Microswimup Procedure EfficacyNCT02672124
A New Micro Swim-up Procedure for Sperm Preparation in ICSI Treatment
An observational study of Microswimup Procedure Efficacy, run by Cervesi Hospital, Cattolica, Italy at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Microswimup Procedure Efficacy
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- Sep 2015to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study included couples submitted to in vitro fertilization treatment at the Unit of Physiopathology of Reproduction (Cervesi Hospital, Cattolica, RN, Italy).
Who may be able to join
- 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
Who cannot join
- recurrent miscarriages
- more than three in vitro fertilization treatment
- azoospermia
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Cervesi Hospital IVF Unit
Cattolica, Rimini, 47841
Silvia De Stefani, 320 1111937, silviadestefani@ymail.com
- Recruiting
Primiterra Mariangela
Cattolica, Rimini, 47841
Mariangela Primiterra, m.primiterra@hotmail.com
About this study
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.
- Conditions
- Microswimup Procedure Efficacy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
semen treatment efficacy
number of obtain blastocysts (%) and number of pregnancy (%)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microswimup Procedure EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cervesi Hospital, Cattolica, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Palini Simone, Cervesi Hospital, Cattolica, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672124
- Sponsor's protocol ID
- NEW MICRO SWIM-UP PROCEDURE
- Status last verified
- Feb 2020
- First submitted
- 19 Jan 2016
- Last updated
- 9 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Micro Swim-up Procedure for Sperm Preparation in ICSI Treatment
- ClinicalTrials.gov ID
- NCT02672124
- Acronym / sponsor ID
- NEW MICRO SWIM-UP PROCEDURE
- Conditions
- Microswimup Procedure Efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cervesi Hospital, Cattolica, ItalyUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study included couples submitted to in vitro fertilization treatment at the Unit of Physiopathology of Reproduction (Cervesi Hospital, Cattolica, RN, Italy).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- recurrent miscarriages
- more than three in vitro fertilization treatment
- azoospermia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
semen treatment efficacy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microswimup Procedure Efficacy, run by Cervesi Hospital, Cattolica, Italy at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiological test (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.