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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
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.
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®.
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
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.
CONCLUSIONS:
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.
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