InfertilityNCT07288866
Effect of Vitrification and Warming Media on Pregnancy Rates in the Context of Oocyte Donation
An observational study of Infertility and Infertility, Female, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Vitrification has become the gold standard for oocyte and embryo cryopreservation. Several commercial kits are available on the market, some are designed for specific developmental stages (e.g. Read more about this study
- Who is it for?
- Ages 18 to 43 years
- Conditions the study is for
- Infertility, Infertility, Female
- What is being tested?
- Vitrification and warming media for oocyte vitrification
- How many people
- 111 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2015to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 43 years
- All sexes
- No healthy volunteers
- Adult
Study population: Oocyte recipient couples undergoing an oocyte donation ICSI
Who may be able to join
- Recipient couples undergoing an oocyte donation ICSI cycle from March 2016 to July 2020 for whom the allocated oocytes were vitrified in our center between July 2015 and January 2020
Who cannot join
- Recipient couples undergoing an oocyte donation ICSI cycle from March 2016 to July 2020 for whom the allocated oocytes were vitrified prior to July 2015 or after January 2020.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Use of Oocyte-specific or Universal Vitrification and Warming Media on Pregnancy Rates in the Context of Oocyte Donation
Vitrification has become the gold standard for oocyte and embryo cryopreservation. Several commercial kits are available on the market, some are designed for specific developmental stages (e.g. oocytes, zygotes, cleavage-stage embryos or blastocysts) and others are suitable for several stages, therefore termed "universal". Oocytes, cleavage-stage embryos and blastocysts display different levels of resistance to cryopreservation, due to stage-specific properties. While the composition and the exposition protocol of stage specific media are optimized for specific developmental stages, "universal" media display a single composition, therefore exposition protocols should be adapted to each specific developmental stage to ensure optimal survival rates.
The main objective of this study is to determine whether the shift from "oocyte specific" vitrification and warming media to "universal" media has an impact oocyte survival, embryological and clinical outcomes.
Read the detailed description
A retrospective, monocentric study comparing the clinical and embryological outcomes of 111 oocyte recipient cycles with ICSI from March 2016 to July 2020. Baseline characteristics (donor age and BMI, ovarian stimulation protocol, number of collected oocytes) of the 81 related donations were also analysed.
Two generations of vitrification and warming media were used during this period:
- "Oocyte-specific": RapidVit™ Oocyte and RapidWarm™ Oocyte, Vitrolife
- "Universal": RapidVit™ Omni and RapidWarm™ Omni, Vitrolife Patients were divided in 3 groups according to the combination of the vitrification medium and the warming medium : "specific/specific" (S/S), "specific/universal" (S/U) and "universal/universal" (U/U)..
- Conditions
- Infertility, Infertility, Female
- Being tested
- Vitrification and warming media for oocyte vitrification
- Keywords
- Cryopreservation, Cryobiology, Vitrification, Oocyte donation, Cryoprotective Agents
- Medical subject headings
- Infertility, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrification and warming media for oocyte vitrificationOther
Different combinations of the vitrification and warming media were used for oocyte vitrification procedure in the context of oocyte donation
| Study group | Role | What they receive |
|---|---|---|
| S/S - Vitrified and warmed with Oocyte-specific medium | 41 oocyte recipient ICSI cycles for which the initial oocyte vitrification procedure was performed with "oocyte- specific" medium RapidVit™ Oocyte (Vitrolife) and the warming procedure was performed with "oocyte-specific" medium RapidWarm™ Oocyte (Vitrolife) Receives: Other: Vitrification and warming media for oocyte vitrification | |
| S/U - Vitrified with Oocyte-specific medium, Warmed with universal medium | 39 oocyte recipient ICSI cycles for which the initial oocyte vitrification procedure was performed with "oocyte- specific" medium RapidVit™ Oocyte (Vitrolife) and the warming procedure was performed with "universal" medium RapidWarm™ Omni (Vitrolife) Receives: Other: Vitrification and warming media for oocyte vitrification | |
| U/U - Vitrified and warmed with universal medium | 31 oocyte recipient ICSI cycles for which the initial oocyte vitrification procedure was performed with "universal" medium RapidVit™ Oocyte (Vitrolife) and the warming procedure was performed with "universal" medium RapidWarm™ Omni (Vitrolife) Receives: Other: Vitrification and warming media for oocyte vitrification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of vitrification and warming media on clinical pregnancy rate per fresh embryo transfer
number of clinical pregnancies (one or more gestational sacs visualized in ultrasonography) expressed per 100 embryo transfers
Measured: UltraSound at 1 month after embryo transfer
Secondary outcomes (9)
Impact of vitrification and warming media on oocyte survival rate
the number of injected oocytes divided by the number of warmed oocytes, expressed as a percentage (%)
Measured: two hours after warming procedure
Impact of vitrification and warming media on fertilization rate
number of 2PN zygotes divided by the number of injected oocytes, expressed as a percentage (%)
Measured: 16-18 hours
Impact of vitrification and warming media on day-2 embryo percentage
number of cleavage-stage embryos obtained divided by the number of 2PN zygotes, expressed as a percentage (%)
Measured: 43-45 hours
Impact of vitrification and warming media on top-quality embryo percentage
Number of top-quality cleavage-stage embryos obtained divided by the total number of cleavage stage embryos, expressed as a percentage (%).
Measured: 43-45 hours
Impact of vitrification and warming media on blastulation rate
number of blastocysts obtained divided by the number of embryos subjected to extended culture, expressed as a percentage (%)
Measured: 114-118 hours
Impact of vitrification and warming media on good quality blastocyst rate
number of good quality blastocysts (ICM and trophoectoderm grade A or B obtained divided by the total number of blastocysts obtained, expressed as a percentage (%)
Measured: 114-118 hours
Impact of vitrification and warming media on implantation rate
number of gestational sacs with a cardiac activity visualized in ultrasonography divided by the number of embryo transferred, expressed as a percentage (%)
Measured: 114-118 hours
Impact of vitrification and warming media on live birth rate per embryo transfer
number live births expressed per 100 embryo transfers
Measured: 42 weeks
Impact of vitrification and warming media on miscarriage rate per embryo transfer
number miscarriages expressed per 100 embryo transfers
Measured: up to 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Jul 2015
- Primary completion2 Jul 2020
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Brugnon, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288866
- Sponsor's protocol ID
- 2025_BRUGNON
- Status last verified
- Apr 2024
- First submitted
- 4 Dec 2025
- Last updated
- 28 Jan 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use of Oocyte-specific or Universal Vitrification and Warming Media on Pregnancy Rates in the Context of Oocyte Donation
- ClinicalTrials.gov ID
- NCT07288866
- Acronym / sponsor ID
- 2025_BRUGNON
- Conditions
- Infertility, Infertility, Female
- Keywords
- Cryopreservation, Cryobiology, Vitrification, Oocyte donation, Cryoprotective Agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 17 Dec 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.
Vitrification has become the gold standard for oocyte and embryo cryopreservation. Several commercial kits are available on the market, some are designed for specific developmental stages (e.g. oocytes, zygotes, cleavage-stage embryos or blastocysts) and others are suitable for several stages, therefore termed "universal". Oocytes, cleavage-stage embryos and blastocysts display different levels of resistance to cryopreservation, due to stage-specific properties. While the composition and the exposition protocol of stage specific media are optimized for specific developmental stages, "universal" media display a single composition, therefore exposition protocols should be adapted to each specific developmental stage to ensure optimal survival rates.
The main objective of this study is to determine whether the shift from "oocyte specific" vitrification and warming media to "universal" media has an impact oocyte survival, embryological and clinical outcomes.
Detailed description
A retrospective, monocentric study comparing the clinical and embryological outcomes of 111 oocyte recipient cycles with ICSI from March 2016 to July 2020. Baseline characteristics (donor age and BMI, ovarian stimulation protocol, number of collected oocytes) of the 81 related donations were also analysed.
Two generations of vitrification and warming media were used during this period:
- "Oocyte-specific": RapidVit™ Oocyte and RapidWarm™ Oocyte, Vitrolife
- "Universal": RapidVit™ Omni and RapidWarm™ Omni, Vitrolife Patients were divided in 3 groups according to the combination of the vitrification medium and the warming medium : "specific/specific" (S/S), "specific/universal" (S/U) and "universal/universal" (U/U)..
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| S/S - Vitrified and warmed with Oocyte-specific medium | – | Other: Vitrification and warming media for oocyte vitrification41 oocyte recipient ICSI cycles for which the initial oocyte vitrification procedure was performed with "oocyte- specific" medium RapidVit™ Oocyte (Vitrolife) and the warming procedure was performed with "oocyte-specific" medium RapidWarm™ Oocyte (Vitrolife) |
| S/U - Vitrified with Oocyte-specific medium, Warmed with universal medium | – | Other: Vitrification and warming media for oocyte vitrification39 oocyte recipient ICSI cycles for which the initial oocyte vitrification procedure was performed with "oocyte- specific" medium RapidVit™ Oocyte (Vitrolife) and the warming procedure was performed with "universal" medium RapidWarm™ Omni (Vitrolife) |
| U/U - Vitrified and warmed with universal medium | – | Other: Vitrification and warming media for oocyte vitrification31 oocyte recipient ICSI cycles for which the initial oocyte vitrification procedure was performed with "universal" medium RapidVit™ Oocyte (Vitrolife) and the warming procedure was performed with "universal" medium RapidWarm™ Omni (Vitrolife) |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Oocyte recipient couples undergoing an oocyte donation ICSI
Key inclusion criteria (1 listed)
- Recipient couples undergoing an oocyte donation ICSI cycle from March 2016 to July 2020 for whom the allocated oocytes were vitrified in our center between July 2015 and January 2020
Key exclusion criteria (1 listed)
- Recipient couples undergoing an oocyte donation ICSI cycle from March 2016 to July 2020 for whom the allocated oocytes were vitrified prior to July 2015 or after January 2020.
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 |
|---|---|---|
| Vitrification and warming media for oocyte vitrificationDifferent combinations of the vitrification and warming media were used for oocyte vitrification procedure in the context of oocyte donation | Other | S/S - Vitrified and warmed with Oocyte-specific medium, S/U - Vitrified with Oocyte-specific medium, Warmed with universal medium, U/U - Vitrified and warmed with universal medium |
Primary outcome
Impact of vitrification and warming media on clinical pregnancy rate per fresh embryo transfer
Time frame: UltraSound at 1 month after embryo transfer
number of clinical pregnancies (one or more gestational sacs visualized in ultrasonography) expressed per 100 embryo transfers
9 secondary outcomes
Impact of vitrification and warming media on oocyte survival rate
Time frame: two hours after warming procedure
Impact of vitrification and warming media on fertilization rate
Time frame: 16-18 hours
Impact of vitrification and warming media on day-2 embryo percentage
Time frame: 43-45 hours
Impact of vitrification and warming media on top-quality embryo percentage
Time frame: 43-45 hours
Impact of vitrification and warming media on blastulation rate
Time frame: 114-118 hours
Impact of vitrification and warming media on good quality blastocyst rate
Time frame: 114-118 hours
Impact of vitrification and warming media on implantation rate
Time frame: 114-118 hours
Impact of vitrification and warming media on live birth rate per embryo transfer
Time frame: 42 weeks
Impact of vitrification and warming media on miscarriage rate per embryo transfer
Time frame: up to 42 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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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. This study is not recruiting at the moment.
Florence Brugnon principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Infertility, Female, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Jan 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of vitrification and warming media on clinical pregnancy rate per fresh embryo transfer (time frame: UltraSound at 1 month after embryo transfer). 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 28 Jan 2026.