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

January 24, 2024 updated by: Ruth Bunker Lathi, Stanford University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other than choice of embryo for transfer, all other medical interventions will be at discretion of treating provider
Active Comparator: Euploid Transfer
Patients desiring pregnancy who are undergoing euploid embryo transfer
Other: Euploid Transfer
Standard of Care Protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Rate
Time Frame: 3 years
Number participants who undergo embryo transfers that lead to a positive pregnancy test
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate
Time Frame: 4 years
Number participants who conceive after embryo transfer and have a live birth.
4 years
Obstetric complications
Time Frame: 4 years
Number of participants who have a maternal of fetal complication after embryo transfer
4 years
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
7 years 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Ruth Lathi, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2019

Primary Completion (Estimated)

April 1, 2035

Study Completion (Estimated)

April 1, 2039

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (Actual)

September 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-46420

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will only reported in aggregate

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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