Day 3 Embryo Cryopreservation: Metabolic and Viability An... | NCT00608010

Studies
Day 3 Embryo Cryopreservation: Metabolic and Viability Analysis

NCT00608010

Sponsor

V.K.V. American Hospital, Istanbul

Status

Completed

Last Update Posted

Feb 6, 2008Estimated

Enrollment

186Actual

Phase

Not Applicable

Conditions

Fertilization in Vitro
Preservation of Supernumerary Embryos

Interventions

Vitrification
Slow freezing

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Jan 2007Actual

Completion Date

Not provided

First Submitted Date

Jan 22, 2008

First Submission Date that Met QC Criteria

Feb 5, 2008

First Posted Date

Feb 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2008

Last Update Posted Date

Feb 6, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

186Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Vitrification	Procedure: Vitrification
2	Active Comparator	Slow freezing	Procedure: Slow freezing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitrification	Procedure	Embryos were vitrified according to a previously described technique	1

Measure	Description	Time Frame
Blastocyst development rate		3 days after thawing

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Basak Balaban, BSc	American Hospital of Istanbul	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
American Hospital of Istanbul		Istanbul		34365	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18544577	Derived	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.

ID	Term
D044367	Phase Transition
D055585	Physical Phenomena