InfertilityNCT05545995
Time Lapse Assisted Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection
An observational study of Infertility and Aneuploidy, run by Assisting Nature at 1 site in Greece.
Trial summary
This is a prospective randomised study of the evaluation of the clinical IVF results after time lapse assisted embryo selection versus Non-invasive PGT-A assisted embryo selection in subfertile women. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Aneuploidy, Chromosome Abnormality
- What is being tested?
- embryo selection
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2022to Mar 2024
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women aged 18- 39, faced with infertility issues, meeting the above inclusion criteria.
Who may be able to join
- Women who followed IVF treatment
- 39 years old or younger
- Single embryo transfer
- blastocyst stage cultured embryos
Who cannot join
- women over the age of 39 years
- not blastocyst transfer (transfers performed at earlier embryo stage)
- double embryotransfer
- women who had invasive PGT-a test
- women whose embryos were not time-lapse monitored
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Assisting Nature
Thessaloniki, 57001
Evaggelos Papanikolaou, MD, PhD, 00302310424294, embryology@assistingnature.gr
Maria Galiotou, MSc, 00302310424294, galiotou@assistingnature.gr
About this study
Official title: IVF Outcomes Based on Time Lapse Assisted Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection
This is a prospective randomised study of the evaluation of the clinical IVF results after time lapse assisted embryo selection versus Non-invasive PGT-A assisted embryo selection in subfertile women.
Read the detailed description
A randomized prospective study focusing on subfertile women undergoing IVF treatment followed by embryo transfer on the blastocyst stage.
Women assigned to group A proceed to embryo transfer, after time lapse assisted embryo selection, while women of group B after non-invasive PGT-A assisted embryo selection.
IVF outcomes, regarding the success rate of the trasnfer and the time required to achieve conception is studied in both groups.
- Conditions
- Infertility, Aneuploidy, Chromosome Abnormality
- Being tested
- embryo selection
- Keywords
- IVF, PGT-A, NON- INVASIVE PGT-A, TIME LAPSE, EMBRYO SELECTION
- Medical subject headings
- Infertility, Aneuploidy, Chromosome Aberrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embryo selectionOther
The basis of embryo seletion for transfer: morphological or genetic after non-invasive PGT-A
| Study group | Role | What they receive |
|---|---|---|
| TIME LAPSE | Women who proceed to embryo transfer after time lapse assisted embryo selection. Receives: Other: embryo selection | |
| NI-PGT-A | Women who proceed to embryo transfer after non-invasive PGT-A assisted embryo selection. Receives: Other: embryo selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryotransfers to conceive
The number of the embryotransfers required for women to conceive
Measured: Up to the embryotransfer of the last enrolled patient (Dec 2023)
Time interval to conceive
Time interval required for women to conceive (in months): from OPU day to positive hCG test
Measured: Up to the pregnancy test after the last embryo transfer of an enrolled patient (Jan 2024)
Cumulative Live Birth Rate
Cumulative Live Birth Rate achieved after one OPU treatment
Measured: Up to 38 weeks after the embryo transfer
Secondary outcomes (2)
Abortion rate
The spontaneous miscarriage of women in both groups
Measured: Up to 2nd trimester miscarriages
DaC rate
The rate of the dilation and curretage rate in both groups
Measured: Up to 24 weeks of pregnancy according to Greek Law
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assisting Nature
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Papanikolaou Evaggelos, Assisting Nature
- Investigators
- Evangelos Papanikolaou, MD,PhD, Principal investigator, Assisting Nature
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545995
- Sponsor's protocol ID
- AN009
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVF Outcomes Based on Time Lapse Assisted Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection
- ClinicalTrials.gov ID
- NCT05545995
- Acronym / sponsor ID
- AN009
- Conditions
- Infertility, Aneuploidy, Chromosome Abnormality
- Keywords
- IVF, PGT-A, NON- INVASIVE PGT-A, TIME LAPSE, EMBRYO SELECTION
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assisting NatureUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 19 Sep 2022 (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.
This is a prospective randomised study of the evaluation of the clinical IVF results after time lapse assisted embryo selection versus Non-invasive PGT-A assisted embryo selection in subfertile women.
Detailed description
A randomized prospective study focusing on subfertile women undergoing IVF treatment followed by embryo transfer on the blastocyst stage.
Women assigned to group A proceed to embryo transfer, after time lapse assisted embryo selection, while women of group B after non-invasive PGT-A assisted embryo selection.
IVF outcomes, regarding the success rate of the trasnfer and the time required to achieve conception is studied in both groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIME LAPSE | – | Other: embryo selectionWomen who proceed to embryo transfer after time lapse assisted embryo selection. |
| NI-PGT-A | – | Other: embryo selectionWomen who proceed to embryo transfer after non-invasive PGT-A assisted embryo selection. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women aged 18- 39, faced with infertility issues, meeting the above inclusion criteria.
Key inclusion criteria (4 listed)
- Women who followed IVF treatment
- 39 years old or younger
- Single embryo transfer
- blastocyst stage cultured embryos
Key exclusion criteria (5 listed)
- women over the age of 39 years
- not blastocyst transfer (transfers performed at earlier embryo stage)
- double embryotransfer
- women who had invasive PGT-a test
- women whose embryos were not time-lapse monitored
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 |
|---|---|---|
| embryo selectionThe basis of embryo seletion for transfer: morphological or genetic after non-invasive PGT-A | Other | NI-PGT-A, TIME LAPSE |
Primary outcome
Embryotransfers to conceive
Time frame: Up to the embryotransfer of the last enrolled patient (Dec 2023)
The number of the embryotransfers required for women to conceive
Time interval to conceive
Time frame: Up to the pregnancy test after the last embryo transfer of an enrolled patient (Jan 2024)
Time interval required for women to conceive (in months): from OPU day to positive hCG test
Cumulative Live Birth Rate
Time frame: Up to 38 weeks after the embryo transfer
Cumulative Live Birth Rate achieved after one OPU treatment
2 secondary outcomes
Abortion rate
Time frame: Up to 2nd trimester miscarriages
DaC rate
Time frame: Up to 24 weeks of pregnancy according to Greek Law
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- 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.
Evangelos Papanikolaou, MD,PhD principal investigator
Assisting Nature
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 and Aneuploidy, run by Assisting Nature at 1 site in Greece.
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 4 inclusion and 5 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 28 Sep 2022. 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 Greece. 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 Evangelos Papanikolaou, MD,PhD (00302310424294, drvagpapanikolaou@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embryotransfers to conceive (time frame: Up to the embryotransfer of the last enrolled patient (Dec 2023)). The study lists 3 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 28 Sep 2022.