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

May 5, 2017 updated by: Heping Zhang, Yale University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

851

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • University of California, San Francisco
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University
      • Storrs, Connecticut, United States, 06269
        • University of Connecticut
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: atmospheric (20%) oxygen tension
Couples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere
Procedure: Atmospheric oxygen tension
Couples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere
Active Comparator: physiologic (5%) oxygen tension
Couples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere
Procedure: Physiologic oxygen tension
Couples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome is live birth rate.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The impact of treatment on embryo cleavage
Time Frame: 2 years
2 years
The impact of treatment on clinical pregnancy
Time Frame: 2 years
2 years
The impact of treatment on multiple pregnancy
Time Frame: 2 years
2 years
The impact of treatment on miscarriage
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pennsylvania
University of California, San Francisco
University of Connecticut

Investigators

  • Study Chair: Esther Eisenberg, MD, MPH, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Study Director: Marcelle Cedars, MD, University of California, San Francisco
  • Study Director: Nanette Santoro, MD, Albert Einstein College of Medicine
  • Principal Investigator: Christos Coutifaris, MD, PhD, University of Pennsylvania
  • Study Director: John Nulsen, MD, University of Connecticut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

November 6, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (Estimate)

November 10, 2009

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMN-PhOx

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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