Preimplantation Genetic Testing in Women of Advanced Maternal Age

GEnetic Testing in Elective Single Embryo Transfer in Women of Advanced Maternal Age

Sponsors

Lead Sponsor: Genomic Prediction Inc.

Source 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 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.

Overall Status Not yet recruiting
Start Date November 1, 2020
Completion Date December 2024
Primary Completion Date November 1, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Ongoing pregnancy rate Up to 18 months
Secondary Outcome
Measure Time Frame
Miscarriage rate Up to 18 months
Enrollment 240
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Preimplantation genetic testing for aneuploidy (PGT-A)

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

Arm Group Label: PGT-A transfer

Other Name: Preimplantation genetic screening (PGS)

Eligibility

Criteria:

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

Gender: Female

Minimum Age: 35 Years

Maximum Age: 40 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Nathan R Treff, PhD Principal Investigator Genomic Prediction
Overall Contact

Last Name: Nathan R Treff, PhD

Phone: (973) 529-4223

Email: [email protected]

Verification Date

September 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: PGT-A transfer

Type: Experimental

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

Label: Untested blastocyst transfer

Type: No Intervention

Description: Transfer of single untested blastocyst based on embryo morphology criteria.

Acronym GETSET
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Prospective randomized clinical trial

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking Description: Allocation information will be handled by researcher coordinators only.

Source: ClinicalTrials.gov