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Live Births With Low Oxygen Blastocyst Culture (Oxygen)

This study has been completed.
Information provided by:
Texas Health Resources Identifier:
First received: June 29, 2008
Last updated: July 1, 2008
Last verified: June 2008
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
Pregnancy Rate, Live Birth
In Vitro Fertilization
Other: Embryo incubator oxygen concentration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 6 weeks ]

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
Experimental: 1
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%.
Active Comparator: 2
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


Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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 identifier: NCT00708487

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Marius Meintjes, Presbyterian Hospital of Dallas Identifier: NCT00708487     History of Changes
Other Study ID Numbers: PresbyterianHDallasARTSO2
Study First Received: June 29, 2008
Last Updated: July 1, 2008

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

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on May 25, 2017