Identifying Molecular Determinants of Infertility in Men (MODIFY)

Recruiting

• Conditions: Male Infertility

• Registration Number: NCT06147700
• Lead Sponsor: Institute for Human Development and Potential (IHDP), Singapore

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.

Study Timeline

• Study First Submitted: 2023-09-25
• Study Start: 2023-10-11
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-21
• Last Update Submitted: 2023-11-21
• Study First Posted: 2023-11-28
• Last Update Posted: 2023-11-28
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comparison of the expression profiles	3-6 months	Comparison of the expression profiles between the two groups (infertile vs fertile)
Expression profiling of sncRNA	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.

Trial Locations

Locations (1)

Human Development Research Centre (HDRC); 🇸🇬 Singapore, Singapore