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

Primary Purpose

Aneuploidy, Mosaicism

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Non-euploid embryo transfer

Euploid Transfer

About this trial

This is an interventional treatment trial for Aneuploidy focused on measuring Preimplantation Genetic Testing for Aneuploidy, Preimplantation Genetic Screening

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Use of gestational carrier
Living outside the United States
Embryos with Trisomy 18, Trisomy 13 or Triploidy are not eligible for transfer in this protocol

Sites / Locations

Stanford Fertility and Reproductive Medicine CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non-euploid Transfer

Euploid Transfer

Arm Description

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).

Patients desiring pregnancy who are undergoing euploid embryo transfer

Outcomes

Primary Outcome Measures

Pregnancy Rate

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

Secondary Outcome Measures

Live birth rate

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

Obstetric complications

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

Pediatric Development

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

Full Information

NCT ID

NCT04109846

First Posted

September 24, 2019

Last Updated

January 9, 2023

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT04109846

Brief Title

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

Acronym

TAME

Official Title

Transfer of Aneuploid or Mosaic Embryos Following Preimplantation Genetic Testing

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 11, 2019 (Actual)

Primary Completion Date

April 2025 (Anticipated)

Study Completion Date

April 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aneuploidy, Mosaicism

Keywords

Preimplantation Genetic Testing for Aneuploidy, Preimplantation Genetic Screening

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Non-euploid Transfer

Arm Type

Experimental

Arm Description

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).

Arm Title

Euploid Transfer

Arm Type

Active Comparator

Arm Description

Patients desiring pregnancy who are undergoing euploid embryo transfer

Intervention Type

Other

Intervention Name(s)

Non-euploid embryo transfer

Intervention Description

Other than choice of embryo for transfer, all other medical interventions will be at discretion of treating provider

Intervention Type

Other

Intervention Name(s)

Euploid Transfer

Intervention Description

Standard of Care Protocol

Primary Outcome Measure Information:

Title

Pregnancy Rate

Description

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

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Live birth rate

Description

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

Time Frame

4 years

Title

Obstetric complications

Description

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

Time Frame

4 years

Title

Pediatric Development

Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Available aneuploid or mosaic embryos No acceptable euploid embryos available Willing to travel to Stanford for treatment English language fluency Exclusion Criteria: Use of gestational carrier Living outside the United States Embryos with Trisomy 18, Trisomy 13 or Triploidy are not eligible for transfer in this protocol

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ronit Mazzoni, MS

Phone

408-688-9892

rmazzoni@stanford.edu

First Name & Middle Initial & Last Name or Official Title & Degree

REI Research Coordinator

Phone

408-688-9892

rei-research@lists.stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ruth Lathi, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford Fertility and Reproductive Medicine Center

City

Sunnyvale

State/Province

California

ZIP/Postal Code

94087

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ronit Mazzoni, MS

Phone

408-688-9749

rmazzoni@stanfordchildrens.org

First Name & Middle Initial & Last Name & Degree

Ruth Lathi, MD

Phone

650-498-7911

rei-research@lists.stanford.edu

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data will only reported in aggregate

Citations:

PubMed Identifier

31445143

Citation

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.

Results Reference

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PubMed Identifier

30691630

Citation

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.

Results Reference

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PubMed Identifier

30246223

Citation

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.

Results Reference

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PubMed Identifier

28579407

Citation

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.

Results Reference

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PubMed Identifier

26581010

Citation

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.

Results Reference

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Links:

URL

https://www.stanfordchildrens.org/en/service/fertility-and-reproductive-health/tame

Description

Stanford Fertility Website

Learn more about this trial

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

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