Frozen EmbryosNCT04255641
Time - Lapse Analysis of Frozen Embryos
An observational study of Frozen Embryos, run by Carmel Medical Center at 1 site in Israel.
Trial summary
A retrospective analysis of embryo defrost cycles that were rated in the EmbryoScope system and frozen will be performed. The study will examine the possible association between the morphokinetic grading received by these embryos as fresh embryos before freezing, and their survival, the morphological grading they… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Frozen Embryos
- What is being tested?
- time lapse analysis
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2020to Dec 2020
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All women who underwent embryo freezing and thawing between the years 2014-2019 in Carmel medical center
Who may be able to join
- All women who underwent embryo freezing and thawing between the years 2014-2019 in Carmel medical center
Who cannot join
- Lack of proper data
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical Center
Haifa, 3436212
Zofnat Wiener, MD, 97248250147
About this study
Official title: Is Morphokinetic Scoring by Time - Lapse Analysis of Embryos Undergoing Cryopreservation During IVF Associated With Post- Thaw Survival and Treatment Outcome: A Retrospective Analysis
A retrospective analysis of embryo defrost cycles that were rated in the EmbryoScope system and frozen will be performed. The study will examine the possible association between the morphokinetic grading received by these embryos as fresh embryos before freezing, and their survival, the morphological grading they received after thawing, their proper rooting and live birth after thawing.
- Conditions
- Frozen Embryos
- Being tested
- time lapse analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
time lapse analysisOther
grading of the embryos before freezing using time lapse/
| Study group | Role | What they receive |
|---|---|---|
| frozen embryos | Not described Receives: Other: time lapse analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth
Measured: 1 day
embryos survival after thawing
Measured: 1-2 days
implantation in the uterus
Measured: 1 week
post thaw grading
post thaw grading of the embryos using time lapse analysis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startFeb 2020 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen EmbryosStudies 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
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255641
- Sponsor's protocol ID
- CMC-19-0121-CTIL
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Morphokinetic Scoring by Time - Lapse Analysis of Embryos Undergoing Cryopreservation During IVF Associated With Post- Thaw Survival and Treatment Outcome: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT04255641
- Acronym / sponsor ID
- CMC-19-0121-CTIL
- Conditions
- Frozen Embryos
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Feb 2020 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 Feb 2020 (actual)
- 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.
A retrospective analysis of embryo defrost cycles that were rated in the EmbryoScope system and frozen will be performed. The study will examine the possible association between the morphokinetic grading received by these embryos as fresh embryos before freezing, and their survival, the morphological grading they received after thawing, their proper rooting and live birth after thawing.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| frozen embryos | – | Other: time lapse analysis |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All women who underwent embryo freezing and thawing between the years 2014-2019 in Carmel medical center
Key inclusion criteria (1 listed)
- All women who underwent embryo freezing and thawing between the years 2014-2019 in Carmel medical center
Key exclusion criteria (1 listed)
- Lack of proper data
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 |
|---|---|---|
| time lapse analysisgrading of the embryos before freezing using time lapse/ | Other | frozen embryos |
Primary outcome
live birth
Time frame: 1 day
embryos survival after thawing
Time frame: 1-2 days
implantation in the uterus
Time frame: 1 week
post thaw grading
Time frame: 1 day
post thaw grading of the embryos using time lapse analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 Frozen Embryos, run by Carmel Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zofnat wiener, dr (0544824046, wiener_zofnat@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth (time frame: 1 day). The study lists 4 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 5 Feb 2020.