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Clinical Trials/NCT04109846
NCT04109846
Recruiting
Not Applicable

Transfer of Aneuploid or Mosaic Embryos Following Preimplantation Genetic Testing

Stanford University2 sites in 1 country300 target enrollmentApril 11, 2019

Overview

Phase
Not Applicable
Intervention
Non-euploid embryo transfer
Conditions
Not specified
Sponsor
Stanford University
Enrollment
300
Locations
2
Primary Endpoint
Pregnancy Rate
Status
Recruiting
Last Updated
8 days ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 11, 2019
End Date
April 1, 2039
Last Updated
8 days ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ruth Bunker Lathi

Professor

Stanford University

Eligibility Criteria

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

Arms & Interventions

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).

Intervention: Non-euploid embryo transfer

Euploid Transfer

Patients desiring pregnancy who are undergoing euploid embryo transfer

Intervention: Euploid Transfer

Outcomes

Primary Outcomes

Pregnancy Rate

Time Frame: 3 years

Number participants who undergo embryo transfers that lead to a positive pregnancy test

Secondary Outcomes

  • Live birth rate(4 years)
  • Obstetric complications(4 years)
  • Pediatric Development(7 years 3 months)

Study Sites (2)

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