SBIR-STTR Award

Preliminary studies performed by applicant in cooperation with Dr. George Betz, University of Colorado Health Sciences Center, indicate that the fertile period in women can be defined by monitoring electrical characteristics of saliva and cervical mucus. Previous investigators have shown that electrolyte constituents of these fluids change cyclically in relation to concentrations of reproductive hormones in women.More data are needed to validate the method. A probable physiological rationale for observed changes in salivary and vaginal ionic content and their relationship to the menstrual cycle has been generated and will be tested.In this study, fifty women will record daily measurements using a specially designed instrument. Basal Body Temperature (BBT) will be recorded, but will not be used to define the time of ovulation. Ovulation will be diagnosed by luteinizing hormone (LH) assay and, where appropriate, by ultrasound scan as well. Statistical evaluation of the correlation of the electrical measurements with ovulation will be performed.If successful, this research will result in a very useful tool for the management of infertility in the near future. Later, it is expected that the instrument will also be used to aid natural family planning.National Institute of Child Health and Human Development (NICHD)

The overall Phase II aim of this project is to examine the usefulness of CUE readings for predicting and confirming ovulation. Methodological refinements will be used to develop it into an instrument that will be simple, inexpensive, and reliable.A detailed and expanded investigation of the concept will be done at the primary site (data on >300 cycles) with independent verification on a smaller scale (150 cycles) at secondary sites. Besides luteinizing hormone assays for defining ovulation in most cycles, ultrasound will be used in 70 cycles to examine the relation of CUE reading changes to ovulation. As a thorough understanding of the physiological mechanisms involved is important, the relationships between ACTH, aldosterone, salivary electrolytes, and CUE salivary readings (SR) will be examined. As part of this trial, the contributions of estrogen through the renin-angiotensin system to changes in aldosterone, hence SR, will be defined.Usefulness of the method in induced ovulations was indicated in preliminary studies. This phase will an important market segment; therefore, this application will be studied in 40 clomiphene and 20 "pergonal" induced cycles. Methodological development will be directed toward refining of sensor design, miniaturizing and prototyping the final microprocessor based instrument.National Institute of Child Health and Human Development (NICHD)