InfertilityNDSNCT01635036
Eeva 12-well Dish Study
An observational study of Infertility, run by Progyny, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate that the Eeva™ System is compatible with the Eeva 12-well Dish. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- What is being tested?
- In-vitro fertilization using Eeva
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Aug 2012
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Women in the United States who undergo IVF treatment
Who may be able to join
- Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
- Subject is at least 18 years of age.
- Subject has basal antral follicle count (BAFC) ≥ 12 prior to stimulation cycle.
- Subjects has basal FSH < 11 IU
- Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
- Subject has at least 8 normally fertilized eggs (2PN)
Show all 9Show fewer
- Willing to have all 2PN embryos monitored by Eeva
- Willing to comply with study protocol and procedures and able to speak English.
- Willing to provide written informed consent.
Who cannot join
- Reinseminated eggs.
- History of cancer.
- Gestational carriers.
- Planned preimplantation genetic diagnosis or preimplantation genetic screening.
- Previously enrolled in this study
- Concurrent participation in another clinical study.
- Any other reason the Investigator believes the subject should not participate in the clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to demonstrate that the Eeva™ System is compatible with the Eeva 12-well Dish.
Read the detailed description
This study is designed to demonstrate that the Eeva System Software successfully tracks the embryo images and identifies the timing of key developmental events using the Eeva 12-well Dish.
This is a prospective, observational, blinded, single arm, nonrandomized, single center clinical study. Images of developing embryos and Eeva predictions will be blinded to embryologists and physicians
- Conditions
- Infertility
- Being tested
- In-vitro fertilization using Eeva
- Keywords
- in vitro fertilization, assisted reproduction techniques, noninvasive imaging of embryos, time lapse imaging of embryos, traditional morphological grading of embryos, prediction of blastocyst formation, infertility, male factor female factor, embryo viability
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-vitro fertilization using EevaDevice
Eeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva results along with traditional morphological grading to assist in selecting embryo(s) for transfer or freezing.
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing IVF treatment | Women undergoing IVF treatment Receives: Device: In-vitro fertilization using Eeva |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate and develop the Eeva Software.
The clinical image data (embryos images) will be used to develop the Eeva System Software. The Eeva software validation will consist in comparing the specificity of the Eeva System Software Blastocyst Prediction from the Eeva 12-well Dish to the specificity of the Eeva System Software from the Eeva 25-well Dish (the specificity of the Eeva System Software from the Eeva 25-well Dish was previously determined during the Eeva System Study TST-1788-r).
Measured: 3 months
Secondary outcomes (1)
Specificity and sensitivity and 95% confidence intervals of the Eeva System Software and the Embryologist Panel (also referred to as Panel) measurements will be computed.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2012
- Study completionAug 2012
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Progyny, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Boostanfar, MD, Principal investigator, HRC Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635036
- Sponsor's protocol ID
- 2012-AUX-001
- Other IDs
- TST-1736-p
- Acronym
- NDS
- Status last verified
- Jan 2014
- First submitted
- 2 Jul 2012
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eeva 12-well Dish Study
- ClinicalTrials.gov ID
- NCT01635036
- Acronym / sponsor ID
- NDS / 2012-AUX-001
- Conditions
- Infertility
- Keywords
- in vitro fertilization, assisted reproduction techniques, noninvasive imaging of embryos, time lapse imaging of embryos, traditional morphological grading of embryos, prediction of blastocyst formation, infertility, male factor female factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Progyny, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Jul 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 study is to demonstrate that the Eeva™ System is compatible with the Eeva 12-well Dish.
Detailed description
This study is designed to demonstrate that the Eeva System Software successfully tracks the embryo images and identifies the timing of key developmental events using the Eeva 12-well Dish.
This is a prospective, observational, blinded, single arm, nonrandomized, single center clinical study. Images of developing embryos and Eeva predictions will be blinded to embryologists and physicians
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing IVF treatment | – | Device: In-vitro fertilization using EevaWomen undergoing IVF treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women in the United States who undergo IVF treatment
Key inclusion criteria (9 listed)
- Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
- Subject is at least 18 years of age.
- Subject has basal antral follicle count (BAFC) ≥ 12 prior to stimulation cycle.
- Subjects has basal FSH < 11 IU
- Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
Key exclusion criteria (7 listed)
- Reinseminated eggs.
- History of cancer.
- Gestational carriers.
- Planned preimplantation genetic diagnosis or preimplantation genetic screening.
- Previously enrolled in this study
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 |
|---|---|---|
| In-vitro fertilization using EevaEeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva results along with traditional morphological grading to assist in selecting embryo(s) for transfer or freezing. | Device | Women undergoing IVF treatment |
Primary outcome
To validate and develop the Eeva Software.
Time frame: 3 months
The clinical image data (embryos images) will be used to develop the Eeva System Software. The Eeva software validation will consist in comparing the specificity of the Eeva System Software Blastocyst Prediction from the Eeva 12-well Dish to the specificity of the Eeva System Software from the Eeva 25-well Dish (the specificity of the Eeva System Software from the Eeva 25-well Dish was previously determined during the Eeva System Study TST-1788-r).
1 secondary outcome
Specificity and sensitivity and 95% confidence intervals of the Eeva System Software and the Embryologist Panel (also referred to as Panel) measurements will be computed.
Time frame: 3 months
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 13 Jan 2014.
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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.
Robert Boostanfar, MD principal investigator
HRC Fertility
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 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: finished, as of the sponsor's last update on 13 Jan 2014. 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?
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?
To validate and develop the Eeva Software. (time frame: 3 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 Jan 2014; AzTrials last refreshed its copy on 28 Oct 2026.