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NCT Number: NCT07288866

Effect of 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.

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Key information

Conditions

Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility, Female Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

About this study

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)..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitrification and warming media for oocyte vitrification

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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 (%)

  2. 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 (%)

  3. 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 (%)

  4. 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 (%).

  5. 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 (%)

  6. 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 (%)

  7. 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 (%)

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Dec 17, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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