INSIDE REPRODUCTIVE HEALTH PODCAST

Ep. #51, All About the Sperm: Testing Standards, Accessibility, and Anonymity - An Interview with Dennis Marchesi

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Donor gametes are a crucial pillar of the field of fertility, but what happens behind the scenes? On this episode of Inside Reproductive Health, Griffin talks to Dennis Marchesi, Director of Laboratory Operations at Xytex, a sperm bank located in Georgia. Together, they talk about the nuances of different labs working together, how Xytex is dealing with cultural changes that are affecting anonymity of donors, and the impact mail-away testing kits are having on the lab.

Learn more about Dennis Marchesi and Xytex by visiting Xytex.com.

To get started on a marketing plan for your company, complete the Goal and Competitive Diagnostic at FertilityBridge.com.

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Welcome to Inside Reproductive Health, the shoptalk of the fertility field. Here, you'll hear authentic and unscripted conversations about practice management, patient relations, and business development from the most forward-thinking experts in our field.

Wall Street and Silicon Valley both want your patients, but there is a plan if you're willing to take action. Visit fertilitybridge.com to learn about the first piece of building a Fertility Marketing System--The Goal and Competitive Diagnostic. Now, here's the founder of Fertility Bridge and the host of Inside Reproductive Health, Griffin Jones.

GRIFFIN JONES 1:03
Today on Inside Reproductive Health, I'm joined by Dennis Marchesi. Dennis is the sperm guy with a Masters in Genetics and certifications as Clinical Lab Tech and andrology and embryology scientist. He has years of experience in the lab. His role now is as Director of Laboratory Operations at Xytex, which allows him to use his broad knowledge base to help others on their fertility journeys. And he is currently pursuing a PhD in Reproductive Clinical Science. Mr. Marchesi, Dennis, welcome to Inside Reproductive Health.

DENNIS MARCHESI 1:33
Thank you very much, Mr. Jones. It’s nice to be here.

JONES 1:35
Well, I'm interested in talking a little bit with you because one of the things that I often admit to neglecting talking about in the show, focusing on in our marketing, is the lab. And it's such a critical piece of everything that we do! It just happens to be on the real back end of the business side very often. So, we've done 40 some episodes of this show, we've done, maybe, you might be the third or fourth that we've done on the lab, and also really haven't focused on andrology at all. So I would like to just maybe start because I see so many different options for focusing on malefactor from the patient acquisition side and kind of want to explore where your knowledge of the science meets those potential business opportunities. And maybe just starting by your take of how semen analysis testing has improved over time and where do you see it going in the next few years?

MARCHESI 2:47
Sure, absolutely. You know, semen analysis is very--it's a subjective test in a lot of ways only because the parameters that we look at, you know, we could read things in, like, WHO manuals and the regulations that are put out there for us, but it's only until you put those into practice that you realize how much variability there can be between people in the lab. So, we have our gold standard semen analysis, and then 40-50 years and some of the morphology criteria were put out. There really hasn't been much to replace a good morphology count as a gold standard. You know, you're talking about count, motility progression, they've now created computers that can also do these readings for us. We're always looking to stay ahead of the curve and just making sure that what I'm seeing in my lab is also what someone in your lab is also going to see. You want to reduce the variability between technicians and we take a lot of pride and practice into making sure that we're all sticking to the standards as best we can, but morphology is definitely the linchpin here because we don't have something better to replace it yet. Morphology is so subjective, that it's hard to get so many people on the same page. So when you're doing the readings we want to make sure that the interpretation is always accurate and is consistent across laboratories. Particularly with a lab such as mine, you know, working at a sperm donor bank, what we're creating in our lab needs to translate to what someone else might use after we've distributed our donor sperm. So, you know, semen analysis, it's definitely a really important part of what we're doing and it, unfortunately, hasn't had too many changes over the years. They've put a few tests in to try to create adjuncts to the gold standard, but kind of as research has looked at these and tested them over the years, nothing's really stuck. So you know, we're left with basically what we've had over many years and try to see what we could make sure that we're all consistent across the board.

JONES 5:02
How about the delivery of the testers, the location of testing now, as opposed to having to go into the lab, there's the prospect of at-home testing. How do those vary?

MARCHESI 5:16
Sure, absolutely. A lot of the at-home testing will use, probably, your smartphone and somehow have an algorithm that can translate between what the smartphone sees into what someone in the lab would see. But those tests are, they're limited. Usually they'll focus on--they could basically tell you whether sperm is present or not and then whether it's moving or not. It hasn't been adapted well enough yet to establish, like, usable thresholds. But at the same time, you know, there have been other mail-away kits that I think that you were referring to before that we can sort of have someone collect at home and then send it into a lab and then the lab itself would perform the analysis. A lot of those are offered for patients that don't have you know, access to a lab or may need to cryopreserve something that may have to do with some sort of cancer treatment or something that would make the cryopreservation time sensitive.

JONES 6:17
Talk a little bit about the effectiveness of mail-away kits. Are they as effective as being right in the lab? I imagine that the risk goes up simply from transportation, but provided that something doesn't happen, is even the amount of time--does that often make the test less effective? How do the mail-away kits compare to testing in the clinic so that you're right next to the lab?

MARCHESI 6:49
The test kits are definitely trying to get as close to being in the lab as possible, but you have to figure the recommendations we go by now tells you you should be analyzing that specimen within 2 hours of production at most. If you're mailing that away, that's just simply not possible. So, you know, how do you overcome something like that? So a lot of the mail-away kits will use some sort of media supplement to, sort of, extend the life of the sperm, but a lot of times if someone is needing to cryopreserve and uses these mail-away kits, it's because, for one reason or another, they're concerned that they won't have any sperm to use further down the line. So in that respect, whatever you can cryopreserve is going to be better than nothing. The kits try to be as reliable as if you were in the lab, but I don't think we're at the point right now where I would recommend mailing something away as opposed to just getting up and going to the lab itself.

JONES 7:49
So part of my interest in the effectiveness of mail-away kits is because anything that gets the male partner involved earlier in the process can be really useful. So in our company, we help fertility centers and companies in the fertility field attract patients. And so we map out from the very beginning, how does someone go from being a total stranger to the field of REI to pursuing effective treatment and seeing an REI. And in those swimlanes, the longest ones are at the OB/GYN office. And a big issue there is that very often the male partner isn't even being tested. And so we might be adding 6 months to a couple years to this whole journey, because we haven't brought in the male partner sooner and so it's a way to help speed that process up if we can do it effectively. So maybe, can you speak about the lack of analysis or study or insight into male factor infertility in earlier stages of diagnosis?

MARCHESI 9:01
Sure, absolutely. You know, unfortunately, what a lot of people don't understand is that the sperm that you might see in an ejaculate today was actually matured over the last 75-80 days. So small lifestyle changes are not going to be effective in the short term, because anything that we're seeing has already been exposed to all of those factors for all of those previous weeks. So what it comes down to when identifying a male factor in contributing to the treatment, you really just want to see whether or not they would qualify or we would have enough sperm in order to perform ICSI or an IVF cycle. Once that's confirmed, if we don't have sperm, the immediate treatment that we would look for is to get the sperm physically with something like a testicular retrieval, but otherwise, there's not a whole lot of options or it really takes a humongous lifestyle change in order to, over a long period of time, to see changes in, you know, the ejaculate that we're working with. For those reasons, I think that it's not analyzed as early as all of the other female factors because it's much more difficult to make changes on those things. It's a lot more convenient for the patient to just have, sort of, mechanical interventions such as you know, like what we said before, if there's not enough sperm for an IUI, we're going to just move right to IVF and for that reason, we need much fewer sperm. So there's not as much that you can do to change the quality of an ejaculate, at least not in the short term.

JONES 10:44
And if those mechanical interventions are proved to be unsuccessful, donor sperm is an option. How have the industry standards for donor sperm changed in the time that you've been in the field?

MARCHESI 11:01
We're definitely looking to sort of keep up with the cutting edge technology. Out of everyone that sort of applies to be a donor with us, somewhere between 1-1.5% actually will hit our books as a qualified donor. So there's a lot of screening that goes on in order to weed out the best possible choices that we would feel confident then offering to patients. I would say in recent years, the part that's probably come the farthest is definitely the genetics. You look at these different expanded carrier screens that we're able to look for and, you know, a patient’s going to want someone who has the least amount of risk as possible. So just, I think, in the past decade, we had gone from a 35 test panel to 180 and right now, we're performing like the 280 test panel. So I think that's really come quite far in what the donor sperm industry's been able to offer to their patients.

JONES 12:04
Describe that a little bit more. What's in the 280 test panel that wasn't in previous versions?

MARCHESI 12:10
We want to make sure that whatever we're offering is as healthy as possible. So you want to try to uncover as many underlying conditions as possible. And I think that in expanding the number of recessive conditions that you can test for, you can then make sure that the recipient is then basically compatible with the donor. So if we're able to identify more recessive conditions, and then our patient can then go to get tested for whatever the donor came up positive for, we can then be assured that you're not going to get two recessive pairs that come together and then impact the health of that child. So you want them to be--have as greatest an opportunity for a healthy life as possible.

JONES 12:58
You mentioned that an average of 1-1.5% percent of initial applicants actually become qualified donors that go through the process. What are those other 98 and a half guys do that don't get them to the finish line?

MARCHESI 13:14
It's definitely a step-wise process and our donor coordinators and our lab personnel work very much in conjunction with one another to be smart about how we're proceeding with these donors. So first things first is you want to make sure that whoever walks through your door has not also walked through someone else's door across the country. So we're always checking to see that the guys who we accept as donors are first time donors. So there's certainly like a registry that we’ll check and make sure that they didn't donate elsewhere so we can be sure you're sort of not redistributing the same genetic material out there into the population. But otherwise--

JONES 13:54
Is that registry satisfactory? When we talk about egg donors often, there's a recurrent concern that--or for gestational carriers for that matter--that there either is no requirement for registry or that it's not satisfactory. And one surrogate could be the gestational carrier for many different pregnancies. How does that compare with the registry that's available to sperm donors?

MARCHESI 14:22
Actually, the registry itself is just a gamete, a donor registry for gametes in general. So it could be sperm or egg donors, it’s called the AGDP, that's Association for Gamete Donor Providers. So you know, many of the other places that I've worked with, we will all sort of register our donors in there so that you don't run the risk of having them donate elsewhere. Or if you might disqualify them for some reason and then they try to get around that, you know, by going to a different bank. will be aware that, hey, this is something that we should be watching out for and it sort of helps us police ourselves.

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JONES 17:02
I interrupted you, you were talking about the other qualifications for donors that are met during the screening process?

MARCHESI 17:09
Sure, we try to do some assessments based on the donor’s ability to adjust throughout life. So we'll offer several different screening tools delivered by clinical professionals. One of them is the HLAP, it's the Hilson Life Adjustment Profile. We’re starting to assess potential for paranoia, potential for depression, trying to get what other information we have right now to project what will our donor be like in the future and then, is that someone that we would want to be distributed? In addition to that, you know, then you might start trickling into some personality assessments, only because a lot of our donors will want to know, hey, what is this person like that I'm choosing? So we’ll use like the Keirsey Personality Questionnaire. We also have a psych-social assessment. This is sort of like long talk therapy, where a clinical professional will have a conversation with them, just to sort of, you know, talk about their history, their childhood, get a good base of the current mental health status of the individual. And so while some of these are simply questionnaires, the psych-social part is really an interaction similar to what we're doing now.

JONES 18:23
When you first started in the field, we could offer the promise of anonymity or the objective of anonymity. That's not so much the case anymore. How has that changed and how the cryobank and the sperm banks have to interface with potential donors and intended parents?

MARCHESI 18:47
Yeah, you definitely hit the nail on the head with that! Years ago, everyone was considered an anonymous donor and there was very little that you could do to kind of figure something like that out. With tests like the 23andme out there, now facial recognition software, all this sort of stuff, it is really--it's very difficult to offer anonymity. You know, speaking for ourselves, Xytex has gone to making all of our donors 100% ID-disclosed. For that reason, we don't feel like in 10 years, we could realistically maintain that anonymity. So we will choose to let all of our donors know upfront that this is sort of the culture that we live in now. We're going to do as much as we can to keep your identity a secret until such time that your offspring would reach 18 years of age, and then they would have the opportunity to have some contact there.

JONES 19:47
This might be a little past your view from working inside the lab, but it has me thinking--and we’ve had this conversation on the show a few times now--now that the field is all but collectively agreed that anonymity is no longer something that can even be suggested as an objective, then what will that do to donor selection? So now that we've said, okay, well, we’re ID-disclosed at this point, anonymity is no longer even possible. What will we start to see in the donor selection process that, Okay, well, now I want to see like, I want references! I want social proof about my daughter. I want to see what his ex-partners have had to say about him. I want to see what people say about him on social media. I want to know what kind of guy he is. Do you think about that? What no longer pursuing anonymity will do to the donor selection interface?

MARCHESI 20:56
Yeah, it definitely is something--we're very transparent with our donors about this from the very beginning. Part of that psych-social conversation introduces the idea that have you thought about how your life might change with this potential contact years from now? Assuming that the bulk of our donors are college-age kids, they may not be projecting that far out into their lifetime, but between our donor coordinators and some of the other clinical professionals that we have talk with them, we definitely introduce that idea, have conversations about it, and we make sure that they have a good understanding of what this will eventually entail. But as far as I don't think we'd ever get to the point where--I think you'd find it really hard to recruit a donor if you told them that, Yeah, your dirty laundry is going to be aired for the rest of the world to see at this point--like you said, you know, ex-partners and things like that. But we do try to provide the opportunity for them to participate, if they would like. We have a program called XY Connects at which point the donors have the option to sign up and potentially communicate with people under that cloak of anonymity because we're able to control what information gets out about the donor. And they can, you know, you'll find some people want to play a more active role in that sort of thing. So we try to have that opportunity available to them, should they choose to want to take it.

JONES 22:27
The screening for donors has become even more rigorous over the years. Do you notice the overall number of donors increasing, decreasing, remaining the same? What's that trend like?

MARCHESI 22:42
I think we're seeing more applications now only because, you know, you could be referred to us by a friend, you're able to just simply Google this and you'll come up with a few options. I think that a lot of the--while we might see an increase in the number of applicants, the number that are actually are thinking this through and taking it seriously are sort of remaining the same.

JONES 23:04
All the while, I assume that demand for donors is increasing. Is that a correct assumption?

MARCHESI 23:11
Yeah, absolutely.

JONES 23:13
Did you notice the spike after Defense of Marriage Act was defeated in 2015? And there were a lot of clinics in different areas saw more same-sex couples starting in 2015, because this option of family building became safer. Was there a noticeable increase in female-intended parents after 2015?

MARCHESI 23:41
Yeah, to be honest, I sort of wish I was on this end of the industry at that time, I had joined this program just about a year ago. So I was unable to see that change after that bill was passed, but it was definitely something that I think would have been nice to have personally experienced and witness that sort of fluctuation, but unfortunately, I don't think I have the background to answer your question appropriately.

JONES 24:04
Well, I'm going on an assumption that intended parents are increasing, that donors may or-- qualified donors may or may not be remaining the same, but I do think what we're seeing in an adjacent category for egg freezing and egg donor, one option is the freeze and share. And where someone can essentially have their fertility preservation cycle paid for by donating an allotment or more. And perhaps the cryopreservation, it might not be as appealing, but one of the other reasons why I was so curious about the effectiveness of mail-away kits is I just believe that by the nature of young men, that there is a market for curiosity of testing. And as I see that being an acquisition point. So whether it's the Xytex business development that wants to get a hold of me or somebody else that wants to take this to market, I'm really interested in this because I think that there is a market that is much broader than who we currently serve that would benefit from semen analysis testing. I believe that even young men that aren't considering building a family right now could benefit from that, but also just the nature of men being really curious and comparing. I know, because I've done it. And I've been in the clinic and texting my friends about my results and wished me luck!

MARCHESI 25:49
I wish I had a nickel for every time someone has, after they realize what you do, if they've ever said, “Oh, have you checked yourself out?” And yeah, now that curiosity definitely always going to be there. The real linchpin for making mail-away semen analysis a viable thing is going to be the reproducibility of are we able to mimic what is seen an hour after production in the lab and then look at it 24 hours later without any sort of decline? And right now, the options are very limited as far as what sort of supplementation that you can add to the sample itself in order to preserve it for that long. In theory, it sounds great, but I just don't think that it's 100% there yet. That's sort of why earlier when you had mentioned these mail-away kits right now, they're heavily geared toward freezing, because we know with certainty that if we can get the sample there within a certain amount of time, we know that we can have it alive and then therefore, it can be used with some of these more invasive procedures at a later point in time. But if I'm going to tell you you've only got 25% motility and I can't compare that to when if you would produce something at the lab and you had 75% motility, you don't want to be making diagnosis or clinical decisions based on something that you realize that it's not as accurate as it could be. For that reason, in order to get those mail-away kits to the point that you're referring to, I think that there's some work to be done to bring them up to that standard.

JONES 27:30
So that brings me to the question--it's a great point--it brings me to a question of how Xytex partners with other clinics. Are donors and those doing testing--are they coming to partner clinics, whether they be REI clinics or neurologists or andrology clinics. How are donors and those going through testing coming to Xytex?

MARCHESI 27:56
Our donors--we have a network of laboratories that the donors come and make their donations at. We then cryopreserve the samples there, and we ship them back to our main biorepository where they'll remain for the duration of their quarantine period. Once they are released from quarantine, they have to pass all the FDA regulations with regards to disease testing and things like that. But once we have them available for sale, we will only sell them to someone who is under the supervision or treatment of a doctor. We won’t just sell to someone just because. Even those individuals who would prefer to have, like, a home ship where they don't want to necessarily try to be inseminated in a clinic, we still always confirm that they are under a doctor's supervision while handling our products in any way.

JONES 28:49
Can any fertility practice become a Xytex lab or does someone have to have an andrology lab?

MARCHESI 28:57
No. Our products are cryopreserved in such a way that any REI lab can use them, but we won't--the donors that we have recruited, we've vetted them, and they've gone through all of these procedures, the qualifications that we were talking about earlier. You wouldn't just have 1 or 2 donors at a random location who would have--that we would have necessarily invested all this time and effort in to qualify them as a donor and then not have them be part of the program. Because that rapport is very important that we have with the donors. They feel comfortable with us, it's another person to say hello to and you understand what they're going through in their life. Without that sort of rapport, it becomes very difficult to then maintain that contact throughout one their donation period, but also, you want to make sure that you keep in contact with them for the long haul, so that when their potential children are of ID-disclosure age, you want to make sure that we can then come in contact with them. We want to form that relationship and that foundation now, so that we can maintain that for when they get older.

JONES 30:07
Dennis, you've given us a lot more insight into the lab, but especially the andrology lab. How would you want to conclude with our audience of fertility specialists and practice managers, whether it be about gamete donation or androology or what you see for the field in the coming years?

MARCHESI 30:28
Yeah, one thing I just would really encourage anyone who's listening to this is, you know, when you have a successful pregnancy, I would encourage greatly, make sure that whatever bank that it's with, wherever you have gotten your gametes from, report back your live birth and your successful pregnancy. You know, there's always so much discussion with having to do with this industry, sort of, self-policing itself, but the only way that we can do that successfully is if we have patients tell us when they've had success with our products. And in that way, I think that we could really improve, like, the whole business of this going forward. So, I know we hadn't sort of touched on it earlier, but that would definitely be something that I would encourage your listeners to do is just make sure that we know when you've had success with these things, because that goes a long way to helping us you know, move forward with this business.

JONES 31:20
Dennis, Mr. Marchesi, thank you very much for coming on Inside Reproductive Health and all the best in defending your PhD.

MARCHESI 31:27
Thank you very much, sir, you take care.

You’ve been listening to the Inside Reproductive Health Podcast with Griffin Jones. If you're ready to take action to make sure that your practice drives beyond the revolutionary changes that are happening in our field and in society, visit fertiltybridge.com to begin the first piece of the Fertility Marketing System, the Goal and Competitive Diagnostic. Thank you for listening to Inside Reproductive Health.