Method and pharmacological composition for the diagnosis and treatment of male
a pharmacological composition and male technology, applied in the field of methods and pharmacological compositions, can solve the problems of significant proportion of patients exhibiting unexplained sub-fertility, and achieve the effects of reducing sperm quality, improving semen quality and fertility potential
Inactive Publication Date: 2011-02-10
PERINESS LTD
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- Abstract
- Description
- Claims
- Application Information
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Benefits of technology
[0024]The present invention is based on the novel and unexpected finding that high levels of cell-free deoxyoligonucleotide present in men's blood circulation is associated with sub-fertility and that administration of exogenous cell free DNA reduces sperm quality and causes sub-fertility. The inventors have thus found that providing sub-fertile males with a DNase may improve semen quality and fertility potential.
[0032]The composition may include in combination with the agent pharmaceutically acceptable carriers. By the term “pharmaceutically acceptable carrier” it is meant any one of inert, non-toxic, excipients, which essentially do not react with the agent that interferes with DNA having an effect on sperm cells and is added thereto in order to give form or consistency to the composition and to provide protection from degradation of the agent and increase its survival outside and inside the body and to obtain penetration into the body and delivery into the body fluids and to facilitates distribution of the agent in the subject's body and delivery to the target site (either to the cell free DNA, to the target cell surface receptor or to get into the sperm cell).
[0038]A. 10 days—This course is aimed at reducing the effect of cell free DNA on sperm cells during epididymal transport.
[0040]C. 26 days—This course is aimed at reducing the effect of cell free DNA on sperm cells during one spermatogenic cycle and during the epididymal transport.
[0041]D. 32 days—This course is aimed at reducing the deleterious effect of cell free DNA on sperm cells during full spermiogenesis and during epididymal transport.Chronic Treatments:
[0042]E. 74 days—This course is aimed at reducing the deleterious effect of cell free DNA on sperm cells during full spermatogenesis and during epididymal transport.
Problems solved by technology
Routine semen analysis, however, has many limitations resulting in a significant proportion of patients exhibiting unexplained sub-fertility.
Method used
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Experimental program
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Materials
Standard DNA Solution:
[0121]100 mM calf thymus DNA was dissolved in double distilled water (DDW).
DPA Solution:
[0122]1.5 gr of Diphenylamine was dissolved in 100 ml glacial acetic acid and 1.5 ml sulfuric acid was added. On the day of use, 0.5 ml of acetaldehyde was added.
Polyvinyl Pyrrolidone (PVP) Solution:
[0123]PVP medium 10890001 obtained from Medi-Cult.
Kunitz DNase Activity Reaction Buffer:
[0124]5 mM MgSO4×7H2O, 0.1 M NaAcetate pH 5, 4 mg % Calf thymus DNA
Methods
DNA and Deoxyoligonucleotide Levels (Burton Method):
[0125]Standard DNA solution was diluted to 5, 10, 20 and 50 μg / ml in 166 μl. To each 166 μl of plasma samples or DNA standard sample, 166 μl of 1N HClO4 and 664 μl of DPA solution were added. Samples were incubated at 37° C. for 20 h, and then centrifuged for 10 min (15,000 g, 37° C.). 300 μl of the supernatant was transferred to a 96 well plate an measured in a spectrophotometer at 600 nm.
Semen Volume, Sperm Density and Sperm Concentration:
[0126]The volume of ...
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Abstract
Pharmaceutical compositions for treating male sub-fertility that include an agent that causes a reduction in an effect of extracellular DNA on sperm cells, are provided. The agent may be, for example, an enzyme that degrades DNA such as DNase, a substance that blocks the interaction between cell free DNA and sperm cell surface receptors, a substance that binds to DNA, a substance that inhibits endogenous sperm cell DNase, a substance that inhibits a member of a signal transduction pathway mediated by DNA binding to sperm cell surface receptors, or an agent that stimulates production of an endogenous substance that causes a reduction in an antifertility effect of cell free DNA on sperm cells. Also provided are methods for treating male sub-fertility by administering the pharmaceutical composition to a subject in need thereof. Further provided are methods for determining a fertility status in a male subject, methods for assisted reproduction, methods for selecting an assisted reproduction technique (ART), and methods for selecting sperm cells in a sperm cell population for use in an assisted reproduction technique.
Description
FIELD OF THE INVENTION[0001]The invention relates to methods and pharmacological compositions, and more specifically to such methods and pharmacological compositions for use in diagnosing and treating male sub-fertility.LIST OF PRIOR ART[0002]The following is a list of prior art references which are considered to be pertinent for understanding the invention. Acknowledgement of these references herein will at times be made by indicating their number from the list below within parentheses.[0003]1. Isidori A, Latini M, Romanelli F. (1) Isidori A, Latini M, Romanelli F. Treatment of male infertility. Contraception. 2005 October; 72(4):314-8.[0004]2. Kerin J F P, Peek J, Warms G M, Kirby C, Jeffrey R, Matthews C D, Cox L W (1984) Improved conception rate after intrauterine insemination of washed spermatozoa from men with poor quality semen. Lancet 1:533-534.[0005]3. Ombelet W, Puttemans P, Bosmans E (1995) Intrauterine insemination: a first step procedure in the algorithm of male subfert...
Claims
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IPC IPC(8): A61K38/46A61K38/14A61K31/194G01N33/566C12Q1/44G01N33/53A61P15/08A61B17/43
CPCA61K31/00A61K31/194A61K38/46G01N33/689Y10T436/143333G01N2510/00A61K38/14A61K38/1709A61K38/465G01N2333/922C12Y301/21001A61P15/08
Inventor BARTOOV, BENJAMINYEHUDA, RONENDOBROSLAV, MELAMED
Owner PERINESS LTD
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