Infertility is a common problem for both men and women. About 9% of men and 11% of women of reproductive age in the United States have experienced fertility issues. Infertility is equally split, with one-third of men and one-third of women affected.
Conception is a complicated process, and many factors can impact the outcome, including age, medical conditions and hormones. Fortunately, medical and diagnostic advancements in infertility tests and treatments are creating more opportunities for physicians working with patients experiencing fertility challenges to support the creation of families.
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David White The journey to start a family inspired David to found Innovative Health Diagnostics, a California-based CLIA-certified clinical testing laboratory. As the head of the first company to bring together clinical laboratory testing, FDA Donor testing, transparent pricing, and financing, his mission is to empower every person with access to accurate and actionable clinical […]
The scale and impact of infertility
Estimates suggest that between 48 million couples and 186 million individuals of reproductive age live with infertility globally. Infertility affects 6.7 million women in the U.S. And not only does infertility impact the patients who experience it, but also their families and communities are touched due to the added stress and hardship it brings. Several factors impact fertility, and 25% of infertile couples have more than one factor contributing to their infertility. These factors create additional complications for providers who help patients navigate their journeys to parenthood.
While 85-90 percent of infertility cases can be treated with conventional medical therapies such as medication or surgery, the path to getting a treatment plan is not so simple. Many factors contribute to disparities in effective fertility treatments. There is limited access to IVF and fertility testing services in the U.S., with only 24 percent of the needs for assisted reproductive technology being met.
While assisted reproductive technology has made major strides, the cost of care continues to be among the greatest barriers to accessing fertility care. More often than not, fertility services are not covered by public or private insurers, and most patients pay out of pocket for fertility treatment. The average cost of one cycle of in vitro fertilization (IVF), the most common type of assisted reproductive technology, is currently around $12,000. LGBTQ patients face an increased amount of barriers to fertility care as they do not meet definitions of “infertility” that would require them for covered services by insurance.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In order to bridge the gap and create increased access to fertility care, some CLIA-FDA accredited labs are delivering a suite of fertility and IVF tests directly to the homes of patients meeting them where they are at, and empowering them to take control of their own healthcare. Time is an important factor with fertility care, so access to reliable, accurate and timely test results from a diagnostics partner is imperative for patients.
Infertility can have a ripple effect that includes mental health and financial status. A study found that 25-60% of infertile couples experienced psychiatric problems. Typically, women felt more discontent from infertility over time than men and were also more likely to develop anxiety and depression from infertility.
The journey to conception for individuals and couples with infertility is typically lengthy, and winding, with several unknowns – and no clear path defined as each journey is different. The ability of healthcare providers to leverage accurate, sophisticated, and timely diagnostic testing for infertility patients is a crucial part of the patient journey.
Managing the impact of infertility with testing
Fertility testing can take place at any stage of a patient’s journey. Some patients are curious about their chances of getting pregnant in the future, while others use fertility tests to detect issues after trying to conceive for months or years. There are a plethora of tests available to healthcare providers that can help them figure out how to treat infertility problems. Fertility clinicians and other healthcare practitioners can perform various tests to assess a woman’s reproductive health and fertility potential – from pelvic ultrasounds to standard ovulation.
One of those tests, the Anti-Müllerian hormone (AMH) test, is generating increased interest and gaining momentum among medical professionals.
AMH testing
For women, regular testing of the AMH level can provide helpful information about a woman’s ability to produce viable eggs for fertilization. An AMH test checks the health and quantity of a woman’s ovarian reserve, which is useful for a woman’s fertility journey. A survey of 796 infertility clinics worldwide, representing nearly 600,000 IVF cycles, indicated that 60% reported testing AMH first.
These tests can provide timely and accurate results for women looking to understand their AMH level while helping healthcare providers chart the best path forward.
Semen analysis
For men, semen analysis is a helpful and simple way to have a more informed conversation between patient and doctor. Semen analysis allows for understanding the shape, count, size, and overall makeup of a man’s sperm, which is an important factor in determining fertility potential.
Increased modern-day testing options like at-home sperm tests can create a more accessible and comfortable environment for men to secure important information for their fertility journey. An at-home semen analysis test helps men determine whether they are medically fit for reproduction based on the count and quality of their sperm.
Accessing partners to support infertility testing
The U.S. lab testing market is approaching $80B in size. For fertility treatments specifically, the global fertility market is expected to grow from $14.27B in 2020 to $21.7B in 2025. Declining fertility rates across the globe will continue to drive growth in the infertility space, creating extensive demand and continued advancements in fertility testing as a key component. Having an awareness of and access to fertility testing partners can lessen the complexity and distress that infertility can have on individuals and couples and serve as a helpful tool for healthcare providers who are navigating the fertility journey alongside the patient/s. It is important for healthcare providers to find a testing partner that delivers reliable, accurate, and timely test results, all while serving as a collaborator through the intricate and unique fertility journey.
The journey to start a family inspired David to found Innovative Health Diagnostics, a California-based CLIA-certified clinical testing laboratory. As the head of the first company to bring together clinical laboratory testing, FDA Donor testing, transparent pricing, and financing, his mission is to empower every person with access to accurate and actionable clinical testing when and where it matters most.
