Vitrification and Slow Freezing for Cryopreservation of Blastocyst
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
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Clermont-Ferrand, France, 63003
- Recruiting
- CHU de Clermont-Ferrand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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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.
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Other Names:
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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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Cumulative delivery rate after fresh and frozen/thawed embryo transfers
Time Frame: 9 months after embryo transfer
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9 months after embryo transfer
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Delivery rate after fresh embryo transfer
Time Frame: 9 months after embryo transfer
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9 months after embryo transfer
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Delivery rate after transfer of frozen embryos (slow freezing)
Time Frame: 9 months after embryo transfer
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9 months after embryo transfer
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Delivery rate after transfer of frozen embryos (vitrification)
Time Frame: 9 months after embryo transfer
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9 months after embryo transfer
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Neonatal outcome
Time Frame: 9 months after embryo transfer
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9 months after embryo transfer
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Brugnon Florence, CHU de Clermont-Ferrand
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-0181
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