Lodovico Parmegiani1,2, M G Minasi3, A Arnone4,5, V Casciani3, G E Cognigni4,5, R Viñoles5,6, M T Varricchio3, L A Quintero5,6, E Greco3, M Filicori4,5. 1. Reproductive Medicine Unit- GynePro Medical Centers, GynePro Medical, Via T. Cremona, 8 -, 40137, Bologna, Italy. Drlparmegiani@hotmail.com. 2. NextClinics International, Aystetten, Germany. Drlparmegiani@hotmail.com. 3. Center for Reproductive Medicine European Hospital, Rome, Italy. 4. Reproductive Medicine Unit- GynePro Medical Centers, GynePro Medical, Via T. Cremona, 8 -, 40137, Bologna, Italy. 5. NextClinics International, Aystetten, Germany. 6. Instituto de Medicina Reproductiva (IMER), Valencia, Spain.
Abstract
PURPOSE: To investigate the clinical efficacy of a "Universal Warming" protocol, based on subsequent steps with 1 M and 0.5 M concentration of extracellular cryoprotectant (ECCP), on shipped oocytes. Oocytes are vitrified using different brands of ready-to-use kits which recommend that the use of their own warming kit and combining different vitrification/warming kits may have legal consequences for assisted reproductive (AR) centers, until this practice has been validated with clinical studies. METHODS: Retrospective multi-center transnational observational study. Number of oocytes warmed 1.898. Vitrification performed with vitrification kit (Kitazato, Japan); warming carried out randomly with two different kits: Kitazato warming kit and Vit Kit®-Thaw (FujiFilm Irvine, USA). Warmed oocytes were assigned to 2 groups: KK (Kitazato/Kitazato) 939, and KI (Kitazato/Irvine) 959. Primary endpoint: survival rate. Secondary endpoints: fertilization rate; blastulation rate; implantation rate; live birth rate. RESULTS: Survival was comparable between the groups: 84.6% (795/939) in group KK vs 82.1% (787/959) in group KI. Fertilization rate was lower (P = 0.027) in group KK (75.7%-602/795) than in group KI (80.4%-633/787). Blastulation and implantation and live birth rates were all statistically comparable between the study groups: blastulation rate was 58.5% (352/602) vs 57.8% (366/633); implantation rate was 41.5% (80/193) vs 45.9% (84/183); live birth rate was 52.5% (62/118) in KK and 45.0% (54/120) in KI. CONCLUSION: The use of this "Universal Warming" protocol simplifies vitrified oocyte exchange between AR centers in different countries, and overcomes potential regulatory/commercial/availability differences affecting clinical practice.
PURPOSE: To investigate the clinical efficacy of a "Universal Warming" protocol, based on subsequent steps with 1 M and 0.5 M concentration of extracellular cryoprotectant (ECCP), on shipped oocytes. Oocytes are vitrified using different brands of ready-to-use kits which recommend that the use of their own warming kit and combining different vitrification/warming kits may have legal consequences for assisted reproductive (AR) centers, until this practice has been validated with clinical studies. METHODS: Retrospective multi-center transnational observational study. Number of oocytes warmed 1.898. Vitrification performed with vitrification kit (Kitazato, Japan); warming carried out randomly with two different kits: Kitazato warming kit and Vit Kit®-Thaw (FujiFilm Irvine, USA). Warmed oocytes were assigned to 2 groups: KK (Kitazato/Kitazato) 939, and KI (Kitazato/Irvine) 959. Primary endpoint: survival rate. Secondary endpoints: fertilization rate; blastulation rate; implantation rate; live birth rate. RESULTS: Survival was comparable between the groups: 84.6% (795/939) in group KK vs 82.1% (787/959) in group KI. Fertilization rate was lower (P = 0.027) in group KK (75.7%-602/795) than in group KI (80.4%-633/787). Blastulation and implantation and live birth rates were all statistically comparable between the study groups: blastulation rate was 58.5% (352/602) vs 57.8% (366/633); implantation rate was 41.5% (80/193) vs 45.9% (84/183); live birth rate was 52.5% (62/118) in KK and 45.0% (54/120) in KI. CONCLUSION: The use of this "Universal Warming" protocol simplifies vitrified oocyte exchange between AR centers in different countries, and overcomes potential regulatory/commercial/availability differences affecting clinical practice.
Authors: L Parmegiani; K H Beilby; A Arnone; S Bernardi; A M Maccarini; E Nardi; G E Cognigni; M Filicori Journal: J Assist Reprod Genet Date: 2018-08-03 Impact factor: 3.412