CCS IVF: Prize Winning Fertility Treatment Update
Three years ago, Reproductive Medicine Associates of Connecticut (RMACT) had news to share with the world and we sent out the press release below, which you can read in its entirety. Since then, CCS has been a scientific technique that has been used successfully by our patients when it’s medically appropriate. Successful as defined by pregnancy and also as defined by babies born. One of the most common reasons for using CCS is for repeated miscarriages of seemingly healthy pregnancies. It’s probably not necessary to say how heartbreaking that is for men and women who are hoping to have a baby. CCS also gives peace of mind when there have been repeat losses, that with CCS, the possibility is much, much lower. Without a doubt, CCS has changed the lives of many men and women who have been trying to become pregnant and to deliver a baby.
Three years later, CCS continues to make significant differences in the lives of our patients.
RMACT recently participated in a breakthrough study titled "A Prospective Randomized Controlled Trial Demonstrating Significantly Increased Clinical Pregnancy Rates Following 24-Chromosome Aneuploidy Screening: Biopsy and Analysis on Day 5 with Fresh Transfer," which was led by Infertility Specialist Richard Scott, M.D. and Nathan Treff, Ph.D., of Reproductive Medicine Associates of New Jersey (RMANJ), an affiliate of RMACT.
Pre-Implantation Genetic Screening (PGS)
This study, which earned the top research award from the American Society for Reproductive Medicine (ASRM) in October 2010, examined technology that is the first and only fully validated system to reliably evaluate all chromosomes in a small biopsy obtained from an embryo during in vitro development. This is the first and only prospectively randomized trial showing real benefit from Pre-Implantation Genetic Screening (PGS) and RMACT is the only fertility practice in New England to offer it.
“This technology will revolutionize reproductive medicine,” said infertility doctor Mark Leondires, M.D., Medical Director of RMACT and Lead Physician for RMACT on the Clinical Study. “The purpose is to identify the best embryos for a healthy pregnancy. By selecting chromosomally normal embryos without damaging them, pregnancy rates were dramatically increased to more than 90 percent and miscarriage rates were lower compared to the control group. This data is historic in its nature and implications.”
Sustained implantation rates were 75 percent in the study group, much higher than compared to 56 percent in the control group. Clinical pregnancies, which are a typical result of genetic abnormalities, were significantly lower in the study group (60 percent) than versus the control group (92 percent).
“Our goal is one embryo, one healthy baby," said Dr. Scott. "So, the driving force behind most of our research is to assess reproductive competency to better predict which embryo will most likely produce one healthy baby. This is the first study of its kind that has shown dramatically improved clinical pregnancy rates with blastocyst biopsy, 24 Chromosome Aneuploidy Screening and fresh embryo transfer. Though similar screening technologies are being marketed, none have been validated through the critical studies, culminating with a randomized clinical trial, which provides this high level of medical evidence.”
The procedure starts when a couple goes through In Vitro Fertilization (IVF) Treatment with intracytoplasmic sperm injection (ICSI); the embryo is then grown to the blastocyst stage and a small biopsy of five to 10 cells is taken from the embryo on day five to six days of life. The biopsy sample then goes through computer analysis to identify any abnormalities among the chromosomes. This process identifies chromosomal disorders such as Down syndrome before the embryo is transferred into the female patient’s uterus. This error rate of the technology is less than one percent in more than 4,000 embryos tested.
About Comprehensive Chromosomal Screening
What separates this technique of Comprehensive Chromosomal Screening (CCS) from other PGS processes is that the embryo is able to grow for five or six days, allowing the cells to split and the chromosomal analysis to be more accurate. In addition, since the technology can be used to find small breaks in chromosomes and even single gene disorders it defines itself as the most robust and reliable technology for evaluating pre-conception embryos available. RMANJ has previously shown 24 chromosome analysis technology to be significantly more reliable than other existing methods. However, with this latest clinical study, the new technology has been improved because it no longer requires freezing embryos for weeks before thaw and use. The breakthrough is based on a shorter timeline, which has better results; the same comprehensive screening is conducted within hours instead of days. It is the first technology of its kind that allows for assessment of blastocysts and still enables a fresh embryo transfer, which generally has a higher success rate than freezing embryos.
The study included patients seeking IVF who were less than 43 years old and had no more than one prior failed IVF cycle. The control group underwent routine care and typical screening methods, whereas the study group underwent biopsy of the blastocyst and CCS on day five.
In a related retrospective evaluation presented with this research, the study shows that this new technology dramatically decreases the occurrence of abnormal pregnancies such as Down or Turner syndromes. This technology will allow women in their late thirties and forties, who normally have a high risk for genetic abnormalities, to nearly eliminate these risks and thereby maximize their chances for a successful pregnancy with in-vitro fertilization. CCS represents a major step forward in helping patients have healthy pregnancies and thereby allowing them to choose a single embryo transfer to minimize the risk of twins.
“A singleton pregnancy is the safest for mother and baby,” stated Leondires. “This technology will allow couples to choose a single embryo transfer without jeopardizing their chance for success. It is truly an amazing advance which will change the landscape of reproductive medicine in the future for both patient and physicians.”
Infertility affects 7.3 million Americans and for 20 percent of infertility patients the cause is unknown, according to The National Infertility Association. Through 24 chromosome aneuploidy screening, fertility doctors can determine which embryos are normal, increase healthy pregnancies while at the same time reduce the number of miscarriages. The technology will transform reproductive medicine and instill confidence in transferring only one embryo, leading to fewer multiple gestations. In addition, for patients who have had several miscarriages, it can enable them to make informed decisions about their next steps, such as working with an egg donor.
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IVF Cost - Lies About Infertility Treatment?
I’m going to push back a little. It may turn out that I will be pushing back a lot. I’ve been reading a lot lately about the lies about fertility treatment, specifically IVF cost and money. And hope.
Latest article in Elle online: "$47,000 Dollars Later, I Have No Baby: The IVF Scam," by Ali Margo. Ali is very specific with who and what deceived her. Maybe it’s because it’s the scientific protocol that RMACT uses that raised my hackles. After all, I wrote last week about "The Big Lie," (See my blog about the book The Big Lie, Motherhood, Feminism and the Reality of the Biological Clock) and I supported what the author said. In some ways.
I feel a little like something is being discovered that was discovered a long time ago. That old joke about Columbus “discovering” America, when the Indians (as they prefer to be called in Arizona) were already living here. What did we really discover?
This isn’t making much sense yet. Here’s what I’m trying to say.
$47,000 is a boatload of money to spend on a product that you don’t get. If I were paying for a car or a boat, I’d expect to pay my money and have my product.
Fertility Treatment Is a Service
Fertility treatment is not actually a product; it’s more akin to a service or even a series of services. Without a doubt, the hope is that the services result in a product; a baby (a successful pregnancy). Still, there is no one out there, that I know of, that guarantees the product; a baby.
Doesn’t this all sound a lot like a business? Yes, sigh, unfortunately. I won’t go into whether other medical fields/treatments are also businesses; I’ll save that for another day.
Here’s something to consider though. We are buying services with fertility treatment. We are buying treatment. Not a guarantee about successful pregnancies resulting in babies. Not buying the end product. And just to be crystal clear, I agree with all the conversations whirling around that we do not talk enough about the patient who leaves treatment unsuccessfully; without their baby. I rarely, if ever, bold a statement in a blog. Maybe twice in over four years of writing five days a week. So if there’s only one take-away message from today’s blog, please let it be that I agree whole heartedly with the message in this blog and so much else that is being discussed in the infertility world; we do not talk enough about patients that leave treatment unfulfilled.
Pregnancy Rates - Clarity About IVF Scams
What I feel like pushing back about is this: when we are told about treatment, we hear numbers. Percentages. We are told that there is a 20%, 30%, 40%, 50% or any other number per cent chance that we could achieve a sucessful pregnancy. That leaves us to understand that directly opposite are the chances of not becoming pregnant. A 70% chance, 60% chance, 50% chance, all the way down to a 20% chance of not becoming pregnant, if you are lucky.
I know we don’t all get that. And that sometimes, in some clinics, we don’t even get told that. (Shame, shame, shame on fertility practices that don’t tell the truth about the chances and non-chances of pregnancy.) But please, please, please. Let’s not pretend that the information isn’t out there. These authors have not discovered something brand new. They really haven’t. If you’re at a fertility program or with a physician (or naturopath or acupuncturist, or reiki master, or yoga instructor) who does not share the possibility that you will not become pregnant in treatment with them, then they are not being honest or candid with you. Shame on them, absolutely.
But please. And I am using the word “but” here very deliberately, knowing that it negates what comes before it. I’m also saying please, trying to be polite. Another truth is that information abounds. It is so abundant. There is a book at least once a year about how fertility treatment doesn’t work. There are articles, blogs, message boards, and more, that speak to the fact that fertility treatment is very expensive and that it often doesn’t work. If you are going into fertility treatment, it is near to impossible to not hear the rampant conversations that go on about fertility treatment, success rates and cost.
In the most respectful way possible, how far does one need to stick one’s head in the sand to NOT know that fertility treatment doesn’t always work? And that you still need to pay for services?
Here’s a quote from Ali Margo’s blog, “The odds for women over 42 are so low some clinics won’t even offer IVF to women of that age—so why would anyone in their right mind even consider it?” Good question. Isn’t that responsible of those clinics? However there are many fertility programs that do offer IVF to 42 year old women, because even with the odds against them, women do get pregnant and that’s also their choice. I would like to add that with CCS, (Comprehensive Chromosomal Screening), which RMACT offers, the chances of pregnancy are as high as 70%. For the most recent pregnancy rates from RMACT, visit SART (Society for Assisted Reproductive Technology) and click here.
We come down to hope. I love what Ms. Margo had to say about that, “But what they don't realize is that not only did we run out of money, we ran out of something far more important—hope.” Even there, though, it has been my experience for the last two-and-a-half decades that hope is a renewable resource. Sometimes, often, much more so than money, hope replenishes itself. I see and experience over and over again, in the trenches with women trying to become pregnant, that hope bottoms out, only to fill again. And again and again.
I wish that Ms. Margo had been treated more gently and lovingly at the fertility practice that she was using. She deserved a phone call or more; she deserved compassionate attention. We all deserve that when news is as catastrophic as the news that she got was; 20 embryos, none of which survived. My heart goes out to her, having to leave treatment without her hoped for baby. It hurts that not everyone leaves with a baby. It really, really hurts; deep down inside in places that you feel will never stop aching.
I admire, support and will continue in these conversations because it brings me back to another point that I want men and women to hear about this. One that I consider crucial and shows us the way to survive. We need to leave as intact human beings. We may not get what we are hoping for or what we think we paid for; still, we need to leave being able to recognize ourselves in the mirror. And if that is not possible, then we need to leave with the tools to create a meaningful and loving life for ourselves.
With or without a baby.
Read the Elle article I reference: "$47,000 Dollars Later, I Have No Baby: The IVF Scam"
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CCS Genetic Screening at RMACT
I plead ignorance. What is Willams Syndrome and could the new research about it enable targeted genetic screening to avoid it? Do you know that Reproductive Medicine Associates of Connecticut (RMACT) is one of a select handful of fertility clinics in the United States that offers genetic screening technology, known as CCS (Comprehensive Chromosomal Screening)? And what's the connection to Williams Syndrome?
Learning More About Williams Syndrome
Chances are you plead ignorance, too. Until ABC ran a news story on June 9, 2011 and brought Williams Syndrome to our attention, not too many people knew about it. Immediately, it was on the top ten highest news stories for three straight days. That's a lot of days for a news story. So much interest was generated in this syndrome that the National Institutes of Health (NIH) got involved as well.
As reported by Edward Lovett for ABC, in Fall 2011, the National Institute of Child Health and Human Development (NICHD) awarded a $5.5 million grant to scientists from several institutions and disciplines to study Williams Syndrome, striving to learn how genes govern behavior. Lovett's recent article on the growth in awareness and research about Williams Syndrome from March 16, 2012, notes that this NICHD study could produce drugs and therapies for those affected.
The connection to infertility research is quite simple. As fertility experts are able to look at embryos and genes more and more closely, we are able to avoid many diseases and syndromes. Is Williams one of those diseases or syndromes that you would choose to screen for? Maybe not. How about some of the more common genetic diseases that are able to be identified through screening? Or, better yet, how about screening every single one of the chromosones that create an embryo and checking that they are normal before transferrring them, to help create a healthy pregnancy?
CCS: Comprehensive Chromosomal Screening
We have that technology now and fertilty doctors at RMACT are using it. CCS or Comprehensive Chromosomal Screening reduces miscarriages as the embryos are normal and healthy; allows for fewer embryos to be transferred in an IVF (in vitro fertilization) cycle, therefore creating less multiple births; and more. We uncover new things each day, technology advances and we are able to treat diseases and syndromes more sucessfully, more often. So, who knows how or if Williams Syndrome will be affected by infertility research and treatment. Already, there is much more research on Williams Syndrome, money and attention being paid to it. Perhaps there will be a link.
Meanwhile we have award-winning research to support a technology that helps create healthy families, one baby at a time. Learn more about genetic screening and the specifics of Comprehensive Chromosomal Screening (CCS) with this informative video below.