Genetic Testing for Infertility

(GETSET Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Nathan Treff, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Genomic Prediction Inc.

Disqualifiers: Donor oocytes, Gestational carrier, RPL, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

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.

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 2 3 4 5}

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 3 4 6 7}

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. ^{4 6 7 8 9}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Preimplantation genetic testing for aneuploidy (PGT-A) (Genetic Testing)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Boston IVF Waltham, MA

Who Is Running the Clinical Trial?

Genomic Prediction Inc. Lead Sponsor

Boston IVF Collaborator

References

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

Impact of preimplantation genetic testing for aneuploidy on obstetrical practice. [2020] To provide updated information on preimplantation genetic testing for aneuploidy (PGT-A), focusing on its implications on prenatal diagnostic approaches after transferal of mosaic aneuploid embryos.

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

The dilemma of aneuploidy screening on low responders. [2019] Preimplantation genetic testing for aneuploidy (PGT-A) has been demonstrated to improve implantation and pregnancy rates and decrease miscarriage rates over standard morphology-based embryo selection. However, there are limited data on its efficacy in patients with diminished ovarian reserve or a poor response to stimulation who may have fewer embryos to select amongst.

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] What is the potential impact of preimplantation genetic testing for aneuploidy (PGT-A) on obstetric and neonatal outcomes?

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] Preimplantation genetic testing for aneuploidy (PGT-A) is an emerging technology that aims to identify euploid embryos for transfer, reducing the risk of embryonic chromosomal abnormalities. However, the clinical benefits of PGT-A in recurrent pregnancy failure (RPF) patients, particularly in young RPF patients, remains uncertain.

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] Current evidence suggests that preimplantation genetic testing for aneuploidy (PGT-A) used during assisted reproductive technology improves per-cycle live-birth rates but cumulative live-birth rate (CLBR) was similar to a strategy of morphological assessment (MA) of embryos. No study has assessed the cost-effectiveness of repeated cycles with PGT-A using longitudinal patient-level data.

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

Does PGT-A affect cumulative live birth rate? [2023] Preimplantation genetic testing for the purpose of aneuploidy screening (PGT-A) has increased in use over the last decade.

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] Preimplantation genetic testing for aneuploidy (PGT-A) is widely used as an embryo selection technique in in vitro fertilization (IVF), but its effectiveness and potential beneficiary populations are unclear.

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

Aneuploidy Screening using Next Generation Sequencing. [2019] Chromosomal aneuploidy is recognized to be a significant contributing factor in implantation failure and spontaneous miscarriage Hellani et al. (Reprod Biomed Online 17:841-847, 2008), Vanneste et al. (Nat Med 15:577-583, 2009) and is likely to be responsible for the majority of IVF failure [Baltaci et al. (Reprod Biomed Online 12:77-82, 2006), Munne (Placenta 24:S70-76, 2003)]. Preimplantation genetic testing for aneuploidy (PGT-A) screening, formerly termed preimplantation genetic screening (PGS), enables the assessment of the numeric chromosomal constitution in blastomere and/or trophectoderm biopsy before embryo transfer.Preimplantation genetic testing for aneuploidy (PGT-A) has been proven to improve the selection of embryos for transfer and therefore also assisted reproductive technology (ART) cycles. In this chapter we describe the current gold standard platform for PGT-A, next generation sequencing (NGS) protocol used in our laboratory.

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

Non-invasive prenatal testing in the context of IVF and PGT-A. [2021] The high incidence of chromosome aneuploidy in human gametes and embryos is a major cause of in vitro fertilization (IVF) failure and miscarriage. In order to improve live birth rates with single embryo transfer, the use of preimplantation genetic testing for aneuploidy (PGT-A) has significantly increased. PGT encompasses methods that allow embryos to be tested for inherited conditions or screened for chromosomal abnormalities. However, PGT-A is a screening method and results can never be used to definitively predict the chromosomal status of the embryo and fetus. The objective of this manuscript is to review prenatal screening and diagnostic methods available in pregnancies conceived by IVF-PGT-A.