Validation of a NICS Method Using the Culture Medium

Completed

• Conditions: Chromosome Abnormality; Abnormality
• Interventions: Diagnostic Test: Noninvasive chromosome screening

• 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

Arm && Interventions

Group	Intervention	Description
Study group	Noninvasive chromosome screening	No intervention. Couples who come to the study center to carry out a PGT-A cycle will be selected. Only couples that will use their own gametes will be selected and the indication of PGT-A will be advanced maternal age, failure of implantation, repeat abortion, male factor or structural chromosomal alterations. The results of chromosomal status of the embryo will be compared using the NICS and the conventional invasive method (PGT-A).

Primary Outcome Measures

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

Trial Locations

Locations (1)

Instituto Bernabeu; 🇪🇸 Alicante, Spain