2000 Participants Needed

Timelapse Imaging + PGT for Infertility

TH
Overseen ByTyl H taylor
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Gattaca Genomics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a link exists between detailed time-lapse images of embryos and genetic test results. The study focuses on embryos from individuals undergoing genetic testing during IVF (in vitro fertilization). Those undergoing IVF and opting for preimplantation genetic testing may be suitable candidates for this trial.

As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could improve IVF outcomes.

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 focuses on patients undergoing IVF with PGT, so it's best to discuss your medications with the trial team.

What prior data suggests that timelapse incubation is safe for embryos?

Research has shown that preimplantation genetic testing for aneuploidy (PGT-A), when performed with next-generation sequencing (NGS), is a safe method in IVF treatments. One study found this advanced testing to be more effective and safer for older women trying to conceive.

Regarding timelapse incubation, studies suggest this method does not harm embryo development. This technique allows for continuous monitoring without moving the embryos, maintaining stable conditions. Research concludes there are no negative effects on pregnancy or birth outcomes when using a timelapse incubator.

Both methods have strong safety records, making them promising options for those considering participation in related clinical trials.12345

Why are researchers excited about this trial?

Researchers are excited about using timelapse imaging combined with preimplantation genetic testing for aneuploidy (PGT-A) with next-generation sequencing (NGS) in IVF. Unlike traditional methods that rely solely on visual embryo assessments, this approach allows for continuous monitoring of embryo development and a deeper genetic analysis. These techniques aim to improve the selection of viable embryos, potentially increasing the success rates of IVF. By combining real-time monitoring with advanced genetic testing, this method could lead to more informed decisions and better outcomes for those dealing with infertility.

What evidence suggests that timelapse incubation is effective for analyzing embryos in PGT?

Research has shown that testing embryos for genetic issues before implantation, known as Preimplantation Genetic Testing for Aneuploidy (PGT-A), can enhance the effectiveness and safety of in vitro fertilization (IVF), particularly for older women. This testing significantly reduces miscarriage rates and increases the likelihood of a successful pregnancy. Additionally, PGT-A can expedite achieving a healthy pregnancy. In this trial, infertile patients undergoing IVF will receive PGT-A. Meanwhile, using timelapse imaging systems to continuously monitor embryo development, another approach studied in this trial, can improve IVF outcomes by providing detailed information for better embryo selection. Although timelapse imaging alone might not increase live birth rates, it offers insights into embryo health, leading to more informed decisions during IVF.12678

Are You a Good Fit for This Trial?

Inclusion Criteria

I am undergoing IVF with genetic testing on the embryos.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stimulation

Patients undergo ovarian stimulation for IVF

0-2 weeks
Multiple visits for monitoring

Embryo Assessment

Embryos are placed in a timelapse incubator and assessed using TLI and PGT-A

1-2 weeks
Continuous monitoring

Transfer and Implantation

Embryos are transferred to the uterus and monitored for implantation

4 weeks
1 visit for transfer, follow-up visits for monitoring

Follow-up

Participants are monitored for pregnancy and live birth outcomes

9 months
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing
  • Timelapse incubation

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Infertile patientsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gattaca Genomics

Lead Sponsor

Trials
1
Recruited
2,000+

Citations

Preimplantation Genetic Testing for Aneuploidy (PGT-A) in ...

The use of PGT-A through NGS is a more clinically effective, safer, and more cost-effective way to provide IVF treatment in women of advanced reproductive age.

The use of preimplantation genetic testing for aneuploidy

The miscarriage rate was significantly lower in the PGT-A group (2.7% vs. 39%, P=.0007). Of all cleavage embryos that were biopsied, they got results for 97.2%, ...

The impact of preimplantation genetic testing for ...

Preimplantation genetic testing for aneuploidy is associated with a shorter time to pregnancy resulting in a live birth for patients who are at least 38 years ...

Preimplantation genetic testing for aneuploidy in ...

Preimplantation genetic testing for aneuploidy decreased clinical pregnancy loss rate (OR, 0.42; 95% CI, 0.27–0.67) and enhanced LBR per ...

Live Birth with or without Preimplantation Genetic Testing ...

Embryo selection with preimplantation genetic testing for aneuploidy (PGT-A) may improve pregnancy outcomes after initial embryo transfer.

In vitro fertilization outcomes after preimplantation genetic ...

The implantation rate was statistically significantly higher for NGS (16 of 20, 80.0%) compared with FISH (11 of 25, 44.0%) and aCGH (16 of 30, 53.3%). There ...

Next generation sequencing for preimplantation genetic ...

Preimplantation genetic testing for aneuploidy (PGT-A) is a screening strategy aiming to identify chromosome abnor- malities in IVF generated embryos. The ...

Conventional in vitro fertilization enhances preimplantation ...

Our data suggested c-IVF could improve PGT-A outcomes in couples with non-male factor infertility and exhibited a low risk of parental contamination.