Advisory method

• US 6,585,663 B1
• Filed: 08/01/1997
• Issued: 07/01/2003
• Est. Priority Date: 08/21/1992
• Status: Expired due to Fees

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Coley, John, Senior, Stephanie J, Davis, Paul J
• Primary Examiner(s): Nasser; Robert L.
• Application Number:
  US08/905,171
• Time in Patent Office: 2,160 Days
• Field of Search: 600/345,551,300
• US Class Current: 600/551
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: G01N 33/76 Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors

Abstract

A method and test kit for providing contraceptive advice during the human ovulation cycle, involving simply the measurement of urinary lutenising hormone (LH) concentration on a daily basis during the early phase of the cycle until the LH surge indicative of ovulation is detected, together with calender means to advise the user to abstain from unprotected intercourse during a time interval commencing not later than a predetermined first day of LH testing and ending at least 2 days following the day of LH surge detection.

Claims

1. A method of reducing the likelihood of conception during the human ovulation cycle by requiring the measurement of only urinary lutenising hormone (LH) concentration, which comprises, commencing on a predetermined day in the interval from numerical day 5 to numerical day 15 inclusive following the onset of menses, and at least 4 but not more than 8 days in advance of the numerical day corresponding to the day of detected LH surge in a previous cycle, performing frequent repeated daily testing of only urinary LH concentration until the LH surge associated with ovulation is detected, and avoiding unprotected intercourse during a time interval commencing on or before the first day of said repeated daily urinary LH concentration testing and ending at least 2 days following the day of LH surge detection.

2. A method according to claim 1, wherein at least during an initial usage cycle, commencement of testing, and avoidance of unprotected intercourse, are both begun not more than 7 numerical days following the onset of menses.

3. A method according to claim 1 or claim 2, wherein unprotected intercourse is avoided during a time interval ending at least 3 days following the day of LH surge detection.

4. A method according to claim 1, wherein the predetermined day on which testing is commenced is determined based upon the numerical day corresponding to the day of detected LH surge in the immediately previous cycle.

5. A plurality of disposable urinary LH assay devices having a sensitivity such that a user thereof can be alerted to the occurance of the LH surge, packaged together with instruction for use in a method according to claim 1.

6. A test kit for providing awareness of the status of the human ovulation cycle, simply comprising a plurality of disposable urinary LH concentration testing devices together with recording/alerting means enabling a user to record the results of repeated daily urinary LH tests and to alert the user to the likelihood of conception occurring, characterized in that the recording/alerting means is adapted to advise the user to commence said repeated daily testing on a predetermined day in the time interval from numerical day 5 to numerical day 15 inclusive following the onset of menses and at least 4 but not more than 8 days in advance of the numerical day corresponding to the day of detected LH surge in a previous cycle and to abstain the predetermined day from unprotected intercourse until at least 2 days have elapsed following the day of detection of the LH surge.

7. A test kit according to claim 6, wherein the user is advised to abstain from unprotected intercourse until at least 3 days have elapsed following the detection of the LH surge.

8. A disposable urinary LH concentration testing device when used as part of a test kit according to claim 6, comprising a reagent-impregnated immunochromatographic assay strip incorporating an anti-LH antibody labelled with a particulate direct label, the assay strip having a urinary LH concentration sensitivity sufficient to provide to the user a test result indicative of the onset of the LH surge.

9. A device according to claim 8, wherein the urinary LH concentration sensitivity is such that an indication is given to the user when the urinary LH concentration rises to a level in the range 20-30 mIU/ml.

10. A test kit according to claim 6, wherein the recording means comprises a chart on which the user can enter daily urinary LH concentration test results.

11. A test kit according to claim 6, wherein the predetermined day on which testing is commenced is determined based upon the numerical day corresponding to the day of detected LH surge in the immediately previous cycle.

13. A test kit according to claim 9, wherein the cursor advises the user of an optimum test starting day in the subsequent cycle.

12. A test kit for providing awareness of the status of the human ovulation cycle, simply comprising a plurality of disposable urinary LH concentration testing devices together with recording/alerting means enabling a user to record the results of repeated daily urinary LH tests and to alert the user to the likelihood of conception occurring, characterized in that the recording/alerting means is adapted to advise the user to commence said repeated daily testing on a predetermined day in the time interval from numerical day 5 to numerical day 15 inclusive following the onset of menses and to abstain the predetermined day from unprotected intercourse until at least 2 days have elapsed following the day of detection of the LH surge, wherein the recording means comprises a chart on which the user can enter daily urinary LH concentration test results and wherein the chart is provided with a cursor that the user can position adjacent a “

day”

on the chart on which the LH surge detection is entered.

14. A recording chart on which daily urinary LH concentrations can be recorded during the course of an ovulation cycle, together with a cursor that can highlight a group of consecutive “

days”

on the chart and which cursor, by alignment with a “

day”

on which the LH surge detection is recorded, can advise the user of the residual unsafe period during the current cycle.

15. A recording chart and cursor combination according to claim 14, wherein the cursor can advise the user to commence urinary LH concentration testing on a predetermined numerical day in the subsequent cycle during the interval of at least 4 but not more than 8 days inclusive in advance of the numerical day in the subsequent cycle corresponding to the numerical day of LH surge detection in the current cycle.