Preimplantation Genetic Testing in Women of Advanced Maternal Age

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-05

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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In this randomized controlled trial, a total of 240 patients divided evenly across the two participating IVF centers 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 transfer with an untested blastocyst with the best morphology. 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. If the initial transfer results in a non-conception cycle and additional euploid embryos are available for transfer, these cycles will be followed and their outcomes collected.

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, these cycles will be followed and their outcomes collected until the embryo cohort is exhausted.

Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Allocation information will be handled by researcher coordinators only.

Study Groups

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PGT-A transfer

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

Group Type EXPERIMENTAL

Preimplantation genetic testing for aneuploidy (PGT-A)

Intervention Type PROCEDURE

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

Untested blastocyst transfer

Transfer of single untested blastocyst based on embryo morphology criteria.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preimplantation genetic testing for aneuploidy (PGT-A)

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

Intervention Type PROCEDURE

Other Intervention Names

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Preimplantation genetic screening (PGS)

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

35 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No