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Clinical Trials/NCT01010386
NCT01010386CompletedPhase 3

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

Yale University8 sites in 1 country851 target enrollmentStarted: March 2010Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
851
Locations
8
Primary Endpoint
The primary outcome is live birth rate.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 42 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

The primary outcome is live birth rate.

Time Frame: 2 years

Secondary Outcomes

  • The impact of treatment on embryo cleavage(2 years)
  • The impact of treatment on multiple pregnancy(2 years)
  • The impact of treatment on clinical pregnancy(2 years)
  • The impact of treatment on miscarriage(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Heping Zhang

Principal Investigator

Yale University

Study Sites (8)

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