NCT04167748

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Mar 2021Dec 2026

First Submitted

Initial submission to the registry

November 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 5, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

4.7 years

First QC Date

November 15, 2019

Last Update Submit

August 19, 2025

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    Number of patients who experience an ongoing pregnancy rate (\>20 weeks of gestation) after their first embryo transfer

    Up to 18 months

Secondary Outcomes (1)

  • Miscarriage rate

    Up to 18 months

Study Arms (2)

PGT-A transfer

EXPERIMENTAL

Transfer of single chromosomally normal (euploid) blastocyst after PGT-A

Procedure: Preimplantation genetic testing for aneuploidy (PGT-A)

Untested blastocyst transfer

NO INTERVENTION

Transfer of single untested blastocyst based on embryo morphology criteria.

Interventions

Preimplantation genetic testing for aneuploidy (PGT-A)PROCEDURE

24-chromosome screening for aneuploidy in the preimplantation embryo (blastocyst stage)

Also known as: Preimplantation genetic screening (PGS)
PGT-A transfer

Eligibility Criteria

Age35 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Patients with anovulatory Polycystic ovarian syndrome (PCOS)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVF Florida Reproductive Associates

Margate, Florida, 33063, United States

RECRUITING

Related Publications (4)

  • Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Electronic address: ASRM@asrm.org; Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. The use of preimplantation genetic testing for aneuploidy (PGT-A): a committee opinion. Fertil Steril. 2018 Mar;109(3):429-436. doi: 10.1016/j.fertnstert.2018.01.002.

    PMID: 29566854BACKGROUND

  • Yang Z, Liu J, Collins GS, Salem SA, Liu X, Lyle SS, Peck AC, Sills ES, Salem RD. Selection of single blastocysts for fresh transfer via standard morphology assessment alone and with array CGH for good prognosis IVF patients: results from a randomized pilot study. Mol Cytogenet. 2012 May 2;5(1):24. doi: 10.1186/1755-8166-5-24.

    PMID: 22551456BACKGROUND

  • Forman EJ, Hong KH, Ferry KM, Tao X, Taylor D, Levy B, Treff NR, Scott RT Jr. In vitro fertilization with single euploid blastocyst transfer: a randomized controlled trial. Fertil Steril. 2013 Jul;100(1):100-7.e1. doi: 10.1016/j.fertnstert.2013.02.056. Epub 2013 Mar 30.

    PMID: 23548942BACKGROUND

  • Scott RT Jr, Upham KM, Forman EJ, Hong KH, Scott KL, Taylor D, Tao X, Treff NR. Blastocyst biopsy with comprehensive chromosome screening and fresh embryo transfer significantly increases in vitro fertilization implantation and delivery rates: a randomized controlled trial. Fertil Steril. 2013 Sep;100(3):697-703. doi: 10.1016/j.fertnstert.2013.04.035. Epub 2013 Jun 1.

    PMID: 23731996BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Nathan R Treff, PhD

    Genomic Prediction

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathan R Treff, PhD

CONTACT

(973) 529-4223nathan@genomicprediction.com

Diego Marin, PhD

CONTACT

(973) 529-4223diego@genomicprediction.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Allocation information will be handled by researcher coordinators only.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomized clinical trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 19, 2019

Study Start

March 5, 2021

Primary Completion

November 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)