Conceive Plus® was cleared safe for use by couples trying-to-conceive by the Food and Drug Administration (FDA) on November 7 2013 under 510(k): K131355. Conceive Plus® is compatible with human sperm, oocytes and embryos and safe for use by trying to conceive couples.
Product code: PEB (lubricant, personal, gamete, fertilization, and embryo compatible) Class II (21 CFR 884.5300)
We are proud of the many studies we have done to confirm the unique nature of our product. The following data presented at the 2009 Annual Meeting of the ASRM (American Society for Reproductive Medicine). The following data represents only a small amount of extensive testing performed on this product.
Development of a Novel, Physiologically Important Ca2+ and Mg2+ ion Containing Non-Spermicidal Vaginal Lubricant
J. Kurtz1,2,3, E. Willmer1,2, B. Nikolic1,3, and V. Gupta1,4
1Aquatrove Biosciences, Inc., Miami FL; 2 Emmanuel College, Boston MA; 3 Massachusetts General Hospital, Harvard Medical School, Boston MA; 4 Miller School of Medicine, University of Miami, Miami FL
Fertility and Sterility, Volume 92, Issue 3, Supplement 1, September 2009, Pages S212-S213
Exposure to over-the-counter spermicidal lubricants results in rapid loss of sperm viability and motility. The combination of suboptimal pH, osmolality, and various additives in these lubricants results in sperm damage and an inability of the sperm to penetrate into the cervix, thereby negatively impacting conception.
A novel water-based lubricant containing essential Ca2+ and Mg2+ ions and optimal pH and osmolality manufactured and marketed as Sasmar Conceive Plus®, has been designed to better mimic the natural fertile cervical fluids to alleviate the problem of vaginal dryness and to assist couples trying-to-conceive.
Objective: The primary objective of this study was to evaluate the performance of the novel calcium and magnesium containing non-spermicidal vaginal lubricant (Sasmar Conceive Plus®) using established in vitro assays. It also measured the effectiveness of Sasmar Conceive Plus® in maintaining sperm viability and motility, as compared to optimum control medium. Trying to conceive couples seek a vaginal lubricant that mimics natural fluids and is not toxic to the sperm.
Results and Conclusions: The physiologically important Ca2+ and Mg2+ ions have been incorporated into a new water-based, pH and osmolality balanced vaginal lubricant to better mimic the natural fertile cervical fluids. This scientifically designed non-spermicidal lubricant does not harm viability or motility of human sperm as compared to treatment with the optimum culture medium alone. It does not create a barrier against sperm motility.
Data shows that the new Ca2+ and Mg2+ containing lubricant does not hinder the process of egg fertilization and does not harm embryo development to the blastocyst stage. Thus, it is an ideal lubricant for assisting with the needs of couples trying-to-conceive.
The in vitro assays used in this study were according to literature protocols and followed the published WHO (World Health Organisation) criteria. Some of the assays were conducted in a blinded fashion by independent third parties on a fee-for-service basis. Optimum media was used as a control in all assays. The newly designed water-based lubricant that has balanced pH and osmolality and that contains Ca2+ and Mg2+ ions was compared to the control optimum media in all assays.
A. Human Sperm Motility Assay
B. Mouse Embryo Assay
C. Ova Penetration Assay
D. Lubricant Barrier Assay (a: Sasmar Conceive Plus® . b: KY Lubricant)
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This study was supported by Aquatrove Biosciences, Inc.
DID YOU KNOW? Conceive Plus® is the ONLY Fertility lubricant that contains calcium and magnesium ions essential for the process of fertilization. (International patents pending).