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

NCT03478592 | Completed

• 1 other identifier: RC31/16/8766
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Slow-freezing; Vitrification; Automated system; Embryos; Implantation

Outcome Measures

Primary Outcomes (1)

• Implantation rate of frozen/thawed embryos

  The number of implantation embryo with cardiac activity in reference technique and in vitrification technic

  1 month

Secondary Outcomes (3)

• Percentage of intact blastomeres after thawing

  1 month

• Implantation rate of transferred embryos.

  1 month

• Live birth rates

  9 months after the implantation

Study Arms (2)

reference technique slow freezing

EXPERIMENTAL

In reference technique slow freezing arm, embryon will be frozen with the conventional slow freezing procedure with the Freezal device apply a slow decreasing in temperature with moderate cryoprotector concentration

Other: reference technique

vitrification technique

EXPERIMENTAL

In vitrification technique arm, embryon will be frozen with automated vitrification system

Other: vitrification technique

Interventions

reference technique OTHER

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

reference technique slow freezing

vitrification technique OTHER

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

vitrification technique

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Couple whose age is \> 18 years and who are included in a IVF procedure with the possibility to cryopreserve embryos according to criteria applied at the hospital of Toulouse
• Signed informed consent by both partners in a couple
• Affiliation to a social security scheme for both partners of the couple

You may not qualify if:

• Couples who does not meet current requirements described by the bioethics law for accession to the ART procedure
• One of the two partners (or both) is (are) in safeguarding justice, under guardianship or trusteeship.
• Couple included in another interventional study.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Hospital university of Toulouse

Toulouse, 31059, France

Location

Study Officials

• Roger Léandri, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 27, 2018
• Study Start: January 19, 2018
• Primary Completion: February 3, 2021
• Study Completion: February 3, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

FR (1)