This past December the FDA cleared DuoFertility, a basal body temperature thermometer sensor developed by Cambridge Temperature Concepts. The device, which is intended for use in measuring and recording basal body temperature as an aid in ovulation prediction to aid in conception, has been available in the UK for some time but only became commercially available in the United States this week. Notably, in its FDA clearance documents, the company wrote that the device is explicitly not intended for use as a contraception device.
DuoFertility is now available for sale on the company's website for $795, which includes 12 months of support from fertility experts. The company says the device users can contact the fertility experts as many times as needed.
DuoFertility is a peel-n-stick sensor that adheres under the woman’s arm to monitor temperature and other indicators to provide 24-hour monitoring for more than six months. The device takes temperature readings up to 20,000 times per day and pits itself up against the much more expensive and invasive IVF. DuoFertility also transfers its data wirelessly. The device only transmits when the user holds the sensor up to a companion “reader” device that has cellular connectivity embedded. The Duofertility Monitor makes use of two thermistor sensors and an accelerometer sensor to track movement.
Cambridge Temperature Concepts is marketing the device to those "financially infertile" couples who cannot afford the $15,000 per cycle cost of in-vitro fertilization (IVF). According to the company, insurance only covers IVF in five states in the US.
The company also claims that: "Although totally non-invasive and drug-free, for appropriately screened patients DuoFertility has shown a pregnancy rate after six months of use that is similar to that from a cycle of IVF."
For more details, read the full commercial launch announcement in the press release below:
PRESS RELEASE: NEW YORK, Apr 23, 2012 -- This week is National Infertility Awareness Week, dedicated to a condition suffered by over two million American couples, run by Resolve, the national infertility charity. The gold-standard treatment, In-Vitro Fertilization (IVF) provides hope to many, but at $15,000 per cycle and with insurance covering the procedure in only five states, there is a rising class of what Resolve term 'financially infertile' couples for whom the cost of tests and treatment is the largest barrier to their family aspirations.
A new technology, DuoFertility, recently cleared FDA medical approvals and provides a fertility monitoring and advisory service to couples. Although totally non-invasive and drug-free, for appropriately screened patients DuoFertility has shown a pregnancy rate after six months of use that is similar to that from a cycle of IVF.
Use of DuoFertility involves the woman wearing a small electronic sensor patch under the arm, which monitors her physiology and relays this information over the internet to DuoFertility HQ for analysis. This produces both a prediction of the most fertile days for the couple over the coming months, and confirmation that ovulation (and hence a chance for conception) did actually occur. Fertility advisors are also available by phone and email, as frequently as needed, for a full year -- all included in the $795 price.
A suitability screening service is also available free of charge, at www.duofertility.com , to ensure that the technology is only offered to appropriate patients. DuoFertility is suitable for patients suffering from unexplained infertility and mild to moderate male and female factors (such as a single blocked fallopian tube). This represents around 80% of infertile couples, including half of those undergoing IVF.
Recently FDA 501(k) cleared, DuoFertility is a new fertility monitoring and advisory service that helps couples achieve natural pregnancy with a similar pregnancy rate to a cycle of IVF at a fraction of the cost. DuoFertility was developed by scientists at the University of Cambridge in England, and has helped thousands of British couples better understand their fertility and achieve a natural pregnancy.
A peer-reviewed academic paper examining the pregnancy rate for DuoFertility in couples who have already been through IVF, or qualify for state-funded IVF in the UK, is available at http://bit.ly/Hqehiu
SOURCE: Cambridge Temperature Concepts