- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04349345
Seminal Fluid's Changes Over 20 Years
April 15, 2020 updated by: Istituto Clinico Humanitas
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
24395
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
Male population who underwent a seminal exam in a tertial fertility care center
Description
Inclusion Criteria:
- male over 18 years old
Exclusion Criteria:
- 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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
sperm count over time
observation
|
total progressive sperm motile count
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
20 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
January 1, 1999
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
April 1, 2020
Study Registration Dates
First Submitted
April 14, 2020
First Submitted That Met QC Criteria
April 15, 2020
First Posted (Actual)
April 16, 2020
Study Record Updates
Last Update Posted (Actual)
April 16, 2020
Last Update Submitted That Met QC Criteria
April 15, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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