NCT06189677

Brief Summary

Collection and conservation of human biological material from fertile subjects, i.e. men with previous parenthood (normospermic men, natural fathers).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress99%
Jun 2016Jun 2026

Study Start

First participant enrolled

June 16, 2016

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Expected
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

8 years

First QC Date

December 19, 2023

Last Update Submit

December 19, 2023

Conditions

Fertility

Keywords

Fertility

Outcome Measures

Primary Outcomes (1)

  • Prognostic role of the biological material

    Biological signature in fertile men predicting potential therapeutic, prognostic and diagnostic biomarkers

    Baseline

Interventions

Observation of biological characteristics of fertile menOTHER

Sampling in outpatient settings, after biopsy or after surgery and collection of biological samples in fertile subjects

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Normospermic male individuals, naturally fertile men recruited on an outpatient and day-hospital basis.

You may qualify if:

  • Normospermic male individuals
  • Naturally fertile male individuals
  • Male individuals \> 18 years

You may not qualify if:

  • Non-normospermic male individuals
  • Male individuals who are not naturally fertile
  • Male individuals \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

RECRUITING

IRCCS San Raffaele Hospital

Milan, 20132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biological samples from fertile men (blood, urine, feces, seminal fluid, saliva, buccal mucosa)

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 3, 2024

Study Start

June 16, 2016

Primary Completion

June 15, 2024

Study Completion (Estimated)

June 15, 2026

Last Updated

January 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)