Vitrification and Slow Freezing for Cryopreservation of Blastocyst
Information source: University Hospital, Clermont-Ferrand
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: Slow freezing versus vitrification (Other)
Phase: N/A
Status: Recruiting
Sponsored by: University Hospital, Clermont-Ferrand Official(s) and/or principal investigator(s): Brugnon Florence, Principal Investigator, Affiliation: CHU de Clermont-Ferrand
Overall contact: Patrick LACARIN, Phone: 04 73 75 11 95, Email: placarin@chu-clermontferrand.fr
Summary
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.
Clinical Details
Official title: Single Embryo Transfer: Comparison of Slow Freezing and Vitrification at Blastocyst Stage
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Cumulative delivery rate after fresh and frozen/thawed embryo transfers
Secondary outcome: Delivery rate after fresh embryo transferDelivery rate after transfer of frozen embryos (slow freezing) Delivery rate after transfer of frozen embryos (vitrification) Neonatal outcome
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 36 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Patrick LACARIN, Phone: 04 73 75 11 95, Email: placarin@chu-clermontferrand.fr
CHU de Clermont-Ferrand, Clermont-Ferrand 63003, France; Recruiting Patrick LACARIN, Phone: 04 73 75 11 95, Email: placarin@chu-celrmontferrand.fr
Additional Information
Starting date: February 2014
Last updated: February 21, 2014
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