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

Aneuploidy Clinical Trial

— TAME  

Official title:

Transfer of Aneuploid or Mosaic Embryos Following Preimplantation Genetic Testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04109846
• Other study ID #: IRB-46420
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2019
• Est. completion date: April 1, 2039

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: Ronit Mazzoni, MS
• Phone: 408-688-9892
• Email: rmazzoni[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 1, 2039
• Est. primary completion date: April 2035
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneuploidy
• Mosaicism

Intervention

Other:
• Non-euploid embryo transfer
Other than choice of embryo for transfer, all other medical interventions will be at discretion of treating provider
• Euploid Transfer
Standard of Care Protocol

Locations

Country	Name	City	State
United States	Stanford Fertility and Reproductive Medicine Center	Sunnyvale	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy Rate	Number participants who undergo embryo transfers that lead to a positive pregnancy test	3 years
Secondary	Live birth rate	Number participants who conceive after embryo transfer and have a live birth.	4 years
Secondary	Obstetric complications	Number of participants who have a maternal of fetal complication after embryo transfer	4 years
Secondary	Pediatric Development	Number of newborns and children who have abnormal pediatric development at 3 months, 2 years and 5 years following birth	7 years 3 months

External Links

•   Stanford Fertility Website