CLINICAL STUDIES
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 six 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.
*Dr. Polan is a member of the Scientific Advisory Board and received
stock options in the company for her service.
If you are a man with low to moderate sperm count or motility, or a woman with
PCOS interested in participating in the ongoing study, see below:
ONGOING CLINICAL STUDY
If you are a male, with low to moderate sperm count or motility,
or a women with PCOS, and live in the San Francisco Bay area, you may want to
participate in a clinical study on improving fertility. Contact Dr. Aileen
Trant at 650-988-8588 x212 for further details. You must be able to make 2-3
visits to Stanford University Medical School to participate.
What's in it for you? Fertility analyses (progesterone
tests in women and semen analysis in men) are done at Stanford free of charge,
and after completion of the study you receive a three month's supply of FertilityBlend.
ADDITIONAL STUDIES
Below are list of published scientific and medical studies that support the
effectiveness and safety of the individual ingredients in FertilityBlend.
Clinical Studies:
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Brown DJ. 1995. Vitex agnus castus. Clinical Monograph.
Townsend Letters for Doctors and Patients, October.
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Propping D, et al. 1988. Diagnosis and therapy of corpus luteum
insufficiency in general practice. Therapiewoche 38:2992-3001.
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Caan B, et al. 1998. Differences in fertility associated with
caffeinated beverage consumption. Am J Public Health 88(2):270-4.
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Bayer R. 1960. Treatment of infertility with vitamin E.
Int J Fertil 5:70-8.
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Rushton DH, et al. 1991. Ferritin and fertility. Lancet
337:1554.
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McCloud D. 1996. Female infertility: a holistic approach.
Aust J Med Herbalism 8(3):68-77.
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Czeizel AE. 1998. Periconceptual folic acid containing multivitamin
supplementation. Eur J Obstet Gynecol Reprod Biol 78(2):151-61.
Clinical Studies:
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Costa M, et al. 1994. L-carnitine in ideopathic asthenospermia:
a multicenter study. Andrologia 26:155-9.
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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.
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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.
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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.
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Dawson EB, et al. 1992. Effect of ascorbic acid supplementation on the
sperm quality of smokers. Fertil & Steril 58(5):1034-9.
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Scott R, et al. 1998. The effect of oral selenium supplementation on human
sperm motility. Br J Urol 82:76-80.
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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.
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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.
