InfertilityPPSNCT02218255
Eeva™ Pregnancy Pilot Study (PPS)
A study testing Eeva™ results in people with Infertility, run by Progyny, Inc. at 1 site in United States.
Trial summary
The purpose of this clinical investigation is to gather pilot data to evaluate the impact of using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on clinical pregnancy rates. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Eeva™ results
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jun 2016
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women undergoing fresh in vitro fertilization treatment using their own eggs
- ≤ 40 years
- ≥ 4 diploid embryos (i.e. having 2 PNs)
- ≤ 3 Prior ART cycles (IVF, ICSI and related procedures)
- All 2PN embryos (for all 3 arms) must be imaged by Eeva
- Subject willing to comply with study protocol and procedures
- Subject willing to provide written informed consent
Who cannot join
- Preimplantation genetic diagnosis or preimplantation genetic screening
- Planned "freeze all" cycle (eggs or embryos)
- Asherman's Syndrome
- Donor egg
- Gestational carrier
- Presence of Hydrosalpinx on ultrasound
- Concurrent participation in an interventional clinical study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Catherine Racowsky, Ph.D., 617-732-5570, cracowsky@partners.org
Catherine Racowsky, Ph.D.
About this study
The purpose of this clinical investigation is to gather pilot data to evaluate the impact of using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on clinical pregnancy rates.
- Conditions
- Infertility
- Being tested
- Eeva™ results
- Keywords
- In Vitro Fertilization
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eeva™ resultsDevice
| Study group | Role | What they receive |
|---|---|---|
| Day 3 eSET combined with Eeva | Active comparator | Traditional Morphology + Eeva™ results Receives: Device: Eeva™ results |
| Day 5 eSET combined with Eeva | Active comparator | Traditional Morphology + Eeva™ results Receives: Device: Eeva™ results |
| Day 5 eSET with Traditonal Morphology | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy
Measured: 7-8 weeks gestation
Secondary outcomes (1)
Ongoing pregnancy rate
Measured: 8-12 week gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Progyny, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218255
- Sponsor's protocol ID
- 2013-AUX-010
- Acronym
- PPS
- Status last verified
- Oct 2015
- First submitted
- 14 Aug 2014
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaser DJ, Bormann CL, Missmer SA, Farland LV, Ginsburg ES, Racowsky C. A pilot randomized controlled trial of Day 3 single embryo transfer with adjunctive time-lapse selection versus Day 5 single embryo transfer with or without adjunctive time-lapse selection. Hum Reprod. 2017 Aug 1;32(8):1598-1603. doi: 10.1093/humrep/dex231.
PubMed 28854588
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
- Eeva™ Pregnancy Pilot Study (PPS)
- ClinicalTrials.gov ID
- NCT02218255
- Acronym / sponsor ID
- PPS / 2013-AUX-010
- Conditions
- Infertility
- Keywords
- In Vitro Fertilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Progyny, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 18 Aug 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 investigation is to gather pilot data to evaluate the impact of using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on clinical pregnancy rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Day 3 eSET combined with Eeva | Active comparator | Device: Eeva™ resultsTraditional Morphology + Eeva™ results |
| Day 5 eSET combined with Eeva | Active comparator | Device: Eeva™ resultsTraditional Morphology + Eeva™ results |
| Day 5 eSET with Traditonal Morphology | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women undergoing fresh in vitro fertilization treatment using their own eggs
- ≤ 40 years
- ≥ 4 diploid embryos (i.e. having 2 PNs)
- ≤ 3 Prior ART cycles (IVF, ICSI and related procedures)
- All 2PN embryos (for all 3 arms) must be imaged by Eeva
Key exclusion criteria (7 listed)
- Preimplantation genetic diagnosis or preimplantation genetic screening
- Planned "freeze all" cycle (eggs or embryos)
- Asherman's Syndrome
- Donor egg
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eeva™ results | Device | Day 3 eSET combined with Eeva, Day 5 eSET combined with Eeva |
Primary outcome
Clinical Pregnancy
Time frame: 7-8 weeks gestation
1 secondary outcome
Ongoing pregnancy rate
Time frame: 8-12 week gestation
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 28854588Kaser DJ, Bormann CL, Missmer SA, Farland LV, Ginsburg ES, Racowsky C. A pilot randomized controlled trial of Day 3 single embryo transfer with adjunctive time-lapse selection versus Day 5 single embryo transfer with or without adjunctive time-lapse selection. Hum Reprod. 2017 Aug 1;32(8):1598-1603. doi: 10.1093/humrep/dex231.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eeva™ results in people with 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 7 inclusion and 7 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?
Contact Monica Ransom (650-627-7604, mransom@auxogyn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy (time frame: 7-8 weeks gestation). 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 NCT02218255, 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.