GEnetic Testing in Elective Single Embryo Transfer (GETSET): A Randomized Clinical Trial (GETSET)

November 15, 2023 updated by: Genomic Prediction Inc.
The GETSET trial is a prospective randomized trial designed to evaluate the clinical outcomes of incorporating preimplantation genetic testing for aneuploidies (PGT-A) in elective single embryo transfer in women between 35 and 40 years of age.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this randomized controlled trial, a total of 240 patients divided evenly across the two participating IVF center will be recruited. Patients will be randomized to a control and to a treatment group, each containing 120 participants.

Only patients with at least one evaluable blastocyst will be randomized. Patients will undergo ovarian hyper-stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by IVF center.

In the control arm, patients will undergo a single frozen embryo transferof the untested, best quality blastocyst. All other blastocysts with lower morphology will undergo trophectoderm biopsy on day 5, 6 or 7 and will be frozen. PGT-A results of the untransferred embryos will be revealed to the patient AFTER the outcome of the initial ET is known.

In the experimental arm, all embryos will be cultured to blastocyst and all viable blastocysts will undergo trophectoderm biopsy and PGT-A. PGT-A will be performed regardless of the number of blastocysts available. Patients will undergo frozen transfer of the single, best quality euploid blastocyst. If the initial transfer results in a non-conception cycle and additional embryos are available for transfer.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • Recruiting
        • Boston IVF
        • Contact:
        • Principal Investigator:
          • Kim Thorton, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Women undergoing IVF of between 35 and 40 years of age at IVF cycle start Utilization of Intracytoplasmic Sperm Injection ICSI (recommended) or Traditional IVF Utilization of ejaculated or testicular sperm Utilization of autologous or donor sperm All Controlled Ovarian Hyperstimulation (COH) protocols

Exclusion Criteria:

Utilization of donor oocytes Utilization of gestational carrier Recurrent Pregnancy Loss (RPL) defined as ≥ 3 consecutive miscarriages Recurrent Implantation Failure (RIF) defined as ≥ 3 more failed embryo transfers Preimplantation genetic testing for monogenic/single gene disorders (PGT-M) Translocation carriers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm - Transfer of Best Quality, Euploid Blastocyst
Transfer of best quality, PGTA normal (euploid) blastocyst.
Other: Preimplantation genetic testing for aneuploidy (PGTA)
24 chromosome screening for aneuploidy in the preimplantation embryo(blastocyst stage)
No Intervention: Control Arm - Transfer of Untested, Best Quality Blastocyst
Transfer of Untested, Best Quality Blastocyst

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing Pregnancy Rate
Time Frame: Up to 2 years
The number of participants who experience an ongoing clinical pregnancy rate after the 1st embryo transfer.
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Miscarriage Rate
Time Frame: Up to 2 years
Number of participants that experience a pregnancy loss after the 1st embryo transfer.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genomic Prediction Inc.

Collaborators

Boston IVF

Investigators

  • Principal Investigator: Nathan Treff, PhD, Genomic Prediction Clinical Labortory

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

November 15, 2024

Study Completion (Estimated)

November 15, 2025

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPCL 20232892

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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