Towards the end of 2013, when my friends (and business partners) Renato, Massimo and Massimiliano decided to undertake this adventure, we had not entirely understood its human and ethical sense: men helping women!
...But let's start from the beginning.
They were all scientists, I was an economist, in early 2014 we focused on supplying a new diagnostic service for assisted procreation centres.
Obviously we were aiming to develop a valid and scientifically tested service, but also one that was productive in socio-economic terms (we weren't too keen on losing our savings which we were investing in an adventure-dream).
Innovation was the key concept which brought us together, the search for solutions which were yet to be used, for the diagnosis and treatment of diseases and disorders, through scientific research and clinical validation. Our aim was then to directly introduce these innovations into people's homes, not just hospitals, to make them immediately available at acceptable prices, to everyone who needed them.
This is how we stumbled upon the obscure realm of infertility, partly in response to certain personal requirements (hahaha), and the consequent search for fertility (happiness!).
Therefore in the beginning there was an intuition for the development of this new test test (which we called IMMUNOX) to detect and diagnose new biomarkers (new signals, in other words) through blood sample laboratory analysis. Signals which could confirm and perhaps explain a few possible causes of infertility, given that in 30% of all cases, it was apparently "unexplained". In the beginning we thought of a code name to indicate something that was complex, then we understood that it was much simpler than expected, because the cause was "we can't find the cause", hence the labelling of the cause as "unexplained". However we did ask ourselves how it was possible that in 2014 (already back then Elon Musk aimed to colonise Mars and was selling 100% electric cars) we could just sit back and accept that science was unable to explain approximately 30% of all cases
However we were shocked and confused when the economist (me) began to analyse data,the market, previously identified innovations, in order to understand what traditional medicine was offering at the time, in generic infertility diagnostics, and above all in more difficult cases defined as "unexplained".
I immediately noticed the sheer difficulties in accessing market data. In order to gain a better understanding of how the medical world of assisted procreation worked, I became an expert in the use of Google, and hidden away in a corner of the web, I found the first report on the state of medically assisted procreation in Italy, which I duly and carefully analysed. I found extremely interesting information, not exactly there for all to see, on the effectiveness of ART (assisted reproductive technology) processes.
DEMORALISING DATA! A comparison of babies born alive as a result of ART and completed fertilisation cycles yielded a result of just under 14%.
FOURTEEN PER CENT!
In view of this finding, in earnest we set about looking for data from all European countries and the USA. We began to ask ourselves about the causes and above all how it was possible that Italy was home to over 350 MAP centres which on average failed to exceed a 14% pregnancy rate, compared to the USA, home to merely 450 clinics clinics ("merely" in virtue of the sheer size of the country's population, well over five times more than Italy's), but where the ART success rate was over 30% (NB: the reason can be found at the end of this article).
The first ART reports
(ART = assisted reproductive technology)
The IMMUNOX test (which we immediately patented), is mainly based on the detection of four specific biomarkers: 3 of these are existing biomarkers (TNF alpha, Glicodeline and HRT)), but which had never been previously associated with the causes of infertility. We discovered the fourth one ourselves. It is called Complement Activity Toxic Factor (CATF) a substance which if contained in the blood, highlights the hyperactivity of a part of the immune system, capable of compromising pregnancy.
Immediately we thought that it could contribute towards increasing assisted procreation success rates, and that ART clinics would have done anything to get hold of it. We developed it as best as we could and even organised a logistics system, ensuring that any ART centre would have to do little more than just give us a call and we'd send our courier to pick up the sample to be analysed, wherever the centre may be.
We began testing it at a few ART centres which trusted us from the outset, and we successfully demonstrated that thanks to IMMUNOX it was truly possible to diagnose most causes of infertility linked to the immune system, namely inflammation and oxidation principles.
Our test was able to explain many (let’s say most) of the causes of so-called "unexplained" fertility.
We had found a new model which could also be applied in the diagnosis of subfertility, a condition of the temporary reduction in the probability of becoming pregnant, a reason for which many women (almost 50% of infertile women), are unable to conceive naturally in a short time.
The United Kingdom is the only country in which national healthcare guidelines regarding ART indicate that subfertile women should not be treated with any ART techniques until at least 24 months after attempted natural conception (36 months until 2014).
Not only did our test work, it also came up with new and truthful answers: it helped women to understand "unexplained" causes. We were really, really proud.
A short time after, in early 2016, the emergence of a few bitter notes made us open our eyes, and above all inspired an almost instinctive reaction: this couldn't be so, this wasn't right.
As we diagnosed an increasing number of unexplained fertility cases, we noticed a drop in the sales of our service. Given that we had no contact with patients of ART centres, we were unable to understand the problem, the true reason for which the product/service wasn't in increasing demand (at the time it costed € 350).
The reason we identified is the same for which the ART success rate in Italy never exceeds 14%: if a market is formally liberal but badly ruled, fundamentally it can never improve.
In the absence of official regulations which require those who offer a medical service (whose sole purpose is pregnancy and birth) to declare data on the effectiveness of said service, in a clear and understandable manner, namely pregnancy and births, none of the operators shall ever be motivated to provide the best possible service.
Unlike the USA, in Europe there is no organisation which requires all ART centres to publish data on the effectiveness for each technique, with reference to the number of treated couples. Unless the publication of such data becomes mandatory, transparency shall never be achieved, to the detriment of the only protagonists and beneficiaries of this system: women who are trying to become mothers.
Therefore our diagnostic test proposed to ART clinics began to fall into oblivion, simply because it rendered their work less profitable and reduced the number of "sellable" cycles. Thanks to our test it is possible to avoid MAP if the problem is of an immune nature, because it is likely that ART shall not yield expected results unless preceded by the diagnosis and treatment of causes. After treating the causes, ART may not be necessary and pregnancy may be achieved naturally.
Obviously this approach and consideration is not universally applicable. In any case we only supplied a few ART centres, and not all of them availed themselves of this approach, however the overall trend we detected was symptomatic and a precursor of a potential market risk.
The arrival of the supplement
Confusion peaked when we began to propose, in vain, our supplement to ART centres, clinically proven to increase the probability of success from 4.7% to approximately 40%. After understanding that the problem for most infertile women was the immune system, we searched for natural products which science, research and clinical validation had already proven capable of resolving similar problems. Then we developed a supplement which not only reduced menstrual cycle disorders, but also bolstered the organism's natural defences, as a natural anti-oxidant.
This second idea came to us after we had opened our eyes.
We said to ourselves: we've got a test and a supplement which work, why don't we directly propose this approach to women? Why not act pre-emptively on the potential need for assisted procreation treatments?
It must be clear that this approach does not work in all cases of infertility, only those where our test helps to discriminate, cases which are nevertheless individually analysed.
Why not for free?
We have been criticised for the fact that our service is not offered for free.
The pursuit of economic purposes does not compromise utmost respect for all individuals involved, in our case, all the women we'd like to help to become mothers. The fact that the service is not free does not mean that the price is prohibitive: we have set prices so that they are feasible for most families, even those on a tight budget. The price is much lower than what appears to us to be the only alternative: medically assisted procreation, renowned not only for its high prices but also for other risks and disappointingly low success rates.
Until today we have funded ourselves by taking out bank loans, because we strongly believe in our mission: to support all subfertile women affected by unexplained infertility, through our customised programme which focuses on providing the best conditions to achieve natural conception.
Berlin and the Startup Bootcamp
It is no coincidence that my search for someone who could help us to develop the market, fine-tune our service and construct it around the requirements of a woman and future mother, has led to me moving to Berlin, from where I am writing to you. I was welcomed with open arms by the international accelerator StartupBootCamp, which selected us as one of the 10 most promising start-ups in the healthcare field in the world, out of over 550 others from all over the globe. WHAT AN HONOUR,!
Why are we talking about ethics?
Because ethics means everything to us. We have drafted an ethical code which distinguishes us, which unequivocally transmits our intentions, provides understanding on how and in which cases we can or cannot be of help, the conditions for which this can be achieved, through respect of important and fundamental rights.
Our aim is to offer a new method for the diagnosis and resolution of unexplained female fertility, of course not for every single cause, grounded in an approach developed around women to preserve their physical and psychological integrity, especially at the most delicate life moment: the search for motherhood.
This is why a page on our site is exclusively dedicated to the I-VITAE ethical code. It shall be constantly improved, also thanks to your contribution.