EP1496747A1

EP1496747A1 - Method and composition for improving fertility health in female and male animals and humans

Info

Publication number: EP1496747A1
Application number: EP02728685A
Authority: EP
Inventors: Aileen Sontag Trant
Original assignee: Daily Wellness Co
Current assignee: Daily Wellness Co
Priority date: 2002-04-08
Filing date: 2002-04-08
Publication date: 2005-01-19
Also published as: AU2002258727A1; WO2003086080A1; CA2481603A1; JP2005522486A; EP1496747A4

Abstract

In a new supplemental combination, the herb, Vitex agnus-castus (chasteberry), enhances hormone balance by increasing luteinizing hormone (LH) and progesterone release and, therefore, ovulation frequency. The antioxidants, green tea, vitamin E, and selenium, improve overall reproductive health. L-arginine, an amino acid, stimulates the reproductive organs by improving circulation. Folic acid, vitamins B6 and B12, iron, zinc and magnesium help promote women's fertility. For men, a combination of L-carnitine, antioxidants, folic acid, zinc and B vitamins can improve fertility. L-carnitine, an amino acid improves sperm quality and motility. Ferulic acid, an antioxidant found in Dong quai, also improves sperm quality. Sperms are highly susceptible to free radical or oxidative damage from environmental toxicants and natural aging. Vitamins C and E, green tea, and selenium are all potent antioxidants that help improve overall reproductive health. zinc and B vitamins (B6, B 12 and folate) are critical nutrients in male reproductive systems for hormone metabolism sperm formation and motility.

Description

Method and Composition for Improving Fertility Health in Female and Male Animals and Humans BACKGROUND OF THE INVENTION Because of delayed child bearing, unhealthy diets and use of tobacco, caffeine, alcohol, drugs and environmental contaminants, difficulties in conceiving have been experienced.

Needs exist for pharmaceutical compounds that improve fertility in both women and men.

SUMMARY OF THE INVENTION

This invention provides combinations of bioeffecting compounds for promoting fertility in men and women. The combinations include nutritional components that benefit fertility health. All the components have been studied separately, to determine their individual efficacy. The invention provides the first products to put these components together synergistically in women's and men's formulations.

As many as 15% of couples in the U.S. have difficulty conceiving a child. In about one third of these cases, it is the man that is infertile; in another third, the female has fertility issues. The remaining is due to a combination of male and female fertility issues, or unknown causes. In many of these cases, causes of infertility are treatable. Nutritional and lifestyle changes should be the first step to increasing chances for conception. Smoking and caffeine, drug and alcohol consumption, environmental toxicants, and stress are related to infertility in men and women. Reproductive organs are highly susceptible to free radical or oxidative damage from environmental toxicants and natural aging. A balanced, nutritional diet, and nutritional supplements with high antioxidant content can help reverse some of that damage. Other nutrients such as L-carnitine, B vitamins and zinc are critical to sperm formation and metabolism. In women, hormone balance is critical to monthly ovulation and development of the corpus luteu (an ovarian follicle that release progesterone after release of the egg to prepare the uterus for implantation) .

These and further and other objects and features of the invention are apparent in the disclosure, which includes the above ongoing written specification with the claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention provides combinations of beneficial bioeffecting compounds for promoting fertility in women. The invention provides a scientifically validated herbal/nutritional blend for women to improve infertility by helping to regulate the menstrual cycle and correct hormone imbalance (corpus luteum insufficiency) without increased chances of multiple births associated with drug therapy. The combination of amino acids, herbs, vitamins and minerals improves overall health and helps with many of the deficiencies that decrease fertility.

The herb, Vitex agnus-castus (chasteberry) , enhances hormone balance in women by increasing luteinizing hormone and progesterone release and, therefore, ovulation frequency. The antioxidants, green tea, vitamin E, and selenium, improve overall reproductive health. L-arginine, an amino acid, stimulates the reproductive organs by improving circulation. Folic acid, vitamins B6 and B12, iron, zinc and magnesium help promote womens' fertility.

The invention provides combinations of beneficial bioeffecting compounds for promoting fertility in men. Sperm are highly susceptible to free radical or oxidative damage from environmental toxicants and natural aging. Vitamins C and E, green tea, with or without coenzyme Q10 and selenium are all potent antioxidants that help improve sperm count and quality. Ferulic acid, an antioxidant found in Dong Quai, also improves sperm quality. Zinc and B vitamins (B6, B12 and folate) are critical nutrients in male reproductive systems for hormone metabolism, sperm formation and motility. The amino acid, L-carnitine, promotes formation of healthy sperm. L-carnitine fumarate is preferred. L-carnitine tartrate may be used.

The invention provides synergistic action of the combinations .

The two dietary supplements in male and female formulas are useful for men and women. Preferably, the distinct combinations are taken by both members of a couple in which the female age is between 21 and 46. The distinct combinations are useful for couples who have tried for 6 months or more, up to three years, to become pregnant without success. Preferably, patients take 2-4 capsules per day of the distinct formulas for three months.

Preferred ranges of the combinations considered in percent by weight are: Women' s Formula

Components Minimum % Maximum %

Vitex

(chasteberry) 2 10

L-arginine 40 60

Green tea 5 20

Vitamin E 5 20

Selenium .01 1

Vitamins

B6, B16 .01 1

Folic acid .01 1

Iron .1 5

Magnesium 10 40

Zinc .1 5

Men's Formula

Components Minimum % Maximum %

L-carnitine 40 70

Ferulic acid in

Dong Quai .01 10

Vitamins

C and E 10 40

Coenzyme coQIO 0 5

Selenium .01 1

Zinc .1 10

B vitamins .001 1 Acceptable ranges of womens' and mens' formulations are: Women's Formula

Components Minimum % Maximum %

Vitex

(chasteberry) 1 20

L-arginine 20 70

Green tea 0 30

Vitamin E .01 30

Selenium 0 2

Vitamins

B6, B16 0 2

Folic acid 0 2

Iron 0 7

Magnesim 0 50

Zinc 0 10

Men's Formula

Components Minimum o Maximum %

L-carnitine 20 80

Ferulic acid in Dong Qua:i 0 20

Vitamins

C and E . 01 40

Coenzyme coQIO 0 10

Selenium 0 3

Zinc 0 15

B vitamins 0 5

Examples of useful formulations in percent by weight are Women's Formula

Components

Vitex

(chasteberry 5

L-arginine 50

Green tea 11

Vitamin E 11

Selenium .6

Vitamins

B6, B16 0.38

Folic acid .02

Iron 1

Magnesium 20

Zinc 1

100^! Men's Formula

Components % Weiσht

L-carnitine 60

Ferulic acid in

Dong Quai 6

Vitamins

C and E 30

Coenzyme coQIO 1

Selenium 0.6

Zinc 2

B vitamins 0.4

100%

In the following, examples 1, 2, 3, provide preferred ranges of the combinations for men's formula considered in percent by weight :

Example 1 :

Components Minimum % Maximum %

L-carnitine 40 70

Ferulic acid in Dong Quai 0.1 10

Vitamins C and E 10 40

Green tea 1 20

Selenium 0.01 1

Zinc 0.1 10

B Vitamins 0.001 1

Example 2 : Components Minimum % Maximum %

L-carnitine 20 80

Ferulic acid in Dong Quai 0 20

Vitamins C and E .01 40

Green tea 0 30

Selenium 0 3

Zinc 0 15

B vitamins 0 5 An example of useful formulations in percent by weight is:

Example 3 :

Components % Weight

L- carnitine 50.4

Dong quai (.190 ferulic acid) 8

Vitamins C and E 23

Green tea 17

Selenium 0.1

Zinc 1.3

B Vitamins 0.2

100%

While the invention has been described with references to specific embodiments, modifications and variations of the invention may be constructed without departing from the scope of the invention, which is defined in the following claims.

Claims

I claim :

1. A pharmaceutical composition having fertility promoting activity in females comprising in combination components in effective amounts of Vitex agnus-castus (chasteberry) , antioxidants, including green tea, vitamin E or selenium, L-arginine, folic acid, vitamins B6 and B12, iron, zinc and magnesium.

2. The pharmaceutical composition of claim 1, wherein the components are present in the proportion in parts by weight of : about 2 to 20% Vitex agnus-castus (chasteberry) , about 5 to 50% antioxidants, including green tea, vitamin E or selenium, about 10 to 80% L-arginine, an amino acid, about .001 to 1% folic acid, about .001 to 1% vitamins B6 and B12, about .1 to 10% iron, about .1 to 10% zinc, and about 5 to 50% magnesium.

3. The pharmaceutical composition of claim 1, wherein the components are present in the proportion in parts by weight of about 4 to 20% Vitex agnus-castus (chasteberry) , about 20 to 50% antioxidants, including green tea, vitamin E or selenium, about 40 to 80% L-arginine, an amino acid, about .01 to 1% folic acid, about .3 to 1% vitamins B6 and B12, about .1 to 5% iron, about .1 to 5% zinc, and about 20 to 50% magnesium.

4. A pharmaceutical composition having fertility promoting activity in females comprising in combination components in effective amounts of the following components present in proportions in parts by weight of about 1 to 20% Vitex agnus-castus (chasteberry) , about 5 to 50% antioxidants, including green tea, vitamin E or selenium, about 10 to 80% L-arginine, an amino acid, about .01 to 1% folic acid, about .01 to 1% vitamins B6 and B12, about .1 to 10% iron, about .1 to 10% zinc, and about 20 to 50% magnesium.

5. A pharmaceutical composition having fertility promoting activity in males comprising in combination components in effective amounts vitamins C and E, selenium, ferulic acid, zinc and B vitamins.

6. The pharmaceutical composition of claim 5, further comprising in combination with the other components an effective amount of L-carnitine.

7. The pharmaceutical composition of claim 6, wherein the components are present in the proportion in parts by weight of about 20 to 80% L-carnitine, about 5 to 30% vitamins C and E, about 0 to 10% coenzyme Q10, about .001 to 1% selenium, about .2 to 20% ferulic acid, about .1 to 2% zinc, and about .001 to 1% B vitamins.

8. The pharmaceutical composition of claim 5, wherein the components are present in the proportion in parts by weight of about 10 to 80% L-carnitine, about 5 to 50% vitamins C and E, about 0 to 15% coenzyme Q10, about .001 to 1% selenium, about .2 to 20% ferulic acid, about .1 to 15% zinc, and about .001 to 1% B vitamins.

9. The pharmaceutical composition of claim 5, wherein the components are present in the proportion in parts by weight of about 60% L-carnitine, about 25% vitamins C and E, about 8% Dong Quai containing ferulic acid, about 5% zinc and B vitamins, about 2% coenzyme coQIO, and about .6% selenium.

10. A supplement, comprising a herb, Vitex agnus-castus (chasteberry) for enhancing hormone balance, increasing progesterone release and ovulation frequency, antioxidants, green tea, vitamin E, and selenium for improving reproductive fertility, L-arginine, an amino acid for stimulating reproductive organs by improving circulation, folic acid, vitamins B6 and B12, iron, zinc and magnesium for promoting women' s fertility.

11. A method of promoting fertility health in women comprising taking a dietary supplement of L-arginine, magnesium, green tea, vitamin E, Vitex agnus-castus, iron, zinc, selenium, vitamins B6 and B12 and folic acid.

12. The method of claim 11, wherein the dietary supplement further comprises the following components in percentages by weight: about 50% L-arginine, about 20% magnesium, about 10% green tea, about 10% vitamin E, about 5% Vitex, about 1% iron, about 1% zinc and less than about 1% of each selenium, vitamins B6 and B12 and folic acid.

13. The method of claim 11, wherein the components are present in the proportion in parts by weight of about 10 to 80% L-arginine, an amino acid, about 5 to 50% magnesium, about 5 to 50% antioxidants, including green tea, vitamin E or selenium, 2 to 20% Vitex agnus-castus (chasteberry) , about .1 to 10% iron, about .1 to 10% zinc, about .001 to 1% folic acid, about .001 to 1% vitamins B6 and^' B12.

14. The method of claim 11, wherein the components are present in the proportion in parts by weight of about 40 to 80% L-arginine, an amino acid, about 20 to 50% antioxidants, including green tea, vitamin E or selenium, about 20 to 50% magnesium, about 4 to 20% Vitex agnus-castus (chasteberry) , about 1 to 10% iron, about 1 to 10% zinc, about .01 to 1% folic acid, and about .3 to 1% vitamins B6 and B12.

15. A method for promoting fertility health in women comprising taking a supplement having fertility promoting activity in females comprising in combination components in effective amounts of the following components present in proportions in parts by weights of about 10 to 80% L- arginine, an amino acid, about 10 to 50% magnesium, about 5 to 50% antioxidants, including green tea, vitamin E or selenium, about 1 to 20% Vitex agnus-castus (chasteberry) , about .1 to 10% iron, about .1 to 10% zinc, about .01 to 1% folic acid, and about .01 to 10% vitamins B6 and B12.

16. A supplement having fertility promoting activity in females comprising in combination components in effective amounts of Vitex agnus-castus (chasteberry) , antioxidants, including green tea, vitamin E or selenium, L-arginine, folic acid, vitamins B6 and B12, iron, zinc and magnesium as a treatment for promoting fertility activity in females.

17. The method of claim 16, wherein the components are present in the proportion in parts by weight of about 10 to 80% L-arginine, an amino acid, about 5 to 50% magnesium, about 5 to 50% antioxidants, including green tea, vitamin E or selenium, 2 to 20% Vitex agnus-castus (chasteberry) , about .1 to 10% iron, about .1 to 10% zinc, about .001 to 1% folic acid, about .001 to 1% vitamins B6 and B12.

18. The method of claim 16, wherein the components are present in the proportion in parts by weight of about 40 to 80% L-arginine, an amino acid, about 20 to 50% antioxidants, including green tea, vitamin E or selenium, about 20 to 50% magnesium, about 4 to 20% Vitex agnus-castus (chasteberry) , about .1 to 5% iron, about .1 to 5% zinc, about .01 to 1% folic acid, and about .3 to 1% vitamins B6 and B12.

19. The method of claim 16, further comprising a supplement having fertility promoting activity in females comprising in combination components in effective amounts of the following components present in proportions in parts by weights of about 10 to 80% L-arginine, an amino acid, about 10 to 50% magnesium, about 5 to 50% antioxidants, including green tea, vitamin E or selenium, about 1 to 20% Vitex agnus- castus (chasteberry), about .1 to 10% iron.

20. A method of promoting a women' s fertility by taking a new supplement, comprising a herb, Vitex agnus-castus

(chasteberry) for enhancing hormone balance, increasing progesterone release and ovulation frequency, antioxidants, green tea, vitamin E, and selenium for improving overall reproductive health, L-arginine, an amino acid for stimulating reproductive organs by improving circulation, folic acid, vitamins B6 and B12, iron, zinc and magnesium for promoting women' s^* fertility.

21. A pharmaceutical composition having fertility promoting activity in males, comprising in combination components in effective amounts of antioxidants, including green tea, vitamin C, vitamin E or selenium, L-carnitine, ferulic acid in Dong quai, vitamins B6, B12, folate and zinc.

22. The pharmaceutical composition of claim 21, wherein the components are present in the proportion in parts by weight of : about 5 to 50% antioxidants, including green tea, vitamin C, vitamin E or selenium, about 10 to 80% L-carnitine, an amino acid, about 0 to 1% ferulic acid in Dong quai, about 0 to 1% vitamins B6, B 12 and folate about 0 to 10% zinc.

23. The pharmaceutical composition of claim 21, wherein the components are present in the proportion in parts by weight of about 20 to 50% antioxidants, including green tea, vitamin C, vitamin E or selenium, about 40 to 80% L-carnitine, an amino acid, about 0.01 to 1% ferulic acid in Dong quai, about 0.003 to 1% vitamins B6 and B12, and folate about 1 to 10% zinc.

24. A pharmaceutical composition having fertility promoting activity in males comprising in combination components in effective amounts of the following components present in proportions in parts by weight of: about 5 to 50% antioxidants, including green tea, vitamin C, vitamin E or selenium, about 10 to 80% L-carnitine, an amino acid, about 0.01 to 1% ferulic acid in Dong quai, about 0.01 to 1% vitamins B6, B12 and folate.,_. about 0.1 to 10% zinc.

25. A pharmaceutical composition having fertility promoting activity in males comprising in combination components in effective amounts vitamins C and E, selenium, ferulic acid, zinc and B vitamins.

26. The pharmaceutical composition of claim 25, further comprising in combination with the other components an effective amount of L-carnitine fumarate.

27. A pharmaceutical composition of claim 26, wherein the components are present in the proportion in parts by weight of about 20 to 80% L-carnitine fumarate, about 5 to 30% vitamins C and E, about 1 to 30% green tea, about 0.001 to 1% selenium, about 2 to 20% Dong quai, about 0.1 to 2% zinc, and about 0.001 to 1% B Vitamins.

28. A pharmaceutical composition of claim 26, wherein the components are present in the proportion in parts by weight of about 20 to 80% L-carnitine fumarate, about 5 to 30% vitamins C and E, about 0.1 to 30% green tea, about 0.001 to 1% selenium, about 2 to 20% Dong quai, about .1 to 2% zinc, and about 0.001 to 1% B Vitamins.

29. A pharmaceutical composition of claim 25, wherein the components are present in the proportion in parts by weight of about 10 to 80% L-carnitine about 5 to 50% vitamins C and E, about 1 to 30% green tea, about 0.001 to 1% selenium, about 0.2 to 20% Dong quai, about 0.1 to 5% zinc, and about 0.001 to 1% B vitamins.

30. A pharmaceutical composition of claim 25, wherein the components are present in the proportion in parts by weight of about 50% L-carnitine, about 23% vitamins C and E, about 8% Dong quai, about 2% zinc and B vitamins, and about 17% green tea.

31. A new supplement for enhancing male fertility health, comprising antioxidants, green tea, vitamin C, vitamin E, and selenium for improving overall reproductive health, L-carnitine, an amino acid, vitamins B6 and B12 and zinc for promoting men' s fertility.

32. A method of promoting fertility health in men comprising taking a dietary supplement of L-carnitine, Dong quai, green tea, vitamins B6, B12, C, E, folate, zinc and selenium.

33. A method of claim 32, wherein the dietary supplement further comprises the following components in percentages by weight: about 50% L-carnitine, about 17% green tea, about 8% Dong quai, about 23% vitamins C and E, about 1% zinc and less than about 1% of each selenium, vitamins B6 and B12 and folate.

34. A method of promoting fertility health in men comprising taking a supplement having fertility promoting activity in males comprising in combination components in effective amounts of the following components present in proportions in parts by weights of about 10 to 80% L- carnitine, an amino acid, about 5 to 50% antioxidants, including green tea, vitamin C, vitamin E or selenium, about .1 to 10% zinc, about .01 to 1% ferulic acid, and about .01 to 10% vitamins B6, B12 and folate.

35. A supplement having fertility promoting activity in males comprising in combination components in effective amounts of antioxidants, including green tea, vitamin C, E or selenium, L-carnitine, Dong quai, vitamins B6, B12, folate and zinc adapted for use as a treatment for promoting fertility in males.

36. A method of promoting men' s fertility by taking a new supplement, comprising antioxidants, green tea, vitamin C, vitamin E, and selenium for improving overall reproductive health, L-carnitine, an amino acid for improving sperm quality, ferulic acid in Dong quai, vitamins B6, B12, folate and zinc for promoting men' s fertility.