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Clinical Trials/NCT06147700
NCT06147700
Completed
Not Applicable

Identifying Molecular Determinants of Infertility in Men (MODIFY)

Institute for Human Development and Potential (IHDP), Singapore1 site in 1 country100 target enrollmentOctober 11, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Male Infertility
Sponsor
Institute for Human Development and Potential (IHDP), Singapore
Enrollment
100
Locations
1
Primary Endpoint
Semen/Sperm quantity analysis
Status
Completed
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 11, 2023
End Date
June 30, 2024
Last Updated
10 months ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Institute for Human Development and Potential (IHDP), Singapore
Responsible Party
Principal Investigator
Principal Investigator

Candida Vaz

Principal Investigator, Senior research scientist

Institute for Human Development and Potential (IHDP), Singapore

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Semen/Sperm quantity analysis

Time Frame: 1 week

sperm count and concentration

Fertility classification

Time Frame: 1 week

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

Semen/Sperm quality analysis

Time Frame: 1 week

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

Sperm RNA extraction and sequencing

Time Frame: 3 months

Sperm RNA extraction and sequencing

Secondary Outcomes

  • Expression profiling of sncRNA(3-6 months)
  • Comparison of the expression profiles(3-6 months)

Study Sites (1)

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