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

Infertility Clinical Trial

— PhOx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010386
• Other study ID #: RMN-PhOx
• Status: Completed
• Phase: Phase 3
• First received: November 6, 2009
• Last updated: May 5, 2017
• Start date: March 2010
• Est. completion date: February 2014

Study information

• Verified date: May 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 851
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Pregnancy

Intervention

Procedure:
• Atmospheric oxygen tension
Couples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere
• Physiologic oxygen tension
Couples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of California, San Francisco	San Francisco	California
United States	University of Connecticut	Storrs	Connecticut

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is live birth rate.		2 years
Secondary	The impact of treatment on embryo cleavage		2 years
Secondary	The impact of treatment on clinical pregnancy		2 years
Secondary	The impact of treatment on multiple pregnancy		2 years
Secondary	The impact of treatment on miscarriage		2 years