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Outcome of Embryo Culture at Two Oxygen Tensions

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ClinicalTrials.gov Identifier: NCT00718822
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : July 21, 2008
Sponsor:
Collaborator:
Slovenian Research Agency
Information provided by:
University Clinical Centre, Maribor

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

Condition or disease Intervention/treatment
Embryo Development Other: oxygen concentration in the culture atmosphere

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 647 participants
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
Study Start Date : August 2006
Primary Completion Date : June 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Ongoing pregnancy rate per cycle [ Time Frame: 10-11 weeks after embryo transfer ]

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


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

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

ClinicalTrials.gov Identifier: NCT00718822     History of Changes
Other Study ID Numbers: P3-0327
First Posted: July 21, 2008    Key Record Dates
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