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Assessment of the New Automated Vitrification System "GAVI" for Early Cleaved Embryos Cryopreservation

NCT03478592 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 423

Last updated 2021-10-28

No results posted yet for this study

Summary

The meta-analysis comparing the cryopreservation of human embryos by vitrification or slow-freezing suggested that more well design studies as randomized trials are necessary to identify the most successful method for cryopreservation. The efficacy of the vitrification with the GAVI system will be compared with the conventional slow freezing method through a randomized control trial. Couples in IVF attempt will be randomized at the day of embryo cryopreservation by the biologist. Supernumerary frozen embryos will be thawed and transferred in utero in case of failure of the "fresh" embryo transfer. The outcomes of the thawing and frozen/thawed embryo transfer will be assessed. In the two groups, the patients will benefit of the standard IVF procedures applied in the Assisted Reproductive Technologies (ART) center of Toulouse.

Conditions

  • Fertility Disorders

Interventions

OTHER

reference technique

Slow-freezing procedure is the reference technique, actually use at the Toulouse hospital, to cryopreserve embryos. Embryon are frozen with a slow freezing.

OTHER

vitrification technique

Vitrification is the new technique to freeze embryons. In this study, the GAVI system will be use for for embryos automatically vitrification

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Roger Léandri, MD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-19
Primary Completion
2021-02-03
Completion
2021-02-03

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03478592 on ClinicalTrials.gov