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Outcome of Embryo Culture at Two Oxygen Tensions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00718822
First Posted: July 21, 2008
Last Update Posted: July 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Slovenian Research Agency
Information provided by:
University Clinical Centre, Maribor
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Does Reduced Oxygen Tension in Embryo Culture Influence Clinical Outcome of ICSI Cycles? A Prospective Randomized Trial

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • clinical pregnancy rate, implantation rate, early pregnancy loss, fertilization rate, embryo quality

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stimulated Intra Cytoplasmic Sperm Injection (ICSI) cycle

Exclusion Criteria:

  • less than one mature (metaphase II) oocyte at the time of denudation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00718822     History of Changes
Other Study ID Numbers: P3-0327
First Submitted: July 17, 2008
First Posted: July 21, 2008
Last Update Posted: July 21, 2008
Last Verified: July 2008

Keywords provided by University Clinical Centre, Maribor:
clinical outcome
ICSI cycles
low oxygen
poor responders
pregnancy rate
prospective randomized study