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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672124
Recruitment Status : Unknown
Verified February 2018 by Palini Simone, Cervesi Hospital, Cattolica, Italy.
Recruitment status was:  Recruiting
First Posted : February 3, 2016
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Palini Simone, Cervesi Hospital, Cattolica, Italy

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
Microswimup Procedure Efficacy

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : September 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019



Primary Outcome Measures :
  1. microbiological test [ Time Frame: 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 [ Time Frame: 6 months ]
    number of obtain blastocysts (%) and number of pregnancy (%)


Other Outcome Measures:
  1. euploid status [ Time Frame: 6 months ]
    molecular analysis of blastocyst's biopsy



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
This study included couples submitted to in vitro fertilization treatment at the Unit of Physiopathology of Reproduction (Cervesi Hospital, Cattolica, RN, Italy).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672124


Locations
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Italy
Cervesi Hospital IVF Unit Recruiting
Cattolica, Rimini, Italy, 47841
Contact: Silvia De Stefani    320 1111937    silviadestefani@ymail.com   
Primiterra Mariangela Recruiting
Cattolica, Rimini, Italy, 47841
Contact: Mariangela Primiterra       m.primiterra@hotmail.com   
Sponsors and Collaborators
Cervesi Hospital, Cattolica, Italy
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Responsible Party: Palini Simone, Embryologist, Cervesi Hospital, Cattolica, Italy
ClinicalTrials.gov Identifier: NCT02672124    
Other Study ID Numbers: NEW MICRO SWIM-UP PROCEDURE
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018