CLINICAL STUDIES

FertilityBlend may enhance reproductive health as an integral part of an overall healthy lifestyle.”

Dr Mary Lake Polan, M.D., PH.D. Chair and Professor of the Department of Gynecology and Obstetrics at Stanford University School of Medicine, USA.
 

NUTRITIONAL SUPPLEMENT IMPROVES FERTILITY IN WOMEN

Lynn M. Westphal, MD, Mary Lake Polan, MD, PhD, MPH*, Aileen Sontag Trant, PhD Objective: To determine the impact of nutritional supplementation on female fertility. Design: A double-blind, placebo-controlled study was initiated to determine the effects of FertilityBlend for Women, a proprietary nutritional supplement containing chasteberry and green tea extracts, L-arginine, vitamins (including folate) and minerals. Changes in progesterone level, basal body temperature, menstrual cycle, pregnancy rate and side effects were monitored.

Results: Ninety-three (93) women, age 24-42 years, who had tried unsuccessfully to conceive for six to 36 months, completed the study. After three months, the FertilityBlend (FB) supplement group (N=53 vs. 40 in placebo group) demonstrated a strong trend toward an increase in mean mid-luteal phase progesterone (from 8.2 to 10.4 ng/ml, p=0.06).  Among women initially low in progesterone (<12 ng/ml, N=34 in FB and 23 in placebo group), the increase in the FB group with low progesterone was highly significant (4.9 to 9.3 ng/ml; p=0.005). The average number of days in cycle with basal temperatures over 98F during luteal phase also increased significantly in the overall FB group (5.5 to 8.1 days, p=0.006). Among women starting with short cycles (<27 days, N=15 in FB and N=9 in placebo group), mean cycle length increased significantly in the FB group (from 24.2 to 27.6 days; p<0.001).  Among women with longer cycles (>32 days, N=11 in FB and 6 in placebo group), cycles tended to shorten in the FB group (from 41.6 to 31.7; p=0.02). The placebo group overall (N=40) did not show any notable changes after treatment, in any of the parameters studied. After five months, 17 of the 53 women in the FB group were pregnant (32%), and four of the 40 women in the placebo group were pregnant (10%; p<0.01). No significant side effects were noted.

Conclusion: Nutritional supplementation may provide an attractive alternative or complement to conventional fertility therapies.  Journal of Women's Health. May2005;14(4):365.

CLINICAL STUDY OF FERTILITYBLEND, A NUTRITIONAL SUPPLEMENT USED FOR THE OPTIMIZATION OF REPRODUCTIVE HEALTH IN WOMEN.

LM Westphal, MD, ML Polan, MD, PhD, MPH, AS Trant, PhD, SB Mooney, MD

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

Study Design: A double-blind, placebo-controlled pilot study was initiated to determine the effects of FertilityBlend, a proprietary nutritional supplement containing chasteberry and green tea extracts, L-arginine, vitamins (including folate) and minerals. Changes in progesterone level, basal body temperature, menstrual cycle, pregnancy rate and side effects were monitored.

Results: 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 16 women in the placebo group were pregnant (p<0.01). No significant side effects were noted.

Conclusion: Nutritional supplementation may provide an attractive alternative or complement to conventional fertility therapies.

NUTRITIONAL SUPPLEMENT IMPROVES FERTILITY IN MEN -
A PILOT STUDY+

Lynn Westphal, MD*, Mary Lake Polan, MD, PhD, MPH**, Aileen Sontag Trant, PhD***

*, **Assistant Professor and Division Chief, Department of Reproductive Endocrinology and Infertility, Chair and Professor Emeritus, respectively, Department of Gynecology/Obstetrics, Stanford University School of Medicine, Stanford, CA
***Vice President, R&D, The Daily Wellness Company, Sunnyvale, CA

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

Study Design: A pilot study was initiated to determine the effects of FertilityBlend for Men, a proprietary nutritional supplement containing L-carnitine, green tea and Dong quai extracts, vitamins C, E, B6, B12 and folate, zinc and selenium. Changes in sperm count, motility, linearity and incidence of side effects were monitored.

Results:  Forty-three (43) men, age 30-58 years, who were initially low in sperm count (<50 M/ml) or motility (<60%), and who had tried unsuccessfully to impregnate spouse for 6-36 months, completed the study. After 3 months, the supplement group (N=21) demonstrated an increase in mean sperm count from 23.2 M/ml initially, to 36.1 M/ml (55% increase, p=0.05).  Motility increased from 29.6% to 39.5% after 3 months supplementation (33% increase, p=0.05). The treatment group also showed higher sperm linearity than the placebo group at 3 months (61.1 v. 52.6, respectively; p=0.04). The placebo group (N=22) demonstrated no significant improvement in any of these parameters. No serious side effects were noted.

Conclusion: FertilityBlend is an attractive option for use in the management and optimization of reproductive health in men, either by itself or as an adjunct to other fertility treatments.

+ Being prepared for publication submission.

ADDITIONAL STUDIES
Below are list of published scientific and medical studies that support the effectiveness and safety of the individual ingredients in FertilityBlend.

FertilityBlend for Women

Clinical Studies:

• Brown DJ.  1995.  Vitex agnus castus.  Clinical Monograph.  Townsend Letters for Doctors and Patients, October.
• Propping D, et al.  1988.  Diagnosis and therapy of corpus luteum insufficiency in general practice.  Therapiewoche 38:2992-3001.
• Caan B, et al.  1998.  Differences in fertility associated with caffeinated beverage consumption.  Am J Public Health 88(2):270-4.
• Bayer R.  1960.  Treatment of infertility with vitamin E.  Int J Fertil 5:70-8.
• Rushton DH, et al. 1991.  Ferritin and fertility.  Lancet 337:1554.
• McCloud D.  1996.  Female infertility: a holistic approach.  Aust J Med Herbalism 8(3):68-77.
• Czeizel AE.  1998.  Periconceptual folic acid containing multivitamin supplementation.  Eur J Obstet Gynecol Reprod Biol 78(2):151-61.

FertilityBlend for Men
Clinical Studies:

• Costa M, et al.  1994.  L-carnitine in ideopathic asthenospermia: a multicenter study.  Andrologia 26:155-9.
• Zheng R-L and Zhang H. 1997. Effects of ferulic acid on fertile and asthenozoospermic infertile human sperm motility, viability, lipid peroxidation, and cyclic nucleotides. Free Rad Biol & Med 22(4):581-6.
• Kessopoulou E, et al. 1995. A double-blind randomized placebo cross-over controlled trial using the antioxidant vitamin E to treat reactive oxygen species associated with male infertility. Fertil & Steril 64(4):825-31.
• Geva E, et al. 1996. The effect of antioxidant treatment on human spermatazoa and fertilization rate in an in vitro fertilization program.  Fertil & Steril 66(3):430-4.
• Dawson EB, et al. 1992. Effect of ascorbic acid supplementation on the sperm quality of smokers. Fertil & Steril 58(5):1034-9.
• Scott R, et al. 1998. The effect of oral selenium supplementation on human sperm motility. Br J Urol 82:76-80.
• Moriyama H, et al. 1987. Studies on the usefulness of a long-term, high-dose treatment of methylcobalamin in patients with oligozoospermia.  Hin Kiyo 33(1):151-6.
• Takihara H, et al.  1987.  Zinc sulphate therapy for infertile male with or without varicocelectomy.  Urol 29(6):638-41.
• Czeizel AE.  1998.  Periconceptual folic acid containing multivitamin supplementation.  Eur J Obstet Gynecol Reprod Biol 78(2):151-61.