Ucwaningo lwezokwelapha olushicilelwe

 

Ucwaningo Lwezokwelapha Olushicilelwe I-Conceive Plus® yamukelwa njengeliphephile ukusetshenziswa ngabalingani abafuna ukukhulelwa yi-Food and Drug Administration (FDA) ngomhlaka 7 Novemba 2013 ngaphansi kwe-510(k): K131355. I-Conceive Plus® iyahambisana nesidoda somuntu, ama-oocyte kanye nama-embryo futhi iphephile ekusetshenzisweni ngabalingani abafuna ukukhulelwa.

Ikhodi yomkhiqizo: PEB (i-lubricant, yomuntu siqu, ama-gamete, ukufakelwa inzalo, futhi iyahambisana ne-embryo) Class II (21 CFR 884.5300)

UCUWANINGO LWEZOKWELAPHA OLUSHICILELWE Siyaziqhenya ngezifundo eziningi esesizenzile ukuqinisekisa ubunikazi obuyingqayizivele bomkhiqizo wethu. Idatha elandelayo yethulwa Emhlanganweni Wonyaka ka-2009 we-ASRM (American Society for Reproductive Medicine). Idatha elandelayo imelela kuphela ingxenye encane yokuhlolwa okubanzi okwenziwe kulo mkhiqizo.

Ukuthuthukiswa kwe-lubricant entsha, ebalulekile ngokomzimba equkethe ama-ion e-Ca2+ ne-Mg2+ engabulali isidoda esisetshenziswa esithweni sangasese sowesifazane J. Kurtz1,2,3, E. Willmer1,2, B. Nikolic1,3, no 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

ISINGENISO Ukuchayeka kuma-lubricant okulula ukuwathenga adambisa isidoda kuholela ekulahlekelweni ngokushesha kwamandla okuphila nokunyakaza kwesidoda. Inhlanganisela ye-pH engeyinhle, i-osmolality, kanye nezithasiselo ezahlukene kule mi-lubricant kuholela ekulimazekeni kwesidoda kanye nokungakwazi kwesidoda ukungena esibelethweni, ngaleyo ndlela kuthinte kabi inqubo yokukhulelwa.

I-lubricant entsha esekelwe emanzini equkethe ama-ion abalulekile e-Ca2+ ne-Mg2+ kanye ne-pH ne-osmolality elungele, ekhiqizwa futhi ethengiswa njenge-Sasmar Conceive Plus®, yakhelwe ukufanisa kangcono uketshezi lwemvelo lwesibeletho ngesikhathi sokuzala ukuze kuncishiswe inkinga yokoma kwesitho sangasese sowesifazane futhi kusizwe abalingani abafuna ukukhulelwa.

ISIFINGQO Inhloso: Inhloso enkulu yalolu cwaningo kwakuwukuhlola ukusebenza kwale-lubricant entsha esifubeni sowesifazane equkethe i-calcium ne-magnesium engabulali isidoda (Sasmar Conceive Plus®) kusetshenziswa izivivinyo ze-in vitro ezisunguliwe. Ibuye yakala ukusebenza kahle kwe-Sasmar Conceive Plus® ekugcineni amandla okuphila nokunyakaza kwesidoda, kuqhathaniswa nendawo yokulima elawulayo elungele kakhulu. Abalingani abafuna ukukhulelwa bafuna i-lubricant yesitho sangasese sowesifazane efana noketshezi lwemvelo futhi engeyona enobuthi esidodeni.

Imiphumela Neziphetho: Ama-ion e-Ca2+ ne-Mg2+ abalulekile emzimbeni afakwe ku-lubricant entsha esekelwe emanzini, enepH ne-osmolality elinganiselwe ukuze kufaniswe kangcono uketshezi lwesibeletho lwemvelo ngesikhathi sokuzala. Le-lubricant eklanywe ngokwesayensi engeyona ebulala isidoda ayilimazi amandla okuphila noma ukunyakaza kwesidoda somuntu uma kuqhathaniswa nokwelashwa ngendawo yokulima elungele kuphela. Ayakhi isithiyo ekunyakazeni kwesidoda.

Idatha ikhombisa ukuthi i-lubricant entsha equkethe i-Ca2+ ne-Mg2+ ayiphazamisi inqubo yokufakelwa inzalo eqandeni futhi ayilimazi ukuthuthuka kwe-embryo kufike esigabeni se-blastocyst. Ngakho-ke, iyona-lubricant efanelekile ukusiza izidingo zabalingani abafuna ukukhulelwa.

IZINDLELA Izivivinyo ze-in vitro ezisetshenziswe kulolu cwaningo zenziwa ngokulandela izinhlelo ezisemibhalweni futhi zalandela izindinganiso ezishicilelwe ze-WHO (World Health Organisation). Ezinye izivivinyo zenziwa ngendlela engaboniyo (blinded) izinhlangothi ezizimele zangaphandle ngemali yenkonzo. Indawo yokulima elungele kakhulu yasetshenziswa njengokulawula kuzo zonke izivivinyo. I-lubricant entsha esekelwe emanzini enepH ne-osmolality elinganiselwe futhi equkethe ama-ion e-Ca2+ ne-Mg2+ yaqathaniswa nendawo yokulima elawulayo elungele kuzo zonke izivivinyo.

IMVELAPHI Ukubaluleka kwama-ion e-Ca2+ ne-Mg2+ Ama-ion e-Calcium ne-Magnesium atholakala ngokwemvelo esidodeni somuntu nasekuketshezeni kwesibeletho. Ukuba khona kwe-Ca2+ esidodeni somuntu kwaboniswa kusukela ngo-1942 ngu-Huggins nabanye (Ref 1). Ama-ion e-Ca2+ ne-Mg2+ abaluleke kakhulu ekuphileleni nasekusebenzeni kwesidoda namaqanda. Isidoda sinemfuneko ephelele yama-ion e-Ca2+ ukuze senze i-acrosome reaction ukuzilungiselela ukufakelwa inzalo eqandeni (Ref 2).

A. Ukuhlolwa Kokunyakaza Kokusidoda Somuntu	B. Ukuhlolwa Kwe-Embryo Yegundane	C. Ukuhlolwa Kokungena Kwe-Ova	D. Ukuhlolwa Kwesithiyo Se-Lubricant (a: Sasmar Conceive Plus® . b: KY Lubricant)

  

IZIPETHO I-Sasmar Conceive Plus® iqukethe ama-ion e-Ca2+ ne-Mg2+ abalulekile emzimbeni ukuze ifanise kangcono uketshezi lwesibeletho lwemvelo ngesikhathi sokuzala. Isekwe emanzini futhi ine-pH ne-osmolality elinganiselwe. Izivivinyo ze-in vitro zibonisa ukuthi i-lubricant ehlukile equkethe i-Ca2+ ne-Mg2+ ayibulali isidoda futhi ayilimazi amandla okuphila noma ukunyakaza kwesidoda somuntu. I-Sasmar Conceive Plus® ayakhi isithiyo ekunyakazeni kwesidoda. I-Sasmar Conceive Plus® ayiphazamisi inqubo yokufakelwa inzalo phakathi kwe-ova yegundane nesidoda esichayeke kule lubricant. I-lubricant entsha equkethe i-Ca2+ ne-Mg2+ ayithinti ukuthuthuka kwe-embryo kufike esigabeni se-blastocyst. Le-lubricant engeyona ebulala isidoda, equkethe i-Ca2+ ne-Mg2+, ifanele kahle ukusiza izidingo zabalingani abafuna ukukhulelwa.

 

ITHENGISWA EZIQWENI EZINGAPHEZUDLULA EZINGAMA-70 ZEZWE

Itholakala Emitholampilo, Ezitolo Zamakhambi, Ezitolo Ezinkulu, Emitholampilo Yokuzala nakuyo yonke indawo kuthengiswa khona izivivinyo zokuzala nemikhiqizo yokusiza ukukhulelwa.

MAYELANA NE-SASMAR®

I-SASMAR® wuyinkampani yamazwe ngamazwe yezemithi egxile ikakhulukazi empilweni yabesifazane nasekuhleleni imindeni. Yasungulwa eSydney, e-Australia ngo-2005, inkampani manje inekomkhulu layo elikhulu lomhlaba eBrussels, eBelgium. I-SASMAR® ingumkhiqizi nomhlinzeki omkhulu wama-lubricant ezinhlelweni zosizo zikahulumeni zokuvimbela i-HIV/AIDS nasekuqwashiseni emazweni asathuthuka nasemazweni asathuthuka kakhulu. Njengomphakeli osemthethweni wama-lubricant omuntu siqu eNhlanganweni Yezizwe, imikhiqizo ye-SASMAR® iyathengiswa nakwamanye amazwe angaphezu kuka-70.

Ngeminye imininingwane nge-SASMAR® vakashela i-website yezinkampani.

IZINKOMBA / UKUBONGA 1 Huggins C, Scott WW, no 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. Lolu cwaningo lwaxhaswa yi-Aquatrove Biosciences, Inc.