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NCT06853418 · ClinicalTrials.gov registry record · NA
Paired Non-inferiority Study Comparing Overture Semi-automated Vitrification System ("DaVitri") to Standard Manual Process for Clinical Pregnancy Outcomes
A NA study of Oocyte Cryopreservation, sponsored by Overture Life.
- Recruiting
- Registry status
- NA
- Development phase
- 260
- Enrollment target
- 1
- Study location
NCT06853418 is a NA study of Oocyte Cryopreservation that is actively recruiting participants, run by Overture Life. The registered enrollment target is 260 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06853418, a NA study of Oocyte Cryopreservation, is actively recruiting participants, sponsored by Overture Life.
- RECRUITING
- Registry status
- NA
- Development phase
- 260 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- DEVICE Oocyte Cryopreservation
Study Locations (1)
California
- Lane Fertility Institute - Novato
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2024-07-18 |
| Est. Completion | 2025-11-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06853418
The ClinicalTrials.gov registry entry for NCT06853418 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Overture Life, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Oocyte Cryopreservation appearing as the primary indexed condition, and to 1 intervention - of which Oocyte Cryopreservation is the first listed.
NCT06853418 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06853418 about?
NCT06853418 is a clinical study titled "Paired Non-inferiority Study Comparing Overture Semi-automated Vitrification System ("DaVitri") to Standard Manual Process for Clinical Pregnancy Outcomes". 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 PRI...
What is the current status of trial NCT06853418?
This trial is currently recruiting. It is a NA study. The enrollment target is 260 participants. The study started on 2024-07-18. Estimated completion is 2025-11-30.
What conditions does trial NCT06853418 study?
This clinical trial studies the following conditions: Oocyte Cryopreservation.
What interventions are being tested in trial NCT06853418?
The interventions under investigation include: Oocyte Cryopreservation (DEVICE).
Who is sponsoring clinical trial NCT06853418?
This trial is sponsored by Overture Life, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06853418 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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