Outcome of Embryo Culture at Two Oxygen Tensions

This study has been completed.
Sponsor:
Collaborator:
Slovenian Research Agency
Information provided by:
University Clinical Centre, Maribor
ClinicalTrials.gov Identifier:
NCT00718822
First received: July 17, 2008
Last updated: July 18, 2008
Last verified: July 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ 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
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

Ages Eligible for Study:   22 Years to 44 Years
Genders 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
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

ClinicalTrials.gov Identifier: NCT00718822     History of Changes
Other Study ID Numbers: P3-0327
Study First Received: July 17, 2008
Last Updated: July 18, 2008
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 April 15, 2014