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

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.

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