SUNNYVALE, Calif.--(BUSINESS WIRE)--Nov. 17, 2003--A 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 with investigators at the Stanford University School of Medicine, the study found a statistically significant increase in pregnancy rate, following nutritional supplementation with FertilityBlend(TM) for three months, as well as improvement in women's mid-luteal phase progesterone levels, and basal body temperatures according to the co-authors, Mary Lake Polan, M.D., Ph.D., M.P.H., professor and chair, and Lynn Westphal, M.D., assistant professor, Department of Gynecology and Obstetrics, Stanford University School of Medicine. The pilot study has been accepted for publication in an upcoming issue of the peer-reviewed, Journal of Reproductive Medicine.
The FertilityBlend pilot study will be presented on Monday, Nov. 17, 2003 at the 131st Annual Meeting of the American Public Health Association (APHA) (Nov. 15-19, 2003) in San Francisco, Calif. The oldest and largest organization of public health professionals in the world, the APHA has been influencing policies and setting priorities in public health for over 125 years. Throughout its history it has been in the forefront of numerous efforts to prevent disease and promote health.
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 its kind for a nutritional supplement in the reproductive health category.
Thirty (30) women, age 24-46 years, who had tried unsuccessfully to conceive for six to 36 months completed the study. After three months, the supplement group (N=15) demonstrated a trend toward an increase in mean mid-luteal phase progesterone level (from 8.2 to 12.8 ng/ml, p=0.08); also a significant increase in the average number of days in cycle with basal temperatures over 37C (98F) during luteal phase (6.8 to 9.7 days, p=0.04). The placebo group (N=15) did not show any notable changes after treatment, in any of the parameters studied. After five months, five of the 15 women in the supplement group were pregnant (33%), and none of the 15 women in the placebo group were pregnant, statistically significant at (p less than 0.01). 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 200 women. Nearly 100 have enrolled in the FertilityBlend Women's study. Evaluation of a FertilityBlend(TM) Formula for Men is in progress to determine its effect on sperm concentration and motility.
"FertilityBlend(TM) may enhance reproductive health as an integral part of an overall healthy lifestyle," said 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," said forty-one-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." Laura, at the age of 41, has recently delivered her second healthy baby.
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.
The United States Patent and Trademark Office has granted patent 6,497,885 to the Daily Wellness Company for FertilityBlend(TM) covering both "Method and Compositions Improving Fertility Health in Female and Male Animals and Humans." FertilityBlend(TM) 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.