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Genetic Testing

Preimplantation Genetic Testing for Female Infertility (GETSET Trial)

N/A
Recruiting
Led By Nathan R Treff, PhD
Research Sponsored by Genomic Prediction Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All Controlled Ovarian Hyperstimulation (COH) protocols
Women undergoing IVF of between 35 and 40 years of age at IVF cycle start
Must not have
Patients with anovulatory Polycystic ovarian syndrome (PCOS)
Recurrent Implantation Failure (RIF) defined as ≥ 3 more failed embryo transfers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will help researchers learn if preimplantation genetic testing for aneuploidies leads to better clinical outcomes for women between 35 and 40 years of age who are undergoing elective single embryo transfer.

Who is the study for?
This trial is for women aged 35-40 undergoing IVF, using any sperm or ovarian stimulation protocol. It's not for those with recurrent implantation failure, using a gestational carrier, diagnosed with PCOS that causes lack of ovulation, or utilizing donor eggs.
What is being tested?
The GETSET trial is testing the effectiveness of preimplantation genetic testing (PGT-A) in improving pregnancy outcomes when used during elective single embryo transfer in women of advanced maternal age.
What are the potential side effects?
While PGT-A itself doesn't have direct side effects, associated IVF procedures can include cramping, bloating, mood swings from hormones and slight bleeding from egg retrieval.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am undergoing or have undergone ovarian stimulation.
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I am a woman aged 35-40 starting an IVF cycle.
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I am using my own or donor sperm for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have PCOS and do not ovulate regularly.
Select...
I have had 3 or more unsuccessful embryo transfers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ongoing pregnancy rate
Secondary study objectives
Miscarriage rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PGT-A transferExperimental Treatment1 Intervention
Transfer of single chromosomally normal (euploid) blastocyst after PGT-A
Group II: Untested blastocyst transferActive Control1 Intervention
Transfer of single untested blastocyst based on embryo morphology criteria.

Find a Location

Who is running the clinical trial?

Genomic Prediction Inc.Lead Sponsor
5 Previous Clinical Trials
11,440 Total Patients Enrolled
Nathan R Treff, PhDPrincipal InvestigatorGenomic Prediction
1 Previous Clinical Trials
10,000 Total Patients Enrolled

Media Library

PGT-A (Genetic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT04167748 — N/A
Female Infertility Research Study Groups: Untested blastocyst transfer, PGT-A transfer
Female Infertility Clinical Trial 2023: PGT-A Highlights & Side Effects. Trial Name: NCT04167748 — N/A
PGT-A (Genetic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04167748 — N/A
Female Infertility Patient Testimony for trial: Trial Name: NCT04167748 — N/A
~0 spots leftby Nov 2024
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