Fertipil Plus Information Catalog

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Information Catalog

2 www.fertipil.co.za Contents Fertipil Plus® for Women Fertipil Plus® for Men Fertipil Plus® ......3 Dosage & Directions.....................................................................................................................................................................................................................4 Ingredients..................................................................................................................................................................................................................5 Inositol (MYO)...............................................................................................................................................................................................................................5 Folic Acid........................................................................................................................................................................................................................................5 Zinc...............................................................................................................................................................................................................................................5-6 Selenium.........................................................................................................................................................................................................6 Nicotinic Acid................................................................................................................................................................................................................................6 Vitamin B6..................................................................................................................................................................................................................................6-7 Vitamin B12 (Methylcobalamin).......................................................................................................................................................................................7 Vitamin D.........................................................................................................................................................................................................................................7 Vitamin E.........................................................................................................................................................................................................................................8 Vitamin A.........................................................................................................................................................................................................................................8 Manganese........................................................................................................................................................................................................................8 Copper..........................................................................................................................................................................................................8 Siberian Ginseng.........................................................................................................................................................................................................................8 Epimedium.............................................................................................................................................................................................................8 L-Arginine........................................................................................................................................................................................................8 Pine Bark Extract.........................................................................................................................................................................................................................8 Muira Puama..................................................................................................................................................................................................................................8 References...........................................................................................................................................................................................................................10

Fertipil Plus®

Fertipil Plus® for Women was developed to improve fertility and enhance general reproductive health. Fertipil Plus® helps to normalise female hormone levels, reduces chances of neural tube defects, improves quality and thickness of uterine lining and egg quality and increases chances of falling pregnant naturally.

Fertipil Plus® for Women contains Folic Acid and 16 other essential ingredients which clinical studies have shown can improve chances of falling pregnant.

Fertipil Plus® is also South Africa’s leading fertility supplement and has been the best seller in the category for a number of years. We believe that this is because of the quality and efficacy of our products.

Who should take Fertipil Plus® for Women?

• All women who are planning on falling pregnant and those who have been struggling to fall pregnant for a while.

• Fertipil Plus® is a general fertility enhancing product which has shown to provide support for several conditions which cause infertility such as hormonal imbalances, polycystic ovary syndrome PCOS), irregular periods and anovulation.

How long should Fertipil Plus® for Women be taken for best results?

• Fertipil Plus® for Women should be taken for at least 3-6 months before treatment is ceased. This is due to varying ovulation rates, nutritional conditioning of the patient, varying hormone levels and female hormone secretion rates.

Fertipil Plus® for Men has been scientifically demonstrated to enhance male fertility and improve overall reproductive wellness as part of a healthy diet and lifestyle. Ideal for men with a low sperm count or for those looking to optimize their sexual health.

Fertipil Plus® for Men:

• Boosts and improves sperm count.

• Improves sperm mobility and morphology.

• Improve spermatogenesis.

• Boost natural reproductive health and sexual function.

Although there are other reasons for men being infertile the above conditions are the main causes of infertility in men worldwide.

Duration of treatment:

• If taken for fertility - Fertipil Plus® for Men should be taken for at least 3-6 months before treatment is ceased.

• Fertipil Plus® for Men can be taken continuously as part of a daily nutritional intake and overall male health.

INGREDIENTS:

(Each capsule contains)

Zinc

INGREDIENTS:

Dosage and directions:

• If planning a family: 1 capsule in the morning after a meal with at least 300ml of water.

• When actively trying to fall pregnant dosage can be increased to 3 capsules daily after a meal with at least 300ml of water.

• Taking 3 capsules daily is not a must but studies show than increased dosages of the ingredients can lead to improved ovulation rates and higher instances of conception.

Dosage and directions:

• If planning a family - 1 capsule in the morning after a meal with at least 300ml of water.

• When actively trying to impregnate partner dosage can be increased to 3 capsules daily after a meal with at least 300ml of water.

• Taking 3 capsules daily is not a must but studies show than increased dosages of the ingredients can lead increased production of good quality sperm.

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Gluconate (equivalent to 10 mg elemental Zinc) 72 mg
Eleutherococcus senticosus (Siberian Ginseng) 30 mg
Trifolium pratense (Red Clover Extract) 50 mg
Vitex agnus-castus (Chasteberry Powder) 50 mg Inositol 50 mg Vitamin E 20 mg DL-Methionine 20 mg Nicotinamide (Vitamin B3) 10 mg Manganese AAC 10% (equivalent to 1 mg elemental Manganese) 10 mg Copper AAC 10% (equivalent to 1 mg elemental Copper) 10 mg Selenium AAC 0,2% (equivalent to 20 µg elemental Selenium) 10 mg Pyridoxine HCL (Vitamin B6) 6 mg Vitamin B12 6 µg Vitamin A 1 000 iu Vitamin D3 150 iu Folic Acid 165 µg
(Each capsule contains)
pinaster (Pine bark) 30 mg L-Methionine 20 mg Nicotinamide (Vitamin B3) 10 mg Epimedium brevicornum (Horney Goat Weed Extract 20:1) 12.5 mg Eleutherococcus senticosus (Siberian Ginseng Extract 10:1) 6 mg Manganese AAC 10% (equivalent to 1 mg elemental Manganese) 10 mg Copper AAC 10% (equivalent to 1 mg elemental Copper) 10 mg Selenium AAC 2% (equivalent to 20 µg elemental Selenium) 1 mg Pyridoxine HCL (Vitamin B6) 6 mg Vitamin B12 6 µg Piper nigrum (Bioperine) Extract 95% 5 mg Vitamin A 1 000 iu Vitamin D3 150 iu Folic Acid 165 µg SUGAR FREE SUGAR FREE SUGAR FREE SUGAR FREE GLUTEN-FREE GLUTEN-FREE GLUTEN-FREE GLUTEN-FREE LACTOSE-FREE LACTOSE -FREE LACTOSE-FREE LACTOSE -FREE
L-Arginine HCL 250 mg Zinc Sulphate (equivalent to 10 mg elemental Zinc) 43.5 mg Ptychopetalum olacoides (Muira powder) 50 mg Inositol 50 mg Vitamin E 20 mg Pinus

Ingredients

INOSITOL (MYO)

Studies have shown that a combination of Inositol and Folic acid substantially reduces the size of ovarian cysts, increases egg quality and reduces the risk of ovarian hyperstimulation syndrome in women undergoing ovulation induction as part of an IVF cycle.

In a study of overweight women with PCOS that were given inositol and folic acid during IVF, 32% of women had a successful pregnancy within the 12-month study period, compared to just 12% of women who only took a straight folic acid supplement without the inositol.

These positive results have been repeated by other researchers that used a similar supplement regime to treat women undergoing intrauterine insemination (IUI) rather than IVF. In a recent study of IUI patients with PCOS, pregnancy rates were improved by approximately 50% (regardless of whether they had insulin resistance or not) after taking myo-inositol for just 3 months beforehand.

Studies have shown that up to 10% of women (at childbearing age) suffer from PCOS.Fertipil Plus contains both Inositol and Folic acid in dosages best suited for women who are trying to conceive. Please refer to the underlying studies to familiarize yourself with the elements and combination of Inositol and Folic Acid.

INOSITOL

Studies have shown that Inositol can contribute to sperm production and sperm motility in Men.

FOLIC ACID

Folic acid and neural tube defects

Folic acid is a vitamin which is crucial for two main reasons, before and during conception; it increases your fertility rate and lowers the risk of birth defects for your baby. This is the case due to its ability to help grow and protect cells in the female body. It is also essential for the development of DNA. This is especially critical during pregnancy, when cells are growing and dividing very quickly in order for the uterus to expand, the placenta to develop, blood circulation to increase, and the fetus to grow. Healthcare professionals recommend folic acid supplementation every day, for at least 3 month before trying to fall pregnant.

It has become a commonly known fact that the use of Folic Acid (which is part of the B vitamin group) before pregnancy prevents neural tube defects. Therefore, public health authorities all over Europe recommend an intake of 400 µg folate per day for women of reproductive age.

Despite several public health campaigns and recommendations for over two decades, the compliance to folic acid supplementation is low in many countries. Results of previous studies have shown that less than 50% of women planning a pregnancy use pre-conceptional folic acid supplementation.

A study, involving more than 18,000 women, concluded that taking a regular daily dose of folic acid supplements significantly improved fertility in women. The data showed that those taking the supplement regularly had a 40% lowered risk of suffering from problems related to egg production.

Birth Defects

Many other studies suggested that folic acid lowers the risk of birth defects by at least 50% and if the patient already had a baby with a defect, it can reduce the risk for a next child by as much as 70%. Some defects are fatal and other can leave the baby permanently disabled.

Examples include:

• Neural tube defects (NTDs)

• Heart and limb defects

• Urinary tract anomalies

• Narrowing of the lower stomach valve

• Oral facial clefts (like cleft lip and cleft palate)

These can occur within the first 3-4 weeks of pregnancy, before the patient is aware that she is pregnant. In a survey of women of childbearing age in the United States, only 7%knew that folic acid should be taken before pregnancy in order to prevent birth defects. Furthermore, only 50% of pregnancies are planned and therefore it is important for every women of childbearing age to make sure that her folic acid intake is sufficient.

Also see Inisotol above – Folic Acid combined with Inisotol has shown to assist in the treatment of Polycistic Ovary Syndrome.

Source: Folate-mediated one-carbon metabolism and its effect on female fertility and pregnancy viability.

FOLIC ACID

Folic Acid is an essential nutrient when it comes to cell division and DNA synthesis

Folic Acid levels measured in semen have been associated with sperm count and health. One study found that low folate levels in semen were associated with poor sperm DNA stability.

From this, we may learn that folate plays an important role in sperm health.One study found that a combined supplementation of folic acid and zinc for a period of 26 weeks increased total sperm count in fertile and sub fertile men. In fact, it increased normal total sperm count by 74 percent.

ZINC

Zinc is the most widely studied nutrient in terms of fertility for both men and women. It is an essential component of genetic material and a zinc deficiency can cause chromosomal changes in women leading to reduced fertility and an increased risk of miscarriage. Zinc is required for the female body to ‘attract and hold’ (utilize efficiently) the reproductive hormones, estrogen, and progesterone.

Zinc is a key factor in effective functioning of the female reproductive system. Without it cells will not divide properly and women may experience estrogen and progesterone imbalances, all of which will result in improper functionality of the reproductive system.

Unfortunately, many women (and men) are sorely lacking in terms of Zinc intake. 12% of people in the US are zinc deficient. The main reasons are due to poor soil health, over cooking and heating of food (lowers Zinc by 50%), stress, exposure to pollution, alcohol and smoking. All these factors lower our supply of zinc in the body and ultimately, if left untreated, may lead to zinc deficiencies. The number in Africa is believed to be close to 35%.

Infertility as a result of Zinc deficiency may manifest itself in the following ways:

Egg Production

Firstly, the production of eggs may be adversely affected since a woman’s body needs a certain amount of zinc to produce mature eggs that are ripe for fertilization.

Follicular Fluid Levels

Secondly, follicular fluid levels may plummet. Without enough fluid, an egg will not be able to travel through the fallopian tubes into the uterus for implantation.

Egg Quality

Thirdly, protein metabolism may be inhibited, lowering the quality of the eggs.

Hormonal Imbalances

Lastly, hormone regulation may be impaired. Zinc harmonizes estrogen, progesterone and testosterone levels throughout the entire menstrual cycle. Deficiencies may lead to hormonal imbalances, ovarian issue, and irregular periods.

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ZINC

Zinc deficiency impedes spermatogenesis and is a reason for sperm abnormalities and has a negative effect on serum testosterone concentration. Based on the findings of the study referred to hereunder Zinc is very essential for male fertility. It could be considered as a nutrient marker with many potentials in prevention, diagnosis, and treatment of male infertility.

SELENIUM

A research team, led by Melanie Ceko, looked at the role of selenium in the ovaries, and found that selenium is crucial to the development of healthy ovarian follicles. Follicles are responsible for production of eggs in women.

According to Ceko:

Selenium is an essential trace element found in protein-rich foods like red meat, seafood and nuts. It is important for many biological functions, such as immune response, thyroid hormone production, and acts as an antioxidant, helping to detoxify damaging chemicals in the body. “We’ve known for some time that selenium is important for male fertility, but until now no-one has researched how this element could be involved in healthy reproduction in women”.

The researchers found exactly where selenium is located in the ovary, and in particular, the seleno-protein known as GPX1.

According to Ceko:

Our findings are important, because they show that selenium and seleno-proteins are at elevated levels in large, healthy ovarian follicles. We suspect they play a critical role as an antioxidant during the late stages of follicle development, helping to lead to a healthy environment for the egg, We found that gene expression of GPX1 was significantly higher – in some cases double – in egg cells that yielded a pregnancy.

SELENIUM

A recent study (2011) has shown that supplementation Selenium and Vitamin E may increase sperm motility, morphology or both.

The study was done on 690 infertile men who received daily supplementations of Selenium and Vitamin E. The study showed that there was a 52.6% improvement in sperm motility and morphology in these men.

NICOTINIC ACID

A study from the Victor Chang Cardiac Research Institute in Sydney, Australia has hit the world headlines with their work showing that the prevention of miscarriage and birth defects can be eliminated by taking a simple nutrient – Niacin (Nicotinic Acid or B3).

In the body, niacin and its derivative nicotinamide are used as coenzymes in cell metabolism pathways to produce energy. Simply put, these two nutrients are involved in breaking down the fats, proteins, carbohydrates and alcohol consumed in our diet and converting it into energy the body can use. Its link to miscarriage and congenital birth defects arose from the study released by the Dunwoodie group.

NICOTINIC ACID

Niacin is notable when it comes to your sex life because it helps make sex hormones and improves circulation. It also regulates things like sleep patterns and may also assist in erectile dysfunction.

You can get a sense of what a nutrient does by looking at what happens when you’re deficient. These are some of the symptoms of niacin deficiency, Memory loss and mental confusion, Fatigue, Depression, Headache, Diarrhea everything you don’t need when you are trying for a baby.

VITAMIN B6

Vitamin B6 is one of the most useful vitamins for women suffering from infertility (especially due to PCOS). Its main importance is in regulating hormone levels (specifically the two hormones which are crucial for conception: progesterone and estrogen). This accomplishes two things: increases female fertility and raises the chances of actually getting pregnant.

The former is caused by Vitamin B6’s ability to harmonize progesterone levels. This, in turn, strengthens the cycle’s luteal phases. The luteal phase is the time between when women ovulate, and when they get their period. It is also the time in which the endometrium is turned into a soft bed in which a fertilized egg can implant, and a baby can grow. And what amazing thing is responsible for this? That’s right: Progesterone. Vitamin B6 makes sure that progesterone levels are optimal so that the luteal phase is long enough and the endometrium is thick enough.

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VITAMIN B6

Our bodies use B vitamins to convert the food we eat into the energy we need to function. Together the complex of eight B vitamins are important for metabolism, brain and liver function, growth, and building blood cells, as well as for maintaining healthy hair, skin, and vision. More specifically, vitamin B6 (pyridoxine) — one of the eight — plays key roles in keeping the brain and nervous system functioning properly.

Vitamin B6 is involved in production of hemoglobin, the protein in blood that carries oxygen throughout the body.

Vitamin B6 is also needed for proper brain function. It helps the body make the hormones serotonin (which regulates mood) and norepinephrine (which helps your body cope with stress). Vitamin B6 also helps the body make melatonin, which is essential for a good night’s sleep. This is obviously not only the case in men but in women as well.

VITAMIN B12 (METHYLCOBALAMIN)

While infertility can be caused by numerous factors, B12 deficiency is one element that is often overlooked as it does not get the publicity and, therefore, the attention that it deserves. Deficiency could lead to infertility and prevent full-term pregnancy.

The former has been noted by several studies, each concluding that a likely symptom of B12 deficiency is irregular ovulation or in severe cases, anovulation. Abnormalities in reproductive tract cells are also a high possibility. This causes the lining of the uterus and cervix to extend and could possibly lead to cervical dysplasia.

Other studies imply a strong connection between a lack of B12 and abnormal estrogen levels, which interfere with fertilized egg implantation. This occurs due thinning of the endometrium lining in egg fertilization, increasing the chances of miscarriage.

VITAMIN B12 (METHYLCOBALAMIN)

Most studies show that men with B12 deficiencies and low sperm counts can significantly benefit from large-dose supplementation. Men not deficient in B12 have also been reported to benefit from additional B12. One theory is that with higher levels of B12 the body is able to increase metabolism and provide more resources to manufacture sperm. Another theory is that increased red blood cell production may improve oxygenation and overall reproductive health.

There are many physical factors that contribute to erectile dysfunction. Insufficient supply of B12 can damage the nerves within the penis. Left untreated, the damage will prevent the development and maintenance of an erection.

This can lead to fertility problems by reducing the ability to sustain intercourse and subsequent ejaculation. It’s important if men are having erectile dysfunction symptoms that they seek medical attention and test vitamin B12 levels. Not only will this vitamin help to protect nerves within the penis, it may also support healthy circulation to promote strong erections.

VITAMIN D

There is an ever-increasing epidemic of vitamin D (more a hormone than a vitamin, which affects every cell in your body) deficiency throughout the developed world (doubled from 1994 to 2004) which can largely be attributed to more and more individuals spending the majority of the day indoors. Among women of childbearing age, more than 40% lack vitamin D.

In a study conducted by The University of North Carolina, supplemental vitamin D has shown to assist reproductive tissues to optimal functional levels. Research showed that vitamin D receptors were found in the female reproductive system, suggesting that it plays an important role in female fertility. They found raising vitamin D levels in the body increased the rate of achieved pregnancies by more than 10%. The main reason for this is largely attributed to vitamin D’s ability to regulate hormones.

In fact, a vast amount of research agrees that vitamin D affects hormone levels, specifically progesterone and estrogen, which regulate menstrual cycles and improve the likelihood of conception. A major cause of infertility can be attributed to hormonal imbalances (especially when it results in PCOS, the most common female endocrine disorder). A 2011 study concluded that “Vitamin D deficiency is associated with multiple metabolic risk factors women with PCOS.” According to a different study conducted in 2010, high doses of vitamin D lowered estradiol and progesterone levels.

VITAMIN D

• Promotes healthy sperm formation. • Helps support erectile function.

Since vitamin D is associated with better cardiovascular health and erectile function and blood flow have an intimate relationship, it seems reasonable to assume that this nutrient could also help support erectile function. Some experts have proposed that a vitamin D deficiency contributes to erectile dysfunction (ED). Evidence to help support this comes from a study that showed a significant number of men with erectile dysfunction had a vitamin D deficiency and that ED was more common among men who had artery flow problems.

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VITAMIN E

Vitamin E has received much attention in recent years due to its ability to improve reproductive health. The most studied benefit (in relation to fertility) of Vitamin E relates to its antioxidative properties and beneficial effects against the reproductive disorders. Hence, it is highly recommended for women to consume vitamin E regularly, especially those who are in their reproductive age.

VITAMIN A

Although Vitamin A is essential for a number of processes in the body during pregnancy, it is the retinoic acid (RA) part of Vitamin A this is essential for male and female reproduction.

This conclusion is based on the ability to reverse most reproductive and developmental blocks found in vitamin A deficiency induced either by nutritional or genetic means with RA, and the ability to recapitulate the majority of embryonic defects in retinoic acid receptor compound.

MANGANESE

A diet low in manganese may increase the risk of anovulation. Researchers at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) assessed the impact of dietary mineral intake on anovulation using data from the BioCycle Study. They found that a diet low in manganese, in reference to the recommended adequate intake (1.8mg/day for adult women), is associated with an increase in risk of anovulation.

COPPER

One of the most common mineral imbalances contributing to infertility involves copper. Both an excess and/or a deficiency can interfere with pregnancy, foetal health and development. Copper can be stored in excessive amounts in cells, organs and tissue, thus producing symptoms of toxicity leading to possible deformities in the foetus such as growth retardation, smaller than normal brain, or they may suffer from a fragile skeletal structure and anaemia.

Women can accumulate copper from taking oestrogen hormone replacement or the oral contraceptive pill. Copper is synergistic with oestrogen and oestrogen encourages an increase in copper tissue levels and copper toxicity may be linked to the promotion of oestrogen dominance.

This may directly affect infertility rates by lowering progesterone levels resulting in annovulation, implantation failure or luteal phase deficits. Copper has also been shown to block the absorption of many essential minerals directly involved with reproductive pathways, especially zinc.

Copper ions are bound to metallothionen with a greater affinity than zinc, so often zinc deficiencies occur in direct titre to copper levels. Zinc deficiency affects various processes involving both male and female reproduction, despite copper toxicity being more common in females.

SIBERIAN GINSENG

Ginseng is often referred to as the King of all herbs, and is found to be a promising agent to improve general well-being. Ginseng has also been reputed as an aphrodisiac, and is used to treat sexual dysfunction as well as to enhance sexual behavior in traditional Chinese medical practices. Data from animal studies have shown a positive correlation among ginseng, libido, and copulatory performances, and these effects have been confirmed in case-control studies in human. In addition, ginseng is found to improve the sperm quality and count of healthy individuals as well as patients with treatment-related infertility. These actions are mostly attributed to ginsenosides, the major pharmacological active components of ginseng.

EPIMEDIUM

Also known as Horny Goat Weed has been used in traditional Chinese medicine to treat erectile disfunction. According to recent studies however, the age-old belief has received backing through a study which was conducted on rats during 2013. The study found that low doses of Epimedium over a 4 week period significantly increased penile blood flow in rats with scarred penile tissues.

L-ARGININE

L-arginine is the amino acid used to make nitric oxide(NO), a molecule that facilitates the flow of blood to the penis during an erection, and is the most common amino acid found in sexual supplements. NO is essential in regulating sperm capacitation and the acrosome reaction, two processes that need to be acquired by sperm in order to achieve fertilization potential. In addition, it has recently been shown that mitochondrial function is positively correlated with human sperm fertilization potential and quality and that NO and NO precursors increase sperm motility by increasing energy production in mitochondria.

PINE BARK EXTRACT

In a recent breakthrough study Pycnogenol therapy resulted in improved capacitated sperm morphology and mannose receptor binding. The increase in morphologically and functionally normal sperm may allow couples diagnosed with teratozoospermia to forgo in vitro fertilization and either experience improved natural fertility or undergo less invasive and less expensive fertility-promoting procedures, such as intrauterine insemination.

MUIRA PUAMA

Muira puama (Ptychopetalum olacoides) is actually the best known Amazonian folk medicine which increases libido and penile hardness. It acts as a nerve stimulant to heighten receptiveness to sexual stimuli as well as physical sensation of sex. Rich in sterols e.g., sitosterol, campesterol and lupol it activates the body’s receptors for hormones like testosterone to heighten libido and enhance performance. Also present are volatile oils like champor which helps restore sex drive and inner depth of libido and mental ability to be aroused.

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9 It is recommended that both you and your partner take Fertipil plus®

Bennett, M. (2001) Vitamin B12 deficiency, infertility and recurrent fetal loss, The Journal of reproductive medicine. U.S. National Library of Medicine. Available at: http://www.ncbi.nlm.nih.gov/ pubmed/11304860 (Accessed: November 8, 2022).

ReferencesMohd Mutalip, S.S., Ab-Rahim, S. and Rajikin, M.H. (2018) Vitamin E as an antioxidant in female reproductive health, Antioxidants (Basel, Switzerland). MDPI. Available at: http://www.ncbi.nlm.nih. gov/pmc/articles/PMC5836012/ (Accessed: November 8, 2022).

Nutrition. Available at: http://www.nutrition.org/a-diet-low-inmanganese-increases-complications-with-ovulation-and-mayimpact-fertility/ (Accessed: November 8, 2022).

Ciotta, L. et al. (2011) Effects of myo-inositol supplementation on oocyte’s quality in PCOS patients: A double blind trial, European review for medical and pharmacological sciences. U.S. National Library of Medicine. Available at: http://www.ncbi.nlm.nih.gov/ pubmed/21744744 (Accessed: November 7, 2022).

Clagett-Dame, M. and Knutson, D. (2011) Vitamin A in reproduction and development, Nutrients. MDPI. Available at: http://www.ncbi. nlm.nih.gov/pmc/articles/PMC3257687/ (Accessed: November 8, 2022).

Moslemi, M.K. and Tavanbakhsh, S. (2011) Selenium-vitamin E supplementation in infertile men: Effects on semen parameters and pregnancy rate, International journal of general medicine. Dove Medical Press. Available at: http://www.ncbi.nlm.nih.gov/ pmc/articles/PMC3048346/ (Accessed: November 7, 2022).

Schaefer, E. and Nock, D. (2019) The impact of preconceptional multiple-micronutrient supplementation on female fertility, Clinical medicine insights. Women’s health. SAGE Publications. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6480978/ (Accessed: November 8, 2022).

Ozay, A.C. et al. (2016) Different effects of myoinositol plus folic acid versus combined oral treatment on androgen levels in PCOS women, International Journal of Endocrinology. Hindawi. Available at: http://www.hindawi.com/journals/ ije/2016/3206872/ (Accessed: November 7, 2022).

The nutritional relationships of copper - nutritional balancing.org (no date). Available at: https://nutritionalbalancing.org/center/ htma/science/_p/_file_dwnld.php?index=15 (Accessed: November 8, 2022).

Gupta, T. et al. (2017) Study of effect of vitamin D supplementation on the clinical, hormonal and metabolic profile of the PCOS women, Journal of obstetrics and gynaecology of India. Springer India. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC5561752/ (Accessed: November 8, 2022).

Papaleo, E. et al. (2009) Myo-inositol may improve oocyte quality in intracytoplasmic sperm injection cycles. A prospective, controlled, randomized trial, Fertility and sterility. U.S. National Library of Medicine. Available at: http://www.ncbi.nlm.nih.gov/ pubmed/18462730 (Accessed: November 7, 2022).

Unexplained infertility (no date) Unexplained Infertility · Nutritional Balancing.org. Available at: http://www.nutritionalbalancing.org/ center/htma/conditions/articles/unexplained-infertility (Accessed: November 8, 2022).

Kamanna, V.S. and Kashyap, M.L. (2008) Mechanism of action of niacin, The American journal of cardiology. U.S. National Library of Medicine. Available at: http://www.ncbi.nlm.nih.gov/ pubmed/18375237 (Accessed: November 8, 2022).

Kennedy, D.O. (2016) B vitamins and the brain: Mechanisms, dose and efficacy--a review, Nutrients. MDPI. Available at: http://www. ncbi.nlm.nih.gov/pubmed/26828517 (Accessed: November 8, 2022).

PubMed (no date) National Center for Biotechnology Information. U.S. National Library of Medicine. Available at: https://pubmed. ncbi.nlm.nih.gov/?myncbishare=pubmedplus (Accessed: November 7, 2022).

Physiological intra-cytoplasmic sperm injection (picsi) outcomes after ... (no date). Available at: https://europeanreview.org/wp/ wp-content/uploads/066-072-Myo-inositol-and-male-fertility.pdf (Accessed: November 8, 2022).

Rivera, O. (2018) A diet low in manganese increases complications with ovulation and may impact fertility, American Society for

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Quality and Product Development

DB Pharmaceuticals is a registered, Grade A certified pharmacy under the South African Pharmacy Council (SAPC) – with registration number Y60310.

We are fully compliant with the current South African Health Products Regulatory Authority (SAHPRA) and the Medicines and Related Substances Control Amendment Act, No. 19 of 1976 requirements for Category D – Complementary Medicines.

DB Pharmaceuticals welcomes SAHPRA’s approach to regulate the manufacture and sale of Complementary Medicines and Health Supplements which we believe will result in a safer, more efficient experience for patients who seek quality natural health products.

The manufacturing facility is licensed with the South African Health Products Regulatory Authority (SAHPRA) which is only granted after a positive GMP inspection by the regulator.

The manufacturing plant is further accredited by the South African Pharmacy Council as a pharmacy owner, grading certificate Grade A, and recording of a pharmacy.

Certification of the manufacturing plant also includes a Department of Health Manufacturing Pharmacy certificate and a Certificate of Acceptability for Food Premises and is registered with the South African National Department of Health.

All our products old and new have been developed by our two in-house responsible pharmacists who have 37 years of experience between them.

Once products and formulations have been researched and developed the formulation is sent to our team of specialist formulary pharmacists at the manufacturing site who review and test formulations against recent research to ensure safety, quality, and efficacy.

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36 Sovereign Drive, Route 21 Corporate Park, Irene, Centurion Gauteng, South Africa 0062 info@fertipil.co.za www.fertipil.co.za Helpline: 012 111 8313

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