niPGT-A for Infertility

(niPGT-A_RCT Trial)

No longer recruiting at 15 trial locations

Overseen By Carmen Rubio, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Igenomix

Disqualifiers: Abnormal karyotype, Surrogate pregnancy, 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: 1

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve success rates in IVF (In Vitro Fertilization) by identifying embryos with the best chance of leading to a successful pregnancy. The study focuses on a non-invasive technique called niPGT-A (Non-Invasive Preimplantation Genetic Testing for Aneuploidy), which analyzes DNA fragments from the embryo found in the culture media, typically discarded. Participants will have their embryos selected based on either traditional appearance methods or this new DNA analysis. The trial seeks IVF patients planning to use their fresh eggs for embryo transfer on days 6 or 7. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that could revolutionize IVF success rates.

Will I have to stop taking my current medications?

The trial protocol 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 this technique is safe for embryo selection in IVF?

Research has shown that non-invasive preimplantation genetic testing for aneuploidy (niPGT-A) can be safer than traditional methods. This approach does not require a sample from the embryo, leaving it undisturbed and enhancing safety.

Studies indicate that niPGT-A accurately detects chromosomal issues in embryos by analyzing the liquid in which they grow during lab culture. This method reduces the chance of errors associated with other testing methods.

Overall, niPGT-A is well-tolerated, with no significant side effects reported in studies, making it a promising option for selecting embryos in IVF programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the niPGT-A technique for infertility because it offers a novel way to select the best embryos for transfer without invasive procedures. Unlike traditional methods that rely on embryo morphology or require a biopsy, niPGT-A analyzes the genetic material in the spent culture media where the embryo grows. This approach could improve embryo selection accuracy while being less stressful for the embryos, potentially leading to higher success rates in IVF treatments.

What evidence suggests that niPGT-A might be an effective treatment for infertility?

Research shows that a new method called non-invasive Preimplantation Genetic Testing for Aneuploidy (niPGT-A) can help select the best embryos in IVF treatments. Some studies have found that niPGT-A leads to better results than older methods. Specifically, research by Huang et al. demonstrated that niPGT-A can identify chromosomal problems without harming the embryo. Other studies suggest that niPGT-A may increase the chances of live births and reduce miscarriages. In this trial, participants in the intervention group will undergo embryo selection using niPGT-A, which uses DNA from the fluid around the embryo, offering a safer and more effective option for IVF. ^{1 3 4 6 7}

Who Is on the Research Team?

Carmen Rubio, PhD

Principal Investigator

Igenomix S.L.

Are You a Good Fit for This Trial?

This trial is for IVF patients aged 20-40 who are planning to have a single embryo transfer on day 6/7 without prior genetic testing. They must follow the study's lab protocol and provide informed consent. Excluded are those with significant uterine issues, unstable medical conditions, or specific treatments like assisted hatching before sample collection.

Inclusion Criteria

I am undergoing IVF or ICSI without genetic testing on the embryos, using my own eggs. Donor sperm is okay.

My eggs or embryos will be handled according to the study's lab protocol.

I am a woman aged between 20 and 40.

Exclusion Criteria

I have had uterine issues like polyps or fibroids corrected before the study.

Time-lapse culture systems are not allowed after day 4 of culture.

I have undergone an ERA test and will follow its recommendations for embryo transfer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Deferred transfer of a single frozen day 6/7 blastocyst based on chromosomal status or morphology

7 days

1 visit (in-person) for ovum pick-up and embryo transfer

Follow-up

Participants are monitored for ongoing pregnancy and chromosomal abnormalities

Up to 6 months after the ovum pick-up

Regular visits as needed for monitoring

Long-term follow-up

Monitoring of obstetrical outcomes and live birth rates

Over 40 weeks

What Are the Treatments Tested in This Trial?

Interventions

• niPGT-A

Trial Overview The trial tests non-invasive Preimplantation Genetic Testing for Aneuploidy (niPGT-A) by analyzing cell-free DNA in Spent Blastocyst Medium against standard morphology criteria. It aims to improve pregnancy rates by selecting embryos with higher implantation potential.

How Is the Trial Designed?

Group I: Intervention group (group 2) Experimental Treatment 1 Intervention

Deferred single day 6/7 blastocyst transfer with blastocyst selection according to the analysis of the spent culture media (niPGT-A).

Group II: Control group (group 1) Active Control 1 Intervention

Deferred single day 6/7 blastocyst transfer with blastocyst selection according to morphology.

niPGT-A is already approved in European Union, United States for the following indications:

Approved in European Union as niPGT-A for:

• Selection of embryos with normal chromosomal status for transfer in IVF programs

Approved in United States as niPGT-A for:

• Identification of aneuploidies in embryos for IVF programs

Who Is Running the Clinical Trial?

Igenomix

Lead Sponsor

Trials

38

Recruited

16,800+

Published Research Related to This Trial

Non-invasive preimplantation genetic testing for aneuploidies (niPGT-A) has shown promise in improving embryo selection for in vitro fertilization (IVF), with a reported reliability of approximately 80% in diagnosing ploidy, which is better than traditional methods like morphology.

The first baby born in Brazil using niPGT-A was delivered after a successful embryo transfer, demonstrating the potential of this method to safely select viable embryos without the risks associated with conventional trophectoderm biopsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Baby Born in Brazil after Simultaneous Diagnosis through Non-Invasive and Conventional PGT-A. Kulmann, MIR., Riboldi, M., Martello, C., et al.[2023]

Non-invasive preimplantation genetic testing (niPGT) using sperm spent culture medium (SCM) has shown promising results, with a 75% ploidy concordance rate for conventional IVF embryos, indicating its potential effectiveness in identifying chromosomal abnormalities.

The study found that niPGT performance was comparable between conventional IVF and ICSI methods, suggesting that niPGT could be a viable option for broader applications in assisted reproductive technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive preimplantation genetic testing for conventional IVF blastocysts. Xie, P., Zhang, S., Gu, Y., et al.[2022]

The study found a high rate of DNA amplification failure (37.3%) in the noninvasive preimplantation genetic testing for aneuploidy (niPGT-A) samples, which raises concerns about its reliability for clinical use.

There was a significant discordance (40.4%) between niPGT-A results and traditional trophectoderm biopsy results, indicating that niPGT-A may not provide consistent or accurate assessments of embryo viability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive preimplantation genetic testing for aneuploidy exhibits high rates of deoxyribonucleic acid amplification failure and poor correlation with results obtained using trophectoderm biopsy. Hanson, BM., Tao, X., Hong, KH., et al.[2021]

The study found that non-invasive preimplantation genetic testing for aneuploidies (niPGT-A) showed a high diagnostic concordance with traditional trophectoderm biopsies, indicating that the technique used for chromosomal analysis does not significantly affect the results.

However, the mosaicism rate was notably higher in spent embryo culture medium (SCM) samples compared to trophectoderm biopsies, suggesting that optimizing culture conditions could enhance the reliability of niPGT-A results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consistent results of non-invasive PGT-A of human embryos using two different techniques for chromosomal analysis. Lledo, B., Morales, R., Ortiz, JA., et al.[2021]

Non-invasive preimplantation genetic testing (niPGT) using cell-free DNA from blastocyst culture medium shows high diagnostic performance for identifying chromosomal abnormalities in putative mosaic blastocysts, with a sensitivity of 100% and no false negatives.

In a study involving 41 mosaic blastocysts, 85.4% were found to be euploid upon further testing, suggesting that niPGT can effectively reassess mosaicism and may provide a viable option for patients with only mosaic embryos.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive preimplantation genetic testing for putative mosaic blastocysts: a pilot study. Li, X., Hao, Y., Chen, D., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7558898/

Noninvasive Preimplantation Genetic Testing for ... Some studies have also reported better results with niPGT-A. Huang et al. (2019), using embryos sent for research, compared the results of niPGT-A and PGT-A.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1472648322000700

Non-invasive preimplantation genetic testing for aneuploidies Ideally, a non-invasive approach would offer the benefits of invasive PGT-A – improved live birth rate at first embryo transfer, reduced rate of miscarriage and ...

3. mdpi.com mdpi.com/2073-4425/16/5/552

Non-Invasive Preimplantation Genetic Testing In this review, we discuss this novel non-invasive approach for aneuploidy detection and embryo prioritisation, as well as the current data and future ...

4. bmcmedgenomics.biomedcentral.com bmcmedgenomics.biomedcentral.com/articles/10.1186/s12920-025-02106-7

Noninvasive preimplantation genetic testing for aneuploidy ... A 98.0% successful SCM sample amplification rate (146/149) was achieved. For the 146 paired TE biopsy and SCM samples, the overall concordance ...

5. pnas.org pnas.org/doi/10.1073/pnas.1907472116

Noninvasive preimplantation genetic testing for ... - PNAS These results suggest that niPGT-A is less prone to errors associated with embryo mosaicism and is more reliable than TE-biopsy PGT-A.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7558897/

Noninvasive preimplantation genetic testing for ... This niPGT-A method avoids the need for embryo biopsy and, therefore, substantially increases the safety of its use.

7. nature.com nature.com/articles/s41598-025-18764-7

Extended blastocyst culture improves DNA yield in non- ... The diagnostic sensitivity of niPGT-A, representing its ability to correctly identify aneuploid embryos, was found to be 91.6%. (Table 3) This ...