Methods and apparatus for diagnosis of fertility status in the mammalian vagina

• US 20050165326A1
• Filed: 06/30/2003
• Published: 07/28/2005
• Est. Priority Date: 07/01/2002
• Status: Active Grant

• Current Assignee: Vaclav Kirsner
• Original Assignee: Vaclav Kirsner
• Inventors: Kirsner, Vaclav
• Granted Patent: US 7,427,271 B2
• Time in Patent Office: Days
• US Class Current: 600/551
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: A61B 2010/0016 based on measurement of electric currents, e.g. conductivity tests

Abstract

Methods and apparatus for interpreting vaginal measurement data by electronic means without the need for the user to take part in the data interpretation process. More specifically, an intelligent probe monitors folliculogenesis and correlates the ovarian function data to probe profile characteristics of the female reproductive cycle. A fertile window is defined with reference to the correlation between folliculogenesis and probe cyclic profiles. Data stored within the apparatus can be downloaded into an external display appliance or data analysis unit. Another aspect of the invention allows for continuous layout of the memory of preceding cycles in the inventory of the apparatus, retaining the most recent while erasing the most distant stored data. These methods assure a reliable fit for the diagnosis of fertility, treatment of infertility as far as timing of treatment procedures, management of subfertility and other gynecological disorders such as luteal phase deficiency or short luteal phase, and the management of premenstrual mood disorders, and of premenopausal and menopausal patients.

Claims

1. A method for diagnosing fertility status in a female mammal comprising the following steps:

monitoring folliculogenesis by means of an intelligent fertility probe whereby ovarian function data is generated,

correlating said folliculogenesis data to various phases of the female reproductive cycle monitored by said probe whereby the correlation makes it possible to interpret the various phases of folliculogenesis, and

defining a fertile window with reference to said correlation.

2. The method of claim 1 wherein the monitoring of ovarian function and predicting and detecting of ovulation is performed by means of a small single-piece self-contained probe with a display in the handle of the device indicating the beginning and the end of the fertile window and/or the actual fertile day numbers within said fertile window.

3. The method of claim 1 wherein the specific detection of the boundaries of the fertile window, i.e., the beginning and the end of intermittent fertility, is by means of certain specific inflections in the probe cyclic profile.

4. The method of claim 1 wherein the fertility status is detected by means of end-organ effects at the cervical epithelium site of action, as opposed to the prior art'"'"'s detection of circulating hormone levels or other biochemicals in remote locations such as peripheral blood or saliva or vaginal fluids away from cervical tissues.

5. The method of claim 1 wherein ovulation is predicted by means of the detection of at least two pre-ovulatory features in the probe cyclic profile as opposed to a single, typically remote, parameter of prior art techniques.

6. The method of claim 1 wherein the tracking of the probe cyclic profile is by means of monitoring a single biophysical variable, and wherein said cyclic profile allows an assessment of the general character of the menstrual cycle, i.e., whether normal or aberrant.

7. The method of claim 1 whereby the timing of the conceptive intercourse can be controlled so as to attempt fetal sex selection by adjusting the said timing at a selected interval with respect to the predicted or the detected time of ovulation.

8. The method of claim 1 whereby the timing can be controlled of the uptake of various types of medications administered to women, and of performing those types of medical procedures and examinations, which must or should be performed in an appropriate phase of the menstrual cycle.

9. The method of claim 1 whereby the timing is determined for the various biological events that occur during folliculogenesis andlor ovarian cyclic function and that are significant for various medical procedures, such as those events included in the group of recruitment, selection, dominance and ovulation, all referring to the dominant follicle.

10. The method of claim 1 whereby an accurate monitoring of pregnancy is possible from the probe-registered time of conceptive intercourse and ovulation, allowing an accurate determination of the expected time of delivery.

11. The method of claim 1 wherein the reliability of the diagnostic interpretation of the current measurement data is evaluated, utilizing the following input parameters:

a. the number of data points in the record of the present cycle,

b. the conception or fecundity statistics for the given day of cycle,

c. reproducibility of the current measurement data, if the user opts to repeat the measurement within the allowed period of time,

d. the amplitude of the interpreted data point with respect to the fertility and ovulation thresholds, and

e. the uncertainty, if registered by the user, about the correctness of the user-entered first day of the present cycle.

12. An apparatus for diagnosing fertility status in a female mammal wherein the monitoring of ovarian function and predicting and detecting of ovulation is performed by means of a small singlepiece self-contained probe with a display in the handle of the device indicating the beginning and the end of the fertile window and/or the actual fertile day numbers within said fertile window.

13. The apparatus of claim 12 wherein the fertility status is detected by means of end-organ effects at the cervical epithelium site of action, as opposed to the detection of circulating hormone levels or other biochemicals in remote locations such as peripheral blood or urine or saliva or vaginal fluids away from cervical tissues.

14. The apparatus of claim 12 wherein the monitoring of a single biophysical variable is used for the determination of the intermittently occurring fertile window, and for the assessment of the general character of the menstrual cycle, i.e., whether normal or aberrant.