Genetic Testing for Infertility

(GETSET Trial)

Overseen By Kristin Rooney

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Genomic Prediction Inc.

Disqualifiers: Donor oocytes, Gestational carrier, RPL, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is preimplantation genetic testing for aneuploidy (PGT-A) safe for humans?

Research indicates that preimplantation genetic testing for aneuploidy (PGT-A) is not linked to negative outcomes for mothers or newborns in single-baby pregnancies, suggesting it is generally safe. ^{1 2 3 4 5}

How is the treatment PGT-A different from other infertility treatments?

Preimplantation genetic testing for aneuploidy (PGT-A) is unique because it screens embryos for chromosomal abnormalities before they are implanted during in vitro fertilization (IVF). This helps select embryos with the correct number of chromosomes, potentially improving the chances of a successful pregnancy and reducing the risk of miscarriage. ^{2 3 5 6 7}

What data supports the effectiveness of the treatment Preimplantation genetic testing for aneuploidy (PGT-A) for infertility?

Research shows that PGT-A can improve implantation and pregnancy rates and decrease miscarriage rates compared to standard methods of selecting embryos based on appearance. However, its effectiveness may vary in patients with fewer embryos to choose from. ^{1 3 4 8 9}

Who Is on the Research Team?

Nathan Treff, PhD

Principal Investigator

Genomic Prediction Clinical Labortory

Are You a Good Fit for This Trial?

The GETSET trial is for women aged 35-40 undergoing IVF with their own or donor sperm, and any COH protocol. It's not for those using donor eggs, gestational carriers, have had ≥3 miscarriages in a row, ≥3 failed embryo transfers, need genetic testing for single gene disorders or are translocation carriers.

Inclusion Criteria

I am using my own or donor sperm for treatment.

I am undergoing or have undergone ovarian stimulation treatment.

I am using or plan to use ICSI or traditional IVF for conception.

Exclusion Criteria

I have undergone genetic testing for specific inherited disorders.

I have had 3 or more unsuccessful embryo transfers.

I have a genetic change known as a translocation.

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

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

4-6 weeks

Embryo Transfer

Participants undergo a single frozen embryo transfer of the best quality blastocyst

1 week

Follow-up

Participants are monitored for pregnancy outcomes, including miscarriage and ongoing pregnancy rates

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Preimplantation genetic testing for aneuploidy (PGT-A)

Trial Overview This study tests if preimplantation genetic testing for aneuploidies (PGT-A) improves pregnancy outcomes when used during elective single embryo transfer in IVF treatments for women between the ages of 35 and 40.

How Is the Trial Designed?

Group I: Experimental Arm - Transfer of Best Quality, Euploid Blastocyst Experimental Treatment 1 Intervention

Transfer of best quality, PGTA normal (euploid) blastocyst.

Group II: Control Arm - Transfer of Untested, Best Quality Blastocyst Active Control 1 Intervention

Transfer of Untested, Best Quality Blastocyst

Preimplantation genetic testing for aneuploidy (PGT-A) is already approved in United States, European Union for the following indications:

Approved in United States as PGT-A for:

• Screening for aneuploidy in embryos generated through IVF

Approved in European Union as PGT-A for:

• Screening for aneuploidy in embryos generated through IVF

Who Is Running the Clinical Trial?

Genomic Prediction Inc.

Lead Sponsor

Trials

6

Recruited

11,700+

Boston IVF

Collaborator

Trials

21

Recruited

21,400+

Published Research Related to This Trial

Preimplantation genetic testing for aneuploidy (PGT-A) helps improve IVF outcomes by screening embryos for chromosomal abnormalities, particularly benefiting older mothers by reducing the negative effects of age on fertility.

The emergence of mosaic aneuploid embryos after PGT-A raises concerns, as these embryos carry risks such as miscarriage and fetal complications; a risk score system has been developed to guide decisions on which mosaic embryos to transfer, but long-term outcomes remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of preimplantation genetic testing for aneuploidy on obstetrical practice. Chan, YM., Li, TC., Poon, LCY.[2020]

Preimplantation genetic testing for aneuploidy (PGT-A) has shown promise in improving pregnancy outcomes, particularly by reducing miscarriage rates and decreasing time to delivery in patients with diminished ovarian reserve or poor response to stimulation.

Initial studies suggest that PGT-A can be beneficial for 'poor responders' in IVF, but more research is needed to understand the different subpopulations within this group and to optimize the use of PGT-A across various clinical scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dilemma of aneuploidy screening on low responders. Morin, SJ., Kaser, DJ., Franasiak, JM.[2019]

A study involving 7146 live births from IVF/ICSI cycles found that preimplantation genetic testing for aneuploidy (PGT-A) does not lead to increased rates of adverse maternal and neonatal outcomes in singleton pregnancies, suggesting its safety in this context.

While initial analyses indicated higher risks of pre-eclampsia and cesarean sections in PGT-A pregnancies, further statistical adjustments showed no significant differences in adverse outcomes, and a subgroup analysis revealed a decreased risk of preterm birth for pregnancies involving blastocysts screened with next-generation sequencing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preimplantation genetic testing for aneuploidy is not related to adverse obstetric and neonatal outcomes in singleton pregnancies. Cozzolino, M., Cecchino, GN., Garcia Velasco, JA., et al.[2023]

Preimplantation genetic testing for aneuploidy (PGT-A) significantly improves clinical outcomes in recurrent pregnancy failure (RPF) patients, with higher implantation rates, clinical pregnancy rates, ongoing pregnancy rates, and live birth rates compared to those not undergoing PGT-A.

The analysis of 13 studies involving 930 RPF patients undergoing PGT-A and over 1,434 without it showed that PGT-A also resulted in a lower clinical miscarriage rate, indicating its potential benefits in enhancing successful pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis: clinical outcomes of recurrent pregnancy failure resulting from preimplantation genetic testing for aneuploidy. Liang, Z., Wen, Q., Li, J., et al.[2023]

Preimplantation genetic testing for aneuploidy (PGT-A) in older women (aged ≥37 years) undergoing assisted reproductive technology resulted in a cumulative live-birth rate of 30.90%, compared to 26.77% for morphological assessment (MA) of embryos, indicating that PGT-A may improve live-birth outcomes.

The study found that PGT-A had an incremental cost-effectiveness ratio of $28,103 per additional live birth, suggesting that it is cost-effective at a willingness-to-pay threshold of $50,000, with over 80% probability of being cost-effective from a healthcare perspective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cost-effectiveness analysis of preimplantation genetic testing for aneuploidy (PGT-A) for up to three complete assisted reproductive technology cycles in women of advanced maternal age. Lee, E., Costello, MF., Botha, WC., et al.[2020]

Preimplantation genetic testing for aneuploidy screening (PGT-A) is designed to improve the chances of a live birth per embryo transfer while reducing risks like miscarriage and aneuploid pregnancies, but it may not necessarily increase the cumulative live birth rate (CLBR) for all patients, particularly younger ones.

Recent studies suggest that while PGT-A can help select healthier embryos, it may inadvertently lower the overall CLBR, highlighting the need to carefully consider its benefits and risks in the context of in-vitro fertilization cycles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does PGT-A affect cumulative live birth rate? Seckin, S., Forman, EJ.[2023]

In a study of 60,580 patients undergoing IVF, preimplantation genetic testing for aneuploidy (PGT-A) did not improve the cumulative live birth rate (CLBR) compared to standard IVF, showing a CLBR of 27.5% for PGT-A users versus 31.1% for non-PGT-A users.

However, PGT-A users experienced significantly higher rates of successful first embryo transfers (63.9% vs. 46.9%) and live births (52.6% vs. 34.2%), along with lower rates of early miscarriage, preterm birth, and low birth weight, indicating its effectiveness for certain populations, particularly women over 38 or those with recurrent pregnancy loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the efficacy and beneficial population of preimplantation genetic testing for aneuploidy start from the oocyte retrieval cycle: a real-world study. Ma, S., Liao, J., Zhang, S., et al.[2023]

Chromosomal aneuploidy is a major cause of implantation failure and miscarriage, significantly impacting the success rates of in vitro fertilization (IVF).

Preimplantation genetic testing for aneuploidy (PGT-A) using next generation sequencing (NGS) improves embryo selection for transfer, enhancing the success of assisted reproductive technology (ART) cycles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aneuploidy Screening using Next Generation Sequencing. Cinnioglu, C., Kayali, R., Darvin, T., et al.[2019]

Preimplantation genetic testing for aneuploidy (PGT-A) has become increasingly important in improving live birth rates during IVF by screening embryos for chromosomal abnormalities.

While PGT-A can help identify embryos with potential aneuploidy, it is important to note that it cannot definitively predict the chromosomal status of the embryo or fetus, highlighting the limitations of this screening method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive prenatal testing in the context of IVF and PGT-A. Kimelman, D., Pavone, ME.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Impact of preimplantation genetic testing for aneuploidy on obstetrical practice. [2020]

2. England pubmed.ncbi.nlm.nih.gov

The dilemma of aneuploidy screening on low responders. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Preimplantation genetic testing for aneuploidy is not related to adverse obstetric and neonatal outcomes in singleton pregnancies. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis: clinical outcomes of recurrent pregnancy failure resulting from preimplantation genetic testing for aneuploidy. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

A cost-effectiveness analysis of preimplantation genetic testing for aneuploidy (PGT-A) for up to three complete assisted reproductive technology cycles in women of advanced maternal age. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Does PGT-A affect cumulative live birth rate? [2023]

7. England pubmed.ncbi.nlm.nih.gov

Exploring the efficacy and beneficial population of preimplantation genetic testing for aneuploidy start from the oocyte retrieval cycle: a real-world study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Aneuploidy Screening using Next Generation Sequencing. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Non-invasive prenatal testing in the context of IVF and PGT-A. [2021]