INTERNATIONAL REVIEW OF MEDICAL SCIENCES

REPRINT Vol 6 - Nº 1, 1994 Edizioni Universitarie Romane DOÑA® 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.

The Authors used the saliva test in 328 women. In 48 cases they found a picture as "Quadro 3" fern-like. In 20 cases they performed a transvaginal Ultrasonography (T.V - U.S.). In 16 cases (80%) they found an ovarian follicle > 2 cm.

Fertility tester, sample of saliva, fertile periods, transvaginal Ultrasonography.

To know the days of her menstrual cycle when fecundation is possible has always been a demand particularly felt by woman. And this both in the case when she 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 reached under our observation, being easily realized and that may be directly realized by woman, in any moment of the day and anywhere.

The prospective advantages that descend from it 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.

It has been considered the use of a minimicroscope, trade name "DOÑA Fertility Tester", made up of a small cylindrical body where we note an optical part with an opposite small slide where a sample of saliva is leant.

As soon as the sample of saliva is dried up, the small cylindrical body is leant on a small container, that leads down the lighting system. By focusing the picture, a fern-like characteristic crystallization is pointed out, in a very near correlation with the ovulation period

Out of the fertile day there is no fern-like crystallization picture, but pictures named "Quadro 1" (during the non-fertile period) and "Quadro 2" (during the intermediate period) (Figure 2 and 3).

We have taken into consideration n. 328 women between 15 and 50 years old, not using OCP who reached under our observation at the out-patients' departments of the Ist Institute of Obstetrics and Gynecology of the University "La Sapienza" in Rome.

We have only invited the patient to leave a sample of saliva on the slide of the minimicroscope, and afterwards age, day of the cycle in which the patient was and length of her cycle were noted.

Nº 48 women, whose sample of saliva gave the fern-like characteristical 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. Nº 20 women accepted our request, nº 28 women kindly refused.

Fig. 1		Fig. 2		Fig. 3

In Table 1 we see nº48 women of 328 who, as far as anamnesis is concerned, are in the ovulation period; nº 40 theme gave us the picture "Quadro 3" type after test, nº 40 gave us the picture "Quadro 2" and nº 248 the picture "Quadro 1" type (Table 2).

At the anamnesis, nº 36 women were in the intermediate period; in all 36 cases of this group, we have noted a picture "Quadro 2" type.

At the anamnesis, nº 244 women were in the non-fertile period and we have noted a picture "Quadro 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 "Quadro 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 3 - Echographic control of nº 20 women by means of picture Quadro 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.

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.

The Fertility Tester can be used to look for a pregnancy: the fertile moments will be identified with a continous use, cycle after cycle.
The Tester will also allow, by repeating every month the tests, to obtain some significant indications about the monthly cycle behaviour and the hormonal situation of the woman.

The Fertility Tester can be used to avoid an undesired pregnancy: the comparison of the figures given in Tables 1 and 2 indicate the following:

In both cases we had a PERFECT COINCIDENCE between supposed fertile or infertile days of the cycle and test executed with "DOÑA Fertility Tester".

- at the anamnesis 48 women were in the fertile period; in 40 of them we have noted a picture "Quadro 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 false negative (in fact fertile) at the saliva testing.

Day of the cycle	Non-fertile period	Intermediate period	Fertile period	Total
N° of women undrgoing test	244	36	48	328

Ovarium Echographic Control	Follicle Absence	Follicle < 1 cm	Follicle > 2 cm
N° cases	0	4	16

Stressed picture	Quadro 1	Quadro 2	Quadro 3	Total
N° cases	248	40	40	328