Aneuploidy, Mosaicism, Pregnancy Outcome
Conditions
Keywords
Preimplantation Genetic Testing for Aneuploidy, Preimplantation Genetic Screening, embryo transfer, mosaic, aneuploid
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. There is no financial compensation for study participants
Interventions
OTHERNon-euploid embryo transfer
Other than choice of embryo for transfer, all other medical interventions will be standard of care protocols
OTHEREuploid Transfer
Standard of Care Protocol
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Rate | 3 years | Number participants who undergo embryo transfers that lead to a positive pregnancy test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTRonit Mazzoni, MS
CONTACTREI Research Coordinator
PRINCIPAL_INVESTIGATORRuth Lathi, MD
Stanford University
Outcome results
None listed