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Vitrification and Slow Freezing for Cryopreservation of Blastocyst

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Slow freezing versus vitrification
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Slow freezing, Vitrification, Single embryo transfer

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

slow freezing

vitrification

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cumulative delivery rate after fresh and frozen/thawed embryo transfers

Secondary Outcome Measures

Delivery rate after fresh embryo transfer
Delivery rate after transfer of frozen embryos (slow freezing)
Delivery rate after transfer of frozen embryos (vitrification)
Neonatal outcome

Full Information

First Posted
February 20, 2014
Last Updated
February 21, 2014
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Vitrolife
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1. Study Identification

Unique Protocol Identification Number
NCT02068924
Brief Title
Vitrification and Slow Freezing for Cryopreservation of Blastocyst
Official Title
Single Embryo Transfer: Comparison of Slow Freezing and Vitrification at Blastocyst Stage
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Vitrolife

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Slow freezing, Vitrification, Single embryo transfer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
slow freezing
Arm Type
Experimental
Arm Description
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.
Arm Title
vitrification
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Slow freezing versus vitrification
Other Intervention Name(s)
Slow freezing:, G Freeze Kit Blast, Vitrolife, Suede, G-Thaw-kit Blast, Vitrolife, Suede, Vitrification:, RapidVit Blast, Vitrolife, Suede, Rapidwam Blast, Vitrolife, Suede
Primary Outcome Measure Information:
Title
Cumulative delivery rate after fresh and frozen/thawed embryo transfers
Time Frame
9 months after embryo transfer
Secondary Outcome Measure Information:
Title
Delivery rate after fresh embryo transfer
Time Frame
9 months after embryo transfer
Title
Delivery rate after transfer of frozen embryos (slow freezing)
Time Frame
9 months after embryo transfer
Title
Delivery rate after transfer of frozen embryos (vitrification)
Time Frame
9 months after embryo transfer
Title
Neonatal outcome
Time Frame
9 months after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brugnon Florence
Organizational Affiliation
CHU de Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-celrmontferrand.fr

12. IPD Sharing Statement

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Vitrification and Slow Freezing for Cryopreservation of Blastocyst

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