| 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.
-
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.

Clinical Studies:
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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.
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