The Effects of Physiologic Oxygen Tension on Clinical In Vitro Fertilization Outcomes (PhOx)
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ClinicalTrials.gov Identifier: NCT01010386 |
Recruitment Status
:
Completed
First Posted
: November 10, 2009
Last Update Posted
: May 8, 2017
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Tracking Information | ||||||||||||||||
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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 |
The primary outcome is live birth rate. [ Time Frame: 2 years ] | |||||||||||||||
Original Primary Outcome Measures ICMJE |
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 |
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Original Secondary Outcome Measures ICMJE |
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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
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
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. |
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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. |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||
Actual Enrollment ICMJE |
851 | |||||||||||||||
Original Estimated Enrollment ICMJE |
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.)
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.
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Sex/Gender |
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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 | |||||||||||||||
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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 |
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Investigators ICMJE |
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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 |