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Effect of Vitrification and Warming Media on Pregnancy Rates in the Context of Oocyte Donation

Effect of the Use of Oocyte-specific or Universal Vitrification and Warming Media on Pregnancy Rates in the Context of Oocyte Donation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07288866
Enrollment
111
Registered
2025-12-17
Start date
2015-07-01
Completion date
2021-08-01
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Infertility, Female

Keywords

Cryopreservation, Cryobiology, Vitrification, Oocyte donation, Cryoprotective Agents

Brief 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. 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)..

Interventions

OTHERVitrification and warming media for oocyte vitrification

Different combinations of the vitrification and warming media were used for oocyte vitrification procedure in the context of oocyte donation

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 43 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Impact of vitrification and warming media on clinical pregnancy rate per fresh embryo transferUltraSound at 1 month after embryo transfernumber of clinical pregnancies (one or more gestational sacs visualized in ultrasonography) expressed per 100 embryo transfers

Secondary

MeasureTime frameDescription
Impact of vitrification and warming media on oocyte survival ratetwo hours after warming procedurethe number of injected oocytes divided by the number of warmed oocytes, expressed as a percentage (%)
Impact of vitrification and warming media on fertilization rate16-18 hoursnumber of 2PN zygotes divided by the number of injected oocytes, expressed as a percentage (%)
Impact of vitrification and warming media on day-2 embryo percentage43-45 hoursnumber of cleavage-stage embryos obtained divided by the number of 2PN zygotes, expressed as a percentage (%)
Impact of vitrification and warming media on top-quality embryo percentage43-45 hoursNumber of top-quality cleavage-stage embryos obtained divided by the total number of cleavage stage embryos, expressed as a percentage (%).
Impact of vitrification and warming media on blastulation rate114-118 hoursnumber of blastocysts obtained divided by the number of embryos subjected to extended culture, expressed as a percentage (%)
Impact of vitrification and warming media on good quality blastocyst rate114-118 hoursnumber of good quality blastocysts (ICM and trophoectoderm grade A or B obtained divided by the total number of blastocysts obtained, expressed as a percentage (%)
Impact of vitrification and warming media on implantation rate114-118 hoursnumber of gestational sacs with a cardiac activity visualized in ultrasonography divided by the number of embryo transferred, expressed as a percentage (%)
Impact of vitrification and warming media on live birth rate per embryo transfer42 weeksnumber live births expressed per 100 embryo transfers
Impact of vitrification and warming media on miscarriage rate per embryo transferup to 42 weeksnumber miscarriages expressed per 100 embryo transfers

Countries

France

Contacts

PRINCIPAL_INVESTIGATORFlorence Brugnon

University Hospital, Clermont-Ferrand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026