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The Effects of Physiologic Oxygen Tension on Clinical In Vitro Fertilization Outcomes (PhOx)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01010386
First Posted: November 10, 2009
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pennsylvania
University of California, San Francisco
University of Connecticut
Information provided by (Responsible Party):
Heping Zhang, Yale University
November 6, 2009
November 10, 2009
May 8, 2017
March 2010
February 2014   (Final data collection date for primary outcome measure)
The primary outcome is live birth rate. [ Time Frame: 2 years ]
The primary outcome is live birth rate. [ Time Frame: November 2009 to November 2011 ]
Complete list of historical versions of study NCT01010386 on ClinicalTrials.gov Archive Site
  • The impact of treatment on embryo cleavage [ Time Frame: 2 years ]
  • The impact of treatment on clinical pregnancy [ Time Frame: 2 years ]
  • The impact of treatment on multiple pregnancy [ Time Frame: 2 years ]
  • The impact of treatment on miscarriage [ Time Frame: 2 years ]
  • The impact of treatment on embryo cleavage [ Time Frame: November 2009 to November 2011 ]
  • The impact of treatment on clinical pregnancy [ Time Frame: November 2009 to November 2011 ]
  • The impact of treatment on multiple pregnancy [ Time Frame: November 2009 to November 2011 ]
  • The impact of treatment on miscarriage [ Time Frame: November 2009 to November 2011 ]
Not Provided
Not Provided
 
The Effects of Physiologic Oxygen Tension on Clinical In Vitro Fertilization Outcomes
A Prospective, Randomized, Double-Blind, Controlled Clinical Trial of the Effects of Oxygen Tension on Clinical In Vitro Fertilization Outcomes

Primary Aim

  • Evaluate whether human embryo exposure to physiologic levels of oxygen during culture improves the percentage of women who deliver a baby following in vitro fertilization and embryo transfer.

Hypothesis to be tested: Physiologic oxygen tension during embryo culture, which approximates the oxygen tension in the fallopian tube and uterus, improves live birth rate in clinical In Vitro Fertilization Embryo Transfer (IVF-ET).

Secondary Aims

Evaluate whether human embryo exposure to physiologic levels of oxygen during culture during in vitro fertilization and embryo transfer

  • improves embryo cleavage
  • improves clinical pregnancy rate
  • reduces multiple pregnancy rate
  • reduces miscarriage rate

Hypothesis to be tested: Physiologic oxygen tension during embryo culture, which approximates the oxygen tension in the fallopian tube and uterus, improves embryo cleavage and clinical pregnancy rates and reduces miscarriage rates in clinical IVF-ET.

Study Design

This will be a multi-center, prospective, double-blind clinical trial of physiologic (5%) oxygen tension in culture media vs. standard of care, atmospheric (SOC, 20%) oxygen tension with 840 eligible couples recruited to participate. The randomization scheme will be coordinated through the central data coordinating center (DCC-Yale) and the randomization will be stratified by age group of the woman (18-34, 35-37, 38-40 and 40-42) and each participating site.

Treatment

Couples will be randomized to either have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere or in the currently widely used atmospheric (20%) oxygen atmosphere.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pregnancy
  • Infertility
  • Procedure: Atmospheric oxygen tension
    Couples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere
  • Procedure: Physiologic oxygen tension
    Couples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere
  • Placebo Comparator: atmospheric (20%) oxygen tension
    Couples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere
    Intervention: Procedure: Atmospheric oxygen tension
  • Active Comparator: physiologic (5%) oxygen tension
    Couples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere
    Intervention: Procedure: Physiologic oxygen tension
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
851
February 2014
February 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

The critical inclusion criteria will be the diagnosis of infertility and the need for in vitro fertilization as determined by the treating clinician. (We do not plan to alter the standard of care for the indication for IVF at any of the sites.)

  • Couple's age must be between 18 and 42 years old
  • Patient and partner are scheduled to undergo in vitro fertilization for treatment of infertility
  • Couple able to participate in a research project and A) Able to understand study requirements B) Willing to sign informed consent C) Able to return for required follow-up D) Have access to telephone

Exclusion Criteria:

Critical exclusion criteria for this trial will be medical conditions which may complicate treatment or no plans to undergo embryo transfer, as in patients banking embryos prior to cancer therapy. In addition, donor egg and frozen embryo transfer cycles will be excluded.

  • Medical contraindication to egg retrieval or pregnancy
  • Inability to participate in a research project (Non-English speaking or unable to read or write and/or concurrent participation in any other interventional trial)
  • Couple with more than three previous failed IVF cycles
  • Donor egg and frozen embryo transfer cycles
Sexes Eligible for Study: All
18 Years to 42 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01010386
RMN-PhOx
Yes
Not Provided
Not Provided
Heping Zhang, Yale University
Yale University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Pennsylvania
  • University of California, San Francisco
  • University of Connecticut
Study Chair: Esther Eisenberg, MD, MPH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Director: Nanette Santoro, MD Albert Einstein College of Medicine, Inc.
Principal Investigator: Christos Coutifaris, MD, PhD University of Pennsylvania
Study Director: Marcelle Cedars, MD University of California, San Francisco
Study Director: John Nulsen, MD University of Connecticut
Yale University
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP