IVFniPGTAdonNCT07364526
Non-Invasive Preimplantation Genetic Screening for Aneuploidies and Clinical Outcomes in Egg Donation Patients
An observational study of IVF, run by Instituto Bernabeu at 1 site in Spain.
Trial summary
Preimplantation genetic testing for aneuploidies (PGT-A) is commonly used in IVF but requires embryo biopsy and shows limited benefit in egg donation cycles. Non-invasive PGT-A (niPGTA), based on the analysis of cell-free embryonic DNA in spent culture media, offers a promising biopsy-free alternative. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF
- How many people
- 164 participants
- Where
- 1 siteSpain
- Study dates
- 26 Feb 2026to 1 Dec 2027
- How long will I take part?
- 3 Years
- 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
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients who are going to undergo an oocyte donation cycle, who meet the inclusion/exclusion criteria and who sign the informed consent form
Who may be able to join
- Women between 18 and 50 years old who are oocyte recipients.
- Signed consent form
- Transfer of a single blastocyst-stage embryo
- Male with normal sperm FISH
Who cannot join
- Uterine malformations
- Abnormal karyotypes in either partner
- Failure to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Instituto Bernabeu
Alicante
BELEN LLEDO, PhD, 965154053, blledo@institutobernabeu.com
About this study
Official title: Non-invasive Preimplantation Genetic Screening (niPGTA) in Oocyte Donation Patients.
Preimplantation genetic testing for aneuploidies (PGT-A) is commonly used in IVF but requires embryo biopsy and shows limited benefit in egg donation cycles. Non-invasive PGT-A (niPGTA), based on the analysis of cell-free embryonic DNA in spent culture media, offers a promising biopsy-free alternative. This prospective, blinded study in egg donation cycles will evaluate whether niPGTA-detected aneuploidy is associated with implantation failure and pregnancy loss, assessing its potential clinical value as a non-invasive embryo selection tool.
Read the detailed description
Preimplantation genetic testing for aneuploidies (PGT-A) is widely used in IVF to improve embryo selection and pregnancy outcomes. However, it requires invasive embryo biopsy and has not shown clear benefit in egg donation cycles, where embryos originate from young donors with lower aneuploidy rates. Non-invasive PGT-A (niPGTA), based on the analysis of cell-free embryonic DNA released into the culture medium, represents a promising alternative that avoids embryo biopsy.
This prospective, blinded, non-selection study will include women undergoing egg donation treatment. Embryos will be selected for transfer using standard morphological criteria only, while niPGTA results will not influence clinical decisions. After embryo transfer, the spent culture medium will be collected and analyzed using next-generation sequencing to determine the presence of chromosomal aneuploidies.
The study aims to evaluate whether aneuploidy detected by niPGTA is associated with implantation failure, biochemical pregnancy loss, and clinical miscarriage. By comparing niPGTA results between embryos that result in pregnancy and those that do not, this project will assess the potential clinical value of niPGTA as a non-invasive embryo selection tool in egg donation cycles.
- Conditions
- IVF
- Keywords
- niPGTA
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Measured: 9 months from enrolment
Secondary outcomes (2)
Pregnancy rate
Measured: 2 weeks from enrolment
Miscarriage rate
Measured: 12 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start26 Feb 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 164 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Instituto Bernabeu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belen Lledo, Instituto Bernabeu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364526
- Sponsor's protocol ID
- IBB23
- Acronym
- niPGTAdon
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Preimplantation Genetic Screening (niPGTA) in Oocyte Donation Patients.
- ClinicalTrials.gov ID
- NCT07364526
- Acronym / sponsor ID
- niPGTAdon / IBB23
- Conditions
- IVF
- Keywords
- niPGTA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Instituto BernabeuUniversity, hospital or other
- Study start
- 26 Feb 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Jan 2026 (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.
Preimplantation genetic testing for aneuploidies (PGT-A) is commonly used in IVF but requires embryo biopsy and shows limited benefit in egg donation cycles. Non-invasive PGT-A (niPGTA), based on the analysis of cell-free embryonic DNA in spent culture media, offers a promising biopsy-free alternative. This prospective, blinded study in egg donation cycles will evaluate whether niPGTA-detected aneuploidy is associated with implantation failure and pregnancy loss, assessing its potential clinical value as a non-invasive embryo selection tool.
Detailed description
Preimplantation genetic testing for aneuploidies (PGT-A) is widely used in IVF to improve embryo selection and pregnancy outcomes. However, it requires invasive embryo biopsy and has not shown clear benefit in egg donation cycles, where embryos originate from young donors with lower aneuploidy rates. Non-invasive PGT-A (niPGTA), based on the analysis of cell-free embryonic DNA released into the culture medium, represents a promising alternative that avoids embryo biopsy.
This prospective, blinded, non-selection study will include women undergoing egg donation treatment. Embryos will be selected for transfer using standard morphological criteria only, while niPGTA results will not influence clinical decisions. After embryo transfer, the spent culture medium will be collected and analyzed using next-generation sequencing to determine the presence of chromosomal aneuploidies.
The study aims to evaluate whether aneuploidy detected by niPGTA is associated with implantation failure, biochemical pregnancy loss, and clinical miscarriage. By comparing niPGTA results between embryos that result in pregnancy and those that do not, this project will assess the potential clinical value of niPGTA as a non-invasive embryo selection tool in egg donation cycles.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who are going to undergo an oocyte donation cycle, who meet the inclusion/exclusion criteria and who sign the informed consent form
Key inclusion criteria (4 listed)
- Women between 18 and 50 years old who are oocyte recipients.
- Signed consent form
- Transfer of a single blastocyst-stage embryo
- Male with normal sperm FISH
Key exclusion criteria (3 listed)
- Uterine malformations
- Abnormal karyotypes in either partner
- Failure to sign informed consent
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
Live birth rate
Time frame: 9 months from enrolment
2 secondary outcomes
Pregnancy rate
Time frame: 2 weeks from enrolment
Miscarriage rate
Time frame: 12 weeks from enrollment
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 23 Jan 2026.
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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.
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 IVF, run by Instituto Bernabeu at 1 site in Spain.
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: looking for participants now, as of the sponsor's last update on 23 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: 9 months from enrolment). 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 23 Jan 2026.