Method of Detecting and Predicting Ovulation and the Period of Fertility

• US 20090326410A1
• Filed: 09/05/2007
• Published: 12/31/2009
• Est. Priority Date: 09/05/2006
• Status: Active Grant

• Current Assignee: Fertility Focus Limited
• Original Assignee: Fertility Focus Limited
• Inventors: James, Michael Howard, Knowles, Toby Grahame
• Granted Patent: US 8,496,597 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 2010/0019 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) analysing 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

1-51. -51. (canceled)

52. 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; and

(v) analysing 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, wherein said extended period is one hour or longer and wherein said temperature readings are taken using an indwelling temperature measuring device.

53. A method according to claim 52, wherein said information relating to the fertility of the female mammal 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.

54. A method according to claim 52, wherein said extended period is of at least 4 hours.

55. A method according to claim 54, wherein at least 25 temperature readings are taken in said extended period.

56. A method according to claim 52, wherein at least 25 temperature readings are taken in said extended period.

57. A method according to claim 52 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 mammal,

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 reading differing so substantially 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.

58. A method according to claim 52, 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 (most commonly occurring temperature reading) of the data collected during 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.

59. A method according to claim 52, wherein at multiple extended periods for which representative temperature values are analysed comprise those collected over at least one ovulatory cycle.

60. A method according to claim 52, 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.

61. A method according to claim 52, wherein said female mammal is a human woman and said information relevant to the fertility of the human woman is provided to her or to her physician.

65. A method as claimed in claim 52, wherein one or more of steps (ii), (iii) and (iv) are carried out by a remote data processing device.

66. A method as claimed in claim 65, wherein between step (i) and step (ii) a further step (ia) is provided, said further step (ia) comprising labelling the temperature readings with a unique identifier and transmitting them to a 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 temperature readings with a unique identifier code and transmitting them to a 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 a 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 mammal to the user'"'"'s terminal;

or

(b) storing said information about fertility of the female mammal 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.

70. Use of a method according to claim 52 as aid to diagnosis of anovulation, as an aid to diagnosis of irregular ovulation, as an aid to conception, as a contraceptive method or to provide an indication of the number of ova released following hyper-stimulation of the ovary.

62. A device for providing information relevant to the fertility of a female mammal comprising:

an indwelling temperature measuring device for taking multiple body temperature readings from the female mammal during multiple extended periods;

a memory for storing said temperature readings;

a processor for identifying temperature readings having one or more characteristics of irrelevant or faulty data and either deleting said readings or labelling them to be subsequently disregarded; and

for obtaining one or several representative temperature values for each extended period; and

for analysing the representative temperature values obtained over multiple extended periods for one or more patterns in the representative temperature values indicative or predicative of ovulation; and

a signalling device to provide information relevant to the fertility of the female mammal to the user, wherein the representative temperature values are not the maximum or minimum temperature readings obtained for the extended period, wherein said extended period is one hour or longer.

63. A device as claimed in claim 62, wherein said information relevant to the fertility of the female mammal 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;

wherein said extended period is at least 4 hours;

wherein at least 25 temperature readings are taken in said extended period;

wherein said one or more characteristics of irrelevant or faulty data are;

a) being more than 2°

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

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 reading differing so substantially 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;

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 (most commonly occurring temperature reading) of the data collected during 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;

wherein said pattern in the representative temperature values 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;

wherein said female mammal is a human woman and said information relevant to the fertility of the human woman is provided to her or to her physician; and

wherein said information about fertility is presented in a form suitable for use as an aid to diagnosis of anovulation, as an aid to diagnosis of irregular ovulation, as an aid to conception, as a contraceptive method or to provide an indication of the number of ova released following hyper-stimulation of the ovary.

64. A device as claimed in claim 63, wherein the temperature measuring device is an indwelling device suitable for introduction into the vagina of the female mammal.

67. A user terminal comprising:

an indwelling temperature measuring device for taking multiple body temperature readings from a female mammal during multiple extended periods;

a memory for storing said temperature readings;

means for communicating the multiple body temperature readings, or a derivative thereof, stored in the memory to a remote data processing device;

means for receiving information relevant to the fertility of the female mammal from a remote computer file server; and

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

68. A remote data processing device comprising:

means for reading multiple body temperature readings of a female animal or a derivative thereof from a user; and

a processor for identifying temperature readings having one or more characteristics of irrelevant or faulty data and either deleting said readings or labelling them to be subsequently disregarded, and for obtaining one or several representative temperature values for each extended period, and for analysing the representative temperature values obtained over multiple extended periods in order to identify a pattern in the representative temperature values indicative or predictive of ovulation and thereby provide information relevant to the fertility of the female mammal to a computer file server for later retrieval by a user;

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

wherein said extended period is one hour or longer.

69. A remote computer file server holding information relevant to the fertility of multiple female mammals, the information relating to each female mammal being labelled with a unique identifier code corresponding to an individual female mammal, said file server being arranged to provide to a user, the information labelled with a particular unique identifier code in response to the provision of that code to the remote computer file server.