Firstly, I want to say thank you to all the people who commented on my previous post regarding the extra treatments my IVF clinic offers. There was some confusion between Google+ and me; unfortunately Google+ responded to my attempts to understand it by removing most of the comments from my blog. So if you need to know where your comment went, you'll have to ask Google because I'm not exactly sure. On the upside, I think I have managed to stop restricting my comments to Google+ only. Thankfully, all your lovely comments are still stored in my account but I have no idea how to link them back to my blog, sorry. I did read them all and they were very helpful; I appreciate that people made the effort to respond to my request for advice.
Okay, back to my normal blogging self:
The days following my fertility specialist announcing that I could improve my chances of achieving pregnancy by intently studying the embryos and/or by gluing them to my uterus, I was a little confused. I asked for your advice and you didn't disappoint, thank you. I was advised to find out more about the procedures before I committed, so that's exactly what I did.
Currently, there are two companies that are offering systems in the UK that analyse the earliest characteristics of developing embryos: Embryoscope and Early embryo viability assessment (Eeva); both technologies monitor early cell division events using time-lapse imaging.
Time-lapse imaging of embryos was first developed in the mid-1990s. Initially it was used as a tool to study embryo movement and development. In those early days, scientists hooked up videocassette recorders to culture incubators and captured the exact sequence of events after sperm met egg. As the research advanced, scientists investigated how early cell division characteristics, captured by time-lapse imaging, could predict the embryos destiny. After beavering away in their laboratories for many days, possibly months, the scientists made a breakthrough discovery: the timing of the first developmental events after fertilisation correlated well with blastocyst formation. Embryos whose fate it was to develop into beautiful blastocysts had a very defined schedule for each of the critical mitosis events. Building on these early observations, investigators have developed software systems, which incorporate fancy mathematical algorithms, that accurately predict which embryos will arrest and which will survive. Amazing, right?
Not only it is now possible to predict blastocyst formation but studies have shown that, using these advancements, embryos likely to yield pregnancies can be identified prior to transfer. Remarkably, transferring embryos that were rated as high, using an imaging system, led to a 66% pregnancy rate. In contrast, when embryos were transferred that were rated low only 8% of women became pregnant.
For me, the most fascinating element of these new technologies is the apparent correlation between embryos that are predicted to be poor and the presence of chromosomal abnormalities. Two studies (here and here) have demonstrated the cell cycle and fragmentation patterns, identified using time-lapse imaging, are diagnostic of faulty chromosomes.
The results from these studies sound wonderful and they are certainly extremely promising; it would be difficult to deny that this really is astonishing science time. However, no one has published any studies or clinical trials which demonstrate these imaging systems are better than an embryologist at predicting which embryos will make it to blast; my clinic is super confident that their embryologists are excellent at choosing embryos for transfer. The truth is that there have been absolutely no clinical trials published assessing whether these technologies increase pregnancy rates when compared with current methods.
A review of the use of time-lapse imaging for embryo assessment, published in March this year, concluded "before time-lapse markers are to be implemented in the clinic, additional clinical validation of their safety and efficacy and their measurement/quantification technologies is urgently required".
The FDA also seems to be under the impression that treatments should demonstrate efficacy prior to routine implementation and, not surprisingly, has decided to wait to evaluate clinical trial data before licensing the technology in the United States.
So why are these systems already in use in European clinics? I asked my fertility specialist that very question; he argued that couples should have access to all opportunities to increase their chances of success. I am unconvinced that, usually pretty desperate, couples should be expected to pay for unproven treatments. Sure, if the clinic wants to boost their success rates and offer it to their patients for free then I'm all for it. Now that I am there, I know that, even though the science is shaky, I want to do everything, even irrational things, to increase my chance of pregnancy.
I think Dr Sue Avery, from the British Fertility Society, sums it up perfectly (play the clip to find out what she says):
I guess I am struggling with the ethics of it all. I am also worried that these scenarios will become more common in the British health system as an increasing number of services are privatised. Good ethical policies in medicine and science are so important and I fear that sometimes the desire for money triumphs over reason. This weekend an argument over the patent granted for this technology has erupted in a British newspaper. The United States Patent Office has recently granted a patent whose claims include the monitoring of embryo division. How can that be? Is it ever okay to patent the measurement of naturally occurring biological processes? I am extremely keen on the idea that innovation and invention is protected by patents, and I would applaud a patent that covered the use of the mathematical algorithms or the imaging software, but the processes that underlie life itself? Should they really be able to be covered by patents?
I don't know the answer. Maybe you have some ideas and opinions about what is and isn't acceptable? If so, do share.
My doctor also suggested we try EmbryoGlue and I have done some research on that too. However, this post is getting quite long now so I am signing off and will cover EmbryoGlue in a separate post.
Side note: I did read the patent and I am not sure that the claims are as extreme as the newspaper article would have us believe.