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

Not Applicable

Completed

• Conditions: Cryopreservation of Embryos

• Registration Number: NCT02013024
• Lead Sponsor: Sophie Debrock

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-17
• Primary Completion: 2014-03
• Study Completion: 2014-05
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-04
• Last Update Posted: 2015-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 417

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Life birth rate per embryo thawed	3 years

Secondary Outcome Measures

Name	Time	Method
survival rate	3 year
live birth rate per embryo transferred	3
implantation rate per embryo thawed	3 years
abortion rate	3 years
implantation rate per embryo transferred	3 years

Trial Locations

Locations (1)

Leuven University Fertility Center; 🇧🇪 Leuven, Belgium