Corona Test

Corona Test for ICSI

With the Corona Test, we aim to help you minimize the cost, time and stress of infertility treatments.  The Corona Test provides valuable insight into the quality of each of your retrieved eggs, predicting which has the highest potential to develop into a baby

The Corona Test measures the quality of your eggs (also called oocytes). The Corona Test is a lab analysis of the cells surrounding the egg. These cells, called corona cells, are normally removed and discarded during ICSI treatment. By analysing these cells, we can predict which eggs your best and will give you the highest chance to have a baby. When your gynaecologist transfers the embryo from your best egg, you will have an increased chance to become pregnant and deliver a healthy baby on your first attempt.

The Corona Test:

  • Allows the identification of the best quality egg and allows the transfer of a single embryo which has the highest chance to implant and become a healthy baby
  • Significantly increases pregnancy rates per transfer
  • Reduces the time needed to achieve pregnancy as your best egg is chosen for your first transfer. Also reduces costs as less transfer cycles are needed
  • Presents no ethical issues as it is performed on the cells surrounding the eggs. In routine treatments those cells are normally discarded prior to injection of sperm (ICSI).
  • Increased confidence in transferring a single embryo to avoid health risks associated with twin or triplet pregnancies

Our aim is to improve fertility treatments to give access to more couples and to reduce the overall burden of the treatment. We strive to have as many women as possible pregnant from the first attempt. Our motto is: one try, one child.

Corona Test for freezing of eggs

More and more women are postponing their decision to become a parent, driven by a variety of factors.    In recent years, women have had the option to freeze their eggs in order to preserve high quality eggs and provide the freedom to decide when they would like to start their family, without having to worry about declining fertility.

If you decide to freeze your eggs, you may need to undergo a series of hormone treatments in order to maximize the number of eggs retrieved.

Corona Test will score your eggs after the first hormone treatment and give you insights into the quality of your collected eggs.

Corona Test results can benefit you twice in your reproductive journey:

  • NOW: Corona Test results will help your gynaecologist decide if you need a second (or third) hormone treatment to collect more eggs
  • LATER: The same results can help the embryologist decide which embryos to transfer when you are ready to become a parent. This could potentially avoid multiple cycles of embryo transfer.

You can get access to the Corona Test via our ongoing clinical trial in IVF Brussels CRG (UZ Brussel, Jette).

 

Patients

The Corona Test process for IVF/ISCI

If you’re having trouble becoming pregnant, in vitro fertilisation (IVF) may be right for you. An IVF cycle involves several different steps that will help you increase the 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 corona cells surrounding the egg are removed to free the egg for sperm injection (ISCI).
  • Those eggs that have been successfully fertilised (now called embryos) will be grown in the laboratory incubator for 2 to 5 days.
  • In the meantime, the corona cells are analysed with the Corona 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 that shows good development and a high Corona Test score will be chosen for your first transfer.
  • Your pregnancy chances will substantially increase with the Corona Test compared to embryo selection with only visual inspection.

Who should use the Corona Test

Corona Test is especially recommended:

  • If you are scheduled for ICSI treatment
  • If you are expected to have many oocytes (>2)

Improving your chances with the Corona Test

  • Higher pregnancy rates after first transfer (from 27% to 63% pregnancy rate with single embryo transferred after 3 days of culture, results from UZ Brussel)
  • Fewer cycles of IVF treatment needed (less time and money). Our clinical study showed saving an average of 3 transfer cycles
  • Increases chance that first transfer will be successful. 55% of the women with Corona Test had a live birth from the first embryo transfer cycle in clinical trial UZ Brussel

The Corona Test process for freezing your eggs

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

  • You will receive hormone stimulation to mature many eggs.
  • After egg collection, the corona cells surrounding the egg are removed to free the egg for freezing.
  • Your eggs will be frozen -198°C.
  • In the meantime, the corona cells are analysed with the Corona Test to know which of your eggs has the highest potential to result in a healthy baby.
  • If you do not have enough eggs with high potential, you might consider a second or third treatment cycle.
  • When you come back to use your eggs, the embryologist can use the Corona Test score to aid in the selection of the embryo to be transferred.

Physicians

Oocyte competence prediction

The Corona Test measures the potential of an oocyte to develop into a normal healthy child after ICSI. After testing the corona cells of each oocyte after hormone stimulation, 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 27% to 63%) and live birth increased from 25% to 55% after the transfer of a single embryo on day 3.

Corona Test Principle for IVF/ICSI

The Corona Test is performed on corona cells surrounding the oocytes from a patient. The test is based on the measurement of expression of five specific genes.

Corona cells are isolated from each oocyte and RNA is extracted from the corona cells. cDNA synthesis and real-time PCR is performed using 3 predictive genes and two control genes. PCR results lead to a quantitative ranking for all oocytes.

Corona Test principle for Social Oocyte Freezing

The Corona Test is performed on corona cells from all oocytes from a patient and follows the same molecular testing. The oocytes are ranked, and then grouped in different quality classes.

Results clinical trial

Doubled clinical pregnancy rate for Day 3 fresh SET

Results clinical trial with eSET & ICSI patients

Results of a prospective clinical study in Europe showed that in the Corona Test arm with single day-3 embryo transfer, the clinical pregnancy rate increased from 27% to 63% in the first fresh transfer cycle in patients undergoing IVF-ICSI after stimulation with HP-hMG (Figure). In the two control arms patients had either day-3 or day-5 single embryo transfer with morphological scoring only.

The Corona Test was developed from 2008 to 2013 (ref. 1-5). From 2013 to 2018 the test was validated in a prospective match case/control study with 62 patients in the interventional arm. Follow-up study of 100 patients showed the same results (unpublished data).

Increased cumulative pregnancy rate

The Corona Test also significantly increased the cumulative pregnancy rate from 56% to 78% in comparison to day-3 control group when the patient undergoes consecutive cycles.

Increased the live birth rate

The live birth rate increased from 23% to 55% in comparison to day-3 control group.

The Corona Test also significantly increased the clinical pregnancy rate in comparison to day-5 control group (from 43%to 63% in fresh cycle and 65% to 78% in cumulative transfers).

 

Inclusion criteria

The application of Corona 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 38 years
  • Good ovarian reserve
  • Excluding severe male infertility
  • Single embryo transfers (fresh or frozen) to avoid twin birth

Corona Test service offered

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

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

Literature

  1. 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)
  2. 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)
  3. 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)
  4. 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
  5. 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)
  6. 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 Jan 9.. [Epub ahead of print]

Patient stories

We were trying 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 to my partner and on my job.  I learned about the Corona 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 Corona 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 Corona Test could help the embryologist in his decision and got it right from the first transfer.  Sarah, 34 years

I also wish to have a child, but I never expected that it would be so heavy. And it wasn’t cheap either. The stress, the money, the many discussions. When the doctor told us about the Corona Test, I pushed my wife to get it. She is very anti-genetic testing and is scared about all new technologies. However, the Corona 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. I am proud to say, we are expecting our first baby soon. Thank you Fertiga to make our dreams come true. Eric, 32 years

About us

Contact us

For more information: info@fertiga.com

For access to the Corona Test, please contact us.

Company

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

UZ Brussel has been pioneering in IVF, with the first ICSI baby worldwide born in 1992 from the Center of Reproductive Medicine of UZ Brussels.

Fertiga is the first provider worldwide on analysis of corona cells to improve live birth rates.

Our aim is to improve fertility treatments to give access to more couples and to reduce the overall burden of the treatment. We strive to have as many women as possible pregnant from the first attempt. Our motto is: one try, one child.

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 member of clinical diagnostics department at 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 outcome 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 from Roche Belgium to start-up Fertiga in 2017.

Prof. Dr. André Rosenthal, Chief Executive Officer

Prof Rosenthal – molecular biologist by training – was 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 the sequence of chromosome 21 in 2000.  He joined Fertiga beginning of 2018.

News

Prospective Corona Test study shows doubling of pregnancy rates in IVF-ICSI treatments

March 2019

In the March issue from the Journal of Assisted Reproduction and Genetics (JARG), for the first time in history, a prospective clinical study on cumulus gene expression analysis was published. The study showed a doubling of pregnancy rates. The patients received a hormone stimulation with HP-hMG. A single day 3 embryo transfer was done after ICSI, based on a combination of embryo morphology and the Corona Test score. Pregnancy rates were 63% in the group with Corona Test versus 27% when ony morphology evaluation was used. This impressive achievement will open new opportunities for couples struggling with infertility.

https://link.springer.com/article/10.1007/s10815-018-01398-2

Fertiga is launched as spin-off from VUB

March 2019

The VUB Research Group Follicile Biology (FOBI) under the direction of Prof. Dr. Johan Smitz developed extensive knowledge and expertise in gene expression of cumulus cells. This resulted in the Corona Test, which is used for determining the oocyte quality in the process of in-vitro fertilization (IVF) and social freezing.

The aim of the Corona Test is to increase the efficiency in IVF-ICSI by selecting the embryo from the oocyte with the highest quality. Results from the first prospective study showed doubling of the pregnancy rate by applying this test.

A second application is the improvement of the outcome of social freezing of oocytes.

Together with ex-employees of Roche Diagnostics, ir. Elien Van Hecke and Prof. Dr. André Rosenthal, Prof. Dr. Johan Smitz co-founded Fertiga in 2017 to further develop and validate this technology. In January 2019 the license agreement was signed and Fertiga became officially a spin-off of VUB.

http://vubtechtransfer.be/news/new-vub-spin-off-fertiga/

About Fertiga
Fertiga nv was founded in August 2017 on the basis of work carried out over the past 10 years within the Vrije Universiteit Brussel(VUB) and University hospital of Brussels (UZ Brussels) with the objective of becoming a major player in improving fertility treatment outcomes by analysis of gene expressions in cumulus cell surrounding the oocyte. In July 2018, they signed an exclusive license with the Vrije Universiteit Brussel and in January 2019 the prospective validation of the Corona Test was published in Journal of Assisted Reproduction and Genetics.
www.fertiga.com

About Vrije Universiteit Brussel (VUB)
Vrije Universiteit Brussel is an internationally oriented university in Brussels, the heart of Europe. By providing excellent research and education on a human scale, VUB wants to make an active and committed contribution to a better society.
www.vub.ac.be