VitrificationGAVIDONCT06238570
Validation of Donor Oocytes Semi-automated Vitrification
A study testing Gavi, Merck® (automated vitrification instrument) and Vitrolife system in people with Vitrification and Egg Donor, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Oocyte vitrification is an effective method of freezing which has been authorized in France since 2011. The arrival of this technique has led to real improvements in the survival rate of oocytes after warming compared to that observed after slow freezing, a method previously applied. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Vitrification, Egg Donor, Fertility
- What is being tested?
- Gavi, Merck® (automated vitrification instrument) and Vitrolife system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2024to Dec 2026
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Egg donor
- Oocyte puncture for donation
- Good quality ovarian reserve (Antral follicle count evaluated by ultrasound: CFA ≥ 7)
- Negative serology status (HIV, hepatitis B and C, syphilis, CMV and HTLV)
- Absence of symptoms or COVID contact
- Absence of genetic contraindication to egg donation
- Woman able to give informed consent to participate in research
- Woman affiliated to a social security scheme
Who cannot join
- Decline to participate
- Pregnant and lactating woman
- Person under guardianship, curatorship, deprivation of liberty, protection of justice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, llaclautre_perrier@chu-clermontferrand.fr
Laure CHAPUT
About this study
Official title: Validation of Semi-automatic Oocyte Vitrification by the GAVI® Machine in Medically Assisted Reproduction With Oocyte Donation
Oocyte vitrification is an effective method of freezing which has been authorized in France since 2011. The arrival of this technique has led to real improvements in the survival rate of oocytes after warming compared to that observed after slow freezing, a method previously applied. Oocytes reheated after vitrification show excellent results in terms of vitality and recovery of cellular functionality. Indeed, the fertilization rates observed after using warmed and fertilized oocytes in Assisted Reproduction Technology (ART) by intracytoplasmic sperm injection (ICSI) are similar to those obtained with fresh oocytes.
However, the manual vitrification techniques used until now involve a learning curve and a potential variability of the completion time depending on the operator and the number of oocytes to be vitrified.
Read more
Oocyte vitrification is a key step to optimize the chances of pregnancy in ART after using these oocytes. However, manual vitrification requires a learning curve, is technician-dependent and requires significant technical time.
A semi-automatic vitrification device (GAVI®, Merck), which recently appeared on the market, has demonstrated its effectiveness in terms of speed of production and reproducibility of vitrification of embryos obtained in ART. To our knowledge, no study has analyzed the effectiveness of semi-automatic vitrification (GAVI®, Merck) on survival and oocyte quality after warming. It would therefore be interesting to evaluate the effectiveness of this automaton on oocyte vitrification in the context of oocyte donation and to determine the impact of semi-automatic vitrification on oocytes compared to manual vitrification.
The main objective of this study is to demonstrate the non-inferiority of vitrification semi-automated device (Gavi) of oocytes with regard to the oocyte survival rate, compared to the manual technique used in ART.
The investigator will compare the effectiveness of semi-automated vitrification device with the manual technique, in terms of ART results by comparing the fertilization rates, the number and quality of embryos obtained as well as the implantation rates in oocyte recipient patients. This study will then allow clinical application of the most efficient protocol for oocyte vitrification in the context of oocyte donation. A cost/effectiveness study will be carried out.
Read the detailed description
The oocytes will be stored in closed devices (Rapid I® straws for the manual vitrification protocol or pods® in cassettes for the semi-automatic vitrification protocol) in liquid nitrogen. All samples are anonymized in the context of oocyte donation by the medically assisted procreation (PMA) department of Clermont-Ferrand University Hospital, according to the method usually used.
The oocyte survival rate will be evaluated by the service technician or biologist. This survival rate corresponds to the ratio between the number of oocytes intact 2 hours after warming and able to be microinjected with a spermatozoon (ICSI), and the number of oocytes heated, after vitrification. We will compare the oocyte survival rate after vitrification and semi-automatic warming vs. after manual vitrification.
The investigator will compare the effectiveness of ART with oocyte donation during semi-automatic vitrification of oocytes compared to the manual technique, with regard to:
- Oocyte functional quality after warming evaluated by the fertilization rate of oocytes after ICSI
- Early development of embryos:
- the number of embryos cleaved on the 2nd day of culture from vitrified oocytes, the blastulation rate defined by the ratio between the number of blastocysts obtained (Gardner classification on the 5th day of culture) and the total number of cleaved embryos.
These parameters will be assessed daily during the embryo reading by a technician or a biologist from the ART department.
We will also compare the effectiveness of ART with oocyte donation during the semi-automatic vitrification of oocytes compared to the manual technique, with regard to:
- The implantation rate of embryos from vitrified oocytes, defined by the ratio between the number of embryo sacs observed (6th week of amenorrhea) and the number of embryos transferred
- The rate of miscarriages in oocyte recipients. These parameters will be evaluated by a biologist from the ART department after the results of the beta hCG of the patients and the performance of the ultrasound at the 6th week of amenorrhea by the gynecologists of the ART department.
- Conditions
- Vitrification, Egg Donor, Fertility, Assisted Reproductive Technology
- Being tested
- Gavi, Merck® (automated vitrification instrument), Vitrolife system
- Keywords
- Fertility, Egg donor, Vitrification, Assisted Reproductive Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gavi, Merck® (automated vitrification instrument)Device
This instrument recently appeared on the market and demonstrated a high effectiveness in terms of processing time and reproducibility for embryo vitrification. To date, no study has analyzed the efficiency of this automated vitrification instrument on oocyte vitrification.
The oocytes will be stored in closed cassettes in liquid nitrogen
Vitrolife systemDevice
The oocytes vitrification will be carried out by an authorized technician according to the manual protocol validated and used routinely.
| Study group | Role | What they receive |
|---|---|---|
| Manual vitrification (using Vitrolife system) | Placebo comparator | The vitrification of the oocytes will be carried out by an authorized technician according to the manual protocol validated and used routinely. Receives: Device: Vitrolife system |
| Semi-automatic vitrification of oocytes using the GAVI® automaton (Merck) | Active comparator | The vitrification of the oocytes will be carried out using the GAVI® automaton Receives: Device: Gavi, Merck® (automated vitrification instrument) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocyte survival
Oocyte survival after semi-automated vitrification by the GAVI® device compared to the manual technique (Vitrolife) with egg donation. A warmed oocyte that has survived can then be used in AMP by ICSI technique.
Measured: two years after the inclusion
Secondary outcomes (2)
Effectiveness of ART with egg donation after oovcytes semi-automated vitrification
- oocyte functional quality after warming by assessing the fertilization rate for each oocyte
- early development of embryos: number of embryos cleaved on the 2nd day of culture from vitrified oocytes, blastulation rate defined by the ratio between the number of blastocysts obtained (Gardner classification on the 5th day of culture) and total number of cleaved embryos.
- implantation rate of embryos from vitrified oocytes, defined by the ratio between the number of embryonic sacs observed (6th week of amenorrhea) and the number of embryos transferred
- rate of miscarriages in egg recipients
Measured: two years after vitrification
Study the costs and cost-effectiveness
Study the costs and cost-effectiveness of ART by egg donation, during semi-automatic oocyte vitrification and during manual technique, from a hospital point of view.
Measured: at the end of the study 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start23 Jan 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitrificationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238570
- Sponsor's protocol ID
- AOI 2020 CHAPUT
- Acronym
- GAVIDO
- Status last verified
- Apr 2026
- First submitted
- 16 Feb 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Semi-automatic Oocyte Vitrification by the GAVI® Machine in Medically Assisted Reproduction With Oocyte Donation
- ClinicalTrials.gov ID
- NCT06238570
- Acronym / sponsor ID
- GAVIDO / AOI 2020 CHAPUT
- Conditions
- Vitrification, Egg Donor, Fertility, Assisted Reproductive Technology
- Keywords
- Fertility, Egg donor, Vitrification, Assisted Reproductive Technology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Feb 2024 (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.
Oocyte vitrification is an effective method of freezing which has been authorized in France since 2011. The arrival of this technique has led to real improvements in the survival rate of oocytes after warming compared to that observed after slow freezing, a method previously applied. Oocytes reheated after vitrification show excellent results in terms of vitality and recovery of cellular functionality. Indeed, the fertilization rates observed after using warmed and fertilized oocytes in Assisted Reproduction Technology (ART) by intracytoplasmic sperm injection (ICSI) are similar to those obtained with fresh oocytes.
However, the manual vitrification techniques used until now involve a learning curve and a potential variability of the completion time depending on the operator and the number of oocytes to be vitrified.
Oocyte vitrification is a key step to optimize the chances of pregnancy in ART after using these oocytes. However, manual vitrification requires a learning curve, is technician-dependent and requires significant technical time.
A semi-automatic vitrification device (GAVI®, Merck), which recently appeared on the market, has demonstrated its effectiveness in terms of speed of production and reproducibility of vitrification of embryos obtained in ART. To our knowledge, no study has analyzed the effectiveness of semi-automatic vitrification (GAVI®, Merck) on survival and oocyte quality after warming. It would therefore be interesting to evaluate the effectiveness of this automaton on oocyte vitrification in the context of oocyte donation and to determine the impact of semi-automatic vitrification on oocytes compared to manual vitrification.
The main objective of this study is to demonstrate the non-inferiority of vitrification semi-automated device (Gavi) of oocytes with regard to the oocyte survival rate, compared to the manual technique used in ART.
The investigator will compare the effectiveness of semi-automated vitrification device with the manual technique, in terms of ART results by comparing the fertilization rates, the number and quality of embryos obtained as well as the implantation rates in oocyte recipient patients. This study will then allow clinical application of the most efficient protocol for oocyte vitrification in the context of oocyte donation. A cost/effectiveness study will be carried out.
Detailed description
The oocytes will be stored in closed devices (Rapid I® straws for the manual vitrification protocol or pods® in cassettes for the semi-automatic vitrification protocol) in liquid nitrogen. All samples are anonymized in the context of oocyte donation by the medically assisted procreation (PMA) department of Clermont-Ferrand University Hospital, according to the method usually used.
The oocyte survival rate will be evaluated by the service technician or biologist. This survival rate corresponds to the ratio between the number of oocytes intact 2 hours after warming and able to be microinjected with a spermatozoon (ICSI), and the number of oocytes heated, after vitrification. We will compare the oocyte survival rate after vitrification and semi-automatic warming vs. after manual vitrification.
The investigator will compare the effectiveness of ART with oocyte donation during semi-automatic vitrification of oocytes compared to the manual technique, with regard to:
- Oocyte functional quality after warming evaluated by the fertilization rate of oocytes after ICSI
- Early development of embryos:
- the number of embryos cleaved on the 2nd day of culture from vitrified oocytes, the blastulation rate defined by the ratio between the number of blastocysts obtained (Gardner classification on the 5th day of culture) and the total number of cleaved embryos.
These parameters will be assessed daily during the embryo reading by a technician or a biologist from the ART department.
We will also compare the effectiveness of ART with oocyte donation during the semi-automatic vitrification of oocytes compared to the manual technique, with regard to:
- The implantation rate of embryos from vitrified oocytes, defined by the ratio between the number of embryo sacs observed (6th week of amenorrhea) and the number of embryos transferred
- The rate of miscarriages in oocyte recipients. These parameters will be evaluated by a biologist from the ART department after the results of the beta hCG of the patients and the performance of the ultrasound at the 6th week of amenorrhea by the gynecologists of the ART department.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual vitrification (using Vitrolife system) | Placebo comparator | Device: Vitrolife systemThe vitrification of the oocytes will be carried out by an authorized technician according to the manual protocol validated and used routinely. |
| Semi-automatic vitrification of oocytes using the GAVI® automaton (Merck) | Active comparator | Device: Gavi, Merck® (automated vitrification instrument)The vitrification of the oocytes will be carried out using the GAVI® automaton |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Egg donor
- Oocyte puncture for donation
- Good quality ovarian reserve (Antral follicle count evaluated by ultrasound: CFA ≥ 7)
- Negative serology status (HIV, hepatitis B and C, syphilis, CMV and HTLV)
- Absence of symptoms or COVID contact
Key exclusion criteria (3 listed)
- Decline to participate
- Pregnant and lactating woman
- Person under guardianship, curatorship, deprivation of liberty, protection of justice
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 |
|---|---|---|
| Gavi, Merck® (automated vitrification instrument)This instrument recently appeared on the market and demonstrated a high effectiveness in terms of processing time and reproducibility for embryo vitrification. To date, no study has analyzed the efficiency of this automated vitrification instrument on oocyte vitrification. The oocytes will be stored in closed cassettes in liquid nitrogen | Device | Semi-automatic vitrification of oocytes using the GAVI® automaton (Merck) |
| Vitrolife systemThe oocytes vitrification will be carried out by an authorized technician according to the manual protocol validated and used routinely. | Device | Manual vitrification (using Vitrolife system) |
Primary outcome
Oocyte survival
Time frame: two years after the inclusion
Oocyte survival after semi-automated vitrification by the GAVI® device compared to the manual technique (Vitrolife) with egg donation. A warmed oocyte that has survived can then be used in AMP by ICSI technique.
2 secondary outcomes
Effectiveness of ART with egg donation after oovcytes semi-automated vitrification
Time frame: two years after vitrification
Study the costs and cost-effectiveness
Time frame: at the end of the study 24 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 30 Apr 2026.
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Ultra-rapid Blastocyst Vitrification: Pilot Randomized Study
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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.
CHU de Clermont-Ferrand
Clermont-Ferrand, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gavi, Merck® (automated vitrification instrument) and Vitrolife system in people with Vitrification and Egg Donor, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 8 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 30 Apr 2026. 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 France. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oocyte survival (time frame: two years after the inclusion). 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 30 Apr 2026.