Abstract: The present invention provides methods and kits for assessing the state of oocyte maturation in a female mammal based on the level of PAPP-A found in the female's bodily fluid sample.

Abstract: This invention provides methods and compositions for testing for pregnancy and non-pregnancy in ungulates and non-hoofed ruminates. The tests provided by this invention are useful during a time that coincides with the estrus cycle during which breeding occurs or the first estrus cycle after breeding of a non-pregnant animal. The tests provided by this invention are useful in estrus and ovulation synchronization programs, with pregnancy testing useful at a time allowing for resynchronization of non-pregnant animals within the first estrus cycle. The tests provided by this invention assay for the presence, absence, or level of a selected IFN-?-induced protein in a sample from a female animal. The tests of this invention are useful for testing cells, blood, plasma, serum, cells, milk, nasal secretions, ocular secretions, vaginal secretions, urine, and saliva samples. The tests provided by this invention are immunoassays.

Abstract: Disclosed are an immunoassay device which comprises a labeled substance dotting portion and a specimen dotting portion provided thereon, and an immunoassay method using the device.

Abstract: By allowing serum or plasma samples collected from humans to react with laminin-1 or a fragment thereof, and then determining whether or not anti-laminin-1 antibody, an auto-antibody against laminin-1, in the sample bound to laminin-1 to detect anti-laminin-1 antibody in the sample, gynecology-related diseases such as habitual abortion, sterility, infertility, and endometriosis can be diagnosed.

Abstract: An increased risk of a fetal chromosomal abnormality, for example, fetal Down syndrome can be detected by separating or discriminating &agr;-fetoproteins present in the body fluid of a pregnant woman, and measuring the proportion of one or more of the &agr;-fetoproteins which have a specific sugar chain structure, relative to the total &agr;-fetoproteins.

Abstract: The present invention relates to the detection of HLA-G. Antibodies to both soluble and membrane bound HLA-G are disclosed. Exemplary antibodies include 2C/C8, 3C/G4, and 4H84. 2C/C8 and 4H84 antibodies bind to the same region of HLA-G, which is a different region than that bound by 3C/G4. Methods of detection and diagnosis are disclosed as well as kits, including a miniaturized assay suitable for a clinical setting. Further, a method of selecting an embryos for in vitro fertilization is disclosed. A sandwich ELISA test is provided using two antibodies that bind to HLA-G at different regions. The HLA-G test according to the invention is over 1000 times more selective in binding to HLA-G than to antigens HLA-A2, HLA-B4, HLA-C, or mixed WBC preparations.

Abstract: Methods for detecting pregnancy in a woman comprise screening a biological sample of the woman for pregnancy markers. The methods of the invention include chemiluminescent assays for the pregnancy markers. The methods of the invention also comprise utilizing at least two capture antibodies that specifically bind different epitopes of the pregnancy marker in one assay. The methods of the invention permit detection of pregnancy within about 7 days after ovulation or implantation.

Abstract: A method for evaluating sperm quality is disclosed. The first step of the method is to obtain a quantity of sample mammalian sperm and a sample of mature mammalian oocytes. The oocytes are fertilized with the sperm and the cumulus cells are removed from the fertilized oocytes. The oocytes are then labelled with antibodies directed to microtubules and the labelled microtubules are observed microscopically. The microtubule pattern is evaluated for microtubule aster size and organization. In one preferred from of the present invention, the mammalian sperm and mammalian oocytes are of the same species. In another preferred form of the present invention, the mammalian sperm and oocytes are of different species.

Abstract: An isolated and purified glycoprotein designated PUP-1 and functional analogs thereof are disclosed and characterized by being a progesterone induced and estradiol inhibited secretory glycoprotein from stromal cells of endometrial origin; having an N-terminal amino acid sequence as set forth in SEQ ID No:1; having a molecular weight of 70,000 daltons and an isoelectric point of 5.7; and synthesized by endometrium at the time of fertilization, early embryogenesis, and implantation. The present invention further provides a method of determining endometrial receptivity, monitoring placental physiology during gestation, and monitoring the effects of protocols to induce ovarian hyperstimulation or ovulation induction on uterine receptivity by monitoring the cyclic presence of PUP-1 in bodily fluid and tissue samples.

Abstract: A method for diagnosing a congenital disease by determining a cell's response to activation of a membrane receptor using a physiological indicator is provided. The method of the invention uses fetal or adult cells in a non-invasive screen for congenital disorders.

Abstract: A quantitative process for monitoring female fertility cycle wherein the process involves directing a laser beam, preferably generated by a diode laser, onto an area of a slide containing an air-dried sample of a female body fluid. The diffraction pattern resulting from the sample is detected by a two-dimensional photo diode array and analyzed by a microprocessor. If a ferning pattern exists, such pattern will generate a characteristic structure in the diffraction pattern which is then detected by the photo diode array. If no ferning occurs, the corresponding diffraction pattern will be structureless. The microprocessor is programmed with an algorithm to produce a quantitative index of ferning indicating quantitatively the ferning level. Preferably, a plurality of spots on the sample are measured to determine the ferning level at each spot, and the microprocessor then makes a final determination as to final ferning level on the basis of the test results of all of the spots.

Abstract: A method for evaluating sperm quality is disclosed. The first step of the method is to obtain a quantity of sample mammalian sperm and a sample of mature mammalian oocytes. The oocytes are fertilized with the sperm and the cumulus cells are removed from the fertilized oocytes. The oocytes are then labelled with antibodies directed to microtubules and the labelled microtubules are observed microscopically. The microtubule pattern is evaluated for microtubule aster size and organization. In one preferred from of the present invention, the mammalian sperm and mammalian oocytes are of the same species. In another preferred form of the present invention, the mammalian sperm and oocytes are of different species.

Abstract: A kit for monitoring mammalian reproductive cycles by monitoring variations in the quantity of one or more low molecular weight volatile compound having a molecular weight of less than 50 grams per mole present in a body constituent sample is disclosed. Samples of a body constituent selected from the group consisting essentially of humoral fluid, breath and body cavity air are collected from a female mammal a multiple number of times during the reproductive cycle. The quantity of a low molecular weight volatile compound in each sample is measured. In the preferred embodiment, the low molecular weight volatile compound, acetaldehyde, will be measured and monitored. Variations in the quantity of the low molecular weight volatile compound appearing in each sample is monitored to determine the phase of the mammal's reproductive cycle and to predict the occurrence of ovulation.

Abstract: A method for evaluating the solubility capacity of free unbound estrogens in body fluids of animals is described.

Abstract: Assays and kits for identifying fertile sperm samples (e.g. for use in an assisted reproductive technology or as an indication of an ineffective male contraception (vasectomy)) and sub-fertile sperm samples (e.g. as an indication of a potentially infertile male donor or an effective male contraception) are disclosed.

Abstract: A method and kit for measurement of a steroid by means of a competitive immunoassay, preferably a competitive enzyme immunoassay. The method and kit involve the use of a steroid analogue conjugated to a label. The steroids that are amenable to detection by the method and kit of the present invention include estradiol and progesterone. The method comprises the steps of:a. incubating a mixture of a test sample suspected of containing a given steroid, a solid phase coupled to an antibody specific for that steroid, and a conjugate of an analogue of that steroid to form steroid/antibody complexes and conjugate/antibody complexes on said solid phase;b. separating said solid phase from said mixture;c. measuring the amount of label present in said mixture or in said solid phase; andd. determining the amount of steroid in said sample from the amount of label. The kit comprises a solid phase coupled to an antibody specific for a steroid and a conjugate of an analogue of that steroid.

Abstract: A method and apparatus for evaluating estrogen dependent physiological conditions includes a substrate having an anthocyanin pigment applied thereto. The pigment yields a color response indicative of how the body fluid responds to changes in its capacity to absorb free estrogens. The pigment is contacted by the body fluid sample, and the response thereto is connected through color response or optical density measurements to predetermined physiological conditions.

Abstract: Kits and assays, incorporating antibodies specific for glutathione peroxidase, for determining the fertilizing ability of a male at home or in a clinical laboratory are disclosed.

Abstract: The invention relates to chemotactic factors for human spermatozoa that are purifiable from human follicular fluid. The factors are of peptidic and hydrophilic nature and have, one, a molecular size of about 13 kDa and, the other, an apparent molecular size smaller than 1.3 kDa, as determined by high pressure gel filtration. They are for use in procedures related to human fertilization, such as in various types of assisted fertilization, particularly artificial insemination, in vitro fertilization, micromanipulation and direct microinjection of sperm into oocytes.

Abstract: A glycoprotein having a molecular weight of 28,000 to 32,000 and an isoelectric point of 7.0 to 9.0, both as determined by two-dimensional SDS polyacrylamide gel electrophoresis, is synthesized and secreted specifically by stromal cells of endometriotic origin. Amino acid residues in the region of the N-terminus of the glycoprotein share amino acid sequence identity with a region of tissue inhibitor of metalloproteinases-1 (TIMP-1). A method of screening for endometriosis is disclosed by detection of lower levels of the protein or TIMP-1 in peritoneal fluid or serum samples of women.

Abstract: This Invention relates to a fertility analysis and reproductive health system that is applicable to both female and male mammals. In particular the Invention is a portable, handheld, integrated unit which can be manufactured out of plastic. The unit can be disposable for hygienic purposes, or cleaned or sterilized for repeated use as desired. The present Invention has numerous aspects.

Abstract: A method for antenatal screening for chromosomal and other abnormalities in an unborn child is determined by measuring the gestational age discrepancy of the pregnant mother. This data is determined (a) by reference to the last menstrual period, and (b) a biometric measurement of the fetus. The difference between the ages as determined using (a) and (b) is calculated. This calculated difference is then examined using reference data to determine fetal abnormalities. These data can also be used with assay of maternal fluids for various pregnancy markers.

Abstract: The present invention involves DNA encoding a mammalian Sp 17 protein, particularly human Sp17 protein, or antigenic peptides which are fragments thereof, along with said antigenic fragments. These proteins and peptides are useful as immunocontraceptive agents and/or for the diagnosis of autoimmune infertility. Avirulent host cells which express the antigenic proteins or peptides and which are useful as immunocontraceptive agents are also disclosed.

Abstract: The invention relates to improvements in determining the fertilizing capacity of a human semen sample using a reagent solution which contains 0.1-5% by weight K.sub.2 PO.sub.4 H/KPO.sub.4 H.sub.2 to adjust the pH of the solution to 6.5-8.0. After treatment with the reagent solution, the result is considered positive when the diameter of the halo is equal to or larger than 7.5.mu. in 10-25% of the spermatozoa read, as long as the membrane of the head of the spermatozoon is intact. Kits suitable for performance of the claimed method are also described.

Abstract: The present invention relates to a method for the diagnosis of male infertility which comprises the steps of a) determining the amount of P34H in a sperm sample; and b) comparing the determined amount of step (a) with a fertile control sample. The present invention also relates to a kit for the diagnosis of male infertility which comprises an anti-P34H antibody enzyme-labeled, an enzyme substrate and a fertile control sample.

Abstract: A method for monitoring mammalian reproductive cycles by monitoring variations in the quantity of one or more low molecular weight volatile compound having a molecular weight of less than 50 grams per mole present in a body constituent sample is disclosed. Samples of a body constituent selected from the group of humoral fluid, breath and body cavity air are collected from a female mammal a multiple number of times during the reproductive cycle. The quantity of a low molecular weight volatile compound in each sample is measured. In the preferred embodiment, the low molecular weight volatile compound, acetaldehyde, will be measured and monitored. Variations in the quantity of the low molecular weight volatile compound appearing in each sample is monitored to determine the phase of the mammal's reproductive cycle and to predict the occurrence of ovulation.

Abstract: Therapeutic and diagnostic methods of use for the growth factor transforming growth factor .beta., are provided by this invention. In accordance with preferred embodiments, methods of determining competence of a conceptus toward uterine implantation are provided as are methods for determining female infertility in mammals.

Abstract: Methods for detecting and isolating acrosome-reacted sperm and complement receptor-bearing oocytes using the complement component C3, fragments, or variants thereof, antibodies to a complement receptor, or antibodies to C3, are disclosed. These methods have application in the assessment of fertility, in the preparation of sperm or oocytes for in vitro fertilization or for gamete intrafallopian tube transfer, in promoting or inhibiting fertilization in vitro and in vivo, and in diagnosing and treating infertility.

Abstract: A method and kit for measurement of asteroid by means of a competitive immunoassay, preferably a competitive enzyme immunoassay. The method and kit involve the use of asteroid analogue conjugated to a label. The steroids that are amenable to detection by the method and kit of the present invention include estradiol and progesterone.The method comprises the steps of:a. incubating a mixture of a test sample suspected of containing a given steroid, a solid phase coupled to an antibody specific for that steroid, and a conjugate of an analogue of that steroid to form steroid/antibody complexes and conjugate/antibody complexes on said solid phase;b. separating said solid phase from said mixture;c. measuring the amount of label present in said mixture or in said solid phase; andd. determining the amount of steroid in said sample from the amount of label.The kit comprises a solid phase coupled to an antibody specific for a steroid and a conjugate of an analogue of that steroid.

Abstract: Substantially pure sex-associated membrane (SAM) proteins are used in methods to detect specific antibodies binding to X- or Y-SAM proteins.

Abstract: A portable fertility tester for identifying days during the menstrual cycle when a woman is most likely to conceive has a circular disc, with transparent regions indexed to each of the days of the cycle, rotatably mounted within a housing and cover. The housing and cover form a window for exposing a transparent region on the disc for depositing a saliva specimen. An ocular is provided with a magnifying lens for examining the appearance of the saliva which is indicative of fertility, and a light emitting diode is provided for backlighting the specimen during examination. The cover may be removed to allow replacement of the disc for each menstrual cycle.

Abstract: An analytical test device useful for example in pregnancy testing, includes a hollow casing (500) constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier (510) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (506) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, wherein the mobility is facilitated by a material comprising sugar, in a amount effective to reduce interaction between the test strip and the labelled reagent, and in a second zone spatially distinct from the first zone unlabeled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilized on the carrier material and is therefore not mobile in the moist state, the two zo

Abstract: Therapeutic and diagnostic applications by the detection and manipulation of mouse ascites golgi factor produced by endometrium and present in other exocrine tissues and defined by an antibody found in mouse ascites are provided by this invention.

Abstract: A filter trap (10) for removing spermatozoa of relatively lower viability from a fluid containing both higher and lower viability spermatozoa includes a conduit (14) which compresses silica glass wool (16) to a density adequate to prevent the passage therethrough of lower viability spermatozoa and undesired extraneous materials, while permitting the passage therethrough of higher viability spermatozoa. The conduit (14) is preferably formed by a nested, locking pair of tubes (18) and (20) having respective downstream ends (22) and (24) which compress the glass wool (16) between them. The invention is particularly advantageous over the prior art in that it assures fixing the density of the glass wool (16) at a useful value, thereby preventing inadequate separation or inadequate flow of the fluid, while avoiding the training costs previously encountered in setting the density of the glass wool manually.

Abstract: Methods and compositions for assessing the quality of an oocyte or pre-implantation embryo are provided. The methods involve comparing the NADH fluorescence of the oocyte or embryo in a control medium to the NADH fluorescence after the oocyte or embryo has been contacted with an essential nutrient.

Abstract: A fertilization method wherein an oocyte puncture is performed and one or more oocytes are inserted into a container containing a culture medium having no added air or CO.sub.2 and intended for the fertilization and culture of the oocyte(s), as well as spermatozoa, whereafter the container is sealed and inserted into the vagina or uterus to allow fertilization of the oocyte(s) and culture of the embryo(s). The method is characterized in that it is performed without stimulating the cycle, with LH supervision by means of blood assays, and by programming the oocyte puncture according to the LH value. The container may be kept at a temperature of approximately 37.degree. C. for 2 to 6 hours for maturation before being inserted into the vagina.

Abstract: A method and apparatus are disclosed for the mechanical sorting of mammalian spermatozoa by sex-type, into a fraction enriched in X-chromosome-bearing spermatozoa, and a fraction enriched in Y-chromosome-bearing spermatozoa. Because of their different DNA content, Y-chromosome spermatozoa are slightly smaller than X-chromosome spermatozoa. A column is packed with two sizes of beads. The size of the smaller beads is chosen such that, on average, Y-chromosome spermatozoa will readily fit into the interstices between the smaller beads, while X-chromosome spermatozoa, on average, will not readily fit into those interstices. The size of the larger beads is chosen such that the smaller beads will not readily fit into the interstices between the larger beads. A liquid sample containing the sperm is run through a column so that the liquid first encounters the larger beads, and then encounters the smaller beads.

Abstract: A method for assessing the fertilization potential of mammalian spermatozoa comprises the steps of incubating a sperm sample with extracellular ATP, determining the level of acrosine secretion from the sperm and comparing with the level of acrosine secretion from a control sample of sperm not treated with ATP. A kit for performing the assessment of fertilization potential includes sterile culture medium, sterile, preferably lyophilized ATP, sterile culture tubes and acrosine substrate. A method of inducing the acrosome reaction in sperm taken from an infertile mammal also comprises the incubation of the sperm with extracellular ATP in appropriate culture medium. Sperm treated in this manner may be used in conventional artificial insemination and in vitro fertilization procedures.

Abstract: Methods for detecting and isolating acrosome-reacted sperm and complement receptor-bearing oocytes using the complement component C3, fragments, or variants thereof, antibodies to a complement receptor, or antibodies to C3, are disclosed. These methods have application in the assessment of fertility, in the preparation of sperm or oocytes for in vitro fertilization or for gamete intrafallopian tube transfer, in promoting or inhibiting fertilization in vitro and in vivo, and in diagnosing and treating infertility.

Abstract: The present invention provides devices, methods and kits for assessing fertility potential of semen samples. Semen samples may be assayed by the present invention to identify those samples having more than 20.times.10.sup.6 motile sperm per milliliter, a concentration associated with fertile samples.

Abstract: A method is disclosed relating to the isolation and purification of certain heparin-binding protein compositions in the seminal plasma of male mammals. The isolated proteins are useful in fertility studies and in enhancing the acrosomal reaction, capacitation and subsequent fertility of sperm cells.

Abstract: A method for detecting the presence of infertility in mammalian male test subjects based upon failure of sperm to undergo successful capacitation. Sperm samples are given the opportunity to undergo capacitation and subsequently contacted with antibodies to polypeptides having an amino acid sequence tripeptide of Arginine-Glycine-Aspartate in their cell binding domains. Binding levels indicate the degree of capacitation and consequently the presence of infertility.

Abstract: A method is provided for rapidly determining the ability of sperm to undergo the acrosome reaction, using fluorescence microscopy, light microscopy or color change on a dot blot assay to determine the relative percentage of acrosome reacted sperm. Sperm are capacitated through use of bromelain or other enzymatic substances capable of capacitating sperm, with the total incubation time required to induce capacitation as little as fifteen minutes, yielding sperm that are fully capacitated and show excellent motility, with as many as 80% of normal sperm consistently induced to acrosome react.

Abstract: A novel method for treating a human female is disclosed comprising the step of exposing the nasal region of said female to at least a portion of the axillary secretions of a human male. This exposure is preferably continued in amounts and for a duration which are effective to significantly alter an endocrine related characteristic, such as the menstrual cycle length, of that female. In particular, the portions of male axillary secretions to be exposed to the female preferably comprise one or more compounds such as androstenol, dehydroepiandrosterone, and/or a compound or compounds exhibiting a burnt heavy axiallary-like odor which elutes at about 50 minutes as shown on the FID response curve of FIG. 3B. Studies show that pooled male donor secretions are effective to alter aberrant menstrual cycles, particularly those exhibiting luteal phase defects such that they become presumptively fertile menstrual cycles having durations of about 29.5.+-.3 days.

Abstract: The present invention describes methods and compositions for detecting the fertility of a canine female based on identification of certain characteristic cLH peptides and carrier proteins found in canine urine. More specifically free or complexed metabolites of luteinizing hormone (LH) are detected.

Abstract: A natural birth control method comprises observance of the first day of menses followed by measurement of urinary progesterone metabolite levels beginning a predetermined number of days after the first day of menses. Urinary progesterone metabolite measurement is performed on days of planned sexual activity until the concentration level exceeds a threshold value indicative of ovulation occurring more than 24 hours previously. Once such a threshold value is observed, the woman may discontinue testing and can consider herself unable to conceive until after the beginning of the subsequent menstrual cycle.

Abstract: The fertility of females, especially human females can be predicted by use of a clomiphene challenge test. The test is based upon comparison of follicle stimulating hormone and/or luteinizing hormone levels in urine or blood samples at two points in the menstrual cycle. The first test is performed on days 2-3 of the cycle. Clomiphene, and most preferably clomiphene in the form of clomiphene citrate, in a dosage of about 100 mg/day, is then administered, preferably on days 5-9. The second test is conducted on days 9-10. The test results are most conveniently compared by colorimetric methods involving monoclonal antibody reactions with follicle stimulating hormone and/or luteininizing hormone.

Abstract: The potential fertility of a semen sample is evaluated using a kit comprising a collection tube with volume gradients on its side; a funnel which is fitted into the collection tube for guiding an ejaculate into the collection tube; a pipet containing a standard aqueous solution of the dye resazurin stored therein for metering a predetermined amount of the solution into the collection tube; an insulating sleeve for surrounding a glass containing hot water and the collection tube and for maintaining the water at an elevated temperature for a predetermined period of time, and a color chart ranging in color from the color of the semen sample and dye solution mixture immediately after mixing to the color of a corresponding mixture of the dye solution and a highly fertile semen sample, after being maintained at the same elevated temperature for the same period of time.

Abstract: A method is disclosed for the separation of seminal plasma from semen by means of a membrane. The invention also includes a method for the determination of enzymes such as acrosin and other components of semen.

Abstract: A method for separating male and female determining spermatozoa includes the initial step of exposing freshly ejaculated spermatozoa in a substantially protein free diluent to an excess concentration of a monoclonal antibody directed against H-Y antigen that binds substantially exclusively with male determining spermatozoa. The method continues with the suspending of the exposed spermatozoa together with a conjugate of (1) an immunoglobulin G antibody that binds substantially exclusively to the monoclonal antibody and (2) an immunoabsorbant substrate in a substantially protein free diluent. This forms a conjugate/spermatozoa preparation. The method concludes with the recovering of the separated male and female determining spermatozoa.