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

Infertility, Female Clinical Trial

— GETSET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06141135
• Other study ID #: GPCL 20232892
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: November 15, 2025

Study information

• Verified date: November 2023
• Source: Genomic Prediction Inc.
• Contact: Talia Metzgar
• Phone: (973) 529- 4223
• Email: talia[@]genomicprediction.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: November 15, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Other:
• Preimplantation genetic testing for aneuploidy (PGTA)
24 chromosome screening for aneuploidy in the preimplantation embryo(blastocyst stage)

Locations

Country	Name	City	State
United States	Boston IVF	Waltham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Genomic Prediction Inc.	Boston IVF

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing Pregnancy Rate	The number of participants who experience an ongoing clinical pregnancy rate after the 1st embryo transfer.	Up to 2 years
Secondary	Miscarriage Rate	Number of participants that experience a pregnancy loss after the 1st embryo transfer.	Up to 2 years