Answers About Ovasitol, Inositols and Male Fertility [Podcast]
You have a lot of questions about Ovasitol, inositols and male fertility. I invited Dr. Mark H. Ratner, an expert on all of these topics, to join the podcast and answer your most burning questions. Every woman considering getting pregnant will benefit from his clear explanations and sage advice. Listen in as we discuss:- What are Ovasitol and inositols and how do they work?
- Why many doctors don’t understand the benefits of inositols for PCOS
- Can I take Ovasitol with metformin or if I am pregnant or nursing?
- Supplements that benefit sperm quality and motility
- Current research and clinical trials on inositols, Ovasitol and male infertility
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A full transcript follows.
Dr. Mark H. Ratner is the Regional Director of Male Reproductive Medicine at Shady Grove Fertility Center in Washington, DC. He is also the Medical Director of Theralogix, a DC-based company which develops products focused on nutrition and reproductive health.
Resources:
Myo-inositol and Gestational Diabetes
- (Corrado et al, 2011) http://www.ncbi.nlm.nih.gov/pubmed/21414183 This study concluded myo-inositol improved insulin resistance in women with gestational diabetes.
- (D’Anna et al, 2013) http://www.ncbi.nlm.nih.gov/pubmed/23340885 Pregnant women with a family history of diabetes given myo-inositol had a lower incidence of gestational diabetes than those taking placebo.
- (Matarelli et al, 2013) http://www.ncbi.nlm.nih.gov/pubmed/23327487 Pregnant women taking myo-inositol had a lower incidence of gestational diabetes, required less insulin, delivered later, and had smaller babies with fewer episodes of neonatal hypoglycemia than those taking placebo.
- (Zheng et al, 2015) http://www.ncbi.nlm.nih.gov/pubmed/26496267 This study concluded that myo-inositol (MYO) supplementation reduces the development of gestational diabetes mellitus.
More articles about Ovasitol and inositols on PCOS Diva:
Studies and Products:
- ConceptionXR Reproductive Health Formula is Theralogix’s base antioxidant formula, recommended for any man trying to father a pregnancy, or for those trying to conceive through IVF/IVF-ICSI.
- ConceptionXR Motility Support Formula contains the same nutrients as the Reproductive Health formula, plus 1000 mg of L-carnitine and extra vitamin D3 to promote sperm motility, recommended for the male partner of couples trying to conceive naturally or through IUI.
- NIH funded MOXI Trial: Conception XR Motility Support Formula is being used in the NIH funded MOXI (Males, Antioxidants, and Infertility) trial, which aims to enroll 790 couples who have been TTC for at least 12 months. Couples will be recruited from the Reproductive Medicine Network (RMN) clinical sites. This will be a multi-center, randomized, placebo-controlled trial testing our Conception XR Motility Support formula for 3-6 months. The primary outcome is live birth rate, and secondary outcomes include pregnancy rate, miscarriage rate, time to pregnancy, semen parameters, and DNA fragmentation at 3 months. We are excited that ConceptionXR was chosen for this trial.For more information, please see the ClinicalTrials.gov website listing- https://clinicaltrials.gov/ct2/show/NCT02421887?term=NCT02421887&rank=1
Full Transcript:
| Amy: | Hello and welcome to another addition of the PCOS Diva Podcast. I’m Amy Medling, a certified health coach and the founder of PCOS Diva. I’m talking today about a supplement that is very popular among PCOS Divas and I think is a hot topic in the PCOS community and that is the supplement Ovasitol. I’m really excited to have with me today, on the call, the medical director of Theralogix, Dr. Mark Ratner. Theralogix is the maker of the supplement Ovasitol. I’m going to actually be picking Dr. Ratner’s brain later on in the call, as well as about male infertility treatments because he is also the regional director of male reproductive medicine at Shady Grove Fertility Center in Washington D.C. Welcome, Dr. Ratner. Thanks for being with us.
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| Dr. Ratner: | Thank you very much Amy.
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| Amy: | I think we’ll just start with the obvious question. What is Ovasitol?
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| Dr. Ratner: | Ovasitol is a nutritional supplement, and it is actually blend, a mixture, of two inositols. Myo-inositol and D-chiro-inositol. Inositols are actually what we call … They’re sugar alcohols. They’re actually in the same family as substances as mannitol, xylitol, which are sometimes used as sweeteners. The inositols, there’s actually nine of them. There’s nine different inositols in nature. Two of those nine, myo-inositol and D-chiro-inositol, offer very specific benefits because they serve very special functions in our cells. Myo-inositol and D-chiro-inositol are blended in this product, Ovasitol, in a very specific ratio. It’s actually 40:1. That’s 40 parts myo-inositol to one part D-chiro-inositol. A daily dose of Ovasitol is actually 4 g of myo-inositol and 100 mg of D-chiro-inositol.
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| It’s actually a powder, and you take a packet of the powder and you stir it just in water. Ovasitol is completely colorless and tasteless once you stir it up and dissolve it in the water. When you drink the water, it just tastes like water and looks like water. Of course, you can mix it with juice or anything else. It’s taken twice a day, roughly every 12 hours, so it’s a packet every 12 hours. That’s essentially what Ovasitol contains and it’s specifically designed to help improve insulin sensitivity and insulin function in women with PCOS.
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| Amy: | I know that there are also some benefits for egg production and fertility for women with PCOS using Ovasitol cycle regulation, can you maybe explain some of the other benefits in addition to insulin sensitivity?
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| Dr. Ratner: | We are still really trying to peel part exactly what’s going on metabolically in women with PCOS because there are different types of PCOS. There are women with PCOS who have a significant amount of insulin resistance and then there are some that don’t. There are women with PCOS who have a great deal of testosterone over-production and then there are some women PCOS who don’t have that. Why is that there are, what we call, different phenotypes, meaning different ways that PCOS can present itself? We don’t really know. Part of our attempt to understand is to get to the level of the cell and understand what’s going wrong in the cells of women with PCOS, why is this happening.
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| To understand the benefits that Ovasitol or the inositols potentially offer, we have to remember what are the derangements, what are the things that go wrong in PCOS? It appears as if much of what happens in women with PCOS does relate to what we call insulin resistance and insulin … the converse or opposite of insulin resistance, which is insulin sensitivity. What do we mean by that? What we mean by that is this. Insulin is a hormone that is produced by our pancreas and then comes out into the blood stream. Insulin’s important function is that it allows our cells to take in glucose and produce energy. In order for insulin to work, what it does is it binds. Insulin’s actually a small molecule, it’s a hormone, and it binds to the surface of the cell at a point which is called the insulin receptor. It’s almost like a lock and key.
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| The insulin receptor is the lock and insulin is the key. It fits into the lock an when the insulin binds to the receptor, it releases what we call second messengers. Those second messengers go into the cells and it’s the second messengers that tell the cell, “Okay, take in the glucose from the blood stream, and start producing energy.”
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| It turns out that what happens when there is, what we call, insulin resistance, is the insulin receptor doesn’t release those second messengers properly. It also turns out that those second messengers are made up from inositols. Inositols, both myo-inositol and D-chiro-inositol, they function in the cell as the second messengers for the insulin receptor.
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| What happens in PCOS is that the balance between myo-inositol and D-chiro-inositol gets out of whack. It turns out that in the ovary, there is too much D-chiro-inositol and not enough my-inositol. In the peripheral tissues there is the exact opposite. In the peripheral tissues, there’s not enough D-chiro and there’s too much my-inositol.
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| What Ovasitol does is it attempts to restore a balance. When it does that, you’re going to get a reduction in the testosterone over-production that occurs in PCOS. You’re going to get improved ovulation, and all of those things occur because you are reducing insulin resistance. What happens in insulin resistance is that if that second messenger doesn’t work, glucose can’t come into the cell and so the glucose builds up in the bloodstream. When glucose builds up in the bloodstream, the pancreas gets a message that says, “Hey, we need more insulin here because there’s a lot of glucose in the bloodstream.” The pancreas responds by producing more insulin.
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| In insulin resistance what happens is blood sugar, glucose, goes up and insulin goes up. This is also what happens in type two diabetes and also in, what we call, gestational diabetes, meaning diabetes that occurs during pregnancy. This is the underlying mechanism, insulin resistance, for not only PCOS, but also for type two diabetes, for what’s called metabolic syndrome in older men and women who have this complex of abnormalities that includes insulin resistances and truncal obesity, elevated serum triglycerides and also this is the underlying mechanism for gestational diabetes.
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| What’s interesting, and keep in mind, for a lot of your listeners, the concept of diabetes may be a little bit confusing. There are basically two different types of diabetes. We physicians, we call it type 1 and type 2. What we’re describing here, insulin resistance leading to too much sugar in the blood because the cells can’t take in the sugar and too much insulin in the blood because the pancreas starts cranking out more insulin in response to the elevated sugar, that’s what we call type 2 diabetes.
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| Type 1 diabetes, just parenthetically, type 1 diabetes is totally different. That’s where the pancreas fails. That’s what we used to call juvenile diabetes, juvenile onset diabetes, or insulin-dependent diabetes. In that situation, what happens is the pancreas stops making insulin. In terms of blood sugar, the same thing happens. The cells can no longer take in the sugar and so the sugar level in the blood goes up. Because the pancreas has been damaged, it doesn’t respond with more insulin, it can’t. The main difference between type 1 and type 2 diabetes is the fact that the serum insulin levels don’t go up in type 1, but they do go up in type 2.
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| In some respect, PCOS, the insulin in PCOS, is very much like what happens in type 2 diabetes, insulin levels go up. It happens that insulin level being elevated, drives the ovary to produce more testosterone. This is like a vicious cycle. When we rebalance the inositols and improve the function of the insulin receptor, we reduce insulin resistance, we reduce serum testosterone, we improve ovarian function, which restores ovulation, improves fertility.
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| Amy: | That was really a fantastic …
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| Dr. Ratner: | That’s basically the mechanism. I’m sorry.
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| Amy: | That was a fantastic explanation.
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| Dr. Ratner: | Good. I do want to also stress the fact that this our best understanding right now, but there’s a ton of research that’s still going on, and one of the things that was recently published is that there are some hormones that come out of the pituitary gland, a hormone which is called luteinizing hormone and another which is called follicle stimulating hormone. We call them LH and FSH. These are pituitary hormones and those hormones actually stimulate the ovary to function. In other words, FSH stimulates the ovary to make eggs. LH stimulates the ovary to make estrogen, and it turns out now that there may be some genetic predisposition having to do with LH and FSH function in women with PCOS. There’s all kinds of new research that’s coming out, but we do not know the full story just yet.
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| Amy: | I have to ask you why is it that so many doctors don’t really understand the benefits of inositols for PCOS. I know I went and had an annual OB/GYN checkup and it was with a new doctor, and I had asked her if she had ever heard of inositol as therapy for women with PCOS. She said, “What is inositol?” I had to educate her on the benefits. Why has this research ….
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| Dr. Ratner: | Yeah, it’s a great question and it’s a strange situation. It’s sort of related to what is jokingly sometimes called NIH syndrome, where NIH is meant to mean not invented here. It turns out virtually all of the inositol research in the past 10 years has come out of Europe. The interesting thing is that the very first inositol study that was published was actually published in the New England Journal of Medicine in 1999. The study was done in Virginia at the University of Virginia and it was published in the New England Journal. It was focusing primarily on D-chiro-inositol, just one of the inositols.
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| The researchers who published that study, they then actually created a company, they were going to go through FDA approval and try to produce D-chiro as a prescription product and make it a drug. They started doing clinical trials here in the states, and for a bunch of reasons having to do with patent law and regulatory stuff, the idea of creating this as a drug and the whole idea of having a pharmaceutical company behind it fell apart.
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| Those researchers, to this day, are still some of the big PCOS researchers in the United States. They have had this very jaundiced view of the commercial benefits of inositols. Interestingly, the inositols, I think part of the reason that the whole idea of pharmaceutical companies getting behind it fell apart, is that it’s a natural substance. It’s a product that we have in our diets and it’s found in nature. You cannot patent, actually, a natural substance. The whole idea of creating this as a drug didn’t really have much of a regulatory foundation to stand on.
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| Today, inositols are a supplement, they’re a dietary supplement in the United States, and there are a bunch of products that are out there. My company produces Ovasitol. Ovasitol is the only one that is actually in that 40 to 1 ratio between myo and D-chiro. The reason it’s a 40 to 1 ratio is because that is essentially the same ratio that’s found in the body between the myo and the D-chiro. The goal here is it try and replicate the natural balance between the two, what we call, isomers of inositol. If you remember your high school chemistry, two molecules are stereoisomers, what it means is that they have the same formula, they just differ slightly in where their bonds are and how the different atoms are attached to one another. Myo and D-chiro are isomers.
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| Amy: | Let me ask you some questions that I get from women when they’re interested in purchasing Ovasitol. I think probably the number one question is can I take this with metformin. I know metformin also acts on insulin sensitivity. Would you take both together?
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| Dr. Ratner: | We have many, many customers that do and I would say that they do so with complete safety. I think that presumably they’re under the care of a physician, otherwise they wouldn’t be taking metformin. Those things that are going to be done to monitor their response, I think, should just stay in place. If the doc is watching their hemoglobin A1C or monitoring their insulin levels or their blood sugar levels or even their testosterone levels, as long as those things are being monitored, combining the two should present no problem at all. We even have some customers, under their doctor’s supervision, have started taking both and then we weaned themselves off of the metformin and stayed just on inositols; again under a doctor’s supervision.
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| Amy: | What about if you are pregnant or nursing? Say you’ve gotten pregnant while Ovasitol. Is that something that you can continue?
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| Dr. Ratner: | That’s a great question and the answer is absolutely, yes. In fact, there are now several studies that have been published over the last three, four years which show a tremendous potential benefit in staying on an inositol product if you have PCOS and become pregnant. The reason is because women with PCOS are at significantly increased risk of developing gestational diabetes, meaning diabetes that occurs, usually, later in the pregnancy. The underlying mechanism of that diabetes is what discussed a moment ago, insulin resistance.
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| The studies that have now been published show that if a woman with PCOS stays on inositols throughout her pregnancy, it roughly halves her risk of developing gestational diabetes. There is a little bit of confusion about the potential for problems if you stay on inositols, and I’ve heard a couple of OB/GYN’s raise this question. One of the concerns, I think, was raised theoretically because it turns out that the inositols also function as the second messengers for oxytocin, which is a hormone in our bodies, in women’s bodies, that is responsible for stimulating uterine contractions. Somebody once, in a paper, raised a theoretical concern that taking inositols as a supplement later in pregnancy could increase the risk of preterm labor if it stimulated uterine contractions.
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| We now have three randomized controlled, placebo controlled, trials that have been published in the last four years looking at the use of inositols through pregnancy. Those three trials in combination have many, many hundreds of patients that have been enrolled in them and there has been absolutely no impact on preterm labor at all. In all three trials, it did reduce the risk of gestational diabetes. I think it’s not only safe, but potentially very beneficial.
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| Amy: | What about nursing, is there any harm to your baby? Does it pass through breast milk or something to be concerned about?
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| Dr. Ratner: | Breast milk contains inositol, and I don’t know that there’s any study that’s ever really looked at that specifically, although I would probably say that if there’s any concern … If you’re going to nurse for three to six months, and you want to stop the inositols at that point, probably no harm in doing that.
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| Amy: | I do get some questions about the ingredients in your little pink package. As you mentioned, it’s really easy to just mix in your … I put it in my morning lemon water. People that have done my jump start program know that I love warm water with lemon in the morning and that’s how I take my Ovasitol. There is a little filler product in there, maltodextrin.
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| Dr. Ratner: | Maltodextrin, yeah.
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| Amy: | I know it helps the inositol flow out of the package.
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| Dr. Ratner: | Exactly, the maltodextrin is just what we call an excipient, meaning it’s not an active ingredient. It’s just really there to help with the production of the product. In this case, the inositols are very, very dry and fluffy and so to try and actually get this blend of inositols into the packet, is challenging and so the maltodextrin is there simply to make it pour more easily. However, we’ve been working … Believe me the amount of maltodextrin is pretty minimal. In terms of calories or anything else, it doesn’t really have much of an impact. Nevertheless, our goal has been to try and have a product that is just simply the inositols, and so we have been working with our manufacturing facility and we’re pretty certain that within a few months we’ll be able to produce the product without any maltodextrin. We’re made some modifications to the way we handle the powder, the inositol powders, that should allow us to get the maltodextrin out of there.
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| I will also point out one thing and that is Ovasitol and Theralogix, all of my company’s products, go through independent, third party content and purity certification. Given that these are dietary supplements, the oversight provided by the FDA of the dietary supplement industry is pretty lax and unfortunately it’s a huge industry and unfortunately the FDA’s ability to police it, is somewhat limited. What we do, is we go through an independent, nonprofit program, which is actually based up in Ann Arbor, Michigan, it’s called NSF International. Used to be, actually, part of the University of Michigan School of Public Health and now it’s a freestanding, nonprofit program. Every one of our products, when we do a production run, we send part of it up to Ann Arbor and it gets tested in NFS’s labs, independent analytical labs so that we can get certification that what we tell you is in this product is actually what you’re getting, no more, no less, and free from any kind of contaminants or impurities.
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| This is especially important in a reproductive time frame. Women who are trying to get pregnant, women who are already pregnant, you want to know that what you’re taking is exactly what you think your taking. Unfortunately, that’s not always assured in the dietary supplement industry.
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| Amy: | Yeah, that’s a really excellent point. These are high-grade nutraceutical products, and there’s a lot of inositol supplements. I hear a lot of women saying, “Well, I’m just using X brand that I bought on Amazon. It might be inositol, but it isn’t that blended form of the D-chiro and myo. You really don’t know what you’re getting often times if it just says inositol. Really great point.
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| I have to ask you. There’s a lot of women that are saying, “Okay, I’m taking Ovasitol, I feel really great, we’re trying to get pregnant, would this be something would benefit my husband?” You being a male reproductive medicine expert, let me pose that question to you.
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| Dr. Ratner: | The short answers no. There is no really substantial evidence of any benefit for male fertility by taking inositols at this point. There are other nutrients that appear to benefit male fertility, but the inositols wouldn’t be one of them.
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| Amy: | Tell us about those nutrients.
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| Dr. Ratner: | The main benefit would be from certain antioxidants. There are number of antioxidants, which are normally present in, what we call, the seminal plasma, meaning the fluid that carries the sperm along. Antioxidants are necessary in the body to prevent, what we call, free radicals. These are molecules that can damage our proteins and DNA, and the free radicals cause that damage by oxidation. Antioxidants, which are normally present in the body, help protect our tissues against damage from these oxidative molecules, the free radicals.
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| In the semen, in the seminal plasma, naturally occurring, in other words, these are the natural antioxidants which are present in the seminal plasma, vitamin C, vitamin E, glutathione, N-acetyl cysteine, coenzyme Q10, selenium. These are naturally occurring in the seminal plasma. It’s been pretty well established that if you supplement those naturally occurring antioxidants, you will improve sperm quality. Not necessarily the number of sperm, but the quality of the sperm.
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| Then there’s a whole other category of nutrients for male fertility, which can actually improve motility. In other words, one of the features that we look at when we do a semen analysis, is what’s called motility, which means movement. When they do a semen analysis, they’ll count … For instance, they say, “Okay, for every 100 sperm, how many of them are swimmers? How many of them under microscope are wiggling their tails and swimming well?” For it to be normal, we want at least 40% of the sperm to be swimmers. Some men have low motility, their sperm don’t swim well, and so there are certain nutrients that can improve sperm motility, the primary one being L-carnitine and another one is also actually one I mentioned a moment ago, coenzyme Q10, which helps with energy production in the sperm.
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| There are nutrients that can help with male fertility, but the inositols wouldn’t be one of them.
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| Amy: | Do you have a blend for …
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| Dr. Ratner: | We actually do make a product. Theralogix actually makes a product that’s being used by hundreds of fertility practices around the company. It’s called ConceptionXR. Actually a year ago we were asked by the NIH; in this case I’m talking about the National Institute of Health and not the other definition of NIH. The NIH came to use a year ago because they are doing a very big clinical trial that is called … I forget the name of the trial now. They always have these really cute little acronyms that they come up with the names of the trial. Oh, it’s the MOXI trial, which stands for males, antioxidants, and infertility. It’s being done in six university centers around the country. They are looking at couples with male factor infertility and they’re randomizing them to either placebo or antioxidants and they came to us a year ago and are actually going to use ConceptionXR as the antioxidant intervention.
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| We’re actually producing the placebo, as well as the antioxidant ConceptionXR for then to use for this trial. The trial’s going to take four years and many millions of dollars to carry out, but we’re excited, and it’ll be a few years before we get the data from that trial, but we think it’s going to be pretty exciting.
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| Amy: | That’s wonderful to get that NIH trial. It would be great if we could that for Ovasitol as well someday.
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| Dr. Ratner: | There’s actually a clinical trial that’s going on with Ovasitol at USC. We’re hoping that there’s going to be a gradual increase in the amount of US-based interest in doing clinical trials with the inositols in PCOS patients. Again, because there’s certain, what would you call it, chauvinism about research that’s published from elsewhere from US clinicians. There’s a tendency to think that if it’s not published in some US-based journal, that somehow it’s not as important or as meritorious. We’re hoping to get some research, more research, underway here in the States on inositols as well.
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| Amy: | Do you know if they’re still recruiting for those trials for the MOXI and at USC?
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| Dr. Ratner: | The USC trial, University of Southern California, is absolutely still recruiting. They are actually doing a clinical trial where they’re going to be looking … They’re doing the trial in women who are undergoing IVF. What they’re doing is they’re either placebo or Ovasitol and they’re looking at the hormone levels in what’s called follicular fluid. When a woman undergoes IVF, when they extract her eggs, that egg extraction, that egg retrieval, is done by draining fluid from the little ovarian follicles. The fluid that the egg is sitting in in that follicle is called follicular fluid, and it actually reflect the chemistry of the ovary. In other words, the health of the ovary is much reflected in the chemistry and the content of the follicular fluid.
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| They’re looking at not only the IVF results and the egg quality, but they’re really looking at follicular fluid in response to treatment with inositols. That’s the USC study and it is still, I believe, enrolling.
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| Amy: | Great, well we’ll post links to those studies, as well as your product ConceptionXR. I just wanted everyone to know on the call that I do take Ovasitol every day, and I’m a big fan and supporter. I actually have it available in my PCOS Diva store. If it’s something that you’re interested in, check it out. There’s lots of other articles, we’ll provide links to those on PCOS Diva about inositols, in particularly Ovasitol. Dr. Ratner, thank you so much for your time today.
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| Dr. Ratner: | Amy, thank you for having me. I was happy to chat with you today. By the way, if anybody has questions directly about Ovasitol that they want to have us answer here at the company, we’re happy to respond by email or by phone.
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| Amy: | Great, I’ll also put the contact information at the of this podcast. Thank you everyone for listening. I have some great guests lined up in the next month. We’re going to be talking to Dr. Nancy Dunne. She was really a PCOS holistic alternative approach pioneer. She’s a naturopath doctor, and we’ll be talking to her, as well as Dr. Rashmi Kudeshia about IVF and the PCOS patient.
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| Thank you again for listening, and I look forward to being with you again soon. Bye-bye.
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