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NCT03520933 · ClinicalTrials.gov registry record
Multi-center Study to Validate niPGT-A
A clinical trial of Infertility and Aneuploidy, sponsored by Igenomix.
- Completed
- Registry status
- 2,586
- Enrollment target
- 10
- Study locations
NCT03520933 is a study of Infertility and Aneuploidy that has completed, run by Igenomix. The registered enrollment target is 2,586 participants, below the 7,555-participant average among 74 other Infertility trials with a reported enrollment target (66% lower). The trial reports 10 study locations across 7 states.
The verdict
NCT03520933, a study of Infertility and Aneuploidy, has completed, sponsored by Igenomix.
- COMPLETED
- Registry status
- 2,586 participants
- Enrollment target
- 10
- Study locations
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 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 2,586 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,555-participant average among 74 other Infertility trials with a reported enrollment target (66% lower). The listed sponsor is Igenomix, which has 4 total studies on file at ClinicalTrials.gov.
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.
NCT03520933 reports 10 study locations spanning 7 distinct geographic areas - top geographies include Other, California, Massachusetts.
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.
What interventions are being tested in trial NCT03520933?
The interventions under investigation include: PGT-A (DIAGNOSTIC_TEST), niPGT-A (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03520933?
This trial is sponsored by Igenomix, which has 4 total clinical trials registered on ClinicalTrials.gov.
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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Related
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