Comparison of “Fertility-Friendly” Nature of Pre-Seed Single-Use Versus Multi-Use Formulations
Date posted: September 8, 2009
Thanks to Pre-Seed for sharing their newsletter with us an allowing us to repost it. 
Comparison of “Fertility-Friendly” Nature of Pre-Seed Single-Use Versus Multi-Use Formulations
Over the past few years a frequent request by Pre-Seed® users has been for a multi-use packaging format to decrease the waste associated with the pre-filled single use applicators. Last year we brought the 40 gm Pre-Seed® tube to market with twist on applicators that allowed individuals to choose the amount of product they wanted to use.
Because this packaging format allowed for multiple uses, based on industry standards, slightly more preservative was added to this version. Everything else about the formulas is exactly the same, including their performance.
It is important to remember that bacteria and their by-products (such as endotoxin) are well known causes of infertility and can result in permanent reproductive tissue damage. Preservatives suppress bacterial growth and are thus needed in products. However, many preservatives damage sperm by their mechanism of action (such as acidic types). In developing Pre-Seed® we did the first, and to our knowledge the only, studies ever done to determine the lowest dose of preservatives we could use that would meet our goal of protecting against bacterial growth while preserving optimal sperm function.
All of our Lot Release specifications are the same for Pre-Seed® multi-use and single-use Formulas. This means that each test that we do, on every lot of product before we can sell it (such as measuring how well sperm swim in the product), has the exact same requirements for both formulations. These tests have been reviewed and accepted by the FDA, as part of us being the first and only lubricant able to state that it is “safe for use by trying- to-conceive couples”.
The following figures show that safety study results for sperm motility, egg fertilization, and embryo development do not differ between Pre-Seed in the single use or multi-use formulation. Most importantly, neither Pre-Seed formulation changes sperm or embryo function over that seen in routine in vitro fertilization media controls.
Please let your community know about this important information! We would also love to hear from you regarding our packaging formats info@preseed.com.
Effect of Pre-Seed Formulations on Human Sperm Motility
No difference between Pre-Seed formulations in average percent motile sperm, expressed as a percent of sperm motility in the control medium (without Pre-Seed). At least 40 ejaculates tested per treatment.
Effect of Pre-Seed Formulations on Mouse Embryo Development
No difference between Pre-Seed formulations in average percent one-cell mouse zygotes developing normally to blastocysts, expressed as a percent of embryo development in the control medium (without Pre-Seed). At least 45 embryos tested per treatment.
Effect of Pre-Seed Formulation on Bovine Embryo Fertilization
No difference between Pre-Seed formulations in average percent in vitro fertilized cow eggs, following 30 min pre-fertilization sperm exposure to either Pre-Seed formula. Data expressed as a percentage of the fertilization seen in control medium (without Pre-Seed). At least 40 eggs tested per treatment.
Effect of Pre-Seed Formulation on Embryo Development
NO difference between Pre-Seed formulations in average embryo development over 6 days, for cow embryos resulting from sperm with 30 min pre-fertilization exposure to either Pre-Seed formula. Data expressed as a percentage of the embryo development seen in control medium (without Pre-Seed). At least 40 eggs tested per treatment.
Leave a Reply
Related Posts:
