Double blind, randomized placebot controlled trial of FertilAid for Women® on pregnancy and hormone regulation.
Principal Investigators: Heather Zwickey, PhD and Carolyn Nygaard, ND
FertilAid for Women® is a dietary supplement that is intended to promote overall reproductive health in women. It was introduced in 2003 by Fairhaven Health LLC, and is manufactured in the United States under Good Manufacturing Practices (GMP) conditions. It includes a full prenatal vitamin and a proprietary blend of herbal ingredients Trifolium pratense (Red Clover), Vitex agnus-castus (Chasteberry), Eleutherococcus senticosus (Siberian Ginseng), and Ginkgo biloba. The benefits of vitamin and mineral supplementation during preconception and throughout pregnancy are well accepted and well documented. This product also contains Vitamin C and Vitamin E in amounts that exceed 100% daily value levels. These antioxidants have been shown to be helpful in reducing free radical damage that can affect ova maturation and reproductive organs.
This double blind, randomized placebo controlled trial will study the efficacy of FertilAid for Women®. Women aged 18-42 with self-reported difficulties trying to conceive will be randomized to take FertilAid or placebo (prenatal vitamin) for 6 months. Up to 140 participants will be recruited in order to have 90 complete the trial. Outcome measures will be collected at baseline, 3 months, and 6 months. We expect that at least 30% of the women taking FertilAid will be pregnant within 6 months.