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Dr. James Grifo program director of the NYU Fertility Center; how was it the NYU Medical Center distinguished in the area of infertility? Well, we have one of the largest centers in the world and most experienced and we have been involved in developing some of the newer technologies in in assisted reproduction, for instance, Preimplantation Genetic Diagnosis. I was actually the first in the United States. We were the second in the world to have a successful delivery from that procedure. We have advanced techniques such as blastocyst culture to improve the chances of IVF success and reduce the chance of getting multiple pregnancies which is the un-desired side effect of assisted reproduction. We have also been involved in some of the other controversial techniques, for instance we were trying to for older women's eggs by doing nuclear transfer but that kind of get stopped by the FDA over probably more political than safety concern issues. What was the political concern? Well the political concern was at the time cloning was you know, all over the media and nuclear transfer is one step used in cloning and I think they got confused between what we were doing and what cloning was because we weren't cloning, but there was a confusion. So I actually received the personal letter from the FDA telling me I can't do the work that they regulated and I had to submit an investigational new drug application in order to continue the work after we had spend half a million dollars of private research money and developed the technique that actually worked. We developed it in a mouse system that there were healthy babies from it. We had done a clinical trial in humans and actually were able to create embryos that way, but no one got pregnant in the limited series and that's when the work stopped because of the politics We subsequently taught the Chinese how to do it and transported the techniques they were able they were allowed to do at that time, and we were successful and there was a successful pregnancy which unfortunately the woman had preterm labor and reptured membranes early and lost her pregnancy. And at that point the Chinese Government stopped the work because they thought the technique was the problem, it wasn't, it was just the complication of medicine. So that became a very political thing. So it was unfortunate because there was a line promising line of research that got stopped by you know, overzealous regulation I think. But so we switched gears on that topic instead of trying to fix older eggs. What we started working on was learning how to freeze eggs so that younger women could freeze their eggs and be their own egg donor later on and not not need this other technique, so . Has that become widespread technique? It's it's not a widespread technique but we have now developed it a method to the extent that we can be very successful with it and we just are trying to publish a clinical series where we showed we had pregnancy rates as good as fresh IVS cycles in in a group of patients group of young patients that were that volunteered to you know, try this technique and we had in 16 cycles and 15 patients we had 10 positive pregnancy tests and seven have delivered, one is about to deliver. So we have a 50 percent delivered pregnancy rate with frozen eggs which it has never been reported that high. How has the medicine of infertility changed since you entered the field? Well, when I first started that I remember I was a Fellow at Yale and we had a 10 percent pregnancy rate and everyone thought that was great. Now, you couldn't stay in business with a 10 percent rate. We have got much more better at having good success. We have limited a lot of the complications. We made the technique a little bit more user friendly and we have been bale to help more patients by adding new new techniques such as egg freezing or Embryo Biopsy, Preimplantation Genetic Diagnosis where we can help couples at genetic with genetic risk not have a baby with a genetic disease. What are the what are the causes of infertility? Well, infertility, firstly I have to define infertility. Infertility is in the text books defined as a year of trying without getting pregnant, so a year of unprotected intercourse without getting pregnant. Well that's just an arbitrary decision. The reason the text book call at that is because in generally takes about 13 months for 100 percent of 25 year old fertile couples to get pregnant. I mean we spend our lives avoiding trying to get pregnant. It's not so easy to get pregnant. Unfortunately I have our friends who you know, we tried one month for pregnant you know, they all talk, but we tried 15 months and finally got pregnant, nobody says that. So it's it's a little different that way. But it is difficult to get pregnant and and pregnancies happen unwanted in many cases too. So you know control of reproduction is something that a lot of us desire, although politically some of us don't, and that's a whole other topic. But you know the causes of infertility in a lot of cases are unexplained. We have this term called idiopathic infertility, which means we can't find the reason, but this couple is not getting pregnant. Potential other terms idiopathic from the Greek, it means "I am an idiot" and I can't figure out the pathology. But you know by giving you this mysterious thing, it makes it sound like you know something. Yeah, well, the reality is that's actually the best diagnosis to have even though it's the most frustrating. But you know patients think we were missing some thing when we can't explain it. But the good news is a lot of those patients are able to get pregnant even with simpler techniques. About 40 percent of infertility is male factor related, so about 60 percent is female related. So it's not always the husband's fault, although most of the time. But you know the cause of female infertility, mainly there is Tubal Disease, there is Fibroids, there is ovarian problem such as endometriosis and their endocrine problems that interfere with ovulation. And the main cause of female infertility is just the late child bearing because as you get older it's more difficult to get pregnant, and that's very true for women and less so true for men. Is that changing for women, the age which infertility sets in? No, no it really isn't changing. And in fact if you look at population studies peak fertility is in the mid 20s. So you know, biologically we are designed to have kids when we are still adolescents. And you know when you look at what society has done; I mean we are much more capable as parents when we are older. So you know our biology and our psychology have diverged and that's kind of created you know, this problem, and why I am so busy because many people are choosing to delay child bearing and and then they are having difficulty getting pregnant. And you you could actually measure decline in fertility in women in late 20s and it's it's modest, but it's there if you look at the population, and you know around 35 there is a little blip, at 37-38 there is a little blip, at 40 there is a little bigger blip, and at 42 there is a much bigger blip and at 44 really the bottom falls out. The number of spontaneous pregnancies in women over 44 is limited. Not according to the super market - checkout stands. Well, you know celebrities are under the knife and they are not so keen on telling the world that they have done egg donation, or use assisted reproduction. So you know what you read isn't always true, although, I think about this point, if any body is watching this kind of educational experience knows that the popular media isn't always so accurate. So what are the treatments for infertility? Well, the treatments involve first the work up and the work up of infertility is really not that complicated. It requires taking a medical history, seeing if there is any medical causes for infertility, and treating those directly and exam looking for things like fibroids and cysts, a test called the hysterosalpingogram which checks the to see if the tubes are open, the fallopian tubes are open, because if they are blocked you are not going to get pregnant, things checking for ovulation, documenting ovulation, checking things like thyroid disease which can interfere with with ovulation, and looking for a hormone called Prolactin which can interfere and these are all treatable things. Sometimes there is tubal disease and that's treatable surgically, where you can fix the tubes, some times fibroids are a problem. You can you can surgically remove fibroids. Sometimes it's a malefactor problem, some times surgery can fix the malefactor problem, and medications can. So you know you have to treat the direct problem, but the reality is that majority of infertility that we treat is unexplained, where there is modest changes in some of these things that have been optimally corrected. And then what we are trying to do is up the odds, you know if the chance of getting pregnant, that is about 10 percent per cycle which is the reality you know, our assisted reproductive techniques improve those odds. And you know for a couple has been trying for a year and hasn't got pregnant, their baseline pregnancy rate is probably somewhere in the two to five percent range. So what we do with those couples initially with open tubes and the sperm count is reasonable, we will give a medication called clomiphene citrate which is a weak fertility medicine that stimulates ovulation and it improves the chances, if you give clomid to fertile women, it doubles their odds. So if you give it to infertile women, it doubles their odds. It's not a miraculous treatment, but it helps a lot of people and it's pretty simple and it's pretty expensive. If that fails we use stronger medicines like injectable medicines, which are stronger and have more problems associated with them like multiple pregnancies. So you have to be very careful with those medicines. And if those treatments fail then we go onto In Vitro fertilization, which in certain groups of patients is quite successful. And for a woman under 37, we have over all 50 percent delivery rate from one attempt in In Vitro fertilization. As women get older it's less efficient. For instance you know, at age 44 IVF has a about a six or seven percent pregnancy rate per attempted cycle, using a woman's own eggs. So you can see that pretty significant decline over that time period. And then some of older patients who are unsuccessful with IVF, where we have identified that the eggs were the problem, then we do things like egg donation, where we take a young women's egg, husband's sperm, make an embryo and then put those embryos back into that woman. So she carries a baby that's not from her egg, but it's her baby and she delivers the baby and that has very high success rate. That's about a 55 percent delivery rate from one attempt. So you dealing with the business of life and helping to create life and you had talked at the outset about political and moral issues. So do you face moral, ethical issues on a frequent basis with the work that you do, is it a or is it all pretty much science and medicine to you? Well, I mean the science and medicine has never done outside the confines of society. I mean so everything we do everyday is moral and political. You know my political statement is I am trying to help people with healthy babies and some of the things that we do doesn't fit well with other people's politics and that creates a lot of dilemmas and there are lots of people out there who are critics of what we do. There are people who are uncomfortable with the fact we actually could "create life in the lab", although I don't view it that way. I think we are just assisting nature. We just do it what nature does, we just see it. So I don't think we are anything other than just agents of nature, of god, whatever you know, you want to say and our goal is to help people healthy babies. And you know we see embryos in lab that aren't viable and we watch them not make a pregnancy and and there is no shame in that. I mean that happens in nature. I mean it happens you take a handful of seeds, you drop them on the ground, most of them don't make plans. Well, embryos are the same way. And I think what's an unpopular political statement to say is that most embryos aren't good, most embryos don't make babies and what we do in IVF is help select the ones that are more likely to make a pregnancy, because most embryos are chromosomally abnormal and unhealthy and would not make a pregnancy. So the people have problems with us doing this kind of work and I understand that. But we are not asking them to participate, we are trying to help patients most of patients we see don't have problems with these technologies and want them because they desperately want to have a family. But yeah it's a tough field filled with lots of dilemmas in politics and lot of inaccuracy in the media. You know a day doesn't go by where you don't read an article about us, unregulated cowboys in the medical field and we are unfortunately probably one of the most highly regulated specialties and I have got to tell you, most of the regulations don't help us be better. They make us make us cost more money and they don't stop the the psychopath is going to do the wrong thing. But it's all window dressing to make the politicians look like they are doing something to protect patients and they are really not. And it's unfortunate because it just makes our job harder and more expensive and it really isn't helping. Do attitudes towards infertility, in the context of some of the issues that you just discussed, differ from the United States to European countries, to rest of the world? Yeah there is there is a lot of diversity around the world about how our specialty is viewed. I think generally there is a lot of the similar politics. I think there is a push to regulation. It's different in different societies. I think there is a lot of a fear around this technology because of the potential misuse of this technology you know, this term that has been developed called "designer babies", it's really not a real term. It was coined by the media as a way to you know, create stories around what we do you know, I don't think we have to worry about those technologies. We don't design babies, we don't have the ability to select for hair color and eye color genes, you know. Is that going to happen? Well the potential is that we could, but right now we don't and you know, it's funny, when I had the first embryo biopsy delivery in the United States, we were the second in the world, and the reason we were the second in world because I couldn't get permission to do it until the Brits were successful. I mean it how under regulated we were as a specialty. But at any rate immediately there was this push towards you know, that we got to stop this work because next thing we are going to be doing is you know, practicing politics in the lab and selecting for certain genes and selecting for certain races and it's just absurd. We saw that in the movies. Yeah, but we don't have the technology to do that. We are not really developing that technology because that's not what we are doing, that's not our patients are asking us to do. They are asking us to help avoid a genetic disease. You know you have a couple who has baby with cystic fibrosis or a baby with a lethal disease that's been born and dies and then they come to you and say, you know, "My doctor said, if I get pregnant again, 25 percent, my babies are going to have this. I want to have a healthy baby." You know, "Could you do a gene test in my embryo, so I don't have to pregnant with another baby with this problem." That's what we are doing. We are not designing babies, we are making healthy babies. So what's on the horizon for the Fertility Center? Well, you know, I think we are going to get better at the techniques that we do. I think a lot of the research centers around, trying to be more effective one of our biggest goals is to reduce the incidents of multiple pregnancies, because to me getting triplets from IVF is not a success. In fact in some way it's a failure, it's just less of a failure than a failed cycle. We have actually been working on techniques to be able to better select which is the embryo that's going to make the baby, because the reason we make so many multiples is we look at embryos and we can't tell which ones are the best and we put back more than we would like to in order to get a good pregnancy rate. And one of the things that we have developed over the last five years, and actually it was just recently published, is a method of growing the embryos in culture for a longer period of time and they kind of declare which ones are more healthy. So we are now putting back on an average one less embryo and we drop to our triplet rates depending on the age group of patient that you are looking at, any where from you know three to five folds. So that's that's a pretty dramatic improvement. We are still making a lot of twins, because we are still you know, getting to the point where a single embryo transfer is scary, but we are doing it and we in a select a group of patients where we can look at embryos, we can say, look if we put back one embryo we can give you a 70 percent delivery rate, if you are in this group of patients. So we shouldn't put the second one and make twins. The problem is a lot of the patients want twins. That's not our goal, because twins are more complicated than singletons. We would rather have someone have a singleton healthy pregnancy and good outcome than have multiple. So on the horizon is finding that healthy embryo and we are working on other techniques where if we could look in the media that the embryo grows in for marker that tells us which embryo is healthy. That's something we are we are researching and then preserving fertility. There are lots of women who are young and diagnosed with cancer and they don't have the same chance as men who can freeze their sperm. Well now they do, we have developed a technique, they can freeze some of their eggs before they get their chemotherapy that destroys their ovaries and destroys their eggs and put them in the freezer. So when they cured of their cancer they can come back and have a pretty good chance of having the baby that they want, because you know, when you get a diagnosis of cancer as a 30 year old woman you are not just thinking about dying of your disease, you are thinking about all the lost the opportunity in part of life, having a baby is part of it and when you tell someone oh, you are going to get this chemotherapy, it's going to cure you, but it's going to ruin your fertility, that's a big part of treating this cancer patients, well, because a lot of them are surviving and they want to have normal lives after their survival. So that's been a really big improvement and we are going to continue to try and get better at that technique. We are doing lots of research to make that technology better. Finally, what do you like most of about what you do? What I like most about what I do that's a great question, because there are so much about what I do that I like, but it's just being able to see the difference you make in a person's life. And I think you know, if you really talked to a lot of people who are passionate about what they do, I think most people feel like they are making a difference. You know, it could be in any field. If you are making a difference in the world and in someone's life and it's a major difference that we make by helping them have babies. That to me is the most rewarding thing. It's just nothing in the world can replace that feeling. That's just the most amazing thing you can't even describe it. But you know, you have a lot of people out there who just whose life you made a huge impact on and to be able to go to work everyday and be able to do something like that is just indescribable. Great, we have to close, thanks very much for your time doctor. All right. Super.