Identifying Molecular Determinants of Infertility in Men (MODIFY)

Institute for Human Development and Potential (IHDP), Singapore100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Male Infertility

Eligibility

Sex: MALEMin age: 21 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Human Development Research Centre (HDRC)

Singapore, Singapore

Outcomes

Primary Outcomes

Semen/Sperm quantity analysis

sperm count and concentration

Time frame: 1 week

Semen/Sperm quality analysis

semen pH, semen volume, sperm motility, sperm morphology, sperm vitality

Time frame: 1 week

Fertility classification

Classification into fertile/infertile groups based on the fertility measures.

Time frame: 1 week

Sperm RNA extraction and sequencing

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 3-6 months

Comparison of the expression profiles

Comparison of the expression profiles between the two groups (infertile vs fertile)

Time frame: 3-6 months

Data from ClinicalTrials.gov

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