Clinical trial NCT01010386: The Effects of Physiologic Oxygen Tension on Clinical In Vitro Fertilization Outcomes
Official title: A Prospective, Randomized, Double-Blind, Controlled Clinical Trial of the Effects of Oxygen Tension on Clinical In Vitro Fertilization Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy
Infertility
Keywords: Pregnancy
Infertility
Physiologic Oxygen Tension
Atmospheric Oxygen Tension
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Pennsylvania
name: University of California, San Francisco
name: University of Connecticut
First posted: 2009-11-10
Enrollment: 851
Sex: ALL
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The primary outcome is live birth rate.
timeFrame: 2 years
Secondary outcomes:
measure: The impact of treatment on embryo cleavage
timeFrame: 2 years
measure: The impact of treatment on clinical pregnancy
timeFrame: 2 years
measure: The impact of treatment on multiple pregnancy
timeFrame: 2 years
measure: The impact of treatment on miscarriage
timeFrame: 2 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Esther Eisenberg, MD, MPH
role: STUDY_CHAIR
affiliation: Albert Einstein College of Medicine
name: Nanette Santoro, MD
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Christos Coutifaris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Marcelle Cedars, MD
role: STUDY_DIRECTOR
affiliation: University of Connecticut
name: John Nulsen, MD
role: STUDY_DIRECTOR
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