Abstract: The present invention provides a method for determining the gender of a fetus by assaying the sex hormones, evaluating the overall reducing/oxidizing (redox) activity, and/or evaluating the radical scavenging capacity of the maternal urine or other body fluid. The method can be used to determine fetal gender at any time point during the entire pregnancy. The body fluid may be processed before assaying. Processing may involve aging the body fluid, or purification of various fractions.

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: The invention relates to the use of plasma membrane calcium ATPase (PMCA) inhibitors for inhibiting sperm mobility to achieve a contraceptive effect. The invention further relates to contraceptive agents comprising one or more PMCA inhibitors.

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: The invention concerns a device for determining an analyte in a liquid sample, comprising: a) a gripping support (1); b) first capillary diffusing means (2) integral with the gripping support (1) comprising a downstream zone (2a) accessible to external observation; c) a set of predetermined reagents for detecting and/or quantifying the analyte; d) a member for collecting (4) the liquid sample mounted on the support (1). The invention is characterized in that the member for collecting (4) the liquid sample is mounted mobile or fixed on the support; second capillary diffusion means (41) extends from a zone collecting (41a) said sample, to a zone transferring (41b) the latter; and an upstream zone (2b) of said first capillary diffusion means (2) is arranged to be urged temporarily to constitute continuous capillary flow with the second diffusion means (41) transferring zone (41b), when the collecting member (4) is in the retracted position.

Abstract: An analytical test device incorporating a dry porous carrier to which a liquid sample, eg. urine, suspected of containing an analyte such as HCG or LH can be applied indirectly, the device also incorporating a labelled specific binding reagent which is freely mobile in the porous carrier when in the moist state, and an unlabelled specific binding reagent which is permanently immobilized in a detection zone on the carrier material, the labelled and unlabelled specific binding reagents being capable of participating in either a sandwich reaction or a competition reaction in the presence of the analyte, in which prior to the application to the device of a liquid sample suspected of containing the analyte, the labelled specific binding reagent is retained in the dry state in a macroporous body, eg.

Abstract: The invention relates to a method to detect male antifertility problems based on the determination of latent phospholipid hydroperoxide glutathione peroxidase (PHGPx).

Abstract: An antibody biding specifically to rat's acrosome reacted sperm is produced and hybridomas (FARS-91 and FARS-92 strains) capable of stably proliferating are obtained by fusing mouse spleen cells having a high antibody titer against rat's acrosome reacted sperm with mouse-origin myeloma cells and screening fused cells reacting strongly with rat's acrosome reacted sperm. From these hybridomas, monoclonal antibodies selectively binding to rat's acrosome reacted sperm can be obtained. Thus, a diagnostic method for evaluating fertility of rat's spermatozoa is presented.

Abstract: The hormone calcitonin promotes fertilizing ability in mammalian sperm and is useful for treatment of conditions of low fertility in humans and animals. Human, porcine or salmon calcitonin may be formulated in a pharmaceutical composition comprising a pharmaceutically acceptable carrier for topical application, e.g. as a cream or jelly containing up to 100 ng/ml or more of salmon calcitonin or up to 2 &mgr;g/ml or more of human calcitonin. Calcitonin may also be administered parenterally, orally, or nasally. For improving in vitro fertilization or artificial insemination methods calcitonin is added to sperm prior to use e.g. salmon calcitonin present at a concentration of from 5 to 50 ng/ml or human calcitonin at a concentration of from 20 to 200 ng/ml in the sperm preparation. Calcitonin levels in seminal plasma can also be used to diagnose infertility.

Abstract: This invention relates to a method of predicting pregnancy, particularly, in a cow, the method comprising taking a milk sample from the cow in which a milk progesterone concentration of >3 ng ml−1 by Day 4 post insemination is indicative that the animal is pregnant. The invention also relates to methods of improving pregnancy success by timely supply of progesterone or a functional equivalent thereof (progestagen); to methods of assessing suitability for progesterone replacement therapy; and to methods of embryo transfer.

Abstract: A method of testing sperm quality including obtaining a sample of sperm to be tested; detecting and measuring the testis-specific HspA2 chaperone protein (or, the chaperone protein homologues to HspA2) in human and animal sperm; and determining a sperm quality parameter based upon the chaperone protein, wherein an increased amount of the chaperone protein species indicates a higher sperm quality. The chaperone protein is detected and measured either by binding one or more antibodies specific to the sperm chaperone protein to the sperm and measuring the antibody content or measuring ATP bound to the sperm chaperone protein. In the case of the latter method, the chaperone protein may be detected and measured by measuring ATP bound to the sperm chaperone protein, and such measuring is by chaperone protein-bound and CK-B generated ATP measurement, or by bioluminescence of the chaperone protein bound-ATP.

Abstract: An analytical test device incorporating a dry porous carrier to which a liquid sample, eg. urine, suspected of containing an analyte such as HCG or LH can be applied indirectly, the device also incorporating a labelled specific binding reagent which is freely mobile in the porous carrier when in the moist state, and an unlabelled specific binding reagent which is permanently immobilised in a detection zone on the carrier material, the labelled and unlabelled specific binding reagents being capable of participating in either a sandwich reaction or a competition reaction in the presence of the analyte, in which prior to the application to the device of a liquid sample suspected of containing the analyte, the labelled specific binding reagent is retained in the dry state in a macroporous body, eg.

Abstract: Methods for labeling mannose lectins on the surface of mammalian sperm cells are described, and methods of categorizing and quantifying the numbers of cells exhibiting particular labeling patterns are also provided. These methods provide ways of detecting whether or not a mammalian male patient has mannose lectin-correlated infertility, which is determined on the basis of the relative numbers of sperm cells labeled with particular labeling patterns. Methods for detecting capacitation-induced changes in the distribution of mannose lectins on mammalian sperm cells are also provided, and these methods can also be used to detect whether or not a mammalian male patient has mannose lectin-correlated infertility, on the basis of the comparative relative labeling in capacitated and non-capacitated sperm cell samples. In addition, the various methods are shown to be useful for determining whether chemical compounds have effects on mammalian sperm cell surface lectin distribution or acrosomal states.

Abstract: It is an object of the present invention to provide the clinicians with a new application for ligands specific to MHC-class I antigens, especially HLA-ABC antigens, this new application residing in the detection and diagnosis of endometriosis. It is also an object of the present invention to provide a method and a test kit for diagnosing endometriosis, preferably by immunohistochemistry, using a monoclonal anti-HLA-ABC antibody as a preferred ligand or diagnostic reagent. This new method is non-invasive and is more reliable as a screening test than the conventionally used laparoscopy. When the endometrium of a woman tests negatively with the claimed method, it prevents the use of laparoscopy which is an invasive method for detecting endometriosis. This method can be practised on a specimen obtained from the endometrium of a patient and does not require a specimen sampled directly from the endometriotic foci.

Abstract: A process for inducing a transcriptionally active chromosome (i.e., a “lampbrush” chromosome) from condensed chromatin or nucleus is disclosed. The condensed chromosome is contacted with the contents of a germinal vesicle. Preferably, the nuclear envelope is disrupted or removed. Moreover, a heterologous system of chromosome and germinal vesicle derived from organisms of different species is preferred because it permits analysis of organisms that do not have lampbrush chromosomes or cannot be manipulated by other techniques. Such lampbrush chromosomes can be attached to a substrate, and then analyzed by a variety of molecular and cytological techniques such as, for example, antibody detection of chromosomal protein, autoradiography, electron and light microscopy, histochemistry, image analysis, immunofluorescence, in situ hybridization of nucleic acids, morphology, and the like.

Abstract: This invention concerns PAPP-A, its immunodetection and the clinical benefits of such immunodetection. Specifically, the invention includes monoclonal antibodies against PAPP-A and the use of these antibodies to detect PAPP-A at a very early stage of pregnancy. The invention also covers the use of the monoclonal antibodies for the detection of specific types of cancer and Down's Syndrome pregnancies.

Abstract: A factor that indicates fertilization of an ovum before implantation, Preimplantation Factor (PIF), has been found. PIF also provides an early indication of pregnancy, malignancy, and autoimmune diseases. Assays for PIF are described. Detection of PIF in mammalian blood and other fluids is utilized in various diagnostic tests.

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

Abstract: A method and apparatus for screening for reproductive tract inflammation and preeclampsia which utilizes the increase in neutrophil defensins to indicate that a patient is at risk of having reproductive tract inflammation or preeclampsia. The apparatus consists either an ELISA based measurement of defensins levels or a dipstick test that can be administered by the provider or self-administered by the patient.

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: A method for determining the capacity of a human sperm to fertilize a human egg is described by assessing sperm activation events in an in vitro assay using a non-mammalian egg extract, particularly a Xenopus laevis frog egg extract. Fertilizing capacity is assessed as a comparison of sperm decondensation, DNA synthesis and/or sperm recondensation as between a test sperm sample sperm and fertile sperm, such as a sperm sample from a proven fertile human male. The method employs results from the in vitro assay to also determine relative sufficiency or insufficiency of a sperm sample for fertilizing a human egg in human couples with a history of a diagnosed unexplained infertility from standard infertility diagnostic tests. The method may also be used to screen human sperm donors in human artificial insemination programs.

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: A method of identifying highly fecund males in which an isotonic, buffered liquid test specimen of semen is layered on top of a barrier medium that inhibits net movement (migration) of less mobile sperm into the barrier medium. Differences in mobility of populations of sperm among test subjects have been found to predict whether a male will be highly fecund or not. Sperm migration into the barrier medium is quantitated, for example by analyzing the barrier medium in a spectrophotometer or a photometer after sperm migration is allowed to occur. Alternatively, a collection member coated with a sperm binding protein may be placed below the barrier medium, and the number of sperm that bind to the collection member quantitated after incubation. The invention also includes a device for incubating the barrier medium at a physiologic temperature for a sufficient period of time to allow the highly mobile sperm to migrate into the barrier medium.

Abstract: The invention provides a process for the recovery of erythorbic acid from an aqueous feed solution containing values of erythorbic acid at a concentration of less than 0.7 mol/kg, comprising adsorbing a major portion of said erythorbic acid with a solid phase adsorbent resin selected from resins carrying a pyridine function and resins of similar or weaker basicity; separating said erythorbic acid-containing resin from residual aqueous solution, and subjecting said erythorbic acid-containing resin to a desorbing operation with a neutral solvent at a temperature of at least 20.degree. C. higher than the temperature at which said adsorption is carried out, whereby there is obtained a solution of erythorbic acid in solvent in which the concentration of erythorbic acid is at least equal to its concentration in said aqueous feed solution.

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: 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 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: A method for testing the potential fertility of spermatozoa in a sample by contacting an aliquot of the sperm sample onto a protein extracted from native vitelline membranes removed from chicken or turkey eggs to enable quantification of the number of sperm which bind to the protein. Typically, the vitelline membrane protein is coated onto a solid substrate and the protein extract is first prepared by dissecting vitelline membranes (lamina perivitelline plus lamina extravitellina) from either a group of chicken eggs or a group of turkey eggs, rinsing the membranes free of albumin and yolk, and subdividing the membranes into small particles. The resulting protein is heat solubilized, purified with centrifugation and concentrated to yield the protein extract in solution. The extracted protein then is used as a protein substrate for spermatozoa binding, with sequential contacting of the protein extract with the spermatozoa and measuring the amount of sperm-egg binding that takes place.

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: 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 factor that indicates fertilization of an ovum before implantation, Preimplantation Factor (PIF), has been found. PIF also provides an early indication of pregnancy, malignancy, and autoimmune diseases. Assays for PIF are described. Detection of PIF in mammalian blood and other fluids is utilized in various diagnostic tests.

Abstract: The present invention provides a method for predicting the outcome of IVF which comprises:(i) determining the level of 11.beta.-hydroxysteroid dehydrogenase (11.beta.-HSD) in a biological sample from a female patient; and(ii) predicting from the level of 11.beta.-HSD determined the probability of establishing pregnancy in said subject by IVF.It has been found that there is an inverse correlation between the levels of 11.beta.-HSD in the environment of the oocyte and subsequent establishment of pregnancy by IVF. The present invention also provides methods of screening female subjects for their suitability to take part in IVF programs, and kits to use in determining levels of 11.beta.-HSD.

Abstract: It is an object of the present invention to provide the clinicians with a new application for ligands specific to MHC-class I antigens, especially HLA-ABC antigens, this new application residing in the detection and diagnosis of endometriosis. It is also an object of the present invention to provide a method and a test kit for diagnosing endometriosis, preferably by immunohistochemistry, using a monoclonal anti-HLA-ABC antibody as a preferred ligand or diagnostic reagent. This new method is non-invasive and is more reliable as a screening test than the conventionnally used laparoscopy. When the endometrium of a woman tests negatively with the claimed method, it prevents the use of laparoscopy which is an invasive method for detecting endometriosis. This method can be practiced on a specimen obtained from the endometrium of a patient and does not require a specimen sampled directly from the endometriotic foci.

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: Two-dimensional polyacrylamide gel electrophoresis of seminal plasma samples indicate that two proteins (26 kDa, pI 6.2; 55 kDa, pI 4.5) predominated in higher fertility bulls and two proteins (16 kDa, pI 4.1; 16 kDa, pI 6.7) predominated in lower fertility bulls. A regression model was developed to predict bull fertility using the four fertility-associated protein densities. A plot of actual bull fertility versus that calculated by this model was linear and positively correlated (r=0.89). These findings indicate that bull seminal plasma contains fertility-associated proteins which are predictive of bull fertility. Additionally, the ability of seminal plasma to alter the in vitro fertility of ejaculated bull sperm was examined using a sperm penetration assay for zona-free bovine oocytes. Washed, ejaculated sperm from bulls of below (low) or above average (high) fertility were mixed with seminal plasma from the same bull, or with seminal plasma from a bull of contrasting fertility.

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: The present invention relates generally to test articles and assays for the detection of analytes in biological fluid samples. More particularly, the present invention relates to test articles an assays which employ dyed microorganisms as visual labels to detect suspected analytes.

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: The present invention relates to the use of leukemia inhibitory factor (LIF) in the enhancement of development and maintenance of mammalian embryos, particularly sheep embryos. It has been observed that following the introduction into foster mothers of embryos cultured in vitro in the presence of LIF, the maintenance of pregnancy is enhanced relative to that seen following introduction of embryos that had not been cultured with LIF prior to introduction into foster mothers.

Abstract: A method for determining the capacity of a human sperm to fertilize a human egg is described by assessing sperm activation events in an in vitro assay using Xenopus laevis frog egg extract. Fertilizing capacity is assessed as a comparison of sperm decondensation, DNA synthesis and/or sperm recondensation as between a test sperm sample sperm and a sperm sample from a proven fertile human male. The method employs results from the in vitro assay to also determine relative sufficiency or insufficient of a sperm sample for fertilizing a human egg in human couples with a history of a diagnosed "unexplained infertility" from standard infertility diagnostic tests. The method may also be used to screen human sperm donors in human artificial insemination programs.

Abstract: A solid diagnostic device for the quantitative determination of substances of biological affinity in biological fluids is described. A process is also described in which the biological fluid is brought into contact with a specific functional sector of the device, the fluid migrates through several functional sectors situated beside one another and containing suitable reagent components, and one or more substances of biological affinity are detected in such functional sectors which contain, for each substance to be detected, at least one combination partner of biological affinity, attached to a solid phase.

Abstract: A solid diagnostic device for the quantitative determination of substances of biological affinity in biological fluids is described. A process is also described in which the biological fluid is brought into contact with a specific functional sector of the device, the fluid migrates through several functional sectors situated beside one another and containing suitable reagent components, and one or more substances of biological affinity are detected in such functional sectors which contain, for each substance to be detected, at least one combination partner of biological affinity, attached to a solid phase.