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

Overview

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.

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.