New NFP Monitor Promises Increased Accuracy and Reliability for Parents
New NFP Monitor Promises Increased Accuracy and Reliability for Parents
by Lawrence F. Roberge, M.S.
With the explosion in biotechnology, biosensor, and microelectronic technology comes renewed hope for both infertile couples and those who want 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 period. The problems with successful natural family planning usually lie in 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 is usually assured.
Conception Technology Inc. (CTI) in Fort Collins, Colorado, has been developing a biosensor which promises to detect and give prior warning to ovulation. With prototypes already built, Dr. Vaclav Kirsner, the CEO and founder of CTI (formerly senior physical chemist at the Wellcome Research Laboratories in England), has been working to develop this product with eventual distribution for both home use and physician office applications. An early clinical trial occurred in Italy, but further clinical trials are occurring in Colorado (recent studies have been held up due to funding shortages).
The device in development is the Ovulontm (for home use) and the Ovulographtm (for use in a physician's office). The Ovulon is a small vaginal sensor which 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 be helpful in early detection of cervical cancer. Although further clinical studies are still in progress, early detection of cervical cancer using this technology is strongly hinted.
The Ovulon will eventually appear as an infertility detector and conception assistance tool. The U.S. Food and Drug Administration (FDA), which monitors medical devices, requires only a Pre-Market Notification filing. But the final market, as a device for NFP, requires extensive FDA involvement via large clinical trials and Pre-Market Approval filings. This is because any device that could lead to "life-threatening" consequences must be vigorously reviewed. It is important to note that, in medical terms, pregnancy is deemed a "life-threatening" consequence.
This final step will be achieved about four years from the time that CTI obtains its venture capital target. Finally, expanded studies will help buttress CTI using the Ovulon as a monitor for early detection of cervical cancer.
The advantages of this technology over other products currently marketed in the United States include:
1) Not dealing with inaccurate or messy chemical assays (as with chemical urine or monoclonal antibody based test kits).
2) Other microchip-based devices are much more expensive and may not assist in detection of other gynecological medical problems (e.g., cervical cancer).
3) Few natural family planning technologies have been approved for the U.S. market.
This technology could increase acceptance of natural family planning in the United States by its ease of use, reliability and accuracy. A further advantage to this technology is that the microelectronic memory data would be useful for physicians in diagnosing infertility problems or cancer in their patients.
Those interested in inquiring about CTI, can contact Dr. Vaclav Kirsner Ph.D., Conception Technology, Inc., Oak Place, Suite L-29, 151 South College Avenue, Fort Collins, CO 80524 tel: 303/482-9564 fax: 303/484- 1835.
Taken from the January 1996 issue of "HLI Reports."
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Copyright (c) 1996 EWTN
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