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

NCT07288866 | Completed

• 1 other identifier: 2025_BRUGNON
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Infertility, Female

Keywords

Cryopreservation; Cryobiology; Vitrification; Oocyte donation; Cryoprotective Agents

Outcome Measures

Primary Outcomes (1)

• 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

  UltraSound at 1 month after embryo transfer

Secondary Outcomes (9)

• Impact of vitrification and warming media on oocyte survival rate

  two hours after warming procedure

• Impact of vitrification and warming media on fertilization rate

  16-18 hours

• Impact of vitrification and warming media on day-2 embryo percentage

  43-45 hours

• Impact of vitrification and warming media on top-quality embryo percentage

  43-45 hours

• Impact of vitrification and warming media on blastulation rate

  114-118 hours

Study Arms (3)

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

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

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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Oocyte recipient couples undergoing an oocyte donation ICSI

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

MeSH Terms

Conditions

Infertility; Infertility, Female

Interventions

Vitrification

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phase Transition; Physical Phenomena

Study Officials

• Florence Brugnon

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: July 1, 2015
• Primary Completion: July 2, 2020
• Study Completion: August 1, 2021
• Last Updated: January 28, 2026

Record last verified: 2024-04

Locations

FR (1)