Until recently, it was thought a normal cycle for women was 28 days. While data now shows this is not the case, innovative tools continue to be developed to better understand what is "normal" for a given woman. Dr Amy Divaraniya, the CEO and co-founder of OOVA speaks with Fempower Health.
What we Discuss
Myths about women's menstrual cycles
Surprising information OOVA is uncovering about women's cycles
Why LH is not the only important hormone for fertility
What women can do to better understand their personal “normal” cycle
The important role of progesterone
Transcript
Georgie Kovacs: Tell us your background.
Amy Divaraniya: Thank you so much for having me, Georgie. It's so nice to sit down and chat with you from afar. Crazy world that we're living in right now. I have a PhD in biomedical sciences focused on genetics. I realized that there was this pivot happening in the biotech space and a new field of bioinformatics was evolving. I was working in virology, inflammation, oncology, and supporting those projects to help them optimize all of their analytics. I ended up going back to school for a PhD in genetics, specifically.
Georgie Kovacs: Tell us about your fertility journey, as I know that influenced what you are doing now.
Amy Divaraniya: I found myself here at OOVA, because I went through a pretty difficult time trying to conceive my son. Honestly, I never saw myself starting a company, but I wanted to do something to make a difference. I was coming to the end of my PhD, I realized there was a really big gap in the fertility space, especially in the face of women's health. I had been trying to conceive and we were not getting pregnant.
We did decide that we wanted to pursue parenthood naturally, and not go down the invasive route, mostly because I just didn't think I could deal with the loss of like a failed cycle or potential miscarriage. I have so much respect for women and couples that are going through that journey. It's like a different level of heroism in my mind. I don't know how you do that. But I just didn't think I could emotionally or mentally go through it. So we agreed, we, being me, my husband agreed that we were going to try to pursue this naturally.
The cards stacked against us. I've had irregular cycles my whole life. My husband and I were both a little older when we started trying. We were already well into our 30s and then I also have an autoimmune disease - celiac. Infertility has been affiliated with celiac disease. Despite all that, we were pretty headstrong that we're going to go about this naturally.
I started doing everything right. I started peeing on sticks every morning. I took my body temperature at 4:30am on the dot. Every single day, I use every fertility tracking app. And luckily, after 18 months, I conceived my son.
But those 18 months were the most devastating of my life. And the worst part was, I didn't really learn or understand the new about my cycle. All I found out was that I had irregular cycles, but I knew that going into my journey. I also quickly realized that all the tools I was using were basically hardwired for that woman who had a perfect 20 to 30 day cycle. And there's this fine print on all those tools. If you have irregular cycles, our data or our results are not reliable for you. Well, that doesn't help me.
Georgie Kovacs: How did the learnings from your fertility journey influence you co-founding OOVA and what it should do for women?
Amy Divaraniya: The piece that is missing is really understanding what my hormones are doing, because our reproductive cycles are driven by hormones. If I understood how my hormones were behaving, I would know exactly what to do and when to do it.
That's really where the idea for OOVA was born. What we've developed three years later, is an at-home test that monitors multiple key fertility hormones, through your urine, completely non-invasively, and in the privacy of your own home. That was a pretty key component for us that it had to be done in a very comfortable way, non invasively and be affordable.
Georgie Kovacs: Why do so many still believe women have and should have a 28-day menstrual cycle?
Amy Divaraniya 08:28
Let's do a little bit of a history lesson. The age women are starting to have their first child is progressively increasing as the decades go on. Now, the average age of women who are trying to conceive the first child is 27. When you go back to 2000, it was about 24. So even in the span of two decades, we're talking about a pretty drastic increase. And it makes sense. Women are just trying to get pregnant later in life. We have goals of like, furthering our career, attaining higher education, and don't want to plan to have a child until we've achieved a certain point in our professional educational career.
All the tools that exist, until I want to say in the past five, six years, have been developed in the 1960s. At that point, women were trying to conceive much earlier in their fertile years, their early 20s. Your cycle is much more regular at that time. So there has been this conception or this model that was generated back then where women have this beautiful LH surge that happens right before and during ovulation. The progesterone has a beautiful curve that happens after an egg is released.
That's really not the norm anymore. Women are having children much later. Our bodies have gone through so many changes in that time. And unfortunately, as we age, we don't ovulate every cycle. It's just biology doing its thing.
It's going to take us decades, like centuries, to get to regulate our bodies to match someone getting pregnant naturally, like 35 or 40 years old. Evolution doesn't happen that quickly.
So what we're realizing with OOVA is that there really is no such thing as normal. And when women email me asking like me, this is what my results look like. Is this normal? It could very well be for you. What we're trying to do with OOVA is really personalize the entire experience.
We capture what every woman's baseline levels are. We then detect fluctuations in your hormones that compare to that baseline. There's no threshold. The reason those previous tests didn't work for me, because they are threshold-based, meaning the test is anticipating your hormone levels to surpass that threshold in order to get a positive result of whether you're ovulating or not. And unfortunately, if you have irregular cycles, or irregular hormone levels, you may be consistently below that threshold or always above it.
So the false positive and false negative rates are quite high for those tests. With OOVA, because we capture what your baseline levels are, I don't care if your baseline is super high or super low. We're trying to calculate what that differential is between your daily hormone levels. So we tell you when you're ovulating based off of your data, not off of some mold that we're trying to push you into. I think that's what a lot of the products today are trying to do. So we really embrace everyone's normal.
Georgie Kovacs: Could birth control have also contributed to this misnomer of a 28-day cycle?
Amy Divaraniya: Absolutely. I mean, we still don't know what the long term effects of birth control are. We're getting the first batches of data, especially with IUDs, and these long lasting birth control medications. It's hard to know what the long term effects are going to be when it comes to your fertility. Yes, we have that early data saying, for instance, if you're on this IUD for X number of years, your fertility should bounce back after this many months. But we don't know what that return on fertility looks like yet across a pretty broad population. So that data is still very fresh.
We do have many users of OOVA that have been on birth control for an extended period of time and are now thinking of getting pregnant and are using OOVA to kind of monitor their cycle. We're seeing that ovulation is not happening every month. Their LH levels are not hitting this typical peak that we all are waiting for.
It's okay, because now what we're learning is that their LH surge is actually much lower than what they would have originally thought. It's just getting that level of objective data. That's the piece that has been missing throughout cycle tracking for generations.
Georgie Kovacs: How does a woman properly measure and monitor her hormone levels?
Amy Divaraniya: Currently, really, the only way to track your cycle, if you take OOVA out of the equation, is to look at subjective symptoms that you're experiencing. Cervical mucus, I'm going to put BBT as a subjective thing, because some of the factors can affect that, which has nothing to do with ovulation. And then also, I'm going to put the urine strips into that as well, because they are qualitative.
We're waiting for that positive or negative. It's funny that you're talking about that blinking smiley face, like that was developed very recently. And that's really where the level of innovation has stopped. And I think that's a huge disservice to the women's health industry, right, we're talking about 51% of the population. And we should be having some more innovation here. Like all of those tools that we just like listed out are basically designed for a perfect cycle, like your BBT.
If you're looking for trends there, it's really only reliable if you are cyclical, and your behavior body behaves in a certain way every single month, or I'm a certain interval. If you have irregular cycles, that BBT measurement is not necessarily as reliable for you.
Georgie Kovacs: Tell us the key hormones that play a role in an optimal menstrual cycle, including ovulation.
There's really four that we should be concerned with. And I'm going to tease the fifth one, too.
So your menstrual cycle is called a cycle because you're basically going through certain steps in a regular interval. Theoretically, that interval, or that the behavior that happened, the different phases of your menstrual cycle are driven by hormones, solely by hormones.
Estrogen
So the whole purpose of estrogen is to indicate that a woman should be well, the first part is to actually help a woman start to grow for uterine lining, and prepare it for implantation. If that's to happen, right? If you remember, your whole menstrual cycle is basically designed to help you conceive. That's like, that's the whole reason that you're having a menstrual cycle.
Let's break up your menstrual cycle into two phases. Okay, there's the follicular phase. And then there's the luteal phase. And the various hormones have different roles. And each of those phases. The first part of your follicular phase is your period. So if you haven't conceived in the cycle before, uterine lining is shedding, and you are basically cleaning out everything so you can optimize your body to conceive in the next cycle.
Now, during this time, all of your hormones should be at their absolute lowest levels of basically zero. Once a period is over, the estrogen levels are going to start to elevate slightly to help the urine line start to kick in again.
Luteinizing Hormone (LH)
Now what the next hormone that matters is LH. So as your estrogen levels are going up, it's actually going to indicate to your pituitary gland your brain to release LH. Now, LH is actually a pulsatile hormone, so it gets released in little bursts. Right? So you can imagine now, every day your LH levels are getting kind of like accumulating in your body. And at some point, it's going to get to a point where it gets so high, so it's surges. A follicle that was growing in your ovary is actually going to release the egg.
So once your LH peaks, that's when the egg is actually released from your ovary and travels down into your uterus. So that's when ovulation has occurred. That's the key point in the trigger from going from follicular phase to luteal phase.
Progesterone
Once the egg has traveled the uterus, it serves to form a corpus luteum which is this yellow sac that the egg lives in and that sac starts to release progesterone. And the role of the progesterone here is to really thicken your uterine lining. And make it a cushion for the egg to nestle and be able to get to meet with the sperm and you create an embryo.
Now, if you don't conceive, you'll see the progesterone levels drop, the LH levels have already come down, your estrogen is going to drop again and you're going to have another period. So that usually happens at the latter part of your luteal phase indicating that now the follicular phase will begin again.
HCG
If you do conceive, you're going to see the progesterone levels actually remain elevated, and the egg will, the embryo will start to release beta HCG, which is not present unless if you're pregnant. So you'll start to see that elevate, and the progesterone is pretty critical to maintain that pregnancy. And so you want to see those levels go up as you progress.
Georgie Kovacs: How do these hormones play out in the fluctuations and degrees of difference that women see?
Amy Divaraniya: So let's talk about the two hormones that I can really dive into luteinizing hormone and progesterone since OOVA measures both of those.
In the 18 months that I was trying to conceive, I only got a high five days. I never got a peak, and I was having periods. I didn't get 18 periods in that window, but I was getting a period. So there's no way that I was not ovulating. But I was not getting that indication from those LH strips. Using OOVA, I actually learned that my LH surge is significantly lower than what those thresholds are based at. But I still ovulate because I see the progesterone rise happen quite nicely after I hit my peak.
We also have other women that I've seen pretty interesting trends with that had polycystic ovarian syndrome (PCOS). Now, this is interesting, because there's a lot of literature saying that your LH levels are going to be elevated if you have PCOS. And I'm seeing that's not necessarily the case. We're seeing some women have elevated luteinizing hormone levels as their baseline. And they do ovulate. They're just the differential is much different, right? They're hitting a much higher level for the peak to happen. So for these women, they probably always got high or peak on those LH strips because they're way above the threshold of the test they're measuring at.
But on the flip side, we're actually seeing a lot of women who have normal-ish or lower baseline levels that are saying that they have polycystic ovarian syndrome, and are ovulating beautifully. So that begs the question, is elevated LH actually a symptom of polycystic ovarian syndrome? Or are these women being business diagnosed?
Georgie Kovacs: Given some of this data, you're seeing I think we're already seeing why it's important to understand your hormones because it impacts conditions. Now does OOVA track or do you have insights through other means around what also these hormone fluctuations indicate?
Amy Divaraniya: Sure. Yeah, there's a lot that we're working on. Let me hop into the progesterone a bit, too, because that's been really interesting for me. We've seen progesterone levels start to rise up to like three to four days after the woman has her LH peak.
Typically, it's not that you're ovulating within 24 to 48 hours. We're seeing it could be a few days later. So a lot of couples stop having intercourse right after their surge. And now I say, “No, keep having intercourse until you get that ovulation confirmation results, because the egg hasn't started really releasing progesterone yet get the sperm in there because they can start it can live inside the uterus up to 48 hours.” That's been kind of an interesting game changer.
The other one that is not something I was surprised with. But I think it's actually brought a lot of ease for women that have faced a lot of miscarriages in the past. They actually focus on using OOVA to monitor their luteal phase, because they want to maintain that their progesterone levels are elevated. So it's actually helped clinicians because that's another channel for us. We're actually working with various clinicians across the country to to allow them to interpret those results with their patients. But clinicians are actually able to make supplement recommendations for progesterone, right after ovulation, to help maintain a pregnancy. That's what's happening. So to avoid the chances of a miscarriage, and that's been pretty eye opening for us, too, because we're directly impacting care with our data.
Georgie Kovacs: I give a lot of credit to Amy Beckley, who's the founder of PROOV. She was the first person who went out there and said, “We have got to look at progesterone.” I had the chance to interview her last year. And I also spoke with Dr. Lora Shahine, who does a lot of work with recurrent pregnancy loss and miscarriage and wrote a great book about it. And through this and attending other conferences, I've really become fascinated with challenges with women who might want to go to their doctor and talk about getting progesterone to help maintain that pregnancy and the type of progesterone that you need to successfully carry that pregnancy to term typically needs the prescription and not all doctors believe that it is needed.
With the women that you're working with are you seeing that change? Are you seeing those clinics who are working with OOVA or who does understand this dynamic that progesterone is much more apt to be able to give women the progesterone that they need to support the pregnancy?
Amy Divaraniya: We're in over 60 clinics across the country. Many of them are recommending progesterone based off of the data that we've been providing. So that's been kind of a big game changer for us. And I think the additional layer is that, previously, there really wasn't a way to know that the woman actually needed to progress in that her levels are dropping, because if you're getting monitored by a doctor, they're probably going to have you go in for a seven days post ovulation blood draw. And that's when they're going to get your progesterone level. And at that point, it’s just a timestamp. You don't know what the trend of the progesterone is over the course of the time post ovulation. You're just looking at seven days post ovulation.
With OOVA, because we're getting all that progesterone data from the beginning, whenever we started testing and up to 15 days. It gives the doctor a lot of confirmation that the progesterone is fluctuating a lot. And it's actually heading towards a lower level. Let's up it and let's get progesterone supplements. So the trend analysis is really the key piece here.
Georgie Kovacs: Interestingly, at the American Society for Reproductive Medicine conference in 2009, one of the head researchers for the PROMISE trial was presenting. Later, data was released, and it was just a devastating report on their website, which said, we were not able to conclusively show that giving women progesterone helps maintain pregnancies.
When I asked Dr. Shahine about it, she made a very interesting statement that I think women need to understand. Apparently, they started the trial in women who were six weeks pregnant, and at that time, the placenta starts to make the progesterone. So therefore, you wouldn't necessarily need the supplementation then.
Amy Divaraniya: When I'm seeing that clinicians are stepping in to give progesterone supplements, I'm talking about like the first week of pregnancy. They're only a few days pregnant, and we're having them up the progesterone levels. So six weeks is way too late. Like most miscarriages are happening much earlier than that. I think that was definitely a steady flow there.
Georgie Kovacs: Are there any other trends that and learnings with OOVA, that you think would be important for women to be aware of when it comes to hormone health trying to conceive?
Amy Divaraniya: Women in general, we just always hold ourselves to some like unrealistic standards. Then we come to your fertility journey, it's a very rough journey to be on, because literally, what you're kind of dealing with is like, my body's failing me, and I can't do anything about it. And I think that's a really difficult concept to kind of come to terms with and overcome.
So what I love about OOVA, and what we're really trying to do is to empower women with information about their bodies. So stop trying to compare yourself to that typical textbook curve. That's not you. And what OOVA does is, we actually go one step further.
One, we show you what your data looks like.
But we also allow you to overlay what that textbook curve is. So you can really embrace your individuality with your data. And we provide you with a report that you can actually share with your doctor. And now if your doctor is saying, for example, to go back to progesterone, that you don't need a progesterone supplement? Well, you can very easily show them your progesterone data and be like, Well, my progesterone is fluctuating like crazy post ovulation, if I am to conceive, shouldn't this be a little bit more stable?
And now you're having an educated conversation with your doctor, rather than just kind of being that sounding board and hearing what they're saying and doing as they say, now you can, I don't want to say challenge. That's a really strong word.
You can ask the right questions and get the answers that you deserve. You're actually being empowered to be your own advocate. I think there's a lot of a lot of talk about becoming your own advocate, but women aren't being given the resources to actually embrace that. And I feel like OOVA is actually arming you with that data. So you can stand behind the numbers and be like, this is what my body's saying. Explain this to me. And then what do we do so it actually behaves the way you want it to?
Georgie Kovacs: What are OOVA’s plans beyond fertility?
Amy Divaraniya: Our menstrual cycle is so critical to our functioning. I feel like women get more knowledgeable about their menstrual cycle once they have trouble getting pregnant. That's when we all become fertility experts because you learn that's when you start Googling. What is LH? What is progesterone? Why does this matter? We're just not taught this early on. So we don't care about it.
But really what we want to do with OOVA is, yes, we can help them to get pregnant. But the reason we're able to do that is because we're so accurate and measuring your hormones and understanding what's going on with your body. So now if we can apply that message across all of women's health, that's where we're headed.
We're scaling really fast in a bunch of different areas, because we have the hormones accurately being measured. So we're already you stepping into menopause, we're stepping into helping you track your pregnancy, we're looking into postpartum care. So let's say we can help you actually detect postpartum depression before it is completely engrossed with you, and you have no more control anymore. We're helping women understand what's going on with their cycle. after birth while they're breastfeeding. They don't have to go on birth control.
For sure. There's a lot of applications for the data that we're capturing that go well above and beyond just helping a woman get pregnant.
Georgie Kovacs: Anything else you would like to share?
Amy Divaraniya: This is like a lesson that or something that I wish somebody had said to me. Very genuinely, I think I knew it in the back of my mind, but I never really applied it to myself. And I hope at least one of your listeners takes this to heart. Exercise self forgiveness. This is the time to do that.
When you're on a fertility journey, whether you're trying to get pregnant, avoid pregnancy, understand what's going on, don't get frustrated with your body and just take a moment to understand what's actually happening. Our bodies are designed to do certain things. You just need to crack that code.
Don't sit there and beat yourself up about going out for some college night, when you have a wild night or being on birth control or taking certain medications or whatever, like procedures you may have had done. Don't beat yourself up about it. Our bodies are so resilient. We've seen what my body went through during pregnancy post delivery. And then now like, our bodies are amazing, and we shouldn't we should definitely exercise in self forgiveness to embrace that. Learn about what's actually going on and then take the right step.
Georgie Kovacs: What is your greatest hope for women's health?
Amy Divaraniya: The biggest thing is I hope it gets them the recognition that it deserves. I think it's starting, but in terms of FemTech, bucketing us into these categories within women's health is actually somewhat of a disservice because it becomes a fad - an article about one of FemTech companies or about menopause because that's the hot topic now. Well, menopause has been around since women have been on this Earth. Why is it a hot topic today?
Women's health needs to be given the importance that it deserves. Women are the majority of the spenders in families and the household. We're the educated ones who are making the major decisions. Why aren't we being given the importance to make sure that we can live our best and healthiest lives? I want that mind shift to happen sooner rather than later because it's taking too long.
Resources
Check out all of Fempower Health's resources on Fertility and Trying to Conceive.
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About Dr Amy Divaraniya
Dr. Amy Divaraniya is the CEO and Co-Founder of OOVA, a women’s health company. She has more than 10 years of experience as a data scientist and has both led and published original research in the areas of personal genomics and biomarker discovery. Her solid understanding of biology and being able to apply complex analyses have led to innovative projects in the healthcare space. In 2017, Dr. Divaraniya chose to pivot her career as a data scientist and devote herself to improving women’s healthcare. After facing her own struggles with conceiving her son, Dr. Divaraniya decided to build a solution to help women having difficulty getting pregnant. Today, her and her team have built the first at home test, OOVA, that measures multiple hormones through urine samples and provides personalized results and insights on a woman’s fertility. As a response to COVID-19, OOVA has done an early release of their product. OOVA has resonated with many women and clinicians and is now being adopted by fertility clinics and hospitals across the country.
About Fempower Health and the Founder
Georgie Kovacs, is the founder of Fempower Health, the go-to resource for all things women health serving women, their providers, and companies looking to build/improve on products for women. She also hosts the Fempower Health Podcast, where she interviews experts to help women better understand how to navigate their health both day-to-day and in partnership with their providers. Her mission is to minimize the years many take to seek proper diagnosis and treatment.
Georgie founded Fempower Health after her first-hand experience with infertility and endometriosis. Leveraging this experience along with her 20+ year tenure in the biopharmaceutical industry and consulting, she leads this movement to empower women. With limited research dollars and women’s “training” to grin and bear it, both women and doctors are in the impossible position to diagnose and treat conditions with little information. Women deserve more and better information, insight and innovative health solutions.
**The information shared by Fempower Health is not medical advice but for information purposes to enable you to have more effective conversations with your doctor. Always talk to your doctor before making health-related decisions.
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