The Effect of Vitrification Versus Slow Freezing on Day 3: a Randomised Controlled Trial.

Cryopreservation of Embryos Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02013024
• Other study ID #: S53410
• Status: Completed
• Phase: N/A
• First received: December 11, 2013
• Last updated: February 4, 2015
• Start date: September 2011
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial Summary

Randomized controlled trial (RCT) testing the hypothesis that vitrification is superior to slow freezing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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)

• One inclusion in the study per patient.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cryopreservation of Embryos

Intervention

Other:
• cryopreservation technique

Locations

Country	Name	City	State
Belgium	Leuven University Fertility Center	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Sophie Debrock

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Life birth rate per embryo thawed		3 years	No
Secondary	live birth rate per embryo transferred		3	No
Secondary	survival rate		3 year	Yes
Secondary	implantation rate per embryo transferred		3 years	No
Secondary	implantation rate per embryo thawed		3 years	No
Secondary	abortion rate		3 years	Yes