Live Births With Low Oxygen Blastocyst Culture

This study has been completed.
Sponsor:
Information provided by:
Texas Health Resources
ClinicalTrials.gov Identifier:
NCT00708487
First received: June 29, 2008
Last updated: July 1, 2008
Last verified: June 2008
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ 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
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

  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
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: 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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marius Meintjes, Presbyterian Hospital of Dallas
ClinicalTrials.gov Identifier: NCT00708487     History of Changes
Other Study ID Numbers: PresbyterianHDallasARTSO2
Study First Received: June 29, 2008
Last Updated: July 1, 2008
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:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 01, 2014