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

Not Applicable

Completed

• Conditions: Cryopreservation of Embryos
• Interventions: Other: cryopreservation technique

• 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

Arm && Interventions

Group	Intervention	Description
cryopreservation technique	cryopreservation technique	slow freezing cryopreservation technique
vitrification cryopreservation technique	cryopreservation technique	vitrification cryopreservation technique

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