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Live Births With Low Oxygen Blastocyst Culture
This study has been completed.
First Received: June 29, 2008   Last Updated: July 1, 2008   History of Changes
Sponsor: Texas Health Resources
Information provided by: Texas Health Resources
ClinicalTrials.gov Identifier: NCT00708487
  Purpose

The potentially damaging effect of free O2 radicals to cultured embryos may be reduced by adding scavengers to the culture media or by reducing the incubator O2 levels. However, lowering the O2 in the culture environment can be expensive, troublesome and may not be justifiable. The objective of this study is to evaluate the effect of lowered incubator O2 tension on live birth rates in a predominately day-5 embryo transfer program. The hypothesis of this study is that a lowered (more physiological)oxygen concentration in embryo culture incubators will increase live birth rates for in vitro fertilization patients. 230 first-cycle women undergoing routine IVF or ICSI with ejaculated sperm will be randomized in a prospective clinical trial and stratified for patient age and physician. Embryos of patients will be randomly assigned for culture in either a 21% O2 (atmospheric) or 5% O2 (reduced) environment. Clinical endpoints monitored will be rates of implantation, clinical pregnancy, live birth and blastocyst cryopreservation.


Condition Intervention
Infertility
Pregnancy Rate, Live Birth
In Vitro Fertilization
Other: Embryo incubator oxygen concentration

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Factorial Assignment, Efficacy Study
Official Title: A Controlled Randomized Trial Evaluating the Effect of Lowered Incubator Oxygen Tension on Live Births in a Predominantly Blastocyst Transfer Program

Resource links provided by NLM:


Further study details as provided by Texas Health Resources:

Primary Outcome Measures:
  • Live birth [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: August 1999
Study Completion Date: August 2001
Primary Completion Date: August 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
5% oxygen embryo culture condition
Other: Embryo incubator oxygen concentration
Two concentrations of oxygen are currently used to culture the embryos of infertile patients in commercial human IVF programs - 21% and 5%.
2: Active Comparator
21% oxygen embryo culture condition
Other: Embryo incubator oxygen concentration
Two concentrations of oxygen are currently used to culture the embryos of infertile patients in commercial human IVF programs - 21% and 5%.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First IVF cycle or donor oocyte cycle
  • IVF or ICSI
  • Ejaculated sperm only for ICSI
  • <41 years of age

Exclusion Criteria:

  • One or more failed IVF cycles

    • 40 years of age
  • Using testicular or epididymal sperm for fertilization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708487

Locations
United States, Texas
Presbyterian Hospital of Palno
Plano, Texas, United States, 75093
Sponsors and Collaborators
Texas Health Resources
Investigators
Principal Investigator: Marius Meintjes, PhD Texas Health Resources
  More Information

No publications provided by Texas Health Resources

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Presbyterian Hospital of Dallas ( Marius Meintjes )
Study ID Numbers: PresbyterianHDallasARTSO2
Study First Received: June 29, 2008
Last Updated: July 1, 2008
ClinicalTrials.gov Identifier: NCT00708487     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Health Resources:
in vitro fertilization
oxygen concentration
blastocyst
live birth
embryo

Additional relevant MeSH terms:
Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on November 20, 2009