PregnancyPhase 3PhOxNCT01010386
The Effects of Physiologic Oxygen Tension on Clinical In Vitro Fertilization Outcomes
A Phase 3 study testing Atmospheric oxygen tension and Physiologic oxygen tension in people with Pregnancy and Infertility, run by Yale University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years
- Conditions the study is for
- Pregnancy, Infertility
- What is being tested?
- Atmospheric oxygen tension and Physiologic oxygen tension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 851 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2010to Feb 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Yale University
New Haven, Connecticut, 06511
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California, San Francisco
San Francisco, California, 94115
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: A Prospective, Randomized, Double-Blind, Controlled Clinical Trial of the Effects of Oxygen Tension on Clinical In Vitro Fertilization Outcomes
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.
Read more
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.
Read the 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.
- Conditions
- Pregnancy, Infertility
- Being tested
- Atmospheric oxygen tension, Physiologic oxygen tension
- Keywords
- Pregnancy, Infertility, Physiologic Oxygen Tension, Atmospheric Oxygen Tension
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atmospheric oxygen tensionProcedure or surgery
Couples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere
Physiologic oxygen tensionProcedure or surgery
Couples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere
| Study group | Role | What they receive |
|---|---|---|
| atmospheric (20%) oxygen tension | Placebo comparator | Couples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere Receives: Procedure: Atmospheric oxygen tension |
| physiologic (5%) oxygen tension | Active comparator | Couples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere Receives: Procedure: Physiologic oxygen tension |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is live birth rate.
Measured: 2 years
Secondary outcomes (4)
The impact of treatment on embryo cleavage
Measured: 2 years
The impact of treatment on clinical pregnancy
Measured: 2 years
The impact of treatment on multiple pregnancy
Measured: 2 years
The impact of treatment on miscarriage
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startMar 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 851 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pennsylvania, University of California, San Francisco, University of Connecticut
- Responsible party
- Principal investigator, Heping Zhang, Yale University
- Investigators
- Esther Eisenberg, MD, MPH, Study chair, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Nanette Santoro, MD, Study director, Albert Einstein College of MedicineChristos Coutifaris, MD, PhD, Principal investigator, University of PennsylvaniaMarcelle Cedars, MD, Study director, University of California, San FranciscoJohn Nulsen, MD, Study director, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010386
- Sponsor's protocol ID
- RMN-PhOx
- Acronym
- PhOx
- Status last verified
- May 2017
- First submitted
- 6 Nov 2009
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Controlled Clinical Trial of the Effects of Oxygen Tension on Clinical In Vitro Fertilization Outcomes
- ClinicalTrials.gov ID
- NCT01010386
- Acronym / sponsor ID
- PhOx / RMN-PhOx
- Conditions
- Pregnancy, Infertility
- Keywords
- Pregnancy, Infertility, Physiologic Oxygen Tension, Atmospheric Oxygen Tension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 851 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pennsylvania, University of California, San Francisco, University of Connecticut
- Study start
- Mar 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atmospheric (20%) oxygen tension | Placebo comparator | Procedure: Atmospheric oxygen tensionCouples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere |
| physiologic (5%) oxygen tension | Active comparator | Procedure: Physiologic oxygen tensionCouples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atmospheric oxygen tensionCouples will have their gametes and embryos placed in the currently widely used atmospheric (20%) oxygen atmosphere | Procedure or surgery | atmospheric (20%) oxygen tension |
| Physiologic oxygen tensionCouples will have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere | Procedure or surgery | physiologic (5%) oxygen tension |
Primary outcome
The primary outcome is live birth rate.
Time frame: 2 years
4 secondary outcomes
The impact of treatment on embryo cleavage
Time frame: 2 years
The impact of treatment on clinical pregnancy
Time frame: 2 years
The impact of treatment on multiple pregnancy
Time frame: 2 years
The impact of treatment on miscarriage
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Eisenberg, MD, MPH study chair
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nanette Santoro, MD study director
Albert Einstein College of Medicine
Christos Coutifaris, MD, PhD principal investigator
University of Pennsylvania
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atmospheric oxygen tension and Physiologic oxygen tension in people with Pregnancy and Infertility, run by Yale University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is live birth rate. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.