]( ;his P R I N C I P L E S & P R A C T I C E

R I C H A R D J . F E H R I N G , R N , D N S c

our basic types of natural family planning (NFP) are taught and used in the world today:

the calendar, basal body temperature (BBT), ovula- tion, and symptothermal methods. The calendar method, often referred to as the rhythm method, is the oldest of the four methods and is based on the pro- jected time of a woman’s ovulation and the average length of her menstrual cycle. Because a woman’s menstrual cycle varies before the time of ovulation, the calendar method is only about 80% effective in avoiding pregnancy.’ Many health-care practitioners

NeW Techology Natural Familv

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Plartning

In recent years, several new devices have been developed to help women achieve or avoid pregnancy. These devtces include computertzed basal body temperature thermometers, electronic fertility monitors, and chemical and hormonal ovulation detection kits. This article describes these new fertility devices and discusses their efectiveness and impact on helping women understand and control their fertility.

Accepted: August 1990

consider this method outdated when compared with today’s standards.

The use of daily BBT was first applied as a method of NFP in the mid-1930s. The principle behind BBT is that, after ovulation, a woman’s body temperature rises from the effects of progesterone. The BBT method can be effective in avoiding pregnancy, espe- cially if intercourse is restricted to the postovulatory period. The disadvantages of BBT are that a woman’s temperature can be elevated for reasons other than ovulation (e.g., fever and stress), a woman does not always ovulate (especially during breastfeeding, post- partum, and premenopause), and the amount of time allowed for intercourse in a given menstrual cycle, if a woman is avoiding pregnancy, is limited.

The ovulation method (often referred to as the Billings method) of NFP was developed by the Austra- lian doctors John and Evelyn Billings in the 1950s and 1960s. First introduced into the United States and Can- ada in the early 1970s, this method is taught in more than 100 countries around the world. The physiologic principle behind the method is that the preovulatory rise of estrogen causes cervical mucus to become stretchy, clear, and lubricative at the time of ovulation. A woman can predict and detect the approximate time of ovulation with this method by observing the daily changes in her cervical mucus on the outside of her vagina. The World Health Organization conducted a multicountry study of the ovulation method and found that almost all of the women who entered the study were able to identify their fertile periods by self-ob- servation of cervical mucus. Method-related pregnan- cies were only 2.8%.’ The method, however, requires a refined teaching system and mutual understanding, motivation, and support between the woman and her partner. The method can be confusing and difficult to learn if a woman has continuous mucus due to cervical or vaginal infection.

As its name indicates, the symptothermal method of NFP combines a number of signs of ovulation, in- cluding the rise in BBT, changes in cervical mucus, and variations of the cervix. Like the ovulation method, the symptothermal method can be effective

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in avoiding pregnancy if mutual understanding, sup- port, and motivation exist between the woman and her partner.

From the time that Ogino and JSnaus designed the first practical NFP method in the late 1920s, devices have been developed to help women and couples monitor their fertility. These devices include calendars, colored beads, specialized BBT thermometers, a device to mea- sure glucose concentrations in cervical mucus, and the rheometer, a device used to measure the viscosity of cervical A number of recently developed de- vices also aid in fertility control. These devices can be classified as computerized methods, electronic ovula- tion detection monitors, and chemical and hormonal ovulation kits and monitors.

computerized Methods

Currently, two commercially available computerized devices aid fertility control: the Bioself 110 fertility indicator (Bioself Canada Inc., Quebec) and the Rab- bit fertility computer (Sanimor Inc., California). Both of these devices are computerized versions of the cal- endar and symptothermal methods of NFP (i.e., the rhythm method and BBT) . The Bioself 110 is essen- tially a small (150 X 60 X 22 mm; weight, 80 g) micro- computer that records and analyzes temperature and the length of the menstrual cycle (Fig. 1). All a woman has to do to use the Bioself is push in a small metal button on the first day of her cycle and then take her temperature daily upon waking. The monitor displays a red or green light, not her BBT. The green light indicates days of infertility, a flashing red light indi- cates days of high fertility, and a constant red light indicates days of low fertility. If a woman wants a rec- ord of her daily temperature readings, the Bioself can be connected to a computer printer that is specially designed for use with the Bioself.

The program and design of the Bioself were based on the research of Dr. Rudolf Vollman, a former con- sultant to the World Health Organization and chief of obstetrics at the National Institutes of Health, Be- thesda, Maryland. Vollman conducted research on the variability of the menstrual cycle and BBT.*

Research data provided by the manufacturer indi- cate that the Bioself is 98% accurate in determining a woman's high fertility period when compared to BBT and the calendar method of NFP. The device also achieved a 98% accuracy rate in determining infertile days when compared to BBT.' However, in 10% of the cycles, no green light readings were displayed (i.e., the device indicated that the women experienced no days of infertility). In comparison with the Billings ovulation method, the Bioself achieved a 94% accu- racy rate in determining the first day of infertility in

Figure 1. Bioalf 11 0 jertili@ indicator.

the presumed postovulatory period of a cycle.' Recent studies have validated the accuracy of determining the fertile and infertile times of women's menstrual cycles by correlating the Bioself 110 with serial ultrasound monitoring of follicular diameter and with luteinizing hormone (LH) surge detection kits.'0."

One limitation of the Bioself is that the device is only as accurate as the NFP methods on which it is based. Therefore, use of the Bioself is limited to ovu- lating women, and data produced by the device would

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be inaccurate for women who are breastfeeding, post- partum, coming off oral contraceptives, or premeno- pausal, and for women who have a history of anovula- tion. According to the United States Federal Drug Ad- ministration (FDA), the Bioself can be marketed only as a device to aid in conception, not as an aid in avoid- ing pregnancy.

In recent years, several new devfces baue been developed to beip women acbfeve or auofd pregnancy.

The Rabbit fertility computer, like the Bioself 110, is based on the calendar and BBT methods of NFP. The Rabbit is a microcomputer that is shaped like a hand-held calculator and has a temperature probe at- tached (Fig. 2 ) . The screen of the computer provides a display of the BBT graph, and the device has recall of the three previous monitored cycles.

All a woman has to do to use the Rabbit is record her temperature daily upon waking. Unlike the Bio- self, the Rabbit records and displays the actual temper- ature readings. The Rabbit requires the user to follow sophisticated instructions to properly program the de- vice. The Rabbit gives a graphic display that indicates the optimal days of fertility. The user manual provided by the manufacturer claims that 95% of normally fer- tile couples who use the device will get pregnant within a six-month period. Although no information is available concerning the effectiveness of the device in avoiding pregnancy, one could assume that the device is as accurate as the methods on which it is based. Like the Bioself, the FDA has approved the Rabbit to be sold only as an aid to conception, not as an aid in avoiding pregnancy.

Electronic Devices

In 1936, Burr and Musselman discovered that the elec- trical charges emanating from a woman's body peak at the time of ovulation." This discovery was, at first, hailed as the answer to having a safe and accurate way of determining the fertile and infertile days of a woman's cycle. The electronic devices at that time, however, were unsophisticated, and results were not replicated with an adequate degree of accuracy to de- termine the time of ovulation. Advances in electronics since 1936 have stimulated new interest in using elec- trical phenomena to detect ovulation.

In 1988, Dr. Robert Friedenberg developed a de- vice called the 0 ~ u l e r t . l ~ The Ovulert operates on the theory that a woman gives off a minute electrical

Figure 2. Ruhhit personal jertili(p1 computer.

charge from her ovaries at the time of ovulation and this electrical charge can be detected on the outside of the woman's body. No data are available on the effec- tiveness or accuracy of the Ovulert, but Friedenberg has conducted studies on earlier ovulation meters. In one study that involved 49 subjects, Friedenberg found a 97% correlation of the electrostatic charge of the body to BBT and LH 1 e ~ e l s . l ~ Independent clinical studies must be completed before the Ovulert can be marketed.

Dr. Heinz Krohn, of West Germany, invented an- other electronic ovulation detection device called De- termine: the OvuTest, which is available in Europe and Canada. Krohn claims that the device is able to detect electrochemical charges associated with ovula- tion and the protein uteroglobulin or blastokinin in the cervical mucus. Independent testing of the device by Daniel et al. found 95.5% false positives in 60 cycles of 20 women subjects (i-e., the device was found to be inaccurate based on the data from this study) .14

A more promising device is the CUE Fertility Monitor (Zetek Inc., Aurora, Colorado). The CUE consists of a hand-held digital monitor and vaginal and oral probes (Fig. 3). The probes detect and record the electrical resistance of saliva and vaginal secretions. The electrical resistance (and ionic concentrations) in both the saliva and vaginal (cervical) secretions change in response to the cyclical changes in estro- gen. The CUE monitor can be used to both predict and confirm ovulation. Therefore, the monitor has the po- tential for avoiding and for achieving pregnancy. The peak electrical resistance in the saliva occurs about

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Figure 3. CUEfertili(v mottitor.

five to seven days before ovulation, and the vaginal nadir of electrical resistance occurs about a day before ovulation. Use of the monitor requires daily assess- ment of the vaginal and oral secretions.

Most of the studies on the CUE monitor empha- size its role in aiding infertility treatment and artificial insemination. Albrecht et al. found that 91% of the time the peak in LH occurred four to five days after the peak in salivary electrical re~istance. '~ Roumen and Dieben, however, found no strong correlation be- tween the CUE salivary peak and the day of the LH surge in 27 cycles measured among 18 female volun- teers.16 These two researchers concluded that the sali- vary electrical resistance peak has no use in predicting the day of ovulation. Moreno et al. conducted the first published study that investigated the possibilities of using the CUE in NFP." These researchers analyzed 29 cycles from 11 women and found that the peak salivary resistance occurred 5 to 11 days before the estimated day of ovulation (i.e., estimated by the urine LH surge) in all cycles. The researchers also found that the vaginal nadir occurred within two days before the estimated day of ovulation in 93% of the cycles. The vaginal nadir occurred after the estimated day of ovulation in only one cycle. Further clinical studies must be conducted before this device can be used for avoiding pregnancy.

Chemical and Hormonal Test Kits

detection kits.I6 These test kits employ monoclonal antibody technology to detect the LH surge that occurs in the urine about 12-24 hours before Ovulation. The manufacturers of these test kits claim greater than 90% accuracy in detecting the LH s ~ r g e . ' ~ . ' ~ This accuracy rate occurs only if a woman uses the test kits twice a day.

Fehring recently conducted a study using the OvuQuick (Monoclonal Antibody, Inc., California) test kits (Fig. 4) and found that 20 women with normal cycles detected an LH surge only in 75% of 38 cycles.20 In the same study, the peak day of cervical mucus (as detected by self-observation) occurred 100% of the time within three days before the LH surge. The re- sults indicate that women can be more accurate in pre- dicting ovulation by the daily observation of cervical mucus performed according to the ovulation method of NFP than by the use of a urine LH test kit. The ovulation self-test kits cost between $30 and $77 per kit, and the test takes from 15 minutes to one hour to conduct. The kits are useful only in helping women to achieve pregnancy, not to avoid it.

Dr. James Brown, a biochemist and colleague of John and Evelyn Billings, invented a device called the Ovarian Monitor. This device helps a woman self- monitor the beginning, peak, and end of her fertile period using enzyme immunoassay of estrogen and pregnanediol glucuronides.21*22 The device is in- tended as a research instrument and an aid in teaching the ovulation method of NFP. The monitor is particu- larly useful for women who have difficulty identifying their fertile periods through self-observation of their cervical mucus. Although the device is somewhat complex and involves urine collections, Brown points out that using the monitor is about as complex and time consuming as making a cup of tea. At this time, the Ovarian Monitor is being field-tested in several countries and is not commercially available in the United States.

Figure 4 . OeuQuick septesl kit: The four-mhzute owlation predictor.

In the past five years, manufacturers have developed and marketed a number of home or self-test ovulation

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Figure S. PG/53 fertili(v tester.

Other chemical kits and devices are being investi- gated and developed to predict and detect ovulation. For example, Tsibris et al., of the University of Illinois, are working on the development of a home test kit that will predict and detect ovulation based on levels of peroxidase in cervical ~ U C U S . ‘ ~ This test kit had not yet been manufactured at the time this article was pre- pared. Studies of the kits are being conducted to de- termine whether they meet FDA approval standards. Monoclonal Antibody, Inc., has a commercially avail- able home urine test of progesterone. Potentially, this home test could be used in NFP as a marker for the postovulatory phase of infertility. Another fertility de- vice, called the PG/53, was developed in Barcelona, Spain (Aplicaciones Opticas; Fig. 5). The PG/53 is, essentially, a small, flat, plastic microscope. A woman tests her fertility and infertility by placing a sample of saliva or cervical mucus on the lens of the device. After the mucus or saliva dries, the woman looks through the lens to determine whether or not ferning (crystal- lization) is present. If ferning is present, the woman is fertile. Marketing literature for the PG/53 states that the device has been clinically tested and that the re- sults correlate with other methods of ovulation pre- diction (e.g., hormonal determinations, ultrasound, laparoscopy, and BBT). The PG/53 does not intro- duce any new concepts regarding the prediction or detection of ovulation. The correlation of ferning with the approximate time of ovulation has been known for a long time. The PG/53, which simply represents

clever packaging and marketing, is not yet available in the United States. A final example of a new device that is being researched and developed is the Rovumeter. The Rovumeter is a simple syringe-type instrument that aspirates and measures cervicovaginal fluid (CVF) volume. A recent study has shown that the CVF vol- ume correlates closely with the time of fertility in a woman’s menstrual cycle.’*

Nursing Implications

Nurses and other health-care professionals who advise and teach women about their fertility should be aware of the advantages and disadvantages of fertility moni- toring devices. One disadvantage of fertility monitor- ing devices is that often they do not provide a lot of pertinent information about a woman’s menstrual cy- cle. This aspect is important because a woman who relies only on an external monitoring device might not gain a proper understanding of her fertility and might miss important information to help explain in- fertility or other health problems. For example, a woman who uses the ovulation method of NFP will know the length and variability of her menstrual cy- cles, be able to predict and detect her approximate time of ovulation, have a good idea of the amount and variability of her mucus cycle and menses, and be able to detect possible infertility problems, such as limited cervical mucus, short luteal phases, and delayed ovu- lation. The woman also will be able to detect potential health problems, such as vaginal or cervical infections and unusual bleeding patterns. In comparison, a woman who uses one of the commercially available ovulation detection kits (e.g., urine LH surge detec- tors) will know her approximate time of Ovulation only in about 75% of her cycles. The woman also will have to purchase an expensive kit to measure every cycle. In contrast, once a woman is taught how to monitor her fertility through the ovulation method, that woman will have that information throughout her reproductive life at little cost.

Another disadvantage of fertility monitoring de- vices is that women often prefer to rely on personal observations of changes in their bodies rather than on chemical tests and electronic monitors. This prefer- ence is often held by women who believe that they will always have their personal observations of body signs available, whereas chemical test kits and moni-

Fertility monitoring devices can provide helpful indicators of fertility to women who are learning natural family planning.

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toring devices will not always be available and can be inconvenient. Women do not like to take these kits or monitoring devices outside the privacy of their homes. A woman may feel embarrassed trying to ex- plain to her friends or colleagues the reason she is testing her urine with a miniature chemistry kit. Fur- thermore, electronic devices can malfunction, chemi- cal tests can provide false readings, and both can be physically intrusive, expensive, and time consuming. This information is important for nurses to know be- cause they should advise their fertility and infertility clients concerning the inconveniences of these moni- toring devices and advise women of all educational backgrounds that they can learn to detect their fertile times without the devices. In addition, nurses should advise their clients that these skills can be acquired in a short period of time when properly taught.'

Nurses should consider the advantages and disadvantages of fertility monitoring devices as compared with currently used metbods of natural family planning.

Professional nurses, however, also should be aware that fertility monitoring devices can be helpful in fertility control. Women who have continuous mucus discharge because of cervical or vaginal infec- tions initially may have difficulty in determining days of fertility and infertility with the ovulation method of NFP (i.e., the infections will obscure the regular cerv- cal mucus patterns). Fertility devices can provide helpful indicators for fertile days in a cycle with con- tinuous mucus and might hasten the learning process for a woman studying NFP. Some women are averse to monitoring their mucus or other bodily signs. These women might be more open to the use of external monitoring devices. Another advantage of fertility monitoring devices is that they do not require the nurse to spend much time teaching clients how to use the devices. Giving a woman an electronic monitor and some verbal and written instructions on interpret- ing BBT or providing a woman with a demonstration of a self-observation LH detection kit takes only about 20 minutes. To instruct a woman in the proper use of the ovulation method usually takes several one-hour teaching sessions. For example, the Creighton Model Ovulation Method developed by Hilgers et al. re- quires a minimum of eight one-hour sessions spread over an entire year.25 Finally, fertility monitors can provide a more quantifiable and objective measure of the fertile period. In comparison, the ovulation and symptothermal methods of NFP require the use of

To be useful, fertility monitoring devices must be safe, eficient, accurate, and nonintrusive.

subjective, but reproducible, observations of body signs. The subject'iveness of the ovulation and symp- tothermal methods of NFP can cause initial confusion and dissatisfaction with the methods.

S*tnm@ry

When purchasing or recommending fertility monitor- ing devices to clients, nurses should consider the ad- vantages and disadvantages of this new technology as compared with currently used methods of NFP. Al- though these new methods can be expensive, do not provide much information about the menstrual cycle, and are, at times, inaccurate, inconvenient, and time consuming for the client, they can be useful aids to patients learning about fertility. The devices are more objective than other NFP methods, and health pro- viders can teach patients how to use these devices in much less time than that involved in teaching other NFP methods. Currently, all of the fertility monitoring devices and ovulation detection kits mentioned in this article can be used in the United States only as an aid in achieving pregnancy, not in avoiding it. Although the marketing information on the devices can be use- ful, nurses should write to the individual manufac- turers to receive reports of actual research studies con- ducted on the devices or kits. The most objective in- formation on this new technology can be obtained from reputable research journals that have published the results of research studies conducted indepen- dently of tests conducted by the manufacturers of these devices.

Of the devices discussed in this article, the ones that are available in the United States are the Bioself, the Rabbit, the CUE fertility monitors, and the urine LH ovulation detection kits. The Bioself monitor is the least expensive of these devices (from about $95 to $125), but if the user wants an actual readout of the Bioself temperature readings, she must purchase a Bioself printer. The Rabbit monitor retails for approxi- mately $150 and the CUE for $500. The CUE can be rented on a month-to-month basis for about $45 per month. A number of manufacturers produce urine LH detection kits, and the prices vary from about $27 to $75.19

In conclusion, experts in the ovulation method of NFP do not believe that fertility monitoring devices will replace the need for the currently used methods of NFP or for NFP practitioner^.'^ Rather, they see the

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These new devices can be expensive, inconvenient, and time consuming, and they do not provide much information about the menstrual cycle; however, they can be more objective than the currently used methods of natural family planning.

devices as patient teaching aids for the practitioner, as research tools, and as helpful indicators to women who are learning NFP. One can expect that, in the future, new fertility monitoring devices will be devel- oped and tested and that some will become commer- cially available to health-care professionals and con- sumers. To be useful, however, these devices must be safe, simple to use, efficient, inexpensive, and as accu- rate as the existing methods of NFP. The devices also must provide as much information about a woman's menstrual cycle as do existing methods of NFP, must be nonintrusive for the woman and her partner, and must be useful to women of all reproductive catego- ries. Health-care professionals and consumers must be cautious and evaluate new fertility monitoring de- vices carefully. However, health-care professionals must be open to this technology's potential for help- ing women and their partners understand the role of the menstrual cycle in reproduction.

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Knaus, H. 1934. Periodic Fertility and Sterility in Women. Vienna: Wilhelm Maudrich. Murphy, J.P., and 3.D. Laux. 1955. The Rhythm Way to Family Happiness. Ithaca, New York: Practical Publishers. Keefe, E.F. 1949. A practical open-scale thermometer for timing human ovulation. N Y State J Med. 49( 11):

Brinberg, C.H., D.J. Wexler, and M. Gross. 1963. Esti- mation of ovulation phase by serial tests of cervical and vaginal glucose. Obstet Gynecol. 21 (2):194-200. Moghissi, K. 1980. Prediction and detection of ovula- tion. Fertil Steril. 34(2):89-98. Vollman, R.F. 1977. The Menstrual Cycle. Philadelphia: W.B. Saunders Co. Bioself Development. 1987. Bioself fertility indicator: The natural alternative. Summa ry and conclusions concerning the accuracy of BioseZfl10. Geneva, Swit- zerland: Bioself Development.

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Address for correspondence: Richard J. Fehring, RN, DNSc, Associate Professor, Marquette University, College of Nursing, 510 N. 16th St.. Milwaukee, WI 53233.

Richard J. Fehring is an associate professor at the Marquette University College of Nursing and the coordinator of #he Marquette University Natural Family Planntng Servtces, Mtlwaukee, Wtsconstn. Dr. Fehring Is a member of NAACOC and Sfgma Theta Tau and tsprestdent of the Amertcan Academy of Natural Family Planntng.

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