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

Tracking Information
First Submitted Date ICMJE	November 6, 2009
First Posted Date ICMJE	November 10, 2009
Last Update Posted Date	May 8, 2017
Study Start Date ICMJE	March 2010
Actual Primary Completion Date	February 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 20, 2011)	The primary outcome is live birth rate. [ Time Frame: 2 years ]
Original Primary Outcome Measures ICMJE; (submitted: November 9, 2009)	The primary outcome is live birth rate. [ Time Frame: November 2009 to November 2011 ]
Change History	Complete list of historical versions of study NCT01010386 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 20, 2011)	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 ]
Original Secondary Outcome Measures ICMJE; (submitted: November 9, 2009)	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 ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	The Effects of Physiologic Oxygen Tension on Clinical In Vitro Fertilization Outcomes
Official Title ICMJE	A Prospective, Randomized, Double-Blind, Controlled Clinical Trial of the Effects of Oxygen Tension on Clinical In Vitro Fertilization Outcomes
Brief Summary	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.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Pregnancy; Infertility
Intervention ICMJE	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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 12, 2014)	851
Original Estimated Enrollment ICMJE; (submitted: November 9, 2009)	1800
Actual Study Completion Date	February 2014
Actual Primary Completion Date	February 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 42 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01010386
Other Study ID Numbers ICMJE	RMN-PhOx
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Heping Zhang, Yale University
Study Sponsor ICMJE	Yale University
Collaborators ICMJE	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Pennsylvania; University of California, San Francisco; University of Connecticut
Investigators ICMJE	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
PRS Account	Yale University
Verification Date	May 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP