OligospermiaNCT04349345
Seminal Fluid's Changes Over 20 Years
An observational study of Oligospermia, run by Istituto Clinico Humanitas.
Trial summary
This is a cohort study including all the first seminal exams performed at the Fertility Center, Humanitas Research Hospital (Rozzano, Milan) between January 1998 and December 2018. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Oligospermia
- What is being tested?
- sperm count
- How many people
- 24,395 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1999to 1 Apr 2020
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male population who underwent a seminal exam in a tertial fertility care center
Who may be able to join
- male over 18 years old
Who cannot join
- error in birth or exam date or age under 18,
- abstinence days < 3 or > 6, volume missing o > 10 ml,
- spermatozoa number/ ml missing o >220 x106,
- normal forms missing,
- progressive motility missing
About this study
Official title: Seminal Fluid's Changes Over Time: a Single Center 20 Years Experience
This is a cohort study including all the first seminal exams performed at the Fertility Center, Humanitas Research Hospital (Rozzano, Milan) between January 1998 and December 2018.
Read the detailed description
The objective of this study is to evaluate retrospectively different changes of TPMSC during last 20 years in male population who underwent a seminal exam in our Center
- Conditions
- Oligospermia
- Being tested
- sperm count
- Medical subject headings
- Oligospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sperm countDiagnostic test
total progressive sperm motile count
| Study group | Role | What they receive |
|---|---|---|
| sperm count over time | observation Receives: Diagnostic Test: sperm count |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesaurement of changes of sperm count over time
The objective of this study is to evaluate retrospectively different changes of TPMSC during last 20 years in male population who underwent a seminal exam in a tertial fertility care center, regardless of infertility diagnosis.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Jan 1999
- Primary completion1 Dec 2018
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligospermiaStudies 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
- 24,395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349345
- Status last verified
- Jan 2020
- First submitted
- 14 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seminal Fluid's Changes Over Time: a Single Center 20 Years Experience
- ClinicalTrials.gov ID
- NCT04349345
- Conditions
- Oligospermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24,395 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 1999 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 16 Apr 2020 (actual)
- 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.
This is a cohort study including all the first seminal exams performed at the Fertility Center, Humanitas Research Hospital (Rozzano, Milan) between January 1998 and December 2018.
Detailed description
The objective of this study is to evaluate retrospectively different changes of TPMSC during last 20 years in male population who underwent a seminal exam in our Center
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sperm count over time | – | Diagnostic Test: sperm countobservation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male population who underwent a seminal exam in a tertial fertility care center
Key inclusion criteria (1 listed)
- male over 18 years old
Key exclusion criteria (5 listed)
- error in birth or exam date or age under 18,
- abstinence days < 3 or > 6, volume missing o > 10 ml,
- spermatozoa number/ ml missing o >220 x106,
- normal forms missing,
- progressive motility missing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sperm counttotal progressive sperm motile count | Diagnostic test | sperm count over time |
Primary outcome
Mesaurement of changes of sperm count over time
Time frame: 20 years
The objective of this study is to evaluate retrospectively different changes of TPMSC during last 20 years in male population who underwent a seminal exam in a tertial fertility care center, regardless of infertility diagnosis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Oligospermia, run by Istituto Clinico Humanitas.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mesaurement of changes of sperm count over time (time frame: 20 years). 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 16 Apr 2020.