COMING SOON: A FERTILITY DETECTOR
p.18
by Lawrence F. Roberge, M.S., copyright 1994

WITH THE EXPLOSION IN BIOTECHNOLOGY, biosensor, and microelectronic 
technology comes renewed hope for both infertile couples and those 
wishing to practice natural family planning (NFP).

Natural family planning is a method of controlling the conception of 
children based on abstaining from sexual intercourse during a woman's 
fertile times. Problems with natural family planning usually lie in 
difficulty with the accurate and timely detection of the fertile 
period. If the fertile period can be determined prior to its onset, 
then the success of natural family planning (either to avoid or to 
achieve pregnancy) is usually assured.

Conception Technology Inc. (CTI) of Fort Collins, Colorado, has been 
developing a biosensor that promises to detect and give prior warning 
of ovulation. With prototypes already built, Dr. Vaclav Kirsner, Ph.D., 
the CEO and founder of CTI (and formerly senior physical chemist at the 
Wellcome Research Laboratories in England), has been working to develop 
this product withdistribution for use both in homes and in physicians' 
offices. An early clinical trial took place in Italy, but further 
clinical trials are going on in Colorado (recent studies have been held 
up due to funding shortages).

The company started in 1991 and has on its Board of Directors such 
prominent names as Eugene Frink (co-founder of AquaTec Corp.), Governor 
Richard Lamm, and Howard Jones, M.D. (a leader in infertility 
research). CTI is currently seeking $4 million in venture capital for 
its four-year product development plan.

The device under development is the Ovulon (for home use) and the 
Ovulograph (for use in a physician's office). The Ovulon is a small 
vaginal sensor that is inserted like a tampon for a few seconds on a 
daily basis. The device makes a bioelectrical measurement of the 
cervical tissue. The electrochemistry of the cervical tissue changes 
prior to, during, and after ovulation. This information provides two 
predictive peaks, warning the woman of the onset of ovulation 
regardless of the regularity (or irregularity) of her menstrual cycle. 
The Ovulon reports in simple language the user's fertility status.

The Ovulon has a computerized memory and the information can be 
downloaded to the Ovulograph in a physician's office. This information 
can help the physician assess whether the woman has any fertility 
problems and may prove helpful in early detection of cervical cancer.

This technology could increase acceptance of natural family planning in 
the United States by its ease of use, reliability, and accuracy. 

CTI plans to market the Ovulon first to the dairy industry, which 
desperately needs help in predicting bovine fertility. (No government 
regulations exist for this market.) 

Later, about 18 months into CTI's four-year plan, the Ovulon will be 
offered as an infertility detector and conception-assistance tool. The 
Food and Drug Administration (FDA), which monitors medical devices, 
requires only a Pre-Market Notification filing (PMN). But the final 
marketing, as a device for NFP, requires extensive FDA involvement via 

large clinical trials and Pre-Market Approval (PMA) filings. This is 
because any device that could, in the FDA's estimation, lead to 
"life-threatening" consequences must be vigorously reviewed. (Pregnancy 
is deemed a "life threatening" consequence.)

CTI hopes to achieve this final step about four years after they obtain 
the needed venture capital ($4 million). 

This technology could increase acceptance of natural family planning in 
the United States by its ease of use, reliability, and accuracy. 

For more information, contact: Dr. Vaclav Kirsner Ph.D., Conception 
Technology, Inc., Oak Place, Suite L-29, 151 South College Avenue, Fort 
Collins, CO 80524. Phone: 303-482-9564; Fax: 303-484-1835.   

Lawrence Roberge lives in Massachusetts.

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