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.
Subcutaneous body fat and Quetelet's Indices (QI) of 52, 18-29 year old normal female volunteers were determined. These body mass indices were then grouped according to the phase of each subject's menstrual cycle, early or late follicular and early or late luteal phase. The subcutaneous body fat is 27.07 +or- 1.0% in the early follicular but drops to 24.68 +or- 1.84% in the late follicular phase. The value then rises significantly higher than that in the late follicular phase to 30.14 +or- 1.15% (P0.02) in the early luteal drops to 27.17 +or- 0.55% towards the level of the early follicular phase (P0.05). Variations in the values of QI during each menstrual cycle exactly mirror those for subcutaneous body fat. The fall in the 2 body mass indices during the late follicular phase coincides somewhat with the established preovulatory LH and FSH surges as well as the high levels of estrogen of this period. On the other hand the significant rise in the 2 parameters during the early luteal phase coincides with the marked rise in the ratio of progesterone to estrogen. Clearly, increased levels of progesterone relative to estrogen appear to cause an increase in the body fat during each menstrual cycle. The implication of this finding for women on contraceptive pills which are predominantly progesterone and those whose normal menstrual cycle is "interrupted" at the early luteal phase by a successful fertilization raises very interesting questions with regards to prediction of ovulation.