The Scientific Basis Behind the OVU-TEC Fertility Detector
By Robert K Wagstaff, Ph.D.

 Introduction:

The Menstrual Cycle of the Child bearing aged woman has been studied extensively for many years.  Ovulation is the prime event in this cycle and the understanding of when this occurs is fundamental to predicting fertilization.  Medical experts have long sought for a method to accurately predict ovulation, however, there appears to be "no one best method" available.  Ovulation time is determined by a combination of measuring hormone levels in the blood and other body fluids, hormone levels in vaginal fluids, vaginal discharges, and body temperature.  During the past several years research has shown that various tests using saliva can also assist women to predict ovulation.  Some of these tests are based on electrolyte levels or the use of ELISA tests or other chemical based tests to determine the hormone levels in the saliva which then are used to predict ovulation.

The most recent test is called "ferning".  Ferning occurs when the luteinizing hormone (LH) produced in the ovary rises in the saliva.  The LH in the saliva will crystallize upon drying and appears like a "fern" when viewed under a microscope.  The LH levels must be quite high (about 10 times normal base levels) in order to form.  The newly developed OVU-TEC Fertility Detector is a miniature microscope designed to allow the average woman to observe "ferning" when her LH levels are elevated during the ovulation phase of the menstrual cycle.

Technical History:

It has long been known that the reproductive cycle in the woman was regulated by hormones.  It has also been known that these hormones are present in blood as well as in other body fluids.  A review article published in 1975 (The detection of ovulation in humans and its application in contraception, J Reprod. Fert. Suppl.  1975 Apr (22):107-20) revealed that saliva was a very good source of both hormones and enzymes and that their levels changed in accordance with the menstrual cycle.

One test in 1992 (Objective and subjective data for fertile period diagnosis in women: comparison of methods. Clin.Exp.Obst.Gynecol.1992 19(1): 15-24) concluded the following: "It emerged clearly from the study that the greatest reliability among the natural methods is obtained through the evaluation of the presence of cervical mucus, while among the biochemical methods the best results are obtained by semi quantitative colorimetric test.  Brilliant prospects have also been opened by research on saliva."  Thus, saliva has evolved as one of the best sources of body fluids to use for the detection of ovulation.

The Importance of "Ferning":

With the understanding that enzyme testing, electrolysis testing, and hormone testing or saliva can be used to effectively predict ovulation it also became evident that a physical test using saliva could be useful to predict ovulation.  One test conducted in 1993 in The Netherlands (Adv.Controcept.1993 Dec: 9(4):335-40) used a commercial pocket microscope.  The test included 32 women who used the pocket microscope to detect their fertile period along with basal body temperature and the appearance of cervical mucus.  Of the 32 women participating in the test 28 women had a good salivary test with positive ferning during the same period as the other markers of fertility.  Ferning began 1-2 days before cervical mucus appeared and lasted a mean of 6.2 days.  They concluded:  There is a direct correlation between salivary ferning and the fertile period.  Salivary ferning may be used as a new parameter to aid women to detect the fertile period in combination with other symptothermal methods of ovulation detection."  This research is supported by other research showing the value of ferning (salivary ferning and the menstrual cycle in women. Clin.Exp.Obstet. Gynecol.1993.20(1):48-54).

Researchers have been examining the phenomenon of "Ferning" since 1945, when Papanicolau observed microscopic crystal formations in cervical fluid (cervical mucus).  Subsequent researchers have studied the ferning of other body fluids, including saliva.

In 1969, Dr. Biel Cassals, a Spanish gynecologist, studied the crystallization of saliva.  His presentation to the Barcelona Medical Board regarded the relationship between hormonal changes during the female menstrual cycle and the crystallization of saliva, indicating that the ferning saliva is virtually identical in appearance to the arborization effect of cervical fluid.  His findings were put into used in 1971 when he developed a microscope intended to test for ferning in saliva.  His clinical experiments involved a number of physicians testing the apparatus for approximately 10 months on a group of 1,000 women.  These women used the saliva test as a method to ascertain when they were fertile.  According to Biel Cassals, this method's success rate was around 96.2%.

A study conducted in 1991 (M. Guida) at the Institute of Gynecology and Obstetrics Clinic in Napoli, Italy, achieved a positive result in 92% of the cases studied, matching salivary ferning to the fertile preovulatory and ovulatory period.  Parameters recorded included basal temperature, subjective sensation of the mucus at the level of the vulva, characteristics of cervical fluid, abdominal and/or lumbar painfulness, and echographic proof of ovulation.

A further study conducted in 1992 in Milan, Italy (M. Barbato, A. Pandolfi) and Naples, Italy, (M. Guida) examined the use-effectiveness of salivary ferning as a diagnostic testing aid to natural family planning.  This study used the PG/53 pocket microscope.  They concluded that there is a direct correlation between salivary ferning and the fertile period.  Their conclusion clearly stated that "Salivary Ferning" may be used as a new parameter to aid women to detect the fertile period in combination with other sympto-thermal methods of ovulation detection.  The ferning event began on average about 7* days before the first day of basal body temperature rise.  In general, salivary ferning was seen to begin 1 to 2 days before the onset of wet cervical fluid.

In 1992 a study involving 300 women from and IVF (in vitro fertilization) program was created at the 2nd Department of Gynaecology and Obstetrics in Brno, Czechoslovakia.  Patients were instructed in the use of a hand held microscope to observe salivary ferning.  In all of the patients, the cycle was stimulated by means of clomiphene citrate/CC/Gravosan Spofa/and hMG/Pergonal Serono/.  Follicular growth was monitored with a 7 MHz US vaginal sound/kretz/.  Serum 17 beta oestradiol and LH levels were evaluated daily by radio-immune methods.  Basal temperature was also recorded daily.  This study found a definite correlation between oestrogen activity and crystallization of saliva, between LH curve and crystallization of saliva and between follicular growth and crystallization of saliva.  The study classified reliability as "very high level", and claimed that combining the sympto-thermal method with the microscope method resulted in a 99% reliabiltiy rate.

We strongly agree with those researchers who have shown the value of ferning as a means to help predict ovulation.  The OVU-TEC Fertility Detector is the finest personal instrument produced in the world.  We encourage every woman of child bearing age to use the OVU-TEC Fertility Detector as part of their menstrual cycle monitoring program.