InfertilityPROSPECTNCT02301637
Eeva System Imaging Study
An observational study of Infertility, run by Progyny, Inc. at 7 sites in 2 countries.
Trial summary
The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Eeva™ Test
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Oct 2014to Dec 2015
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing in vitro fertilization treatment who fulfill all eligibility criteria.
Who may be able to join
- At least 18 years of age
- Women undergoing in vitro fertilization treatment using their own eggs
- Fresh or Frozen Blastocyst (Day 5-6) transfer
- At least 5 diploid (2PN) embryos at fertilization check
- Willing to have all 2PN embryos imaged by Eeva
- Willing to comply with study protocol and procedures
- Willing to provide written informed consent
Who cannot join
- Freeze-all due to ovarian hyperstimulation syndrome (OHSS)
- Use of donor egg / gestational carrier
- Fertilization using surgically removed sperm
- History of cancer
- Assisted Hatching (AH) on Day 3
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Texas Fertility Center
Austin, Texas, 78731
Midwest Fertility Specialists
Carmel, Indiana, 46032
FCI (River North)
Chicago, Illinois, 60610
Houston Fertility Institute
Houston, Texas, 77063
University of Iowa
Iowa City, Iowa, 52242
Seattle Reproductive Medicine
Seatlle, Washington, 98109
About this study
Official title: Prospective Observational Study Utilizing the Eeva™ System 2.2.1 for Ongoing Collection of Development and Validation Data
The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.
Read the detailed description
The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.
Primary Objectives Include:
To collect imaging data on embryos followed to blastocyst stage (Day 5-6)
Secondary Objectives Include:
To collect enrollment data: demographics, IVF and pregnancy history To collect Day 3, Day 5 and Day 6 embryo morphology data To collect pregnancy test and outcome data To collect pre-implantation genetic screening (PGS) data (if applicable) To collect Frozen Embryo Transfer (FET) data (if applicable)
- Conditions
- Infertility
- Being tested
- Eeva™ Test
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eeva™ TestDevice
The Eeva System is indicated to provide adjunctive information on events occurring during the first two days of development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3 when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Progyny, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sheua Shen, MD, Study chair, Vice President, Scientific and Medical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301637
- Sponsor's protocol ID
- 2014-AUX-012
- Acronym
- PROSPECT
- Status last verified
- Jul 2015
- First submitted
- 18 Nov 2014
- Last updated
- 13 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Utilizing the Eeva™ System 2.2.1 for Ongoing Collection of Development and Validation Data
- ClinicalTrials.gov ID
- NCT02301637
- Acronym / sponsor ID
- PROSPECT / 2014-AUX-012
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Progyny, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 26 Nov 2014 (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.
The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.
Detailed description
The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.
Primary Objectives Include:
To collect imaging data on embryos followed to blastocyst stage (Day 5-6)
Secondary Objectives Include:
To collect enrollment data: demographics, IVF and pregnancy history To collect Day 3, Day 5 and Day 6 embryo morphology data To collect pregnancy test and outcome data To collect pre-implantation genetic screening (PGS) data (if applicable) To collect Frozen Embryo Transfer (FET) data (if applicable)
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing in vitro fertilization treatment who fulfill all eligibility criteria.
Key inclusion criteria (7 listed)
- At least 18 years of age
- Women undergoing in vitro fertilization treatment using their own eggs
- Fresh or Frozen Blastocyst (Day 5-6) transfer
- At least 5 diploid (2PN) embryos at fertilization check
- Willing to have all 2PN embryos imaged by Eeva
Key exclusion criteria (5 listed)
- Freeze-all due to ovarian hyperstimulation syndrome (OHSS)
- Use of donor egg / gestational carrier
- Fertilization using surgically removed sperm
- History of cancer
- Assisted Hatching (AH) on Day 3
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 |
|---|---|---|
| Eeva™ TestThe Eeva System is indicated to provide adjunctive information on events occurring during the first two days of development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3 when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. | Device | – |
Primary outcome
Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit.
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
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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.
Sheua Shen, MD study chair
Vice President, Scientific and Medical Affairs
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Progyny, Inc. at 7 sites in 2 countries.
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 7 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: status not confirmed, as of the sponsor's last update on 13 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, New Zealand. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit. (time frame: 36 months). 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 13 Jul 2015.