Multi-center Study to Validate niPGT-A

Completed

Conditions studied: Aneuploidy, Chromosome Abnormality, Infertility

In brief

Abnormal chromosome number, or aneuploidy, is common in human embryos. It is responsible for more than half of all miscarriages, and it is the leading cause of congenital birth defects. Besides, it has been described that aneuploidy may also affect embryo implantation. Therefore, selecting embryos that have the best chance of implanting and growing into a healthy baby is one of the most important steps in the field of assisted reproduction. Recent advances in genetic technologies, such as Next-Generation Sequencing (NGS), have allowed aneuploidy to be detected with greater sensitivity. The application of this technique to trophectoderm biopsies, taken from embryos before transfer to the uterus, has provided insight into the clinical impact of chromosomal status. This process of screening embryos to make sure they have the right number of chromosomes and to look for any structural abnormalities in the chromosomes is called Preimplantation Genetic Testing for Aneuploidy (PGT-A). It requires specific equipment and trained personnel that will add costs and risks, so non-invasive techniques are sought as an alternative. These non-invasive procedures have been explored by some groups analyzing the spent culture medium where the embryo is cultured up to the time of transfer or freezing. In daily routine, this media is discarded after finishing the embryo culture, but it has been reported that contains traces of embryonic cell-free DNA (cfDNA) that can represent the genetic load of the embryo. However, at the moment there is a high variability in results across studies, with a percentage of concordant results between the media and the trophectoderm biopsy ranging from 3.5 to 85.7%. Thus, the main objective of this project is to validate a new non-invasive method for PGT-A (niPGT-A), based on improved collection and analysis of the culture media to achieve higher rates of sensitivity and specificity and to decrease the effect of some intrinsic difficulties such as low embryonic cfDNA input, mosaicism and maternal contamination.

Key facts

Study ID

NCT03520933

Run by

Igenomix

People needed

2586

Starts

2018-04-27

Expected to finish

2023-02-10

Last updated by the study team

2023-05-24

Who can join

Age: 20 and older, up to 44. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• PGT-A cases with trophectoderm biopsy and SET for any medical indication and signed written informed consent form approved by the EC/IRB after having been duly informed of the nature of the research and voluntarily accepted to participate in the study.
• ICSI (Intra Cytoplasmic Sperm Injection), IVF (In Vitro Fertilization) or ICSI/IVF performed in fresh oocytes from couples are allowed.
• Note: Donor sperm is allowed.
• Only fresh oocytes allowed.
• Fresh and Deferred Embryo Transfer are allowed. Note: In case of Deferred Embryo Transfer, embryos must be vitrified always after the blastocyst biopsy.
• Age: 20-44 years of age (both included).

You may not qualify if…

• A known abnormal karyotype in a member of the couple.
• Preimplantation Genetic Testing for Monogenic diseases (PGT-M) or Preimplantation Genetic Testing for Structural Rearrangements (PGT-SR) cases excluded.

Where it is running

• San Diego Fertility Center — San Diego, California, United States
• Boston IVF Fertility Clinic — Boston, Massachusetts, United States
• Dominion Fertility — Arlington, Washington, United States
• Pregna Medicina Reproductiva — Buenos Aires, Argentina
• Nilo Frantz - Centro de Reprodução Humana — Boa Vista, Porto Alegre, Brazil
• Genera Rome — Rome, Roma, Italy
• NASCERE — Mexico City, Mexico City, Mexico
• Inmater - Clínica de Fertilidad — Lima, Peru
• ProcreaTec — Madrid, Spain
• Bahçeci Group — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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