Comparing a new semi-automated system for freezing eggs to the standard manual method
Paired Non-inferiority Study Comparing Overture Semi-automated Vitrification System ("DaVitri") to Standard Manual Process for Clinical Pregnancy Outcomes
This study is testing a new semi-automated system for freezing eggs to see if it works as well as the traditional manual method for women looking to preserve their fertility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Overture Life Industry-sponsored |
| Locations | 1 site (Novato, California) |
| Trial ID | NCT06853418 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the Overture Semi-automated Vitrification System, known as DaVitri, in comparison to the traditional manual process for oocyte cryopreservation. The study will recruit 260 female recipients and up to 130 donors, focusing on the clinical pregnancy outcomes associated with each method. Donors will provide informed consent and undergo egg retrieval, with their oocytes assessed for maturity and morphology before being randomly assigned to either the DaVitri or control group. The primary endpoint will be the blastocyst rate, which will help determine the non-inferiority of the new system.
Who should consider this trial
Good fit: Ideal candidates include premenopausal females aged 18-45 undergoing IVF with egg donation.
Not a fit: Patients over 45 years of age or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the efficiency and outcomes of egg freezing procedures for patients undergoing IVF.
How similar studies have performed: Other studies have shown promising results with similar vitrification techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Inclusion Criteria (donors) Ages 18-35 AMH range (2-10) ng/ml Healthy females (no pre-existing medical conditions) Inclusion Criteria (recipient) Undergoing an in-vitro fertilization (IVF) cycle with egg donation Premenopausal female, 18-45 years of age Normal uterine cavity Single embryo transfer Exclusion Criteria: \- Exclusion Criteria (donors) Age \>35 years of age BMI \<18.5 or \>25 Infertility history Three previously failed IVF cycles, including abortions. Abnormal ovulation cycle FSH \>10 or AMH \<2 Alcoholism, drug addiction Infectious diseases (such as HIV, hepatitis, sexually transmitted infections) Donors producing less than 12 mature oocytes of good quality (according to Vienna Consensus criteria) Sperm Exclusion Criteria Severe male factor Infertility (unless donated sperm is used) Alcoholism, drug addiction Exclusion Criteria (recipients) Age \>45 years of age BMI \<18.5 or \>29 Patients using a surrogate. Evidence of uterine pathologies Severe male factor Infertility (unless donated sperm is used) Alcoholism, drug addiction Infectious diseases (such as HIV, hepatitis, sexually transmitted infections)
Where this trial is running
Novato, California
- Lane Fertility Institute — Novato, California, United States (Recruiting)
Study contacts
- Study coordinator: M Ángeles Romero, Bachelors Degree on Bioligy
- Email: mromero@overture.life
- Phone: +34 663047056
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.