Infertility, FemaleNCT06419127
Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing
An observational study of Infertility, Female and Infertility, Male, run by Gattaca Genomics at 1 site in United States.
Trial summary
The goal of this observational study is to discern if there is a relationship between timelapse imagery of human oocytes/embryos and PGT results. Embryos of patients that are undergoing PGT will be placed into a timelapse incubator. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Infertility, Female, Infertility, Male, Infertility
- What is being tested?
- Timelapse incubation and PGT
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to Jun 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Adult
Study population: All infertile patients undergoing IVF with PGT
Who may be able to join
- all patients undergoing IVF with PGT
Who cannot join
- patients undergoing IVF and not electing for PGT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to discern if there is a relationship between timelapse imagery of human oocytes/embryos and PGT results.
Embryos of patients that are undergoing PGT will be placed into a timelapse incubator. The data obtained by the timelapse incubator will be used in conjunction with the PGT data to determine any relationships.
Read the detailed description
Timelapse imagery (TLI) is a multifaceted technology being utilized within the in vitro fertilization (IVF) space. With this technology it is possible to have a live, continuous video of embryo development from fertilization to implantation. During this live evaluation multiple datapoints can be extrapolated and used to determine embryo viability. Another technology used in the IVF space is preimplantation genetic testing for aneuploidy (PGT-A). With this technology, individual cells from the embryo are removed, amplified, and the chromosomal content of the cells is analyzed by next generation sequencing (NGS)-based technology, allowing the chromosomal content of the embryos to be determined prior to embryo transfer.
To date, no one has combined the data from both tools to try to advance the IVF field.
Gattaca Genomics is proposing utilizing the data obtained from TLI, in conjunction with the data obtained from PGT-A, to create a computer model that can accurately predict which embryos will lead to a successful outcome during IVF.
- Conditions
- Infertility, Female, Infertility, Male, Infertility, IVF, Aneuploidy
- Being tested
- Timelapse incubation and PGT
- Keywords
- ivf, infertility, pgt, embryo
- Medical subject headings
- Infertility, Female, Infertility, Male, Infertility, Aneuploidy, Long Qt Syndrome 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timelapse incubation and PGTDiagnostic test
Patients will have their embryos cultured in a timelapse incubator and their PGT results will be compared to the data collected during timelapse incubation.
| Study group | Role | What they receive |
|---|---|---|
| Infertile patients | Infertile patients undergoing IVF with PGT. Receives: Diagnostic Test: Timelapse incubation and PGT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first cleavage
time of embryo to undergo first cleavage
Measured: 24 hours
Time to blastulation
time of embryo to form a blastocoel
Measured: 5-7 days
Fertilization morphology
the morphological appearance of the pronuclei
Measured: 24 hours
Embryo morphology
the morphological appearance of the embryos
Measured: 2-7 days
Patient age
Patient age
Measured: 0 days
Partner age
Partner age
Measured: 0 days
Partner diagnosis
Partner diagnosis
Measured: 0 days
Metabolomics of culture media
measurement of the spent culture media for amino acids, enzymes, and metabolites
Measured: 7 days
AMH
antimullerian hormone level in female's blood
Measured: 0 days
Days of stimulation
the number of days the patient underwent stimulation for IVF
Measured: 0-15 days
Dosage of stimulation meds
the amount of stimulation meds the patient took during IVF treatment
Measured: 0-15 days
Pregnancy
initial bhCG levels
Measured: 2 weeks after transfer
Patient diagnosis
Number of patients with each specific diagnosis, including low ovarian reserve, PCOS, primary infertility, secondary infertility, endometrosis, and unknown infertility.
Measured: 0 days
implantation
Number of patients that develope a sac within the uterus post transfer
Measured: 4 weeks post transfer
fetal cardiac heartbeat
Number of patients that develop a fetal cardiac heartbeat after transfer
Measured: 6 weeks
livebirth
Number of patients that have a livebirth of an infant after IVF
Measured: approximately 9 months after transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Jan 2025
- Primary completionJun 2031 (estimated)
- Study completionJun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gattaca Genomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419127
- Sponsor's protocol ID
- GG1001
- Status last verified
- Jan 2026
- First submitted
- 14 May 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing
- ClinicalTrials.gov ID
- NCT06419127
- Acronym / sponsor ID
- GG1001
- Conditions
- Infertility, Female, Infertility, Male, Infertility, IVF, Aneuploidy
- Keywords
- ivf, infertility, pgt, embryo
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Gattaca GenomicsIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 17 May 2024 (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.
The goal of this observational study is to discern if there is a relationship between timelapse imagery of human oocytes/embryos and PGT results.
Embryos of patients that are undergoing PGT will be placed into a timelapse incubator. The data obtained by the timelapse incubator will be used in conjunction with the PGT data to determine any relationships.
Detailed description
Timelapse imagery (TLI) is a multifaceted technology being utilized within the in vitro fertilization (IVF) space. With this technology it is possible to have a live, continuous video of embryo development from fertilization to implantation. During this live evaluation multiple datapoints can be extrapolated and used to determine embryo viability. Another technology used in the IVF space is preimplantation genetic testing for aneuploidy (PGT-A). With this technology, individual cells from the embryo are removed, amplified, and the chromosomal content of the cells is analyzed by next generation sequencing (NGS)-based technology, allowing the chromosomal content of the embryos to be determined prior to embryo transfer.
To date, no one has combined the data from both tools to try to advance the IVF field.
Gattaca Genomics is proposing utilizing the data obtained from TLI, in conjunction with the data obtained from PGT-A, to create a computer model that can accurately predict which embryos will lead to a successful outcome during IVF.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertile patients | – | Diagnostic Test: Timelapse incubation and PGTInfertile patients undergoing IVF with PGT. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- All infertile patients undergoing IVF with PGT
Key inclusion criteria (1 listed)
- all patients undergoing IVF with PGT
Key exclusion criteria (1 listed)
- patients undergoing IVF and not electing for PGT
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 |
|---|---|---|
| Timelapse incubation and PGTPatients will have their embryos cultured in a timelapse incubator and their PGT results will be compared to the data collected during timelapse incubation. | Diagnostic test | Infertile patients |
Primary outcome
Time to first cleavage
Time frame: 24 hours
time of embryo to undergo first cleavage
Time to blastulation
Time frame: 5-7 days
time of embryo to form a blastocoel
Fertilization morphology
Time frame: 24 hours
the morphological appearance of the pronuclei
Embryo morphology
Time frame: 2-7 days
the morphological appearance of the embryos
Patient age
Time frame: 0 days
Patient age
Partner age
Time frame: 0 days
Partner age
Partner diagnosis
Time frame: 0 days
Partner diagnosis
Metabolomics of culture media
Time frame: 7 days
measurement of the spent culture media for amino acids, enzymes, and metabolites
AMH
Time frame: 0 days
antimullerian hormone level in female's blood
Days of stimulation
Time frame: 0-15 days
the number of days the patient underwent stimulation for IVF
Dosage of stimulation meds
Time frame: 0-15 days
the amount of stimulation meds the patient took during IVF treatment
Pregnancy
Time frame: 2 weeks after transfer
initial bhCG levels
Patient diagnosis
Time frame: 0 days
Number of patients with each specific diagnosis, including low ovarian reserve, PCOS, primary infertility, secondary infertility, endometrosis, and unknown infertility.
implantation
Time frame: 4 weeks post transfer
Number of patients that develope a sac within the uterus post transfer
fetal cardiac heartbeat
Time frame: 6 weeks
Number of patients that develop a fetal cardiac heartbeat after transfer
livebirth
Time frame: approximately 9 months after transfer
Number of patients that have a livebirth of an infant after IVF
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No. Data will not be shared with other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infertility, Female and Infertility, Male, run by Gattaca Genomics 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: enrolling by invitation, as of the sponsor's last update on 29 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to first cleavage (time frame: 24 hours). The study lists 16 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 29 Jan 2026.