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Sponsored by: |
Presbyterian Hospital of Dallas |
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Information provided by: | Presbyterian Hospital of Dallas |
ClinicalTrials.gov Identifier: | NCT00708487 |
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 |
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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 |
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 |
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1: Experimental
5% oxygen embryo culture condition
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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%.
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2: Active Comparator
21% oxygen embryo culture condition
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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%.
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Ages Eligible for Study: | 20 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
One or more failed IVF cycles
United States, Texas | |
Presbyterian Hospital of Palno | |
Plano, Texas, United States, 75093 |
Principal Investigator: | Marius Meintjes, PhD | Presbyterian Hospital of Dallas |
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 |
Health Authority: | United States: Institutional Review Board |
in vitro fertilization oxygen concentration blastocyst live birth embryo |
Genital Diseases, Female Infertility Genital Diseases, Male |