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“Universal Warming” protocol for vitrified oocytes to streamline cell exchange for transnational donation programs: a multi-center study

  • Assisted Reproduction Technologies
  • Published:
Journal of Assisted Reproduction and Genetics Aims and scope Submit manuscript

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.

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Acknowledgments

The authors wish to thank Ms. Maggie Baigent for revising the manuscript. Lodovico Parmegiani wishes to thank all the embryologists worldwide who have shared with him in these last years their opinions and impressions about “Universal Warming”.

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Authors and Affiliations

  1. Reproductive Medicine Unit- GynePro Medical Centers, GynePro Medical, Via T. Cremona, 8 -, 40137, Bologna, Italy

    Lodovico Parmegiani, A. Arnone, G. E. Cognigni & M. Filicori

  2. NextClinics International, Aystetten, Germany

    Lodovico Parmegiani, A. Arnone, G. E. Cognigni, R. Viñoles, L. A. Quintero & M. Filicori

  3. Center for Reproductive Medicine European Hospital, Rome, Italy

    M. G. Minasi, V. Casciani, M. T. Varricchio & E. Greco

  4. Instituto de Medicina Reproductiva (IMER), Valencia, Spain

    R. Viñoles & L. A. Quintero

Authors
  1. Lodovico Parmegiani
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  2. M. G. Minasi
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  3. A. Arnone
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  4. V. Casciani
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  5. G. E. Cognigni
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  6. R. Viñoles
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  7. M. T. Varricchio
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  8. L. A. Quintero
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  9. E. Greco
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  10. M. Filicori
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Contributions

LP: study design, execution, analysis and manuscript drafting

MGM: study analysis, statistics

AA: study execution

VC: study execution

GEC: study execution

RV: study execution

MTV: study execution

LAQ: study execution, manuscript revision and critical discussion

EG: study execution, manuscript revision and critical discussion

MF: study execution, manuscript revision and critical discussion

Corresponding author

Correspondence to Lodovico Parmegiani.

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Conflict of interest

LP is shareholder of Nterilizer Srl and reports fees from Origio-Coopersurgical, Merck, and Irvine-Fujifilm outside the submitted work. Co-authors have no interest to declare.

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Parmegiani, L., Minasi, M.G., Arnone, A. et al. “Universal Warming” protocol for vitrified oocytes to streamline cell exchange for transnational donation programs: a multi-center study. J Assist Reprod Genet 37, 1379–1385 (2020). https://doi.org/10.1007/s10815-020-01798-3

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  • DOI: https://doi.org/10.1007/s10815-020-01798-3

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