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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

Sponsor
Anecova SA (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03191890
Collaborator
(none)
0
Enrollment
1
Location
9.5
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jun 15, 2017
    Actual Primary Completion Date :
    Mar 31, 2018
    Actual Study Completion Date :
    Mar 31, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Fertilization rate [1 day]

      Number of zygotes over all transferred injected/inseminated oocytes

    Secondary Outcome Measures

    1. Biochemical Pregnancy rate [15 days]

      hCG test

    2. Implantation rate [5 weeks]

      number of gestational sac per transferred embryos

    3. Clinical pregnancy rate [9 weeks]

      beating heart

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 43 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IVI Bilbao Leioa Euskadi Spain

    Sponsors and Collaborators

    • Anecova SA

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anecova SA
    ClinicalTrials.gov Identifier:
    NCT03191890
    Other Study ID Numbers:
    • NCV_REG_01
    First Posted:
    Jun 19, 2017
    Last Update Posted:
    Apr 4, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Anecova SA
    in vivo culture
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Apr 4, 2019