Tubal factor infertility FAQs, covered live

Understanding tubal factor infertility: the essential FAQ

We had the pleasure of chatting with Kathy Lee-Sepsick, the Founder of Femasys, to learn about the signs and symptoms of tubal factor infertility.

We also chat through the Femasys testing and diagnostics product, FemVue – this  groundbreaking device allows your doctor to easily check your fallopian tubes in-office as part of your initial infertility work-up.

Your questions about tubal factor infertility

• Recognizing signs and symptoms: fallopian tubal blockages may go unnoticed as they don’t present with signs.
• Exploring links to pelvic conditions: Kathy tells us how they’ve introduced an excellent diagnostic product that facilitates assessments of fallopian tube health. Once we fully understand the connections to pelvic conditions, it can help us in comprehensive diagnosis and treatment planning.
• Navigating your options: armed with insights from FemVue, you can explore tailored treatment options.
• Promoting your empowerment: educating yourself and being aware will play a crucial role in empowering you to navigate your fertility journey with confidence.

Once you’re informed, have access to innovative diagnostics like FemVue, and are part of a collaborative care team, you can take bigger strides toward overcoming tubal factor infertility. And we, at TRB, are committed to supporting you every step of the way!

Learn more about the FemVue test on the Femasys website, and access education, support with initiating conversations with your healthcare provider, and more.

Transcript

Eloise Edington

Hi, welcome everyone. I’m going live today with the founder of Femasys, Kathy Lee Sepsick, who will be sharing invaluable information about tubal blockage and how to discuss this with your physician. Here she is now, so please have your questions ready. Welcome to those who are joining. Hello, Kathy, welcome!

Kathy Lee-Sepsick

Hello, thank you so much for having me. It’s an absolute honor to be here today. 

Eloise Edington

We’ve met multiple times at fertility conferences around the world, and I’m thrilled that we can bring your expertise on tubal blockages to our audience. Everything you’ve accomplished as the founder of Femasys is incredible. Please introduce yourself.

Kathy Lee-Sepsick

Thank you. I’m Kathy Lee Sepsick, founder, president, and CEO of Femasys. I started this company with the mission of advancing women’s health products in critical areas lacking innovation. I’m excited to discuss one of our products today.

Eloise Edington

Great, and the product is FemVue, correct?

Kathy Lee-Sepsick

Absolutely. 

Eloise Edington

If anyone has questions while we’re talking, please feel free to ask Kathy. To start, how do you define tubal factor infertility, and is it the same as having blocked fallopian tubes?

Kathy Lee-Sepsick

Yes, it is in fact the same thing. Tubal factor infertility is often undiagnosed, and we’ll discuss potential symptoms and related issues. It’s a prevalent issue—around 30% of women struggling with infertility may have one or both tubes blocked.

Eloise Edington

And people may not know they have blocked tubes, right?

Kathy Lee-Sepsick

Correct. Generally, they are asymptomatic, with no indication of the issue. Unlike other infertility factors that present clear signs, tubal blockages can go unnoticed. 

Eloise Edington

Some people even start IVF treatment without checking their tubes, potentially missing the chance to conceive naturally.

Kathy Lee-Sepsick

And generally, if they’re at an infertility specialist, at that level of treatment and care, checking the fallopian tubes is a baseline requirement. It’s really outside of the infertility care. If they’re at a OGYN, are they having all of their factors evaluated as part of their treatment planning? Because it definitely changes the course of how you would approach your journey if you don’t have all the answers.

Eloise Edington

Would you say that it is common that people, especially in the States, when they’re starting treatment, would have these tests done, or is it often later down the line that this might be something that’s looked at?

Kathy Lee-Sepsick

I mean, one of the reasons I advanced FemVue was to change the point of care for this test. So prior to FemVue, a female could have all of her potential infertility factors evaluated by her GYN, absent her tubes. It required a referral to a radiology center; it’s costly, it’s a separate visit, and it also bears some risk because there’s radiation exposure for this extra test. So for all those reasons, oftentimes women wouldn’t get that test, and so they’d have part of the answers, and they would potentially be prescribed medication or other things that maybe wouldn’t be the right course had they known the answer.

So, FemVue changes that because we add on to the existing ultrasound exam so that all the factors can be evaluated in the same visit. This ultrasound is definitely more prevalent in your country where you are, in Europe, in Canada. I would say the US is unfortunately a bit behind, particularly from a GYN standpoint, but, you know, in the discussion with FemVue, this helps make a complete exam so she has everything done in an affordable way at the same time.

Eloise Edington

And if anyone watching has had experience with, you know, having blocked fallopian tubes diagnosed or having this testing done, please do share your experience. 

A question for you: Can someone have both tubes blocked at once, and what’s the difference between proximal blockage and distal blockage of the fallopian tubes?

Kathy Lee-Sepsick

So, a woman can have both tubes blocked, called bilateral blockage, but oftentimes she has one blockage, and for fertilization to occur, she only does need one operable tube. So she can still get pregnant naturally or even with enhanced treatment modalities with a single tube.

Location of a blockage, proximal or distal, is just where in the tube that block exists.

Eloise Edington

Because we do see patients, of course, don’t we, who may have had an ectopic pregnancy and have lost a tube. So then, obviously, there’s a concern around can they still conceive naturally with one tube or through IUI.

Kathy Lee-Sepsick

And sometimes the treatment plan is to remove a tube, right, if she has susceptibility to that, or to put something in the tube to prevent a pregnancy from occurring, you know, on that side.

Yeah, important. So that baseline diagnostic test is important so they know which tube is actually viable.

Eloise Edington

Absolutely.

How does FemVue work as a product in a physician’s office?

Kathy Lee-Sepsick

So, ultrasound is the basis for the imaging. FemVue creates a natural saline and air contrast that allows the physician to evaluate the fallopian tubes. When they evaluate the uterus in contrast, they use just plain saline, because they want—and saline presents itself as black under ultrasound, so they’re able to see any issues in the uterine cavity because they put saline in, and that’s standard of care. 

But you cannot see the tubes if you’re filled with saline. So FemVue uniquely puts a train of bubbles in a consistent manner. It allows that train to go into the tube, so we can evaluate whether or not she has an open tube or if, in fact, she’s blocked.

So it can be, like, again, added on to that existing exam where they look at the uterine cavity and then subsequently can look at the tubes.

Eloise Edington

Okay, amazing. And do you find that lots of physicians are using the product? So is it something that’s becoming more commonplace around the world?

Kathy Lee-Sepsick

So, you know, we, as a company, we’re small and we’re emerging, and we have dedicated most of our dollars up until recently to our clinical programs as we advance other products. So we are just at the impetus of formalizing a commercial team to allow for us to bring this product forward in a more significant way in the US, and we are partnering with others outside the US. We are undergoing the CE mark process for Europe, and we already have Canadian approval.

And this has started as part of our process because of our FemVue product therapeutic option that requires at least one tube be open. As we take that next step in therapy after FemVue for diagnosis occurs, we then have an option where women could have sperm placed directly in the open tube.

So the two products go hand in hand.

Eloise Edington

Absolutely.

Could people who might be watching who are potential patients or soon-to-be patients or current patients take this to their physician, to their center, and say this is something that I would like to try?

Kathy Lee-Sepsick

Yeah, and we’re at the point where FemVue has been available in the US market and in other select markets. So in these markets, yes, she can go to her practitioner and say, “You know, I’m interested in having this type of exam instead of having a referral to a radiology center.” We also have a practice locator on the website, so patients can put in their zip code and be presented with practicing locations where they could go for the exam.

Eloise Edington

And we have linked up your website in our bio, so please do check it out for anyone who is interested in finding out more, because it will obviously be of great support and help to so many people who are watching this.

This is a question I’ve always wondered to know, like, would someone normally have any signs or symptoms that they may have a blocked fallopian tube?

Kathy Lee-Sepsick

Asymptomatic generally, so no symptoms at all, which is the concerning part because it could be the culprit, and you just have no signs that it’s occurring.

And I know you, I think you’re probably going to ask me, like, you know, what other ailments, what could cause it?

It could be pelvic inflammatory disease, sexually transmitted diseases like syphilis or gonorrhea, could be endometriosis, which could be diagnosed within the cavity, but it could affect the tubes. It could be, like, as you mentioned earlier, that she had an ectopic pregnancy, and that caused blockage in her tube, or she had some abdominal surgery that caused scarring. So there are other issues, but blocked tubes in it of itself don’t generally cause any symptoms. The symptom is she isn’t able to get pregnant.

Eloise Edington

Yeah, yeah, absolutely. And say someone is using the product and that’s identified as a problem, what would be the course of treatment?

Kathy Lee-Sepsick

It really depends on her situation. So that’d be something her doctor would have to look at; the physician would have to look at the complete story. In combination with something else, it may require a different treatment plan. If she only has one operable tube, it could be that she’s a perfect FemVue candidate, and that intratubal insemination is the next appropriate step for her. So all of those things would be on the table, but each individual has such an individual journey that there could be other factors involved.

What I will mention, however, is if someone has mucus in their fallopian tube and they undergo this test, it is a known potential benefit that FemVue or even if she had the radiology exam, that high pressure from trying to evaluate that tube could move mucus out of the way. And some have had pregnancies as a result, more of a flushing effect. So that is, again, a known side effect and potential benefit. If it’s a true blockage of ingrowth of scar tissue, that’s a different treatment plan.

Eloise Edington

Absolutely fascinating what you’ve created. I’d love to know a bit more about how you got into this field and where this originated from.

Kathy Lee-Sepsick

So, I have a long history in MedTech, and I decided to start FemVue Assist 20 years ago. It was a very deliberate decision—I’m the lead inventor on all of the products, and I’ve looked at areas where I thought, “Why are there not better options?” Why are we leaning on hundred-year-old technologies and saying that’s okay? And I get it—the journey I’ve had for 20 years has been challenging from a fundraising standpoint and keeping the company afloat. When nobody really, you know… they say they care about women’s health, but stepping up and really doing something about it has been a void. And so these innovative products are so, so very important, and we find ourselves with no competitive threat. We’re addressing areas where there are big voids. 

So it’s a mission of passion. I think as you age, you always look for something more; it’s not just work, it’s how you leave something behind. And this is my leave-behind. I still have a lot of work to do to make sure that we get all of these types of products—they’re all innovative—the ones that we’re working on. And how do we move the needle for women? How do we make sense of the options that they have laid out in front of them so that we have better care and can address these major issues in the market?

Eloise Edington

Absolutely, that’s absolutely amazing. And I also wanted to ask you, for people who are reading, watching, or finding out more about this incredible option that you’re giving people, at what stage in their fertility journey should people be exploring tubal factor as a potential cause of not getting pregnant?

Kathy Lee-Sepsick

Right at the very beginning. It is a baseline diagnostic test. So if you’re approached by your physician and they’re not checking all your factors, it’s up to you—women are empowered to ask. You want a complete view of what your issues may or may not be, check the boxes, and make sure all of those factors are being considered before a treatment plan is laid out for you. 

So, empower yourself, learn; there are lots of resources out there. But tubes are a critical part; conception happens in the tube. So if you have blocked tubes, it’s never going to happen unless you come up with a treatment plan. Most of the time, it’s a unilateral blockage, a single tube that’s blocked. So options aren’t cut off; it’s just a different way to approach the next part of the journey.

I’ve also seen patients that are advancing in their years and want to know that all their reproductive organs are working the way they should be. I’ve seen patients go in and say, “I just want to know that I could get pregnant,” and that could be an appropriate test for that person as well.

Eloise Edington

Absolutely, absolutely, a really good point. And also, like we touched on before—and I know we’ve talked about this when we met in person—if people can avoid going down the full treatment route of needing IVF, for example, without needing it, if it can be resolved through tube blockage, for example, that means people don’t necessarily need to spend the money, the time, or put their body through the injections, medication, etc., to go through the IVF process.

Kathy Lee-Sepsick

Agreed. I think you always want to address the problem in the least risky, least costly, least invasive way first. And time is always of the essence—we know this, as you and I have intimately spoken to women who are going through their own personal journeys. 

So yes, but don’t skip steps because it’s important to make sure that you do these exams and know what your actual situation is, to ensure that the proper treatment plans are laid out, and for you to make the best choice.

Eloise Edington

Do you think that this would be a good thing for people to speak to their physicians about if they’re about to do IUI, for example, as well?

Kathy Lee-Sepsick

100%. You cannot get pregnant… you know, IUI deposits sperm into the uterine cavity, and if the tube is blocked, it’s not going to work. With FemVue, we have the next approach beyond a standard IUI, where we put sperm directly into the fallopian tube. In that case, we need to know which tube is operable. If she only has one operable tube, where do we put it? 

Further to that, if she’s ovulating, which side is she ovulating on? Stack the odds in your favor—the journey is very clear from a biology standpoint; the sperm needs to make it into the tube to conceive. So how do we ensure that that happens? The tube is an integral part of the whole solution.

Eloise Edington

And you don’t want to waste the sperm as well.

Kathy Lee-Sepsick

Agreed, absolutely. 

Eloise Edington

If anyone has any questions for Kathy, please feel free to ask. What is the current standard for diagnosing blocked tubes in the U.S.? You’ve touched on it, but tell us a bit more about the current approach and the need to change, and maybe how we’re a little more advanced in the UK and Europe. Tell us a bit more about that.

Kathy Lee-Sepsick

So, I guess what would be considered the standard of care is an x-ray exam called a hysterosalpingogram, or HSG. This requires a referral to a radiology center, and a radiologist generally performs it. It exposes the patient to radiation, and they have to use a radiopaque or x-ray dye, which is sticky and viscous. Those are some of the clear advantages of FemVue, as we use a natural contrast with saline and air, which is not sticky, travels easily through the tubes, and utilizes ultrasound. Importantly, she stays with her same practitioner, as every OB-GYN and infertility specialist has ultrasound as a core part of their practice. 

All of this allows them to use their existing equipment and move the test. But that’s the current test, and fluoroscopy is used for the heart and other areas of the body, but only for looking at the tubes because standard care uses ultrasound and saline to evaluate the cavity. The tube is the part that can’t be seen without FemVue.

Eloise Edington

How long would the procedure typically take?

Kathy Lee-Sepsick

It depends on if it’s an add-on. Let’s say they’re doing an ultrasound to look at her ovaries or evaluate other things. The exam runs about 10 minutes from start to finish. They can evaluate the cavity, then replace the syringe with FemVue, deliver the bubbles, look at the tubes, and it’s done. So it’s a quick exam.

Eloise Edington

Will it show the physician if there’s a problem or not straight away?

Kathy Lee-Sepsick

Straight away. We’ve had patients study the website and know what it looks like because they can see the ultrasound images, and they’ll be like, “Whoa, look at that!” Sometimes, the physician has to work for it a little bit. They might have free flow on one tube and need to assess the other, but that’s part of the course of the procedure, and it’s pretty fast.

Eloise Edington

That’s good to know. We’ve talked about other testing available and why people should ask their physician about FemVue’s products. Is there anything else people should know about why it’s worth mentioning?

Kathy Lee-Sepsick

In summary, it’s about completeness. If you’re undergoing an exam for other potential factors, it’s better to have it done simultaneously. If your tubes need re-evaluation, so be it, but at the beginning of your journey, it’s a critical factor that should be evaluated, and you shouldn’t have to go to a second place. It’s more expensive, it’s a foreign doctor, it’s a referral, they have to insert a catheter again—all things that, if done simultaneously, benefit the patient in terms of cost, affordability, convenience, speed for treatment planning, and knowing the results to create a treatment plan faster. 

You know, when you go to a radiologist, you have to wait for the report. Yes, you have to check in again. There are all these time elements and extra inconvenience and aggravation and all those things, and again, crossing your cervix and putting another product into your body. You know, once you’ve already had another exam, two separate exams as opposed to an add-on to an existing exam. So those are all, you know, really important reasons to at least explore it as an option.

It may be that because the company is small and because we haven’t had a sales force, the doctor doesn’t know. You know, they’re able to train online, it’s that simple of a procedure, and we can, you know, attend to them and be able to get them to be effective and be able to offer it to their patients very quickly. 

Eloise Edington

If it was me and I was having this checked, I would probably, and was potentially struggling with unexplained infertility, I guess there might be a sense of relief that comes with it, knowing that an issue has been identified so that you can work on a plan to, get it sorted or, move on to your next stage or whatever it might be to sort of move along with the process of trying to conceive.

I think there’s also relief in knowing when there’s not an issue.

Kathy Lee-Sepsick

Yes, of course. So checking the boxes is just an important part of the initial journey—just knowing that things are functioning the way that they need to. And again, things can change over time.

If you’re in the journey for a long time, or even in cases of secondary infertility, you’re surprised, and it happens. We have lots of patients that have secondary infertility where they conceived once before and don’t understand why things have changed over time. So it’s really important to check the basic factors.

In addition to the male’s sperm count, right? So the male’s part of this equation too. But all of those factors for the female, this is part of her baseline diagnostic test, and it should not be overlooked. 

Eloise Edington

I think secondary infertility is a really good point because it’s very easy to assume that because it happened before, it should be fine to happen again. But as you said, things can change, especially over time, or whatever the circumstance might be. So I guess it’s about covering your bases, as you said, getting checks done sooner rather than later, and making sure that no steps are being skipped so that you’re following the right protocol to get you to where you want to be.

Kathy Lee-Sepsick

Exactly, I couldn’t have said it better. 

Eloise Edington

Well, thank you so much, Kathy. Is there anything you want to leave us with today as people go to our link in bio and check out more about FemVue and the product and potentially bringing up this conversation with their fertility specialist?

Kathy Lee-Sepsick

We as a company, our mission has been the same for 20 years. We’re looking to help women, bring options, accessibility, and it’s really about empowering yourself in your personal journey. And making sure, you know, we are trying to offer these solutions, but it’s really about what’s best for you. Looking at things that are safer, less expensive, convenient, reliable, all those things that are important—these are the things that should weigh into the decision-making. 

If there are questions, send them along our way. And we have other products to come, so we’re appreciative of the support as a company as we continue as a small company trying to make a big difference in women’s health. So appreciate the time and the interest.

Eloise Edington

Absolutely, and it’s so nice to be speaking to someone who has the same goals of empowering women to help with getting you to where you want to be in terms of women’s health.

Kathy Lee-Sepsick

Absolutely. 

Eloise Edington

All right, well, thank you so much for your time, Kathy, and thanks to those who have joined and are watching back. Please do check out our link in bio to find out more about testing for blocked tubes and the product FemVue to help with a solution for this. Thank you very much.

Kathy Lee-Sepsick

Thanks! Bye.

Want to hear more from Femasys?

Read this next: Blocked fallopian tubes diagnosis – ask your team about the FemVue Test