Infertility Clinical Trial
Official title:
Observational, Non-Interventional, Prospective, Post Market Surveillance & Post Market Clinical Follow up, International, Medical Registry to Confirm the Safety and the Performance of the Anecova Intra Uterine Culture Device for Participants With Subfertility Issue Undergoing Assisted Reproductive Medical Treatment in Routine Clinical Practice
This study is designed to generate a comprehensive survey of the use on the market of the Anecova device within its intended indications according to the Instructions For Use. The Anecova Registry is part of the Anecova quality system, to enable the Post Marketing Surveillance and the Post Market Clinical Follow-up.
As soon as the very first minute of the fertilization process, very important biological
events, critical for the future developmental competency of the embryo are taking place.
These biological events, after the sperm cell entry in the oocyte cytoplasm and prior to the
first cleavage, include: the completion of the meiosis, the exclusion of the second polar
body, the pronuclei formation, the replication of the male and female DNA and the chromosome
segregation on the newly formed mitotic spindle.
If any of these events is aberrant, one or both of the two daughter cells and their
descendants may carry chromosomal anomalies. In other words an uneven first cleavage in size
or in content is associated with chromosomal abnormality and aneuploidy.
In vivo all these events occur in a natural environment where the presence of specific
molecules and of a dynamic and physiological environment might be an advantage over in vitro
culture conditions to ensure optimal cellular functions.
The Registry will capture information from the Anecova procedure, from the outcomes, from the
procedure performance, from the safety and from the utilization of the Anecova Medical Device
in clinical routine.
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