niPGT-A for Infertility

(niPGT-A_RCT Trial)

Recruiting at 12 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

1108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, non-invasive method to check embryos for chromosomal issues by analyzing DNA in the culture medium. It aims to help IVF patients who prefer not to use invasive testing. The goal is to improve pregnancy rates by selecting the healthiest embryos without needing invasive procedures. This method emerged from the discovery of embryonic DNA in spent embryo culture medium.

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.

Is niPGT-A safe for use in humans?

The research indicates that niPGT-A has been used successfully in humans, as evidenced by the birth of a healthy baby in Brazil following its use. However, there are some concerns about the reliability of the test results, with about 80% accuracy in diagnosing chromosomal issues, which is better than some other non-invasive methods. ^{1 2 3 4 5}

What makes the niPGT-A treatment unique for infertility?

The niPGT-A treatment is unique because it is a non-invasive method that analyzes cell-free embryonic DNA from the culture media to identify chromosomal abnormalities, avoiding the need for a biopsy of the embryo. This approach can potentially reduce the risk of harming the embryo compared to traditional methods that require a biopsy. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment niPGT-A for Infertility?

Research shows that non-invasive preimplantation genetic testing for aneuploidy (niPGT-A) can be about 80% reliable in identifying chromosomal abnormalities in embryos, which is better than other non-invasive methods like looking at embryo shape and development speed. This method has been used successfully in cases where parents wanted to avoid genetic issues, leading to the birth of healthy babies. ^{1 2 3 4 5}

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

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]

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]

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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Consistent results of non-invasive PGT-A of human embryos using two different techniques for chromosomal analysis. [2021]

2. United States 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. [2021]

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

Non-invasive preimplantation genetic testing for putative mosaic blastocysts: a pilot study. [2021]

4. Brazil pubmed.ncbi.nlm.nih.gov

First Baby Born in Brazil after Simultaneous Diagnosis through Non-Invasive and Conventional PGT-A. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Non-invasive preimplantation genetic testing for conventional IVF blastocysts. [2022]