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

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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

Tracking Information
First Submitted Date January 19, 2016
First Posted Date February 3, 2016
Last Update Posted Date February 8, 2018
Study Start Date September 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2016)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 29, 2016)
semen treatment efficacy [ Time Frame: 6 months ]
number of obtain blastocysts (%) and number of pregnancy (%)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 29, 2016)
euploid status [ Time Frame: 6 months ]
molecular analysis of blastocyst's biopsy
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title A New Micro Swim-up Procedure for Sperm Preparation in ICSI Treatment
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Microswimup Procedure Efficacy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 29, 2016)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02672124
Other Study ID Numbers NEW MICRO SWIM-UP PROCEDURE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Palini Simone, Cervesi Hospital, Cattolica, Italy
Study Sponsor Cervesi Hospital, Cattolica, Italy
Collaborators Not Provided
Investigators Not Provided
PRS Account Cervesi Hospital, Cattolica, Italy
Verification Date February 2018