Skip to main content
OpenTrials
Completed

NCT Number: NCT06147700

Identifying Molecular Determinants of Infertility in Men (MODIFY)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

21 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Human Development Research Centre (HDRC)

Singapore, 117597

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Semen/Sperm quantity analysis

    Time frame: 1 week

    sperm count and concentration

  2. Semen/Sperm quality analysis

    Time frame: 1 week

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

  3. Fertility classification

    Time frame: 1 week

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

  4. Sperm RNA extraction and sequencing

    Time frame: 3 months

    Sperm RNA extraction and sequencing

Secondary outcomes

  1. Expression profiling of sncRNA

    Time frame: 3-6 months

    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.

  2. Comparison of the expression profiles

    Time frame: 3-6 months

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

Sponsors and collaborators

Lead sponsor

Institute for Human Development and Potential (IHDP), Singapore

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 28, 2023
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.