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Identifying Molecular Determinants of Infertility in Men (MODIFY)

Identifying Molecular Determinants of Infertility in Men (MODIFY)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06147700
Enrollment
100
Registered
2023-11-28
Start date
2023-10-11
Completion date
2024-06-30
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Infertility

Brief summary

The purpose of this study is to understand the underlying mechanisms of infertility caused by unknown factors. The investigator propose to identify small non-coding RNA (sncRNA) biomarkers of infertility and advance towards developing a more accurate and robust approach for infertility diagnosis.

Detailed description

The goal of the study is to identify small non-coding RNA signatures of infertility in men through the comparison of sperm sncRNA profiles from around 100 men (21-50 years of age). The participants will be classified into fertile and infertile groups by the conventional method. Through the project, the investigator intends to understand the underlying mechanisms of idiopathic infertility. By utilizing semen as liquid biopsy, through sperm sncRNA profiling and comparison (infertile vs fertile). The investigator proposes to identify the sncRNA (miRNAs, piRNAs and tRFs) as biomarkers of infertility. The investigator proposes to generate a validated signature of sncRNAs that will help in selecting high quality sperms for IVF.

Interventions

None listed

Sponsors

Institute for Human Development and Potential (IHDP), Singapore
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
21 Years to 50 Years

Inclusion criteria

* Male, aged 21 - 50 years old * Proficient in English language * Willing to comply to study protocol * Able to provide written informed consent

Exclusion criteria

* Current and/or previous diagnosis of Tuberculosis, Acquired immunodeficiency syndrome (AIDs), and other sexually transmitted diseases * Experiencing severely limited mobility (eg. Wheelchair bound, need walking aid) * Diagnosed with severe unstable mental conditions (eg. Dementia, or cognitive impairment) * Alcohol or drug abuse

Design outcomes

Primary

MeasureTime frameDescription
Semen/Sperm quantity analysis1 weeksperm count and concentration
Semen/Sperm quality analysis1 weeksemen pH, semen volume, sperm motility, sperm morphology, sperm vitality
Fertility classification1 weekClassification into fertile/infertile groups based on the fertility measures.
Sperm RNA extraction and sequencing3 monthsSperm RNA extraction and sequencing

Secondary

MeasureTime frameDescription
Expression profiling of sncRNA3-6 monthsCounts of miRNA, piRNA, tRF from the sequenced data through Bioinformatics analysis. All three sncRNA will be quantified from the RNA sequencing data using bioinformatics tools, with the same unit of measure.
Comparison of the expression profiles3-6 monthsComparison of the expression profiles between the two groups (infertile vs fertile)

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026