InfertilityCASNCT01617993
Eeva™ Continued Access Study: Assessing the Usability of Eeva in a Clinical Setting
An observational study of Infertility, run by Progyny, Inc. at 3 sites in United States.
Trial summary
User questionnaire of Eeva System usability and reports of device malfunctions. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2012to Feb 2013
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women in the United States who undergo IVF treatment and imaging of their embryos with Eeva.
Who may be able to join
- Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs
- Subject is ≥ 18 and ≤ 40 years of age.
- Subject has basal antral follicle count (AFC) ≥ 8 prior to stimulation cycle.
- Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
- Subject has ≥ 5 normally fertilized eggs (2 PN)
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pacific Fertility Center
San Francisco, California, 94133
Fertility Physicians of Northern California
San Jose, California, 95124
Reproductive Science Center
San Ramon, California, 94583
About this study
Official title: Eeva Continued Access Study.
User questionnaire of Eeva System usability and reports of device malfunctions.
Read the detailed description
This study is designed to evaluate the use of Eeva by IVF laboratory staff during routine procedures. The fertilized eggs will be placed in an Eeva dish and the development of the embryos will be monitored by the Eeva system in a standard incubator. On day 3 of embryo culture, Eeva blastocyst prediction data will be printed from the system to be used to assist the embryologist in selecting the best embryo(s). The performance of the system will be summarized and the user feedback from the embryologists will be collected.
- Conditions
- Infertility
- Keywords
- in vitro fertilization, assisted reproduction, noninvasive imaging of embryos, time lapse imaging of embryos, traditional morphological grading of embryos, prediction of blastocysts, infertility, Genital Diseases, Male, Genital Diseases, Female
- Medical subject headings
- Infertility, Genital Diseases, Male, Genital Diseases, Female
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 |
|---|---|---|
| Women undergoing IVF treatment | Women undergoing IVF treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
User questionnaire of Eeva System usability and reports of device malfunctions.
Measured: Participants will be followed through ongoing pregnancy, at approximately 10-12 weeks gestational age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Progyny, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shehua Shen, ELD, MD, Study director, Progyny, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617993
- Sponsor's protocol ID
- 2012-AUX-002
- Acronym
- CAS
- Status last verified
- Jan 2014
- First submitted
- 8 Jun 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 Continued Access Study.
- ClinicalTrials.gov ID
- NCT01617993
- Acronym / sponsor ID
- CAS / 2012-AUX-002
- Conditions
- Infertility
- Keywords
- in vitro fertilization, assisted reproduction, noninvasive imaging of embryos, time lapse imaging of embryos, traditional morphological grading of embryos, prediction of blastocysts, infertility, Genital Diseases, Male
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Progyny, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 13 Jun 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.
User questionnaire of Eeva System usability and reports of device malfunctions.
Detailed description
This study is designed to evaluate the use of Eeva by IVF laboratory staff during routine procedures. The fertilized eggs will be placed in an Eeva dish and the development of the embryos will be monitored by the Eeva system in a standard incubator. On day 3 of embryo culture, Eeva blastocyst prediction data will be printed from the system to be used to assist the embryologist in selecting the best embryo(s). The performance of the system will be summarized and the user feedback from the embryologists will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing IVF treatment | – | –Women undergoing IVF treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women in the United States who undergo IVF treatment and imaging of their embryos with Eeva.
Key inclusion criteria (8 listed)
- Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs
- Subject is ≥ 18 and ≤ 40 years of age.
- Subject has basal antral follicle count (AFC) ≥ 8 prior to stimulation cycle.
- Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
- Subject has ≥ 5 normally fertilized eggs (2 PN)
Key exclusion criteria (6 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.
Primary outcome
User questionnaire of Eeva System usability and reports of device malfunctions.
Time frame: Participants will be followed through ongoing pregnancy, at approximately 10-12 weeks gestational age.
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.
- Auxogyn, Inc. websiteLink provided by the sponsor.
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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, ELD, MD study director
Progyny, Inc.
3 sites 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 3 sites 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 8 inclusion and 6 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 3 sites 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?
User questionnaire of Eeva System usability and reports of device malfunctions. (time frame: Participants will be followed through ongoing pregnancy, at approximately 10-12 weeks gestational age.). 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.