The Effect of Vitrification Versus Slow Freezing on Day 3: a Randomised Controlled Trial.
1 other identifier
interventional
417
1 country
1
Brief Summary
Randomized controlled trial (RCT) testing the hypothesis that vitrification is superior to slow freezing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 11, 2013
CompletedFirst Posted
Study publicly available on registry
December 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFebruary 5, 2015
February 1, 2015
2.5 years
December 11, 2013
February 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Life birth rate per embryo thawed
3 years
Secondary Outcomes (5)
live birth rate per embryo transferred
3
survival rate
3 year
implantation rate per embryo transferred
3 years
implantation rate per embryo thawed
3 years
abortion rate
3 years
Study Arms (2)
cryopreservation technique
ACTIVE COMPARATORslow freezing cryopreservation technique
vitrification cryopreservation technique
ACTIVE COMPARATORvitrification cryopreservation technique
Interventions
Eligibility Criteria
You may qualify if:
- Patients (with female age \< 40 years)
- Patients undergoing a 1st oocyte retrieval for an IVF/Intracytoplasmatic Sperm Injection (ICSI) treatment
- Patients planned for an embryo transfer on day 3.
- Patients with supernumerary embryos of sufficient quality for freezing/vitrifying on day 3.
- Fresh personal (own oocytes)
You may not qualify if:
- Patients undergoing a 2nd or higher ranked oocyte retrieval after a fresh cycle with failed pregnancy.
- Female age ≥ 40 year
- Patients with Preimplantation Genetic Diagnosis (PGD)
- Patients with donor oocytes
- Patients with positive serology whose embryos may not be frozen.
- Patients planned for a transfer on day 2 or day 5.
- Patients receiving assisted hatching in the embryo transfer in the frozen cycles.
- Patients who have been included in the study before.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sophie Debrocklead
Study Sites (1)
Leuven University Fertility Center
Leuven, 3000, Belgium
Related Publications (1)
Debrock S, Peeraer K, Fernandez Gallardo E, De Neubourg D, Spiessens C, D'Hooghe TM. Vitrification of cleavage stage day 3 embryos results in higher live birth rates than conventional slow freezing: a RCT. Hum Reprod. 2015 Aug;30(8):1820-30. doi: 10.1093/humrep/dev134. Epub 2015 Jun 18.
PMID: 26089301DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas M D'Hooghe, Prof Dr
Universitaire Ziekenhuizen KU Leuven
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- clinical embryologist PhD
Study Record Dates
First Submitted
December 11, 2013
First Posted
December 17, 2013
Study Start
September 1, 2011
Primary Completion
March 1, 2014
Study Completion
May 1, 2014
Last Updated
February 5, 2015
Record last verified: 2015-02