Monitoring method

• US 6,454,726 B1
• Filed: 10/10/1996
• Issued: 09/24/2002
• Est. Priority Date: 08/21/1992
• Status: Expired due to Fees

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Coley, John, Catt, Michael, Davis, Paul J
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US08/728,191
• Time in Patent Office: 2,175 Days
• Field of Search: 128/738, 128/897, 128/898, 436/65
• US Class Current: 600/551
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: G01N 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.

Claims

1. A method of predicting the fertile period during a current human ovulation cycle of an individual human female 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 said individual human female from measurements of the E3G concentration in her urine during the pre-ovulation phase of at least one previous ovulation cycle 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.

2. A method according to claim 1 wherein the urinary E3G threshold concentration is 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.

3. A method according to claim 1 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.

4. Electronic means for use in a method of monitoring the status of a current mammalian ovulation cycle, comprising means for processing analyte concentration test data obtained from testing a body fluid conducted during at least part of the pre-ovulation phase of the current cycle of an individual human female subject, and means to identify via said processing an analyte concentration change indicative of imminent ovulation, relative to an analyte concentration reference value that is adapted to said individual subject on the basis of analyte concentration test data obtained from the individual subject during one or more previous ovulation cycles wherein the urinary E3G threshold concentration adopted for the current cycle is the concentration that, in a previous cycle, 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.

5. Electronic means according to claim 4, wherein the urinary E3G 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.