An evaluation of the BIOSELF 110 fertility indicator.

The BIOSELF 110 is a hand-held, non-invasive electronic instrument that measures basal body temperature and cycle length, and automatically identifies the fertile and infertile phases of the menstrual cycle with flashing red light and green light signals, respectively. The device was evaluated in 77 cycles from 33 ovulatory women in Kuala Lumpur, Malaysia. Ultrasound monitoring of maximum follicular diameter (MFD) and urinary LH measurements with Ovustick were used as reference methods to estimate the time of ovulation and the fertile period. Based on the MFD day, the BIOSELF correctly identified the entire fertile period, and at least four fertile days, in 89% and 94% of the cycles studied, respectively. The mean duration of the fertile period as determined by the number of flashing red light days was 11.0 days (SD 2.9). The device correctly identified the onset of the postovulatory infertile phase in 94% of cycles, with a mean duration of about 10 (green light) days. The results were similar using the LH peak day as the reference method. The mean interval from the onset of the fertile period (first flashing red light day) to the MFD day was 6.9 days (SD 2.6), and from the MFD day to the end of the fertile period, 3.1 days (SD 2.2). The BIOSELF 110 showed itself to be a reliable device for identifying the fertile and infertile phases of the menstrual cycle and, thus, should be a useful aid for couples seeking pregnancy. Prospective clinical trials are underway to assess the contraceptive effectiveness of the device.