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

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.

Conditions

• Pregnancy
• Infertility

Interventions

PROCEDURE

Atmospheric oxygen tension

Couples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere

PROCEDURE

Physiologic oxygen tension

Couples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of Pennsylvania

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Connecticut

  collaborator OTHER

• Yale University

  lead OTHER

Principal Investigators

• Esther Eisenberg, MD, MPH · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

• Nanette Santoro, MD · Albert Einstein College of Medicine

• Christos Coutifaris, MD, PhD · University of Pennsylvania

• Marcelle Cedars, MD · University of California, San Francisco

• John Nulsen, MD · University of Connecticut

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

42 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2014-02-28

Completion

2014-02-28

Countries

• United States

Study Locations