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

NCT ID: NCT01010386

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 851 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-02-28

Brief 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.

Detailed Description

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.

Conditions

Pregnancy; Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

atmospheric (20%) oxygen tension

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

Group Type: PLACEBO_COMPARATOR

Atmospheric oxygen tension

Intervention Type: PROCEDURE

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

physiologic (5%) oxygen tension

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

Group Type: ACTIVE_COMPARATOR

Physiologic oxygen tension

Intervention Type: PROCEDURE

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

Interventions

Atmospheric oxygen tension

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

Intervention Type: PROCEDURE

Physiologic oxygen tension

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Heping Zhang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esther Eisenberg, MD, MPH

Role: STUDY_CHAIR

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

Nanette Santoro, MD

Role: STUDY_DIRECTOR

Albert Einstein College of Medicine

Christos Coutifaris, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Marcelle Cedars, MD

Role: STUDY_DIRECTOR

University of California, San Francisco

John Nulsen, MD

Role: STUDY_DIRECTOR

University of Connecticut

Locations

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

Countries

United States

Other Identifiers

RMN-PhOx

Identifier Type: -

Identifier Source: org_study_id