Developing a Device for Self Monitoring of Progesterone During in Vitro Fertilization (IVF)

Assistance for women who have difficulty conceiving often relies on in vitro fertilization technology. The number of "test-tube babies" born is increasing each year around the world, but the success rate remains low and might be improved by enhanced monitoring after implantation of a fertilized egg. The aim of this project was to contribute to the development of a prototype lateral flow test based on measurement of progesterone levels after egg implantation. This involved, developing: 1) the lateral flow device, and 2) the assay chemistry. In developing the device, different pads and membranes were assembled in a plastic cartridge. Trials were performed to identify the minimum volume of sample that could be used to run the device, and the best dimensions for sample pad, conjugate pad, absorbent pad, and membrane. Lateral flow was tested with a small-molecule dye, fluorescein, and a large-molecule dye, blue dextran. Lateral flow was considered more successful when the dye moved completely from the front end of the device to the distal end of the device. The best performing assembly pads, membrane and cartridge were used for the final lateral flow device prototype. Avidin, 2-(4-hydroxyazobenzene) benzoic acid (HABA), and biotin were used to develop the binding assay chemistry. A prototype lateral flow device was developed. Function of the device was tested with a model binding system. Results of this assessment support continuing efforts by Seacoast Science to develop and market a device to test progesterone levels for women undergoing IVF.