Vitrification and Slow Freezing for Cryopreservation of Blastocyst

NCT02068924 | Unknown

• 1 other identifier: CHU-0181
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Slow freezing; Vitrification; Single embryo transfer

Outcome Measures

Primary Outcomes (1)

• Cumulative delivery rate after fresh and frozen/thawed embryo transfers

  9 months after embryo transfer

Secondary Outcomes (4)

• Delivery rate after fresh embryo transfer

  9 months after embryo transfer

• Delivery rate after transfer of frozen embryos (slow freezing)

  9 months after embryo transfer

• Delivery rate after transfer of frozen embryos (vitrification)

  9 months after embryo transfer

• Neonatal outcome

  9 months after embryo transfer

Study Arms (2)

slow freezing

EXPERIMENTAL

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

vitrification

OTHER

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

Interventions

Slow freezing versus vitrification OTHER

Also known as: Slow freezing:, G Freeze Kit Blast, Vitrolife, Suede, G-Thaw-kit Blast, Vitrolife, Suede, Vitrification:, RapidVit Blast, Vitrolife, Suede, Rapidwam Blast, Vitrolife, Suede

slow freezing; vitrification

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Vitrolife: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Vitrification

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phase Transition; Physical Phenomena

Study Officials

• Brugnon Florence

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 21, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: February 24, 2014

Record last verified: 2014-02

Locations

FR (1)