SUNNYVALE, Calif.--(BUSINESS WIRE)--May 14, 2002--A recently published double-blind, placebo-controlled pilot study on the role of a nutritional supplement for female reproductive health offers surprising results and an interesting alternative for women. Conducted in conjunction with investigators at the Stanford University School of Medicine, the study found improvement in women's mid-luteal phase progesterone levels, basal body temperatures, and a statistically significant increase in pregnancy rate, following nutritional supplementation with FertilityBlend(TM) for three months, according to the co-authors, Mary Lake Polan, MD, PhD, MPH, Professor and Chair, and Lynn Westphal, M.D., Assistant Professor, Department of Gynecology and Obstetrics, Stanford University School of Medicine.
Sixty million American women are of childbearing age, and twenty-four million couples are trying to start a family. But, one out of every six couples in the U.S., and one out of every three couples in their late thirties have difficulty conceiving a child. In many of these cases, the causes of infertility are treatable. If low fertility is due to hormonal imbalance or nutritional deficiencies, nutrition may play a critically important role.
While many are familiar with the concept of taking a prenatal vitamin before childbirth, relatively little research has looked into the benefit of a pre-pregnancy nutritional supplement for the optimization of fertility health. Until now. The study conducted on FertilityBlend(TM) is the first of it's kind for a nutritional supplement in the reproductive health category.
Twenty-nine (29) women, age 24-46 years, who have tried unsuccessfully to conceive for 6 to 36 months were enrolled in the study and completed the three-month trial. None of the participants received any pharmacological treatments for infertility during the course of the study and one month prior. Following a randomized double-blind, placebo-controlled design, neither the women volunteers nor the investigators knew who was getting the nutritional supplements or the placebo during the study. Of the 29, 15 received placebo and 14 received FertilityBlend(TM). 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, statistically significant). 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, 42.6% increase, p=0.04), and an increase in mean mid-luteal phase progesterone levels (from 8.2 to 13.1 ng/ml, 59.8% increase, p=0.08) at the end of the three months. The placebo group did not show any notable changes, before or after treatment, in any of the parameters studied. No significant side-effects were noted.
This FertilityBlend(TM) pilot study is currently being expanded to a multi-center study, with the goal of evaluating at least 100 women. Evaluation of a FertilityBlend(TM) Formula for Men is in progress to determine its effect on sperm concentration and motility. The pilot study abstract is published in the April/May issue of the peer-reviewed, Journal of Women's Health and Gender-Based Medicine (Volume 11, Number 3).
"FertilityBlend(TM) may enhance reproductive health as an integral part of an overall healthy lifestyle," says Lynn Westphal, M.D., Assistant Professor of Department of Gynecology and Obstetrics at Stanford University. "This seems to be a very reasonable alternative and I would recommend it to my patients."
"We always wanted kids, but waited for the timing to be right, and I just never imagined we would encounter problems," says forty-year-old study participant, Laura Davies. "We tried for about a year and a half and I was told by my physician that I would never be able to conceive a child naturally. I really wasn't interested in invasive procedures, so when I learned of the FertilityBlend(TM) study we enrolled immediately. To our surprise and delight I was pregnant within three months."
Smoking, certain types of stress and the consumption of caffeine, drugs and alcohol may cause oxidative damage to reproductive organs in both men and women. FertilityBlend(TM) can potentially help counter such oxidative damages and promote overall health prior to conception.
FertilityBlend(TM) for Women ingredients include chasteberry (vitex agnus-castus) -- an herb that encourages healthy ovulation; folic acid -- for the prevention of certain birth defects; green tea, vitamin E and selenium - antioxidants that may promote reproductive wellness; L-arginine -- an essential amino acid that benefits sexual and reproductive health; plus vitamins B6 and B12, iron, magnesium and zinc -- nutrients which can be directly related to fertility health.
FertilityBlend(TM) for Men improves the health of sperm. Ingredients include L-carnitine -- an amino acid critical to the formation of healthy, active sperm; ferulic acid -- an antioxidant shown to improve sperm quality; vitamins C and E, green tea and selenium-antioxidants essential for overall reproductive health; plus zinc, folic acid and vitamins B6 and B12 -- nutrients involved in hormone metabolism, sperm formation and motility.
FertilityBlend(TM) is a patent-pending formula that is available nationwide in leading drug stores, super markets, GNC and health food stores, on line at www.fertilityblend.com, or by calling 1-866-Baby-To-Be.
Interviews with medical experts and FertilityBlend(TM) study participant are available.