Day 3 Embryo Cryopreservation: Metabolic and Viability Analysis - Full Text View

Purpose

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.

Condition	Intervention
Fertilization in Vitro Preservation of Supernumerary Embryos	Procedure: Vitrification Procedure: Slow freezing

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment

Official Title:	Day 3 Embryo Cryopreservation: Metabolic and Viability Analysis

Further study details as provided by V.K.V. American Hospital, Istanbul:

Primary Outcome Measures:

Blastocyst development rate [ Time Frame: 3 days after thawing ] [ Designated as safety issue: No ]

Enrollment:	186
Study Start Date:	October 2006
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Vitrification	Procedure: Vitrification Embryos were vitrified according to a previously described technique
2: Active Comparator Slow freezing	Procedure: Slow freezing Embryos were frozen with slow freezing technique

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608010

Locations


Turkey
	American Hospital of Istanbul
	Istanbul, Turkey, 34365

Sponsors and Collaborators

V.K.V. American Hospital, Istanbul

Investigators


Principal Investigator:	Basak Balaban, BSc	American Hospital of Istanbul

More Information

Publications indexed to this study:

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. Epub 2008 Jun 10.

Responsible Party:	American Hospital of Istanbul ( Basak Balaban, Chief Embryologist )
Study ID Numbers:	AH-ART-06/13
First Received:	January 22, 2008
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00608010
Health Authority:	Turkey: Ministry of Health

Keywords provided by V.K.V. American Hospital, Istanbul:

Preservation of supernumerary embryos in an IVF program

ClinicalTrials.gov processed this record on November 03, 2008

Sponsored by:	V.K.V. American Hospital, Istanbul
Information provided by:	V.K.V. American Hospital, Istanbul
ClinicalTrials.gov Identifier:	NCT00608010