Vitrification Versus Slow Cooling of Human Cleavage Stage Embryos
NCT00886431 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146
Last updated 2014-12-02
Summary
Human embryos can be preserved for later transfers by freezing. Traditionally the slow cooling method has been used. About 70% of the embryos remain fully intact after thawing. However, the remaining 30% of the embryos become (partially) damaged, and this freezing damage reduces their chance to implant. Recently an ultra rapid freezing method, called vitrification has been developed. During vitrification no damaging ice crystals are formed and the embryo freezes in a glass like state.
It appears that the freezing damage is reduced when embryos are vitrified. Observational studies in humans indicate that embryos are successfully preserved by vitrification, as indicated by promising pregnancy rates following thawing. However, the effectiveness of vitrification in relation to slow cooling with respect to pregnancy rates has so far not been evaluated by a randomised, controlled trial. The aim of this study is to investigate whether vitrification significantly improves embryo survival and ongoing pregnancy rates when compared to embryos frozen by slow cooling.
Conditions
Interventions
- OTHER
-
embryo vitrification
Ultra rapid cooling of embryos by immersion in liquid nitrogen. The formation of potentially damaging ice crystals is prevented by briefly incubating the embryos in high concentrations of a mix of cryoprotectants.
Sponsors & Collaborators
-
Vrije Universiteit Brussel
collaborator OTHER -
UMC Utrecht
lead OTHER
Principal Investigators
-
Bart C Fauser, Prof.,MD,PhD · UMC Utrecht
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-05-31
- Primary Completion
- 2012-05-31
Countries
- Belgium
- Netherlands
Study Locations
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