It is essential for the reader to fully acquaint herself with the workings of the ingredients as well as the studies conducted as per the references inserted.
Each ingredient contained in this product has been included after ample research was done to identify the most suited manner in which to assist in the treatment of Polycystic Ovary Syndrome.
INOSITOL (Myo-Inositol & D-Chiro Inositol)
Studies have shown that a combination of Inositol and Folic acid substantially reduces the size of ovarian cysts and 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 really 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) after taking myo-inositol for just 3 months beforehand
Fertipil Plus PCOS 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.
Clinical Evidence: Inositol (Myo-Inositol or “MI”)
MI has been found to improve the number of good quality oocytes, clinical pregnancies, and delivery rates in overweight women with PCOS.
In one trial, a daily dose of 2 g MI was used over an observation period of 3–6 months. The biochemical, endocrine, and clinical benefits of MI were thought to be due to its insulin-sensitizing action.
The study used MI and folic acid as a soluble powder, twice daily, continuously, till the end of study (6 months) or until a positive pregnancy test was obtained.
In a study of 25 women with PCOS, 22 (88%) experienced a first menstrual cycle after an average 35 days. Of these 22 women, 18 continued to have regular menstruation and documented spontaneous ovulation. The length of successive cycles improved to 31.7 ± 3.2 days, and there was a significant decrease of androgens (male hormone levels, which is one cause of PCOS).
Two more women showed follicular development on ultrasound, but did not exhibit an elevation of progesterone, thus suggesting anovulation. A total of ten biochemical pregnancies occurred during 6 months. MI can, thus, be used as a safe means of induction of ovulation in women with PCOS.
In a study of fifty women with PCOS, MI was found to reduce the risk of ovarian hyper stimulation syndrome. Concentrations of amongst others, insulin were reduced significantly. Insulin sensitivity improved as well.
MI administration achieved lower oocyte retrieval, but had a greater proportion of large dimension (top quality) oocytes, which translated to a higher pregnancy rate. Biochemical pregnancy occurred in 15, clinical pregnancy in 10, and successful delivery in 8 women treated with MI, as compared to 8, 4, and 3 non-MI-treated participants. All these differences were statistically significant.
Therefore in summary, Myo- Inositol has shown to increase the proportion of top quality oocytes and has shown to decrease the size of ovarian cysts by having an insulin sensitizing effect (reminding that insulin resistance is a major cause of PCOS) and by lowering androgen levels in women who suffer from PCOS.
It has also shown to induce regular ovulation in women suffering from PCOS.
Clinical Evidence: D-Chiro-Inositol (DCI)
Various studies have been conducted on the effect of DCI on endocrine, metabolic, and reproductive parameters in PCOS.
Administration of DCI every day for 6-8 weeks to lean women reduced insulin and free testosterone levels (reminding that high levels of androgens have been associated with PCOS), while decreasing systolic blood pressure, diastolic blood pressure, and serum triglycerides.
In obese PCOS women also, DCI was found to improve endocrine parameters including serum testosterone, serum androstenedione, and gonadotropin-releasing hormone-induced LH response. It was also found to reduce BMI and improved insulin sensitivity markers in PCOS patients with diabetic relatives, who exhibit a greater response as compared to those with no family history of diabetes.
The effect of DCI extends to menstrual regularity, which improves with its supplementation. This regularity is associated with a decrease in serum AMH and in insulin resistance.
This effect may be mediated through a decrease in follicular fluid oxidative stress status. In a study conducted on 68 participants, women with PCOS were pretreated before ovarian stimulation with either DCI 500 mg or metformin 850 mg or left untreated for 3 months. DCI improved the maturity and quality of oocytes significantly, while reducing oxidative stress (as measured by amino acidic free - SH group labeling). The usage of DCI was not associated with any adverse effect in this study.
In summary – DCI has shown to drastically reduce insulin and male hormone levels (both causes of PCOS) in the body and has also shown to increase the quality of oocytes.
ALPHA LIPOIC ACID
Several studies reported that insulin resistance is common in PCOS patients, regardless of the body mass index (BMI) – (insulin resistance is more often found in overweight patients than in “healthy” weight patients.
In fact, hyperinsulinemia due to insulin resistance occurs in approximately 80% of women with PCOS and central obesity as well as in 15–30% of lean women diagnosed with PCOS.
Obesity however exacerbates insulin resistance and it is often a material reason why some women fail to ovulate and in addition thereto why some women have higher than normal androgen (male hormone) levels.
Among the many possible intervention in PCOS, other than pharmacological treatments such as the use of metformin , various integrative compounds have been proposed such as the two isoforms of inositol, that is myo-inositol (MYO- as discussed above) and d-chiro-inositol (DCI – as discussed above), and alpha lipoic acid.
Both Myo-and-Chiro-inositol and ALA were reported to be effective in reducing the insulin resistance in PCOS patients. While inositol are involved in the structure of the post receptor transduction of the signal induced by the linkage of insulin on its receptor, ALA has been demonstrated in the animal model to increase glucose utilization.
Folic Acid and PCOS
Several clinical studies have found success when combining folic acid with myo-inositol. The combination is thought to improve fertility in women with PCOS by improving insulin sensitivity, which is also a feature of PCOS (insulin sensitivity is where your body doesn’t use insulin effectively).
In another study, women with PCOS took folic acid and myo-inositol every day for 12 weeks. All those who had been having irregular periods at the start of the study were having a normal cycle by the time it ended. Another study also found 72 percent of women who had previously had infrequent or no periods went on to have normal periods after taking folic acid with myo-inositol.
Folic acid and neural tube defects
Folic acid (also known as folate or vitamin B9) 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 your body. It is also essential for the development of DNA. This is especially critical during pregnancy, when cells in your body are growing and dividing very quickly in order for your uterus to expand, the placenta to develop, blood circulation to increase, and the fetus to grow. The CDC recommends that you take folic acid supplements every day, for at least a month before you become pregnant, and every day while 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 periconceptional folic acid supplementation.
A study, involving more than 18,000 women, concluded that taking a regular daily dose of folic acid supplements 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 (20%, the second biggest cause, of female infertility is as a result of ovulation issues).
Many other studies suggested that folic acid lowers the risk of birth defects by at least 50% and if you've already had a baby with a defect, it can reduce the risk for your next child by as much as 70%. Some defects are fatal and other can leave your baby permanently disabled. They are scary problems, to say the least, and shouldn’t be taken lightly. 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 woman is even 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 she has enough folic acid in her body.
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.
Laanpere M, Altmäe S, Stavreus-Evers A, Nilsson TK, Yngve A, Salumets A
Nutr Rev. 2010 Feb; 68(2):99-113.