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

NCT ID: NCT06853418

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-18
• Study Completion Date: 2025-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Manually vitrified oocytes

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Test Oocytes

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.

Group Type: EXPERIMENTAL

Oocyte Cryopreservation

Intervention Type: 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.

Interventions

Oocyte Cryopreservation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Overture Life

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lane Fertility Institute

Novato, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

M Ángeles Romero, Bachelors Degree on Bioligy

Role: CONTACT

mromero@overture.life

+34 663047056

Facility Contacts

Danielle Elizabeth Lane MD, Gynecology and obstetric

Role: primary

DR.LANE@LANEFERTILITY.COM

415-893-0391

Other Identifiers

CP-DV-000-GEN-004

Identifier Type: -

Identifier Source: org_study_id