Identifying Molecular Determinants of Infertility in Men (MODIFY)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Identifying Molecular Determinants of Infertility in Men (MODIFY)

Conditions
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Male Infertility

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy fertile male<br>No intervention for this study. | |
| Healthy infertile male<br>No intervention for this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semen/Sperm quantity analysis | sperm count and concentration | 1 week | 
| Semen/Sperm quality analysis | semen pH, semen volume, sperm motility, sperm morphology, sperm vitality | 1 week | 
| Fertility classification | Classification into fertile/infertile groups based on the fertility measures. | 1 week | 
| Sperm RNA extraction and sequencing | Sperm RNA extraction and sequencing | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression profiling of sncRNA | Counts 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. | 3-6 months | 
| Comparison of the expression profiles | Comparison of the expression profiles between the two groups (infertile vs fertile) | 3-6 months |