New research study results show that virtual fertility testing using remote ultrasonography is comparable to in-clinic exams in providing women with high quality information, via quality clinical imaging and antral follicle counts, to help guide fertility management decisions.
Clarius Mobile Health, a leading provider of high-definition wireless ultrasound systems, and Turtle Health, a virtual gynecology clinic, today announced their partnership to bring a virtual transvaginal ultrasonography solution to market that can bring the convenience of at-home testing to women.
“Women have a fundamental right to information about their bodies, and we founded Turtle Health to empower women to access information when they need and want it, from the convenience and privacy of home,” says Amy Zwanziger, Co-Founder and CEO of Turtle Health. “We are delighted that new data support clear at-home visualization of the uterus and ovaries in a diverse range of women, which can be used for a variety of gynecological applications.”
According to the CDC, for instance, infertility affects one in five reproductive-aged women in the United States. A study funded by Turtle Health and published in the April 2022 edition of the Journal of Obstetrics and Gynecology shows that self-administered transvaginal ultrasound exams guided remotely by a trained technologist are comparable to in-clinic ultrasonography in producing clinical-quality images and assessing antral follicle count to estimate ovarian reserve, which is an important element in evaluating a women’s reproductive potential.
“In a head-to-head crossover trial, participants performed self-administered virtual transvaginal ultrasonography at home guided by a remote-certified technologist, and then repeated the exam in-clinic,” says Co-Founder Josh Haselkorn. “The uterus and ovaries were visualized with ultrasound using the Clarius EC7 transvaginal scanner. Independent, blinded reproductive endocrinologists reviewed the ultrasound cine clips captured and confirmed that antral follicle counts were equivalent across settings. We’re thrilled that the study results show the efficacy of virtual transvaginal ultrasonography, and moreover, that participants reported greater satisfaction with their at-home experience.”
Turtle Health’s at-home testing solution uses a Clarius EC7 HD handheld wireless ultrasound scanner that works with the Clarius Ultrasound App on a smart phone. To perform the test, a trained technologist connects with the user using Clarius Live telemedicine to provide real-time guidance for capturing clinical-quality images, which are subsequently sent for analysis. Turtle Health is currently seeking regulatory authorization to use the Clarius scanner in this novel context, and therefore, Turtle Health’s at-home testing solution is still investigational. The study, and associated regulatory filing, are under review by the U.S. Food and Drug Administration (FDA).
“We’re delighted to see the results of this research showing the efficacy of using Clarius ultrasound to empower virtual women’s health. Our easy-to-use wireless endocavity scanner, combined with the power of artificial intelligence, connection to the cloud, and one-touch telemedicine, offers a unique solution for patient engagement,” says Clarius President Ohad Arazi. “At Clarius, we’re working with partners to deliver highly specialized ultrasound imaging solutions to market. Today, we’re pleased to announce our partnership with Turtle Health as we work together to fuel their mission to make gynecological care virtual and unlock access to affordable, patient-enabled ultrasound imaging.”
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