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NCT Number: NCT04109846

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

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.

Recruiting

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Key information

Conditions

Aneuploidy Chromosome Aberrations Mosaicism Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Outcome

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-euploid embryo transfer

Other

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

Euploid Transfer

Other

Standard of Care Protocol

Primary outcomes

  1. Pregnancy Rate

    Time frame: 3 years

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

Secondary outcomes

  1. Live birth rate

    Time frame: 4 years

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

  2. Obstetric complications

    Time frame: 4 years

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

  3. Pediatric Development

    Time frame: 7 years 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

REI Research Coordinator

CONTACT

[email protected]

408-688-9892

Ronit Mazzoni, MS

CONTACT

[email protected]

408-688-9892

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Transfer of Aneuploid or Mosaic Embryos Following Preimplantation Genetic Testing

Acronym: TAME

Important dates

Study start
2019
Primary completion
2035
Study completion
2039
First posted
Sep 30, 2019
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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