Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-04 @ 9:35 AM
Study NCT ID:
NCT07288866
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2025-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vitrification and Warming Media on Pregnancy Rates in the Context of Oocyte Donation
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Effect of the Use of Oocyte-specific or Universal Vitrification and Warming Media on Pregnancy Rates in the Context of Oocyte Donation
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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)..
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: