ABSTRACT
The Bioself 110 is a hand-held electronic device that combines the BBT and calendar methods of fertility regulation for planning or preventing pregnancy. A pilot study was undertaken in three centers in the United Kingdom to evaluate the Bioself 110 as a contraceptive aid. This paper deals with 1238 cycles from 131 women. Only one unplanned pregnancy occurred where a volunteer correctly used the Bioself 110 and had intercourse on a supposedly "safe" day. A second pregnancy was experienced by a volunteer who incorrectly used the device and had intercourse on what she though was a "safe" day. Another 11 unplanned pregnancies occurred due to barrier method failures, as well as 11 pregnancies where the volunteers knowingly had unprotected intercourse during the fertile phase. There were five planned pregnancies. The Bioself 110 was correctly used in 71% of the cycles studied. Eighty-four percent of the volunteers indicated that they were satisfied with the Bioself 110 after six to twelve cycles of use. It was concluded that the Bioself 110 can serve as an effective family planning aid and should be added to the menu of contraceptive methods available to women today.
PIP: The Bioself 110 is a handheld electronic device that combines the BBT and calendar methods of fertility regulation for planning or preventing pregnancy. A pilot study was undertaken in 3 centers in the United KIngdom to evaluate the Bioself 110 as a contraceptive aid. This paper deals with 1238 cycles from 131 women. There was only 1 unplanned pregnancy which occurred when a volunteer correctly used the Bioself 110 and had intercourse on what was supposed to be a "safe" day. A 2nd pregnancy was experienced by another volunteer who incorrectly used the device and had intercourse on what was also thought to be a "safe" day. Another 11 unplanned pregnancies occurred due to barrier method failures, as well as another 11 where the volunteers knowingly had unprotected intercourse during the fertile phase. There were 5 planned pregnancies. The Bioself 110 was used correctly in 71% of the studied cycles. 84% of the volunteers indicated that they were satisfied with the Bioself 110 after 6-12 cycles of use. It was concluded that the Bioself 110 can serve as an effective family planning aid and should be added to the contraceptive choices available to women today.
Subject(s)
Contraception/methods , Electronics, Medical , Ovulation Detection/methods , Adolescent , Adult , Basal Metabolism , Body Temperature , Coitus , Evaluation Studies as Topic , Female , Humans , Menstrual Cycle , Patient Compliance , Pilot Projects , Pregnancy , Pregnancy, UnwantedABSTRACT
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.
PIP: The BIOSELF 110 is a handheld, noninvasive 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 and green light signals. 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 guides 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 4 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 (1st 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 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.
