Infertility, Pregnancy
Conditions
Keywords
Pregnancy, Infertility, Physiologic Oxygen Tension, Atmospheric Oxygen Tension
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.
Interventions
PROCEDUREAtmospheric oxygen tension
Couples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere
PROCEDUREPhysiologic oxygen tension
Couples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pennsylvania
University of California, San Francisco
University of Connecticut
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 42 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is live birth rate. | 2 years |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed