InfertilityCCSNCT01635049
Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results
An observational study of Infertility, run by Progyny, Inc. at 2 sites in United States.
Trial summary
The purpose of this research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva System parameters with comprehensive chromosome screening (CCS) results, implantation and live birth. Read more about this study
- Who is it for?
- Ages Up to 43 years, women only
- Conditions the study is for
- Infertility
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Dec 2014
- 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 Up to 43 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women undergoing fresh IVF treatment and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.
Who may be able to join
- Subject is ≤43 years of age.
- Women undergoing fresh IVF treatment using her own eggs or donor eggs and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.
- Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
- Willing to have all 2PN embryos monitored by Eeva
- Not previously enrolled in this study.
- No concurrent participation in another clinical study.
- Willing to comply with study protocol and procedures and able to speak English.
- Willing to provide written informed consent.
Who cannot join
- BMI ≥ 40
- Prior IVF cycle with < 4 x 2PN
- Diminished ovarian reserve as demonstrated by any one of the following:
- BAFC < 6 at time of cycle start
- Maximum prior FSH > 15
- AMH < 0.5
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Reproductive Medicine Associates of New Jersey
Morristown, New Jersey, 07960
Reproductive Medicine Associates of New York
New York, New York, 10022
About this study
Official title: Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results,Implantation and Live Birth
The purpose of this research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva System parameters with comprehensive chromosome screening (CCS) results, implantation and live birth.
Read the detailed description
The present study was designed to determine if there is a correlation between the Eeva System parameters and CCS results. Embryos will be selected for transfer based on CCS results and morphology. The Clinical site will have no access to the Eeva analysis at the time of the transfer.
- 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 blastocysts, infertility, preimplantation genetic diagnosis, comprehensive chromosome screening
- 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 |
|---|---|---|
| Women undergoing IVF treatment and CCS | •Women undergoing fresh IVF treatment and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eeva time-lapse parameters and CCS
Analyse the correlation of time-lapse parameters collected by the Eeva System and comprehensive chromosome screening (CCS) results.
Measured: 5-6 days
Secondary outcomes (6)
Correlation of time-lapse parameters collected by the Eeva System and implantation rate.
Measured: 6 weeks
Correlation of time-lapse parameters collected by the Eeva System and clinical pregnancy rate
Measured: 6 weeks
Correlation of time-lapse parameters collected by the Eeva System and ongoing pregnancy rate
Measured: 7 - 8 weeks
Correlation of time-lapse parameters collected by the Eeva System and delivery rate
Measured: live birth
Correlation of time-lapse parameters collected by the Eeva System and spontaneous miscarriage rate
Measured: live birth
Correlation of time-lapse parameters collected by the Eeva System and multiple pregnancy rate
Measured: live birth
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 completionDec 2014
- Study completionDec 2014
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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Progyny, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard T Scott, Jr., MD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635049
- Sponsor's protocol ID
- 2012-AUX-004
- Acronym
- CCS
- Status last verified
- Jan 2015
- First submitted
- 2 Jul 2012
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results,Implantation and Live Birth
- ClinicalTrials.gov ID
- NCT01635049
- Acronym / sponsor ID
- CCS / 2012-AUX-004
- 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 blastocysts, infertility, preimplantation genetic diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Progyny, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (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 research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva System parameters with comprehensive chromosome screening (CCS) results, implantation and live birth.
Detailed description
The present study was designed to determine if there is a correlation between the Eeva System parameters and CCS results. Embryos will be selected for transfer based on CCS results and morphology. The Clinical site will have no access to the Eeva analysis at the time of the transfer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing IVF treatment and CCS | – | –•Women undergoing fresh IVF treatment and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist. |
Who may qualify
- Ages
- Up to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women undergoing fresh IVF treatment and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.
Key inclusion criteria (8 listed)
- Subject is ≤43 years of age.
- Women undergoing fresh IVF treatment using her own eggs or donor eggs and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.
- Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
- Willing to have all 2PN embryos monitored by Eeva
- Not previously enrolled in this study.
Key exclusion criteria (6 listed)
- BMI ≥ 40
- Prior IVF cycle with < 4 x 2PN
- Diminished ovarian reserve as demonstrated by any one of the following:
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
Eeva time-lapse parameters and CCS
Time frame: 5-6 days
Analyse the correlation of time-lapse parameters collected by the Eeva System and comprehensive chromosome screening (CCS) results.
6 secondary outcomes
Correlation of time-lapse parameters collected by the Eeva System and implantation rate.
Time frame: 6 weeks
Correlation of time-lapse parameters collected by the Eeva System and clinical pregnancy rate
Time frame: 6 weeks
Correlation of time-lapse parameters collected by the Eeva System and ongoing pregnancy rate
Time frame: 7 - 8 weeks
Correlation of time-lapse parameters collected by the Eeva System and delivery rate
Time frame: live birth
Correlation of time-lapse parameters collected by the Eeva System and spontaneous miscarriage rate
Time frame: live birth
Correlation of time-lapse parameters collected by the Eeva System and multiple pregnancy rate
Time frame: live birth
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 14 Jan 2015.
- 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.
Richard T Scott, Jr., MD principal investigator
Reproductive Medicine Associates of New Jersey
2 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 2 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 14 Jan 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 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?
Eeva time-lapse parameters and CCS (time frame: 5-6 days). 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 14 Jan 2015.