Live Births With Low Oxygen Blastocyst Culture
Oxygen
A Controlled Randomized Trial Evaluating the Effect of Lowered Incubator Oxygen Tension on Live Births in a Predominantly Blastocyst Transfer Program
1 other identifier
interventional
230
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 1999
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
June 29, 2008
CompletedFirst Posted
Study publicly available on registry
July 2, 2008
CompletedJuly 2, 2008
June 1, 2008
2 years
June 29, 2008
July 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Live birth
9 months
Secondary Outcomes (1)
Implantation rate
6 weeks
Study Arms (2)
1
EXPERIMENTAL5% oxygen embryo culture condition
2
ACTIVE COMPARATOR21% oxygen embryo culture condition
Interventions
Two concentrations of oxygen are currently used to culture the embryos of infertile patients in commercial human IVF programs - 21% and 5%.
Eligibility Criteria
You may qualify if:
- First IVF cycle or donor oocyte cycle
- IVF or ICSI
- Ejaculated sperm only for ICSI
- \<41 years of age
You may not qualify if:
- One or more failed IVF cycles
- years of age
- Using testicular or epididymal sperm for fertilization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Presbyterian Hospital of Palno
Plano, Texas, 75093, United States
Related Publications (1)
Meintjes M, Chantilis SJ, Douglas JD, Rodriguez AJ, Guerami AR, Bookout DM, Barnett BD, Madden JD. A controlled randomized trial evaluating the effect of lowered incubator oxygen tension on live births in a predominantly blastocyst transfer program. Hum Reprod. 2009 Feb;24(2):300-7. doi: 10.1093/humrep/den368. Epub 2008 Oct 16.
PMID: 18927130DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marius Meintjes, PhD
Texas Health Resources
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 29, 2008
First Posted
July 2, 2008
Study Start
August 1, 1999
Primary Completion
August 1, 2001
Study Completion
August 1, 2001
Last Updated
July 2, 2008
Record last verified: 2008-06