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CompletedNCT04349345Updated Apr 16, 2020

Seminal Fluid's Changes Over 20 Years

An observational study in Oligospermia, sponsored by Istituto Clinico Humanitas. Completed. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-16.

Sponsored by Istituto Clinico Humanitas · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
24,395
Ages
18 Years and older
Sex
Male
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Study 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 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

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Conditions studied

  • Oligospermia

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03

In context

Oligospermia

64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.

This study's enrollment of 24,395 is above the median of 300 across 17 observational studies indexed under Oligospermia.

Browse Oligospermia studies →

Lead sponsor

Istituto Clinico Humanitas is the lead sponsor of 279 studies on the registry; 70 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • male over 18 years old

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
24,395 participants (actual)
Patient registry
No

Groups and cohorts

  • sperm count over time

    observation

    Diagnostic Test: sperm count

Interventions

  • Diagnostic testsperm count

    total progressive sperm motile count

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What researchers measure

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.

    Time frame: 20 years

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 1999 to primary completion in Dec 2018, 239 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2020
First posted
Apr 16, 2020
StartActual
Jan 1, 1999
Primary completionActual
Dec 1, 2018
CompletionActual
Apr 1, 2020
Last update
Apr 16, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04349345
Responsible party
Sponsor
First posted
Apr 16, 2020
Start date
Jan 1, 1999
Primary completion
Dec 1, 2018
Completion
Apr 1, 2020
Last update
Apr 16, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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