Fertiga

The Aurora Test for IVF (ICSI)

If you’re having trouble becoming pregnant, in vitro fertilisation (IVF) may be the right choice for you and so might also the Aurora Test. An IVF cycle involves several different steps that will help you increase your chances of becoming pregnant. The most important step is selecting the embryo with the highest potential to result in the birth of a healthy baby.

• You will receive hormone stimulation to mature many eggs.
• After egg collection, the embryologist removes the cumulus cells surrounding the egg to free the egg for sperm injection (ICSI).
• The successfully fertilized eggs (now called embryos) grow in the laboratory incubator for 3 days.
• In the meantime, the cumulus cells are analysed with the Aurora Test to know which of your eggs has the highest potential to result in a healthy baby.
• Your embryologist will monitor the development of the embryos.
• The embryo with good development and a high Aurora Test score will be chosen for your first transfer.
• In conclusion, your pregnancy chances will substantially increase with this test compared to embryo selection with only visual evaluation.

Who should use the Aurora Test?

• If you are scheduled for ICSI treatment.
• If you are expected to have a sufficient number of eggs to obtain at least 2 embryos.
• If you are a maximum of 39 years old.
• Please contact your gynecologist if the test is applicable to your situation.

Improving your chances with the Aurora Test

• Our study shows higher pregnancy rates after the first transfer (from 29% to 61% pregnancy rate with single embryo transferred after 3 days of culture, results from UZ Brussel).
• You will have fewer treatment cycles (meaning it will cost less time and money). Our clinical study showed saving an average of 3 transfer cycles.
• The chance that your first transfer will be successful increases. 50% of the women with the Aurora Test had a live birth from the first embryo transfer cycle in the clinical trial at UZ Brussel.

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The Aurora Test process for freezing your eggs

When you decide to freeze your eggs for future use, you will have to follow these steps:

• First, you will receive hormone stimulation to mature many eggs.
• After egg collection, the embryologist removes the cumulus cells surrounding the egg to free the egg for freezing.
• Your clinic will freeze your eggs at -198°C.
• In the meantime, the cumulus cells are analysed with the Aurora Test to know which of your eggs has the highest potential to result in a healthy baby.
• When you come back to use your eggs, the embryologist can use this score to aid in the selection of the embryo to be transferred.

Oocyte competence prediction

The Aurora Test is a non-invasive gene expression test, performed in the cumulus cells of the Cumulus Oocyte Complex (COC), that provides a ranking for the oocytes of a patient.

The Aurora Test measures the potential of an oocyte to develop into a normal healthy child for patients scheduled for ICSI. After analysing the cumulus cells of each oocyte, the embryo from the oocyte with the highest potential will be transferred into the uterus.

Applying this technology in IVF practice has shown that pregnancy rates have doubled (from 29% to 61%) and live birth increased from 27% to 50% after the transfer of a single embryo on day 3.

Aurora Test Principle for IVF (ICSI)

To be able to analyse the cumulus cells of each individual oocyte, the classic group oocyte denudation needs to be adapted to an individual denudation procedure.

The Aurora Test is performed on cumulus cells surrounding the oocytes of a patient and it is based on the measurement of the expression of five specific genes.

Cumulus cells are isolated from each oocyte and RNA is extracted from the cumulus cells. cDNA synthesis and real-time PCR are performed using three predictive genes and two control genes. PCR results lead to a quantitative ranking for all oocytes.

Aurora Test principle for Social Oocyte Freezing

The Aurora Test is performed on cumulus cells from all oocytes from a patient and follows the same molecular testing as for an ICSI patient. The oocytes are ranked, and then, in the future, the highest-ranked oocytes can be used first.

Results clinical trial

Doubled clinical pregnancy rate for Day 3 fresh SET

Results of our latest prospective clinical study in Europe showed that in the Aurora Test arm with single embryo transfer (SET) on day 3, the clinical pregnancy rate increased from 29% to 61% in the first fresh transfer cycle (ref.1). These were ICSI patients stimulated with HP-hMG. In the control arm patients also had day 3 single embryo transfer, but with morphological scoring only.

Increased cumulative pregnancy rate

In an earlier study (ref.2) cumulative rates were followed up and the Aurora Test also significantly increased the cumulative pregnancy rate from 56% to 78% in comparison to the day 3 control group when the patient undergoes consecutive cycles.

Increased the live birth rate

The live birth rate increased from 27% to 50% in comparison to the day 3 control group.

Inclusion criteria

The application of Aurora Test is validated for patients with the following criteria:

• Stimulation with HP-hMG hormones (e.g. Menopur) followed by ICSI
• Patient age between 22 to 39 years
• Good ovarian reserve
• Excluding severe male infertility
• Single embryo transfers on day 3 (fresh or frozen) to avoid twin birth

Aurora Test service offered

• DAY 0: Cumulus-oocyte-complex pick-up. Cumulus cells must be removed for each oocyte by an embryologist and individually snap-frozen at -80°C in bar-coded cryovials.
• DAY 0-1: Samples will be transported in a container (dry shipper with N2 or dry ice) to a clinical testing lab nearby which runs the Aurora Test
• DAY 1-2: Aurora Test (RNA isolation, QPCR, and analysis) is done in the clinical testing lab.
• DAY 2-3: Clinical testing lab will communicate Clinical Report to the IVF clinic. The report gives a ranking of all oocytes and specifies which oocyte has the best score.
• DAY 3: The embryologist uses this score along with a morphological evaluation to select the best embryo for transfer.
• In case there is no pregnancy from the first transfer, the supernumerary embryos which were vitrified will also be transferred following the score.

In the future, the Aurora Test application will be broadened to other gonadotrophins.

Literature

1. Van Vaerenbergh I, Adriaenssens T, Coucke W, Van Landuyt L, Verheyen G, De Brucker M, Camus M, Platteau P, De Vos M, Van Hecke E, Rosenthal A, Smitz J. Improved clinical outcomes after non-invasive oocyte selection and Day 3 eSET in ICSI patients. Reprod Biol Endocrinol. 2021 Feb 19;19(1):26. https://pubmed.ncbi.nlm.nih.gov/33608027/
2. Adriaenssens T, Van Vaerenbergh I, Coucke W, Segers I, Verheyen G, Anckaert E, De Vos M, Smitz J. Cumulus-corona gene expression analysis combined with morphological embryo scoring in single embryo transfer cycles increases live birth after fresh transfer and decreases time to pregnancy. J Assist Reprod Genet. 2019 Mar;36(3):433-443. https://pubmed.ncbi.nlm.nih.gov/30627993/
3. Wathlet S, Adriaenssens T, Segers I, Verheyen G, Van Landuyt L, Coucke W, Devroey P, Smitz J. Pregnancy prediction in single embryo transfer cycles after ICSI using QPCR: validation in oocytes from the same cohort. PLoS One. 2013;8(4)
4. Wathlet S, Adriaenssens T, Segers I, Verheyen G, Janssens R, Coucke W, Devroey P, Smitz J. New candidate genes to predict pregnancy outcome in single embryo transfer cycles when using cumulus cell gene expression. Fertil Steril. 2012 Aug;98(2)
5. Wathlet S, Adriaenssens T, Segers I, Verheyen G, Van de Velde H, Coucke W, Ron El R, Devroey P, Smitz J. Cumulus cell gene expression predicts better cleavage-stage embryo or blastocyst development and pregnancy for ICSI patients. Hum Reprod. 2011 May;26(5)
6. Adriaenssens T, Segers I, Wathlet S, Smitz J. The cumulus cell gene expression profile of oocytes with different nuclear maturity and potential for blastocyst formation. J Assist Reprod Genet. 2011 Jan;28(1):31-40
7. Adriaenssens T, Wathlet S, Segers I, Verheyen G, De Vos A, Van der Elst J, Coucke W, Devroey P, Smitz J. Cumulus cell gene expression is associated with oocyte developmental quality and influenced by patient and treatment characteristics. Hum Reprod. 2010 May;25(5)

Thanks to the Aurora test, couples are much more likely to get pregnant from their first IVF treatment as the test helps with the identification of the most suitable embryos for implantation. Read their stories here.

“We tried to have a baby for more than 1 year and we hoped this was our solution. Quickly I realized that the many doctor visits, hormones, etc brought a lot of emotional stress and pressure on my partner and on my job.  I learned about the Aurora Test, a safe test that could help me get pregnant faster. No doubt, we immediately agreed to get this test. I had 7 oocytes resulting in 4 viable embryos. The test allowed the embryologist to transfer the best-scoring embryo immediately. And guess what, I was pregnant after my first transfer!” -Jennifer, 30 years

“We had one baby after IVF and were dreaming about our second one. We were still considering when a friend told us about the Aurora Test. It would increase our chances as the best embryo could be chosen from the best-scoring egg. It appealed to us and we decided to go for it. I had 12 oocytes and 7 viable embryos. We were so happy that the Aurora Test could help the embryologist in his decision and got it right from the first transfer.” – Sarah, 34 years

“I also wished to have a child, but I definitely underestimated how hard the process would be. And it wasn’t cheap either. The stress, the money, the many discussions. When the doctor told us about the Aurora Test, I convinced my wife to get it. She is very anti-genetic testing and is scared about all new technologies. However, the Aurora Test does not touch the embryo. It is not a genetic test and is safe. It helped us to get pregnant faster and saved us a lot of money. Thank you Fertiga for making our dreams come true.” -Eric, 32 years

Read more about the Aurora test

Disclaimer:

The names and pictures of the patients referred to on this page “Patient Stories” have been changed for privacy reasons. 

Fertiga is a spin-off company from one of the global IVF leading centers, UZ Brussels in Belgium.

UZ Brussels (and its Center of Reproductive Medicine) has been pioneering IVF, with the first ICSI baby (Intracytoplasmic Sperm Injection) worldwide being born in 1992.  Fertiga is the first provider worldwide on the analysis of cumulus cells to improve live birth rates.

Our goal is to improve fertility treatments, make them accessible to more couples and reduce the overall burden of treatment. We aim to get as many women as possible pregnant from the first attempt.

Our motto is one try, one child.

Meet our founders

Prof. Dr. Johan Smitz, Chief Medical Officer

Prof Smitz – a medical doctor by training – is the head of the Follicle Biology (FOBI) group at the Free University of Brussels (VUB) and a member of the clinical diagnostics department at the University Hospital of VUB (UZ Brussels). Johan has been involved for more than 10 years in the development of new diagnostic modalities to predict oocyte competence for pregnancy outcomes in women undergoing in-vitro fertilization after hormone stimulation. This technology is a key component of Fertiga’s offering in the market.

Ir. Elien Van Hecke, Chief Commercial Officer

Ms. Van Hecke is a bioengineer by training and holds a master’s in business economics. She has seven years of experience in different marketing and sales roles both in Biotech (Innogenetics) and large diagnostic companies (Fujirebio/Roche). Elien decided to exit Roche Belgium to start up Fertiga in 2017.

Prof. Dr. André Rosenthal, Chief Executive Officer

Prof Rosenthal – a molecular biologist by training – was a member of the leadership group (2015-2017) of Roche Sequencing, a business unit headquartered in California. He was the sole founder and CEO of Signature Diagnostic, a cancer diagnostic company in Germany, which he sold to Roche in 2015. Andre has extensive experience in clinical and experimental cancer research, human genetics, and genomics. From 1994 to 2001 he was the head of the German Human Genome Sequencing Project contributing to the sequencing of chromosome 21 in 2000.  He joined Fertiga at the beginning of 2018.

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Contact us

For more information and to access the Aurora Test, please contact us here  or via info@fertiga.com

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