Paired Non-inferiority Study Comparing Overture Semi-automated Vitrification System ("DaVitri") to Standard Manual Process for Clinical Pregnancy Outcomes

NCT06853418 | Recruiting FDA Device

• 1 other identifier: CP-DV-000-GEN-004
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

This study will recruit 260 female recipients (and up to a maximum of 130 donors). This study is a sequel to the protocol CP-DV-000-GEN-003, entitled, "NON-INFERIORITY STUDY COMPARING OVERTURE SEMI-AUTOMATED VITRIFICATION SYSTEM ("DaVitri") TO STANDARD MANUAL PROCESS USING BLASTOCYST RATE AS THE PRIMARY END POINT". Donors will provide informed consent and will be enrolled before egg retrieval. Once the oocytes are retrieved, they will undergo thorough denudation to remove corona cells and will be assessed for maturity. Subsequently, mature MII oocytes exhibiting good morphology, as per the Vienna Consensus, ranging between 12 and 30 in number, will be processed. These oocytes will then be randomly divided into groups comprising 6 to 8 oocytes each. Therefore, from a single donor, 2 to 4 groups can be generated. An identifier will be assigned for each group. One of the groups will be randomly selected. This group will be randomly assigned to DaVitri or Control. The remaining groups will be randomly selected and assigned alternatively to Control and DaVitri groups: Control oocytes will be manually vitrified and placed into cryogenic storage. Test oocytes will be prepared for vitrification using the DaVitri system. Following preparation with DaVitri, test oocytes will be loaded onto a cryogenic device that is placed into cryogenic storage. The same preservation media (Kitazato) will be used to prepare all oocytes. All oocytes will be warmed manually. Survival rate will be recorded following warming. After warming, the oocytes will be fertilized via Intracytoplasmic Sperm Injection (ICSI) with either donor or patient's partner sperm and resulting embryos cultured to blastocyst stage, keeping score of which embryos come from the Test or Control group. Fertilization rate will be recorded. Embryos will be morphologically assessed (according to Gardner grading system) on day 5-6 to determine blastulation rates and embryo quality in both groups. All the embryos will be vitrified according to the clinic\'s routine process and stored for further recipients. Recipients will provide informed consent and will be enrolled before the retrieval of donor eggs. Once the donor has been matched with the recipient according to the phenotypic, demographic characteristics (following the regular clinical process established in the clinic donation program), the group of oocytes assigned will be randomly selected from either the DaVitri processed group or the manually processed group. Recipients of donated eggs will receive a single embryo transfer (SET). The primary endpoint is Clinical Pregnancy Rate. Clinical Pregnancy will be confirmed by the presence of sac in uterus and chemical confirmation at 6-7 weeks after embryo transference, via ultrasound. Only the first embryo transfers will be used to calculate the primary endpoint. Successive transfers of any embryo group will not be considered inside the study.

Conditions

Oocyte Cryopreservation

Keywords

vitrification; oocytes

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy Rate

  Presence of sac in uterus and chemical confirmation at 6-7 weeks

  From enrollment to 6-7 weeks

Secondary Outcomes (8)

• Warming survival rates of oocytes

  From enrollment to 2 weeks

• Fertilization Rates

  From enrollment to 2 weeks

• Gardner Score

  From enrollment to 2 weeks

• Blastocyst Formation

  From enrollment to 2 weeks

• Implantation rate

  From enrollment to 3 weeks

Study Arms (2)

Manually vitrified oocytes

NO INTERVENTION

Control oocytes will be manually vitrified and placed into cryogenic storage.

Test Oocytes

EXPERIMENTAL

Test oocytes will be prepared for vitrification using the DaVitri system. Following preparation with DaVitri, test oocytes will be loaded onto a cryogenic device that is placed into cryogenic storage.

Device: Oocyte Cryopreservation

Interventions

Oocyte Cryopreservation DEVICE

The DaVitri System is intended to semi-automate vitrification preparation of human oocytes. The Overture Semi-Automated Vitrification System ("DaVitri") is a medical device that uses semi-automated oocyte vitrification. The system comprises the DaVitri Station, and the DaVitri Dish. The DaVitri Station is a piece of capital equipment with touch screen control that manages the vitrification preparation. The DaVitri Dish is a cartridge-like device onto which oocytes and vitrification reagents are loaded. When the DaVitri Dish is loaded into the DaVitri Station, and the cryo process is initiated, a microfluidic pump controls the flow of reagents to and from the DaVitri Dish containing the oocytes.

Test Oocytes

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Overture Life: lead

Study Sites (1)

Lane Fertility Institute

Novato, California, 94945, United States

RECRUITING

Central Study Contacts

M Ángeles Romero, Bachelors Degree on Bioligy

CONTACT

+34 663047056; mromero@overture.life

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: March 3, 2025
• Study Start: July 18, 2024
• Primary Completion: October 31, 2025
• Study Completion: November 30, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

US (1)