Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
1999-02-24
2001-05-22
Travers, Russell (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C514S558000, C514S458000
Reexamination Certificate
active
06235783
ABSTRACT:
This invention relates to improvement of male fertility.
All animal species' spermatozoa have high concentrations of polyunsaturated phospholipids. In mammalian species e.g. the bull, boar, ram and man, the substantial level of polyunsaturates present is characteristically dominated by docosahexaenoic acid (22:6, n-3), a fatty acid of 22 carbon atoms in chain length, containing 6 double bonds in n-3 conformation and belonging to the alpha-linolenic acid (18:3, n-3) series. Thus in the case of the bovine, docosahexaenoic acid accounts for around 55% of the total phospholipid fatty acids, with particular concentrations occurring within the phosphatidyl ethanolamine and phosphatidyl choline species. By contrast, avian spermatozoa exhibit in general very low concentrations of docosahexaenoic acid and acids of the n-3 series but this is compensated for by the presence of substantial concentrations within the phospholipids of polyunsaturated fatty acids having chain lengths of 20 and 22 carbon atoms, containing 4 double bonds in n-6 conformation and belonging to the linoleic acid (18:2, n-6) series; these are arachidonic (20:4, n-6) and docosatetraenoic acid (22:4, n-6) respectively.
The lipid composition of the spermatozoan membrane may be a major determinant of motility, cold sensitivity and a wide selection of factors associated with overall viability within fresh ejaculates or stored ejaculates maintained at −196° C. for artificial insemination.
According to the present invention there is provided an antioxidant to enhance sperm function and/or viability.
Further according to the present invention there is provided a polyunsaturated fatty acid (PUFA) to enhance sperm function and/or viability.
Still further according to the present invention there is provided an antioxidant accompanied by a PUFA to enhance sperm function and/or viability.
The antioxidant and/or PUFA may be administered to the animal producing the sperm, for example in its diet, or intravenously or intramuscularly, or may be added to the sperm or to fluid surrounding the sperm.
Preferably the antioxidant is selected from vitamins, plant extracts and carotenoids.
Preferably the PUFA is an n-3 fatty acid, for example docosahexaenoic acid (DHA) or another member of the alpha-linolenic acid (18:3, n-3) series.
In a further aspect, the present invention provides a method of enhancing sperm function and/or viability, comprising adding to the semen of an animal substantially sperm-free seminal fluid containing an antioxidant and/or a PUFA.
The seminal fluid is preferably produced from the semen of another animal which may have been vasectomised or from whose semen sperm has been removed.
The mixture of the semen and seminal fluid can then be stored at low temperature for use in artificial insemination.
The semen in this aspect of the invention may already have been boosted in function or viability by virtue of the animal having antioxidant and/or PUFA administered to it. The PUFA is preferably administered to the animal in an amount of at least 10 mg/kg of body weight, most preferably 10-45 mg/kg.
The invention also provides a method of enhancing the function and/or viability of sperm, the method comprising controlling the PUFA content of the sperm, preferably the plasma membrane of the sperm, although the control of PUFA content of the seminal plasma can also be of benefit. The PUFA content of the plasma membrane can be controlled eg by adding PUFA or antioxidant to the sperm directly or administering the PUFA or the antioxidant to the animal's diet.
The invention also provides a method of combatting sperm dysfunction, comprising controlling the PUFA content of the sperm, preferably the content of the sperm plasma membrane, eg by exposing the sperm to a PUFA or an antioxidant.
The term “combat” as used herein refers to the prevention of a condition (ie prophylactic use) as well as treatment of an existing condition to ameliorate that condition or to delay or prevent its further deterioration.
The PUFA can be added direct to the ejaculate, or can be administered to an animal to enhance the function and/or viability of sperm from that animal. In such a case, the PUFA is preferably administered in quantities of at least 10-45 mg/kg body weight. The PUFA can be provided in substantially pure form or in combination with a pharmaceutical carrier or excipient, or in impure form. For example, the PUFA may be provided in the form of fish oil, or can be extracted from brain tissue by conventional methods. The PUFA may be incorporated into the fatty acid pool of the sperm, or may remain in the seminal fluid in order to exert its beneficial effects.
The PUFA is preferably a C18-C24 fatty acid.
The viability can be enhanced by increased mobility, cold resistance or related factors.
Two embodiments of the invention include:
(i) the maximisation of male fertility in vivo through the dietary manipulation of the lipid composition and/or antioxidant capacities of the fresh ejaculate.
(ii) the development of effective antioxidant/lipid additives for semen diluents and effective carrier systems for inclusion of the additives into the sperm membrane in order to ensure sperm viability in vitro and in vivo and fertility capacities after storage.
REFERENCES:
patent: 97/16965 (1997-05-01), None
H.M.Sinclair, “Essential Fatty Acids in Perspective”, Human Nutrition: Clinical Nutrition, vol. 38, No. 4, 1984, pp. 245-260.
Paulenz et al., “A Preliminary Study on the Effect of Dietary Supplementation with Cod Liver Oil . . . ”, Veterinary Research Communications, vol. 19, No. 4, 1995, pp. 273-284.
Kessopoulou et al., “A double-blind randomized placebo cross-over controlled trial using the antioxidant vitamin E . . . ”, Fertility and Sterility, vol. 64, No. 5, 1995, pp. 825-831.
Geva et al., “The effect of antioxidant treatment on human spermatoza and fertilization rate in an in vitro fertilization program”, Fertility and Sterility, vol. 66, No. 3, 1996, pp. 430-434.
Sharma et al., “Role of Reactive Oxygen Species in Male Infertility”, Urology, vol. 48, No. 6, 1996, pp. 835-850.
Aurich et al., “Effects of Antioxidants on Motility and Membrane Integrity of Chilled-Stored Stallion Semen”, Theriogenology, vol. 48, No. 2, 1997, pp. 185-192.
Noble Raymond Clifford
Surai Peter
Heslin & Rothenberg, P.C.
JSR Clover Ltd.
Travers Russell
Wang Shengjun
LandOfFree
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