Gepubliceerde Klinische Studie
Published Clinical Study 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)
PUBLISHED CLINICAL STUDY 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
INTRODUCTION 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.
ABSTRACT 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.
METHODS 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.
BACKGROUND Importance of Ca2+ and Mg2+ Ions Calcium and Magnesium ions are naturally present in human semen and cervical fluids. Presence of Ca2+ in human semen was shown as early as 1942 by Huggins et al. (Ref 1). Ca2+ and Mg2+ ions are critically important for the viability and function of sperm and eggs. Sperm has an absolute requirement for Ca2+ ions to undergo acrosome reaction in preparation for egg fertilization (Ref 2).
A. Human Sperm Motility Assay
B. Mouse Embryo Assay
C. Ova Penetration Assay
D. Lubricant Barrier Assay (a: Sasmar Conceive Plus® . b: KY Lubricant)
CONCLUSIONS Sasmar Conceive Plus® contains the physiologically important Ca2+ and Mg2+ ions to better mimic the natural fertile cervical fluids. It is water-based and has balanced pH and osmolality. In vitro tests shows that the unique Ca2+ and Mg2+ containing lubricant is non-spermicidal and does not harm viability or motility of human sperm. Sasmar Conceive Plus® does not create a barrier against sperm motility. Sasmar Conceive Plus® does not hinder the process of fertilization between mouse ova and sperm that are exposed to this lubricant. The new Ca2+ and Mg2+ containing lubricant does not affect embryo development to the blastocyst stage. This non-spermicidal, Ca2+ and Mg2+ containing lubricant is ideally suited for assisting with the needs of couples trying-to-conceive.
MARKETED IN MORE THAN 70 COUNTRIES
Available in Pharmacies, Drug Stores, Supermarkets, Fertility Clinics and wherever fertility tests and conception products are sold.
SASMAR® is a multinational pharmaceutical company with a particular focus on women’s health and family planning. Founded in Sydney, Australia in 2005, the company now has its global headquarters located in Brussels, Belgium. SASMAR® is a manufacturer and major supplier of lubricants to governmental aid organisations in HIV/AIDS prevention and awareness programs in Third World and developing countries. Official supplier of personal lubricants to the United Nations, SASMAR® brands are also sold in over 70 countries.
For more information on SASMAR® visit the corporate website.
REFERENCES / ACKNOWLEDGEMENTS 1 Huggins C, Scott WW, and J Heinen JH, Chemical composition of human semen and of the secretions of the prostate and seminal vesicles, Am J Physiol 136: 467-473, 1942. 2 Evans JP, Florman HM. The state of the union: the cell biology of fertilization. Nat Cell Biol. 2002 Oct;4 Suppl:s57. 3 Huggins G and Preti G, Volatile constituents of human vaginal secretions, Am J Obstet Gynecol, 1976 Sep 1;126(1):129-36. 4 Preti G, Huggins G and Silverberg G, Alterations in the organic compounds of vaginal secretions caused by sexual arousal, Fertil Steril 1979;32:47–54. 5 Huggins G and Preti G, Vaginal odors and secretions, Clinical Obstetrics and Gynecology, 1981; 24; 355-377. 6 Owen D and Katz D, A vaginal fluid simulant, Contraception, 1999 Feb;59(2):91-5. 7 Tulandi T, McInnes RA. Vaginal lubricants: effect of glycerin and egg white on sperm motility and progression in vitro. Fertil Steril, 1984; 41:151. 8 Critser JK, Huse-Benda AR, Aaker DV, Arneson BW, Ball GD. Cryopreservation of human spermatozoa. III. The effect of cryoprotectants on motility. Fertil Steril. 1988 Aug;50(2):314. 9 Goldenberg RL, White R. The effect of vaginal lubricants on sperm motility in vitro, Fertil Steril, 1975; 26:872. This study was supported by Aquatrove Biosciences, Inc.