Ingenious Fertility Alternative to IVF

New Fertility Technology Provides Inexpensive, and Equally Effective, Alternative to IVF

Hundreds of thousands of couples struggle with fertility issues, and about 1 out of every 3 couples have what doctors simply describe as “unexplained infertility.”  In 2007, for instance, 138,198 assisted fertility treatments were administered in the United States, resulting in 54,656 babies born.  But that means that more than 83,542 couples were unsuccessful.  There is no evident biological or medical cause for their inability to get pregnant, it simply hasn’t happened for them.  This can be psychologically devastating, and there are few alternatives to In-Vitro Fertilization (IVF), a procedure that works around 30-40% of the time, is costly, and is invasive, requiring both drugs and hormones that can cause their own problems.  IVF is the last-resort for many couples, and if it is unsuccessful, there may be nowhere else to turn.  For other couples, IVF is prohibitively expensive, costing an average of $15,000 per cycle in the United States—and many couples require multiple cycles.

A new technology has only recently been approved by the FDA for use in the United States.  DuoFertility is the invention of Dr Shamus Husheer, the British CEO of Cambridge Temperature Concepts.  DuoFertility has been available in Europe since 2009, and has been praised by such prominent UK media sources as the BBC.  And yet it is so new to the United States that few people know of it.  It represents optimism for tens of thousands of American couples who have struggled with infertility.

DuoFertility is a surprisingly simple concept.  It is a patch worn by women that measures their temperature to an incredibly precise degree: 2500 measurements per day, to be precise.  This information is transferred into a computer program that comes with the patch, allowing couples to track the ovulation process far more thoroughly than they could either through a normal thermometer or frequent, expensive trips to the doctor.  This level of temperature measurement means that the moment of ovulation, and the optimal timing for conception, can be known precisely.  DuoFertility is non-invasive, includes no drugs or hormones, and has been documented in peer-reviewed scientific journals to be just as effective as IVFs, successful in 39% of couples who try it (the journal European Obstetrics & Gynaecology, 2011).

While IVFs are expensive and can result in numerous complications (down-regulation, stimulation, risk of hyper-stimulation, egg retrieval, sperm collection, embryo selection, re-implantation, risk of multiple pregnancy, risk of pre-term delivery, etc), DuoFertility has no side-effects and essentially zero risk.  Perhaps best of all is the price.  DuoFertility costs £500 (about $700), a one-time cost that is 100% refundable if it is not successful after a year of regular use.  If the purchasing couple is not pregnant within one year of purchasing DuoFertility, they get their money back.

The Secret History of Art interviewed the inventor of DuoFertility, Dr Shamus Husheer.  Here are some of his answers to our questions:

When, where, and what did you study? + Where did you work and what did you do prior to DuoFertility?

My academic education started off at the local polytechnic in New Zealand – not an obvious start for a Cambridge PhD. However I got some of the best quality teaching of my life there, which put me in a strong position when I went on for degree study at Waikato University in New Zealand, to study Industrial Chemistry.

The reason for studying Industrial Chemistry is that my father ran a small chemical packaging company in our town, and unfortunately passed away when I was 16, leaving behind a rusty motorbike and a company almost at the limit of its overdraft. Although not obvious at the time, this was probably the greatest gift he could have given us. My 18 year old brother and I therefore needed to run the company and get qualified ASAP (it had 3 technicians, but was now missing the guy who knew everything!). We took turns running the company while the other went to school or University, and by 1998 had both qualified with degrees in Chemistry. Of course by that time we had been running the company for 5 years, so had the school-of-hard-knocks business degree as well.

Having completed our degrees, my brother and I sat down one afternoon and decided that University was a whole lot more interesting than a small chemical packaging business, possibly aided by my having won a summer research scholarship to Australian National University in Canberra, which is probably the best research institution in the southern hemisphere. Within six months we had sold the business to our main competitors, and got enough for our mother to get the family home completely restored and my brother and I to pay for a couple more degrees.

Although I found my first taste of research enticing, I didn’t find Canberra overly appealing, and three months later I was back in New Zealand on a Masters scholarship at the University of Otago, researching the impact of increasing atmospheric CO2 on the oceans. This project was my first real taste of instrumentation design, and the result of my work was (at the time) the world’s most precise ocean-going pH meter – the ones you may have seen in undergraduate chemistry labs generally read out something like pH = 8.12, mine read out pH=8.1234 (and on a good day, with a back wind, would get a 5th digit of resolution). That meant we could watch the impact of CO2 entering the ocean over the course of a day – almost like watching the ocean breathe. I did this at something like one-twentieth the cost of the previous best instruments, and so unsurprisingly many labs started using the idea and this got me noticed as an instrument designer.

So that’s how I ended up with a scholarship to the University of Cambridge in England to do a PhD in basically whatever I wanted as long as it was building scientific instruments. I had not appreciated the problem then, and perhaps most non-scientists still do not, but pretty much all science in the past 30 years has been advancing almost entirely as a function of improvements in instrumentation and software to analyse the measurements from these instruments. Yet there is still no “degree in Instrumentation” like a “degree in Chemistry” (though there are degrees in bio-informatics for example, so things are improving).

Anyway, I digress… I chose to do my PhD on instruments for particle accelerators, mainly because of the overwhelming “cool” factor (for geeks at least), and specifically in an area called “time resolved structural chemistry”. The basic idea is to literally watch reactions happen at the molecular and atomic level – making movies of chemistry actually happening. This was done by using a very powerful laser and a particle accelerator x-ray camera in a manner similar to a disco and strobe light – the laser would repetitively excite molecules in the same way that the music keeps dancers in time on the dance floor, and a bright pulse of x-rays and camera would capture a picture of the molecule in the middle of it’s dance moves. By changing the laser and x-ray timing (or analogously the beat and strobe-light timing), you could build up a movie of a whole dance that is normally all over in one-billionth of a second.

Incredibly cool PhD research though it was, there was something missing. During my time studying global warming, practically everyone (my grandma included) had some idea of what I was trying to do (“you’re saving the world, right?” – “urm, no, more like watching us screw it up in incredible detail”). My exceedingly cool PhD research didn’t quite get the same reaction, and I learned that I’m someone who needs that social proof that what I’m working on really matters.

How did you first get the idea for this system?

So one long night in the basement of a particle accelerator in the south of France, an idea struck. My parents had had huge difficulties conceiving my brother and I, and tried just about everything available at the time (in-vitro fertilization had not yet gotten out of the research lab). One of the things they did, and that directly resulted in my conception, was to monitor my mother’s temperature early each morning and plot this on a chart. This is a decades-old technique for monitoring ovulation, and hence identifying a woman’s most fertile days, but it is highly error-prone and most couples simply give up within weeks of trying it. Moreover, even those that do collect the measurements reliably, usually cannot interpret them if there are any of a range of underlying issues. But when done correctly, this method gave a really good insight into the changing levels of the hormone progesterone, which is one of the most important fertility hormones. So people still try.

Being “an instrument guy” I naturally came up with an instrument to solve the problem.

What various incarnations did the product take on before you settled on the current version?

Looking back, the initial idea was shockingly bad. I wanted to make an implant that the woman would wear, that regularly sampled her blood to directly measure the hormones of interest, and log this to an internal memory. This would be read out by a handheld reader, which would then tell her what was going on. Because the same fertility information could be used both for conception and contraception, the woman might want to keep using it between children. The main problems being (1) sampling blood = multi-year research program and (2) implantable device = decades of trials prior to human use, and (3) contraceptive use = massive legal liability for failure and thus more massive trials and regulatory approval required.

When I got back to Cambridge University from the particle accelerator, I met up with other researchers who had complimentary skills – a medical doctor, an ex-paramedic, an medical device engineer studying business, and two women doing their PhDs on infertility. All of us (particularly the women) could see the massive size of the infertility problem, and so we figured there must be a market for this – we quickly figured out that competing with the pill (which is highly effective and free in many health systems) was a bad idea, so we canned the contraceptive angle (although we still get asked about it all the time – and the answer is still “no”).

After about six months of bouncing around various ideas, we settled on an externally worn, removable patch that monitored temperature, and still talked to a hand-held reader. That’s pretty much the design concept as it is now, though at the time we had never envisaged or recognized the importance of the service element – it was only through our product development trials that we found women really needed someone knowledgeable to talk to about all this.

How long after the invention of DuoFertility did the first consistent successes come about?

Our first success was a lady called Marije, who lives in Italy. She was on our first development trial, and had been trying for a family for several years. In her case, the problem was recurrent miscarriage with no obvious cause, and so what she needed to do was to maximise the chance of pregnancy as rapidly as possible. She was one of the women who brought home to us the need for the service angle for what we do – recurrent miscarriage is exceedingly distressing, and patients need a significant level of counselling to get back up and try again with the right frame of mind. Marije now has a delightful little boy called Alec, who is getting up to all sorts of mischief – we periodically get pictures, as we do from many of our proud parents.

In terms of consistent success, the moment we realized something unusual was happening was during preparation for a company shareholder’s meeting in early 2010. Directly out of our PhDs, we had raised funding from a series of local Angel investors, and as such they expected us to present the results of our work periodically. We had recently hit the 100 user mark, and on looking at the data found something very unexpected – our pregnancy rate for the “difficult” cases who had been facing IVF was actually about the same as for those couples who had only been trying for a year or less. The number of patients was quite small, but the result appeared to be statistically significant – the average couple who have been trying for 2 years has only a 12% chance of pregnancy in the next year, and we had something like 19% after 6 months. This was interesting enough that my colleague was invited to a conference to talk about what we were doing, and we started collecting statistics more carefully.

By mid 2011 we had hit the 500 user mark, and by the end of the year we had some publishable quality data (I’ve attached the paper). The scientific community are (quite rightly) highly skeptical of any claims about helping to get women pregnant who have not experienced any difficulty, so we focused on just the 242 women who had been through IVF or qualified for state funding for it in the UK. The pregnancy rate for these women was on average 39% after a year using Duofertility, which was statistically significantly higher than the pregnancy rate from the cycle of IVF that they were considering. I should stress that DuoFertility and IVF are vastly different procedures (IVF involves a pile of drugs and minor surgery), so they are not comparable in this sense. However, both are designed to help a woman get pregnant, and so most certainly are comparable from that perspective.
What’s the average time lapse between start of DuoFertility process and pregnancy in successful users?

There is no “average time lapse” so to speak. A woman has a certain chance of getting pregnant in any given month, and keeps trying until she does so. In this case it is sort of like rolling a dice until you get a “six” – except that, for many women, the dice is loaded against them. This “fixed chance per month” model is what statisticians call a “binomial model”, in which you will always get more women getting pregnant in month 1 than in month 2 and so on. This is because all of the woman are trying in month 1, and a certain fraction of them get pregnant. Fewer women are trying in month 2, but the same fraction of these get pregnant – meaning fewer women in total get pregnant in month 2 than in month 1.

So our job is to increase this “fixed chance per month” so that more women get pregnant, sooner. To give some perspective, the statistic quoted above of 12% chance of pregnancy per year for couples trying for more than two years equates to a 1% chance of pregnancy per month – whereas for these same couples we find that one year using DuoFertility yields a 39% pregnancy rate, which is 4% per month. You could say we quadruple their chances of natural pregnancy every month (though to do so relies on this simplistic binomial model).

What this also means is that we’re still seeing pregnancies in women who have been using DuoFertility for 18+ months, and looking at the data it appears that this factor-of-4 improvement in chances still holds this far out.

What is the success rate % for users of DuoFertility, and what is the total number of cases?

The most important thing for women to understand about success rates for DuoFertility, IVF or any other treatment is that they need to ask what the success rate is for women like them. We could easily claim a massive success rate by giving away DuoFertility to women who are under 30 as a wedding present – we would then expected to find something like 80% of them pregnant within a year. However, this would be totally unethical to present to a struggling 38 year old who has already been trying for 2 years – statistically speaking, she is in a very different group.

In the attached paper you will see that we break down pregnancy rate by both age (the single most important factor) and time trying to conceive (the second most important factor for natural pregnancy, though much less important for IVF). Barring any significant medical history, these are the two critical things to help a woman determine her chances of natural conception, and set a reasonable expectation of how long it will take. As an example, for that hypothetical 38 year old woman who has been trying for 2 years with no significant identified medical issues, you can see that the pregnancy rate for DuoFertility broken down by age and time trying are both around the 40% mark. By contrast, her chances from a single cycle of IVF are about 20%.

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