Back to results

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

Primary Purpose

Pregnancy, Infertility

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Atmospheric oxygen tension

Physiologic oxygen tension

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring Pregnancy, Infertility, Physiologic Oxygen Tension, Atmospheric Oxygen Tension

Eligibility Criteria

18 Years - 42 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of California, San Francisco
Yale University
University of Connecticut
University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

atmospheric (20%) oxygen tension

physiologic (5%) oxygen tension

Arm Description

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

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

Outcomes

Primary Outcome Measures

The primary outcome is live birth rate.

Secondary Outcome Measures

The impact of treatment on embryo cleavage

The impact of treatment on clinical pregnancy

The impact of treatment on multiple pregnancy

The impact of treatment on miscarriage

Full Information

NCT ID

NCT01010386

First Posted

November 6, 2009

Last Updated

May 5, 2017

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

1. Study Identification

Unique Protocol Identification Number

NCT01010386

Brief Title

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

Acronym

PhOx

Official Title

A Prospective, Randomized, Double-Blind, Controlled Clinical Trial of the Effects of Oxygen Tension on Clinical In Vitro Fertilization Outcomes

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the 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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy, Infertility

Keywords

Pregnancy, Infertility, Physiologic Oxygen Tension, Atmospheric Oxygen Tension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

851 (Actual)

8. Arms, Groups, and Interventions

Arm Title

atmospheric (20%) oxygen tension

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

physiologic (5%) oxygen tension

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Atmospheric oxygen tension

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Physiologic oxygen tension

Intervention Description

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

Primary Outcome Measure Information:

Title

The primary outcome is live birth rate.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

The impact of treatment on embryo cleavage

Time Frame

2 years

Title

The impact of treatment on clinical pregnancy

Time Frame

2 years

Title

The impact of treatment on multiple pregnancy

Time Frame

2 years

Title

The impact of treatment on miscarriage

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

42 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: