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

January 26, 2026 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Auvergne
      • Clermont-Ferrand, Auvergne, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Oocyte recipient couples undergoing an oocyte donation ICSI

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Other: Vitrification 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
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)
Other: Vitrification 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
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)
Other: Vitrification 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
UltraSound at 1 month after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of vitrification and warming media on oocyte survival rate
Time Frame: two hours after warming procedure
the number of injected oocytes divided by the number of warmed oocytes, expressed as a percentage (%)
two hours after warming procedure
Impact of vitrification and warming media on fertilization rate
Time Frame: 16-18 hours
number of 2PN zygotes divided by the number of injected oocytes, expressed as a percentage (%)
16-18 hours
Impact of vitrification and warming media on day-2 embryo percentage
Time Frame: 43-45 hours
number of cleavage-stage embryos obtained divided by the number of 2PN zygotes, expressed as a percentage (%)
43-45 hours
Impact of vitrification and warming media on blastulation rate
Time Frame: 114-118 hours
number of blastocysts obtained divided by the number of embryos subjected to extended culture, expressed as a percentage (%)
114-118 hours
Impact of vitrification and warming media on implantation rate
Time Frame: 114-118 hours
number of gestational sacs with a cardiac activity visualized in ultrasonography divided by the number of embryo transferred, expressed as a percentage (%)
114-118 hours
Impact of vitrification and warming media on live birth rate per embryo transfer
Time Frame: 42 weeks
number live births expressed per 100 embryo transfers
42 weeks
Impact of vitrification and warming media on miscarriage rate per embryo transfer
Time Frame: up to 42 weeks
number miscarriages expressed per 100 embryo transfers
up to 42 weeks
Impact of vitrification and warming media on top-quality embryo percentage
Time Frame: 43-45 hours
Number of top-quality cleavage-stage embryos obtained divided by the total number of cleavage stage embryos, expressed as a percentage (%).
43-45 hours
Impact of vitrification and warming media on good quality blastocyst rate
Time Frame: 114-118 hours
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 (%)
114-118 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Florence Brugnon, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

July 2, 2020

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025_BRUGNON

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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