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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-40
SponsorGenomic Prediction Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preimplantation genetic testing for aneuploidy (PGTA)

    Other intervention

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

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Experimental Arm - Transfer of Best Quality, Euploid BlastocystExperimental treatment 1 intervention
Group B: Control Arm - Transfer of Untested, Best Quality BlastocystNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Ongoing Pregnancy Rate

The number of participants who experience an ongoing clinical pregnancy rate after the 1st embryo transfer.

Time frame
Up to 2 years

Secondary outcomes

1

Miscarriage Rate

Number of participants that experience a pregnancy loss after the 1st embryo transfer.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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