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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