AneuploidyTAMENCT04109846
Pregnancy and Developmental Outcomes After Transfer of Reportedly Aneuploid or Mosaic Embryos
A study testing Non-euploid embryo transfer and Euploid Transfer in people with Aneuploidy and Mosaicism, run by Stanford University at 1 site in United States.
Trial summary
To determine how often embryos reported to be abnormal by preimplantation genetic testing result in liveborn infants. To evaluate whether the pregnancies that result from these embryos are higher risk for complications and whether the resulting babies have higher risk for health or developmental issues in the first… 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
- Aneuploidy, Mosaicism, Pregnancy Outcome
- What is being tested?
- Non-euploid embryo transfer and Euploid Transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2019to 1 Apr 2039
- Phase
- Interventional
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Available aneuploid or mosaic embryos
- No other acceptable embryos available
- Willing to travel to Stanford for treatment
- English language fluency
Who cannot join
- Use of international donor eggs or sperm not tested according to FDA guidelines.
- Living outside the United States
- Embryos with Triploidy are not eligible for transfer in this protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Fertility and Reproductive Medicine Center
Sunnyvale, California, 94087
Ronit Mazzoni, MS, 408-688-9749, rmazzoni@stanfordchildrens.org
Ruth Lathi, MD, 650-498-7911, rei-research@lists.stanford.edu
About this study
Official title: Transfer of Aneuploid or Mosaic Embryos Following Preimplantation Genetic Testing
To determine how often embryos reported to be abnormal by preimplantation genetic testing result in liveborn infants. To evaluate whether the pregnancies that result from these embryos are higher risk for complications and whether the resulting babies have higher risk for health or developmental issues in the first five years after birth.
Read the detailed description
Genetic testing modality and results will be recorded
Pregnancy per transfer will be recorded
Patients in the study agree to provide medical records of their pregnancy.
Any genetic testing or fetal testing will be carefully reviewed and recorded by the study team.
For patients with live births, pediatric records will be collected for up to 5 years.
As well as surveys for developmental milestones.
There is no financial compensation for study participants
- Conditions
- Aneuploidy, Mosaicism, Pregnancy Outcome
- Being tested
- Non-euploid embryo transfer, Euploid Transfer
- Keywords
- Preimplantation Genetic Testing for Aneuploidy, Preimplantation Genetic Screening, embryo transfer, mosaic, aneuploid
- Medical subject headings
- Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-euploid embryo transferOther
Other than choice of embryo for transfer, all other medical interventions will be standard of care protocols
Euploid TransferOther
Standard of Care Protocol
| Study group | Role | What they receive |
|---|---|---|
| Non-euploid Transfer | Experimental | Patients desiring pregnancy who have no acceptable euploid embryos available for transfer who chose to undergo embryo transfer of a non-euploid embryo (either aneuploid or mosaic). Receives: Other: Non-euploid embryo transfer |
| Euploid Transfer | Active comparator | Patients desiring pregnancy who are undergoing euploid embryo transfer Receives: Other: Euploid Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate
Number participants who undergo embryo transfers that lead to a positive pregnancy test
Measured: 3 years
Secondary outcomes (3)
Live birth rate
Number participants who conceive after embryo transfer and have a live birth.
Measured: 4 years
Obstetric complications
Number of participants who have a maternal of fetal complication after embryo transfer
Measured: 4 years
Pediatric Development
Number of newborns and children who have abnormal pediatric development at 3 months, 2 years and 5 years following birth
Measured: 7 years 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start11 Apr 2019
- Primary completionApr 2035 (estimated)
- Study completion1 Apr 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AneuploidyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients desiring frozen embryo transfer or aneuploid or mosaic embryo. Patients will be counseled regarding risks and obstetric and pediatric outcomes will be collected.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Bunker Lathi, Stanford University
- Investigators
- Ruth Lathi, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109846
- Sponsor's protocol ID
- IRB-46420
- Acronym
- TAME
- Status last verified
- Apr 2026
- First submitted
- 24 Sep 2019
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only reported in aggregate
Publications
Tise CG, Verma K, Rivera-Cruz G, Chamanara S, Gerber SK, Boyd A, Mazzoni R, Nel-Themaat L, Behr B, Milki AA, Lathi RB. Healthy euploid dizygotic twin birth after transfer of nonmosaic aneuploid embryos. Fertil Steril. 2025 Nov 15;124(5 Pt 2):1016-1023. doi: 10.1016/j.fertnstert.2025.06.033. Epub 2025 Jun 25.
PubMed 40578663Munne S, Spinella F, Grifo J, Zhang J, Beltran MP, Fragouli E, Fiorentino F. Clinical outcomes after the transfer of blastocysts characterized as mosaic by high resolution Next Generation Sequencing- further insights. Eur J Med Genet. 2020 Feb;63(2):103741. doi: 10.1016/j.ejmg.2019.103741. Epub 2019 Aug 21.
PubMed 31445143Victor AR, Tyndall JC, Brake AJ, Lepkowsky LT, Murphy AE, Griffin DK, McCoy RC, Barnes FL, Zouves CG, Viotti M. One hundred mosaic embryos transferred prospectively in a single clinic: exploring when and why they result in healthy pregnancies. Fertil Steril. 2019 Feb;111(2):280-293. doi: 10.1016/j.fertnstert.2018.10.019.
PubMed 30691630Zhang L, Wei D, Zhu Y, Gao Y, Yan J, Chen ZJ. Rates of live birth after mosaic embryo transfer compared with euploid embryo transfer. J Assist Reprod Genet. 2019 Jan;36(1):165-172. doi: 10.1007/s10815-018-1322-2. Epub 2018 Sep 24.
PubMed 30246223Munne S, Blazek J, Large M, Martinez-Ortiz PA, Nisson H, Liu E, Tarozzi N, Borini A, Becker A, Zhang J, Maxwell S, Grifo J, Babariya D, Wells D, Fragouli E. Detailed investigation into the cytogenetic constitution and pregnancy outcome of replacing mosaic blastocysts detected with the use of high-resolution next-generation sequencing. Fertil Steril. 2017 Jul;108(1):62-71.e8. doi: 10.1016/j.fertnstert.2017.05.002. Epub 2017 Jun 1.
PubMed 28579407Greco E, Minasi MG, Fiorentino F. Healthy Babies after Intrauterine Transfer of Mosaic Aneuploid Blastocysts. N Engl J Med. 2015 Nov 19;373(21):2089-90. doi: 10.1056/NEJMc1500421. No abstract available.
PubMed 26581010
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer of Aneuploid or Mosaic Embryos Following Preimplantation Genetic Testing
- ClinicalTrials.gov ID
- NCT04109846
- Acronym / sponsor ID
- TAME / IRB-46420
- Conditions
- Aneuploidy, Mosaicism, Pregnancy Outcome
- Keywords
- Preimplantation Genetic Testing for Aneuploidy, Preimplantation Genetic Screening, embryo transfer, mosaic, aneuploid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- Apr 2035 (estimated)
- Study completion
- 1 Apr 2039 (estimated)
- First posted
- 30 Sep 2019 (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.
To determine how often embryos reported to be abnormal by preimplantation genetic testing result in liveborn infants. To evaluate whether the pregnancies that result from these embryos are higher risk for complications and whether the resulting babies have higher risk for health or developmental issues in the first five years after birth.
Detailed description
Genetic testing modality and results will be recorded
Pregnancy per transfer will be recorded
Patients in the study agree to provide medical records of their pregnancy.
Any genetic testing or fetal testing will be carefully reviewed and recorded by the study team.
For patients with live births, pediatric records will be collected for up to 5 years.
As well as surveys for developmental milestones.
There is no financial compensation for study participants
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients desiring frozen embryo transfer or aneuploid or mosaic embryo. Patients will be counseled regarding risks and obstetric and pediatric outcomes will be collected.
| Arm | Type | Receives |
|---|---|---|
| Non-euploid Transfer | Experimental | Other: Non-euploid embryo transferPatients desiring pregnancy who have no acceptable euploid embryos available for transfer who chose to undergo embryo transfer of a non-euploid embryo (either aneuploid or mosaic). |
| Euploid Transfer | Active comparator | Other: Euploid TransferPatients desiring pregnancy who are undergoing euploid embryo transfer |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Available aneuploid or mosaic embryos
- No other acceptable embryos available
- Willing to travel to Stanford for treatment
- English language fluency
Key exclusion criteria (3 listed)
- Use of international donor eggs or sperm not tested according to FDA guidelines.
- Living outside the United States
- Embryos with Triploidy are not eligible for transfer in this protocol
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 |
|---|---|---|
| Non-euploid embryo transferOther than choice of embryo for transfer, all other medical interventions will be standard of care protocols | Other | Non-euploid Transfer |
| Euploid TransferStandard of Care Protocol | Other | Euploid Transfer |
Primary outcome
Pregnancy Rate
Time frame: 3 years
Number participants who undergo embryo transfers that lead to a positive pregnancy test
3 secondary outcomes
Live birth rate
Time frame: 4 years
Obstetric complications
Time frame: 4 years
Pediatric Development
Time frame: 7 years 3 months
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 24 Apr 2026.
- Background: PubMed 40578663Tise CG, Verma K, Rivera-Cruz G, Chamanara S, Gerber SK, Boyd A, Mazzoni R, Nel-Themaat L, Behr B, Milki AA, Lathi RB. Healthy euploid dizygotic twin birth after transfer of nonmosaic aneuploid embryos. Fertil Steril. 2025 Nov 15;124(5 Pt 2):1016-1023. doi: 10.1016/j.fertnstert.2025.06.033. Epub 2025 Jun 25.
- Background: PubMed 31445143Munne S, Spinella F, Grifo J, Zhang J, Beltran MP, Fragouli E, Fiorentino F. Clinical outcomes after the transfer of blastocysts characterized as mosaic by high resolution Next Generation Sequencing- further insights. Eur J Med Genet. 2020 Feb;63(2):103741. doi: 10.1016/j.ejmg.2019.103741. Epub 2019 Aug 21.
- Background: PubMed 30691630Victor AR, Tyndall JC, Brake AJ, Lepkowsky LT, Murphy AE, Griffin DK, McCoy RC, Barnes FL, Zouves CG, Viotti M. One hundred mosaic embryos transferred prospectively in a single clinic: exploring when and why they result in healthy pregnancies. Fertil Steril. 2019 Feb;111(2):280-293. doi: 10.1016/j.fertnstert.2018.10.019.
- Background: PubMed 30246223Zhang L, Wei D, Zhu Y, Gao Y, Yan J, Chen ZJ. Rates of live birth after mosaic embryo transfer compared with euploid embryo transfer. J Assist Reprod Genet. 2019 Jan;36(1):165-172. doi: 10.1007/s10815-018-1322-2. Epub 2018 Sep 24.
- Background: PubMed 28579407Munne S, Blazek J, Large M, Martinez-Ortiz PA, Nisson H, Liu E, Tarozzi N, Borini A, Becker A, Zhang J, Maxwell S, Grifo J, Babariya D, Wells D, Fragouli E. Detailed investigation into the cytogenetic constitution and pregnancy outcome of replacing mosaic blastocysts detected with the use of high-resolution next-generation sequencing. Fertil Steril. 2017 Jul;108(1):62-71.e8. doi: 10.1016/j.fertnstert.2017.05.002. Epub 2017 Jun 1.
- Background: PubMed 26581010Greco E, Minasi MG, Fiorentino F. Healthy Babies after Intrauterine Transfer of Mosaic Aneuploid Blastocysts. N Engl J Med. 2015 Nov 19;373(21):2089-90. doi: 10.1056/NEJMc1500421. No abstract available.
- Stanford Fertility Research websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will only reported in aggregate
Related trials for Aneuploidy
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
RecruitingObservational study
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
Pregnant Individuals, Aneuploidy
Not yet recruiting
AI-Assisted Euploid Embryo Selection for Single-Blastocyst Transfer in Women of Advanced Maternal Age
Female Infertility
RecruitingObservational study
Detection of Aneuploidy in Cell Free DNA to Improve the Sensitivity of Diagnostic Peritoneal Lavage in Gastric Cancer
Gastric Cancer
RecruitingObservational study
Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy
Down Syndrome, Fetal Aneuploidy
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.
Ruth Lathi, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-euploid embryo transfer and Euploid Transfer in people with Aneuploidy and Mosaicism, run by Stanford University 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: looking for participants now, as of the sponsor's last update on 24 Apr 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?
Contact Ronit Mazzoni, MS (408-688-9892, rmazzoni@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Rate (time frame: 3 years). 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 NCT04109846, which also lists 6 linked publications.
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 24 Apr 2026.