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

Stanford University

Status: Enrolling

Conditions: Mosaicism; Aneuploidy; Pregnancy Outcome

Treatments: Other: Non-euploid embryo transfer; Other: Euploid Transfer

Study type: Interventional

Funder types: Other

Identifiers

NCT04109846

IRB-46420

Details and patient eligibility

About

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.

Full 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

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Non-euploid Transfer

Experimental group

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).

Treatment:

Other: Non-euploid embryo transfer

Euploid Transfer

Active Comparator group

Description:

Patients desiring pregnancy who are undergoing euploid embryo transfer

Treatment:

Other: Euploid Transfer