NCT01010386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
851

participants targeted

Target at P50-P75 for phase_3 pregnancy

Timeline
Completed

Started Mar 2010

Typical duration for phase_3 pregnancy

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

3.9 years

First QC Date

November 6, 2009

Last Update Submit

May 5, 2017

Conditions

PregnancyInfertility

Keywords

PregnancyInfertilityPhysiologic Oxygen TensionAtmospheric Oxygen Tension

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is live birth rate.

    2 years

Secondary Outcomes (4)

  • The impact of treatment on embryo cleavage

    2 years

  • The impact of treatment on clinical pregnancy

    2 years

  • The impact of treatment on multiple pregnancy

    2 years

  • The impact of treatment on miscarriage

    2 years

Study Arms (2)

atmospheric (20%) oxygen tension

PLACEBO COMPARATOR

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

Procedure: Atmospheric oxygen tension

physiologic (5%) oxygen tension

ACTIVE COMPARATOR

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

Procedure: Physiologic oxygen tension

Interventions

Atmospheric oxygen tensionPROCEDURE

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

atmospheric (20%) oxygen tension
Physiologic oxygen tensionPROCEDURE

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

physiologic (5%) oxygen tension

Eligibility Criteria

Age18 Years - 42 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Esther Eisenberg, MD, MPH

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    STUDY CHAIR

  • Nanette Santoro, MD

    Albert Einstein College of Medicine

    STUDY DIRECTOR

  • Christos Coutifaris, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Marcelle Cedars, MD

    University of California, San Francisco

    STUDY DIRECTOR

  • John Nulsen, MD

    University of Connecticut

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2009

First Posted

November 10, 2009

Study Start

March 1, 2010

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations

US(4)