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

Completed · Phase 3

Conditions studied: Pregnancy, Infertility

In brief

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.

Key facts

Study ID

NCT01010386

Run by

Yale University

People needed

851

Starts

2010-03-01

Expected to finish

2014-02-01

Last updated by the study team

2017-05-08

Who can join

Age: 18 and older, up to 42. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Yale University — New Haven, Connecticut, United States
• University of Connecticut — Storrs, Connecticut, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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