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AzTrials

InfertilityNCT07556601

Ultra-rapid Blastocyst Vitrification: Pilot Randomized Study

A study testing Standard Vitrification and Ultra-Rapid Vitrification in people with Infertility, run by Fundacion Dexeus at 2 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Blastocyst vitrification is standard in assisted reproduction, but clinical data on ultra-rapid vitrification are limited. This pilot study evaluates the safety, feasibility, and preliminary clinical performance of an ultra-rapid blastocyst vitrification protocol compared with the standard approach. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Infertility
What is being tested?
Standard Vitrification and Ultra-Rapid Vitrification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesSpain
Study dates
1 Jun 2026to Mar 2028
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 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Recipients of donor oocytes
  • Blastocysts suitable for cryopreservation

Who cannot join

  • Cycles involving PGT
  • Cycles not reaching blastocyst stage.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Monica Parriego, PhD contact

0034932274700

monpar@dexeus.com

Ignacio Rodríguez, MSc contact

0034932274700 ext. 22029

nacrod@dexeus.com

Spain2 sites, 2 recruiting
  • Hospital Universitario Quiron Dexeus

    Barcelona, 08028

    Monica Parriego, PhD, 0034932274700, monpar@dexeus.com

    Ignacio Rodriguez, MSc, 0034932274700, nacrod@dexeus.com

    Not yet recruiting
  • Hospital Universitario Quiron Dexeus

    Barcelona, 08028

    Ignacio Rodríguez, MSc, 0034932274700, nacrod@dexeus.com

    Recruiting

Other trials in Spain

About this study

Official title: Clinical Validation of Ultra-rapid Blastocyst Vitrification: a Randomized Pilot Study in Oocyte Donation Cycles

Blastocyst vitrification is standard in assisted reproduction, but clinical data on ultra-rapid vitrification are limited. This pilot study evaluates the safety, feasibility, and preliminary clinical performance of an ultra-rapid blastocyst vitrification protocol compared with the standard approach.

Read the detailed description

Blastocyst cryopreservation by vitrification is currently the standard approach in assisted reproductive technology, providing high post-warming survival rates and clinical outcomes comparable to those of fresh embryo transfer. Ongoing refinements of vitrification techniques aim to further improve laboratory efficiency and workflow while maintaining biological safety and clinical effectiveness.

Ultra-rapid vitrification protocols have been developed to shorten equilibration times by modifying exposure kinetics to cryoprotectants, while preserving the fundamental biophysical principles of vitrification. Although ultra-rapid warming protocols are well established, clinical data specifically evaluating ultra-rapid vitrification of blastocysts remain limited.

Moreover, ultra-rapid vitrification requires mechanical collapse of the blastocyst before cooling, introducing an additional embryological manipulation with potential biological implications that warrant careful clinical validation. In this context, the present pilot study aims to evaluate the safety, feasibility, and preliminary clinical performance of ultra-rapid blastocyst vitrification compared with the standard vitrification protocol, prior to broader clinical implementation.

Conditions
Infertility
Being tested
Standard Vitrification, Ultra-Rapid Vitrification
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard VitrificationOther

    1. Equilibration step: Blastocysts are equilibrated in Equilibration Solution (ES) for 10-12 minutes at room temperature.
    2. Vitrification solution exposure: Blastocysts are then transferred to Vitrification Solution (VS) for a maximum exposure time of 90 seconds.
    3. Loading: The blastocyst is loaded onto a Cryotop device (Kitazato).
    4. Vitrification: The Cryotop is plunged directly into liquid nitrogen within 1 second of loading to ensure ultra-rapid cooling.
    5. Capping: The Cryotop is immediately capped under liquid nitrogen conditions.
  • Ultra-Rapid VitrificationOther

    The ultra-rapid vitrification protocol is identical to the standard protocol in terms of media, devices, and laboratory conditions, with the following modifications:

    Preparation step - Blastocyst shrinkage: Prior to equilibration, artificial collapse of the blastocyst is performed using a single laser pulse to induce blastocoel shrinkage.

    The subsequent steps are:

    1. Equilibration step: Blastocysts are equilibrated in Equilibration Solution (ES) for 2-4 minutes.
    2. Vitrification solution exposure: Transfer to Vitrification Solution (VS) for a maximum of 90 seconds.
    3. Loading: Loading of the blastocyst onto a Cryotop device.
    4. Vitrification: Immediate plunging of the Cryotop into liquid nitrogen within 1 second.
    5. Capping: Immediate capping under liquid nitrogen.
Study groups in NCT07556601
Study groupRoleWhat they receive
Standard Vitrification ProtocolActive comparatorThe standard vitrification protocol corresponds to the routine clinical practice of the laboratory and consists of the following steps: 1. Equilibration step: Blastocysts are equilibrated in Equilibration Solution (ES) for 10-12 minutes at room temperature. 2. Vitrification solution exposure: Blastocysts are then transferred to Vitrification Solution (VS) for a maximum exposure time of 90 seconds. 3. Loading: The blastocyst is loaded onto a Cryotop device (Kitazato). 4. Vitrification: The Cryotop is plunged directly into liquid nitrogen within 1 second of loading to ensure ultra-rapid cooling. 5. Capping: The Cryotop is immediately capped under liquid nitrogen conditions.
Receives: Other: Standard Vitrification
Ultra-Rapid Vitrification ProtocolExperimentalThe ultra-rapid vitrification protocol is identical to the standard protocol in terms of media, devices, and laboratory conditions, with the following modifications: Preparation step - Blastocyst shrinkage: Prior to equilibration, artificial collapse of the blastocyst is performed using a single laser pulse to induce blastocoel shrinkage. The subsequent steps are: 1. Equilibration step: Blastocysts are equilibrated in Equilibration Solution (ES) for 2-4 minutes. Vitrification solution exposure: Transfer to Vitrification Solution (VS) for a maximum of 90 seconds. 3. Loading: Loading of the blastocyst onto a Cryotop device. 4. Vitrification: Immediate plunging of the Cryotop into liquid nitrogen within 1 second. 5. Capping: Immediate capping under liquid nitrogen.
Receives: Other: Ultra-Rapid Vitrification

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-warming survival rate

    the proportion of vitrified blastocysts that remain morphologically viable after warming, expressed as a percentage of all warmed blastocysts.

    Measured: Immediately after warming (within the same laboratory session)

  2. Clinical pregnancy rate per transfer (only first transfer will be considered).

    defined as the proportion of embryo transfers resulting in a clinical pregnancy, confirmed by the presence of an intrauterine gestational sac on ultrasound. Only the first embryo transfer per patient is included in the analysis.

    Measured: 6-8 weeks after embryo transfer

Secondary outcomes (4)
  1. Blastocyst re-expansion

    defined as the resumption of blastocoel expansion after warming, as assessed by partial or complete reformation of the blastocyst cavity, indicating post-warming viability

    Measured: Within 2 hours after warming

  2. Post-warming blastocyst morphokinetic parameters

    Assessment of post-warming embryo developmental dynamics based on time-lapse observation. Morphokinetic parameters will include time to blastocoel re-expansion and time to resumption of blastocyst development, measured in hours from warming to embryo transfer.

    Measured: From embryo warming until embryo transfer (within 2-6 hours post-warming)

  3. Post-warming blastocyst morphological quality

    Evaluation of blastocyst morphological quality after warming and prior to embryo transfer. Blastocysts will be graded according to standard morphological criteria based on blastocoel expansion, inner cell mass quality, and trophectoderm appearance. Results will be reported as the proportion of embryos achieving good-quality blastocyst grade per standard scoring system.

    Measured: From embryo warming until embryo transfer (within 2-6 hours post-warming)

  4. Technical or embryological adverse events.

    defined as any unexpected or unfavorable technical or laboratory-related events occurring during blastocyst warming, handling, culture, or preparation for transfer, including damage to the embryo, procedural errors, or protocol deviations that may affect embryo viability.

    Measured: From blastocyst warming until embryo transfer, within the same clinical procedure (up to 6 hours post-warming)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study start1 Jun 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07556601
Sponsor's protocol ID
FSD-UFV-2026-04
Status last verified
Jun 2026
First submitted
13 Apr 2026
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Boyard J, Reignier A, Chtourou S, Lefebvre T, Barriere P, Freour T. Should artificial shrinkage be performed prior to blastocyst vitrification? A systematic review of the literature and meta-analysis. Hum Fertil (Camb). 2022 Feb;25(1):24-32. doi: 10.1080/14647273.2019.1701205. Epub 2020 Jan 24.

    PubMed 31973647
  • George JS, Keefe KW. Freezer burn or learning curve? Prolonged time since blastocyst vitrification and impact on pregnancy outcomes. Fertil Steril. 2023 Jan;119(1):45-46. doi: 10.1016/j.fertnstert.2022.11.017. Epub 2022 Nov 19. No abstract available.

    PubMed 36410446
  • Gunst J, Joris H, Vynck M, Godderis K, Vercammen M, Roggeman S, van de Vijver A. Validation and clinical study of single-step vitrification combined with single-step warming of human blastocysts. J Assist Reprod Genet. 2026 Mar;43(3):837-850. doi: 10.1007/s10815-025-03790-1. Epub 2026 Feb 13.

    PubMed 41686351
  • Kovacic B, Taborin M, Vlaisavljevic V, Reljic M, Knez J. To collapse or not to collapse blastocysts before vitrification? A matched case-control study on single vitrified-warmed blastocyst transfers. Reprod Biomed Online. 2022 Oct;45(4):669-678. doi: 10.1016/j.rbmo.2022.03.030. Epub 2022 Apr 10.

    PubMed 35963753
  • Li Z, Wang YA, Ledger W, Edgar DH, Sullivan EA. Clinical outcomes following cryopreservation of blastocysts by vitrification or slow freezing: a population-based cohort study. Hum Reprod. 2014 Dec;29(12):2794-801. doi: 10.1093/humrep/deu246. Epub 2014 Oct 14.

    PubMed 25316444
  • Martinez-Rodero I, Gallardo M, Pisaturo V, Scarica C, Conaghan J, Liebermann J, Cuevas-Saiz I. Shorter protocols for vitrification and post-warming dilution of human oocytes and embryos: a narrative review. Reprod Biomed Online. 2025 Aug;51(2):104857. doi: 10.1016/j.rbmo.2025.104857. Epub 2025 Feb 7.

    PubMed 40479947
  • Perez-Sanchez M, Pardinas ML, Diez-Juan A, Quinonero A, Dominguez F, Martin A, Vidal C, Beltran D, Mifsud A, Mercader A, Pellicer A, Cobo A, de Los Santos MJ. The effect of vitrification on blastocyst mitochondrial DNA dynamics and gene expression profiles. J Assist Reprod Genet. 2023 Nov;40(11):2577-2589. doi: 10.1007/s10815-023-02952-3. Epub 2023 Oct 6.

    PubMed 37801195
  • Rienzi L, Gracia C, Maggiulli R, LaBarbera AR, Kaser DJ, Ubaldi FM, Vanderpoel S, Racowsky C. Oocyte, embryo and blastocyst cryopreservation in ART: systematic review and meta-analysis comparing slow-freezing versus vitrification to produce evidence for the development of global guidance. Hum Reprod Update. 2017 Mar 1;23(2):139-155. doi: 10.1093/humupd/dmw038.

    PubMed 27827818
  • Sciorio R, Tramontano L, Campos G, Greco PF, Mondrone G, Surbone A, Greco E, Talevi R, Pluchino N, Fleming S. Vitrification of human blastocysts for couples undergoing assisted reproduction: an updated review. Front Cell Dev Biol. 2024 May 17;12:1398049. doi: 10.3389/fcell.2024.1398049. eCollection 2024.

    PubMed 38827525
  • Sekhon L, Lee JA, Flisser E, Copperman AB, Stein D. Blastocyst vitrification, cryostorage and warming does not affect live birth rate, infant birth weight or timing of delivery. Reprod Biomed Online. 2018 Jul;37(1):33-42. doi: 10.1016/j.rbmo.2018.03.023. Epub 2018 Apr 21.

    PubMed 29706285
  • Van Landuyt L, Polyzos NP, De Munck N, Blockeel C, Van de Velde H, Verheyen G. A prospective randomized controlled trial investigating the effect of artificial shrinkage (collapse) on the implantation potential of vitrified blastocysts. Hum Reprod. 2015 Nov;30(11):2509-18. doi: 10.1093/humrep/dev218. Epub 2015 Sep 12.

    PubMed 26364080

Questions about this trial

What is this clinical trial studying?

A study testing Standard Vitrification and Ultra-Rapid Vitrification in people with Infertility, run by Fundacion Dexeus at 2 sites in Spain.

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 2 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 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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 Monica Parriego, PhD (0034932274700, monpar@dexeus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-warming survival rate (time frame: Immediately after warming (within the same laboratory session)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07556601, which also lists 11 linked publications.

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 Jun 2026.

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