By CRG staff - interview with Judy Stern

Judy Stern, PhD, is Director of the Dartmouth-Hitchcock Medical Center's Embryology and Andrology Laboratory.


GeneWatch: What kinds of procedures does your lab handle? Who are your patients?

Judy Stern: We do IVF and ICSI (intracytoplasmic sperm injection). We also do embryo freezing. We used to do GIFT (gamete intrafallopian transfer ) years ago, but we don't do that anymore. We haven't done a lot of PGD (preimplantation genetic diagnosis), but we offer it. We basically do the gamut. We offer embryo donation and surrogacy as well, and other things that are out there, but a lot of the procedures like that we do less frequently than just standard, bread and butter IVF.

GW:  And when you say bread and butter IVF, you mean a couple comes in and ...?

JS: They use their own gametes, so we take the eggs from the woman and the sperm from the man and mix them together and they go back to the same couple. We do some donor eggs, sperm and embryos, but for the majority of what we do, the intended parents are also the gamete donors and the gestators.

GW: It seems like a lot of the talk about success of IVF and a lot of other assisted reproductive technologies focuses on success rate in terms of live births. How do you measure the success of the procedure that your lab carries out?

JS: We look at live birth rates, we submit our numbers to the CDC and to SART (the Society for Assisted Reproductive Technology) the way most other programs do. We're always evaluating live birth rates per cycle, per retrieval, and per transfer. Those numbers tell us different things. Live birth rate per cycle gives us an overall success of the procedure. Live birth rate per retrieval gives us more information about what is happening at the laboratory level. And live birth rate per transfer tells us about the quality of our embryos.

GW: Do you have any way of tracking what happens down the road after people leave the lab? 

JS: We don't specifically. We know whether or not there are live births, but we don't track long term. I'm presently involved in a study, the Infertility Family Research Registry, an NIH-funded project in which we are trying to recruit volunteers nationwide who've been fertility patients to look at the long term health of women and children from these procedures; but we don't do that specifically with the patients that we have here. From the clinic perspective, that is a massive undertaking. We have a lot of trouble just keeping track of the people who have frozen embryos here, truthfully. And to track people-who very often don't want to be tracked, by the way-is a whole other endeavor.

GW: About how many embryos do you suppose you have at the lab at any given time?

JS: Hang on, I'll look it up ... seven hundred and fifty two embryos.

GW: You've mentioned that the goal of IVF is the delivery of a single healthy child. Can you explain where that goal comes from, and have you run into much opposition pushing for it?

JS: We want a single healthy child because multiple pregnancies are much more risky than single pregnancies. So what we're trying to do is have singleton pregnancies be the result of our procedures-not even twins, and certainly not high order multiples. We've gotten better about higher multiples; twins, less so. We've had a fairly high twin rate, which on the one hand means that we're making very nice embryos; when we transfer two, we often end up with two. But we don't want that. We've really been pushing lately to go down to single embryo transfer, but it's very difficult, particularly in New Hampshire, where we don't have mandated coverage. You have patients who come in and are paying out of pocket. They have one chance to do a cycle. They're sitting there with two beautiful embryos. We can't tell them that both of them are going to be good and maybe one will be and the other one won't be... so which one do you transfer? There's a lot of push back from patients who very often are saying that they want to have both of them transferred. We're very careful, and we stick within the ASRM (American Society for Reproductive Medicine) guidelines. We never transfer more than two, for example, in women under thirty five. But when it goes from two to one, it becomes very difficult sometimes to convince patients to do that. We're working very hard on that at the moment. We're offering it to everybody and we're pushing it especially for people who have good quality embryos.

GW: If a patient asks to have six embryos transferred, can you say no?

JS: Yes, we can, and we do.

GW: At what point can you say no?

JS: We tell them that right up front. We tell them that we follow the national guidelines, so six is actually out of range of the guidelines at any age. We actually give them a table with the national guidelines and say, "These give you the max that we will do in whatever age category, and if the cycle has gone well and the embryos look good, we're going to recommend transferring the lower end of whatever that range is for your age."

GW: So for somebody who is older, the range is higher?

JS: The range is higher, yes. We might transfer three or four in somebody 40 years old, which we would never do with someone under 35, but we stick within those guidelines. I mean, we are always willing to transfer fewer if somebody wants to transfer fewer, and there are occasionally patients in the older age ranges who say no, that they wouldn't want multiples no matter what. That's great, but that's not the way the conversation usually goes. It's usually the reverse.

GW: What do you do to convince people? How do you convince someone to do a single embryo transfer if they are, say, 30 years old?

JS: I think that discussing the risks of multiple pregnancies and making that real to people is what is really important. People very often think when they go through this, when they're trying to have a child, that it looks as though having two at the same time would be great. Then they've gone through it once, they have their family and they're done. What people don't always realize is how risky those pregnancies can be. I think getting patients to understand that is really critical. 

GW: You also do a lot of work with SART. What's your role there currently? You're the research chair, is that right?

JS: I was the research chair for five years, and I'm still on the research committee. I've done a lot of work with that and what we did, and are still busy doing, are a lot of studies on outcomes of ART looking at different categories of patients. We did a whole set on obesity; we've looked at patients' outcomes related to number of embryos transferred; we've looked at trying to maximize pregnancy rates while minimizing multiple rates in older patients by looking at the characteristics of patients and what we're transferring and that sort of thing.

We're also involved with several grants right now. We're trying to link information from the SART core data base to existing vital record information. For example, in Massachusetts, we're working with a group at Boston University and the Massachusetts Department of Public Health on this. We have two NIH grants with them to try to look at long term health of children from ARTs and to compare that to subfertile women and fertile women within Massachusetts. What we're really trying to get a handle on is long term health of kids after these procedures, which unfortunately we know less about than we would like to know.


GW: Are there any procedures which seem to be particularly risky or that you would have some reservations about going through with?


JS: Well, there's always concern about newer procedures when they come in.  I mean, when we first started doing ICSI (intracytoplasmic sperm injection), there were concerns about whether or not it was an increased risk, and we're still concerned that there might be a very small increased risk using this. I mean, when you think about that procedure, you're bypassing all of the physiology of fertilization and you're taking a sperm and putting it into an egg with a needle. You would imagine that there might be risks. So that's something that was a concern early on. There have now been thousands and thousands of births from ICSI, and while there are still papers that indicate that there may be a risk, we are pretty sure that it's fairly low. But, you know, that's still a concern.

As newer procedures are brought in, there's always some concern about this kind of thing. Egg freezing now is one that is raising these sorts of concerns-is this safe? And we're not sure. It's still being  done under experimental protocol because we don't know how safe that is. Egg freezing is different than embryo freezing, which we've been doing since the late 80s. Egg freezing is very new. It's just freezing the unfertilized egg, but that's where there is some concern, even though it's being marketed at a number of clinics for women who want to delay childbearing. They should be aware that there are some potential risks there and that we don't know the outcome of these procedures. 

In vitro maturation is another one of those. It involves taking immature eggs from the ovaries and maturing them in vitro. Currently we give women lots of hormones to make multiple mature eggs in their follicles and we retrieve the eggs at the mature stage and use them for IVF; with in vitro maturation we don't do the hormone manipulation, or we do a minimal hormone manipulation and get the eggs out at an immature state and grow them up at the laboratory. This means that they're spending a lot  more time in the laboratory, and it also means that the maturation process may be modified in some way from what it is in the body, in vivo. We don't know what the risk of that is yet, even though that's now being used a little bit more than it used to be.

So every time we bring in a new procedure, particularly new laboratory procedures, there's concern about the risk. It's kind of a Catch 22 in some ways, in that we can't really learn about the risk in people-assuming we have reasonable animal studies on all of these, which we usually do-until we really do it; and we can't do it, or we don't want to do a lot of it, until we know what the risk is. So we end up in a situation where if we really think it's valuable, we have to move forward cautiously to begin with. One of the things that we should include in that caution is human subject approval and the full consent of patients who realize how new the procedures are. But we won't learn about it unless we do it, you know ... and we can't do it unless we overcome some of that caution.

GW: Another part of what SART does is create guidelines for assisted reproductive practices.

JS: Yes, most recently in 2009. Every couple of years, they come out with slightly lower numbers.

GW: You mean a slightly lower number of embryos?

JS: Yes, telling us to transfer fewer. Which is good. Keep in mind as I've been doing this for twenty five years, when we first started going this, the success rate was about five percent per cycle nationally. And over the past twenty five years, we've gotten much, much better at keeping embryos alive and in good condition and at the point where they will implant. As we get better and better and better, the number that we've wanted to transfer has gone down.

GW: But these are still just guidelines, right? They aren't actually enforceable?

JS: They're not laws.  In some countries, the number transferred is legislated, but not in this country. 

GW: So, do you think that there's good reason for it to be regulated here?

JS: Well, I have concerns about anything that goes to a legislature in this country, given the state of our political system. I think that a much more effective way of dealing with this would be for insurance companies to recognize that covering IVF with a limitation on the number of embryos transferred makes far more financial sense to them than what they are doing now, which is insisting that people do multiple cycles of intrauterine insemination (IUI), where we have no control at all over multiple births, before they do IVF. And insurance companies may pay for some of the IVF procedure or not pay for any of it, but they end up paying for all of the neonatal intensive care unit (NICU) costs. They pay all of the NICU costs for multiple pregnancies, yet they won't, for the most part, come out with policies that say that "We'll pay for five or six cycles of IVF if you only transfer one embryo at a time." That makes a heck of a lot more sense to me than laws or any other way of doing it, and I think that it would make a huge difference in the multiple rate in this country because, as I said, one of the driving forces behind patients' desire to transfer more embryos is that they're paying out of pocket. So they pay for IVF out of pocket and transfer multiple embryos, then they end up with a million dollars in NICU costs that are paid by the same insurance company that refuses to pay for the IVF.  That just doesn't make any sense to me.

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