Estimation of drop-out and embryo loss rates during genetic preimplantation screening (PGS / PGT-A

Recruiting

• Conditions: There is currently no evident indication for PGT-APatients with sub- or infertility; N97; Female infertility

• Registration Number: DRKS00022540
• Lead Sponsor: EXTCLINIC IVF Zentren Prof. Zech, Bregenz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

All patients who had IVF therapy with PGS / PGT-A analysis performed at the NEXTCLINICS centers in Bregenz, Salzburg (AT), Pilsen (CZ) and Meran (I) between 01/2016 and 04/2020. The specification of which patients have access to a PGS / PGT-A depends on the respective country-specific legal situation. In Austria this is regulated by §2a of the FMedG. Prerequisite for participation is written consent to the pseudonymized evaluation of the medical data in connection with IVF therapy.

Exclusion Criteria

PGT-M or PGT-SR candidates, which includes couples whith known translocations or monogenetic diseases

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Analysis of the proportion of (non-) biopsy viable embryos <br>- analysis of the proportion of embryos in which no PGS / PGT-A result is not obtained after biopsy due to hybridization and amplification errors<br>- percentage of embryos with euploid status / respectively uniform numerical and structural chromosomal aberrations (%) <br>- proportion of mosaic embryos with structural or numerical aberrations (%)<br>- combinations of structural or numerical mosaic (%)<br> - number of remaining blastocysts suitable for transfer according to PGT-A (mean)<br> - clinical outcome parameters after embryo transfer such as pregnancy rate; clinical pregnancy rate; abortion rate; birth rate –<br>-number of IVF cycles required to obtain euploid, transferable blastocysts (mean)<br>

Secondary Outcome Measures

Name	Time	Method
It should be examined whether there are possible correlations with regard to the drop-out rate, mosaic rate and (a) anamnestic patient parameters (e.g. type of infertility; male & female age, hormonal stimulation, ..) or (b) possible IVF culture parameters ( eg type of culture medium, morphokinetic parameters, number of biopsied TE cells, location at which the TE cells are removed, ..)