FertilityNCT06454058
Association Between Euploid Embryo Grade and Maternal Age
An observational study of Fertility, run by Inception Fertility Research Institute, LLC at 1 site in United States.
Trial summary
Background: Advanced maternal age (AMA) is associated with a reduction in live birth rate (LBR) after ART cycles. The main reason for this reduction is the lower number of oocytes aspirated, the number of developing embryos and the low number of euploid embryos available for transfer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fertility
- How many people
- 502 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2024to 26 Mar 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have completed IVF egg retrieval with PGT-A testing at a fertility clinic in The Prelude Network (US clinics, excluding NYU).
Who may be able to join
- Patients who have completed IVF egg retrieval with PGT-A testing at a fertility clinic in The Prelude Network (US clinics, excluding NYU)
- PGT biopsy was conducted in 2023,
- PGT biopsy was performed on blastocyst stage embryo,
- PGT-A result is euploid.
Who cannot join
- PGT-A result is mosaic,
- Embryos in which PGT-M was done and were found to be carriers of the mutation,
- Embryos in which PGT-SR was done and were found to be carriers of the structural rearrangement.
Trial locations and contacts
1 site in 1 country.
United States1 site
Inception Fertility Research Institute, LLC
Houston, Texas, 77081
About this study
Official title: Association Between Euploid Embryo Grade and Maternal Age, a Retrospective Cross-sectional Study
Background: Advanced maternal age (AMA) is associated with a reduction in live birth rate (LBR) after ART cycles. The main reason for this reduction is the lower number of oocytes aspirated, the number of developing embryos and the low number of euploid embryos available for transfer. The impact of age on success rates after the transfer of an euploid embryo has been a matter of discussion, with a recent meta-analysis showing a reduction in LBR after the transfer of an euploid blastocyst to women of AMA (1). There could be many reasons for this reduced LBR but they can be categorized into two broad categories - the uterus (including the mother's health) and the embryo (including the oocyte and the sperm).
It is possible that factors associated with reduced embryo quality would manifest in a lower embryo grade.
Read the detailed description
Objective: To study if there is an association between advanced maternal age and lower embryo grading of euploid embryos.
Hypothesis: Advanced maternal age is associated with a lower embryonic grade in euploid embryos.
Study Design: This is a retrospective cross-sectional study of euploid embryos from patients who have completed IVF with PGT-A testing at a fertility clinic in The Prelude Network (US sites only). A comparison of embryo grade between different age groups (<35, 40+) will be done after controlling for baseline demographic characteristics.
- Conditions
- Fertility
- Keywords
- Advanced Maternal Age, Embryo Grade
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo Grade
Embryo grade for PGT-A confirmed euploid embryos
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start7 Jun 2024
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Why it stopped: Preliminary findings of inconsistent embryo grading across sites.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FertilityStudies 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
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inception Fertility Research Institute, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454058
- Sponsor's protocol ID
- INC-IIS-2024-004
- Status last verified
- Jul 2025
- First submitted
- 6 Jun 2024
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vitagliano A, Paffoni A, Vigano P. Does maternal age affect assisted reproduction technology success rates after euploid embryo transfer? A systematic review and meta-analysis. Fertil Steril. 2023 Aug;120(2):251-265. doi: 10.1016/j.fertnstert.2023.02.036. Epub 2023 Mar 5.
PubMed 36878347
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Euploid Embryo Grade and Maternal Age, a Retrospective Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06454058
- Acronym / sponsor ID
- INC-IIS-2024-004
- Conditions
- Fertility
- Keywords
- Advanced Maternal Age, Embryo Grade
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Preliminary findings of inconsistent embryo grading across sites.
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Inception Fertility Research Institute, LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 12 Jun 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.
Background: Advanced maternal age (AMA) is associated with a reduction in live birth rate (LBR) after ART cycles. The main reason for this reduction is the lower number of oocytes aspirated, the number of developing embryos and the low number of euploid embryos available for transfer. The impact of age on success rates after the transfer of an euploid embryo has been a matter of discussion, with a recent meta-analysis showing a reduction in LBR after the transfer of an euploid blastocyst to women of AMA (1). There could be many reasons for this reduced LBR but they can be categorized into two broad categories - the uterus (including the mother's health) and the embryo (including the oocyte and the sperm).
It is possible that factors associated with reduced embryo quality would manifest in a lower embryo grade.
Detailed description
Objective: To study if there is an association between advanced maternal age and lower embryo grading of euploid embryos.
Hypothesis: Advanced maternal age is associated with a lower embryonic grade in euploid embryos.
Study Design: This is a retrospective cross-sectional study of euploid embryos from patients who have completed IVF with PGT-A testing at a fertility clinic in The Prelude Network (US sites only). A comparison of embryo grade between different age groups (<35, 40+) will be done after controlling for baseline demographic characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have completed IVF egg retrieval with PGT-A testing at a fertility clinic in The Prelude Network (US clinics, excluding NYU).
Key inclusion criteria (4 listed)
- Patients who have completed IVF egg retrieval with PGT-A testing at a fertility clinic in The Prelude Network (US clinics, excluding NYU)
- PGT biopsy was conducted in 2023,
- PGT biopsy was performed on blastocyst stage embryo,
- PGT-A result is euploid.
Key exclusion criteria (3 listed)
- PGT-A result is mosaic,
- Embryos in which PGT-M was done and were found to be carriers of the mutation,
- Embryos in which PGT-SR was done and were found to be carriers of the structural rearrangement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Embryo Grade
Time frame: 6 months
Embryo grade for PGT-A confirmed euploid embryos
Results and safety
The study was stopped early (reason given: Preliminary findings of inconsistent embryo grading across sites.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Background: PubMed 36878347Vitagliano A, Paffoni A, Vigano P. Does maternal age affect assisted reproduction technology success rates after euploid embryo transfer? A systematic review and meta-analysis. Fertil Steril. 2023 Aug;120(2):251-265. doi: 10.1016/j.fertnstert.2023.02.036. Epub 2023 Mar 5.
- 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.
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 Fertility, run by Inception Fertility Research Institute, LLC 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 4 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 20 Jul 2025. 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?
The study was stopped early (reason given: Preliminary findings of inconsistent embryo grading across sites.). Results are not available in the source record.
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?
Embryo Grade (time frame: 6 months). 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 NCT06454058, 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 20 Jul 2025.