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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014