Oocyte CryopreservationNCT06853418
Paired Non-inferiority Study Comparing Overture Semi-automated Vitrification System ("DaVitri") to Standard Manual Process for Clinical Pregnancy Outcomes
A study testing Oocyte Cryopreservation in people with Oocyte Cryopreservation, run by Overture Life at 1 site in United States.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oocyte Cryopreservation
- What is being tested?
- Oocyte Cryopreservation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lane Fertility Institute
Novato, California, 94945
Danielle Elizabeth Lane MD, Gynecology and obstetric, 415-893-0391, DR.LANE@LANEFERTILITY.COM
About this study
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.
Read more
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\&#39;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
- Being tested
- Oocyte Cryopreservation
- Keywords
- vitrification, oocytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte CryopreservationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Oocyte Cryopreservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
Presence of sac in uterus and chemical confirmation at 6-7 weeks
Measured: From enrollment to 6-7 weeks
Secondary outcomes (8)
Warming survival rates of oocytes
Vitrified and warmed Oocytes in this study will be evaluated for survival rates post warming. A skilled embryologist will evaluate survival based on a morphological assessment performed under a microscope. Warmed oocytes are considered to have survived if oocytes demonstrate the following characteristics:
Expansion of oocyte, No dark/degenerated or contracted ooplasm No cracked zona pellucida
Measured: From enrollment to 2 weeks
Fertilization Rates
Oocytes collected will be fertilized via Intracytoplasmic Sperm Injection (ICSI) where a single sperm cell is directly injected into the oocyte. Fertilization will be confirmed via the observation of two polar nuclear bodies (2PN) 18h
Measured: From enrollment to 2 weeks
Gardner Score
This score will assess embryo quality based on the trophectoderm (TE) and inner cell mass (ICM). The resulting assessment will categorize embryos into two groups: non-viable embryos with very low implantation potential (DX, XD and DD embryo
Measured: From enrollment to 2 weeks
Blastocyst Formation
Rates Fertilized oocytes (as confirmed via 2PN) will be cultured in an incubator for 5-7 days up to blastocyst stage. The number of fertilized oocytes which survive to the blastocyst stage will determine the blastocyst formation rate
Measured: From enrollment to 2 weeks
Implantation rate
Embryos selected for transfer will be monitored for implantation. Implantation rate will be determined via a serum pregnancy test for human chorionic gonadotropin (hCG) 9-11 days post transference.
Measured: From enrollment to 3 weeks
On-going pregnancy rate
12 weeks post transference the pregnancy rate will be evaluated by the presence of fetal heartbeat. It will confirm the absence of abortions. This heartbeat will be evaluated by ultrasound echography.
Measured: From enrollment to 12 weeks
Congenital abnormality rate
Congenital abnormalities, also known as birth defects, are structural or functional abnormalities present at birth that can affect various parts of the body. The congenital abnormality rate will be measured for each group and
Measured: From enrollment to 9 months
Delivery success rate
This rate is calculated by dividing the number of successful deliveries (live births) by the total number of treatment cycles or procedures performed, and then multiplying by 100 to express it as a percentage.
Measured: From enrollment to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start18 Jul 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oocyte CryopreservationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Overture Life
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853418
- Sponsor's protocol ID
- CP-DV-000-GEN-004
- Status last verified
- Aug 2025
- First submitted
- 7 Sep 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired Non-inferiority Study Comparing Overture Semi-automated Vitrification System ("DaVitri") to Standard Manual Process for Clinical Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT06853418
- Acronym / sponsor ID
- CP-DV-000-GEN-004
- Conditions
- Oocyte Cryopreservation
- Keywords
- vitrification, oocytes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Overture LifeIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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\&#39;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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manually vitrified oocytes | No intervention | –Control oocytes will be manually vitrified and placed into cryogenic storage. |
| Test Oocytes | Experimental | Device: Oocyte CryopreservationTest 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oocyte CryopreservationThe 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. | Device | Test Oocytes |
Primary outcome
Clinical Pregnancy Rate
Time frame: From enrollment to 6-7 weeks
Presence of sac in uterus and chemical confirmation at 6-7 weeks
8 secondary outcomes
Warming survival rates of oocytes
Time frame: From enrollment to 2 weeks
Fertilization Rates
Time frame: From enrollment to 2 weeks
Gardner Score
Time frame: From enrollment to 2 weeks
Blastocyst Formation
Time frame: From enrollment to 2 weeks
Implantation rate
Time frame: From enrollment to 3 weeks
On-going pregnancy rate
Time frame: From enrollment to 12 weeks
Congenital abnormality rate
Time frame: From enrollment to 9 months
Delivery success rate
Time frame: From enrollment to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oocyte Cryopreservation in people with Oocyte Cryopreservation, run by Overture Life at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact M Ángeles Romero, Bachelors Degree on Bioligy (+34 663047056, mromero@overture.life), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy Rate (time frame: From enrollment to 6-7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.