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

Phase 3

Completed

• Conditions: Infertility; Pregnancy
• Interventions: Procedure: Physiologic oxygen tension; Procedure: Atmospheric oxygen tension

• Registration Number: NCT01010386
• Lead Sponsor: Yale University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-11-06
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Study Start: 2010-03
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-05
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 851

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The primary outcome is live birth rate.	2 years

Secondary Outcome Measures

Name	Time	Method
The impact of treatment on clinical pregnancy	2 years
The impact of treatment on miscarriage	2 years
The impact of treatment on embryo cleavage	2 years
The impact of treatment on multiple pregnancy	2 years

Trial Locations

Locations (4)

University of Connecticut; 🇺🇸 Storrs, Connecticut, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States