Twenty-nine (29) women, age 24-46 years, who had tried unsuccessfully to conceive for 6 to 36 months were enrolled in the study, and completed the 3-month trial. None of the participants received any pharmacological treatments for infertility during the course of the study, and at least one month prior to enrolling. Of the 29, 15 received placebos and 14 received FertilityBlend™; administered in a randomized, double blind, placebo-controlled fashion. Supplements were taken daily, 3 capsules per day, for 3 menstrual cycles after initial baseline measurements. FertilityBlend™ is a proprietary, natural nutritional supplement containing chasteberry and green tea extracts, the amino acid L-arginine, vitamins E, B6, B12 and folate, iron, magnesium, zinc and selenium. Changes in mid-luteal phase progesterone level and basal body temperature, as well as length of menstrual cycle, pregnancy rate and incidence of side effects were monitored. Progesterone levels were evaluated via immunoassay, specifically using the Immulite 2000 Hormone Analyzer. Measurements were made at baseline and after 3 months of nutritional supplementation.
Mean age, weight and months of attempting to become pregnant were similar (p>0.10) for the supplement and placebo groups (Table 1). Mean ages for the supplement and the placebo groups were 34 and 35 years of age, average weights were 143 and 142 pounds, and months of attempting to conceive were 17.6 and 14.2, respectively.
After 3 months, an increase in mean mid-luteal phase progesterone levels was noted in the supplement group (from 8.2 to 13.1 ng/ml, p=0.08), whereas the placebo group remained relatively constant (from 11.4 to 12.3 ng/ml, p=0.38; Figure 1). The supplement group also demonstrated an increase in the average number of days in cycle with basal temperatures over 98F during luteal phase (6.8 to 9.7 days, p=0.04; Figure 2). The placebo group remained relatively constant in temperature at an average of 6.7 days over 98F at month 1, to 6.5 at month 3 (p=0.44). Neither group exhibited any consistent patterns in cycle lengths (Table 2).
By the end of the 3-month study, 4 of the 14 women in the FertilityBlend™ supplement group were pregnant (29%; p=0.02), and none of the 15 women in the placebo group were pregnant (0%; Table 1). The four women who became pregnant ranged in age from 24 to 38 years (mean age of 32.3 years), and had been attempting to conceive from 12 to 30 months (mean of 18 months). Two had abnormally low progesterone levels initially. All four demonstrated an increase in the number of days over 98F on their basal temperature charts. Two noted distinct signs of ovulation on their temperature charts that they hadn't seen before. Ovulation was confirmed by home ovulation kit.
No significant side effects were noted in this study. Two women in the active group (none in the placebo group) complained of nausea if the supplement was taken on an empty stomach. One woman in the supplement group noted that menstrual cycles were more regular, two noted shortened cycles, and one noted more irregular cycles. Of the 14 on the supplement, one noted less spotting and improved PMS symptoms. Two women on placebo noted increased PMS symptoms, and four noted irregular cycles. Since this was the first time many of these women had charted their basal body temperature, they may have become more aware of irregularities in their cycles.
Nutritional supplementation may play an important role in optimizing fertility health, which may lead to improved conception rates, and provide an alternative or complement to conventional fertility therapies. Without significant side effects, FertilityBlend™ is an attractive option for use in the management and optimization of reproductive health in women. Good nutrition is a pre-requisite for fertility and childbearing, and is particularly important for those deciding to become pregnant at a more advanced age. In the current pilot study, nutritional supplementation increased mean mid-luteal phase progesterone levels, increased the average number of days in cycle with basal temperatures over 98F during luteal phase, and resulted in a pregnancy rate of 29% compared to 0% in the placebo group.