An evaluation of the BIOSELF 110 fertility indicator

Area of Science:

• Reproductive Endocrinology
• Medical Device Technology

Background:

• Accurate identification of fertile and infertile phases is crucial for family planning.
• Existing methods for cycle tracking can be complex or invasive.

Purpose of the Study:

• To evaluate the reliability of the BIOSELF 110 electronic instrument in identifying fertile and infertile menstrual cycle phases.
• To compare the device's performance against ultrasound monitoring and urinary LH measurements.

Main Methods:

• The BIOSELF 110 was evaluated in 77 cycles from 33 ovulatory women.
• Ultrasound monitoring of maximum follicular diameter (MFD) and urinary LH levels served as reference methods.
• The device's identification of fertile/infertile phases was compared to reference method data.

Main Results:

• BIOSELF 110 correctly identified the entire fertile period in 89% of cycles based on MFD.
• The device correctly identified at least four fertile days in 94% of cycles.
• The onset of the infertile phase was correctly identified in 94% of cycles.

Conclusions:

• The BIOSELF 110 is a reliable device for identifying fertile and infertile menstrual cycle phases.
• The instrument shows potential as a useful aid for couples seeking pregnancy.
• Further clinical trials are planned to assess contraceptive effectiveness.