Outcome of Embryo Culture at Two Oxygen Tensions

July 18, 2008 updated by: University Medical Centre Maribor

Does Reduced Oxygen Tension in Embryo Culture Influence Clinical Outcome of ICSI Cycles? A Prospective Randomized Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

647

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Maribor, Slovenia, 2000
        • University Clinical Centre Maribor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • stimulated Intra Cytoplasmic Sperm Injection (ICSI) cycle

Exclusion Criteria:

  • less than one mature (metaphase II) oocyte at the time of denudation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ongoing pregnancy rate per cycle
Time Frame: 10-11 weeks after embryo transfer
10-11 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
clinical pregnancy rate, implantation rate, early pregnancy loss, fertilization rate, embryo quality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Maribor

Collaborators

Slovenian Research Agency

Investigators

  • Study Chair: Veljko Vlaisavljević, Prof., University Medical Centre Maribor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

July 17, 2008

First Submitted That Met QC Criteria

July 18, 2008

First Posted (Estimate)

July 21, 2008

Study Record Updates

Last Update Posted (Estimate)

July 21, 2008

Last Update Submitted That Met QC Criteria

July 18, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P3-0327 (Other Grant/Funding Number: Slovenian Research Agency)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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