Fertility Issues
Conditions
Keywords
Vitrification
Brief summary
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.
Detailed description
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.
Interventions
DEVICEManual Vitrification
Oocytes will be prepared for vitrification using the manual protocol
DEVICEAutomated Vitrification
Oocytes will be prepared for vitrification using the DaVitri device
Sponsors
Overture Life
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Donors will be selected according to the clinic's usual inclusion criteria in terms of infectious diseases, genetic diseases, karyotype, etc.
Exclusion criteria
* BMI\<18.5 or BMI \>25 * Implantation failure * Abnormal ovulation cycle * Endometrial thickness \> 7mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thaw survival rates of oocytes | Day 1 | Number of valid oocytes/numbers of randomized oocytes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blastocyst formation rate | Day 5 | Number of blastocysts at day 5 or 6/number of fertilized oocytes |
Countries
Argentina
Outcome results
None listed