The Science Behind Fertility Friendly Lubricant Preseed

PreSeed is the only fertility friendly lubricant the world that has been formulated by a reproductive physiologist to mimic and supplement natural fertile cervical mucus.

There is over a decade of research the confirms both the safety and effectiveness of Pre Seed.

The following studies a sample of some of the studies that prove that Pre Seed works.  PreSeed from its inception has since been designated as the first ‘fertility-friendly’ Class II Medical Device with an allowed label “safe to use when trying to conceive”.

Full Publications

Effect of Vaginal Lubricants on Sperm Motility and Chromatin Integrity: A Prospective Comparative Study – Fertility & Sterility. 2008 Feb;89:375-379

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.

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 Slug Mucosal Irritation Assay – Sexually Transmitted Diseases. 2008 May;35:512-516

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 mucosal irritation potency of personal lubricants is related to varying product osmolalities.

Conclusions: Commonly used personal lubricants show a full range of mucosal irritation potential, which is related to product osmolality.

Sperm Toxicity of ‘Nonspermicidal’ Lubricant and Ultrasound Gels Used in Reproductive Medicine – In preparation for submission 2010

Josefina Vargas, M.Sc.; Michel Crausaz, M.Sc.; Alfred Senn, Ph.D.; Marc Germond, M.D. Fondation F.A.B.E.R., Rue de la Vigie 5, 1003 Lausanne, Switzerland

Objective: To compare sperm toxicity of four commercial “non-spermicidal” gels used in Reproductive Medicine including: Aquasonic Ultrasound Gel, Felis Lubricant, Pre-Seed Lubricant and Replens Moisturizer, in a range of concentrations (0.083% – 8.3%) believed to be physiologically relevant.

Conclusions: Three of the “nonspermicidal” gels were toxic to sperm, including Aquasonic Gel which is widely used for transvaginal ultrasound during ovulation. Pre-Seed alone did not cause sperm toxicity at any time or concentration. It is appropriate for use by patients trying to conceive or clinicians during fertility procedures, including facilitating vaginal insertion of ultrasound probes.

Medical Review Articles

Optimizing Natural Fertility – Fertility & Sterility. 2008 Nov;90(Suppl 3):S1-S6

Practice Committee of the American Society for Reproductive Medicine in collaboration with the Society for Reproductive Endocrinolgy and Infertility

Synopsis: Some vaginal lubricants may decrease fertility, based on their observed effects on sperm survival in vitro. Whereas commercially available water-based lubricants (e.g., Astroglide®, KY Jelly®, and Touch®) inhibit sperm motility in vitro by 60% to 100% within 60 minutes of incubation, canola oil has no similar detrimental effect (32). KY Jelly, olive oil, and saliva diluted to concentrations even as low as 6.25% adversely affect sperm motility and velocity….

Hydroxyethylcellulose-based lubricants such as Pre-Seed® (INGfertility, Valleyford, WA) also have no demonstrable adverse impact on semen parameters (35). Although there is no evidence to indicate that use of any vaginal lubricant decreases fertility, it seems prudent to recommend… hydroxyethylcellulose-based lubricants when they are needed.

Dyspareunia and Vaginal Dryness after Breast Cancer Treatment – SRM Sexuality, Reproduction & Menopause. 2008 Aug;6:18-22

Doreen Leyden Wiggins, MD1 & Don S. Dizon, MD2. 1Clinical Assistant Professor, Program in Women’s Oncology and 2Assistant Professor, Obstetrics and Gynecology and Medicine. Co-Directors, Center for Sexuality, Intimacy & Fertility, Women and Infants Hospital of Rhode Island, Providence, RI

An animal model using slugs has been validated to test mucosal irritation in human mucosal membranes. A recent study using the slug mucosal irritation assay determined that product osmolality was an important component to mucosal tolerability. The iso-osmotic lubricant (Pre-Seed) caused no changes and, therefore, was the best tolerated.

The hypoosmotic lubricant (Femglide) caused negative mllCllS production, thereby decreasing natural response. Two moderately hyperosmotic lubricants (Replens, K-Y jelly) induced mild and moderate irritation, respectively. The highly hyperosmotic lubricant (Astroglide) resulted in severe irritation and tissue damage. Pre-Seed has been marketed to couples who need lubrication that does not inhibit fertility.

Medical Meeting Presentations

Safety and Anti-HIV Activity of Over-the-Counter Lubricant Gels – International Microbicide Conference, Pittsburgh, PA, 2010Julie Russo, Lisa C. Rohan, Bernard Moncla, Ratiya Pamela Na Ayudhya, Lin Wang, Marilyn Cost, Kara Pryke, Marc-André LeBlanc, Jim Pickett, and Charlene S. Dezzutti Magee-Women’s Research Institute, University of Pittsburgh, Pittsburgh, PA; University of Pittsburgh, Pittsburgh, PA; International Rectal Microbicide Advocates, Chicago, IL

Background: Because lubricants may decrease trauma during coitus, it is hypothesized that they could aid in the prevention of HIV acquisition. However, the safety and anti-HIV activity is currently unknown for over-the counter (OTC) lubricant gels.

Conclusions: Our data suggests that PRÉ and Wet Platinum were safest. The hyperosmolar nature of the other lubricant gels was associated with cellular toxicity and may lead to increased risk of HIV infection. —

Effect of Lubricants Developed for Fertility Markets on In Vitro Fertilization and Embryo Development – American Society of Andrology, Philadelphia PA, 2009Raymond W. Wright Jr, PhD. Washington State University, Center for Repro Biology, Pullman, WAIntroduction: Traditional lubricants damage sperm and should not be used when pregnancy is desired. Newer products have been developed for this consumer/patient group. Bovine and human embryos share similar paternal sperm regulatory pathways, making this species a model for detection of sublethal sperm damage. Objective: Experiments were done to evaluate in vitro fertilization and embryo development following bull sperm exposure to lubricants developed for the fertility market. Results: CE and PC exposure resulted in sperm that a) were significantly less able to participate in fertilization and b) had reduced embryo development rates compared to that seen for sperm in control media. Sperm exposed to Pré did not differ in these outcomes from sperm in controls.
Conclusion: Sperm contact with Pré did not interfere with fertilization or embryo development, whereas other lubricants caused significant declines in these end points. Several lubricants marketed to trying- to-conceive couples, caused a large decline in the subsequent ability of embryos to develop normally after a 30 min pre-fertilization exposure of sperm to the lubricants. The reasons for these differences require additional study.Animal Model Study of a New Patient Lubricant’s Affect on In Vitro Fertilization & Embryo Development – American Society of Andrology, Orlando FL, April 2007RW Wright Jr, PhD. Center for Reproductive Biology, Washington State University, Pullman, WAExperiments were done to evaluate in vitro fertilization and embryo development following sperm exposure to products used to lubricate devices in fertility medicine including: KY® Gel, Aquasonic® Ultrasound Gel and Pre’® (a new Patient Lubricant recently cleared for use during fertility interventions). Bovine in vitro fertilization and embryo culture methods are standard and have been proposed as an excellent model for gamete toxicity studies (ReprodBioMed Online 2002;4:170-5).In this study, cryopreserved bull sperm (from a single bull) were routinely washed, resuspended in a TALP medium and placed into one of 5 treatments. These included: 1) Control sperm in medium alone; or sperm medium suspensions with the following added (v/v) 2) 10% Pre’® lubricant; 3) 50% Pre’® lubricant; 4) 10% KY®; or 5) 10% Aquasonic® Gel. Sperm were incubated in treatments for 30 min at body temperature, and placed into fertilization wells with mature oocytes (1 x 106 sperm cells per well). At 8 hrs, putative zygotes were transferred into embryo culture medium and further incubated.At 32 hr of culture, dividing embryos were counted (% fertilization in each treatment). Final development rates were evaluated on Day 7 (post IVF) to determine the % of total oocytes that had developed to the morula or blastocyst stage. ANOVA was used to compare the % fertilization of oocytes & the % of normal embryo development resulting from sperm in each treatment (as seen in Table below, data are mean +/- sd).In Vitro Fertilization & Embryo Development After Sperm Exposure

Treatment Total Oocyte Number % Fertilized Oocytes(+ sd) % Embryos Developing(+ sd)
Control Medium 80 61(5)a 40(9)a
Pre’® 10% 80 60(8)a 39(8)a
Pre’® 50% 80 59(6)a 43(10)a
KY 10% 80 23(6)b 6(5)b
Aquasonic10% 80 0c 0c

a,b,c denote means that differ within column by p<0.0001(ANOVA).

Pre’® Patient Lubricant did not interfere with the ability of sperm to fertilize oocytes or support embryo development in vitro (using a bovine model) even at high concentrations. Conversely, KY® and Aquasonic® significantly impacted the ability of sperm to fertilize oocytes, and allow normal embryo development. —

Changes in Sperm Motility and Chromatin Integrity Following Contact with Vaginal Lubricants – American Society for Reproductive Medicine, Montreal Quebec, October 2005Agarwal 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.

Conclusion: Pre-Seed® does not cause a significant decrease in progressive sperm motility or chromatin integrity in contrast to other lubricants used by couples.

The Effects of Vaginal Lubricants and Moisturizers on Computer Assisted Sperm Analysis (CASA) Parameters Associated with Cervical Mucus Penetration – American Society for Reproductive Medicine, Philadelphia PA, October 2004JE Ellington and J Schimmels. INGfertility, Spokane, WA & Washington State University, Spokane, WA

Objective: The incidence of vaginal dryness is increased in trying-to-conceive (TTC) couples; however, numerous papers have cited the detrimental effect of common vaginal lubricants and moisturizers on sperm motility.

To date, studies have not been done using CASA to evaluate the effects of lubricant products on the motion characteristics of sperm thought to be associated with cervical mucus transport.

Specifically, samples of sperm with mean average path velocity (VAP), % straightness (STR) and Amplitude of Lateral Head Displacement (ALH) exceeding a predetermined level have recently been proposed to have a superior likelihood of good cervical mucus penetration in vivo. Numerous studies have found a correlation between such ability of sperm to penetrate cervical mucus and pregnancy outcomes.

The current study evaluated sperm motion parameters following contact with several vaginal lubricants/moisturizers, to determine their impact on CASA outcomes associated with good cervical mucus penetration, as well as overall motility.

Results: The mean motion characteristics for these specific CASA criteria (+/- SEM) and percent samples with a positive penetration score are shown in the Table below. Means with differing superscripts differ from the control at p<0.05.

Replens caused the media to abruptly turn very acidic and opaque. Further, sperm clumping occurred to the point that meaningful CASA data could not be generated.

Conclusion: Within 30 minutes of exposure, a 10% v/v concentration of the most commonly used lubricant products significantly decreased sperm motility and penetration scores.

The percentage of samples with a positive penetration score was significantly improved with Pre~Seed® as compared to the other treatments. Products used to alleviate vaginal dryness that negatively affect sperm motility and transport should be avoided by TTC couples. Studies to determine the in vivo impact of vaginal lubricants/moisturizers on cervical mucus penetration are ongoing.

Prevalence of Vaginal Dryness in Trying-to-Conceive Couples – Pacific Coast Reproductive Society, Rancho Mirage CA, April 2003JE Ellington and RA Short. INGfertility, Spokane, WA & Washington State University, Spokane, WADyspareunia, primarily due to vaginal dryness, has been reported to occur “sometimes” or “more often” in at least 46% of all reproductive age women. However, it is currently not known if vaginal dryness is increased in trying-to-conceive (TTC) couples.Additionally, it is not known how TTC couples are managing symptoms of vaginal dryness, given numerous reports on the sperm-toxic nature of most personal lubricants and even saliva. This study was done to determine the prevalence of vaginal dryness among TTC couples, and their level of understanding of appropriate interventions for such dryness. An opt-in internet survey of 900 TTC couples was conducted over 5 months. Thirty questions regarding fertility and vaginal dryness were asked of each participant.Summary statistics for the group were compiled and analyzed. Average TTC time for the group was 7 months, with 33% TTC 1 year or more. Medical care for their fertility issues included: 23% no doctor, 13% PCP, 43% ObGyn, 16% Fertility Specialist, 4% Urologist. Most couples (78%) had no definitive diagnosis for cause of fertility problems. Most (69%) routinely used some ovulation prediction method. Only 16% were currently taking “fertility medications”. While TTC, vaginal dryness negatively affected sexual intimacy for most couples: 11% always, 35% often, 42% sometimes, 9% rarely, 3% never.Vaginal dryness episodes also increased while TTC: 19% a lot, 57% some, 23% not at all. Although 30% knew not to use a lubricant while TTC, another 26% often or always used such products. Use by this later group included mostly that of KY® (40%) and Astroglide® (19%). Only 20% of couples had ever discussed their dryness problem with a doctor. Of those that had, 75% of the doctors reiterated the sperm-toxic effects of lubricants. Rates of vaginal dryness in TTC couples appears to be as much as twice that seen in the general population. Patients are not discussing this problem with their care providers adequately.Fully one-quarter of TTC couples are utilizing personal lubricant products which reportedly are as toxic to sperm as are contraceptive jellies. Products designed specifically to relieve vaginal dryness without harming sperm, such as Pre~Seed®, are needed for use by TTC couples. —Effects of Personal Lubricants on In Vitro Fertilization and Embryo Development American Society of Andrology, Phoenix AZ, March 2003RW Wright1, PhD; RA Short2, PhD; & JE Ellington3 DVM, PhD. 1Dept Animal Science & 2Health Research Center, Washington State University; and 3INGfertility, Spokane, WAUse of personal lubricants is not recommended for couples that are trying to conceive based on several studies reporting their deleterious effect on sperm motility. In spite of this, 43% of all trying-to-conceive couples use personal lubricant products due to a high frequency of vaginal dryness. The current study was designed to compare in vitro fertilization and embryo development of bovine oocytes in the presence of moderate doses (10%) of several different products.In vitro matured cow oocytes were fertilized by bull sperm with: 10% KY Jelly®; 10% FemGlide® (labeled as “sperm compatible”); 10% Pre~Seed® (a new moisturizer developed to provide an optimal sperm environment); and control TALP IVF media. Lubricants were only present during the fertilization incubation of sperm and oocytes. The bovine IVF model allows for detection of sperm DNA damage which can inhibit embryo development. Embryos were cultured for 7 days and then scored for normal development for blastocyst (multi-cell) stage. Data are expressed as Mean (SEM).Treatment

# Oocytes % Fertilized % Blasts
KY Jelly® 100 12 (2.0)a 2 (1.2)a
FemGlide® 200 72 (3.4)b 42 (0.7)b
PreSeed® 200 73 (4.6)b 47 (0.9)c
Control® 200 77 (3.4)b 44 (0.8)b,c

KY Jelly® in the fertilization medium had a very negative effect on fertilization and development (a,c differ by p<0.001), with only 2% of all eggs developing to the blastocyst stage. FemGlide® decreased embryo development as compared to the Pre~Seed® treated sperm (b,c differ by p=0.05). Pre~Seed® did not affect embryo development as compared to the control media in this model, in fact a trend for improved development was seen. Mouse embryo development studies with 10% volume of test product are routinely done as a toxicology screen for assisted reproduction media. A similar design, using cow embryos detected a harmful effect of KY Jelly® and FemGlide® on embryo development after sperm exposure to these products.

Effect of New Intimate Moisturizer on Sperm Motility – American Society of Andrology, Phoenix AZ, March 2003
JE Ellington PhD; RA Short PhD; & J Schimmels. iNGfertility, Spokane, WA & Health Research Center, Washington State University, Spokane, WANumerous publications cite the deleterious effect of existing commercial lubricants on sperm motility. Additionally, 75% of trying-to-conceive couples have an increased incidence of vaginal dryness. This study compared motility parameters for human sperm (n=25 ejaculates) cultured for 30 min in HTF media with HSA (control), to which either 10% KY Jelly®; 10% Astroglide®; 10% FemGlide® (marketed as “sperm compatible”); or 10% Pre~Seed® (specifically developed to not harm sperm) were added.

Treatment % Progressive
Control 100a 53 (2)a 89 (3)a 59 (2)a
KY® 62 (6)b 37 (2)b 67 (2)b 40 (2)b
FemGlide® 92 (4)c 44 (4)c 79 (3)c 50 (4)c
PreSeed® 100 (5)a 51 (2)a 79 (2)c 56 (3)a,c
Astroglide® <5 NA NA NA

a,b,c Superscripts show means (SEM) within a column that differ at p<0.05.

Due in part to viscosity change, all lubricants slowed sperm velocity as compared to control medium. However, sperm in Pre~Seed® retained motility equivalent to the control over the 30 min of culture, whereas sperm in the other lubricants had decreased motility (p<0.05). This effect was profound with Astroglide®. Placed side by side, FemGlide® and KY® created a distinct barrier whereby sperm in raw semen had difficulty penetrating into the products (photos available). In contrast, sperm moved freely between raw semen and the Pre~Seed®