RCT Study to Validate niPGT-A Clinical Benefit.

NATerminatedINTERVENTIONAL
Enrollment

296

Participants

Timeline

Start Date

June 29, 2020

Primary Completion Date

April 18, 2025

Study Completion Date

April 18, 2025

Conditions
AneuploidyChromosome AbnormalityInfertility
Interventions
DIAGNOSTIC_TEST

niPGT-A

"Two scenarios should be considered according to the results in the SBM analysis:~1. The couple decides to transfer the blastocyst selected according to the SBM result (blastocyst prioritization system).~2. The couple decides to biopsy the blastocysts (if SBM results show low euploidy score). This PGT-A analysis will be offered for free but the outcome of these transfers will be excluded for the analysis per completed protocol. However, all transfers will be included in the intention-to-treat analysis.~In the exceptional case of getting a non-informative result for all the SBM analysed, the niPGT-A could be performed again on new SBM samples collected after an additional culture of the embryos for, at least, 8 hours."

OTHER

Morphology criteria

Embryos for transfer will be selected by the only applicable technique, the assessment of morphology according to Gardner´s criteria, which is the most standardized method.

Trial Locations (8)

4400

Saresa - Reproducción Humana Asistida, Salta

28035

Hospital Ruber Internacional, Madrid

40138

Società Italiana Studi di Medicina della Riproduzione (S.I.S.M.e.R.), Bologna

50141

Centro Procreazione Assistita DEMETRA, Florence

92150

Hôpital Foch, Suresnes

Unknown

Crecer: Centro de Reproducción y Genética Humana, Mar del Plata

91330-002

Nilo Frantz - Centro de Reprodução Humana, Boa Vista

22793-080

Vida - Centro de Fertilidade, Rio de Janeiro

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Igenomix

INDUSTRY

NCT04000152 - RCT Study to Validate niPGT-A Clinical Benefit. | Biotech Hunter | Biotech Hunter