Outcome of Embryo Culture at Two Oxygen Tensions

This study has been completed.

First Received: July 17, 2008 Last Updated: July 18, 2008 History of Changes

Sponsors and Collaborators:	University Clinical Centre, Maribor Slovenian Research Agency
Information provided by:	University Clinical Centre, Maribor
ClinicalTrials.gov Identifier:	NCT00718822

Purpose

The purpose of this study is to assess whether reduced oxygen tension in embryo culture has any effect on clinical outcome.

Condition	Intervention
Embryo Development	Other: oxygen concentration in the culture atmosphere

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	Does Reduced Oxygen Tension in Embryo Culture Influence Clinical Outcome of ICSI Cycles? A Prospective Randomized Trial

Further study details as provided by University Clinical Centre, Maribor:

Primary Outcome Measures:

Ongoing pregnancy rate per cycle [ Time Frame: 10-11 weeks after embryo transfer ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

clinical pregnancy rate, implantation rate, early pregnancy loss, fertilization rate, embryo quality [ Designated as safety issue: Yes ]

Enrollment:	647
Study Start Date:	August 2006
Study Completion Date:	September 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental 5% oxygen concentration in the culture atmosphere	Other: oxygen concentration in the culture atmosphere
II: Experimental 20% oxygen concentration in the culture atmosphere	Other: oxygen concentration in the culture atmosphere

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718822

Locations

Slovenia
University Clinical Centre Maribor
Maribor, Slovenia, 2000

Sponsors and Collaborators

University Clinical Centre, Maribor

Slovenian Research Agency

Investigators

Study Chair:

Veljko Vlaisavljević, Prof.

University Clinical Centre, Maribor

More Information

No publications provided

Study ID Numbers:	P3-0327
Study First Received:	July 17, 2008
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00718822 History of Changes
Health Authority:	Slovenia: Ethics Committee

Keywords provided by University Clinical Centre, Maribor:

clinical outcome
ICSI cycles
low oxygen

poor responders
pregnancy rate
prospective randomized study

ClinicalTrials.gov processed this record on May 07, 2009