What is the mechanism of action of this treatment?

Preimplantation Genetic Testing for Aneuploidy (PGT-A) is a common treatment that involves screening embryos created through in vitro fertilization (IVF) for chromosomal abnormalities before implantation. The process includes a biopsy of a few cells from the embryo, followed by genetic analysis to identify aneuploidies. Embryos with the correct number of chromosomes are selected for transfer to the uterus, while those with abnormalities are not used. This method increases the chances of a successful pregnancy and reduces the risk of miscarriage by ensuring that only euploid embryos are implanted, which is crucial for aneuploidy patients.

What side effects are associated with this type of intervention?

Preimplantation Genetic Testing for Aneuploidy (PGT-A) is used to identify genetic abnormalities in embryos before implantation. Known side effects include a potential reduction in the overall probability of pregnancy due to the discarding of embryos deemed aneuploid, which may result in fewer embryos available for transfer. Additionally, the process of embryo biopsy and subsequent freezing may negatively impact embryo viability. Despite selecting for euploid embryos, PGT-A has not been shown to improve live birth rates significantly and may lead to fewer embryo transfers per cycle.

What prior FDA approvals exist?

The FDA has not approved specific drugs for the treatment of aneuploidy. Instead, the management of aneuploidy in the context of in vitro fertilization (IVF) primarily involves preimplantation genetic testing (PGT). PGT is a technique used to identify genetic abnormalities in embryos before implantation, allowing for the selection of euploid embryos, which are more likely to result in successful pregnancies. This approach helps reduce the risk of miscarriage and increases the chances of a healthy live birth.

What other types of research exist?

Promising novel alternatives to Preimplantation Genetic Testing (PGT) for aneuploidy include: 1) Non-invasive prenatal testing (NIPT) using cell-free DNA, which can detect chromosomal abnormalities without the need for invasive procedures. 2) Advanced genomic sequencing techniques, such as whole-genome sequencing (WGS) and whole-exome sequencing (WES), which provide comprehensive genetic information. 3) CRISPR-based diagnostic tools, which offer precise and rapid detection of genetic abnormalities. These alternatives are being actively researched and show potential for improved accuracy and reduced risk compared to traditional PGT.

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Genetic Testing

Non-euploid Embryo Transfer for Aneuploidy and Mosaicism (TAME Trial)

N/A

Recruiting

Led By Ruth Lathi, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No acceptable euploid embryos available

Available aneuploid or mosaic embryos

Must not have

Embryos with Trisomy 18, Trisomy 13 or Triploidy are not eligible for transfer in this protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses genetic testing on embryos before they are implanted in the womb to check for abnormalities. It focuses on patients undergoing procedures with embryos that have been flagged as abnormal. The goal is to see if these embryos can still lead to healthy babies and to monitor any risks over time.

Who is the study for?

This trial is for individuals who can travel to Stanford, speak English fluently, and have aneuploid or mosaic embryos ready for transfer but no healthy euploid embryos available. It's not open to those using a gestational carrier, living outside the U.S., or with embryos diagnosed with Trisomy 18, Trisomy 13, or Triploidy.

What is being tested?

The study is testing the outcomes of transferring non-euploid (abnormal) embryos into participants compared to normal (euploid) embryo transfers. The focus is on live birth rates and any health or developmental issues in children up to five years post-birth.

What are the potential side effects?

Since this trial involves pregnancy through embryo transfer, potential side effects are related to fertility procedures and pregnancy complications rather than medication side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I do not have any healthy embryos for use.

Select...

I have embryos that are not typical in their chromosome number.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My embryos do not have Trisomy 18, Trisomy 13, or Triploidy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pregnancy Rate

Secondary study objectives

Live birth rate

Obstetric complications

Pediatric Development

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Non-euploid TransferExperimental Treatment1 Intervention

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).

Group II: Euploid TransferActive Control1 Intervention

Patients desiring pregnancy who are undergoing euploid embryo transfer

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Preimplantation Genetic Testing for Aneuploidy (PGT-A) is a common treatment that involves screening embryos created through in vitro fertilization (IVF) for chromosomal abnormalities before implantation. The process includes a biopsy of a few cells from the embryo, followed by genetic analysis to identify aneuploidies. Embryos with the correct number of chromosomes are selected for transfer to the uterus, while those with abnormalities are not used. This method increases the chances of a successful pregnancy and reduces the risk of miscarriage by ensuring that only euploid embryos are implanted, which is crucial for aneuploidy patients.

Using outcome data from one thousand mosaic embryo transfers to formulate an embryo ranking system for clinical use.