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