InfertilityUS EPICNCT01671657
US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)
An observational study of Infertility, run by Progyny, Inc. at 1 site in United States.
Trial summary
The purpose of this clinical investigation is to gather data to evaluate the impact of using Eeva with traditional morphology grading on implantation rates. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2016
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing in vitro fertilization treatment who provide informed consent and plan to undergo Day 3 embryo transfer.
Who may be able to join
- Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
- IVF cycle attempts ≤ 2.
- Egg age ≤ 40 years.
- Planned Day 3 embryo transfer.
- At least 4 normally fertilized eggs (2PN).
- All 2PN embryos must be imaged by Eeva.
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- Ejaculated sperm or sperm from the epididymis (fresh or frozen).
- Willing to comply with study protocol and procedures.
- Willing to provide written informed consent.
Who cannot join
- Planned preimplantation genetic diagnosis or preimplantation genetic screening.
- Planned "freeze all" cycle (oocytes or embryos).
- Sperm retrieved from testicular tissue.
- Abnormal uterine cavity as evaluated by standard methods.
- Gestational carrier.
- Endometriosis
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- Hydrosalpinx.
- History of cancer.
- Concurrent participation in another clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fertility Physicians of Northern California
San Jose, California, 95124
About this study
The purpose of this clinical investigation is to gather data to evaluate the impact of using Eeva with traditional morphology grading on implantation rates.
Read the detailed description
The purpose of this clinical investigation is to gather data to evaluate the impact of implantation rates for Day 3 embryo transfers using Eeva and morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (from a concurrent control group).
- Conditions
- Infertility
- Keywords
- In vitro fertilization, Assisted reproductive therapy, Time-lapse image recording, Image analysis software
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Eeva Test Group | Day 3 embryo transfers that used Eeva with morphology grading (Test Group). | |
| Matched case control group | Day 3 embryo transfers using morphology grading only (from concurrent Control Group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of implantation
To compare implantation rates for the Day 3 embryo transfers that used Eeva with morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (control group).
Measured: 5-6 gestational age
Secondary outcomes (4)
To evaluate clinical pregnancy rates from the Eeva Test group to the Control group
Measured: 5-6 weeks gestational age
Ongoing pregnancy rate
Measured: Gestational age week 8-12
Multiple pregnancy rate
Measured: Gestational age weeks 5-6 and 8-12
Spontaneous miscarriage rate
Measured: Gestational age week 8-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational model
- Case-control
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Progyny, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shehua Shen, MD, ELD, Study director, Progyny, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671657
- Sponsor's protocol ID
- 2012-AUX-008
- Acronym
- US EPIC
- Status last verified
- Oct 2015
- First submitted
- 21 Aug 2012
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Adamson GD, Abusief ME, Palao L, Witmer J, Palao LM, Gvakharia M. Improved implantation rates of day 3 embryo transfers with the use of an automated time-lapse-enabled test to aid in embryo selection. Fertil Steril. 2016 Feb;105(2):369-75.e6. doi: 10.1016/j.fertnstert.2015.10.030. Epub 2015 Nov 18.
PubMed 26604069
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)
- ClinicalTrials.gov ID
- NCT01671657
- Acronym / sponsor ID
- US EPIC / 2012-AUX-008
- Conditions
- Infertility
- Keywords
- In vitro fertilization, Assisted reproductive therapy, Time-lapse image recording, Image analysis software
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Progyny, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 23 Aug 2012 (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 investigation is to gather data to evaluate the impact of using Eeva with traditional morphology grading on implantation rates.
Detailed description
The purpose of this clinical investigation is to gather data to evaluate the impact of implantation rates for Day 3 embryo transfers using Eeva and morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (from a concurrent control group).
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eeva Test Group | – | –Day 3 embryo transfers that used Eeva with morphology grading (Test Group). |
| Matched case control group | – | –Day 3 embryo transfers using morphology grading only (from concurrent Control Group). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing in vitro fertilization treatment who provide informed consent and plan to undergo Day 3 embryo transfer.
Key inclusion criteria (9 listed)
- Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
- IVF cycle attempts ≤ 2.
- Egg age ≤ 40 years.
- Planned Day 3 embryo transfer.
- At least 4 normally fertilized eggs (2PN).
Key exclusion criteria (9 listed)
- Planned preimplantation genetic diagnosis or preimplantation genetic screening.
- Planned "freeze all" cycle (oocytes or embryos).
- Sperm retrieved from testicular tissue.
- Abnormal uterine cavity as evaluated by standard methods.
- Gestational carrier.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of implantation
Time frame: 5-6 gestational age
To compare implantation rates for the Day 3 embryo transfers that used Eeva with morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (control group).
4 secondary outcomes
To evaluate clinical pregnancy rates from the Eeva Test group to the Control group
Time frame: 5-6 weeks gestational age
Ongoing pregnancy rate
Time frame: Gestational age week 8-12
Multiple pregnancy rate
Time frame: Gestational age weeks 5-6 and 8-12
Spontaneous miscarriage rate
Time frame: Gestational age week 8-12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
- Derived from this study: PubMed 26604069Adamson GD, Abusief ME, Palao L, Witmer J, Palao LM, Gvakharia M. Improved implantation rates of day 3 embryo transfers with the use of an automated time-lapse-enabled test to aid in embryo selection. Fertil Steril. 2016 Feb;105(2):369-75.e6. doi: 10.1016/j.fertnstert.2015.10.030. Epub 2015 Nov 18.
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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.
Shehua Shen, MD, ELD study director
Progyny, Inc.
1 site in 1 country: 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 1 site 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 9 inclusion and 9 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 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Rate of implantation (time frame: 5-6 gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01671657, which also lists 1 linked publication.
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 20 Oct 2015.