Abstract: Nucleic acid and protein sequences relating to a cation channel which is sperm-specific (CatSper2) are disclosed. The CatSper2 protein is shown to be specifically expressed in sperm. Nucleic acids, vectors, transformed cells, transgenic animals, polypeptides, and antibodies relating to the CatSper2 gene and protein are disclosed. Also provided are methods of in vitro fertilization and contraception, methods of identifying modulators of CatSper2 activity, methods of genotyping subjects with respect to CatSper2, methods of diagnosing and treating CatSper2-mediated disorders, including infertility, as well as methods of doing business related to CatSper2-mediated disorders.

Abstract: Oral, topical and injectable contraceptives, which are based on sperm protein 22 kDa (SP22) polypeptides and antibodies and infertility diagnostics are provided.

Abstract: This invention describes unique patterns of distribution of ganglioside GM1 in non-capacitated sperm and demonstrates that the pattern of distribution of GM1 undergoes changes that can be correlated with the process of capacitation and/or with acrosomal exocytosis. Accordingly, the present invention discloses a method for determining the ability of sperm to respond to capacitation and/or acrosomal exocytosis stimuli. The method comprises determination of distribution pattern for GM1. The method can be used for both diagnostic and predictive purposes when assessing male reproductive fitness, and can also be used to assess the effects on sperm of cryoprotective agents and protocols, and contraceptive agents.

Abstract: The invention relates to the in vitro transfer of the Sperm Adhesion Molecule 1 (SPAM 1) to spermatozoa. The SPAM1 protein can be obtained from the epididmys or the uterus and should have an intact lipid anchor. The SPAM 1 protein attaches to the surface of mammalian spermatozoa via it's lipid anchor in an in vitro environment in order to increase the sperm's capability of fertilizing an egg.

Abstract: This invention describes unique patterns of distribution of ganglioside GM1 in non-capacitated sperm and demonstrates that the pattern of distribution of GM1 undergoes changes that can be correlated with the process of capacitation and/or with acrosomal exocytosis. Accordingly, the present invention discloses a method for determining the ability of sperm to respond to capacitation and/or acrosomal exocytosis stimuli. The method comprises determination of distribution pattern for GM1. The method can be used for both diagnostic and predictive purposes when assessing male reproductive fitness, and can also be used to assess the effects on sperm of cryoprotective agents and protocols, and contraceptive agents.

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: 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: A method of determining the gender of a bird in ovo comprises detecting the presence or absence of an elevated level of a sex-related hormone in the extra-embryonic fluid of the bird egg, and then determining the gender of the bird within the egg from the presence of an elevated level of a sex-related hormone therein. Preferably, the sex-related hormone is an estrogen. Further preferred are methods in which the extra-embryonic fluid is allantoic fluid. The method is preferably carried out on chicken eggs prior to or during transfer of the eggs from incubator to hatcher.

Abstract: Immunogenic compositions capable of generating an immune response in mammals against GnRH are disclosed. The immunogenic compositions are effective in methods of treating gonadotropin and gonadal steroid hormone dependent diseases and immunological contraception of mammals.

Abstract: A 22 kD sperm protein, SP-22, correlates with fertility and predicts fertility in males. The protein can be assayed to detect decreases in fertility resulting from exposure to toxicants and pollutants which are known or suspected to decrease fertility. If an antibody is generated to this protein, the antibody recognition by sperm in an epididymal sperm sample or ejaculate would reflect the fertility of the sample. This antibody can be used as a contraceptive to inactivate sperm, screen for toxicity, select animals for artificial insemination, and select men for assisted reproductive technologies. The protein itself can be inactivated by gene knockout, which is another approach to contraception, or the protein can be added to sperm from infertile men to make fertility techniques more feasible.

Abstract: A method for increasing the percentage of mammalian offspring of either sex which comprises contacting a semen sample with an antibody specific for the spermatozoa determinative of one sex and separating said spermatozoa from spermatozoa determinative of the other sex, said antibody being bound to a non-porous magnetic bead support having a diameter of 0.1 to 2 microns.

Abstract: Immunogenic compositions capable of generating an immune response in mammals against GnRH are disclosed. The immunogenic compositions are effective in methods of treating gonadotropin and gonadal steroid hormone dependent diseases and immunological contraception of mammals.

Abstract: A purified polypeptide which provides for initial binding of sperm to oocyte investments and has an active amino acid sequence of SEQ ID NO:12 (Cys-Gln-Ser-Leu-Gln-Glu-Tyr-Leu-Ala-Glu-Gln-Asn-Gln-Arg-Gln-Leu-Glu-Ser-A sn-Lys-Ile-Pro-Glu-Val-Asp-Leu-Ala-Arg-Val-Val-Ala-Pro-Phe-Met-Ser-Asn-Ile- Pro-Leu-Leu-Leu-Tyr-Pro-Gln-Asp-Arg-Pro-Arg-Ser-Gln-Pro-Gln-Pro-Lys-Ala-Asn -Glu-Asp-Val-Cys); or SEQ ID NO:13 (Cys-Glu-Ser-Leu-Gln-Lys-His-Leu-Ala-Glu-Leu-Asn-His-Gln-Lys-Gln-Leu-Glu-S er-Asn-Lys-Ile-Pro-Glu-Leu-Asp-Met-Thr-Glu-Val-Val-Ala-Pro-Phe-Met-Ala-Asn- Ile-Pro-Leu-Leu-Leu-Tyr-Pro-Gln-Asp-Gly-Pro-Arg-Ser-Lys-Pro-Gln-Pro-Lys-Asp -Asn-Gly-Asp-Val-Cys); or the shorter but biologically active SEQ ID NO:1 and SEQ ID NO:9 (Tyr-Pro-Gln-Asp-Arg-X-Arg-Ser-Gln-Pro-Gln-Pro-Lys-Ala-Asn, where X is Thr or Pro).

Abstract: A purified polypeptide which provides for initial binding of sperm to oocyte investments and has an active amino acid sequence of SEQ ID NO:12 (Cys-Gln-Ser-Leu-Gln-Glu-Tyr-Leu-Ala-Glu-Gln-Asn-Gln-Arg-Gln-Leu-Glu-Ser-A sn-Lys-Ile-Pro-Glu-Val-Asp-Leu-Ala-Arg-Val-Val-Ala-Pro-Phe-Met-Ser-Asn-Ile- Pro-Leu-Leu-Leu-Tyr-Pro-Gln-Asp-Arg-Pro-Arg-Ser-Gln-Pro-Gln-Pro-Lys-Ala-Asn -Glu-Asp-Val-Cys); or SEQ ID NO:13 (Cys-Glu-Ser-Leu-Gln-Lys-His-Leu-Ala-Glu-Leu-Asn-His-Gln-Lys-Gln-Leu-Glu-S er-Asn-Lys-Ile-Pro-Glu-Leu-Asp-Met-Thr-Glu-Val-Val-Ala-Pro-Phe-Met-Ala-Asn- Ile-Pro-Leu-Leu-Leu-Tyr-Pro-Gln-Asp-Gly-Pro-Arg-Ser-Lys-Pro-Gln-Pro-Lys-Asp -Asn-Gly-Asp-Val-Cys); or the shorter but biologically active SEQ ID NO:1 and SEQ ID NO:9 (Tyr-Pro-Gln-Asp-Arg-X-Arg-Ser-Gln-Pro-Gln-Pro-Lys-Ala-Asn, where X is Thr or Pro).

Abstract: The present invention relates to the use of acrosomal sperm protein in immunocontraception of male and female subjects and uses thereof as a marker for fertility.

Abstract: The present invention is directed to protamine-reactive, IgM antibodies, and their uses in prognosis, diagnosis, and therapy. In a specific embodiment, the invention relates to low affinity binding, protamine-reactive serum IgM antibodies. In particular, such antibodies can recognize a sequence comprising four arginyl residues, including a triplet, within a six amino acid residue sequence. Such antibodies may be natural antibodies (i.e., not induced). A low affinity subset of serum protamine-reactive IgM antibodies may be assayed for prognosis or diagnosis of AIDS. Such antibodies are detectable in sera of normal subjects and HIV-infected individuals who subsequently exhibit a significant period of latency, but are absent or deficient in sera of individuals diagnosed with AIDS and sera of HIV infected individuals, who though asymptomatic at the time of the sampling, proceed to AIDS within a relatively short time.

Abstract: A substantially purified intra-acrosomal primate sperm antigen useful in a contraceptive vaccine is disclosed herein. The antigen remains associated with primate sperm after the acrosome reaction. In particular, it remains associated with the inner and outer acrosomal membranes. Modified antigens and fragments thereof prepared by protein modification techniques are also disclosed as well as methods for purifying and using the antigens. Also disclosed are monoclonal and polyclonal antibodies to the antigen and methods of making and using such antibodies. Methods of use include purification of the antigen or use in various diagnostic techniques. Also disclosed are cDNA, expression vectors, and transformed microorganisms that produce the antigen.

Abstract: Immunogenic compositions capable of generating an immune response in mammals against GnRH are disclosed. The immunogenic compositions are effective in methods of treating gonadotropin and gonadal steroid hormone dependent diseases and immunological contraception of 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: Substantially pure sex-associated membrane (SAM) proteins are used in methods to detect specific antibodies binding to X- or Y-SAM proteins.

Abstract: A method for Avian sex-preselection by identifying sex-specific proteins for maternal immunization to embryonic proteins is described. Sex-preselection proteins are used in sexing offsprings.

Abstract: Based on the discovery that normal pregnant mice have a striking reduction in committed precursors of B lymphocytes, which could be documented in mice as early as day 6 of gestation, when IL-7 responding colony forming cells were reduced as much as two-thirds of normal levels, it has been determined that estrogen and other hormones elevated in pregnancy induce a specific modulation of lymphocyte formation during pregnancy and lactation. It is therefore possible to immunomodulate in a specific manner an animal by administration of hormones elevated during pregnancy, such as estrogen and estrogen-like compounds, or antagonists of estrogen. This has potential in the treatment of a number of disorders, especially those found in very high percentages of women as compared with men, such as many of the autoimmune disorders, as well as in immune tolerance during pregnancy, cyclic neutropenia, and osteoporosis.

Abstract: It has been determined that estrogen and other hormones elevated in pregnancy induce a specific modulation of lymphocyte precursor cell production. The immune system of an animal or bone marrow cells in culture can therefore be modulated in a specific manner by administration of hormones elevated during pregnancy, such as estrogen and estrogen-like compounds or compounds that interfere with the synthesis or activity of these hormones, to increase or decrease production of B lymphocyte precursor cells.

Abstract: A substantially purified intra-acrosomal human sperm antigen useful in a contraceptive vaccine is disclosed herein. The antigen remains associated with human sperm after the acrosome reaction. In particular, it remains associated with the inner and outer acrosomal membranes. Modified antigens and fragments thereof prepared by protein modification techniques are also disclosed as well as methods for purifying and using the antigens. Also disclosed are monoclonal and polyclonal antibodies to the antigen and methods of making and using such antibodies. Methods of use include purification of the antigen or use in various diagnostic techniques. Also disclosed are cDNA, expression vectors, and transformed microorganisms that produce the antigen.

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: Disclosed are lyophilized gonadotropin containing preparations containing a dicarboxylic acid salt stabilizer. The particular proteins (e.g. LH, TSH, FSH, or HCG) are in admixture with, and at least partially capable of stabilization by, the particular stabilizer in lyophilized form. The preparations contain a sufficient amount of dicarboxylic acid salt to stabilize the protein in freeze-dried form for a desired time at a desired temperature. Typical dicarboxylic acid salts disclosed are the salts of citric, tartaric, and aspartic acids. The preparations preferably include a non-reducing disaccharide to increase the collapse temperature of the solution to be lyophilized. Methods of making the preparations in lyophilized form and the resulting injectable preparations are also disclosed.

Abstract: A process for preparing nucleoproteic material which comprises immersing organic material into a suitable solvent for a sufficient time to extract nucleoproteins from said material, adding a sufficient amount of an acid to form a precipitate of nucleoproteic material, and recovering said nucleoproteic material precipitate. A composition of nucleoproteic material produced according to this process. A method for alleviating symptoms of neoplastic diseases which comprises sterilizing the composition of nucleoproteic material, preparing a formulation comprising an effective amount of said sterilized composition, and administering said formulation to a patient having symptoms of a neoplastic disease.