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A New Micro Swim-up Procedure for Sperm Preparation in ICSI Treatment

Sponsor
Cervesi Hospital, Cattolica, Italy (Other)
Overall Status
Unknown status
CT.gov ID
NCT02672124
Collaborator
(none)
100
Enrollment
2
Locations
76
Duration (Months)
50
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the microbiological safety and the efficacy of a new not expensive, easy and fast technique (Direct Microswimup) for sperm preparation in In Vitro Fertilization (IVF) treatments without the use of centrifuge, able to simplify the procedure and to avoid mismatches by ensuring the same results of the standard techniques in terms of fertilization rate, blastulation rate, pregnancy/abortion rate, cryostorage rate, and a better euploid status of the embryos.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Study Start Date :
    Sep 1, 2015
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Jan 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. microbiological test [3 months]

      A standard bacteriological culture [based on inoculation of blood and "chocolate" agar plates and Brain-Heart Infusion broth, followed by incubation at 37°C for up to 72 hours] was performed in order to investigate the presence and amount of colonizing bacteria delivered with the semen at ejaculation and after treatment

    Secondary Outcome Measures

    1. semen treatment efficacy [6 months]

      number of obtain blastocysts (%) and number of pregnancy (%)

    Other Outcome Measures

    1. euploid status [6 months]

      molecular analysis of blastocyst's biopsy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • at least 8 oocytes retrieved at pickup

    • oocyte insemination with ICSI technique

    • only elective single embryo transfer (eSET) at blastocyst stage

    • sperm concentration ≥ 1 X 106 /ml

    • absence of antibiotic treatment in the previous four weeks for male patients

    Exclusion Criteria:

    • recurrent miscarriages

    • more than three in vitro fertilization treatment

    • azoospermia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cervesi Hospital IVF Unit Cattolica Rimini Italy 47841
    2 Primiterra Mariangela Cattolica Rimini Italy 47841

    Sponsors and Collaborators

    • Cervesi Hospital, Cattolica, Italy

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Palini Simone, Embryologist, Cervesi Hospital, Cattolica, Italy
    ClinicalTrials.gov Identifier:
    NCT02672124
    Other Study ID Numbers:
    • NEW MICRO SWIM-UP PROCEDURE
    First Posted:
    Feb 3, 2016
    Last Update Posted:
    Feb 9, 2021
    Last Verified:
    Feb 1, 2020

    Study Results

    No Results Posted as of Feb 9, 2021