Dr. Elan Simckes blog
Tags >> In Vitro Fertilization (IVF)

 

Recently it was calculated that approximately 125 IVF cases per 1 million capita are performed in in the USA during the course of a year. In most of the major westernized countries in Europe they are performing between 400 – 500 cases per 1 million capita. That is just one fourth of the cases that are done in these other countries! Despite the fact that on average USA IVF success rates are higher than those countries, we do not help nearly as many people. Why? The answer is obvious. IVF is not a covered medical treatment in the USA and so, the overwhelming majority of Americans just can't afford the procedure. In many European countries there is generally some form of coverage, but  if the family has to pay out of their own, the costs are less than half than what they are in this country. With one in seven couples in the USA struggling to build their families, that leaves many people left to fend for themselves.

Two and half years ago, we opened the Fertility Partnership with the goal of providing state-of-the-art reproductive health care in a caring and compassionate environment. As we opened our doors in the heart of the worst economic crisis in 70 years, it was clear that the best way to be compassionate was to make it as affordable as possible. In August 2010 the Fertility Partnership was featured in  Newsweek Magazine describing our efforts to lower the cost of Advanced Reproductive Technology. It was a fascinating article that stirred up some controversy. For example, it touched upon some difficult topics such as the "economic selection" that created by the high cost of fertility procedures . That is to say, only infertile couples with economic means will be able to reproduce. We have learned a lot since we've opened, and so I thought it appropriate in honor of National Fertility Week to reflect on what we've learned during our quest to provide the best care at the most reasonable cost.

The fact of the matter is that the materials and equipment needed to run and maintain an IVF laboratory, staff an IVF clinic, and all that is needed to maintain state-of-the-art clinic in full compliance with all regulatory statutes is just very expensive. So how do you bring the cost down? Some clinics have tried what are called "shared risk programs". That is where you pay for more than one round of IVF upfront and are given certain assurances that there will be a successful outcome. There are even promises or guarantees to return money if all attempts fail. We initially considered pursuing this at Fertility Partnership because there is something to be said about calming the frightened couples with guarantees and opportunities to try more than once. What eventually dissuaded us from pursuing this practice is the simple fact that some of the companies that provide these services are publicly held and annual profits are visible to any and all. They are apparently doing quite well financially with these programs and post millions of dollars of gains each year. This somehow seems too businesslike to us and not in the spirit of practicing medicine. Also, typically patients can only get in on these "shared risk" programs if they meet certain criteria which in fact make them very likely to be successful at IVF, ad so they are "safe bets". I like to use the metaphor of throwing darts at a balloon. IVF is like paying thousands of dollars for a dart to hit a balloon and win the most wonderful of prizes. But, there are no guarantees. I believe that you have to keep your darts very sharp, that is to say the best science and medical/clinical care. You have to engage your patients and keep them focused and calm as they take their shot at being successful. Also, our philosophy has been to provide each dart at the lowest cost possible. We are not going to “sell” you two or three darts at a time with guaranteed results. In the end, we believe that works out better for the patients.

 

So what about "low intensity" in vitro fertilization? It comes under various names such as "low dose", "micro", and other names that are in fact trademarked and so I will not mention them. It is my understanding that these protocols for IVF were developed with the idea that there are women who would benefit from lower doses of fertility medications during their cycles. Unfortunately it has not panned out. In a recent publication Dr. Norbert Gleicher reported on their results. He states that "with an identical number of embryos transferred, after adjusting for age, patients using standard IVF demonstrated a 7-fold better odds for pregnancy and a cumulative pregnancy rate that was more than six times higher than that achieved in patients using low intensity IVF cycles". He also calculated that the average cost to bring a baby into the world from these technologies i.e. live birth, was “$23,100 when low intensity IVF cycles were used and $20,333 when standard IVF cycles were used (these are cumulative results, meaning multiple attempts may have been necessary). Dr. Gleicher concluded from his research that "low intensity IVF currently lacks clinical and economic foundations, and therefore should be offered only under experimental study conditions". Unfortunately, there are some clinics that are marketing these protocols as low-cost alternatives to standard IVF. I feel certain that there are some couples who could benefit from this approach; however we do not know who these couples are at this time. At Fertility Partnership we don't provide low intensity IVF, but, it's in fact quite easy to do and we are ready to implement these protocols once we are convinced that is beneficial for a particular couple.

So what's the answer? How do you lower the cost of in vitro fertilization? The answer is by doing just that, lower the cost of in vitro fertilization. I believe that physicians need to lower their expectations of what they will ”earn"  from each cycle and be prepared to provide care to the increased number of couples who will come seeking care because it's less expensive. We are only taking care of one fourth of the patients in the USA who require in vitro fertilization and all that goes with it. Clinics need to just lower their prices and roll up their sleeves to work harder and provide good care for more people.

 

 


Unexplained infertility is by far the most frustrating of all conditions I see. To get this diagnosis, all the testing patients have undergone show that everything is normal. There are adequate sperm for the male, and female patients seem to be ovulating or “making eggs.” The “plumbing” has been checked through an ultrasound and hysterosalpingogram, or “dye test,” and there are no abnormalities. We cannot find a medical reason for failure to conceive. 

I have sat before many patients with this diagnosis, including many that are in the medical profession, and the look of utter frustration is intense. They say “Everything checks out, so why won’t it all work?” The fact is that as many as 20 to 30 percent of all the patients we treat for infertility are not truly explained. The patients look to us for a treatment plan, but what are we treating? Doctors, as a general rule, like to know what and why they are doing things before they do anything. But unexplained infertility defies that rule because the lack of a plan of action is unacceptable. So, we need guidelines.

Clearly, if you do not know what you are treating then anything you do is empiric. In other words, we will rely on observation and experience rather than clear cut science. The general rule is if the woman is 35 or younger, and there is a normal semen analysis, doctors should provide Intrauterine Insemination (IUI) three times. That yields about a 30 to 35 percent overall pregnancy rate after three attempts. 

If IUI fails, you move on to IVF for 3 attempts. The combined IUIx3/IVFx3 yields between 85 and 90 percent success rate. But, if the semen analysis is significantly abnormal, or if the woman is older (or there is evidence of a diminished egg reserve), you should recommend going straight to IVF. 

Obviously, patients have choices. There have been many patients who have insisted on trying IUI first, and some who wanted to skip the IUIs and go straight to the most effective tool we have, In-Vitro Fertilization. Medical ethics dictate that the choice must be made by affirming “patient autonomy” and the “Doctor’s Beneficence.” That means the patient should be involved in making the choice, but the doctor can only do what has a real chance of working.

Before I initiate a treatment plan, I review the history closely, especially the family history. It is my experience that many unexplained infertility patients are in fact getting pregnant, but they are miscarrying and do not know it. Incredibly, a study showed that probably 70 percent of all pregnancies never make it. The woman may get her menstrual cycle on time or may not. It may come a few days late, the patient may feel that the breasts are tender and may think to themselves that it doesn't come tomorrow I will run out and buy a pregnancy test. Then the menstrual cycle starts. 

In other words, I believe that many of these patients are in fact getting pregnant but repeatedly losing pregnancies. Recurrent pregnancy loss, however, is the subject of an entire different blog. Regardless, I very often if not always look at the possibility that the patient is experiencing recurrent pregnancy loss. It’s extremely important - imagine finding out you have a treatable recurrent miscarriage condition after losing viable IVF pregnancies. 

Unfortunately, no doctor can find answers for every patient. Sometimes unexplained infertility, despite our best efforts and the use of the latest technology and tests, stubbornly remains unexplained. For those patients, gestational carriers or adoption may be their best paths to parenthood. As disappointing as this can be, the good news is that more than 50,000 people in the U.S. every year become parents through these methods. The path to parenthood can be a rocky one, and those who battle unexplained infertility certainly have among the rockiest of journeys, but in most cases there can be a happy ending.


It’s another week and another “IVF linked to cancer” study: a recent study from the Netherlands has raised the possibility that in vitro fertilization may heighten the risk of ovarian cancer in patients who have undergone the fertility treatment. Obviously this is going to cause great concern in a large and growing population of patients who've accessed advanced reproductive care – but as always, I’m urging caution as you consider this study.

First, it is important to state that the researchers thought the results were preliminary only and recommended that much larger studies be done. In other words, there is no confirmation yet that this risk is in fact true. Secondly, it is important to remember that women who never give birth in their lifetimes (i.e. nulliparous) are at increased risk for ovarian cancer. Pregnancy, as well as birth-control pills, actually helps protect women from this deadly disease. In fact, women who have a strong family history of ovarian cancer are actually advised to be on birth control pills until they bear children. Once they are done having children, I usually recommend that these women undergo a preventative removal of their ovaries. 

So is there cause for concern? The first question to consider is if there is biological plausibility to the idea that IVF can cause ovarian cancer – and there is biological plausibility. The current thinking about certain types of ovarian cancer is that it occurs because of the “injury theory” – if the ovary is incessantly exposed to ovulation, it increases the risk of cancer. Again, birth-control pills help reduce the risk because most women don’t ovulate while on the pill, and pregnancy also helps for the same reason. With IVF, we put a needle into the ovary to retrieve eggs, which in theory causes an “injury” to the ovary. Does this mean we should stop doing IVF? And, does this mean that women who cannot bear children should stop the attempts to build the family? I don't think so.

In my opinion, we should do more research to see if this risk is real. If a concrete link is found, then current IVF protocols will need to adjust. There are some very simple adjustments that can be made, such as putting women back on the pill if they complete an IVF cycle and don’t get pregnant. Also, we can closely monitor women post-IVF for ovarian cancer with yearly ultrasounds and (although some disagree) the CA 125 blood test.  

My final thoughts on this topic are that, with anything in medicine, there is always the potential for side effects, and unfortunately sometimes those side effects can be serious. Diligent, ongoing study to continuously refine and improve our treatments, diagnostic tests and overall medical care are absolutely vital and must be continued around the world. I know I’ll be following ongoing studies very closely, but I certainly would not discourage anyone from pursuing their dream of having a baby because of one preliminary study.


I’ve been following the events surrounding E! News personality Giuliana Rancic’s recent diagnosis of breast cancer with much concern. There is so much at stake here for women trying to build a family, and Ms. Rancic’s unfortunate diagnosis could be used to confuse many people. 

Obviously I hope all goes well for Ms. Rancic. For those unfamiliar with her story, Ms. Rancic’s fertility specialist ordered a mammogram for what appears to be screening purposes and found what is believed to be an early cancer in a 36-year-old woman who had undergone IVF twice before. This raises two questions that need to be addressed. First, did the IVF cause her breast cancer? The answer is no. Fertility treatments do not increase the risk of breast cancer. In fact, successful fertility treatments could potentially lower the risk if the mother breastfeeds. A number of studies have shown that breastfeeding reduces the incidence of breast cancer. By helping facilitate a successful pregnancy, we can help women access this proven preventative measure as well as the dream of family. There is no convincing data that proves that fertility treatment increases the lifetime risk, although the researchers are diligently following this.

The second question is much more serious and potentially controversial: can fertility treatments accelerate early, as yet undetected, breast cancers? I searched the literature and could not find any definite proof that this is true. But, the pragmatist in me has to admit that this concern has a lot of biological basis to be concerned. For example, breast cancers very often have receptors for estrogen and progesterone, two hormones that rise dramatically during fertility treatments and the subsequent pregnancy. In fact, cancers discovered after a recent pregnancy are associated with a poorer prognosis, but ironically these are cancers that lack these receptors

So we know that pregnancy can worsen a diagnosis of breast cancer, even though the treatment to get pregnant may not. As many of our patients are older and requiring help to conceive, I think it is fair to assume that we could be accelerating or worsening the prognosis of an as yet undiagnosed breast cancer. How do we best help our patients with this issue? Mammograms are the obvious screening tool, but unfortunately, debate rages over when women should begin mammogram screening. The U.S. Preventive Services Task Forces recommends breast cancer testing start at age 50, although the American Cancer Society advises yearly mammograms beginning at age 40 for women with an average risk. Some earlier studies even suggested age 35. I believe that any patient who is at increased risk, (i.e. family history) be screened, perhaps as early as age 30. Perhaps we need to screen everyone who goes through IVF treatment, and certainly those ages 35 and older; however, the benefit of this is again controversial.

Giuliana Rancic’s diagnosis has certainly brought this important issue to the forefront, but I’m not happy with the fact that this story is fodder for all those constantly looking for ways that advances in medicine can hurt us. The sensationalist press also will irresponsibly try to raise fear solely to increase their readership. At the end of the day, we need to realize that there are no free rides, no sure things, and no easy answers in medicine. Drugs have side effects and surgeries have complications. IVF has helped millions of people around the world, and we must stay diligent to make sure the risks are minimized. 


If you’ve been following this blog or Fertility Partnership, you probably know that I created this clinic specifically to help as many people as possible have the baby of their dreams at the most affordable cost that  I could provide. I’m proud of the success we’ve had in doing that since we opened in December 2009; most notably, not only has Fertility Partnership offered IVF approximately 30 percent lower than the national average, but other St. Louis area fertility clinics have lowered their price since we entered the market. 

I am always looking for opportunities to make fertility treatments even more accessible, so that’s why I am excited to announce that Fertility Partnership will be giving away one free IVF cycle at the Midwest Infertility Awareness (MIA) Conference on Saturday, Nov. 12. The package we’ll be giving away is valued at more than $9,000 and will be handed out at the end of the conference to one attendee who must be present to win. 

For more details or to register for the conference, please visit the MIA website or Facebook page. I’ll be at the conference as well, and I’m looking forward to meeting as many of the attendees as possible as well as speaking at the event. I hope to see you there, and I look forward to meeting the winner of the IVF cycle giveway.


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Fertility Partnership

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Saint Peters, MO 63376

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FertilityPrtnrs: Dr. Simckes was on STL Moms this week discussing a new study on fertility treaments and birth defects. Check it out: http://t.co/EizFa9PS


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