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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Randomized, Double-Blind, Controlled Clinical Trial of the Effects of Oxygen Tension on Clinical In Vitro Fertilization Outcomes

Conditions
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Pregnancy, Infertility

Intervention / Treatment
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* Procedure: Atmospheric oxygen tension
* Procedure: Physiologic oxygen tension


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: atmospheric (20%) oxygen tension<br>Couples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere | Procedure: Atmospheric oxygen tension<br>* Couples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere<br>|
| Active Comparator: physiologic (5%) oxygen tension<br>Couples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere | Procedure: Physiologic oxygen tension<br>* Couples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is live birth rate. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of treatment on embryo cleavage |  | 2 years | 
| The impact of treatment on clinical pregnancy |  | 2 years | 
| The impact of treatment on multiple pregnancy |  | 2 years | 
| The impact of treatment on miscarriage |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Infertility, Physiologic Oxygen Tension, Atmospheric Oxygen Tension