InfertilityEPICNCT01671644
Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study
An observational study of Infertility, run by Progyny, Inc. at 2 sites in 2 countries.
Trial summary
The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- How many people
- 104 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2013to Oct 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 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 ≤ 3.
- Egg age ≤ 40 years.
- Planned Day 3 embryo transfer.
- At least 5 normally fertilized eggs (2PN).
- All 2PN embryos must be imaged by Eeva.
Show all 10Show fewer
- Normal uterine cavity as evaluated by standard methods.
- Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
- Willing to comply with study protocol and procedures.
- Willing to provide written informed consent.
Who cannot join
- Planned preimplantation genetic diagnosis.
- Planned "freeze all" cycle (oocytes or embryos).
- Concurrent participation in another clinical study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
VU University Medical Center
Amsterdam, South Holland, 2500 BH
About this study
The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates.
Read the detailed description
The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates, as compared to a matched case control group that used morphology grading only to select embryos for transfer.
- 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 predictions with morphology grading. | |
| Matched case control group | Day 3 embryo transfers using morphology grading only (from a matched concurrent control group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical pregnancy
To compare the rate of clinical pregnancy at approximately 5-8 weeks gestational age for the Day 3 embryo transfers that used Eeva predictions with morphology grading to that for Day 3 embryo transfers using morphology grading only (from a matched concurrent control group at each clinical site comprised of year 2011-2013 patients).
Measured: 5-8 weeks gestational age
Secondary outcomes (4)
Implantation rate (# of implanted embryos out of # of total embryos transferred)
Measured: 5-8 weeks gestational age.
Ongoing Pregnancy Rate (gestational week 10-12)
Measured: Gestational age week 10-12
Multiple pregnancy rate
Measured: Gestational weeks 5-8 and 10-12
Spontaneous miscarriage rate
Measured: Gestational age week 10-12
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 startFeb 2013
- Primary completionJun 2015
- Study completionOct 2015
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
- 104 participants (actual)
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
- NCT01671644
- Sponsor's protocol ID
- 2012-AUX-005
- Other IDs
- TST-1872-p
- Acronym
- EPIC
- Status last verified
- Oct 2015
- First submitted
- 21 Aug 2012
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kieslinger DC, De Gheselle S, Lambalk CB, De Sutter P, Kostelijk EH, Twisk JW, van Rijswijk J, Van den Abbeel E, Vergouw CG. Embryo selection using time-lapse analysis (Early Embryo Viability Assessment) in conjunction with standard morphology: a prospective two-center pilot study. Hum Reprod. 2016 Nov;31(11):2450-2457. doi: 10.1093/humrep/dew207. Epub 2016 Sep 12.
PubMed 27619774
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 Investigational Clinical Study: A Postmarket Follow-Up Study
- ClinicalTrials.gov ID
- NCT01671644
- Acronym / sponsor ID
- EPIC / 2012-AUX-005
- Conditions
- Infertility
- Keywords
- In vitro fertilization, Assisted reproductive therapy, Time-lapse image recording, Image analysis software
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Progyny, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- 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 postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates.
Detailed description
The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates, as compared to a matched case control group that used morphology grading only to select embryos for transfer.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eeva Test Group | – | –Day 3 embryo transfers that used Eeva predictions with morphology grading. |
| Matched case control group | – | –Day 3 embryo transfers using morphology grading only (from a matched 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 (10 listed)
- Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
- IVF cycle attempts ≤ 3.
- Egg age ≤ 40 years.
- Planned Day 3 embryo transfer.
- At least 5 normally fertilized eggs (2PN).
Key exclusion criteria (3 listed)
- Planned preimplantation genetic diagnosis.
- Planned "freeze all" cycle (oocytes or embryos).
- Concurrent participation in another clinical study.
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 clinical pregnancy
Time frame: 5-8 weeks gestational age
To compare the rate of clinical pregnancy at approximately 5-8 weeks gestational age for the Day 3 embryo transfers that used Eeva predictions with morphology grading to that for Day 3 embryo transfers using morphology grading only (from a matched concurrent control group at each clinical site comprised of year 2011-2013 patients).
4 secondary outcomes
Implantation rate (# of implanted embryos out of # of total embryos transferred)
Time frame: 5-8 weeks gestational age.
Ongoing Pregnancy Rate (gestational week 10-12)
Time frame: Gestational age week 10-12
Multiple pregnancy rate
Time frame: Gestational weeks 5-8 and 10-12
Spontaneous miscarriage rate
Time frame: Gestational age week 10-12
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 20 Oct 2015.
- Derived from this study: PubMed 27619774Kieslinger DC, De Gheselle S, Lambalk CB, De Sutter P, Kostelijk EH, Twisk JW, van Rijswijk J, Van den Abbeel E, Vergouw CG. Embryo selection using time-lapse analysis (Early Embryo Viability Assessment) in conjunction with standard morphology: a prospective two-center pilot study. Hum Reprod. 2016 Nov;31(11):2450-2457. doi: 10.1093/humrep/dew207. Epub 2016 Sep 12.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
2 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 2 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 10 inclusion and 3 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 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 2 sites in Belgium, Netherlands. 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?
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?
Rate of clinical pregnancy (time frame: 5-8 weeks 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 NCT01671644, 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.