Melanie Cole (Host): Welcome to Fertility Talk with RSCNJ, the Reproductive Science Center of New Jersey. I'm Melanie Cole. And today, we're talking about the regulatory oversight of fertility practices.

Joining me is Dr. William Ziegler. He's a specialist in reproductive endocrinology and infertility, and he's the Medical Director of the Reproductive Science Center of New Jersey. Dr. Ziegler, I'm so glad to have you on with us today. And this is a topic you and I have done a lot of podcasts together, and this is one we have not ever touched on. Will you tell me a little bit about the evolution of regulatory oversight of fertility clinics across the board? What's different now? How did this all kind of happen?

Dr William Ziegler: Well, thanks very much for having me, but I just like to go through a little bit of an introduction and kind of put this into perspective. In the United States, infertility affects approximately 7.3 million women and their partners. That accounts for around 12% of the reproductive age population.

And for many of these couples, the answer for conceiving lies in the conventional medical therapy, such as drug treatment or surgery to repair of reproductive organs. Since 1978, ART has provided another solution for these many would-be parents and this ART or assisted reproductive technology, just so everybody understands what this is, it's basically all treatments that involve manipulation of a woman's egg as well as sperm in vitro or in glass that helps a woman become pregnant. And that basically, when we put these numbers into real perspective, it's approximately one in every hundred babies born in the United States currently are conceived using this technology. And there's been such a growth in this field that there needed to be oversight. Many have heard of the woman who conceived with eight children through assisted reproductive means. Well, now we are in a quandary. We are here to help a woman get pregnant, but yet we need to make sure that we're not putting her health in jeopardy with having too many children or even having these children born early and therefore putting a stress on the healthcare system.

So in December of 2009, there was a convention, a meeting of professionals, patient advocates, congressional and federal agencies to come up with how do we oversee these facilities that provide this type of technology? And basically, it's broken down into several different areas. We do have state regulations, which basically requires a physician to be licensed by their specific medical board and monitors physicians' performance, as well as provide discipline or revoking of a license who failed to uphold basically the law. And then we go into the federal regulations.

And our society or our specialty is overseen by three federal agencies. It's the CDC, the Centers for Disease Control; the FDA, which is the food and drug administration; as well as the centers for Medicare and Medicaid services. And each one of these monitors an ART clinic in several different ways. The CDC mandates us to report our data. This is basically pregnancy rates, live birth rates, and that was established in 1992. And what this does, it provides transparency for patients to know what's happening in a clinic and how does that clinic compare nationwide?

And then you have the FDA who controls the drugs, the biological products in which we use. And they also oversee the screening and testing of reproductive tissues such as donor eggs and donor sperm. So we are actually inspected by the FDA and we're inspected usually every two years. They just drop into our office and they basically go through our charts. And if we are not abiding by their guidelines, they can actually close a clinic down.

And then we have the center for Medicare and Medicaid services, which is responsible for basically the laboratory testing in which we do within our office. And then we also have self-testing or self-regulation and that's coming from our governing board, the American Board of Obstetricians and Gynecologists, which basically make sure that we are up-to-date with our training and making sure we are continually learning throughout the time we are practicing medicine.

But we talk about the regulatory part, it's not just from the physician's point of view, but it's also from the lab. Every ART lab has to be certified by the College of American Pathologists and they come in basically, make sure that our lab is adhering to the guidelines that have to be put in place both ethically as well as their practice cons. We have to conform these high national standards for our lab to be accredited and to be accredited to do embryology.

So we are basically overseen by several different organizations. And when we hear about women who are giving birth in their 60s or we're hearing about women who are giving birth to octuplets, well, that's when we need to really see whether or not those clinics are adhering to the guidelines. And in many cases, those clinics are inspected at that point in time. So this is publicity you really don't want your clinic to have, because that is kind of a mark on your clinic that you may not be adhering to the guidelines in which you need to.

In many cases, we have patients that come to us and they are of the one and done mentality, meaning, "Put back as many embryos as you can, because I want to only go through this one time." And in reality, we have regulations on us that mandate how many embryos we can actually transfer. And some patients are kind of upset with that because they want two embryos transferred, "Well, in your age group and the quality of embryos, I really can't do that." And that's really for their benefit and for their pregnancy's benefit.

Currently, assisted reproductive technology is one of the highly regulated medical practices within the United States. So when I hear patients say, you know, that they're putting back too many embryos or that there's really nobody overseeing IVF and well, in reality, we are very, very highly regulated and patients need to be aware of that. And also when they're checking out clinics, they need to make sure that the clinic has a certified lab. Make sure that they are reporting their data so that they are transparent and they're going to a practice that is adhering to the high ethical standards and the technology which they deserve.

Melanie Cole (Host): That was such a comprehensive... That was a Ted Talk. Dr. Ziegler. You answered all the questions that I had. What a fascinating topic we're discussing. So as the FDA oversees, as you said, medications, biological products, devices, CDC is collecting and publishing that data and Medicare and Medicaid are doing your lab testing services, that sort of thing. Are success rates reported? You mentioned that sometimes, you know, newsworthy ones are, but are success rates reported? And do they generate any sort of investigative analysis when they are?

Dr William Ziegler: Yes. We report our pregnancy rates prospectively to the Society of Assisted Reproductive Technology. And they have a website it's called sart.org. And this is where the data is published. The problem is with the data is that it's outdated. You have to realize that if a patient gets pregnant in 2021, they're not going to deliver until 2022. And then the data is released in 2023. So it's always two or three years behind. The other issue is that there are some clinics that will manipulate their numbers to make them look better on the website. And those clinics are being called out and they're trying to make changes in the website to help it be more accurate for clinics like ourselves. We report all of our cycles. There are some clinics that don't. They only report those that are good responders or those that have high pregnancy rates. So therefore, their data is a bit skewed. So when a patient looks at any data on the internet, even from the SART registry, they have to take it with a grain of salt that if there are practices where their success rates are so far out in left field, you really need to question whether or not they're doing accurate reporting.

Melanie Cole (Host): So interesting. As we wrap up, what do you want the take home message to be about the regulatory oversight of fertility practices, such as the Reproductive Science Center of New Jersey, that will reassure couples. Because I think to me, listening to everything you just said, it is very reassuring to know that these things are at least looked at and your reporting and all of these things. So what would you like the take home message to be, Dr. Ziegler, for couples that are looking at the Reproductive Science Center of New Jersey or any fertility clinic to help them with assisted reproductive technology?

Dr William Ziegler: I think they need to make sure those that the clinic in which they're going to is adhering to federal guidelines. And the best way to find that out is to see whether or not they've been inspected then by the FDA, as well as their lab. And then if their lab is CAP certified or from the College of American Pathologists. And that kind of gives you some reassurance that the clinic you're going to is adhering to the standards in which have been discussed at length and have been published. And that is what we are supposed to be adhering to.

But the bottom line is that the patient really needs to feel comfortable with their provider and making sure again, that that board certification that is important, it shows in which you have met the standards for that college and you have achieved their backing basically to say in which you are adhering to standard of care and you're providing good quality medical care. So I think there are some things out there that a patient can look into and get a feeling that, "Okay, the place I'm going to is going to give me the best care possible," and that's what a patient deserves and what they should be given.

Melanie Cole (Host): Very well said, Dr. Ziegler, and thank you so much for joining us and explaining what could be considered a pretty complex topic, but you explained it so well. And thank you again for everything that you're doing for couples out there and for doing these podcasts with us, because they're so informative and we just love to do them. So thanks.

And that concludes this episode of Fertility Talk with RSCNJ, the Reproductive Science Center of New Jersey. For more information, please visit fertilitynj.com to get connected with one of our providers. I'm Melanie Cole. Thanks so much for listening.