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Sponsor stopped the study due to poor enrollment
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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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| Measure | Description | Time Frame |
|---|---|---|
| Fertilization rate | Number of zygotes over all transferred injected/inseminated oocytes | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Pregnancy rate | hCG test | 15 days |
| Implantation rate | number of gestational sac per transferred embryos | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Participants following a normal course of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) can benefit from the use of the Anecova device
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVI Bilbao | Leioa | Basque Country | Spain |
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| Clinical pregnancy rate | beating heart | 9 weeks |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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