Monitoring methods and devices for use therein

Details Monitoring methods and devices for use therein Monitoring methods and devices for use therein

1995-09-22

2002-09-17

Graser, Jennifer E. (Department: 1645)

Chemistry: analytical and immunological testing

Involving diffusion or migration of antigen or antibody

C436S165000, C436S169000, C436S065000, C435S007920, C435S007930, C435S007940, C435S007900, C435S007100, C422S051000, C422S051000, C422S067000

Reexamination Certificate

active

06451619

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to methods devices and test kits for use in monitoring the ovulation cycle in female mammals especially humans.
The invention is particularly, although not solely, concerned with simple practical procedures that can readily be applied by unskilled persons, e.g. in the home, to provide reliable information concerning fertility status as an aid to contraception. An important objective of the invention is to provide such information while avoiding the necessity for tests to be conducted on a frequent (eg. daily) basis throughout every ovulation cycle. The necessity for regular, e.g. daily, testing throughout the cycle has characterised many ovulation cycle monitoring systems previously proposed.
The invention may also be used by persons wishing to enhance the likelihood of conception, by providing an indication of the time during the ovulation cycle when fertilization is most likely to occur.
BACKGROUND OF THE INVENTION
To provide reliable information concerning fertility status, the user must be given adequate warning of the onset of the fertile phase in the cycle. A wide variety of techniques have proposed in the art, some relying on the monitoring of one or more parameters which alter as the event of ovulation approaches. Typical parameters which have been invoked are the concentration of a body fluid analyte, such as estradiol and metabolites thereof, for example estrone-3-glucuronide (E3G). Other parameters that have been used are basal body temperature (which can only provide predictive information of use in subsequent cycles) and various physiological changes such as the characteristics of vaginal muccus.
Many excellent academic studies have been carried out using such parameters. Such studies have established how these parameters can be correlated with the fertility status of an average member of a large population sample. An example is Collins et al (1981)
Proc. Xth International Congress on Fertility and Sterility
, Publ MTP Ltd, p 19-33. An underlying objective in many such studies is to promote conception in individuals previously regarded as being infertile.
However, when attempting to develop a practical monitoring system suitable for use by individuals, it is found that many individual subjects do not conform to the average in terms of cycle length and/or the duration and timing of the fertile phase. The extend of variation from one individual to another, and indeed, from one cycle to another in the same individual, renders average population data too unreliable for consistent practical use.
Understandably, because the severe consequence of imperfect advice concerning fertility status may be an unwanted pregnancy, the tendency has been to exercise extreme caution and to require testing of the relevant parameter or parameters throughout the cycle, and particularly right from the onset of the cycle (onset of menses). From the individual user's point of view, it would be advantageous if the necessity for such constant testing could be avoided and, instead, for the testing to be performed over a comparatively brief portion of each cycle. Not merely may this benefit the user in terms of convenience, but the cost of the method may also be reduced if the method utilises disposable testing devices and only a few such disposable testing devices are required each month.
An example of a system for detecting the onset of ovulation, using water-swellable polymer pellets to “measure” the water content of vaginal mucus, which, apparently increases at the time of ovulation, is described in U.S. Pat. No. 4,151,833 (Polishuk). It is stated that the peak variation in the size of the pellets, as a result of the absorption of water from cervical mucus, is closely related to the LH surge and the variation in basal body temperature. From the experimental data provided in U.S. Pat. No. 4,151,833 (FIG.
8
), it appears that the pellet diameter is indeed very closely related to the timing of the LH surge, and in consequence the system proposed cannot in practice provide a reliable warning of the onset of ovulation earlier than that obtainable from a knowledge of the LH concentration.
In EP-A-385621 (Coley et al/Unilever) the defects of ovulation cycle monitoring systems which rely primarily on the change in BBT to estimate the time of ovulation are described, and we propose therein a system which uses regular BBT measurement in combination with a knowledge of other parameters, particularly the measurement of certain urinary hormone levels. A particular proposal is that BBT is measured daily throughout each cycle and is used to estimate the timing of fertility status changes in a forthcoming cycle. During the course of this forthcoming (predicted) cycle, urinary hormone levels are checked at certain times to confirm that the progress of the cycle, as predicted from the previous BBT knowledge, is consistent. Particular hormones selected are E3G, P3G and LH. It is suggested that the level of urinary E3G is measured on at least one day during the interval from day 5 to 7 of the predicted cycle, and again on at least one day during the interval from day 10 to day 15 of the predicted cycle. According to the example in EP 385621, it is sufficient for the hormone level to be either “high” or “low” relative to a threshold value. The emphasis throughout EP 385621 is that occasional hormone level measurements are used to supplement a monitoring system which relies on BBT measurement. There is no suggestion that hormone measurements alone could provide the basis for a reliable fertility monitoring system personalised for an individual subject.
OBJECTIVES OF THE INVENTION
An objective of the present invention is to provide a system for monitoring the fertility status of an individual subject, which provides sufficient warning of the onset of the fertile phase to enable contraceptive advice to be given and which can be personalised to the individual subject, while being based solely on body fluid analyte measurements. The inherent unreliability, or limited usefulness, of other measuring systems (such as BBT) can thereby be avoided. A further objective is to avoid the use of average data obtained from population studies, with its inherent risk that in an individual subject, the parameter under test can fluctuate considerably from the population norm.
Another objective of the invention is to provide a monitoring system which is “fail-safe”, in terms of advising the user of the onset of the fertile phase, without denying the user of the benefits of a simple overall procedure and limited testing regime.
A further objective is to provide the option of basing an effective monitoring system solely, or at least primarily, on the measurement of a single body fluid analyte, such as estradiol or a metabolite thereof. Other advantages of the invention will be apparent from the following description.
Another objective of the invention is to provide a testing regime which is a good balance between the desire to minimise the testing burden on the user and the need to give the user worthwhile advice about the fertility status.
Another objective of the present invention is to provide a method and devices for determining the presence and/or concentration of two or more analytes in a single sample liquid when at least one of the analytes is a multivalent analyte which is readily determined by means of two different specific binding agents in a “sandwich-format” complex, whereas another of the analytes is a monovalent analyte, such as a hapten, which is not amenable to determination via a sandwich-reaction.
It is a further objective of the invention to provide such a dual analyte assay method/device in which a particulate direct label is used to reveal the result of both assays.
The use of particulate direct labels is already known in simpler assay systems. Sometimes the use of particulate direct labels enables the assay result to be evaluated easily by eye. This may also be the case in assays in accordance with the present invention, although it is envisaged that in gene

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