In 2018, after finding out that her fetus had a birth defect, Amy Zwanziger made the devastating decision to end her pregnancy at 19 weeks. Afterward, she and her husband decided to embark on fertility testing, hoping to find out if having a child was still a possibility.
It was, and today they have a 3-year-old, Jethro, and a 10-month-old, Lilah. But Zwanziger knew that access to fertility testing is elusive; more than 18 million women in the United States — nearly one-third of the reproductive-age population — live in an area with no assisted reproductive technology clinics, according to a 2017 study. Even of those who do, some are unnerved by the possibility of invasive procedures.
Advertisement
To lower the barriers, Zwanziger decided to start Turtle Health, a Boston-based startup that offers a virtual fertility clinic to help patients assess their reproductive health from home. It’s similar to work she had done at Sanofi, building digital clinical trials for patients with Parkinson’s.
“I thought, if we could digitize things and move things to the home environment and that population,” said Zwanziger. “Why are we asking women in their twenties and thirties to go through all these hoops just to get information about their fertility?”
Today, Turtle has raised about $5.4 million in seed funding, and has secured a partnership with Mayo Clinic, which is also an investor. The linchpin of Turtle’s operation is a transvaginal ultrasound that patients can self-administer with the help of a trained sonographer over the phone.
The wireless probing device, made by Clarius, is the same as you’d find in a fertility clinic, and technicians can see real-time images through an app. But the novel use of the device in an at-home setting is currently under review by the Food and Drug Administration, and Turtle is running clinical trials in eight states, including Massachusetts. A study, funded by Turtle and published in the medical journal Obstetrics & Gynecology in April, found that the at-home ultrasound was “noninferior to in-clinic” examination, and resulted in greater patient satisfaction.
Advertisement
So, how does the consult work? Patients fill out a health questionnaire, and Turtle sends them the equipment for the at-home ultrasound, blood work, and semen analysis from its Mansfield warehouse and lab facility. The ultrasound determines how many antral follicles are left in the ovaries, a measure used to estimate the number of remaining eggs.
“You have to pretty much relearn the concepts of ultrasound,” said Jessica Galante, director of ultrasound operations at Turtle, who said she was initially skeptical of the at-home use. “As time went on, and I saw how how good quality it was, I was not concerned about anything coming in poorly.”
The data generated from these tests is then used to assess overall fertility risk — as well as possible diagnoses, like PCOS or endometriosis — along with a note from a doctor. The results, said Zwanziger, are meant to help women decide the best path forward, such as whether to freeze their eggs or move up their pregnancy timeline.
At a time when women are waiting later to have children — the median age was 30 in 2019, compared to 27 in 1990, according to the Census Bureau — and about one in five women experience infertility, access to this sort of information is all the more relevant.
Advertisement
“The risk tolerance differs significantly by women and by situation, but we try to give people the information to make the right choice for them,” said Zwanziger.
Reproductive care has also been complicated by the fall of Roe v. Wade, with many worried that procedures like IVF are now in jeopardy. “In this moment in time that we live in, privacy is even more important,” she said.
And patient responses to the at-home model, said Galante, have been overwhelmingly positive. “Being able to scan themselves at home without being poked and prodded at a doctor’s office, I think is very empowering,” she said.
Ali Ainsworth, a senior associate consultant in reproductive endocrinology and infertility at Mayo Clinic, said she believes that Turtle’s model will improve access to fertility care.
“It’s something that you have to obviously go out of your way to do, to ask to request, and then make time to do it at a certain point in your menstrual cycle, so that alone is kind of a big ask of our patients,” she said. “So to be able to do this at home, I think, makes that information available to a much broader group of patients.”
Depending on trial results, Zwanziger said she hopes for FDA approval in 2023.
Dana Gerber can be reached at dana.gerber@globe.com. Follow her on Twitter @danagerber6.