Ep 30: “The Chain of Custody” – Keeping Eggs, Sperm and Embryos Safe in the Lab

So, you’ve undergone an egg retrieval and your partner has provided a semen sample. How does the IVF lab keep your eggs, sperm and embryos safe? Join Dr. Carrie Bedient from The Fertility Center of Las Vegas, Dr. Abby Eblen from Nashville Fertility Center and Dr. Susan Hudson from Texas Fertility Center as they chat with Tex VerMilyea, the Vice President of Scientific Advancement at Ovation® Fertility. He’ll explain how Ovation labs use “the chain of custody” to keep precious reproductive materials safe in IVF labs around the country. Have questions about infertility? Visit FertilityDocsUncensored.com to ask our docs. Selected questions will be answered anonymously in future episodes.

Transcript

Speaker 1 0:01

You're listening to the fertility docs, uncensored podcast, featuring insight on all things, fertility from some of the top rated doctors around America, whether you're struggling to conceive or just planning for your future family, we're here to guide you every step of the way.

Speaker 2 0:19

Hello everyone. This is Dr. Carrie BDN from the fertility center of Las Vegas here for another episode of fertility docs. Uncensored. I am here with my delightful colleagues, Dr. Susan Hudson , uh , Texas fertility center and Dr. Abby Ablin of Nashville fertility center, guys. Good to see ya . And also with our guests today, whose name I am taking a very conscious effort to not 100% completely butcher , um, tax Vermilion from ovation. Um, and I don't even know what the full, oh my God, this is embarrassing. I am going to get completely axed by all the ovation folks. What is the full name of ovation guys? Is it ovation laboratories or is it more extensive than that? Isn't it elevation fertility?

Speaker 3 1:15

Yeah, pretty much ovation. Fertility preservation . Fertility, let's go with

Speaker 2 1:22

In the clinic. It's always just ovation because it's the lab and that encompasses everything with the lab. And so, you know, it's just, okay, well, she knows everything about everything that goes on with all the laboratories stuff that we do. And it's, it's the all encompassing, it's the all encompassing, they just know everything. So , um, so we're delighted to have texts with us today. Um, you have many titles and we will go into that in a little bit, but as we were chatting before we hit the record button , um, you have some fabulous hobbies and one of the most impressive, especially given the fact that as an embryologist, your hands and fingers and fine motor movement is extraordinarily important. You're a welder.

Speaker 3 2:10

Um, yeah, I think called a welder's a little bit, a little bit over the top. I like to, well, I can't say that all my welds sticks together all the time, but , um, yeah. I occasionally like to , uh, yeah, man , the metal and put two pieces together and stuff ,

Speaker 2 2:29

Uh , like welding art or welding functional or combination .

Speaker 3 2:35

Yeah. A little bit of both. I've been known to do some horseshoe art , um , made my mom a Turkey for Thanksgiving and friends , um , you know, kind of a pumpkin. Um, but yeah, I think it's just, you're , you're absolutely right. Doing such meticulous stuff with the fingers. It's nice to, you know, bang a hammer and get dirty and um, yeah, two hot pieces of metal together up

Speaker 4 2:59

The art of welding or the skills welding. W w what kind of training would you have to have?

Speaker 5 3:04

So Abby is our resident artist here. So all , all of the pictures you can see in the background , um , she has done all of those. So this is, this is coming from our semi-professional

Speaker 4 3:15

Hair . Maybe it will be these hobby for me.

Speaker 3 3:17

That's right. Um, yeah. Um, education, YouTube and Pinterest. That's my, those are my go tos. Yeah. Self-taught never took a class. Just kind of read a book and , uh, went to town.

Speaker 2 3:33

And do you need to get, I mean, do you just orange ?

Speaker 3 3:37

Yeah. No. So you've got, I mean, there's different, definitely different kinds, but I tend to do arc welding , um , which is just using a box with high amperage electric , um, electrodes and yeah, you just sort of put two pieces of metal together and use a hot arc to meld them together. Um, there's all bunch of different types that you can use with regards to, you know, proper torch and so on and so forth, but we've ever made . Oh , um, that's a good question. I mean, I've done some welding on the car before and the empty car . Um, yeah, I restored a, a old plastic car.

Speaker 5 4:18

So

Speaker 2 4:18

You welded something and then you got in and you drove it.

Speaker 3 4:22

Um, I did, yes. I still, I still do. I haven't fallen apart yet. Doors are still on, so that's a good sign. I think

Speaker 2 4:27

You can call yourself a welder, sir.

Speaker 3 4:29

Well, thank you. I will take that title.

Speaker 4 4:32

You're worried about with this hobby that you have that may not , not be a great hobby for an embryologist since your hands are so important in your daily work and eyeballs

Speaker 2 4:40

For that matter.

Speaker 3 4:41

Yeah. You know, you've got to make sure you wear the proper, you know, thick leather gloves and welding helmet. In fact, a funny story. I , I was in an airport and doing some flying , uh , last week and saw someone in the airport with a welding helmet on as part of their anti COVID. So that's one way to do it, but yeah, but yeah, proper equipment and you should be, you should be okay. And again, it's kind of, you know, you can't really hurt anything other than, you know, your hands, but the weld is not good. You just cut it off. Well , true little burns here and there, but , uh, yeah, if you don't like what you do, you just kind of cut it off and try again with the welding. That is, yeah .

Speaker 5 5:24

I remember from medical school when they taught us about like, like welders and like being worried about an MRI, because they tend to get like little micro fragments, like back in your brain somewhere.

Speaker 4 5:40

Yeah. Hey Susan, I wouldn't have thought about that, but I just happened to have an MRI last week, my first one ever. And they ask questions like that. Like, do you have shrapnel? Do you have like, no. So good thing to know, Tex , if you ever have an MRI, you might see ,

Speaker 3 5:55

I may need to rethink this hobby .

Speaker 5 6:01

Good stuff. Good stuff. So, Abby, do you have our question of the week?

Speaker 4 6:06

Do you have a question of the week and I'll try and sort of summarize this, that we have a listener who says my husband and I just got married. I'm 27 and he's 28. He just started law school this week. And the ideal plan would be to wait until he's out of law school to start a family. However, I'm worried about waiting three years to get pregnant. Um, what are your thoughts on that? Do you have a crystal ball

Speaker 2 6:30

Short answer to that one is that my crystal ball has been in the shop for over 12 years now. And they seem to show no signs of returning it. So I don't have a crystal ball. What about the two of you?

Speaker 5 6:41

Well, I don't think we have a crystal ball, but that doesn't mean that there's nothing that we could offer some , uh , a couple like this, you know, I think that any couple who is contemplating fertility and has concerns that it's very reasonable to go see a reproductive endocrinologist and have a basic workup, and just kind of see how things look, have that talk with your doctor, because they're going to be able to kind of match up your, your health, your age, your evaluation, kind of give you a little bit of an idea of what we expect for your fertility over the next few years. And also know that there, there are options available like for fertility preservation. So if you want to freeze eggs or freeze embryos for UTS in 2, 3, 4 or five years down the road , um, you know, those are, those are some options that could potentially , um, take advantage of your forethought and increase your chances of having the family , um, of the size of the family that you truly want to in the timeframe you, you desire to have them

Speaker 4 7:49

Also some basic tests that you can do. And, you know, certainly it doesn't indicate that if you have these tests, now that you're going to still be fine in three or four years. But, you know, if you know, now that your husband has a really low sperm count, or you have a really unusually low egg number for somebody that's 27, or if you're fully contingent or blocked, you already know that you've got some challenges. So it may be worthwhile to think about doing just some basic testing first, so that you'll at least know that right now, hopefully everything's good and that you don't have some issues that could be a problem in the future.

Speaker 2 8:20

And I also, and this is coming from the perspective of someone who is a list-maker I live and die by checklists. And I will. I'm the person who goes to the grocery store with a list, thinks of something else I need, because I see it on the shelf. I pick it up, put it in my basket. I go back to my list, I write it on, I put a box next to it. And then I check it. That is, that is the mentality I have of, I want the record and to show that I did it and make sure that it's all documented. I am a planner to the Hills. And so , um, for me, and many of our fertility patients fall into kind of a similar basket, especially someone who is thinking ahead and asking this kind of question. Um, you want to know what your options are, and if it's something where having your own biologically related children is important to you, then plan to be more aggressive about it. Because one of the things that all of us have seen in our practices is that life happens and life happens in very unexpected and at times unkind and unfriendly ways. And so sometimes it's a cancer diagnosis. Sometimes it's a freak accident of an ovarian torsion and , or a car accident or whatever job change, you know? Yeah. And, and something happens that changes, you know, a sick , a significant other change or whatever it may be. And so I tend to go with the philosophy of if you know, that you are a professional and, you know, or for whatever reason that your childbearing is going to be delayed, but that it is very important for you be proactive about it now, because your fertility starts to decline in your early thirties. It doesn't get more pronounced until mid thirties, but I've definitely had patients come in their early thirties where they've seen that decline and we can get you pregnant one way or the other, but sometimes that one way or the other involves egg donation, sperm donation, or gestational carrier. And sometimes we can avoid that if we see someone earlier rather than later. And so it's never going to hurt to have the conversation and at least know the options, even if you don't do a single test or a single thing. So, okay. So our topic of today is chain of custody. And whenever I think of that term, I always think of all the big crime shows because of course, you know, CSI Las Vegas is it goes through all of that stuff. And especially as a kid and a young adult, because I'm a dork now I watch TV anymore because I don't have time , but I used to love all those crime shows. And so you'd see the chain of custody and all the lawyers' shows where they talk about, well, something happened, dah, dah, dah, with the evidence and blah, blah, blah. And so we can't use it in court and blah, blah, blah. Well, that also applies in the lab. And , and it's something that's super important with everything that we do. And so one of the things that we wanted to talk about with texts today is once you have the eggs, once you have the sperm in the laboratory, how does everything get tracked? How do we know what happens? Where how do we keep it safe, all of those types of things. And he can kind of give everybody a little bit of your background so that they understand why you so much about this and what we asked you here today, because you are the, with a capital , the expert, especially in all of our worlds, because all three of our labs, despite the fact that they are in Nashville and Texas and Vegas, you are the big kahuna. You are the technical grand Poobah And you wailed . Yes.

Speaker 3 12:21

That's great. Well, thank you. It's , it's a great opportunity to be here and get invited on , uh, you know , to , to share some of my experiences. Um, yeah, so I've got a pretty colorful background to be honest. Um, I , uh, graduated from Cornell university , uh , south Texas, born and raised. And first time I ever saw snow up in Ithaca, New York , um, and I was , uh , dead set to be a veterinarian. Um, thought that school was going to be my path of career choice. And ,

Speaker 2 12:52

And you went to Ethica to become a veterinarian.

Speaker 3 12:57

I kind of bypass Texas a and M I understand. Yes . I had an opportunity to actually pole vault , um , at Cornell. So I decided to go pole vault , uh , at Cornell

Speaker 2 13:11

Interesting activities. That's going to be one of the topics of the next time we talk with ,

Speaker 3 13:18

Uh, yeah. Um , I did say it was colorful, so I , uh , yeah, I got up ethic in New York , um, animal science, major preset to , to go to vet or to go down that pathway and then organic chemistry kicked my butt and , uh , decided to , uh , kind of shift gears. So I started working in the animal science reproductive physiology department and did some cow cloning, a lot of dairy cows up in the Northeast. And so got into embryo manipulation. Um, you're working with reproductive systems with the cow and , uh , actually after university got my first job as a human embryologist at a large , uh , very successful IVF clinic up in the Northeast. And , uh, did that for two years and had a fantastic mentor who said, Hey, you know, if you want to run one of these labs, some point once you go off and get your PhD. So I thought, okay, that was great. Um, so decided to go to university of Birmingham in the UK and moved to the United Kingdom , um , whereby I studied and got a PhD in genetics. And , uh, yeah, I kind of went off and did some mouse cloning work in Japan after that for awhile . Um, and then returned back to the U S wanting to do more clinical work , um , at the university of Pennsylvania for awhile , and then got recruited to New Zealand and moved to Oakland for two and a half years, and then came back and got recruited to start and build the, what we now know as ovation fertility. So yeah, kind of been around the block, so to speak with regards to, yeah, exactly. But it's great to be back in Texas currently and the yeah. Kind of overseeing the operations and the scientific events of what we do in our network of laboratories. So yeah, I hope that answers your question

Speaker 5 15:14

A little bit about why is, what is, what exactly is chain of custody? I mean, we see it on CSI Miami, but I mean,

Speaker 3 15:23

That's right. That's right. And it is obviously extremely important. So I can imagine , um , it's very scary to drop off your eggs in one room and then drop off your sperm in another room and then go home with a baby. Um , so what happens in between that? So that's where we take chain of custody very seriously. And, and so doing , um, there's there's protocols in place whereby uh , every specimen is labeled , um, most likely, you know , with three identifiers, whether it be the patient's name, date of birth , um, in addition to a , a assigned, randomly assigned number that's specific to that patient or that couple. Um, and then we actually go step further by using a colored tape, different colored tape as an immediate first visual indicator that , um, you know, a matches a and B matches B . But every time we do a bit of a handoff of that specimen , um, we , we don't just leave everything on the, on the countertop and walk away and come back. Um , there's usually what we call a manual witness , uh , which was usually a physical person watching us do a certain procedure and identifying that everything matches up at that certain point. So, you know, as I mentioned, you drop off your eggs, drop off your sperm. At some point, we need to then process that , um , that sperm sample. And so that goes through multiple tubes. And so each one of those tubes has the same patient name has the same identified, a number has the same color. Um, and during each one of those steps whereby we go through each and every one of those tubes, you know, we have a witnessing step where by somebody else , um, usually a , a physical warm body , um , is identifying and saying yes, texts . Um, you know, I can confirm that , uh , patient John Deere is , uh, you know, continuing on through, you know , that particular process, but what's, what's really great is, you know, that that's all good and dandy. You know, we need to have that, that , uh, that , that confidence in our, in our colleagues to be able to have our backs witnessed . Um, but technology has, has suddenly changed that in a way whereby we're doing electronic witnessing now , um, and actually implementing that into our , uh , laboratories as we speak , uh , into this month. In fact, how long

Speaker 5 17:30

Has that been

Speaker 3 17:30

Available? So he witnessing has been , um , available for maybe 10 or so years. However, it continues to get perfected . Um, you know, originally it was , uh , a laser scanning of the dish and using , um , uh , either , uh , you know, etching of the dish to be able to identify and record, you know , patient to patient. But now with technology we're using , um, you know, QR codes that small little box with all those little dots in it. Um, in addition to , uh , typical barcodes , like, you know, at the grocery store , um, and even now using RFID chips, you know, radio-frequency identification chips that are on each piece of plastic or each part of the actual process,

Speaker 2 18:15

How do you keep those the same if you have, you know , like them , or how does, how does that work? Like how do you make it? How do you make sure it's the same for, you know, Mrs. Mrs. John DOE and Mr. Jondou that are married, how do you make sure that they have all the same stuff that sticks together and that it's not for Mr. And Mrs. Smith who are coming in two hours later?

Speaker 3 18:40

Yeah. Great question. So before the patient even comes into the laboratory , um, usually they are provided a ID card and on that card actually has one of these barcodes . So similar to, you know, if you've gone to the doctor and they do a timeout and they read your handbag or your arm and your wristband saying that , you know , you are John DOE and this is who's ready to have a procedure on the left knee. Okay. So we kind of do the same thing we confirm with the patient, what they're there for , um, the we'll usually scan or we'll scan their ID card. And then based on obviously the previous knowledge of knowing what sort of cycle type they're coming to the lab to do , um, you're right. What you said, Susan, we print off a sheet of all these labels specific to that cycle type for that couple, and literally peel those barcodes off of those sheets and stick them on to each piece of plastic where that's going to be required for that particular cycle

Speaker 4 19:40

To text. You mentioned that , um, you know, the first step is processing the eggs and the sperm. Can you just kind of walk us through kind of more of a simplistic path through the embryology lab of the embryos or first of the eggs and the sperm, and then when they are , they're made into embryos kind of how, what those steps are .

Speaker 3 19:57

Yeah. So, you know , eggs are , are taken from , uh , at egg retrieval. Um, and then a sperm sample is produced by the man and we , um, kind of clean up the sperm and clean up the eggs. And then once we fertilize the eggs with the sperm , um, we check for fertilization to make sure that sperm actually entered the egg and the DNA material has been changed. Um, and then we keep them nice and safe , um, in our laboratory and grow them out to embryos. So , uh , usually anywhere from five to seven days in the laboratory , um, and then depending on what kind of cycle type, you know, those embryos are either transferred fresh back into the woman or they're frozen for use later. So obviously there's many, many steps within that process. And that's where that chain of custody, you know , comes into play, making sure that , uh, you know, each step that we do, it's consistent with the patients that were doing that process for.

Speaker 2 20:53

So when you're working with embryos in particular, I mean, an IUI or an insemination cycle is , is more efficient in the sense that it's one and done within a day. It , but for an embryology or for , uh , an IVF cycle that stretches over a minimum of several days. I mean, it takes five days for a blastocyst to grow. And so how do you keep things straight when you've got 10, 20, however many patients couples are going through over the course of that time, because you have one laboratory and however many incubators, how do you make sure that each day when you're going to check on, you know, Mrs. Smith versus Mrs. Doe's embryos, how do you make sure that you are looking at and working with the correct set of embryos and that all the way through those five days, it stays with the correct labeling and the correct set of, of everything and nothing gets crossed or mixed or

Speaker 3 22:03

Great question. Yeah. Great question. Um, so for starters, we only look at one patient material at a time. Okay. So we may have multiple patients in the laboratory and we have multiple embryologists. Um, and these are the scientists that are looking at the embryos and , um , you know , kind of working with the, the specimens, but , um, you know, never at one point, and this is, you know, strictly enforced, never at one point, would you have two patients, two separate patients materials out in the work environment at the same time? Um, so in addition to that, we have kind of like a real-time , uh , workflow , uh , whereby we , we know which patients , um, which patient embryos need to be looked at at certain times of the day. And so we sort of stagger that out whereby um, if someone had an egg retrieval and an insemination , um , yesterday, tomorrow morning, we're going to focus on verifying fertilization for those particular patients. And then we kind of work out , uh , depending on the rest of the day, you know, what patient's embryos need to be looked at and really keeping it , um, quite structured. Um , so it's , uh, goes by kind of a schedule so to speak, but the beauty of something like the witnessing system or electronic witnessing system is that every time we take , um, a dish culture ditch , um, in which the embryos grow in , uh, every time we take it and take it into our working , um, called the hood, our , our working cabinets , um, we scan it and we verify that , uh , Mrs . Smith is, this is Mrs. Smith fish and their farm looking at Mrs. Smith's embryos and recording that accordingly. Um, and then when I go back to that incubator, I then scan incubator , um , which houses these, and grows these embryos and making sure that Mr. Smith embryos or Mrs. Smith and embryos are going directly back into that specific incubator. So it's very time consuming pipe that electronic witnessing system kind of gives us another glances to protection to confirm that the events are occurring correctly.

Speaker 5 24:04

So I have a question , um, as a former IVF patient myself, I think , um, one thing that patients are often the most nervous about is not even what happens in the lab, but what about those embryos are cryopreserved to be used later on. So embryos that are getting shipped via FedEx or whatever, you know, courier system we're using to somewhere else in the country for long-term storage. And then, you know, when we're needing them getting shipped back and forth, can you describe how that works? I mean, like, this is really cool for like, within your own system, but how, how, how are things kind of watch when you're going from one company to another company and w what are some things that we had ovation do that might be a little bit different?

Speaker 3 24:54

Uh, another good question. So all of it is , of course is , is confirming the chain of custody up to that point where we freeze the embryos. Now , um, innovation we use are , uh , one specific courier , um, whereby we know that , um, our, our tanks hold this liquid nitrogen, that's very, very cold coolant. Um, they're these tanks verify their temperature controlled . They actually have a GPS tracking system on these things . And so we know that when we're, when we're putting these embryos that are frozen , um , into these tanks and shipping them from Texas to Las Vegas , uh, these tanks are monitored , uh , 24 7. And we know exactly anywhere in the world where these tanks are. Um, now that unfortunately can't be said for all labs, the chip , um, you know, you can't really do that with FedEx and , um, uh, you know, some of our couriers , but , uh , we've really taking , um , uh , big steps to confirm, to make sure that , um, our shipping processes is legitimately probably the best in the industry. Um, and we do, we want to make sure that when they leave our laboratories, that may arrive wherever they're going. Um, they're in the same status as when they left. Um, and, you know, just all kind of really depends and making sure that those cloud devices of course have the patient's label and the numbers, and if they have a tracking system with regards to , um , even possibly read that barcode at the receiving laboratory to confirm the materials.

Speaker 4 26:20

Another question I think patients have too, is even for the embryos that are stored in each individual lab, what kind of alarms are available to, you know, if something happens in the middle of the night and the power goes off, what kind of alarms are available , um , to our clinics to let everybody know that we need to get in there and take care of

Speaker 3 26:39

Yeah, a great question as well. So obviously we want to safeguard our frozen , um , assets right now are , are frozen materials. And so these tanks, which hold again, liquid nitrogen and our frozen embryos at roughly negative 196 degrees Celsius , um , these tanks are monitored 24 7 , uh , by physical , uh, the monitor probes that are drilled , um, from the top of the tanks and into inserted in the tanks. And they monitor not only the level of the liquid that keeps these embryos cold, but also the temperature. And so these are run simultaneously. I think the data points are within seconds , um, all throughout the day and all of that goes to a network of alarms . So if there's a slight breach of , um , temperature variation, so to speak, then , uh , we go through a phone tree and we'll call , um, members of our experts, the expert team to go back into the lab, 24 7, whatever time it is, it's their, you know , responsibility for their duties . I want to make sure that these are protected , um , you know, all the time. So we will go in, see if there's any issues. If there are, we'd have backup containers whereby we can move all the contents out and, you know , continue to safeguard them accordingly. Um, but obviously , uh , alarm system and verifying that our materials and materials to patients are kept , um , and proper conditions is , are very, very high priority.

Speaker 5 28:01

That's awesome. That's awesome. Are there any other , um, reassurances or words of advice, texts that you would give to our listeners when they're concerned about chain of custody about maybe reaching out to their respective labs and that

Speaker 3 28:16

Absolutely. Yeah, it's always a great question. Just, you know , ask your laboratory and say, you know, Hey, what can you , uh, what , what protocols do you have in place to , um, ensure that , uh , you know, chain of custody is currently being actively monitored, as well as being done. And, you know, again, if we have a witnessing system, electronic witnessing system where you're able to log all of that accordingly, and , um , we're now getting to the visibility that may one day be supplied with a patient's cycle once it's complete. So you can see the time points, you can see the signatures when things are done. Um , and they're even thinking about the potential of making it , um, real time whereby you get a text message when embryos have been looked on , on, on , And not only barcodes, we are getting to that , uh, you know, photo photographic part where we'll be taking pictures. It's not necessarily the embryos itself, but actual the device system, which numbers are being frozen on the dishes of the embarrassment and culture . So , um, a lot of great capabilities, but yeah, definitely what sort of , what sort of safeguards being used.

Speaker 2 29:24

Awesome. Well, thank you so much for going through all of that with us texts. We appreciate it and are looking forward to talking to you about the next lab based episode that we're going to do with you coming up here soon, but to our audience, thank you so much for listening and be sure to tune in next week for more also be sure to subscribe and leave us a review in iTunes. We would love to hear from you.

Speaker 5 29:50

You can also visit fertility, the accents , sensor.com to schedule an appointment with any of us or submit questions that you may have about your fertility journey. All questions will be answered on the podcast anonymously for our ask the doc segment and don't hold back. We really want to help answer all your questions. All right, guys, we'll talk to you soon. Bye

Speaker 6 30:16

[inaudible] .