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

February 4, 2015 updated by: Sophie Debrock
Randomized controlled trial (RCT) testing the hypothesis that vitrification is superior to slow freezing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Leuven University Fertility Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: cryopreservation technique
slow freezing cryopreservation technique
Other: cryopreservation technique
Active Comparator: vitrification cryopreservation technique
Other: cryopreservation technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Life birth rate per embryo thawed
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
live birth rate per embryo transferred
Time Frame: 3
3
survival rate
Time Frame: 3 year
3 year
implantation rate per embryo transferred
Time Frame: 3 years
3 years
implantation rate per embryo thawed
Time Frame: 3 years
3 years
abortion rate
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sophie Debrock

Investigators

  • Principal Investigator: Thomas M D'Hooghe, Prof Dr, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

December 11, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Estimate)

February 5, 2015

Last Update Submitted That Met QC Criteria

February 4, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • S53410

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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