Contact information
Type
Scientific
Primary contact
Mrs Lisbet Van Landuyt
ORCID ID
Contact details
UZBrussel
Centre for Reproductive Medicine
Laarbeeklaan 101
Brussels
1090
Belgium
+32 (0)2 477 6698
lisbet.vanlanduyt@uzbrussel.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomised controlled trial comparing the implantation potential of a frozen-thawed cleavage-stage embryo cryopreserved using vitrification or slow freezing
Acronym
Study hypothesis
To avoid multiple pregnancies, the proportion of elective single embryo transfers (SET) has increased substantially in our centre. Consequently, the impact of the cryopreservation program on the in vitro fertilisation (IVF)/intra-cytoplasmic sperm injection (ICSI) success rate is augmented since more surplus embryos become available. SET requires a cryopreservation program which optimally preserves the vitality of the surplus embryos. The first step to improve the efficiency of a cryopreservation program is to improve the post-thaw embryo survival. Retrospective analysis of our slow-cooling and thawing cryopreservation program showed that about 35% of day 3 cleavage stage embryos are severely damaged after freezing and thawing and are not suitable for transfer and another 15% is moderately damaged.
According to recent findings, vitrification as a new cryopreservation method is assumed to reduce cryo-damage and thus better preserves the embryo viability. During vitrification the formation of intracellular ice formation is prevented by short incubation of the embryos in high concentrations of cryoprotective agents. Successful vitrification of embryos at all preimplantation stages has been reported. Retrospective analyses show higher or similar survival and implantation rates after vitrification compared to the results obtained after traditional slow freezing and thawing. However, these data remain unvalidated in prospectively randomised studies.
The aim of the study is to compare the live birth rate after transfer of one frozen-thawed day 3 embryo using either vitrification or slow freezing as the cryopreservation method.
Ethics approval
Medical Ethics Committee UZ Brussel-VUB gave approval on the 6th November 2008 (ref: B.U.N B14320084732)
Study design
Double-blinded prospectively randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
In vitro fertilisation
Intervention
IVF patients will receive a frozen-thawed embryo that was frozen using the vitrification method or the standard slow freezing method.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Live birth rate per frozen-thawed embryo
Secondary outcome measures
1. Post-thaw survival of thawed embryos (the percentage of intact blastomeres on the total number of blastomeres present before freezing)
2. Post-thaw development of embryos after overnight culture
3. Implantation rate per transferred embryo
4. Ongoing pregnancy rate per thawing cycle
5. Live birth rate per transferred embryo
Overall trial start date
01/12/2008
Overall trial end date
01/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female aged less than 38 years
2. Patients with day 3 single or double embryo transfer and surplus embryos frozen
3. Cryopreservation criteria:
3.1. 6 - 7 cell embryos on day 3 with less than or equal to 20% fragmentation
3.2. Greater than or equal to 8 cell embryos on day 3 with less than or equal to 50% fragmentation
3.3. No multi-nucleated embryos
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
306
Participant exclusion criteria
Patients with preimplantation genetic diagnosis treatment
Recruitment start date
01/12/2008
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Belgium
Trial participating centre
UZBrussel
Brussels
1090
Belgium
Sponsor information
Organisation
Research Foundation Flanders (Belgium)
Sponsor details
Egmontstraat 5
Brussels
B-1000
Belgium
Sponsor type
Research organisation
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Brussels (Universitair Ziekenhuis Brussel [UZ Brussel]) (Belgium) - covering incidental costs
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list