Written by: Dr. Amy Beckley, PhD, Founder and Inventor of the Proov test — the first and only FDA-cleared test to confirm successful ovulation at home.
Amy Beckley, PhD:
Welcome everybody to another episode of the Proov Podcast, where it's all about educating, empowering and having honest conversations with fertility professionals. And it is my pleasure to welcome Dr. Gary Levy from Fertility Cloud. [Fertility Cloud] is a virtual online clinic that helps women and couples actually dealing with infertility to get them fertility treatments. It's actually a pretty novel idea.
I think it's quite genius and we've been partnering with Fertility Cloud for, I think the past couple months. And it has been amazing! The women that have come through love Dr. Gary and have gotten great results, he really helps these couples get to the next step and provides them with answers. So welcome Dr. Gary, please tell us a little bit about yourself and how you got to where you are today.
Dr. Gary Levy:
Thank you so much, Amy. And I want to extend that all of the welcome to the Proov community, and we want to say thank you for having us on the podcast. It's an absolute pleasure and a privilege.
So I am Dr. Gary, and I'm the CMO of Fertility Cloud. You know, just by convention, I asked to tell everybody my credentials. So I am a Board Certified Reproductive Endocrinologist, residency and fellowship trained and primarily worked in an academic practice up until our partnership.
And I came up with the idea of starting an online fertility practice. And so we are established in all 50 States. We're open 24 hours, seven days a week, and we evaluate couples, single women, single men same and sex couples. But we can certainly treat up to a point to what's available to us through telemedicine.
So especially with the ongoing pandemic what we have been able to do is to bring all of the fertility testing and most of the fertility treatment directly into your residence, into your home. So there's absolutely no reason to go somewhere where you don't want to go to have your fertility testing, to talk to your fertility doctor and to have most treatment that's available through telemedicine.
So that's us, in a nutshell, we have been working with a lot of patients or customers, and so far, I think we've had a very satisfactory relationship, I think, for a lot of your patients and certainly for our clinic as well.
Amy:
I founded this company in 2016 after my own personal battle with infertility and recurrent miscarriage. And the experience that I had was this arbitrary, “You've got to wait 12 months or have three losses before you can seek care.” And you're often turned away by traditional doctors because they hear those guidance and they go, “Oh, well, you're only 28. And you’ve only been trying 10 months,” and you get dismissed.
Or you get put off saying, “Oh, just wait a couple more months, come talk to us.” And what I love about you guys is you're so willing to help. It doesn't matter if it's their second month or their 12th month or their first loss or fourth, whatever it is, whatever their background is, you're willing to listen and to help, which I think is phenomenal.
Because a lot of people with the advance of technology take these testing things at home on their one month, and they find a problem, but they still haven't hit that arbitrary 12 months. No one will talk to them. So that's what I was most uniquely excited about you guys and your ability to help. Because a lot of couples spend a significant amount of time and effort understanding their body and they realize something's not working and when they go to their healthcare professional and are dismissed because of whatever their doctor said, it doesn't seem fair. So I like how you guys are there to listen and to help them move forward, whatever that is.
Dr. Gary:
So you bring up an excellent point, the guidance is actually very specific. That 12 months or six months for women who are over 35, that only is there for your patients or couples or women who don't have pathology, right.
Because that's based on a statistical probability of conception within a certain amount of time. But if there's pathology, that's identified, there's absolutely no reason. It's actually the recommendation to not wait for months until initiating the evaluation and any necessary treatment immediately. So I mean that's what is when you're a specialist and you've established and contributed to developing some of the guidelines.
Now again, the primary care doctors are very busy and they have to manage everything a lot of times [inaudible]. So their knowledge of certain things is superficial and that it has to be because they have to master a lot of things.
So yes, they are aware of guidelines that mandate or dictate, or sometimes there's insurance policies involved in dictating and certain people of a certain age have to try for a certain time, but it absolutely does not mean you have to be trying to be identified by technology. So if you have a novel test that detects something in the comfort of your own home, that would prevent you from conceiving or puts you at risk for miscarriage, then there's absolutely no reason.
And it's actually, certainly not recommended to wait the six to 12 months. And so the benefit of us bringing specialty care directly into the home is that we don't comply with bad recommendations, but it’s not a recommendation to wait for the prolonged period of time. Especially when there's underlying pathology, that Proov helps identify.
Amy:
Awesome, I love hearing that. So, walk me through typically what a couple's journey is. I know you are a medical doctor, but you're not here to treat patients. We're just talking about education. I'm a couple, I'm dealing with infertility, I stumbled on your website, myfertilitycloud.com, I clicked on it. What can I expect? What kind of things can you do virtually?
I mean, because everyone's like, “Oh, I need IVF. I need to get ultrasounds and I need to get blood draws. Like I have to get egg retrievals.” So the whole thought of a virtual fertility clinic kind of is a little bit not accepted as much. So please tell me everything you can do.
Dr. Gary:
Everything that we can do is articulated on our website, but a summary of the experience would be something like this. Certainly we have a very big diversity of patients. We have patients who just started trying and they stumble on our website or somebody recommends our website and then they come in and they ask for a consultation in order to optimize their ability to get pregnant. So we certainly would love to see those patients because that's also an important medical encounter. Or we have patients that have been trying for years on multiple rounds of IVF and they want a second opinion.
So we essentially have a spectrum of everyone, but a typical would be something like this couple have been trying for a while. They haven't really been successful, so they don't have a reproductive endocrinologist or they don't want to be referred to endocrinologists or they have an insurance mandate that prevents them from seeing a reproductive endocrinologist so they can book a consultation with us.
The beauty of reproductive endocrinology is that you can do a lot through a conversation, right? You can determine whether somebody is mostly ovulatory or if they have to move back your risk factors. There's some risk factors for sperm problems through a conversation.
And so based on that conversation, then we can direct the necessary testing. And we've partnered with some very excellent partners in terms of testing at home. And we can perform all of the testing that, for example, a woman would need to identify ovarian function, ovulation status risk factors for a tubal blockage all in the comfort of your home. So if we determine that those tests are necessary then we would send you the testing kits. The tests are done through a needle pinprick. So it's not those big, scary needles that go into your arm.
Typically the patient puts a couple of drops of blood on the papers, ships it back to our laboratory and the labs are available within a week or so. If we think that a sperm analysis is necessary, and most of the time it is, because it is indeed in couples that haven't been tested that sperm problems are the most common problems that we identify.
The tests come directly to your home without having to go to the lab or actually make an appointment in the fertility clinic to collect again, sperm tests come back very quickly within seven to 10 days. And based on those results, we can recommend treatment. Now, most fertility treatment is kind of an algorithm, but certainly tweaked to the diagnosis. Mostly women and couples start, we will call it ovarian stimulation where they take oral medicines that can be combined with an intrauterine semination depending on the diagnosis.
So typically we can do most of the things leading up to in vitro fertilization. And so all of the ovarian stimulation is done on oral agents. And we are in the process of partnering with a company that can do home inseminations as well. So pretty much everything up to IVF we’ll be able to do through telemedicine.
Certainly at this point we haven't been able to perfect our telemedicine IVF process, but we're certainly in discussions with clinics where we can have like a combined IVF process where I would keep the patient's costs low. At this point, we haven't been able to figure out how to retrieve eggs through telemedicine, but, you know, 2021 is becoming a weird year. So it's not over yet.
Amy:
That'd be pretty amazing.
Dr. Gary:
So that's kind of a summary we can offer, and then we can treat people at three, four, five, six months. And at that point, if we think that couples, women, same sex couples, if they need to go to IVF then we certainly have that discussion with them.
Amy:
Talking about your treatments, I love the all-in-one kind of way that you bundle things. You either treat them, you buy one month, three months, four months, whatever package, and it comes with all the doctor visits, all the things you need to track ovulation, all the medications, like the prenatals, and it's delivered straight to your door. You really literally do not have to leave your house, that transparency and that single pricing, there's no surprises. I just love that model.
Dr. Gary:
We try because most women that are going to be utilizing our service are younger. And they've grown up in a technological age. So they don't necessarily want to take time off of work or take time off of their friends and get in the car, drive somewhere. It's a new generation, right? So we're trying to cater to that.
We're 24/7, instant communication. Our patients text us, they use the patient portal, and they're very happy with that versus calling the office, leaving a message, waiting a couple of days for somebody to call you back. By the time somebody calls you back, you probably forgot what question you had or what problem you had or something like that. We are trying to innovate at the point of care making it extremely accessible, convenient, and cheap. And so by eliminating all of the overhead that's associated with a lot of things in medicine, we're able to deliver all those things in a convenient way, effective way and hopefully successful way.
Amy:
I did IVF, gosh, 11 or 12 years ago. I was on the IVF train and I would have to come to work late continuously because of all the blood work. And it was the middle of the summer. And I always had to wear long sleeves to cover all my tracks from getting blood work. So I can totally understand that it's a huge time commitment to go through fertility treatments as well, to constantly go to the appointments.
Dr. Gary:
Every person has their experience and a lot of women, from what we found is, it's a personal thing, they don't want to make it known to anyone. We're trying to cater to that and we're trying to provide a service to make it accessible for as many people as possible, even people who aren’t vocal about it. A lot of people prefer to keep it to themselves.
And so by having everything delivered into your house we're able to satisfy a big majority of people who are going through this process. Now I have talked to patients who are actively cooking dinner, on the phone, putting in their pasta. They're talking to me, I've had people call me from the gym. They don't want to interrupt their workout. And that's perfectly fine with me. I've had patients call me from work on their lunch break, or even as they're working, we don't have a problem with that at all. Our goal is to provide these services to you. So you don't have to take time out of your day to deal with this issue.
Amy:
I think what you guys are doing is amazing. I see real value in what you guys were doing. And we started this kind of a deeper conversation in this deeper partnership with people that are using Proov, women that are getting their Proov results. They're not positive.
So the Proov protocol is testing seven, eight, nine, and 10 days after suspected ovulation. And that really helps you understand kind of the health. We like to say, is that hormone level high enough, long enough, for that? You give it enough time for that fertilized embryo to go all the way down the fallopian tube and implant in the uterus. Because if you get your period too soon, or it's not the right environment, it could cause infertility or miscarriage.
We’ve invented this new technology and this new way of assessing successful ovulation and one of the biggest ways to fix a poor or weak, insufficient ovulation, whatever luteal phase defect, whatever words you want to call it, is to just supplement with progesterone after ovulation. And that's what we usually recommend when women talk to their doctors.
And what we found was a lot of doctors didn't know about Proov, they didn't have that most recent information, their single blood draw was fine. I don't understand why you think it's bad ovulation. And so they weren't willing to listen to these patients.
So we started this partnership where we could connect our Proovers with you and just go over those results and say, “Hey, they weren't positive. Let’s try to [improve ovulation].” And so it's a very amazing partnership where we are helping women kind of complete that treatment loop and have their words listened to and have actionable insights.
We've found that low progesterone is a common cause of infertility. A lot of women have ovulatory issues that cause low progesterone and Proov is helping them understand that. But sometimes it's not the only reason that they might not be conceiving.
I'm shocked at the number of women that do not have their husbands get a semen analysis. We pee on sticks and go through this crazy stuff, take all these vitamins and then assume that the husband's fine, where the ladies just get your husband checked.
We have this system where progesterone could be the miracle drug that you need. Let's try it for a couple of months, but if not, you're already connected with a Board Certified Reproductive Endocrinologist that has all these other cool tools in his tool belt that can help you conceive.
So that's what I think is really amazing is, I don't want to do a disservice to women and to couples and say, “Oh, well, it's gotta be just progesterone. That's the only reason that you're not conceiving.” But to be able to give them that resource, and if it doesn't work, you guys have all these other things that you can also help with.
Dr. Gary:
You're absolutely right. It's important, the other thing that we offer is for women to access a fertility specialist early, because a lot of times what we see happens is if they go through the step sequence of accessing specialty care there's pathology, that it's not identified early, which then is not managed as successfully as it could be.
If you are identified [at an] early age, it does have a very significant impact on prognosis, whether it's natural prognosis or whether it's prognosis with any intervention that a fertility doctor can provide for these couples or women or men. And so what we do see is a lot of our visits are education, talking about reproductive physiology and common pathology, but yes, you're absolutely correct about public service announcements. If a semen analysis is very important and a necessary tool and identifying problems with conception, we all take commerce that is still going to be the most common problem that we find we'll need to address.
I feel like a lot of women internalize the struggle and they want to find something wrong with no kind of neglect to their partner, or don't necessarily put the primary responsibility on the male partner where a lot of times it actually is the male partner that is primarily responsible for either infertility or subfertility.
So it's very important to address that as well, but with your point to progesterone, you're absolutely right. We had this concept of luteal phase deficiency for a long time. We used to diagnose it, it would actually show biopsy. So painful. We bring women into the office multiple times after the biopsy, then compare the day after ovulation, what we're supposed to find on these biopsies and what we found pouring lean, accurate test, even had the same doctor read the biopsy, their plannings didn't agree with what we saw in one day versus another day.
So we've abandoned it. And then we abandoned this concept of luteal phase deficiency or sub-optimal ovulation, cause we just didn't have a diagnostic test board. So we either just empirically supplemented eventually, or just ignored women in general, which is obviously, probably not the right thing to do in either case.
And so this is a great novel test to kind of look at the area under the curve of progesterone, right? We talked about this a lot with the pandemic, flatten the curve. But the issue is one of the curves is up like this, or whether it's the area under the curve is, is the same thing. So if the area under the line is higher, obviously there's more progesterone, right? And so that's kind of what Proov tests right there, the quantity of the progesterone secreted in a single blood test.
Every single doctor that's trained in this field knows if we're just doing this and, you know, progesterone level of time T and time that T plus 60 or 30 is going to be different. So when a blood test can tell us if a binary outcome is isolated or no ovulation, the blood test doesn't tell us anything other than that. And so the benefit and the utility of Proov is a cumulative volume or cumulative tests for progesterone, right? And so if it's not positive, cause you set a threshold there that would potentially indicate pathology.
Amy:
Progesterone is the progestational hormone, right? You need it to prepare the uterus to accept the embryo. It creates the receptors so that it's sticky and then the embryo can actually implant and thrive. And so there's a critical amount of hormone that's needed and it's gotta be there for the critical days of your cycle. And so that's exactly what Proov is addressing, you don't need a single blood draw. Absolutely not, you need more information. So it's not like an LH surge, you just need one surge and then you ovulate, it's like a continual hormone that needs to be produced.
Dr. Gary:
Right? Exactly. Because essentially the area under the curve is what we're really, really worried about. And when you increase that area under the curve to ensure that it does its physiologic duty and gives that particular individual, the approach, the age appropriate probability of conception, right?
So one of the things that a lot of women ask us and we've addressed, I think a couple of times on email is how vaginal progesterone is most of the time we always do that? How does vaginal progesterone interfere or change Proov results? And from what I understand, the vaginal ones are not right. And will make your Proov test positive. Because with the first pass effect in the liver, it increases PdG. But vaginal progesterone isn't going to change most of the time.
Amy:
Usually we tell women once you're on progesterone, whether it be oral, rational, or whatever way that your doctor wants you to take it to stop taking Proov tests because it's just going to confuse you. So for example, if you're taking it orally and you get a positive Proov test, it just means that you took it orally, you know, and if you take it badly and you're not getting a positive test, I don't want you to think that the progesterone is not working because it is, it's just not effective in the Proov result.
Once a woman is put on progesterone you can use an approved test to confirm ovulation prior to starting the progesterone. It's kind of shocking the number of women that come on the group and they're like, “I got my doctor to prescribe progesterone, tell me how to use it. Here's the bottle.” And it's like, take one daily by mouth and they don't know what cycle day it is to take it on or they just say, just start it cycle day 16 and take it for 14 days and then take a pregnancy test. It's like, well, how do you know I'm going to ovulate on day 14?
Dr. Gary:
Then they're actually prescribing birth control.
Amy:
It's really important that you not only get the progesterone, but you understand how to use it and you make sure you're using it correctly. So always, always make sure you confirm ovulation before starting progesterone at home. And you know, you guys are great because you know exactly when they should start it, you're going to get clear advice recommendations. It's not like, yep, “Here's your prescription, have a good day.”
Dr. Gary:
That's another thing that we're very diligent about doing, we provide every one of our patients with verbal and written communication written immediately after the appointment. So after every appointment, every patient is going to get a letter or an email indicating exactly what we talked about and then the plan for the short term and then long term strategy for their treatment.
And we were very, very clear about how women should use their progesterone again, as if it started at the wrong time in the cycle it will actually act as birth control — counterproductive to what everyone's trying to do.
Everybody's different, but typically our regimen starts three days after the peak, we supplement with compound progesterone which eliminates most of the allergies, select peanut oil and sesame oil. And depending on the pharmacy, these are compound preparation, which also minimizes the local side effects that some of the manufactured progesterone supplements can put women at risk for.
And then we have them take it until they have a positive pregnancy test or they start the period. And then once a woman is pregnant on the progesterone we recommend they take it until they're eight weeks pregnant, when that placenta begins to take over and make the majority of the progesterone for the pregnancy.
Amy:
That's a question we get a lot too is: “I'm on progesterone. When should I stop it? I don't want to start my period.” Well, I get a period on the progesterone. I don't know if there's a single answer to that. I don't know if you could provide clarity. You said you take it until you get your period. So what I understood is you'll get your period if you're not pregnant while you're still on the progesterone.
Dr. Gary:
Most of the time, yes, most women will get their period if they're not pregnant, even if they're on the progesterone, some won't. And so what we do is we have them take a pregnancy test if they haven't gotten their period 14 days after their peak.
And if they haven't gotten their period or if they have a negative pregnancy test then they stop at that point, the progesterone withdrawal of whether it's natural or whether it's exciting, progesterone’s being supplemented will make them have their cycle. And then they essentially start again after the next week, but this should never ever take their progesterone without knowing their cycle timing because that will again act as birth control.
Amy:
Well in the few minutes we have left I just wanted to kind of tell the people that are listening, you have a choice of providers. If you're going somewhere, you have a clinic, you have a diagnosis, you're struggling, no one will listen to you, whatever it is, it is your prerogative to get a second opinion.
And so if you are being dismissed, if you have data, nobody wants to look at your data, you're doing all the right things and trying to advocate for yourself and where you went, you don't feel like you're getting the right answer. Please go get a second opinion, if that's Fertility Cloud, awesome. If it's someone else awesome.
Just don't feel like you have to take that one opinion for scientific truth because you know, there are different opinions, there's different types of doctors, there are different situations. So definitely advocate for yourself. Try to find someone that will listen. I just like to throw that in there as kind of my parting thoughts to people listening, because sometimes they feel frustrated. They're not listening, not being listened to. Do you have any kind of closing remarks or any, any other things you want to talk about?
Dr. Gary:
I completely agree with your statement. Now, the answer is, it's not something that you're always gonna want to hear, but it's something that if it's a response after, you know, a thoughtful conversation and where you felt that you're a medical professional and I did due diligence and it was a productive conversation. You may not always have an answer that's pleasant, but it has to be satisfactory to you.
Amy:
Sometimes you get an answer you don't want to hear. And so you have to ask it again, if you get the same answer, you're like, all right, fine. I guess you were right. But still until they have peace, you know, that I'm going to have that peace until they get that second opinion.
Dr. Gary:
I agree. We do see a lot of patients who come to us for that second opinion, they would be done again, like I said earlier in the podcast, multiple treatments with multiple different clinics. So I guess we would be the third or fourth opinion. But again, we provide that convenience where you can do this in the comfort of home at the time of your choosing for the most part.
So it's easy to get that from us. And we have decades of IVF and fertility experience. So we will go through all of the data at once. Anything that you provide for us we won't discount, anything and that's kind of where innovators in this space, so that's why we're here.
Amy:
I'm going to post the links below for the progesterone consultation or the full fertility workup, depending on what people want. For people listening on the radio, it's myfertilitycloud.com. That's how you can find Dr. Gary and everything that he does. So I thank you for being on this. I'm extremely excited to partner and provide these resources to the couples and I hope you have a good day.
Dr. Gary:
Thank you so much for having us and best of luck to you. And thanks again. Take care.
