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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transfer of Aneuploid or Mosaic Embryos Following Preimplantation Genetic Testing

Conditions
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Aneuploidy, Mosaicism

Intervention / Treatment
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* Other: Non-euploid embryo transfer
* Other: Euploid Transfer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate | 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 | Number participants who conceive after embryo transfer and have a live birth. | 4 years | 
| Obstetric complications | Number of participants who have a maternal of fetal complication after embryo transfer | 4 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preimplantation Genetic Testing for Aneuploidy, Preimplantation Genetic Screening