Identifying Molecular Determinants of Infertility in Men (MODIFY)

June 28, 2025 updated by: Candida Vaz, Institute for Human Development and Potential (IHDP), Singapore
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117597
        • Human Development Research Centre (HDRC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Healthy male in the general population

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy fertile male
No intervention for this study.
Healthy infertile male
No intervention for this study.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3-6 months
Comparison of the expression profiles
Time Frame: 3-6 months
Comparison of the expression profiles between the two groups (infertile vs fertile)
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Human Development and Potential (IHDP), Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 28, 2023

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 28, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

PDPA law in Singapore

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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