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Status unknownNCT02672124Updated Feb 9, 2021

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

An observational study in Microswimup Procedure Efficacy, sponsored by Cervesi Hospital, Cattolica, Italy. Status unknown at 2 sites in Italy. Open to participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-09.

Sponsored by Cervesi Hospital, Cattolica, Italy · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
20 Years to 35 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Microswimup Procedure Efficacy
03

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
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).

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

Exclusion Criteria:

  • recurrent miscarriages
  • more than three in vitro fertilization treatment
  • azoospermia
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. microbiological test

    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

    Time frame: 3 months

Secondary outcomes

  1. semen treatment efficacy

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

    Time frame: 6 months

Other outcomes

  1. euploid status

    molecular analysis of blastocyst's biopsy

    Time frame: 6 months

06

Study locations

2 of 2 sites recruiting
  • Cervesi Hospital IVF Unit
    Cattolica, Rimini 47841, Italy
    Recruiting
  • Primiterra Mariangela
    Cattolica, Rimini 47841, Italy
    Recruiting
07

Registry details

Key details

Study ID
NCT02672124
Lead sponsor
Cervesi Hospital, Cattolica, Italy
Responsible party
Palini Simone (Embryologist, Cervesi Hospital, Cattolica, Italy) — Principal investigator
First posted
Feb 3, 2016
Start date
Sep 2015
Primary completion
Dec 2021 (estimated)
Completion
Jan 2022 (estimated)
Last update
Feb 9, 2021
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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