HEALTH NEWS

New At-Home Fertility Test Worries Experts

Written by Whitney Akers on October 24, 2017

A Silicon Valley startup is allowing people to preorder at-home fertility test kits for $149, but they haven’t shared any scientific studies that show they can deliver accurate results.

 

Modern Fertility co-founders Afton Vechery and Carly Leahy are already selling at-home fertility test kits for $149, but the test is merely a “wellness” assessment.

Over the past two years, more women have shown up at the Center for Reproductive Health at the University of California, San Francisco (UCSF) stressed about infertility, even though they haven’t been trying to get pregnant.

Dr. Evelyn Mok-Lin, a reproductive endocrinologist and medical director of the center, said several of these patients originally requested a fertility workup, often because their friends had gotten one done, and were worried by their low antimüllerian hormone (AMH) levels or how many ovarian eggs they have left.

This scenario is even more concerning following a study published last week that low AMH levels are not tied to a woman’s chances of getting pregnant.

“There’s a pervasive misconception that AMH predicts fertility and is a measure of egg quality — both of those things are false,” explained Mok-Lin. “AMH is purely a measure of egg quantity,” not successful pregnancy outcomes.

There’s a lot of worry around infertility.

According to a Johns Hopkins study, 19 percent of 18- to 29-year-old women think they’re probably infertile, while only 6 percent are likely to be.

Half of women report they are putting off parenthood, often until their mid-30s when it’s harder to conceive.

The rising age of motherhood has likely added to women’s uncertainty around fertility.

Modern Fertility is hoping to stem that anxiety by “giving people the tools they need to have more control over their fertility,” Afton Vechery, the co-founder of the startup told Healthline.

Vechery and co-founder Carly Leahy believe information is the first step to helping women who aren’t quite ready for kids learn about their fertility health.

When she was talking to her 20- and 30-something female friends, Vechery realized “a common theme was really high anxiety around infertility and that there was no easy way for them to get answers.”

To change that, Modern Fertility is launching an at-home testing kit that will analyze 10 hormones related to fertility.

Here’s how it works: You’ll receive a package in the mail with clear instructions.

Then, you prick your finger and put four drops of blood onto a blood collection card. You’ll ship the card back to a CLIA- and CAP-accredited lab.

Modern Fertility will then provide women with a “simple, easy to understand” online report.

That analysis will include Modern Fertility’s proprietary fertility score — still in development — which will compare an individual’s fertility health to that of other women her age.

“We also give you the option to swing by a local lab,” and will provide a lab slip to bring in, Vechery noted. You can preorder kits now for $149, which will ship later this year.

Vox writes that the business of fertility tests is a “booming market for a new arm of medicine,” and lists Modern Fertility’s competitors, like Future Family, as companies capitalizing on the proactive — and possibly unnecessary — test.

“In this case, I worry people just want more info because it’s easy and cheap. It could lead them to pursue fertility treatment before they actually know they need it,” Mok-Lin said.

Also, reproductive endocrinologists and clinical chemists specializing in fertility are skeptical about the actual scientific accuracy of the promised product, which is positioned as a replacement for more expensive in-office tests.

modern fertility

Image source: modernfertility.com

Potentially a $149 extra expense

Dr. Aimee Eyvazzadeh, a reproductive endocrinologist who encourages women to start routinely checking their fertility health by 25 years old, believes “anything that can raise awareness about women’s fertility is a positive thing.”

That includes Modern Fertility, which has the marketing savvy and ease-of-use to reach thousands of women.

“I want the same number of people that know about 23andMe to get their fertility checked,” said Eyvazzadeh.

She’s impressed by Modern Fertility’s mission to make testing accessible to all women regardless of socioeconomic status.

A Modern Fertility test kit sells for $149, which Vechery calls “a fraction of the cost” of the same tests at hospitals or at fertility clinics.

However, actual savings — if any — vary widely depending on the woman’s insurance, the clinic she goes to, and the state she lives in. A fertility panel typically runs from fully covered by insurance to $350.

If you want to follow up on your results with a doctor, you aren’t saving any money.

“If a woman brought her Modern Fertility results to a fertility doctor, the tests would need to be repeated,” Dr. Janet Choi, a reproductive endocrinologist at CCRM New York explained.

So, instead of saving you $149 dollars, the kit could be an extra expense.

While positioning themselves as a cheaper alternative to fertility testing, Modern Fertility writes on its site that “tests are exclusively intended to be used for wellness monitoring.”

Vechery clarified, “Our test is designed to supplement the interaction between a woman and her doctor. We do not diagnose any conditions and instead, inform a female about these hormones and fertility/infertility more broadly so she can make decisions that are right for her.”

She also noted that all of the content that accompanies each of the results has been developed alongside and approved by medical professionals.

These professionals haven’t been named by the company, but Vechery told Healthline that they’re in the process of hiring a chief medical officer.

fertility

“Checking your fertility is not the same thing as getting your cholesterol checked. It’s extremely personal and intimate,” Eyvazzadeh said. Image source: Aimee Eyvazzadeh

Sensitive results without counseling

Modern Fertility’s test is not meant to replace tests needed in a full fertility work-up — it’s just a supplement.

The ease of online ordering and at-home testing has the potential to reach more women than in-office tests and close the fertility awareness gap.

But Eyvazzadeh and Choi worry that the intimate nature of fertility makes delivering results online irresponsible.

For example, if a woman finds out that she doesn’t have as high of an egg count as expected at her age, it could cause her to become depressed unnecessarily or seek out fertility treatment.

Certain results could lead a woman to freeze her eggs, undergo in vitro fertilization (IVF), or have a baby sooner.

Even with recently published studies showing egg count isn’t connected to getting pregnant, many fertility doctors recommend women get a screening by the time they’re 30 as a first step to understanding their overall fertility health.

Modern Fertility says they’re pairing with physicians to analyze tests, which Eyvazzadeh says is essential.

But all fertility experts expressed concern about the lack of explanation and comfort a doctor traditionally provides.

“They say that they have a panel of advisors to help interpret results, but I don’t think that’s enough counseling for a patient,” Choi said.

However, she’s positive about the potential conversation about fertility that the startup could help advance.

“If these tests are truly pretty accurate, it’s a good starting point for women to do these in the privacy in their own home. Women could use it as stepping stone to get consultation with doctors, but need to follow up” to really understand results, Choi said.

fertility

Image source: modernfertility.com

Fertility is more complicated than a score

Modern Fertility’s kit is testing for how many eggs a woman has left in her ovaries — not their quality — as well as for endocrine, or hormone, disorders.

Not all fertility issues are caused by endocrine disorders, and further evidence shows that there’s no link between egg count and getting pregnant. The AMH test was actually developed as a complementary test for egg extraction during IVF.

Modern Fertility will analyze some biomarkers related to the endocrine system, including thyroid-stimulating hormone (TSH) and some hormones closely associated with fertility, like AMH.

Mok-Lin says some analysis of the other hormones Modern Fertility is testing for, like TSH, “is very cut and dry. There are set cutoffs in the lab between what’s normal and what isn’t. You can give a quick interpretation.”

What concerns Mok-Lin is the interpretation of the hormones targeted at fertility — follicle-stimulating hormone (FSH), estradiol (E2), luteinizing hormone (LH), and progesterone (P4) specifically — that some tests call for.

To give a woman an accurate picture of her fertility health, the hormone test needs to be analyzed in the context of a woman’s age, family and medical history, and lifestyle.

“A hormone test alone is not the whole story but it’s definitely a start,” Eyvazzadeh said.

Reproductive endocrinologists and the clinical chemists that specialize in fertility hormones also stress that there is no 100 percent accurate test of egg health.

What makes analyzing a woman’s fertility workup even more complicated is that “each one of those 10 markers has limitations and have to be interpreted within the full clinical picture,” said Joely Straseski, PhD, the medical director of endocrinology for ARUP Laboratory and a spokesperson for the American Association for Clinical Chemistry.

“I’m extremely concerned about how they will be interpreted,” Straseski stated.

The interpretation is so nuanced that even OB-GYNs refer patients to fertility endocrinologists.

“I worry the results would cause panic and stress because there’s not good interpretation,” Mok-Lin further explained.

The emotional reaction of patients to results is also less controlled and supportive than in an office setting.

Choi explains how she’d approach two scenarios where egg count wouldn’t be used as a sole indicator of fertility.

For example, if a woman gets a fertility health workup at age 35 that says her egg count is high, a fertility doctor would run more bloodwork or propose an ultrasound.

“Even if I see a low AMH in a 30-year-old woman, I’m not going to counsel her and say ‘you’re doomed to infertility.’ I’d counsel her to think about having a family sooner,” Choi said.

fertility

Image source: modernfertility.com

Fertility score is a “red flag”

The ability to have a personalized conversation about options contrasts with Modern Fertility’s delivery of results.

Along with hormone test analysis, women will get a fertility score. This score will compare data on your ovarian reserve, ovulation, and general body systems with that of other women your age.

“The fertility score raises a whole bunch of red flags for me,” David Grenache, PhD, a clinical chemist, chief scientific officer at TriCore Reference Laboratories, and a spokesperson for the American Association for Clinical Chemistry, told Healthline.

“How was that equation developed? Is it based upon actual patients that have known outcomes? Will it be published and peer-reviewed or is it a trade secret?” he questioned.

Modern Fertility’s website says the score is “approved for ages 21–40.” “Who approved it?” Grenache asked.

According to Vechery, “The fertility score is in development. Today the fertility score is physician mediated and used for tracking purposes of females every year. We eventually intend to publish in a peer-reviewed journal.”

“I wouldn’t even know how to counsel a patient based on that fertility score,” Choi said. That the score could be confusing or distressing to a patient is also problematic.

Is accurate at-home blood testing for fertility possible?

Modern Fertility’s promise of easy-to-read results delivered to your door is part of a trend toward accessible care in the United States.

Patrick Beattie, who has a background in chemical engineering and rapid diagnostics, is passionate about accessible care. He believes people should have much more control over their health.

A main way to do that is to move health access like testing and pharmacies to much more convenient locations, including the home.

As an acquaintance of the co-founders who is not involved with Modern Fertility, he’s impressed by the co-founders’ commitment to accessible care. He also reiterated the need for solid science.

“It’s important to combine this passion for concept — more convenient care — with the rigor of science to make sure we’re not creating hype,” Beattie said. “There’s a potential downside if you overhype things, especially in the consumer market.”

Modern Fertility’s lack of peer-reviewed or published science — all while they’re pre-selling kits on their website — is troubling to several people Healthline talked to.

Dried blood spot (DBS) samples, like the ones Modern Fertility plans to use in their at-home kits, have been around for decades.

But this consumer testing, as well as use of small sample sizes, could create some accuracy issues — giving women anxiety about infertility or assuring them they’re fine when they’re not.

It’s not clear what type of method or methods the company plans to use to measure each of the 10 hormones.

“The number of things (analytes) [able to be measured] would entirely depend on the method being used… which we don’t know in this case,” Straseski said.

While “there isn’t a finite number of things (analytes) that you could theoretically measure in one drop of blood,” Straseski clarified, it’s most common to measure one analyte per dried blood spot.

That’s because smaller amounts of blood contain fewer molecules of each analyte. To test for 10 different things, you need to provide a sufficient amount of blood.

That’s why, as Grenache explained, “More is better.” It’s both easier to analyze, and you get more reliable results.

Grenache is extremely skeptical of the analysis that Modern Fertility is selling. “I am doubtful they can do what they claim with any degree of accuracy required of clinical blood tests,” he said.

Not only is the amount of blood being collected minimal, compared to many protocols — though this cannot be assessed further since Modern Fertility won’t be sharing their methods until later this year — but the finger prick method could cause a few additional problems when analyzing this sensitive information.

“The quality of a test result is only as good as the quality of the sample” is the core tenet of laboratory chemistry, Grenache shared.

To ensure the quality of blood samples, the blood spots must dry for three to four hours in a horizontal position and at room temperature, which will be impossible to ensure at home.

Some tests also need to be collected on a specific day during a woman’s cycle.

Also, blood from a finger prick is not as high quality as blood taken with a needle at your doctor’s office. The blood is affected as it passes through skin and tissue. “Many tests are compromised by that type of collection,” Grenache confirmed.

Modern Fertility is not yet publicly disclosing details, but said they plan to publish peer-reviewed information.

“It’s up to Modern Fertility to prove that they can deliver these tests from a technically feasible standpoint,” Beattie said.

Expanding awareness of fertility can empower women

Although questions around the scientific legitimacy of Modern Fertility’s fertility test remain, most of the experts believed the company could help bringing awareness to fertility health and give women access to more important information.

“Fertility is extremely complex. It’s rarely as easy as getting a simple score and knowing your fertility health,” Straseski told Healthline.

For women who want to know more about their fertility health now, keep these three things in mind:

  • If you’re able to, visit a doctor in person or virtually to make medical decisions or get feedback on potentially emotional issues instead of using consumer products.
  • Talk to your OB-GYN about your lifestyle habits, family history, and potential timeline for having a child to see if a fertility health test is right for you.
  • Check consumer health products’ websites for published scientific studies before sending them any money.
  • If you do order a fertility health test from a website, schedule an immediate follow-up with your doctor to make sure you’re interpreting the results and recommended next steps accurately.
CMS Id: 135120