Method of detecting and predicting ovulation and the period of fertility

• US 8,496,597 B2
• Filed: 09/05/2007
• Issued: 07/30/2013
• Est. Priority Date: 09/05/2006
• Status: Active Grant

• Current Assignee: Fertility Focus Limited
• Original Assignee: Fertility Focus Limited
• Inventors: Knowles, Toby Grahame, James, Michael Howard
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US12/440,231
• Publication Number:
  US 20090326410A1
• Time in Patent Office: 2,155 Days
• Field of Search: 600/300, 600/301, 600/551
• US Class Current: 600/551
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: A61B 2010/0019 based on measurement of temperature
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/6801 specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6802 Sensor mounted on worn items
• CPC Class Codes: A61B 5/6867 specially adapted to be attached or implanted in a specific body part A61B5/6847 takes precedence
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A method of providing information relating to the fertility of a female mammal comprising the steps of: (i) taking multiple temperature readings from the female mammal during an extended period; (ii) identifying and disregarding temperature readings having one or more characteristics of irrelevant or faulty data; (iii) obtaining one or several representative temperature values for the extended period; (iv) repeating steps (i) to (iii) over multiple extended periods; (v) analyzing the representative temperature values obtained over multiple extended periods for one or more patterns in the representative temperature values indicative or predictive of ovulation in order to provide information relating to the fertility of the female mammal to a user, wherein the representative temperature values are not the maximum or minimum temperature readings obtained for the extended period; and related uses and apparatus.

Claims

1. A method of providing an indication related to the fertility of a female human comprising the steps of:

(i) taking multiple measured temperature readings from the female human during an extended overnight period using an intra-vaginal temperature measuring device;

using a processor to process the measured temperature readings to determine at least one representative temperature reading for the overnight period, the processing comprising the steps of;

(ii) identifying and disregarding measured temperature readings having one or more characteristics of irrelevant or faulty data to obtain a plurality of non-disregarded temperature readings;

(iii) processing the plurality of non-disregarded temperature readings to obtain one or several representative temperature values for the extended period;

(iv) repeating steps (i) to (iii) over multiple extended overnight periods; and

(v) analysing the representative temperature values obtained over multiple extended overnight periods for one or more patterns in the representative temperature values indicative or predictive of ovulation in order to provide information relating to the fertility of the female human to a user, wherein the representative temperature values are not the maximum or minimum temperature readings obtained for the extended period, wherein said extended overnight period is one hour or longer, and providing intervention if said information provides an indication as to whether a significant event related to the fertility of the female human has occurred.

2. A method according to claim 1, wherein said indication relating to the fertility of the female human is:

a) information identifying the timing of ovulation,

b) a binary indication of “

fertile”

or “

non-fertile”

,

c) an indication of the timing of the next fertile period,

d) an indication of normal fertility, subfertility or infertility, or

e) an indication of the number of ova released following ovarian hyper-stimulation.

3. A method according to claim 1, wherein said extended overnight period is of at least 4 hours.

4. A method according to claim 1, wherein at least 25 temperature readings are taken in said overnight extended period.

5. A method according to claim 1 wherein temperature readings are disregarded if they are characteristic of irrelevant or faulty data by reason of one of the following:

a) being more than 2°

C. higher or lower than the normal temperature of said female human,

b) differing from the preceding or following values by such a degree as to indicate heating or cooling rates of greater than 0.2°

C. per minute,

c) being a single reading or relatively few readings that differ so much from the other temperature readings collected during the same extended period so as to be unlikely to indicate a true change in temperature,

d) being characteristic of diurnal temperature fluctuations unconnected to levels of female hormones and therefore unrelated to ovulation, or

e) being tagged as such by user input.

6. A method according to claim 1, wherein said representative temperature value(s) for the extended period is/are obtained by:

a) calculating the mean of the non-disregarded temperature readings collected during the extended period or a part thereof,

b) calculating the median of the non-disregarded temperature readings collected during the extended period or a part thereof,

c) calculating the mode of the data collected during the extended period or a part thereof,

d) choosing the temperature reading or readings occurring at a particular distance in time from the start or the end of a stretch of non-disregarded temperature readings,

e) choosing all of the temperature readings remaining after those having one or more characteristics of irrelevant or faulty data are disregarded, or

f) choosing a single representative temperature value for each extended period that is the 11^th to the 50^th percentile of the temperature readings obtained for that extended period.

7. A method according to claim 1, wherein the multiple extended overnight periods for which representative temperature values are analysed comprise those collected over at least one ovulatory cycle of the female human.

8. A method according to claim 1, wherein said pattern indicative or predictive of ovulation is the peak in body temperature associated with the LH peak, or the dip in body temperature associated with a rise in oestradiol.

9. A method according to claim 1, wherein said indication relating to the fertility of the female human is provided to her or to her physician.

10. A method as claimed in claim 1, wherein one or more of steps (ii), (iii) and (iv) are carried out by a remote data processing device.

11. A method as claimed in claim 10, wherein between step (i) and step (ii) a further step (ia) is provided, said further step (ia) comprising labelling the measured temperature readings with a unique identifier and transmitting them to the remote data processing device, wherein said steps (ii), (iii), (iv) and (v) are carried out by the remote data processing device, or wherein between step (ii) and step (iii) a further step (iia) is provided, said further step (iia) comprising labelling the measured temperature readings with a unique identifier code and transmitting them to the remote data processing device, wherein said steps (iii), (iv) and (v) are carried out by the remote data processing device, or wherein between step (iii) and step (iv) a further step (iiia) is provided, said further step (iiia) comprising labelling the representative temperature values with a unique identifier code and transmitting them to the remote data processing device, wherein said steps (iv) and (v) are carried out by the remote data processing device, or wherein after step (v) there follows a further step (vi) comprising either:

(a) transmitting said information about fertility of the female human to the user'"'"'s terminal;

or

(b) storing said information about fertility of the female human on a computer server for retrieval by the user'"'"'s terminal; and

optionally by one or more further nominated terminals in possession of the unique identifier code.

12. The method of claim 1 further comprising using the indication relating to fertility as:

aid to diagnosis of anovulation, an aid to diagnosis of irregular ovulation, an aid to conception, a contraceptive method or an indication of the number of ova released following hyper-stimulation of the ovary.

13. The method of claim 1 wherein said intra-vaginal temperature measuring device is removed from the female human during the day.

14. A device for providing an indication related to the fertility of a female human, comprising:

an intra-vagina temperature measuring device for taking multiple measured temperature readings from the female human during multiple extended overnight periods;

a non-transitory memory for storing said temperature readings;

a processor for processing the measured temperature readings to determine at least one representative temperature reading for the overnight period,

wherein the processor is configured to process the measured temperature readings to identify measured temperature readings having one or more characteristics of irrelevant or faulty data and either delete said readings or label them to be subsequently disregarded to obtain a plurality of non-disregarded temperature readings; and

wherein the processor is configured to calculate using the plurality of non-disregarded temperature readings one or several representative temperature values for each extended overnight period; and

wherein the processor is configured to analyse the representative temperature values obtained over multiple extended overnight periods for one or more patterns in the representative temperature values indicative or predicative of ovulation; and

a signalling device to provide an indication related to the fertility of the female human to the user, wherein the

representative temperature values are not the maximum or minimum temperature readings obtained for the extended overnight period, wherein said extended overnight period is one hour or longer, and provide intervention if said indication indicates whether a significant event related to the fertility of the female human has occurred.

15. A device as claimed in claim 14,

wherein said signaling device is configured to provide information relating to the fertility of the female human, the information comprising:

a) information identifying the timing of ovulation,

b) a binary indication of “

fertile”

or “

non-fertile”

,

c) an indication of the timing of the next fertile period,

d) an indication of normal fertility, subfertility or infertility, or

e) an indication of the number of ova released following ovarian hyper-stimulation.

16. A device as in claim 14 wherein said extended overnight period is at least 4 hours and wherein the intra-vaginal temperature measuring device is configured to take at least 25 temperature readings in said extended overnight period.

17. A device as in claim 14 wherein said processor is configured to process the measured temperature readings to identify measured temperature readings having one or more characteristics of irrelevant or faulty data comprising:

a) being more than 2°

C. higher or lower than the normal temperature of said female human,

b) differing from the preceding or following values by such a degree as to indicate heating or cooling rates of greater than 0.2°

C. per minute,

c) being a single reading or relatively few readings that differ so much from the other temperature readings collected during the same extended period so as to be unlikely to indicate a true change in temperature,

d) being characteristic of diurnal temperature fluctuations unconnected to levels of female hormones and therefore unrelated to ovulation, or

e) being tagged as such by user input.

18. A device as in claim 14 wherein said representative temperature value(s) for the extended period is/are obtained by a processor further configured to:

a) calculate the mean of the non-disregarded temperature readings collected during the extended period or a part thereof,

b) calculate the median of the non-disregarded temperature readings collected during the extended period or a part thereof,

c) calculate the mode (most commonly occurring temperature reading) of the data collected during extended period or a part thereof,

d) choose the temperature reading or readings occurring at a particular distance in time from the start or the end of a stretch of non-disregarded temperature readings;

e) choose all of the temperature readings remaining after those having one or more characteristics of irrelevant or faulty data are disregarded, or

f) choose a single representative temperature value for each extended period that is the 11th to the 50th percentile of the temperature readings obtained for that extended period.

19. A device as in claim 14 wherein the processor is configured to analyse the representative temperature values to identify a pattern comprising a peak in body temperature associated with the LH peak, or a dip in body temperature associated with a rise in oestradiol.

20. An apparatus comprising:

an indwelling temperature measuring device suitable for intravaginal use for taking multiple body temperature readings from a female human during multiple extended overnight periods; and

a separate unit configured to accommodate the indwelling temperature measuring device, wherein the separate unit comprises;

a non-transitory memory for storing said temperature readings;

an internet, telephonic, or wireless link arranged for communicating the multiple body temperature readings, or a derivative thereof, stored in the non-transitory memory to a data processing device; and

an internet, telephonic, or wireless link for receiving indication relating to the fertility of the female human from a remote computer file server; and

a signalling device to provide said information relating to the fertility of the female human to a user, wherein said extended overnight period is one hour or longer.

21. A data processing device comprising:

a processor configured to;

receive multiple measured body temperature having one or more characteristics of irrelevant or faulty data and either deleting said readings or labelling them to be subsequently disregarded, thereby obtaining a plurality of non-disregarded temperature readings;

process the plurality of non-disregarded temperature readings to obtain one or several representative temperature values for each extended period;

analyse the representative temperature values obtained over multiple extended overnight periods in order to identify a pattern in the representative temperature values indicative or predictive of ovulation; and

provide, based on the analysis, an indication related to the fertility of the female human to a computer file server for later retrieval by a user;

wherein the representative temperature values are not the maximum or minimum measured temperature readings obtained for the extended period; and

wherein said extended overnight period is one hour or longer.

22. The device of claim 21, further comprising:

a non-transitory memory configured to store an indication related to the fertility of multiple female humans, the indication stored in the non-transitory memory relating to each female human being labelled with a unique identifier code corresponding to an individual female human, wherein said information relating to the fertility of the female human received on the internet telephonic or wireless link comprises the indication labelled with a particular unique identifier code in response to the internet, telephonic or wireless link communicating that code to the computer file server.

23. A method of providing an indication relating to the fertility of a female human comprising:

taking a plurality of measured temperature readings from the female human during an extended period using an intra-vaginal temperature measuring device;

using a processor to process the plurality of measured temperature readings to disregard measured temperature readings having one or more characteristics of irrelevant or faulty data and determine from the filtered plurality of measured temperature readings at least one representative temperature reading for the extended period;

repeating the steps of taking readings and processing the readings for a plurality of extended periods to obtain at least one representative temperature reading for each extended period over several days;

using a processor to analyse the representative temperature readings based on stored data of expected patterns of variations in temperature related to ovulation in the female human; and

using a processor to output an indication relating to the fertility of the female human based on the analysis, and providing intervention if said indication indicates whether a significant event related to the fertility of the female human has occurred.

24. A system for providing information relating to the fertility of a female human comprising:

an intra-vaginal temperature measuring device for taking multiple body temperature readings from the female human during multiple overnight periods, the intra-vaginal temperature measuring device further comprising a rechargeable power supply;

a base unit for receiving the intra-vaginal temperature measuring device, the base unit comprising a charger for charging the rechargeable power supply for the intra-vaginal temperature measuring device; and

one or more processors for performing a method comprising;

taking a plurality of measured temperature readings from the female human during an extended overnight period using an intra-vaginal temperature measuring device;

processing the plurality of measured temperature readings to;

disregard measured temperature readings having one or more characteristics of irrelevant or faulty data; and

determine from a plurality of measured temperature readings at least one representative temperature reading for the extended overnight period;

repeating the steps of taking readings and processing the readings for a plurality of extended overnight periods to obtain at least one representative temperature reading for each extended overnight period;

analysing the representative temperature readings to identify one or more patterns indicative or predictive of ovulation in the female human; and

outputting an indication relating to the fertility of the female human based on the analysis, and providing intervention if said indication indicates whether a significant event related to the fertility of the female human has occurred.