SBIR-STTR Award

Although many techniques are available for detecting the occurrence of ovulation, a simple screening technique that would detect either anovulation or ovulation disorders is not readily available. It is proposed to study the feasibility of extending the use of "CUE" technology now used for predicting and confirming ovulation, to screening for and possibly identifying such disorders as anovulation, polycystic ovarian disease, luteal phase defect, and unruptured mature follicles. It is proposed that specific salivary reading (SR) and vaginal reading (VR) signals can be related to particular steps of selection, maturation and ovum release during the ovulatory process. SR and VR data, basal body temperature, ultrasound scans, assays for estradiol, luteinizing hormone, and progesterone will be evaluated from approximately 75 cycles of subject with ovulation disorders. The method is expected to provide for early screening of infertility patients as well as women at risk for reproductiv effects of exposure to hazardous substances in the workplace or the environment.National Institute of Child and Human Development (NICHD)

Although many techniques for detecting ovulation are now available, a simple screening tool for detecting either anovulation or other ovulation disorders is not available. Preliminary findings in Phase I research have shown that specific atypic patterns in the ovulatory trends of salivary electrical resistance (SR) and vaginal electrical resistance (VR) are related to certain ovulatory disorders, i.e., anovulation, polycystic ovarian disease, luteinized unruptured follicle, and luteal phase defect.In Phase II research, SR and VR will be monitored in groups of subjects representing each of the disorders mentioned and a well-defined control group of subjects. Methods of screening for these disorders using SR and VR will be developed using these data and incorporated in an instrument that will combine these capabilities with predicting the time of ovulation. The method is expected to provide for early screening of infertility patients as well as women at risk for reproductive effects from exposure to hazardous substances in the workplace or the environment.Awardee's statement of the potential commercial applications of the research:Ovulation disorders account for a major part of infertility in the female, which affects 60 percent of over 6 million couples who are infertile. Thus, screening for major ovulation disorders plays a significant role during the diagnosis and monitoring of the treatment of these women. The ability to combinq both ovulation prediction and screening for disorders is expected to create a large market for the proposed method.National Institute of Child Health and Human Development (NICHD)