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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 June 2023 |
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Main ID: |
NCT03520933 |
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Date of registration:
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27/04/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Multi-center Study to Validate niPGT-A
niPGT-A |
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Scientific title:
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A Prospective, Observational, Multi-center, International Study to Validate a Non-invasive Preimplantation Genetic Test for Embryo Aneuploidy in the Spent Culture Media (niPGT-A). |
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Date of first enrolment:
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April 27, 2018 |
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Target sample size:
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2586 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03520933 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Argentina
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Brazil
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Italy
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Mexico
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Peru
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Spain
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Turkey
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United States
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Contacts
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Name:
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Carmen Rubio, BSc PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Igenomix |
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Name:
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Carlos Simón, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Igenomix |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Age minimum:
20 Years
Age maximum:
44 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Chromosome Abnormality
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Infertility
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Aneuploidy
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Intervention(s)
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Diagnostic Test: PGT-A
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Diagnostic Test: niPGT-A
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Primary Outcome(s)
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Chromosomal status of the embryos
[Time Frame: 6 to 7 days of embryo development]
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Secondary Outcome(s)
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Pregnancy rate
[Time Frame: 20 weeks]
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Live birth rate
[Time Frame: 40 weeks]
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Analysis of the Products of Conception (POC)
[Time Frame: Up to 20 weeks]
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Clinical miscarriage rate
[Time Frame: 20 weeks]
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Secondary ID(s)
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IGX1-NIP-CS-18-02-SUB1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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