Cambridge Temperature Concepts Ltd. received 510(k) approval for their DuoFertility ovulation Monitor. The DuoFertility monitor has been featured previously on Medgadget and comprises a wearable sensor and reader unit for measuring ovulation patterns. The sensor is worn under the armpit and measures subtle changes in basal body temperature which is indicative of ovulation. The reader wirelessly receives the sensor data and predicts when you are most likely to become pregnant up to six days in advance. A number of additional parameters can also be entered into the reader unit to improve the prediction quality. The recorded data can be visualized by connecting the reader unit to a PC, as shown in the video below.
The DuoFertility has been commercially available in Europe since 2009 and was the subject of a research paper published last year which demonstrated its efficacy in some couples eligible for IVF.
From the product website:
The study followed the first 500 couples using DuoFertility from launch in 2009, including 242 who qualified for IVF/ICSI treatment, of whom 90 had previously had the procedure. The one-year clinical pregnancy rate for those who qualified for IVF was 39%, which is higher than either the UK or EU clinical pregnancy rates for a cycle of IVF (26% and 28% respectively), whilst the corresponding rate for those who had already been through a cycle of IVF/ICSI was 28%.
The study included couples with unexplained infertility, as well as those with mild to moderate male and female factor infertility. This accounts for approximately 80% of all infertile couples, and half of all IVF patients.