Preimplantation Genetic Testing for Female Infertility

(GETSET Trial)

Overseen By Nathan R Treff, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Genomic Prediction Inc.

Disqualifiers: Anovulatory PCOS, Donor oocytes, Gestational carrier, RPL, RIF

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how preimplantation genetic testing for aneuploidies (PGT-A) affects the success of in vitro fertilization (IVF) for women aged 35 to 40. The test checks embryos for the correct number of chromosomes before implantation, potentially helping to select the healthiest embryo. Participants will join one of two groups: one with embryos tested using PGT-A and one without testing. Women who have been trying IVF, using their own or donor sperm, and meet certain criteria are suitable candidates. This includes using specific IVF techniques but excludes those with certain fertility issues, such as repeated miscarriages or failed transfers.

As an unphased trial, this study offers participants the chance to contribute to important research that could improve IVF success rates.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that preimplantation genetic testing for aneuploidies (PGT-A) is safe for female infertility?

Research has shown that preimplantation genetic testing for aneuploidies (PGT-A) is generally safe. Studies suggest that PGT-A might reduce the risk of miscarriage. For instance, one study found a miscarriage rate of 8.9% for those who had PGT-A, compared to 21.1% for those who did not, indicating a possible safety benefit.

Another study found that PGT-A can lower the chances of multiple births, which can be risky for both the mother and babies. However, some experts believe there isn't enough strong evidence to confirm all the benefits for older women.

Overall, PGT-A is well-tolerated, with no major safety concerns reported in these studies. Consulting a healthcare provider is advisable to understand what these findings mean for personal health decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Preimplantation Genetic Testing for Aneuploidy (PGT-A) because it offers a more precise way to select embryos for transfer during in vitro fertilization (IVF). Unlike traditional methods that rely on visual assessment of embryo morphology, PGT-A involves genetic screening to ensure that only chromosomally normal (euploid) embryos are chosen. This can potentially increase the chances of successful implantation and reduce the risk of miscarriage. By providing a more targeted approach, PGT-A could improve IVF success rates and offer new hope for individuals facing female infertility.

What evidence suggests that PGT-A is effective for female infertility?

Research has shown that testing embryos for genetic issues before implantation, known as PGT-A, can improve pregnancy outcomes. In this trial, one group of participants will receive PGT-A, which involves transferring a single chromosomally normal (euploid) blastocyst. Studies have found that PGT-A increases the chances of embryos successfully implanting, developing into pregnancies, and resulting in live births. Additionally, PGT-A lowers the risk of miscarriage, with data showing an 8.9% miscarriage rate for PGT-A compared to 21.1% without it. It also reduces the number of embryo transfers needed to achieve a successful pregnancy. These findings suggest that PGT-A may help women aged 35 to 40 achieve successful pregnancies. Meanwhile, another group in this trial will undergo the transfer of a single untested blastocyst based on embryo morphology criteria. ^{1 3 4 6 7}

Who Is on the Research Team?

Nathan R Treff, PhD

Principal Investigator

Genomic Prediction

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am undergoing or have undergone ovarian stimulation.

I am a woman aged 35-40 starting an IVF cycle.

I am using or have used ICSI for conception.

Exclusion Criteria

I have PCOS and do not ovulate regularly.

You have experienced three or more miscarriages in a row.

I have had 3 or more unsuccessful embryo transfers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ovarian Hyper-stimulation and Embryo Culture

Patients undergo ovarian hyper-stimulation, oocyte retrieval, fertilization, and embryo culture per standard clinical protocol

4-6 weeks

Embryo Transfer

Transfer of a single embryo, either untested or euploid, based on trial arm assignment

1 week

Follow-up

Participants are monitored for ongoing pregnancy and miscarriage rates after embryo transfer

Up to 18 months

What Are the Treatments Tested in This Trial?

Interventions

• PGT-A

Trial Overview 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.

How Is the Trial Designed?

Group I: PGT-A transfer Experimental Treatment 1 Intervention

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

Group II: Untested blastocyst transfer Active Control 1 Intervention

Transfer of single untested blastocyst based on embryo morphology criteria.

Who Is Running the Clinical Trial?

Genomic Prediction Inc.

Lead Sponsor

Trials

6

Recruited

11,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10914495/

Clinical outcomes of preimplantation genetic testing for ... PGT-A was associated with significant improvements in the implantation rate (IR) and the ongoing pregnancy rate/live birth rate (OPR/LBR) per embryo transfer ...

2. asrm.org asrm.org/practice-guidance/practice-committee-documents/the-use-of-preimplantation-genetic-testing-for-aneuploidy-a-committee-opinion-2024/

The use of preimplantation genetic testing for aneuploidy On the basis of the reported data, the calculated spontaneous abortion rates for the PGT-A and control groups were 8.9% and 21.1%, respectively, and twin rates ...

3. mdpi.com mdpi.com/2077-0383/13/20/6192?

Preimplantation Genetic Testing for Aneuploidy (PGT-A) in ... Past studies assessing the clinical efficacy of PGT-A in improving clinical outcomes have been conflicting and the associated clinical pregnancy rates and live ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10879326/

Preimplantation genetic testing for aneuploidy optimizes ... Results found that RPL sufferers using PGT-A (n = 660) had significantly higher CPR (73 vs. 61%, p = 0.01), LBR (62 vs. 41%, p < 0.01), and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S001502822500216X

The impact of preimplantation genetic testing for ... Overall, in both age groups, patients who underwent PGT-A had fewer oocyte retrievals and needed fewer transfers to achieve a successful pregnancy. Our findings ...

6. hfea.gov.uk hfea.gov.uk/treatments/treatment-add-ons/pre-implantation-genetic-testing-for-aneuploidy-pgt-a/

Pre-implantation genetic testing for aneuploidy (PGT-A) The use of PGT-A is rated grey for reducing the chances of miscarriage in older women. This is because there is insufficient moderate/high quality evidence ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9674466/

The Effects of Preimplantation Genetic Testing for Aneuploidy ... The aim of this study was to evaluate the effect of preimplantation genetic testing for aneuploidy (PGT-A) on patient-important reproductive outcomes after in ...