Monitoring method

• US 5,467,778 A
• Filed: 08/20/1993
• Issued: 11/21/1995
• Est. Priority Date: 08/21/1992
• Status: Expired due to Term

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Unilever Patent Holdings BV (Unilever PLC)
• Inventors: Davis, Paul J., Catt, Michael, Coley, John
• Primary Examiner(s): Sykes, Angela D.
• Application Number:
  US08/109,503
• Time in Patent Office: 823 Days
• Field of Search: 128/738, 128/897-898, 436/65
• US Class Current: 600/551
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: G01N 2800/36 Gynecology or obstetrics
• CPC Class Codes: G01N 33/689 related to pregnancy or the gonads
• CPC Class Codes: G01N 33/743 Steroid hormones
• CPC Class Codes: G01N 33/76 Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors

Abstract

A method of monitoring the status of a current ovulation cycle of an individual human female subject, involving testing of the body fluid concentration of an analyte of significance in relation to the status of the ovulation cycle, such as urinary E3G, during at least part of the pre-ovulation phase of the current ovulation cycle of the individual subject, and identification from the results of such testing an analyte concentration change indicative of imminent ovulation, relative to an analyte concentration reference value that has been adapted to the individual human subject on the basis of analyte concentration test data obtained from the individual human subject during one or more previous ovulation cycles. Preferably testing for said analyte concentration during the current ovulation cycle is commenced a plurality of days (preferably at least 5) following the onset of menses but at least 2 numerical days in advance of the earliest numerical day on which actual ovulation has occurred in one or more previous ovulation cycles in the same individual subject.

Claims

1. A method of monitoring the status of a current ovulation cycle of an individual mammalian female subject, involving repeated testing of the body fluid concentration of at least one analyte of significance in relation to the status of the ovulation cycle during at least the pre-ovulation phase of the current ovulation cycle of the individual subject, wherein

a) testing for said analyte concentration during the current ovulation cycle is commenced a plurality of days following the onset of menses but at least 2 numerical days in advance of the earliest numerical day on which actual ovulation has occurred in one or more previous ovulation cycles in the same individual subject;

and

b) an analyte concentration change indicative of imminent ovulation is identified from the results of such testing by reference to an analyte concentration reference value that has been adapted to the individual subject on the basis of analyte concentration test data obtained from the individual subject during one or more previous ovulation cycles,

said testing commencing on a numerical day in advance of the earliest numerical day on which actual ovulation has occurred in one or more previous ovulation cycles in the same individual subject, said testing commencement day being calculated according to the following relationship;

space="preserve" listing-type="tabular">______________________________________ Earliest previous Testing commencement ovulation day day ______________________________________ 8-10 -4 11-14 -5 15-18 -6 19-23 -7 24-28 -8 29+ -9 ______________________________________

2. A method according to claim 1, wherein testing is commenced at least 3 numerical days in advance of the earliest numerical day on which actual ovulation has occurred in one or more previous ovulation cycles in the same individual subject.

3. A method according to claim 1, wherein testing is commenced at least 4 numerical days in advance of the earliest numerical day on which actual ovulation has occurred in one or more previous ovulation cycles in the same individual subject.

4. A method according to any one of claims 1 to 3, wherein testing is commenced at least 5 numerical days following the onset of menses.

5. A method according to claim 1, wherein the body fluid is urine.

6. A method according to claim 1, wherein the analyte is estradiol or a metabolite thereof, such as E3G.

7. A method according to claim 1, wherein 2 or more analytes are tested to provide comparative data, for the concentration ratio of two analytes tested simultaneously.

8. A method according to claim 1, wherein the earliest actual ovulation day is derived from data collected during at least 3 consecutive previous cycles.

9. A method according to claim 1, wherein the earliest actual ovulation day is derived from data collected during at least 5 consecutive previous cycles.

10. A method according to claim 1, wherein the earliest ovulation day is derived from data obtained during at least the immediately preceding cycle.

11. A method according to claim 10, wherein the earliest ovulation day is derived from data obtained from a rolling reference base consisting of a fixed number of consecutive cycles immediately preceding the current cycle.

12. A method according to claim 11, wherein the rolling reference base consists of the immediately preceding 4 to 10 cycles.

13. A method according to claim 11, wherein the rolling reference base consists of the immediately preceding 5 or 6 cycles.

14. A method according to claim 1, wherein actual ovulation day is determined by detecting the peak concentration of urinary LH.

15. A method according to claim 1, wherein actual ovulation is determined by detecting the urinary LH surge.

16. A method according to claim 1, wherein the subject is human.

17. A method according to claim 16 for predicting the fertile period during a current human ovulation cycle by detecting an elevated urinary E3G concentration in the pre-ovulation phase, wherein the elevated urinary E3G concentration is determined by reference to a threshold concentration determined for an individual human female from measurements of the E3G concentration in her urine during the pre-ovulation phase of at least one previous ovulation cycle.

18. A method according to claim 17, wherein the urinary E3G threshold concentration adopted for the current cycle is the concentration that is, in a previous ovulation cycle, exceeded more frequently during the total number of days constituting the transition phase of that previous cycle than during the same number of days in the infertile phase immediately preceding said transition phase.

19. A method according to claim 18, wherein the threshold concentration is the concentration that is exceeded on not more than 20% of the days in the infertile phase but is exceeded on not fewer than 80% of the days in the transition phase.

20. A method according to claim 17, wherein urinary LH and/or P3G concentration is measured to provide an indication of the end of the fertile phase.

21. A method according to claim 1, which relies solely on the results of urine tests.

22. A method according to claim 1, which does not involve the measurement of basal body temperature.

23. A method according to claim 1, wherein a body fluid concentration change of an analyte of significance in relation to the status of the ovulation cycle, is detected by reference to a threshold concentration determined for the individual subject from measurement of the analyte concentration in the body fluid during the pre-ovulation phase of at least one previous ovulation cycle in the same subject.

24. A method according to claim 1, wherein the analyte concentration reference value is derived from data obtained from a "rolling" reference base consisting of a fixed number of consecutive cycles immediately preceding the current cycle.

25. A method according to claim 24, wherein the rolling analyte concentration reference base consists of the immediately preceding 4 to 10 cycles.

26. A method according to claims 25, wherein the rolling analyte concentration reference base consists of the immediately preceding 5 or 6 cycles.

27. A method of monitoring the status of a current ovulation cycle of an individual mammalian female subject, involving repeated testing of the body fluid concentration of at least one analyte of significance in relation to the status of the ovulation cycle during at least the pre-ovulation phase of the current ovulation cycle of the individual subject, wherein

a) testing for said analyte concentration during the current ovulation cycle is commenced a plurality of days following the onset of menses but at least 2 numerical days in advance of the earliest numerical day on which actual ovulation has occurred in one or more previous ovulation cycles in the same individual subject;

and

b) an analyte concentration change indicative of imminent ovulation is identified from the results of such testing by reference to an analyte concentration reference value that has been adapted to the individual subject on the basis of analyte concentration test data obtained from the individual subject during one or more previous ovulation cycles,

said method being used for predicting the fertile period during a current human ovulation cycle by detecting an elevated urinary E3G concentration in the pre-ovulation phase, the elevated urinary E3G concentration being determined by reference to a threshold concentration determined for an individual human female from measurements of the E3G concentration in her urine during the pre-ovulation phase of at least one previous ovulation cycle, said urinary E3G threshold concentration being the concentration that is exceeded on not more than 30% of the days in the infertile phase but is exceeded on not fewer than 60% of the days in the transition phase.