Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT04109846

Conditions

Aneuploidy

Mosaicism

Pregnancy Outcome

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Non-euploid embryo transfer

Euploid Transfer

Study Details

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.

Conditions

Aneuploidy

Mosaicism

Pregnancy Outcome

Study ID

NCT04109846

Start date

Apr 11, 2019

Status verified date

Apr, 2026

Completion date

Apr 1, 2039

Anticipated

Primary completion date

Apr, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

active comparator: Euploid Transfer

Patients desiring pregnancy who are undergoing euploid embryo transfer

Interventions

Non-euploid embryo transfer

Other than choice of embryo for transfer, all other medical interventions will be standard of care protocols

Euploid Transfer

Standard of Care Protocol

Primary outcome measure

  • Pregnancy Rate [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Ronit Mazzoni, MS

408-688-9892rmazzoni@stanford.edu

REI Research Coordinator

408-688-9892rei-research@lists.stanford.edu

Locations

Stanford Fertility and Reproductive Medicine Center

Recruiting

Sunnyvale, California, United States, 94087

Contacts

Ronit Mazzoni, MS

408-688-9749rmazzoni@stanfordchildrens.org

Ruth Lathi, MD

650-498-7911rei-research@lists.stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • Preimplantation Genetic Testing for Aneuploidy
  • Preimplantation Genetic Screening
  • embryo transfer
  • mosaic
  • aneuploid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-04-24.