New "System Medicine" Approach for the Development of Primary Prevention Strategies for Comorbidities in Infertile Men
Sponsor study identifier
observational
200
1 country
1
Study Start
January 18, 2021
Actual (reported)Primary Completion
July 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
By applying a "system medicine" approach, the project aims to identify new biomarkers and/or prognostic tools aimed at developing personalized strategies to prevent the onset of comorbidities in infertile men.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 18, 2021
Actual (reported)December 5, 2023
Actual (reported)December 27, 2023
Actual (reported)July 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Medical anamnesis
Data collection on Charlson Comorbidity Index (CCI), partner's age, partner's health status;
Baseline
Objective examination
presence of varicocele; testicular size and number
Baseline
Testosterone
data on testosterone (ng/dL)
Baseline
Genetic profile
Data on karyotype and microdeletions of the Y chromosome
Baseline
Men with a diagnosis of pure Male Factor Infertility, as for WHO criteria
Fathers with at least one child, spontaneously conceived, with a time-to-pregnancy within 12 months, as for WHO criteria
During medical history evaluation, all factors that could negatively affect male fertility, like prevalent comorbidities, previous testis surgery, and any disorder affecting testicular function will be investigated in fertile and infertile men. Moreover, family history will be deeply investigated, including fertility status and prevalence of malignant Non Communicables Diseases. A comprehensive physical examination will be performed on each infertile and fertile man.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Fertile and infertile men according to WHO criteria (2010)
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
Andrea Salonia, MD
IRCCS Ospedale San Raffaele
First Submitted
December 5, 2023
First Posted
December 27, 2023
Study Start
January 18, 2021
Actual (reported)Primary Completion
July 2025
Estimated (date passed)Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
Semen volume
Semen volume (ml)
Baseline
Body mass index
Dataon Body mass index
Baseline
Follicle-stimulating hormone
Data on follicle-stimulating hormone (mIU/ml)
Baseline
Luteinizing hormone
Data on luteinizing hormone (mIU/dl)
Baseline
Anti-Müllerian hormone
Data on Anti-Müllerian hormone (ng/ml)
Baseline
Inhibin B
Data on Inhibin B (UI/mL)
Baseline
Prolactin
Data on Prolactin (µg/l)
Baseline
Thyroid-stimulating hormone
Data on thyroid-stimulating hormone (mU/L)
Baseline
Osteocalcin levels
Data on osteocalcin levels (ng/ml)
Baseline
Semen concentration
number of spermatozoa (million/ml)
Baseline
Spermatozoa motility and morphology
motility and morphology of spermatozoa (%)
Baseline
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 27, 2023
Record last verified: 2023-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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