Validation of a NICS Method Using the Culture Medium

Completed

• Conditions: Chromosome Abnormality; Abnormality

• Registration Number: NCT03879265
• Lead Sponsor: Instituto Bernabeu

Brief Summary

This study aims to validate a non-invasive method of chromosomal screening (NICS), based on the Multiple Annealing and Looping Based Amplification Cycles- Next-generation Sequencing (MALBAC-NGS) technology, in order to determine the chromosomal endowment of a blastocyst from the DNA of the embryonic culture medium.

The chromosomal status of the embryo from an embryo biopsy of trophoectoderm will be established (usual clinical practice), the chromosomal endowment from the DNA of the embryonic culture medium will be determined, and the results using the NICS and the conventional invasive method (Preimplantation Genetic Testing for Aneuploidy \[PGT-A\]) will be compared.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-18
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-20
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Treatment by oocyte donation or own oocyte nd preimplantation genetic screening of aneuploidies (PGT-A).
• Embryonic cryopreservation.
• Informed consent signature

Exclusion Criteria

• Embryo transfer without embryo freezing
• Embryonic block.
• Bad embryo quality.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of Mosaicism	At Day 5-6 after FIV	Presence of mosaicism
Quality value of NICS DLRS	At Day 5-6 after FIV	Quality value of noninvasive chromosome screening (NICS) derivative Log Ratio Spread (DLRS)

Trial Locations

Locations (1)

Instituto Bernabeu; 🇪🇸 Alicante, Spain