A Prospective, Randomized, Double-Blind, Controlled Clinical Trial of the Effects of Oxygen Tension on Clinical In Vitro Fertilization Outcomes
| City: |
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San Francisco |
| State: |
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California |
| Zip Code: |
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94115 |
| Conditions: |
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Pregnancy - Infertility |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01010386 |
| Primary Contact: |
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Study Chair
Esther Eisenberg, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Heping Zhang, PhD
Phone: 203-785-5185
Email: rmn-Coordinators@panlists.yale.edu
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| Backup Contact: |
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Email: meizhuo.zhang@yale.edu
Meizhuo Zhang, PhD
Phone: 203-785-6759
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| Location Contact: |
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San Francisco, California 94115
United States
Marcelle Cedars, MD
Email: Marcelle.Cedars@ucsfmedctr.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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