It does so by investigating the cumulus cells, a ‘cloud’ of cells which surrounds the egg somewhat like an eggshell. This shell is normally removed and discarded during an ICSI treatment, as it’s of no use for the fertility treatment itself. But in the last decade, researchers of the VUB and UZ Brussel have taken a hard look at the cumulus cells and found that they contain essential information.
“A lot of useful information about the development of the egg cell is stored in the cumulus cells. The UZ Brussel scientists managed to extract much of this info, and we used this expertise to produce the Aurora test.” – Elien Van Hecke, Fertiga
“The cumulus cells are closely linked to the egg cells and support them in their development. As a result of this intense collaboration, a lot of useful information about the development of the egg cell is stored in the cumulus cells. The UZ Brussel scientists managed to extract much of this info, and we used this expertise to produce the Aurora test. The test specifically examines the gene expression of three particular genes in the cells, plus that of two control genes.”
Not that kind of corona
The researchers of the UZ Brussel were not the only ones interested in these cumulus cells, but they were the first to achieve this breakthrough. Their triumph was helped by factors that have contributed to previous Belgian successes in this domain. “The UZ Brussel is the largest fertility clinic in Europe and provides researchers with a unique link to patients, a link which is crucial to carrying out clinical trials. Another important factor is that Belgium has a liberal legislation when it comes to research on embryos, thus stimulating studies in this field.”
For the moment, the Aurora test can only be used at the UZ Brussel, but Fertiga is currently in talks with interested fertility centers in multiple countries. The commercial expansion of the young company has been strongly hampered by the COVID-19 crisis. “We were ready to get into full gear in the spring of last year, just at the time when the pandemic broke out and fertility centers had to close their doors,” says Van Hecke. “Thankfully, we still managed to carry out an important clinical trial, so we can now back up our claims with clear figures.”
The new name chosen for the test was inspired by Aurora – the goddess of dawn and the coming of the sun – as a reference to the creation of new life.
The coronavirus pandemic also forced the start-up to radically adjust the branding of its test. “Cumulus cells are also called corona cells, so we initially came up with the name ‘corona test’ for our innovation. I guess I don’t have to explain why that turned out to be quite a bad idea.” The new name chosen for the test was inspired by Aurora – the goddess of dawn and the coming of the sun – as a reference to the creation of new life.
Growing the company to help more couples
In addition to launching its product in other parts of the world, Fertiga is now also preparing a second investment round. The company’s first financing round was carried out in 2019, with Novalis Biotech Incubation as lead investor supported by a number of international private investors.
Furthermore, the start-up is currently planning a large-scale randomized clinical trial with patients from fertility centers in several different countries. The results of this study will hopefully help convince governments to make the test refundable for would-be parents – it currently costs between €1000 – €1,500; a price that not everyone is able to pay.
“Refunding our test would save the health sector a lot of money in the long term because the increased chance of pregnancy success means that fewer costly fertility treatments would need to be carried out,” says Van Hecke. She also emphasizes the strong need, globally, to improve the efficiency of fertility treatments. “According to the World Health Organization, 1 in 6 couples suffer from problems with infertility. Of course, not all of the affected couples go to a fertility center, but the numbers that do are growing every year. Although we will never be able to aid everyone, it feels very rewarding to help so many couples fulfill their dream of having a child.”
Belgium is the world leader in research into fertility problems in couples. The start-up Fertiga is the result of this. “Helping couples who want to have children, that’s what we do it for.”
Image by Kristof Vadino.
Every year 5,000 to 6,000 babies are born in Belgium through ‘assisted reproduction’, artificial fertilization. That’s about one in 20, which means that almost every kindergarten class in our country has a test-tube baby. For most women and couples, this is preceded by a months-long process: hormone treatments, hospital visits, failed attempts and a lot of trial and error. While the techniques for making the impossible have evolved, more than 40 years after the birth of the UK’s first test-tube baby, there’s still a lot of room for improvement.
The essence
The Brussels start-up Fertiga has developed a test that doubles the chance of success in a first IVF attempt to more than 60 percent.
This test costs 1,000 to 1,500 euros and is already offered at UZ Brussel.
The roll-out in Belgium and in the rest of the world was delayed due to the pandemic.
Doubling the chance of pregnancy
One of these recent improvements comes from Johan Smitz, professor, and researcher at the VUB in Brussels. His scientific breakthrough resulted in the start-up Fertiga. “With our knowledge, we succeed in doubling the chance of pregnancy and birth,” says Elien Van Hecke, one of the founders.
With the classic approach, only 30 percent of women achieve a healthy baby on their first attempt. Those are the lucky ones, because with an average couple who goes to a fertility clinic, several embryos are implanted before it hits. And one in three just doesn’t succeed.
Big leap forward
A new study of more than 600 women shows that Fertiga increases the chance of success on the first try by up to 61 percent. After three attempts, that’s almost 80 percent. “That’s a big leap forward,” he said. That can mean a big saving for the health budget of the government. And most importantly, it makes a huge difference to the patient.
“A journey like this is very important. If you don’t experience it, you can’t imagine it,” says Smitz. “A wish to have children is very drastic and puts pressure on the patient and the couple. You are constantly working on it. You undergo the procedure, you anxiously await the pregnancy test. If it’s negative, that’s hugely demoralizing. Then you have to pick yourself up again so that it will work next time. Many – one in four – drop out after just one failure.”
15% THE WORLD HEALTH ORGANIZATION ESTIMATES THAT 15 PERCENT OF COUPLES STRUGGLE WITH FERTILITY PROBLEMS.
More attention for couples
Van Hecke: ‘Couples deserve more attention. Moreover, they deserve to have techniques developed that make the process more comfortable for them.’ A classic approach consists of hormone treatment, after which an average of ten eggs are harvested and fertilized. A doctor then chooses one embryo to implant, the rest goes into the freezer for possible later. This choice is not made on the basis of a visual inspection and the morphology of the embryo. “That’s not optimal. The most beautiful is not always the strongest,’ says Smitz. “We add an extra dimension to that.”
“Cell cloud”
With Fertiga everything revolves around a cloud of small cells that form a kind of shell around the egg cell. That cloud of cells is of no use for the treatment itself and will be removed, but it does contain a lot of valuable information about how the egg has developed. ‘We analyze the molecular properties of that cloud of cells and give all oocytes a quality score based on that. In combination with the embryo inspection, this produces great results’, says Van Hecke.
Ten years of research preceded this. ‘It is fantastic that the technology is finding its way to the market. That’s what you do it all for, to help couples with problems’, says Smitz. Patients who request the test still have to pay for it out of their own pocket. The price is between 1,000 and 1,500 euros. A luxury product? Only for the lucky few? “We feel the willingness to pay for that, and it makes the process so much more comfortable for the woman,” it sounds. “In Belgium, a lot is repaid, but an enormous amount of time is lost. As a starting company, we cannot count on that. But we have no doubt that the test is interesting from a health economic point of view.’
Image by Kristof Vadino.
GOVERNMENT SAVINGS
Fertiga estimates that the government can save several million euros per year in this way. With full reimbursement of the test, Fertiga speaks of 1 million euros per 1,000 women who start a fertility program.
The test is already offered at UZ Brussel, which houses the largest fertility center in our country. But that’s where it ends. Commercialization has been delayed due to the pandemic. The timing of the start-up’s launch was particularly unfortunate. Between January and March last year, Fertiga hired six people, only to find that fertility centers – non-essential care – closed for several months, both in the spring and in the autumn. “We have to live with that harsh reality,” she says. And another fun anecdote. The cells we analyze are actually corona cells. We originally launched our test under the brand name Coronatest. We have now adjusted that,” says Van Hecke, who used to work at Roche Diagnostics.
International potential
Fertiga also targets non-Belgian couples. It is conducting talks in Germany. “This has international potential,” says Van Hecke. “According to the World Health Organization (WHO), one in six couples have difficulties conceiving. Of course, not everyone goes to a fertility center, but even with a fraction of that, we are talking about large numbers. We see an annual growth of 5 to 10 percent. In Europe it is more like 5 percent, in China, where it is still on the rise, it’s more like 10 percent.’
Van Hecke realizes that Fertiga is not the holy grail for all couples. “One try, one child. That should be the goal for everyone. But it’s not that simple. Medicine will still make progress, but there will always be a group of patients who will never succeed.”
The start-up of Fertiga is yet another proof that Belgium is the world leader in fertility research.
In vitro fertilization (IVF) can help women unable to naturally conceive to have a child. However, even if this expensive treatment is successful right away, it is still arduous for the couple. New technology developed by Fertiga ensures an enhanced success rate and increased comfort, while also highlighting Belgium’s position as a leader in the field of fertility research.
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Women facing fertility issues usually opt for hormone treatment to fulfil their desire to have children. On average, a dozen or so eggs are harvested and fertilised. After a visual check, the doctor will then implant the embryo presenting the best morphology. However, this is not always necessarily the strongest embryo. Scientists at the VUB have now developed a test to select the most suitable egg cells possible.
The cells surrounding the removed egg cells play a crucial role in the new test, as they provide an excellent indication of how the latter have developed and thus their quality. Those with the highest quality score, as also determined by the conventional inspection, are fertilised and replaced. The results are astonishing, with the pregnancy rate doubling to as much as 61% at the first attempt!
From a medical and health standpoint, the benefits are considerable, resulting in less physical and mental strain for the parents, saving them both time and money.
If you’re curious to learn more about the Aurora test, click here.
Study data confirm the results of the performance of the Aurora test. The pilot study already showed a positive outcome and has now been confirmed in a large patient cohort. The latest study included a total of 633 patients. 113 patients were tested using the Aurora test. The other 520 patients served as a control group.
The Aurora test results in non-invasive oocyte quality scoring. The test is based on cumulus cell analysis combined with morphology scoring. The study data have confirmed the results of the pilot study. It has concluded the Aurora test can increase the clinical pregnancy and live birth rates in Day 3 eSET ICSI patients. To learn more about the Aurora test for ICSI, click here.
The paper reports positive results of a prospective study on 633 patients (113 tested with the Aurora Test and 520 control patients). The study data confirm the results of the performance of the Aurora Test nicely.
Results
The clinical pregnancy rate (CPR) was 61% in the experimental arm (n = 113) compared to 29% in the control arm (n = 520, p < 0.0001).
Furthermore, the live birth rate (LBR) in the experimental arm (50%) was significantly higher than in the control arm (27%,p < 0.0001).
The time-to-pregnancy was significantly shortened by 3 transfer cycles independent of the number of embryos available on Day 3 (Kaplan-Meier, p < 0.0001).
Read the full publication in BioMedicCentral here:
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