Vitrification and Slow Freezing for Cryopreservation of Blastocyst

February 21, 2014 updated by: University Hospital, Clermont-Ferrand

Single Embryo Transfer: Comparison of Slow Freezing and Vitrification at Blastocyst Stage

Improvement in the treatment of infertility by Assisted Reproductive Techniques (ART) allows single embryo transfer to be applied without compromising pregnancy rates after the first in vitro fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) attempt in women less than 36 years old with good embryo quality. The policy of transferring more than one embryo after IVF or ICSI has been the main reason for the numerous twin or triple pregnancies reported in Europe and United States over the past 15 years. These multiple pregnancies are the main disadvantage of ART because of their negative impact on obstetrical, neonatal and economic outcome. In the past, embryos were replaced in the uterus on either Day-2 or 3 of development at the cleavage stage. With the development of physiologically-based sequential culture media, it has also been suggested that extending embryo culture to Day-5 in order to transfer the embryo at the blastocyst stage would enhance the likelihood of pregnancy. Nevertheless, it has been observed higher pregnancy rate after the transfer of fresh blastocyst but not after the transfer of thawed blastocyst frozen by slow freezing procedure.

However a recent embryo freezing technique (vitrification) seems to show significant higher pregnancy rates when blastocyst are frozen by this method. To our knowledge, no publications have reported the outcome of single embryo transfer at blastocyst stage by a prospective randomized and comparative study including the results of fresh and frozen/thawed blastocyst by these two methods (slow freezing vs. vitrification) in case of single embryo transfer .

Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Improvement in the treatment of infertility by Assisted Reproductive Techniques (ART) allows single embryo transfer to be applied without compromising pregnancy rates after the first in vitro fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) attempt in women less than 36 years old with good embryo quality. The policy of transferring more than one embryo after IVF or ICSI has been the main reason for the numerous twin or triple pregnancies reported in Europe and United States over the past 15 years. These multiple pregnancies are the main disadvantage of ART because of their negative impact on obstetrical, neonatal and economic outcome. In the past, embryos were replaced in the uterus on either Day-2 or 3 of development at the cleavage stage. With the development of physiologically-based sequential culture media, it has also been suggested that extending embryo culture to Day-5 in order to transfer the embryo at the blastocyst stage would enhance the likelihood of pregnancy. Nevertheless, it has been observed higher pregnancy rate after the transfer of fresh blastocyst but not after the transfer of thawed blastocyst frozen by slow freezing procedure.

However a recent embryo freezing technique (vitrification) seems to show significant higher pregnancy rates when blastocyst are frozen by this method. To our knowledge, no publications have reported the outcome of single embryo transfer at blastocyst stage by a prospective randomized and comparative study including the results of fresh and frozen/thawed blastocyst by these two methods (slow freezing vs. vitrification) in case of single embryo transfer .

Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 36 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • woman < 36 years old
  • first IVF or ICSI attempt with ejaculated sperm
  • at least 5 ovocytes at the pick up
  • at least 3 top embryos at day-2
  • at least one supernumerary blastocyst with good quality at day-5 or day-6

Exclusion Criteria:

  • - woman : FSH >12UI/l
  • ICSI with epididymal or testicular spermatozoa
  • None supernumerary blastocyst with good quality at day-5 or day-6
  • Refuse by the couple to have an embryo transfer at day-5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: slow freezing
Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure.
Other: Slow freezing versus vitrification
Other Names:
  • Slow freezing:
  • G Freeze Kit Blast, Vitrolife, Suede
  • G-Thaw-kit Blast, Vitrolife, Suede
  • Vitrification:
  • RapidVit Blast, Vitrolife, Suede
  • Rapidwam Blast, Vitrolife, Suede
OTHER: vitrification
Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure.
Other: Slow freezing versus vitrification
Other Names:
  • Slow freezing:
  • G Freeze Kit Blast, Vitrolife, Suede
  • G-Thaw-kit Blast, Vitrolife, Suede
  • Vitrification:
  • RapidVit Blast, Vitrolife, Suede
  • Rapidwam Blast, Vitrolife, Suede

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative delivery rate after fresh and frozen/thawed embryo transfers
Time Frame: 9 months after embryo transfer
9 months after embryo transfer

Secondary Outcome Measures

Outcome Measure
Time Frame
Delivery rate after fresh embryo transfer
Time Frame: 9 months after embryo transfer
9 months after embryo transfer
Delivery rate after transfer of frozen embryos (slow freezing)
Time Frame: 9 months after embryo transfer
9 months after embryo transfer
Delivery rate after transfer of frozen embryos (vitrification)
Time Frame: 9 months after embryo transfer
9 months after embryo transfer
Neonatal outcome
Time Frame: 9 months after embryo transfer
9 months after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Vitrolife

Investigators

  • Principal Investigator: Brugnon Florence, CHU de Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ANTICIPATED)

March 1, 2018

Study Completion (ANTICIPATED)

March 1, 2018

Study Registration Dates

First Submitted

February 20, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (ESTIMATE)

February 21, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 24, 2014

Last Update Submitted That Met QC Criteria

February 21, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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