Ovulation cycle monitoring methods

• US 6,403,380 B1
• Filed: 02/18/1997
• Issued: 06/11/2002
• Est. Priority Date: 09/27/1996
• Status: Expired due to Term

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Catt, Michael, May, Keith
• Primary Examiner(s): SNAY, JEFFREY R
• Application Number:
  US08/801,212
• Time in Patent Office: 1,939 Days
• Field of Search: 436/65, 128/738, 600/551
• US Class Current: 436/65
• CPC Class Codes: G01N 33/743 Steroid hormones

Abstract

A method of providing warning of the onset of the fertile phase of the human ovulation cycle, involving measurement in absolute or relative terms of the body fluid concentration of an analyte such as estradiol or a metabolite thereof wherein if in the current cycle a concentration measurement conducted at about the termination of menses reveals a body fluid concentration that is typical of that found in the body fluid of an average human female subject about 3 days prior to the time of ovulation during a 28-day cycle, the current cycle is immediately declared to be in its fertile phase. Where the a analyte is E3G, the E3G concentration measurement is conducted on at least one or numerical days 4 to 7 of the current cycle, counting from the onset of menses, and the fertile phase is declared immediately if the E3G measurement reveals a concentration equal to or greater than a threshold concentration chosen in the range of about 25 to about 35 ng/ml.

Claims

1. In a method of providing warning of the onset of the fertile phase of the human ovulation cycle, involving measurement in absolute or relative terms of the body fluid concentration of an analyte indicative of fertile status, wherein said analyte is selected from the group consisting of estradiol and metabolites thereof, the improvement which comprises obtaining, a body fluid concentration standard measurement for said analyte as found in the body of an average human female subject 3 days prior to the time of ovulation during a 28-day cycle, conducting a concentration measurement on a single day in a current cycle at about the termination of menses, comparing the resulting measurement with said previously obtained body fluid concentration as found in the body fluid of said average human female subject 3 days prior to the time of ovulation during a 28-day cycle, and, if the comparison shows the concentration measurement as obtained at about the termination of menses in the current cycle to be typical of said standard body fluid concentration, immediately declaring the current cycle to be in its fertile phase.

2. An improved method according to claim 1, wherein the urinary concentration of estrone-3-glucuronide (E3G) is measured.

3. A method according to claim 1, wherein the urinary concentration of E3G is measured on day 5 or day 6.

7. A method of providing warning of the onset of the fertile phase of the human ovulation cycle according to claim 1, 4 or 6 which comprises making a single measurement of the urinary concentration of E3G at about the termination of menses and immediately declaring the cycle to be in the fertile phase if the E3G measurement conducted at about the termination of menses reveals a concentration equal to or greater than a threshold concentration chosen in the range of about 25 about 35 ng/ml.

8. An improved method according to claim 7, wherein said E3G concentration measurement is conducted on one of numerical days 4 to 7 of the current cycle, counting from the onset of menses.

4. In a method of monitoring the fertility status of the mammalian ovulation cycle, involving determining a change in the body fluid concentration of an analyte the concentration of which alters as the fertile phase of the cycle approaches, said analyte being selected from the group consisting of estradiol and metabolites thereof, and wherein a concentration measurement is made during the interval spanning days 4 to 8 from the beginning of the current cycle, the improvement that a single such concentration measurement is made and if the measurement reveals a concentration level at least equal to that expected 3 days prior to the time of ovulation, based on measurements taken in one or more previous cycles in the same individual, the onset of the fertile phase is declared immediately.

5. An improved method according to claim 4, wherein said analyte is E3G.

6. In a method of monitoring the fertility status of the human ovulation cycle, involving determining a change in the urinary concentration of E3G during the early part of the cycle as a warning of the onset of the fertile phase, and wherein the E3G concentration is measured in relative or absolute terms on or about day 6 of the current cycle, the improvement which comprises measuring the E3G concentration on a single day on or about day 6 of the current cycle and comparing the measured E3G concentration with the concentration attained in the same individual 3 days prior to the time of ovulation during one or more previous cycles, and, if the E3G concentration so obtained for the current cycle is at least equal to said previously attained concentration, immediately declaring the onset of the fertile phase in the current cycle.