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

February 8, 2021 updated by: Palini Simone, Cervesi Hospital, Cattolica, Italy
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Rimini
      • Cattolica, Rimini, Italy, 47841
      • Cattolica, Rimini, Italy, 47841

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
semen treatment efficacy
Time Frame: 6 months
number of obtain blastocysts (%) and number of pregnancy (%)
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
euploid status
Time Frame: 6 months
molecular analysis of blastocyst's biopsy
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cervesi Hospital, Cattolica, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 29, 2016

First Posted (Estimate)

February 3, 2016

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • NEW MICRO SWIM-UP PROCEDURE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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