Seminal Fluid's Changes Over 20 Years | NCT04349345

Studies
Seminal Fluid's Changes Over 20 Years

NCT04349345

Sponsor

Istituto Clinico Humanitas

Status

Completed

Last Update Posted

Apr 16, 2020Actual

Enrollment

24,395Actual

Phase

Not provided

Conditions

Oligospermia

Interventions

sperm count

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 1999Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Apr 1, 2020Actual

First Submitted Date

Apr 14, 2020

First Submission Date that Met QC Criteria

Apr 15, 2020

First Posted Date

Apr 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2020

Last Update Posted Date

Apr 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24,395Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sperm count over time		observation	Diagnostic Test: sperm count

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sperm count	Diagnostic Test	total progressive sperm motile count	sperm count over time

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	20 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Male population who underwent a seminal exam in a tertial fertility care center

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D009845	Oligospermia

Ancestor Terms

ID	Term
D007248	Infertility, Male
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013076	Sperm Count

Ancestor Terms

ID	Term
D002452	Cell Count
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided