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RecruitingNCT04109846TAMEUpdated Apr 24, 2026

Pregnancy and Developmental Outcomes After Transfer of Reportedly Aneuploid or Mosaic Embryos

An interventional study of Non-euploid embryo transfer and Euploid Transfer in Aneuploidy, Mosaicism and Pregnancy Outcome, sponsored by Stanford University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Apr 2019, registered Sep 2019).
  • Started Apr 2019; still recruiting 7 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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 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

02

Conditions studied

  • Aneuploidy
  • Mosaicism
  • Pregnancy Outcome

Browse trials for

Keywords

  • Preimplantation Genetic Testing for Aneuploidy
  • Preimplantation Genetic Screening
  • embryo transfer
  • mosaic
  • aneuploid
03

In context

Aneuploidy

73 studies on the registry are indexed under Aneuploidy; 10 are open to participants now.

This study's planned enrollment of 300 is above the median of 200 across 34 interventional studies indexed under Aneuploidy.

Browse Aneuploidy studies →

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Available aneuploid or mosaic embryos
  • No other acceptable embryos available
  • Willing to travel to Stanford for treatment
  • English language fluency

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Non-euploid Transfer

    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).

    Other: Non-euploid embryo transfer

  • Active comparator
    Euploid Transfer

    Patients desiring pregnancy who are undergoing euploid embryo transfer

    Other: Euploid Transfer

Interventions

  • OtherNon-euploid embryo transfer

    Other than choice of embryo for transfer, all other medical interventions will be standard of care protocols

  • OtherEuploid Transfer

    Standard of Care Protocol

06

What researchers measure

Primary outcomes

  1. Pregnancy Rate

    Number participants who undergo embryo transfers that lead to a positive pregnancy test

    Time frame: 3 years

Secondary outcomes

  1. Live birth rate

    Number participants who conceive after embryo transfer and have a live birth.

    Time frame: 4 years

  2. Obstetric complications

    Number of participants who have a maternal of fetal complication after embryo transfer

    Time frame: 4 years

  3. Pediatric Development

    Number of newborns and children who have abnormal pediatric development at 3 months, 2 years and 5 years following birth

    Time frame: 7 years 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 40578663 ↗
  • Munne 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 31445143 ↗
  • Victor 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 30691630 ↗
  • Zhang 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 30246223 ↗
  • Munne 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 28579407 ↗
  • Greco 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 ↗

Individual participant data

Plan to share: No — Data will only reported in aggregate

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2019 (actual). Primary completion is estimated for Apr 2035, 192 months after the start.

Of 19 interventional studies with no phase under Aneuploidy, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 49. This study's planned 192 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 24, 2019
First posted
Sep 30, 2019
StartActual
Apr 11, 2019
Primary completionEst.
Apr 2035
CompletionEst.
Apr 1, 2039
Last update
Apr 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04109846
Responsible party
Ruth Bunker Lathi (Professor, Stanford University) — Principal investigator
First posted
Sep 30, 2019
Start date
Apr 11, 2019
Primary completion
Apr 2035 (estimated)
Completion
Apr 1, 2039 (estimated)
Last update
Apr 24, 2026

Study contacts

Ronit Mazzoni, MS
Contact
rmazzoni@stanford.edu
408-688-9892
REI Research Coordinator
Contact
rei-research@lists.stanford.edu
408-688-9892
Ruth Lathi, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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