Clinical Trial

Study of Abnormally Fertilized Embryos

Study acronym: SAFE
Not Yet Recruiting
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Summary
The goal of this observational study is to determine the diploidy rate of haploid and triploid embryos from in vitro fertilization (IVF) cycles. The main questions it aims to answer are: * Can a molecular genetic fertilization check of abnormally fertilized embryos be used to expand opportunities for couples undergoing assisted reproduction treatment? * Is the chromosomal loss or gain present in abnormally fertilized embryos predominantly maternal in origin? For this purpose, we will evaluate the morphokinetics and ploidy of about 300 embryos with different types of abnormal pronuclear patterns (1PN, 2.1PN, and 3PN) that reach the blastocyst stage. Whenever possible, embryos with a non-diploid chromosomal complement will also be assessed to determine the origin (maternal or paternal) of the chromosomal set that has been lost or gained. Study subjects will follow their previously scheduIed IVF/ICSI treatment and no additional visits/interventions will be required for participating.
Trial Details
NCT Number NCT06940973
Lead Sponsor Igenomix
Conditions Infertility (IVF Patients)
Enrollment 300 participants
Start Date 2025-04
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2025-04-23