An interventional study of Manual Vitrification and Automated Vitrification in Fertility Issues, sponsored by Overture Life. Recruiting at 2 sites in Argentina. Open to female participants aged 30 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Overture Life · Not applicable, Interventional, and Other
The main objective of this clinical study is to demonstrate the non-inferiority of the semi automated device (DaVitri) developed by Overture Life in the preparation procedures for vitrification of human samples.
Vitrification is a manual technique that is routinely used in assisted reproduction clinics for the cryopreservation of oocytes and embryos in liquid nitrogen at -196oC. There are different methods of vitrification, the most used being the Cryotop of Kitazato. This is a manual process that requires precision and experience to achieve a good result. For this reason, the correct execution of the technique is considered key in in vitro fertilization (IVF) treatments, as it can favor the preservation of fertility and optimize clinical results.
The purpose of the study is to validate the viability of the semi automated vitrification process, to obtain survival rates similar to or superior to manual processes, and also the capacity to provide greater reproducibility in the results.
The semi automatic exchange of vitrification fluids in human oocytes is as efficient as the manual procedure, in terms of survival (85-90%), but with significantly lower variability between technicians and between centers (95% reproducibility), as well as reduced manual processing times.
The initial hypothesis is that semi automated vitrification equals or improves the manual technique, thus introducing a new standardized protocol for clinical use.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 72 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Overture Life is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Oocytes will be prepared for vitrification using the manual protocol
Device: Manual Vitrification
Oocytes will be prepared for vitrification using Davitri device
Device: Automated Vitrification
Oocytes will be prepared for vitrification using the manual protocol
Oocytes will be prepared for vitrification using the DaVitri device
Thaw survival rates of oocytes
Number of valid oocytes/numbers of randomized oocytes
Time frame: Day 1
Blastocyst formation rate
Number of blastocysts at day 5 or 6/number of fertilized oocytes
Time frame: Day 5
Plan to share: No
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