Monitoring method

• US 6,234,974 B1
• Filed: 12/24/1996
• Issued: 05/22/2001
• Est. Priority Date: 08/21/1992
• Status: Expired due to Term

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Unilever Patent Holdings BV (Unilever PLC)
• Inventors: Coley, John, Catt, Michael, Davis, Paul J
• Primary Examiner(s): Lacyk, John P.
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US08/772,522
• Time in Patent Office: 1,610 Days
• Field of Search: 436/65, 435/7.95, 361/413.12, 600/551
• 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 test kit for conducting 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, comprising:

a) one or more testing devices for determining the concentration of said at least one analyte in said body fluid,

b) means enabling a user to derive from said concentration an indication of fertility status in the current ovulation cycle by reference to a concentration reference value determined from one or more previous ovulation cycles in the same subject; and

c) means for determining the day on which actual ovulation occurred during at least one previous ovulation cycle; and

d) means enabling a user to derive a precise testing commencement day from knowledge of the numerical day on which actual ovulation occurred during at least one previous ovulation cycle in the same subject.

2. A test kit according to claim 1, wherein means b) and c) are combined.

3. A test kit according to claim 1, wherein means b) and c) comprise electronic means.

4. A test kit according to claim 1, incorporating a plurality of disposable body fluid testing devices.

5. A plurality of disposable body fluid testing devices, packaged with instructions for use in a method according to claim 1.

11. A test kit according to claim 2, wherein means b) and c) comprise electronic means.

6. A device for monitoring the human ovulation cycle, comprising means for initiating the recording of a cycle, means for measuring and recording urinary E3G concentration, means for determining a threshold urinary E3G concentration from measurements taken during the infertile and transition phases of at least one preceding cycle, and means for alerting a user if a measured urinary E3G concentration during the pre-fertile phase of a current cycle exceeds the determined threshold, means for measuring and recording urinary LH and/or P3G concentration, means for determining from such LH and/or P3G concentration the earliest numerical day on which actual ovulation occurred in one or more previous ovulation cycles, and means for alerting a user to an optimum E3G testing commencement day in the current cycle, said optimum E3G testing commencement day being at least 5 numerical days following the onset of menses in the current cycle but at least 2 numerical days in advance of said earliest numerical day on which actual ovulation occurred.

8. A device for monitoring the human ovulation cycle, comprising a device according to claim 6 together with at least one testing device capable of being used to measure urinary E3G concentration and P3G concentration.

10. A device according to claim 6 plurality of disposable urinary analyte testing devices, and instructions for use in conjunction with said monitoring device.

12. A device according to claim 8, comprising a plurality of said testing device each disposable after individual use.

7. A kit for monitoring the human ovulation cycle, comprising means for initiating the recording of a cycle, means for measuring and recording urinary E3G concentration, means for determining a threshold urinary E3G concentration from measurements taken during the infertile and transition phases of at least one preceding cycle, and means for alerting a user if a measured urinary E3G concentration during the pre-fertile phase of a current cycle exceeds the determined threshold, means for measuring and recording urinary LH and/or P3G concentration, means for determining from such LH and/or P3G concentration the earliest numerical day on which actual ovulation occurred in one or more previous ovulation cycles, and means for alerting a user to an optimum E3G testing commencement day in the current cycle, said optimum E3G testing commencement day being at least 5 numerical davs following the onset of menses in the current cycle but at least 2 numerical days in advance of said earliest numerical day on which actual ovulation occurred and at least one testing device capable of being used to measure urinary E3G concentration and LH concentration.

9. A device according to claim 7, comprising a plurality of said testing devices each disposable after individual use.

13. A test kit for conducting 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, comprising:

a) one or more testing devices for determining the concentration of said at least one analyte in said body fluid,

b) means enabling a user to derive from said concentration an indication of fertility status in the current ovulation cycle by reference to a concentration reference value determined from one or more previous ovulation cycles in the same subject; and

c) means enabling a user to derive a precise testing commencement day from knowledge of the numerical day on which actual ovulation occurred during at least one previous ovulation cycle in the same subject.