The Book on Legacy Fertility Operations

When families head to Disney for their once-in-a-lifetime vacations, their “magical experience” is no accident. The company is famous for handling every detail — from building miles of underground tunnels to hide utility and operations to painting distant buildings a specific color designed to fade into the background. Visitors never see the effort that goes into making their stay magical and never will.

Legacy offers a straightforward service: Test your sperm from home and freeze your best samples until you’re ready to start a family. But like Disney, what goes into this straightforward service is much more operationally complex. People dramatically underestimate just how complex sperm is — it’s a time-sensitive, temperature-sensitive biological material that requires Legacy to consider every possible detail to handle and transport.

We’re the largest fertility clinic in North America by volume and also the largest sperm bank. We accomplish this while providing convenient and comfortable at-home testing and an unparalleled customer experience. Let’s peel back the curtain to find out exactly what happens to your sperm from the moment you decide to work with us.

We started this process long before you thought about ordering a kit

We began orchestrating the smoothest, easiest experience with top-quality products long before you ever considered Legacy. The kit you receive in the mail required years of research, relationship building with suppliers, and input from our medical experts, product developers, and operations team.

The most significant piece of our operational puzzle comes from our relationships. Whether it’s our lab experts, supply chain partners, or our fantastic warehouse manager, a people-first approach to supply chain and fulfillment helps us overcome the typical challenges.

We source materials from all over the world. As you can imagine, we’ve navigated a whirlwind of complexity in the supply chain — static ocean shipments, customs challenges, two-year back orders, and discontinued products. You name it, and we’ve experienced it. What sets us apart from others is just how hands-on operations is in watching every step of our supply chain. We’re ready to make mountains move if it means getting your kit precisely as it should be exactly when we say it should arrive.

For example, during COVID, our manufacturer in China was massively delayed on a shipment. A delay like this would typically mean receiving an apology email stating that your kit wouldn’t be arriving. Other companies might even sweeten the blow with some kind of discount code.

We took a different tack. Our Head of Operations woke up at 4am to call our contact in China every single day for 2 weeks straight until we finally got through. We worked with another Y Combinator company to send men on motorcycles (not a joke — thank you, Assembly!) to the warehouse to ensure that the work got done and the shipment was issued on time.

Once we worked out the obstacles overseas, we had to smooth and expedite customs in the US. We worked directly with government officials in LA to get our shipment released so that we had kits arrive on time. Throughout this entire process, including all of COVID, there was only one single day where we could not ship out kits.

Even building our labs required years of expert input and hundreds of hours of sourcing

Our labs are state of the art and exceed industry standards.

That’s something nearly everyone says, but in our case, we’ve done nearly the impossible. If our operations and product strategy is like the Disney of the fertility world, building a lab and hiring talent to run it is like the most complex Sudoku puzzle you’ve ever completed. There are so many moving parts and pieces that have to fit together just right.

The physical lab

The first piece of the puzzle was the physical location of the lab. Just pick a large major city with tax benefits, right? In reality, nothing could be further from the truth. Instead, we needed:

• A location close to our largest demographic so that we can manage delivery speed for the kits. We did extensive research with a major real estate company into where our customers are located to narrow down locations.
• A location outside of known disaster areas–no earthquake zones or tornado alleys that could wipe out your valuable samples.
• A lab-ready space inside our ideal locations. Even a little detail such as one or two steps would prevent our cryotanks from safely moving into the building, and it’s amazing how many buildings have stairs!

We conducted extensive site visits to get to know the area and ensure our lab equipment and your samples would be safe. From there, Legacy entered into negotiations with the site authorities to secure the location for our purposes.

Now that we’ve found our Goldilocks location and all of the pieces fit together, it’s time to build the lab. Our team included six or seven individuals–architecture teams, building experts, and science experts to plan the layout of the lab down to the smallest detail. Where should emergency showers be? How high are the tables? What is the optimal workflow that reduces human error as much as possible? These are serious considerations when handling biological materials.

The building materials themselves are also a lengthy consideration. We can’t just run down to the closest home improvement store for flooring. Everything from the windows, to the flooring, to lighting must be medical grade safe, with CLIA and FDA regulations by themselves.

Next, we had to go through licensing requirements at the federal and state level. To further complicate things, each state has its own licensing requirements that we had to find out through a ton of research. The process of outfitting a lab and receiving certification could take a minimum of six to nine months from the moment we start. If one thing goes wrong, we start over.

Legacy wasn’t satisfied with taking other people’s word for what equipment to use in our labs either. We are the first fertility company we know of to conduct large-scale, real-world trials of 10+ pieces of hardware to find out which tools offered the best results, the easiest usage, and the most affordable costs for what we do.

Our team members went on-site and coordinated with multiple supply chain manufacturers (and you remember how much goes into that with our operations section above) to ensure that the equipment and all related materials down to the smallest pipettes would be delivered at the same time to this test location. After all, one missing piece means the entire process doesn’t work .This means dozens of items, each with different lead times, manufacturers, and supply chains, all arriving within a day or two of one another.

The team proceeded to spend several weeks working with this equipment before making a final decision on what to purchase for our new labs. We didn’t rely on the manufacturer’s reported range for results. We created our own experiments and documented real comparative results from each equipment piece.

We found the machine that provides the broadest parameter range with the greatest precision. We chose the machine that performs well with the lower level semen parameters many of our clients come to us to measure. Legacy isn’t interested in reporting simple “less than…” parameters; we can provide a specific measurement. Some of these numbers may seem trivial, but specificity can impact the decisions clients make with their clinicians — and ultimately, whether they are able to have a family.

We’re publishing our study soon. It’s the first of its kind and we are proud of the lengths our teams will go to in making sure we deliver an experience and results like no other company on the planet.

The people

As many details that go into creating a lab, there are exponentially more considerations for the people. Our relationships form the bulk of our superpowers and the search for a lab director, general lab supervisor, and lab technicians are no exception.

Do you know what goes into hiring a lab director? This is a highly specialized field — as in, only a handful of people exist with such stringent qualifications. You’d need decades of experience, certifications, and education to even qualify. In addition, each state has its own, sometimes confusing, standards and no one communicates these requirements in a simplified checklist. It took us months to sort out what we needed and then to find exactly the right candidate.

Lab directors are only allowed to manage a certain number of labs–maybe it’s two or as many as five. Not per company. At all. So even if we find someone, it’s possible that they’re already almost at capacity and couldn’t manage every location we needed.

So we need a unicorn candidate with qualifications that match the state where our lab is located and with the capacity to run the labs we need. This process also took us months.

A general lab supervisor isn’t quite as complicated in that perspective, but they still need to be a unicorn candidate. We need someone who understands the pace and nature of startups in addition to fertility lab design and direction. And they must be up for the challenge of being a team of one for a long time until we get a lab up and running with a full staff. Not everyone in the traditional fertility world is willing to jump into the world of startups.

Finally, our lab technicians must be experienced and knowledgeable of the fertility industry and its processes, as well as willing to jump into a startup environment. This isn’t traditional fertility clinics with slow timelines and bottlenecks. We are delivering the Amazon one-click, Disney frictionless experience in a Sudoku world. They have to be ok with how that alters their work environment.

Now that we’ve handled every single detail, it’s time to order your kit.

Once we have our materials in place, we have to get your kit to you quickly and safely. First, operations collaborates with product and other internal teams to purchase suitable materials and design kits that live up to our standards. They work to put the puzzle together — high-quality materials plus what materials we can actually purchase and from where plus moving those materials quickly across an international supply chain.

These are not standard kits. We had to create something entirely different from the very beginning. For example, while we offer free at-home pick-up for our clients, some folks prefer to drop off samples themselves, either at a shipping location or through a dropbox.

One of the unexpected operational challenges we found was that our original kit didn’t fit every dropbox in every city — as certain major cities have slightly smaller dimensions for their dropboxes! This meant going back to our manufacturers to redesign the kit, ensure it fits into every dropbox in every city in the United States, and ultimately lead to a better client experience for all involved.

In another example, we couldn’t get our hands on our gold-standard collection cup thanks to a plastic shortage. We went on an absolute rampage —calling manufacturers in multiple countries, sliding into folks’ LinkedIn DMs, and showing up at suppliers’ offices to see how we could secure the cups we needed. We were able to set up an individual production run for us specifically, meaning that we were able to use the highest-quality collection cup, which has 52% less leakage than its alternatives.

Beyond the kit itself, Legacy operates within a 100k square foot warehouse. Outside of the normal operational challenges that come with fulfilling out of a 3rd party logistics warehouse, each analysis kit requires several levels of QC and meticulous attention to detail. We have a right-hand woman there who uses her expertise and personal involvement to ensure that each step is followed to the letter. Operations keeps a close, meticulous eye on each shipping stage in and out of this warehouse to complete the loop.

More specifically, this means spending time on-site, working side-by-side with staff at the fulfillment center, to rework and optimize every step of the kit preparation process. Our goal was to create the most efficiency, minimizing the number of touches necessary for a kit to be ready for shipping.

One of these considerations is temperature. Each day, components are picked and brought to the preparation table. Given the temperature requirements of different components of your kit, certain components are required out of our Just-In-Time inventory and thus have to be picked and packed brand new each day to ensure they are never exposed to temperatures outside their acceptable ranges.

As a result, we also expedite the shipping of our analysis kits. This comes with a web of challenges on its own. Some shipping companies operate more effectively in certain cities or states. And so we decided to integrate our technology with multiple shipping companies, saving us $500,000 in yearly costs, reducing delays by 7%, and leading to a higher NPS with happier clients.

Today, you can request a pick-up of our kit from your home just by scanning a QR code and clicking “I’m ready for pick-up”. We handle the rest ourselves, and provide ongoing status updates on your client dashboard, without you even having to think twice.

Technology ensures that quality control and privacy are a well-balanced guarantee

Once your kit arrives at our location, several coordinating operational procedures are in play that ensure privacy, the most intensive analysis available, and continued quality control.

We protect your privacy and the sanctity of your sample

There is nothing more important than ensuring the security of your sample, and so this is an area of particular focus for us.

Your particular kit has a unique bar code assigned to you and only you. The barcodes are scanned and must match exactly to ensure the kit is going to the right client. This is a rigorous process but inevitably leads to the most accurate output possible, so that once you’ve produced your sample, we arrive that same day to whisk the kit back to our lab and verify that its yours.

Your unique QR code provides a unique yet anonymized and encrypted identifier that protects your privacy while ensuring no samples ever get mixed up. The identity of samples arriving to the lab is validated by matching information present on the QR code and shipping label. This closes a quality control loop that was initiated at fulfillment and transport. We use military-grade encryption, including SOC 2 compliance (the highest level), partly because we freeze the sperm of the US military, including the Navy SEALs, which means we are held to military-grade security standards.

Once at the lab, our technicians scan the QR code of each sample, providing information on the persona associated with that particular client — you. We take an additional step to make sure that the sample has not spent too long in transit, or been exposed to temperatures that were too high.

When it comes to the analysis, we’ve developed our own SOPs that meet and exceed any fertility clinic in the country. We analyze your sperm using a systematic and reproducible process, along with automated and manual quality control for all results. This is necessary because we handle exponentially more sperm samples than most fertility clinics.

We also test for more factors than most clinics including volume, count, concentration, motility, morphology and even DNA Fragmentation. Ultimately, you’ll know that you receive clinic grade semen-analysis from Legacy, along with every other client we’ve serviced that day.

The analysis itself is unprecedented for fertility labs, much less an at-home choice

This diligence also applies directly to sperm analysis, where Legacy reviews 15 different parameters to confirm accuracy with individual values as well as how those values were generated in the semen analysis. Computer-assisted analysis supports our lab experts — computers never get tired or have an off day.

We offer more advanced sperm testing options than any other at-home kit and even many conventional clinics. Our sperm testing includes a post-thaw analysis and a quick freeze-and-thaw of a small percentage of your sperm to give the client a better understanding of what their sperm’s viability will be after it has been frozen. No one has to wonder if their sperm will be viable after being frozen for the short or long term.

We account for a hundred minor challenges when it comes to analyzing sperm, like a temporary bump in motility that happens when placing sperm on the slide — an action that “activates” sperm and can skew motility results if not accounted for.

Your analysis includes:

• Volume: How much semen you’re producing
• Count: The total number of sperm in your sample
• Concentration: The ratio between semen and sperm
• Motility: How many of your sperm are actually moving, a metric not included in other at-home sperm count tests.
• Morphology: How many of your sperm are the proper size and shape.

Plus, we provide the option to add a sperm DNA fragmentation analysis, an assessment of your sperm’s genetic health, which may illuminate deeper causes of fertility difficulties. Combining this optional metric with our standard analysis gives you the most comprehensive picture of your sperm health and fertility. We are the only at-home sperm test to offer this option and one of just a handful of physical labs to do so.

Our labs are state of the art, even among traditional fertility clinics

Legacy performs daily quality control checks to guarantee that analytical machines (i.e., the CASA machines) are reading samples accurately and reliably. This specific step is included in our SOPs and leverages manufacturer-designed accubeads to validate that the machine is reporting count accurately. This is an absolute standard for all labs and Legacy follows these quality control SOPs to the letter despite our unique operating model.

For motility, we use pre-recorded motility analyses to test that the machine can read the correct level of motility day after day at precise levels.

In parallel, we calibrate all pieces of equipment in the lab. This concerns pipettes, pro-pipettes, microscopes, centrifuges, and all other equipment down to the smallest pipette. Technicians from our equipment providers come twice a year to validate the calibration of all the equipment. This guarantees that the protocol is completed precisely the same way for each successive client. Consistency is key!

For example, when you pipette 10uL with a pipette, it will always be 10uL. When the centrifuge is set on a program of 20K rpm for 10min, you get the exact same number of rotations each time you use it under these settings. This guarantees consistency in our SOPs.

Plus, our labs are CLIA registered. This implies that CLIA will come and inspect our lab once a year and is shortly followed by the FDA completing an audit of its own. During this process, the CLIA inspector reviews everything — personnel qualifications, training history, machine calibration, protocol reliability, sample storage, accessioning process, and procedure completion.

Legacy uses computer-assisted semen analysis (CASA), and there are only a few FDA-approved machines. We follow CLIA guidelines to create a validation study–we analyze first by hand to establish the gold-standard baseline and then test that against CASA. We do that over several standards to verify that the data is reported the same. Basically, is our machine as good or better than manual processes? We complete each of these parameters to ensure accuracy of our tests.

Where Legacy went above and beyond this gold standard by testing our own machines. We created a research project to analyze donor samples (ever tried buying sperm samples?) using several different machines. We were able to determine which machine offered the most accurate results for Legacy’s specific operational context. We were not satisfied with just industry standard accuracy. We wanted results that were as accurate as possible to help our clients make better decisions.

Every single process within the lab is up for continuous improvement. The analysis we do is one that has been established for decades. Legacy asks “are we doing these analyses in the best way possible?” Everything from how long to wait before placing a sample on a slide after transport to how long to leave samples in the refrigerator before freezing–we do not take any protocol for granted, even those that have been around for decades (in fact, especially when that process has been around for decades). Every little process or component in the lab matters. This is what allows us to bring the male fertility world out of the 1970s and into the 21st century where it belongs.

Storing your samples is a multi-location operation with fail-safes straight from a heist movie

Once your sperm analysis is complete, our medically-trained experts review the results to ensure consistency and to check for any outliers. Once that’s done, your results are “approved”, and you’ll receive your results through your personalized client dashboard. The technology that creates your dashboard in real-time accounts for about 96,000 permutations of possible results, including hundreds of specific edge cases that our team has studied and provided solutions for.

All results are put through an automated quality control test to check for errors or abnormalities. We have a staffed QC specialist whose job is to manually review results for errors or abnormalities that the automated test may have missed.

Common QCs we check for are total motility compared to progressive motility and post-thaw metrics compared to pre-freeze metrics and their variability. This is done by referencing WHO (World Health Organization) ranges and cross comparing calculations from the client’s original sample concentration to determine accuracy.

Now the magic begins. Your samples are critical biological material, and we can’t just be a self-storage facility housing your old couches and CDs. If something goes wrong, you can’t get those samples back. Here’s how we ensure your samples are safe no matter how long you store them:

1. At the end of the analysis, client specimens are stored in 4 vials that are identified with labels to guarantee an error-free matching of samples with cryo-vials. Each label possesses a distinct QR code that is scanned each time the vial is moved. No scan, no move.
2. These vials are scanned before being stored in LN2 tanks. They are given a unique set of coordinates in our Laboratory Information Management System to allow for their fast and easy retrieval when the time comes.
3. Our lab staff follows rigorous SOPs and chain of custody practices to load and ship samples to our third-party storage facilities (and to our own internal biobanks). Legacy works with industry leaders in the storage space to create state-of-the-art sperm freezing and storage facilities.
4. Not only are samples separated into four vials, but we also provide multi-geographic storage as a fail-safe. If something happens to a storage facility in one place, you still have samples at a different facility.

These fail-safes take “don’t put all your eggs (or sperm) in one basket” literally.

Because of those geographic coordinates, we can tell you exactly where your samples are: from the geographic location down to the actual position inside the storage tank. We don’t keep this knowledge from you either. Your dashboard also shows you exactly where your samples are stored for as long as you have samples with us.

Traditional fertility clinics typically store sperm in-clinic for short periods. Legacy is changing that paradigm, meaning we needed a new set of requirements for our third-party network. Legacy staff personally visit each third-party storage facility before bringing them into the Legacy family. We get to know the staff, we see the actual tanks our samples will be in, and get an overview of their SOPs. We work only with companies we’ve visited and audited and that have satisfied our requirements.

We conduct annual or biannual reviews of the facility as well. For example, just after COVID-19 restrictions were lifted, we visited one of our storage sites. We shared a randomized list of client vials from the inception of Legacy to the present. While we were there, they pulled each vial to ensure that everything is running smoothly no matter how long the sample has been in storage.

Once again, our relationships with our third party partners are significant as we invent a process that accounts for this entirely new storage paradigm–one that encourages sperm storage even before you need it and offers sperm holders white glove service. We treat our third party vendors as an extension of Legacy’s core business, another line of Legacy team members that bring expertise to the table.

Withdrawing your samples is just as safe as storing them, thanks to our industry-leading fail-safes

Once you decide to start a family — or withdraw from Legacy for any reason — we leverage all our power and our entire network to ensure the safest withdrawal possible.

1. We connect with your clinic to determine where and when to deliver the sample. We handle all the required paperwork for the clinic and our own FDA regulations. This means up to ten different documents for a single withdrawal, but all of that is handled on Legacy’s end so you can focus on what’s important.
2. Next, we communicate with the clinic to determine the best procedures. This means deciding when to ship the sample based on the type of procedure, when it’s happening, and what storage the new facility has on-site. It also includes discussing the ideal number of vials for the specific procedure. Remember that we have highly trained medical staff and fertility experts on staff who can make these delicate decisions alongside your doctor.
3. Your samples are stored in different geographic locations, so we use our geographic coordinates to locate them and send shippers — sometimes across the entire US — to retrieve them.
4. We partner with an industry-leading shipping service to ship the vials in liquid nitrogen tanks to the receiving clinic. We provide constant communication regarding shipping updates to you and the clinic throughout the entire journey.
5. Once we complete the withdrawal and shipping process, we update your dashboard to reflect how many samples you have left and where they’re stored.

Shipping is a complex process that we monitor at all times. Each state has its own license requirements for clinics and storage facilities. Some facilities can ship to certain states while others must make a stop in a compatible state before heading to the final destination. When we coordinate withdrawals, we not only must consider where the samples are located, but we also consider where the clinic is located. Because of multi-geographic storage, we must ensure that samples all arrive at the same time regardless of how long the shipping takes. This is a hands-on process that requires over-communication to overcome this particular shipping complexity.

That doesn’t mean our shipping never experiences hiccups. Shipping can have unexpected challenges, especially with biomaterials, but this uncertainty just gives Legacy another area to shine. We work with our shipping partners and monitor every stage of the process so that we can step in immediately if something goes awry.

For example, a client scheduled a withdrawal for a procedure. We initiated the procedure, handled the paperwork, and scheduled the pickup, only our shipper didn’t show up on time. Even a minor delay in delivery could cause the appointment to delay for months and the clinic may not be able to store the sample long-term. This is not a moment for a wait-and-see approach.

This particular clinic did not have storage. We called all the medical couriers we could find in the area and found one that could do it within that hour. The courier picked up the tank, we sent extra paperwork to satisfy even the smallest need, and got the sample to the clinic later that day.

Our tanks have geographic tracking, and we can monitor the contents to estimate how long we have to deliver the sample. Our Ops team is working behind the scenes constantly to monitor this process. In this particular situation, we found out because we personally followed up with the storage facility, and they communicated that our shipper did not show up. Our relationships and close communication ensure we’re always on top of left-field situations like this one.

Everything is viewable right from your dashboard

Our recently revamped dashboard is one of our biggest sources of pride. With traditional testing reports, you receive rows of numbers with no context and confusing medical language. These papers don’t update over time, and you’re likely to misplace them with all the other paperwork you have.

• With Legacy, you can view your results and — most importantly — an explanation of the context for those numbers. It’s user-friendly and helps you digest information about your sperm and fertility without confusion.
• It shows you where your samples are and updates shipping and tracking for any samples you withdraw. You’ve trusted us with your sperm freezing and storage, and we are absolutely transparent about what’s happening to those samples.
• Your analysis report is more than just numbers, and it should empower you to make decisions about your future. You’ll understand what each result means for you and receive personalized recommendations for your next steps. And if you need further clarification, you can book consultations with our fertility experts without waiting weeks to get a live person on the phone.

We accomplish all this while accounting for around 96,000 permutations that could affect your overall results. There are so many variables, so many edge cases, and we’ve created a recommendation system that can provide clear, transparent guidance to literally anyone who comes to us for sperm testing. Results are displayed within 24 hours of testing, and we can connect you to a results specialist to talk through your results anytime you want.

With Legacy, you receive two ways to look at your results. First, our dynamic client dashboard helps provide context for the numbers and offer suggestions for next steps. It makes it simple to understand what your results mean and the context of those results so you can use them to make real decisions about your fertility health and future.

And here’s what our dynamic client dashboard looks like:

And compare that to a traditional semen analysis report:

Next, you receive a traditional report designed to share with your fertility specialist and other doctors or healthcare professionals. These reports are the standard for fertility testing results and allow you to quickly email or print results when you need them. At traditional fertility clinics, you only receive the traditional report and (unless you’re already a medical fertility expert) must wait for your fertility specialist or doctor to explain what it all means.

That’s a significant difference. Not only have we made sperm testing more convenient, but we’ve also made it easier to understand what happens next, even if you have no medical knowledge or understanding of the science behind fertility.

Our experts are unmatched

We did not skimp on experts. Our advisory board is made up of leading experts in men’s sexual and reproductive urology, pioneers in sperm transport media, chief medical officers, and international experts in andrology. They’ve led organizations like Veterans Affairs, Boston IVF, Aspire Fertility, and have even received Orders of the British Empire from the Queen of England. And this all works hand-in-hand with our Chief Medical Officer, a urologist who has trained at Harvard University and has worked at some of the leading institutions in the country.

When you have an appointment with one of our specialists, you’re speaking with experts in the field and people who are willing to work in a startup environment that’s disrupting the fertility industry. You can speak directly with them instead of waiting weeks for a medical professional to call you.

In conclusion…

So here’s what you need to know: when you work with Legacy, you are working with a team of highly-trained professionals who obsess about creating a modern, cutting-edge, and gold standard process for taking care of your future kids from start to finish. We don’t skimp, we don’t cut corners, and it’s why we are the best at what we do, the leader in our space, and the largest fertility clinic by volume in North America.

When it comes to your legacy — you’ll be safe with us.