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Comparison Between Three Freezing Protocols to Preserve Human Embryos

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fasano Giovanna, Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT00910390
First received: May 28, 2009
Last updated: July 25, 2016
Last verified: July 2016
  Purpose
This randomized study compares three different freezing methods to store human in vitro fertilization (IVF) embryos: vitrification with two commercial kits or slow freezing. After information, all patients undergoing IVF treatment can be included in the study. If qualified, embryos at different developmental stages will be allocated between the three methods. At the end of the first year survival and developmental rates, and implantation and pregnancy rates will be analyzed in order to determine the best method.

Condition Intervention
Human Embryo Cryopreservation
Other: Slow freezing
Other: VIT-Irvine
Other: Vit-Vitrolife

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparison to Freeze Human Embryos by Either Vitrification or Slow Freezing Protocols

Further study details as provided by Erasme University Hospital:

Primary Outcome Measures:
  • Survival embryo rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Delivery rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 584
Study Start Date: April 2009
Study Completion Date: May 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Slow Freezing
Standard freezing protocol (slow freezing) of preimplantation embryos
Other: Slow freezing
Embryos at different developmental stages will be frozen using a solution that contains propanediol and sucrose, individually placed in high security straws, cooled with a programmator and stored in liquid nitrogen.
Other Names:
  • Home-made solutions
  • propanediol
Experimental: VIT-Irvine
Vitrification with Irvine solution (rapid freezing) of preimplantation embryos
Other: VIT-Irvine
Embryos at different developmental stages will be frozen using the vitrification solution according to the manufacturer's instructions, individually placed in high security vitrification devices and plunged directly in liquid nitrogen for storing.
Other Names:
  • IRVINE, California
  • ethylene glycol
  • DMSO
Experimental: VIT-Vitrolife
Vitrification (rapid freezing) with Vitrolife solution
Other: Vit-Vitrolife
Embryos at different developmental stages will be frozen using the vitrification solution according to the manufacturer's instructions, individually placed in high security vitrification devices and plunged directly in liquid nitrogen for storing.
Other Names:
  • VITROLIFE, Sweden
  • ethylene glycol
  • propanediol

Detailed Description:

Despite all the advances achieved in vitro fertilized treatments, it is known that the chances of implantation for fertilised in vitro embryo remain limited, at around 20%. Cryopreservation of supernumerary embryos produced during IVF cycles provides an opportunity for patients to increase the number of transfers per oocyte harvest cycle, increasing then their chances of conception.

The freezing technique may involve different media and methods, which lead to different survival and developmental rates after thawing.

Vitrification is a new freezing method, which consists in exposing cells to high concentrations of cryoprotectants and then cooling them ultra-rapidly; this induces an increase in viscosity which favours the formation of a vitreous state without any ice crystals formation. This method contrasts with the slow freezing method (currently employed), which is based on exposure to very low concentrations of cryoprotectants combined with long cooling times and associated with a higher risk of ice crystal formation.

Both methods can reduce cell survival and embryo ability to develop, either by the high concentrations of cryoprotectants in case of vitrification, or by ice crystals formation in case of slow freezing. The advantages of vitrification in embryology may be considerable because embryos seem more sensitive to ice crystal formation than to cyroportectant concentration; consequently, the elimination of office crystal injury may increase their survival chances. Additionally in the case of vitrification, the time required for equilibration and cooling is considerably reduced as well as the need for expensive equipment such as programmable machine is eliminated.

At present, vitrification and slow freezing are used for the cryopreservation of oocytes and embryos at all stages of development. Encouraging results have been obtained with vitrification, but no study has randomly compared in one study, the two protocols and cryoprotectors. The purpose of this clinic randomised study is to compare three treatments: traditional slow freezing method currently employed (control group) and two different commercial vitrification methods (experimental groups) to assess the efficacy that this technique may involve.

  Eligibility

Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infertility requiring IVF

Exclusion Criteria:

  • Women's age > 43 years
  • Patients positive for hepatitis B or C
  • Patients positive for HIV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910390

Locations
Belgium
IVF laboratory, Hospital Erasme, Route de Lennik 808
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
Investigators
Study Director: Anne Delbaere, Ph.D. Fertility Clinic, Hospital Erasme
  More Information

Publications:

Responsible Party: Fasano Giovanna, Clinical Embryologist, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT00910390     History of Changes
Other Study ID Numbers: VITR-1-EMBRYOS 
Study First Received: May 28, 2009
Last Updated: July 25, 2016
Health Authority: Belgium: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Erasme University Hospital:
IVF
embryo cryopreservation
vitrification
Human Embryo
Embryonic development
Pregnancy rate

Additional relevant MeSH terms:
Pharmaceutical Solutions
Ethylene
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016