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

This study is ongoing, but not recruiting participants.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01010386
First received: November 6, 2009
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Pregnancy
Infertility
 Procedure: Atmospheric oxygen tension
Procedure: Physiologic oxygen tension
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Controlled Clinical Trial of the Effects of Oxygen Tension on Clinical In Vitro Fertilization Outcomes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • The primary outcome is live birth rate. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The impact of treatment on embryo cleavage [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The impact of treatment on clinical pregnancy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The impact of treatment on multiple pregnancy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The impact of treatment on miscarriage [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 840
Study Start Date: March 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: atmospheric (20%) oxygen tension
Couples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere
 Procedure: Atmospheric oxygen tension
Couples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere
Active Comparator: physiologic (5%) oxygen tension
Couples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere
 Procedure: Physiologic oxygen tension
Couples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010386

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
University of Connecticut
Storrs, Connecticut, United States, 06269
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
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
Investigators
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 of Yeshiva University
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
  More Information

Additional Information:
Reproductive Medicine Network Homepage  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Heping Zhang, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01010386     History of Changes
Other Study ID Numbers: RMN-PhOx
Study First Received: November 6, 2009
Last Updated: May 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Pregnancy
Infertility
Physiologic Oxygen Tension
Atmospheric Oxygen Tension

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013