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Multi-center Study to Validate niPGT-A
NCT03520933 · View on ClinicalTrials.gov ↗
Study Summary
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 embr
Conditions Studied
Interventions
- DIAGNOSTIC_TEST PGT-A
- DIAGNOSTIC_TEST niPGT-A
Study Locations (10)
Other
- Pregna Medicina Reproductiva — Buenos Aires
- Inmater - Clínica de Fertilidad — Lima
- ProcreaTec — Madrid
- Bahçeci Group — Istanbul
California
- San Diego Fertility Center — San Diego
Massachusetts
- Boston IVF Fertility Clinic — Boston
Washington
- Dominion Fertility — Arlington
Porto Alegre
- Nilo Frantz - Centro de Reprodução Humana — Boa Vista
Roma
- Genera Rome — Rome
Mexico City
- NASCERE — Mexico City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,586 participants |
| Start Date | 2018-04-27 |
| Est. Completion | 2023-02-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03520933
The ClinicalTrials.gov registry entry for NCT03520933 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,586 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Igenomix, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Infertility appearing as the primary indexed condition, and to 2 interventions — of which PGT-A is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03520933 reports 10 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03520933 about?
NCT03520933 is a clinical study titled "Multi-center Study to Validate niPGT-A". 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 t...
What is the current status of trial NCT03520933?
This trial is currently completed. The enrollment target is 2,586 participants. The study started on 2018-04-27. Estimated completion is 2023-02-10.
What conditions does trial NCT03520933 study?
This clinical trial studies the following conditions: Infertility, Aneuploidy, Chromosome Abnormality. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03520933?
The interventions under investigation include: PGT-A (DIAGNOSTIC_TEST), niPGT-A (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03520933?
This trial is sponsored by Igenomix, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03520933 being conducted?
This trial has 10 study locations across California, Massachusetts, Washington, Porto Alegre, Roma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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