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.

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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.

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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. 

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Recently, yet another major article was published in the fertility literature that demonstrates the negative impact of being severely obese on infertility treatment outcomes. Piggybacking on that, Canada is currently debating whether obese women should even be allowed to undergo In Vitro Fertilization (IVF). As we have long known, being extremely obese (i.e. a BMI over 50) greatly impacts a woman’s chances to conceive. Obesity reduces the body’s ability to respond well to fertility medications, can make egg retrieval a nightmare, reduces the pregnancy rate after IVF, and increases the possibility that the woman will miscarry. 

So now what? Do we just tell overweight women that they are out of luck unless they can diet and exercise, throwing guilt into the frustration and sadness that they already have regarding their inability to conceive? The reality is that most of these women have dieted and tried to control their weight for many years. In fact, many have a metabolic condition that makes it extremely hard to lose weight. 

So what is the best way to help these heavy ladies? Weight loss, exercise, and diet plans work for some, but even with the motivation brought on by their desire to have a baby, they rarely can acheive the goals. It also takes time to institute lifestyle changes, which is a big problem when you’re talking about having a baby. In many cases, time is of the essence, since egg quality and quantity decline so rapidly after age 30. How do we get these patients to lose weight quickly in order to proceed to fertility management? 

There are number of approved prescription medications available that currently are in use. Some have been used and reported in the fertility literature, but the only drug I have found useful is phentermine, of Phen-Fen infamy. Go with me for a moment on this. In the Phen-Fen debacle, the treatment regimen included two drugs: fenfluramine which tragically caused some fatalities and is rightfully off the market; and phentermine, which has been on the market for over 40 years and has been shown to be very useful with rapid weight loss. 

Unfortunately for patients, however, the use of phentermine is largely vilified in the medical community. Why? In my opinion, it is frowned upon because it is perceived as a quick fix and, while results will include rapid weight loss, the dependence on a drug rather than lifestyle changes virtually guarantees the weight will go right back on post-medication use.

Most doctors probably think, “What's the point of using a weight loss drug if the patient will gain it all back right soon after?” But in the field of fertility, that’s really exactly what I’m trying to achieve with my patients. I want my patients to lose enough weight to successfully and safely get pregnant, then gain weight (albeit carefully and by making healthy choices) as their baby grows. 

Under the watchful eye of a careful doctor, phentermine can work very well. A well motivated patient who exercises 3 times a week for 30-40 minutes, watches carbohydrate intake and takes the prescribed dose of phentermine daily can lose 40 pounds or more in six months. Many patients who typically do not ovulate on their own will start to do so after losing that much weight, and some even conceive spontaneously. 

Is phentermine safe? Yes. I have now had over 500 patients on a regimen that included phentermine and have found many of the bad press the drug has received to be unfounded. Other than the annoying side effects of “cotton mouth” and constipation, my patients have done extremely well with short-term, carefully monitored use of the drug.

There is no doubt that if you are very overweight, your fertility journey is going to be harder and less successful. Instead of turning you away, however, as some other infertility clinics do, Fertility Partnership will work with you to safely and effectively manage your weight and help you get pregnant. We have seen great results from our philosophy that well-supervised weight loss programs - which include the short-term use of medications like phentermine - are very successful in getting the weight off quickly in preparation for achieving the dream of having a baby.

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Ever since the 1930s, science and medicine have been searching for an effective way to collect immature eggs from the ovaries and mature them in the lab so they can be successfully fertilized.  In Vitro Maturation – or IVM – has captured the imaginations of various researchers but results to this point have never been reliable or consistent. Over the years there have been scattered successes, and one estimate is that there are 500 or so babies born this way. Unfortunately, results were so non-reproducible that few programs bothered with it – until now.

Researchers at Brown University report that their IVM technique has produced consistent pregnancy results. Overall, they believe that their IVM technique can achieve a success rate that is approximately 80 percent as strong as traditional In Vitro Fertilization (IVF) rates. Certainly this is great news for those patients who would most benefit from IVM – namely Polycystic Ovarian Syndrome (PCOS) and cancer patients. 

Recently, the Fertility Partnership team was invited to Brown to undergo the training program necessary to bring IVM to our area. In fact, we already have patients who are ready to undergo our very first IVM procedures. We are looking forward to working with patients who understand IVM and want to be a part of this exciting process that may not only give them the baby they’ve been waiting for but also have a major impact on fertility care.

Why is IVM so attractive? There are a number of very good reasons.

Traditional IVF requires the use of strong and expensive “fertility drugs”(gonadotropins) and a long preparation process that lasts weeks before the mature eggs are retrieved in a process called “superovulation.” With IVM, the patient receives little or no stimulation meds, and the patient’s preparation for egg retrieval takes just a few days. The eggs get the fertility stimulation in the lab rather than in the woman’s body, requiring a tiny fraction of the amount of the drugs.

Why is this good and who does it help? When going through IVF, patients with PCOS may be at risk of superovulation and can develop a dangerous condition called Ovarian Hyperstimulation Syndrome (OHSS). PCOS patients represent 12-15 percent of the general population and 20-30 percent of IVF patients, so that means almost one-third of the women going through IVF are at risk for OHSS. Since IVM avoids hyperstimulation altogether, Ovarian Hyperstimulation Syndrome in PCOS patients is entirely avoidable.

IVM also provides a huge benefit to women diagnosed with cancer who want to preserve their fertility. These patients find out suddenly one day they have a disease such as leukemia or breast cancer and need (and want) treatment as soon as possible, but they quickly learn the treatments may destroy their ovarian function. They’re faced with a terrible choice – take the treatments that may save their life but leave them infertile, or avoid the cancer treatments and gamble with their life. Normally with IVF, we go ahead with the collection and freezing of eggs for later use, but this traditional approach delays their cancer treatment by several often critical weeks. IVM allows the eggs to be retrieved quickly - within just a few days; in fact, the retrieval probably is done before the work-up for the cancer is completed.  

Perhaps the greatest feature of In Vitro Maturation is that it can potentially eliminate the danger of superovulation for everyone since patients do not need to be given daily injections of powerful and expensive medicines. This will end the need for women to inject large doses of hormones, and it also should dramatically reduce the cost of infertility treatments. IVM should cost one third of IVF with minimal medication costs, and I am looking forward to offering it as another option for our patients at Fertility Partnership.

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