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

NCT ID: NCT03191890

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-15
• Study Completion Date: 2018-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Infertility; Reproductive Sterility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 43,
• Hormonal serum levels within normal ranges for the routinely or specifically tested hormones (FSH, LH, AMH, E2, PRL, P4, TSH),
• BMI between 18 and 29, If assessed normal antral follicular count and regular menses

Exclusion Criteria

• Endometrial, autoimmune or hormonal specificities, as well as presence of pathology that could be potentially deleterious to the healthy development of embryos in the uterine cavity (i.e. severe endometriosis),
• Acute or chronic gynecological infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Anecova SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IVI Bilbao

Leioa, Basque Country, Spain

Countries

Spain

Other Identifiers

NCV_REG_01

Identifier Type: -

Identifier Source: org_study_id