InfertilityNCT02246309
Comparison Of The Embryoscope Time-Lapse System With Standard Embryo Culture
A study testing Embryoscope Time Lapse System and Standard Embryo Culture in people with Infertility, run by Center for Human Reproduction at 1 site in United States.
Trial summary
"Embryoscopes," allow for embryo culture to be performed in an automated incubation system under time lapse photography. Manufacturers of these systems (and investigators who have used these systems) claim that the availability of 24-hour time-lapse photographic control improves embryo selection and, therefore, IVF… Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Embryoscope Time Lapse System and Standard Embryo Culture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients already planning to undergo in vitro fertilization
Who cannot join
- Patients with more than 12 oocytes will be excluded from this trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Human Reproduction
New York, New York, 10021
About this study
Official title: Comparison Of The Embryoscope Time-Lapse System With Standard Embryo Culture at Center for Human Reproduction(CHR):an Open Label Randomized Clinical Trial
"Embryoscopes," allow for embryo culture to be performed in an automated incubation system under time lapse photography. Manufacturers of these systems (and investigators who have used these systems) claim that the availability of 24-hour time-lapse photographic control improves embryo selection and, therefore, IVF (in vtro fertilization) pregnancy rates. They also claim that use of this system saves laboratory personnel time.
This study will randomize approximately 120 patients (60 in each arm) to standard embryo culture or to culture in an Embryoscope. The primary endpoint will be a comparison of time spent by the laboratory personnel with each system. Secondary endpoints will be IVF outcomes.
Read the detailed description
A large number of IVF centers all around the world are converting from standard embryology practice, where embryos are by embryologists manually processed during culture, to so-called "embryoscopes," where embryo culture is performed in an automated incubation system under time lapse photography.
Manufacturers of these systems (and investigators who have used these systems) claim that the availability of 24-hour time-lapse photographic control improves embryo selection and, therefore, IVF pregnancy rates. They also claim that use of this system saves laboratory personnel time. The FDA has so far, therefore, approved for sale at least 2 such systems In the USA.
(i) Our analysis of the published literature has failed to find studies in support of the claim that utilization of such equipment really improves pregnancy rates with IVF; and (ii) Investigators are concerned that CHR's highly adversely selected patient population may demonstrate different utilization outcomes from standard patient populations, especially since this equipment is usually utilized to culture embryos to blastocyst stage (days 5/6), while CHR cultures most patients only to day-3.
Investigators, therefore, contacted the manufacturer of the first FDA approved system, and explained our concerns. The manufacturer agreed to loan us one of their systems for a 4-months long study free of charge (CHR just pays a nominal amount for installation and training costs) but will be financially responsible for supplies.
During these 4 months, CHR will perform an open-label prospective (registered) and randomized clinical trial, in which investigators, based on computerized randomization, will assign all CHR patients (who agree to participate with informed written consent), either to standard embryology or "embryoscope" embryology.
Recruiting approximately 30 patients per month into the study is anticipated, which would give us a population of ~n=60 in each study group.
Patient with excessive numbers of eggs retrieved (>12) will be excluded since the purpose of this study is to investigate the utility of the system in a relatively adversely selected patient population. All other patients will be offered participation.
The study will have as primary end point a time analysis of laboratory manpower, under which the time spent on each patient by embryologist will be recorded and compared and as secondary end point IVF cycle outcome, defined by number of good quality embryos available for transfer, implantation rates and clinical pregnancy rates.
- Conditions
- Infertility
- Being tested
- Embryoscope Time Lapse System, Standard Embryo Culture
- Keywords
- Infertility, Embryo Culture, Laboratory Technique
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embryoscope Time Lapse SystemDevice
The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection.
Standard Embryo CultureDevice
Also called Standard water jacketed incubator system
Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.
| Study group | Role | What they receive |
|---|---|---|
| Embryoscope Time Lapse System | Experimental | All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed. Receives: Device: Embryoscope Time Lapse System |
| Standard Embryo Culture | Active comparator | All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed. Receives: Device: Standard Embryo Culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personnel Effort
Number of minutes spent by laboratory personnel technical staff in support of each system
Measured: Three days
Secondary outcomes (1)
Embryo Quality
Number of Grade A best quality of day 3 embryos (based on cell number and degree of fragmentation)
Measured: Three Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Equipment was loaned Lifglobal, Guilford, CT, USA and had to be returned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Human Reproduction
- Sponsor type
- University, hospital or other
- Collaborators
- FertiliTech Inc.
- Responsible party
- Sponsor
- Investigators
- David Barad, MD, Principal investigator, Center for Human Reproduction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246309
- Sponsor's protocol ID
- ER08282014-01
- Status last verified
- Dec 2015
- First submitted
- 18 Sep 2014
- Last updated
- 17 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wu YG, Lazzaroni-Tealdi E, Wang Q, Zhang L, Barad DH, Kushnir VA, Darmon SK, Albertini DF, Gleicher N. Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study. Reprod Biol Endocrinol. 2016 Aug 24;14(1):49. doi: 10.1186/s12958-016-0181-x.
PubMed 27553622
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Embryoscope Time-Lapse System With Standard Embryo Culture at Center for Human Reproduction(CHR):an Open Label Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02246309
- Acronym / sponsor ID
- ER08282014-01
- Conditions
- Infertility
- Keywords
- Infertility, Embryo Culture, Laboratory Technique
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Equipment was loaned Lifglobal, Guilford, CT, USA and had to be returned.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Center for Human ReproductionUniversity, hospital or other
- Collaborators
- FertiliTech Inc.
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Posted 17 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Embryoscopes," allow for embryo culture to be performed in an automated incubation system under time lapse photography. Manufacturers of these systems (and investigators who have used these systems) claim that the availability of 24-hour time-lapse photographic control improves embryo selection and, therefore, IVF (in vtro fertilization) pregnancy rates. They also claim that use of this system saves laboratory personnel time.
This study will randomize approximately 120 patients (60 in each arm) to standard embryo culture or to culture in an Embryoscope. The primary endpoint will be a comparison of time spent by the laboratory personnel with each system. Secondary endpoints will be IVF outcomes.
Detailed description
A large number of IVF centers all around the world are converting from standard embryology practice, where embryos are by embryologists manually processed during culture, to so-called "embryoscopes," where embryo culture is performed in an automated incubation system under time lapse photography.
Manufacturers of these systems (and investigators who have used these systems) claim that the availability of 24-hour time-lapse photographic control improves embryo selection and, therefore, IVF pregnancy rates. They also claim that use of this system saves laboratory personnel time. The FDA has so far, therefore, approved for sale at least 2 such systems In the USA.
(i) Our analysis of the published literature has failed to find studies in support of the claim that utilization of such equipment really improves pregnancy rates with IVF; and (ii) Investigators are concerned that CHR's highly adversely selected patient population may demonstrate different utilization outcomes from standard patient populations, especially since this equipment is usually utilized to culture embryos to blastocyst stage (days 5/6), while CHR cultures most patients only to day-3.
Investigators, therefore, contacted the manufacturer of the first FDA approved system, and explained our concerns. The manufacturer agreed to loan us one of their systems for a 4-months long study free of charge (CHR just pays a nominal amount for installation and training costs) but will be financially responsible for supplies.
During these 4 months, CHR will perform an open-label prospective (registered) and randomized clinical trial, in which investigators, based on computerized randomization, will assign all CHR patients (who agree to participate with informed written consent), either to standard embryology or "embryoscope" embryology.
Recruiting approximately 30 patients per month into the study is anticipated, which would give us a population of ~n=60 in each study group.
Patient with excessive numbers of eggs retrieved (>12) will be excluded since the purpose of this study is to investigate the utility of the system in a relatively adversely selected patient population. All other patients will be offered participation.
The study will have as primary end point a time analysis of laboratory manpower, under which the time spent on each patient by embryologist will be recorded and compared and as secondary end point IVF cycle outcome, defined by number of good quality embryos available for transfer, implantation rates and clinical pregnancy rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embryoscope Time Lapse System | Experimental | Device: Embryoscope Time Lapse SystemAll embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed. |
| Standard Embryo Culture | Active comparator | Device: Standard Embryo CultureAll embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients already planning to undergo in vitro fertilization
Key exclusion criteria (1 listed)
- Patients with more than 12 oocytes will be excluded from this trial
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 |
|---|---|---|
| Embryoscope Time Lapse SystemThe EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection. | Device | Embryoscope Time Lapse System |
| Standard Embryo CultureAlso: Standard water jacketed incubator systemStandard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system. | Device | Standard Embryo Culture |
Primary outcome
Personnel Effort
Time frame: Three days
Number of minutes spent by laboratory personnel technical staff in support of each system
1 secondary outcome
Embryo Quality
Time frame: Three Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27553622Wu YG, Lazzaroni-Tealdi E, Wang Q, Zhang L, Barad DH, Kushnir VA, Darmon SK, Albertini DF, Gleicher N. Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study. Reprod Biol Endocrinol. 2016 Aug 24;14(1):49. doi: 10.1186/s12958-016-0181-x.
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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.
David Barad, MD principal investigator
Center for Human Reproduction
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embryoscope Time Lapse System and Standard Embryo Culture in people with Infertility, run by Center for Human Reproduction 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 17 May 2018. 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?
Yes. Results are posted in the registry (first posted 17 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Personnel Effort (time frame: Three days). 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 NCT02246309, 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 17 May 2018.