Testing a new semi-automated method for freezing human eggs and embryos
Paired Non-inferiority Study Comparing Overture Semi-Automated Vitrification System ("DaVitri") to Standard Manual Process
This study is testing a new semi-automated device for freezing human eggs and embryos to see if it works as well or better than the traditional manual freezing methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 30 Years to 45 Years |
| Sex | Female |
| Sponsor | Overture Life Industry-sponsored |
| Locations | 2 sites (Buenos Aires and 1 other locations) |
| Trial ID | NCT05607771 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the effectiveness of a semi-automated device called DaVitri for the vitrification of human oocytes and embryos, comparing its performance to traditional manual methods. Vitrification is a critical process in assisted reproduction that preserves fertility by freezing samples at extremely low temperatures. The study will assess whether the semi-automated process can achieve similar or better survival rates and reproducibility compared to manual techniques, potentially standardizing the procedure across clinics. The goal is to enhance the efficiency and consistency of fertility preservation methods.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals undergoing fertility treatments who meet the clinic's standard inclusion criteria.
Not a fit: Patients with a BMI outside the range of 18.5 to 25, or those with specific reproductive issues such as implantation failure or abnormal ovulation cycles, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the success rates of fertility preservation techniques, benefiting patients undergoing in vitro fertilization.
How similar studies have performed: While the concept of semi-automated vitrification is innovative, similar studies have shown promising results in improving the consistency and efficiency of fertility preservation techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Buenos Aires and 1 other locations
- WeFIV Buenos Aires — Buenos Aires, Argentina (Recruiting)
- Halitus Instituto Médico — Buenos Aires, Argentina (Active_not_recruiting)
Study contacts
- Principal investigator: Fernando Neuspiller, MD — WeFiv
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.