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COPYRIGHTED MATERIAL. NOT FOR REPRINT.
The Journal of Reproductive Medicine®
A Nutritional Supplement for Improving
Fertility in Women
A Pilot Study
Lynn M. Westphal, M.D., Mary Lake Polan, M.D., Ph.D., M.P.H., Aileen Sontag Trant,
Ph.D., and Stephen B. Mooney, M.D.
OBJECTIVE: To determine the impact of nutritional P = .04). The placebo group (n = 15) did not show any no- supplementation on optimization of reproductive health table changes after treatment in any of the parameters [This product] is a well-tolerated
supplement that could be an
attractive option for the optimization were (P < .01). No signifi-
of reproductive health in some
women.
arginine, vitamins (including folate) and minerals. tional fertility therapy. (J Reprod Med 2004;49:289– Changes in progesterone level, basal body temperature, menstrual cycle, pregnancy rate and side effects weremonitored. Keywords: infertility, female; nutritional support;
RESULTS: Thirty women aged 24–46 years who had tried unsuccessfully to conceive for 6–36 months com-pleted the study. After 3 months, the supplement group One of every 6 couples in the United States, and 1 of (n = 15) demonstrated a trend toward an increase in every 3 couples in their late 30s, have difficulty con- mean midluteal phase progesterone level (from 8.2 to ceiving a child. In 30% of these couples, the man is 12.8 ng/mL, P = .08) and a significant increase in the av- infertile or subfertile; another 30% have difficulty erage number of days in the cycle with basal tempera- conceiving due to female fertility issues. The re- tures > 37°C during the luteal phase (6.8–9.7 days, maining third is attributable to both male and fe- From the Department of Obstetrics and Gynecology, Stanford University School of Medicine, Stanford, and Daily Wellness Co., Sunny-vale, California.
Supported in part by the Asian Cultural Teaching Foundation.
Address reprint requests to: Lynn M. Westphal, M.D., Department of Obstetrics and Gynecology, Stanford University School of Medi-cine, 300 Pasteur Drive, Stanford, CA 94305 ([email protected]).
Financial Disclosure: Dr. Trant is Director of Research and Development, Daily Wellness Co., manufacturer of FertilityBlend,TM the sub-ject of this study. Dr. Polan is on the Scientific Advisory Board of Daily Wellness Co. and has options in the company. Daily Wellness Co.
provided the authors with a grant to continue this study.
0024-7758/04/4904-0289/$15.00/0 Journal of Reproductive Medicine®, Inc.
The Journal of Reproductive Medicine® The Journal of Reproductive Medicine®
male issues or has an unknown cause. In many of gestation. Vitex functions in a more natural and these cases, the infertility problems are treatable. If gentle fashion with the body to harmonize hormon- low fertility is due to a hormonal imbalance or nu- al balance. Vitex has also been shown to reduce PMS tritional deficiencies, nutritional supplementation symptoms and other menstrual cycle irregu- may play an important role and should be consid- ered a reasonable method of optimizing reproduc- Vitamin B (pyridoxine) has been shown to im- prove conception rates as well as to treat PMS Good nutrition and a healthful lifestyle can have symptoms, but whether this is due to primary a positive effect on fertility and childbearing. For insufficiency is unclear.8 Vitamin B ,9 folic acid,10 example, an adequate intake of essential nutrients, vitamin E,11 multivitamins,12 magnesium,13 seleni- such as folic acid, in the periconceptual period can um13, iron14 and zinc15 have been shown to im- lower the incidence of neural tube defects. Vita- mins, minerals and specific cofactors play a major Antioxidants may be helpful in reducing oxida- role in fertility function, although this is still an area tive stress to ova, sperm and reproductive organs.
that needs further investigation. William Keye, Jr., Vitamins C and E are usually used for this purpose, M.D., President of the American Society for Repro- but green tea may work equally as well. In studying ductive Medicine, commented, “The more we dis- the effects of caffeine on conception (usually con- cover about the effects of nutrition on fertility, the sidered a negative effect), Caan et al17 found that better advice we can give our patients.”1 drinking tea (as opposed to other caffeinated bever- Hormonal imbalance can be determined by blood ages) approximately doubled the odds of concep- tests of reproductive hormone levels. Measuring follicle-stimulating hormone, luteinizing hormone L-arginine, an amino acid, helps improve circula- (LH) and estrogen on day 3 and progesterone on tion to the reproductive organs; that may enhance day 21 (luteal phase) of a normal cycle can indicate oocyte development and implantation of the em- whether the hormonal state is compatible with bryo. Battaglia et al18 monitored uterine and follic- pregnancy. Abnormal LH or progesterone produc- ular Doppler flow in response to L-arginine treat- tion may result in an abnormal monthly basal body ment during in vitro fertilization treatment cycles in temperature chart. If progesterone is low, basal poor responders. The L-arginine–treated group body temperature may not increase during the sec- demonstrated improved Doppler flow rates, a ond half of the cycle after ovulation. Without suffi- lower cancellation rate and an increased number of cient progesterone, the endometrium is not ade- oocytes collected and embryos transferred. Of the quately prepared for implantation of an embryo.
17 women in the L-arginine supplementation Vitex agnus-castus is an herb used to optimize group, 3 became pregnant as compared to zero of luteal phase function. Clinical studies in Europe2-4 the 17 in the nonsupplemented group.
used Vitex successfully to restore progesterone bal- As a result of both the documented and proposed ance and improve fertility. In one study,2,3 39 of 45 mechanisms of various natural products, it was women treated with Vitex tincture (40 drops) postulated that a combination regimen (Fertility- demonstrated increased progesterone levels, with 7 BlendTM, Daily Wellness Co., Sunnyvale, Califor- becoming pregnant within 3 months. In another nia), as a systematically designed blend of natural study,4 among 67 infertile women with oligomen- products, might provide a synergistic impact in orrhea or amenorrhea, those treated with a homeo- support of human reproductive health.
pathic Vitex preparation demonstrated increases inspontaneous menstruation, shorter cycles, earlier Materials and Methods
ovulation, improved progesterone levels during the Thirty women, aged 24–46 years, who had tried un- luteal phase and more pregnancies. Loch et al5 successfully to conceive for 6–36 months, were en- noted an increase in the pregnancy rate in women rolled in the study, and completed the 3-month taking Vitex in a study of its effects on premenstru- trial. Written, informed consent was obtained from al syndrome (PMS) symptoms. No serious side ef- each participant before entry into the study. Institu- fects were noted in that study of 1,634 women in tional review board approval was obtained. None Germany. One advantage of using Vitex rather than of the participants received any pharmacologic the commonly prescribed fertility medication, treatments for infertility during the course of the clomiphene citrate, is the decreased risk of multiple study or for at least 1 month prior to enrolling. Of Volume 49, Number 4/April 2004
the 30, 15 received placebo, and 15 received Fertili- cause of infertility (Table I). More women had pre- tyBlendTM, administered in a randomized, double- viously been pregnant in the placebo group; that blind, placebo-controlled fashion. Supplements could be considered a positive bias for that group, were taken daily, 3 capsules per day (could be taken although no one conceived in that group during the at one time), for 3 menstrual cycles after initial base- line measurements. All subjects received an addi- After 3 months, an increase in mean midluteal tional 3 months of supplement after successful phase progesterone levels was noted in the supple- completion of the study. FertilityBlendTM is a pro- ment group (8.2–12.8 ng/mL, P = .08), whereas the prietary, natural nutritional supplement containing levels in the placebo group remained relatively con- chasteberry and green tea extracts; the amino acid stant (11.4–12.3 ng/mL, P = .38 [Figure 1]). The sup- L-arginine; vitamins E, B , B and folate; iron; mag- plement group also demonstrated an increase in the nesium; zinc and selenium. Changes in midluteal average number of days in the cycle with basal tem- phase progesterone level and basal body tempera- peratures > 37°C during the luteal phase (6.8–9.7 ture, as well as length of menstrual cycle, pregnan- days, P = .04 [Figure 2] ). The placebo group re- cy rate and incidence of side effects, were moni- mained relatively constant in luteal temperatures tored. Progesterone levels were evaluated via > 37°C, with an average of 6.7 days > 37°C at month immunoassay. Luteal measurements were made at 1 and 6.5 at month 3 (P = .44). Neither group exhib- baseline and after 3 months of nutritional supple- ited any consistent patterns in cycle length changes (Table II), although 4 of the 15 women in the sup-plement group moved toward a more normal, Results
28–30-day cycle from shorter or longer cycle Mean age, weight and number of months attempt- ing to conceive were similar (P > .10) for the women By the end of the 3-month study, 4 of the 15 in the supplement and placebo groups (Table I).
women in the FertilityBlendTM group were preg- Mean ages for the supplement and placebo groups nant (27%) as compared to none in the placebo were 34.3 and 35.3 years of age, respectively; aver- group (P = .02 [Table I]). An additional subject be- age weights for both groups were 64.5 kg, and came pregnant during her fifth month on the sup- lengths of time attempting to conceive (before the plement (33%, P < .01). (All subjects were given a 3- study) were 16.8 and 14.2 months, respectively.
month supply of free supplement after completing There were no significant differences between the 2 the study.) The 5 women who became pregnant groups in regard to previous evaluation and the ranged in age from 24 to 38 years (mean, 32.4) andhad been attempting to conceive for 6–30 months(mean, 15.6). Two had abnormally low proges- Table I Patient Characteristics and Pregnancy Rates in the
terone levels initially. The 4 who were pregnant in the first 3 months all demonstrated an increase in Supplement
the number of days with temperatures > 37°C on Characteristic
mean (n = 15)
mean (n = 15)
their basal temperature charts. The subject who was pregnant after 5 months on the supplement did not show this temperature rise until later. Two noted distinct signs of ovulation on their temperature charts that they had not observed before. Ovulation was confirmed by home ovulation kit.
The pregnancies resulted in 4 healthy, live births.
One pregnancy resulted in a miscarriage; implanta- tion on a leiomyoma appeared to contribute to this loss. After the study was completed, 1 of the pa- tients in the placebo group switched to the supple- ment and conceived 2 months later. This pregnancyalso resulted in a healthy, live birth.
*Months of actively trying to conceive.
aStatistically higher number than in placebo group at P = .02, Bayesian bi- No significant side effects were noted in the study. Three women in the active group (none in Significantly higher number than in placebo group at P = .02 and P < .01, respectively, Bayesian binomial analysis.
the placebo group) complained of slight nausea The Journal of Reproductive Medicine®
Mean progesterone level (ng/mL)
FertilityBlend
P= .08
Figure 1 Mean progesterone levels at baseline and after 3 months of FertilityBlendTM Supplement (N = 30).
when taking the supplement on an empty stomach, noted irregular cycles. Since this was the first time but that was corrected by taking it with food. Two many of these women had charted their basal body women in the supplement group noted that their temperature, they may have become more aware of menstrual cycles were more regular, 2 noted short- ened cycles, and 1 noted more erratic cycles. Of the14 women on the supplement, 1 noted less spotting Discussion
Nutritional supplementation may play an impor- placebo noted increased PMS symptoms, and 4 tant role in optimizing fertility health, leading to Mean Number Days (N=30) 2.0
Figure 2 Mean number of
days > 37°C in the lutealphase on the basal Month of Fertility Study
Volume 49, Number 4/April 2004
Table II Comparison of Progesterone Levels, Days > 37°C on
yashree Kelshikar and the REI Laboratory, Stanford Basal Temperature Chart (Luteal Phase) and Menstrual Hospital, which performed the progesterone analy- Cycle Length Between the Supplement and Placebo Supplement
References
Variable
mean (n=15)
mean (n=15)
1. Keyes W: Highlights from Fertility & Sterility, March 2002; 2. Propping D, Katzorke T, Balkien L: Diagnosis and therapy of corpus luteum deficiency in general practice. Thera- 3. Brown DJ: Vitex agnus-castus. Townsend Lett Doctors Pa- 4. Bergmann J, Luft B, Boehmann S, et al: The efficacy of the complex medication Phyto-Hpophyson L in female, hormone-related sterility: A randomized, placebo-controlled double-blind study. Forsch Komplementarmed Klass **Number of days in cycle with basal temperature readings > 37°C during 5. Loch E, Selle H, Boblitz N: Treatment of premenstrual syn- Significantly higher than initial time value at P = .08, 1-tailed t test.
bSignificantly higher than initial value at P = .04 and higher than placebo drome with a phytopharmaceutical formulation containing group value at P = .06, 1-tailed t test.
Vitex agnus castus. J Womens Health Gend Based Med 2000;9:315–320 6. Dittmar F, Bohnart KJ, Peeters M: Premenstrual syndrome: Treatment with a phytopharmaceutical. Therapiewoche Gy- improved conception rates and providing an alter- native or complement to conventional fertility ther- 7. Peteres-Welter C, Albrecht M: Menstrual abnormalities and apy. FertilityBlendTM is a well-tolerated supple- PMS: Vitex agnus-castus in a study of application. Thera- ment that could be an attractive option for the optimization of reproductive health in some 8. Abraham GE, Hargrove JT: Treatment of premenstrual syn- women. Good nutrition is a prerequisite of fertility drome with pyridoxine. Med World News, March 19, 1979 and childbearing and may be particularly impor- tant for those deciding to become pregnant at an ad- fetal loss. J Reprod Med 2001;46:209–212 vanced age. In the current pilot study, nutritional 10. Dawson DW, Sawers AH: Infertility and folate deficiency: Case reports. Br J Obstet Gynaecol 1982;89:678–680 supplementation increased mean midluteal phaseprogesterone levels, increased the average number 11. Bayer R: Treatment of infertility with vitamin E. Int J Fertil of days in the cycle with basal temperatures > 37°C 12. Czeizel AE, Metneki J, Dudas I: The effect of preconceptual during the luteal phase and resulted in a pregnancy multivitamin supplementation on fertility. Int J Vit Nutr Res rate of 33% as compared to 0% in the placebo group.
The role of nutritional supplementation in fertili- 13. Howard JM, Davies S, Hunnisett A: Red cell magnesium and ty is an extremely important area of research. This glutathine peroxidase in infertile women: Effects of oral sup- pilot study is being expanded to a larger, multicen- plementation with magnesium and selenium. Magnes Res ter study with the goal of evaluating at least 100 women, including those with low luteal phase 14. Rushton DH, Ramsay ID, Gilkes JJH, et al: Ferritin and fertil- progesterone or menstrual irregularities. In this way, we may be able to define the women most like- 15. Bedwal RS, Bahuguna A: Zinc, copper and selenium in re- ly to benefit from nutritional supplements. Similar- production. Experientia 1994;50:626–640 ly, evaluation of a FertilityBlendTM formulated for 16. McCloud D: Female infertility: A holistic approach. Aust J men is in progress to determine its effect on spermconcentration and motility in men initially low in 17. Caan B, Quesenberry CP, Coates AO: Differences in fertility associated with caffeinated beverages. Am J Public Health Acknowledgments
18. Battaglia C, Salvatori M, Maxia N, et al: Adjuvant L-arginine treatment for in-vitro fertilization in poor responder pa- Many thanks for help with the study from Bhag-

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