A NEW TEST FOR HUMAN FEMALE OVULATION DIAGNOSIS

Abstract Material and Method Results References Conclusions

REPRINT Vol: 6 - No 1, 1994 Edizioni Universitarie Romane Saliva Fertility Tester

G. GALATI*, E.TRAPANI, M.YACOUB, M.R. TOCCACELI, G.M. GALATI, C. FIORELLI, F. BANDIERA, A. PAOLILLO III Clinica Ostetrica e Ginecologica, Università degli Studi di Roma "La Sapienza" (Direttore: Prof. L. Marzetti) *Professore Associato - Titolare insegnamento di Fisiopatologia della Riproduzione.

Abstract

The Authors performed the saliva test on 328 women using the Saliva Tester. In 48 cases the test results revealed a fern-like crystallized structures as illustrated in "Figure 3"below. In 20 cases they performed a Transvaginal Ultrasonography (T.V.U.S.). In 16 cases (80%) they found an ovarian follicle greater than 2 cm.

To know the days of their menstrual cycle when fecundation is possible has always been a demand felt by women and this both in the case when they want to avoid it (1). Many methodologies exist that enable us to verify or not the presence of a mature ovarian follicle or its happened explosion. A very simple methodology was reached with observation and testing of the Saliva Tester; results that may be easily and directly realized by any woman, at any moment of the day, anywhere. The prospective advantages that descend as to the knowledge of the useful days for a fecundation are such that they led us to directly and correctly try this new test.

Material and Method

It has been considered the use of a mini-microscope, or "Saliva Microscope", made up of a small cylindrical body or eyepiece where we note an optical part with an opposite small slide where a sample of saliva is placed. As soon as the sample of saliva has dried, the small eyepiece body is put into a cylindrical container, that leads down to a lighting system. By focusing the lens, a fern-like characteristic crystallization is pointed out, in a very near correlation with the ovulation period (Figure 3). Out of the fertile days there are no fern-like crystallization structures seen, as pictures named "Figure 1" (during the non-fertile period) and "Figure 2" (during the intermediate period) indicate.

We have taken into consideration 328 women between 15 and 50 years old, not using OCP who were placed under our observation at the out-patients' departments of the Institute of Obstetrics and Gynecology of the University "La Sapienza" in Rome. No selective principle has been adopted. We have only invited the patient to leave a sample of saliva on the slide of the mini-microscope, and afterwards age, day of the cycle in which the patient was and length of her cycle were noted. 48 women, whose sample of saliva gave the fern-like characteristically stratification were invited to undergo an ultrasonography with transvaginal sound for the control of the ovarium and of the presence or not of the pertinent follicle. 20 women accepted our request, 28 women kindly refused.

Results

Results are reported by Tables 1,2 and 3. In Table 1 we see 48 women of 328 who, as far as anamnesis is concerned, are in the ovulation period; 40 of these women gave us the picture "Figure 3" type after test, 40 gave us the picture "Figure 2" and 248 the picture "Figure 1" type (Table 2). At the anamnesis, 36 women were in the intermediate period; in all 36 cases of this group, we have noted a picture "Figure 2" type. At the anamnesis, 244 women were in the non-fertile period and we have noted a picture "Figure 1" type in all the 244 cases. In the Table 3, are pointed out the 20 cases who, at the saliva test, showed a picture "Figure 3" type and have accepted to undergo sonographic control by means of transvaginal sound.

Table 1 -Number of women undergoing the saliva test, correlated to the supposed fertile or non-fertile period of the cycle.

Table 2 -Picture stressed by means of the saliva test.

Table 3 -Echographic control of 20 women by means of picture Figure 3 type of the saliva test

In 16 cases, equal to 80% of the total, an ovarian follicle has been stressed having dimension over 2 cm, in 4 cases a follicle having diameter less than 1 cm has been stressed.

References

1) Zondek B., Rozin S.: Cervical mucus arborization: its use in determining of corpus luteum function. Obstet. and Gynec., 3: 463, 1954.

2) Barbato M., Boerci M., et al.: Natural methods for fertility control. New Trends Gynaec. Obstet.,2: 325, 1986.

3) Calamera J.C., Vilar O., Nicholson R., change in sialic acid concentration in human saliva during the menstrual cycle. Int.Fertility 1986, 31; s.43-45

4) Folan J., Gosling J.P., Finn M.F., Fottrell P.F.; Solid Phase, Enzimoimmunoassay of estrone in saliva, Clin.Chem., 1989, 35; s.569-571

5) Mancuso S., Van Look P.F.A.: Natural fertility regulation today. Intern. J. Gynecol. Obstet., Suppl. I, 1989.

Conclusions

A Saliva Microscope can be used to help determine the fertile period: the fertile cycle will be identified with a continuous use, cycle after cycle. The Tester can also allow, by repeating every month the tests, to obtain some significant indications about the monthly cycle behavior and the hormonal situation of the woman.

The tester can also be used to help avoid an undesired pregnancy: the comparison of the figures given in Tables 1 and 2 indicate the following: at the anamnesis 244 women were in the non-fertile period and we have noted a picture "Figure 1" type. In all 244 cases at the anamnesis 36 women were in the intermediate period; in all 36 cases of this group, we have noted a picture "Figure 2" type. In both cases we had a perfect coincidence between supposed fertile or infertile days of the cycle and tests executed with "The Saliva Fertility Tester". At the anamnesis 48 women were in the fertile period; in 40 of them we have noted a picture "Figure 3" type. Such difference is due to the fact that 4 of them had a meal one hour before testing, thus invalidating the result, and the other 4 may have not correctly performed the test. Therefore, even if we assume that all these 8 women were in fact fertile (very unlikely), the final result of such test is that ONLY 8 women out a panel of 328, i.e. less than 3%, resulted in false negative (in fact fertile) at the saliva testing.

We can conclude stating the following:

• To our knowledge the saliva microscope can be significantly helpful in providing an additional aid to women wanting to identify their likely fertile period during the menstrual cycle.
• The outcome is that its accuracy, in determining fertile moments of the monthly cycle, is close to 98%, higher than other contraceptive devices like condom, spyral, diaphragm, not to mention billings and ogino-knaus methods, placed at the lower end of this scale.
• To prevent a pregnancy only the contraceptive pill has a higher rate (99%) ; at the same time everybody today is aware of bad secondary effects of the use of the pill. this tester is not invasive and there is no need of reagents or other evidence system.
• Any woman can easily do the test. she can perform it anytime and anywhere.

Saliva Ferning Is Fertility Clue

Researchers have been observing and studying the phenomenon of ferning in cervical fluid 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 was in regard to 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. He put his findings into use 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 1/2 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 an 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 handheld 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, which used a PC-2000 microscope, classified reliability as "very high level," and claimed that combining the sympto-thermal method with the microscope method resulted in a 99% reliability rate.

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