NCT04349345

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24,395

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
19.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
Last Updated

April 16, 2020

Status Verified

January 1, 2020

Enrollment Period

19.9 years

First QC Date

April 14, 2020

Last Update Submit

April 15, 2020

Conditions

Oligospermia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

sperm count over time

observation

Diagnostic Test: sperm count

Interventions

sperm countDIAGNOSTIC_TEST

total progressive sperm motile count

sperm count over time

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • male over 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Oligospermia

Interventions

Sperm Count

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSemen AnalysisInvestigative TechniquesCell Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 16, 2020

Study Start

January 1, 1999

Primary Completion

December 1, 2018

Study Completion

April 1, 2020

Last Updated

April 16, 2020

Record last verified: 2020-01