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We are very pleased to have access to the following full publications, written by independent third parties about our product line:
Effect of Vaginal Lubricants on Sperm Motility and Chromatin Integrity:
A Prospective Comparative Study
A Prospective Comparative Study
Fertility & Sterility, 2008 Feb;89(2):375-379
Agarwal A, Deepinder F, Cocuzza M, Short RA, Evenson DP. Reproductive Research Center, Glickman Urological Institute and Department of Obstetrics-Gynecology, Cleveland Clinic, Cleveland, Ohio.
Agarwal A, Deepinder F, Cocuzza M, Short RA, Evenson DP. Reproductive Research Center, Glickman Urological Institute and Department of Obstetrics-Gynecology, Cleveland Clinic, Cleveland, Ohio.
Objective: To evaluate the effect of vaginal lubricants Pre~seed®, FemGlide®, Astroglide®, and Replens® on human sperm motility and chromatin integrity.
Design: Prospective, comparative, in vitro study.
Setting: Andrology laboratory at tertiary care hospital.
Patient(s): Thirteen normozoospermic donors.
Intervention(s): Semen samples from 13 subjects were incubated in human tubal fluid media (HTF) controls and 10% (vol/vol) of Pre~seed®, FemGlide®, Astroglide®, and Replens lubricants. After 30 minutes, progressive sperm motility was assessed by light microscopy. Semen samples of 12 patients were placed in positive control (HTF), negative control (10% K-Y Jelly® lubricant), and 10% vol/vol Pre~seed® and FemGlide® lubricants. After 4 hours culture, spermatozoa were analyzed for percent DNA fragmentation index with use of the acridine orange-based sperm chromatin structure assay.
Main Outcome Measure(s): Sperm motility and percent DNA fragmentation index.
Results: Percent motility did not differ significantly between HTF controls and Pre~seed® whereas FemGlide®, Replens®, and Astroglide® lubricants demonstrated a significant decrease in motility. There was no significant difference in percent DNA fragmentation index between the HTF controls and Pre~seed®, but a significant decline in sperm chromatin quality occurred with FemGlide® and
K-Y Jelly®.
K-Y Jelly®.
Conclusion: Pre~seed® does not cause a significant decrease in progressive sperm motility or chromatin integrity in contrast to other lubricants used by couples.
Mucosal Irritation Potential of Personal Lubricants Relates to Product Osmolality as Detected by the SMI (Slug Mucosal Irritation Assay)
Sexually Transmitted Diseases, 2008 May;35(5):512-516
Els ADRIAENS, PhD; Jean Paul REMON, PharmD. Laboratory of Pharmaceutical Technology, Ghent University, Harelbekestraat 72, 9000 Ghent, Belgium
Els ADRIAENS, PhD; Jean Paul REMON, PharmD. Laboratory of Pharmaceutical Technology, Ghent University, Harelbekestraat 72, 9000 Ghent, Belgium
Background: The slug mucosal irritation assay has recently been used as a sensitive measure of mucus membrane tolerance for vaginal microbicide products and carriers. In the current study, it was determined whether musosal irritation potency of personal lubricants is related to varying product osmolalities.
Methods: Five commercial lubricants with an osmolality range were evaluated using the previously validated slug mucosal irritation assay. Specifically, Arion lusitanicus were treated with lubricants over 5 days to quantify mucus production and tissue damage, allowing assignment of each product into an irritation potency category (none, mild, moderate, or severe).
Results: The irritation potency (assessed by the mucus production) of the lubricants showed a significant, quadratic relationship with the product osmolality (P = 0.001; R (2) = 0.99). Femglide, a hypo-osmotic lubricant (32 mOsm/kg), caused a negative mucus production. Pré®, an iso-osmotic lubricant (316 mOsm/kg), caused no changes. Two moderately hyperosmotic lubricants, Replens and K-Y jelly (2143 and 2463 mOsm/kg), induced mild and moderate irritation, respectively. The highly hyperosmotic lubricant Astroglide (5848 mOsm/kg) resulted in severe irritation and tissue damage.
Conclusion: Commonly used personal lubricants show a full range of mucosal irritation potential, which is related to product osmolality.
Methods: Five commercial lubricants with an osmolality range were evaluated using the previously validated slug mucosal irritation assay. Specifically, Arion lusitanicus were treated with lubricants over 5 days to quantify mucus production and tissue damage, allowing assignment of each product into an irritation potency category (none, mild, moderate, or severe).
Results: The irritation potency (assessed by the mucus production) of the lubricants showed a significant, quadratic relationship with the product osmolality (P = 0.001; R (2) = 0.99). Femglide, a hypo-osmotic lubricant (32 mOsm/kg), caused a negative mucus production. Pré®, an iso-osmotic lubricant (316 mOsm/kg), caused no changes. Two moderately hyperosmotic lubricants, Replens and K-Y jelly (2143 and 2463 mOsm/kg), induced mild and moderate irritation, respectively. The highly hyperosmotic lubricant Astroglide (5848 mOsm/kg) resulted in severe irritation and tissue damage.
Conclusion: Commonly used personal lubricants show a full range of mucosal irritation potential, which is related to product osmolality.
Toxicity Tests Carried Out On the Pre~seed® Lubricant Compared With Other Commercially Available Brands (FELIS®, REPLENS®, AQUASONIC®)
Human Reproduction, In Press 2009
Josefina Vargas, Dr Alfred Senn , Prof. Marc Germond. Fondation Faber, Lausanne Switzerland
Several studies have shown that gels used to treat vaginal dryness are liable to affect the motility, chromatin integrity and kinetic parameters of human spermatozoids to varying degrees. The chemical-physical elements that play a role in the mechanism for reducing motility are principally a drop in pH and a change in ionic strength. In our study, we compared different commercially available lubricants (Felis®, Replens® and Pre~seed®) with a gel routinely used by gynecologists during vaginal US (Aquasonic®). Several concentrations of these products were tested in an HTF medium to which albumin was added (10% SSS), and were also subject to two periods of exposure (1 hr and 24 hrs). In order that all of the solutions tested should be subject to identical handling, we selected the weakest C1 concentration (0.083%) as the control. Taken together, these conditions allow the motility of spermatozoids to be maintained in the controls for 24 hours at values close to those at time 0. In our study, Replens lubricant and the Aquasonic® US gel have a negative effect on the motility of spermatozoids even at the weakest concentrations (C2, C3 and C4). The Felis lubricant, in contrast, exercises a negative action at higher concentrations, i.e. C3 and C4. Pre~seed®, on the other hand, has no negative effect on the survival of spermatozoids at any of the concentrations tested. In conclusion, of all of the gels and lubricants tested, Pre~seed® appears to guarantee optimal conditions for the survival of spermatozoids in vitro and can be recommended by gynecologists to infertile patients suffering from vaginal dryness. The negative role of the gels used for vaginal US poses a significant problem, because these are regularly used for echographs to monitor ovarian stimulation in infertile patients.
Our formula is unique, in using components that provide moisture, but also that ensures sperm encounter an optimal environment. This includes arabinogalactan for antioxidant support. Our formulas do also contain very low concentrations of parabens as a preservative. We are aware this has caused concern for some; however, the paraben level in our products is 25% of the minimum concentration found to interfere with sperm function. It is clear that even 50% direct contact of our formula with gametes did not interfere with fertilisation or embryo development. This data assured us that the paraben level in our products is appropriate as a preservative for user protection, without harming gamete function.
Over the past decade there have been many presentations at medical meetings and some full publications on our technology, from both in house and third party investigators. These include those having to do with the beneficial role of arabinogalactan on sperm cell function, primarily through mitigation of oxidative stress damage to motility and chromatin integrity. We are proud of the many studies we have done to confirm the unique nature of our products. These studies have allowed Pre'® Lubricant to be the first ever with specific indications of use including fertility interventions. Such uses include: • Semen collection using polyurethane condoms • Embryo transfer • Transvaginal collection of oocytes • Intrauterine insemination • Post coital testing.
Over the past decade there have been many presentations at medical meetings and some full publications on our technology, from both in house and third party investigators. These include those having to do with the beneficial role of arabinogalactan on sperm cell function, primarily through mitigation of oxidative stress damage to motility and chromatin integrity. We are proud of the many studies we have done to confirm the unique nature of our products. These studies have allowed Pre'® Lubricant to be the first ever with specific indications of use including fertility interventions. Such uses include: • Semen collection using polyurethane condoms • Embryo transfer • Transvaginal collection of oocytes • Intrauterine insemination • Post coital testing.
Pre~seed® the first ever clearance by the FDA to be able to state:
“safe to use when trying to conceive”.
“safe to use when trying to conceive”.
The Science Behind Our Products
Our patented formula, used to develop both Pre´® Lubricant and Pre~seed® Intimate Moisturiser, is unique. Traditional lubricants have been developed to decrease friction or pain during sexual intercourse. Their basic formulations can harm sperm within minutes of contact. Pre~seed® is the only intimate moisturiser formulated by an Andrologist, based on the physiologic requirements of sperm, so as to provide an environment that will not harm them.
Our patented formula, used to develop both Pre´® Lubricant and Pre~seed® Intimate Moisturiser, is unique. Traditional lubricants have been developed to decrease friction or pain during sexual intercourse. Their basic formulations can harm sperm within minutes of contact. Pre~seed® is the only intimate moisturiser formulated by an Andrologist, based on the physiologic requirements of sperm, so as to provide an environment that will not harm them.
