PROGRESS REPORT INTERNATIONAL REVIEW OF MEDICAL SCIENCES A NEW TEST FOR HUMAN FEMALE OVULATION DIAGNOSIS REPRINT Vol: 6 - N? 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
Abstract
The
Authors performed the saliva test on n?328 women using the Saliva
Tester. In n?48 cases the test results revealed a fern-like
crystallized structures as illustrated in "Figure 3"below. In n?20
cases they performed a Transvaginal Ultrasonography (T.V.U.S.). In n?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 n?48 women of n?328
who, as far as anamnesis is concerned, are in the ovulation period;
n?40 of these women gave us the picture "Figure 3" type after test,
n?40 gave us the picture "Figure 2" and n?248 the picture "Figure 1"
type (Table 2). At the anamnesis, n? 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, n? 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 n?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.
|
Day of the cycle
|
Non-fertile period
|
Intermediate period
|
Fertile period
|
Total
|
|
N° of women undergoing test
|
244
|
36
|
48
|
328
|
Table 2 -Picture stressed by means of the saliva test.
|
Stressed picture
|
Figure 1
|
Figure 2
|
Figure 3
|
Total
|
|
N° Cases
|
248
|
40
|
40
|
328
|
Table 3 -Echographic control of n? 20 women by means of picture Figure 3 type of the saliva test
|
Ovarium Echographic Control
|
Follicle Absence
|
Follicle < 1 cm
|
Follicle > 2 cm
|
|
N° cases
|
0
|
4
|
16
|
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 n° 244 women
were in the non-fertile period and we have noted a picture "Figure 1"
type. In all 244 cases at the anamnesis n° 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
"
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