AU2019246816A1 - A system and method for assisting conception - Google Patents

Abstract

A system (10) for assisting conception, the system (10) comprising: at least one female fertility aid intended for assisting a female to conceive; and at least one male fertility aid intended to assist their male counterpart. Preferably, the at least one female fertility aid comprises one or more of a supply of preconception vitamins (20) formulated for use by a female, an ovulation predictor (40), a pregnancy test, a thermometer (50) and a fertility calendar (60). Preferably, the at least one male fertility aid comprises a supply of preconception vitamins (30) formulated for use by a male. k - E /)

Description

A SYSTEM AND METHOD FOR ASSISTING CONCEPTION

Field of the Invention [001] The present invention relates to products and methods for assisting couples to successfully conceive.

[002] The invention has been developed primarily for use in fertility treatment and will be described hereinafter with reference to this application. However, it will be appreciated that the invention is not limited to this particular field of use.

Background of the Invention [003] Many women trying to conceive a child seek the assistance of over-the counter products to improve their chances of conception. A wide range of disparate products are available and women seeking assistance from these products must educate themselves in their various uses and compatibilities of the various products when used in conjunction with one another. Too often, this can result in an ad hoc approach with limited chances of success often resulting in increased frustration.

[004] Furthermore, women adopting this approach can tend to focus on their own fertility issues, whereas successful conception requires the cooperation, and support of their male counterpart. Often, the male has an issue that is inhibiting conception and this may go unaddressed.

[005] There remains a need to provide improved solutions to assist women and couples in successfully conceiving children.

[006] The present invention seeks to provide a system and method for assisting conception, which will overcome or substantially ameliorate at least some of the deficiencies of the prior art, or to at least provide an alternative.

[007] It is to be understood that, if any prior art information is referred to herein, such

2019246816 09 Oct 2019 reference does not constitute an admission that the information forms part of the common general knowledge in the art, in Australia or any other country.

Summary of the Invention [008] According to a first aspect of the present invention, there is provided a system for assisting conception, the system comprising:

- at least one female fertility aid intended for assisting a female to conceive; and at least one male fertility aid intended to assist their male counterpart.

The invention can be in the form provides a system for assisting conception, the system comprising:

- at least one female fertility aid intended for assisting a female to conceive; and

- at least one male fertility aid intended to assist their male counterpart wherein the system includes providing a predefined range of preconception supplements formulated for use by a female; and wherein the system includes providing a predefined range of preconception supplements formulated for use by a male;

wherein the supplements for the male and female in combination provides a synergistic enhancing aid for conception or conception health.

[009] Preferably, the at least one female fertility aid comprises one or more of:

- a supply of preconception vitamins formulated for use by a female;

- an ovulation predictor;

- a pregnancy test;

- a thermometer; and

- a fertility calendar.

[0010] Preferably, the at least one male fertility aid comprises a supply of preconception vitamins formulated for use by a male.

[0011] Preferably, the system further comprises products intended for use beyond

2019246816 09 Oct 2019 the initial stage of conception.

[0012] According to a second aspect of the present invention, there is provided a method of assisting a couple to conceive, the method comprising the step of:

- providing the couple with a system according to the first aspect of the present invention along with instructions relating to use of the system.

[0013] According to a third aspect of the present invention, there is provided a system for use in assisting conception, the system comprising:

- a supply of preconception vitamins formulated for use by a female; and

- an ovulation predictor.

[0014] Preferably, the ovulation predictor comprises a test for detecting luteinizing hormone.

[0015] Preferably, the system further comprises one or more of:

- a pregnancy test;

- a thermometer; and

- a fertility calendar.

[0016] Preferably, the system further comprises products intended for use beyond the initial stage of conception.

[0017] In another aspect, the present invention provides a system for assisting conception, the system comprising: at least one female fertility aid intended for assisting a female to conceive comprising one or more of: a supply of preconception vitamins formulated for use by a female;

an ovulation predictor;

a pregnancy test;

a thermometer; and a fertility calendar.

2019246816 09 Oct 2019 [0018] Preferably, the system further comprises:

at least one male fertility aid intended to assist their male counterpart comprising a supply of preconception vitamins formulated for use by a male.

[0019] Preferably, the vitamins for a female comprises one or more of the following:

- B vitamins; and - Iodine [0020] Preferably, the B vitamins comprise one or more of:

- Vitamin B6; and

- Vitamin B9 (Folic acid) [0021] Preferably, the male preconception vitamins comprises one or more of:

- Zinc

- Selenium

- Calcium

- Vitamin B9

- Vitamin C

- Vitamin D

- Vitamin E

- Lycopene; and

- Garlic.

[0022] In another aspect, the present invention provides a system for assisting conception comprising a male fertility aid comprising a supply of preconception vitamins, the vitamins comprising vitamin D.

[0023] Preferably, the vitamin D is in the form of vitamin D3 (cholecalciferol).

[0024] Preferably, the vitamin D is provided in combination with calcium.

[0025] Preferably, the vitamin E is provided as a-tocopherol.

2019246816 09 Oct 2019 [0026] Preferably, the male preconception composition comprises the following as active ingredients:

INGREDIENT	AMOUNT (per tablet)
Vitamin C (ascorbic acid)	125 mg
Zinc (zinc oxide)	30 mg
Vitamin E (d-alpha-Tocopherol)	400 iu
Vitamin b9 (folic acid)	600 mcg
Lycopene	5 mg
Garlic oil	330 mg
Selenium (Selenomethionine)	75 mg
Vitamin D3 (cholecalciferol)	500 iu
Calcium Carbonate	125 mg

[0027] Other aspects of the invention are also disclosed wherein there is a preconception and pregnancy vitamin pack for a female wherein the female preconception and pregnancy composition comprises a combination of vitamins and minerals that work together as active ingredients to provide the essential nutrients important to support reproduction and help support conception and pregnancy in a female and wherein the delivery of effective quantities of these active ingredients is accomplished through oral administration of single or multiple units given at one time or multiple times throughout the day according to a predefined schedule.

Brief Description of the Drawings [0028] Notwithstanding any other forms which may fall within the scope of the present invention, preferred embodiments of the invention will now be described, by way of examples only, with reference to the accompanying drawings in which: [0029] Fig. 1 shows a diagram of the system in accordance with a preferred embodiment of the present invention;

2019246816 09 Oct 2019 [0030] Fig. 2 shows a preconception and pregnancy vitamin pack for a female for the system of the preferred embodiment;

[0031] Fig. 3 shows a preconception and pregnancy vitamin pack for a male for the system of the preferred embodiment;

[0032] Fig. 4 shows an ovulation test pack for the system of the preferred embodiment;

[0033] Fig. 5 shows a thermometer for the system of the preferred embodiment;

[0034] Fig. 6 shows a fertility calendar for use by couples when following the steps of the method of the preferred embodiment;

[0035] Fig. 7 shows a flow diagram outlining the steps of the method for assisting couples to conceive in accordance with the preferred embodiment of the present invention;

[0036] Fig. 8 is another diagram showing the steps of the method of the system of the preferred embodiment;

[0037] Fig. 9 shows information for the instructional DVD of the system of the preferred embodiment;

[0038] Fig. 10 shows information of all the contents of the system of the preferred embodiment.

Description of Embodiments [0039] It should be noted in the following description that like or the same reference numerals in different embodiments denote the same or similar features.

[0040] Systems according to the invention comprise a combination of products and devices which assist conception.

[0041] Figure 1 shows a diagram of the system 10 according to the preferred embodiment of the present invention. The system 10 generally comprises the steps of preparing the body 12 of the male and female for conception, monitoring the body of the female for ovulation 14, baby making time 16 and testing for pregnancy 18.

2019246816 09 Oct 2019 [0042] In one embodiment, the system includes the following products:

1. Preconception and pregnancy vitamins and minerals formulated for assisting a female:

[0043] Figure 2 shows a preconception and pregnancy vitamin pack 20 for a female for step 12 above. The female preconception and pregnancy composition comprises a combination of vitamins and minerals that work together as active ingredients to provide the essential nutrients important to support reproduction and help support conception and pregnancy in a female. The delivery of effective quantities of these active ingredients may be accomplished through oral administration of single or multiple units given at one time or multiple times throughout the day.

B VITAMINS [0044] B vitamins are a group of water-soluble vitamins that play important roles in cell metabolism. In the case of females looking to conceive and take a pregnancy through to full term, are recommended to take at least the following B vitamins.

Vitamin B6 [0045] Vitamin B6 helps regulate female hormones. Being deficient in B6 can cause irregular menstrual cycles, a progesterone imbalance, as well as poor egg development. Vitamin B6 is reported to help lengthen the luteal phase of the female menstrual cycle and regulate blood sugar levels.

[0046] In a preferred embodiment, the vitamin B6 used in the female preconception and pregnancy composition is provided in the form of pyridoxine.

[0047] In other embodiments, the vitamin B6 may be provided in other forms including, but not limited to: pyridoxine hydrochloride, pyridoxal 5'-phosphate (activated form), or any nutritionally acceptable salt of pyridoxine.

2019246816 09 Oct 2019

Vitamin B9 [0048]Vitamin B9 is vital to many bodily functions from synthesizing and repairing DNA to influencing and playing a role in the reaction of rapid cell division and growth. Vitamin B9 is necessary for the production and maintenance of new cells, which is especially important during periods of rapid cell division and growth such as infancy and pregnancy. A vitamin B9 deficiency during pregnancy may cause birth defects therefore supplementation or ingestion of foods high in folic acid should be consumed during pregnancy to prevent this.

[0049] In a preferred embodiment, the vitamin B9 used in the female preconception and pregnancy composition is provided in the form of folic acid.

MINERALS

Iodine

Iodine supplementation is recommended, particularly in the case of females looking to conceive, to avoid the onset of iodine deficiency. Iodine is important in pregnancy to help assist in the development of the foetal nervous system [0050] In preferred embodiments, the female preconception and pregnancy composition is formulated for oral ingestion in a solid, semi-solid, or liquid form by combining the active ingredients of the composition with one or more suitable excipients.

[0051] Solid dosage forms for oral administration include capsules, tablets, pills, powders, and granules. Solid dosage forms of preferred embodiments of the present invention may be produced using any pharmaceutically acceptable excipients including any one or more of the following binders: proteins such as gelatine, polysaccharides such as starch, cellulose, methyl cellulose, carboxymethylcellulose, cellulose ether, gelatin, natural sugars (e.g., sucrose, glucose or beta-lactose), corn sweeteners, natural and synthetic gums (e.g., acacia, tragacanth or sodium alginate),

2019246816 09 Oct 2019 polymers such as polyvinylpyrrolidone and polyethylene glycol, as well as calcium carbonate, rice flour, glycine, waxes, and the like.

[0052] For example, in the case of tablets, these may be formed by combining all of the active ingredients with one or more suitable binders through a simple mixing process. The resulting tablets may then be sugar coated or film-coated to mask any unpleasant taste and to protect the active ingredients within the tablet from deterioration by moisture in the air. An enteric coating may be used to provide selective disintegration in, e.g., the gastrointestinal tract. For most coated tablets, a cellulose ether hydroxypropyl methylcellulose (HPMC)film coating is used which is free of sugar and potential allergens. Occasionally, other coating materials are used, for example synthetic polymers, shellac, corn protein, zein, or other polysaccharides.

[0053] The tablets may be manufactured as immediate-release, mixed-release or sustained-release formulations to provide for a range of release of the active ingredients within the female preconception and pregnancy composition over a period of minutes to hours.

[0054] The tablets may also comprise suitable lubricants, disintegrating agents, colouring agents, flavouring agents, flow-inducing agents, gummy agents, chewing agents and/or melting agents as required.

[0055] In this embodiment, the active ingredients of the female preconception and pregnancy composition are formulated for oral ingestion as tablets, packaged in blister packs of 30 tablets for daily use over a one-month period [0056] The blister packs are provided for convenience so one can easily take one out and slip it into a handbag when travelling, rather than having to carry a whole bottle or box.

2. Male preconception vitamins and minerals formulated for use by a male:

ίο

2019246816 09 Oct 2019 [0057] Figure 3 shows a preconception and pregnancy vitamin pack 30 for step 12 above. The male preconception composition comprises a combination of vitamins and minerals that work together as active ingredients to provide the essential nutrients important to support testosterone and sperm production by improving the quality of the sperm DNA and improving sperm function such as, for example, sperm motility. The delivery of effective quantities of these active ingredients may be accomplished through oral administration of single or multiple units given at one time or multiple times throughout the day.

[0058] In this embodiment, the active ingredients of the male preconception composition are formulated for oral ingestion as tablets, packaged in blister packs of tablets for daily use over a one month period.

[0059] The male preconception composition comprises an effective amount of certain active ingredients that have antioxidant properties, which are capable of slowing or preventing the oxidation of other molecules within the male so as to support testosterone and sperm production.

MINERALS

Zinc [0060] Zinc has a variety of functions. It is important for growth and development, immune response, and neurological and reproductive functions. It is also related to the normal absorption of vitamins especially the B complex. A zinc deficiency may retard growth, prolong wound healing and sexual maturity.

[0061] The zinc used in the male preconception composition may be provided in the form of zinc oxide, zinc glutonate, or any other nutritionally acceptable zinc salt.

[0062] In a preferred embodiment, the zinc used in the male preconception composition is provided in the form of zinc oxide.

2019246816 09 Oct 2019

Selenium

In humans, selenium is a trace element nutrient that functions as cofactor for reduction of antioxidant enzymes.

[0063] In a preferred embodiment, the selenium used in the male preconception composition is provided in the form of selenomethionine.

Calcium

Calcium plays an important role in building stronger, denser bones early in life and keeping bones strong and healthy. It is often delivered in combination with vitamin D for the reasons described above.

[0064] In a preferred embodiment, the calcium used in the male preconception composition is provided in the form of calcium carbonate.

VITAMINS

Vitamin B9 [0065] As described above, vitamin B9 is vital to many bodily functions from synthesizing and repairing DNA to influencing and playing a role in the reaction of rapid cell division and growth.

[0066] In a preferred embodiment, the vitamin B9 used in the male preconception composition is provided in the form of folic acid.

Vitamin C [0067] Vitamin C or L-ascorbic acid is an essential nutrient for humans and certain other animal species. As an antioxidant agent, vitamin C protects cells against damage by free radicals, which are by-products of normal cell activity that participate in

2019246816 09 Oct 2019 chemical reactions, some of which can be harmful. The ascorbate ion acts as an antioxidant by protecting the body against oxidative stress.

[0068] In a preferred embodiment, the vitamin C is provided as a nutrient in the form of L-ascorbic acid.

[0069] In other embodiments, the vitamin C may be provided in other forms including, but not limited to: magnesium ascorbate, sodium ascorbate, calcium ascorbate, potassium ascorbate, or fatty acid esters of ascorbic acid: ascorbyl palmitate, or ascorbyl stearate.

Vitamin D [0070] Vitamin D is a fat-soluble vitamin that directly and indirectly controls more than 200 genes. Vitamin D acts as a powerful antioxidant agent which protects against free radical damage. There are a number of vitamin D receptors in testes, and studies have shown that higher vitamin D levels in males leads to higher testosterone production, higher sperm motility, and ultimately, higher conception rates. Vitamin D, when delivered in combination with the mineral, calcium, has been reported to convert to a hormone in the body, which then induces the synthesis of intestinal proteins responsible for calcium absorption to enhance calcium levels to normal within males. Studies have shown that normalization of serum calcium in vitamin D deficient male rats has been found to restore their fertility.

[0071] In a preferred embodiment, the vitamin D used in the male preconception composition is provided in the form of vitamin D3 (cholecalciferol).

[0072] More preferably, vitamin D is provided in the male preconception composition in combination with calcium.

Vitamin E

2019246816 09 Oct 2019 [0073] Vitamin E refers to a group of eight fat-soluble compounds that include both tocopherols and tocotrienols. One of the many different forms of vitamin E, a tocopherol, is the most biologically active form of vitamin E, and can be found most abundantly in wheat germ oil, sunflower, and safflower oils. a-Tocopherol is a fat soluble antioxidant agent that stops the production of reactive oxygen species formed when fat undergoes oxidation, thereby protecting cell membranes within the body.

[0074] In a preferred embodiment, the vitamin E used in the male preconception composition is provided as a-tocopherol.

[0075] In other embodiments, the vitamin E may be provided in one of its other naturally occurring forms, or nutritionally acceptable salt thereof.

OTHER INGREDIENTS

Lycopene

Lycopene is a bright red carotene and carotenoid pigment and phytochemical found in tomatoes and other red fruits and vegetables. Lycopene is a powerful antioxidant due to the large number of conjugated double bonds. Lycopene is mainly distributed to fatty tissues and organs such as the adrenal glands, liver, prostate and testes.

Garlic

Garlic supplementation is reported to increase testosterone levels.

[0076] In a preferred embodiment, the garlic used in the male preconception composition is provided in the form of garlic oil.

EXAMPLE [0077] The following example is put forth so as to provide persons skilled in the art with a complete disclosure and description of how to make and use the male preconception composition according to the preferred embodiments of the present

2019246816 09 Oct 2019 invention, and is not intended to limit the scope of the present invention.

[0078] Efforts have been made to ensure accuracy with respect to numbers (e.g., amounts, etc.) but some errors and deviations should be accounted for.

[0079] In a preferred embodiment, the male preconception composition comprises the following as active ingredients:

INGREDIENT	AMOUNT (per tablet)
Vitamin C (ascorbic acid)	125 mg
Zinc (zinc oxide)	30 mg
Vitamin E (d-alpha-Tocopherol)	400 iu
Vitamin b9 (folic acid)	600 mcg
Lycopene	5 mg
Garlic oil	330 mg
Selenium (Selenomethionine)	75 mg
Vitamin D3 (cholecalciferol)	500 iu
Calcium Carbonate	125 mg

3. Ovulation test:

[0080] Figure 4 shows an ovulation test pack 40 for step 14 above. Consisting of 5 x urine LH (luteinizing hormone) ovulation tests for use by the female - complete with instructions on how to use them. The ovulation urine sticks each comprise a colour change paper strip which is configured to show a colour change in accordance with an increased level of LH in the urine, often referred to as an LH surge, which is indicative of impending ovulation in the female. This allows the user to pin point

2019246816 09 Oct 2019 when ovulation is about to occur and the best time for the couple to have sexual intercourse (called Timed Intercourse) to try for a baby.

4. Thermometer:

[0081] Figure 5 shows a thermometer 50 for step 14 above. 1 x digital thermometer for the female partner to take her body temperature for ovulation prediction.

5. Fertility calendar:

[0082] Figure 6 shows a fertility calendar 60 for use by couples to assist them in monitoring ovulation for step 14 above. The fertility calendar 60 shows the days of the month 62, a temperature gradient 63 and day graph with easy step by step instructions for the female partner on how to use the digital thermometer to take her oral temperature, and how to graph/plot her temperature and ovulation urine stick results 64 on the fertility calendar 200 to monitor when ovulation may occur, timing sexual intercourse 65 and heighten the possibilities of conception.

6. Pregnancy test:

[0083] 2 x urine pregnancy test sticks to confirm a positive or negative pregnancy test. The urine pregnancy test sticks each comprise an indicator which provides a positive reading in response to the presence of human chorionic gonadotropin (hCG) in urine, which is a known marker indicative of pregnancy. The hCG marker can be detected in urine after implantation, which occurs six to twelve days after fertilization.

7. Instructional booklet:

[0084] The booklet contains step by step instructions on how to use the system 10 to assist in conception. This booklet also includes simple and practical education on fertility health and reproduction covering both male and female reproduction including topics such as the menstrual cycle, and ovulation, the frequency of sexual intercourse, the need for nutrients especially Folic acid, and how both of them can have a healthy lifestyle to prepare for pregnancy. The booklet may also provide instructions on how to access a website that is regularly updated with the latest

2019246816 09 Oct 2019 support and education information.

8. Instructional DVD:

[0085] Explaining the simple steps needed to use the system and next steps if conception is not achieved within a reasonable period of time, such as suggesting visiting a healthcare professional after a period of six months.

[0086] In some embodiments, the system may include products intended to support the couple beyond the initial stage of conception including:

* Breast and lactation support: providing essential vitamins and nutrients to support milk production for breast feeding.

* Supporting tired mothers by providing natural ingredients to assist in sleep * Stretch mark cream for pregnant women and postnatal women * Homeopathic & Herbal Nappy rash products * Homeopathic & Herbal teething products * Pre Menstrual support * Natural Menopause solutions * Separately available additional male and female one month fertility vitamin pack

USE [0087] Figures 7 and 8 show diagrams 100 showing the steps of the method of how the system 10 is implemented by a couple looking to conceive.

[0088] According to action 110, the male and female prepare their respective bodies (step 12) for conception by taking the corresponding male and female preconception tablets, respectively, on a daily basis at least one month in advance of ovulation.

[0089] According to action 120, the female then monitors her ovulation (step 14) utilises the digital thermometer on a daily basis to monitor her basal body temperature and to plot the recorded temperature on the fertility calendar 60 so as to

2019246816 09 Oct 2019 predict when the desired rise in temperature of 0.5 degrees Celsius indicative of ovulation may occur.

[0090] According to action 130, and often in conjunction with action 120, the female utilises the ovulation urine sticks to monitor for a colour change in accordance with an increased level of LH, the LH surge, in her urine, being indicative of impending 16 ovulation. When a colour change is observed, ovulation is considered to occur within the following 24 to 36 hours, the ovulation period.

[0091] According to action 140, based on a positive outcome from the action 120 and/or action 130, the couple are required to engage in sexual intercourse (step 16), or, timed intercourse, during the ovulation period to heighten their chances of conceiving.

[0092] According to action 150, the female utilises one or more urine pregnancy test sticks to confirm a positive or negative pregnancy, namely the presence of hCG in her urine (step 18).

[0093] In the case of a positive pregnancy test, and according to action 160, the female continues to consume vitamin supplements on a daily basis during at least the term of the pregnancy, as the vitamins are also formulated to support a healthy pregnancy. It will be appreciated that the female may continue to consume the prescribed vitamin supplements while breastfeeding.

[0094] In the case of a negative pregnancy test, the male and female can choose to return to action 110 to start the process again to prepare their respective bodies again for conception.

[0095] Figure 9 shows information 120 for the instructional DVD of the system

10. The system 10 will have an educational booklet and DVD researched and written by a gynaecologist and fertility expert. The booklet contains step-by-step instructions on how to use the system to assist in conception. The booklet also includes simple and practical education on fertility health and reproduction covering

2019246816 09 Oct 2019 both male and female reproduction, including topics such as the menstrual cycle, ovulation, the frequency of sexual intercourse, the need for nutrients especially folic acid, and how both of the male and the female can have a healthy lifestyle to prepare for pregnancy. The booklet will also provide instructions to access a website that is regularly updated with the latest in medical and natural support educational information.

[0096] Fig. 10 shows information of all of the contents of the system 10 of the preferred embodiment, which includes the components described above. It can be 17 seen that the system 10 provides all the contents that will assist in maximising a couple's chances of conceiving.

[0097] It can be seen that preferred embodiments of the present invention have at least one of the following advantages:

* Women and couples are provided with a comprehensive set of compatible and reinforcing products to maximise their chances of successful conception.

* The system encourages and involves the support of male counterparts. By including the male in the process of improving conception improves the levels of cooperation and support of the male. Furthermore, it addresses the fact that conception may be being inhibited due to a fertility issue with the male in the relationship.

[0098] It is anticipated that the system will be supplied with the following quantities: one-month supply, three-month supply or nine-month supply. The system will the made available for purchase online, in pharmacies, health food stores, medical centres, natural health clinics, mail order catalogues and via global affiliates.

OTHER EMBODIMENTS [0099] In other embodiments, the male and female preconception vitamins and minerals may be prepared for oral ingestion in liquid dosage form. Examples of suitable liquid dosage forms include solutions or suspensions in water,

2019246816 09 Oct 2019 pharmaceutically acceptable fats and oils, alcohols or other organic solvents, including esters, emulsions, syrups or elixirs, suspensions, solutions and/or suspensions reconstituted from non-effervescent granules and effervescent preparations reconstituted from effervescent granules. Such liquid dosage forms may contain, for example, suitable solvents, preservatives, emulsifying agents, suspending agents, diluents, sweeteners, thickeners, and melting agents, mixtures thereof, and the like. Liquid dosage forms for oral administration may also include colouring and flavouring agents.

[00100] In other embodiments, the male and female preconception compositions may be prepared for oral ingestion in a powder or granule form, either 18 by itself, or by encapsulating the powder or granules within a hard or soft gelatin capsule, together with one or more suitable powdered inert carriers such as, for example, lactose, starch, a cellulose derivative, magnesium stearate, stearic acid, dicalcium phosphate, and the like.

Interpretation

Embodiments:

[00101] Reference throughout this specification to one embodiment or an embodiment means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases in one embodiment or in an embodiment in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments.

[00102] Similarly it should be appreciated that in the above description of example embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or

2019246816 09 Oct 2019 more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the Detailed Description of Specific Embodiments are hereby expressly incorporated into this Detailed Description of Specific Embodiments, with each claim standing on its own as a separate embodiment of this invention.

[00103] Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in 19 the following claims, any of the claimed embodiments can be used in any combination.

Different Instances of Objects [00104] As used herein, unless otherwise specified the use of the ordinal adjectives first, second, third, etc., to describe a common object, merely indicate that different instances of like objects are being referred to, and are not intended to imply that the objects so described must be in a given sequence, either temporally, spatially, in ranking, or in any other manner.

Specific Details [00105] In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

Terminology

2019246816 09 Oct 2019 [00106] In describing the preferred embodiment of the invention illustrated in the drawings, specific terminology will be resorted to for the sake of clarity.

However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar technical purpose. Terms such as forward, rearward, radially, peripherally, upwardly, downwardly, and the like are used as words of convenience to provide reference points and are not to be construed as limiting terms.

Comprising and Including [00107] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word comprise or variations such as comprises or comprising are used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

[00108] Any one of the terms: including or which includes or that includes as used herein is also an open term that also means including at least the elements/features that follow the term, but not excluding others. Thus, including is synonymous with and means comprising.

Scope of Invention [00109] Thus, while there has been described what are believed to be the preferred embodiments of the invention, those skilled in the art will recognize that other and further modifications may be made thereto without departing from the spirit of the invention, and it is intended to claim all such changes and modifications as fall within the scope of the invention. For example, any formulas given above are merely representative of procedures that may be used. Functionality may be added or deleted from the block diagrams and operations may be interchanged among functional blocks. Steps may be added or deleted to methods described within the

2019246816 09 Oct 2019 scope of the present invention.

[00110] Although the it its own no invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms.

Industrial Applicability [00111] It is apparent from the above, that the arrangements described are applicable to the health industry, specifically fertility clinics.

Claims (12)

1. CLAIMS DEFINING THE INVENTION:

   1. A method of preconception treatment for assisting conception, the method comprising:

   - providing at least one female fertility aid for administering to the female in at least the one month prior to conception for assisting a female to conceive; and

   - providing at least one male fertility aid for administering to the male in at least the one month prior to conception to assist the male counterpart wherein the female fertility aid includes a predefined range of preconception supplements formulated for use by a female comprising of the combination of:

   Vitamin B6;

   - Vitamin B9 (Folic acid) and

   Iodine .

   and wherein the method includes providing a predefined range of preconception supplements formulated for use by a male comprising the combination of: an effective amount of each of

   - Vitamin B9

   - Vitamin C

   - Vitamin D

   - Vitamin E

   Together with the active ingredients of:

   -- Zinc

   - Selenium

   - Calcium

   Lycopene; and

   - Garlic.

   2019246816 09 Oct 2019 wherein the supplements for the male and female in combination provides a synergistic enhancing aid for conception or conception health.
2. 2. The method of claim 1, wherein the at least one female fertility aid comprises one or more of:

   - the supply of a predefined range of preconception supplements formulated for use by a female;

   - an ovulation predictor;

   - a pregnancy test;

   - a thermometer; and

   - a fertility calendar.
3. 3. The method of claim 2, wherein the ovulation predictor includes a test for detecting luteinizing hormone.
4. 4. The method of claim 1 wherein the vitamin D is in the form of vitamin D3 (cholecalciferol).
5. 5. The method of claim 1 wherein the vitamin D is provided in combination with calcium.
6. 6. The method of claim 1 wherein the vitamin E is provided as a-tocopherol.
7. 7. The method of any one of claims 1 to 6 wherein the male preconception composition comprises the following as active ingredients:

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   INGREDIENT AMOUNT (per tablet) Vitamin C (ascorbic acid) 125 mg Zinc (zinc oxide) 30 mg Vitamin E (d-alpha-Tocopherol) 400 iu Vitamin b9 (folic acid) 600 mcg Lycopene 5 mg Garlic oil 330 mg Selenium (Selenomethionine) 75 mg Vitamin D3 (cholecalciferol) 500 iu Calcium Carbonate 125 mg
8. 8 A composition for use as a male fertility aid in a method of preconception treatment of any one of claims 1 to 7 comprising in combination:

   an effective amount of each of

   - Vitamin B9

   - Vitamin C

   - Vitamin D

   - Vitamin E

   Together with the active ingredients of:

   -- Zinc

   - Selenium

   - Calcium

   Lycopene; and

   - Garlic.

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9. 9. A composition according to claim 8 wherein the composition in combination is provided in at least one tablet.
10. 10 A composition according to claim 8 wherein the composition in combination is provided in a tablet having a dosage for a daily intake.
11. 11. A composition according to claim 10 wherein each tablet comprises in combination:

    INGREDIENT AMOUNT (per tablet) Vitamin C (ascorbic acid) 125 mg Zinc (zinc oxide) 30 mg

    Vitamin E (d-alpha-Tocopherol) 400 iu

    Vitamin b9 (folic acid) 600 mcg Lycopene 5 mg Garlic oil 330 mg Selenium (Selenomethionine) 75 mg Vitamin D3 (cholecalciferol) 500 iu Calcium Carbonate 125 mg
12. 12. Use of combination of compositions in the manufacture of a medicament for the treatment of a male in preconception to a female to improve conception wherein the combination of compositions comprises:

    an effective amount of each of

    - Vitamin B9

    - Vitamin C

    - Vitamin D

    - Vitamin E together with the active ingredients of:

    2019246816 09 Oct 2019

    -- Zinc

    - Selenium

    - Calcium

    Lycopene; and

    - Garlic.