InfertilityNCT03522350
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
A study testing EmbryoScope and EmbryoScope+ in people with Infertility, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of the study is to compare the current EmbryoScope Time-Lapse System being used in IVF which has become standard of care to the new model EmbryoScope to demonstrate that the EmbryoScope+ is as safe and reliable as the EmbryoScope. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Infertility
- What is being tested?
- EmbryoScope and EmbryoScope+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2017to 4 Jun 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years of age or younger (maternal)
- 65 years of age or younger (paternal)
- Fresh or frozen (including donor) sperm can be used
- Fresh oocytes only (including donor)
- Frozen embryos from this study can be included in the outcome portion of this study.
- Single or double Blastocyst transfer only
Who cannot join
- 3 or more previous failed cycles
- Sperm obtained by testicular biopsy
- Co-culture patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Reproductive Medicine
New York, New York, 10065
About this study
Official title: Randomized Controlled Trial Comparing EmbryoScope Time-Lapse System With the New Model EmbryoScope+.
The purpose of the study is to compare the current EmbryoScope Time-Lapse System being used in IVF which has become standard of care to the new model EmbryoScope to demonstrate that the EmbryoScope+ is as safe and reliable as the EmbryoScope.
Read the detailed description
This is a randomized, controlled, single-center study in otherwise healthy infertile female subjects undergoing in vitro fertilization (IVF). The subjects recruited for this study will be among those patients who have been diagnosed with infertility and are planning to undergo IVF at the center where this study is being performed. The subjects will have undergone the usual informed consent procedure at the center.
Subjects will undergo ovarian stimulation, oocyte retrieval, IVF, and Intra Cytoplasmic Sperm Injection (ICSI) procedure following the center's usual procedures. At the time of retrieval, participant's oocytes will be randomly assigned to both groups for comparison: Standard EmbryoScope Time-Lapse system versus EmbryoScope+. The best quality embryos are selected for embryo transfer and the pregnancy outcome is evaluated.
"Best grade" embryos will be transferred regardless of EmbryoScope use. The standard EmbryoScope as well as the EmbryoScope+ monitor system as assigned during the randomization process will be used to observe the embryo development and document timing of embryo cleavages and morphology dynamics. Subjects will not be provided with the time- lapse images.
Endpoints will be Day 3 and Day 5/6 embryo development, implantation and pregnancy rate. The study is approximately 2 months, the estimated time it takes a physician to perform one IVF-ART treatment cycle. If embryos are frozen, the patient may be in the study until the time they choose to thaw the embryos or up to 1 year if they become pregnant.
- Conditions
- Infertility
- Being tested
- EmbryoScope, EmbryoScope+
- Keywords
- Infertility, Embryo develpoment, IVF, ICSI, EmbryoScope
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbryoScopeDevice
Standard of care arm
EmbryoScope+Device
Experimental arm
| Study group | Role | What they receive |
|---|---|---|
| EmbryoScope | Active comparator | Standard of care embryo incubator. Receives: Device: EmbryoScope |
| EmbryoScope+ | Experimental | New experimental embryo incubator. Receives: Device: EmbryoScope+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Day 3 Embryos
Comparing number of embryos that fertilized normally and had development at Day 3 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+
Measured: Day 3 post retrieval
Number of Day 5 Embryos
Comparing the number pf embryos that developed at Day 5 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+
Measured: Day 5 post retrieval
Secondary outcomes (2)
Implantation Rate
Presence of a gestational sac
Measured: 5-6 weeks post retrieval
Pregnancy Rate
Positive Bhcg
Measured: 2 weeks post retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start6 Sep 2017
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
Why it stopped: Device has been FDA approved.
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.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Vitrolife
- Responsible party
- Sponsor
- Investigators
- Nikica Zaninovic, PhD, Principal investigator, Center for Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522350
- Sponsor's protocol ID
- 1612017837
- Status last verified
- May 2019
- First submitted
- 20 Feb 2018
- Last updated
- 31 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing EmbryoScope Time-Lapse System With the New Model EmbryoScope+.
- ClinicalTrials.gov ID
- NCT03522350
- Acronym / sponsor ID
- 1612017837
- Conditions
- Infertility
- Keywords
- Infertility, Embryo develpoment, IVF, ICSI, EmbryoScope
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device has been FDA approved.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Vitrolife
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Posted 31 May 2019
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 the study is to compare the current EmbryoScope Time-Lapse System being used in IVF which has become standard of care to the new model EmbryoScope to demonstrate that the EmbryoScope+ is as safe and reliable as the EmbryoScope.
Detailed description
This is a randomized, controlled, single-center study in otherwise healthy infertile female subjects undergoing in vitro fertilization (IVF). The subjects recruited for this study will be among those patients who have been diagnosed with infertility and are planning to undergo IVF at the center where this study is being performed. The subjects will have undergone the usual informed consent procedure at the center.
Subjects will undergo ovarian stimulation, oocyte retrieval, IVF, and Intra Cytoplasmic Sperm Injection (ICSI) procedure following the center's usual procedures. At the time of retrieval, participant's oocytes will be randomly assigned to both groups for comparison: Standard EmbryoScope Time-Lapse system versus EmbryoScope+. The best quality embryos are selected for embryo transfer and the pregnancy outcome is evaluated.
"Best grade" embryos will be transferred regardless of EmbryoScope use. The standard EmbryoScope as well as the EmbryoScope+ monitor system as assigned during the randomization process will be used to observe the embryo development and document timing of embryo cleavages and morphology dynamics. Subjects will not be provided with the time- lapse images.
Endpoints will be Day 3 and Day 5/6 embryo development, implantation and pregnancy rate. The study is approximately 2 months, the estimated time it takes a physician to perform one IVF-ART treatment cycle. If embryos are frozen, the patient may be in the study until the time they choose to thaw the embryos or up to 1 year if they become pregnant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EmbryoScope | Active comparator | Device: EmbryoScopeStandard of care embryo incubator. |
| EmbryoScope+ | Experimental | Device: EmbryoScope+New experimental embryo incubator. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 40 years of age or younger (maternal)
- 65 years of age or younger (paternal)
- Fresh or frozen (including donor) sperm can be used
- Fresh oocytes only (including donor)
- Frozen embryos from this study can be included in the outcome portion of this study.
Key exclusion criteria (3 listed)
- 3 or more previous failed cycles
- Sperm obtained by testicular biopsy
- Co-culture patients
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 |
|---|---|---|
| EmbryoScopeStandard of care arm | Device | EmbryoScope |
| EmbryoScope+Experimental arm | Device | EmbryoScope+ |
Primary outcome
Number of Day 3 Embryos
Time frame: Day 3 post retrieval
Comparing number of embryos that fertilized normally and had development at Day 3 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+
Number of Day 5 Embryos
Time frame: Day 5 post retrieval
Comparing the number pf embryos that developed at Day 5 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+
2 secondary outcomes
Implantation Rate
Time frame: 5-6 weeks post retrieval
Pregnancy Rate
Time frame: 2 weeks post retrieval
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Nikica Zaninovic, PhD principal investigator
Center for Reproductive Medicine
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 and EmbryoScope+ in people with Infertility, run by Weill Medical College of Cornell University 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 6 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: stopped early, as of the sponsor's last update on 31 May 2019. 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 31 May 2019). 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?
Number of Day 3 Embryos (time frame: Day 3 post retrieval). The study lists 2 primary outcomes in all. 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 31 May 2019.