NCT00710723

Brief Summary

In assisted reproduction technology (ART), cryopreservation of embryos maximizes the potential of IVF cycles. Currently different cryopreservation methods are used, the conventional slow freezing method and vitrification. There is, therefore an immediate need to assess which cryopreservation technique is preferential in human IVF. In this prospective randomised study conventional slow freezing and vitrification, using the Hemi-straw carrier system, of human day 3 embryos were compared.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
901

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 4, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 4, 2008

Status Verified

January 1, 2008

First QC Date

January 4, 2008

Last Update Submit

July 3, 2008

Conditions

Cleavage Stage, Ovum

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    9 months

Secondary Outcomes (1)

  • survival rate after thawing of embryos

    24 hours

Study Arms (2)

1

EXPERIMENTAL

vitrification

Procedure: vitrification

2

NO INTERVENTION

Slow freezing

Interventions

vitrificationPROCEDURE

Vitrification using Hemi-straw carrier system.

1

Eligibility Criteria

Age18 Years - 43 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Embryos of sufficient embryo quality: at least 6 cells on day 3 and less than 20 % fragmentation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

Vitrification

Intervention Hierarchy (Ancestors)

Phase TransitionPhysical Phenomena

Study Officials

  • D'Hooghe Thomas, Prof. Dr.

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2008

First Posted

July 4, 2008

Study Start

October 1, 2005

Study Completion

December 1, 2008

Last Updated

July 4, 2008

Record last verified: 2008-01

Locations

BE(1)