Pilot Study of FertilityBlend™

by Lynn Westphal, MD*, Mary Lake Polan, MD, PhD, MPH, Aileen Sontag Trant, PhD, Stephen B. Mooney, MD

Abstract

Objective: To determine the impact of nutritional supplementation on the optimization of reproductive health in women.

Design: A double-blind, placebo-controlled clinical pilot study was initiated to determine the effects of FertilityBlend™, 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.

Results: Twenty-nine (29) women, age 24-46 years, who have tried unsuccessfully to conceive for 6 to 36 months were enrolled in the study. None of the participants received any pharmacological treatments for infertility during the course of the study. Of the 29, 15 received placebo and 14 received FertilityBlend™. 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). 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). The placebo group did not show any notable changes, before or after treatment, in any of the parameters studied. By the end of the 3-month study, 4 of the 14 women in the supplement group were pregnant (29%), and none of the 15 women in the placebo group were pregnant (p=0.02). No significant side effects were noted.

Conclusion: Nutritional supplementation may provide an alternative or complement to conventional fertility therapies. This supplement is a potentially attractive option for use in the management and optimization of reproductive health. The pilot study is being expanded to a multi-center study, with the goal of evaluating at least 100 women. Similarly, evaluation of a FertilityBlend™ formulated for men is in progress to determine its effect on sperm concentration and motility.

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Introduction

One out of every six couples in the U.S., and one out of every three couples in their late 30's, have difficulty conceiving a child. In about one third of these cases, it is the man that is infertile or subfertile; in another third, the female has fertility issues. The remaining third is attributable to both men and women, or is of unknown causes. In many of these cases, the causes of infertility are treatable. If low fertility is due to hormonal imbalance or nutritional deficiencies, nutritional supplementation may play an important role and should be considered as a reasonable alternative in the optimization of one's overall reproductive health.

It is well established in the literature that a healthy lifestyle is important in optimizing one''s reproductive health. Vitamins, minerals, and specific co-factors play a major role in fertility function. Good nutrition is a pre-requisite for fertility and childbearing. William Keye, Jr., M.D., (Wong, 2002), President of the American Society for Reproductive Medicine commented that "…The more we discover about the effects of nutrition on fertility, the better advice we can give our patients."