TAME: Pregnancy and Developmental Outcomes After Transfer of Reportedly Aneuploid or Mosaic Embryos
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Pregnancy Rate [3 years]
Number participants who undergo embryo transfers that lead to a positive pregnancy test
Secondary Outcome Measures
- Live birth rate [4 years]
Number participants who conceive after embryo transfer and have a live birth.
- Obstetric complications [4 years]
Number of participants who have a maternal of fetal complication after embryo transfer
- Pediatric Development [7 years 3 months]
Number of newborns and children who have abnormal pediatric development at 3 months, 2 years and 5 years following birth
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford Fertility and Reproductive Medicine Center | Sunnyvale | California | United States | 94087 |
Sponsors and Collaborators
- Stanford University
Investigators
- Principal Investigator: Ruth Lathi, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- Munné 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.
- Munné 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.
- 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.
- 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.
- IRB-46420