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Recruiting NCT04109846

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

No phase Interventional Aneuploidy Mosaicism Pregnancy Outcome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-euploid embryo transfer, Euploid Transfer.
Who it may be relevant to
Registry conditions: Aneuploidy, Mosaicism, Pregnancy Outcome. Basic parameters: 18 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Transfer of Aneuploid or Mosaic Embryos Following Preimplantation Genetic Testing

Overview

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

Interventions

  • Other Non-euploid embryo transfer
    Other than choice of embryo for transfer, all other medical interventions will be standard of care protocols
  • Other Euploid Transfer
    Standard of Care Protocol

Primary outcome measures

  • Pregnancy Rate [Time frame: 3 years]
Secondary outcome measures (3)
  • Live birth rate [Time frame: 4 years]
  • Obstetric complications [Time frame: 4 years]
  • Pediatric Development [Time frame: 7 years 3 months]

Eligibility criteria

Inclusion criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford Fertility and Reproductive Medicine Center — Sunnyvale

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. PMID 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. PMID 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. PMID 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. PMID 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.fertnst PMID 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. PMID 26581010

Identifiers

NCT: NCT04109846 · IRB-46420

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗