The Effects of Physiologic Oxygen Tension on Clinical In Vitro Fertilization Outcomes - Full Text View

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
Information provided by (Responsible Party):	Yale University
ClinicalTrials.gov Identifier:	NCT01010386

Purpose

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.

Condition	Intervention	Phase
Pregnancy Infertility	Procedure: Atmospheric oxygen tension Procedure: Physiologic oxygen tension	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Prospective, Randomized, Double-Blind, Controlled Clinical Trial of the Effects of Oxygen Tension on Clinical In Vitro Fertilization Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Infertility Miscarriage Oxygen Therapy

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

The primary outcome is live birth rate. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The impact of treatment on embryo cleavage [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The impact of treatment on clinical pregnancy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The impact of treatment on multiple pregnancy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The impact of treatment on miscarriage [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	840
Study Start Date:	March 2010
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 42 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010386

Contacts

Contact: Heping Zhang, PhD	203-785-5185	rmn-Coordinators@panlists.yale.edu
Contact: Meizhuo Zhang, PhD	203-785-6759	meizhuo.zhang@yale.edu

Locations

United States, California
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94115
Contact: Marcelle Cedars, MD Marcelle.Cedars@ucsfmedctr.org
Contact: Thomas A Remble, MS, MPH 415-353-7394 thomas.remble@ucsfmedctr.org
Principal Investigator: Marcelle Cedars, MD
United States, Connecticut
Yale University	Not yet recruiting
New Haven, Connecticut, United States, 06511
Contact: Heping Zhang, PhD 203-785-5185 heping.zhang@yale.edu
Contact: Meizhuo Zhang, PhD 203- 785-6759 meizhuo.zhang@yale.edu
Principal Investigator: Heping Zhang, PhD
Sub-Investigator: Robert Makuch, PhD
Sub-Investigator: Pasquale Patrizio, MD, MBE
Sub-Investigator: Lawrence Scahill, PhD
Sub-Investigator: Hugh Taylor, MD
University of Connecticut	Recruiting
Storrs, Connecticut, United States, 06269
Contact: John Nulsen, MD nulsen@nso1.uchc.edu
Contact: Matthew Piscatelli 860-679-4612 PISCATELLI@uchc.edu
Principal Investigator: John Nulsen, MD
Sub-Investigator: Lawrence Engmann, MD
United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Christos Coutifaris, MD, PhD 215-662-2977 ccoutifaris@obgyn.upenn.edu
Contact: Linda Martino, MSN, CRNP 215- 615-3364 lmartino@obgyn.upenn.edu
Principal Investigator: Christos Coutifaris, MD, PhD
Sub-Investigator: Kurt Barnhart, MD, MSCE
Sub-Investigator: Peter Snyder, MD
Sub-Investigator: Mary Sammel, PhD
Sub-Investigator: William Stauffer

Sponsors and Collaborators

Yale University

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

University of Pennsylvania

University of California, San Francisco

University of Connecticut

Investigators

Study Chair:	Esther Eisenberg, MD, MPH	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Director:	Nanette Santoro, MD	Albert Einstein College of Medicine of Yeshiva University
Principal Investigator:	Christos Coutifaris, MD, PhD	University of Pennsylvania
Study Director:	Marcelle Cedars, MD	University of California, San Francisco
Study Director:	John Nulsen, MD	University of Connecticut

More Information

Additional Information:

Reproductive Medicine Network Homepage This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Yale University
ClinicalTrials.gov Identifier:	NCT01010386 History of Changes
Other Study ID Numbers:	RMN-PhOx
Study First Received:	November 6, 2009
Last Updated:	May 2, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

Pregnancy
Infertility
Physiologic Oxygen Tension
Atmospheric Oxygen Tension

Additional relevant MeSH terms:

Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2012