NCT00608010

Brief Summary

Embryo preservation through freezing plays a significant role in human assisted reproduction. It provides an opportunity for patients to have more than one attempt following an ovarian stimulation cycle, thereby decreasing the exposure of patients to exogenous gonadotrophins and improving cumulative pregnancy rates. The purpose of this study is to compare effectiveness of two different freezing methods.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
Last Updated

February 6, 2008

Status Verified

January 1, 2008

Enrollment Period

3 months

First QC Date

January 22, 2008

Last Update Submit

February 5, 2008

Conditions

Fertilization in VitroPreservation of Supernumerary Embryos

Keywords

Preservation of supernumerary embryos in an IVF program

Outcome Measures

Primary Outcomes (1)

  • Blastocyst development rate

    3 days after thawing

Study Arms (2)

1

EXPERIMENTAL

Vitrification

Procedure: Vitrification

2

ACTIVE COMPARATOR

Slow freezing

Procedure: Slow freezing

Interventions

VitrificationPROCEDURE

Embryos were vitrified according to a previously described technique

1
Slow freezingPROCEDURE

Embryos were frozen with slow freezing technique

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ICSI with own gametes
  • Couples who did not wish to cryopreserve their excess embryos for possible transfer in a future cyle
  • Donating excess embryos for research purposes

You may not qualify if:

  • Embryos derived from surgically retrieved spermatozoa
  • Blastocysts
  • Embryos of low quality (Grade 3 or 4 according to Hardarson)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American Hospital of Istanbul

Istanbul, 34365, Turkey (Türkiye)

Location

Related Publications (1)

  • Balaban B, Urman B, Ata B, Isiklar A, Larman MG, Hamilton R, Gardner DK. A randomized controlled study of human Day 3 embryo cryopreservation by slow freezing or vitrification: vitrification is associated with higher survival, metabolism and blastocyst formation. Hum Reprod. 2008 Sep;23(9):1976-82. doi: 10.1093/humrep/den222. Epub 2008 Jun 10.

    PMID: 18544577DERIVED

MeSH Terms

Interventions

Vitrification

Intervention Hierarchy (Ancestors)

Phase TransitionPhysical Phenomena

Study Officials

  • Basak Balaban, BSc

    American Hospital of Istanbul

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 6, 2008

Study Start

October 1, 2006

Primary Completion

January 1, 2007

Last Updated

February 6, 2008

Record last verified: 2008-01

Locations

TU(1)