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

Not Applicable

Recruiting

• Conditions: Infertility, Female
• Interventions: Other: Preimplantation genetic testing for aneuploidy (PGTA)

• Registration Number: NCT06141135
• Lead Sponsor: Genomic Prediction Inc.

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.

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 Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-15
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Study First Posted: 2023-11-21
• Last Update Posted: 2023-11-21
• Primary Completion: 2024-11-15
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm - Transfer of Best Quality, Euploid Blastocyst	Preimplantation genetic testing for aneuploidy (PGTA)	Transfer of best quality, PGTA normal (euploid) blastocyst.

Primary Outcome Measures

Name	Time	Method
Ongoing Pregnancy Rate	Up to 2 years	The number of participants who experience an ongoing clinical pregnancy rate after the 1st embryo transfer.

Secondary Outcome Measures

Name	Time	Method
Miscarriage Rate	Up to 2 years	Number of participants that experience a pregnancy loss after the 1st embryo transfer.

Trial Locations

Locations (1)

Boston IVF; 🇺🇸 Waltham, Massachusetts, United States